MDedge Surgery

Three-year results from the Evolut trial seem to provide more reassurance on the use of transcatheter aortic valve replacement (TAVR) in low-surgical-risk patients.

The 3-year results show that low-surgical-risk patients undergoing aortic valve replacement continue to show lower rates of all-cause mortality and disabling stroke with TAVR, compared with surgery.

The rates of all-cause mortality or disabling stroke (the primary endpoint) at 3 years were 7.4% with TAVR and 10.4% with surgery.

Rates of new pacemaker implantation continued to be higher after TAVR and the frequency of new onset atrial fibrillation was more common after surgery.

“At 3 years, the rate of all-cause mortality or disabling stroke after TAVR with the Evolut valve compared very favorably to surgery. The absolute difference between treatment arms remained consistent with a 30% relative reduction in the hazard of death or disabling stroke, with a P value that just missed statistical significance,” said Evolut investigator John Forrest, MD, Yale University School of Medicine, New Haven, Conn.

“The Kaplan-Meier curves show what we’ve come to expect – an early separation of the curves – but what’s unique here, and seen for the first time, is that the early separation is maintained at year 1 and year 2, and between years 2 and 3 the curve didn’t start to come together, but, if anything, separated a little,” Dr. Forrest commented. 

“Both components of the primary endpoint – all cause mortality and disabling stroke – numerically favor TAVR. The separation of the curves for stroke are maintained, and if anything, we see a further slight separation of the curves as we go forward out to 3 years in terms of all-cause mortality,” he added.  

Dr. Forrest presented the 3-year results from the Evolut trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. They were simultaneously published online in the Journal of the American College of Cardiology.

Dr. Forrest also reported that TAVR patients continued to have better valve hemodynamics at 3 years and very low rates of valve thrombosis; moreover, rates of moderate or greater paravalvular regurgitation and paravalvular leak (factors that can affect valve durability) were also low, although mild paravalvular regurgitation was higher with TAVR.

“In these low-risk patients, the durability of the valve is going to be critically important,” Dr. Forrest commented. “The excellent valve performance and durable outcomes out to 3 years in low-risk patients affirms the role of TAVR in this population,” he concluded.

On how these results may affect clinical practice, Dr. Forrest said: “I think in the U.S. these results reaffirm what we are doing. It gives us confidence to continue treating low-risk patients and being comfortable with that.”

He added: “Outside the U.S., the guidelines are a little different. Maybe we should reconsider some of these guidelines based on these data.”

David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., who is not involved in the TAVR studies, said: “The results provide a little more reassurance ... that will go a little way further.”

“Uncertainty remains regarding long-term durability of the transcatheter valve in low-risk patients who are generally younger and likely more active than higher-risk cohorts,” he added. “The current 3-year results provide more confidence as the outcome curves for death and disabling stroke are trending in the right direction for TAVR versus surgery.”

Dr. Moliterno pointed out that while rates of paravalvular regurgitation and permanent pacemaker placement are decreasing with newer generation Evolut devices and implantation techniques, he noted that according to the U.S. Social Security Administration, patients aged 74 years as enrolled in this low-risk cohort have an additional life expectancy of approximately 12 years. “So, we have more device durability (and coronary access feasibility) to prove.”

In his presentation, Dr. Forrest explained that TAVR is now approved in the United States for all patients with aortic stenosis regardless of surgical risk and has become the dominant form of aortic valve replacement. Current ACC/AHA guidelines recommend that heart teams utilize a shared decision-making process when discussing aortic valve replacement with patients aged 65-80 years. In younger, lower-risk patients, the faster recovery and short-term benefits after TAVR must be balanced with long-term durability; however, only limited intermediate and long-term data exist to guide such discussions in this patient population.

The Evolut Low Risk trial randomly assigned 1,414 patients in need of aortic valve replacement to TAVR with a self-expanding, supra-annular valve or surgery. Results at 1 and 2 years have shown a similar benefit in the primary endpoint of all-cause mortality/disabling stroke for the less invasive TAVR procedure.  

The current 3-year results suggest the benefit appears to be maintained out for another year. 

The main results show that the rate of death or disabling stroke was 7.4% in the TAVR group versus 10.4% in the surgery group, giving a hazard ratio of 0.70 (P = .051).

In the JACC paper, the authors report that the absolute difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: –1.8% at year 1; –2.0% at year 2; and –2.9% at year 3.

Other key results on valve durability show that mild paravalvular regurgitation was increased in the TAVR group (20.3%) versus 2.5% with surgery. However, rates of moderate or greater paravalvular regurgitation for both groups were below 1% and not significantly different between groups.

Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs. 12.1 mm Hg surgery; P < .001) at 3 years.

However, pacemaker placement was much higher in the TAVR group (23.2%), compared with 9.1% in the surgery group.

On the other hand, the surgery group had a greater incidence of atrial fibrillation (40%) versus 13% with TAVR.

Quality-of-life results looked good in both groups.

“As we’ve come to expect, patients recover more quickly after TAVR, so at 30 days their quality of life is better than those who have undergone surgery,” Dr. Forrest commented. “But by 1 year, both groups are doing exceptionally well and, remarkably, here by 3 years both groups have greater than a 20-point increase in their KCCQ score, showing a very large improvement in quality of life.”

Discussant of these latest results at the ACC late-breaking trials session, James Hermiller, MD, St. Vincent Ascension Heart Center, Indianapolis, said: “This 3-year data continues to demonstrate that the gift of TAVR keeps giving.”

Noting that the divergence in the effect curves was primarily driven by mortality rather than stroke, he asked whether this was cardiac or noncardiac mortality that was reduced.

Dr. Forrest responded: “It was a fairly equal contribution – a little bit more cardiac death. We have to remember that although the average age in this study was 74, there were some patients over 80 who were still low-surgical-risk included so we are going to see noncardiac death as well.”

Dr. Hermiller drew attention to the high pacemaker rate in the TAVR group and asked how these patients fared in comparison to those who didn’t need a pacemaker.

Dr. Forrest replied: “I think it’s fair to say that putting in a pacemaker is not a benign procedure. Patients who got a pacemaker did slightly worse than those who didn’t get a pacemaker, so we need to try to drive that rate down.”

He added that the number of patients needing a pacemaker after TAVR has come down with new implantation techniques and new generation valves.

“We realize that using a cusp overlap technique can significantly reduce the need for a pacemaker, and we see from registry data that with the use of this new technique the need for a pacemaker has dropped down to 8%-9%, significantly less than seen in this study,” Dr. Forrest commented.    

Dr. Hermiller also asked about how TAVR affects future access for catheterization or percutaneous coronary intervention.  

Dr. Forrest noted that 24 patients in the TAVR group required PCI in first 3 years, and all the PCI procedures had been successful. He noted that operators reported the procedure to be easy or moderately easy in about 75%-80% of cases and difficult in about 20% of patients. “So, it is slightly more challenging to engage the coronaries and have to go through the frame, but it is very feasible.”

Dr. Forrest concluded that: “These results provide patients and heart teams important data to aid in the shared decision-making process.”

But he acknowledged that longer term data are still needed. “And the potential impact that hemodynamics, valve design, new pacemakers, and other secondary endpoints have on long-term outcomes will be important to follow in this group of low-risk patients.”

The Evolut Low Risk trial was funded by Medtronic. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic.

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

Three-year results from the Evolut trial seem to provide more reassurance on the use of transcatheter aortic valve replacement (TAVR) in low-surgical-risk patients.

The 3-year results show that low-surgical-risk patients undergoing aortic valve replacement continue to show lower rates of all-cause mortality and disabling stroke with TAVR, compared with surgery.

The rates of all-cause mortality or disabling stroke (the primary endpoint) at 3 years were 7.4% with TAVR and 10.4% with surgery.

Rates of new pacemaker implantation continued to be higher after TAVR and the frequency of new onset atrial fibrillation was more common after surgery.

“At 3 years, the rate of all-cause mortality or disabling stroke after TAVR with the Evolut valve compared very favorably to surgery. The absolute difference between treatment arms remained consistent with a 30% relative reduction in the hazard of death or disabling stroke, with a P value that just missed statistical significance,” said Evolut investigator John Forrest, MD, Yale University School of Medicine, New Haven, Conn.

“The Kaplan-Meier curves show what we’ve come to expect – an early separation of the curves – but what’s unique here, and seen for the first time, is that the early separation is maintained at year 1 and year 2, and between years 2 and 3 the curve didn’t start to come together, but, if anything, separated a little,” Dr. Forrest commented. 

“Both components of the primary endpoint – all cause mortality and disabling stroke – numerically favor TAVR. The separation of the curves for stroke are maintained, and if anything, we see a further slight separation of the curves as we go forward out to 3 years in terms of all-cause mortality,” he added.  

Dr. Forrest presented the 3-year results from the Evolut trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. They were simultaneously published online in the Journal of the American College of Cardiology.

Dr. Forrest also reported that TAVR patients continued to have better valve hemodynamics at 3 years and very low rates of valve thrombosis; moreover, rates of moderate or greater paravalvular regurgitation and paravalvular leak (factors that can affect valve durability) were also low, although mild paravalvular regurgitation was higher with TAVR.

“In these low-risk patients, the durability of the valve is going to be critically important,” Dr. Forrest commented. “The excellent valve performance and durable outcomes out to 3 years in low-risk patients affirms the role of TAVR in this population,” he concluded.

On how these results may affect clinical practice, Dr. Forrest said: “I think in the U.S. these results reaffirm what we are doing. It gives us confidence to continue treating low-risk patients and being comfortable with that.”

He added: “Outside the U.S., the guidelines are a little different. Maybe we should reconsider some of these guidelines based on these data.”

David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., who is not involved in the TAVR studies, said: “The results provide a little more reassurance ... that will go a little way further.”

“Uncertainty remains regarding long-term durability of the transcatheter valve in low-risk patients who are generally younger and likely more active than higher-risk cohorts,” he added. “The current 3-year results provide more confidence as the outcome curves for death and disabling stroke are trending in the right direction for TAVR versus surgery.”

Dr. Moliterno pointed out that while rates of paravalvular regurgitation and permanent pacemaker placement are decreasing with newer generation Evolut devices and implantation techniques, he noted that according to the U.S. Social Security Administration, patients aged 74 years as enrolled in this low-risk cohort have an additional life expectancy of approximately 12 years. “So, we have more device durability (and coronary access feasibility) to prove.”

In his presentation, Dr. Forrest explained that TAVR is now approved in the United States for all patients with aortic stenosis regardless of surgical risk and has become the dominant form of aortic valve replacement. Current ACC/AHA guidelines recommend that heart teams utilize a shared decision-making process when discussing aortic valve replacement with patients aged 65-80 years. In younger, lower-risk patients, the faster recovery and short-term benefits after TAVR must be balanced with long-term durability; however, only limited intermediate and long-term data exist to guide such discussions in this patient population.

The Evolut Low Risk trial randomly assigned 1,414 patients in need of aortic valve replacement to TAVR with a self-expanding, supra-annular valve or surgery. Results at 1 and 2 years have shown a similar benefit in the primary endpoint of all-cause mortality/disabling stroke for the less invasive TAVR procedure.  

The current 3-year results suggest the benefit appears to be maintained out for another year. 

The main results show that the rate of death or disabling stroke was 7.4% in the TAVR group versus 10.4% in the surgery group, giving a hazard ratio of 0.70 (P = .051).

In the JACC paper, the authors report that the absolute difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: –1.8% at year 1; –2.0% at year 2; and –2.9% at year 3.

Other key results on valve durability show that mild paravalvular regurgitation was increased in the TAVR group (20.3%) versus 2.5% with surgery. However, rates of moderate or greater paravalvular regurgitation for both groups were below 1% and not significantly different between groups.

Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs. 12.1 mm Hg surgery; P < .001) at 3 years.

However, pacemaker placement was much higher in the TAVR group (23.2%), compared with 9.1% in the surgery group.

On the other hand, the surgery group had a greater incidence of atrial fibrillation (40%) versus 13% with TAVR.

Quality-of-life results looked good in both groups.

“As we’ve come to expect, patients recover more quickly after TAVR, so at 30 days their quality of life is better than those who have undergone surgery,” Dr. Forrest commented. “But by 1 year, both groups are doing exceptionally well and, remarkably, here by 3 years both groups have greater than a 20-point increase in their KCCQ score, showing a very large improvement in quality of life.”

Discussant of these latest results at the ACC late-breaking trials session, James Hermiller, MD, St. Vincent Ascension Heart Center, Indianapolis, said: “This 3-year data continues to demonstrate that the gift of TAVR keeps giving.”

Noting that the divergence in the effect curves was primarily driven by mortality rather than stroke, he asked whether this was cardiac or noncardiac mortality that was reduced.

Dr. Forrest responded: “It was a fairly equal contribution – a little bit more cardiac death. We have to remember that although the average age in this study was 74, there were some patients over 80 who were still low-surgical-risk included so we are going to see noncardiac death as well.”

Dr. Hermiller drew attention to the high pacemaker rate in the TAVR group and asked how these patients fared in comparison to those who didn’t need a pacemaker.

Dr. Forrest replied: “I think it’s fair to say that putting in a pacemaker is not a benign procedure. Patients who got a pacemaker did slightly worse than those who didn’t get a pacemaker, so we need to try to drive that rate down.”

He added that the number of patients needing a pacemaker after TAVR has come down with new implantation techniques and new generation valves.

“We realize that using a cusp overlap technique can significantly reduce the need for a pacemaker, and we see from registry data that with the use of this new technique the need for a pacemaker has dropped down to 8%-9%, significantly less than seen in this study,” Dr. Forrest commented.    

Dr. Hermiller also asked about how TAVR affects future access for catheterization or percutaneous coronary intervention.  

Dr. Forrest noted that 24 patients in the TAVR group required PCI in first 3 years, and all the PCI procedures had been successful. He noted that operators reported the procedure to be easy or moderately easy in about 75%-80% of cases and difficult in about 20% of patients. “So, it is slightly more challenging to engage the coronaries and have to go through the frame, but it is very feasible.”

Dr. Forrest concluded that: “These results provide patients and heart teams important data to aid in the shared decision-making process.”

But he acknowledged that longer term data are still needed. “And the potential impact that hemodynamics, valve design, new pacemakers, and other secondary endpoints have on long-term outcomes will be important to follow in this group of low-risk patients.”

The Evolut Low Risk trial was funded by Medtronic. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic.

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

Three-year results from the Evolut trial seem to provide more reassurance on the use of transcatheter aortic valve replacement (TAVR) in low-surgical-risk patients.

The 3-year results show that low-surgical-risk patients undergoing aortic valve replacement continue to show lower rates of all-cause mortality and disabling stroke with TAVR, compared with surgery.

The rates of all-cause mortality or disabling stroke (the primary endpoint) at 3 years were 7.4% with TAVR and 10.4% with surgery.

Rates of new pacemaker implantation continued to be higher after TAVR and the frequency of new onset atrial fibrillation was more common after surgery.

“At 3 years, the rate of all-cause mortality or disabling stroke after TAVR with the Evolut valve compared very favorably to surgery. The absolute difference between treatment arms remained consistent with a 30% relative reduction in the hazard of death or disabling stroke, with a P value that just missed statistical significance,” said Evolut investigator John Forrest, MD, Yale University School of Medicine, New Haven, Conn.

“The Kaplan-Meier curves show what we’ve come to expect – an early separation of the curves – but what’s unique here, and seen for the first time, is that the early separation is maintained at year 1 and year 2, and between years 2 and 3 the curve didn’t start to come together, but, if anything, separated a little,” Dr. Forrest commented. 

“Both components of the primary endpoint – all cause mortality and disabling stroke – numerically favor TAVR. The separation of the curves for stroke are maintained, and if anything, we see a further slight separation of the curves as we go forward out to 3 years in terms of all-cause mortality,” he added.  

Dr. Forrest presented the 3-year results from the Evolut trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. They were simultaneously published online in the Journal of the American College of Cardiology.

Dr. Forrest also reported that TAVR patients continued to have better valve hemodynamics at 3 years and very low rates of valve thrombosis; moreover, rates of moderate or greater paravalvular regurgitation and paravalvular leak (factors that can affect valve durability) were also low, although mild paravalvular regurgitation was higher with TAVR.

“In these low-risk patients, the durability of the valve is going to be critically important,” Dr. Forrest commented. “The excellent valve performance and durable outcomes out to 3 years in low-risk patients affirms the role of TAVR in this population,” he concluded.

On how these results may affect clinical practice, Dr. Forrest said: “I think in the U.S. these results reaffirm what we are doing. It gives us confidence to continue treating low-risk patients and being comfortable with that.”

He added: “Outside the U.S., the guidelines are a little different. Maybe we should reconsider some of these guidelines based on these data.”

David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., who is not involved in the TAVR studies, said: “The results provide a little more reassurance ... that will go a little way further.”

“Uncertainty remains regarding long-term durability of the transcatheter valve in low-risk patients who are generally younger and likely more active than higher-risk cohorts,” he added. “The current 3-year results provide more confidence as the outcome curves for death and disabling stroke are trending in the right direction for TAVR versus surgery.”

Dr. Moliterno pointed out that while rates of paravalvular regurgitation and permanent pacemaker placement are decreasing with newer generation Evolut devices and implantation techniques, he noted that according to the U.S. Social Security Administration, patients aged 74 years as enrolled in this low-risk cohort have an additional life expectancy of approximately 12 years. “So, we have more device durability (and coronary access feasibility) to prove.”

In his presentation, Dr. Forrest explained that TAVR is now approved in the United States for all patients with aortic stenosis regardless of surgical risk and has become the dominant form of aortic valve replacement. Current ACC/AHA guidelines recommend that heart teams utilize a shared decision-making process when discussing aortic valve replacement with patients aged 65-80 years. In younger, lower-risk patients, the faster recovery and short-term benefits after TAVR must be balanced with long-term durability; however, only limited intermediate and long-term data exist to guide such discussions in this patient population.

The Evolut Low Risk trial randomly assigned 1,414 patients in need of aortic valve replacement to TAVR with a self-expanding, supra-annular valve or surgery. Results at 1 and 2 years have shown a similar benefit in the primary endpoint of all-cause mortality/disabling stroke for the less invasive TAVR procedure.  

The current 3-year results suggest the benefit appears to be maintained out for another year. 

The main results show that the rate of death or disabling stroke was 7.4% in the TAVR group versus 10.4% in the surgery group, giving a hazard ratio of 0.70 (P = .051).

In the JACC paper, the authors report that the absolute difference between treatment arms for all-cause mortality or disabling stroke remained broadly consistent over time: –1.8% at year 1; –2.0% at year 2; and –2.9% at year 3.

Other key results on valve durability show that mild paravalvular regurgitation was increased in the TAVR group (20.3%) versus 2.5% with surgery. However, rates of moderate or greater paravalvular regurgitation for both groups were below 1% and not significantly different between groups.

Patients who underwent TAVR had significantly improved valve hemodynamics (mean gradient 9.1 mm Hg TAVR vs. 12.1 mm Hg surgery; P < .001) at 3 years.

However, pacemaker placement was much higher in the TAVR group (23.2%), compared with 9.1% in the surgery group.

On the other hand, the surgery group had a greater incidence of atrial fibrillation (40%) versus 13% with TAVR.

Quality-of-life results looked good in both groups.

“As we’ve come to expect, patients recover more quickly after TAVR, so at 30 days their quality of life is better than those who have undergone surgery,” Dr. Forrest commented. “But by 1 year, both groups are doing exceptionally well and, remarkably, here by 3 years both groups have greater than a 20-point increase in their KCCQ score, showing a very large improvement in quality of life.”

Discussant of these latest results at the ACC late-breaking trials session, James Hermiller, MD, St. Vincent Ascension Heart Center, Indianapolis, said: “This 3-year data continues to demonstrate that the gift of TAVR keeps giving.”

Noting that the divergence in the effect curves was primarily driven by mortality rather than stroke, he asked whether this was cardiac or noncardiac mortality that was reduced.

Dr. Forrest responded: “It was a fairly equal contribution – a little bit more cardiac death. We have to remember that although the average age in this study was 74, there were some patients over 80 who were still low-surgical-risk included so we are going to see noncardiac death as well.”

Dr. Hermiller drew attention to the high pacemaker rate in the TAVR group and asked how these patients fared in comparison to those who didn’t need a pacemaker.

Dr. Forrest replied: “I think it’s fair to say that putting in a pacemaker is not a benign procedure. Patients who got a pacemaker did slightly worse than those who didn’t get a pacemaker, so we need to try to drive that rate down.”

He added that the number of patients needing a pacemaker after TAVR has come down with new implantation techniques and new generation valves.

“We realize that using a cusp overlap technique can significantly reduce the need for a pacemaker, and we see from registry data that with the use of this new technique the need for a pacemaker has dropped down to 8%-9%, significantly less than seen in this study,” Dr. Forrest commented.    

Dr. Hermiller also asked about how TAVR affects future access for catheterization or percutaneous coronary intervention.  

Dr. Forrest noted that 24 patients in the TAVR group required PCI in first 3 years, and all the PCI procedures had been successful. He noted that operators reported the procedure to be easy or moderately easy in about 75%-80% of cases and difficult in about 20% of patients. “So, it is slightly more challenging to engage the coronaries and have to go through the frame, but it is very feasible.”

Dr. Forrest concluded that: “These results provide patients and heart teams important data to aid in the shared decision-making process.”

But he acknowledged that longer term data are still needed. “And the potential impact that hemodynamics, valve design, new pacemakers, and other secondary endpoints have on long-term outcomes will be important to follow in this group of low-risk patients.”

The Evolut Low Risk trial was funded by Medtronic. Dr. Forrest has received grant support/research contracts and consultant fees/honoraria/speakers bureau fees from Edwards Lifesciences and Medtronic.

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

Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.

As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.

“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.

Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.

Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.

Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.

An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.

Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.

Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.

People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.

“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”

Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.

“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.

That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.

“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”

Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.

“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.

Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.

“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”

When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.

Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.

Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.

Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.

Then she got a bill for nearly $2,000.

Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.

“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.

Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.

As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.

“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.

Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.

Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.

Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.

An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.

Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.

Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.

People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.

“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”

Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.

“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.

That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.

“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”

Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.

“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.

Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.

“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”

When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.

Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.

Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.

Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.

Then she got a bill for nearly $2,000.

Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.

“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.

Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Sam Chavarría said her doctor was clear about the birth defects her medication could cause if she became pregnant but agreed to keep her on it as long as she had an IUD.

As she was waiting to get her contraceptive intrauterine device replaced at her local clinic, however, the billing nurse told her that her insurance wouldn’t cover the removal – or a new IUD. Chavarría didn’t understand why not.

“Then she said very delicately, ‘Well, people on this insurance typically tend to be older,’ ” Chavarría recalled.

Although Chavarría is 34, she is enrolled in Medicare, the government insurance program designed for those 65 and older. Chavarría, who lives in Houston, is disabled by fibromyalgia, rheumatoid arthritis, and mental health issues. Medicare automatically enrolls anyone who has received Social Security disability benefits for two years and this was her first time getting an IUD while in the government program.

Without insurance, just removing her expired IUD would cost Chavarría $350 out of pocket; exchanging it for a new one would be $2,000. She left the clinic in tears.

Chavarría’s experience is not rare. Medicare was originally intended for people of retirement age. Over the years, the program has evolved to include new populations, such as those who have disabilities or are critically ill, said Jennifer Lea Huer, a public health expert at Yale University, New Haven, Conn. In 2020, 1.7 million people ages 18-44 were enrolled in Medicare.

An estimated 70% of childbearing-age women on Medicare are also eligible for Medicaid, a state and federal program for those with low incomes, which should fill the gap for contraception. It’s not clear how many transgender or nonbinary people – who also might need contraception – are on Medicare or are eligible for Medicaid.

Medicaid, like the plans offered via the federal Affordable Care Act, mandates coverage of birth control. But those who aren’t eligible for Medicaid are left in the lurch – Medicare’s origins mean it does not require access to birth control.

Traditional Medicare includes two parts: Part A covers hospital costs, while Part B covers physicians’ care and certain other services, such as ambulance rides. Neither ordinarily includes contraception.

People can get contraception through a Medicare Advantage plan or Part D of Medicare, which covers prescription drugs, but those come at a cost. And even people who pay for Part D often aren’t covered for some types of birth control, such as IUDs.

“So, if you are disabled, if you are locked outside of the labor market, if you do not have the means or any other way to financially support yourself, you were likely still on traditional Medicare, which is Part A and Part B,” Huer said. “In which case, your access to contraception is incredibly difficult.”

Contraception for those with traditional Medicare is given on a case-by-case basis, Huer said. It can be covered only if a doctor can make a credible case that the patient needs it for medical reasons – because their body cannot sustain a pregnancy – as opposed to merely wanting to avoid one.

“You have to have a champion physician who’s willing to partner with you and make those arguments,” Huer said.

That’s what Chavarría’s doctor tried to do. Before she left the clinic, staffers there told her they would try to make the case she needed the IUD for medical reasons. The IUD exchange was scheduled almost 10 weeks later, but during those weeks, she got pregnant. Her body couldn’t sustain a pregnancy, so she and her partner rushed to get an abortion just before Texas tightened its rules Sept. 1, 2021.

“If Medicare had just covered the IUD removal or exchange to begin with, none of this would have happened,” Chavarría said. “It would have saved me having to make a really tough decision that I never thought I’d have to make.”

Women with disabilities often face a stigma from health care practitioners, especially when it comes to birth control, said Willi Horner-Johnson, a public health researcher specializing in disabilities at Oregon Health & Science University, Portland. In her research, women with disabilities have described being treated like children or having to go to multiple doctors to find someone with whom they felt comfortable.

“We don’t want to acknowledge that disabled people have sex,” said Miriam Garber, a 36-year-old sex worker who lives in Rhode Island and is also on Medicare because of her disabilities. Garber got an IUD from Planned Parenthood because her insurance wouldn’t cover it.

Even those who pay for Part D to have their prescription drugs covered and have a “champion physician” face difficulties. Liz Moore, a nonbinary person in their 30s who lives in the Washington, D.C., area, could not get Medicare to pay for the Mirena IUD their doctor prescribed for their polycystic ovary syndrome. Moore is disabled with fibromyalgia and dysautonomia, a condition of the autonomic nervous system, which regulates breathing, heart rate, and more.

“After literally months of phone calls, it seemed like my Medicare Part D and original Medicare could not agree on who should pay for my IUD,” they wrote in a direct message. “Was it a prescription or durable medical equipment?”

When Moore finally learned it would cost $800 upfront, they said, they decided to get a hysterectomy – which Medicare would pay for – instead.

Chavarría’s doctor told her a tubal ligation also was more likely to be approved by Medicare than an IUD, because older people have that procedure more often. Like all surgeries, both come with risks of complications and recovery.

Even for those on both Medicare and Medicaid, getting contraception also isn’t always easy, as in Katie Elizabeth Walsh’s case.

Walsh, 34, who lives in northeastern Connecticut, is disabled by a traumatic brain injury, depression, and chronic fatigue syndrome. She got an IUD at an ob.gyn. clinic and was told there her insurance would cover it.

Then she got a bill for nearly $2,000.

Medicaid should cover contraceptive devices for dual-eligibility people, according to Centers for Medicare & Medicaid Services policy guidance, but when Walsh tried to get her bill covered, Medicare and Medicaid could not agree on which of them should pay.

“Every single time I have called one of the insurance offices, they are like, ‘Oh, no, you have to talk to the other one, and we don’t really talk to each other,’ ” Walsh said.

Walsh said the hassle to get her contraception covered feels like a kick in the stomach: “Like truly you do not have a place in this world, and your insurance is telling you that.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

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

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

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

Nearly 2 years after a whistleblower alleged that the University of Pittsburgh Medical Center (UPMC) and its head of cardiothoracic surgery participated in billing fraud and dangerous operating room practices, the case has ended in an $8.5 million settlement, the Department of Justice (DOJ) announced.

The lawsuit alleges that James L. Luketich, MD, the longtime chair of the school’s cardiothoracic surgery department, regularly performed up to three complex surgical procedures simultaneously, moving among multiple operating rooms and attending to matters other than patient care. The investigation began after Jonathan D’Cunha, MD, a former UPMC surgeon, raised concerns about his colleague’s surgical scheduling and billing practices.

Dr. Luketich’s overbooking of procedures led to patients enduring hours of medically unnecessary anesthesia time and risking surgical complications, according to court documents.

In addition, the complaint states that these practices violated the False Claims Act, which prohibits “teaching physicians” like Dr. Luketich from billing Medicare and other government health plans for “concurrent surgeries” – regulations federal authorities say UPMC leadership were aware of and the University of Pittsburgh Physicians (UPP), also named in the suit, permitted Dr. Luketich to skirt.

The whistleblower provision of the False Claims Act allows private parties to file an action on behalf of the United States and receive a portion of the recovery to help deter health care fraud, says the DOJ.

The defendants previously asked the court to dismiss the case, but a judge denied the request in June 2022.

Paul Wood, vice president and chief communications officer for UPMC, told this news organization that the lawsuit pertained to Dr. Luketich’s “most complicated, team-based surgical procedures.”

“At issue was compliance with the Centers for Medicare & Medicaid Services’ (CMS’s) Teaching Physician Regulation and related billing guidance as well as with UPMC’s internal surgical policies,” he said.

“While UPMC continues to believe Dr. Luketich’s surgical practice complies with CMS requirements, it has agreed to [the settlement] to avoid the distraction and expense of further litigation,” said Mr. Wood, adding that all parties agree that UPMC can seek clarity from CMS regarding future billing of these surgeries.

Efrem Grail, JD, Dr. Luketich’s attorney, said in an interview that he and Dr. Luketich are pleased that the settlement puts an end to the case and that he hopes the United States will issue “authoritative guidance” on billing regulations for teaching physicians, something medical schools and hospitals have sought for years.

Dr. Luketich, UPMC, and UPP face more legal challenges from a separate medical malpractice lawsuit. In March 2018, Bernadette Fedorka underwent a lung transplant at UPMC. Although Dr. Luketich did not perform the surgery, Ms. Fedorka alleges that his poor leadership caused understaffing of the lung transplant program and contributed to surgical complications, including a 4-inch piece of wire left in her neck.

Ms. Fedorka claims that suboxone impaired Dr. Luketich’s decision-making. He began taking the drug in 2008 to manage the pain from a slipped disc injury after a history of prescription drug abuse. Both UPMC and Dr. Luketich have denied the validity of Ms. Fedorka’s claims.

The malpractice suit centers on a recording of a conversation between Dr. Luketich and David Wilson, MD, who prescribed the suboxone and treated the surgeon’s opioid use disorder for several years. Dr. Luketich has accused former colleagues, Dr. D’Cunha and Lara Schaheen, MD, of illegally recording the private conversation that discussed Dr. Luketich’s suboxone prescription – something both physicians deny.

For the billing fraud case, Dr. Luketich has agreed to complete a corrective action plan and submit to a third-party audit of his Medicare billings for 1 year.

“This is an important settlement and a just conclusion to the United States’ investigation into Dr. Luketich’s surgical and billing practices and UPMC and UPP’s acceptance of those practices,” Acting U.S. Attorney Troy Rivetti said in a statement that, “no medical provider – however renowned – is excepted from scrutiny or above the law.”

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

Patients with degenerative mitral valve (MV) regurgitation that calls for surgery may, for the most part, safely choose either a standard procedure requiring a midline sternotomy or one performed through a minithoracotomy, suggests a randomized comparison of the two techniques.

Still, the minimally invasive approach showed some advantages in the study. Patients’ quality of recovery was about the same with both procedures at 12 weeks, but those who had the minimally invasive thoracoscopy-guided surgery had shown greater improvement 6 weeks earlier.

Also in the UK Mini Mitral Trial, hospital length of stay (LOS) was significantly shorter for patients who underwent the mini-thoracotomy procedure, and that group spent fewer days in the hospital over the following months.

But neither procedure had an edge in terms of postoperative clinical risk in the study. Rates of clinical events, such as death or hospitalization for heart failure (HHF), were about the same over 1 year.

Patients in this trial had been deemed suitable for either of the two surgeries, which were always performed by surgeons specially chosen by the steering committee for their experience and expertise.

This first randomized head-to-head comparison of the two approaches in such patients should make both patients and clinicians more confident about choosing the minimally invasive surgery for degenerative MV disease, said Enoch Akowuah, MD, Newcastle (England) University, United Kingdom.

Dr. Akowuah presented the UK Mini-Mitral Trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

A “main takeaway” for clinical practice from the trial would be that minithoracotomy MV repair “is as safe and effective as conventional sternotomy for degenerative mitral regurgitation,” said discussant Amy E. Simone, PA-C, following Dr. Akowuah’s presentation.

“I think this study is unique in that its focus is on delivering high-quality, cost-efficient care for mitral regurgitation, but also with an emphasis on patients’ goals and wishes,” said Ms. Simone, who directs the Marcus Heart Valve Center of the Piedmont Heart Institute, Atlanta.

Cardiac surgeon Thomas MacGillivray, MD, another discussant, agreed that the data presented from at least this study suggest neither the minithoracotomy nor sternotomy approach is better than the other. But he questioned whether that would hold true if applied to broader clinical practice.

Dr. MacGillivray, of MedStar Washington Hospital Center, Washington, observed that only 330 patients were randomly assigned among a total of 1,167 candidates for candidates for MV repair surgery.

Indeed, he noted, more than 200 declined and about 600 were declared ineligible for the study, “even though it had seemed as if all were appropriate for mitral valve repair. That could be viewed as a significant limitation in terms of scalability in the real world.”

Some of those patients weren’t randomly assigned because they ultimately were not considered appropriate for both procedures, and some expressed a preference for one or the other approach, Dr. Akowuah replied. Those were the most common reasons. Many others did not enter the study, he said, because their mitral regurgitation was functional, not degenerative.

The two randomization groups fared similarly for the primary endpoint reflecting recovery from surgery, so the trial was actually “negative,” Dr. Akowuah said in an interview. However, “I see it as very much a win for minithoracotomy. The outstanding questions for clinicians and patients have been about the clinical efficacy and safety of the technique. And we’ve shown in this trial that minithoracotomy is safe and effective.”

If the minithoracotomy procedure is available, he continued, “and it’s just as clinically effective and safe – and we weren’t sure that was the case until we did this trial – and the repair is almost as durable, then why have a sternotomy?”

The researchers assigned 330 patients with degenerative MV disease who were deemed suitable for either type of surgery to undergo the standard operation via sternotomy or the minithoracotomy procedure at 10 centers in the United Kingdom. The steering committee had hand-selected its 28 experienced surgeons, each of whom performed only one of the two surgeries consistently for the trial’s patients.

The technically more demanding minithoracotomy procedure took longer to perform by a mean of 44 minutes,  it prolonged cross-clamp time by 11 minutes, and it required 30 minutes more cardiopulmonary bypass support, Dr. Akowuah reported.

The two patient groups showed no significant differences in the primary endpoint of physical function and ability to return to usual activity levels at 12 weeks, as assessed by scores on the 36-Item Short Form Survey and wrist-worn accelerometer monitoring. At 6 weeks, however, the mini-thoracotomy patients had shown a significant early but temporary advantage for those recovery measures.

The minithoracotomy group clearly fared better, however, on some secondary endpoints. For example, their median hospital LOS was 5 days, compared with 6 days for the sternotomy group (P = .003), and 33.1% of the mini-thoracotomy patients were discharged within 4 days of the surgery, compared with only 15.3% of patients who had the standard procedure (P < .001).

The minithoracotomy group also had marginally more days alive out of the hospital at both 30 days (23.6 days vs. 22.4 days in the sternotomy group) and 90 days (82.7 days and 80.5 days, respectively) after the surgery (P = .03 for both differences).

Safety outcomes at 12 weeks were similar, with no significant differences in rate of death, strokes, MI, or renal impairment, or in ICU length of stay or need for more than 48 hours of mechanical ventilation, Dr. Akowuah reported.

Safety outcomes at 1 year were also similar. Mortality by then was 2.4% for the minithoracotomy patients and 2.5% for the sternotomy group, nor were there significant differences in HHF rates or need for repeat MV surgical repair.

Dr. Akowuah said the patients will be followed for up to 5 years for the primary outcomes, echocardiographic changes, and clinical events.

The minithoracotomy surgery’s longer operative times and specialized equipment make it more a expensive procedure than the standard surgery, he said. “So we need to work out in a cost-effectiveness analysis whether that is offset by the benefits,” such as shorter hospital stays or perhaps fewer transfusions or readmissions.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reported no relevant financial relationships with industry.

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

Patients with degenerative mitral valve (MV) regurgitation that calls for surgery may, for the most part, safely choose either a standard procedure requiring a midline sternotomy or one performed through a minithoracotomy, suggests a randomized comparison of the two techniques.

Still, the minimally invasive approach showed some advantages in the study. Patients’ quality of recovery was about the same with both procedures at 12 weeks, but those who had the minimally invasive thoracoscopy-guided surgery had shown greater improvement 6 weeks earlier.

Also in the UK Mini Mitral Trial, hospital length of stay (LOS) was significantly shorter for patients who underwent the mini-thoracotomy procedure, and that group spent fewer days in the hospital over the following months.

But neither procedure had an edge in terms of postoperative clinical risk in the study. Rates of clinical events, such as death or hospitalization for heart failure (HHF), were about the same over 1 year.

Patients in this trial had been deemed suitable for either of the two surgeries, which were always performed by surgeons specially chosen by the steering committee for their experience and expertise.

This first randomized head-to-head comparison of the two approaches in such patients should make both patients and clinicians more confident about choosing the minimally invasive surgery for degenerative MV disease, said Enoch Akowuah, MD, Newcastle (England) University, United Kingdom.

Dr. Akowuah presented the UK Mini-Mitral Trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

A “main takeaway” for clinical practice from the trial would be that minithoracotomy MV repair “is as safe and effective as conventional sternotomy for degenerative mitral regurgitation,” said discussant Amy E. Simone, PA-C, following Dr. Akowuah’s presentation.

“I think this study is unique in that its focus is on delivering high-quality, cost-efficient care for mitral regurgitation, but also with an emphasis on patients’ goals and wishes,” said Ms. Simone, who directs the Marcus Heart Valve Center of the Piedmont Heart Institute, Atlanta.

Cardiac surgeon Thomas MacGillivray, MD, another discussant, agreed that the data presented from at least this study suggest neither the minithoracotomy nor sternotomy approach is better than the other. But he questioned whether that would hold true if applied to broader clinical practice.

Dr. MacGillivray, of MedStar Washington Hospital Center, Washington, observed that only 330 patients were randomly assigned among a total of 1,167 candidates for candidates for MV repair surgery.

Indeed, he noted, more than 200 declined and about 600 were declared ineligible for the study, “even though it had seemed as if all were appropriate for mitral valve repair. That could be viewed as a significant limitation in terms of scalability in the real world.”

Some of those patients weren’t randomly assigned because they ultimately were not considered appropriate for both procedures, and some expressed a preference for one or the other approach, Dr. Akowuah replied. Those were the most common reasons. Many others did not enter the study, he said, because their mitral regurgitation was functional, not degenerative.

The two randomization groups fared similarly for the primary endpoint reflecting recovery from surgery, so the trial was actually “negative,” Dr. Akowuah said in an interview. However, “I see it as very much a win for minithoracotomy. The outstanding questions for clinicians and patients have been about the clinical efficacy and safety of the technique. And we’ve shown in this trial that minithoracotomy is safe and effective.”

If the minithoracotomy procedure is available, he continued, “and it’s just as clinically effective and safe – and we weren’t sure that was the case until we did this trial – and the repair is almost as durable, then why have a sternotomy?”

The researchers assigned 330 patients with degenerative MV disease who were deemed suitable for either type of surgery to undergo the standard operation via sternotomy or the minithoracotomy procedure at 10 centers in the United Kingdom. The steering committee had hand-selected its 28 experienced surgeons, each of whom performed only one of the two surgeries consistently for the trial’s patients.

The technically more demanding minithoracotomy procedure took longer to perform by a mean of 44 minutes,  it prolonged cross-clamp time by 11 minutes, and it required 30 minutes more cardiopulmonary bypass support, Dr. Akowuah reported.

The two patient groups showed no significant differences in the primary endpoint of physical function and ability to return to usual activity levels at 12 weeks, as assessed by scores on the 36-Item Short Form Survey and wrist-worn accelerometer monitoring. At 6 weeks, however, the mini-thoracotomy patients had shown a significant early but temporary advantage for those recovery measures.

The minithoracotomy group clearly fared better, however, on some secondary endpoints. For example, their median hospital LOS was 5 days, compared with 6 days for the sternotomy group (P = .003), and 33.1% of the mini-thoracotomy patients were discharged within 4 days of the surgery, compared with only 15.3% of patients who had the standard procedure (P < .001).

The minithoracotomy group also had marginally more days alive out of the hospital at both 30 days (23.6 days vs. 22.4 days in the sternotomy group) and 90 days (82.7 days and 80.5 days, respectively) after the surgery (P = .03 for both differences).

Safety outcomes at 12 weeks were similar, with no significant differences in rate of death, strokes, MI, or renal impairment, or in ICU length of stay or need for more than 48 hours of mechanical ventilation, Dr. Akowuah reported.

Safety outcomes at 1 year were also similar. Mortality by then was 2.4% for the minithoracotomy patients and 2.5% for the sternotomy group, nor were there significant differences in HHF rates or need for repeat MV surgical repair.

Dr. Akowuah said the patients will be followed for up to 5 years for the primary outcomes, echocardiographic changes, and clinical events.

The minithoracotomy surgery’s longer operative times and specialized equipment make it more a expensive procedure than the standard surgery, he said. “So we need to work out in a cost-effectiveness analysis whether that is offset by the benefits,” such as shorter hospital stays or perhaps fewer transfusions or readmissions.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reported no relevant financial relationships with industry.

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

Patients with degenerative mitral valve (MV) regurgitation that calls for surgery may, for the most part, safely choose either a standard procedure requiring a midline sternotomy or one performed through a minithoracotomy, suggests a randomized comparison of the two techniques.

Still, the minimally invasive approach showed some advantages in the study. Patients’ quality of recovery was about the same with both procedures at 12 weeks, but those who had the minimally invasive thoracoscopy-guided surgery had shown greater improvement 6 weeks earlier.

Also in the UK Mini Mitral Trial, hospital length of stay (LOS) was significantly shorter for patients who underwent the mini-thoracotomy procedure, and that group spent fewer days in the hospital over the following months.

But neither procedure had an edge in terms of postoperative clinical risk in the study. Rates of clinical events, such as death or hospitalization for heart failure (HHF), were about the same over 1 year.

Patients in this trial had been deemed suitable for either of the two surgeries, which were always performed by surgeons specially chosen by the steering committee for their experience and expertise.

This first randomized head-to-head comparison of the two approaches in such patients should make both patients and clinicians more confident about choosing the minimally invasive surgery for degenerative MV disease, said Enoch Akowuah, MD, Newcastle (England) University, United Kingdom.

Dr. Akowuah presented the UK Mini-Mitral Trial at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

A “main takeaway” for clinical practice from the trial would be that minithoracotomy MV repair “is as safe and effective as conventional sternotomy for degenerative mitral regurgitation,” said discussant Amy E. Simone, PA-C, following Dr. Akowuah’s presentation.

“I think this study is unique in that its focus is on delivering high-quality, cost-efficient care for mitral regurgitation, but also with an emphasis on patients’ goals and wishes,” said Ms. Simone, who directs the Marcus Heart Valve Center of the Piedmont Heart Institute, Atlanta.

Cardiac surgeon Thomas MacGillivray, MD, another discussant, agreed that the data presented from at least this study suggest neither the minithoracotomy nor sternotomy approach is better than the other. But he questioned whether that would hold true if applied to broader clinical practice.

Dr. MacGillivray, of MedStar Washington Hospital Center, Washington, observed that only 330 patients were randomly assigned among a total of 1,167 candidates for candidates for MV repair surgery.

Indeed, he noted, more than 200 declined and about 600 were declared ineligible for the study, “even though it had seemed as if all were appropriate for mitral valve repair. That could be viewed as a significant limitation in terms of scalability in the real world.”

Some of those patients weren’t randomly assigned because they ultimately were not considered appropriate for both procedures, and some expressed a preference for one or the other approach, Dr. Akowuah replied. Those were the most common reasons. Many others did not enter the study, he said, because their mitral regurgitation was functional, not degenerative.

The two randomization groups fared similarly for the primary endpoint reflecting recovery from surgery, so the trial was actually “negative,” Dr. Akowuah said in an interview. However, “I see it as very much a win for minithoracotomy. The outstanding questions for clinicians and patients have been about the clinical efficacy and safety of the technique. And we’ve shown in this trial that minithoracotomy is safe and effective.”

If the minithoracotomy procedure is available, he continued, “and it’s just as clinically effective and safe – and we weren’t sure that was the case until we did this trial – and the repair is almost as durable, then why have a sternotomy?”

The researchers assigned 330 patients with degenerative MV disease who were deemed suitable for either type of surgery to undergo the standard operation via sternotomy or the minithoracotomy procedure at 10 centers in the United Kingdom. The steering committee had hand-selected its 28 experienced surgeons, each of whom performed only one of the two surgeries consistently for the trial’s patients.

The technically more demanding minithoracotomy procedure took longer to perform by a mean of 44 minutes,  it prolonged cross-clamp time by 11 minutes, and it required 30 minutes more cardiopulmonary bypass support, Dr. Akowuah reported.

The two patient groups showed no significant differences in the primary endpoint of physical function and ability to return to usual activity levels at 12 weeks, as assessed by scores on the 36-Item Short Form Survey and wrist-worn accelerometer monitoring. At 6 weeks, however, the mini-thoracotomy patients had shown a significant early but temporary advantage for those recovery measures.

The minithoracotomy group clearly fared better, however, on some secondary endpoints. For example, their median hospital LOS was 5 days, compared with 6 days for the sternotomy group (P = .003), and 33.1% of the mini-thoracotomy patients were discharged within 4 days of the surgery, compared with only 15.3% of patients who had the standard procedure (P < .001).

The minithoracotomy group also had marginally more days alive out of the hospital at both 30 days (23.6 days vs. 22.4 days in the sternotomy group) and 90 days (82.7 days and 80.5 days, respectively) after the surgery (P = .03 for both differences).

Safety outcomes at 12 weeks were similar, with no significant differences in rate of death, strokes, MI, or renal impairment, or in ICU length of stay or need for more than 48 hours of mechanical ventilation, Dr. Akowuah reported.

Safety outcomes at 1 year were also similar. Mortality by then was 2.4% for the minithoracotomy patients and 2.5% for the sternotomy group, nor were there significant differences in HHF rates or need for repeat MV surgical repair.

Dr. Akowuah said the patients will be followed for up to 5 years for the primary outcomes, echocardiographic changes, and clinical events.

The minithoracotomy surgery’s longer operative times and specialized equipment make it more a expensive procedure than the standard surgery, he said. “So we need to work out in a cost-effectiveness analysis whether that is offset by the benefits,” such as shorter hospital stays or perhaps fewer transfusions or readmissions.

The study was funded by the United Kingdom’s National Institute for Health and Care Research. Dr. Akowuah reported no relevant financial relationships with industry.

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

Immediate complete revascularization during the index procedure might become the new treatment paradigm in patients with an acute coronary syndrome (ACS) and multivessel disease, based on results of the BIOVASC trial.

In the trial, in patients presenting with ACS and multivessel disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischemia-driven revascularization.

The BIOVASC trial was presented on March 5 by Roberto Diletti, MD, Erasmus University Medical Center, Rotterdam, the Netherlands, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published online in The Lancet.

“We did not detect an early safety signal against an immediate complete revascularization strategy,” the authors state in the Lancet paper, adding: “Treating physicians should not be concerned about potential risks associated with immediate treatment of nonculprit lesions.”

They note, “This strategy might be particularly effective in patients with only two-vessel disease and reasonably simple lesions, with a high likelihood of procedural success without excessive use of radiation, contrast dye, or other resources.”

The trial also showed a shorter hospital stay with an immediate complete revascularization strategy.

“Immediate complete revascularization might have potential health economic benefits because of the lower rate of myocardial infarction, including spontaneous myocardial infarction, and unplanned revascularizations, and the shorter overall hospital stay,” the researchers conclude.

Introducing his presentation, Dr. Diletti explained that multiple studies have established the clinical benefit of complete coronary revascularization as compared with exclusive reperfusion of the culprit lesion, but the optimal timing for nonculprit lesion revascularization remains unclear.

The BIOVASC trial, conducted in Belgium, Italy, the Netherlands, and Spain, involved 1,525 patients with ST-segment elevation MI (STEMI) or non-STEMI ACS and multivessel coronary artery disease with a clearly identifiable culprit lesion.

They were randomly assigned to undergo immediate complete revascularization (percutaneous coronary intervention [PCI] of the culprit lesion first, followed by other nonculprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularization (PCI of only the culprit lesion during the index procedure and PCI of all nonculprit lesions deemed to be clinically significant within 6 weeks after the index procedure).

The primary outcome was the composite of all-cause mortality, MI, any unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure.

The trial had a noninferiority design, with noninferiority of immediate to staged complete revascularization considered to be met if the upper boundary of the 95% confidence interval of the hazard ratio for the primary outcome did not exceed 1.39.

Among the trial population, 40% of patients had STEMI, 52% had non-STEMI, and 8% had unstable angina.

In the immediate complete revascularization group, 16 patients did not receive complete revascularization during the index procedure primarily because of prolonged procedure time, procedural complexity, or excessive contrast dye use. 

In the staged group, 30% of patients underwent all subsequent procedures during the index hospitalization.

Results showed that the primary composite outcome at 1 year occurred in 7.6% of the immediate revascularization group and in 9.4% of the staged group, meeting the noninferiority criteria (HR, 0.78; 95% CI, 0.55-1.11; P for noninferiority = .0011).

Superiority of the immediate over the staged complete revascularization strategy was not met at 1-year follow-up (P for superiority = .17).

However, in the prespecified analysis of clinical events at 30 days after the index procedure, immediate complete revascularization was superior to staged revascularization in terms of the composite primary outcome (2.2% vs. 5.8%; HR, 0.38; P for superiority = .0007).

One-year results showed no difference in all-cause death between the two groups, but the immediate complete revascularization group appeared to have a reduction in MI (1.9% vs. 4.5%)  and fewer unplanned ischemia-driven revascularizations (4.2% vs. 6.7%).

The difference in MI was mainly driven by spontaneous MIs (not procedure related) that predominantly occurred in the time window between the index procedure and the planned date for the staged intervention, and an originally nonculprit lesion was identified as the cause for these events in almost all cases.

Subgroup analysis showed similar results across the patient population, including age, sex, and STEMI vs. non-STEMI presentation.

High rate of MI in staged group

Discussant of the study at the ACC session, Dipti Itchhaporia, MD, University of California, Irvine, said this was a “very important trial.”  

She expressed surprise over the “remarkably high rate” of MI in the staged procedure group and asked Dr. Diletti why that might have occurred.

He responded that the operator may have misjudged the culprit lesion or that patients with ACS may have multiple unstable plaques and “treating the culprit lesion alone does not do the job.”

He added: “We need to look at the data more thoroughly to better understand this, but in both scenarios, immediate complete revascularization would prevent these events.” 

Dr. Itchhaporia also pointed out a low rate of functional imaging used in the study.  

Dr. Diletti replied that this reflected current European practice, but he acknowledged that, “in my opinion this reduces our ability to detect the culprit lesion.”

Commenting at an ACC press conference, David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., said the trial poses the question  “Can we fix it all at once?” and the results suggest “Yes, we can.”

He said this approach had the advantage of removing any uncertainly as to which was the culprit lesion. “We just fix everything – leave no blockage behind.”

But he pointed out that for  some patients this may not be appropriate, such as those with compromised renal function, in whom excessive amounts of contrast material should be avoided.

CABG still needs to be considered

In a comment accompanying the Lancet publication, Tobias Pustjens, MD, Pieter Vriesendorp, MD, and Arnoud W.J. van’t Hof, MD, Cardiovascular Research Institute Maastricht (the Netherlands), note that more than half of the patients presenting with an ACS have multivessel coronary disease. 

They say the trial results suggest that “pursuing an immediate complete revascularisation strategy, especially in times of reduced hospital capacity and staff scarcity, not only benefits the individual patient in clinical outcomes but can also safely reduce the pressure on health care systems.”

But they also point out that the possibility of coronary artery bypass grafting (CABG) should not be omitted, and that CABG is still the treatment of choice in patients with diabetes or complex coronary artery disease.

They conclude: “The results of the BIOVASC study move clinical practice forward from culprit-only to an immediate, complete revascularisation strategy. … However, further fine tuning of this treatment strategy to substantiate a role for intracoronary physiology assessment, intracoronary imaging, and guidance of the heart team decision is needed.”

The BIOVASC trial was supported by an unrestricted research grant from Biotronik AG. Dr. Diletti has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. Dr. van’t Hof has received institutional research grants from Biotronik.

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

Immediate complete revascularization during the index procedure might become the new treatment paradigm in patients with an acute coronary syndrome (ACS) and multivessel disease, based on results of the BIOVASC trial.

In the trial, in patients presenting with ACS and multivessel disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischemia-driven revascularization.

The BIOVASC trial was presented on March 5 by Roberto Diletti, MD, Erasmus University Medical Center, Rotterdam, the Netherlands, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published online in The Lancet.

“We did not detect an early safety signal against an immediate complete revascularization strategy,” the authors state in the Lancet paper, adding: “Treating physicians should not be concerned about potential risks associated with immediate treatment of nonculprit lesions.”

They note, “This strategy might be particularly effective in patients with only two-vessel disease and reasonably simple lesions, with a high likelihood of procedural success without excessive use of radiation, contrast dye, or other resources.”

The trial also showed a shorter hospital stay with an immediate complete revascularization strategy.

“Immediate complete revascularization might have potential health economic benefits because of the lower rate of myocardial infarction, including spontaneous myocardial infarction, and unplanned revascularizations, and the shorter overall hospital stay,” the researchers conclude.

Introducing his presentation, Dr. Diletti explained that multiple studies have established the clinical benefit of complete coronary revascularization as compared with exclusive reperfusion of the culprit lesion, but the optimal timing for nonculprit lesion revascularization remains unclear.

The BIOVASC trial, conducted in Belgium, Italy, the Netherlands, and Spain, involved 1,525 patients with ST-segment elevation MI (STEMI) or non-STEMI ACS and multivessel coronary artery disease with a clearly identifiable culprit lesion.

They were randomly assigned to undergo immediate complete revascularization (percutaneous coronary intervention [PCI] of the culprit lesion first, followed by other nonculprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularization (PCI of only the culprit lesion during the index procedure and PCI of all nonculprit lesions deemed to be clinically significant within 6 weeks after the index procedure).

The primary outcome was the composite of all-cause mortality, MI, any unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure.

The trial had a noninferiority design, with noninferiority of immediate to staged complete revascularization considered to be met if the upper boundary of the 95% confidence interval of the hazard ratio for the primary outcome did not exceed 1.39.

Among the trial population, 40% of patients had STEMI, 52% had non-STEMI, and 8% had unstable angina.

In the immediate complete revascularization group, 16 patients did not receive complete revascularization during the index procedure primarily because of prolonged procedure time, procedural complexity, or excessive contrast dye use. 

In the staged group, 30% of patients underwent all subsequent procedures during the index hospitalization.

Results showed that the primary composite outcome at 1 year occurred in 7.6% of the immediate revascularization group and in 9.4% of the staged group, meeting the noninferiority criteria (HR, 0.78; 95% CI, 0.55-1.11; P for noninferiority = .0011).

Superiority of the immediate over the staged complete revascularization strategy was not met at 1-year follow-up (P for superiority = .17).

However, in the prespecified analysis of clinical events at 30 days after the index procedure, immediate complete revascularization was superior to staged revascularization in terms of the composite primary outcome (2.2% vs. 5.8%; HR, 0.38; P for superiority = .0007).

One-year results showed no difference in all-cause death between the two groups, but the immediate complete revascularization group appeared to have a reduction in MI (1.9% vs. 4.5%)  and fewer unplanned ischemia-driven revascularizations (4.2% vs. 6.7%).

The difference in MI was mainly driven by spontaneous MIs (not procedure related) that predominantly occurred in the time window between the index procedure and the planned date for the staged intervention, and an originally nonculprit lesion was identified as the cause for these events in almost all cases.

Subgroup analysis showed similar results across the patient population, including age, sex, and STEMI vs. non-STEMI presentation.

High rate of MI in staged group

Discussant of the study at the ACC session, Dipti Itchhaporia, MD, University of California, Irvine, said this was a “very important trial.”  

She expressed surprise over the “remarkably high rate” of MI in the staged procedure group and asked Dr. Diletti why that might have occurred.

He responded that the operator may have misjudged the culprit lesion or that patients with ACS may have multiple unstable plaques and “treating the culprit lesion alone does not do the job.”

He added: “We need to look at the data more thoroughly to better understand this, but in both scenarios, immediate complete revascularization would prevent these events.” 

Dr. Itchhaporia also pointed out a low rate of functional imaging used in the study.  

Dr. Diletti replied that this reflected current European practice, but he acknowledged that, “in my opinion this reduces our ability to detect the culprit lesion.”

Commenting at an ACC press conference, David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., said the trial poses the question  “Can we fix it all at once?” and the results suggest “Yes, we can.”

He said this approach had the advantage of removing any uncertainly as to which was the culprit lesion. “We just fix everything – leave no blockage behind.”

But he pointed out that for  some patients this may not be appropriate, such as those with compromised renal function, in whom excessive amounts of contrast material should be avoided.

CABG still needs to be considered

In a comment accompanying the Lancet publication, Tobias Pustjens, MD, Pieter Vriesendorp, MD, and Arnoud W.J. van’t Hof, MD, Cardiovascular Research Institute Maastricht (the Netherlands), note that more than half of the patients presenting with an ACS have multivessel coronary disease. 

They say the trial results suggest that “pursuing an immediate complete revascularisation strategy, especially in times of reduced hospital capacity and staff scarcity, not only benefits the individual patient in clinical outcomes but can also safely reduce the pressure on health care systems.”

But they also point out that the possibility of coronary artery bypass grafting (CABG) should not be omitted, and that CABG is still the treatment of choice in patients with diabetes or complex coronary artery disease.

They conclude: “The results of the BIOVASC study move clinical practice forward from culprit-only to an immediate, complete revascularisation strategy. … However, further fine tuning of this treatment strategy to substantiate a role for intracoronary physiology assessment, intracoronary imaging, and guidance of the heart team decision is needed.”

The BIOVASC trial was supported by an unrestricted research grant from Biotronik AG. Dr. Diletti has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. Dr. van’t Hof has received institutional research grants from Biotronik.

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

Immediate complete revascularization during the index procedure might become the new treatment paradigm in patients with an acute coronary syndrome (ACS) and multivessel disease, based on results of the BIOVASC trial.

In the trial, in patients presenting with ACS and multivessel disease, immediate complete revascularization was noninferior to staged complete revascularization for the primary composite outcome and was associated with a reduction in myocardial infarction and unplanned ischemia-driven revascularization.

The BIOVASC trial was presented on March 5 by Roberto Diletti, MD, Erasmus University Medical Center, Rotterdam, the Netherlands, at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The study was simultaneously published online in The Lancet.

“We did not detect an early safety signal against an immediate complete revascularization strategy,” the authors state in the Lancet paper, adding: “Treating physicians should not be concerned about potential risks associated with immediate treatment of nonculprit lesions.”

They note, “This strategy might be particularly effective in patients with only two-vessel disease and reasonably simple lesions, with a high likelihood of procedural success without excessive use of radiation, contrast dye, or other resources.”

The trial also showed a shorter hospital stay with an immediate complete revascularization strategy.

“Immediate complete revascularization might have potential health economic benefits because of the lower rate of myocardial infarction, including spontaneous myocardial infarction, and unplanned revascularizations, and the shorter overall hospital stay,” the researchers conclude.

Introducing his presentation, Dr. Diletti explained that multiple studies have established the clinical benefit of complete coronary revascularization as compared with exclusive reperfusion of the culprit lesion, but the optimal timing for nonculprit lesion revascularization remains unclear.

The BIOVASC trial, conducted in Belgium, Italy, the Netherlands, and Spain, involved 1,525 patients with ST-segment elevation MI (STEMI) or non-STEMI ACS and multivessel coronary artery disease with a clearly identifiable culprit lesion.

They were randomly assigned to undergo immediate complete revascularization (percutaneous coronary intervention [PCI] of the culprit lesion first, followed by other nonculprit lesions deemed to be clinically significant by the operator during the index procedure) or staged complete revascularization (PCI of only the culprit lesion during the index procedure and PCI of all nonculprit lesions deemed to be clinically significant within 6 weeks after the index procedure).

The primary outcome was the composite of all-cause mortality, MI, any unplanned ischemia-driven revascularization, or cerebrovascular events at 1 year after the index procedure.

The trial had a noninferiority design, with noninferiority of immediate to staged complete revascularization considered to be met if the upper boundary of the 95% confidence interval of the hazard ratio for the primary outcome did not exceed 1.39.

Among the trial population, 40% of patients had STEMI, 52% had non-STEMI, and 8% had unstable angina.

In the immediate complete revascularization group, 16 patients did not receive complete revascularization during the index procedure primarily because of prolonged procedure time, procedural complexity, or excessive contrast dye use. 

In the staged group, 30% of patients underwent all subsequent procedures during the index hospitalization.

Results showed that the primary composite outcome at 1 year occurred in 7.6% of the immediate revascularization group and in 9.4% of the staged group, meeting the noninferiority criteria (HR, 0.78; 95% CI, 0.55-1.11; P for noninferiority = .0011).

Superiority of the immediate over the staged complete revascularization strategy was not met at 1-year follow-up (P for superiority = .17).

However, in the prespecified analysis of clinical events at 30 days after the index procedure, immediate complete revascularization was superior to staged revascularization in terms of the composite primary outcome (2.2% vs. 5.8%; HR, 0.38; P for superiority = .0007).

One-year results showed no difference in all-cause death between the two groups, but the immediate complete revascularization group appeared to have a reduction in MI (1.9% vs. 4.5%)  and fewer unplanned ischemia-driven revascularizations (4.2% vs. 6.7%).

The difference in MI was mainly driven by spontaneous MIs (not procedure related) that predominantly occurred in the time window between the index procedure and the planned date for the staged intervention, and an originally nonculprit lesion was identified as the cause for these events in almost all cases.

Subgroup analysis showed similar results across the patient population, including age, sex, and STEMI vs. non-STEMI presentation.

High rate of MI in staged group

Discussant of the study at the ACC session, Dipti Itchhaporia, MD, University of California, Irvine, said this was a “very important trial.”  

She expressed surprise over the “remarkably high rate” of MI in the staged procedure group and asked Dr. Diletti why that might have occurred.

He responded that the operator may have misjudged the culprit lesion or that patients with ACS may have multiple unstable plaques and “treating the culprit lesion alone does not do the job.”

He added: “We need to look at the data more thoroughly to better understand this, but in both scenarios, immediate complete revascularization would prevent these events.” 

Dr. Itchhaporia also pointed out a low rate of functional imaging used in the study.  

Dr. Diletti replied that this reflected current European practice, but he acknowledged that, “in my opinion this reduces our ability to detect the culprit lesion.”

Commenting at an ACC press conference, David Moliterno, MD, Gill Heart and Vascular Institute, Lexington, Ky., said the trial poses the question  “Can we fix it all at once?” and the results suggest “Yes, we can.”

He said this approach had the advantage of removing any uncertainly as to which was the culprit lesion. “We just fix everything – leave no blockage behind.”

But he pointed out that for  some patients this may not be appropriate, such as those with compromised renal function, in whom excessive amounts of contrast material should be avoided.

CABG still needs to be considered

In a comment accompanying the Lancet publication, Tobias Pustjens, MD, Pieter Vriesendorp, MD, and Arnoud W.J. van’t Hof, MD, Cardiovascular Research Institute Maastricht (the Netherlands), note that more than half of the patients presenting with an ACS have multivessel coronary disease. 

They say the trial results suggest that “pursuing an immediate complete revascularisation strategy, especially in times of reduced hospital capacity and staff scarcity, not only benefits the individual patient in clinical outcomes but can also safely reduce the pressure on health care systems.”

But they also point out that the possibility of coronary artery bypass grafting (CABG) should not be omitted, and that CABG is still the treatment of choice in patients with diabetes or complex coronary artery disease.

They conclude: “The results of the BIOVASC study move clinical practice forward from culprit-only to an immediate, complete revascularisation strategy. … However, further fine tuning of this treatment strategy to substantiate a role for intracoronary physiology assessment, intracoronary imaging, and guidance of the heart team decision is needed.”

The BIOVASC trial was supported by an unrestricted research grant from Biotronik AG. Dr. Diletti has received institutional research grants from Biotronik, Medtronic, ACIST Medical Systems, and Boston Scientific. Dr. van’t Hof has received institutional research grants from Biotronik.

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

NEW ORLEANS – In the first pivotal randomized, controlled trial of a transcatheter device for the repair of severe tricuspid regurgitation, a large reduction in valve dysfunction was associated with substantial improvement in quality of life (QOL) persisting out of 1 year of follow-up, according to results of the TRILUMINATE trial.

Based on the low procedural risks of the repair, the principal investigator, Paul Sorajja, MD, called the results “very clinically meaningful” as he presented the results at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

Ted Bosworth/MDedge News

Conducted at 65 centers in the United States, Canada, and North America, TRILUMINATE evaluated a transcatheter end-to-end (TEER) repair performed with the TriClip G4 Delivery System (Abbott). The study included two cohorts, both of which will be followed for 5 years. One included patients with very severe tricuspid regurgitation enrolled in a single arm. Data on this cohort is expected later in 2023.

In the randomized portion of the study, 350 patients enrolled with severe tricuspid regurgitation underwent TEER with a clipping device and then were followed on the guideline-directed therapy (GDMT) for heart failure they were receiving at baseline. The control group was managed on GDMT alone.

The primary composite endpoint at 1 year was a composite of death from any cause and/or tricuspid valve surgery, hospitalization for heart failure, and quality of life as measured with the Kansas City Cardiomyopathy questionnaire (KCCQ).
 

Benefit driven by quality of life

For the primary endpoint, the win ratio, a statistical calculation of those who did relative to those who did not benefit, was 1.48, signifying a 48% advantage (P = .02). This was driven almost entirely by the KCCQ endpoint. There was no significant difference death and/or tricuspid valve surgery, which occurred in about 10% of both groups (P = .75) or heart failure hospitalization, which was occurred in slightly more patients randomized to repair (14.9% vs. 12.1%; P = .41).

For KCCQ, the mean increase at 1 year was 12.3 points in the repair group versus 0.6 points (P < .001) in the control group. With an increase of 5-10 points typically considered to be clinically meaningful, the advantage of repair over GDMT at the threshold of 15 points or greater was highly statistically significant (49.7% vs. 26.4%; P < .0001).

This advantage was attributed to control of regurgitation. The proportion achieving moderate or less regurgitation sustained at 1 year was 87% in the repair group versus 4.8% in the GDMT group (P < .0001).

When assessed independent of treatment, KCCQ benefits at 1 year increased in a stepwise fashion as severity of regurgitation was reduced, climbing from 2 points if there was no improvement to 6 points with one grade in improvement and then to 18 points with at least a two-grade improvement.

For regurgitation, “the repair was extremely effective,” said Dr. Sorajja of Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis. He added that the degree of regurgitation control in the TRILUMINATE trial “is the highest ever reported.” With previous trials with other transcatheter devices in development, the improvement so far has been on the order of 70%-80%.

For enrollment in TRILUMINATE, patients were required to have at least an intermediate risk of morbidity or mortality from tricuspid valve surgery. Exclusion criteria included a left ventricular ejection fraction (LVEF) less than 20% and severe pulmonary hypertension.

More than 70% of patients had the highest (torrential) or second highest (massive) category of regurgitation on a five-level scale by echocardiography. Almost all the remaining were at the third level (severe).

Of those enrolled, the average age was roughly 78 years. About 55% were women. Nearly 60% were in New York Heart Association class III or IV heart failure and most had significant comorbidities, including hypertension (> 80%), atrial fibrillation (about 90%), and renal disease (35%). Patients with diabetes (16%), chronic obstructive pulmonary disease (10%), and liver disease (7.5%) were represented in lower numbers.
 

Surgery is not necessarily an option

All enrolled patients were considered to be at intermediate or greater risk for mortality with surgical replacement of the tricuspid valve, but Dr. Sorajja pointed out that surgery, which involves valve replacement, is not necessarily an alternative to valve repair. Even in fit patients, the high morbidity, mortality, and extended hospital stay associated with surgical valve replacement makes this procedure unattractive.

In this trial, most patients who underwent the transcatheter procedure were discharged within a day. The safety was excellent, Dr. Sorajja said. Only three patients (1.7%) had a major adverse event. This included two cases of new-onset renal failure and one cardiovascular death. There were no cases of endocarditis requiring surgery or any other type of nonelective cardiovascular surgery, including for any device-related issue.

In the sick population enrolled, Dr. Sorajja characterized the number of adverse events over 1 year as “very low.”

Ted Bosworth/MDedge News

These results are important, according to Kendra Grubb, MD, surgical director of the Structural Heart and Valve Center, Emory University, Atlanta. While she expressed surprise that there was no signal of benefit on hard endpoints at 1 year, she emphasized that “these patients feel terrible,” and they are frustrating to manage because surgery is often contraindicated or impractical.

“Finally, we have something for this group,” she said, noting that the mortality from valve replacement surgery even among patients who are fit enough for surgery to be considered is about 10%.

Ajay Kirtane, MD, director of the Cardiac Catheterization Laboratories at Columbia University, New York, was more circumspect. He agreed that the improvement in QOL was encouraging, but cautioned that QOL is a particularly soft outcome in a nonrandomized trial in which patients may feel better just knowing that there regurgitation has been controlled. He found the lack of benefit on hard outcomes not just surprising but “disappointing.”

Still, he agreed the improvement in QOL is potentially meaningful for a procedure that appears to be relatively safe.

Dr. Sorajja reported financial relationships with Boston Scientific, Edwards Lifesciences, Foldax. 4C Medical, Gore Medtronic, Phillips, Siemens, Shifamed, Vdyne, xDot, and Abbott Structural, which provided funding for this trial. Dr. Grubb reported financial relationships with Abbott Vascular, Ancora Heart, Bioventrix, Boston Scientific, Edwards Lifesciences, 4C Medical, JenaValve, and Medtronic. Dr. Kirtane reported financial relationships with Abbott Vascular, Amgen, Boston Scientific, Chiesi, Medtronic, Opsens, Phillips, ReCor, Regeneron, and Zoll.

NEW ORLEANS – In the first pivotal randomized, controlled trial of a transcatheter device for the repair of severe tricuspid regurgitation, a large reduction in valve dysfunction was associated with substantial improvement in quality of life (QOL) persisting out of 1 year of follow-up, according to results of the TRILUMINATE trial.

Based on the low procedural risks of the repair, the principal investigator, Paul Sorajja, MD, called the results “very clinically meaningful” as he presented the results at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

Ted Bosworth/MDedge News

Conducted at 65 centers in the United States, Canada, and North America, TRILUMINATE evaluated a transcatheter end-to-end (TEER) repair performed with the TriClip G4 Delivery System (Abbott). The study included two cohorts, both of which will be followed for 5 years. One included patients with very severe tricuspid regurgitation enrolled in a single arm. Data on this cohort is expected later in 2023.

In the randomized portion of the study, 350 patients enrolled with severe tricuspid regurgitation underwent TEER with a clipping device and then were followed on the guideline-directed therapy (GDMT) for heart failure they were receiving at baseline. The control group was managed on GDMT alone.

The primary composite endpoint at 1 year was a composite of death from any cause and/or tricuspid valve surgery, hospitalization for heart failure, and quality of life as measured with the Kansas City Cardiomyopathy questionnaire (KCCQ).
 

Benefit driven by quality of life

For the primary endpoint, the win ratio, a statistical calculation of those who did relative to those who did not benefit, was 1.48, signifying a 48% advantage (P = .02). This was driven almost entirely by the KCCQ endpoint. There was no significant difference death and/or tricuspid valve surgery, which occurred in about 10% of both groups (P = .75) or heart failure hospitalization, which was occurred in slightly more patients randomized to repair (14.9% vs. 12.1%; P = .41).

For KCCQ, the mean increase at 1 year was 12.3 points in the repair group versus 0.6 points (P < .001) in the control group. With an increase of 5-10 points typically considered to be clinically meaningful, the advantage of repair over GDMT at the threshold of 15 points or greater was highly statistically significant (49.7% vs. 26.4%; P < .0001).

This advantage was attributed to control of regurgitation. The proportion achieving moderate or less regurgitation sustained at 1 year was 87% in the repair group versus 4.8% in the GDMT group (P < .0001).

When assessed independent of treatment, KCCQ benefits at 1 year increased in a stepwise fashion as severity of regurgitation was reduced, climbing from 2 points if there was no improvement to 6 points with one grade in improvement and then to 18 points with at least a two-grade improvement.

For regurgitation, “the repair was extremely effective,” said Dr. Sorajja of Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis. He added that the degree of regurgitation control in the TRILUMINATE trial “is the highest ever reported.” With previous trials with other transcatheter devices in development, the improvement so far has been on the order of 70%-80%.

For enrollment in TRILUMINATE, patients were required to have at least an intermediate risk of morbidity or mortality from tricuspid valve surgery. Exclusion criteria included a left ventricular ejection fraction (LVEF) less than 20% and severe pulmonary hypertension.

More than 70% of patients had the highest (torrential) or second highest (massive) category of regurgitation on a five-level scale by echocardiography. Almost all the remaining were at the third level (severe).

Of those enrolled, the average age was roughly 78 years. About 55% were women. Nearly 60% were in New York Heart Association class III or IV heart failure and most had significant comorbidities, including hypertension (> 80%), atrial fibrillation (about 90%), and renal disease (35%). Patients with diabetes (16%), chronic obstructive pulmonary disease (10%), and liver disease (7.5%) were represented in lower numbers.
 

Surgery is not necessarily an option

All enrolled patients were considered to be at intermediate or greater risk for mortality with surgical replacement of the tricuspid valve, but Dr. Sorajja pointed out that surgery, which involves valve replacement, is not necessarily an alternative to valve repair. Even in fit patients, the high morbidity, mortality, and extended hospital stay associated with surgical valve replacement makes this procedure unattractive.

In this trial, most patients who underwent the transcatheter procedure were discharged within a day. The safety was excellent, Dr. Sorajja said. Only three patients (1.7%) had a major adverse event. This included two cases of new-onset renal failure and one cardiovascular death. There were no cases of endocarditis requiring surgery or any other type of nonelective cardiovascular surgery, including for any device-related issue.

In the sick population enrolled, Dr. Sorajja characterized the number of adverse events over 1 year as “very low.”

Ted Bosworth/MDedge News

These results are important, according to Kendra Grubb, MD, surgical director of the Structural Heart and Valve Center, Emory University, Atlanta. While she expressed surprise that there was no signal of benefit on hard endpoints at 1 year, she emphasized that “these patients feel terrible,” and they are frustrating to manage because surgery is often contraindicated or impractical.

“Finally, we have something for this group,” she said, noting that the mortality from valve replacement surgery even among patients who are fit enough for surgery to be considered is about 10%.

Ajay Kirtane, MD, director of the Cardiac Catheterization Laboratories at Columbia University, New York, was more circumspect. He agreed that the improvement in QOL was encouraging, but cautioned that QOL is a particularly soft outcome in a nonrandomized trial in which patients may feel better just knowing that there regurgitation has been controlled. He found the lack of benefit on hard outcomes not just surprising but “disappointing.”

Still, he agreed the improvement in QOL is potentially meaningful for a procedure that appears to be relatively safe.

Dr. Sorajja reported financial relationships with Boston Scientific, Edwards Lifesciences, Foldax. 4C Medical, Gore Medtronic, Phillips, Siemens, Shifamed, Vdyne, xDot, and Abbott Structural, which provided funding for this trial. Dr. Grubb reported financial relationships with Abbott Vascular, Ancora Heart, Bioventrix, Boston Scientific, Edwards Lifesciences, 4C Medical, JenaValve, and Medtronic. Dr. Kirtane reported financial relationships with Abbott Vascular, Amgen, Boston Scientific, Chiesi, Medtronic, Opsens, Phillips, ReCor, Regeneron, and Zoll.

NEW ORLEANS – In the first pivotal randomized, controlled trial of a transcatheter device for the repair of severe tricuspid regurgitation, a large reduction in valve dysfunction was associated with substantial improvement in quality of life (QOL) persisting out of 1 year of follow-up, according to results of the TRILUMINATE trial.

Based on the low procedural risks of the repair, the principal investigator, Paul Sorajja, MD, called the results “very clinically meaningful” as he presented the results at the joint scientific sessions of the American College of Cardiology and the World Heart Federation.

Ted Bosworth/MDedge News

Conducted at 65 centers in the United States, Canada, and North America, TRILUMINATE evaluated a transcatheter end-to-end (TEER) repair performed with the TriClip G4 Delivery System (Abbott). The study included two cohorts, both of which will be followed for 5 years. One included patients with very severe tricuspid regurgitation enrolled in a single arm. Data on this cohort is expected later in 2023.

In the randomized portion of the study, 350 patients enrolled with severe tricuspid regurgitation underwent TEER with a clipping device and then were followed on the guideline-directed therapy (GDMT) for heart failure they were receiving at baseline. The control group was managed on GDMT alone.

The primary composite endpoint at 1 year was a composite of death from any cause and/or tricuspid valve surgery, hospitalization for heart failure, and quality of life as measured with the Kansas City Cardiomyopathy questionnaire (KCCQ).
 

Benefit driven by quality of life

For the primary endpoint, the win ratio, a statistical calculation of those who did relative to those who did not benefit, was 1.48, signifying a 48% advantage (P = .02). This was driven almost entirely by the KCCQ endpoint. There was no significant difference death and/or tricuspid valve surgery, which occurred in about 10% of both groups (P = .75) or heart failure hospitalization, which was occurred in slightly more patients randomized to repair (14.9% vs. 12.1%; P = .41).

For KCCQ, the mean increase at 1 year was 12.3 points in the repair group versus 0.6 points (P < .001) in the control group. With an increase of 5-10 points typically considered to be clinically meaningful, the advantage of repair over GDMT at the threshold of 15 points or greater was highly statistically significant (49.7% vs. 26.4%; P < .0001).

This advantage was attributed to control of regurgitation. The proportion achieving moderate or less regurgitation sustained at 1 year was 87% in the repair group versus 4.8% in the GDMT group (P < .0001).

When assessed independent of treatment, KCCQ benefits at 1 year increased in a stepwise fashion as severity of regurgitation was reduced, climbing from 2 points if there was no improvement to 6 points with one grade in improvement and then to 18 points with at least a two-grade improvement.

For regurgitation, “the repair was extremely effective,” said Dr. Sorajja of Allina Health Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis. He added that the degree of regurgitation control in the TRILUMINATE trial “is the highest ever reported.” With previous trials with other transcatheter devices in development, the improvement so far has been on the order of 70%-80%.

For enrollment in TRILUMINATE, patients were required to have at least an intermediate risk of morbidity or mortality from tricuspid valve surgery. Exclusion criteria included a left ventricular ejection fraction (LVEF) less than 20% and severe pulmonary hypertension.

More than 70% of patients had the highest (torrential) or second highest (massive) category of regurgitation on a five-level scale by echocardiography. Almost all the remaining were at the third level (severe).

Of those enrolled, the average age was roughly 78 years. About 55% were women. Nearly 60% were in New York Heart Association class III or IV heart failure and most had significant comorbidities, including hypertension (> 80%), atrial fibrillation (about 90%), and renal disease (35%). Patients with diabetes (16%), chronic obstructive pulmonary disease (10%), and liver disease (7.5%) were represented in lower numbers.
 

Surgery is not necessarily an option

All enrolled patients were considered to be at intermediate or greater risk for mortality with surgical replacement of the tricuspid valve, but Dr. Sorajja pointed out that surgery, which involves valve replacement, is not necessarily an alternative to valve repair. Even in fit patients, the high morbidity, mortality, and extended hospital stay associated with surgical valve replacement makes this procedure unattractive.

In this trial, most patients who underwent the transcatheter procedure were discharged within a day. The safety was excellent, Dr. Sorajja said. Only three patients (1.7%) had a major adverse event. This included two cases of new-onset renal failure and one cardiovascular death. There were no cases of endocarditis requiring surgery or any other type of nonelective cardiovascular surgery, including for any device-related issue.

In the sick population enrolled, Dr. Sorajja characterized the number of adverse events over 1 year as “very low.”

Ted Bosworth/MDedge News

These results are important, according to Kendra Grubb, MD, surgical director of the Structural Heart and Valve Center, Emory University, Atlanta. While she expressed surprise that there was no signal of benefit on hard endpoints at 1 year, she emphasized that “these patients feel terrible,” and they are frustrating to manage because surgery is often contraindicated or impractical.

“Finally, we have something for this group,” she said, noting that the mortality from valve replacement surgery even among patients who are fit enough for surgery to be considered is about 10%.

Ajay Kirtane, MD, director of the Cardiac Catheterization Laboratories at Columbia University, New York, was more circumspect. He agreed that the improvement in QOL was encouraging, but cautioned that QOL is a particularly soft outcome in a nonrandomized trial in which patients may feel better just knowing that there regurgitation has been controlled. He found the lack of benefit on hard outcomes not just surprising but “disappointing.”

Still, he agreed the improvement in QOL is potentially meaningful for a procedure that appears to be relatively safe.

Dr. Sorajja reported financial relationships with Boston Scientific, Edwards Lifesciences, Foldax. 4C Medical, Gore Medtronic, Phillips, Siemens, Shifamed, Vdyne, xDot, and Abbott Structural, which provided funding for this trial. Dr. Grubb reported financial relationships with Abbott Vascular, Ancora Heart, Bioventrix, Boston Scientific, Edwards Lifesciences, 4C Medical, JenaValve, and Medtronic. Dr. Kirtane reported financial relationships with Abbott Vascular, Amgen, Boston Scientific, Chiesi, Medtronic, Opsens, Phillips, ReCor, Regeneron, and Zoll.

Liver transplant recipients with nonalcoholic steatohepatitis (NASH) who received grafts from older donors are at higher risk for posttransplant death, especially from infection, according to a new study.

All-cause mortality was twice as high and death from an infectious cause was more than three times as high for patients with NASH who received liver grafts from octogenarian donors than for those who received a liver from someone younger than 50.

“The findings from this study implicate a critical need to investigate donor age as an important risk factor for poorer host and graft survival,” wrote the authors, led by David Lee, MD, of the University of Maryland, Baltimore.

“Given the possibility of infectious graft complications, post–liver transplant follow-ups may need to be more comprehensive and frequent in these individuals who receive grafts from older donors,” they add.

The study was published online in Digestive and Liver Disease.
 

Donor age trends

Dr. Lee and colleagues pulled data from the United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research database, a national database of deidentified donor and recipient transplant data. The analysis excluded recipients younger than 18, those with a living donor, those who had hepatocellular carcinoma prior to transplant, and those who had been diagnosed with additional liver disorders apart from NASH.

The team identified 8,88 recipients with NASH who received a liver transplant from 2005–2019. They stratified recipients by donor age. The 5,187 patients who received livers from donors who were younger than 50 served as the reference group. The remainder were placed into four cohorts – 1,842 whose donors were in their 50s, 1,290 whose donors were in their 60s, 504 whose donors were in their 70s, and 65 whose donors were in their 80s.

The researchers found that in comparison with the reference group, the average age of recipients in each donor-age cohort was progressively older. Two donor-age cohorts had significantly higher proportions of recipients with diabetes than the 46.5% in the reference group – the sexagenarian cohort (51.7%) and the octogenarian group (66.2%).

The median follow-up time ranged from 2.35–3.61 years across all age groups.

The researchers found that for all donor-age groups excluding donors in their 60s, recipients had higher risk of all-cause mortality after transplant than the reference group. Recipients with donors in their 50s had a 16% greater risk for death (P = .01), and recipients with donors in their 70s had a 20% greater risk (P = .05). For recipients with octogenarian donors, the adjusted hazard ratio for all-cause mortality was 2.01 (P < .001).

Only recipients in the octogenarian donor cohort were at increased risk of graft failure, compared with the reference group (aHR, 3.72; P = .002).

As donor age increased, the recipient’s risk of dying from sepsis and infectious causes rose, compared with the reference group. Recipients’ likelihood of sepsis death increased by 71% (P = .001) with donors in their 50s, 73% (P = .003) with donors in their 60s, and 76% (P = .03) with donors in their 70s. For recipients with octogenarian donors, the risk more than tripled (aHR, 3.58; P = .007). Likewise, recipients with donors in their 70s were 73% more likely to die from infectious causes. That risk nearly quadrupled among those with donors in their 80s.
 

Recipient factors at play?

While the study found a relationship between liver donor age and recipient outcomes, it is not clear whether any other recipient factors may have contributed to the higher risk of all-cause mortality, sad Nancy Reau, MD, chief of the hepatology section at Rush University Medical Center, Chicago. The researchers did not parse out whether younger recipients did better with older organs than older recipients or whether older recipients fared worse with younger organs, she said in an interview.

“I wasn’t convinced that they had demonstrated that the recipient may not have played a role in that,” said Dr. Reau, who wasn’t involved with the study.

The analysis only a found an increased risk of graft failure among recipients who received organs from octogenarian donors, so factors other than liver transplant may have contributed to all-cause mortality, she noted.

The UNOS database has some limitations, noted Timothy Pruett, MD, who directs the liver transplant program at the University of Minnesota, Minneapolis. Because the database pulls information from transplantation centers across the country, it can be difficult to standardize specific patient variables in the data.

While it’s clear that a patient died, it’s less certain whether an infection was the cause of death and whether that infection was somehow associated with the liver, noted Dr. Pruett, who wasn’t involved in the research. For example, a patient could have had broken a hip, gone to the hospital, and contracted pneumonia, which led to their death.

“There’s just not much granularity in the database, and we can’t overextrapolate what we see,” Dr. Pruett said in an interview.
 

Knowledge gaps

Dr. Lee agreed that more research is needed to understand what may be driving higher mortality rates among patients who receive older organs. “There are still a lot of gaps in knowledge with respect to why.”

Dr. Reau said she is curious as to whether certain comorbidities, such as previous infection, diabetes, or obesity, could predict worse outcomes for recipients with older organs.

“We would love to give all of our patients younger organs, but if that leads to even more disparity in need [compared] to availability and the alternative is not surviving, I think you have to place [this work] into context,” she said.

The study findings shouldn’t be used to deter patients with NASH from considering older organs, Dr. Reau said. More insight as to which populations might want to be choosier owing to an elevated risk would be beneficial, she added.

Dr. Lee, Dr. Pruett, and Dr. Reau reported no relevant financial relationships.

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

Liver transplant recipients with nonalcoholic steatohepatitis (NASH) who received grafts from older donors are at higher risk for posttransplant death, especially from infection, according to a new study.

All-cause mortality was twice as high and death from an infectious cause was more than three times as high for patients with NASH who received liver grafts from octogenarian donors than for those who received a liver from someone younger than 50.

“The findings from this study implicate a critical need to investigate donor age as an important risk factor for poorer host and graft survival,” wrote the authors, led by David Lee, MD, of the University of Maryland, Baltimore.

“Given the possibility of infectious graft complications, post–liver transplant follow-ups may need to be more comprehensive and frequent in these individuals who receive grafts from older donors,” they add.

The study was published online in Digestive and Liver Disease.
 

Donor age trends

Dr. Lee and colleagues pulled data from the United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research database, a national database of deidentified donor and recipient transplant data. The analysis excluded recipients younger than 18, those with a living donor, those who had hepatocellular carcinoma prior to transplant, and those who had been diagnosed with additional liver disorders apart from NASH.

The team identified 8,88 recipients with NASH who received a liver transplant from 2005–2019. They stratified recipients by donor age. The 5,187 patients who received livers from donors who were younger than 50 served as the reference group. The remainder were placed into four cohorts – 1,842 whose donors were in their 50s, 1,290 whose donors were in their 60s, 504 whose donors were in their 70s, and 65 whose donors were in their 80s.

The researchers found that in comparison with the reference group, the average age of recipients in each donor-age cohort was progressively older. Two donor-age cohorts had significantly higher proportions of recipients with diabetes than the 46.5% in the reference group – the sexagenarian cohort (51.7%) and the octogenarian group (66.2%).

The median follow-up time ranged from 2.35–3.61 years across all age groups.

The researchers found that for all donor-age groups excluding donors in their 60s, recipients had higher risk of all-cause mortality after transplant than the reference group. Recipients with donors in their 50s had a 16% greater risk for death (P = .01), and recipients with donors in their 70s had a 20% greater risk (P = .05). For recipients with octogenarian donors, the adjusted hazard ratio for all-cause mortality was 2.01 (P < .001).

Only recipients in the octogenarian donor cohort were at increased risk of graft failure, compared with the reference group (aHR, 3.72; P = .002).

As donor age increased, the recipient’s risk of dying from sepsis and infectious causes rose, compared with the reference group. Recipients’ likelihood of sepsis death increased by 71% (P = .001) with donors in their 50s, 73% (P = .003) with donors in their 60s, and 76% (P = .03) with donors in their 70s. For recipients with octogenarian donors, the risk more than tripled (aHR, 3.58; P = .007). Likewise, recipients with donors in their 70s were 73% more likely to die from infectious causes. That risk nearly quadrupled among those with donors in their 80s.
 

Recipient factors at play?

While the study found a relationship between liver donor age and recipient outcomes, it is not clear whether any other recipient factors may have contributed to the higher risk of all-cause mortality, sad Nancy Reau, MD, chief of the hepatology section at Rush University Medical Center, Chicago. The researchers did not parse out whether younger recipients did better with older organs than older recipients or whether older recipients fared worse with younger organs, she said in an interview.

“I wasn’t convinced that they had demonstrated that the recipient may not have played a role in that,” said Dr. Reau, who wasn’t involved with the study.

The analysis only a found an increased risk of graft failure among recipients who received organs from octogenarian donors, so factors other than liver transplant may have contributed to all-cause mortality, she noted.

The UNOS database has some limitations, noted Timothy Pruett, MD, who directs the liver transplant program at the University of Minnesota, Minneapolis. Because the database pulls information from transplantation centers across the country, it can be difficult to standardize specific patient variables in the data.

While it’s clear that a patient died, it’s less certain whether an infection was the cause of death and whether that infection was somehow associated with the liver, noted Dr. Pruett, who wasn’t involved in the research. For example, a patient could have had broken a hip, gone to the hospital, and contracted pneumonia, which led to their death.

“There’s just not much granularity in the database, and we can’t overextrapolate what we see,” Dr. Pruett said in an interview.
 

Knowledge gaps

Dr. Lee agreed that more research is needed to understand what may be driving higher mortality rates among patients who receive older organs. “There are still a lot of gaps in knowledge with respect to why.”

Dr. Reau said she is curious as to whether certain comorbidities, such as previous infection, diabetes, or obesity, could predict worse outcomes for recipients with older organs.

“We would love to give all of our patients younger organs, but if that leads to even more disparity in need [compared] to availability and the alternative is not surviving, I think you have to place [this work] into context,” she said.

The study findings shouldn’t be used to deter patients with NASH from considering older organs, Dr. Reau said. More insight as to which populations might want to be choosier owing to an elevated risk would be beneficial, she added.

Dr. Lee, Dr. Pruett, and Dr. Reau reported no relevant financial relationships.

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

Liver transplant recipients with nonalcoholic steatohepatitis (NASH) who received grafts from older donors are at higher risk for posttransplant death, especially from infection, according to a new study.

All-cause mortality was twice as high and death from an infectious cause was more than three times as high for patients with NASH who received liver grafts from octogenarian donors than for those who received a liver from someone younger than 50.

“The findings from this study implicate a critical need to investigate donor age as an important risk factor for poorer host and graft survival,” wrote the authors, led by David Lee, MD, of the University of Maryland, Baltimore.

“Given the possibility of infectious graft complications, post–liver transplant follow-ups may need to be more comprehensive and frequent in these individuals who receive grafts from older donors,” they add.

The study was published online in Digestive and Liver Disease.
 

Donor age trends

Dr. Lee and colleagues pulled data from the United Network for Organ Sharing (UNOS) Standard Transplant Analysis and Research database, a national database of deidentified donor and recipient transplant data. The analysis excluded recipients younger than 18, those with a living donor, those who had hepatocellular carcinoma prior to transplant, and those who had been diagnosed with additional liver disorders apart from NASH.

The team identified 8,88 recipients with NASH who received a liver transplant from 2005–2019. They stratified recipients by donor age. The 5,187 patients who received livers from donors who were younger than 50 served as the reference group. The remainder were placed into four cohorts – 1,842 whose donors were in their 50s, 1,290 whose donors were in their 60s, 504 whose donors were in their 70s, and 65 whose donors were in their 80s.

The researchers found that in comparison with the reference group, the average age of recipients in each donor-age cohort was progressively older. Two donor-age cohorts had significantly higher proportions of recipients with diabetes than the 46.5% in the reference group – the sexagenarian cohort (51.7%) and the octogenarian group (66.2%).

The median follow-up time ranged from 2.35–3.61 years across all age groups.

The researchers found that for all donor-age groups excluding donors in their 60s, recipients had higher risk of all-cause mortality after transplant than the reference group. Recipients with donors in their 50s had a 16% greater risk for death (P = .01), and recipients with donors in their 70s had a 20% greater risk (P = .05). For recipients with octogenarian donors, the adjusted hazard ratio for all-cause mortality was 2.01 (P < .001).

Only recipients in the octogenarian donor cohort were at increased risk of graft failure, compared with the reference group (aHR, 3.72; P = .002).

As donor age increased, the recipient’s risk of dying from sepsis and infectious causes rose, compared with the reference group. Recipients’ likelihood of sepsis death increased by 71% (P = .001) with donors in their 50s, 73% (P = .003) with donors in their 60s, and 76% (P = .03) with donors in their 70s. For recipients with octogenarian donors, the risk more than tripled (aHR, 3.58; P = .007). Likewise, recipients with donors in their 70s were 73% more likely to die from infectious causes. That risk nearly quadrupled among those with donors in their 80s.
 

Recipient factors at play?

While the study found a relationship between liver donor age and recipient outcomes, it is not clear whether any other recipient factors may have contributed to the higher risk of all-cause mortality, sad Nancy Reau, MD, chief of the hepatology section at Rush University Medical Center, Chicago. The researchers did not parse out whether younger recipients did better with older organs than older recipients or whether older recipients fared worse with younger organs, she said in an interview.

“I wasn’t convinced that they had demonstrated that the recipient may not have played a role in that,” said Dr. Reau, who wasn’t involved with the study.

The analysis only a found an increased risk of graft failure among recipients who received organs from octogenarian donors, so factors other than liver transplant may have contributed to all-cause mortality, she noted.

The UNOS database has some limitations, noted Timothy Pruett, MD, who directs the liver transplant program at the University of Minnesota, Minneapolis. Because the database pulls information from transplantation centers across the country, it can be difficult to standardize specific patient variables in the data.

While it’s clear that a patient died, it’s less certain whether an infection was the cause of death and whether that infection was somehow associated with the liver, noted Dr. Pruett, who wasn’t involved in the research. For example, a patient could have had broken a hip, gone to the hospital, and contracted pneumonia, which led to their death.

“There’s just not much granularity in the database, and we can’t overextrapolate what we see,” Dr. Pruett said in an interview.
 

Knowledge gaps

Dr. Lee agreed that more research is needed to understand what may be driving higher mortality rates among patients who receive older organs. “There are still a lot of gaps in knowledge with respect to why.”

Dr. Reau said she is curious as to whether certain comorbidities, such as previous infection, diabetes, or obesity, could predict worse outcomes for recipients with older organs.

“We would love to give all of our patients younger organs, but if that leads to even more disparity in need [compared] to availability and the alternative is not surviving, I think you have to place [this work] into context,” she said.

The study findings shouldn’t be used to deter patients with NASH from considering older organs, Dr. Reau said. More insight as to which populations might want to be choosier owing to an elevated risk would be beneficial, she added.

Dr. Lee, Dr. Pruett, and Dr. Reau reported no relevant financial relationships.

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

When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.

The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.

Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.¹ Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.¹ Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.

The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.

Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.

Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.^2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.^2,3

The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.⁴ Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.⁴ The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.

The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.^1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.

Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.² Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.^2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.

2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.

3. Jacoby A et al. J Urol. 2019;201(6):1171-5.

4. Smith SM et al. J Sex Med. 2022;10(6):100572.

When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.

The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.

Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.¹ Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.¹ Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.

The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.

Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.

Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.^2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.^2,3

The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.⁴ Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.⁴ The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.

The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.^1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.

Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.² Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.^2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.

2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.

3. Jacoby A et al. J Urol. 2019;201(6):1171-5.

4. Smith SM et al. J Sex Med. 2022;10(6):100572.

When the Food and Drug Administration first approved the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, Calif.) for adult use in 2000, it altered the face of minimally invasive surgery across a multitude of specialties. Improved three-dimensional visualization and enhanced instrument articulation facilitates complex dissections and intracorporeal suturing. While the standard of care for gender-affirming vaginoplasty remains the single-stage penile inversion vaginoplasty, robotic procedures are quickly emerging as alternative options for both primary and revisional surgeries.

The single-stage penile inversion vaginoplasty requires an adequate amount of penoscrotal tissue not only to line a neovaginal canal that measures 12-15 cm, but also to create external vulvar structures. While this is often sufficient in most candidates, there is an increasing number of patients who are receiving puberty blockers, resulting in penoscrotal hypoplasia.

Alternatively, there are patients who experience loss of vaginal depth and vaginal stenosis who seek revisional surgeries. Additional donor sites for skin grafting are available and include the lower abdomen and thighs, although patients may not want these donor site scars. With these donor sites, there is also concern about graft contracture, which could lead to recurrent vaginal stenosis.¹ Robotic peritoneal vaginoplasty and robotic enteric vaginoplasty can serve as additional options for patients seeking revisional surgery or who have insufficient genital skin. One benefit of using peritoneal flaps is that they are hairless and are well vascularized with minimal donor site morbidity.¹ Currently, there are two predominant techniques that utilize peritoneal flaps: the modified Davydov procedure and the tubularized urachus-peritoneal hinge flap.

The modified Davydov technique, which originated in the treatment of congenital vaginal agenesis in cisgender women, involves the creation of anterior and posterior peritoneal flaps. This type of peritoneal vaginoplasty is more commonly utilized for primary cases.

Ideally, there is a robotic surgeon (typically a urologist) working in tandem with the perineal surgeon. The robotic surgeon makes a horizontal incision along the peritoneal ridge at the rectovesical junction and continues the dissection within Denonvilliers fascia, between the prostate and rectum, to the pelvic floor. This dissection is like that performed in a robot-assisted laparoscopic prostatectomy.

Simultaneously, the perineal surgeon will break through the pelvic floor with assistance of the robotic view. Peritoneal flaps are raised from the anterior rectum and posterior bladder.^2,3 In primary cases, the penoscrotal flap is introduced into the abdomen from the perineum and sutured to the anterior and posterior peritoneum to create a circumferential canal. At the apex of the neovagina, these anterior and posterior flaps are then sutured together.^2,3

The tubularized urachus-peritoneal hinge flap technique is predominantly used for revision cases in patients who experienced neovaginal shortening and desire increased neovaginal depth. As peritoneal reach is limited, candidates for this procedure must have both adequate width and neovaginal canal depth.⁴ Once intra-abdominal access is achieved, an anterior peritoneal flap is mobilized to the level of the bladder and rotated 180 degrees inferiorly.⁴ The superior aspect of the flap is flipped is mobilized and is sutured to the peritoneum at the apex of the neovaginal canal.

The main benefit of these procedures, compared with traditional techniques, is increased neovaginal depth. The average vaginal length in patients undergoing peritoneal vaginoplasties is 14.2 cm, compared with 11.6 cm achieved in those using skin grafts.^1,3 However, many surgeons report achieving 14-15 cm of depth with the traditional vaginoplasty. There are insufficient short- and long-term data for the peritoneal technique to recommend this as a first-line procedure.

Complications for peritoneal vaginoplasty procedures are similar to those of single-stage penile inversion vaginoplasty cases but with additional operative risks associated with laparoscopic/robotic surgery. These risks include injury to viscera and major vessels during initial intra-abdominal access, intra-abdominal adhesions, port site hernias, need to convert to an open procedure, and equipment malfunction.² Additional postoperative risks include pelvic abscess formation, dehiscence of the peritoneal-vaginal incision, and peritoneal perforation during dilation.^2,3 Surgeons and institutions must also weigh the cost of using the robot versus the cost of additional revisional surgical procedures. While initial studies evaluating robotic peritoneal vaginoplasty procedures have yielded promising preliminary results, additional studies are warranted.

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Salibian AA et al. Plast Reconstr Surg. 2021;147(4):634e-43e.

2. Dy GW et al. In: Nikolavsky D and Blakely SA, eds. Urological care for the transgender patient: A comprehensive guide. Switzerland: Springer, 2021:237-48.

3. Jacoby A et al. J Urol. 2019;201(6):1171-5.

4. Smith SM et al. J Sex Med. 2022;10(6):100572.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.

In a pooled analysis from two randomized trials, transcatheter aortic valve implantation (TAVI) was associated with significantly less bioprosthetic valve dysfunction (BVD) than a surgical prosthetic implantation, according to data presented as a late-breaker at the Cardiovascular Research Technologies conference, sponsored by MedStar Heart & Vascular Institute.

“The difference in valve performance was driven by a twofold lower SVD [structural valve deterioration] and a 3-fold lower severe PPM [prothesis-patient mismatch] for TAVI versus surgery,” reported Steven J. Yakubov, MD.

Ted Bosworth/MDedge News

The data were pooled from the CoreValve U.S. Pivotal and SURTAVI randomized trials. Of patients participating in these two trials, 5-year follow-up data were available for 1,128 randomized to the CoreValve/Evolut TAVI and 971 randomized to surgical prosthetic valve replacement.

The major focus of the study was on the cumulative incidence of BVD, but the study also included separate analyses on the relationship between BVD and clinical outcomes. Preprocedural indicators for BVD at 5 years were also analyzed.

SVD was defined as a mean gradient increase of at least 10 mm Hg from discharge to 30 days, along with at least 20 mm Hg at last echo or new-onset aortic regurgitation. Nonstructural valve deterioration (NSVD) was defined as severe PPM at discharge or 30 days or severe paravalvular regurgitation through 5 years. In addition to these two components, the BVD endpoint also included thrombosis and endocarditis.
 

Surgical valve deterioration high at 5 years

On the basis of these definitions, the rate of BVD at 5 years was 14.2% in the surgery group and 7.8% in the TAVI group, translating into a 50% risk reduction in favor of TAVI (hazard ratio, 0.50; P < .001).

Thrombosis or endocarditis occurred in low rates in both groups, but every other component of BVD favored TAVI significantly, not just numerically. This included SVD (2.2% vs. 4.4%; P = .004), and the two components of NSVD, PPM (3.7% vs. 11.8%; P < .001) and severe paravalvular regurgitation (0.2% vs. 1.2%; P = .02).

When stratified by annular diameter, the relative advantage of TAVI over surgery was greatest in those valves with diameters of up to 23 mm. In this group, the lower relative rate in the TAVI group (8.6% vs. 19.7%) represented a nearly 70% reduction in risk of valve deterioration at 5 years (HR, 0.31; P < .001).

However, the advantage at 5 years also remained substantial and significant in larger valves (8.1% vs. 12.6%), translating into a 40% risk reduction in favor of TAVI (HR, 0.60; P = .002).

Independent of type of valve replacement, BVD at 5 years was associated with worse outcomes, including significantly increased risks for all-cause mortality (HR, 1.46; P = .004), cardiovascular mortality (1.84; P < .001), and hospitalization for valve disease or worsening heart failure (HR, 1.67; P = .001).

The baseline characteristics that were statistically associated with BVD at 5 years on multivariate analysis in pooled data from both the TAVI and surgical groups included age (P = .02), a creatinine clearance less than 30 mL/min per 1.73 m² (P = .006), and a low relative baseline left ventricular ejection fraction (P < .001).
 

BVD criteria validated for outcome prediction

The four components of valve performance employed in this analysis (SVD, NSVD, thrombosis, and endocarditis) were drawn from consensus documents issued by the Valve Academic Research Consortium and the European Association of Percutaneous Cardiovascular Interventions, but the relative importance of these components for predicting valve survival was previously unknown, according to Dr. Yakubov.

“This is the first analysis to validate clinical criteria for valve performance and its association with clinical outcomes,” said Dr. Yakubov, medical director of cardiovascular studies, OhioHealth Research Institute at Riverside Methodist Hospital, Columbus.

This is also the first study to employ randomized data to prove an advantage of TAVI over surgery in long-term follow-up.

A 10-year follow-up is planned for the patients who participated in these two trials, but the lower rate of BVD in the TAVI arm at 5 years is already a threat to surgical repairs, acknowledged several surgeons who served as panelists in the session where these results were presented.

“I think that these data are a reflection of the fact that we [surgeons] are not being as aggressive as we should be,” said Gregory P. Fontana, MD, who is national director, cardiothoracic surgery, HCA Healthcare, and is affiliated with Los Robles Health System, Thousand Oaks, Calif. “We need to be employing larger prostheses.”

Ted Bosworth/MDedge News

A very similar comment was made by Michael J. Reardon, MD, a professor of cardiothoracic surgery at Houston Methodist Hospital. Pointing to the higher rate of PVL as an example of a common postsurgical complication, he agreed that surgeons should be moving to bigger valve sizes.

While adjustments in valve size might address the steeper rise in NSVD subtypes of BVD observed in the surgical group, but Dr. Reardon and others pointed out that late BVD events also rose at a greater pace in the surgical group. These suggest other improvements in technique might also be needed to keep surgical valve repairs competitive.

Dr. Yakubov reported financial relationships with Medtronic and Boston Scientific, both of which provided funding for this study. Dr. Fontana reported financial relationships with Abbott and Medtronic. Dr. Reardon reported financial relationships with Abbott, Boston Scientific, Medtronic, and Gore Medical.