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Living-donor liver transplants linked with substantial survival benefit

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Changed
Tue, 09/13/2022 - 13:33

Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

Dr. Whitney Jackson

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

Dr. Renu Dhanasekaran

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

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Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

Dr. Whitney Jackson

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

Dr. Renu Dhanasekaran

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

Living-donor liver transplant recipients gained an additional 13-17 years of life, compared with patients who remained on the wait list, according to a retrospective case-control study.

The data suggest that the life-years gained are comparable to or greater than those conferred by either other lifesaving procedures or liver transplant from a deceased donor, wrote the researchers, led by Whitney Jackson, MD, assistant professor of gastroenterology and medical director of living-donor liver transplantation at the University of Colorado Anschutz Medical Campus.

Dr. Whitney Jackson

“Despite the acceptance of living-donor liver transplant as a lifesaving procedure for end-stage liver disease, it remains underused in the United States,” the authors wrote in JAMA Surgery. “This study’s findings challenge current perceptions regarding when the survival benefit of a living-donor transplant occurs.”

Dr. Jackson and colleagues conducted a retrospective, secondary analysis of the Scientific Registry of Transplant Recipients database for 119,275 U.S. liver transplant candidates and recipients from January 2012 to September 2021. They assessed the survival benefit, life-years saved, and the Model for End-Stage Liver Disease incorporating sodium levels (MELD-Na) score at which the survival benefit was obtained, compared with those who remained on the wait list.

The research team included 116,455 liver transplant candidates who were 18 and older and assigned to the wait list, as well as 2,820 patients who received a living-donor liver transplant. Patients listed for retransplant or multiorgan transplant were excluded, as were those with prior kidney or liver transplants.

The mean age of the study participants was 55 years, and 63% were men. Overall, 70.2% were White, 15.8% were Hispanic or Latinx, 8.2% were Black or African American, 4.3% were Asian, 0.9% were American Indian or Alaska Native, and 0.2% were Native Hawaiian or Pacific Islander. The most common etiologies were alcoholic cirrhosis (23.8%) and nonalcoholic steatohepatitis (15.9%).

Compared with patients on the wait list, recipients of a living-donor liver transplant were younger, more often women, more educated, and more often White. A greater proportion of transplant recipients had a primary etiology of nonalcoholic steatohepatitis (19.8%) and cholestatic liver disease (24.1%). At wait list placement, one-third of candidates had a MELD-Na score of 14 or higher.

The research team found a significant survival benefit for patients receiving a living-donor liver transplant based on mortality risk and survival scores. The survival benefit was significant at a MELD-Na score as low as 11, with a 34% decrease(95% confidence interval [CI], 17.4%-52.0%) in mortality compared with the wait list. In addition, mortality risk models confirmed a survival benefit for patients with a MELD-Na score of 11 or higher at 1 year after transplant (adjusted hazard ratio, 0.64; 95% CI, 0.47-0.88; P = .006). At a MELD-Na score of 14-16, mortality decreased by about 50% (aHR, 0.47; 95% CI, 0.34-0.66; P < .001).

The probability of death from a living-donor liver transplant for patients with very low MELD-Na scores (between 6 and 10) was greater than that for patients on the wait list for the first 259 days, at which point the risk of death for both groups was equal. At 471 days, the probability of survival in both groups was equal. As the MELD-Na score increased, both the time to equal risk of death and the time to equal survival decreased, demonstrating that the survival benefit occurs much earlier for patients with a higher MELD-Na score.

Analysis of life-years from transplant showed living-donor transplant recipients gained 13-17 life-years compared to those who didn’t receive one.

“Living-donor liver transplantation is a valuable yet underutilized strategy to address the significant organ shortage and long waiting times on the transplant list in the U.S.,” said Renu Dhanasekaran, MD, PhD, assistant professor of gastroenterology and hepatology at Stanford (Calif.) University.

Dr. Dhanasekaran, who wasn’t involved with this study, also welcomed the finding that living-donor liver transplantation can benefit patients with low MELD-Na scores, even below the expected cutoff at 15. According to the study authors, previous research had suggested benefit would be seen only at MELD-Na 15 and above.

Dr. Renu Dhanasekaran

“In my practice, I have several patients whose symptoms are out of proportion to their MELD score, and data like this will convince them and their potential donors to avail a transplant at an earlier stage,” she said.

The findings challenge the current paradigm around the timing of referral for a liver transplant and may have ramifications for allocation policies for deceased donors, the study authors wrote. The data can also help to contextualize risk-benefit discussions for donors and recipients.

“Donating a part of one’s liver to save a patient suffering from end-stage liver disease is an incredible act of selfless love,” Dr. Dhanasekaran said. “I hope strong positive data from studies like this one encourage more donors, patients, and transplant centers to expand the use of [living-donor liver transplant].”

The authors reported no grant support or funding sources for this study. One author disclosed being married to the current chair of the United Network for Organ Sharing’s Liver and Intestinal Organ Transplantation Committee. No other conflicts of interest were reported. Dr. Dhanasekaran reported no relevant disclosures.

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Prior decompensation in alcohol-associated hepatitis not an ‘absolute contraindication’ for early liver transplant

Article Type
Changed
Tue, 07/26/2022 - 14:32

Past decompensation in alcohol-associated hepatitis may be linked with worse survival following liver transplantation, but it’s not all bad news, according to a retrospective study.

Traditionally, patients with alcoholic liver disease were asked to be alcohol free for 6 months before consideration for a liver transplantation. In recent years, there’s been a loosening of that policy, with physicians considering “early” liver transplantation (early LT) instead of waiting 6 months. “It became obvious that a lot of patients do resume alcohol use after transplant, and most of them don’t appear to suffer too much in the way of adverse consequences,” said Paul Martin, MD, chief of hepatology at the University of Miami, who was not involved in the current research.

In 2011, a study confirmed that suspicion, finding that 6-month survival was 77% among carefully selected patients with alcohol-associated hepatitis for whom the 6-month sobriety requirement was waived; 6-month survival in those who did not receive a transplant was 22%. The selection criteria included the presence of supportive family members, the absence of severe coexisting conditions, and a commitment to abstaining from alcohol.

xray of injured liver
Sebastian Kaulitzki/Science Photo Library

However, authors of the current study, published in the American Journal of Gastroenterology sought nuance: The appropriateness of prior decompensation as exclusion criteria in published studies is unknown, so the researchers compared outcomes of patients with prior versus first-time liver decompensation in alcohol-associated hepatitis.
 

Not all bad news

The study included 241 patients from six sites who consecutively received early LT between 2007 and 2020. Among these, 210 were identified as having a first-time liver decompensation event and 31 as having had a prior history of liver decompensation, defined as being diagnosed with ascites, hepatic encephalopathy, variceal bleeding, or jaundice.

There was no significant difference in median age, Model for End-Stage Liver Disease (MELD) scores, or post–liver transplant follow-up time between those with first-time liver decompensation or a prior history. The unadjusted 1-year survival rate was 93% in the first decompensation group (95% confidence interval, 89%-96%) and 86% in the prior decompensation group (95% CI, 66%-94%). The unadjusted 3-year survival rates were 85% (95% CI, 79%-90%) and 78% (95% CI, 57%-89%), respectively.

Importantly, the researchers found an association between prior decompensation and higher adjusted post–liver transplantation mortality (adjusted hazard ratio, 2.72; 95% CI, 1.61-4.59) and harmful alcohol use (aHR, 1.77; 95% CI, 1.07-2.92).

However, the researchers noted that these patients, who had MELD scores of 39 and previous decompensation, were at exceptionally high risk of short-term mortality, but still had 1- and 3-year survival rates above 85% and 75%, respectively, with early LT. “While longer follow-up is desirable as graft failure related to alcohol is most apparent after 5-years post LT, these results suggest that prior decompensation alone should not be considered an absolute contraindication to early LT.”

Limitations of the study included its retrospective data and small sample size for patients with prior decompensation.

“These findings validate the value of the ‘first decompensation’ criteria in published experiences regarding early LT for [alcoholic hepatitis],” the investigators concluded. “Further larger and prospective studies with longer-term follow-up will be needed to assess ways to optimally select patients in this cohort who may benefit most from early LT, and ways to manage patients at highest risk for worse outcomes post LT.”
 

 

 

A note of caution for early LT

About half of all liver mortality is attributable to alcoholic-associated liver disease. Corticosteroids can improve short-term survival, but there are no medications proven to increase long-term survival. That leaves liver transplant as the sole alternative for patients who don’t respond to corticosteroids.

“Programs in North America have liberalized their acceptance criteria for patients with alcoholic liver disease, and that’s resulted in large numbers of patients being transplanted who have less than 6 months abstinence. And overall, the results seem good, but I think this paper strikes an appropriate note of caution. In essence, if a patient had at least one prior episode of liver failure related to alcoholic excess and had recovered from that, and continued to drink and got into trouble again, [and then] presented for consideration for liver transplantation, the fact that they resumed alcohol use after prior episodes of decompensation suggests that they may be less-than-ideal candidates [for liver transplantation],” said Dr. Martin.

He pointed out important caveats to the study, including its retrospective nature and its inclusion of a relatively small number of patients with a history of liver decompensation. But it reinforces what physicians generally know, which is that some patients with severe alcohol use disorder also have liver failure, and they tend to fare worse than others after a liver transplant.

Still, physicians also face a conundrum because there are increasing numbers of younger patients who won’t survive if they don’t get a liver transplant. “The challenge is picking out patients who are going to be good candidates from a purely medical point of view, but have a low likelihood of resuming alcohol use after transplantation [which could injure] the new liver,” said Dr. Martin. The new study has the potential to provide some additional guidance in patient selection.

The study authors disclosed no relevant conflicts of interest. Dr. Martin has no relevant financial disclosures.

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Past decompensation in alcohol-associated hepatitis may be linked with worse survival following liver transplantation, but it’s not all bad news, according to a retrospective study.

Traditionally, patients with alcoholic liver disease were asked to be alcohol free for 6 months before consideration for a liver transplantation. In recent years, there’s been a loosening of that policy, with physicians considering “early” liver transplantation (early LT) instead of waiting 6 months. “It became obvious that a lot of patients do resume alcohol use after transplant, and most of them don’t appear to suffer too much in the way of adverse consequences,” said Paul Martin, MD, chief of hepatology at the University of Miami, who was not involved in the current research.

In 2011, a study confirmed that suspicion, finding that 6-month survival was 77% among carefully selected patients with alcohol-associated hepatitis for whom the 6-month sobriety requirement was waived; 6-month survival in those who did not receive a transplant was 22%. The selection criteria included the presence of supportive family members, the absence of severe coexisting conditions, and a commitment to abstaining from alcohol.

xray of injured liver
Sebastian Kaulitzki/Science Photo Library

However, authors of the current study, published in the American Journal of Gastroenterology sought nuance: The appropriateness of prior decompensation as exclusion criteria in published studies is unknown, so the researchers compared outcomes of patients with prior versus first-time liver decompensation in alcohol-associated hepatitis.
 

Not all bad news

The study included 241 patients from six sites who consecutively received early LT between 2007 and 2020. Among these, 210 were identified as having a first-time liver decompensation event and 31 as having had a prior history of liver decompensation, defined as being diagnosed with ascites, hepatic encephalopathy, variceal bleeding, or jaundice.

There was no significant difference in median age, Model for End-Stage Liver Disease (MELD) scores, or post–liver transplant follow-up time between those with first-time liver decompensation or a prior history. The unadjusted 1-year survival rate was 93% in the first decompensation group (95% confidence interval, 89%-96%) and 86% in the prior decompensation group (95% CI, 66%-94%). The unadjusted 3-year survival rates were 85% (95% CI, 79%-90%) and 78% (95% CI, 57%-89%), respectively.

Importantly, the researchers found an association between prior decompensation and higher adjusted post–liver transplantation mortality (adjusted hazard ratio, 2.72; 95% CI, 1.61-4.59) and harmful alcohol use (aHR, 1.77; 95% CI, 1.07-2.92).

However, the researchers noted that these patients, who had MELD scores of 39 and previous decompensation, were at exceptionally high risk of short-term mortality, but still had 1- and 3-year survival rates above 85% and 75%, respectively, with early LT. “While longer follow-up is desirable as graft failure related to alcohol is most apparent after 5-years post LT, these results suggest that prior decompensation alone should not be considered an absolute contraindication to early LT.”

Limitations of the study included its retrospective data and small sample size for patients with prior decompensation.

“These findings validate the value of the ‘first decompensation’ criteria in published experiences regarding early LT for [alcoholic hepatitis],” the investigators concluded. “Further larger and prospective studies with longer-term follow-up will be needed to assess ways to optimally select patients in this cohort who may benefit most from early LT, and ways to manage patients at highest risk for worse outcomes post LT.”
 

 

 

A note of caution for early LT

About half of all liver mortality is attributable to alcoholic-associated liver disease. Corticosteroids can improve short-term survival, but there are no medications proven to increase long-term survival. That leaves liver transplant as the sole alternative for patients who don’t respond to corticosteroids.

“Programs in North America have liberalized their acceptance criteria for patients with alcoholic liver disease, and that’s resulted in large numbers of patients being transplanted who have less than 6 months abstinence. And overall, the results seem good, but I think this paper strikes an appropriate note of caution. In essence, if a patient had at least one prior episode of liver failure related to alcoholic excess and had recovered from that, and continued to drink and got into trouble again, [and then] presented for consideration for liver transplantation, the fact that they resumed alcohol use after prior episodes of decompensation suggests that they may be less-than-ideal candidates [for liver transplantation],” said Dr. Martin.

He pointed out important caveats to the study, including its retrospective nature and its inclusion of a relatively small number of patients with a history of liver decompensation. But it reinforces what physicians generally know, which is that some patients with severe alcohol use disorder also have liver failure, and they tend to fare worse than others after a liver transplant.

Still, physicians also face a conundrum because there are increasing numbers of younger patients who won’t survive if they don’t get a liver transplant. “The challenge is picking out patients who are going to be good candidates from a purely medical point of view, but have a low likelihood of resuming alcohol use after transplantation [which could injure] the new liver,” said Dr. Martin. The new study has the potential to provide some additional guidance in patient selection.

The study authors disclosed no relevant conflicts of interest. Dr. Martin has no relevant financial disclosures.

Past decompensation in alcohol-associated hepatitis may be linked with worse survival following liver transplantation, but it’s not all bad news, according to a retrospective study.

Traditionally, patients with alcoholic liver disease were asked to be alcohol free for 6 months before consideration for a liver transplantation. In recent years, there’s been a loosening of that policy, with physicians considering “early” liver transplantation (early LT) instead of waiting 6 months. “It became obvious that a lot of patients do resume alcohol use after transplant, and most of them don’t appear to suffer too much in the way of adverse consequences,” said Paul Martin, MD, chief of hepatology at the University of Miami, who was not involved in the current research.

In 2011, a study confirmed that suspicion, finding that 6-month survival was 77% among carefully selected patients with alcohol-associated hepatitis for whom the 6-month sobriety requirement was waived; 6-month survival in those who did not receive a transplant was 22%. The selection criteria included the presence of supportive family members, the absence of severe coexisting conditions, and a commitment to abstaining from alcohol.

xray of injured liver
Sebastian Kaulitzki/Science Photo Library

However, authors of the current study, published in the American Journal of Gastroenterology sought nuance: The appropriateness of prior decompensation as exclusion criteria in published studies is unknown, so the researchers compared outcomes of patients with prior versus first-time liver decompensation in alcohol-associated hepatitis.
 

Not all bad news

The study included 241 patients from six sites who consecutively received early LT between 2007 and 2020. Among these, 210 were identified as having a first-time liver decompensation event and 31 as having had a prior history of liver decompensation, defined as being diagnosed with ascites, hepatic encephalopathy, variceal bleeding, or jaundice.

There was no significant difference in median age, Model for End-Stage Liver Disease (MELD) scores, or post–liver transplant follow-up time between those with first-time liver decompensation or a prior history. The unadjusted 1-year survival rate was 93% in the first decompensation group (95% confidence interval, 89%-96%) and 86% in the prior decompensation group (95% CI, 66%-94%). The unadjusted 3-year survival rates were 85% (95% CI, 79%-90%) and 78% (95% CI, 57%-89%), respectively.

Importantly, the researchers found an association between prior decompensation and higher adjusted post–liver transplantation mortality (adjusted hazard ratio, 2.72; 95% CI, 1.61-4.59) and harmful alcohol use (aHR, 1.77; 95% CI, 1.07-2.92).

However, the researchers noted that these patients, who had MELD scores of 39 and previous decompensation, were at exceptionally high risk of short-term mortality, but still had 1- and 3-year survival rates above 85% and 75%, respectively, with early LT. “While longer follow-up is desirable as graft failure related to alcohol is most apparent after 5-years post LT, these results suggest that prior decompensation alone should not be considered an absolute contraindication to early LT.”

Limitations of the study included its retrospective data and small sample size for patients with prior decompensation.

“These findings validate the value of the ‘first decompensation’ criteria in published experiences regarding early LT for [alcoholic hepatitis],” the investigators concluded. “Further larger and prospective studies with longer-term follow-up will be needed to assess ways to optimally select patients in this cohort who may benefit most from early LT, and ways to manage patients at highest risk for worse outcomes post LT.”
 

 

 

A note of caution for early LT

About half of all liver mortality is attributable to alcoholic-associated liver disease. Corticosteroids can improve short-term survival, but there are no medications proven to increase long-term survival. That leaves liver transplant as the sole alternative for patients who don’t respond to corticosteroids.

“Programs in North America have liberalized their acceptance criteria for patients with alcoholic liver disease, and that’s resulted in large numbers of patients being transplanted who have less than 6 months abstinence. And overall, the results seem good, but I think this paper strikes an appropriate note of caution. In essence, if a patient had at least one prior episode of liver failure related to alcoholic excess and had recovered from that, and continued to drink and got into trouble again, [and then] presented for consideration for liver transplantation, the fact that they resumed alcohol use after prior episodes of decompensation suggests that they may be less-than-ideal candidates [for liver transplantation],” said Dr. Martin.

He pointed out important caveats to the study, including its retrospective nature and its inclusion of a relatively small number of patients with a history of liver decompensation. But it reinforces what physicians generally know, which is that some patients with severe alcohol use disorder also have liver failure, and they tend to fare worse than others after a liver transplant.

Still, physicians also face a conundrum because there are increasing numbers of younger patients who won’t survive if they don’t get a liver transplant. “The challenge is picking out patients who are going to be good candidates from a purely medical point of view, but have a low likelihood of resuming alcohol use after transplantation [which could injure] the new liver,” said Dr. Martin. The new study has the potential to provide some additional guidance in patient selection.

The study authors disclosed no relevant conflicts of interest. Dr. Martin has no relevant financial disclosures.

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Colonic Crohn’s: Segmental vs. total colectomy

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Changed
Fri, 07/22/2022 - 12:07

Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.

Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.

CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.

The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.

Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).

The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.

The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.

Morbidity and mortality were similar in the SC and TC groups.

Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.

The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.

“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.

“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“

The authors and Dr. Regueiro declared no relevant financial relationships.

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Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.

Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.

CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.

The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.

Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).

The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.

The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.

Morbidity and mortality were similar in the SC and TC groups.

Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.

The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.

“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.

“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“

The authors and Dr. Regueiro declared no relevant financial relationships.

Segmental rather than total colectomy may be a safe and effective choice for some patients with colonic Crohn’s disease (cCD), showing significantly lower rates of repeat surgery and reduced need for stoma, according to long-term data.

Gianluca Pellino, MD, with the department of advanced medical and surgical sciences, Università degli Studi della Campania “Luigi Vanvitelli” in Naples, Italy, led the study, which was published in the Journal of Crohn’s and Colitis.

CD of the colon has gotten less attention than the more prevalent small bowel disease, according to the authors, but it can be debilitating and permanently reduce quality of life. Isolated cCD incidence ranges between 14% and 32% of all CD cases from the start of disease. Historically, extensive resection has been linked with longer disease-free intervals, and reduced repeat surgeries compared with segmental resections. However, most of the data have included low-quality evidence and reports typically have not adequately considered the role of biologics or advances in perioperative management of patients with cCD, the authors wrote.

The Segmental Colectomy for Crohn’s disease (SCOTCH) international study included a retrospective analysis of data from six European Inflammatory Bowel Disease referral centers on patients operated on between 2000 and 2019 who had either segmental or total colectomy for cCD.

Among 687 patients (301 male; 386 female), segmental colectomy was performed in 285 (41.5%) of cases and total colectomy in 402 (58.5%). The 15-year surgical recurrence rate was 44% among patients who had TC and 27% for patients with segmental colectomy (P = .006).

The SCOTCH study found that segmental colectomy may be performed safely and effectively and reduce the need for stoma in cCD patients without increasing risk of repeat surgeries compared with total colectomy, which was the primary measure investigators studied.

The findings of this study also suggest that biologics, when used early and correctly, may allow more conservative options for cCD, with a fivefold reduction in surgical recurrence risk in patients who have one to three large bowel locations.

Morbidity and mortality were similar in the SC and TC groups.

Among the limitations of the study are that the total colectomy patients in the study had indications for total colectomy that were also higher risk factors for recurrence – for instance, perianal disease.

The authors wrote, “The differences between patients who underwent SC vs TC might have accounted for the choice of one treatment over the other. It is however difficult to obtain a homogenous population of cCD patients.” They also cite the difficulties in gathering enough patients for randomized trials.

“These findings need to be discussed with the patients, and the choice of operation should be individualised,” they concluded. “Multidisciplinary management of patients with cCD is of critical importance to achieve optimal long-term results of bowel-sparing approaches.”

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at the Cleveland Clinic, who was not part of the study, told this publication the findings should be considered confirmatory rather than suggestive of practice change.

“If a patient has a limited segment of Crohn’s, for example ileocecal Crohn’s – a common phenotype – then the standard of care is a segmental resection and primary anastomosis,” he said. “If the patient has more extensive CD – perianal fistula, colonic-only CD – they’re more likely to undergo a total colectomy. This study confirms that.“

The authors and Dr. Regueiro declared no relevant financial relationships.

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Gender surgeons on TikTok, Instagram: Appropriate or not?

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Mon, 07/11/2022 - 16:28

A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

 

 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

 

 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

 

 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

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A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

 

 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

 

 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

 

 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

A woman wearing purple surgical scrubs stares into a camera, looking frustrated, but doesn’t speak. Superimposed over her head is the text “just realized I only get to Yeet 4 Teets next week,” and a crying emoji. Rain appears to drip down over her while “Stan” by Eminem plays in the background.

That October 2020 TikTok by Sidhbh Gallagher, MD, a Miami-based plastic surgeon known as @gendersurgeon, had almost 10,000 likes and was tagged #topsurgery, #masculoplasty, #ftm, and #transman, among other hashtags.

“What health check do I have to get in preparation for teetus deletus?” is the question in another Dr. Gallagher TikTok. Dr. Gallagher is a prolific user of social media with over 268K TikTok followers and over 44K Instagram followers. Another Dr. Gallagher TikTok account, @thevagicianmd, has some 7K followers.

Another cosmetic surgeon, Tony Mangubat, MD, known as @Tikdoctony to his more than 200K followers, uses similar hashtags – like #teetusdeleetus – in his TikToks.

Clearly not medical terms, hashtags like #yeettheteet and #teetusdeletus are often used by the transgender community. The posts by Dr. Gallagher and Dr. Mangubat are part of an ever-growing wave of social media activity by medical professionals.  

Plastic surgeons have never been shy about advertising their work – and many have taken to social media to do so, including showing before and after photos. A 2020 study published in Plastic and Reconstructive Surgery found that the majority of such surgeons, especially those in private practice, use social media.

But the use of TikTok, Instagram, and other social media platforms by surgeons who specialize in gender reassignment raises questions about the appropriateness of promoting such procedures, especially to a younger-skewing audience.

Because of the limits on pornography and nudity of social media platforms, most social media posts by gender surgeons are about female-to-male (FTM) mastectomies, the fastest-growing transgender procedure.

The American Society of Plastic Surgeons (ASPS) started separately tracking gender-affirmation procedures in 2015. That year, members reported doing 1,360 FTM procedures.

In 2020, the ASPS further separated procedures into additional categories. That year – when many surgeries were postponed because of the COVID-19 pandemic – FTM mastectomies grew by 15%, with 8,548 procedures performed, a far greater number than for any other transgender surgery, and a sixfold increase in the number of procedures done in 2015.
 

‘Gimmicky,’ but building community

Surgeons interviewed for this article said they use social media primarily to connect with patients and to educate in a light-hearted way.

While Dr. Gallagher acknowledges that using #teetusdeletus is “kind of gimmicky,” she said she doesn’t view it as unprofessional because she is “using the words of the community I serve.” Many of her patients have seen a medical professional “who just didn’t understand what it is to have gender dysphoria, didn’t understand what it is to be trans, so going from that experience to somebody who uses the same language as the community uses can be quite a comfortable experience,” she said in an interview.

Dr. Mangubat, a Seattle-area plastic surgeon who has been doing mastectomies for trans male patients since 1988, said he tailors his TikToks to that group. He likes TikTok – which he started using in early 2021 – because it has rules against bullying, swearing, and pornography, he told this news organization.

“It’s really not ... advertising ... it’s a community-building platform,” said Dr. Mangubat. “If you build community, people will trust you, and if you provide good accurate information, then people will be safer,” he said. 

But, “I’m not telling them to come to me,” he stressed.

He always appears in scrubs and doesn’t do music, doesn’t dance, and doesn’t post before and after photos, but he still gets thousands – or sometimes hundreds of thousands – of likes.

His mission, he said, is to answer the community’s questions. “We’re reaching patients that have had their top surgery, that are going to have their top surgery, that are looking for how to get top surgery, that are just starting on testosterone, that haven’t started on testosterone – it’s the whole spectrum of patients,” said Dr. Mangubat.
 

 

 

Risks downplayed?

Other surgeons have expressed concern about ethical boundaries and the tendency of social media posts to downplay risks of what are life-changing procedures.

A 2020 study of YouTube videos on top surgery, for instance, concluded that “there were no unbiased videos by board-certified plastic surgeons explaining the risks, benefits, treatment options, and alternatives to surgery.”

Alison Clayton, MBBS, an Australian psychiatrist, said that social media posts can create false expectations because they emphasize style over substance, omit risks, and can create an unwarranted sense of trust in the doctor that can spill over into the physician-patient relationship.

Dr. Clayton also believes that “the gender-affirming surgical procedures being offered to these youth have a scant empirical evidence base for benefits to psychological health and well-being.”

It is known that a number of those who transition, using either opposite sex hormones and/or surgical procedures, later have regret and “detransition,” but statistics are lacking. It is also a controversial area, with many detransitioners saying they didn’t get appropriate care and weren’t properly assessed before being given hormones or heading to surgery.

Most of the gender surgeons interviewed for this article said they see almost “zero” regret if proper mental health evaluations are performed before surgery, and they added, the procedures can relieve dysphoria.

Nevertheless, posts should not be “all fun and games,” said Josef Hadeed, MD, chair of the ASPS Patient Safety Committee and Public Education Committee and a member of its Social Media Subcommittee.

“When someone makes a decision to undergo a surgical procedure, they should be very aware there are some risks and potentially serious risks involved,” he told this news organization.

The ASPS “wants members to use social media in a judicious manner” in a way that educates the public and encourages patients to learn about a procedure and to consult with board-certified plastic surgeons, said Dr. Hadeed.

The Beverly Hills, Calif.–based surgeon does gender-affirmation procedures himself and uses Instagram, on which he has 53.4K followers, to educate patients and highlight his work using before and after photos.

“I like to think I do it in a very tasteful way,” Dr. Hadeed said. “It’s not in a way that’s sort of suggestive to patients, including minors, that this is something they need to get done, because if they are thinking about getting it done there is a lengthy process that they have to go through before they even set foot in our office.”

And he said “it may be inappropriate” to use certain hashtags or terminology, “even if it does ‘speak’ to the patients. Professionally, plastic surgeons should maintain a higher standard and maintain that even with their social media.”

Marci Bowers, MD, a gynecologic surgeon who performs gender-affirming procedures, and who is transgender herself, agreed.

“Some of the posts out there seem sensational, distasteful, and risk compromising patient confidentiality,” Dr. Bowers said in an interview.

“Much of this seemed to cross the line of good taste and appropriateness,” added Dr. Bowers, who is the incoming president of the World Professional Association for Transgender Health (WPATH). “Creating an idealized video without addressing risk is inappropriate and misleading,” she stressed.

“These surgeons would perhaps better serve their clients by focusing on and improving their clinical care,” she added.  

Dr. Bowers said that although WPATH has not addressed social media use in the past, its ethics committee will be taking on the topic this year.

Social media posts about gender-affirming procedures “don’t usually talk about the barriers, they don’t talk about bad outcomes, they tend to just focus on success stories,” said Gwendolyn P. Quinn, MD, a bioethicist, and Livia S. Wan, MD, professor of obstetrics and gynecology at the NYU Grossman School of Medicine.

But she also sees some positives. The posts can help normalize gender-affirming surgery, and post-procedure photos might “help people realize that they can’t just have everything exactly the way they want it to be,” said Dr. Quinn.
 

 

 

Does social media influence or educate?

Studies have documented the power of social media to influence desire and decisionmaking, especially when it comes to cosmetic surgery.

“The use of social media creates a vague area between patient confidentiality and entertainment,” writes Nisha Gupta and colleagues of the UCLA David Geffen School of Medicine in a review published in the Aesthetic Surgery Journal.

While social media use is on the rise by plastic surgeons and has the potential to educate, it has also “compromised the integrity of the doctor-patient relationship,” they add.

Surgeons can use tools to place themselves higher in searches, and patients might assume that those who have hundreds of thousands of followers “are the most qualified or trusted, although this is not always the case,” they note.

Markus Rach, PhD, a researcher with the University of Applied Sciences and Arts Northwestern Switzerland, analyzed the impact of TikTok’s plastic surgery content on how adolescents perceived themselves and how it influenced their decision to have a procedure.

Most TikTok users are under age 24, and #plasticsurgery has a huge viewership with some 3.8 billion views at the time of publication, said Dr. Rach. He found that influencers tended to make adolescents feel bad and want surgery but that plastic surgeons had a moderating effect on both negative feelings and the intent to get surgery.

Dr. Bowers said that, despite her concerns, she does not “believe social media influences like TikTok and Facebook create artificial demand.”

However, Dr. Mangubat said social media can make plastic surgery seem enticing. “It can happen, and it does happen,” he said, but he added that’s true for any cosmetic procedure, not just gender-affirming surgery.

The pitfall with social media is that “patients are being sold a vision of themselves that may or may not be possible,” he observed.

Dr. Quinn worries less about people being talked into a procedure and more about those who don’t want surgery.

“There are people who identify as transgender but do not feel the need to change any parts of their body,” she said. “And that should be okay.”
 

Concerns about minors

New guidance from WPATH, their Standards of Care (SOC) 8 – the first update in 10 years – are due to be published this month. As reported by this news organization, and as stated in the draft of the SOC 8 published for comment in December 2021, the organization has recommended lowering the age for “top” surgery from 18 to 15 years.

Dr. Clayton has concerns about young people with gender dysphoria, who she says are “often vulnerable youth, many of whom have comorbid psychiatric and neurodevelopmental disorders.”

“This may contribute to a greater vulnerability of this population to undue influence,” added Dr. Clayton.

Sean Devitt, MD, and Jeffrey M. Kenkel, MD, of the University of Texas Southwestern Medical Center, Dallas, expressed concern that social media posts by plastic surgeons could be especially dangerous for young people.

“Given that the prefrontal cortex, which is largely responsible for impulse control, is not fully developed until the age of 25, is it ethical to allow younger patients to make life-lasting decisions under the guise of education?” they ask in a commentary on the review by Ms. Gupta and colleagues about plastic surgeons’ use of social media. The review did not focus on gender-affirmation procedures.

Many surgeons – but not all – steer clear of genital (“bottom”) surgeries in minors. However, bilateral mastectomies are being performed in those as young as age 13 based on surgeons’ risk-benefit calculus for the patient.

A study, published in May in the Annals of Plastic Surgery, showed there was a 13-fold increase in the number of bilateral mastectomies performed on under-18s between January 2013 and the end of July 2020. Of the 209 minors (age 12-17) who had the surgery, two (0.95%) expressed regret by the time of follow-up, at 3 and 7 years post-operatively, but neither had reversal surgery.

A small 2018 study, published in JAMA Pediatrics, among trans males who had top surgery found high rates of satisfaction, though one of the 68 patients reported experiencing regret “sometimes.” The mean age of patients in the surgical group was 19 years and the youngest patient was 14.

“Most of us who practice heavily in this field will make exceptions, not for genital surgery but typically for top surgery,” said Dr. Gallagher, who added that she operates on one minor [under 18] a month, while doing some 400-500 gender-affirmative surgeries a year. For some patients, “doing nothing isn’t necessarily a no-harm option,” said Dr. Gallagher.

“Arbitrarily picking the age of 18 and sentencing that patient to another year of dysphoria” might not be the best risk-benefit calculus, she said.  

Dr. Mangubat agrees, especially if, for example, a trans man develops double D breasts by age 14. “You’ve sentenced them to 4 years of misery” before they can get insurance coverage, he said. His youngest top surgery patient was age 15. He said the person’s family, mental health professional, and primary care physician were all in favor of the procedure.

Dr. Mangubat also noted that some insurers, such as Kaiser Permanente, now cover bilateral mastectomy starting at age 16.

Dr. Quinn, the bioethicist, said not every minor or young adult is equipped to make the best long-term decisions.

She works with younger patients who have cancer, for example, and said her suggestions that they consider fertility preservation are often met with protestations “that they will never have children.”

The same issue arises with transgender patients. They may not want to think about having children or issues such as breast feeding while in their teens or early 20s. “But you know from your experience that they may feel differently in 10 years, but they’re just not in the mind frame to think about it,” said Dr. Quinn.

Some young people may accurately never want children, said Dr. Quinn, “but there is a lack of maturity shown when a person just shuts down a conversation and won’t even listen to infertility threats and potential preservation options.”  
 

 

 

Concerns about regret?

Dr. Gallagher said she follows the WPATH standards, which require mental health evaluations, and as a result, “the risk of regret is incredibly low.”

However, one of Dr. Gallagher’s patients who detransitioned, Grace, who goes by @HormoneHangover on social media, said she has taken umbrage at some of the Miami surgeon’s TikToks, including one, “Why might some patients feel sad after surgery ... despite wanting it for so long??”

“This is actually not uncommon with ANY kind of surgery, but it’s temporary!” said the TikTok text. Dr. Gallagher is wearing a red dress and heels and flips her hair while the text scrolls above her.

But to Grace, the TikTok “really bothered me, because sometimes there is regret, and I think that sort of advertising paints a falsely rosy picture,” she said in an interview.

And it is emblematic of what she feels was Dr. Gallagher’s “breezy” approach to explaining the procedure to her. “The surgery itself was a shocking experience for me,” she said. “The physical experience was very jarring. It was very disturbing in a way I hadn’t anticipated or understood in advance,” said Grace.

Dr. Mangubat, who does 100 bilateral mastectomies in trans patients a year, said he goes to great lengths to ensure his patients are good candidates. Everyone – even those who self-pay – must have counseling, and if the individual seems to be considering the surgery because it’s “trendy,” he steers clear.

“If they’re not serious about it, I don’t want to operate on them,” said Dr. Mangubat. “There have been maybe two patients who have come back” to detransition, he said. 

Dr. Hadeed also said he has not seen regret. He attributes this to his vetting process, which includes investigating the background of the mental health professionals who write support letters.

“We’ve turned away a lot of patients from our office either because of inadequate letters or because the person writing the letter just doesn’t really have any proper credentials,” he said.
 

Is social media use by plastic surgeons the new normal?

With so many plastic surgeons – including those who perform transgender procedures – using social media, it may increasingly be just part of doing business.

“Undoubtedly gender surgery teams will have a greater presence on social media in the future,” write Alireza Hamidian Jahromi, MD, and a colleague of the plastic surgery department at Rush University Medical Center, Chicago, in a letter published in Plastic and Reconstructive Surgery.  

Kyle R. Latack, MD, and colleagues at the University of Southern California and the University of Michigan, have studied the use of social media by the transgender community and write that they believe “there should be an increased effort to develop high-quality and unbiased resources for patient education that can be made [available] on social media.”

Dr. Gallagher said TikTok helped her erase fear. “A bilateral mastectomy is a scary surgery for an 18-year-old or a 20-year-old,” she said, “but they have to do it for their well-being.”

“That is a criticism I’ve heard – that I seek to minimize it or that I’m flippant about it,” said Dr. Gallagher.

For “top surgery the risk profile is pretty low,” she said, “so what I try to do is educate people that it’s maybe not as scary a procedure as they think.”

Dr. Mangubat, however, is concerned about some of what he sees, especially the explosion of surgeons offering gender-affirming procedures. “Now everybody wants a piece of it,” he said.

“Let’s face it, it’s money now. You get paid for doing this surgery. Hospitals get paid a lot of money for their operating rooms for doing the surgery,” said Dr. Mangubat. “There are some surgeons who believe the transgender community is just another market.”

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

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Add AFib to noncardiac surgery risk evaluation: New support

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Mon, 06/27/2022 - 09:35

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images


Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.

The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”

“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.

The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.

Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.

The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.

The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.

That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.

Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.

“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.

The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.  

Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).

Corresponding 30-day ORs for other events, all significant at P < .001, were:  

  • 1.31 (95% CI, 1.30-1.33) for heart failure
  • 1.40 (95% CI, 1.37-1.43) for stroke
  • 1.59 (95% CI, 1.43-1.75) for systemic embolism
  • 1.14 (95% CI, 1.13-1.16) for major bleeding  
  • 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

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Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images


Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.

The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”

“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.

The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.

Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.

The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.

The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.

That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.

Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.

“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.

The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.  

Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).

Corresponding 30-day ORs for other events, all significant at P < .001, were:  

  • 1.31 (95% CI, 1.30-1.33) for heart failure
  • 1.40 (95% CI, 1.37-1.43) for stroke
  • 1.59 (95% CI, 1.43-1.75) for systemic embolism
  • 1.14 (95% CI, 1.13-1.16) for major bleeding  
  • 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

Practice has gone back and forth on whether atrial fibrillation (AFib) should be considered in the preoperative cardiovascular risk (CV) evaluation of patients slated for noncardiac surgery, and the Revised Cardiac Risk Index (RCRI), currently widely used as an assessment tool, doesn’t include the arrhythmia.

But consideration of preexisting AFib along with the RCRI predicted 30-day mortality more sharply than the RCRI alone in an analysis of data covering several million patients slated for such procedures.

enot-poloskun/Getty Images


Indeed, AFib emerged as a significant, independent risk factor for a number of bad postoperative outcomes. Mortality within a month of the procedure climbed about 30% for patients with AFib before the noncardiac surgery. Their 30-day risks for stroke and for heart failure hospitalization went up similarly.

The addition of AFib to the RCRI significantly improved its ability to discriminate 30-day postoperative risk levels regardless of age, sex, and type of noncardiac surgery, Amgad Mentias, MD, Cleveland Clinic, told this news organization. And “it was able to correctly up-classify patients to high risk, if AFib was there, and it was able to down-classify some patients to lower risk if it wasn’t there.”

“I think [the findings] are convincing evidence that atrial fib should at least be part of the thought process for the surgical team and the medical team taking care of the patient,” said Dr. Mentias, who is senior author on the study published in the Journal of the American College of Cardiology, with lead author Sameer Prasada, MD, also of the Cleveland Clinic.

The results “call for incorporating AFib as a risk factor in perioperative risk scores for cardiovascular morbidity and mortality,” the published report states.

Supraventricular arrhythmias had been part of the Goldman Risk Index once widely used preoperatively to assess cardiac risk before practice adopted the RCRI in the past decade, observe Anne B. Curtis, MD, and Sai Krishna C. Korada, MD, University at Buffalo, New York, in an accompanying editorial.

The current findings “demonstrate improved prediction of adverse postsurgical outcomes” from supplementing the RCRI with AFib, they write. Given associations between preexisting AFib and serious cardiac events, “it is time to ‘re-revise’ the RCRI and acknowledge the importance of AFib in predicting adverse outcomes” after noncardiac surgery.

The new findings, however, aren’t all straightforward. In one result that remains a bit of a head-scratcher, postoperative risk of myocardial infarction (MI) in patients with preexisting AFib went in the opposite direction of risk for death and other CV outcomes, falling by almost 20%.

That is “hard to explain with the available data,” the report states, but “the use of anticoagulation, whether oral or parenteral (as a bridge therapy in the perioperative period), is a plausible explanation” given the frequent role of thrombosis in triggering MIs.

Consistent with such a mechanism, the group argues, the MI risk reduction was seen primarily among patients with AFib and a CHA2DS2-VASc score of 2 or higher – that is, those at highest risk for stroke and therefore most likely to be on oral anticoagulation. The MI risk reduction wasn’t seen in such patients with a CHA2DS2-VASc score of 0 or 1.

“I think that’s part of the explanation, that anticoagulation can reduce risk of MI. But it’s not the whole explanation,” Dr. Mentias said in an interview. If it were the sole mechanism, he said, then the same oral anticoagulation that protected against MI should have also cut the postoperative stroke risk. Yet that risk climbed 40% among patients with preexisting AFib.

The analysis started with 8.6 million Medicare patients with planned noncardiac surgery, seen from 2015 to 2019, of whom 16.4% had preexisting AFib. Propensity matching for demographics, urgency and type of surgery, CHA2DS2-VASc score, and RCRI index created two cohorts for comparison: 1.13 million patients with and 1.92 million without preexisting AFib.  

Preexisting AFib was associated with a higher 30-day risk for death from any cause, the primary endpoint being 8.3% versus 5.8% for those without such AFib (P < .001), for an odds ratio of 1.31 (95% confidence interval, 1.30-1.32).

Corresponding 30-day ORs for other events, all significant at P < .001, were:  

  • 1.31 (95% CI, 1.30-1.33) for heart failure
  • 1.40 (95% CI, 1.37-1.43) for stroke
  • 1.59 (95% CI, 1.43-1.75) for systemic embolism
  • 1.14 (95% CI, 1.13-1.16) for major bleeding  
  • 0.81 (95% CI, 0.79-0.82) for MI

Those with preexisting AFib also had longer hospitalizations at a median 5 days, compared with 4 days for those without such AFib (P < .001).

The study has the limitations of most any retrospective cohort analysis. Other limitations, the report notes, include lack of information on any antiarrhythmic meds given during hospitalization or type of AFib.

For example, AFib that is permanent – compared with paroxysmal or persistent – may be associated with more atrial fibrosis, greater atrial dilatation, “and probably higher pressures inside the heart,” Dr. Mentias observed.

“That’s not always the case, but that’s the notion. So presumably people with persistent or permanent atrial fib would have more advanced heart disease, and that could imply more risk. But we did not have that kind of data.”

Dr. Mentias and Dr. Prasada report no relevant financial relationships; disclosures for the other authors are in the report. Dr. Curtis discloses serving on advisory boards for Abbott, Janssen Pharmaceuticals, Sanofi, and Milestone Pharmaceuticals; receiving honoraria for speaking from Medtronic and Zoll; and serving on a data-monitoring board for Medtronic. Dr. Korada reports he has no relevant financial relationships.

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

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New guideline for in-hospital care of diabetes says use CGMs

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Thu, 12/15/2022 - 15:38

Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”



On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

 

 

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

  • CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
  • Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
  • Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
  • Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
  • Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
  • Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
  • Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
  • Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
  • Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
  • Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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

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Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”



On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

 

 

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

  • CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
  • Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
  • Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
  • Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
  • Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
  • Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
  • Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
  • Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
  • Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
  • Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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

Goal-directed glycemic management – which may include new technologies for glucose monitoring – for non–critically ill hospitalized patients who have diabetes or newly recognized hyperglycemia can improve outcomes, according to a new practice guideline from the Endocrine Society.  

Even though roughly 35% of hospitalized patients have diabetes or newly discovered hyperglycemia, there is “wide variability in glycemic management in clinical practice,” writing panel chair Mary Korytkowski, MD, from the University of Pittsburgh, said at the annual meeting of the Endocrine Society. “These patients get admitted to every patient service in the hospital, meaning that every clinical service will encounter this group of patients, and their glycemic management can have a major effect on their outcomes. Both short term and long term.”

This guideline provides strategies “to achieve previously recommended glycemic goals while also reducing the risk for hypoglycemia, and this includes inpatient use of insulin pump therapy or continuous glucose monitoring [CGM] devices, among others,” she said.

It also includes “recommendations for preoperative glycemic goals as well as when the use of correctional insulin – well known as sliding scale insulin – may be appropriate” and when it is not.

The document, which replaces a 2012 guideline, was published online in the Journal of Clinical Endocrinology & Metabolism.

A multidisciplinary panel developed the document over the last 3 years to answer 10 clinical practice questions related to management of non–critically ill hospitalized patients with diabetes or newly discovered hyperglycemia.
 

Use of CGM devices in hospital

The first recommendation is: “In adults with insulin-treated diabetes hospitalized for noncritical illness who are at high risk of hypoglycemia, we suggest the use of real-time [CGM] with confirmatory bedside point-of-care blood glucose monitoring for adjustments in insulin dosing rather than point-of-care blood glucose rather than testing alone in hospital settings where resources and training are available.” (Conditional recommendation. Low certainty of evidence).

“We were actually very careful in terms of looking at the data” for use of CGMs, Dr. Korytkowski said in an interview.

Although CGMs are approved by the Food and Drug Administration in the outpatient setting, and that’s becoming the standard of care there, they are not yet approved for in-hospital use.

However, the FDA granted an emergency allowance for use of CGMs in hospitals during the COVID-19 pandemic.

That was “when everyone was scrambling for what to do,” Dr. Korytkowski noted. “There was a shortage of personal protective equipment and a real interest in trying to limit the amount of exposure of healthcare personnel in some of these really critically ill patients for whom intravenous insulin therapy was used to control their glucose level.”



On March 1, the FDA granted Breakthrough Devices Designation for Dexcom CGM use in the hospital setting.

The new guideline suggests CGM be used to detect trends in glycemic management, with insulin dosing decisions made with point-of-care glucose measure (the standard of care).

To implement CGM for glycemic management in hospitals, Dr. Korytkowski said, would require “extensive staff and nursing education to have people with expertise available to provide support to nursing personnel who are both placing these devices, changing these devices, looking at trends, and then knowing when to remove them for certain procedures such as MRI or radiologic procedures.”

“We know that not all hospitals may be readily available to use these devices,” she said. “It is an area of active research. But the use of these devices during the pandemic, in both critical care and non–critical care setting has really provided us with a lot of information that was used to formulate this suggestion in the guideline.”

The document addresses the following areas: CGM, continuous subcutaneous insulin infusion pump therapy, inpatient diabetes education, prespecified preoperative glycemic targets, use of neutral protamine Hagedorn insulin for glucocorticoid or enteral nutrition-associated hyperglycemia, noninsulin therapies, preoperative carbohydrate-containing oral fluids, carbohydrate counting for prandial (mealtime) insulin dosing, and correctional and scheduled (basal or basal bolus) insulin therapies.

 

 

Nine key recommendations

Dr. Korytkowski identified nine key recommendations:

  • CGM systems can help guide glycemic management with reduced risk for hypoglycemia.
  • Patients experiencing glucocorticoid- or enteral nutrition–associated hyperglycemia require scheduled insulin therapy to address anticipated glucose excursions.
  • Selected patients using insulin pump therapy prior to a hospital admission can continue to use these devices in the hospital if they have the mental and physical capacity to do so with knowledgeable hospital personnel.
  • Diabetes self-management education provided to hospitalized patients can promote improved glycemic control following discharge with reductions in the risk for hospital readmission. “We know that is recommended for patients in the outpatient setting but often they do not get this,” she said. “We were able to observe that this can also impact long-term outcomes “
  • Patients with diabetes scheduled for elective surgery may have improved postoperative outcomes when preoperative hemoglobin A1c is 8% or less and preoperative blood glucose is less than 180 mg/dL. “This recommendation answers the question: ‘Where should glycemic goals be for people who are undergoing surgery?’ ”
  • Providing preoperative carbohydrate-containing beverages to patients with known diabetes is not recommended.
  • Patients with newly recognized hyperglycemia or well-managed diabetes on noninsulin therapy may be treated with correctional insulin alone as initial therapy at hospital admission.
  • Some noninsulin diabetes therapies can be used in combination with correction insulin for patients with type 2 diabetes who have mild hyperglycemia.
  • Correctional insulin – “otherwise known as sliding-scale insulin” –  can be used as initial therapy for patients with newly recognized hyperglycemia or type 2 diabetes treated with noninsulin therapy prior to hospital admission.
  • Scheduled insulin therapy is preferred for patients experiencing persistent blood glucose values greater than 180 mg/dL and is recommended for patients using insulin therapy prior to admission. 

The guideline writers’ hopes

“We hope that this guideline will resolve debates” about appropriate preoperative glycemic management and when sliding-scale insulin can be used and should not be used, said Dr. Korytkowski.

The authors also hope that “it will stimulate research funding for this very important aspect of diabetes care, and that hospitals will recognize the importance of having access to knowledgeable diabetes care and education specialists who can provide staff education regarding inpatient glycemic management, provide oversight for patients using insulin pump therapy or CGM devices, and empower hospital nurses to provide diabetes [self-management] education prior to patient discharge.”

Claire Pegg, the patient representative on the panel, hopes “that this guideline serves as the beginning of a conversation that will allow inpatient caregivers to provide individualized care to patients – some of whom may be self-sufficient with their glycemic management and others who need additional assistance.” 

Development of the guideline was funded by the Endocrine Society. Dr. Korytkowski has reported no relevant financial disclosures.

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

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Women are not being warned that anesthetic may reduce birth pill efficacy

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Tue, 07/05/2022 - 15:24

The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

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The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

The effectiveness of hormonal contraceptives, including the pill and mini-pill, may be compromised by sugammadex, a drug widely used in anesthesia for reversing neuromuscular blockade induced by rocuronium or vecuronium.

Yet women are not routinely informed that the drug may make their contraception less effective, delegates at Euroanaesthesia, the annual meeting of the European Society of Anaesthesiology and Intensive Care in Milan were told.

New research presented at the meeting supports the authors’ experience that “robust methods for identifying at-risk patients and informing them of the associated risk of contraceptive failures is not common practice across anesthetic departments within the United Kingdom, and likely further afield.”

This is according to a survey of almost 150 anesthetic professionals, including consultants, junior doctors, and physician assistants, working at University College London Hospitals NHS Foundation Trust.

Dr. Neha Passi, Dr. Matt Oliver, and colleagues at the trust’s department of anesthesiology sent out a seven-question survey to their 150 colleagues and received 82 responses, 94% of which claimed awareness of the risk of contraceptive failure with sugammadex. However, 70% of the respondents admitted that they do not routinely discuss this with patients who have received the drug.
 

Risk with all forms of hormonal contraceptive

Yet current guidance is to inform women of child-bearing age that they have received the drug and, because of increased risk of contraceptive failure, advise those taking oral hormonal contraceptives to follow the missed pill advice in the leaflet that comes with their contraceptives. It also counsels that clinicians should advise women using other types of hormonal contraceptive to use an additional nonhormonal means of contraception for 7 days.

The study authors also carried out a retrospective audit of sugammadex use in the trust and reported that during the 6 weeks covered by the audit, 234 patients were administered sugammadex of whom 65 (28%) were women of childbearing age. Of these, 17 had a medical history that meant they weren’t at risk of pregnancy, but the other 48 should have received advice on the risks of contraceptive failure – however there was no record in the medical notes of such advice having been given for any of the at-risk 48 women.

While sugammadex is the only anesthetic drug known to have this effect, it is recognized to interact with progesterone and so may reduce the effectiveness of hormonal contraceptives, including the progesterone-only pill, combined pill, vaginal rings, implants, and intrauterine devices.

Dr. Passi said: “It is concerning that we are so seldom informing patients of the risk of contraceptive failure following sugammadex use.

“Use of sugammadex is expected to rise as it becomes cheaper in the future, and ensuring that women receiving this medicine are aware it may increase their risk of unwanted pregnancy must be a priority.”

She added: “It is important to note, however, that most patients receiving an anesthetic do not need a muscle relaxant and that sugammadex is one of several drugs available to reverse muscle relaxation.”

Dr. Oliver said: “We only studied one hospital trust but we expect the results to be similar in elsewhere in the U.K.”

In response to their findings, the study’s authors have created patient information leaflets and letters and programmed the trust’s electronic patient record system to identify “at-risk” patients and deliver electronic prompts to the anesthetists caring for them in the perioperative period.

A version of this article first appeared on Medscape UK.

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Liver transplanted after 3 days outside body

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Thu, 06/02/2022 - 14:21

A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

 

 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

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A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

 

 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

A poor-quality human liver, rejected by all transplant centers, was treated outside the body for 3 days using a perfusion machine that simulated some functions of the human body and has been successfully transplanted into a patient with advanced cirrhosis.

The 62-year-old patient rapidly returned to normal quality of life and at the 1-year follow-up had no signs of liver damage, such as rejection or bile duct injury, according to the report published in Nature Biotechnology.

The study team was led by Pierre-Alain Clavien, MD, PhD, with the department of surgery and transplantation, Swiss Hepato-Pancreato-Biliary and Transplant Center, University Hospital Zürich, and the Wyss Zürich Translational Center, ETH Zürich and University of Zürich.
 

Expanding the viability window

Livers for transplant are routinely preserved in a static cold solution and implanted within a few hours. Most centers limit the time in the cold solution to 12 hours as the organ’s viability drops quickly after that time.

“This inaugural clinical success opens new horizons in clinical research and promises an extended time window of up to 10 days for assessment of viability of donor organs as well as converting an urgent and highly demanding surgery into an elective procedure,” the authors wrote.

The Liver4Life team, made up of physicians, engineers, and biochemists, developed the complex perfusion machine. Features of the machine, which mimics human body functions, include automated remote control of all key parameters. A pump mimics the heart, an oxygenator replaces the lungs, and a dialysis unit performs as kidneys would. Hormone and nutrient infusions take over the work of the intestines and pancreas. The machine also moves the liver to the rhythm of simulated breathing.

The team had to solve factors that limit viability for any solid organ outside the body over a few hours including hemolysis, hemodynamic stability, glucose control, pathologic glycogen deposition and perfusate quality and dilution.

Additionally, because the organ would be under machine perfusion for several days, the scientists also had to address pressure necrosis.
 

History behind the procedure

The process started in 2015 with the support of the Wyss Zürich Translational Center, with the goal of long-term ex situ machine perfusion of injured liver grafts.

As part of the agreement from the Swiss regulatory authority (the Federal Office of Public Health) the process would be used only if the organ was rejected by all transplant centers, the recipient had no other options for a donor liver, and if the organ met a rigorous bar for viability.

On May 19, 2021, the team was offered a liver graft from a 29-year-old female donor who had an invasive abdominal desmoid fibromatosis associated with chronic intra-abdominal abscesses and recurrent sepsis episodes from multiresistant bacteria. The donor needed long-term multiple medications and parenteral nutrition. Additionally, there was a 4-cm tumor in segment 1 of the liver.

The liver was refused by all other centers, “primarily because it required diagnostic workup of the liver lesion, which was not immediately possible, and because of the ongoing sepsis in the donor with multiresistant microorganisms,” the authors wrote.

The team removed the liver, and the graft was connected to the Wyss perfusion device for normothermic (37 °C) ex situ perfusion after 4 hours of cold preservation.

A 62-year-old male potential recipient on the official national transplant list, had earlier agreed to be considered for receiving a graft preserved ex situ in the Wyss machine.

The patient was fully informed about the process and the presence of a benign lesion in the graft and accepted the transplantation procedure. The patient had advanced cirrhosis, severe portal hypertension, and multiple and recurrent hepatocellular carcinoma (HCC).
 

 

 

Recipient had ‘near-zero’ chance to get a liver in time

The authors wrote that the patient had “a near-zero chance to receive a graft in time.”

For patients with HCC in Switzerland, the wait for liver transplant is longer than a year and no living-donor options were available.

The transplant operation took 5 hours and 26 minutes and blood loss was limited (600 mL). No transfusion was required. The patient was extubated in the operating room, transferred to the ICU, and discharged 12 days later.

Because a biopsy showed no detectable liver injury or rejection, and based on previous evidence of lower immunogenicity in perfused livers and kidneys, the researchers chose a reduced immunosuppressive regimen with quickly tapering steroids. The steroids were completely discontinued 6 weeks after surgery.

The authors wrote: “In our experience, the absence or very low degree of reperfusion injury seen in our transplant is observed only in living donation, where ‘close-to-perfect’ livers from healthy young donors are transplanted immediately as both donors and recipient are operated in parallel.”

In a press release, the team said the next step is to assess the procedure in other patients in a multicenter study.

Dr. Clavien and several coauthors affiliated with ETH (the Swiss Federal Institute of Technology in Zürich) and the University of Zürich have applied for patents on this new perfusion technology. No other authors have any competing interest.

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Index cholecystectomy reduces readmissions after acute cholangitis

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Tue, 05/31/2022 - 13:38

– Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

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– Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

– Patients with acute cholangitis are twice as likely to be readmitted within 30 days if they don’t get a cholecystectomy in the same hospital admission for which they get biliary decompression, researchers say.

The readmissions result mostly from sepsis and recurrence of the acute cholangitis, said Ahmad Khan, MD, MS, a gastroenterology fellow at Case Western Reserve University in Cleveland, at Digestive Diseases Week® (DDW) 2022. “These added readmissions can cause a significant burden in terms of costs and extra days of hospitalization in these patients.”

Acute cholangitis in patients without bile duct stents is most often caused by biliary calculi, benign biliary stricture, or malignancy. A gastrointestinal emergency, it requires treatment with biliary decompression followed by cholecystectomy, but the cholecystectomy is considered an elective procedure.

Surgeons may delay it if the patient is very sick, or simply for scheduling reasons, Dr. Khan said. “There are some areas where the surgeons may be too busy,” he said. Or if the patient first presents at the end of the week, some surgeons will send the patient home so they don’t have to operate on the weekend, he said.

To understand the consequences of these decisions, Dr. Khan and his colleagues analyzed data from 2016 to 2018 from the National Readmission Database of the U.S. Agency for Healthcare Research and Quality.

They found that 11% of patients who went home before returning for a cholecystectomy had to be readmitted versus only 5.5% of those who got a cholecystectomy during the same (index) admission as their biliary decompression.

Patients who got cholecystectomies during their index admissions were slightly younger and healthier: Their mean age was 67.29 years and 20.59% had three or more comorbidities at index admission versus 70.77 years of age and 39.80% with three or more comorbidities at index admission for those who got their cholecystectomies later.

The researchers did not find any significant differences in the hospitals’ characteristics, such as being urban or academic, between the two groups.

Mortality was higher for those who received their cholecystectomy after returning home, but they spent less time in the hospital at lower total cost. The differences in outcomes between the index admission and readmission were all statistically significant (P < .01).

This observational study could not determine cause and effect, but it justifies a prospective trial that could more definitely determine which approach results in better outcomes, Dr. Khan said.

That patients are less likely to need readmission if they return home without a gall bladder after treatment for acute cholangitis “makes sense,” said session comoderator Richard Sterling, MD, MSc, chief of hepatology at Virginia Commonwealth University in Richmond.

“Should you do it immediately or can you wait a day or 2? They didn’t really address when during that admission, so we still don’t know the optimal sequence of events.”

If a patient has so many comorbidities that the surgeon and anesthesiologist don’t think the patient could survive a cholecystectomy, then the surgeon might do a cholecystostomy instead, he said.

Dr. Khan said he hopes to delve deeper into the data to determine what factors might have influenced the surgeons’ decisions to delay the cholecystectomy. “I want to see, of the patients who did not get same-admission cholecystectomies, how many had diabetes, how many had coronary artery disease, how many were on blood thinners, and things like that.”

Neither Dr. Khan nor Dr. Sterling reported any relevant financial interests.

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Endoscopic obesity treatments offer alternatives to surgery

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Mon, 05/16/2022 - 13:49

– Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

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– Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

– Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m2 who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

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