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Living donor liver transplants on rise for most urgent need

Article Type
Changed
Mon, 11/14/2022 - 11:59

Living donor liver transplants (LDLT) for recipients with the most urgent need for a liver transplant in the next 3 months – a model for end-stage liver disease (MELD) score of 25 or higher – have become more frequent during the past decade, according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Among LDLT recipients, researchers found comparable patient and graft survival at low and high MELD scores. But among patients with high MELD scores, researchers found lower adjusted graft survival and a higher transplant rate among those with living donors, compared with recipients of deceased donor liver transplantation (DDLT).

Dr. Benjamin Rosenthal

The findings suggest certain advantages of LDLT over DDLT may be lost in the high-MELD setting in terms of graft survival, said Benjamin Rosenthal, MD, an internal medicine resident focused on transplant hepatology at the Hospital of the University of Pennsylvania, Philadelphia.

“Historically, in the United States especially, living donor liver transplantation has been offered to patients with low or moderate MELD,” he said. “The outcomes of LDLT at high MELD are currently unknown.”

Previous data from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) found that LDLT offered a survival benefit versus remaining on the wait list, independent of MELD score, he said. A recent study also has demonstrated a survival benefit across MELD scores of 11-26, but findings for MELD scores of 25 and higher have been mixed.

Trends and outcomes in LDLT at high MELD scores

Dr. Rosenthal and colleagues conducted a retrospective cohort study of adult LDLT recipients from 2010 to 2021 using data from the Organ Procurement and Transplantation Network (OPTN), the U.S. donation and transplantation system.

In baseline characteristics among LDLT transplant recipients, there weren’t significant differences in age, sex, race, and ethnicity for MELD scores below 25 or at 25 and higher. There also weren’t significant differences in donor age, relationship, use of nondirected grafts, or percentage of right and left lobe donors for LDLT recipients. However, recipients with high MELD scores had more nonalcoholic steatohepatitis (29.5% versus 24.6%) and alcohol-assisted cirrhosis (21.6% versus 14.3%).

The research team evaluated graft survival among LDLT recipients by MELD below 25 and at 25 or higher. They also compared posttransplant patient and graft survival between LDLT and DDLT recipients with a MELD of 25 or higher. They excluded transplant candidates on the wait list for Status 1/1A, redo transplant, or multiorgan transplant.

Among the 3,590 patients who had LDLT between 2010 and 2021, 342 patients (9.5%) had a MELD of 25 or higher at transplant. There was some progression during the waiting period, Dr. Rosenthal noted, with a median listing MELD score of 19 among those who had a MELD of 25 or higher at transplant and 21 among those who had a MELD of 30 or higher at transplant.

For LDLT recipients with MELD scores above or below 25, researchers found no significant differences in adjusted patient survival or adjusted graft survival.

Then the team compared outcomes of LDLT and DDLT in high-MELD recipients. Among the 67,279-patient DDLT comparator group, 27,552 patients (41%) had a MELD of 25 or higher at transplant.

In terms of LDLT versus DDLT, unadjusted and adjusted patient survival were no different for patients with MELD of 25 or higher. In addition, unadjusted graft survival was no different.

However, adjusted graft survival was worse for LDLT recipients with high MELD scores. In addition, the retransplant rate was higher in LDLT recipients, at 5.7% versus 2.4%.

The reason why graft survival may be worse remains unclear, Dr. Rosenthal said. One hypothesis is that a low graft-to-recipient weight ratio in LDLT can cause small-for-size syndrome. However, these ratios were not available from OPTN.

“Further studies should be done to see what the benefit is, with graft-to-recipient weight ratios included,” he said. “The differences between DDLT and LDLT in this setting should be further explored as well.”

The research team also described temporal and transplant center trends for LDLT by MELD group. For temporal trends, they expanded the study period from 2002-2021.

The found a marked U.S. increase in the percentage of LDLT with a MELD of 25 or higher, particularly in the last decade and especially in the last 5 years. But the percentage of LDLT with high MELD remains lower than 15%, even in recent years, Dr. Rosenthal noted.

Across transplant centers, there was a trend toward centers with increasing LDLT volume having a greater proportion of LDLT recipients with a MELD of 25 or higher. At the 19.6% of centers performing 10 or fewer LDLT during the study period, none of the LDLT recipients had a MELD of 25 or higher, Dr. Rosenthal said.

The authors didn’t report a funding source. The authors declared no relevant disclosures.

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Living donor liver transplants (LDLT) for recipients with the most urgent need for a liver transplant in the next 3 months – a model for end-stage liver disease (MELD) score of 25 or higher – have become more frequent during the past decade, according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Among LDLT recipients, researchers found comparable patient and graft survival at low and high MELD scores. But among patients with high MELD scores, researchers found lower adjusted graft survival and a higher transplant rate among those with living donors, compared with recipients of deceased donor liver transplantation (DDLT).

Dr. Benjamin Rosenthal

The findings suggest certain advantages of LDLT over DDLT may be lost in the high-MELD setting in terms of graft survival, said Benjamin Rosenthal, MD, an internal medicine resident focused on transplant hepatology at the Hospital of the University of Pennsylvania, Philadelphia.

“Historically, in the United States especially, living donor liver transplantation has been offered to patients with low or moderate MELD,” he said. “The outcomes of LDLT at high MELD are currently unknown.”

Previous data from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) found that LDLT offered a survival benefit versus remaining on the wait list, independent of MELD score, he said. A recent study also has demonstrated a survival benefit across MELD scores of 11-26, but findings for MELD scores of 25 and higher have been mixed.

Trends and outcomes in LDLT at high MELD scores

Dr. Rosenthal and colleagues conducted a retrospective cohort study of adult LDLT recipients from 2010 to 2021 using data from the Organ Procurement and Transplantation Network (OPTN), the U.S. donation and transplantation system.

In baseline characteristics among LDLT transplant recipients, there weren’t significant differences in age, sex, race, and ethnicity for MELD scores below 25 or at 25 and higher. There also weren’t significant differences in donor age, relationship, use of nondirected grafts, or percentage of right and left lobe donors for LDLT recipients. However, recipients with high MELD scores had more nonalcoholic steatohepatitis (29.5% versus 24.6%) and alcohol-assisted cirrhosis (21.6% versus 14.3%).

The research team evaluated graft survival among LDLT recipients by MELD below 25 and at 25 or higher. They also compared posttransplant patient and graft survival between LDLT and DDLT recipients with a MELD of 25 or higher. They excluded transplant candidates on the wait list for Status 1/1A, redo transplant, or multiorgan transplant.

Among the 3,590 patients who had LDLT between 2010 and 2021, 342 patients (9.5%) had a MELD of 25 or higher at transplant. There was some progression during the waiting period, Dr. Rosenthal noted, with a median listing MELD score of 19 among those who had a MELD of 25 or higher at transplant and 21 among those who had a MELD of 30 or higher at transplant.

For LDLT recipients with MELD scores above or below 25, researchers found no significant differences in adjusted patient survival or adjusted graft survival.

Then the team compared outcomes of LDLT and DDLT in high-MELD recipients. Among the 67,279-patient DDLT comparator group, 27,552 patients (41%) had a MELD of 25 or higher at transplant.

In terms of LDLT versus DDLT, unadjusted and adjusted patient survival were no different for patients with MELD of 25 or higher. In addition, unadjusted graft survival was no different.

However, adjusted graft survival was worse for LDLT recipients with high MELD scores. In addition, the retransplant rate was higher in LDLT recipients, at 5.7% versus 2.4%.

The reason why graft survival may be worse remains unclear, Dr. Rosenthal said. One hypothesis is that a low graft-to-recipient weight ratio in LDLT can cause small-for-size syndrome. However, these ratios were not available from OPTN.

“Further studies should be done to see what the benefit is, with graft-to-recipient weight ratios included,” he said. “The differences between DDLT and LDLT in this setting should be further explored as well.”

The research team also described temporal and transplant center trends for LDLT by MELD group. For temporal trends, they expanded the study period from 2002-2021.

The found a marked U.S. increase in the percentage of LDLT with a MELD of 25 or higher, particularly in the last decade and especially in the last 5 years. But the percentage of LDLT with high MELD remains lower than 15%, even in recent years, Dr. Rosenthal noted.

Across transplant centers, there was a trend toward centers with increasing LDLT volume having a greater proportion of LDLT recipients with a MELD of 25 or higher. At the 19.6% of centers performing 10 or fewer LDLT during the study period, none of the LDLT recipients had a MELD of 25 or higher, Dr. Rosenthal said.

The authors didn’t report a funding source. The authors declared no relevant disclosures.

Living donor liver transplants (LDLT) for recipients with the most urgent need for a liver transplant in the next 3 months – a model for end-stage liver disease (MELD) score of 25 or higher – have become more frequent during the past decade, according to new findings presented at the annual meeting of the American Association for the Study of Liver Diseases.

Among LDLT recipients, researchers found comparable patient and graft survival at low and high MELD scores. But among patients with high MELD scores, researchers found lower adjusted graft survival and a higher transplant rate among those with living donors, compared with recipients of deceased donor liver transplantation (DDLT).

Dr. Benjamin Rosenthal

The findings suggest certain advantages of LDLT over DDLT may be lost in the high-MELD setting in terms of graft survival, said Benjamin Rosenthal, MD, an internal medicine resident focused on transplant hepatology at the Hospital of the University of Pennsylvania, Philadelphia.

“Historically, in the United States especially, living donor liver transplantation has been offered to patients with low or moderate MELD,” he said. “The outcomes of LDLT at high MELD are currently unknown.”

Previous data from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) found that LDLT offered a survival benefit versus remaining on the wait list, independent of MELD score, he said. A recent study also has demonstrated a survival benefit across MELD scores of 11-26, but findings for MELD scores of 25 and higher have been mixed.

Trends and outcomes in LDLT at high MELD scores

Dr. Rosenthal and colleagues conducted a retrospective cohort study of adult LDLT recipients from 2010 to 2021 using data from the Organ Procurement and Transplantation Network (OPTN), the U.S. donation and transplantation system.

In baseline characteristics among LDLT transplant recipients, there weren’t significant differences in age, sex, race, and ethnicity for MELD scores below 25 or at 25 and higher. There also weren’t significant differences in donor age, relationship, use of nondirected grafts, or percentage of right and left lobe donors for LDLT recipients. However, recipients with high MELD scores had more nonalcoholic steatohepatitis (29.5% versus 24.6%) and alcohol-assisted cirrhosis (21.6% versus 14.3%).

The research team evaluated graft survival among LDLT recipients by MELD below 25 and at 25 or higher. They also compared posttransplant patient and graft survival between LDLT and DDLT recipients with a MELD of 25 or higher. They excluded transplant candidates on the wait list for Status 1/1A, redo transplant, or multiorgan transplant.

Among the 3,590 patients who had LDLT between 2010 and 2021, 342 patients (9.5%) had a MELD of 25 or higher at transplant. There was some progression during the waiting period, Dr. Rosenthal noted, with a median listing MELD score of 19 among those who had a MELD of 25 or higher at transplant and 21 among those who had a MELD of 30 or higher at transplant.

For LDLT recipients with MELD scores above or below 25, researchers found no significant differences in adjusted patient survival or adjusted graft survival.

Then the team compared outcomes of LDLT and DDLT in high-MELD recipients. Among the 67,279-patient DDLT comparator group, 27,552 patients (41%) had a MELD of 25 or higher at transplant.

In terms of LDLT versus DDLT, unadjusted and adjusted patient survival were no different for patients with MELD of 25 or higher. In addition, unadjusted graft survival was no different.

However, adjusted graft survival was worse for LDLT recipients with high MELD scores. In addition, the retransplant rate was higher in LDLT recipients, at 5.7% versus 2.4%.

The reason why graft survival may be worse remains unclear, Dr. Rosenthal said. One hypothesis is that a low graft-to-recipient weight ratio in LDLT can cause small-for-size syndrome. However, these ratios were not available from OPTN.

“Further studies should be done to see what the benefit is, with graft-to-recipient weight ratios included,” he said. “The differences between DDLT and LDLT in this setting should be further explored as well.”

The research team also described temporal and transplant center trends for LDLT by MELD group. For temporal trends, they expanded the study period from 2002-2021.

The found a marked U.S. increase in the percentage of LDLT with a MELD of 25 or higher, particularly in the last decade and especially in the last 5 years. But the percentage of LDLT with high MELD remains lower than 15%, even in recent years, Dr. Rosenthal noted.

Across transplant centers, there was a trend toward centers with increasing LDLT volume having a greater proportion of LDLT recipients with a MELD of 25 or higher. At the 19.6% of centers performing 10 or fewer LDLT during the study period, none of the LDLT recipients had a MELD of 25 or higher, Dr. Rosenthal said.

The authors didn’t report a funding source. The authors declared no relevant disclosures.

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Have you heard the one about the emergency dept. that called 911?

Article Type
Changed
Fri, 11/11/2022 - 12:49

 

Who watches the ED staff?

We heard a really great joke recently, one we simply have to share.

A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”

Chinnapong/iStock/Getty Images

“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”

“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”

“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.

“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”

“That is quite serious,” the therapist says, scribbling down unseen notes.

“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”

“And how does all this make you feel?” the therapist asks.

“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”

“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”

The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”

Good joke. Everybody laugh. Roll on snare drum. Curtains.

Myth buster: Supplements for cholesterol lowering

When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.

Sally Kubetin/MDedge News

Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.

In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.

Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.

Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.

So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.

Consider this myth mostly busted.
 

 

 

COVID dept. of unintended consequences, part 2

The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.

Luis Alvarez/Getty Images

We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.

The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.

They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.

The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”

Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.

At this point, we probably should mention that appropriation is the second-most sincere form of flattery.

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Who watches the ED staff?

We heard a really great joke recently, one we simply have to share.

A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”

Chinnapong/iStock/Getty Images

“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”

“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”

“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.

“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”

“That is quite serious,” the therapist says, scribbling down unseen notes.

“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”

“And how does all this make you feel?” the therapist asks.

“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”

“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”

The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”

Good joke. Everybody laugh. Roll on snare drum. Curtains.

Myth buster: Supplements for cholesterol lowering

When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.

Sally Kubetin/MDedge News

Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.

In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.

Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.

Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.

So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.

Consider this myth mostly busted.
 

 

 

COVID dept. of unintended consequences, part 2

The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.

Luis Alvarez/Getty Images

We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.

The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.

They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.

The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”

Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.

At this point, we probably should mention that appropriation is the second-most sincere form of flattery.

 

Who watches the ED staff?

We heard a really great joke recently, one we simply have to share.

A man in Seattle went to a therapist. “I’m depressed,” he says. “Depressed, overworked, and lonely.”

Chinnapong/iStock/Getty Images

“Oh dear, that sounds quite serious,” the therapist replies. “Tell me all about it.”

“Life just seems so harsh and cruel,” the man explains. “The pandemic has caused 300,000 health care workers across the country to leave the industry.”

“Such as the doctor typically filling this role in the joke,” the therapist, who is not licensed to prescribe medicine, nods.

“Exactly! And with so many respiratory viruses circulating and COVID still hanging around, emergency departments all over the country are facing massive backups. People are waiting outside the hospital for hours, hoping a bed will open up. Things got so bad at a hospital near Seattle in October that a nurse called 911 on her own ED. Told the 911 operator to send the fire department to help out, since they were ‘drowning’ and ‘in dire straits.’ They had 45 patients waiting and only five nurses to take care of them.”

“That is quite serious,” the therapist says, scribbling down unseen notes.

“The fire chief did send a crew out, and they cleaned rooms, changed beds, and took vitals for 90 minutes until the crisis passed,” the man says. “But it’s only a matter of time before it happens again. The hospital president said they have 300 open positions, and literally no one has applied to work in the emergency department. Not one person.”

“And how does all this make you feel?” the therapist asks.

“I feel all alone,” the man says. “This world feels so threatening, like no one cares, and I have no idea what will come next. It’s so vague and uncertain.”

“Ah, I think I have a solution for you,” the therapist says. “Go to the emergency department at St. Michael Medical Center in Silverdale, near Seattle. They’ll get your bad mood all settled, and they’ll prescribe you the medicine you need to relax.”

The man bursts into tears. “You don’t understand,” he says. “I am the emergency department at St. Michael Medical Center.”

Good joke. Everybody laugh. Roll on snare drum. Curtains.

Myth buster: Supplements for cholesterol lowering

When it comes to that nasty low-density lipoprotein cholesterol, some people swear by supplements over statins as a holistic approach. Well, we’re busting the myth that those heart-healthy supplements are even effective in comparison.

Sally Kubetin/MDedge News

Which supplements are we talking about? These six are always on sale at the pharmacy: fish oil, cinnamon, garlic, turmeric, plant sterols, and red yeast rice.

In a study presented at the recent American Heart Association scientific sessions, researchers compared these supplements’ effectiveness in lowering LDL cholesterol with low-dose rosuvastatin or placebo among 199 adults aged 40-75 years who didn’t have a personal history of cardiovascular disease.

Participants who took the statin for 28 days had an average of 24% decrease in total cholesterol and a 38% reduction in LDL cholesterol, while 28 days’ worth of the supplements did no better than the placebo in either measure. Compared with placebo, the plant sterols supplement notably lowered HDL cholesterol and the garlic supplement notably increased LDL cholesterol.

Even though there are other studies showing the validity of plant sterols and red yeast rice to lower LDL cholesterol, author Luke J. Laffin, MD, of the Cleveland Clinic noted that this study shows how supplement results can vary and that more research is needed to see the effect they truly have on cholesterol over time.

So, should you stop taking or recommending supplements for heart health or healthy cholesterol levels? Well, we’re not going to come to your house and raid your medicine cabinet, but the authors of this study are definitely not saying that you should rely on them.

Consider this myth mostly busted.
 

 

 

COVID dept. of unintended consequences, part 2

The surveillance testing programs conducted in the first year of the pandemic were, in theory, meant to keep everyone safer. Someone, apparently, forgot to explain that to the students of the University of Wyoming and the University of Idaho.

Luis Alvarez/Getty Images

We’re all familiar with the drill: Students at the two schools had to undergo frequent COVID screening to keep the virus from spreading, thereby making everyone safer. Duck your head now, because here comes the unintended consequence.

The students who didn’t get COVID eventually, and perhaps not so surprisingly, “perceived that the mandatory testing policy decreased their risk of contracting COVID-19, and … this perception led to higher participation in COVID-risky events,” Chian Jones Ritten, PhD, and associates said in PNAS Nexus.

They surveyed 757 students from the Univ. of Washington and 517 from the Univ. of Idaho and found that those who were tested more frequently perceived that they were less likely to contract the virus. Those respondents also more frequently attended indoor gatherings, both small and large, and spent more time in restaurants and bars.

The investigators did not mince words: “From a public health standpoint, such behavior is problematic.”

Current parents/participants in the workforce might have other ideas about an appropriate response to COVID.

At this point, we probably should mention that appropriation is the second-most sincere form of flattery.

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Physicians react: Climate change and other social issues

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Changed
Fri, 11/11/2022 - 08:38

 

This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

 

 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

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This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

 

 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

 

This year Medscape surveyed more than 2,300 physicians about how they prioritized various social issues. Around half of them rated climate change among their five most important issues. Slightly lower percentages of doctors prioritized domestic violence and immigration/refugee policies that highly, and about 40% did so regarding reproductive rights in the United States.

Survey responses and comments left on the Physicians’ Views on Today’s Divisive Social Issues 2022 report provide insights into doctors’ attitudes and thinking about these four social challenges.
 

Relevance of climate change to health care

In the Medscape report, 61% of physicians described themselves as “very concerned” or “concerned” about climate change, and about 7 in 10 agreed with the statement that it should be a top worldwide priority. “Climate change is the most pressing issue of this century,” a psychiatrist respondent wrote.

What about direct effects on patients’ health? An internist worried that rising temperatures will cause “pathogens to spread and infect disadvantaged people who do not have health access and have immunocompromised conditions.” A family medicine physician predicted “more weather disasters, more asthma, more hormonal changes, and more obesity.”

However, physician viewpoints ran the gamut with an issue that has become politically and emotionally charged. Descriptions such as “overblown,” “hysteria,” “hoax,” and “farce” were used. “Climate change is a natural phenomenon under God’s purview,” an emergency medicine physician said.

And there was some middle-ground thinking. “It’s overstated but quite real,” a pediatrician respondent wrote. Added an ophthalmologist: “It has gone on for ages. We must work to decrease man-made conditions that affect climate change, but it must be done in an intelligent fashion.”
 

Domestic violence: What physicians can do

About 7 in 10 physicians surveyed by Medscape said they don’t think the United States is adequately tackling domestic violence. “It is underrecognized and ignored,” a psychiatrist respondent argued. The problem is “rampant and unacceptable, pushed into a closet and normalized, with associated shame,” an emergency medicine doctor wrote.

Many respondents noted that physicians are under a mandate to report abuse of or a suspicious injury to a patient. Some shared anecdotes about how they reported action they had taken when they suspected it. “I’ve told patients who may be in dangerous situations that I’m a safe person and provide a safe space,” a radiologist added. An internist said, “I’ve recently started to ask about safety at home during triage on every patient.”

Other doctors bemoaned a lack of adequate education on detecting and managing domestic violence and abuse. “Domestic violence is often not recognized by health care providers,” a psychiatrist respondent observed.
 

Expanding legal immigration

In the Medscape report, 34% of physicians felt U.S. immigration/refugee policies need to be tougher, while 28% said they are too restrictive, and about a fifth saw them as appropriate.

“As an immigrant, I can tell you that the system is flawed and needs a complete overhaul, which will take a bipartisan effort,” an endocrinologist respondent wrote.

A number of respondents argued that it’s critical to simplify the process of obtaining U.S. citizenship so that fewer will feel forced to enter the country illegally. “For a country that relies very heavily on immigrants to sustain our health care system, we behave like idiots in denying safe harbor,” a nephrologist asserted.

A neurologist concurred. “Legal immigration needs to be encouraged. It should be easier to exchange visitor or student visa to immigrant visa in order to retain talent in the health care and technology fields, which would alleviate the shortage of workers in health care.”
 

 

 

Reproductive rights: No easy answers

Medscape’s survey was conducted before the U.S. Supreme Court in June reversed Roe v. Wade. In the report, 71% of physicians described themselves as very to somewhat concerned about women’s reproductive rights, but their viewpoints became nuanced after that. “There is a big disparity among physicians on this topic,” an oncologist respondent wrote.

At one end of the spectrum, 3% of doctors felt that abortions should never be permitted. “The human baby in the womb is an independent person with the right to life,” a pathologist said. At the other end, nearly one-fourth of physicians believed abortion should be accessible under all circumstances, regardless of trimester or reason. “I am just here to support the woman and make her decision a reality,” an internist said.

While saying an abortion should be granted after “fetal viability” only “in extenuating circumstances,” an ob.gyn. respondent said she is “extremely concerned” about attacks on abortion rights. “Some of us are old enough to remember women coming to the ER in extremis after illegal procedures, prior to Roe v. Wade.”

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

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The danger when doctors don’t get mental health help

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Wed, 11/09/2022 - 13:37

Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

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Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

Staying mentally healthy is essential for everyone, and it’s vital for physicians. As medical professionals, you’re continually exposed to overwork, burnout, stressful situations, and challenging ethical decisions. Yet seeking help for mental health care may be last on your to-do list – or completely off your radar.

That’s sad and dangerous, since the American College of Emergency Physicians said 300-400 physicians die by suicide each year, and the stigma keeps 69% of female physicians from seeking mental health care, according to a prepandemic study.

In the 2022 Medscape Physician Suicide Report, 11% of female doctors and 9% of male doctors said they have had thoughts of suicide, and 64% experienced colloquial depression (feeling down, sad, or blue).

What’s more, physicians are typically seen as strong and capable and are often put on a pedestal by loved ones, patients, and the public and thought of as superhuman. No wonder it isn’t easy when you need to take time away to decompress and treat your mental well-being.

“There is a real fear for physicians when it comes to getting mental health care,” said Emil Tsai, MD, PhD, MAS, professor at the department of psychiatry and behavioral sciences at the University of California, Los Angeles, and an internationally reputed scientist in neurosciences and brain disorders.

The fear, said Dr. Tsai, comes from the stigma of mental health issues, potential repercussions to employment, and conceivable medical board suspension or revocation of your medical license.

Dr. Tsai said in an interview that to combat anxiety about “punishment” that many physicians fear when seeking care for their mental health, we must allow physicians to take time away from their day-to-day patient care for respite and treatment without reprisal.

Since the medical profession is high stress and has a high depression and suicide rate, finding solutions is imperative. And physicians must feel supported enough to seek treatment when needed. So how can we normalize seeking mental health care among physicians?
 

Get honest about stress and burnout

The only way to normalize any behavior is to be open and candid, Dr. Tsai said in an interview. The mental health conversation must occur across the board, not just within the medical profession.

“The greatest thing we can do to try and lift the burden that we place on physicians is to be willing to talk and be honest about the stress that physicians deal with and the importance of everyone feeling free to seek treatment and rest to strengthen their mental health,” said Dr. Tsai.

The more we talk about mental health and its treatment, the more we lessen the stigma, said Dr. Tsai. That could be more employer-employee check-ins, counseling as part of physician wellness, and programs structured so as not to construe a penal system.

“Mental health in the medical profession is a big issue and one that has to be met with the same compassion and care as it should be for any patient. We have annual physical checkups. Why don’t we offer annual mental health checkups for all, physicians included?” asked Dr. Tsai.
 

Evaluate the workload

Elizabeth Lombardo, PhD, psychologist, coach, and global keynote speaker, thinks that health care employers should reexamine their physicians’ workloads to see if they’re contributing to mental health issues.

The conversation on mental health in the workplace shouldn’t be about whether a certain person can handle stressors that are “normal” for health care settings. Instead, workplace managers in health care institutions should redefine workloads to ensure that physicians aren’t too heavily burdened with responsibilities that can cause overwork, burnout, and mental health problems,” she said.
 

Lessen the stigma

Even when physicians want to seek help for their psychological struggles, they may be weary of how their colleagues would react if they knew.

Raffaello Antonino, MD, clinical director at Therapy Central in London, said several underlying fears may exist at a physician’s core that prevent them from seeking care – being seen as weak, being judged as unfit to practice medicine, and the notion that “something is wrong with them.”

Dr. Antonino said we need to understand that physicians face challenges of bereavement and trauma derived from losing patients and the inability to save someone’s life. “These issues can easily develop into an accumulation of difficult, unprocessed emotions, later arising in symptoms and signs of PTSD, anxiety, and depression.”

Education is the best way to end this stigma, just like with any form of prejudice and stereotypes. For instance, we know that health care professionals are at risk of developing burnout. So, educating physicians on the symptoms and management of burnout and its consequences and prevention strategies is a must.

“Imagine what could happen if there were regular opportunities to work through the day’s events before signing out from a shift. The idea that individual weekly therapy is the only way to relieve mental distress is false,” said Lori McIsaac Bewsher, MSW, RSW, a trauma therapist and owner of a trauma-focused mental health clinic in New Brunswick.

“There are ways of integrating individual care into our doctor’s offices and hospitals that can be brief, effective, and confidential. The best way to introduce these interventions is early and collectively; no one is immune to the potential impact of exposure to trauma. The earlier these interventions can be accessed, the better the outcomes for everyone,” she said.

Dr. Antonino suggests, perhaps in the future, organizations can have “burnout checks” or mental health wellness checks for physicians akin to how we also have quick examinations for various physical ailments. What if physicians regularly answered a 10-question mental health survey as part of a burnout or trauma prevention strategy?

“Theirs is a profession and an identity which is often linked with a sense of strength, leadership and [benevolent] power: adjectives, which on the surface one might see as incompatible with what instead, unfortunately, and wrongly, may be associated with mental health issues,” said Dr. Antonino.
 

Keep it private

When it comes to removing the stigma from mental health care and treatment for physicians, privacy is top of mind. There needs to be some form of privacy protection for physicians who seek professional help for mental health reasons. Dr. Lombardo said physicians need to have the choice to keep their mental health journeys private. “Ideally, normalization should mean openly conversing about mental health, but for physicians, it can be a matter of life or death for their career, so the choice to remain private is something that should be afforded to them.”

Along those lines, the American Medical Association is pushing for system changes in legislative and regulatory arenas to support the mental health of practicing physicians, residents, and medical students. The organization is also urging health systems and state medical licensing bodies to remove questions on their applications that ask about prior treatment for mental health conditions.

Among many programs across the country, the Foundation of the Pennsylvania Medical Society has also created a Physicians’ Health Program, which provides confidential assessment, counseling, and referral services for physicians with mental health concerns.

“All of these initiatives are important in helping to destigmatize mental health issues among physicians,” said Harold Hong, MD, a board-certified psychiatrist in Raleigh, N.C.
 

Hail the benefits of treatment

Dr. Hong said to continue to destigmatize mental health among physicians and normalize its treatment, we not only have to emphasize how attending to mental health has individual benefits but also how it helps us help our patients.

“One key aspect that perhaps underpins this issue is the still present separation between mental and physical health, between mind and body, Dr. Hong said in an interview. “Feeling sad or angry or anxious should become a fact of life, a characteristic of being human, just like catching a cold or breaking a leg.”

It’s a normalization that, perhaps more than anything else, can lead the way for improving physicians’ mental health outcomes while also improving them for the rest of society. When society can finally see the health and well-being of someone in both their psychological and physical status, some of the stigmas may dissipate, and perhaps more physicians’ lives can be saved.

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

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Doc trains family physicians in vasectomy care

Article Type
Changed
Tue, 11/08/2022 - 11:51

Men across the nation took matters into their own hands by signing up for vasectomies in the days after the Supreme Court ruling in June that delegated abortion regulation to the states.

One physician has made it his mission to help. 

Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies. 

“Now I am booked out 3 months,” he said.

In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia. 

In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period. 

Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008. 

Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said. 

Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”

With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.

Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein. 

“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.

Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.

“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.

Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.

Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men. 

“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”

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

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Men across the nation took matters into their own hands by signing up for vasectomies in the days after the Supreme Court ruling in June that delegated abortion regulation to the states.

One physician has made it his mission to help. 

Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies. 

“Now I am booked out 3 months,” he said.

In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia. 

In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period. 

Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008. 

Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said. 

Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”

With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.

Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein. 

“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.

Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.

“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.

Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.

Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men. 

“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”

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

Men across the nation took matters into their own hands by signing up for vasectomies in the days after the Supreme Court ruling in June that delegated abortion regulation to the states.

One physician has made it his mission to help. 

Charles W. Monteith Jr., MD, medical director of his own practice in Raleigh, N.C., said that before the Court’s decision in Dobbs v. Jackson , he was booked “2-3 weeks” in advance for vasectomies. 

“Now I am booked out 3 months,” he said.

In September, Dr. Monteith launched a training program for physicians interested in providing vasectomies in their offices. The course, which Dr. Monteith conceived in 2021 before the Supreme Court’s latest ruling, offers one-on-one training and mentorship for physicians who want to learn to perform minimally invasive vasectomies under local anesthesia. 

In addition to training, Dr. Monteith provides all the necessary equipment, including eye loupes, exam room surgical furniture, and instrument sterilization system. The program can be completed over 4 weekends and costs $38,000; participants typically perform 40 vasectomy procedures during the training period. 

Dr. Monteith, who trained in obstetrics and gynecology, said that he has performed over 7,000 no-scalpel vasectomies since 2008. 

Requests for vasectomy consultations at the end of June – when the Dobbs decision was announced – came from men of all ages but particularly from younger men with fewer than two children, Dr. Monteith said. 

Prior to the ruling, men with no children accounted for 10% of his patient roster; now, he added, “some days, it is 80%.”

With the increase in demand came a unique opportunity for more doctors to offer the service. The majority of vasectomies in the United States, around 75%, are performed by urologists, but 25% are performed by specialists in family medicine or general surgery.

Some research shows that urologists are typically unwilling to train family physicians on the procedure, citing concerns over competition and not enough cases to go around. But Doug Stein, MD, a urologist and director of Vasectomy and Reversal Centers of Florida in Tampa, offers a similar training for physicians, most of whom are family physicians. Opening the door for more men to get a vasectomy may be a net good, according to Dr. Stein. 

“There’s a lot of trust required for vasectomy,” Dr. Stein noted. “Men are probably more likely to go to their family medicine doctor,” that they have a rapport with than a specialist they’ve never met.

Alex Shteynshlyuger, MD, director of urology at New York Urology Specialists, said that he supports family physicians performing vasectomies. However, he cautioned that like any other procedure, complications can arise, and thorough training is essential.

“While complications are not common, they do occur, including pain, bleeding, infection, granuloma formation, and fistula tract,” Dr. Shteynshlyuger said. Family physicians must also know when to refer patients to a specialist.

Dr. Monteith said that safety considerations are why he designed his training program for clinicians who want to offer 10-20 vasectomies per week.

Dr. Monteith sees his work in teaching family care physicians on how to perform vasectomies similar to his previous role as medical director of Planned Parenthood of Central North Carolina. There, he helped provide family planning options, mostly to women. Now, he offers the options to men. 

“Most of our public health efforts seem to be focused on female reproduction,” Dr. Monteith said. “It is never a good idea to let specialists be the main providers of a preventive healthcare treatment or service, kind of like only allowing patients to go to a cardiologist to get a prescription for cholesterol medication. I needed to do what I could do to increase the number of providers offering easier access to vasectomy.”

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

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Surgical site dressing turns blue when it needs changing

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Tue, 11/08/2022 - 11:17

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

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Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

Surgical site infections are one of the top causes of postoperative morbidity and death worldwide, but there is little agreement and much debate over the most effective wound dressing to improve outcomes and reduce the health care burden.

Recent clinical trials have indicated that transparent, semiocclusive films have advantages over gauze held by adhesive tape.

But current transparent film bandages may become dislodged during activities such as showering, say authors of a pilot study published in the Journal of Wound Care. Patients may not realize the bandage has been disrupted, which can lead to infection.

The paper describes a novel product called DrySee dressing (DSD), which features a liquid indicator that turns blue around the edges if moisture is present.

“Clinicians, patients, and caregivers are alerted to the loss of dressing integrity and can replace the dressing when any portion of the perimeter changes to a blue [color],” the authors explain. “In addition, the dressing turns blue when the central pad is saturated with fluid, allowing the patient or provider to change the dressing.”

DSD is indicated for wounds that have low levels of exudate.
 

Two transparent film dressings compared

Researchers recruited 20 patients from the general population in Pittsburgh, for a small pilot study to test DSD against a comparator film dressing (3M Tegaderm + Pad). The volunteers received “a small stipend,” according to the paper.

A 1.5-centimeter incision was made in both forearms of each volunteer. The forearms were randomized regarding which got which bandage. Both bandages have been cleared by the U.S. Food and Drug Administration as nonsignificant-risk devices.

Volunteers were instructed to wear the dressing and continue their typical activities of daily living.

The average age of the volunteers was 52 years (range, 20-80 years). Among the 20 volunteers, 11 reported no comorbidities, and 45% reported at least one comorbidity.

Most of the volunteers favored DSD over the comparator in a postoperative survey – 75% to 25%, according to the report.

The wear time between the two transparent dressings across all subjects was 1.4 days. There was no difference in wear time, logged by the volunteers, between the two groups.   

There were no infectious complications, the paper states.

The maker, DrySee (Houston), which holds three patents on the product, supported the research with an unrestricted grant.

DrySee CEO Brad Greer told this news organization, “With DrySee, you know when to change your dressing. All other dressings look the same wet, saturated, or dry.”

He said the study confirms what they have seen in practice, adding that the product is unique.

“No one else in the world has this technology,” Mr. Greer said.
 

Surgeons want to see more data

Heather Evans, MD, a general surgeon with the Medical University of South Carolina, MUSC Health, Charleston, who was not involved with the study, praised the color-indicator design and said she liked the bandage’s narrow indication for low-exudate wounds.

She said in an interview, “It’s a lot to put on a layperson to suddenly know how to take care of wounds when you leave the hospital.”

Giving them the confidence that their wound is safe if the blue doesn’t appear “is a really cool concept,” she said.

She said that, although the volunteers included some elderly people and people with conditions such as diabetes that could affect wound healing, the bandage needs to be tested with a bigger trial to see if it is effective outside controlled conditions.

She also said that some occlusive dressings will be more durable and stay on days longer than DSD or the comparator, which may affect the choice for some.

“The average length of dressing time in this study was less than 2 days,” she pointed out.

Jim Rickert, MD, an orthopedic surgeon with Indiana University Health Bedford, who was not involved with the study, agreed that any surgical or wound dressing, including transparent films, can become dislodged, and said, “This type of product has promise but this is a small pilot study. I would want to see results from a trial of actual surgical patients to see if this type of dressing did indeed decrease post-op infections compared to standard dressing materials.”

Not all are convinced either that there is a need to be filled or that DSD will be the right solution.

Therese Duane, MD, a general surgeon with Texas Health Harris Methodist Fort Worth, who was not part of the study, said in an interview that she “has no issues with the current products.”

She added that more information is needed before considering DSD a better solution, including animal studies and use “on very sick patients.”

“Twenty volunteers with cuts on their arm is barely a start for comparison,” she said.

The authors, led by Kristy Breisinger, a research analyst with the SerenaGroup Research Foundation in Cambridge, Mass., acknowledged the limitations, including the small sample size and that the trial was conducted at only one institution. Additionally, the analysis is based on descriptive statistics.

They write that the trial design was chosen “to simulate a real-world setting that is not always achievable in animal studies.”

The research was sponsored by an unrestricted grant from the maker of DSD, DrySee Inc., in Houston.

Mr. Greer is DrySee’s CEO. The authors and Dr. Duane, Dr. Rickert, and Dr. Evans declared no relevant financial relationships.

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

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New Medicare physician fee schedule leaves docs fuming over pay cuts

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Tue, 11/15/2022 - 11:23

Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

 

 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

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Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

 

 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

Medicare’s recently announced 2023 physician payment rule likely trims doctors’ pay even as it aims to expand patients’ access to behavioral health services, chronic pain management, and hearing screening. The rule also seeks to ease financial and administrative burdens on accountable care organizations (ACOs).

But physician groups’ initial reactions centered on what the American Medical Association describes as a “damaging across-the-board reduction” of 4.4% in a base calculation, known as a conversion factor.

The reduction is only one of the current threats to physician’s finances, Jack Resneck Jr, MD, AMA’s president, said in a statement. Medicare payment rates also fail to account for inflation in practice costs and COVID-related challenges. Physician’s Medicare payments could be cut by nearly 8.5% in 2023, factoring in other budget cuts, Dr. Resneck said in the statement.

That “would severely impede patient access to care due to the forced closure of physician practices and put further strain on those that remained open during the pandemic,” he said.

A key driver of these cuts is a law that was intended to resolve budget battles between Congress and physicians, while also transitioning Medicare away from fee-for-service payments and pegging reimbursement to judgments about value of care provided. The Centers for Medicare & Medicaid Services thus had little choice about cuts mandated by the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015.

For AMA and other physician groups, the finalization of the Medicare rule served as a rallying point to build support for pending legislation intended to stave off at least some payment cuts.

Federal officials should act soon to block the expected cuts before this season of Congress ends in January, said Anders Gilberg, senior vice president for government affairs at the Medical Group Management Association, in a statement.

“This cannot wait until next Congress – there are claims-processing implications for retroactively applying these policies,” Mr. Gilberg said.

He said MGMA would work with Congress and CMS “to mitigate these cuts and develop sustainable payment policies to allow physician practices to focus on treating patients instead of scrambling to keep their doors open.”
 

Chronic budget battles

Once seen as a promising resolution to chronic annual budget battles between physicians and Medicare, MACRA has proven a near-universal disappointment. A federal advisory commission in 2018 recommended that Congress scrap MACRA’s  Merit-based Incentive Payment System (MIPS) and replace it with a new approach for attempting to tie reimbursement to judgments about the quality of medical care.

MACRA replaced an earlier budgeting approach on Medicare physician pay, known as the sustainable growth rate (SGR). Physician groups successfully lobbied Congress for many years to block threatened Medicare payment cuts. Between 2003 and April 2014, Congress passed 17 laws overriding the cuts to physician pay that the lawmakers earlier mandated through the SGR.

A similar pattern has emerged as Congress now acts on short-term fixes to stave off MACRA-mandated cuts. A law passed last December postponed cuts in physician pay from MACRA and federal budget laws.

And more than 70 members of the House support a bill (HR 8800) intended to block a slated 4.4% MACRA-related cut in physician pay for 2023. Two physicians, Rep. Ami Bera, MD, (D-CA) and Rep. Larry Bucshon (R-IN) sponsored the bill.

Among the groups backing the bill are the AMA, American Academy of Family Physicians, and American College of Physicians. The lawmakers may try to attach this bill to a large spending measure, known as an omnibus, that Congress will try to clear in December to avoid a partial government shutdown.

In a statement, Tochi Iroku-Malize, MD, MPH, MBA, the president of AAFP, urged Congress to factor in inflation in setting physician reimbursement and to reconsider Medicare’s approach to paying physicians.

“It’s past time to end the untenable physician payment cuts – which have now become an annual threat to the stability of physician practices – caused by Medicare budget neutrality requirements and the ongoing freeze in annual payment updates,” Dr. Iroku-Malize said.

Congress also needs to retool its approach to alternative payment models (APMs) intended to improve the quality of patient care, Dr. Iroku-Malize said.

“Physicians in APMs are better equipped to address unmet social needs and provide other enhanced services that are not supported by fee-for-service payment rates,” Dr. Iroku-Malize said. “However, insufficient Medicare fee-for-service payment rates, inadequate support, and burdensome timelines are undermining the move to value-based care and exacerbating our nation’s underinvestment in primary care.”
 

 

 

Policy changes

But the new rule did have some good news for family physicians, Dr. Iroku-Malize told this news organization in an email.

CMS said it will pay psychologists and social workers to help manage behavioral health needs as part of the primary care team, in addition to their own services. This change will give primary care practices more flexibility to coordinate with behavioral health professionals, Dr. Iroku-Malize noted.

“We know that primary care physicians are the first point of contact for many patients, and behavioral health integration increases critical access to mental health care, decreases stigma for patients, and can prevent more severe medical and behavioral health events,” she wrote.

CMS also eased a supervision requirement for nonphysicians providing behavioral health services.

It intends to allow certain health professionals to provide this care without requiring that a supervising physician or nurse practitioner be physically on site. This shift from direct supervision to what’s called general supervision applies to marriage and family therapists, licensed professional counselors, addiction counselors, certified peer recovery specialists, and behavioral health specialists, CMS said.

Other major policy changes include:

Medicare will pay for telehealth opioid treatment programs allowing patients to initiate treatment with buprenorphine. CMS also clarified that certain programs can bill for opioid use disorder treatment services provided through mobile units, such as vans.

Medicare enrollees may see audiologists for nonacute hearing conditions without an order from a physician or nurse practitioner. The policy is meant to allow audiologists to examine patients to prescribe, fit, or change hearing aids, or to provide hearing tests unrelated to disequilibrium.

CMS created new reimbursement codes for chronic pain management and treatment services to encourage clinicians to see patients with this condition. The codes also are meant to encourage practitioners already treating Medicare patients with chronic pain to spend more time helping them manage their condition “within a trusting, supportive, and ongoing care partnership,” CMS said.

CMS also made changes to the Medicare Shared Savings Program (MSSP) intended to reduce administrative burdens and offer more financial support to practices involved in ACOs. These steps include expanding opportunities for certain low-revenue ACOs to share in savings even if they do not meet a target rate.

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

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In CABG, radial artery works best for second key graft: RAPCO at 15 years

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Lower risk of MACE shown

 

– With more than 15 years of follow-up from two related trials, the best conduit for the second most important target vessel in coronary artery bypass grafting (CABG) appears to be resolved.

The radial artery (RA) graft is linked with a lower risk of major adverse cardiac events (MACE) relative to a saphenous vein (SV) or the free right internal thoracic artery (FRITA).

On the basis of these findings, “a radial artery graft should be considered in all isolated CABG operations unless there are contraindications,” reported David L. Hare, MBBS, director of research in the department of cardiology, University of Melbourne.

For the primary graft, there is general agreement that the left internal thoracic artery (LITA) is the first choice for the left anterior descending vessel, but the optimal graft for the second most important target has never been established, according to Dr. Hare.

Almost 25 years ago, two randomized controlled trials called RAPCO-RITA and RAPCO-SV were initiated to address the question. There is now 15 years of follow-up for both of the RAPCO (Radial Artery Patency and Clinical Outcomes) trials, which were presented together at the American Heart Association scientific sessions.
 

Two trials conducted simultaneously

The RAPCO-RITA trial randomized CABG patients less than 70 years of age (less than 60 years in those with diabetes) to grafting of the second target vessel with an RA or FRITA graft. The RAPCO-SV trial randomized those 70 years or older (60 years or older with diabetes) to an RA or SV graft.

The two primary endpoints were graft patency at 10 years and a composite MACE at 10 years. The assessment of the MACE endpoint, which consisted of cardiovascular mortality, acute myocardial infarction, and coronary revascularization, was later amended to include a comparison at 15 years.

Ten-year patency results, favoring the RA in both studies, were previously published in Circulation. In the new data presented at the meeting, the RA was associated with a significant reduction in MACE relative to the comparator graft in both studies.

“The main driver was a reduction in all-cause mortality,” Dr. Hare reported.

In RAPCO-RITA, 394 patients were randomized with follow-up data available for all but 1 patient at 15 years. Similarly, only 1 patient was lost to follow-up among the 225 randomized in RAPCO-SV. In both studies, baseline characteristics were well balanced.

MACE curves separate at 5 years

In RAPCO-RITA, the MACE survival curves began to separate at about 5 years and then gradually widened. By 15 years, the lower rate of MACE in the RA group (38% vs. 48%) translated into a 26% relative reduction (hazard ratio, 0.74; P = .04).

In RAPCO-SV, the pattern was similar, by 15 years, the rates of MACE were 60% and 73% for the RA and SV groups, respectively, translating into a 29% relative reduction (HR, 0.71; P = .04).

There was no heterogeneity in benefit across prespecified subgroups such as presence or absence of diabetes, gender, or age. In RAPCO-RITA, there was 8% absolute and 31% relative reduction in all-cause mortality. In RAPCO-SV, the absolute and relative reductions were 11% and 26%.

When the trial was initiated, Dr. Hare hypothesized that RITA would prove more durable than RA, so the outcome was not anticipated.

“This is the first randomized controlled trial program to address the question,” said Dr. Hare, who noted that there have been numerous retrospective and case control analyses that have produced mixed results in the past.
 

 

 

Discussant praises trial quality

The AHA-invited discussant, Marc Ruel, MD, chair of cardiac surgery, University of Ottawa (Ont.) Heart Institute, called these data “important,” and he congratulated Dr. Hare for conducting the first randomized trial to address the question about second graft durability.

However, he noted that, although the study was randomized, it was not blinded, and he questioned whether postoperative care, in particular, was similar. He also pointed out that the MACE rate seemed high, particularly among the older patients randomized in RAPCO-SV.

“All of the patients were referred to an independently run CABG rehab program that was quite separate from the trial but that provided identical mandated care,” Dr. Hare responded, indicating that there was no opportunity for differences in postprocedural management.

In the United States, the SV graft is often preferred on the basis of easy harvesting and handling characteristics, according to Dr. Hare, who estimated that fewer than 10% of the 200,000 CABG procedures performed in the United States employ the RA conduit for second target vessels. He believes the RAPCO trials data support a change.

“My personal view is [that, on the basis of] this data, given that it is from a controlled trial rather than from patient-level meta-analyses, all isolated CABG operations should be using a radial graft if it is suitable,” Dr. Hare said.

Dr. Hare reports financial relationships with Abbott, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, CSL-Biotherapies, Lundbeck, Menarini, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Vifor. Dr. Ruel reports financial relationships with Cryolife, Edwards, and Medtronic.

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Lower risk of MACE shown

Lower risk of MACE shown

 

– With more than 15 years of follow-up from two related trials, the best conduit for the second most important target vessel in coronary artery bypass grafting (CABG) appears to be resolved.

The radial artery (RA) graft is linked with a lower risk of major adverse cardiac events (MACE) relative to a saphenous vein (SV) or the free right internal thoracic artery (FRITA).

On the basis of these findings, “a radial artery graft should be considered in all isolated CABG operations unless there are contraindications,” reported David L. Hare, MBBS, director of research in the department of cardiology, University of Melbourne.

For the primary graft, there is general agreement that the left internal thoracic artery (LITA) is the first choice for the left anterior descending vessel, but the optimal graft for the second most important target has never been established, according to Dr. Hare.

Almost 25 years ago, two randomized controlled trials called RAPCO-RITA and RAPCO-SV were initiated to address the question. There is now 15 years of follow-up for both of the RAPCO (Radial Artery Patency and Clinical Outcomes) trials, which were presented together at the American Heart Association scientific sessions.
 

Two trials conducted simultaneously

The RAPCO-RITA trial randomized CABG patients less than 70 years of age (less than 60 years in those with diabetes) to grafting of the second target vessel with an RA or FRITA graft. The RAPCO-SV trial randomized those 70 years or older (60 years or older with diabetes) to an RA or SV graft.

The two primary endpoints were graft patency at 10 years and a composite MACE at 10 years. The assessment of the MACE endpoint, which consisted of cardiovascular mortality, acute myocardial infarction, and coronary revascularization, was later amended to include a comparison at 15 years.

Ten-year patency results, favoring the RA in both studies, were previously published in Circulation. In the new data presented at the meeting, the RA was associated with a significant reduction in MACE relative to the comparator graft in both studies.

“The main driver was a reduction in all-cause mortality,” Dr. Hare reported.

In RAPCO-RITA, 394 patients were randomized with follow-up data available for all but 1 patient at 15 years. Similarly, only 1 patient was lost to follow-up among the 225 randomized in RAPCO-SV. In both studies, baseline characteristics were well balanced.

MACE curves separate at 5 years

In RAPCO-RITA, the MACE survival curves began to separate at about 5 years and then gradually widened. By 15 years, the lower rate of MACE in the RA group (38% vs. 48%) translated into a 26% relative reduction (hazard ratio, 0.74; P = .04).

In RAPCO-SV, the pattern was similar, by 15 years, the rates of MACE were 60% and 73% for the RA and SV groups, respectively, translating into a 29% relative reduction (HR, 0.71; P = .04).

There was no heterogeneity in benefit across prespecified subgroups such as presence or absence of diabetes, gender, or age. In RAPCO-RITA, there was 8% absolute and 31% relative reduction in all-cause mortality. In RAPCO-SV, the absolute and relative reductions were 11% and 26%.

When the trial was initiated, Dr. Hare hypothesized that RITA would prove more durable than RA, so the outcome was not anticipated.

“This is the first randomized controlled trial program to address the question,” said Dr. Hare, who noted that there have been numerous retrospective and case control analyses that have produced mixed results in the past.
 

 

 

Discussant praises trial quality

The AHA-invited discussant, Marc Ruel, MD, chair of cardiac surgery, University of Ottawa (Ont.) Heart Institute, called these data “important,” and he congratulated Dr. Hare for conducting the first randomized trial to address the question about second graft durability.

However, he noted that, although the study was randomized, it was not blinded, and he questioned whether postoperative care, in particular, was similar. He also pointed out that the MACE rate seemed high, particularly among the older patients randomized in RAPCO-SV.

“All of the patients were referred to an independently run CABG rehab program that was quite separate from the trial but that provided identical mandated care,” Dr. Hare responded, indicating that there was no opportunity for differences in postprocedural management.

In the United States, the SV graft is often preferred on the basis of easy harvesting and handling characteristics, according to Dr. Hare, who estimated that fewer than 10% of the 200,000 CABG procedures performed in the United States employ the RA conduit for second target vessels. He believes the RAPCO trials data support a change.

“My personal view is [that, on the basis of] this data, given that it is from a controlled trial rather than from patient-level meta-analyses, all isolated CABG operations should be using a radial graft if it is suitable,” Dr. Hare said.

Dr. Hare reports financial relationships with Abbott, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, CSL-Biotherapies, Lundbeck, Menarini, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Vifor. Dr. Ruel reports financial relationships with Cryolife, Edwards, and Medtronic.

 

– With more than 15 years of follow-up from two related trials, the best conduit for the second most important target vessel in coronary artery bypass grafting (CABG) appears to be resolved.

The radial artery (RA) graft is linked with a lower risk of major adverse cardiac events (MACE) relative to a saphenous vein (SV) or the free right internal thoracic artery (FRITA).

On the basis of these findings, “a radial artery graft should be considered in all isolated CABG operations unless there are contraindications,” reported David L. Hare, MBBS, director of research in the department of cardiology, University of Melbourne.

For the primary graft, there is general agreement that the left internal thoracic artery (LITA) is the first choice for the left anterior descending vessel, but the optimal graft for the second most important target has never been established, according to Dr. Hare.

Almost 25 years ago, two randomized controlled trials called RAPCO-RITA and RAPCO-SV were initiated to address the question. There is now 15 years of follow-up for both of the RAPCO (Radial Artery Patency and Clinical Outcomes) trials, which were presented together at the American Heart Association scientific sessions.
 

Two trials conducted simultaneously

The RAPCO-RITA trial randomized CABG patients less than 70 years of age (less than 60 years in those with diabetes) to grafting of the second target vessel with an RA or FRITA graft. The RAPCO-SV trial randomized those 70 years or older (60 years or older with diabetes) to an RA or SV graft.

The two primary endpoints were graft patency at 10 years and a composite MACE at 10 years. The assessment of the MACE endpoint, which consisted of cardiovascular mortality, acute myocardial infarction, and coronary revascularization, was later amended to include a comparison at 15 years.

Ten-year patency results, favoring the RA in both studies, were previously published in Circulation. In the new data presented at the meeting, the RA was associated with a significant reduction in MACE relative to the comparator graft in both studies.

“The main driver was a reduction in all-cause mortality,” Dr. Hare reported.

In RAPCO-RITA, 394 patients were randomized with follow-up data available for all but 1 patient at 15 years. Similarly, only 1 patient was lost to follow-up among the 225 randomized in RAPCO-SV. In both studies, baseline characteristics were well balanced.

MACE curves separate at 5 years

In RAPCO-RITA, the MACE survival curves began to separate at about 5 years and then gradually widened. By 15 years, the lower rate of MACE in the RA group (38% vs. 48%) translated into a 26% relative reduction (hazard ratio, 0.74; P = .04).

In RAPCO-SV, the pattern was similar, by 15 years, the rates of MACE were 60% and 73% for the RA and SV groups, respectively, translating into a 29% relative reduction (HR, 0.71; P = .04).

There was no heterogeneity in benefit across prespecified subgroups such as presence or absence of diabetes, gender, or age. In RAPCO-RITA, there was 8% absolute and 31% relative reduction in all-cause mortality. In RAPCO-SV, the absolute and relative reductions were 11% and 26%.

When the trial was initiated, Dr. Hare hypothesized that RITA would prove more durable than RA, so the outcome was not anticipated.

“This is the first randomized controlled trial program to address the question,” said Dr. Hare, who noted that there have been numerous retrospective and case control analyses that have produced mixed results in the past.
 

 

 

Discussant praises trial quality

The AHA-invited discussant, Marc Ruel, MD, chair of cardiac surgery, University of Ottawa (Ont.) Heart Institute, called these data “important,” and he congratulated Dr. Hare for conducting the first randomized trial to address the question about second graft durability.

However, he noted that, although the study was randomized, it was not blinded, and he questioned whether postoperative care, in particular, was similar. He also pointed out that the MACE rate seemed high, particularly among the older patients randomized in RAPCO-SV.

“All of the patients were referred to an independently run CABG rehab program that was quite separate from the trial but that provided identical mandated care,” Dr. Hare responded, indicating that there was no opportunity for differences in postprocedural management.

In the United States, the SV graft is often preferred on the basis of easy harvesting and handling characteristics, according to Dr. Hare, who estimated that fewer than 10% of the 200,000 CABG procedures performed in the United States employ the RA conduit for second target vessels. He believes the RAPCO trials data support a change.

“My personal view is [that, on the basis of] this data, given that it is from a controlled trial rather than from patient-level meta-analyses, all isolated CABG operations should be using a radial graft if it is suitable,” Dr. Hare said.

Dr. Hare reports financial relationships with Abbott, Amgen, AstraZeneca, Bayer, Boehringer-Ingelheim, CSL-Biotherapies, Lundbeck, Menarini, Merck, Novartis, Pfizer, Regeneron, Sanofi, Servier, and Vifor. Dr. Ruel reports financial relationships with Cryolife, Edwards, and Medtronic.

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Puzzling, unique ECG from pig-to-human transplanted heart

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Changed
Wed, 11/09/2022 - 08:51

 

In the first transplant of a genetically altered pig heart into a human in January, initial unexpected, prolonged ECG readings apparently did not affect the heart’s function, although the organ suddenly began to fail at day 50.

A study of these ECG changes, scheduled for presentation by Calvin Kagan, MD, and colleagues at the American Heart Association scientific sessions, offers insight into this novel operation.

As widely reported, the patient, 57-year-old David Bennett of Maryland, had end-stage heart disease and was a poor candidate for a ventricular assist device and was ineligible for a human heart, when he consented to be the first human to be transplanted with a pig heart that had a number of genes added or subtracted with the goal, in part, to prevent rejection.

University of Maryland Medical Center
The first pig-to-human heart transplant, performed at University of Maryland Medical Center, Baltimore

The heart initially performed well after it was transplanted in an operation at the University of Maryland School of Medicine (UMSOM) in Baltimore on Jan. 7, but failed in the second month, and Mr. Bennett died on March 9.



The Food and Drug Administration had granted emergency authorization for the surgery through its expanded access (compassionate use) program, coauthor Muhammad Mohiuddin, MD, said in an interview.

“We have learned a lot and hope we can do more,” said Dr. Mohiuddin, scientific and program director of the cardiac xenotransplantation program at UMSOM.

“Suddenly on day 50, the heart started to get thicker and was not relaxing enough,” explained senior author Timm-Michael Dickfeld, MD, PhD, director of electrophysiology research at UMSOM. A biopsy revealed substantial buildup of interstitial fluid that restricted movement. The fluid was replaced by fibrous tissue, leading to irreversible damage.

Persistent, prolonged ECG parameters

In the heart from a genetically modified pig, three genes associated with antibody-mediated rejection and a gene associated with pig heart tissue growth had been inactivated and six human genes associated with immune acceptance had been added. The donor pig was supplied by Revivicor (Blacksburg, Va.).

The patient’s immunosuppressant therapy included an experimental antirejection medication (Kiniksa Pharmaceuticals; Lexington, Mass.).  

The patient had daily 12-lead ECGs after the transplant.

In prior research using a pig heart transplanted into a pig body, ECG readings showed a short PR interval (50-120 ms), short QRS duration (70-90 ms) and short QT intervals (260-380 ms).

However, in the transplanted xenograft heart, the initial ECG readings showed a longer PR interval of 190 ms, QRS duration of 138 ms, and QT of 538 ms.

Prolonged intrinsic PR intervals remained stable during the postoperative course (210 ms, range 142-246 ms).

QRS duration also remained prolonged (145 ms, range 116-192 ms), but shortened during the postoperative course (days 21-40 vs. 41-60: 148 ms vs. 132 ms; P < .001).

Increased QT persisted (509 ms, range 384-650 ms) with dynamic fluctuations. The shortest QT duration was observed on day 14 (P < .001).

“In a human heart, when those parameters get longer, this can indicate signs of electrical or myocardial disease,” Dr. Dickfeld explained in a press release from the AHA.

“The QRS duration may prolong when, for example, the muscle and the electrical system itself is diseased, and that is why it takes a long time for electricity to travel from cell to cell and travel from one side of the heart to the other,” he said.

“In the human heart, the QT duration is correlated with an increased risk of abnormal heart rhythms,” he noted. “In our patient, it was concerning that the QT measure was prolonged. While we saw some fluctuations, the QT measure remained prolonged during the whole 61 days.”
 

 

 

‘Interesting study’

Two experts who were not involved with this research weighed in on the findings for this news organization.

“This very interesting study reinforces the difficulties in xenotransplantation, and the need for more research to be able to safely monitor recipients, as baseline values are unknown,” said Edward Vigmond, PhD.

Dr. Vigmond, from the Electrophysiology and Heart Modeling Institute at the University of Bordeaux in France, published a related study about a model of translation of pig to human electrophysiology.

The ECG is sensitive to the electrical activation pattern of the heart, along with the cellular and tissue electrical properties, he noted.

“Although pigs and humans may be similar in size, there are many differences between them,” Dr. Vigmond observed, including “the extent of the rapid conduction system of the heart, the number of nuclei in the muscle cells, the proteins in the cell membrane which control electrical activity, the orientation of the heart and thorax, and the handling of calcium inside the cell.”

“On top of this,” he continued, “donor hearts are denervated, so they no longer respond to nervous modulation, and circulating compounds in the blood which affect heart function vary between species.

“With all these differences, it is not surprising that the ECG of a pig heart transplanted into a human resembles neither that of a human nor that of a pig,” Dr. Vigmond said.

“It is interesting to note that the humanized-gene-edited porcine heart exhibited abnormal electrical conduction parameters from the outset,” said Mandeep R. Mehra, MD.

“Whether these changes were due to the gene modifications (i.e., already inherent in the pig ECG prior to transplant) or a result of the transplant operation challenges (such as the ischemia reperfusion injury and early immunological interactions) is uncertain and should be clarified,” said Dr. Mehra, of Harvard Medical School and Brigham and Women’s Medicine in Boston.

“Knowledge of these changes is important to determine whether a simple ECG parameter may be useful to identify changes that could indicate developing pathology,” Dr. Mehra added.

“In the older days of human transplantation, we often used ECG parameters such as a change in voltage amplitude to identify signals for rejection,” he continued. “Whether such changes occurred in this case could be another interesting aspect to explore as changes occurred in cardiac performance in response to the physiological and pathological challenges that were encountered in this sentinel case.”

The study authors reported having no outside sources of funding.
 

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

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In the first transplant of a genetically altered pig heart into a human in January, initial unexpected, prolonged ECG readings apparently did not affect the heart’s function, although the organ suddenly began to fail at day 50.

A study of these ECG changes, scheduled for presentation by Calvin Kagan, MD, and colleagues at the American Heart Association scientific sessions, offers insight into this novel operation.

As widely reported, the patient, 57-year-old David Bennett of Maryland, had end-stage heart disease and was a poor candidate for a ventricular assist device and was ineligible for a human heart, when he consented to be the first human to be transplanted with a pig heart that had a number of genes added or subtracted with the goal, in part, to prevent rejection.

University of Maryland Medical Center
The first pig-to-human heart transplant, performed at University of Maryland Medical Center, Baltimore

The heart initially performed well after it was transplanted in an operation at the University of Maryland School of Medicine (UMSOM) in Baltimore on Jan. 7, but failed in the second month, and Mr. Bennett died on March 9.



The Food and Drug Administration had granted emergency authorization for the surgery through its expanded access (compassionate use) program, coauthor Muhammad Mohiuddin, MD, said in an interview.

“We have learned a lot and hope we can do more,” said Dr. Mohiuddin, scientific and program director of the cardiac xenotransplantation program at UMSOM.

“Suddenly on day 50, the heart started to get thicker and was not relaxing enough,” explained senior author Timm-Michael Dickfeld, MD, PhD, director of electrophysiology research at UMSOM. A biopsy revealed substantial buildup of interstitial fluid that restricted movement. The fluid was replaced by fibrous tissue, leading to irreversible damage.

Persistent, prolonged ECG parameters

In the heart from a genetically modified pig, three genes associated with antibody-mediated rejection and a gene associated with pig heart tissue growth had been inactivated and six human genes associated with immune acceptance had been added. The donor pig was supplied by Revivicor (Blacksburg, Va.).

The patient’s immunosuppressant therapy included an experimental antirejection medication (Kiniksa Pharmaceuticals; Lexington, Mass.).  

The patient had daily 12-lead ECGs after the transplant.

In prior research using a pig heart transplanted into a pig body, ECG readings showed a short PR interval (50-120 ms), short QRS duration (70-90 ms) and short QT intervals (260-380 ms).

However, in the transplanted xenograft heart, the initial ECG readings showed a longer PR interval of 190 ms, QRS duration of 138 ms, and QT of 538 ms.

Prolonged intrinsic PR intervals remained stable during the postoperative course (210 ms, range 142-246 ms).

QRS duration also remained prolonged (145 ms, range 116-192 ms), but shortened during the postoperative course (days 21-40 vs. 41-60: 148 ms vs. 132 ms; P < .001).

Increased QT persisted (509 ms, range 384-650 ms) with dynamic fluctuations. The shortest QT duration was observed on day 14 (P < .001).

“In a human heart, when those parameters get longer, this can indicate signs of electrical or myocardial disease,” Dr. Dickfeld explained in a press release from the AHA.

“The QRS duration may prolong when, for example, the muscle and the electrical system itself is diseased, and that is why it takes a long time for electricity to travel from cell to cell and travel from one side of the heart to the other,” he said.

“In the human heart, the QT duration is correlated with an increased risk of abnormal heart rhythms,” he noted. “In our patient, it was concerning that the QT measure was prolonged. While we saw some fluctuations, the QT measure remained prolonged during the whole 61 days.”
 

 

 

‘Interesting study’

Two experts who were not involved with this research weighed in on the findings for this news organization.

“This very interesting study reinforces the difficulties in xenotransplantation, and the need for more research to be able to safely monitor recipients, as baseline values are unknown,” said Edward Vigmond, PhD.

Dr. Vigmond, from the Electrophysiology and Heart Modeling Institute at the University of Bordeaux in France, published a related study about a model of translation of pig to human electrophysiology.

The ECG is sensitive to the electrical activation pattern of the heart, along with the cellular and tissue electrical properties, he noted.

“Although pigs and humans may be similar in size, there are many differences between them,” Dr. Vigmond observed, including “the extent of the rapid conduction system of the heart, the number of nuclei in the muscle cells, the proteins in the cell membrane which control electrical activity, the orientation of the heart and thorax, and the handling of calcium inside the cell.”

“On top of this,” he continued, “donor hearts are denervated, so they no longer respond to nervous modulation, and circulating compounds in the blood which affect heart function vary between species.

“With all these differences, it is not surprising that the ECG of a pig heart transplanted into a human resembles neither that of a human nor that of a pig,” Dr. Vigmond said.

“It is interesting to note that the humanized-gene-edited porcine heart exhibited abnormal electrical conduction parameters from the outset,” said Mandeep R. Mehra, MD.

“Whether these changes were due to the gene modifications (i.e., already inherent in the pig ECG prior to transplant) or a result of the transplant operation challenges (such as the ischemia reperfusion injury and early immunological interactions) is uncertain and should be clarified,” said Dr. Mehra, of Harvard Medical School and Brigham and Women’s Medicine in Boston.

“Knowledge of these changes is important to determine whether a simple ECG parameter may be useful to identify changes that could indicate developing pathology,” Dr. Mehra added.

“In the older days of human transplantation, we often used ECG parameters such as a change in voltage amplitude to identify signals for rejection,” he continued. “Whether such changes occurred in this case could be another interesting aspect to explore as changes occurred in cardiac performance in response to the physiological and pathological challenges that were encountered in this sentinel case.”

The study authors reported having no outside sources of funding.
 

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

 

In the first transplant of a genetically altered pig heart into a human in January, initial unexpected, prolonged ECG readings apparently did not affect the heart’s function, although the organ suddenly began to fail at day 50.

A study of these ECG changes, scheduled for presentation by Calvin Kagan, MD, and colleagues at the American Heart Association scientific sessions, offers insight into this novel operation.

As widely reported, the patient, 57-year-old David Bennett of Maryland, had end-stage heart disease and was a poor candidate for a ventricular assist device and was ineligible for a human heart, when he consented to be the first human to be transplanted with a pig heart that had a number of genes added or subtracted with the goal, in part, to prevent rejection.

University of Maryland Medical Center
The first pig-to-human heart transplant, performed at University of Maryland Medical Center, Baltimore

The heart initially performed well after it was transplanted in an operation at the University of Maryland School of Medicine (UMSOM) in Baltimore on Jan. 7, but failed in the second month, and Mr. Bennett died on March 9.



The Food and Drug Administration had granted emergency authorization for the surgery through its expanded access (compassionate use) program, coauthor Muhammad Mohiuddin, MD, said in an interview.

“We have learned a lot and hope we can do more,” said Dr. Mohiuddin, scientific and program director of the cardiac xenotransplantation program at UMSOM.

“Suddenly on day 50, the heart started to get thicker and was not relaxing enough,” explained senior author Timm-Michael Dickfeld, MD, PhD, director of electrophysiology research at UMSOM. A biopsy revealed substantial buildup of interstitial fluid that restricted movement. The fluid was replaced by fibrous tissue, leading to irreversible damage.

Persistent, prolonged ECG parameters

In the heart from a genetically modified pig, three genes associated with antibody-mediated rejection and a gene associated with pig heart tissue growth had been inactivated and six human genes associated with immune acceptance had been added. The donor pig was supplied by Revivicor (Blacksburg, Va.).

The patient’s immunosuppressant therapy included an experimental antirejection medication (Kiniksa Pharmaceuticals; Lexington, Mass.).  

The patient had daily 12-lead ECGs after the transplant.

In prior research using a pig heart transplanted into a pig body, ECG readings showed a short PR interval (50-120 ms), short QRS duration (70-90 ms) and short QT intervals (260-380 ms).

However, in the transplanted xenograft heart, the initial ECG readings showed a longer PR interval of 190 ms, QRS duration of 138 ms, and QT of 538 ms.

Prolonged intrinsic PR intervals remained stable during the postoperative course (210 ms, range 142-246 ms).

QRS duration also remained prolonged (145 ms, range 116-192 ms), but shortened during the postoperative course (days 21-40 vs. 41-60: 148 ms vs. 132 ms; P < .001).

Increased QT persisted (509 ms, range 384-650 ms) with dynamic fluctuations. The shortest QT duration was observed on day 14 (P < .001).

“In a human heart, when those parameters get longer, this can indicate signs of electrical or myocardial disease,” Dr. Dickfeld explained in a press release from the AHA.

“The QRS duration may prolong when, for example, the muscle and the electrical system itself is diseased, and that is why it takes a long time for electricity to travel from cell to cell and travel from one side of the heart to the other,” he said.

“In the human heart, the QT duration is correlated with an increased risk of abnormal heart rhythms,” he noted. “In our patient, it was concerning that the QT measure was prolonged. While we saw some fluctuations, the QT measure remained prolonged during the whole 61 days.”
 

 

 

‘Interesting study’

Two experts who were not involved with this research weighed in on the findings for this news organization.

“This very interesting study reinforces the difficulties in xenotransplantation, and the need for more research to be able to safely monitor recipients, as baseline values are unknown,” said Edward Vigmond, PhD.

Dr. Vigmond, from the Electrophysiology and Heart Modeling Institute at the University of Bordeaux in France, published a related study about a model of translation of pig to human electrophysiology.

The ECG is sensitive to the electrical activation pattern of the heart, along with the cellular and tissue electrical properties, he noted.

“Although pigs and humans may be similar in size, there are many differences between them,” Dr. Vigmond observed, including “the extent of the rapid conduction system of the heart, the number of nuclei in the muscle cells, the proteins in the cell membrane which control electrical activity, the orientation of the heart and thorax, and the handling of calcium inside the cell.”

“On top of this,” he continued, “donor hearts are denervated, so they no longer respond to nervous modulation, and circulating compounds in the blood which affect heart function vary between species.

“With all these differences, it is not surprising that the ECG of a pig heart transplanted into a human resembles neither that of a human nor that of a pig,” Dr. Vigmond said.

“It is interesting to note that the humanized-gene-edited porcine heart exhibited abnormal electrical conduction parameters from the outset,” said Mandeep R. Mehra, MD.

“Whether these changes were due to the gene modifications (i.e., already inherent in the pig ECG prior to transplant) or a result of the transplant operation challenges (such as the ischemia reperfusion injury and early immunological interactions) is uncertain and should be clarified,” said Dr. Mehra, of Harvard Medical School and Brigham and Women’s Medicine in Boston.

“Knowledge of these changes is important to determine whether a simple ECG parameter may be useful to identify changes that could indicate developing pathology,” Dr. Mehra added.

“In the older days of human transplantation, we often used ECG parameters such as a change in voltage amplitude to identify signals for rejection,” he continued. “Whether such changes occurred in this case could be another interesting aspect to explore as changes occurred in cardiac performance in response to the physiological and pathological challenges that were encountered in this sentinel case.”

The study authors reported having no outside sources of funding.
 

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

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ACC/AHA issues updated guidance on aortic disease

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Changed
Fri, 11/04/2022 - 13:50

The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

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The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

The American College of Cardiology and the American Heart Association have published an updated guideline on the diagnosis and management of aortic disease, focusing on surgical intervention considerations, consistent imaging practices, genetic and familial screenings, and the importance of multidisciplinary care.

“There has been a host of new evidence-based research available for clinicians in the past decade when it comes to aortic disease. It was time to reevaluate and update the previous, existing guidelines,” Eric M. Isselbacher, MD, MSc, chair of the writing committee, said in a statement.

“We hope this new guideline can inform clinical practices with up-to-date and synthesized recommendations, targeted toward a full multidisciplinary aortic team working to provide the best possible care for this vulnerable patient population,” added Dr. Isselbacher, codirector of the Thoracic Aortic Center at Massachusetts General Hospital, Boston.

The 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease was simultaneously published online in the Journal of the American College of Cardiology and Circulation.

The new guideline replaces the 2010 ACCF/AHA Guidelines for the Diagnosis and Management of Patients With Thoracic Aortic Disease and the 2015 Surgery for Aortic Dilation in Patients With Bicuspid Aortic Valves: A Statement of Clarification From the ACC/AHA Task Force on Clinical Practice Guidelines.

The new guideline is intended to be used with the 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease.

It brings together guidelines for both the thoracic and abdominal aorta and is targeted to cardiovascular clinicians involved in the care of people with aortic disease, including general cardiovascular care clinicians and emergency medicine clinicians, the writing group says.

Among the key recommendations in the new guideline are the following:

  • Screen first-degree relatives of individuals diagnosed with aneurysms of the aortic root or ascending thoracic aorta, or those with aortic dissection to identify individuals most at risk for aortic disease. Screening would include genetic testing and imaging.
  • Be consistent in the way CT or MRI are obtained and reported; in the measurement of aortic size and features; and in how often images are used for monitoring before and after repair surgery or other intervention. Ideally, all surveillance imaging for an individual should be done using the same modality and in the same lab, the guideline notes.
  • For individuals who require aortic intervention, know that outcomes are optimized when surgery is performed by an experienced surgeon working in a multidisciplinary aortic team. The new guideline recommends “a specialized hospital team with expertise in the evaluation and management of aortic disease, in which care is delivered in a comprehensive, multidisciplinary manner.”
  • At centers with multidisciplinary aortic teams and experienced surgeons, the threshold for surgical intervention for sporadic aortic root and ascending aortic aneurysms has been lowered from 5.5 cm to 5.0 cm in select individuals, and even lower in specific scenarios among patients with heritable thoracic aortic aneurysms.
  • In patients who are significantly smaller or taller than average, surgical thresholds may incorporate indexing of the aortic root or ascending aortic diameter to either patient body surface area or height, or aortic cross-sectional area to patient height.
  • Rapid aortic growth is a risk factor for rupture and the definition for rapid aneurysm growth rate has been updated. Surgery is now recommended for patients with aneurysms of aortic root and ascending thoracic aorta with a confirmed growth rate of ≥ 0.3 cm per year across 2 consecutive years or ≥ 0.5 cm in 1 year.
  • In patients undergoing aortic root replacement surgery, valve-sparing aortic root replacement is reasonable if the valve is suitable for repair and when performed by experienced surgeons in a multidisciplinary aortic team.
  • Patients with acute type A aortic dissection, if clinically stable, should be considered for transfer to a high-volume aortic center to improve survival. The operative repair of type A aortic dissection should entail at least an open distal anastomosis rather than just a simple supracoronary interposition graft.
  • For management of uncomplicated type B aortic dissection, there is an increasing role for . Clinical trials of repair of thoracoabdominal aortic aneurysms with endografts are reporting results that suggest endovascular repair is an option for patients with suitable anatomy.
  • Shared decision-making between the patient and multidisciplinary aortic team is highly encouraged, especially when the patient is on the borderline of thresholds for repair or eligible for different types of surgical repair.
  • Shared decision-making should also be used with individuals who are pregnant or may become pregnant to consider the risks of pregnancy in individuals with aortic disease.

The guideline was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American College of Radiology, the Society of Cardiovascular Anesthesiologists, the Society for Cardiovascular Angiography and Interventions, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.

It has been endorsed by the Society of Interventional Radiology and the Society for Vascular Surgery.

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

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