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.

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

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

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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.

Dear colleagues,

Welcome to the November edition of The New Gastroenterologist! Our fall newsletter features a particularly interesting compilation of articles. As the pandemic lingers on, we are forced to face the realities of coexisting with COVID-19 as the virus certainly seems to be here to stay.

To protect against ongoing risk of exposure, health care workers and other high-risk subsets of patients are now being offered booster shots. For our patients with inflammatory bowel disease (IBD) on immune-modifying therapies, there has always been a question of vaccine efficacy. Dr. Freddy Caldera and Dr. Trevor Schell (University of Wisconsin-Madison) shed some much needed light on recommendations on the COVID-19 vaccine for IBD patients.

In April of 2021, a federal rule was implemented mandating that patients have immediate and free access to their electronic health information – which includes all documentation from their health care providers. Some physicians have been concerned about this practice, namely how patients will respond and whether this will increase the burden on clinicians. Clearly, this issue is multifaceted: Dr. Sachin Shah (University of Chicago) discusses the ethical implications from a clinical standpoint, while attorney Valerie Guttman Koch (University of Houston Law Center, MacLean Center for Clinical Medical Ethics, University of Chicago) shares a riveting legal perspective.

Colonic diverticular bleeding is the most common etiology of overt lower gastrointestinal bleeding and one of the most frequent consults we receive as gastroenterologists. However, even with the use of colonoscopy, obtaining a definitive diagnosis can often be difficult. Our “In Focus” feature for November, is an excellent piece written by Dr. Vivy Cusumano, Dr. Christopher Paiji, and Dr. Dennis Jensen (all with University of California, Los Angeles), detailing the pathophysiology, diagnosis, and treatment.

Navigating pregnancy and parental leave during training is difficult. Drs. Joy Liu, Keith Summa, Ronak Patel, Erica Donnan, Amanda Guentner, and Leila Kia (all with Northwestern University) share their program’s experience, providing incredibly helpful and practical recommendations for both gastroenterology trainees and fellowship directors.

The Association of Black Gastroenterologists and Hepatologists emerged against the backdrop of recent social and health care injustices. Dr. Kafayat Busari (Florida State University) and Dr. Alexandra Guillaume (Stony Brook University Hospital) discuss the critical importance and mission of this association and how it will help shape the field of gastroenterology in the years to come.

Medical pancreatology is a subspecialty that most gastroenterology fellows have little, if any, exposure to. In our post-fellowship pathways section, Dr. Sajan Nagpal (University of Chicago) details his own experiences in addition to discussing the important role of a medical pancreatologist within a gastroenterology division.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. Sanjay Sandhir (Dayton [Ohio] Gastroenterology), discusses the importance of education and screening for nonalcoholic fatty liver disease.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.


Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the November edition of The New Gastroenterologist! Our fall newsletter features a particularly interesting compilation of articles. As the pandemic lingers on, we are forced to face the realities of coexisting with COVID-19 as the virus certainly seems to be here to stay.

To protect against ongoing risk of exposure, health care workers and other high-risk subsets of patients are now being offered booster shots. For our patients with inflammatory bowel disease (IBD) on immune-modifying therapies, there has always been a question of vaccine efficacy. Dr. Freddy Caldera and Dr. Trevor Schell (University of Wisconsin-Madison) shed some much needed light on recommendations on the COVID-19 vaccine for IBD patients.

In April of 2021, a federal rule was implemented mandating that patients have immediate and free access to their electronic health information – which includes all documentation from their health care providers. Some physicians have been concerned about this practice, namely how patients will respond and whether this will increase the burden on clinicians. Clearly, this issue is multifaceted: Dr. Sachin Shah (University of Chicago) discusses the ethical implications from a clinical standpoint, while attorney Valerie Guttman Koch (University of Houston Law Center, MacLean Center for Clinical Medical Ethics, University of Chicago) shares a riveting legal perspective.

Colonic diverticular bleeding is the most common etiology of overt lower gastrointestinal bleeding and one of the most frequent consults we receive as gastroenterologists. However, even with the use of colonoscopy, obtaining a definitive diagnosis can often be difficult. Our “In Focus” feature for November, is an excellent piece written by Dr. Vivy Cusumano, Dr. Christopher Paiji, and Dr. Dennis Jensen (all with University of California, Los Angeles), detailing the pathophysiology, diagnosis, and treatment.

Navigating pregnancy and parental leave during training is difficult. Drs. Joy Liu, Keith Summa, Ronak Patel, Erica Donnan, Amanda Guentner, and Leila Kia (all with Northwestern University) share their program’s experience, providing incredibly helpful and practical recommendations for both gastroenterology trainees and fellowship directors.

The Association of Black Gastroenterologists and Hepatologists emerged against the backdrop of recent social and health care injustices. Dr. Kafayat Busari (Florida State University) and Dr. Alexandra Guillaume (Stony Brook University Hospital) discuss the critical importance and mission of this association and how it will help shape the field of gastroenterology in the years to come.

Medical pancreatology is a subspecialty that most gastroenterology fellows have little, if any, exposure to. In our post-fellowship pathways section, Dr. Sajan Nagpal (University of Chicago) details his own experiences in addition to discussing the important role of a medical pancreatologist within a gastroenterology division.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. Sanjay Sandhir (Dayton [Ohio] Gastroenterology), discusses the importance of education and screening for nonalcoholic fatty liver disease.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.


Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Dear colleagues,

Welcome to the November edition of The New Gastroenterologist! Our fall newsletter features a particularly interesting compilation of articles. As the pandemic lingers on, we are forced to face the realities of coexisting with COVID-19 as the virus certainly seems to be here to stay.

To protect against ongoing risk of exposure, health care workers and other high-risk subsets of patients are now being offered booster shots. For our patients with inflammatory bowel disease (IBD) on immune-modifying therapies, there has always been a question of vaccine efficacy. Dr. Freddy Caldera and Dr. Trevor Schell (University of Wisconsin-Madison) shed some much needed light on recommendations on the COVID-19 vaccine for IBD patients.

In April of 2021, a federal rule was implemented mandating that patients have immediate and free access to their electronic health information – which includes all documentation from their health care providers. Some physicians have been concerned about this practice, namely how patients will respond and whether this will increase the burden on clinicians. Clearly, this issue is multifaceted: Dr. Sachin Shah (University of Chicago) discusses the ethical implications from a clinical standpoint, while attorney Valerie Guttman Koch (University of Houston Law Center, MacLean Center for Clinical Medical Ethics, University of Chicago) shares a riveting legal perspective.

Colonic diverticular bleeding is the most common etiology of overt lower gastrointestinal bleeding and one of the most frequent consults we receive as gastroenterologists. However, even with the use of colonoscopy, obtaining a definitive diagnosis can often be difficult. Our “In Focus” feature for November, is an excellent piece written by Dr. Vivy Cusumano, Dr. Christopher Paiji, and Dr. Dennis Jensen (all with University of California, Los Angeles), detailing the pathophysiology, diagnosis, and treatment.

Navigating pregnancy and parental leave during training is difficult. Drs. Joy Liu, Keith Summa, Ronak Patel, Erica Donnan, Amanda Guentner, and Leila Kia (all with Northwestern University) share their program’s experience, providing incredibly helpful and practical recommendations for both gastroenterology trainees and fellowship directors.

The Association of Black Gastroenterologists and Hepatologists emerged against the backdrop of recent social and health care injustices. Dr. Kafayat Busari (Florida State University) and Dr. Alexandra Guillaume (Stony Brook University Hospital) discuss the critical importance and mission of this association and how it will help shape the field of gastroenterology in the years to come.

Medical pancreatology is a subspecialty that most gastroenterology fellows have little, if any, exposure to. In our post-fellowship pathways section, Dr. Sajan Nagpal (University of Chicago) details his own experiences in addition to discussing the important role of a medical pancreatologist within a gastroenterology division.

Lastly, our DHPA Private Practice Perspectives article, written by Dr. Sanjay Sandhir (Dayton [Ohio] Gastroenterology), discusses the importance of education and screening for nonalcoholic fatty liver disease.

If you have interest in contributing or have ideas for future TNG topics, please contact me ([email protected]), or Ryan Farrell ([email protected]), managing editor of TNG.


Stay well,

Vijaya L. Rao, MD
Editor-in-Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition

Many years ago, drug development in psychiatry turned to control of specific symptoms across disorders rather than within disorders, but regulatory agencies are still not yet on board, according to an expert psychopharmacologist outlining the ongoing evolution at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

If this reorientation is going to lead to the broad indications the newer drugs likely deserve, which is control of specific types of symptoms regardless of the diagnosis, “we have to move the [Food and Drug Administration] along,” said Stephen M. Stahl, MD, PhD, chairman of the Neuroscience Institute and an adjunct professor of psychiatry at the University of California, San Diego.

On the side of drug development and clinical practice, the reorientation has already taken place. Dr. Stahl described numerous brain circuits known to produce symptoms when function is altered that are now treatment targets. This includes the ventral medial prefrontal cortex where deficient information processing leads to depression and the orbital frontal cortex where altered function leads to impulsivity.

“It is not like each part of the brain does a little bit of everything. Rather, each part of the brain has an assignment and duty and function,” Dr. Stahl explained. By addressing the disturbed signaling in brain circuits that lead to depression, impulsivity, agitation, or other symptoms, there is an opportunity for control, regardless of the psychiatric diagnosis with which the symptom is associated.

For example, Dr. Stahl predicted that pimavanserin, a highly selective 5-HT_2A inverse agonist that is already approved for psychosis in Parkinson’s disease, is now likely to be approved for psychosis associated with other conditions on the basis of recent positive clinical studies in these other disorders.

Brexpiprazole, a serotonin-dopamine activity modulator already known to be useful for control of the agitation characteristic of schizophrenia, is now showing the same type of activity against agitation when it is associated with Alzheimer’s disease. Again, Dr. Stahl thinks this drug is on course for an indication across diseases once studies are conducted in each disease individually.

Another drug being evaluated for agitation, the N-methyl-D-aspartate receptor antagonist dextromethorphan bupropion, is also being tested for treatment of symptoms across multiple disorders, he reported.

However, the FDA has so far taken the position that each drug must be tested separately for a given symptom in each disorder for which it is being considered despite the underlying premise that it is the symptom, not the disease, that is important.

“Psychiatric disorders are syndromes, categorized by a collection of symptoms defined descriptively but not neurobiologically,” Dr. Stahl said. Unlike physiological diseases where symptoms, like a fever or abdominal cramps, are the product of a disease, psychiatric symptoms are the disease and a fundamental target – regardless of the DSM-based diagnosis.

To some degree, the symptoms of psychiatric disorders have always been the focus of treatment, but a pivot toward developing therapies that will control a symptom regardless of the underlying diagnosis is an important conceptual change. It is being made possible by advances in the detail with which the neuropathology of these symptoms is understood .

“By my count, 79 symptoms are described in DSM-5, but they are spread across hundreds of syndromes because they are grouped together in different ways,” Dr. Stahl observed.

He noted that clinicians make a diagnosis on the basis symptom groupings, but their interventions are selected to address the manifestations of the disease, not the disease itself.

“If you are a real psychopharmacologist treating real patients, you are treating the specific symptoms of the specific patient,” according to Dr. Stahl.

So far, the FDA has not made this leap, insisting on trials in these categorical disorders rather than permitting trial designs that allow benefit to be demonstrated against a symptom regardless of the syndrome with which it is associated.

Of egregious examples, Dr. Stahl recounted a recent trial of a 5-HT₂ antagonist that looked so promising against psychosis in Alzheimer’s disease that the trialists enrolled patients with psychosis regardless of type of dementia, such as vascular dementia and Lewy body disease. The efficacy was impressive.

“It worked so well that they stopped the trial, but the FDA declined to approve it,” Dr. Stahl recounted. Despite clear evidence of benefit, the regulators insisted that the investigators needed to show a significant benefit in each condition individually.

While the trial investigators acknowledged that there was not enough power in the trial to show a statistically significant benefit in each category, they argued that the overall benefit and the consistent response across categories required them to stop the trial for ethical reasons.

“That’s your problem, the FDA said to the investigators,” according to Dr. Stahl.

The failure of the FDA to recognize the efficacy of psychopharmacologic therapies across symptoms regardless of the associated disease is a failure to stay current with an important evolution in medicine, Dr. Stahl indicated.

“What we have come to understand is the neurobiology of any given symptom is likely to be the same across disorders,” he said.
 

Agency’s arbitrary decisions cited

“I completely agree with Dr. Stahl,” said Henry A. Nasrallah, MD, professor of psychiatry, neurology, and neuroscience, University of Cincinnati.

In addition to the fact that symptoms are present across multiple categories, many patients manifest multiple symptoms at one time, Dr. Nasrallah pointed out. For neurodegenerative disorders associated with psychosis, depression, anxiety, aggression, and other symptoms, it is already well known that the heterogeneous symptoms “cannot be treated with a single drug,” he said. Rather different drugs targeting each symptom individually is essential for effective management.

Dr. Nasrallah, who chaired the Psychopharmacology Update meeting, has made this point many times in the past, including in his role as the editor of Current Psychiatry. In one editorial 10 years ago, he wrote that “it makes little sense for the FDA to mandate that a drug must work for a DSM diagnosis instead of specific symptoms.”

“The FDA must update its old policy, which has led to the widespread off-label use of psychiatric drugs, an artificial concept, simply because the FDA arbitrarily decided a long time ago that new drugs must be approved for a specific DSM diagnosis,” Dr. Nasrallah said.

Dr. Stahl reported financial relationships with more than 20 pharmaceutical companies, including those that are involved in the development of drugs included in his talk. Medscape Live and this news organization are owned by the same parent company.

Many years ago, drug development in psychiatry turned to control of specific symptoms across disorders rather than within disorders, but regulatory agencies are still not yet on board, according to an expert psychopharmacologist outlining the ongoing evolution at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

If this reorientation is going to lead to the broad indications the newer drugs likely deserve, which is control of specific types of symptoms regardless of the diagnosis, “we have to move the [Food and Drug Administration] along,” said Stephen M. Stahl, MD, PhD, chairman of the Neuroscience Institute and an adjunct professor of psychiatry at the University of California, San Diego.

On the side of drug development and clinical practice, the reorientation has already taken place. Dr. Stahl described numerous brain circuits known to produce symptoms when function is altered that are now treatment targets. This includes the ventral medial prefrontal cortex where deficient information processing leads to depression and the orbital frontal cortex where altered function leads to impulsivity.

“It is not like each part of the brain does a little bit of everything. Rather, each part of the brain has an assignment and duty and function,” Dr. Stahl explained. By addressing the disturbed signaling in brain circuits that lead to depression, impulsivity, agitation, or other symptoms, there is an opportunity for control, regardless of the psychiatric diagnosis with which the symptom is associated.

For example, Dr. Stahl predicted that pimavanserin, a highly selective 5-HT_2A inverse agonist that is already approved for psychosis in Parkinson’s disease, is now likely to be approved for psychosis associated with other conditions on the basis of recent positive clinical studies in these other disorders.

Brexpiprazole, a serotonin-dopamine activity modulator already known to be useful for control of the agitation characteristic of schizophrenia, is now showing the same type of activity against agitation when it is associated with Alzheimer’s disease. Again, Dr. Stahl thinks this drug is on course for an indication across diseases once studies are conducted in each disease individually.

Another drug being evaluated for agitation, the N-methyl-D-aspartate receptor antagonist dextromethorphan bupropion, is also being tested for treatment of symptoms across multiple disorders, he reported.

However, the FDA has so far taken the position that each drug must be tested separately for a given symptom in each disorder for which it is being considered despite the underlying premise that it is the symptom, not the disease, that is important.

“Psychiatric disorders are syndromes, categorized by a collection of symptoms defined descriptively but not neurobiologically,” Dr. Stahl said. Unlike physiological diseases where symptoms, like a fever or abdominal cramps, are the product of a disease, psychiatric symptoms are the disease and a fundamental target – regardless of the DSM-based diagnosis.

To some degree, the symptoms of psychiatric disorders have always been the focus of treatment, but a pivot toward developing therapies that will control a symptom regardless of the underlying diagnosis is an important conceptual change. It is being made possible by advances in the detail with which the neuropathology of these symptoms is understood .

“By my count, 79 symptoms are described in DSM-5, but they are spread across hundreds of syndromes because they are grouped together in different ways,” Dr. Stahl observed.

He noted that clinicians make a diagnosis on the basis symptom groupings, but their interventions are selected to address the manifestations of the disease, not the disease itself.

“If you are a real psychopharmacologist treating real patients, you are treating the specific symptoms of the specific patient,” according to Dr. Stahl.

So far, the FDA has not made this leap, insisting on trials in these categorical disorders rather than permitting trial designs that allow benefit to be demonstrated against a symptom regardless of the syndrome with which it is associated.

Of egregious examples, Dr. Stahl recounted a recent trial of a 5-HT₂ antagonist that looked so promising against psychosis in Alzheimer’s disease that the trialists enrolled patients with psychosis regardless of type of dementia, such as vascular dementia and Lewy body disease. The efficacy was impressive.

“It worked so well that they stopped the trial, but the FDA declined to approve it,” Dr. Stahl recounted. Despite clear evidence of benefit, the regulators insisted that the investigators needed to show a significant benefit in each condition individually.

While the trial investigators acknowledged that there was not enough power in the trial to show a statistically significant benefit in each category, they argued that the overall benefit and the consistent response across categories required them to stop the trial for ethical reasons.

“That’s your problem, the FDA said to the investigators,” according to Dr. Stahl.

The failure of the FDA to recognize the efficacy of psychopharmacologic therapies across symptoms regardless of the associated disease is a failure to stay current with an important evolution in medicine, Dr. Stahl indicated.

“What we have come to understand is the neurobiology of any given symptom is likely to be the same across disorders,” he said.
 

Agency’s arbitrary decisions cited

“I completely agree with Dr. Stahl,” said Henry A. Nasrallah, MD, professor of psychiatry, neurology, and neuroscience, University of Cincinnati.

In addition to the fact that symptoms are present across multiple categories, many patients manifest multiple symptoms at one time, Dr. Nasrallah pointed out. For neurodegenerative disorders associated with psychosis, depression, anxiety, aggression, and other symptoms, it is already well known that the heterogeneous symptoms “cannot be treated with a single drug,” he said. Rather different drugs targeting each symptom individually is essential for effective management.

Dr. Nasrallah, who chaired the Psychopharmacology Update meeting, has made this point many times in the past, including in his role as the editor of Current Psychiatry. In one editorial 10 years ago, he wrote that “it makes little sense for the FDA to mandate that a drug must work for a DSM diagnosis instead of specific symptoms.”

“The FDA must update its old policy, which has led to the widespread off-label use of psychiatric drugs, an artificial concept, simply because the FDA arbitrarily decided a long time ago that new drugs must be approved for a specific DSM diagnosis,” Dr. Nasrallah said.

Dr. Stahl reported financial relationships with more than 20 pharmaceutical companies, including those that are involved in the development of drugs included in his talk. Medscape Live and this news organization are owned by the same parent company.

Many years ago, drug development in psychiatry turned to control of specific symptoms across disorders rather than within disorders, but regulatory agencies are still not yet on board, according to an expert psychopharmacologist outlining the ongoing evolution at the virtual Psychopharmacology Update presented by Current Psychiatry and the American Academy of Clinical Psychiatrists, sponsored by Medscape Live.

If this reorientation is going to lead to the broad indications the newer drugs likely deserve, which is control of specific types of symptoms regardless of the diagnosis, “we have to move the [Food and Drug Administration] along,” said Stephen M. Stahl, MD, PhD, chairman of the Neuroscience Institute and an adjunct professor of psychiatry at the University of California, San Diego.

On the side of drug development and clinical practice, the reorientation has already taken place. Dr. Stahl described numerous brain circuits known to produce symptoms when function is altered that are now treatment targets. This includes the ventral medial prefrontal cortex where deficient information processing leads to depression and the orbital frontal cortex where altered function leads to impulsivity.

“It is not like each part of the brain does a little bit of everything. Rather, each part of the brain has an assignment and duty and function,” Dr. Stahl explained. By addressing the disturbed signaling in brain circuits that lead to depression, impulsivity, agitation, or other symptoms, there is an opportunity for control, regardless of the psychiatric diagnosis with which the symptom is associated.

For example, Dr. Stahl predicted that pimavanserin, a highly selective 5-HT_2A inverse agonist that is already approved for psychosis in Parkinson’s disease, is now likely to be approved for psychosis associated with other conditions on the basis of recent positive clinical studies in these other disorders.

Brexpiprazole, a serotonin-dopamine activity modulator already known to be useful for control of the agitation characteristic of schizophrenia, is now showing the same type of activity against agitation when it is associated with Alzheimer’s disease. Again, Dr. Stahl thinks this drug is on course for an indication across diseases once studies are conducted in each disease individually.

Another drug being evaluated for agitation, the N-methyl-D-aspartate receptor antagonist dextromethorphan bupropion, is also being tested for treatment of symptoms across multiple disorders, he reported.

However, the FDA has so far taken the position that each drug must be tested separately for a given symptom in each disorder for which it is being considered despite the underlying premise that it is the symptom, not the disease, that is important.

“Psychiatric disorders are syndromes, categorized by a collection of symptoms defined descriptively but not neurobiologically,” Dr. Stahl said. Unlike physiological diseases where symptoms, like a fever or abdominal cramps, are the product of a disease, psychiatric symptoms are the disease and a fundamental target – regardless of the DSM-based diagnosis.

To some degree, the symptoms of psychiatric disorders have always been the focus of treatment, but a pivot toward developing therapies that will control a symptom regardless of the underlying diagnosis is an important conceptual change. It is being made possible by advances in the detail with which the neuropathology of these symptoms is understood .

“By my count, 79 symptoms are described in DSM-5, but they are spread across hundreds of syndromes because they are grouped together in different ways,” Dr. Stahl observed.

He noted that clinicians make a diagnosis on the basis symptom groupings, but their interventions are selected to address the manifestations of the disease, not the disease itself.

“If you are a real psychopharmacologist treating real patients, you are treating the specific symptoms of the specific patient,” according to Dr. Stahl.

So far, the FDA has not made this leap, insisting on trials in these categorical disorders rather than permitting trial designs that allow benefit to be demonstrated against a symptom regardless of the syndrome with which it is associated.

Of egregious examples, Dr. Stahl recounted a recent trial of a 5-HT₂ antagonist that looked so promising against psychosis in Alzheimer’s disease that the trialists enrolled patients with psychosis regardless of type of dementia, such as vascular dementia and Lewy body disease. The efficacy was impressive.

“It worked so well that they stopped the trial, but the FDA declined to approve it,” Dr. Stahl recounted. Despite clear evidence of benefit, the regulators insisted that the investigators needed to show a significant benefit in each condition individually.

While the trial investigators acknowledged that there was not enough power in the trial to show a statistically significant benefit in each category, they argued that the overall benefit and the consistent response across categories required them to stop the trial for ethical reasons.

“That’s your problem, the FDA said to the investigators,” according to Dr. Stahl.

The failure of the FDA to recognize the efficacy of psychopharmacologic therapies across symptoms regardless of the associated disease is a failure to stay current with an important evolution in medicine, Dr. Stahl indicated.

“What we have come to understand is the neurobiology of any given symptom is likely to be the same across disorders,” he said.
 

Agency’s arbitrary decisions cited

“I completely agree with Dr. Stahl,” said Henry A. Nasrallah, MD, professor of psychiatry, neurology, and neuroscience, University of Cincinnati.

In addition to the fact that symptoms are present across multiple categories, many patients manifest multiple symptoms at one time, Dr. Nasrallah pointed out. For neurodegenerative disorders associated with psychosis, depression, anxiety, aggression, and other symptoms, it is already well known that the heterogeneous symptoms “cannot be treated with a single drug,” he said. Rather different drugs targeting each symptom individually is essential for effective management.

Dr. Nasrallah, who chaired the Psychopharmacology Update meeting, has made this point many times in the past, including in his role as the editor of Current Psychiatry. In one editorial 10 years ago, he wrote that “it makes little sense for the FDA to mandate that a drug must work for a DSM diagnosis instead of specific symptoms.”

“The FDA must update its old policy, which has led to the widespread off-label use of psychiatric drugs, an artificial concept, simply because the FDA arbitrarily decided a long time ago that new drugs must be approved for a specific DSM diagnosis,” Dr. Nasrallah said.

Dr. Stahl reported financial relationships with more than 20 pharmaceutical companies, including those that are involved in the development of drugs included in his talk. Medscape Live and this news organization are owned by the same parent company.

Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.

“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”

The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.

In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.

Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).

Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.

“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.

In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.

Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”

The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment. 

From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”

The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.

Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.

“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”

The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.

In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.

Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).

Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.

“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.

In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.

Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”

The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment. 

From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”

The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.

Mirroring the opioid crisis, maternal and newborn hepatitis C infections (HCV) more than doubled in the United States between 2009 and 2019, with disproportionate increases in people of White, American Indian, and Alaska Native race, especially those with less education, according to a cross-sectional study published in JAMA Health Forum. However, the level of risk within these populations was mitigated in counties with higher employment, reported Stephen W. Patrick, MD, of Vanderbilt University, in Nashville, Tenn., and coauthors.

“As we develop public health approaches to prevent HCV infections, connect to treatment, and monitor exposed infants, understanding these factors can be of critical importance to tailoring interventions,” Dr. Patrick said in an interview. “HCV is one more complication of the opioid crisis,” he added. “These data also enable us to step back a bit from HCV and look at the landscape of how the opioid crisis continues to grow in complexity and scope. Throughout the opioid crisis we have often failed to recognize and address the unique needs of pregnant people and infants.”

The study authors used data from the National Center for Health Statistics at the Centers for Disease Control and Prevention, and from the Area Health Resource File to examine maternal-infant HCV infection among all U.S. births between 2009 and 2019. The researchers also examined community-level risk factors including rurality, employment, and access to medical care.

In counties reporting HCV, there were 39,380,122 people who had live births, of whom 138,343 (0.4%) were diagnosed with HCV. The overall rate of maternal HCV infection increased from 1.8 to 5.1 per 1,000 live births between 2009 and 2019.

Infection rates were highest in American Indian/Alaska Native (AI/AN) and White people (adjusted odds ratio [aOR] 7.94 and 7.37, respectively) compared with Black people. They were higher among individuals without a 4-year degree compared to those with higher education (aOR, 3.19).

Among these groups considered to be at higher risk for HCV infection, high employment rates somewhat mitigated the risk. Specifically, in counties in the 10th percentile of employment, the predicted probability of HCV increased from 0.16% to 1.37%, between 2009 and 2019, whereas in counties at the 90th percentile of employment, the predicted probability remained similar, at 0.36% in 2009 and 0.48% in 2019.

“With constrained national resources, understanding both individual and community-level factors associated with HCV infections in pregnant people could inform strategies to mitigate its spread, such as harm reduction efforts (e.g., syringe service programs), improving access to treatment for [opioid use disorder] or increasing the obstetrical workforce in high-risk communities, HCV testing strategies in pregnant people and people of childbearing age, and treatment with novel antiviral therapies,” wrote the authors.

In the time since the authors began the study, universal HCV screening for every pregnancy has been recommended by a number of groups, including the U.S. Preventive Services Task Force, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine (SMFM). However, Dr. Patrick says even though such recommendations are now adopted, it will be some time before they are fully operational, making knowledge of HCV risk factors important for obstetricians as well as pediatricians and family physicians. “We don’t know how if hospitals and clinicians have started universal screening for HCV and even when it is completely adopted, understanding individual and community-level factors associated with HCV in pregnant people is still of critical importance,” he explained. “In some of our previous work we have found that non-White HCV-exposed infants are less likely to be tested for HCV than are White infants, even after accounting for multiple individual and hospital-level factors. The pattern we are seeing in our research and in research in other groups is one of unequal treatment of pregnant people with substance use disorder in terms of being given evidence-based treatments, being tested for HCV, and even in child welfare outcomes like foster placement. It is important to know these issues are occurring, but we need specific equitable approaches to ensuring optimal outcomes for all families.

Jeffrey A. Kuller, MD, one of the authors of the SMFM’s new recommendations for universal HCV screening in pregnancy, agreed that until universal screening is widely adopted, awareness of maternal HCV risk factors is important, “to better determine who is at highest risk for hep C, barriers to care, and patients to better target.” This information also affects procedure at the time of delivery, added Dr. Kuller, professor of obstetrics and gynecology in the division of maternal-fetal medicine at Duke University, Durham, N.C. “We do not perform C-sections for the presence of hep C,” he told this publication. However, in labor, “we try to avoid internal fetal monitoring when possible, and early artificial rupture of membranes when possible, and avoid the use of routine episiotomy,” he said. “Hep C–positive patients should also be assessed for other sexually transmitted diseases including HIV, syphilis, gonorrhea, chlamydia, and hep B. “Although we do not typically treat hep C pharmacologically during pregnancy, we try to get the patient placed with a hepatologist for long-term management.”

The study has important implications for pediatric patients, added Audrey R. Lloyd, MD, a med-peds infectious disease fellow who is studying HCV in pregnancy at the University of Alabama at Birmingham. “In the setting of maternal HCV viremia, maternal-fetal transmission occurs in around 6% of exposed infants and around 10% if there is maternal HIV-HCV coinfection,” she said in an interview. “With the increasing rates of HCV in pregnant women described by Dr. Patrick et al., HCV infections among infants will also rise. Even when maternal HCV infection is documented, we often do not do a good job screening the infants for infection and linking them to treatment. This new data makes me worried we may see more complications of pediatric HCV infection in the future,” she added. She explained that safe and effective treatments for HCV infection are approved down to 3 years of age, but patients must first be diagnosed to receive treatment. 

From whichever angle you approach it, tackling both the opioid epidemic and HCV infection in pregnancy will inevitably end up helping both parts of the mother-infant dyad, said Dr. Patrick. “Not too long ago I was caring for an opioid-exposed infant at the hospital where I practice who had transferred in from another center hours away. The mother had not been tested for HCV, so I tested the infant for HCV antibodies which were positive. Imagine that, determining a mother is HCV positive by testing the infant. There are so many layers of systems that should be fixed to make this not happen. And what are the chances the mother, after she found out, was able to access treatment for HCV? What about the infant being tested? The systems are just fragmented and we need to do better.”

The study was funded by the National Institute on Drug Abuse of the National Institutes of Health. Neither Dr. Patrick, Dr. Kuller, nor Dr. Lloyd reported any conflicts of interest.