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Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?

Best Doctor lists are clearly popular with readers and make money for the magazines.  They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.

For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.

But many doctors don’t make it onto these lists. Will they lose business or prestige?

While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.

Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.

Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.

The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.

Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.

Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
 

How do doctors get on these lists?

In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected. 

Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.

The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.

Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.

Orlando Family Magazine  says its annual Top Doctor selections are based on reader polls and doctor nominations.

Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies. 

Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.

Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.

Employers also like to spread the word when their doctors make it on “Top Doctor” lists.

“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
 

Patients may be impressed: What about your peers?

Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.

“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.  

Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.

“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”

Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado. 

He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”

He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”

He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.

Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.

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

A New York appeals court has upheld a $1.2 million verdict against an eye surgeon after his patient went blind after cataract removal and lens replacement surgery.

Carola Rozon visited New York ophthalmologic surgeon Edwin Schottenstein, MD, in 2013 to undergo a second eye surgery, according to court documents. As with the previous surgery, Dr. Schottenstein performed phacoemulsification, a technique by which the tip of an ultrasonic machine is inserted into the lens through a small incision in the anterior chamber. The machine’s vibrations break up the hard, inner portion of the nucleus that is affected by the cataract, and the lens is then extracted with irrigation and suction, leaving the capsular bag filled with fluid.

Dr. Schottenstein made a 2.75-mm incision in the anterior chamber and successfully removed most of the nucleus of the cataract lens, according to the appellate decision. However, complications arose during the surgery when the capsular bag tore, and a piece of the lens dropped through the tear into the back of the patient’s eye.

Following the complications, Dr. Schottenstein injected a folded 6-mm intraocular lens (IOL) into the patient’s eye, but it was off center and moved toward the back, according to court documents. He removed it with holding forceps, pulling the unfolded 6-mm IOL through the 2.75-mm incision.

Because it was New Years Eve, Dr. Schottenstein did not immediately seek assistance from a vitreoretinal surgeon. Two days later, on Jan. 2, 2014, the patient was referred to a vitreoretinal surgeon for removal of the dropped lens. The vitreoretinal surgeon reported signs of trauma to the patient’s eye, including corneal edema and blood from a vitreous hemorrhage. Neither the ophthalmologist nor the vitreoretinal surgeon reported any injury to the patient’s iris.

Because of the vitreous hemorrhage, the vitreoretinal surgeon could not visualize the back of the eye. He used a B-scan ultrasound to create an image of the back of the eye to determine whether there were any retinal tears. According to court records, the vitreoretinal surgeon reported that the B-scan did not detect any retinal tears, and the vitreoretinal surgeon scheduled the patient for a follow-up the following week.

On Jan. 9, 2014, there was still blood in the patient’s eye from the hemorrhage. The vitreoretinal surgeon did not perform another B scan and stated that, with a fundoscope, he could see the back of the eye and the piece of fallen lens, according to court documents. No retinal tears were seen. Surgery was scheduled for 6 days later.

During the surgery, the vitreoretinal surgeon noted a choroidal effusion, swelling of the blood vessels that feed the retina. After draining it, he saw a giant retinal tear and retinal detachment at the top of the patient’s eye. Over the course of a year, the vitreoretinal surgeon performed five more surgeries to repair the giant retinal tear, but they were unsuccessful. Ultimately, the patient lost sight in her right eye.

The patient sued Dr. Schottenstein for malpractice in 2016, alleging that, as a result of his negligence, she suffered the retinal tear and is now blind in her right eye. A trial took place in November 2019.
 

What did the experts say?

At trial, the plaintiff’s expert, an ophthalmologic surgeon, testified that removing the 6-mm IOL through the 2.75-mm incision and the associated manipulations of the patient’s eye caused the retinal tear and the ensuing retinal detachment, according to court documents. The small tear was not immediately seen by the physician because he was not looking at that part of the eye. The tear grew to become the giant tear eventually seen by the vitreoretinal surgeon, the expert testified.

The vitreoretinal surgeon would not have seen the small retinal tear when he first examined the patient because B-scan ultrasounds are not generally used to diagnose retinal tears, he testified.

A vitreoretinal expert for Dr. Schottenstein testified that retinal tears that are tractional in origin tend to have a retinal flap that can be seen as a small indentation on a B-scan ultrasound. However, a tear with no flap would not be visualized by the scan. An ophthalmologic surgeon who testified for Dr. Schottenstein said it’s possible the retinal tear would not have been visible to Dr. Schottenstein or the vitreoretinal surgeon if vitreous fluid that was pulled into the anterior chamber was not a strand but just a blob too small to distort the pupil.

The jury found for the plaintiff, awarding the patient $1.2 million. Dr. Schottenstein requested the trial court to overturn the jury’s verdict and award judgment in his favor or grant a new trial, which was denied.

On March 1, 2022, the Supreme Court Appellate Division of the First Judicial Department affirmed the decision.

“To be against the weight of the evidence, a verdict must be palpably wrong,” the judges wrote in their opinion. “In this case, we cannot say the verdict is palpably wrong. The jury found that plaintiff’s injuries were proximately caused by defendant. They deemed the testimony of plaintiff’s expert, when considered with the documentary evidence and all the other evidence in the case, more credible than the testimony of the vitreoretinal surgeon, and defendant’s expert witnesses. The differing testimony and conclusions on causation given by defendant’s witnesses do not require a different outcome.”

Attorneys for the parties in this case did not return messages seeking comment.

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

A New York appeals court has upheld a $1.2 million verdict against an eye surgeon after his patient went blind after cataract removal and lens replacement surgery.

Carola Rozon visited New York ophthalmologic surgeon Edwin Schottenstein, MD, in 2013 to undergo a second eye surgery, according to court documents. As with the previous surgery, Dr. Schottenstein performed phacoemulsification, a technique by which the tip of an ultrasonic machine is inserted into the lens through a small incision in the anterior chamber. The machine’s vibrations break up the hard, inner portion of the nucleus that is affected by the cataract, and the lens is then extracted with irrigation and suction, leaving the capsular bag filled with fluid.

Dr. Schottenstein made a 2.75-mm incision in the anterior chamber and successfully removed most of the nucleus of the cataract lens, according to the appellate decision. However, complications arose during the surgery when the capsular bag tore, and a piece of the lens dropped through the tear into the back of the patient’s eye.

Following the complications, Dr. Schottenstein injected a folded 6-mm intraocular lens (IOL) into the patient’s eye, but it was off center and moved toward the back, according to court documents. He removed it with holding forceps, pulling the unfolded 6-mm IOL through the 2.75-mm incision.

Because it was New Years Eve, Dr. Schottenstein did not immediately seek assistance from a vitreoretinal surgeon. Two days later, on Jan. 2, 2014, the patient was referred to a vitreoretinal surgeon for removal of the dropped lens. The vitreoretinal surgeon reported signs of trauma to the patient’s eye, including corneal edema and blood from a vitreous hemorrhage. Neither the ophthalmologist nor the vitreoretinal surgeon reported any injury to the patient’s iris.

Because of the vitreous hemorrhage, the vitreoretinal surgeon could not visualize the back of the eye. He used a B-scan ultrasound to create an image of the back of the eye to determine whether there were any retinal tears. According to court records, the vitreoretinal surgeon reported that the B-scan did not detect any retinal tears, and the vitreoretinal surgeon scheduled the patient for a follow-up the following week.

On Jan. 9, 2014, there was still blood in the patient’s eye from the hemorrhage. The vitreoretinal surgeon did not perform another B scan and stated that, with a fundoscope, he could see the back of the eye and the piece of fallen lens, according to court documents. No retinal tears were seen. Surgery was scheduled for 6 days later.

During the surgery, the vitreoretinal surgeon noted a choroidal effusion, swelling of the blood vessels that feed the retina. After draining it, he saw a giant retinal tear and retinal detachment at the top of the patient’s eye. Over the course of a year, the vitreoretinal surgeon performed five more surgeries to repair the giant retinal tear, but they were unsuccessful. Ultimately, the patient lost sight in her right eye.

The patient sued Dr. Schottenstein for malpractice in 2016, alleging that, as a result of his negligence, she suffered the retinal tear and is now blind in her right eye. A trial took place in November 2019.
 

What did the experts say?

At trial, the plaintiff’s expert, an ophthalmologic surgeon, testified that removing the 6-mm IOL through the 2.75-mm incision and the associated manipulations of the patient’s eye caused the retinal tear and the ensuing retinal detachment, according to court documents. The small tear was not immediately seen by the physician because he was not looking at that part of the eye. The tear grew to become the giant tear eventually seen by the vitreoretinal surgeon, the expert testified.

The vitreoretinal surgeon would not have seen the small retinal tear when he first examined the patient because B-scan ultrasounds are not generally used to diagnose retinal tears, he testified.

A vitreoretinal expert for Dr. Schottenstein testified that retinal tears that are tractional in origin tend to have a retinal flap that can be seen as a small indentation on a B-scan ultrasound. However, a tear with no flap would not be visualized by the scan. An ophthalmologic surgeon who testified for Dr. Schottenstein said it’s possible the retinal tear would not have been visible to Dr. Schottenstein or the vitreoretinal surgeon if vitreous fluid that was pulled into the anterior chamber was not a strand but just a blob too small to distort the pupil.

The jury found for the plaintiff, awarding the patient $1.2 million. Dr. Schottenstein requested the trial court to overturn the jury’s verdict and award judgment in his favor or grant a new trial, which was denied.

On March 1, 2022, the Supreme Court Appellate Division of the First Judicial Department affirmed the decision.

“To be against the weight of the evidence, a verdict must be palpably wrong,” the judges wrote in their opinion. “In this case, we cannot say the verdict is palpably wrong. The jury found that plaintiff’s injuries were proximately caused by defendant. They deemed the testimony of plaintiff’s expert, when considered with the documentary evidence and all the other evidence in the case, more credible than the testimony of the vitreoretinal surgeon, and defendant’s expert witnesses. The differing testimony and conclusions on causation given by defendant’s witnesses do not require a different outcome.”

Attorneys for the parties in this case did not return messages seeking comment.

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

A New York appeals court has upheld a $1.2 million verdict against an eye surgeon after his patient went blind after cataract removal and lens replacement surgery.

Carola Rozon visited New York ophthalmologic surgeon Edwin Schottenstein, MD, in 2013 to undergo a second eye surgery, according to court documents. As with the previous surgery, Dr. Schottenstein performed phacoemulsification, a technique by which the tip of an ultrasonic machine is inserted into the lens through a small incision in the anterior chamber. The machine’s vibrations break up the hard, inner portion of the nucleus that is affected by the cataract, and the lens is then extracted with irrigation and suction, leaving the capsular bag filled with fluid.

Dr. Schottenstein made a 2.75-mm incision in the anterior chamber and successfully removed most of the nucleus of the cataract lens, according to the appellate decision. However, complications arose during the surgery when the capsular bag tore, and a piece of the lens dropped through the tear into the back of the patient’s eye.

Following the complications, Dr. Schottenstein injected a folded 6-mm intraocular lens (IOL) into the patient’s eye, but it was off center and moved toward the back, according to court documents. He removed it with holding forceps, pulling the unfolded 6-mm IOL through the 2.75-mm incision.

Because it was New Years Eve, Dr. Schottenstein did not immediately seek assistance from a vitreoretinal surgeon. Two days later, on Jan. 2, 2014, the patient was referred to a vitreoretinal surgeon for removal of the dropped lens. The vitreoretinal surgeon reported signs of trauma to the patient’s eye, including corneal edema and blood from a vitreous hemorrhage. Neither the ophthalmologist nor the vitreoretinal surgeon reported any injury to the patient’s iris.

Because of the vitreous hemorrhage, the vitreoretinal surgeon could not visualize the back of the eye. He used a B-scan ultrasound to create an image of the back of the eye to determine whether there were any retinal tears. According to court records, the vitreoretinal surgeon reported that the B-scan did not detect any retinal tears, and the vitreoretinal surgeon scheduled the patient for a follow-up the following week.

On Jan. 9, 2014, there was still blood in the patient’s eye from the hemorrhage. The vitreoretinal surgeon did not perform another B scan and stated that, with a fundoscope, he could see the back of the eye and the piece of fallen lens, according to court documents. No retinal tears were seen. Surgery was scheduled for 6 days later.

During the surgery, the vitreoretinal surgeon noted a choroidal effusion, swelling of the blood vessels that feed the retina. After draining it, he saw a giant retinal tear and retinal detachment at the top of the patient’s eye. Over the course of a year, the vitreoretinal surgeon performed five more surgeries to repair the giant retinal tear, but they were unsuccessful. Ultimately, the patient lost sight in her right eye.

The patient sued Dr. Schottenstein for malpractice in 2016, alleging that, as a result of his negligence, she suffered the retinal tear and is now blind in her right eye. A trial took place in November 2019.
 

What did the experts say?

At trial, the plaintiff’s expert, an ophthalmologic surgeon, testified that removing the 6-mm IOL through the 2.75-mm incision and the associated manipulations of the patient’s eye caused the retinal tear and the ensuing retinal detachment, according to court documents. The small tear was not immediately seen by the physician because he was not looking at that part of the eye. The tear grew to become the giant tear eventually seen by the vitreoretinal surgeon, the expert testified.

The vitreoretinal surgeon would not have seen the small retinal tear when he first examined the patient because B-scan ultrasounds are not generally used to diagnose retinal tears, he testified.

A vitreoretinal expert for Dr. Schottenstein testified that retinal tears that are tractional in origin tend to have a retinal flap that can be seen as a small indentation on a B-scan ultrasound. However, a tear with no flap would not be visualized by the scan. An ophthalmologic surgeon who testified for Dr. Schottenstein said it’s possible the retinal tear would not have been visible to Dr. Schottenstein or the vitreoretinal surgeon if vitreous fluid that was pulled into the anterior chamber was not a strand but just a blob too small to distort the pupil.

The jury found for the plaintiff, awarding the patient $1.2 million. Dr. Schottenstein requested the trial court to overturn the jury’s verdict and award judgment in his favor or grant a new trial, which was denied.

On March 1, 2022, the Supreme Court Appellate Division of the First Judicial Department affirmed the decision.

“To be against the weight of the evidence, a verdict must be palpably wrong,” the judges wrote in their opinion. “In this case, we cannot say the verdict is palpably wrong. The jury found that plaintiff’s injuries were proximately caused by defendant. They deemed the testimony of plaintiff’s expert, when considered with the documentary evidence and all the other evidence in the case, more credible than the testimony of the vitreoretinal surgeon, and defendant’s expert witnesses. The differing testimony and conclusions on causation given by defendant’s witnesses do not require a different outcome.”

Attorneys for the parties in this case did not return messages seeking comment.

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

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

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

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

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

Regardless of the pandemic’s sometimes mercurial behavior, the cardiology community appears set to reclaim valued traditions perhaps taken for granted in the pre-COVID era.

They include the bustling scientific congress and its myriad educational and networking prospects, along with pleiotropic effects like unplanned reunions with colleagues and catching up face-to-face with old friends.

That seems evident in the growing number of registrants for live attendance at at the annual scientific sessions of the American College of Cardiology, set for this Saturday through Monday in Washington as well as virtually, for a global reach that was unattainable in the pre-COVID era.

Registrations had hit the 11,000 mark and were picking up speed in recent weeks, ACC 2022 cochair Pamela B. Morris, MD, Medical University of South Carolina, Charleston, said at a mid-March presentation to the media.

They had reached about 12,880 and were still climbing a week before the conference, the ACC confirmed to this news organization. By then the professional registration had surpassed 9,900, of whom more than two-thirds reported plans to attend in person.

Dr. Morris said there had been 117 international submissions for what turned out to be 39 coveted spots on the meeting’s Late-Breaking Clinical Trial (LBCT) and Featured Clinical Research agenda spread across eight separate sessions.

On-site participants at the Walter E. Washington Convention Center should head for the Main Tent in Hall D for all LBCT presentations; venues for the Featured Clinical Research sessions are as noted below. Their real-time virtual equivalents will reside on the online platform’s Hot Topics channel. All noted session times are Eastern Daylight Time.
 

Saturday, April 2, 9:30 a.m.–10:30 a.m. Joint American College of Cardiology/Journal of the American College of Cardiology LBCT (I)

Leading off the conference’s first LBCT session, the randomized VALOR-HCM trial explored whether 16 weeks of mavacamten (MyoKardia) could help patients with severe obstructive hypertrophic cardiomyopathy (HCM) avoid septal reduction therapy, either surgical or by alcohol ablation.

The 22-center VALOR-HCM trial with an estimated enrollment of 100 follows EXPLORER-HCM, which in 2020 suggested the novel myosin-inhibiting agent could improve symptoms, exercise capacity, cardiac remodeling, and quality of life in such patients.

Simply advising people with heart failure (HF) to consume less salt is one thing, but it’s another to show them clinical trial evidence that it might help keep them out of the hospital. The SODIUM-HF (Study of Dietary Intervention Under 100 mmol in Heart Failure) study, conducted at 27 sites in six countries, sought to provide that evidence.

The trial randomly assigned 1,000 patients with NYHA class 2-3 HF to consume no more than 1,500 mg/day in sodium or to receive standard advice to limit sodium intake, and followed them for a year for the endpoint of death from any cause, cardiovascular (CV) hospitalization, or CV emergency department visit.

SODIUM-HF “may provide a rigorous evidence base for sodium restriction in patients with heart failure and may truly change our practice and how we recommend dietary modification,” ACC 2022 vice chair Douglas E. Drachman, MD, Massachusetts General Hospital, Boston, said at the media presentation.

In the same session, the CHAP (Chronic Hypertension and Pregnancy) study explored whether blood pressure (BP) control in pregnant women with new or untreated chronic hypertension could help avert preeclampsia, poor fetal outcomes, and other adverse events.

CHAP assigned about 2,400 women to receive either stepwise antihypertensive therapy to a BP goal of 140/90 mm Hg or lower or no such meds unless their BP reached or exceeded 160/105 mm Hg. Stepwise therapy featured either labetalol or extended-release nifedipine to start, the other agent added as necessary.

The LBCT block also includes the POISE-3 (Perioperative Ischemic Evaluation-3) comparison of the hemostatic agent tranexamic acid vs. placebo in nearly 10,000 patients undergoing noncardiac surgery. A separate randomization of the same cohort, to be reported at a Monday LBCT session, compared pre- and perioperative BP-control strategies.
 

Saturday, April 2, 12:00 p.m.–1:15 p.m. Featured Clinical Research I. Room 143A

This session features a subgroup analysis by age from the REVERSE-IT trial, which had previously showcased the monoclonal antibody bentracimab (PhaseBio Pharmaceuticals) for its ability to reverse the antiplatelet effects of ticagrelor.

REVERSE-IT is accompanied on the schedule by several secondary-endpoint presentations from trials whose primary outcomes have already been presented at meetings or in the journals.

They include the SCORED trial of sotagliflozin in patients with diabetes and chronic kidney disease (CKD); COMPLETE, which explored complete revascularization of multivessel coronary disease at primary stenting; and the FAME-3 comparison of coronary bypass surgery (CABG) vs. percutaneous coronary intervention (PCI) guided by fractional flow reserve (FFR) readings.

The session is to conclude with EDIT-CMD, which was a small, randomized assessment of diltiazem for improving microvascular dysfunction in patients with chronic angina despite nonobstructive coronary disease.
 

Sunday, April 3, 8:00 a.m.–9:15 a.m. Joint American College of Cardiology/Journal of the American Medical Association LBCT (II)

The SuperWIN (Supermarket Web Intervention) study tested an innovative strategy for community-based promotion of healthy lifestyle choices: point-of-purchase dietary education for grocery shoppers with an online instructional component, and follow-up to determine whether it influenced future food choices.

“Dietary interventions are notoriously difficult for us to implement, let alone to study scientifically,” Dr. Drachman observed. “So we think that there may be opportunity for dietary interventions to be best implemented at grocery stores where people are doing their shopping for food.”

SuperWIN compared supermarket shoppers with at least one CV risk factor who participated in the education intervention to a nonintervention control group for any changes in their DASH scores. The scores reflected consistency with the venerable DASH diet based on participants’ food purchases over 3 months.

In the same session, the MITIGATE trial explored whether daily administration of icosapent ethyl (Vascepa) might cut the risk of upper respiratory infection (especially from SARS-CoV-2 or seasonal influenza virus) in persons 50 or older with a history of clinical coronary, neurovascular, or peripheral vascular disease or revascularization. The trial has an estimated enrollment of 39,600.

Accompanying SuperWIN and MITIGATE are studies of several dyslipidemia drugs, including the discontinued antisense agent vupanorsen (Pfizer), as tested in TRANSLATE-TIMI 70;  the PCSK9 inhibitor alirocumab (Praluent), explored for its effects on coronary plaque volume and composition in the PACMAN-AMI trial; and the APOLLO trial, a phase 1 evaluation of SLN360 (Silence Therapeutics), a short interfering ribonucleic acid (siRNA) that suppresses the molecular machinery in the liver that produces lipoprotein(a), or Lp(a).

The 32-patient APOLLO trial’s recently released top-line results suggested that SLN360 at varying dosages reduced Lp(a) levels by about one-half to more than 90%. Although elevated Lp(a) is known to track with CV risk, it remains to be shown whether dropping Lp(a) levels pharmacologically is protective.
 

Sunday, April 3, 9:45 a.m.–11:00 a.m. Joint American College of Cardiology/New England Journal of Medicine LBCT (III)

The meeting’s all-HF late-breaker session includes the METEORIC-HF trial, which compared the myotropic agent omecamtiv mecarbil (Cytokinetics) against placebo for effects on exercise performance over 20 weeks. The trial entered 276 patients with HF with reduced ejection fraction (HFrEF) and reduced peak VO₂.

The GALACTIC-HF trial had previously suggested that the drug improved the risk of HF-related events or CV death in more than 8000 patients with HFrEF, those with the lowest ejection fractions benefiting the most.

This block of trials also features DIAMOND, the latest trial with a gemologic name to look at the potassium sequestrant patiromer (Veltassa) for any protection against hyperkalemia, a familiar side effect of renin-angiotensin-aldosterone inhibitors. DIAMOND tested patiromer in 878 patients with HFrEF who were on beta-blockers and other HF-appropriate medications and had a history of drug-associated hyperkalemia.

Previously, the AMBER trial of patients with CKD or refractory hypertension on spironolactone had suggested the drug might be protective enough against hyperkalemia to allow higher and more consistent dosing of BP-lowering agents.

Also in the session: the randomized IVVE (Influenza Vaccine to Prevent Adverse Vascular Events) trial, with an estimated 5,000 patients with HF in Africa, Asia, and the Middle East; PROMPT-HF, with a projected 1,310 HF patients and billed as a cluster-randomized pragmatic trial of a strategy for improving guideline-directed outpatient medical therapy; and MAVA-LTE, the long-term extension study of an estimated 310 patients who were in the MAVERICK-HCM and EXPLORER-HCM mavacamten trials.
 

Sunday, April 3, 12:15–1:30 p.m. Featured Clinical Research II. Main Tent, Hall D

The arrhythmia-centric session includes PARTITA, with its estimated 590 patients with primary- or secondary-prevention implantable cardioverter-defibrillators (ICDs). The trial followed them initially for burden of untreated nonsustained ventricular tachycardia (VT) or events treated with anti-tachycardia pacing. Then it randomly assigned those who experienced a first appropriate ICD shock to either immediate VT ablation or standard care. The latter included ablation on next occurrence of arrhythmic storm.

Investigational oral factor XIa inhibitors, viewed by many as potentially safer as anticoagulants than contemporary oral inhibitors of factor Xa, are now on the scene and include milvexian (Bristol-Myers Squibb/Janssen) and, lately, asundexian (BAY 2433334; Bayer). The latter agent was compared to the factor Xa inhibitor apixaban (Eliquis) in 753 patients with AF in the phase 2 PACIFIC-AF trial, which looked at the newer drug’s safety and optimal dosing.

Also on the bill: a long-term follow-up of the mAFA-2 (Mobile AF Application 2) extension study, which explored the value of a smartphone-based atrial fibrillation (AF) screening app for improving risk of AF-related events; a presentation billed as “Residual Leaks Post Left Atrial Appendage Occlusion”; and one that declares “low rates of guideline-directed care” to be “associated with higher mortality” in patients with pacemakers or ICDs.
 

Monday, April 4, 8:30 a.m.–9:45 a.m. LBCT IV

This session is to open with the PROTECT trial, which sought to determine whether perioperative “aggressive warming” may be cardioprotective in patients with CV risk factors undergoing noncardiac surgery. Its estimated 5,100 patients were randomly assigned to a procedure that achieves normothermia, that is 37° C (98.6° F), vs. standard care in which patients’ core temperature may decline to no further than 35.5° C (95.9° F).

Next on the list are a second POISE-3 comparison of BP-control strategies comparing hypotension avoidance vs. hypertension avoidance in patients undergoing noncardiac surgery; the pivotal CLASP 2 TR trial of patients with symptomatic tricuspid regurgitation on optimal medical therapy with vs. without treatment with the Edwards PASCAL Transcatheter Repair System; and one said to provide “insights from the Corevalve US Pivotal and SURTAVI trials” on 5-year incidence, timing, and predictors of hemodynamic valve deterioration transcatheter and surgical aortic bioprostheses.”

Rounding out the block of presentations: the ADAPT-TAVR comparison of the factor Xa inhibitor edoxaban (Lixiana) to dual-antiplatelet therapy for prevention of leaflet thrombosis after successful transcatheter aortic valve replacement (TAVR). The 235-patient trial was conducted at five centers in South Korea, Hong Kong, and Taiwan.
 

Monday, April 4, 11:00–12:15 p.m. LBCT V

This session includes the FLAVOUR randomized comparison of PCI guided by either FFR or intravascular ultrasound (IVUS) in 1,700 patients with 40%-70% stenoses. The patients from centers in China and South Korea were followed for death from any cause, MI, or any repeat revascularization at 24 months.

Also scheduled: the 2-year report on 4,000 patients with ST-segment elevation MI (STEMI) in the ACC-sponsored quality improvement program GHATI (Global Heart Attack Treatment Initiative); the GIPS-4 myocardial protection study of an estimated 380 patients with STEMI assigned to receive pre- and post-PCI infusions of sodium thiosulfate or placebo, with infarct size at 4 months as the primary endpoint; and a randomized test of an arrhythmia-monitoring implant for influence on clinical outcomes in 802 patients with a history of MI but no pacemaker or ICD indication, called BIO-GUARD-MI,

Last in the session: the Chocolate Touch Study of peripheral-artery angioplasty using a drug-coated balloon (DCB) with a confectionery name that treats lesions not with theobromine, but the antiproliferative mainstay paclitaxel.

The randomized comparison of the Chocolate Touch DCB (TriReme Medical) and the more established Lutonix DCB (Bard) assigned a projected 585 patients with symptomatic peripheral vascular disease to treatment of superficial femoral or popliteal artery lesions with one of the two paclitaxel-coated balloon catheters.
 

Monday, April 4, 12:45–2 p.m. Featured Clinical Research III. Room 143A 

The final session features five subgroup analyses or other updates from trials that have already reported their primary outcomes. Among them is the SPYRAL HTN-ON MED trial, which helped to revitalize hopes for renal denervation therapy as a catheter-based treatment for drug-resistant hypertension by showing significant effects on both systolic and diastolic blood pressure. The new data follow the trial’s more than 400 patients out to 3 years.

There is also a symptom and quality-of-life analysis from the 530-patient EMPULSE trial of 530 patients with stabilized acute HF assigned in-hospital to start on empagliflozin (Jardiance) or placebo. The trial made a splash last year when it reported a significant improvement in risk for death or HF rehospitalization for its patients put on the SGLT2 inhibitor.

A secondary analysis from CANTOS is also featured; the trial had randomly assigned more than 10,000 patients with recent acute MI and elevated C-reactive protein (CRP) levels to receive or not receive the anti-inflammatory canakinumab (Ilaris). Those assigned to active therapy showed benefits for a range of outcomes, including CV mortality and stroke, but no decreases in cholesterol levels. Billing for the new CANTOS analysis promises insights on the “differential impact of residual inflammatory risk and residual cholesterol risk among atherosclerosis patients with and without chronic kidney disease.”

The session also features “trends and final results” from the NACMI (North American COVID-19 Myocardial Infarction) registry, which had shown excellent primary-PCI results without compromise of door-to-balloon times in patients with confirmed SARS-CoV-2 infection; and a FIDELITY analysis of cardiorenal endpoints by history of CV disease in the study’s more than 13,000 patients with diabetes and CKD assigned to placebo or finerenone (Kerendia), a mineralocorticoid receptor antagonist.

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

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

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

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

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

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

Jessica Furby struggled with weight most of her life, constantly dieting and exercising to shed pounds. But nothing seemed to help. By her 22nd birthday, she tipped the scales at more than 300 pounds.

So, in 2011, while a college student in Pittsburgh, she decided to have gastric band surgery. Doctors placed a synthetic belt around her stomach to limit what she could eat. It seemed like a good option at the time and, after her surgery, she lost about 60 pounds.

But the benefits didn’t last. In the months that followed, she had pain and other complications. Worst of all, she eventually regained all the weight she’d lost – and then some. By 2016, she weighed 350 pounds and was becoming prediabetic.

That’s when she decided to have the band removed and, on her doctor’s recommendation, had gastric sleeve surgery.

Studies have found the sleeve surgeries carry fewer complications and a much higher success rate than gastric band procedures, which Ms. Furby’s experience has confirmed.

Today, at age 32, she’s down to 288 pounds and says she is on her way to hitting her ultimate goal of 200 pounds.

“The surgery has been a godsend,” she said. “I have not had any complications with it at all. The sleeve was life-changing for me.”

Ms. Furby’s experience has become more common as the risks, complications, and failures of gastric band surgeries have been rising over the past decade.

More band patients are choosing to have conversion surgery to gastric sleeve and gastric bypass. At the same time, fewer doctors are doing gastric band procedures, because of problems like Ms. Furby’s.

According to the latest figures from the American Society for Metabolic and Bariatric Surgery, gastric band procedures account for fewer than 1% of the 256,000 bariatric operations done in the United States each year, while gastric sleeves add up to nearly 60%. That makes sleeve surgeries the most commonly performed bariatric operation today.

By comparison, 35% of bariatric surgeries were gastric band procedures in 2011, while sleeve operations accounted for under 18%.

Ms. Furby’s surgeon, Anita P. Courcoulas, MD, said the trend is being driven by many of the things Ms.Furby experienced firsthand.

Dr. Courcoulas, chief of minimally invasive bariatric and general surgery at the University of Pittsburgh, said there are two main reasons for the decline in gastric band procedures.

“It has been shown to be less effective for weight loss [than] other bariatric surgical procedures, and band intolerance often results in band removal,” she noted.

Gastric sleeve, followed by gastric bypass, are the two most commonly performed operations in the United States and worldwide, she said.

Dr. Courcoulas said the shift from gastric bypass to gastric sleeve procedures “is likely driven by the decline in the band usage, patient preferences for a less invasive operation, such as the sleeve compared to bypass, and surgeon preferences about which operation(s) to offer a given patient.”

Ali Aminian, MD, director of the Bariatric and Metabolic Institute at the Cleveland Clinic, agrees that gastric band complications and failures, in addition to ineffective weight loss, are behind the trend, driving patients and doctors to choose safer and more effective procedures.

He said the Cleveland Clinic no longer does band operations, and he has done a lot of conversions.

“Around 50%-60% of [gastric band] patients require reoperation to take care of the complications,” he says. “So, when you have a surgery where more than half of the time the patients require reoperation, we cannot claim that’s a safe operation.”
 

Evolution in bariatric surgery

Bariatric surgeries for weight loss date back to the 1950s and 1960s, when surgeons at the University of Minnesota first did experimental bypass operations. Adjustable gastric banding appeared in the late 1970s and early 1980s.

But these procedures didn’t gain widespread mainstream use until gastric band procedures gained full Food and Drug Administration approval in 2001. Clinical trials have found people who have bariatric surgery have a significantly lower risk of heart disease and other obesity-related health problems.

In the decade that followed the FDA’s approval of gastric band surgery, it became a popular weight loss procedure, accounting for more than a third of all bariatric surgeries by 2011.

“Fifteen to 20 years ago, [gastric] band was the most commonly performed procedure for bariatric surgery worldwide and in the United States,” Dr. Aminian said. “It was very easy to do, it was quick – it takes 20 minutes to do the procedure – recovery was short, and initially patients had great outcomes. They would lose weight and were healthy.”

But over the past decade, surgeons found that patients often regained the weight they’d lost, and complication and failure rates rose.

“Because the [gastric] band is a foreign body that we place inside the body, many patients had complications related to that foreign body,” Dr. Aminian said.

The band can sometimes move or be displaced, causing blockage of the stomach, experts noted. Other common complications include nausea, vomiting, acid reflux, and esophageal issues (such as a hard time swallowing). Some patients feel pain, constant food cravings, or that they can’t eat or drink anything. And painful infections and other problems can develop with the tubing or the port placed under the skin that is connected to the band, which doctors use to make adjustments after surgery.

“Scar tissue can also form around the [gastric] band that can cause a blockage in the stomach,” Dr. Aminian said. “Then if the band is too tight, it can erode into the stomach tissue or even go inside the stomach and cause perforation or bleeding.”

By contrast, gastric sleeve and bypass procedures have been found to be safer, result in longer-lasting weight loss, carry fewer complications, and require fewer patient reoperations. Dr. Aminian estimates that 2%-3% of patients need second operations.

Another key factor: Metabolic ‘reset’

Sleeve and bypass procedures offer another critical advantage over band operations: They help reset the body’s metabolism better, changing appetite- and weight-related hormones in the body.

Those hormones can affect food cravings, help people feel full after eating, or boost weight gain in ways that can trump willpower, experts say.

“The [gastric] band doesn’t change the hormones in the body, it’s just a restrictive band around the esophagus or the upper part of the stomach, so it limits the patient’s ability to eat too much,” Dr. Aminian said. “That’s why it doesn’t have the metabolic effects.”

But other procedures, like the gastric sleeve, change the hormones in the body. Removing the source of those hormones means the patient won’t have the same appetite, Dr. Aminian said.

“And that’s why it’s very effective. The problem with the [gastric] band is the patient always has the feeling and desire to eat – they’re always hungry. That’s why in the long run, they fail,” he said.

“They change the setpoints,” Dr. Aminian said. “When the hormones in your body change, the [metabolic] setpoint in the brain also changes.”

He likens the metabolic setpoint to a thermostat in your home that regulates temperature inside.

“When a patient goes on a diet or goes on the [gastric] band, the thermostat doesn’t change,” he says. “They may lose some weight, but they’re going to regain it because the thermostat is the same. But when the hormones in your body change, then the thermostat will change and you’re not going to regain the weight that you have lost.”

Sachin Kukreja, MD, a surgeon and CEO at DFW Bariatrics and General Surgery in Dallas, said he believes these metabolic changes are the biggest things behind successful surgeries.

“People synonymize bariatric surgery with weight loss surgery, but really the metrics we should be using are more related to metabolic measures,” said Dr. Kukreja, who hasn’t done a band surgery since 2013. “And so, the metabolic parameters that change with bariatric surgery are much more significant in the setting with sleeve and gastric sleeve, and much less significant with [gastric] band.”

David Arterburn, MD, agrees that resetting metabolism is important but said the issue is “controversial and challenging” among bariatric surgeons.

“The metabolic setpoint is the idea that we have a biologically controlled set body weight that we will always return to. Clearly, this is not the case for everyone, as some people lose and maintain long-term weight loss,” said Dr. Arterburn, a general internist and bariatric surgery researcher at Kaiser Permanente Washington Health Research Institute in Seattle.
 

Postop lifestyle changes critical to success

Bariatric surgeons and patients alike also say that no surgical procedure is a magic-bullet solution for weight loss. Patients who have any type of bariatric surgery must embrace postop lifestyle changes – adopting healthier diets, getting more exercise, cutting out unhealthy habits – to lose weight and maintain weight loss.

Jan Lasecki, 54, a health care specialist in Akron, Ohio, who had band-to-sleeve conversion surgery in 2020, said the postop follow-up was at least as important as the surgery itself in helping her shed pounds.

She said at first, she chose gastric band surgery several years ago because it was “less invasive” than gastric sleeve or bypass. But while she lost about 50 pounds, she regained it after about 6 years and had other complications.

So, 2 years ago, Ms. Lasecki had two surgeries 6 months apart – one to remove her band, and a second to create a gastric sleeve. And the results, she said, have been very successful, in part because of the changes she made after surgery, with the help of her doctor’s staff.

“I have now lost about 90 pounds and have kept if off since surgery,” she says. “I would tell anyone considering any bariatric surgery, it was definitely worth it [and] having the sleeve resulted in greater weight loss.”

The follow-up was key to the success, she said.

The staff “have the tools and support to help you when you tend to fall back on old behaviors and start to regain weight,” Ms. Lasecki said. “They can help you before it gets out of control. I had no issues following either procedure from a surgery perspective.”

Sally and Robert Cordova – who had gastric bypass and sleeve surgeries, respectively, 3 years ago – agreed that the postop lifestyle changes are critical to success.

“When we agreed to have this surgery, we agreed that this will be a lifestyle change for the rest of our lives,” said Sally, 48, an accounting specialist who’s lost 150 pounds – half her body weight – since her surgery. “You can’t just get to your ideal weight and then stop.”

Robert, 47, a federal border control agent whose workmates nicknamed him “Big Rob” when he tipped the scales at 336 pounds, said it’s a mistake to think of the surgery as a “magic-bullet” solution to obesity. There’s more to it than that, he said.

“One of the things I like about the process I’ve taken is, in my opinion, they set you up for success,” he said. “Because it’s not just having the surgery and you’re done; it’s all the classes educating you about all the lifestyle changes you have to do, and starting them before the surgery. The only people that I know personally who haven’t been successful with the surgery are those who haven’t made the lifestyle changes.”

Today, at 230 pounds, Robert says he’s never felt better.

“I feel great,” he says. “I have become more active, obviously doing everything is a lot easier. It got to the point where it was a task to just tying up my shoes!”
 

Should band patients convert to sleeve or bypass?

Bariatric surgeons interviewed for this article were reluctant to say that all people who had gastric band procedures should convert to gastric sleeve or bypass. But they made it clear that sleeve and bypass procedures are safer and more effective than gastric band surgery, which is why it is rarely done today.

“If a patient experiences poor weight loss or complications from a band, they can consider conversion/revision to a sleeve or bypass,” said Dr. Courcoulas, echoing the views of other doctors.

“The choice of revision procedure should be based on patient factors, including diabetes and total weight. Converting a band to a sleeve is a technically easier operation, and some studies show that there are fewer complications, compared to conversion to a bypass. These considerations need to be balanced with data that show that both weight loss and metabolic improvements such as diabetes are greater after bypass, compared to sleeve.”

Doctors and experts also say it’s important for patients who are considering a gastric band conversion to gastric sleeve or bypass to understand the differences among these three primary procedures, all endorsed by the American Society for Metabolic and Bariatric Surgery.

Here’s a primer, including the pros and cons of each procedure:
 

Gastric band

In gastric band surgery, an adjustable gastric band made of silicone is placed around the top part of the stomach, creating a small pouch above it, to limit the amount of food a person can eat. The size of the opening between the pouch and the stomach can be adjusted with fluid injections through a port placed underneath the skin.

Food goes through the stomach but is limited by the smaller opening of the band.

Advantages:

• Lowest rate of complications right after surgery.
• No division of the stomach or intestines.
• Patients go home on the day of surgery, and recovery is quick.
• The band can be removed, if necessary.

Disadvantages:

• The band may need to be adjusted from time to time, and patients must make monthly office visits during the first year.
• There’s less weight loss than with other surgical procedures.
• It comes with the risk of band movement (slippage) or damage to the stomach over time (erosion).
• The surgery means that a foreign implant has to remain in the body.
• It has a high rate of reoperation.
• The surgery can bring swallowing problems, enlargement of the esophagus, and other complications.

Gastric sleeve

For laparoscopic sleeve gastrectomy – often called gastric sleeve – surgeons remove about 80% of the stomach, so the remaining stomach is the size and shape of a banana.

The new, smaller stomach holds less food and liquid, reducing how much food (and how many calories) the patient can get. By removing the portion of the stomach that produces hunger and appetite hormones, the surgery also helps reset the body’s metabolism – decreasing hunger, increasing feelings of fullness, and allowing the body to reach and maintain a healthy weight as well as control blood sugar.

Advantages:

• It’s technically simple and has a short surgery time.
• It can be done in certain patients with high-risk medical conditions.
• It may be the first step for patients with severe obesity or as a bridge to gastric bypass.
• The surgery brings effective weight loss and improvement of obesity-related conditions (typically 50%-60%, by Mayo Clinic estimates), with a low complication rate (2%-3%).

Disadvantages:

• Nonreversible procedure.
• May worsen or cause new reflux and heartburn.
• Less impact on metabolism, compared to bypass procedures.

Gastric bypass

Gastric bypass, also known as the Roux-en-Y gastric bypass (French for “in the form of a Y”) is another effective procedure used to treat obesity and obesity-related diseases (done laparoscopically since the 1990s).

For the operation, surgeons divide the stomach into a smaller top portion (pouch) about the size of an egg, then the larger part of the stomach is bypassed and no longer stores or digests food.

The small intestine is divided and connected to the new egg-sized stomach pouch to allow food to pass.

Gastric bypass works by limiting the amount of food and calories a patient can consume. It also decreases hunger and increases fullness, allowing the patient to reach and maintain a healthy weight. The impact on hormones and metabolic health often results in improvement of diabetes and helps patients with reflux.

Advantages:

• Reliable and long-lasting weight loss.
• Effective for remission of obesity-associated conditions.
• Effective weight loss (60%-70%, by Mayo Clinic estimates).

Disadvantages:

• Technically more complex when compared to gastric sleeve or band.
• More vitamin and mineral deficiencies than with gastric sleeve or band.
• Risk for small bowel complications and obstruction, as well as ulcers, especially with NSAID or tobacco use.
• May cause “dumping syndrome,” a feeling of sickness after eating or drinking, especially sweets.

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

Editor’s Note: This story has been updated to properly identify a product referenced in the story.

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

Younger patients with appendicitis appear to be increasingly likely to have cancer of the appendix, a new study suggests.

While acute appendicitis can often be managed with antibiotics instead of surgery, patients who do not have surgery need to be closely followed to avoid missed diagnoses, the authors write.

“The most important finding is that between 2004 and 2017, relative to right-sided colon cancer, the number of appendiceal cancer cases increased,” said Mustafa Raoof, MD, who was not involved in the study. He is a surgical oncologist and an assistant professor of surgical oncology at City of Hope Comprehensive Cancer Center, Duarte, Calif. “Approximately one-fourth of these were carcinoid tumors, and this category saw the greatest increase, particularly in individuals under 50 years of age.”

“There is a push to treat acute appendicitis with only antibiotics to avoid surgery,” Dr. Raoof told this news organization by email. “One underappreciated downside of this strategy is that an appendiceal cancer can be missed if the appendix is not removed.”

As reported in Journal of the American College of Surgeons, lead study author Michelle C. Salazar, MD, MHS, a general surgery resident at Yale School of Medicine in New Haven, Conn., and her colleagues conducted a retrospective analysis of the National Cancer Database (NCDB). The NCDB contains hospital registry data of around 70% of new cancer diagnoses in the United States.

The researchers extracted data on patients aged 18 years and older who were diagnosed with right-sided colon cancer between 2004 and 2017 and who underwent appendectomy. The authors also identified all patients with appendiceal cancer. They divided that group into patients with carcinoid tumors and those with other types of appendiceal cancer. They also investigated trends by age group.

Of 387,867 patients with right-sided colon cancer, 19,570 (5%) had appendiceal cancer, and 5,628 of those patients (29%) had carcinoid tumor. The odds of appendiceal cancer, compared with other right-sided colon cancers, rose over the years studied (odds ratio, 2.56; 95% confidence interval, 2.35-2.79).

This increase in odds occurred in all age groups but was steepest among patients between 40 and 49 years of age, among whom it increased from 10% in 2004 (95% CI, 9-12) to 18% in 2017 (95% CI, 16-20; P < .001).

Odds of appendiceal carcinoid, compared with other appendiceal cancers, also rose during this period (OR, 1.70; 95% CI, 1.40-2.07). The sharpest increase occurred in the likelihood of carcinoid in patients younger than 40, from 24% in 2004 (95% CI, 15-34) to 45% in 2017 (95% CI, 37-53; P < .001).

“The findings in this study are yet another reason to temper excitement about nonoperative management of acute appendicitis in adults,” Richard S. Hoehn, MD, a surgical oncologist at University Hospitals Seidman Cancer Center, Cleveland, said. “The study is important because it reveals a potential risk of deferring appendectomy in adult patients with appendiceal pathology.”

“As our pathologic examinations of appendiceal cancers improve, we are gaining better understanding of these tumors and how to best manage these patients,” Dr. Hoehn, who also was not involved in the study, added in an email. “The findings should make surgeons more suspicious of malignant causes of acute appendicitis in adults, especially those under 40. Colonoscopy and appendectomy are necessary in adult patients with appendicitis.”

Gregory Botta, MD, PhD, a medical oncologist and associate professor of medicine at the University of California San Diego Health, mentioned limitations of the study in an email. They include the NCDB’s omission of around 30% of cases nationally and the study’s omission of patients diagnosed with primary appendiceal tumor, as well as patients who underwent total colectomies and those who did not have surgery.

“Appendiceal tumors are not normally seen during colonoscopies; screening colonoscopies are not recommended to younger patients under 40, and there is less surgical management for appendicitis,” explained Dr. Botta, who also was not involved in the study. “Thus, the cause of the increasing incidence is not due to increased detection on surveillance.

“Gastrointestinal oncologists are seeing an increase in colon cancer in younger patients and a parallel increase in appendix tumors. While carcinoid tumors are usually found localized and [are] therefore curable postsurgical resection, adenocarcinoma or mucinous subtypes tend to be more diffuse, metastatic, and noncurable,” he added. “Although the increase in colon cancer is being found in our younger population, the authors hint at causes not captured by the NCDB, including environmental exposures or each patient’s diet.”

“There is no good answer as to why there is an increase in carcinoids,” Dr. Salazar said in a press release. “It could be due to environmental reasons, or it could be due to better diagnostics technology.”

The researchers and independent experts share concerns that, because surgery provides the only definitive diagnosis of appendiceal cancer, among patients managed nonsurgically, there may be a delay in cancer diagnosis.

“I would counsel patients based on age,” Dr. Salazar added. “If you’re older, you are at less risk for appendiceal cancer and greater risk for complications from surgery. Younger, healthy patients are more likely to be able to tolerate an operation and may want to rule out cancer by undergoing the operation. The characteristics of appendicitis should be considered in the decision.”

Funding information was not provided. The authors, Dr. Raoof, Dr. Hoehn, and Dr. Botta have disclosed no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.

Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.

The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.

Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.

The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.

The researchers found that rates of VTE were higher among patients discharged to facilities.

Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).

However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.

Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).

“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.

“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.

Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.

He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”

Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.

“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.

“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.

Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.

The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.

Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

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

CHICAGO – Patients undergoing primary reverse shoulder arthroplasty (RSA) for their glenohumeral osteoarthritis had more complications of care and higher hospital costs when they also had a diagnosis of depression, new data show.

The abstract was presented at the annual meeting of the American Academy of Orthopedic Surgeons.

Researchers, led by Keith Diamond, MD, an orthopedic surgeon at Maimonides Medical Center in New York, queried a private payer database looking for patients who had primary RSA for treatment of glenohumeral OA and also had a diagnosis of depressive disorder (DD) from 2010 to 2019. Patients without DD served as the controls.

After the randomized matching with controls at a 1:5 ratio, the study consisted of 28,410 patients: 4,084 in the DD group and 24,326 in the control group.

Researchers found that patients with depression had longer hospital stays (3 vs. 2 days, P = .0007). They also had higher frequency and odds of developing side effects within the period of care (47.4% vs. 14.7%; odds ratio, 2.27; 95% CI, 2.10-2.45,  P < .0001).

Patients with depression also had significantly higher rates of medical complications surrounding the surgery and costs were higher ($19,363 vs. $17,927, P < .0001).

Pneumonia rates were much higher in patients with DD (10% vs. 1.8%; OR, 2.88; P < .0001).

Patients with depression had higher odds of cerebrovascular accident (3.1% vs. 0.7%; OR, 2.69, P < .0001); myocardial infarctions (2% vs. 0.4%; OR, 2.54; P < .0001); acute kidney injuries (11.1% vs. 2.3%; OR, 2.11, P < .0001); surgical site infections (4.4% vs. 2.4%; OR, 1.52, P < .0001); and other complications, the authors wrote.

Dr. Diamond said in an interview that there may be a few potential reasons for the associations.

In regard to the strong association with pneumonia, Dr. Diamond hypothesized, “patients with depression can be shown to have lower respiratory drive. If a patient isn’t motivated to get out of bed, that can lead to decreased inflation of the lungs.”

Acute kidney injury could be linked with depression-related lack of self-care in properly hydrating, he said. Surgical site infections could come from suboptimal hygiene related to managing the cast after surgery, which may be more difficult when patients also struggle with depression.

Asked to comment on Dr. Diamond’s study, Grant Garrigues, MD, an associate professor at Rush University Medical Center, Chicago, and director of upper extremity research, told this news organization the study helps confirm known associations between depression and arthritis.

“We know that people with depression and anxiety feel pain differently,” he said. “It might have to do with your outlook – are you catastrophizing or thinking it’s a minor inconvenience? It’s not that it’s just in your head – you physically feel it differently. That is something we’re certainly attuned to. We want to make sure the mental health part of the picture is optimized as much as possible.”

He added that there is increasing evidence of links between depression and the development of arthritis.

“I’m not saying that everyone with arthritis has depression, but with arthritis being multifactorial, there’s a relatively high incidence of symptomatic arthritis in patients with depression,” Dr. Garrigues said.

“We think it may have something to do with the fight-or-flight hormones in your body that may be revved up if you are living in a stressful environment or are living with a mental health problem. Those will actually change – on a cellular and biochemical basis – some of the things that affect arthritis.”
 

Stronger emphasis on mental health

Dr. Diamond said the field needs more emphasis on perioperative state of mind.  

“As orthopedic surgeons, we are preoccupied with the mechanical, the structural aspects of health care as we try to fix bones, ligaments, and tendons. But I think we need to recognize and explore the connection between the psychiatric and psychological health with our musculoskeletal health.”

He noted that, in the preoperative setting, providers look for hypertension, diabetes, smoking status, and other conditions that could complicate surgical outcomes and said mental health should be a factor in whether a surgery proceeds.

“If someone’s diabetes isn’t controlled you can delay an elective case until their [hemoglobin] A1c is under the recommended limit and you get clearance from their primary care doctor. I think that’s something that should be applied to patients with depressive disorders,” Dr. Diamond said.

This study did not distinguish between patients who were being treated for depression at the time of surgery and those not on treatment. More study related to whether treatment affects depression’s association with RSA outcomes is needed, Dr. Diamond added.

Dr. Garrigues said he talks candidly with patients considering surgery about how they are managing their mental health struggles.

“If they say they haven’t seen their psychiatrist or are off their medications, that’s a nonstarter,” he said.

“Anything outside of the surgery you can optimize, whether it’s mental health, medical, social situations – you want to have all your ducks in a row before you dive into surgery,” Dr. Garrigues said.

He added that patients’ mental health status may even affect the venue for the patient – whether outpatient or inpatient, where they can get more supervision and help in making transitions after surgery.

Dr. Diamond and coauthors and Dr. Garrigues disclosed no relevant financial relationships.

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

CHICAGO – Patients undergoing primary reverse shoulder arthroplasty (RSA) for their glenohumeral osteoarthritis had more complications of care and higher hospital costs when they also had a diagnosis of depression, new data show.

The abstract was presented at the annual meeting of the American Academy of Orthopedic Surgeons.

Researchers, led by Keith Diamond, MD, an orthopedic surgeon at Maimonides Medical Center in New York, queried a private payer database looking for patients who had primary RSA for treatment of glenohumeral OA and also had a diagnosis of depressive disorder (DD) from 2010 to 2019. Patients without DD served as the controls.

After the randomized matching with controls at a 1:5 ratio, the study consisted of 28,410 patients: 4,084 in the DD group and 24,326 in the control group.

Researchers found that patients with depression had longer hospital stays (3 vs. 2 days, P = .0007). They also had higher frequency and odds of developing side effects within the period of care (47.4% vs. 14.7%; odds ratio, 2.27; 95% CI, 2.10-2.45,  P < .0001).

Patients with depression also had significantly higher rates of medical complications surrounding the surgery and costs were higher ($19,363 vs. $17,927, P < .0001).

Pneumonia rates were much higher in patients with DD (10% vs. 1.8%; OR, 2.88; P < .0001).

Patients with depression had higher odds of cerebrovascular accident (3.1% vs. 0.7%; OR, 2.69, P < .0001); myocardial infarctions (2% vs. 0.4%; OR, 2.54; P < .0001); acute kidney injuries (11.1% vs. 2.3%; OR, 2.11, P < .0001); surgical site infections (4.4% vs. 2.4%; OR, 1.52, P < .0001); and other complications, the authors wrote.

Dr. Diamond said in an interview that there may be a few potential reasons for the associations.

In regard to the strong association with pneumonia, Dr. Diamond hypothesized, “patients with depression can be shown to have lower respiratory drive. If a patient isn’t motivated to get out of bed, that can lead to decreased inflation of the lungs.”

Acute kidney injury could be linked with depression-related lack of self-care in properly hydrating, he said. Surgical site infections could come from suboptimal hygiene related to managing the cast after surgery, which may be more difficult when patients also struggle with depression.

Asked to comment on Dr. Diamond’s study, Grant Garrigues, MD, an associate professor at Rush University Medical Center, Chicago, and director of upper extremity research, told this news organization the study helps confirm known associations between depression and arthritis.

“We know that people with depression and anxiety feel pain differently,” he said. “It might have to do with your outlook – are you catastrophizing or thinking it’s a minor inconvenience? It’s not that it’s just in your head – you physically feel it differently. That is something we’re certainly attuned to. We want to make sure the mental health part of the picture is optimized as much as possible.”

He added that there is increasing evidence of links between depression and the development of arthritis.

“I’m not saying that everyone with arthritis has depression, but with arthritis being multifactorial, there’s a relatively high incidence of symptomatic arthritis in patients with depression,” Dr. Garrigues said.

“We think it may have something to do with the fight-or-flight hormones in your body that may be revved up if you are living in a stressful environment or are living with a mental health problem. Those will actually change – on a cellular and biochemical basis – some of the things that affect arthritis.”
 

Stronger emphasis on mental health

Dr. Diamond said the field needs more emphasis on perioperative state of mind.  

“As orthopedic surgeons, we are preoccupied with the mechanical, the structural aspects of health care as we try to fix bones, ligaments, and tendons. But I think we need to recognize and explore the connection between the psychiatric and psychological health with our musculoskeletal health.”

He noted that, in the preoperative setting, providers look for hypertension, diabetes, smoking status, and other conditions that could complicate surgical outcomes and said mental health should be a factor in whether a surgery proceeds.

“If someone’s diabetes isn’t controlled you can delay an elective case until their [hemoglobin] A1c is under the recommended limit and you get clearance from their primary care doctor. I think that’s something that should be applied to patients with depressive disorders,” Dr. Diamond said.

This study did not distinguish between patients who were being treated for depression at the time of surgery and those not on treatment. More study related to whether treatment affects depression’s association with RSA outcomes is needed, Dr. Diamond added.

Dr. Garrigues said he talks candidly with patients considering surgery about how they are managing their mental health struggles.

“If they say they haven’t seen their psychiatrist or are off their medications, that’s a nonstarter,” he said.

“Anything outside of the surgery you can optimize, whether it’s mental health, medical, social situations – you want to have all your ducks in a row before you dive into surgery,” Dr. Garrigues said.

He added that patients’ mental health status may even affect the venue for the patient – whether outpatient or inpatient, where they can get more supervision and help in making transitions after surgery.

Dr. Diamond and coauthors and Dr. Garrigues disclosed no relevant financial relationships.

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

CHICAGO – Patients undergoing primary reverse shoulder arthroplasty (RSA) for their glenohumeral osteoarthritis had more complications of care and higher hospital costs when they also had a diagnosis of depression, new data show.

The abstract was presented at the annual meeting of the American Academy of Orthopedic Surgeons.

Researchers, led by Keith Diamond, MD, an orthopedic surgeon at Maimonides Medical Center in New York, queried a private payer database looking for patients who had primary RSA for treatment of glenohumeral OA and also had a diagnosis of depressive disorder (DD) from 2010 to 2019. Patients without DD served as the controls.

After the randomized matching with controls at a 1:5 ratio, the study consisted of 28,410 patients: 4,084 in the DD group and 24,326 in the control group.

Researchers found that patients with depression had longer hospital stays (3 vs. 2 days, P = .0007). They also had higher frequency and odds of developing side effects within the period of care (47.4% vs. 14.7%; odds ratio, 2.27; 95% CI, 2.10-2.45,  P < .0001).

Patients with depression also had significantly higher rates of medical complications surrounding the surgery and costs were higher ($19,363 vs. $17,927, P < .0001).

Pneumonia rates were much higher in patients with DD (10% vs. 1.8%; OR, 2.88; P < .0001).

Patients with depression had higher odds of cerebrovascular accident (3.1% vs. 0.7%; OR, 2.69, P < .0001); myocardial infarctions (2% vs. 0.4%; OR, 2.54; P < .0001); acute kidney injuries (11.1% vs. 2.3%; OR, 2.11, P < .0001); surgical site infections (4.4% vs. 2.4%; OR, 1.52, P < .0001); and other complications, the authors wrote.

Dr. Diamond said in an interview that there may be a few potential reasons for the associations.

In regard to the strong association with pneumonia, Dr. Diamond hypothesized, “patients with depression can be shown to have lower respiratory drive. If a patient isn’t motivated to get out of bed, that can lead to decreased inflation of the lungs.”

Acute kidney injury could be linked with depression-related lack of self-care in properly hydrating, he said. Surgical site infections could come from suboptimal hygiene related to managing the cast after surgery, which may be more difficult when patients also struggle with depression.

Asked to comment on Dr. Diamond’s study, Grant Garrigues, MD, an associate professor at Rush University Medical Center, Chicago, and director of upper extremity research, told this news organization the study helps confirm known associations between depression and arthritis.

“We know that people with depression and anxiety feel pain differently,” he said. “It might have to do with your outlook – are you catastrophizing or thinking it’s a minor inconvenience? It’s not that it’s just in your head – you physically feel it differently. That is something we’re certainly attuned to. We want to make sure the mental health part of the picture is optimized as much as possible.”

He added that there is increasing evidence of links between depression and the development of arthritis.

“I’m not saying that everyone with arthritis has depression, but with arthritis being multifactorial, there’s a relatively high incidence of symptomatic arthritis in patients with depression,” Dr. Garrigues said.

“We think it may have something to do with the fight-or-flight hormones in your body that may be revved up if you are living in a stressful environment or are living with a mental health problem. Those will actually change – on a cellular and biochemical basis – some of the things that affect arthritis.”
 

Stronger emphasis on mental health

Dr. Diamond said the field needs more emphasis on perioperative state of mind.  

“As orthopedic surgeons, we are preoccupied with the mechanical, the structural aspects of health care as we try to fix bones, ligaments, and tendons. But I think we need to recognize and explore the connection between the psychiatric and psychological health with our musculoskeletal health.”

He noted that, in the preoperative setting, providers look for hypertension, diabetes, smoking status, and other conditions that could complicate surgical outcomes and said mental health should be a factor in whether a surgery proceeds.

“If someone’s diabetes isn’t controlled you can delay an elective case until their [hemoglobin] A1c is under the recommended limit and you get clearance from their primary care doctor. I think that’s something that should be applied to patients with depressive disorders,” Dr. Diamond said.

This study did not distinguish between patients who were being treated for depression at the time of surgery and those not on treatment. More study related to whether treatment affects depression’s association with RSA outcomes is needed, Dr. Diamond added.

Dr. Garrigues said he talks candidly with patients considering surgery about how they are managing their mental health struggles.

“If they say they haven’t seen their psychiatrist or are off their medications, that’s a nonstarter,” he said.

“Anything outside of the surgery you can optimize, whether it’s mental health, medical, social situations – you want to have all your ducks in a row before you dive into surgery,” Dr. Garrigues said.

He added that patients’ mental health status may even affect the venue for the patient – whether outpatient or inpatient, where they can get more supervision and help in making transitions after surgery.

Dr. Diamond and coauthors and Dr. Garrigues disclosed no relevant financial relationships.

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

Five international cardiac surgery associations have banded together to address “substantive concerns” regarding the recently updated Valve Academic Research Consortium 3 (VARC-3) clinical endpoint definitions for aortic valve research.

The VARC-3 update was a multidisciplinary effort that included more than a dozen new or modified definitions for use in transcatheter and surgical aortic valve replacement (TAVR/SAVR) clinical trials, but drew criticism last year from surgeons that some of its definitions favor TAVR over surgery and that its writing committee had deep ties to industry and lacked diversity.

The new surgical associations’ position statement calls out five specific VARC-3 definitions – rehospitalization, valve thrombosis, bleeding, myocardial infarction (MI), and left bundle-branch block (LBBB).

The statement was jointly issued by the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery, the European Association for Cardio-Thoracic Surgery, the Asian Society for Cardiovascular and Thoracic Surgery, and the Latin American Association of Cardiac and Endovascular Surgery.

It was copublished in Annals of Thoracic Surgery, the Journal of Thoracic and Cardiovascular Surgery, the European Journal of Cardio-Thoracic Surgery, and the Asian Cardiovascular and Thoracic Annals.

“We hope that this message can be seen, even if it’s somewhat difficult to hear sometimes, as positive constructive criticism compared to some of the dialogue that we’ve had on social media,” lead author Patrick O. Myers, MD, Lausanne (Switzerland) University Hospital, said in an interview. “It’s not criticizing people or the process but just trying to make these definitions better to ensure the good design of clinical trials.”

The president of each surgical association recommended representatives to help write the position statement, and once completed over Zoom meetings, it received formal endorsement from each association prior to publication, he said.

Reached for comment, VARC-3 lead author Philippe Généreux, MD, Gagnon Cardiovascular Institute, Morristown (N.J.) Medical Center, said, “I was pleasantly surprised that their comments were actually pretty minor and that most of these comments are really more a reflection, not of the validity of the definitions, but rather their applications.”

He noted that all the potential issues with the definitions were already discussed during the making of VARC-3 and resolved by consensus of more than 50 experts including the STS president at the time, Food and Drug Administration officials, and experts from the community.

“To be quite honest, I’m not sure they have consensus,” Dr. Généreux said. He added that the writing committee welcomes input from anyone, but “we’re not going to change the definitions to please eight individuals if we strongly believe by consensus of experts in the field that this is not the right thing to do.”

Rehospitalizations and valve thrombosis

The surgical associations praise VARC-3 for providing a standardized definition of bioprosthetic valve failure, but say they will not endorse the inclusion of rehospitalization as a component of the primary efficacy composite endpoint along with all-cause mortality, stroke, and quality of life.

They note that rehospitalizations outnumber mortality events, especially in short follow-up trials, and that the superiority of TAVR at 1 year in the PARTNER 3 trial of low-risk patients was driven primarily by more rehospitalizations in the surgical arm, but that this superiority was waning at 2 years of follow-up.

“The first thing we are calling for is that it shouldn’t be part of the primary composite outcome measure,” Dr. Myers said. But if it really has to be included, a 30-day blanking period for rehospitalization “would acknowledge that there’s a greater risk of rehospitalization during the acute phase of recovering from surgery.”

Dr. Généreux said that VARC-3 provides granular details for defining the different types of hospitalizations, but that a 30-day blanking period makes no sense. “If you close your eyes to anything within 30 days because you don’t like it, you’re missing the opportunity to improve your procedure, to improve your treatment, and to characterize precisely what happened with your patient.”

The new document lauds VARC-3’s focus on patient-centered and clinically relevant endpoints but questions the definition of valve thrombosis as a “clinically significant” thrombus. It points out that the incidence of valve thrombosis was significantly higher with TAVR versus SAVR in PARTNER 3 using the older VARC-2 definition, which did not require evidence of clinical sequelae (2.6% vs. 0.7%; P = .02). Under the new definition, however, half of the thrombi would be relabeled as “nothing there,” Dr. Myers said.

“As we’re doing this in younger and younger patients who will survive longer, there is a question of thrombus having an effect on the valve and leading to earlier structural valve deterioration,” he added. “All this is conjecture. We don’t have the data. So mainly what we’re advocating is that all thrombi should be reported.”
 

MIs, bleeding, and LBBB

The policy statement also criticizes VARC-3’s decision to define periprocedural (type 5) MI using a biomarker-only definition without need of clinical confirmation. Such definitions have been shown to have a very poor prognostic significance in surgical series compared with the Universal Definitions of Myocardial Infarction, Dr. Myers said.

“What’s interesting is that for thrombus and bleeding, they require clinical correlation, but on the perioperative MI they now use a definition that does not require clinical significance, meaning no ECG changes, no regional wall motion abnormalities or things like that,” he observed.

The decision also seems to disregard the EXCEL trial controversy that illustrated how outcomes and a trial’s message can change depending on which definition of periprocedural MI is used.

With regard to bleeding, the surgical associations agree with the VARC-3 recommendation to use different thresholds when bleeding is integrated into a composite endpoint (type 2 or greater for TAVR and types 3 or greater for SAVR) but suggest this important point should be featured in the chapter on bleeding rather than the section on composite endpoints.

The surgical associations say VARC-3 also got it right adding the need for a new permanent pacemaker to the early composite safety endpoint, but that it was a “missed opportunity” not to include new left bundle-branch block in the safety composite, despite recognizing that this may become an important endpoint to consider in the future.

Dr. Myers said that left bundle-branch block could have implications for survival as TAVR moves into lower-risk, younger patients, as some data with 1-year follow-up suggest it has a prognostic impact, even in the higher-risk older patients with more competing risks.

Finally, the surgical associations point out that only two of the 23 VARC-3 authors were practicing cardiac surgeons and say that a more diverse writing group “may help mitigate issues related to the duality of interests.”

Dr. Généreux said that the final author list is not a reflection of the rigorous work done by 11 cardiac surgeons including the two surgeon authors. The VARC-3 writing committee also had a good representation of women, unlike the surgical position statement, which was penned by eight men.

Dr. Myers reported no relevant financial relationships. Coauthors disclosed ties with EACTS, Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, CryoLife, Shockwave, and JenaValve. Dr. Généreux disclosed ties with Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, Pi-Cardia, and Puzzle Medical.

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

Five international cardiac surgery associations have banded together to address “substantive concerns” regarding the recently updated Valve Academic Research Consortium 3 (VARC-3) clinical endpoint definitions for aortic valve research.

The VARC-3 update was a multidisciplinary effort that included more than a dozen new or modified definitions for use in transcatheter and surgical aortic valve replacement (TAVR/SAVR) clinical trials, but drew criticism last year from surgeons that some of its definitions favor TAVR over surgery and that its writing committee had deep ties to industry and lacked diversity.

The new surgical associations’ position statement calls out five specific VARC-3 definitions – rehospitalization, valve thrombosis, bleeding, myocardial infarction (MI), and left bundle-branch block (LBBB).

The statement was jointly issued by the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery, the European Association for Cardio-Thoracic Surgery, the Asian Society for Cardiovascular and Thoracic Surgery, and the Latin American Association of Cardiac and Endovascular Surgery.

It was copublished in Annals of Thoracic Surgery, the Journal of Thoracic and Cardiovascular Surgery, the European Journal of Cardio-Thoracic Surgery, and the Asian Cardiovascular and Thoracic Annals.

“We hope that this message can be seen, even if it’s somewhat difficult to hear sometimes, as positive constructive criticism compared to some of the dialogue that we’ve had on social media,” lead author Patrick O. Myers, MD, Lausanne (Switzerland) University Hospital, said in an interview. “It’s not criticizing people or the process but just trying to make these definitions better to ensure the good design of clinical trials.”

The president of each surgical association recommended representatives to help write the position statement, and once completed over Zoom meetings, it received formal endorsement from each association prior to publication, he said.

Reached for comment, VARC-3 lead author Philippe Généreux, MD, Gagnon Cardiovascular Institute, Morristown (N.J.) Medical Center, said, “I was pleasantly surprised that their comments were actually pretty minor and that most of these comments are really more a reflection, not of the validity of the definitions, but rather their applications.”

He noted that all the potential issues with the definitions were already discussed during the making of VARC-3 and resolved by consensus of more than 50 experts including the STS president at the time, Food and Drug Administration officials, and experts from the community.

“To be quite honest, I’m not sure they have consensus,” Dr. Généreux said. He added that the writing committee welcomes input from anyone, but “we’re not going to change the definitions to please eight individuals if we strongly believe by consensus of experts in the field that this is not the right thing to do.”

Rehospitalizations and valve thrombosis

The surgical associations praise VARC-3 for providing a standardized definition of bioprosthetic valve failure, but say they will not endorse the inclusion of rehospitalization as a component of the primary efficacy composite endpoint along with all-cause mortality, stroke, and quality of life.

They note that rehospitalizations outnumber mortality events, especially in short follow-up trials, and that the superiority of TAVR at 1 year in the PARTNER 3 trial of low-risk patients was driven primarily by more rehospitalizations in the surgical arm, but that this superiority was waning at 2 years of follow-up.

“The first thing we are calling for is that it shouldn’t be part of the primary composite outcome measure,” Dr. Myers said. But if it really has to be included, a 30-day blanking period for rehospitalization “would acknowledge that there’s a greater risk of rehospitalization during the acute phase of recovering from surgery.”

Dr. Généreux said that VARC-3 provides granular details for defining the different types of hospitalizations, but that a 30-day blanking period makes no sense. “If you close your eyes to anything within 30 days because you don’t like it, you’re missing the opportunity to improve your procedure, to improve your treatment, and to characterize precisely what happened with your patient.”

The new document lauds VARC-3’s focus on patient-centered and clinically relevant endpoints but questions the definition of valve thrombosis as a “clinically significant” thrombus. It points out that the incidence of valve thrombosis was significantly higher with TAVR versus SAVR in PARTNER 3 using the older VARC-2 definition, which did not require evidence of clinical sequelae (2.6% vs. 0.7%; P = .02). Under the new definition, however, half of the thrombi would be relabeled as “nothing there,” Dr. Myers said.

“As we’re doing this in younger and younger patients who will survive longer, there is a question of thrombus having an effect on the valve and leading to earlier structural valve deterioration,” he added. “All this is conjecture. We don’t have the data. So mainly what we’re advocating is that all thrombi should be reported.”
 

MIs, bleeding, and LBBB

The policy statement also criticizes VARC-3’s decision to define periprocedural (type 5) MI using a biomarker-only definition without need of clinical confirmation. Such definitions have been shown to have a very poor prognostic significance in surgical series compared with the Universal Definitions of Myocardial Infarction, Dr. Myers said.

“What’s interesting is that for thrombus and bleeding, they require clinical correlation, but on the perioperative MI they now use a definition that does not require clinical significance, meaning no ECG changes, no regional wall motion abnormalities or things like that,” he observed.

The decision also seems to disregard the EXCEL trial controversy that illustrated how outcomes and a trial’s message can change depending on which definition of periprocedural MI is used.

With regard to bleeding, the surgical associations agree with the VARC-3 recommendation to use different thresholds when bleeding is integrated into a composite endpoint (type 2 or greater for TAVR and types 3 or greater for SAVR) but suggest this important point should be featured in the chapter on bleeding rather than the section on composite endpoints.

The surgical associations say VARC-3 also got it right adding the need for a new permanent pacemaker to the early composite safety endpoint, but that it was a “missed opportunity” not to include new left bundle-branch block in the safety composite, despite recognizing that this may become an important endpoint to consider in the future.

Dr. Myers said that left bundle-branch block could have implications for survival as TAVR moves into lower-risk, younger patients, as some data with 1-year follow-up suggest it has a prognostic impact, even in the higher-risk older patients with more competing risks.

Finally, the surgical associations point out that only two of the 23 VARC-3 authors were practicing cardiac surgeons and say that a more diverse writing group “may help mitigate issues related to the duality of interests.”

Dr. Généreux said that the final author list is not a reflection of the rigorous work done by 11 cardiac surgeons including the two surgeon authors. The VARC-3 writing committee also had a good representation of women, unlike the surgical position statement, which was penned by eight men.

Dr. Myers reported no relevant financial relationships. Coauthors disclosed ties with EACTS, Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, CryoLife, Shockwave, and JenaValve. Dr. Généreux disclosed ties with Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, Pi-Cardia, and Puzzle Medical.

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

Five international cardiac surgery associations have banded together to address “substantive concerns” regarding the recently updated Valve Academic Research Consortium 3 (VARC-3) clinical endpoint definitions for aortic valve research.

The VARC-3 update was a multidisciplinary effort that included more than a dozen new or modified definitions for use in transcatheter and surgical aortic valve replacement (TAVR/SAVR) clinical trials, but drew criticism last year from surgeons that some of its definitions favor TAVR over surgery and that its writing committee had deep ties to industry and lacked diversity.

The new surgical associations’ position statement calls out five specific VARC-3 definitions – rehospitalization, valve thrombosis, bleeding, myocardial infarction (MI), and left bundle-branch block (LBBB).

The statement was jointly issued by the Society of Thoracic Surgeons (STS), the American Association for Thoracic Surgery, the European Association for Cardio-Thoracic Surgery, the Asian Society for Cardiovascular and Thoracic Surgery, and the Latin American Association of Cardiac and Endovascular Surgery.

It was copublished in Annals of Thoracic Surgery, the Journal of Thoracic and Cardiovascular Surgery, the European Journal of Cardio-Thoracic Surgery, and the Asian Cardiovascular and Thoracic Annals.

“We hope that this message can be seen, even if it’s somewhat difficult to hear sometimes, as positive constructive criticism compared to some of the dialogue that we’ve had on social media,” lead author Patrick O. Myers, MD, Lausanne (Switzerland) University Hospital, said in an interview. “It’s not criticizing people or the process but just trying to make these definitions better to ensure the good design of clinical trials.”

The president of each surgical association recommended representatives to help write the position statement, and once completed over Zoom meetings, it received formal endorsement from each association prior to publication, he said.

Reached for comment, VARC-3 lead author Philippe Généreux, MD, Gagnon Cardiovascular Institute, Morristown (N.J.) Medical Center, said, “I was pleasantly surprised that their comments were actually pretty minor and that most of these comments are really more a reflection, not of the validity of the definitions, but rather their applications.”

He noted that all the potential issues with the definitions were already discussed during the making of VARC-3 and resolved by consensus of more than 50 experts including the STS president at the time, Food and Drug Administration officials, and experts from the community.

“To be quite honest, I’m not sure they have consensus,” Dr. Généreux said. He added that the writing committee welcomes input from anyone, but “we’re not going to change the definitions to please eight individuals if we strongly believe by consensus of experts in the field that this is not the right thing to do.”

Rehospitalizations and valve thrombosis

The surgical associations praise VARC-3 for providing a standardized definition of bioprosthetic valve failure, but say they will not endorse the inclusion of rehospitalization as a component of the primary efficacy composite endpoint along with all-cause mortality, stroke, and quality of life.

They note that rehospitalizations outnumber mortality events, especially in short follow-up trials, and that the superiority of TAVR at 1 year in the PARTNER 3 trial of low-risk patients was driven primarily by more rehospitalizations in the surgical arm, but that this superiority was waning at 2 years of follow-up.

“The first thing we are calling for is that it shouldn’t be part of the primary composite outcome measure,” Dr. Myers said. But if it really has to be included, a 30-day blanking period for rehospitalization “would acknowledge that there’s a greater risk of rehospitalization during the acute phase of recovering from surgery.”

Dr. Généreux said that VARC-3 provides granular details for defining the different types of hospitalizations, but that a 30-day blanking period makes no sense. “If you close your eyes to anything within 30 days because you don’t like it, you’re missing the opportunity to improve your procedure, to improve your treatment, and to characterize precisely what happened with your patient.”

The new document lauds VARC-3’s focus on patient-centered and clinically relevant endpoints but questions the definition of valve thrombosis as a “clinically significant” thrombus. It points out that the incidence of valve thrombosis was significantly higher with TAVR versus SAVR in PARTNER 3 using the older VARC-2 definition, which did not require evidence of clinical sequelae (2.6% vs. 0.7%; P = .02). Under the new definition, however, half of the thrombi would be relabeled as “nothing there,” Dr. Myers said.

“As we’re doing this in younger and younger patients who will survive longer, there is a question of thrombus having an effect on the valve and leading to earlier structural valve deterioration,” he added. “All this is conjecture. We don’t have the data. So mainly what we’re advocating is that all thrombi should be reported.”
 

MIs, bleeding, and LBBB

The policy statement also criticizes VARC-3’s decision to define periprocedural (type 5) MI using a biomarker-only definition without need of clinical confirmation. Such definitions have been shown to have a very poor prognostic significance in surgical series compared with the Universal Definitions of Myocardial Infarction, Dr. Myers said.

“What’s interesting is that for thrombus and bleeding, they require clinical correlation, but on the perioperative MI they now use a definition that does not require clinical significance, meaning no ECG changes, no regional wall motion abnormalities or things like that,” he observed.

The decision also seems to disregard the EXCEL trial controversy that illustrated how outcomes and a trial’s message can change depending on which definition of periprocedural MI is used.

With regard to bleeding, the surgical associations agree with the VARC-3 recommendation to use different thresholds when bleeding is integrated into a composite endpoint (type 2 or greater for TAVR and types 3 or greater for SAVR) but suggest this important point should be featured in the chapter on bleeding rather than the section on composite endpoints.

The surgical associations say VARC-3 also got it right adding the need for a new permanent pacemaker to the early composite safety endpoint, but that it was a “missed opportunity” not to include new left bundle-branch block in the safety composite, despite recognizing that this may become an important endpoint to consider in the future.

Dr. Myers said that left bundle-branch block could have implications for survival as TAVR moves into lower-risk, younger patients, as some data with 1-year follow-up suggest it has a prognostic impact, even in the higher-risk older patients with more competing risks.

Finally, the surgical associations point out that only two of the 23 VARC-3 authors were practicing cardiac surgeons and say that a more diverse writing group “may help mitigate issues related to the duality of interests.”

Dr. Généreux said that the final author list is not a reflection of the rigorous work done by 11 cardiac surgeons including the two surgeon authors. The VARC-3 writing committee also had a good representation of women, unlike the surgical position statement, which was penned by eight men.

Dr. Myers reported no relevant financial relationships. Coauthors disclosed ties with EACTS, Edwards Lifesciences, Medtronic, Abbott Vascular, Boston Scientific, CryoLife, Shockwave, and JenaValve. Dr. Généreux disclosed ties with Abbott Vascular, Abiomed, Boston Scientific, Cardinal Health, Cardiovascular Systems, Edwards Lifesciences, Medtronic, Opsens, Siemens, SoundBite Medical Solutions, Sig.Num, Saranas, Teleflex, Tryton Medical, Pi-Cardia, and Puzzle Medical.

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

CHICAGO - Posterior-stabilized (PS) bearings used in total knee arthroplasty (TKA) may increase the risk of revision compared with bearings of other design, new data suggest.

That possibility has previously been reported in studies outside the United States, and now an analysis of more than 300,000 cases in the American Joint Replacement Registry (AJRR) suggests it’s the case in the United States as well.

Principal investigator Ryland Kagan, MD, of the department of orthopedic surgery at Oregon Health & Science University in Portland, told this news organization, “What’s unique about our experience in the U.S. is our overall high use of PS implants.”

More than half of TKAs in the United States use the PS bearings; in comparison, in Australia and European countries, PS use is closer to 20%, he said. Because of this disparity, previous studies have not been seen as generalizable to the United States, he said.

Researchers used AJRR data from 2012 to 2019 and identified all primary TKA procedures performed during that period. Cases were linked to supplemental Centers for Medicare & Medicaid Services data to find revision procedures that may not have been included in the AJRR database.

Jamil Kendall, MD, an orthopedic resident at OHSU, was first author on the study. The team evaluated patient demographics, polyethylene characteristics, procedure dates, and cause for revision in the 305,279 cases.

Of those cases in which implant characteristics were reported, 161,486 (52.9%) patients received PS bearings, and 143,793 (47.1%) received minimally stabilized bearings.

The researchers compared three minimally stabilized implants (cruciate retaining [CR], anterior stabilized [AS], or pivot bearing designs) with each other for risk and then compared minimally stabilized options as a group with the PS bearings.

They found no significant differences among the three minimally stabilized options.

But revision risk was higher when they compared the minimally stabilized implants with the PS bearing implants. Use of PS bearings had a hazard ratio of 1.25 (95% confidence interval, 1.2-1.3; P < .0001) for all-cause revision and an HR of 1.18 (95% CI, 1.0-1.4; P = .02) for infection.

Among the patients with minimally stabilized bearings, 1,693 (1.2%) underwent revision for any cause, and 334 (0.2%) underwent revision for infection. For patients with PS bearings, 2,406 (1.5%) underwent revision for any cause, and 446 (0.3%) underwent revision for infection.

Even a small difference significant

Dr. Kagan said, “The difference isn’t dramatic, but when you think of the total number of total knee arthroplasties done, you’re talking about millions of procedures. Even with a small increased risk, you’re going to see a large influence for a population.”

Richard Lynn Illgen, MD, director of the University of Wisconsin-Madison joint replacement program, told this news organization this work identifies a trend, but he pointed out that registry-based studies have important limitations.

“They cannot establish causality,” he said. “There are many potential confounding variables and potential selection biases that could affect the study. Specifically, the study did not control for degree of deformity or medical comorbidities. Although some surgeons routinely use PS designs for all primary TKAs, others use PS designs for patients with more severe deformities. It is possible that PS designs were used more frequently in patients with a greater degree of deformity, and this could introduce a selection bias.”

He added that no data were included to enable stratification of groups according to medical comorbidities.

“It is possible that selection bias exists comparing the relative degree of medical comorbidities between patients in the PS TKA and minimally constrained TKA groups,” Dr. Illgen said.

He said further prospective, randomized studies are needed to eliminate selection bias and to better determine whether the observed pattern of increased risk of revision holds up, compared with the minimally supported versions.

The authors acknowledged those limitations, but Dr. Kagan said the high percentage of PS procedures in the United States helps mitigate potential bias.

Dr. Illgen serves as a consultant and developer for Stryker, is chair of the AAOS AJRR Research Projects Subcommittee, and is a member of the AJRR Steering Committee. Dr. Kagan receives research support from KCI, Ortho Development, and Smith & Nephew, where he is also a paid consultant. Dr. Kendall reports no relevant financial relationships. Another coauthor of the study is a paid consultant for 3M, Heraeus, Immunis, Smith & Nephew, Zimmer Biomet, and Total Joint Orthopedics and has stock or stock options in Joint Development.

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

CHICAGO - Posterior-stabilized (PS) bearings used in total knee arthroplasty (TKA) may increase the risk of revision compared with bearings of other design, new data suggest.

That possibility has previously been reported in studies outside the United States, and now an analysis of more than 300,000 cases in the American Joint Replacement Registry (AJRR) suggests it’s the case in the United States as well.

Principal investigator Ryland Kagan, MD, of the department of orthopedic surgery at Oregon Health & Science University in Portland, told this news organization, “What’s unique about our experience in the U.S. is our overall high use of PS implants.”

More than half of TKAs in the United States use the PS bearings; in comparison, in Australia and European countries, PS use is closer to 20%, he said. Because of this disparity, previous studies have not been seen as generalizable to the United States, he said.

Researchers used AJRR data from 2012 to 2019 and identified all primary TKA procedures performed during that period. Cases were linked to supplemental Centers for Medicare & Medicaid Services data to find revision procedures that may not have been included in the AJRR database.

Jamil Kendall, MD, an orthopedic resident at OHSU, was first author on the study. The team evaluated patient demographics, polyethylene characteristics, procedure dates, and cause for revision in the 305,279 cases.

Of those cases in which implant characteristics were reported, 161,486 (52.9%) patients received PS bearings, and 143,793 (47.1%) received minimally stabilized bearings.

The researchers compared three minimally stabilized implants (cruciate retaining [CR], anterior stabilized [AS], or pivot bearing designs) with each other for risk and then compared minimally stabilized options as a group with the PS bearings.

They found no significant differences among the three minimally stabilized options.

But revision risk was higher when they compared the minimally stabilized implants with the PS bearing implants. Use of PS bearings had a hazard ratio of 1.25 (95% confidence interval, 1.2-1.3; P < .0001) for all-cause revision and an HR of 1.18 (95% CI, 1.0-1.4; P = .02) for infection.

Among the patients with minimally stabilized bearings, 1,693 (1.2%) underwent revision for any cause, and 334 (0.2%) underwent revision for infection. For patients with PS bearings, 2,406 (1.5%) underwent revision for any cause, and 446 (0.3%) underwent revision for infection.

Even a small difference significant

Dr. Kagan said, “The difference isn’t dramatic, but when you think of the total number of total knee arthroplasties done, you’re talking about millions of procedures. Even with a small increased risk, you’re going to see a large influence for a population.”

Richard Lynn Illgen, MD, director of the University of Wisconsin-Madison joint replacement program, told this news organization this work identifies a trend, but he pointed out that registry-based studies have important limitations.

“They cannot establish causality,” he said. “There are many potential confounding variables and potential selection biases that could affect the study. Specifically, the study did not control for degree of deformity or medical comorbidities. Although some surgeons routinely use PS designs for all primary TKAs, others use PS designs for patients with more severe deformities. It is possible that PS designs were used more frequently in patients with a greater degree of deformity, and this could introduce a selection bias.”

He added that no data were included to enable stratification of groups according to medical comorbidities.

“It is possible that selection bias exists comparing the relative degree of medical comorbidities between patients in the PS TKA and minimally constrained TKA groups,” Dr. Illgen said.

He said further prospective, randomized studies are needed to eliminate selection bias and to better determine whether the observed pattern of increased risk of revision holds up, compared with the minimally supported versions.

The authors acknowledged those limitations, but Dr. Kagan said the high percentage of PS procedures in the United States helps mitigate potential bias.

Dr. Illgen serves as a consultant and developer for Stryker, is chair of the AAOS AJRR Research Projects Subcommittee, and is a member of the AJRR Steering Committee. Dr. Kagan receives research support from KCI, Ortho Development, and Smith & Nephew, where he is also a paid consultant. Dr. Kendall reports no relevant financial relationships. Another coauthor of the study is a paid consultant for 3M, Heraeus, Immunis, Smith & Nephew, Zimmer Biomet, and Total Joint Orthopedics and has stock or stock options in Joint Development.

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

CHICAGO - Posterior-stabilized (PS) bearings used in total knee arthroplasty (TKA) may increase the risk of revision compared with bearings of other design, new data suggest.

That possibility has previously been reported in studies outside the United States, and now an analysis of more than 300,000 cases in the American Joint Replacement Registry (AJRR) suggests it’s the case in the United States as well.

Principal investigator Ryland Kagan, MD, of the department of orthopedic surgery at Oregon Health & Science University in Portland, told this news organization, “What’s unique about our experience in the U.S. is our overall high use of PS implants.”

More than half of TKAs in the United States use the PS bearings; in comparison, in Australia and European countries, PS use is closer to 20%, he said. Because of this disparity, previous studies have not been seen as generalizable to the United States, he said.

Researchers used AJRR data from 2012 to 2019 and identified all primary TKA procedures performed during that period. Cases were linked to supplemental Centers for Medicare & Medicaid Services data to find revision procedures that may not have been included in the AJRR database.

Jamil Kendall, MD, an orthopedic resident at OHSU, was first author on the study. The team evaluated patient demographics, polyethylene characteristics, procedure dates, and cause for revision in the 305,279 cases.

Of those cases in which implant characteristics were reported, 161,486 (52.9%) patients received PS bearings, and 143,793 (47.1%) received minimally stabilized bearings.

The researchers compared three minimally stabilized implants (cruciate retaining [CR], anterior stabilized [AS], or pivot bearing designs) with each other for risk and then compared minimally stabilized options as a group with the PS bearings.

They found no significant differences among the three minimally stabilized options.

But revision risk was higher when they compared the minimally stabilized implants with the PS bearing implants. Use of PS bearings had a hazard ratio of 1.25 (95% confidence interval, 1.2-1.3; P < .0001) for all-cause revision and an HR of 1.18 (95% CI, 1.0-1.4; P = .02) for infection.

Among the patients with minimally stabilized bearings, 1,693 (1.2%) underwent revision for any cause, and 334 (0.2%) underwent revision for infection. For patients with PS bearings, 2,406 (1.5%) underwent revision for any cause, and 446 (0.3%) underwent revision for infection.

Even a small difference significant

Dr. Kagan said, “The difference isn’t dramatic, but when you think of the total number of total knee arthroplasties done, you’re talking about millions of procedures. Even with a small increased risk, you’re going to see a large influence for a population.”

Richard Lynn Illgen, MD, director of the University of Wisconsin-Madison joint replacement program, told this news organization this work identifies a trend, but he pointed out that registry-based studies have important limitations.

“They cannot establish causality,” he said. “There are many potential confounding variables and potential selection biases that could affect the study. Specifically, the study did not control for degree of deformity or medical comorbidities. Although some surgeons routinely use PS designs for all primary TKAs, others use PS designs for patients with more severe deformities. It is possible that PS designs were used more frequently in patients with a greater degree of deformity, and this could introduce a selection bias.”

He added that no data were included to enable stratification of groups according to medical comorbidities.

“It is possible that selection bias exists comparing the relative degree of medical comorbidities between patients in the PS TKA and minimally constrained TKA groups,” Dr. Illgen said.

He said further prospective, randomized studies are needed to eliminate selection bias and to better determine whether the observed pattern of increased risk of revision holds up, compared with the minimally supported versions.

The authors acknowledged those limitations, but Dr. Kagan said the high percentage of PS procedures in the United States helps mitigate potential bias.

Dr. Illgen serves as a consultant and developer for Stryker, is chair of the AAOS AJRR Research Projects Subcommittee, and is a member of the AJRR Steering Committee. Dr. Kagan receives research support from KCI, Ortho Development, and Smith & Nephew, where he is also a paid consultant. Dr. Kendall reports no relevant financial relationships. Another coauthor of the study is a paid consultant for 3M, Heraeus, Immunis, Smith & Nephew, Zimmer Biomet, and Total Joint Orthopedics and has stock or stock options in Joint Development.

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