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Weight loss failures drive bariatric surgery regrets
Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD, of Harvard Medical School, Boston.
A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders, Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
However, postprocedure problems don’t always equal regrets, he said. “Although many women [in the 2014 study] reported negative thoughts and health issues after weight loss surgery, none of them said they regret undergoing the procedure,” he noted.
To further examine decision regret in patients who underwent gastric bypass and gastric banding, Dr. Jones participated in a study of patients’ attitudes 4 years after gastric bypass and gastric banding (Obes Surg. 2019;29:1624-31).
“Weight loss surgery is neither risk free nor universally effective, yet few studies have examined what proportion of patients regret having undergone weight loss surgery,” he noted.
Dr. Jones and colleagues interviewed patients at two weight loss surgery centers and used specific metrics and a multivariate analysis to examine associations among weight loss, quality of life, and decision regret.
A total of 205 Roux-en-Y gastric bypass (RYGB) patients responded at 1 year after surgery: 181, 156, and 134 patients responded at 2, 3, and 4 years, respectively.
At 1 year, 2% reported regret and that they would not choose the surgery again, and by 4 years, 5% reported regret, based on overall regret scores greater than 50. In addition, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects.
The researchers also interviewed gastric band patients: 170, 157, 146, and 123 responded at years 1,2,3, and 4.
Overall, 8% of these patients expressed regret at 1 year, and 20% expressed regret at 4 years, said Dr. Jones.
“Almost 20% did not think they made the right decision,” he said.
Dr. Jones noted. An average weight loss of 7.4% of excess body weight was associated with regret scores greater than 50, while an average weight loss of 21.1% was associated with regret scores less than 50, he said.
In addition, poor sexual function, but not weight loss or other quality-of-life factors was significantly associated with regret among RYGB patients.
Many surgeons are performing sleeve gastrectomies, which appear to yield greater weight loss than gastric banding and fewer complications than gastric bypass, said Dr. Jones. His study did not include sleeve gastrectomies, but “I expect a sleeve gastrectomy to do pretty well in this analysis,” and to be associated with less patient regret, he said.
Overall, better patient education is key to improving patients’ experiences and reducing feelings of regret, said Dr. Jones.
“The better patients understand the difference between band, bypass, and sleeve preoperatively, the better we can set expectations,” he said. Dr. Jones’ institution has developed an app for laparoscopic sleeve that guides patients through the process from preop through postoperative stay, he noted.
Given the association between amount of weight lost and regret, “setting expectations is very important,” and could include not only written consent but also webinars, information sessions, and apps for patients in advance to help mitigate regrets after the procedure, Dr. Jones concluded.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones disclosed serving on the medical advisory board for Allurion.
Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD, of Harvard Medical School, Boston.
A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders, Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
However, postprocedure problems don’t always equal regrets, he said. “Although many women [in the 2014 study] reported negative thoughts and health issues after weight loss surgery, none of them said they regret undergoing the procedure,” he noted.
To further examine decision regret in patients who underwent gastric bypass and gastric banding, Dr. Jones participated in a study of patients’ attitudes 4 years after gastric bypass and gastric banding (Obes Surg. 2019;29:1624-31).
“Weight loss surgery is neither risk free nor universally effective, yet few studies have examined what proportion of patients regret having undergone weight loss surgery,” he noted.
Dr. Jones and colleagues interviewed patients at two weight loss surgery centers and used specific metrics and a multivariate analysis to examine associations among weight loss, quality of life, and decision regret.
A total of 205 Roux-en-Y gastric bypass (RYGB) patients responded at 1 year after surgery: 181, 156, and 134 patients responded at 2, 3, and 4 years, respectively.
At 1 year, 2% reported regret and that they would not choose the surgery again, and by 4 years, 5% reported regret, based on overall regret scores greater than 50. In addition, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects.
The researchers also interviewed gastric band patients: 170, 157, 146, and 123 responded at years 1,2,3, and 4.
Overall, 8% of these patients expressed regret at 1 year, and 20% expressed regret at 4 years, said Dr. Jones.
“Almost 20% did not think they made the right decision,” he said.
Dr. Jones noted. An average weight loss of 7.4% of excess body weight was associated with regret scores greater than 50, while an average weight loss of 21.1% was associated with regret scores less than 50, he said.
In addition, poor sexual function, but not weight loss or other quality-of-life factors was significantly associated with regret among RYGB patients.
Many surgeons are performing sleeve gastrectomies, which appear to yield greater weight loss than gastric banding and fewer complications than gastric bypass, said Dr. Jones. His study did not include sleeve gastrectomies, but “I expect a sleeve gastrectomy to do pretty well in this analysis,” and to be associated with less patient regret, he said.
Overall, better patient education is key to improving patients’ experiences and reducing feelings of regret, said Dr. Jones.
“The better patients understand the difference between band, bypass, and sleeve preoperatively, the better we can set expectations,” he said. Dr. Jones’ institution has developed an app for laparoscopic sleeve that guides patients through the process from preop through postoperative stay, he noted.
Given the association between amount of weight lost and regret, “setting expectations is very important,” and could include not only written consent but also webinars, information sessions, and apps for patients in advance to help mitigate regrets after the procedure, Dr. Jones concluded.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones disclosed serving on the medical advisory board for Allurion.
Not all weight loss surgery patients “live happily ever after,” according to Daniel B. Jones, MD, of Harvard Medical School, Boston.
A 2014 study of 22 women who underwent weight loss surgery reported lower energy, worse quality of life, and persistent eating disorders, Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium by Global Academy for Medical Education.
However, postprocedure problems don’t always equal regrets, he said. “Although many women [in the 2014 study] reported negative thoughts and health issues after weight loss surgery, none of them said they regret undergoing the procedure,” he noted.
To further examine decision regret in patients who underwent gastric bypass and gastric banding, Dr. Jones participated in a study of patients’ attitudes 4 years after gastric bypass and gastric banding (Obes Surg. 2019;29:1624-31).
“Weight loss surgery is neither risk free nor universally effective, yet few studies have examined what proportion of patients regret having undergone weight loss surgery,” he noted.
Dr. Jones and colleagues interviewed patients at two weight loss surgery centers and used specific metrics and a multivariate analysis to examine associations among weight loss, quality of life, and decision regret.
A total of 205 Roux-en-Y gastric bypass (RYGB) patients responded at 1 year after surgery: 181, 156, and 134 patients responded at 2, 3, and 4 years, respectively.
At 1 year, 2% reported regret and that they would not choose the surgery again, and by 4 years, 5% reported regret, based on overall regret scores greater than 50. In addition, 13% of patients at 1 year and 4 years reported that weight loss surgery caused “some” or “a lot” of negative effects.
The researchers also interviewed gastric band patients: 170, 157, 146, and 123 responded at years 1,2,3, and 4.
Overall, 8% of these patients expressed regret at 1 year, and 20% expressed regret at 4 years, said Dr. Jones.
“Almost 20% did not think they made the right decision,” he said.
Dr. Jones noted. An average weight loss of 7.4% of excess body weight was associated with regret scores greater than 50, while an average weight loss of 21.1% was associated with regret scores less than 50, he said.
In addition, poor sexual function, but not weight loss or other quality-of-life factors was significantly associated with regret among RYGB patients.
Many surgeons are performing sleeve gastrectomies, which appear to yield greater weight loss than gastric banding and fewer complications than gastric bypass, said Dr. Jones. His study did not include sleeve gastrectomies, but “I expect a sleeve gastrectomy to do pretty well in this analysis,” and to be associated with less patient regret, he said.
Overall, better patient education is key to improving patients’ experiences and reducing feelings of regret, said Dr. Jones.
“The better patients understand the difference between band, bypass, and sleeve preoperatively, the better we can set expectations,” he said. Dr. Jones’ institution has developed an app for laparoscopic sleeve that guides patients through the process from preop through postoperative stay, he noted.
Given the association between amount of weight lost and regret, “setting expectations is very important,” and could include not only written consent but also webinars, information sessions, and apps for patients in advance to help mitigate regrets after the procedure, Dr. Jones concluded.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones disclosed serving on the medical advisory board for Allurion.
FROM MISS
Managing pain expectations is key to enhanced recovery
Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.
, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.
Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.
Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO2 bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.
The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.
Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.
In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.
Questions include whether the opioid-free technique translates more broadly, he said.
In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.
Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.
Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.
, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.
Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.
Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO2 bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.
The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.
Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.
In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.
Questions include whether the opioid-free technique translates more broadly, he said.
In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.
Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.
Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.
, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.
Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.
Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO2 bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.
The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.
Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.
In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.
Questions include whether the opioid-free technique translates more broadly, he said.
In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.
Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.
FROM MISS
Pursue multimodal pain management in patients taking opioids
For surgical patients on chronic opioid therapy, , according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.
“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.
A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.
Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.
Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.
“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.
Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.
“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones had no financial conflicts to disclose.
For surgical patients on chronic opioid therapy, , according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.
“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.
A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.
Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.
Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.
“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.
Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.
“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones had no financial conflicts to disclose.
For surgical patients on chronic opioid therapy, , according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.
“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.
“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.
A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.
Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.
Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.
“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.
Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.
“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.
Global Academy for Medical Education and this news organization are owned by the same parent company.
Dr. Jones had no financial conflicts to disclose.
FROM MISS
ACIP plans priority groups in advance of COVID-19 vaccine
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
according to Sarah Mbaeyi, MD, MPH, of the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases.
A COVID-19 vaccine work group is developing strategies and identifying priority groups for vaccination to help inform discussions about the use of COVID-19 vaccines, Dr. Mbaeyi said at a virtual meeting of the CDC’s Advisory Committee on Immunization Practices.
“Preparing for vaccination during a pandemic has long been a priority of the CDC and the U.S. government,” said Dr. Mbaeyi. The work group is building on a tiered approach to vaccination that was updated in 2018 after the H1N1 flu pandemic, with occupational and high-risk populations placed in the highest-priority groups, Dr. Mbaeyi said.
There are important differences between COVID-19 and influenza, Dr. Mbaeyi said. “Vaccine prioritization is challenging due to incomplete information on COVID-19 epidemiology and vaccines, including characteristics, timing, and number of doses.”
However, guidance for vaccine prioritization developed after the H1N1 outbreak in 2018 can be adapted for COVID-19.
To help inform ACIP deliberations, the work group reviewed the epidemiology of COVID-19. A large proportion of the population remains susceptible, and prioritizations should be based on data to date and continually refined, she said.
The work group defined the objectives of the COVID-19 vaccine program as follows: “Ensure safety and effectiveness of COVID-19 vaccines; reduce transmission, morbidity, and mortality in the population; help minimize disruption to society and economy, including maintaining health care capacity; and ensure equity in vaccine allocation and distribution.”
Based on current information, the work group has proposed that vaccine priority be given to health care personnel, essential workers, adults aged 65 years and older, long-term care facility residents, and persons with high-risk medical conditions.
Among these groups “a subset of critical health care and other workers should receive initial doses,” Dr. Mbaeyi said.
However, vaccines will not be administered until safety and efficacy have been demonstrated, she emphasized. The timing and number of vaccine doses are unknown, and subprioritization may be needed, assuming the vaccine becomes available in incremental quantities over several months.
Next steps for the work group are refinement of priority groups based on ACIP feedback, and assignment of tiers to other groups such as children, pregnant women, and racial/ethnic groups at high risk, Dr. Mbaeyi said.
The goal of the work group is to have a prioritization framework for COVID-19 vaccination to present at the next ACIP meeting.
Committee member Helen Keipp Talbot, MD, of Vanderbilt University, Nashville, Tenn., emphasized that “one of the things we need to know is how is the virus [is] transmitted and who is transmitting,” and that this information will be key to developing strategies for vaccination.
Sarah E. Oliver, MD, an epidemiologist at the National Center for Immunization and Respiratory Diseases, responded that household transmission studies are in progress that will help inform the prioritization process.
Dr. Mbaeyi and Dr. Oliver had no financial conflicts to disclose.
Older adults boost muscle mass after bariatric surgery
Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.
Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.
In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.
At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).
The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.
The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.
“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.
The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”
Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”
Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.
Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.
Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.
In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.
At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).
The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.
The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.
“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.
The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”
Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”
Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.
Bariatric surgery may yield increases in muscle mass from baseline among older adults, findings from a small study suggest.
Although bariatric surgery can be used to treat obesity and related comorbidities in older adults, “here are concerns of excess loss of muscle mass after bariatric surgery, especially in elderly patients whose muscle tends to be less, compared to younger patients, at baseline,” wrote Moiz Dawood, MD, of Banner Gateway Medical Center, Gilbert, Ariz., and colleagues.
In a study presented in a poster at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education, the researchers reviewed data from 89 adults older than 65 years (74% women) who underwent either laparoscopic sleeve gastrectomy (87 patients) or Roux-en-Y gastric bypass (2 patients) between May 2015 and March 2017.
At baseline, the average total body weight was 251 pounds and the average muscle mass percent was 50%. At 12 months after surgery, the average weight of the patients decreased to 197 pounds and the percentage of muscle mass increased to 55% (P < .001 for both).
The study findings were limited by the small sample size and retrospective design. However, the results support the benefits of bariatric surgery for older adults, not only with reductions in total body weight loss, but also increasing the total percentage of muscle mass, the researchers said.
The study is important in light of the ongoing discussion regarding the age limit for bariatric surgery, Dr. Dawood said in an interview. “Currently there is no upper age cutoff for patients who undergo bariatric surgery, and understanding the relationship between muscle mass and bariatric surgery would help in determining if there was a negative relationship,” he said.
“The results definitely point toward evidence that suggests that elderly patients do not lose muscle mass to a significant degree,” Dr. Dawood noted. “Muscle mass definitions and calculations also include variables such as weight and fat content. With the additional loss in weight after surgery, it was expected that the muscle mass composition would be affected,” he explained. “However, the results clearly show that even up to 1 year after surgery, older patients who lose weight do not lose significant weight from their muscle mass,” he noted.
The take-home message for clinicians, said Dr. Dawood, is “to understand that metabolic and bariatric surgery, when performed cohesively in a unified program that focuses on lifestyle and dietary changes, is the best way to achieve sustained weight loss.” He added, “this study indicates that physiologic changes that occur after weight loss surgery are not detrimental in the elderly population.”
Next steps for research include further studies in the elderly population to examine the physiologic changes that occur after weight loss surgery, said Dr. Dawood. “Being able to characterize the metabolic changes will help in answering the question of whether there is an upper age cut-off for patients undergoing bariatric surgery.”
Global Academy for Medical Education and this news organization are owned by the same parent company. The researchers had no relevant financial conflicts to disclose.
FROM MISS
Encourage parents to follow pediatric plans for vaccination
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
Outpatient medical care has been severely disrupted during the COVID-19 pandemic with a reduction of nearly 70% in outpatient visits since March before starting to rebound, Melinda Wharton, MD, said at the virtual meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
Pediatrics was among the hardest hit specialties, with a 62% reduction in outpatient visits by April 5, said Dr. Wharton, director of the immunization services division at the CDC’s National Center for Immunization and Respiratory Diseases. However, visits for all pediatric age groups increased in May, compared with April, and the CDC emphasized the need to educate families about the importance of routine vaccination and well-child visits, Dr. Wharton said.
The CDC strategies to support routine childhood vaccination include monitoring vaccination service delivery to inform targeted interventions, said Dr. Wharton. In addition, the CDC will continue to support providers by identifying gaps in the Vaccines For Children (VFC) program network, increasing VFC funding, developing guidance materials, and identifying policy interventions.
Many small practices have struggled during the pandemic, and financial support is available through the Provider Relief Fund, which is now available to all Medicaid and Children’s Health Insurance Program (CHIP) providers, said Dr. Wharton.
because more families may now qualify for the program because of changes in job status and income, and parents may not be aware that their children may be eligible, she said.
“Vaccination is an essential medical service for all children and adolescents, ideally in the medical home,” Dr. Wharton said. The CDC’s interim guidance for immunization during the COVID-19 pandemic calls for administering all current or overdue vaccines according to the routine immunization schedule during the same visit, and implementing strategies to get patients caught up, prioritizing newborns, infants, and children up to age 24 months. The guidance includes details on safe delivery of vaccines, including physical distance and the use of personal protective equipment.
In addition, encourage parents to return for well-child visits, and use reminder systems to help keep patients current on visits and vaccines. “Discuss the safety protocols that have been put in place,” Dr. Wharton emphasized. The CDC also offers resources for providers to help communicate with parents about routine vaccination.
Looking ahead, back-to-school vaccination requirements “provide a critical checkpoint for children’s vaccination status,” Dr. Wharton said. Catch-up vaccination during the summer will help clinical capacity manage back-to-school and influenza vaccination in the fall, she emphasized. “Influenza vaccination will be an important strategy to decrease stress on our health care system.”
Flu vaccination strategies should focus on adults at higher risk for COVID-19 infections, such as health care providers. In addition, identifying and reducing disparities will be important for future COVID-19 vaccines, as well as for the flu this season, she noted.
View the complete guidance online.
Dr. Wharton had no relevant financial disclosures.
ACIP approves flu vaccine recommendations for 2020-2021
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
– Fluzone high-dose quadrivalent, which replaces the trivalent Fluzone high-dose and Fluad quadrivalent (Seqirus), according to the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
At a virtual meeting on June 24, the committee voted unanimously to approve the vaccine recommendations for annual influenza immunization of all individuals aged 6 months and older. They also voted to accept some guidance and language changes to the recommendations.
The past flu season was unique in its overlap with the emergence of the COVID-19 coronavirus, which likely contributed to a third peak in reported cases of influenza-like illness at approximately week 14 of last season, said Lisa Grohskopf, MD, of the CDC’s influenza division, who presented data on last year’s activity and the updates for next season.
The CDC estimates that 39,000,000-56,000,000 flu illnesses occurred in the United States from Oct. 1, 2019, to April 4, 2020, said Dr. Grohskopf. Estimates also suggest as many as 740,000 hospitalizations and 62,000 deaths related to the seasonal flu.
Preliminary results of vaccine effectiveness showed 39% overall for the 2019-2020 season, with more substantial protection against influenza B and lower protection against A/H1N1pmd09.
Vaccine safety data from the Vaccine Adverse Event Reporting System and Vaccine Safety Datalink showed no new safety concerns for any flu vaccine types used last year, Dr. Grohskopf noted.
Based on this information, three components (A/H1N1pdm09, A/H3N2, and B/Victoria) have been updated for the 2020-2021 vaccines, said Dr. Grohskopf. The egg-based influenza vaccines will include hemagglutinin derived from an A/Guangdong-Maonan/SWL1536/2019(H1N1)pdm09–like virus, an A/Hong Kong/2671/2019(H3N2)–like virus and a B/Washington/02/2019 (Victoria lineage)–like virus, and (for quadrivalent vaccines) a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
Nonegg vaccines will contain hemagglutinin derived from an A/Hawaii/70/2019 (H1N1)pdm09–like virus, an A/Hong Kong/45/2019 (H3N2)–like virus, a B/Washington/02/2019 (Victoria lineage)–like virus, and a B/Phuket/3073/2013 (Yamagata lineage)–like virus.
New guidance for next year’s flu season includes a change to the language in the contraindications and precautions table to simply read “Contraindications,” with more details in the text explaining package insert contraindications and ACIP recommendations, Dr. Grohskopf said. In addition, updated guidance clarifies that live-attenuated influenza vaccine quadravalents (LAIV4) should not be used in patients with cochlear implants, active cerebrospinal fluid leaks, and anatomical or functional asplenia, based on ACIP’s review of the latest evidence and the availability of alternative vaccines.
ACIP also updated guidance on the use of antivirals and LAIV4. Based on half-lives, language was added indicating that clinicians should assume interference if antivirals are given within certain intervals of LAIV4, Dr. Grohskopf explained. “Newer antivirals peramivir and baloxavir have longer half-lives than oseltamivir and zanamivir, and insufficient data are available on the use of LAIV4 in the setting of antiviral use.”
The ACIP members had no financial conflicts to disclose.
Combined PH subtypes predicts poor survival in kidney disease
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
based on data from a retrospective study of 12,618 patients.
Pulmonary hypertension (PH) occurs in up to 41% of chronic kidney disease (CKD) patients, but most studies of PH in this population have not examined PH subtypes, wrote Daniel L. Edmonston, MD, of Duke University, Durham, N.C., and colleagues.
“Among patients with CKD with PH, the combined pre- and postcapillary PH subtype (elevated pulmonary capillary wedge pressure with increased pulmonary vascular resistance) may be a substantial contributor to the overall PH burden in CKD” because of factors including chronic volume overload, pulmonary vascular remodeling, inflammation, and comorbid lung disease, they wrote.
In a study published in the American Journal of Kidney Diseases, The researchers investigated subtypes of precapillary, postcapillary, and combination PH, and their associations with all-cause mortality for different levels of CKD severity. The study population included 12,618 adults aged 18 years and older with qualifying right-heart catheterizations. Of these, 4,772 had chronic kidney disease. The average age was 57 years in patients without CKD and 69 years in patients with CKD.
Overall, 73.4% of patients with CKD and 56.9% of patients without CKD had PH. For CKD patients, the most common PH subtypes were isolated postcapillary (39.0%) and combined pre- and postcapillary (38.3%).
Combined pre- and postcapillary PH was associated with higher mortality risk, compared with no PH in CKD patients, with adjusted hazard ratios of 1.89, 1.87, 2.13, and 1.63 for glomerular filtration rate categories G3a, G3b, G4, and G5/G5D, respectively.
For patients without CKD, precapillary PH was the most common subtype (35.9%) and was associated with the highest mortality risk, compared with no PH (HR, 2.27).
Relationships between mortality and specific PH features of mean pulmonary artery pressure, pulmonary capillary wedge pressure, and right atrial pressure were similar for patients with and without CKD.
The study findings were limited by several factors including the observational design, potential lack of generalizability because of the use of data from a single center, and lack of data on vascular access for hemodialysis, and exclusion of patients with heart or lung transplants, the researchers noted.
However, the results suggest that “processes that increase pulmonary vascular resistance and/ or remodeling represent a prominent mechanism and potential therapeutic target for patients with CKD that is complicated by PH,” they said.
Patients with CKD and combined pre- and postcapillary PH are at increased risk for mortality and “recognition of this large combined pre- and postcapillary PH cohort in CKD may present new therapeutic options,” they concluded.
The study was supported by the National Institutes of Health and the American Society of Nephrology. The researchers had no financial conflicts to disclose.
SOURCE: Edmonston DL et al. Am J Kidney Dis. 2019;75:713-24.
.
FROM THE AMERICAN JOURNAL OF KIDNEY DISEASES
New quadrivalent meningococcal vaccine joins VFC arsenal
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
No changes to the current meningococcal vaccination recommendations were made. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) voted 14-0 to include MenACWY-TT as an option for vaccination against meningococcal serogroups A, C, W, and Y in the VFC program. The vote took place in a virtual meeting held on June 24.
The currently available MenACWY vaccines in the United States are MenACWY-D (Menactra), MenACWY-CRW (Menveo), and MenACWY-TT (MedQuadfi), with MenACWY-TT approved by the Food and Drug Administration in April 2020.
Meningococcal vaccination is currently recommended for adolescents, with one dose at age 11 or 12 years and a booster at age 16 years, as well as individuals aged 2 months and older at increased risk for meningococcal disease, according to Lucy McNamara, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases.
Dr. McNamara presented considerations from the Meningococcal Work Group, which determined that the inclusion of MenACWY-TT “is of public health importance given recent vaccine licensure and to support security of vaccine supply.”
The Work Group reviewed 10 studies (phase 2 or 3) of MenACWY-TT that included data on short-term immune response, persistence of immune response, immune interference because of coadministration with other routine adolescent vaccines, and incidence of serious adverse events. Overall, the data showed noninferiority of MenACWY-TT, compared with other available products, in terms of response rates, as well as higher levels of immune response in some studies. Serious adverse events were similar, and none determined to be associated with the vaccines.
ACIP member Paul Hunter, MD, of the University of Milwaukee, Wisc., expressed some concerns about pain or side effects for the new vaccine and Tdap when given together. However, a study of coadministration of MedACWY-TT and Tdap, compared with Tdap alone, showed no impact on geometric mean titer ratios.
Overall, the Work Group concluded that “desirable effects outweigh undesirable effects” and that the data favor the inclusion of MenACWY-TT as an option for meningococcal vaccination.
The committee members and Dr. McNamara had no relevant financial conflicts to disclose.
LAA Closure noninferior to DOACs to prevent AF-related events
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
Left atrial appendage closure was noninferior to use of direct oral anticoagulants for the prevention of atrial fibrillation (AFib)–related events in high-risk patients, based on data from 402 adults.
Given the limitations of vitamin K antagonists for preventing stroke in AFib, “a novel site-specific therapeutic alternative, mechanical left atrial appendage occlusion [LAAO], entered clinical practice,” but has not been compared with current safe and effective oral anticoagulants, wrote Pavel Osmancik, MD, of University Hospital Kralovske Vinohrady, Prague, and colleagues.
In a study published in the Journal of the American College of Cardiology, the researchers randomized 201 moderate- or high-risk adults with nonvalvular AFib to LAAO and another 201 to direct oral anticoagulants (DOAC).
Patients in the LAAO group underwent transesophageal echocardiography to exclude left atrial thrombi and underwent implantation with Boston Scientific’s Watchman, Watchman-FLX, or Abbott’s Amulet devices. Patients in the DOAC group received rivaroxaban, apixaban, or dabigatran at the manufacturer-recommended dose.
The primary outcome was a composite of complications related to procedures or devices, thromboembolic events (including stroke), and clinically significant bleeding. After an average of 20 months follow-up, 35 patients in the LAAO group and 41 in the DOAC group met the primary outcome (11% per 100 patient-years vs. 13% per 100 patient-years).
In addition, no differences appeared between the groups for the endpoint components of all-stroke/transient ischemic attack event (subdistribution hazard ratio, 1.00), clinically significantly bleeding (sHR, 0.81), or cardiovascular death (sHR, 0.75).
Nine patients experienced major complications related to LAAO, including clinically significant bleeding (sHR, 0.81; 95% CI, 0.44-1.52) and cardiovascular death (sHR, 0.75; 95% CI, 0.34-1.62). Major LAAO-related complications occurred in nine (4.5%) patients, with a short-term (up to 7 days or hospital discharge) complication rate of 2.1% and a 2.7% late complication rate. The late complications included three pericardial effusions, one of which resulted in death, the researchers wrote.
The study findings were limited by several factors, including the inability to assess the differences among the components of the composite primary endpoint. For example, “Regarding the primary endpoint, stroke reduction may be more important than bleeding reduction,” the investigators wrote.
The results were strengthened, however, by the enrollment of a high-risk AF population and is the first known randomized trial to compare percutaneous LAAO and DOACs for stroke prevention in this group. But the late complication rate of 2.7% is “suboptimal” and safety issues reinforce the need for refinement of operator technique and device technology with LAAO, they concluded.
‘Important step forward,’ with caveats
“How LAAO might stack up against DOAC therapy has remained an open question: Compared with warfarin, DOACs are easier to use and are associated with a reduction in mortality, driven by a substantially lower risk of intracranial hemorrhage and fatal bleeding,” wrote Matthew J. Price, MD, of the Scripps Clinic in La Jolla, Calif., and Jacqueline Saw, MD, of Vancouver General Hospital, in an accompanying editorial.
Previous studies of LAAO have shown a reduced risk of gastrointestinal bleeding, but procedure hazards interfered with long-term benefits, they said. The current study findings of similar rates of stroke and lower bleeding rates with LAAO, compared with DOAC, “are provocative given the clinical consensus that DOACs are safer, well tolerated, and generally better than warfarin, which was an easy target for transcatheter LAAO, given warfarin’s extensive limitations,” the editorialists wrote. Although the findings lend support to the use of LAAO, clinicians should consider several caveats such as the inclusion of patients who were “not optimal candidates for long-term OAC but were selected because they were at high risk for bleeding or because OAC treatment had already failed.”
However, “despite its imperfections, PRAGUE-17 is an important step forward and reinforces the role of transcatheter LAAO as a stroke-prevention strategy for patients with [AFib] at high risk of bleeding or medical treatment failure, even in the modern era of the DOACs,” they concluded. “Going forward, successful enrollment in ongoing and planned clinical trials while avoiding off-label procedures will be critical to define the appropriate use of transcatheter LAAO in expanded patient populations.”
The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot. Dr. Price’s financial disclosures included honoraria, speaker bureau fees, and/or research grants from Abbott Vascular, AstraZeneca, Boston Scientific, Chiesi USA, Daiichi Sankyo, and Medtronic. Dr. Saw disclosed receiving unrestricted research grant support several Canadian research institutes and fees and honoraria from AstraZeneca, Abbott Vascular, Boston Scientific, and Servier, among other drug companies.
SOURCES: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Key clinical point:
Major finding: A composite primary outcome including stroke and death was not significantly different in high-risk patients randomized to left atrial appendage occlusion or direct oral anticoagulants at roughly 20 months’ follow-up (11% vs. 13%, respectively).
Study details: The data come from the PRAGUE-17 study, a randomized trial of 402 adults at increased risk for atrial fibrillation.
Disclosures: The study was supported by the Ministry of Health of the Czech Republic. Dr. Osmancik disclosed speaking honoraria from Bayer and Abbot.
Sources: Osmancik P et al. J Am Coll Cardiol. 2020;75:3122-35; Price MJ, Saw J. J Am Coll Cardiol. 2020;75:3136-9.