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Bariatric surgery tied to 22% lower 5-year stroke risk

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Patients with obesity who underwent bariatric surgery had 46% lower odds of stroke 1 year later, similar odds of stroke 3 years later, and 22% lower odds of stroke 5 years later, compared with matched control patients, in new research.

Illustration of stroke in the brain
purestock/Thinkstock

Michael D. Williams, MD, presented the study findings (abstract A002) at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings are “very good news,” even though the protection against stroke declined further out from the surgery, John D. Scott, MD, scientific program chair of the ASMBS meeting, told this news organization.

The investigators matched more than 56,000 patients with obesity who had bariatric surgery with an equal number of similar patients who did not have this surgery, from a large national insurance database, in what they believe is the largest study of this to date.

“Any intervention that decreases your risk of [cardiovascular] events is good news,” said Dr. Scott, a clinical professor of surgery at the University of South Carolina, Greenville, and metabolic and bariatric surgery director at Prisma Health in Greenville, S.C. “And having a 22%-45% chance of reduction in stroke risk is a very worthwhile intervention.”

Asked how this would change the way clinicians inform patients of what to expect from bariatric surgery, he said: “I would advise patients that studies like this show that surgery would not increase your risk of having a stroke.

“This is consistent with many studies that show that the risks of all macrovascular events decrease after the comorbidity reductions seen after surgery.”

According to Dr. Scott, “the next steps might include a prospective randomized trial of medical treatment versus surgery alone for [cardiovascular]/stroke outcomes, but this is unlikely.”

Similarly, Dr. Williams told this news organization that “I would tell [patients] that surgery is an effective and durable method for weight loss. It also can improve comorbid conditions, particularly diabetes and hypertension.”

Even with this study, “I’m not sure it’s appropriate to say that bariatric surgery will reduce the risk of stroke,” he cautioned.

“However, as we continue to investigate the effects of bariatric surgery, this study contributes to the greater body of knowledge that suggests that reduction in ischemic stroke risk is yet another benefit of bariatric surgery.”

The assigned discussant, Corrigan L. McBride, MD, MBA wanted to know if the lower odds ratio at 1 year might be because preoperative patient selection might eliminate patients at high risk of poor cardiovascular outcomes.

Dr. Williams, a resident at Rush Medical College, Chicago, replied that it is difficult to eliminate potential selection bias, despite best efforts, but this study shows that he can tell patients: “Having surgery is not going to increases your risk of stroke.”

“This is an important study,” Dr. McBride, professor and chief of minimally invasive surgery and bariatric surgery, University of Nebraska Medical Center, Omaha, told this news organization.

“It is the first large study to show a decreased [or no increased] risk of stroke 1, 3, and 5 years after bariatric surgery compared to matched patients, and it had enough data to look at stroke as a standalone endpoint,” Dr. McBride said. “It is important too, for patients and their physicians to understand that there is a lower chance of them having a stroke if they have surgery than if they do not.”
 

 

 

‘Important,’ ‘good news’ for stroke risk after bariatric surgery

The impact of bariatric surgery on remission of type 2 diabetes is well known, Dr. Williams noted, and other studies have reported how bariatric surgery affects the risk of major adverse cardiovascular events – a composite of stroke, myocardial infarction, coronary artery disease, and all-cause death – including a study presented in the same meeting session.

However, a very large sample size is needed to be able to demonstrate the effect of bariatric surgery on stroke, since stroke is a rare event.

The researchers analyzed data from the Mariner (PearlDiver.) all-payer insurance national claims database of patients in the United States.

They matched 56,514 patients with a body mass index over 35 kg/m2 and comorbidities or a BMI of more than 40 who underwent sleeve gastrectomy or Roux-en-Y gastric bypass during 2010-2019 with 56,514 control patients who did not undergo bariatric surgery.

A year after bariatric surgery, patients in that group had a lower stroke rate than patients in the control group (0.6% vs. 1.2%), and they had close to 50% lower odds of having a stroke (odds ratio, 0.54; 95% CI, 0.47-0.61).

Three years after bariatric surgery, there were 44,948 patients in each group; the rate of stroke was 2.1% in the surgery group and 2.2% in the control group, and there was no significant difference in the odds of having a stroke (OR, 0.96; 95% CI, 0.91-1.00).

Five years after bariatric surgery, there were 27,619 patients in each group; the stroke rate was lower in the bariatric surgery group than in the control group (2.8% vs 3.6%), but reduced odds of stroke was not as great as after 1 year (OR, 0.78; 95% CI, 0.65-0.90).

Dr. Williams has no relevant financial disclosures. Dr. McBride and Dr. Scott disclosed that they are speakers/trainers/faculty advisers for Gore. Dr. Scott is also a consultant for C-SATS (part of Johnson & Johnson).

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Patients with obesity who underwent bariatric surgery had 46% lower odds of stroke 1 year later, similar odds of stroke 3 years later, and 22% lower odds of stroke 5 years later, compared with matched control patients, in new research.

Illustration of stroke in the brain
purestock/Thinkstock

Michael D. Williams, MD, presented the study findings (abstract A002) at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings are “very good news,” even though the protection against stroke declined further out from the surgery, John D. Scott, MD, scientific program chair of the ASMBS meeting, told this news organization.

The investigators matched more than 56,000 patients with obesity who had bariatric surgery with an equal number of similar patients who did not have this surgery, from a large national insurance database, in what they believe is the largest study of this to date.

“Any intervention that decreases your risk of [cardiovascular] events is good news,” said Dr. Scott, a clinical professor of surgery at the University of South Carolina, Greenville, and metabolic and bariatric surgery director at Prisma Health in Greenville, S.C. “And having a 22%-45% chance of reduction in stroke risk is a very worthwhile intervention.”

Asked how this would change the way clinicians inform patients of what to expect from bariatric surgery, he said: “I would advise patients that studies like this show that surgery would not increase your risk of having a stroke.

“This is consistent with many studies that show that the risks of all macrovascular events decrease after the comorbidity reductions seen after surgery.”

According to Dr. Scott, “the next steps might include a prospective randomized trial of medical treatment versus surgery alone for [cardiovascular]/stroke outcomes, but this is unlikely.”

Similarly, Dr. Williams told this news organization that “I would tell [patients] that surgery is an effective and durable method for weight loss. It also can improve comorbid conditions, particularly diabetes and hypertension.”

Even with this study, “I’m not sure it’s appropriate to say that bariatric surgery will reduce the risk of stroke,” he cautioned.

“However, as we continue to investigate the effects of bariatric surgery, this study contributes to the greater body of knowledge that suggests that reduction in ischemic stroke risk is yet another benefit of bariatric surgery.”

The assigned discussant, Corrigan L. McBride, MD, MBA wanted to know if the lower odds ratio at 1 year might be because preoperative patient selection might eliminate patients at high risk of poor cardiovascular outcomes.

Dr. Williams, a resident at Rush Medical College, Chicago, replied that it is difficult to eliminate potential selection bias, despite best efforts, but this study shows that he can tell patients: “Having surgery is not going to increases your risk of stroke.”

“This is an important study,” Dr. McBride, professor and chief of minimally invasive surgery and bariatric surgery, University of Nebraska Medical Center, Omaha, told this news organization.

“It is the first large study to show a decreased [or no increased] risk of stroke 1, 3, and 5 years after bariatric surgery compared to matched patients, and it had enough data to look at stroke as a standalone endpoint,” Dr. McBride said. “It is important too, for patients and their physicians to understand that there is a lower chance of them having a stroke if they have surgery than if they do not.”
 

 

 

‘Important,’ ‘good news’ for stroke risk after bariatric surgery

The impact of bariatric surgery on remission of type 2 diabetes is well known, Dr. Williams noted, and other studies have reported how bariatric surgery affects the risk of major adverse cardiovascular events – a composite of stroke, myocardial infarction, coronary artery disease, and all-cause death – including a study presented in the same meeting session.

However, a very large sample size is needed to be able to demonstrate the effect of bariatric surgery on stroke, since stroke is a rare event.

The researchers analyzed data from the Mariner (PearlDiver.) all-payer insurance national claims database of patients in the United States.

They matched 56,514 patients with a body mass index over 35 kg/m2 and comorbidities or a BMI of more than 40 who underwent sleeve gastrectomy or Roux-en-Y gastric bypass during 2010-2019 with 56,514 control patients who did not undergo bariatric surgery.

A year after bariatric surgery, patients in that group had a lower stroke rate than patients in the control group (0.6% vs. 1.2%), and they had close to 50% lower odds of having a stroke (odds ratio, 0.54; 95% CI, 0.47-0.61).

Three years after bariatric surgery, there were 44,948 patients in each group; the rate of stroke was 2.1% in the surgery group and 2.2% in the control group, and there was no significant difference in the odds of having a stroke (OR, 0.96; 95% CI, 0.91-1.00).

Five years after bariatric surgery, there were 27,619 patients in each group; the stroke rate was lower in the bariatric surgery group than in the control group (2.8% vs 3.6%), but reduced odds of stroke was not as great as after 1 year (OR, 0.78; 95% CI, 0.65-0.90).

Dr. Williams has no relevant financial disclosures. Dr. McBride and Dr. Scott disclosed that they are speakers/trainers/faculty advisers for Gore. Dr. Scott is also a consultant for C-SATS (part of Johnson & Johnson).

Patients with obesity who underwent bariatric surgery had 46% lower odds of stroke 1 year later, similar odds of stroke 3 years later, and 22% lower odds of stroke 5 years later, compared with matched control patients, in new research.

Illustration of stroke in the brain
purestock/Thinkstock

Michael D. Williams, MD, presented the study findings (abstract A002) at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings are “very good news,” even though the protection against stroke declined further out from the surgery, John D. Scott, MD, scientific program chair of the ASMBS meeting, told this news organization.

The investigators matched more than 56,000 patients with obesity who had bariatric surgery with an equal number of similar patients who did not have this surgery, from a large national insurance database, in what they believe is the largest study of this to date.

“Any intervention that decreases your risk of [cardiovascular] events is good news,” said Dr. Scott, a clinical professor of surgery at the University of South Carolina, Greenville, and metabolic and bariatric surgery director at Prisma Health in Greenville, S.C. “And having a 22%-45% chance of reduction in stroke risk is a very worthwhile intervention.”

Asked how this would change the way clinicians inform patients of what to expect from bariatric surgery, he said: “I would advise patients that studies like this show that surgery would not increase your risk of having a stroke.

“This is consistent with many studies that show that the risks of all macrovascular events decrease after the comorbidity reductions seen after surgery.”

According to Dr. Scott, “the next steps might include a prospective randomized trial of medical treatment versus surgery alone for [cardiovascular]/stroke outcomes, but this is unlikely.”

Similarly, Dr. Williams told this news organization that “I would tell [patients] that surgery is an effective and durable method for weight loss. It also can improve comorbid conditions, particularly diabetes and hypertension.”

Even with this study, “I’m not sure it’s appropriate to say that bariatric surgery will reduce the risk of stroke,” he cautioned.

“However, as we continue to investigate the effects of bariatric surgery, this study contributes to the greater body of knowledge that suggests that reduction in ischemic stroke risk is yet another benefit of bariatric surgery.”

The assigned discussant, Corrigan L. McBride, MD, MBA wanted to know if the lower odds ratio at 1 year might be because preoperative patient selection might eliminate patients at high risk of poor cardiovascular outcomes.

Dr. Williams, a resident at Rush Medical College, Chicago, replied that it is difficult to eliminate potential selection bias, despite best efforts, but this study shows that he can tell patients: “Having surgery is not going to increases your risk of stroke.”

“This is an important study,” Dr. McBride, professor and chief of minimally invasive surgery and bariatric surgery, University of Nebraska Medical Center, Omaha, told this news organization.

“It is the first large study to show a decreased [or no increased] risk of stroke 1, 3, and 5 years after bariatric surgery compared to matched patients, and it had enough data to look at stroke as a standalone endpoint,” Dr. McBride said. “It is important too, for patients and their physicians to understand that there is a lower chance of them having a stroke if they have surgery than if they do not.”
 

 

 

‘Important,’ ‘good news’ for stroke risk after bariatric surgery

The impact of bariatric surgery on remission of type 2 diabetes is well known, Dr. Williams noted, and other studies have reported how bariatric surgery affects the risk of major adverse cardiovascular events – a composite of stroke, myocardial infarction, coronary artery disease, and all-cause death – including a study presented in the same meeting session.

However, a very large sample size is needed to be able to demonstrate the effect of bariatric surgery on stroke, since stroke is a rare event.

The researchers analyzed data from the Mariner (PearlDiver.) all-payer insurance national claims database of patients in the United States.

They matched 56,514 patients with a body mass index over 35 kg/m2 and comorbidities or a BMI of more than 40 who underwent sleeve gastrectomy or Roux-en-Y gastric bypass during 2010-2019 with 56,514 control patients who did not undergo bariatric surgery.

A year after bariatric surgery, patients in that group had a lower stroke rate than patients in the control group (0.6% vs. 1.2%), and they had close to 50% lower odds of having a stroke (odds ratio, 0.54; 95% CI, 0.47-0.61).

Three years after bariatric surgery, there were 44,948 patients in each group; the rate of stroke was 2.1% in the surgery group and 2.2% in the control group, and there was no significant difference in the odds of having a stroke (OR, 0.96; 95% CI, 0.91-1.00).

Five years after bariatric surgery, there were 27,619 patients in each group; the stroke rate was lower in the bariatric surgery group than in the control group (2.8% vs 3.6%), but reduced odds of stroke was not as great as after 1 year (OR, 0.78; 95% CI, 0.65-0.90).

Dr. Williams has no relevant financial disclosures. Dr. McBride and Dr. Scott disclosed that they are speakers/trainers/faculty advisers for Gore. Dr. Scott is also a consultant for C-SATS (part of Johnson & Johnson).

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Medically suspect criterion can determine bariatric surgery coverage

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Fri, 06/18/2021 - 14:33

A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

Empty pill bottles and pills
PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m2 who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)



The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

 

 

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

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A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

Empty pill bottles and pills
PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m2 who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)



The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

 

 

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

A delaying tactic used by some U.S. health insurers to limit coverage of bariatric surgery does not jibe with the clinical experience at one U.S. center with 461 patients who underwent primary or revisional bariatric surgery.

Empty pill bottles and pills
PhotoDisk

The tactic applies to patients with a baseline body mass index (BMI) of 35-39 kg/m2 who usually also need at least one comorbidity to qualify for insurance coverage for bariatric surgery, and specifically to the subgroup for whom hypertension is the qualifying comorbidity.

Some insurers limit surgery coverage to patients with hypertension who fail to reach their goal blood pressure on agents from three different drug classes, a policy that is “extremely frustrating and dangerous,” said Yannis Raftopoulos, MD, PhD, in his presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Using number of antihypertensive drugs ‘is not correct’

“Using the number of antihypertensive medications to justify surgery is not correct because blood pressure control is not [always] better when patients take two or three medications, compared with when they are taking one. This harms patients because the more severe their hypertension, the worse their control,” said Dr. Raftopoulos, director of the weight management program at Holyoke (Mass.) Medical Center.

He presented findings from a retrospective study of 461 patients who underwent either sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass at his center, including 213 (46%) diagnosed with hypertension at the time of their surgery. Within this group were 68 patients with a BMI of 35-39, which meant that they could get insurance coverage for bariatric surgery only if they also had a relevant comorbidity such as hypertension, diabetes, or severe sleep apnea.

Among these patients, 36 (17% of those with hypertension) had only hypertension as their relevant comorbidity and would not have qualified for bariatric surgery under the strictest criteria applied by some insurers that require patients to remain hypertensive despite treatment with at least three different antihypertensive medications. (These 36 patients underwent bariatric surgery because their insurance coverage did not have this restriction.)



The analyses Dr. Raftopoulos presented also documented the rate of hypertension resolution among patients in the series who had hypertension at baseline and 1-year follow-up results. Among 65 patients on one antihypertensive drug at baseline, 43 (66%) had complete resolution of their hypertension after 1 year, defined as blood pressure of less than 130/90 mm Hg while completely off antihypertensive treatment. In contrast, among 55 patients on two antihypertensive medications at baseline, 28 (51%) had complete resolution after 1 year, and among 24 patients on three or more antihypertensive medications at baseline, 3 (13%) had complete resolution 1 year after bariatric surgery, he reported.

“Patients who were treated with one oral antihypertensive medication preoperatively had a higher likelihood of postoperative hypertension resolution,” concluded Dr. Raftopoulos.

Restricting access to bariatric surgery to patients with a BMI of less than 40 based on the preoperative intensity of their antihypertensive treatment “is not supported by our data, and can be potentially harmful,” he declared.

“This study was the result of discussions about this problem with multiple insurers in my area,” he added. “This affects a good number of patients.”

 

 

Waiting for hypertension to become less treatable

The results Dr. Raftopoulos presented “are not surprising, because they confirm the hypothesis that earlier intervention in the course of a disease like hypertension is more likely to be successful,” commented Bruce D. Schirmer, MD, a professor of surgery at the University of Virginia, Charlottesville, and designated discussant for the report.

The policy followed by some health insurers to delay coverage for bariatric surgery until patients fail three medications “forces patients with more treatable hypertension to wait until their disease worsens and becomes less treatable before they can receive appropriate treatment,” he said.

Dr. Schirmer attributed the motivation for this approach to a “despicable” and “reprehensible” reason: “Actuarial calculations that show paying for curative therapy is not cost effective in the short term. The duration of a patient’s policy may not be long enough to yield a positive financial outcome, so it becomes more appropriate to deny optimal care and have patients become sicker from their disease.”

“I applaud the authors for accumulating the data that point out this unfortunate rule of some insurance companies,” Dr. Schirmer added.

The practice is comparable with an insurer requiring that a patient’s cancer must be metastatic before allowing coverage for treatment, commented Ann M. Rogers, MD, professor and director of the Penn State University surgical weight loss program in Hershey, Penn., and a moderator of the session.

Dr. Raftopoulos, Dr. Schirmer, and Dr. Rogers had no disclosures.

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Bariatric surgery cuts insulin needs in type 1 diabetes with severe obesity

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Tue, 05/03/2022 - 15:05

While bariatric surgery does nothing to directly improve the disease of patients with type 1 diabetes, it can work indirectly by moderating severe obesity and improving insulin sensitivity to cut the total insulin needs of patients with type 1 diabetes and obesity, based on a single-center, retrospective chart review of 38 U.S. patients.

Two years following their bariatric surgery, these 38 patients with confirmed type 1 diabetes and an average body mass index of 43 kg/m2 before surgery saw their average daily insulin requirement nearly halved, dropping from 118 units/day to 60 units/day, a significant decrease, Brian J. Dessify, DO, said in a presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Another measure of this effect showed that the percentage of patients who required more than one drug for treating their hyperglycemia fell from 66% before surgery to 52% 2 years after surgery, a change that was not statistically significant, said Dr. Dessify, a bariatric surgeon at Geisinger Medical Center in Danville, Pa.
 

Appropriate for patients with ‘double diabetes’

These results “provide good evidence for [using] bariatric surgery” in people with both obesity and type 1 diabetes,” he concluded. This includes people with what Dr. Dessify called “double diabetes,” meaning that they do not make endogenous insulin, and are also resistant to the effects of exogenous insulin and hence have features of both type 2 and type 1 diabetes.

Patrice Wendling/MDedge News
Dr. Ali Aminian

“This is a really important study,” commented Ali Aminian, MD, director of the Bariatric and Metabolic Institute of the Cleveland Clinic. “For patients with type 1 diabetes, the primary goal of bariatric surgery is weight loss and improvement of obesity-related comorbidities. Patients with type 2 diabetes can be a candidate for bariatric surgery regardless of their weight,” Dr. Aminian said as designated discussant for the report.

“The goal of bariatric surgery in patients with type 1 diabetes is to promote sensitivity to the exogenous insulin they receive,” agreed Julie Kim, MD, a bariatric surgeon at Mount Auburn Hospital in Waltham, Mass., and a second discussant for the report. Patients with double diabetes “are probably a subclass of patients [with type 1 diabetes] who might benefit even more from bariatric surgery.”
 

Using gastric sleeves to avoid diabetic ketoacidosis

Dr. Aminian also noted that “at the Cleveland Clinic we consider a sleeve gastrectomy the procedure of choice” for patients with type 1 diabetes or type 2 diabetes with insulin insufficiency “unless the patient has an absolute contraindication” because of the increased risk for diabetic ketoacidosis in these patients “undergoing any surgery, including bariatric surgery.” Patients with insulin insufficiency “require intensive diabetes and insulin management preoperatively to reduce their risk for developing diabetic ketoacidosis,” and using a sleeve rather than bypass generally results in “more reliable absorption of carbohydrates and nutrients” while also reducing the risk for hypoglycemia, Dr. Aminian said.

In the series reported by Dr. Dessify, 33 patients underwent gastric bypass and 5 had sleeve gastrectomy. The decision to use bypass usually stemmed from its “marginal” improvement in weight loss, compared with a sleeve procedure, and an overall preference at Geisinger for bypass procedures. Dr. Dessify added that he had not yet run a comprehensive assessment of diabetic ketoacidosis complications among patients in his reported series.

Those 38 patients underwent their bariatric procedure during 2002-2019, constituting fewer than 1% of the 4,549 total bariatric surgeries done at Geisinger during that period. The 38 patients with type 1 diabetes averaged 41 years of age, 33 (87%) were women, and 37 (97%) were White. Dr. Dessify and associates undertook this review “to help provide supporting evidence for using bariatric surgery in people with obesity and type 1 diabetes,” he noted.

Dr. Dessify, Dr. Aminian, and Dr. Kim had no disclosures.

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While bariatric surgery does nothing to directly improve the disease of patients with type 1 diabetes, it can work indirectly by moderating severe obesity and improving insulin sensitivity to cut the total insulin needs of patients with type 1 diabetes and obesity, based on a single-center, retrospective chart review of 38 U.S. patients.

Two years following their bariatric surgery, these 38 patients with confirmed type 1 diabetes and an average body mass index of 43 kg/m2 before surgery saw their average daily insulin requirement nearly halved, dropping from 118 units/day to 60 units/day, a significant decrease, Brian J. Dessify, DO, said in a presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Another measure of this effect showed that the percentage of patients who required more than one drug for treating their hyperglycemia fell from 66% before surgery to 52% 2 years after surgery, a change that was not statistically significant, said Dr. Dessify, a bariatric surgeon at Geisinger Medical Center in Danville, Pa.
 

Appropriate for patients with ‘double diabetes’

These results “provide good evidence for [using] bariatric surgery” in people with both obesity and type 1 diabetes,” he concluded. This includes people with what Dr. Dessify called “double diabetes,” meaning that they do not make endogenous insulin, and are also resistant to the effects of exogenous insulin and hence have features of both type 2 and type 1 diabetes.

Patrice Wendling/MDedge News
Dr. Ali Aminian

“This is a really important study,” commented Ali Aminian, MD, director of the Bariatric and Metabolic Institute of the Cleveland Clinic. “For patients with type 1 diabetes, the primary goal of bariatric surgery is weight loss and improvement of obesity-related comorbidities. Patients with type 2 diabetes can be a candidate for bariatric surgery regardless of their weight,” Dr. Aminian said as designated discussant for the report.

“The goal of bariatric surgery in patients with type 1 diabetes is to promote sensitivity to the exogenous insulin they receive,” agreed Julie Kim, MD, a bariatric surgeon at Mount Auburn Hospital in Waltham, Mass., and a second discussant for the report. Patients with double diabetes “are probably a subclass of patients [with type 1 diabetes] who might benefit even more from bariatric surgery.”
 

Using gastric sleeves to avoid diabetic ketoacidosis

Dr. Aminian also noted that “at the Cleveland Clinic we consider a sleeve gastrectomy the procedure of choice” for patients with type 1 diabetes or type 2 diabetes with insulin insufficiency “unless the patient has an absolute contraindication” because of the increased risk for diabetic ketoacidosis in these patients “undergoing any surgery, including bariatric surgery.” Patients with insulin insufficiency “require intensive diabetes and insulin management preoperatively to reduce their risk for developing diabetic ketoacidosis,” and using a sleeve rather than bypass generally results in “more reliable absorption of carbohydrates and nutrients” while also reducing the risk for hypoglycemia, Dr. Aminian said.

In the series reported by Dr. Dessify, 33 patients underwent gastric bypass and 5 had sleeve gastrectomy. The decision to use bypass usually stemmed from its “marginal” improvement in weight loss, compared with a sleeve procedure, and an overall preference at Geisinger for bypass procedures. Dr. Dessify added that he had not yet run a comprehensive assessment of diabetic ketoacidosis complications among patients in his reported series.

Those 38 patients underwent their bariatric procedure during 2002-2019, constituting fewer than 1% of the 4,549 total bariatric surgeries done at Geisinger during that period. The 38 patients with type 1 diabetes averaged 41 years of age, 33 (87%) were women, and 37 (97%) were White. Dr. Dessify and associates undertook this review “to help provide supporting evidence for using bariatric surgery in people with obesity and type 1 diabetes,” he noted.

Dr. Dessify, Dr. Aminian, and Dr. Kim had no disclosures.

While bariatric surgery does nothing to directly improve the disease of patients with type 1 diabetes, it can work indirectly by moderating severe obesity and improving insulin sensitivity to cut the total insulin needs of patients with type 1 diabetes and obesity, based on a single-center, retrospective chart review of 38 U.S. patients.

Two years following their bariatric surgery, these 38 patients with confirmed type 1 diabetes and an average body mass index of 43 kg/m2 before surgery saw their average daily insulin requirement nearly halved, dropping from 118 units/day to 60 units/day, a significant decrease, Brian J. Dessify, DO, said in a presentation at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

Another measure of this effect showed that the percentage of patients who required more than one drug for treating their hyperglycemia fell from 66% before surgery to 52% 2 years after surgery, a change that was not statistically significant, said Dr. Dessify, a bariatric surgeon at Geisinger Medical Center in Danville, Pa.
 

Appropriate for patients with ‘double diabetes’

These results “provide good evidence for [using] bariatric surgery” in people with both obesity and type 1 diabetes,” he concluded. This includes people with what Dr. Dessify called “double diabetes,” meaning that they do not make endogenous insulin, and are also resistant to the effects of exogenous insulin and hence have features of both type 2 and type 1 diabetes.

Patrice Wendling/MDedge News
Dr. Ali Aminian

“This is a really important study,” commented Ali Aminian, MD, director of the Bariatric and Metabolic Institute of the Cleveland Clinic. “For patients with type 1 diabetes, the primary goal of bariatric surgery is weight loss and improvement of obesity-related comorbidities. Patients with type 2 diabetes can be a candidate for bariatric surgery regardless of their weight,” Dr. Aminian said as designated discussant for the report.

“The goal of bariatric surgery in patients with type 1 diabetes is to promote sensitivity to the exogenous insulin they receive,” agreed Julie Kim, MD, a bariatric surgeon at Mount Auburn Hospital in Waltham, Mass., and a second discussant for the report. Patients with double diabetes “are probably a subclass of patients [with type 1 diabetes] who might benefit even more from bariatric surgery.”
 

Using gastric sleeves to avoid diabetic ketoacidosis

Dr. Aminian also noted that “at the Cleveland Clinic we consider a sleeve gastrectomy the procedure of choice” for patients with type 1 diabetes or type 2 diabetes with insulin insufficiency “unless the patient has an absolute contraindication” because of the increased risk for diabetic ketoacidosis in these patients “undergoing any surgery, including bariatric surgery.” Patients with insulin insufficiency “require intensive diabetes and insulin management preoperatively to reduce their risk for developing diabetic ketoacidosis,” and using a sleeve rather than bypass generally results in “more reliable absorption of carbohydrates and nutrients” while also reducing the risk for hypoglycemia, Dr. Aminian said.

In the series reported by Dr. Dessify, 33 patients underwent gastric bypass and 5 had sleeve gastrectomy. The decision to use bypass usually stemmed from its “marginal” improvement in weight loss, compared with a sleeve procedure, and an overall preference at Geisinger for bypass procedures. Dr. Dessify added that he had not yet run a comprehensive assessment of diabetic ketoacidosis complications among patients in his reported series.

Those 38 patients underwent their bariatric procedure during 2002-2019, constituting fewer than 1% of the 4,549 total bariatric surgeries done at Geisinger during that period. The 38 patients with type 1 diabetes averaged 41 years of age, 33 (87%) were women, and 37 (97%) were White. Dr. Dessify and associates undertook this review “to help provide supporting evidence for using bariatric surgery in people with obesity and type 1 diabetes,” he noted.

Dr. Dessify, Dr. Aminian, and Dr. Kim had no disclosures.

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Bariatric surgery’s cardiovascular benefit extends to 7 years

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Patients with obesity who had bariatric surgery had a lower risk of having a major adverse cardiovascular event (MACE) or dying from all causes during a median 7-year follow-up, compared with similar patients who did not undergo surgery.

Dr. Philippe Bouchard, from McGill University in Montreal
Dr. Philippe Bouchard

These findings, from a province-wide retrospective cohort study from Quebec, follow two recent, slightly shorter similar trials.

Now we need a large randomized clinical trial (RCT), experts say, to definitively establish cardiovascular and mortality benefits in people with obesity who have metabolic/bariatric surgery. And such a trial is just beginning.

Philippe Bouchard, MD, a general surgery resident from McGill University in Montreal presented the Quebec study in a top papers session at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings showed that, among obese patients with metabolic syndrome, bariatric/metabolic surgery is associated with a sustained decrease in the incidence of MACE and all-cause mortality of at least 5 years, Dr. Bouchard said.

“The results of this population-based observational study should be validated in randomized controlled trials,” he concluded.

In the meantime, “we believe our study adds to the body of evidence in mainly two ways,” Dr. Bouchard told this news organization in an email.

It has a longer follow-up than recent observational studies, “a median of 7 years, compared to 3.9 years in a study from the Cleveland Clinic, and 4.6 years in one from Ontario, he said.

“This allows us to [estimate] an absolute risk reduction of MACE of 5.11% at 10 years,” he added. This is a smaller risk reduction than the roughly 40% risk reduction seen in the other two studies, possibly because of selection bias, Dr. Bouchard speculated.

“Second, most of the larger cohorts are heavily weighted on Roux-en-Y gastric bypass,” he continued. In contrast, their study included diverse procedures, including sleeve gastrectomy, duodenal switch, and adjustable gastric banding.

“Given the rise in popularity of a derivative of the duodenal switch – the single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADi-S) – we believe this information is timely and relevant to clinicians,” Dr. Bouchard said.
 

RCT on the subject is coming

“I totally agree that we need a large randomized controlled trial of bariatric surgery versus optimal medical therapy to conclusively establish” the impact of bariatric surgery on cardiovascular outcomes, said the assigned discussant, Mehran Anvari, MD. And their research group is just about to begin one.

Dr. Mehran Anvari, professor and director of the Centre for Minimal Access Surgery, McMaster University, Hamilton, Ontario
Dr. Mehran Anvari

In the absence of RCT data, clinicians “may currently not refer [eligible] patients for bariatric surgery because of the high risk they pose,” said Dr. Anvari, professor and director of the Centre for Minimal Access Surgery of McMaster University, Hamilton, Ont., and senior author in the Ontario study.

Furthermore, an important point is that the current trial extended the follow-up to 7 years, he told this news organization in an email.

That study included patients with diabetes and hypertension, he added, whereas his group included patients with a history of cardiovascular disease and/or heart failure.

“We hope these studies encourage general practitioners and cardiologists to consider bariatric surgery as a viable treatment option to prevent and reduce the risk of MACE in the obese patients [body mass index >35 kg/m2] with significant cardiovascular disease,” he said.

“We have embarked on a pilot RCT among bariatric centers of excellence in Ontario,” Dr. Anvari added, which showed the feasibility and safety of such a study.

He estimates that the RCT will need to recruit 2,000 patients to demonstrate the safety and effectiveness of bariatric surgery in reducing MACE and cardiac and all-cause mortality among patients with existing cardiovascular disease.

This “will require international collaboration,” he added, “and our group is currently establishing collaboration with sites in North America, Europe, and Australia to conduct such a study.”
 

 

 

Patients matched for age, sex, number of comorbidities

Quebec has a single public health care system that covers the cost of bariatric surgery for eligible patients; that is, those with a BMI greater than 35 kg/m2 and comorbidities or a BMI greater than 40 kg/m2.

Using this provincial health care database, which covers over 97% of the population, the researchers identified 3,637 patients with diabetes and/or hypertension who had bariatric surgery during 2007-2012.

They matched the surgery patients with 5,420 control patients with obesity who lived in the same geographic region and had a similar age, sex, and number of Charlson Comorbidity Index comorbidities, but did not undergo bariatric surgery.

The patients had a mean age of 50 and 64% were women.

Half had zero to one comorbidities, a quarter had two comorbidities, and another quarter had at least three comorbidities.

Most patients in the surgery group had type 2 diabetes (70%) and 50% had hypertension, whereas in the control group, most patients had hypertension (82%) and 41% had diabetes.

The most common type of bariatric surgery was adjustable gastric banding (42% of patients), followed by duodenal switch (24%), sleeve gastrectomy (23%), and Roux-en-Y gastric bypass (11%).

The primary outcome was the incidence of MACE, defined as coronary artery events (including myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft), stroke, heart failure, and all-cause mortality,

After a median follow-up of 7-11 years, fewer patients in the surgical group than in the control group had MACE (20% vs. 25%) or died from all causes (4.1% vs. 6.3%, both statistically significant at P < .01)

Similarly, significantly fewer patients in the surgical group than in the control group had a coronary artery event or heart failure (each P < .01).

However, there were no significant between-group difference in the rate of stroke, possibly because of the small number of strokes.

The risk of MACE was 17% lower in the group that had bariatric surgery than in the control group (adjusted hazard ratio, 0.83; 95% confidence interval, 0.78-0.89), after adjusting for age, sex, and number of comorbidities.

In subgroup analysis, patients who had adjustable gastric banding, Roux-en-Y gastric bypass, or duodenal switch had a significantly lower risk of MACE than control patients.

The risk of MACE was similar in patients who had sleeve gastrectomy and in control patients.

However, these subgroup results need to be interpreted with caution since the surgery and control patients in each surgery type subgroup were not matched for age, sex, and comorbidities, said Dr. Bouchard.

He acknowledged that study limitations include a lack of information about the patients’ BMI, weight, medications, and glycemic control (hemoglobin A1c).

Dr. Bouchard and Dr. Anvari have no relevant financial disclosures.

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Patients with obesity who had bariatric surgery had a lower risk of having a major adverse cardiovascular event (MACE) or dying from all causes during a median 7-year follow-up, compared with similar patients who did not undergo surgery.

Dr. Philippe Bouchard, from McGill University in Montreal
Dr. Philippe Bouchard

These findings, from a province-wide retrospective cohort study from Quebec, follow two recent, slightly shorter similar trials.

Now we need a large randomized clinical trial (RCT), experts say, to definitively establish cardiovascular and mortality benefits in people with obesity who have metabolic/bariatric surgery. And such a trial is just beginning.

Philippe Bouchard, MD, a general surgery resident from McGill University in Montreal presented the Quebec study in a top papers session at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings showed that, among obese patients with metabolic syndrome, bariatric/metabolic surgery is associated with a sustained decrease in the incidence of MACE and all-cause mortality of at least 5 years, Dr. Bouchard said.

“The results of this population-based observational study should be validated in randomized controlled trials,” he concluded.

In the meantime, “we believe our study adds to the body of evidence in mainly two ways,” Dr. Bouchard told this news organization in an email.

It has a longer follow-up than recent observational studies, “a median of 7 years, compared to 3.9 years in a study from the Cleveland Clinic, and 4.6 years in one from Ontario, he said.

“This allows us to [estimate] an absolute risk reduction of MACE of 5.11% at 10 years,” he added. This is a smaller risk reduction than the roughly 40% risk reduction seen in the other two studies, possibly because of selection bias, Dr. Bouchard speculated.

“Second, most of the larger cohorts are heavily weighted on Roux-en-Y gastric bypass,” he continued. In contrast, their study included diverse procedures, including sleeve gastrectomy, duodenal switch, and adjustable gastric banding.

“Given the rise in popularity of a derivative of the duodenal switch – the single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADi-S) – we believe this information is timely and relevant to clinicians,” Dr. Bouchard said.
 

RCT on the subject is coming

“I totally agree that we need a large randomized controlled trial of bariatric surgery versus optimal medical therapy to conclusively establish” the impact of bariatric surgery on cardiovascular outcomes, said the assigned discussant, Mehran Anvari, MD. And their research group is just about to begin one.

Dr. Mehran Anvari, professor and director of the Centre for Minimal Access Surgery, McMaster University, Hamilton, Ontario
Dr. Mehran Anvari

In the absence of RCT data, clinicians “may currently not refer [eligible] patients for bariatric surgery because of the high risk they pose,” said Dr. Anvari, professor and director of the Centre for Minimal Access Surgery of McMaster University, Hamilton, Ont., and senior author in the Ontario study.

Furthermore, an important point is that the current trial extended the follow-up to 7 years, he told this news organization in an email.

That study included patients with diabetes and hypertension, he added, whereas his group included patients with a history of cardiovascular disease and/or heart failure.

“We hope these studies encourage general practitioners and cardiologists to consider bariatric surgery as a viable treatment option to prevent and reduce the risk of MACE in the obese patients [body mass index >35 kg/m2] with significant cardiovascular disease,” he said.

“We have embarked on a pilot RCT among bariatric centers of excellence in Ontario,” Dr. Anvari added, which showed the feasibility and safety of such a study.

He estimates that the RCT will need to recruit 2,000 patients to demonstrate the safety and effectiveness of bariatric surgery in reducing MACE and cardiac and all-cause mortality among patients with existing cardiovascular disease.

This “will require international collaboration,” he added, “and our group is currently establishing collaboration with sites in North America, Europe, and Australia to conduct such a study.”
 

 

 

Patients matched for age, sex, number of comorbidities

Quebec has a single public health care system that covers the cost of bariatric surgery for eligible patients; that is, those with a BMI greater than 35 kg/m2 and comorbidities or a BMI greater than 40 kg/m2.

Using this provincial health care database, which covers over 97% of the population, the researchers identified 3,637 patients with diabetes and/or hypertension who had bariatric surgery during 2007-2012.

They matched the surgery patients with 5,420 control patients with obesity who lived in the same geographic region and had a similar age, sex, and number of Charlson Comorbidity Index comorbidities, but did not undergo bariatric surgery.

The patients had a mean age of 50 and 64% were women.

Half had zero to one comorbidities, a quarter had two comorbidities, and another quarter had at least three comorbidities.

Most patients in the surgery group had type 2 diabetes (70%) and 50% had hypertension, whereas in the control group, most patients had hypertension (82%) and 41% had diabetes.

The most common type of bariatric surgery was adjustable gastric banding (42% of patients), followed by duodenal switch (24%), sleeve gastrectomy (23%), and Roux-en-Y gastric bypass (11%).

The primary outcome was the incidence of MACE, defined as coronary artery events (including myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft), stroke, heart failure, and all-cause mortality,

After a median follow-up of 7-11 years, fewer patients in the surgical group than in the control group had MACE (20% vs. 25%) or died from all causes (4.1% vs. 6.3%, both statistically significant at P < .01)

Similarly, significantly fewer patients in the surgical group than in the control group had a coronary artery event or heart failure (each P < .01).

However, there were no significant between-group difference in the rate of stroke, possibly because of the small number of strokes.

The risk of MACE was 17% lower in the group that had bariatric surgery than in the control group (adjusted hazard ratio, 0.83; 95% confidence interval, 0.78-0.89), after adjusting for age, sex, and number of comorbidities.

In subgroup analysis, patients who had adjustable gastric banding, Roux-en-Y gastric bypass, or duodenal switch had a significantly lower risk of MACE than control patients.

The risk of MACE was similar in patients who had sleeve gastrectomy and in control patients.

However, these subgroup results need to be interpreted with caution since the surgery and control patients in each surgery type subgroup were not matched for age, sex, and comorbidities, said Dr. Bouchard.

He acknowledged that study limitations include a lack of information about the patients’ BMI, weight, medications, and glycemic control (hemoglobin A1c).

Dr. Bouchard and Dr. Anvari have no relevant financial disclosures.

Patients with obesity who had bariatric surgery had a lower risk of having a major adverse cardiovascular event (MACE) or dying from all causes during a median 7-year follow-up, compared with similar patients who did not undergo surgery.

Dr. Philippe Bouchard, from McGill University in Montreal
Dr. Philippe Bouchard

These findings, from a province-wide retrospective cohort study from Quebec, follow two recent, slightly shorter similar trials.

Now we need a large randomized clinical trial (RCT), experts say, to definitively establish cardiovascular and mortality benefits in people with obesity who have metabolic/bariatric surgery. And such a trial is just beginning.

Philippe Bouchard, MD, a general surgery resident from McGill University in Montreal presented the Quebec study in a top papers session at the annual meeting of the American Society for Metabolic & Bariatric Surgery.

The findings showed that, among obese patients with metabolic syndrome, bariatric/metabolic surgery is associated with a sustained decrease in the incidence of MACE and all-cause mortality of at least 5 years, Dr. Bouchard said.

“The results of this population-based observational study should be validated in randomized controlled trials,” he concluded.

In the meantime, “we believe our study adds to the body of evidence in mainly two ways,” Dr. Bouchard told this news organization in an email.

It has a longer follow-up than recent observational studies, “a median of 7 years, compared to 3.9 years in a study from the Cleveland Clinic, and 4.6 years in one from Ontario, he said.

“This allows us to [estimate] an absolute risk reduction of MACE of 5.11% at 10 years,” he added. This is a smaller risk reduction than the roughly 40% risk reduction seen in the other two studies, possibly because of selection bias, Dr. Bouchard speculated.

“Second, most of the larger cohorts are heavily weighted on Roux-en-Y gastric bypass,” he continued. In contrast, their study included diverse procedures, including sleeve gastrectomy, duodenal switch, and adjustable gastric banding.

“Given the rise in popularity of a derivative of the duodenal switch – the single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADi-S) – we believe this information is timely and relevant to clinicians,” Dr. Bouchard said.
 

RCT on the subject is coming

“I totally agree that we need a large randomized controlled trial of bariatric surgery versus optimal medical therapy to conclusively establish” the impact of bariatric surgery on cardiovascular outcomes, said the assigned discussant, Mehran Anvari, MD. And their research group is just about to begin one.

Dr. Mehran Anvari, professor and director of the Centre for Minimal Access Surgery, McMaster University, Hamilton, Ontario
Dr. Mehran Anvari

In the absence of RCT data, clinicians “may currently not refer [eligible] patients for bariatric surgery because of the high risk they pose,” said Dr. Anvari, professor and director of the Centre for Minimal Access Surgery of McMaster University, Hamilton, Ont., and senior author in the Ontario study.

Furthermore, an important point is that the current trial extended the follow-up to 7 years, he told this news organization in an email.

That study included patients with diabetes and hypertension, he added, whereas his group included patients with a history of cardiovascular disease and/or heart failure.

“We hope these studies encourage general practitioners and cardiologists to consider bariatric surgery as a viable treatment option to prevent and reduce the risk of MACE in the obese patients [body mass index >35 kg/m2] with significant cardiovascular disease,” he said.

“We have embarked on a pilot RCT among bariatric centers of excellence in Ontario,” Dr. Anvari added, which showed the feasibility and safety of such a study.

He estimates that the RCT will need to recruit 2,000 patients to demonstrate the safety and effectiveness of bariatric surgery in reducing MACE and cardiac and all-cause mortality among patients with existing cardiovascular disease.

This “will require international collaboration,” he added, “and our group is currently establishing collaboration with sites in North America, Europe, and Australia to conduct such a study.”
 

 

 

Patients matched for age, sex, number of comorbidities

Quebec has a single public health care system that covers the cost of bariatric surgery for eligible patients; that is, those with a BMI greater than 35 kg/m2 and comorbidities or a BMI greater than 40 kg/m2.

Using this provincial health care database, which covers over 97% of the population, the researchers identified 3,637 patients with diabetes and/or hypertension who had bariatric surgery during 2007-2012.

They matched the surgery patients with 5,420 control patients with obesity who lived in the same geographic region and had a similar age, sex, and number of Charlson Comorbidity Index comorbidities, but did not undergo bariatric surgery.

The patients had a mean age of 50 and 64% were women.

Half had zero to one comorbidities, a quarter had two comorbidities, and another quarter had at least three comorbidities.

Most patients in the surgery group had type 2 diabetes (70%) and 50% had hypertension, whereas in the control group, most patients had hypertension (82%) and 41% had diabetes.

The most common type of bariatric surgery was adjustable gastric banding (42% of patients), followed by duodenal switch (24%), sleeve gastrectomy (23%), and Roux-en-Y gastric bypass (11%).

The primary outcome was the incidence of MACE, defined as coronary artery events (including myocardial infarction, percutaneous coronary intervention, and coronary artery bypass graft), stroke, heart failure, and all-cause mortality,

After a median follow-up of 7-11 years, fewer patients in the surgical group than in the control group had MACE (20% vs. 25%) or died from all causes (4.1% vs. 6.3%, both statistically significant at P < .01)

Similarly, significantly fewer patients in the surgical group than in the control group had a coronary artery event or heart failure (each P < .01).

However, there were no significant between-group difference in the rate of stroke, possibly because of the small number of strokes.

The risk of MACE was 17% lower in the group that had bariatric surgery than in the control group (adjusted hazard ratio, 0.83; 95% confidence interval, 0.78-0.89), after adjusting for age, sex, and number of comorbidities.

In subgroup analysis, patients who had adjustable gastric banding, Roux-en-Y gastric bypass, or duodenal switch had a significantly lower risk of MACE than control patients.

The risk of MACE was similar in patients who had sleeve gastrectomy and in control patients.

However, these subgroup results need to be interpreted with caution since the surgery and control patients in each surgery type subgroup were not matched for age, sex, and comorbidities, said Dr. Bouchard.

He acknowledged that study limitations include a lack of information about the patients’ BMI, weight, medications, and glycemic control (hemoglobin A1c).

Dr. Bouchard and Dr. Anvari have no relevant financial disclosures.

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Bariatric surgery tied to fewer HFpEF hospitalizations

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Wed, 06/16/2021 - 09:05

Patients who underwent metabolic and bariatric surgery had fewer than half the number of hospitalizations for both acute and chronic episodes of heart failure with preserved ejection fraction (HFpEF) in a retrospective analysis of more than 2 million Americans collected in a national database.

In a multivariate analysis that adjusted for several variables patients without a history of bariatric surgery had three- to fivefold more hospitalizations for acute events involving HFpEF, and more than double the rate of hospitalizations for chronic HFpEF events, David R. Funes, MD, said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

While this analysis has the limitations of being retrospective, observational, and entirely reliant on procedure codes to define medical histories and outcomes, it had the advantage of using a large database designed to represent the U.S. adult population, said Dr. Funes, a bariatric surgeon at the Cleveland Clinic in Weston, Fla.
 

HFpEF effects could ‘extend’ surgery’s use

The report “adds an important article to the literature where there is a true void in trying to discern the effect of bariatric surgery on HFpEF,” commented Tammy L. Kindel, MD, PhD, director of the bariatric surgery program at the Medical College of Wisconsin, Milwaukee, and designated discussant for the report. “Minimal studies [up to now] demonstrate that weight loss in any form can modify diastolic dysfunction in patients with HFpEF. Studies that investigate the impact of bariatric surgery on clinical outcomes in patients with HFpEF are probably the most important for extending use of metabolic surgery,” Dr. Kindel said.

She added that “one of the most difficult parts of studying HFpEF” is making a firm diagnosis that often involves excluding other potential causes. She also questioned Dr. Funes about his confidence that his analysis correctly identified patients only with HFpEF. Dr. Funes replied that the diagnostic codes his team used allowed for a clear distinction between patients identified with HFpEF and those with heart failure with reduced ejection fraction, but he also admitted that his study’s complete reliance on these codes introduced a limitation to the analysis.
 

Including patients with diastolic dysfunction as well as HFpEF

The study used data collected during 2010-2015 by the National Inpatient Sample, run by the U.S. Department of Health & Human Services in a case-control analysis that included 296,041 patients who had undergone some form of bariatric surgery and 2,004,804 people with no history of bariatric surgery selected as controls on the basis of their obesity.

The absolute numbers showed that, during the observation period, the incidence of acute HFpEF hospitalizations was 0.19% among those with prior bariatric surgery and 0.86% among those with no surgery, and the incidence of chronic heart failure hospitalizations was 0.01% among people with prior bariatric surgery and 0.05% among those without prior surgery. Dr. Funes said. He noted that, during the period studied patients, with HFpEF were usually identified as having diastolic heart failure, an older name for the same disease.

In multivariate analyses that adjusted for age, sex, race, hypertension, diabetes, smoking, and coronary artery disease, people without prior bariatric surgery and with hypertension had a 2.8-fold increased rate of acute hospitalizations for HFpEF, while those without hypertension or prior bariatric surgery had a 5.2-fold increased rate. In addition, control patients, regardless of hypertension status, had a 2.9-fold increased rate of hospitalizations for chronic HFpEF events. All these differences were statistically significant.

Dr. Funes also reported results from additional analyses that focused on a roughly 68,000-patient subgroup of those included in the study who had a history of coronary artery disease, including about 62,000 with no prior bariatric surgery and nearly 6,000 people with prior bariatric surgery. In a multivariate analysis of this subgroup, people without prior bariatric surgery had a 2.65-fold increased rate of hospitalization for a HFpEF event (either acute or chronic), compared with those who had undergone bariatric surgery.

Dr. Funes and associates and Dr. Kindel had no relevant disclosures.

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Patients who underwent metabolic and bariatric surgery had fewer than half the number of hospitalizations for both acute and chronic episodes of heart failure with preserved ejection fraction (HFpEF) in a retrospective analysis of more than 2 million Americans collected in a national database.

In a multivariate analysis that adjusted for several variables patients without a history of bariatric surgery had three- to fivefold more hospitalizations for acute events involving HFpEF, and more than double the rate of hospitalizations for chronic HFpEF events, David R. Funes, MD, said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

While this analysis has the limitations of being retrospective, observational, and entirely reliant on procedure codes to define medical histories and outcomes, it had the advantage of using a large database designed to represent the U.S. adult population, said Dr. Funes, a bariatric surgeon at the Cleveland Clinic in Weston, Fla.
 

HFpEF effects could ‘extend’ surgery’s use

The report “adds an important article to the literature where there is a true void in trying to discern the effect of bariatric surgery on HFpEF,” commented Tammy L. Kindel, MD, PhD, director of the bariatric surgery program at the Medical College of Wisconsin, Milwaukee, and designated discussant for the report. “Minimal studies [up to now] demonstrate that weight loss in any form can modify diastolic dysfunction in patients with HFpEF. Studies that investigate the impact of bariatric surgery on clinical outcomes in patients with HFpEF are probably the most important for extending use of metabolic surgery,” Dr. Kindel said.

She added that “one of the most difficult parts of studying HFpEF” is making a firm diagnosis that often involves excluding other potential causes. She also questioned Dr. Funes about his confidence that his analysis correctly identified patients only with HFpEF. Dr. Funes replied that the diagnostic codes his team used allowed for a clear distinction between patients identified with HFpEF and those with heart failure with reduced ejection fraction, but he also admitted that his study’s complete reliance on these codes introduced a limitation to the analysis.
 

Including patients with diastolic dysfunction as well as HFpEF

The study used data collected during 2010-2015 by the National Inpatient Sample, run by the U.S. Department of Health & Human Services in a case-control analysis that included 296,041 patients who had undergone some form of bariatric surgery and 2,004,804 people with no history of bariatric surgery selected as controls on the basis of their obesity.

The absolute numbers showed that, during the observation period, the incidence of acute HFpEF hospitalizations was 0.19% among those with prior bariatric surgery and 0.86% among those with no surgery, and the incidence of chronic heart failure hospitalizations was 0.01% among people with prior bariatric surgery and 0.05% among those without prior surgery. Dr. Funes said. He noted that, during the period studied patients, with HFpEF were usually identified as having diastolic heart failure, an older name for the same disease.

In multivariate analyses that adjusted for age, sex, race, hypertension, diabetes, smoking, and coronary artery disease, people without prior bariatric surgery and with hypertension had a 2.8-fold increased rate of acute hospitalizations for HFpEF, while those without hypertension or prior bariatric surgery had a 5.2-fold increased rate. In addition, control patients, regardless of hypertension status, had a 2.9-fold increased rate of hospitalizations for chronic HFpEF events. All these differences were statistically significant.

Dr. Funes also reported results from additional analyses that focused on a roughly 68,000-patient subgroup of those included in the study who had a history of coronary artery disease, including about 62,000 with no prior bariatric surgery and nearly 6,000 people with prior bariatric surgery. In a multivariate analysis of this subgroup, people without prior bariatric surgery had a 2.65-fold increased rate of hospitalization for a HFpEF event (either acute or chronic), compared with those who had undergone bariatric surgery.

Dr. Funes and associates and Dr. Kindel had no relevant disclosures.

Patients who underwent metabolic and bariatric surgery had fewer than half the number of hospitalizations for both acute and chronic episodes of heart failure with preserved ejection fraction (HFpEF) in a retrospective analysis of more than 2 million Americans collected in a national database.

In a multivariate analysis that adjusted for several variables patients without a history of bariatric surgery had three- to fivefold more hospitalizations for acute events involving HFpEF, and more than double the rate of hospitalizations for chronic HFpEF events, David R. Funes, MD, said at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

While this analysis has the limitations of being retrospective, observational, and entirely reliant on procedure codes to define medical histories and outcomes, it had the advantage of using a large database designed to represent the U.S. adult population, said Dr. Funes, a bariatric surgeon at the Cleveland Clinic in Weston, Fla.
 

HFpEF effects could ‘extend’ surgery’s use

The report “adds an important article to the literature where there is a true void in trying to discern the effect of bariatric surgery on HFpEF,” commented Tammy L. Kindel, MD, PhD, director of the bariatric surgery program at the Medical College of Wisconsin, Milwaukee, and designated discussant for the report. “Minimal studies [up to now] demonstrate that weight loss in any form can modify diastolic dysfunction in patients with HFpEF. Studies that investigate the impact of bariatric surgery on clinical outcomes in patients with HFpEF are probably the most important for extending use of metabolic surgery,” Dr. Kindel said.

She added that “one of the most difficult parts of studying HFpEF” is making a firm diagnosis that often involves excluding other potential causes. She also questioned Dr. Funes about his confidence that his analysis correctly identified patients only with HFpEF. Dr. Funes replied that the diagnostic codes his team used allowed for a clear distinction between patients identified with HFpEF and those with heart failure with reduced ejection fraction, but he also admitted that his study’s complete reliance on these codes introduced a limitation to the analysis.
 

Including patients with diastolic dysfunction as well as HFpEF

The study used data collected during 2010-2015 by the National Inpatient Sample, run by the U.S. Department of Health & Human Services in a case-control analysis that included 296,041 patients who had undergone some form of bariatric surgery and 2,004,804 people with no history of bariatric surgery selected as controls on the basis of their obesity.

The absolute numbers showed that, during the observation period, the incidence of acute HFpEF hospitalizations was 0.19% among those with prior bariatric surgery and 0.86% among those with no surgery, and the incidence of chronic heart failure hospitalizations was 0.01% among people with prior bariatric surgery and 0.05% among those without prior surgery. Dr. Funes said. He noted that, during the period studied patients, with HFpEF were usually identified as having diastolic heart failure, an older name for the same disease.

In multivariate analyses that adjusted for age, sex, race, hypertension, diabetes, smoking, and coronary artery disease, people without prior bariatric surgery and with hypertension had a 2.8-fold increased rate of acute hospitalizations for HFpEF, while those without hypertension or prior bariatric surgery had a 5.2-fold increased rate. In addition, control patients, regardless of hypertension status, had a 2.9-fold increased rate of hospitalizations for chronic HFpEF events. All these differences were statistically significant.

Dr. Funes also reported results from additional analyses that focused on a roughly 68,000-patient subgroup of those included in the study who had a history of coronary artery disease, including about 62,000 with no prior bariatric surgery and nearly 6,000 people with prior bariatric surgery. In a multivariate analysis of this subgroup, people without prior bariatric surgery had a 2.65-fold increased rate of hospitalization for a HFpEF event (either acute or chronic), compared with those who had undergone bariatric surgery.

Dr. Funes and associates and Dr. Kindel had no relevant disclosures.

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