Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Use of cannabis is common in patients with multiple sclerosis (MS), especially for the treatment of MS-related spasticity, new research suggests. Findings from a survey conducted through a large registry in 2020 showed that 31% of patients with MS reported trying cannabis to treat their symptoms – and 20% reported regular use.

Spasticity was reported by 80% as the reason why they used cannabis, while pain was cited as the reason by 69% and sleep problems/insomnia was cited by 61%.

Investigators noted that the new data reflect the latest patterns of use amid sweeping changes in recreational and medical marijuana laws.

“Interest in the use of cannabis for managing MS symptoms continues to increase as more data become available and access becomes easier,” co-investigator Amber Salter, PhD, associate professor, UT Southwestern Medical Center, Dallas, told attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
 

Administration routes vary

The survey was conducted through the longitudinal North American Research Committee on Multiple Sclerosis (NARCOMS) Registry, a voluntary, self-report registry for patients with MS. Of 6,934 registry participants invited to participate, 3,249 (47%) responded. The majority of responders were women (79%) and the mean age was 61 years. About 63% were being treated with disease-modifying therapies.

Overall, 31% of respondents reported having used cannabis to treat their MS symptoms. In addition, 20% reported regular current cannabis use, with an average use of 20 days in the past month. As many as 40% of the current users reported using cannabis daily.

“In general we saw some small differences in current users, who tended to include more males; have higher spasticity, pain, and sleep symptoms; and [were] more likely to be unemployed and younger,” Dr. Salter said.

The most common forms of cannabis administration were smoking (33%) and eating (20%). In addition, 12% reported vaporizing cannabis with a highly concentrated material, 11% administered cannabis sublingually, and 11% reported swallowing it.

Further, 8% reported vaporizing cannabis as a dried flower, 5% used it topically, and 1% reported drinking it.

Of note, the definition of “cannabis/marijuana” in the study excluded hemp cannabidiol (CBD) or products marketed as CBD only.
 

Consistent use

The most common reason for use by far was spasticity (80%). This was followed by for pain (69%) and sleep/insomnia problems (61%). Among users, 37% reported doing so to treat all three of those problems.

Regarding other symptoms, 36% used cannabis for anxiety, 24% for depression, 18% for overactive bladder, 17% for nausea or gastrointestinal problems, 16% for migraine or headaches, 14% for tremors, and 6% for other purposes.

The vast majority (95%) reported cannabis to be very or somewhat helpful for their symptoms.

Among the 69% of respondents who reported not using cannabis for their MS symptoms, the most commonly cited reasons were a lack of evidence on efficacy (40%) or safety (27%), concerns of legality (25%), lack of insurance coverage (22%), prohibitive cost (18%), and adverse side effects.

Surprisingly, the dramatic shift in the legalization of cannabis use in many states does not appear to be reflected in changes in cannabis use for MS, Dr. Salter said.

“We conducted an anonymous NARCOMS survey a couple of years prior to this survey, and our results are generally consistent. There’s been a small increase in the use and an acceptance or willingness to consider cannabis, but it’s relatively consistent,” she said.

“Despite the changes in access, the landscape hasn’t really changed very much in terms of evidence of the effects on MS symptoms, so that could be why,” Dr. Salter added.

Most patients appear to feel comfortable discussing their cannabis use with their physician, with 75% reporting doing so. However, the most common primary source of medical guidance for treating MS with cannabis was “nobody/self”; for 20%, the source for medical guidance was a dispensary professional.

As many as 62% of respondents reported obtaining their cannabis products from dispensaries, while other sources included family/friend (18%) or an acquaintance (13%). About 31% reported their most preferred type of cannabis to be equal parts THC and cannabidiol, while 30% preferred high THC/low cannabidiol (30%).
 

Mirrors clinical practice findings

Commenting on the study, Laura T. Safar, MD, vice chair of Psychiatry at Lahey Hospital and Medical Center and assistant professor of psychiatry at Harvard Medical School, Boston, said the findings generally fall in line with cannabis use among patients with MS in her practice.

“This is [consistent] with my general experience: A high percentage of my patients with MS are using cannabis with the goal of addressing their MS symptoms that way,” said Dr. Safar, who was not involved with the research.

One notable recent change in patients’ inquiries about cannabis is their apparent confidence in the information they’re getting, she noted. This is a sign of the ever-expanding sources of information – but from sources who may or may not have an understanding of effects in MS, she added.

“What seems new is a certain level of specificity in the information patients state – regardless of its accuracy. There is more technical information widely available about cannabis online and in the dispensaries,” said Dr. Safar.

“A lot of that information may not have been tested scientifically, but it is presented with an aura of truth,” she said.

While misconceptions about cannabis use in MS may not be new, “the conviction with which they are stated and believed seems stronger,” even though they have been validated by questionably expert sources, Dr. Safar noted.

She pointed out that psychiatric effects are among her patients’ notable concerns of cannabis use in MS.

“Cannabis use, especially daily use in moderate to large amounts, can have negative cognitive side effects,” she said. “In addition, it can have other psychiatric side effects: worsening of mood and anxiety, apathy, and anhedonia, a lack of pleasure or enjoyment, and a flattening of the emotional experience.”
 

Countering misinformation

Dr. Safar said she works to counter misinformation and provide more reliable, evidence-based recommendations.

“I educate my patients about what we know from scientific trials about the potential benefits, including possible help with pain, excluding central pain, and with spasticity,” she said. Dr. Safar added that she also discusses possible risks, such as worsening of cognition, mood, and anxiety.

On the basis of an individual’s presentation, and working in collaboration with their neurologist as appropriate, Dr. Safar said she discusses the following issues with the patient:

• Does cannabis make sense for the symptoms being presented?
• Has the patient received benefit so far?
• Are there side effects they may be experiencing?
• Would it be appropriate to lower the cannabis dose/frequency of its use?
• If a patient is using cannabis with an objective that is not backed up by the literature, such as depression, are they open to information about other treatment options?

The study was sponsored by GW Research. Dr. Salter has conducted research for GW Pharmaceuticals companies. Dr. Safar has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians.

Courtesy of Dr. Ghattas

Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD.

Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr. Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus.

“Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Dr. Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year.

Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas.
 

Targeted lung denervation

The targeted lung denervation system under study (dNerva^®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr. Ghattas said.

The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added.

In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr. Ghattas.

In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts.

Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration.

There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts.

Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Further data are available from AIRFLOW-2, a randomized, sham-controlled trial enrolling patients with symptomatic COPD.

In that study, targeted lung denervation plus optimal drug treatment led to fewer respiratory adverse events of interest, including hospitalizations for COPD exacerbation, according to a report on the study that appears in The American Journal of Respiratory and Critical Care Medicine.

Respiratory adverse events occurred in 32% of treated patients versus 71% of sham-treated patients in a predefined 3- to 6.5-month postprocedure window, the report says.

Currently underway is AIRFLOW-3, a randomized study of targeted lung denervation versus sham procedure in patients with COPD. The study has a primary outcome measure of moderate or severe COPD exacerbations over 12 months and is slated to enroll 480 patients.

To be eligible for AIRFLOW-3, patients must have had at least two moderate or one severe COPD exacerbation in the previous year, Dr. Ghattas said.
 

Metered cryospray

One novel intervention with the potential to benefit patients with chronic bronchitis is metered cryospray (RejuvenAir), which works by delivering liquid nitrogen to the tracheobronchial airways, according to Dr. Ghattas.

This targeted delivery ablates abnormal epithelium, facilitating the regeneration of healthy mucosa, according to investigators in a recently published single-arm prospective trial.

Metered cryospray was safe, feasible, and linked to clinically meaningful improvements in patient-reported outcomes among patients with COPD, according to authors of the study, which appears in the European Respiratory Journal.

In the study, 34 of 35 participants received three treatments 4-6 weeks apart.

Investigators reported that at 3 months there were significant reductions in the COPD Assessment Test that were durable to 6 months, and changes in the St. George’s Respiratory Questionnaire and the Leicester Cough Questionnaire that were durable to 9 months.

There were 14 serious adverse events, none of which were device- or procedure related, according to investigators.

An ongoing randomized study called SPRAY-CB is comparing metered cryospray to sham procedure in an anticipated 210 patients with COPD with chronic bronchitis.
 

Bronchial rheoplasty

Bronchial rheoplasty (RheOx, Gala Therapeutics), is another promising intervention under investigation for the treatment of chronic bronchitis, according to Dr. Ghattas.

This system delivers nonthermal pulsed electrical energy, Dr. Ghattas said, with the intention of ablating goblet cells in the airways.

“The preclinical studies have demonstrated epithelial ablation, followed by regeneration of normalized epithelium,” he said in his presentation.

In 12-month results of multicenter clinical trial, bronchial rheoplasty was technically feasible and safe, with reductions in goblet cell hyperplasia and changes in patient-reported quality of life seen following the procedure, investigators reported in The American Journal of Respiratory and Critical Care Medicine.

The mean goblet cell hyperplasia score was reduced by 39% from baseline to treatment, according to study results. Four procedure-related serious adverse events were observed through 6 months, and there were no procedure- or device-related serious adverse events over the next 6 months. Mild hemoptysis occurred in 47% of patients, investigators reported.

A larger randomized, double-blind prospective trial with a sham control arm is underway and will include 270 patients, according to Dr. Ghattas. “We’re going to have to wait for the results,” he said.

Dr. Ghattas reported serving as a site principal investigator for clinical trials involving the bronchoscopic interventions he discussed, including AIRFLOW-3 (evaluating the targeted lung denervation system), SPRAY-CB (metered cryospray), and RheSolve (bronchial rheoplasty).

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has endorsed a two-dose regimen of Pfizer’s lower-dose mRNA vaccine for children ages 5 through 11 years-old – meaning the shots are now available for immediate use.

The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.

“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.

President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.

The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.

“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.

“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.

Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.

“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.

She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.

“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.

The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.

To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.

The CDC also addressed the question of kids who are close to age 12 when they get their first dose.

In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.

For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.

COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.

In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.

Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.

Weighing benefits and risks

In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.

These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.

No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.

Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.

Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.

Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.

Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.

Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.

The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.

What about benefits?

Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.

The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.

For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.

CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.

The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.

CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.

This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.

An updated consensus guideline on routine clinical use of magnetic resonance imaging in multiple sclerosis (MS) has been released collaboratively by three international expert groups.

The guideline represents a collaboration between the Consortium of Multiple Sclerosis Centers, the European-based Magnetic Resonance Imaging in Multiple Sclerosis, and North American Imaging in Multiple Sclerosis.

Among its recommendations for improving diagnosis and management of MS is the establishment of much-needed ways to boost protocol adherence. “The key part of these recommendations that we want to emphasize is how important it is for them to be used,” said David Li, MD, University of British Columbia, Vancouver, and cochair of the MRI guideline committee.

Dr. Li noted that there was a widespread lack of adherence among MRI centers to compliance with the 2018 CMSC guidelines in imaging for MS. This potentially compromised clinicians’ ability to identify lesions that allow for earlier and confident diagnoses and to monitor for disease changes that may necessitate the initiation or change of therapy, he said.

“The key to being able to know that brain changes have occurred in patients over time is to have scans that have been performed using standardized protocols – to be certain that the change is truly the result of a change in disease activity and progression and not erroneously due to differences resulting from different MRI scanning procedures,” he said to attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

The guideline was also published this summer as a position paper in Lancet Neurology.

Key recommendations

The new guideline covers a broad range of imaging topics, with key areas of focus including the use of three-dimensional imaging, when and when not to use gadolinium contrast, and spinal cord imaging.

For example, a 3 Tesla magnet strength is preferred when imaging the brain with MRI because of its increased sensitivity for detecting lesions – but a minimum magnet strength of at least 1.5 T can also be used. For the spinal cord, there is no advantage of 3 T over 1.5 T, the guideline notes.

Other recommendations include:

• Core sequences for the brain should include sagittal and axial T2-weighted 3D fluid-attenuated inversion recovery (FLAIR), along with axial T2-weighted and diffusion-weighted sequences.
• 3D acquisition, which is now available on most scanners, is preferable to 2D acquisitions.
• Use of the subcallosal plane for consistent and reproducible alignment of axial scans is again emphasized, as it allows for easier and more confident comparison of follow-up studies to detect changes over time.
• At least two of three sagittal sequences are recommended for spinal cord MRI.
• The judicious use of macrocyclic gadolinium-based contrast agents (GBCA) is reemphasized because of its invaluable role in specific circumstances.
• However, for routine follow-up monitoring for subclinical disease activity, high-quality nonenhanced scans will allow for identification of new or enlarging T2 lesions without the need for GBCA.
• A new baseline brain MRI scan without gadolinium is recommended at least 3 months after treatment initiation, with annual follow-up scans without gadolinium.

For the diagnosis of MS, imaging of the entire spinal cord, as opposed to only the cervical segments, is recommended for the detection of lesions in the lower thoracic spinal segments and conus. However, 1.5-T scans are acceptable in that imaging, as 3-T scans provide no advantage. For routine follow-up monitoring, spinal cord MRI is optional.

“The current guidelines do not recommend routine follow-up spinal cord MRI, as it remains technically challenging and would disproportionately increase the scanning time, however experienced centers have the option to do so as a small number of asymptomatic spinal cord lesions do develop on follow-up,” the authors noted.

“However, follow up spinal cord MRI is recommended in special circumstances, including unexpected disease worsening and the possibility of a diagnosis other than multiple sclerosis,” they added.

Although the central vein sign has gained significant interest as a potential biomarker of inflammatory demyelination to help distinguish between MS and non-MS lesions, the 2021 protocol does not currently recommend imaging for the feature. However, those recommendations may change in future guidelines, the authors noted.

Low protocol adherence

The ongoing lack of adherence to guidelines that has resulted in frustrating inconsistencies in imaging was documented in no less than four studies presented at the meeting. They showed compliance with standard protocols to be strikingly poor.

Among the studies was one presented by Anthony Traboulsee, MD, professor and research chair of the MS Society of Canada, and from the University of British Columbia in Vancouver. Findings showed that only about half of scans acquired in a real-world dataset satisfied 2018 CMSC Standardized Brain MRI recommendations.

“Of note was that all the scans that were compliant were acquired in 3D while none of the 2D-acquired sequences were adherent,” Dr. Li commented.

Another study assessed use of standardized MRI protocols in a pragmatic, multisite MS clinical trial, the Traditional vs. Early Aggressive Therapy in Multiple Sclerosis (TREAT-MS) trial. Results showed that, upon enrollment, only 10% of scans followed CMSC guidelines for all three structural contrasts.

In that study, when the images provided by Johns Hopkins University Medical School were excluded, that figure dropped to 2.75% of remaining scans that met the criteria.

“Despite the importance of standardization of high-quality MRIs for the monitoring of people with MS, adoption of recommended imaging remains low,” the investigators wrote.

Resistance to change?

Commenting on the research and new guideline, Blake E. Dewey, PhD student, department of electrical and computer engineering at Johns Hopkins University, Baltimore, speculated that the noncompliance is often simply a matter of resistance to change.

“There are a number of reasons that are given for the retention of older, noncompliant MRI scans at different institutions, such as timing and patient throughput; but in my mind the issue is institutional inertia,” he said.

“It is difficult in many instances to get the clinician [radiologist] and institutional buy-in to make these kinds of changes across the board,” Mr. Dewey noted.

“The most common protocol that we see acquired is a set of 2D, low-resolution images with gaps between slices. These are simply not sufficient given modern MRI technology and the needs of MS clinicians,” he added.

Importantly, Mr. Dewey noted that, through direct communication with imaging staff and practitioners in the trial, compliance increased substantially – nearly 20-fold, “indicating a real possibility for outreach, including to commonly used outpatient radiology facilities.”

The updated MAGNIMS-CMSC-NAIMS MRI protocol is beneficial in providing “simple, reasonable guidelines that can be easily acquired at almost any imaging location in the U.S., and much of the rest of the world,” he said.

“As imaging researchers, we often reach for more that is needed clinically to properly diagnose and monitor a patient’s disease,” Mr. Dewey added. “This updated protocol has ‘trimmed the fat’ and left some discretion to institutions, which should help with compliance.”

Mr. Dewey said he also encourages imaging professionals to consider performing the sequences described as “optional” as well.

“Some of these are useful in measuring potential biomarkers currently under extensive validation, such as brain volumetrics and the central vein sign, that may help patient populations that are currently underserved by more traditional imaging, such as progressive patients and patients that could be potentially misdiagnosed,” he said.

Spreading the word

In the meantime, as part of its own outreach efforts, the CMSC is providing laminated cards that detail in simplified tables the 2021 updated MRI protocol. This makes it easy for centers to access the information and patients to help improve awareness of the protocol.

“We are urging clinicians to provide the cards to their MS patients and have them present the cards to their imaging center,” Dr. Li said. “This effort could make such an important difference in helping to encourage more to follow the protocol.”

Clinicians and patients alike can download the MRI protocol card from the CMSC website.

A version of this article first appeared on Medscape.com.

An updated consensus guideline on routine clinical use of magnetic resonance imaging in multiple sclerosis (MS) has been released collaboratively by three international expert groups.

The guideline represents a collaboration between the Consortium of Multiple Sclerosis Centers, the European-based Magnetic Resonance Imaging in Multiple Sclerosis, and North American Imaging in Multiple Sclerosis.

Among its recommendations for improving diagnosis and management of MS is the establishment of much-needed ways to boost protocol adherence. “The key part of these recommendations that we want to emphasize is how important it is for them to be used,” said David Li, MD, University of British Columbia, Vancouver, and cochair of the MRI guideline committee.

Dr. Li noted that there was a widespread lack of adherence among MRI centers to compliance with the 2018 CMSC guidelines in imaging for MS. This potentially compromised clinicians’ ability to identify lesions that allow for earlier and confident diagnoses and to monitor for disease changes that may necessitate the initiation or change of therapy, he said.

“The key to being able to know that brain changes have occurred in patients over time is to have scans that have been performed using standardized protocols – to be certain that the change is truly the result of a change in disease activity and progression and not erroneously due to differences resulting from different MRI scanning procedures,” he said to attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

The guideline was also published this summer as a position paper in Lancet Neurology.

Key recommendations

The new guideline covers a broad range of imaging topics, with key areas of focus including the use of three-dimensional imaging, when and when not to use gadolinium contrast, and spinal cord imaging.

For example, a 3 Tesla magnet strength is preferred when imaging the brain with MRI because of its increased sensitivity for detecting lesions – but a minimum magnet strength of at least 1.5 T can also be used. For the spinal cord, there is no advantage of 3 T over 1.5 T, the guideline notes.

Other recommendations include:

• Core sequences for the brain should include sagittal and axial T2-weighted 3D fluid-attenuated inversion recovery (FLAIR), along with axial T2-weighted and diffusion-weighted sequences.
• 3D acquisition, which is now available on most scanners, is preferable to 2D acquisitions.
• Use of the subcallosal plane for consistent and reproducible alignment of axial scans is again emphasized, as it allows for easier and more confident comparison of follow-up studies to detect changes over time.
• At least two of three sagittal sequences are recommended for spinal cord MRI.
• The judicious use of macrocyclic gadolinium-based contrast agents (GBCA) is reemphasized because of its invaluable role in specific circumstances.
• However, for routine follow-up monitoring for subclinical disease activity, high-quality nonenhanced scans will allow for identification of new or enlarging T2 lesions without the need for GBCA.
• A new baseline brain MRI scan without gadolinium is recommended at least 3 months after treatment initiation, with annual follow-up scans without gadolinium.

For the diagnosis of MS, imaging of the entire spinal cord, as opposed to only the cervical segments, is recommended for the detection of lesions in the lower thoracic spinal segments and conus. However, 1.5-T scans are acceptable in that imaging, as 3-T scans provide no advantage. For routine follow-up monitoring, spinal cord MRI is optional.

“The current guidelines do not recommend routine follow-up spinal cord MRI, as it remains technically challenging and would disproportionately increase the scanning time, however experienced centers have the option to do so as a small number of asymptomatic spinal cord lesions do develop on follow-up,” the authors noted.

“However, follow up spinal cord MRI is recommended in special circumstances, including unexpected disease worsening and the possibility of a diagnosis other than multiple sclerosis,” they added.

Although the central vein sign has gained significant interest as a potential biomarker of inflammatory demyelination to help distinguish between MS and non-MS lesions, the 2021 protocol does not currently recommend imaging for the feature. However, those recommendations may change in future guidelines, the authors noted.

Low protocol adherence

The ongoing lack of adherence to guidelines that has resulted in frustrating inconsistencies in imaging was documented in no less than four studies presented at the meeting. They showed compliance with standard protocols to be strikingly poor.

Among the studies was one presented by Anthony Traboulsee, MD, professor and research chair of the MS Society of Canada, and from the University of British Columbia in Vancouver. Findings showed that only about half of scans acquired in a real-world dataset satisfied 2018 CMSC Standardized Brain MRI recommendations.

“Of note was that all the scans that were compliant were acquired in 3D while none of the 2D-acquired sequences were adherent,” Dr. Li commented.

Another study assessed use of standardized MRI protocols in a pragmatic, multisite MS clinical trial, the Traditional vs. Early Aggressive Therapy in Multiple Sclerosis (TREAT-MS) trial. Results showed that, upon enrollment, only 10% of scans followed CMSC guidelines for all three structural contrasts.

In that study, when the images provided by Johns Hopkins University Medical School were excluded, that figure dropped to 2.75% of remaining scans that met the criteria.

“Despite the importance of standardization of high-quality MRIs for the monitoring of people with MS, adoption of recommended imaging remains low,” the investigators wrote.

Resistance to change?

Commenting on the research and new guideline, Blake E. Dewey, PhD student, department of electrical and computer engineering at Johns Hopkins University, Baltimore, speculated that the noncompliance is often simply a matter of resistance to change.

“There are a number of reasons that are given for the retention of older, noncompliant MRI scans at different institutions, such as timing and patient throughput; but in my mind the issue is institutional inertia,” he said.

“It is difficult in many instances to get the clinician [radiologist] and institutional buy-in to make these kinds of changes across the board,” Mr. Dewey noted.

“The most common protocol that we see acquired is a set of 2D, low-resolution images with gaps between slices. These are simply not sufficient given modern MRI technology and the needs of MS clinicians,” he added.

Importantly, Mr. Dewey noted that, through direct communication with imaging staff and practitioners in the trial, compliance increased substantially – nearly 20-fold, “indicating a real possibility for outreach, including to commonly used outpatient radiology facilities.”

The updated MAGNIMS-CMSC-NAIMS MRI protocol is beneficial in providing “simple, reasonable guidelines that can be easily acquired at almost any imaging location in the U.S., and much of the rest of the world,” he said.

“As imaging researchers, we often reach for more that is needed clinically to properly diagnose and monitor a patient’s disease,” Mr. Dewey added. “This updated protocol has ‘trimmed the fat’ and left some discretion to institutions, which should help with compliance.”

Mr. Dewey said he also encourages imaging professionals to consider performing the sequences described as “optional” as well.

“Some of these are useful in measuring potential biomarkers currently under extensive validation, such as brain volumetrics and the central vein sign, that may help patient populations that are currently underserved by more traditional imaging, such as progressive patients and patients that could be potentially misdiagnosed,” he said.

Spreading the word

In the meantime, as part of its own outreach efforts, the CMSC is providing laminated cards that detail in simplified tables the 2021 updated MRI protocol. This makes it easy for centers to access the information and patients to help improve awareness of the protocol.

“We are urging clinicians to provide the cards to their MS patients and have them present the cards to their imaging center,” Dr. Li said. “This effort could make such an important difference in helping to encourage more to follow the protocol.”

Clinicians and patients alike can download the MRI protocol card from the CMSC website.

A version of this article first appeared on Medscape.com.

An updated consensus guideline on routine clinical use of magnetic resonance imaging in multiple sclerosis (MS) has been released collaboratively by three international expert groups.

The guideline represents a collaboration between the Consortium of Multiple Sclerosis Centers, the European-based Magnetic Resonance Imaging in Multiple Sclerosis, and North American Imaging in Multiple Sclerosis.

Among its recommendations for improving diagnosis and management of MS is the establishment of much-needed ways to boost protocol adherence. “The key part of these recommendations that we want to emphasize is how important it is for them to be used,” said David Li, MD, University of British Columbia, Vancouver, and cochair of the MRI guideline committee.

Dr. Li noted that there was a widespread lack of adherence among MRI centers to compliance with the 2018 CMSC guidelines in imaging for MS. This potentially compromised clinicians’ ability to identify lesions that allow for earlier and confident diagnoses and to monitor for disease changes that may necessitate the initiation or change of therapy, he said.

“The key to being able to know that brain changes have occurred in patients over time is to have scans that have been performed using standardized protocols – to be certain that the change is truly the result of a change in disease activity and progression and not erroneously due to differences resulting from different MRI scanning procedures,” he said to attendees at the 2021 Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).

The guideline was also published this summer as a position paper in Lancet Neurology.

Key recommendations

The new guideline covers a broad range of imaging topics, with key areas of focus including the use of three-dimensional imaging, when and when not to use gadolinium contrast, and spinal cord imaging.

For example, a 3 Tesla magnet strength is preferred when imaging the brain with MRI because of its increased sensitivity for detecting lesions – but a minimum magnet strength of at least 1.5 T can also be used. For the spinal cord, there is no advantage of 3 T over 1.5 T, the guideline notes.

Other recommendations include:

• Core sequences for the brain should include sagittal and axial T2-weighted 3D fluid-attenuated inversion recovery (FLAIR), along with axial T2-weighted and diffusion-weighted sequences.
• 3D acquisition, which is now available on most scanners, is preferable to 2D acquisitions.
• Use of the subcallosal plane for consistent and reproducible alignment of axial scans is again emphasized, as it allows for easier and more confident comparison of follow-up studies to detect changes over time.
• At least two of three sagittal sequences are recommended for spinal cord MRI.
• The judicious use of macrocyclic gadolinium-based contrast agents (GBCA) is reemphasized because of its invaluable role in specific circumstances.
• However, for routine follow-up monitoring for subclinical disease activity, high-quality nonenhanced scans will allow for identification of new or enlarging T2 lesions without the need for GBCA.
• A new baseline brain MRI scan without gadolinium is recommended at least 3 months after treatment initiation, with annual follow-up scans without gadolinium.

For the diagnosis of MS, imaging of the entire spinal cord, as opposed to only the cervical segments, is recommended for the detection of lesions in the lower thoracic spinal segments and conus. However, 1.5-T scans are acceptable in that imaging, as 3-T scans provide no advantage. For routine follow-up monitoring, spinal cord MRI is optional.

“The current guidelines do not recommend routine follow-up spinal cord MRI, as it remains technically challenging and would disproportionately increase the scanning time, however experienced centers have the option to do so as a small number of asymptomatic spinal cord lesions do develop on follow-up,” the authors noted.

“However, follow up spinal cord MRI is recommended in special circumstances, including unexpected disease worsening and the possibility of a diagnosis other than multiple sclerosis,” they added.

Although the central vein sign has gained significant interest as a potential biomarker of inflammatory demyelination to help distinguish between MS and non-MS lesions, the 2021 protocol does not currently recommend imaging for the feature. However, those recommendations may change in future guidelines, the authors noted.

Low protocol adherence

The ongoing lack of adherence to guidelines that has resulted in frustrating inconsistencies in imaging was documented in no less than four studies presented at the meeting. They showed compliance with standard protocols to be strikingly poor.

Among the studies was one presented by Anthony Traboulsee, MD, professor and research chair of the MS Society of Canada, and from the University of British Columbia in Vancouver. Findings showed that only about half of scans acquired in a real-world dataset satisfied 2018 CMSC Standardized Brain MRI recommendations.

“Of note was that all the scans that were compliant were acquired in 3D while none of the 2D-acquired sequences were adherent,” Dr. Li commented.

Another study assessed use of standardized MRI protocols in a pragmatic, multisite MS clinical trial, the Traditional vs. Early Aggressive Therapy in Multiple Sclerosis (TREAT-MS) trial. Results showed that, upon enrollment, only 10% of scans followed CMSC guidelines for all three structural contrasts.

In that study, when the images provided by Johns Hopkins University Medical School were excluded, that figure dropped to 2.75% of remaining scans that met the criteria.

“Despite the importance of standardization of high-quality MRIs for the monitoring of people with MS, adoption of recommended imaging remains low,” the investigators wrote.

Resistance to change?

Commenting on the research and new guideline, Blake E. Dewey, PhD student, department of electrical and computer engineering at Johns Hopkins University, Baltimore, speculated that the noncompliance is often simply a matter of resistance to change.

“There are a number of reasons that are given for the retention of older, noncompliant MRI scans at different institutions, such as timing and patient throughput; but in my mind the issue is institutional inertia,” he said.

“It is difficult in many instances to get the clinician [radiologist] and institutional buy-in to make these kinds of changes across the board,” Mr. Dewey noted.

“The most common protocol that we see acquired is a set of 2D, low-resolution images with gaps between slices. These are simply not sufficient given modern MRI technology and the needs of MS clinicians,” he added.

Importantly, Mr. Dewey noted that, through direct communication with imaging staff and practitioners in the trial, compliance increased substantially – nearly 20-fold, “indicating a real possibility for outreach, including to commonly used outpatient radiology facilities.”

The updated MAGNIMS-CMSC-NAIMS MRI protocol is beneficial in providing “simple, reasonable guidelines that can be easily acquired at almost any imaging location in the U.S., and much of the rest of the world,” he said.

“As imaging researchers, we often reach for more that is needed clinically to properly diagnose and monitor a patient’s disease,” Mr. Dewey added. “This updated protocol has ‘trimmed the fat’ and left some discretion to institutions, which should help with compliance.”

Mr. Dewey said he also encourages imaging professionals to consider performing the sequences described as “optional” as well.

“Some of these are useful in measuring potential biomarkers currently under extensive validation, such as brain volumetrics and the central vein sign, that may help patient populations that are currently underserved by more traditional imaging, such as progressive patients and patients that could be potentially misdiagnosed,” he said.

Spreading the word

In the meantime, as part of its own outreach efforts, the CMSC is providing laminated cards that detail in simplified tables the 2021 updated MRI protocol. This makes it easy for centers to access the information and patients to help improve awareness of the protocol.

“We are urging clinicians to provide the cards to their MS patients and have them present the cards to their imaging center,” Dr. Li said. “This effort could make such an important difference in helping to encourage more to follow the protocol.”

Clinicians and patients alike can download the MRI protocol card from the CMSC website.

A version of this article first appeared on Medscape.com.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

Datascope/Getinge/Maquet is recalling CardioSave Hybrid and Rescue intra-aortic balloon pumps (IABPs) because some battery packs may have a shortened run time and fail unexpectedly, according to a medical device recall notice posted on the U.S. Food and Drug Administration website.

The FDA has identified this as a class I recall, the most serious type of recall, because of the risk for serious injury or death.

The recalled IABPs have substandard batteries that do not meet performance specifications and were mistakenly released to a limited number of customers.

If a patient requires life-supporting therapy with an IABP and the device does not work or stops working during use because of battery failure, the patient will be at risk for serious injury, including death, the FDA cautions.

Both IABP monitors display battery life and have low battery alarms when alternative power sources are needed.

Datascope/Getting/Maquet has received six complaints but no reports of injury or death related to this issue.

“However, there is a potential for underreporting since the end user reporting a failed battery or short battery run time cannot be aware that they originally received a substandard battery,” the FDA said.

The recall involves 137 battery packs distributed in the United States between Sept. 23, 2017, and Aug. 17, 2021. Product codes and lot numbers are available in the recall notice.  

The company sent an urgent medical device removal letter to customers requesting that they check inventory to determine if there are any CardioSave LiIon battery packs with part number/reference number 0146-00-0097 and with serial numbers listed in the letter.

Customers are asked to replace any affected battery with an unaffected battery and remove the affected product from areas of use.

The company will issue credit or a replacement battery at no cost to the facility upon receipt of the response form attached to the letter.

Distributors who shipped any affected product to customers are asked to forward the device removal letter to customers.

All customers, regardless of whether or not they have defective batteries, are asked to complete and sign the response form to acknowledge that they received the notification and disposed of the affected batteries.

Completed forms can be scanned and emailed to Datascope/Getinge/Maquet at [email protected] or by FAX to 1-877-446-3360.

Customers who have questions about this recall should contact their Datascope/Getinge/Maquet sales representative or, for technical questions, customer service (1-888-943-8872, option 2), Monday through Friday, 8:00 a.m. to 6:00 p.m. ET.

Any adverse events or suspected adverse events related to the recalled CardioSave Hybrid/Rescue IABPs should be reported to the FDA through MedWatch, its adverse event reporting program.

A version of this article first appeared on Medscape.com.

In patients with metastatic urothelial carcinoma, immunotherapy, antibody drug conjugates and targeted agents are being added to the potential treatment options for this incurable condition, which has a limited life expectancy. This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.

“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”

Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.

For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.

While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.

“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”

Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.

For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.

“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.

Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy. 

The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.

“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.

They declared that there are no conflicts of interest.

In patients with metastatic urothelial carcinoma, immunotherapy, antibody drug conjugates and targeted agents are being added to the potential treatment options for this incurable condition, which has a limited life expectancy. This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.

“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”

Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.

For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.

While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.

“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”

Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.

For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.

“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.

Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy. 

The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.

“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.

They declared that there are no conflicts of interest.

In patients with metastatic urothelial carcinoma, immunotherapy, antibody drug conjugates and targeted agents are being added to the potential treatment options for this incurable condition, which has a limited life expectancy. This is according to a review of the recent therapeutic advances and ongoing clinical trials in metastatic urothelial carcinoma.

“Survival in the metastatic setting is 12-15 months with cisplatin-based combination chemotherapy, but only 3-6 months if left untreated,” wrote Srikala S. Sridhar, MD, of the University of Toronto, and colleagues. Their report is in Therapeutic Advances in Medical Oncology. “More recently, with the advent of immunotherapy, antibody-drug conjugates, and targeted agents, the treatment landscape has changed significantly, with overall survival now approaching two years.”

Both the incidence and mortality from bladder cancer have risen over the past few decades. Around 5% of patients are metastatic at presentation, but nearly half of patients with muscle-invasive bladder cancer will eventually relapse and develop metastatic disease.

For first-line treatment in metastatic urothelial carcinoma, cisplatin-based chemotherapy remains the preferred option with response rates up to 72%, but durability is an issue with most patients experiencing disease progression. In patients with locally advanced or metastatic disease, who are not eligible for cisplatin-based chemotherapy and whose tumors express PD-L1, or patients who are not eligible for any platinum-based regimen regardless of PD-L1 status, the immune checkpoint inhibitors atezolizumab and pembrolizumab have received accelerated Food and Drug administration approval. More recently, pembrolizumab gained full FDA approval for use in patients not eligible to receive platinum-based chemotherapy.

While phase 3 studies are evaluating chemotherapy combined with atezolizumab or pembrolizumab, the results have not been promising. Moreover, the decreased survival observed in the immunotherapy-alone arms of these trials led the FDA to issue a warning that single agent immunotherapy should be used only in patients who are not eligible for cisplatin-based therapy and have PD-L1 expression, or in those not eligible for any platinum-based regimens regardless of PD-L1 expression.

“More intensive treatment in metastatic urothelial carcinoma is not always better,” the authors wrote. “Some of the reasons for this could be that chemotherapy and immunotherapy are targeting a similar population of cells, or that chemotherapy and immunotherapy are antagonistic on some level.”

Maintenance strategies are considered standard of care for other advanced solid tumors. In patients with bladder cancer without disease progression after a first line platinum-based chemotherapy, maintenance avelumab, an anti PD-L1, has shown an overall survival of 21.4 months versus 14.3 months with best supportive care, a finding that the authors described as “practice changing.” Meanwhile, a separate trial showed increased progression-free survival with maintenance pembrolizumab, but no increased overall survival.

For second-line treatment, immunotherapy is currently the standard of care in patients with disease progression during or after platinum-based chemotherapy. While the efficiency of five anti PD-1 and PD-L1 antibodies has been reported in the second-line setting, pembrolizumab is the only immune checkpoint inhibitor to receive full FDA approval. Atezolizumab, nivolumab, avelumab, and durvalumab have received accelerated approval.

“In urothelial carcinomas, PD-1 appears to have an advantage over anti PD-L1 in the second-line setting, but in the maintenance setting, it seems to be the opposite,” the authors wrote.

Erdafitinib is the only fibroblast growth factor receptor (FGFR) inhibitor approved for locally advanced or metastatic urothelial carcinoma, progressing on platinum-based chemotherapy. The oral potent tyrosine kinase inhibitor of FGFR 1-4 is approved for use only in patients with susceptible FGFR3 gene mutations or FGFR2/3 gene fusions. Despite being approved for second-line treatment, erdafitinib is used mainly in third-line treatment after progression on immunotherapy. 

The antibody drug conjugates sacituzumab govitecan and enfortumab vedotin, which have gained accelerated FDA approval, provide other options for patients with metastatic urothelial carcinoma resistant to chemotherapy and checkpoint inhibitors. As these antibody drug conjugates have different mechanisms of action and toxicity profiles, they could be used in the same patient throughout the disease course, but further research is needed. Meanwhile, many chemotherapy options, including docetaxel, gemcitabine, ifosfamide, and pemetrexed, have been tested in metastatic urothelial carcinoma with some response after platinum-based treatment.

“A number of studies evaluating promising therapeutic strategies are still ongoing and will hopefully provide information for some important unanswered questions and further guide treatment sequencing in advanced urothelial carcinoma,” the authors wrote.

They declared that there are no conflicts of interest.

Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.

Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.

“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.

However, health use trends by adolescents who identify as LGB have not been well studied, they noted.

In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.

The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.

Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.

Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).

Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).

The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.

Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.

Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.

The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.

The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.

However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
 

Adolescents suffer barriers similar to those of adults

“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.

Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.

Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.

Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.

Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.

Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.

The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.

Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.

“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.

However, health use trends by adolescents who identify as LGB have not been well studied, they noted.

In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.

The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.

Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.

Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).

Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).

The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.

Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.

Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.

The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.

The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.

However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
 

Adolescents suffer barriers similar to those of adults

“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.

Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.

Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.

Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.

Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.

Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.

The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Youth identifying as lesbian, gay, or bisexual were significantly less likely than were their peers to communicate with a physician or utilize health care in the past 12 months, according to data from a cohort study of approximately 4,000 adolescents.

Disparities in physical and mental health outcomes for individuals who identify as lesbian, gay, or bisexual (LGB) persist in the United States, and emerge in adolescents and young adults, wrote Sari L. Reisner, ScD, of Boston Children’s Hospital, and colleagues.

“LGB adult research indicates substantial unmet medical needs, including needed care and preventive care,” for reasons including “reluctance to disclose sexual identity to clinicians, lower health insurance rates, lack of culturally appropriate preventive services, and lack of clinician LGB care competence,” they said.

However, health use trends by adolescents who identify as LGB have not been well studied, they noted.

In a study published in JAMA Network Open, the researchers analyzed data from 4,256 participants in the third wave (10th grade) of adolescents in Healthy Passages, a longitudinal, observational cohort study of diverse public school students in Birmingham, Ala.; Houston; and Los Angeles County. Data were collected in grades 5, 7, and 10.

The study population included 640 youth who identified as LGB, and 3,616 non-LGB youth. Sexual status was based on responses to questions in the grade 10 youth survey. Health care use was based on the responses to questions about routine care, such as a regular checkup, and other care, such as a sick visit. Data on delayed care were collected from parents and youth. At baseline, the average age of the study participants in fifth grade was 11 years, 48.9% were female, 44.5% were Hispanic or Latino, and 28.9% were Black.

Overall, more LGB youth reported not receiving needed medical care when they thought they needed it within the past 12 months compared with non-LGB youth (42.4% of LGB vs. 30.2% of non-LGB youth; adjusted odds ratio 1.68). The most common conditions for which LGB youth did not seek care were sexually transmitted infections, contraception, and substance use.

Overall, the main reason given for not seeking medical care was that they thought the problem would go away (approximately 26% for LGB and non-LGB). Approximately twice as many LGB youth as non-LGB youth said they avoided medical care because they did not want their parents to know (14.5% vs. 9.4%).

Significantly more LGB youth than non-LGB youth reported difficulty communicating with their physicians in the past 12 months (15.3% vs. 9.4%; aOR 1.71). The main reasons for not communicating with a clinician about a topic of concern were that the adolescent did not want parents to know (40.7% of LGB and 30.2% of non-LGB) and that they were too embarrassed to talk about the topic (37.5% of LGB and 25.9% of non-LGB).

The researchers were not surprised that “LGB youth self-reported greater difficulty communicating with a clinician about topics they wanted to discuss,” but they found no significant differences in reasons for communication difficulty based on sexual orientation.

Approximately two-thirds (65.8%) of LGB youth reported feeling “a little or not at all comfortable” talking to a health care clinician about their sexual attractions, compared with approximately one-third (37.8%) of non-LGB youth.

Only 12.5% of the LGB youth said that their clinicians knew their sexual orientation, the researchers noted. However, clinicians need to know youths’ sexual orientation to provide appropriate and comprehensive care, they said, especially in light of the known negative health consequences of LGB internalized stigma, as well as the pertinence of certain sexual behaviors to preventive care and screening.

The study findings were limited by several factors including the cross-sectional design and inability to show causality, and by the incongruence of different dimensions of sexual orientation, the researchers noted. Other limitations included the use only of English and Spanish language, and a lack of complete information on disclosure of sexual orientation to parents, the researchers noted.

The results were strengthened by the diverse demographics, although they may not be generalizable to a wider population, they added.

However, the data show that responsive health care is needed to reduce disparities for LGB youth, they emphasized. “Care should be sensitive and respectful to sexual orientation for all youth, with clinicians taking time to ask adolescents about their sexual identity, attractions, and behaviors, particularly in sexual and reproductive health,” they concluded.
 

Adolescents suffer barriers similar to those of adults

“We know that significant health disparities exist for LGBTQ adults and adolescents,” Kelly Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview. “LGBTQ adults often have had poor experiences during health care encounters – ranging from poor interactions with inadequately trained clinicians to frank discrimination,” she said. “These experiences can prevent individuals from seeking health care in the future or disclosing important information during a medical visit, both of which can contribute to worsened health outcomes,” she emphasized.

Prior to this study, data to confirm similar patterns of decreased health care utilization in LGB youth were limited, Dr. Curran said. “Identifying and understanding barriers to health care for LGBTQ youth are essential to help address the disparities in this population,” she said.

Dr. Curran said she was not surprised by the study findings for adolescents, which reflect patterns seen in LGBTQ adults.

Overcoming barriers to encourage LGB youth to seek regular medical care involves “training health care professionals about LGBTQ health, teaching the skill of taking a nonjudgmental, inclusive history, and making health care facilities welcoming and inclusive, such as displaying a pride flag in clinic, and using forms asking for pronouns,” Dr. Curran said.

Dr. Curran said she thinks the trends in decreased health care use are similar for transgender youth. “I suspect, if anything, that transgender youth will have even further decreased health care utilization when compared to cisgender heterosexual peers and LGB peers,” she noted.

Going forward, it will be important to understand the reasons behind decreased health care use among LGB youth, such as poor experiences, discrimination, or fears about confidentiality, said Dr. Curran. “Additionally, it would be important to understand if this decreased health utilization also occurs with transgender youth,” she said.

The Healthy Passages Study was funded by the Centers for Disease Control and Prevention. One of the study coauthors disclosed funding from the Agency for Healthcare Research and Quality as part of the Harvard-wide Pediatric Health Services Research Fellowship Program. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

Suzanne L. Kilmer, MD, will never forget the day when the center of her vision became blurry after performing cutaneous laser surgery.

The laser light reflected off the patient’s protective eye shield and caused a photo-induced foveal injury to Dr. Kilmer’s eye even though she was wearing protective goggles. “It was like the central part of my vision was browned out,” Dr. Kilmer, director of the Laser and Skin Surgery Center of Northern California, Sacramento, recalled during a virtual course on laser and aesthetic skin therapy. “My injury completely resolved, but you may not get so lucky. You can really get into trouble with longer pulse widths and higher-energy lasers.”

The injury occurred, she said, because the goggles she wore were sufficient for 1,064-nm wavelengths, but she was treating the patient with a 532 nm–wavelength laser. “I did not have the protection I needed,” she said. “You have to make sure to check the glasses yourself before you treat so that what happened to me doesn’t happen to you.”

Dr. Kilmer, who is also a clinical professor of dermatology at the University of California, Davis, said that during cutaneous laser surgery, “we want to pay attention all the time to minimize our risk.” She also recommended to make sure “all personnel in the room have had good safety training and have baseline eye exams. The door needs to be closed. The windows need to be covered, and you need a warning sign on the door that contains the specific wavelength, pulse width, and energy being used.”

The most important element of the sign, she added, pertains to the wavelength, because that determines the most appropriate goggles or eyewear to use “to ensure that you have an optical density high enough to protect your eyes.”

She advised using only eyewear designed for the specific laser wavelength being used, and to check the optical density prior to firing the laser. “You want the optical density to be greater than 4-6; you want as much protection as possible,” Dr. Kilmer said. “If you’re using a 1,064-nm laser and a 532-nm laser, you want glasses that protect you from both of those wavelengths. Multi- and dual-wavelength glasses are now available. The newer eyewear also allows you to see much better so there’s less risk with you taking it off the goggles [during the procedure].”

Dr. Kilmer recommends keeping a set of goggles outside of the procedure room door that matches every set of goggles being used in the room. “In one room, you may have several different lasers,” she said. “So you want some way to ‘attach’ the goggles to that particular laser, whether it’s a tray or some type of a coding system – some way to keep those together.”

For eye shield protection, the David-Baker lid clamp and the Jaeger plate are appropriate for ablative laser resurfacing, but most dermatologists use individual steel eye shields that are placed externally or internally. “Make sure you have different-sized eye shields on hand,” she advised during the meeting, which was named What’s the Truth? and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine.

“Depending on what you’re performing, you will need anywhere from neonate size to larger adult size. Some adults may require child-size shields,” she said, noting that there are external eye shields that can be cleaned after each use. “But we tend to use LASER-Aid disposable eye shields, which have metal in the middle and stick over the eyelid. You only use these when you’re working outside of the orbital rim. If you’re treating within the orbital rim, you have to use an internal eye shield.”

She reported having no relevant financial disclosures related to her presentation.

[email protected]

In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.

Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.

The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.

“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”

It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.

HM in rural communities

Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.¹ Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.

A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.

Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.

“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.

SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.

COVID reaches rural America

Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.

“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.²

Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.

In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.

Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.³

Community connections and proactive staffing

Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.

A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.

“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.

Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”

Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.

For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.

“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”

There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.

Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.

But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.

“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”

Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”

How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.

Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”

Critical medicine

Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.

“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.

Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”

Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.

Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.

But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”

Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”

For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at [email protected].
 

References

1. Personal communication from Peiyin Hung, June 2021.

2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.

3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.

In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.

Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.

The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.

“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”

It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.

HM in rural communities

Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.¹ Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.

A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.

Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.

“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.

SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.

COVID reaches rural America

Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.

“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.²

Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.

In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.

Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.³

Community connections and proactive staffing

Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.

A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.

“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.

Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”

Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.

For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.

“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”

There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.

Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.

But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.

“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”

Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”

How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.

Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”

Critical medicine

Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.

“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.

Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”

Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.

Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.

But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”

Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”

For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at [email protected].
 

References

1. Personal communication from Peiyin Hung, June 2021.

2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.

3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.

In 2018, Atashi Mandal, MD, a hospitalist residing in Orange County, Calif., was recruited along with several other doctors to fill hospitalist positions in rural Bishop, Calif. She has since driven 600 miles round trip every month for a week of hospital medicine shifts at Northern Inyo Hospital.

Dr. Mandal said she has really enjoyed her time at the small rural hospital and found it professionally fulfilling to participate so fully in the health of its local community. She was building personal bonds and calling the experience the pinnacle of her career when the COVID-19 pandemic swept across America and the world, even reaching up into Bishop, population 3,760, in the isolated Owens Valley.

The 25-bed hospital has seen at least 100 COVID patients in the past year and some months. Responsibility for taking care of these patients has been both humbling and gratifying, Dr. Mandal said. The facility’s hospitalists made a commitment to keep working through the pandemic. “We were able to come together (around COVID) as a team and our teamwork really made a difference,” she said.

“One of the advantages in a smaller hospital is you can have greater cohesiveness and your communication can be tighter. That played a big role in how we were able to accomplish so much with fewer resources as a rural hospital.” But staffing shortages, recruitment, and retention remain a perennial challenge for rural hospitals. “And COVID only exacerbated the problems,” she said. “I’ve had my challenges trying to make proper treatment plans without access to specialists.”

It was also difficult to witness so many patients severely ill or dying from COVID, Dr. Mandal said, especially since patients were not allowed family visitors – even though that was for a good reason, to minimize the virus’s spread.

HM in rural communities

Hospital medicine continues to extend into rural communities and small rural hospitals. In 2018, 35.7% of all rural counties in America had hospitals staffed with hospitalists, and 63.3% of rural hospitals had hospitalist programs (compared with 79.2% of urban hospitals). These numbers come from Medicare resources files from the Department of Health & Human Services, analyzed by Peiyin Hung, PhD, assistant professor of health services management and policy at the University of South Carolina, Columbia.¹ Hospitalist penetration rates rose steadily from 2011 to 2017, with a slight dip in 2018, Dr. Hung said in an interview.

A total of 138 rural hospitals have closed since 2010, according to the Cecil G. Sheps Center for Health Services Research in Chapel Hill, N.C. Nineteen rural hospitals closed in 2020 alone, although many of those were caused by factors predating the pandemic. Only one has closed so far in 2021. But financial pressures, including low patient volumes and loss of revenue from canceled routine services like elective surgeries during the pandemic, have added to hospitals’ difficulties. Pandemic relief funding may have helped some hospitals stay open, but that support eventually will go away.

Experts emphasize the diversity of rural America and its health care systems. Rural economies are volatile and more diverse than is often appreciated. The hospital may be a cornerstone of the local economy; when one closes, it can devastate the community. Workforce is one of the chief components of a hospital’s ability to meet its strategic vision, and hospitalists are a big part in that. But while hospitalists are valued and appreciated, if the hospital is suffering severe financial problems, that will impact its doctors’ jobs and livelihoods.

“Bandwidth” varies widely for rural hospitalists and their hospitalist groups, said Ken Simone, DO, SFHM, executive chair of SHM’s Rural Special Interest Group and founder and principal of KGS Consultants, a Hospital Medicine and Primary Care Practice Management Consulting company. They may face scarce resources, scarce clinical staffing, lack of support staff to help operations run smoothly, lack of access to specialists locally, and lack of technology. While practicing in a rural setting presents various challenges, it can be rewarding for those clinicians who embrace its autonomy and broad scope of services, Dr. Simone said.

SHM’s Rural SIG focuses on the unique needs of rural hospitalists, providing them with an opportunity to share their concerns, challenges and solutions through roundtable discussions every other month and a special interest forum held in conjunction with the SHM Converge annual conference, Dr. Simone said. (The next SHM Converge will be April 7-10, 2022, in Nashville, Tenn.) The Rural SIG also collaborates with other hospital medicine SIGs and committees and is working on a white paper, “Key Principles and Characteristics of an Effective Rural Hospital Medicine Group.” It is also looking to develop a rural mentorship exchange program.

COVID reaches rural America

Early COVID caseloads tended to be in urban areas, but subsequent surges of infections have spread to many rural areas. Some rural settings became epicenters for the pandemic in November and December 2020. More recent troubling rises in COVID cases, particularly in areas with lower vaccination rates – suggest that the challenges of the pandemic are still not behind us.

“By no means is the crisis done in rural America,” said Alan Morgan, CEO of the National Rural Health Association, in a Virtual Rural Health Journalism workshop on rural health care sponsored by the Association of Health Care Journalists.²

Mr. Morgan’s colleague, Brock Slabach, NRHA’s chief operations officer, said in an interview that, while 453 of the 1,800 hospitals in rural areas fit NRHA’s criteria as being vulnerable to closure, the rest are not, and are fulfilling their missions for their communities. Hospitalists are becoming more common in these hospitals, he said, and rural hospitalists can be an important asset in attracting primary care physicians – who might not appreciate being perpetually on call for their hospitalized patients – to rural communities.

In many cases, traveling doctors like Dr. Mandal or telemedicine backup, particularly for after-hours coverage or ICU beds, are important pieces of the puzzle for smaller hospitals. There are different ways to use the spectrum of telemedicine services to interact with a hospital’s daytime and night routines. In some isolated locations, nurse practitioners or physician assistants provide on-the-ground coverage with virtual backup. Rural hospitals often affiliate with telemedicine networks within health systems – or else contract with independent specialized providers of telemedicine consultation.

Mr. Slabach said another alternative for staffing hospitals with smaller ED and inpatient volumes is to have one doctor on duty who can cover both departments simultaneously. Meanwhile, the new federal Rural Emergency Hospital Program proposes to allow rural hospitals to become essentially freestanding EDs – starting Jan. 1, 2023 – that can manage patients for a maximum of 24 hours.³

Community connections and proactive staffing

Lisa Kaufmann, MD, works as a hospitalist for a two-hospital system in North Carolina, Appalachian Regional Health Care. She practices at Watauga Medical Center, with 100 licensed beds in Boone, and at Cannon Memorial Hospital, a critical access hospital in unincorporated Linville. “We are proud of what we have been able to accomplish during the pandemic,” she said.

A former critical care unit at Watauga had been shut down, but its wiring remained intact. “We turned it into a COVID unit in three days. Then we opened another COVID unit with 18 beds, but that still wasn’t enough. We converted half of our med/surg capacity into a COVID unit. At one point almost half of all of our acute beds were for COVID patients. We made plans for what we would do if it got worse, since we had almost run out of beds,” she said. Demand peaked at the end of January 2021.

“The biggest barrier for us was if someone needed to be transferred, for example, if they needed ECMO [extracorporeal membrane oxygenation], and we couldn’t find another hospital to provide that technology.” In ARHC’s mountainous region – known as the “High Country” – weather can also make it difficult to transport patients. “Sometimes the ambulance can’t make it off the mountain, and half of the time the medical helicopter can’t fly. So we have to be prepared to keep people who we might think ought to be transferred,” she said.

Like many rural communities, the High Country is tightly knit, and its hospitals are really connected to their communities, Dr. Kaufmann said. The health system already had a lot of community connections beyond acute care, and that meant the pandemic wasn’t experienced as severely as it was in some other rural communities. “But without hospitalists in our hospitals, it would have been much more difficult.”

Proactive supply fulfillment meant that her hospitals never ran out of personal protective equipment. “Staffing was a challenge, but we were proactive in getting traveling doctors to come here. We also utilized extra doctors from the local community,” she said. Another key was well-established disaster planning, with regular drills, and a robust incident command structure, which just needed to be activated in the crisis. “Small hospitals need to be prepared for disaster,” Dr. Kaufmann said.

For Dale Wiersma, MD, a hospitalist with Spectrum Health, a 14-hospital system in western Michigan, telemedicine services are coordinated across 8 rural regional hospitals. “We don’t tend to use it for direct hospitalist work during daytime hours, unless a facility is swamped, in which case we can cross-cover. We do more telemedicine at night. But during daytime hours we have access to stroke neurology, cardiology, psychiatry, critical care and infectious disease specialists who are able to offer virtual consults,” Dr. Wiersma said. A virtual critical care team of doctor and nurse is often the only intensivist service covering Spectrum’s rural hospitals.

“In our system, the pandemic accelerated the adoption of telemedicine,” Dr. Wiersma said. “We had been working on the tele-ICU program, trying to get it rolled out. When the pandemic hit, we launched it in just 6 weeks.”

There have been several COVID surges in Michigan, he said. “We were stretched pretty close to our limit several times, but never to the breaking point. For our physicians, it was the protracted nature of the pandemic that was fatiguing for everyone involved. Our system worked hard to staff up as well as it could, to make sure our people didn’t go over the edge.” It was also hard for hospitals that typically might see one or two deaths in a month to suddenly have five in a week.

Another Spectrum hospitalist, Christopher Skinner, MD, works at two rural Michigan hospitals 15 minutes apart in Big Rapids and Reed City. “I prefer working in rural areas. I’ve never had an ambition to be a top dog. I like the style of practice where you don’t have all of the medical subspecialties on site. It frees you up to use all your skills,” Dr. Skinner said.

But that approach was put to the test by the pandemic, since it was harder to transfer those patients who normally would not have stayed at these rural hospitals. “We had to make do,” he said, although virtual backup and second opinions from Spectrum’s virtual critical care team helped.

“It was a great collaboration, which helped us to handle critical care cases that we hadn’t had to manage pre-COVID. We’ve gotten used to it, with the backup, so I expect we’ll still be taking care of these kind of sick ventilator patients even after the pandemic ends,” Dr. Skinner said. “We’ve gotten pretty good at it.”

Sukhbir Pannu, MD, a hospitalist in Denver and CEO and founder of Rural Physicians Group, said the pandemic was highly impactful, operationally and logistically, for his firm, which contracts with 54 hospitals to provide their hospitalist staffing. “There was no preparation. Everything had to be done on the fly. Initially, it was felt that rural areas weren’t at as great a risk for COVID, but that proved not to be true. Many experienced a sudden increase in very sick patients. We set up a task force to manage daily census in all of our contracted facilities.”

How did Rural Physicians Group manage through the crisis? “The short answer is telemedicine,” he said. “We had physicians on the ground in these hospitals. But we needed intensivists at the other end of the line to support them.” A lot of conversations about telemedicine were already going on in the company, but the pandemic provided the impetus to launch its network, which has grown to include rheumatologists, pulmonologists, cardiologists, infection medicine, neurology, and psychiatry, all reachable through a central command structure.

Telemedicine is not a cure-all, Dr. Pannu said. It doesn’t work in a vacuum. It requires both a provider on the ground and specialists available remotely. “But it can be a massive multiplier.”

Critical medicine

Other hospitals, including small and rural ones, have reported taking on the challenge of covering critical care with nonintensivist physicians because the pandemic demanded it. David Aymond, MD, a hospitalist at 60-bed Byrd Regional Hospital in Leesville, La., population 6,612, has advocated for years for expanded training and credentialing opportunities in intensive care medicine beyond the traditional path of becoming a board-certified intensivist. Some rural hospitalists were already experienced in providing critical care for ICU patients even before the pandemic hit.

“What COVID did was to highlight the problem that there aren’t enough intensivists in this country, particular for smaller hospitals,” Dr. Aymond said. Some hospitalists who stepped into crisis roles in ICUs during COVID surges showed that they could take care of COVID patients very well.

Dr. Aymond, who is a fellowship-trained hospitalist with primary training in family medicine, has used his ICU experience in both fellowship and practice to make a thorough study of critical care medicine, which he put to good use when the seven-bed ICU at Byrd Memorial filled with COVID patients. “Early on, we were managing multiple ventilators throughout the hospital,” he said. “But we were having good outcomes. Our COVID patients were surviving.” That led to Dr. Aymond being interviewed by local news media, which led to other patients across the state asking to be transferred to “the COVID specialist who practices at Byrd.”

Dr. Aymond would like to see opportunities for abbreviated 1-year critical care fellowships for hospitalists who have amassed enough ICU experience in practice or in residency, and to make room for family medicine physicians in such programs. He is also working through SHM with the Society of Critical Care Medicine to generate educational ICU content. SHM now has a critical care lecture series at: www.hospitalmedicine.org/clinical-topics/critical-care/.

Dr. Mandal, who also works as a pediatric hospitalist, said that experience gave her more familiarity with using noninvasive methods for delivering respiratory therapies like high-flow oxygen. “When I saw a COVID patient who had hypoxia but was still able to talk, I didn’t hesitate to deliver oxygen through noninvasive means.” Eventually hospital practice generally for COVID caught up with this approach.

But she ran into personal difficulties because N95 face masks didn’t fit her face. Instead, she had to wear a portable respirator, which made it hard to hear what her patients were saying. “I formulated a lot of workarounds, such as interviewing the patient over the phone before going into the room for the physical exam.”

Throughout the pandemic, she never wavered in her commitment to rural hospital medicine and its opportunities for working in a small and wonderful community, where she could practice at the top of her license, with a degree of autonomy not granted in other settings. For doctors who want that kind of practice, she said, “the rewards will be paid back in spades. That’s been my experience.”

For more information on SHM’s Rural SIG and its supports for rural hospitalists, contact its executive chair, Kenneth Simone, DO, at [email protected].
 

References

1. Personal communication from Peiyin Hung, June 2021.

2. Association of Health Care Journalists. Rural Health Journalism Workshop 2021. June 21, 2021. https://healthjournalism.org/calendar-details.php?id=2369.

3. Congress Establishes New Medicare Provider Category and Reimbursement for Rural Emergency Hospitals. National Law Review. Jan. 5, 2021. https://www.natlawreview.com/article/congress-establishes-new-medicare-provider-category-and-reimbursement-rural.

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults.¹ Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage.^2-5 The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage (SRH) in a single diverticulum (TIC), which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot.^2-4 Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques. However, as subsequently discussed, this SRH is documented in only 26% of definitive diverticular bleeds found on urgent colonoscopy, so diagnostic yields of these techniques will be low.^2-5

The diagnosis of patients with severe hematochezia and diverticulosis, as well as triage of all of them to specific medical, endoscopic, radiologic, or surgical management, is facilitated by an urgent endoscopic approach.^2-5 Patients who are diagnosed with definitive diverticular hemorrhage on colonoscopy represent about 30% of all true TIC bleeds when urgent colonoscopy is the management approach.^2-5 That is because approximately 50% of all patients with colon diverticulosis and first presentation of severe hematochezia have incidental diverticulosis; they have colonic diverticulosis, but another site of bleeding is identified as the cause of hemorrhage in the gastrointestinal tract.^2-4 Presumptive diverticular hemorrhage is diagnosed when colonic diverticulosis without TIC stigmata are found but no other GI bleeding source is found on colonoscopy, anoscopy, enteroscopy, or capsule endoscopy.^2-5 In our experience with urgent colonoscopy, the presumptive diverticular bleed group accounts for about 70% of patients with documented diverticular hemorrhage (e.g., not including incidental diverticulosis bleeds but combining subgroups of patients with either definitive or presumptive TIC diagnoses as documented TIC hemorrhage).

Clinical presentation

Patients with diverticular hemorrhage present with severe, painless large volume hematochezia. Hematochezia may be self-limited and spontaneously resolve in 75%-80% of all patients but with high rebleeding rates up to 40%.^5-7 Of all patients with diverticulosis, only about 3%-5% develop diverticular hemorrhage.⁸ Risk factors for diverticular hemorrhage include medications (e.g., nonsteroidal anti-inflammatory drugs – NSAIDs, antiplatelet drugs, and anticoagulants) and other clinical factors, such as older age, low-fiber diet, and chronic constipation.^9,10 On urgent colonoscopy, more than 70% of diverticulosis in U.S. patients are located anatomically in the descending colon or more distally. In contrast, about 60% of definitive diverticular hemorrhage cases in our experience had diverticula with stigmata identified at or proximal to the splenic flexure.^2,4,11

Pathophysiology

Colonic diverticula are herniations of mucosa and submucosa with colonic arteries that penetrate the muscular wall. Bleeding can occur when there is asymmetric rupture of the vasa recta at either the base of the diverticulum or the neck.⁴ Thinning of the mucosa on the luminal surface (such as that resulting from impacted fecaliths and stool) can cause injury to the site of the penetrating vessels, resulting in hemorrhage.¹²

Initial management

Patients with acute, severe hematochezia should be triaged to an inpatient setting with a monitored bed. Admission to an intensive care unit should be considered for patients with hemodynamic instability, persistent bleeding, and/or significant comorbidities. Patients with TIC hemorrhage often require resuscitation with crystalloids and packed red blood cell transfusions for hemoglobin less than 8 g/dl.⁴ Unlike upper GI hemorrhage, which has been extensively reported on, data regarding a more restrictive transfusion threshold, compared with a liberal transfusion threshold, in lower intestinal bleeding are very limited. Correction of underlying coagulopathies is recommended but should be individualized, particularly in those patients on antithrombotic agents or with underlying bleeding disorders.

Urgent diagnosis and hemostasis

Urgent colonoscopy within 24 hours is the most accurate way to make a diagnosis of definitive diverticular hemorrhage and to effectively and safely treat them.^2-4,10,11 For patients with severe hematochezia, when the colonoscopy is either not available in a medical center or does not reveal the source of bleeding, nuclear scintigraphy or angiography (CT, MRI, or interventional radiology [IR]) are recommended. CT angiography may be particularly helpful to diagnose patients with hemodynamic instability who are suspected to have active TIC bleeding and are not able to complete a bowel preparation. However, these imaging techniques require active bleeding at the time of the study to be diagnostic. This SRH is also uncommon for definitive diverticular hemorrhage, so the diagnostic yield is usually quite low.^2-5,10,11 An additional limitation of scintigraphy and CT or MRI angiography is that, if active bleeding is found, some other type of treatment, such as colonoscopy, IR angiography, or surgery, will be required for definitive hemostasis.

For urgent colonoscopy, adequate colon preparation with a large volume preparation (6-8 liters of polyethylene glycol-based solution) is recommended to clear stool, blood, and clots to allow endoscopic visualization and localization of the bleeding source. Use of a nasogastric tube should be considered if the patient is unable to drink enough prep.^2-4,13 Additionally, administration of a prokinetic agent, such as Metoclopramide, may improve gastric emptying and tolerance of the prep. During colonoscopy, careful inspection of the colonic mucosa during insertion and withdrawal is important since lesions may bleed intermittently and SRH can be missed. An adult or pediatric colonoscope with a large working channel (at least 3.3 mm) is recommended to facilitate suctioning of blood clots and stool, as well as allow the passage of endoscopic hemostasis accessories. Targeted water-jet irrigation, an expert colonoscopist, a cap attachment, and adequate colon preparation are all predictors for improved diagnosis of definitive diverticular hemorrhage.^4,14

SRH in definitive TIC bleeds all have a high risk of TIC rebleeding,^2-4,10,11 including active bleeding, nonbleeding visible vessel, adherent clot, and a flat spot (See Figure).

Courtesy Dr. Vivy T. Cusumano, Dr. Christopher L. Paiji, and Dr. Dennis M. Jensen

Based on CURE Hemostasis Group data of 118 definitive TIC bleeds, 26% had active bleeding, 24% had a nonbleeding visible vessel, 37% had an adherent clot, and 13% had a flat spot (with underlying arterial blood flow by Doppler probe monitoring).⁴ Approximately 50% of the SRH were found in the neck of the TIC and 50% at the base, with actively bleeding cases more often from the base. In CURE Doppler endoscopic probe studies, 90% of all stigmata had an underlying arterial blood flow detected with the Doppler probe.^4,10 The Doppler probe is reported to be very useful for risk stratification and to confirm obliteration of the arterial blood flow underlying SRH for definitive hemostasis.^4,10
 

Endoscopic treatment

Given high rates of rebleeding with medical management alone, definitive TIC hemorrhage can be effectively and safely treated with endoscopic therapies once SRH are localized.^4,10 Endoscopic therapies that have been reported in the literature include electrocoagulation, hemoclip, band ligation, and over-the-scope clip. Four-quadrant injection of 1:20,000 epinephrine around the SRH can improve visualization of SRH and provide temporary control of bleeding, but it should be combined with other modalities because of risk of rebleeding with epinephrine alone.¹⁵ Results from studies reporting rates of both early rebleeding (occurring within 30 days) and late rebleeding (occurring after 30 days) are listed in the Table.

Multipolar electrocoagulation (MPEC), which utilizes a focal electric current to generate heat, can coaptively coagulate small TIC arteries.¹⁶ For SRH in the neck of TIC, MPEC is effective for coaptive coagulation at a power of 12-15 watts in 1-2 second pulses with moderate laterally applied tamponade pressure. MPEC should be avoided for treating SRH at the TIC base because of lack of muscularis propria and higher risk of perforation.

Hemoclip therapy has been reported to be safe and efficacious in treatment of definitive TIC hemorrhage, by causing mechanical hemostasis with occlusion of the bleeding artery.¹⁶ Hemoclips are recommended to treat stigmata in the base of TICs and should be targeted on either side of visible vessel in order to occlude the artery underneath it.^4,10 With a cap on the tip of the colonoscope, suctioning can evert TICs, allowing more precise placement of hemoclip on SRH in the base of the TIC.¹⁷ Hemoclip retention rates vary with different models and can range from less than 7 days to more than 4 weeks. Hemoclips can also mark the site if early rebleeding occurs; then, reintervention (e.g., repeat endoscopy or angioembolization) is facilitated.

Another treatment is endoscopic band ligation, which provides mechanical hemostasis. Endoscopic band ligation has been reported to be efficacious for TIC hemorrhage.¹⁸ Suctioning the TIC with the SRH into the distal cap and deploying a band leads to obliteration of vessels and potentially necrosis and disappearance of banded TIC.¹⁶ This technique carries a risk of perforation because of the thin walls of TICs. This risk may be higher for right-sided colon lesions since an exvivo colon specimen study reported serosal entrapment and inclusion of muscularis propria postband ligation, both of which may result in ischemia of intestinal wall and delayed perforation.¹⁹

Over-the-scope clip (OTSC) has been reported in case series for treatment of definitive TIC hemorrhage. With a distal cap and large clip, suctioning can evert TICs and facilitate deployment over the SRH.20,21 OTSC can grasp an entire TIC with the SRH and obliterate the arterial blood flow with a single clip.^20,21 No complications have been reported yet for treatment of TIC hemorrhage. However, the OTSC system is relatively expensive when compared with other modalities.

After endoscopic treatment is performed, four-quadrant spot tattooing is recommended adjacent to the TIC with the SRH. This step will facilitate localization and treatment in the case of TIC rebleeding.^4,10

Outcomes following endoscopic treatment

Following endoscopic treatment, patients should be monitored for early and late rebleeding. In a pooled analysis of case series composed of 847 patients with TIC bleeding, among the 137 patients in which endoscopic hemostasis was initially achieved, early rebleeding occurred in 8% and late rebleeding occurred in 12% of patients.²² Risk factors for TIC rebleeding within 30 days were residual arterial blood flow following hemostasis and early reinitiation of antiplatelet agents.

Remote treatment of TIC hemorrhage distant from the SRH is a significant risk factor for early TIC rebleeding.4, 10 For example, using hemoclips to close the mouth of a TIC when active bleeding or an SRH is located in the TIC base often fails because arterial flow remains open in the base and the artery is larger there.^4,10 This example highlights the importance of focal obliteration of arterial blood flow underlying SRH in order to achieve definitive hemostasis.^4,10

Salvage treatments

For TIC hemorrhage that is not controlled by endoscopic therapy, transcatheter arterial embolization (TAE) is recommended. If bleeding rate is high enough (at least 0.5 milliliters per minute) to be detected by angiography, TAE can serve as an effective method of diagnosis and immediate hemostasis.²³ However, the most common major complication of embolization is intestinal ischemia. The incidence of intestinal ischemia has been reported as high as 10%, with highest risk with embolization of at least three vasa recta.²⁴

Surgery is also recommended if TIC hemorrhage cannot be controlled with endoscopic therapy or TAE. Segmental colectomy is recommended if the bleeding site can be localized before surgery with colonoscopy or angiography resulting from significantly lower perioperative morbidity than subtotal colectomy.²⁵ However, subtotal colectomy may be necessary if preoperative localization of bleeding is unsuccessful.

There are very few reports of short- or long-term results that compare endoscopy, TAE, and surgery for management of TIC bleeding. However, a recent retrospective study reported better outcomes with endoscopic treatment of definitive TIC bleeding.²⁶ Patients who underwent endoscopic treatment had fewer RBC transfusions, shorter hospitalizations, and lower rates of postprocedure complications.
 

Management after cessation of hemorrhage

Medical management is important following an episode of TIC hemorrhage. A mainstay is daily fiber supplementation every morning and stool softener in the evening. Furthermore, patients are advised to drink an extra liter of fluids (not containing alcohol or caffeine) daily. By reducing colon transit time and increasing stool weight, these measures can help control constipation and prevent future complications of TIC disease.²⁷

Patients with recurrent TIC hemorrhage should undergo evaluation for elective surgery, provided they are appropriate surgical candidates. If preoperative localization of bleeding site is successful, segmental colectomy is preferred. Segmental resection is associated with significantly decreased rebleeding rate, with lower rates of morbidity compared with subtotal colectomy.³²

Chronic NSAIDs, aspirin, and antiplatelet drugs are risk factors for recurrent TIC hemorrhage, and avoiding these medications is recommended if possible.^33,34 Although anticoagulants have shown to be associated with increased risk of all-cause gastrointestinal bleeding, these agents have not been shown to increase risk of recurrent TIC hemorrhage in recent large retrospective studies. Since antiplatelet and anticoagulation agents serve to reduce risk of thromboembolic events, the clinician who recommended these medications should be consulted after a TIC bleed to re-evaluate whether these medications can be discontinued or reduced in dose.
 

Conclusion

The most effective way to diagnose and treat definitive TIC hemorrhage is to perform an urgent colonoscopy within 24 hours to identify and treat TIC SRH. This procedure requires thoroughly cleansing the colon first, as well as an experienced colonoscopist who can identify and treat TIC SRH to obliterate arterial blood flow underneath SRH and achieve definitive TIC hemostasis. Other approaches to early diagnosis include nuclear medicine scintigraphy or angiography (CT, MRI, or IR). However, these techniques can only detect active bleeding which is documented in only 26% of colonoscopically diagnosed definitive TIC hemorrhages. So, the expected diagnostic yield of these tests will be low. When urgent colonoscopy fails to make a diagnosis or TIC bleeding continues, TAE and/or surgery are recommended. After definitive hemostasis of TIC hemorrhage and for long term management, control of constipation and discontinuation of chronic NSAIDs and antiplatelet drugs (if possible) are recommended to prevent recurrent TIC hemorrhage.

Dr. Cusumano and Dr. Paiji are fellow physicians in the Vatche and Tamar Manoukian Division of Digestive Diseases at University of California Los Angeles. Dr. Jensen is a professor of medicine in Vatche and Tamar Manoukian Division of Digestive Diseases and is with the CURE Digestive Diseases Research Center at the VA Greater Los Angeles Healthcare System, Calif. All authors declare that they have no competing interests or disclosures.

References

1. Longstreth GF. Am J Gastroenterol. 1997;92(3):419-24.

2. Jensen DM et al. The New England Journal of Medicine. 2000;342(2):78-82.

3. Jensen DM et al. Techniques in Gastrointestinal Endoscopy. 2001;3(4):192-8.

4. Jensen DM. Am J Gastroenterol. 2018;113(11):1570-3.

5. Zuckerman GR et al. Gastrointestinal Endoscopy. 1999;49(2):228-38.

6. Stollman N et al. Lancet. 2004;363(9409):631-9.

7. McGuire HH et al. Ann Surg. 1994;220(5):653-6.

8. McGuire HH et al. Ann Surg. 1972;175(6):847-55.

9. Strate LL et al. Clinical gastroenterology and hepatol. 2008;6(9):1004-10.

10. Jensen DM et al. Gastrointestinal endoscopy. 2016;83(2):416-23.

11. Jensen DM et al. Gastrointest Endosc Clin N Am. 1997;7(3):477-98.

12. Maykel JA et al. Clin Colon Rectal Surg. 2004;17(3):195-204.

13. Green BT et al. Am J Gastroenterol. 2005;100(11):2395-402.

14. Niikura R et al. Journal of Clinical Gastroenterol. 2015;49(3):e24-30.

15. Bloomfeld RS et al. Am J Gastroenterol. 2001;96(8):2367-72.

16. Parsi MA,et al. VideoGIE. 2019;4(7):285-99.

17. Kaltenbach T et al. Clinical Gastroenterology and Hepatol. 2012;10(2):131-7.

18. Nakano K et al. Endosc Int Open. 2015;3(5):E529-33.

19. Barker KB et al. Gastrointestinal Endoscopy. 2005;62(2):224-7.

20. Kaltenbach T et al. Gastrointest Endosc Clin N Am. 2020;30(1):13-23.

21. Yamazaki K et al. VideoGIE. 2020;5(6):252-4.

22. Strate LL et al. Clinical Gastroenterology and Hepatol. 2010;8(4):333-43.

23. Evangelista et al. J Vasc Interv Radiol. 2000;11(5):601-6.

24. Kodani M et al. J Vasc Interv Radiol. 2016;27(6):824-30.

25. Mohammed et al. Clin Colon Rectal Surg. 2018;31(4):243-50.

26. Wongpongsalee T et al. Gastrointestinal Endoscopy. 2020;91(6):AB471-2.

27. Böhm SK. Viszeralmedizin. 2015;31(2):84-94.

28. Prakash C et al. Endoscopy. 1999;31(6):460-3.

29. Yen EF et al. Digestive Diseases and Sciences. 2008;53(9):2480-5.

30. Ishii N et al. Gastrointestinal Endoscopy. 2012;75(2):382-7.

31. Nagata N et al. Gastrointestinal Endoscopy. 2018;88(5):841-53.e4.

32. Parkes BM et al. Am Surg. 1993;59(10):676-8.

33. Vajravelu RK et al. Gastroenterology. 2018;155(5):1416-27.

34. Oakland K et al. Clin Gastroenterol Hepatol. 2019;17(7):1276-84.e3.

35. Yamada A et al. Dis Colon Rectum. 2008;51(1):116-20.

36. Coleman CI et al. Int J Clin Pract. 2012;66(1):53-63.

37. Holster IL et al. Gastroenterology. 2013;145(1):105-12.e15.

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults.¹ Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage.^2-5 The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage (SRH) in a single diverticulum (TIC), which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot.^2-4 Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques. However, as subsequently discussed, this SRH is documented in only 26% of definitive diverticular bleeds found on urgent colonoscopy, so diagnostic yields of these techniques will be low.^2-5

The diagnosis of patients with severe hematochezia and diverticulosis, as well as triage of all of them to specific medical, endoscopic, radiologic, or surgical management, is facilitated by an urgent endoscopic approach.^2-5 Patients who are diagnosed with definitive diverticular hemorrhage on colonoscopy represent about 30% of all true TIC bleeds when urgent colonoscopy is the management approach.^2-5 That is because approximately 50% of all patients with colon diverticulosis and first presentation of severe hematochezia have incidental diverticulosis; they have colonic diverticulosis, but another site of bleeding is identified as the cause of hemorrhage in the gastrointestinal tract.^2-4 Presumptive diverticular hemorrhage is diagnosed when colonic diverticulosis without TIC stigmata are found but no other GI bleeding source is found on colonoscopy, anoscopy, enteroscopy, or capsule endoscopy.^2-5 In our experience with urgent colonoscopy, the presumptive diverticular bleed group accounts for about 70% of patients with documented diverticular hemorrhage (e.g., not including incidental diverticulosis bleeds but combining subgroups of patients with either definitive or presumptive TIC diagnoses as documented TIC hemorrhage).

Clinical presentation

Patients with diverticular hemorrhage present with severe, painless large volume hematochezia. Hematochezia may be self-limited and spontaneously resolve in 75%-80% of all patients but with high rebleeding rates up to 40%.^5-7 Of all patients with diverticulosis, only about 3%-5% develop diverticular hemorrhage.⁸ Risk factors for diverticular hemorrhage include medications (e.g., nonsteroidal anti-inflammatory drugs – NSAIDs, antiplatelet drugs, and anticoagulants) and other clinical factors, such as older age, low-fiber diet, and chronic constipation.^9,10 On urgent colonoscopy, more than 70% of diverticulosis in U.S. patients are located anatomically in the descending colon or more distally. In contrast, about 60% of definitive diverticular hemorrhage cases in our experience had diverticula with stigmata identified at or proximal to the splenic flexure.^2,4,11

Pathophysiology

Colonic diverticula are herniations of mucosa and submucosa with colonic arteries that penetrate the muscular wall. Bleeding can occur when there is asymmetric rupture of the vasa recta at either the base of the diverticulum or the neck.⁴ Thinning of the mucosa on the luminal surface (such as that resulting from impacted fecaliths and stool) can cause injury to the site of the penetrating vessels, resulting in hemorrhage.¹²

Initial management

Patients with acute, severe hematochezia should be triaged to an inpatient setting with a monitored bed. Admission to an intensive care unit should be considered for patients with hemodynamic instability, persistent bleeding, and/or significant comorbidities. Patients with TIC hemorrhage often require resuscitation with crystalloids and packed red blood cell transfusions for hemoglobin less than 8 g/dl.⁴ Unlike upper GI hemorrhage, which has been extensively reported on, data regarding a more restrictive transfusion threshold, compared with a liberal transfusion threshold, in lower intestinal bleeding are very limited. Correction of underlying coagulopathies is recommended but should be individualized, particularly in those patients on antithrombotic agents or with underlying bleeding disorders.

Urgent diagnosis and hemostasis

Urgent colonoscopy within 24 hours is the most accurate way to make a diagnosis of definitive diverticular hemorrhage and to effectively and safely treat them.^2-4,10,11 For patients with severe hematochezia, when the colonoscopy is either not available in a medical center or does not reveal the source of bleeding, nuclear scintigraphy or angiography (CT, MRI, or interventional radiology [IR]) are recommended. CT angiography may be particularly helpful to diagnose patients with hemodynamic instability who are suspected to have active TIC bleeding and are not able to complete a bowel preparation. However, these imaging techniques require active bleeding at the time of the study to be diagnostic. This SRH is also uncommon for definitive diverticular hemorrhage, so the diagnostic yield is usually quite low.^2-5,10,11 An additional limitation of scintigraphy and CT or MRI angiography is that, if active bleeding is found, some other type of treatment, such as colonoscopy, IR angiography, or surgery, will be required for definitive hemostasis.

For urgent colonoscopy, adequate colon preparation with a large volume preparation (6-8 liters of polyethylene glycol-based solution) is recommended to clear stool, blood, and clots to allow endoscopic visualization and localization of the bleeding source. Use of a nasogastric tube should be considered if the patient is unable to drink enough prep.^2-4,13 Additionally, administration of a prokinetic agent, such as Metoclopramide, may improve gastric emptying and tolerance of the prep. During colonoscopy, careful inspection of the colonic mucosa during insertion and withdrawal is important since lesions may bleed intermittently and SRH can be missed. An adult or pediatric colonoscope with a large working channel (at least 3.3 mm) is recommended to facilitate suctioning of blood clots and stool, as well as allow the passage of endoscopic hemostasis accessories. Targeted water-jet irrigation, an expert colonoscopist, a cap attachment, and adequate colon preparation are all predictors for improved diagnosis of definitive diverticular hemorrhage.^4,14

SRH in definitive TIC bleeds all have a high risk of TIC rebleeding,^2-4,10,11 including active bleeding, nonbleeding visible vessel, adherent clot, and a flat spot (See Figure).

Courtesy Dr. Vivy T. Cusumano, Dr. Christopher L. Paiji, and Dr. Dennis M. Jensen

Based on CURE Hemostasis Group data of 118 definitive TIC bleeds, 26% had active bleeding, 24% had a nonbleeding visible vessel, 37% had an adherent clot, and 13% had a flat spot (with underlying arterial blood flow by Doppler probe monitoring).⁴ Approximately 50% of the SRH were found in the neck of the TIC and 50% at the base, with actively bleeding cases more often from the base. In CURE Doppler endoscopic probe studies, 90% of all stigmata had an underlying arterial blood flow detected with the Doppler probe.^4,10 The Doppler probe is reported to be very useful for risk stratification and to confirm obliteration of the arterial blood flow underlying SRH for definitive hemostasis.^4,10
 

Endoscopic treatment

Given high rates of rebleeding with medical management alone, definitive TIC hemorrhage can be effectively and safely treated with endoscopic therapies once SRH are localized.^4,10 Endoscopic therapies that have been reported in the literature include electrocoagulation, hemoclip, band ligation, and over-the-scope clip. Four-quadrant injection of 1:20,000 epinephrine around the SRH can improve visualization of SRH and provide temporary control of bleeding, but it should be combined with other modalities because of risk of rebleeding with epinephrine alone.¹⁵ Results from studies reporting rates of both early rebleeding (occurring within 30 days) and late rebleeding (occurring after 30 days) are listed in the Table.

Multipolar electrocoagulation (MPEC), which utilizes a focal electric current to generate heat, can coaptively coagulate small TIC arteries.¹⁶ For SRH in the neck of TIC, MPEC is effective for coaptive coagulation at a power of 12-15 watts in 1-2 second pulses with moderate laterally applied tamponade pressure. MPEC should be avoided for treating SRH at the TIC base because of lack of muscularis propria and higher risk of perforation.

Hemoclip therapy has been reported to be safe and efficacious in treatment of definitive TIC hemorrhage, by causing mechanical hemostasis with occlusion of the bleeding artery.¹⁶ Hemoclips are recommended to treat stigmata in the base of TICs and should be targeted on either side of visible vessel in order to occlude the artery underneath it.^4,10 With a cap on the tip of the colonoscope, suctioning can evert TICs, allowing more precise placement of hemoclip on SRH in the base of the TIC.¹⁷ Hemoclip retention rates vary with different models and can range from less than 7 days to more than 4 weeks. Hemoclips can also mark the site if early rebleeding occurs; then, reintervention (e.g., repeat endoscopy or angioembolization) is facilitated.

Another treatment is endoscopic band ligation, which provides mechanical hemostasis. Endoscopic band ligation has been reported to be efficacious for TIC hemorrhage.¹⁸ Suctioning the TIC with the SRH into the distal cap and deploying a band leads to obliteration of vessels and potentially necrosis and disappearance of banded TIC.¹⁶ This technique carries a risk of perforation because of the thin walls of TICs. This risk may be higher for right-sided colon lesions since an exvivo colon specimen study reported serosal entrapment and inclusion of muscularis propria postband ligation, both of which may result in ischemia of intestinal wall and delayed perforation.¹⁹

Over-the-scope clip (OTSC) has been reported in case series for treatment of definitive TIC hemorrhage. With a distal cap and large clip, suctioning can evert TICs and facilitate deployment over the SRH.20,21 OTSC can grasp an entire TIC with the SRH and obliterate the arterial blood flow with a single clip.^20,21 No complications have been reported yet for treatment of TIC hemorrhage. However, the OTSC system is relatively expensive when compared with other modalities.

After endoscopic treatment is performed, four-quadrant spot tattooing is recommended adjacent to the TIC with the SRH. This step will facilitate localization and treatment in the case of TIC rebleeding.^4,10

Outcomes following endoscopic treatment

Following endoscopic treatment, patients should be monitored for early and late rebleeding. In a pooled analysis of case series composed of 847 patients with TIC bleeding, among the 137 patients in which endoscopic hemostasis was initially achieved, early rebleeding occurred in 8% and late rebleeding occurred in 12% of patients.²² Risk factors for TIC rebleeding within 30 days were residual arterial blood flow following hemostasis and early reinitiation of antiplatelet agents.

Remote treatment of TIC hemorrhage distant from the SRH is a significant risk factor for early TIC rebleeding.4, 10 For example, using hemoclips to close the mouth of a TIC when active bleeding or an SRH is located in the TIC base often fails because arterial flow remains open in the base and the artery is larger there.^4,10 This example highlights the importance of focal obliteration of arterial blood flow underlying SRH in order to achieve definitive hemostasis.^4,10

Salvage treatments

For TIC hemorrhage that is not controlled by endoscopic therapy, transcatheter arterial embolization (TAE) is recommended. If bleeding rate is high enough (at least 0.5 milliliters per minute) to be detected by angiography, TAE can serve as an effective method of diagnosis and immediate hemostasis.²³ However, the most common major complication of embolization is intestinal ischemia. The incidence of intestinal ischemia has been reported as high as 10%, with highest risk with embolization of at least three vasa recta.²⁴

Surgery is also recommended if TIC hemorrhage cannot be controlled with endoscopic therapy or TAE. Segmental colectomy is recommended if the bleeding site can be localized before surgery with colonoscopy or angiography resulting from significantly lower perioperative morbidity than subtotal colectomy.²⁵ However, subtotal colectomy may be necessary if preoperative localization of bleeding is unsuccessful.

There are very few reports of short- or long-term results that compare endoscopy, TAE, and surgery for management of TIC bleeding. However, a recent retrospective study reported better outcomes with endoscopic treatment of definitive TIC bleeding.²⁶ Patients who underwent endoscopic treatment had fewer RBC transfusions, shorter hospitalizations, and lower rates of postprocedure complications.
 

Management after cessation of hemorrhage

Medical management is important following an episode of TIC hemorrhage. A mainstay is daily fiber supplementation every morning and stool softener in the evening. Furthermore, patients are advised to drink an extra liter of fluids (not containing alcohol or caffeine) daily. By reducing colon transit time and increasing stool weight, these measures can help control constipation and prevent future complications of TIC disease.²⁷

Patients with recurrent TIC hemorrhage should undergo evaluation for elective surgery, provided they are appropriate surgical candidates. If preoperative localization of bleeding site is successful, segmental colectomy is preferred. Segmental resection is associated with significantly decreased rebleeding rate, with lower rates of morbidity compared with subtotal colectomy.³²

Chronic NSAIDs, aspirin, and antiplatelet drugs are risk factors for recurrent TIC hemorrhage, and avoiding these medications is recommended if possible.^33,34 Although anticoagulants have shown to be associated with increased risk of all-cause gastrointestinal bleeding, these agents have not been shown to increase risk of recurrent TIC hemorrhage in recent large retrospective studies. Since antiplatelet and anticoagulation agents serve to reduce risk of thromboembolic events, the clinician who recommended these medications should be consulted after a TIC bleed to re-evaluate whether these medications can be discontinued or reduced in dose.
 

Conclusion

The most effective way to diagnose and treat definitive TIC hemorrhage is to perform an urgent colonoscopy within 24 hours to identify and treat TIC SRH. This procedure requires thoroughly cleansing the colon first, as well as an experienced colonoscopist who can identify and treat TIC SRH to obliterate arterial blood flow underneath SRH and achieve definitive TIC hemostasis. Other approaches to early diagnosis include nuclear medicine scintigraphy or angiography (CT, MRI, or IR). However, these techniques can only detect active bleeding which is documented in only 26% of colonoscopically diagnosed definitive TIC hemorrhages. So, the expected diagnostic yield of these tests will be low. When urgent colonoscopy fails to make a diagnosis or TIC bleeding continues, TAE and/or surgery are recommended. After definitive hemostasis of TIC hemorrhage and for long term management, control of constipation and discontinuation of chronic NSAIDs and antiplatelet drugs (if possible) are recommended to prevent recurrent TIC hemorrhage.

Dr. Cusumano and Dr. Paiji are fellow physicians in the Vatche and Tamar Manoukian Division of Digestive Diseases at University of California Los Angeles. Dr. Jensen is a professor of medicine in Vatche and Tamar Manoukian Division of Digestive Diseases and is with the CURE Digestive Diseases Research Center at the VA Greater Los Angeles Healthcare System, Calif. All authors declare that they have no competing interests or disclosures.

References

1. Longstreth GF. Am J Gastroenterol. 1997;92(3):419-24.

2. Jensen DM et al. The New England Journal of Medicine. 2000;342(2):78-82.

3. Jensen DM et al. Techniques in Gastrointestinal Endoscopy. 2001;3(4):192-8.

4. Jensen DM. Am J Gastroenterol. 2018;113(11):1570-3.

5. Zuckerman GR et al. Gastrointestinal Endoscopy. 1999;49(2):228-38.

6. Stollman N et al. Lancet. 2004;363(9409):631-9.

7. McGuire HH et al. Ann Surg. 1994;220(5):653-6.

8. McGuire HH et al. Ann Surg. 1972;175(6):847-55.

9. Strate LL et al. Clinical gastroenterology and hepatol. 2008;6(9):1004-10.

10. Jensen DM et al. Gastrointestinal endoscopy. 2016;83(2):416-23.

11. Jensen DM et al. Gastrointest Endosc Clin N Am. 1997;7(3):477-98.

12. Maykel JA et al. Clin Colon Rectal Surg. 2004;17(3):195-204.

13. Green BT et al. Am J Gastroenterol. 2005;100(11):2395-402.

14. Niikura R et al. Journal of Clinical Gastroenterol. 2015;49(3):e24-30.

15. Bloomfeld RS et al. Am J Gastroenterol. 2001;96(8):2367-72.

16. Parsi MA,et al. VideoGIE. 2019;4(7):285-99.

17. Kaltenbach T et al. Clinical Gastroenterology and Hepatol. 2012;10(2):131-7.

18. Nakano K et al. Endosc Int Open. 2015;3(5):E529-33.

19. Barker KB et al. Gastrointestinal Endoscopy. 2005;62(2):224-7.

20. Kaltenbach T et al. Gastrointest Endosc Clin N Am. 2020;30(1):13-23.

21. Yamazaki K et al. VideoGIE. 2020;5(6):252-4.

22. Strate LL et al. Clinical Gastroenterology and Hepatol. 2010;8(4):333-43.

23. Evangelista et al. J Vasc Interv Radiol. 2000;11(5):601-6.

24. Kodani M et al. J Vasc Interv Radiol. 2016;27(6):824-30.

25. Mohammed et al. Clin Colon Rectal Surg. 2018;31(4):243-50.

26. Wongpongsalee T et al. Gastrointestinal Endoscopy. 2020;91(6):AB471-2.

27. Böhm SK. Viszeralmedizin. 2015;31(2):84-94.

28. Prakash C et al. Endoscopy. 1999;31(6):460-3.

29. Yen EF et al. Digestive Diseases and Sciences. 2008;53(9):2480-5.

30. Ishii N et al. Gastrointestinal Endoscopy. 2012;75(2):382-7.

31. Nagata N et al. Gastrointestinal Endoscopy. 2018;88(5):841-53.e4.

32. Parkes BM et al. Am Surg. 1993;59(10):676-8.

33. Vajravelu RK et al. Gastroenterology. 2018;155(5):1416-27.

34. Oakland K et al. Clin Gastroenterol Hepatol. 2019;17(7):1276-84.e3.

35. Yamada A et al. Dis Colon Rectum. 2008;51(1):116-20.

36. Coleman CI et al. Int J Clin Pract. 2012;66(1):53-63.

37. Holster IL et al. Gastroenterology. 2013;145(1):105-12.e15.

Diverticular hemorrhage is the most common cause of colonic bleeding, accounting for 20%-65% of cases of severe lower intestinal bleeding in adults.¹ Urgent colonoscopy after purging the colon of blood, clots, and stool is the most accurate method of diagnosing and guiding treatment of definitive diverticular hemorrhage.^2-5 The diagnosis of definitive diverticular hemorrhage depends upon identification of some stigmata of recent hemorrhage (SRH) in a single diverticulum (TIC), which can include active arterial bleeding, oozing, non-bleeding visible vessel, adherent clot, or flat spot.^2-4 Although other approaches, such as nuclear medicine scans and angiography of various types (CT, MRI, or standard angiography), for the early diagnosis of patients with severe hematochezia are utilized in many medical centers, only active bleeding can be detected by these techniques. However, as subsequently discussed, this SRH is documented in only 26% of definitive diverticular bleeds found on urgent colonoscopy, so diagnostic yields of these techniques will be low.^2-5

The diagnosis of patients with severe hematochezia and diverticulosis, as well as triage of all of them to specific medical, endoscopic, radiologic, or surgical management, is facilitated by an urgent endoscopic approach.^2-5 Patients who are diagnosed with definitive diverticular hemorrhage on colonoscopy represent about 30% of all true TIC bleeds when urgent colonoscopy is the management approach.^2-5 That is because approximately 50% of all patients with colon diverticulosis and first presentation of severe hematochezia have incidental diverticulosis; they have colonic diverticulosis, but another site of bleeding is identified as the cause of hemorrhage in the gastrointestinal tract.^2-4 Presumptive diverticular hemorrhage is diagnosed when colonic diverticulosis without TIC stigmata are found but no other GI bleeding source is found on colonoscopy, anoscopy, enteroscopy, or capsule endoscopy.^2-5 In our experience with urgent colonoscopy, the presumptive diverticular bleed group accounts for about 70% of patients with documented diverticular hemorrhage (e.g., not including incidental diverticulosis bleeds but combining subgroups of patients with either definitive or presumptive TIC diagnoses as documented TIC hemorrhage).

Clinical presentation

Patients with diverticular hemorrhage present with severe, painless large volume hematochezia. Hematochezia may be self-limited and spontaneously resolve in 75%-80% of all patients but with high rebleeding rates up to 40%.^5-7 Of all patients with diverticulosis, only about 3%-5% develop diverticular hemorrhage.⁸ Risk factors for diverticular hemorrhage include medications (e.g., nonsteroidal anti-inflammatory drugs – NSAIDs, antiplatelet drugs, and anticoagulants) and other clinical factors, such as older age, low-fiber diet, and chronic constipation.^9,10 On urgent colonoscopy, more than 70% of diverticulosis in U.S. patients are located anatomically in the descending colon or more distally. In contrast, about 60% of definitive diverticular hemorrhage cases in our experience had diverticula with stigmata identified at or proximal to the splenic flexure.^2,4,11

Pathophysiology

Colonic diverticula are herniations of mucosa and submucosa with colonic arteries that penetrate the muscular wall. Bleeding can occur when there is asymmetric rupture of the vasa recta at either the base of the diverticulum or the neck.⁴ Thinning of the mucosa on the luminal surface (such as that resulting from impacted fecaliths and stool) can cause injury to the site of the penetrating vessels, resulting in hemorrhage.¹²

Initial management

Patients with acute, severe hematochezia should be triaged to an inpatient setting with a monitored bed. Admission to an intensive care unit should be considered for patients with hemodynamic instability, persistent bleeding, and/or significant comorbidities. Patients with TIC hemorrhage often require resuscitation with crystalloids and packed red blood cell transfusions for hemoglobin less than 8 g/dl.⁴ Unlike upper GI hemorrhage, which has been extensively reported on, data regarding a more restrictive transfusion threshold, compared with a liberal transfusion threshold, in lower intestinal bleeding are very limited. Correction of underlying coagulopathies is recommended but should be individualized, particularly in those patients on antithrombotic agents or with underlying bleeding disorders.

Urgent diagnosis and hemostasis

Urgent colonoscopy within 24 hours is the most accurate way to make a diagnosis of definitive diverticular hemorrhage and to effectively and safely treat them.^2-4,10,11 For patients with severe hematochezia, when the colonoscopy is either not available in a medical center or does not reveal the source of bleeding, nuclear scintigraphy or angiography (CT, MRI, or interventional radiology [IR]) are recommended. CT angiography may be particularly helpful to diagnose patients with hemodynamic instability who are suspected to have active TIC bleeding and are not able to complete a bowel preparation. However, these imaging techniques require active bleeding at the time of the study to be diagnostic. This SRH is also uncommon for definitive diverticular hemorrhage, so the diagnostic yield is usually quite low.^2-5,10,11 An additional limitation of scintigraphy and CT or MRI angiography is that, if active bleeding is found, some other type of treatment, such as colonoscopy, IR angiography, or surgery, will be required for definitive hemostasis.

For urgent colonoscopy, adequate colon preparation with a large volume preparation (6-8 liters of polyethylene glycol-based solution) is recommended to clear stool, blood, and clots to allow endoscopic visualization and localization of the bleeding source. Use of a nasogastric tube should be considered if the patient is unable to drink enough prep.^2-4,13 Additionally, administration of a prokinetic agent, such as Metoclopramide, may improve gastric emptying and tolerance of the prep. During colonoscopy, careful inspection of the colonic mucosa during insertion and withdrawal is important since lesions may bleed intermittently and SRH can be missed. An adult or pediatric colonoscope with a large working channel (at least 3.3 mm) is recommended to facilitate suctioning of blood clots and stool, as well as allow the passage of endoscopic hemostasis accessories. Targeted water-jet irrigation, an expert colonoscopist, a cap attachment, and adequate colon preparation are all predictors for improved diagnosis of definitive diverticular hemorrhage.^4,14

SRH in definitive TIC bleeds all have a high risk of TIC rebleeding,^2-4,10,11 including active bleeding, nonbleeding visible vessel, adherent clot, and a flat spot (See Figure).

Courtesy Dr. Vivy T. Cusumano, Dr. Christopher L. Paiji, and Dr. Dennis M. Jensen

Based on CURE Hemostasis Group data of 118 definitive TIC bleeds, 26% had active bleeding, 24% had a nonbleeding visible vessel, 37% had an adherent clot, and 13% had a flat spot (with underlying arterial blood flow by Doppler probe monitoring).⁴ Approximately 50% of the SRH were found in the neck of the TIC and 50% at the base, with actively bleeding cases more often from the base. In CURE Doppler endoscopic probe studies, 90% of all stigmata had an underlying arterial blood flow detected with the Doppler probe.^4,10 The Doppler probe is reported to be very useful for risk stratification and to confirm obliteration of the arterial blood flow underlying SRH for definitive hemostasis.^4,10
 

Endoscopic treatment

Given high rates of rebleeding with medical management alone, definitive TIC hemorrhage can be effectively and safely treated with endoscopic therapies once SRH are localized.^4,10 Endoscopic therapies that have been reported in the literature include electrocoagulation, hemoclip, band ligation, and over-the-scope clip. Four-quadrant injection of 1:20,000 epinephrine around the SRH can improve visualization of SRH and provide temporary control of bleeding, but it should be combined with other modalities because of risk of rebleeding with epinephrine alone.¹⁵ Results from studies reporting rates of both early rebleeding (occurring within 30 days) and late rebleeding (occurring after 30 days) are listed in the Table.

Multipolar electrocoagulation (MPEC), which utilizes a focal electric current to generate heat, can coaptively coagulate small TIC arteries.¹⁶ For SRH in the neck of TIC, MPEC is effective for coaptive coagulation at a power of 12-15 watts in 1-2 second pulses with moderate laterally applied tamponade pressure. MPEC should be avoided for treating SRH at the TIC base because of lack of muscularis propria and higher risk of perforation.

Hemoclip therapy has been reported to be safe and efficacious in treatment of definitive TIC hemorrhage, by causing mechanical hemostasis with occlusion of the bleeding artery.¹⁶ Hemoclips are recommended to treat stigmata in the base of TICs and should be targeted on either side of visible vessel in order to occlude the artery underneath it.^4,10 With a cap on the tip of the colonoscope, suctioning can evert TICs, allowing more precise placement of hemoclip on SRH in the base of the TIC.¹⁷ Hemoclip retention rates vary with different models and can range from less than 7 days to more than 4 weeks. Hemoclips can also mark the site if early rebleeding occurs; then, reintervention (e.g., repeat endoscopy or angioembolization) is facilitated.

Another treatment is endoscopic band ligation, which provides mechanical hemostasis. Endoscopic band ligation has been reported to be efficacious for TIC hemorrhage.¹⁸ Suctioning the TIC with the SRH into the distal cap and deploying a band leads to obliteration of vessels and potentially necrosis and disappearance of banded TIC.¹⁶ This technique carries a risk of perforation because of the thin walls of TICs. This risk may be higher for right-sided colon lesions since an exvivo colon specimen study reported serosal entrapment and inclusion of muscularis propria postband ligation, both of which may result in ischemia of intestinal wall and delayed perforation.¹⁹

Over-the-scope clip (OTSC) has been reported in case series for treatment of definitive TIC hemorrhage. With a distal cap and large clip, suctioning can evert TICs and facilitate deployment over the SRH.20,21 OTSC can grasp an entire TIC with the SRH and obliterate the arterial blood flow with a single clip.^20,21 No complications have been reported yet for treatment of TIC hemorrhage. However, the OTSC system is relatively expensive when compared with other modalities.

After endoscopic treatment is performed, four-quadrant spot tattooing is recommended adjacent to the TIC with the SRH. This step will facilitate localization and treatment in the case of TIC rebleeding.^4,10

Outcomes following endoscopic treatment

Following endoscopic treatment, patients should be monitored for early and late rebleeding. In a pooled analysis of case series composed of 847 patients with TIC bleeding, among the 137 patients in which endoscopic hemostasis was initially achieved, early rebleeding occurred in 8% and late rebleeding occurred in 12% of patients.²² Risk factors for TIC rebleeding within 30 days were residual arterial blood flow following hemostasis and early reinitiation of antiplatelet agents.

Remote treatment of TIC hemorrhage distant from the SRH is a significant risk factor for early TIC rebleeding.4, 10 For example, using hemoclips to close the mouth of a TIC when active bleeding or an SRH is located in the TIC base often fails because arterial flow remains open in the base and the artery is larger there.^4,10 This example highlights the importance of focal obliteration of arterial blood flow underlying SRH in order to achieve definitive hemostasis.^4,10

Salvage treatments

For TIC hemorrhage that is not controlled by endoscopic therapy, transcatheter arterial embolization (TAE) is recommended. If bleeding rate is high enough (at least 0.5 milliliters per minute) to be detected by angiography, TAE can serve as an effective method of diagnosis and immediate hemostasis.²³ However, the most common major complication of embolization is intestinal ischemia. The incidence of intestinal ischemia has been reported as high as 10%, with highest risk with embolization of at least three vasa recta.²⁴

Surgery is also recommended if TIC hemorrhage cannot be controlled with endoscopic therapy or TAE. Segmental colectomy is recommended if the bleeding site can be localized before surgery with colonoscopy or angiography resulting from significantly lower perioperative morbidity than subtotal colectomy.²⁵ However, subtotal colectomy may be necessary if preoperative localization of bleeding is unsuccessful.

There are very few reports of short- or long-term results that compare endoscopy, TAE, and surgery for management of TIC bleeding. However, a recent retrospective study reported better outcomes with endoscopic treatment of definitive TIC bleeding.²⁶ Patients who underwent endoscopic treatment had fewer RBC transfusions, shorter hospitalizations, and lower rates of postprocedure complications.
 

Management after cessation of hemorrhage

Medical management is important following an episode of TIC hemorrhage. A mainstay is daily fiber supplementation every morning and stool softener in the evening. Furthermore, patients are advised to drink an extra liter of fluids (not containing alcohol or caffeine) daily. By reducing colon transit time and increasing stool weight, these measures can help control constipation and prevent future complications of TIC disease.²⁷

Patients with recurrent TIC hemorrhage should undergo evaluation for elective surgery, provided they are appropriate surgical candidates. If preoperative localization of bleeding site is successful, segmental colectomy is preferred. Segmental resection is associated with significantly decreased rebleeding rate, with lower rates of morbidity compared with subtotal colectomy.³²

Chronic NSAIDs, aspirin, and antiplatelet drugs are risk factors for recurrent TIC hemorrhage, and avoiding these medications is recommended if possible.^33,34 Although anticoagulants have shown to be associated with increased risk of all-cause gastrointestinal bleeding, these agents have not been shown to increase risk of recurrent TIC hemorrhage in recent large retrospective studies. Since antiplatelet and anticoagulation agents serve to reduce risk of thromboembolic events, the clinician who recommended these medications should be consulted after a TIC bleed to re-evaluate whether these medications can be discontinued or reduced in dose.
 

Conclusion

The most effective way to diagnose and treat definitive TIC hemorrhage is to perform an urgent colonoscopy within 24 hours to identify and treat TIC SRH. This procedure requires thoroughly cleansing the colon first, as well as an experienced colonoscopist who can identify and treat TIC SRH to obliterate arterial blood flow underneath SRH and achieve definitive TIC hemostasis. Other approaches to early diagnosis include nuclear medicine scintigraphy or angiography (CT, MRI, or IR). However, these techniques can only detect active bleeding which is documented in only 26% of colonoscopically diagnosed definitive TIC hemorrhages. So, the expected diagnostic yield of these tests will be low. When urgent colonoscopy fails to make a diagnosis or TIC bleeding continues, TAE and/or surgery are recommended. After definitive hemostasis of TIC hemorrhage and for long term management, control of constipation and discontinuation of chronic NSAIDs and antiplatelet drugs (if possible) are recommended to prevent recurrent TIC hemorrhage.

Dr. Cusumano and Dr. Paiji are fellow physicians in the Vatche and Tamar Manoukian Division of Digestive Diseases at University of California Los Angeles. Dr. Jensen is a professor of medicine in Vatche and Tamar Manoukian Division of Digestive Diseases and is with the CURE Digestive Diseases Research Center at the VA Greater Los Angeles Healthcare System, Calif. All authors declare that they have no competing interests or disclosures.

References

1. Longstreth GF. Am J Gastroenterol. 1997;92(3):419-24.

2. Jensen DM et al. The New England Journal of Medicine. 2000;342(2):78-82.

3. Jensen DM et al. Techniques in Gastrointestinal Endoscopy. 2001;3(4):192-8.

4. Jensen DM. Am J Gastroenterol. 2018;113(11):1570-3.

5. Zuckerman GR et al. Gastrointestinal Endoscopy. 1999;49(2):228-38.

6. Stollman N et al. Lancet. 2004;363(9409):631-9.

7. McGuire HH et al. Ann Surg. 1994;220(5):653-6.

8. McGuire HH et al. Ann Surg. 1972;175(6):847-55.

9. Strate LL et al. Clinical gastroenterology and hepatol. 2008;6(9):1004-10.

10. Jensen DM et al. Gastrointestinal endoscopy. 2016;83(2):416-23.

11. Jensen DM et al. Gastrointest Endosc Clin N Am. 1997;7(3):477-98.

12. Maykel JA et al. Clin Colon Rectal Surg. 2004;17(3):195-204.

13. Green BT et al. Am J Gastroenterol. 2005;100(11):2395-402.

14. Niikura R et al. Journal of Clinical Gastroenterol. 2015;49(3):e24-30.

15. Bloomfeld RS et al. Am J Gastroenterol. 2001;96(8):2367-72.

16. Parsi MA,et al. VideoGIE. 2019;4(7):285-99.

17. Kaltenbach T et al. Clinical Gastroenterology and Hepatol. 2012;10(2):131-7.

18. Nakano K et al. Endosc Int Open. 2015;3(5):E529-33.

19. Barker KB et al. Gastrointestinal Endoscopy. 2005;62(2):224-7.

20. Kaltenbach T et al. Gastrointest Endosc Clin N Am. 2020;30(1):13-23.

21. Yamazaki K et al. VideoGIE. 2020;5(6):252-4.

22. Strate LL et al. Clinical Gastroenterology and Hepatol. 2010;8(4):333-43.

23. Evangelista et al. J Vasc Interv Radiol. 2000;11(5):601-6.

24. Kodani M et al. J Vasc Interv Radiol. 2016;27(6):824-30.

25. Mohammed et al. Clin Colon Rectal Surg. 2018;31(4):243-50.

26. Wongpongsalee T et al. Gastrointestinal Endoscopy. 2020;91(6):AB471-2.

27. Böhm SK. Viszeralmedizin. 2015;31(2):84-94.

28. Prakash C et al. Endoscopy. 1999;31(6):460-3.

29. Yen EF et al. Digestive Diseases and Sciences. 2008;53(9):2480-5.

30. Ishii N et al. Gastrointestinal Endoscopy. 2012;75(2):382-7.

31. Nagata N et al. Gastrointestinal Endoscopy. 2018;88(5):841-53.e4.

32. Parkes BM et al. Am Surg. 1993;59(10):676-8.

33. Vajravelu RK et al. Gastroenterology. 2018;155(5):1416-27.

34. Oakland K et al. Clin Gastroenterol Hepatol. 2019;17(7):1276-84.e3.

35. Yamada A et al. Dis Colon Rectum. 2008;51(1):116-20.

36. Coleman CI et al. Int J Clin Pract. 2012;66(1):53-63.

37. Holster IL et al. Gastroenterology. 2013;145(1):105-12.e15.