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A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.

In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.

The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.

Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.

Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.

MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.

“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.

The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”

It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”

Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.

The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.

“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.

But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”

The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.

MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”

CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.

Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.

The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.

Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular  mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.

The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.

Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.

In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).

But  whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.

That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”

MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.

“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”

CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.

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

A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.

In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.

The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.

Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.

Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.

MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.

“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.

The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”

It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”

Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.

The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.

“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.

But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”

The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.

MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”

CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.

Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.

The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.

Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular  mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.

The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.

Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.

In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).

But  whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.

That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”

MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.

“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”

CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.

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

A newly available transcatheter device for edge-to-edge mitral valve (MV) repair, named for a famed scientist-inventor, is similar to the long-available MitraClip (Abbott) for short-term efficacy and safety, suggests an interim but prespecified analysis from a randomized trial.

In its comparison with MitraClip, the PASCAL transcatheter valve repair system (Edwards Lifesciences) was noninferior with respect to 30-day major adverse events and to success at achieving mitral regurgitation (MR) of no more than moderate severity within 6 months. The trial had entered patients with significant, symptomatic degenerative MR considered too high-risk for surgical repair or replacement.

The interim analysis covers 180 of the 300 patients followed in the study, of whom 117 received the PASCAL device and 63 were given MitraClip. Both groups showed significant gains in functional class, symptom status, and quality of life over 6 months, reported D. Scott Lim, MD, University of Virginia Health System Hospital, Charlottesville, and Konstantinos Koulogiannis, MD, Morristown Medical Center, N.J., jointly on Sept. 17 at the Transcatheter Cardiovascular Therapeutics (TCT) 2022 annual meeting in Boston.

Dr. Lim, one of the trial’s principal investigators, is also lead author on its same-day publication in JACC: Cardiovascular Interventions.

Based largely on those results from the CLASP IID pivotal trial, the U.S. Food and Drug Administration recently approved the PASCAL system for use in patients with degenerative MR, Edwards announced on Sept. 15. The device was approved in the European Union on Aug. 17.

MitraClip has been available in various iterations in the United States since 2013 and in Europe since 2008.

“It’s good for the field to be able to say we have two devices that are comparable,” giving clinicians more options, Vinod H. Thourani, MD, Piedmont Heart Institute, Atlanta, told this news organization.

The current analysis shows that “we’ve yet to figure out what patient pathologies will be beneficial” for each of the devices, Dr. Thourani said. “The goal will be to find out if there are certain anatomical considerations where one device is better than the other.”

It will be necessary to study “more patients, a larger cohort, with longer follow-up to allow us to see their true benefits,” he said, as well as to conduct more subgroup analyses. For now, the choice of device will probably be “operator-specific, which they feel comfortable with.”

Dr. Thourani, not an author on the current study, is the U.S. principal investigator for the CLASP IIF study looking at clinical outcomes with the two devices and says he consults for both Edwards and Abbott.

The findings are “preliminary for now,” said Michael Young, MD, Dartmouth-Hitchcock Medical Center, Lebanon, N.H., in part because, like most randomized trials, CLASP IID entered a select, not broadly representative population.

“They want to make, as best as they could, an apples-to-apples comparison, without confounding that might make it more difficult to interpret it afterwards,” Dr. Young, not associated with the trial, told this news organization.

But CLASP IID “did enroll patients that we do see and treat, so undoubtedly it’s a compelling study. We now have another device that is shown to be safe and effective. How we’re going to extrapolate it to all the patients that are being referred to our practices will, I think, be under debate and deliberation.”

The PASCAL and MitraClip devices each may be more suitable for different patients with varying mitral valve pathologies because of differences in their designs, Dr. Lim said. The PASCAL’s relative flexibility might make it preferable in patients with smaller mitral valves, and its ability to elongate during delivery could make it more suitable for patients with chordal-dense areas around the valve, he speculated.

MitraClip, Dr. Lim told this news organization, has a mechanical closure system for anchoring that may make it more appropriate for “more complicated, thicker leaflets with calcium.”

CLASP IID enrolled patients with grade 3+ or 4+ degenerative MR considered to be “at prohibitive surgical risk” at 43 sites in North America and Europe. It randomly assigned them 2-to-1 to receive the PASCAL device or MitraClip.

Either of two PASCAL versions were used, the original device or the “smaller, narrower” PASCAL Ace, Dr. Lim observed. Both versions are covered by the PASCAL Precision System FDA approval. About 40% of patients assigned to MitraClip received older versions of the device and about 60%, more recent versions, as they were entered into practice.

The mean procedure times were 88 minutes for PASCAL and 79 minutes for MitraClip (P = .023), with much of the difference attributable to the earliest PASCAL procedures. Procedure times for the device declined with greater operator experience, the published report states.

Rates of the primary safety endpoint of major adverse events at 30 days were 3.4% for PASCAL and 4.8% for MitraClip. The endpoint was a composite of cardiovascular  mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, or nonelective MV reintervention.

The proportion of patients with MR grade 2+ or lower at 6 months, the primary effectiveness endpoint, assessed at a core laboratory, was 96.5% for the PASCAL group over a median follow-up of 179.5 days and 96.8% over a median of 184.5 days for those who received MitraClip.

Comparisons for both primary endpoints met the prespecified criteria for PASCAL noninferiority.

In a secondary analysis, the proportion of PASCAL patients with MR grade 1+ or less held about steady from postprocedure discharge out to 6 months, at 87.2% and 83.7%, respectively (P = .317).

But  whereas 88.5% of MitraClip patients had MR grade 1+ or better at discharge, 71.2% were at that grade by 6 months (P = .003). That apparent hemodynamic deterioration raised some eyebrows at the TCT sessions as a potential sign that PASCAL functional results are more durable.

That sort of judgment is premature, offered Anita W. Asgar, MD, MSc, Montreal Heart Institute, Quebec City, as an invited discussant after the CLASP IID trial’s formal presentation at the meeting, which was sponsored by the Cardiovascular Research Foundation.

The trial is notable in part for “showing how safe this procedure is and how successful it is for these patients – this is phenomenal,” she said, but “I would caution comparing one device being better than another with such a small number of patients.”

MitraClip, Dr. Young observed, “has been, up to this point, our only option for edge-to-edge repair of the mitral valve. And many of us have years of experience and a lot of patients that we treat with that device.” His center hasn’t yet used PASCAL, but that may change as the field gains more familiarity with the device. Operators may use either device in different cases, he said.

“Depending on the program, and depending on the volume of mitral patients that you see and edge-to-edge repair that you do, it could be that you stick with one, or switch to another, or you integrate both of them and try to decide which patients might be better suited for one or the other.”

CLASP IID was sponsored by Edwards Lifesciences. Dr. Lim discloses consulting for Philips, Venus, and Valgen and receiving research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr. Koulogiannis discloses consulting and serving on an advisory board for Edwards Lifesciences and as a speaker for Abbott and discloses holding equity, stocks, or stock options in 4C. Dr. Thourani discloses serving as a consultant to both Abbott and Edwards Lifesciences. Dr. Young discloses receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic. Dr. Asgar discloses receiving research support from or holding a research contract with Abbott Vascular and receiving consulting fees or honoraria or serving on a speaker’s bureau for Medtronic, Edwards Lifesciences, and W. Gore & Associates.

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

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

Among patients with severe isolated aortic stenosis younger than 65, the rate of transcatheter aortic valve replacement (TAVR) now almost matches that of surgical aortic valve replacement (SAVR), despite guideline recommendations to the contrary, a study in a national U.S. population shows.

The 2020 American Heart Association/American College of Cardiology (AHA/ACC) valve guideline recommends SAVR for patients younger than 65 with severe aortic stenosis, the researchers note, but their study showed “near equal utilization between TAVR and SAVR in these younger patients by 2021,” at 48% and 52% respectively.

Toishi Sharma, MD, and colleagues presented these findings in an oral poster session at Transcatheter Cardiovascular Therapeutics 2022, and the study was simultaneously published as a Research Letter in the Journal of the American College of Cardiology (JACC).

“To our knowledge, the current findings represent the first national temporal trends study stratifying [aortic stenosis] therapies according to guideline-recommended age groups: our observations demonstrate the dramatic growth of TAVR in all age groups, including young patients,” the researchers conclude.

They analyzed changes in rates of TAVR and SAVR in a U.S. sample stratified by age: younger than 65 years, 65-80, and older than 80 years.

These findings have implications for lifetime management of younger patients who undergo TAVR, they write, “including issues related to lifetime coronary access, valve durability, and the potential for subsequent TAVR procedures over time.”
 

Three age groups

In a study published in JACC, this group examined changes in uptake of TAVR versus SAVR in 4,161 patients with aortic stenosis in Vermont, New Hampshire, and Maine, senior author Harold L. Dauerman, MD, said in an interview.

The greatest rate of rise of TAVR was in the group younger than 65, but that study ended in 2019, said Dr. Dauerman, from the University of Vermont Health Network, Burlington.

The 2020 guideline stratifies TAVR and SAVR recommendations such that “less than 65 should primarily be a surgical approach and greater than 80 primarily a TAVR approach, while 65 to 80 is a gray zone, and shared decision-making becomes important,” he noted.

The group hypothesized that recent trials and technology have led to a national increase in TAVR in people younger than 65.

From the Vizient clinical database, including more than 250 U.S. academic centers that perform both TAVR and SAVR, the researchers identified 142,953 patients who underwent TAVR or SAVR for isolated aortic stenosis from Oct. 1, 2015, to Dec. 31, 2021. From 2015 to 2021, the valve replacement rates in the three age groups changed as follows:

• Age less than 65: TAVR rose from 17% to 48%; SAVR fell from 83% to 52%.
• Age 65-80: TAVR rose from 46% to 87%; SAVR fell from 54% to 12%.
• Age greater than 80: TAVR rose from 83% to 99%; SAVR fell from 16% to 1%.

“All ages have grown in the last 7 years in TAVR,” Dr. Dauerman summarized. “The one that’s surprising, and in contradiction to the guideline, is the growth of TAVR in young patients less than 65.”

Among patients younger than 65, prior bypass surgery and congestive heart failure predicted the use of TAVR instead of surgery, whereas bicuspid aortic valve disease was the biggest predictor of surgery instead of TAVR.

Most studies on TAVR valve durability are limited to patients in the randomized trials who were primarily in their mid-70s to mid-80s, some of whom died before a 10-year follow-up, Dr. Dauerman noted.

European guidelines recommend surgery for patients younger than 70, and it would be interesting to see if clinicians there follow this recommendation or if TAVR is now the preferred approach, he added.

There is a need for further, longer study of TAVR in younger patients, he said, to determine whether there are long-term clinical issues of concern.
 

Strategy depends on more than age

The “findings are not too surprising,” John Carroll, MD, who was not involved in this research, said in an email.

University of Colorado Hospital

“Age is only one of multiple patient characteristics that enter into consideration of TAVR versus SAVR,” said Dr. Carroll, from Anschutz Medical Campus, University of Colorado, Aurora.

“As the article reports,” he noted, “those less than 65 having TAVR are more likely to have comorbid conditions that likely made the risk of SAVR higher.”

Dr. Carroll was lead author of a review article published in 2020 based on data from the ACC–Society of Thoracic Surgeons (STS)–Transcatheter Valve Therapy (TVT) registry on 276,316 patients who had TAVR in the United States from 2011-2019.

He pointed out that Figure 2 in that review shows that “SAVR is often performed in conjunction with other surgical procedures – another major reason why SAVR remains an important treatment for valvular heart disease.”

“We are awaiting long-term data comparing TAVR to SAVR durability,” Dr. Carroll added, echoing Dr. Dauerman. “So far [there are] no major differences, but it remains a key need to fully understand TAVR and the various models in commercial use.”

“Both TAVR and SAVR used in adults are tissue valves (SAVR with mechanical valves is used in younger patients),” Dr. Carroll noted, “and all tissue valves will eventually fail if the patient lives long enough.”

Patient management strategies need to consider what treatment options exist when the first valve fails. “If the first valve is SAVR, there is now extensive experience with placing a TAVR valve inside a failing SAVR valve, so called Valve-in-Valve or TAVR-in-SAVR. This is the preferred treatment in most patients with failing SAVR valves,” he said.

“On the other hand,” he continued, “we are just beginning to see more and more patients with failing TAVR valves, and the TAVR-in-TAVR procedure is less well understood.”

“Issues such as acute coronary occlusion and long-term difficulty in accessing coronary arteries are being encountered in some patients having TAVR-in-TAVR,” Dr. Carroll noted, which he discusses in a recent editorial he coauthored about the complexities of redo TAVR, published in JACC: Cardiovascular Interventions.

The study received no funding. Dr. Dauerman has research grants and is a consultant for Medtronic and Boston Scientific. Dr. Carroll is a local principal investigator in trials sponsored by Medtronic, Abbott, and Edwards Lifesciences.

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

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

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

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

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

In patients with severe mitral regurgitation (MR) and cardiogenic shock, successful transcatheter edge-to-edge repair (TEER) is associated with a substantial reduction in all-cause mortality and lower morbidity at 1 year, according to an analysis of registry data.

The data from this analysis also confirm that “successful reduction of MR is achievable with TEER in most patients with cardiogenic shock,” reported Mohamad A. Alkhouli, MD, an interventional cardiologist and professor of medicine at the Mayo Clinic, Rochester, Minn.

STS/ACC TCT registry data queried

Drawn from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry, 3,797 patients with cardiogenic shock underwent MR repair between November 2013 and December 2021. Outcomes at 1 year were evaluable in 2,773 of these patients. For inclusion, all had to meet at least one of the definitions of cardiogenic shock, such as inotrope use or mechanical circulatory support.

At baseline, 94.5% had a MR severity of at least 3+, and most of these had 4+. Thirty days after treatment, 88.8% had MR severity of 2+ or less, the majority of which had a severity of 1+.

These data address an important question not previously well studied, according to Dr. Alkhouli. In MR patients, cardiogenic shock is associated with a high risk of death, but there has been little evidence that valve repair does not exacerbate, let alone modify, this risk.

These data support the value of intervention, which was performed in almost all patients with MitraClipä (Abbott), the only device available for most of the period in which the registry was queried. However, Dr. Alkhouli cautioned that his data are best considered “hypothesis generating.”

“We need a randomized trial,” he said at the meeting sponsored by the Cardiovascular Research Foundation. He pointed out that this is a complex population for which multiple variables might have skewed results when data are analyzed retrospectively. Not least, those MR patients with cardiogenic shock in the database considered for TEER might well have been relatively healthy and not representative of an unselected population with both MR and cardiogenic shock.

The question might be better answered by the multicenter Canadian trial CAPITAL MINOS, which has just started. Described in an article in the American Heart Journal, it has a planned enrollment of about 150 MR patients with cardiogenic shock randomized to TEER or medical therapy. Results are expected in about 1 year, according to Dr. Alkhouli.

But regarding the present analysis, Dr. Alkhouli did note that sensitivity analyses conducted within his data across risk factors, such as degenerative versus nondegenerative MR, low (< 30%) versus higher left ventricular ejection fraction (LVEF), and presence or absence of an acute coronary syndrome (ACS), consistently supported a benefit from intervention.

Also, cardiogenic shock did not appear to be a factor in device failure, according to Dr. Alkhouli, addressing a potential criticism that cardiogenic shock was an underlying reason for device failure.
 

More than 90% in NYHA class III or IV heart failure

In this study, the mean age was 73 years. More than 90% were in class III or IV heart failure in the 2 weeks prior to TEER. More than half had established coronary artery disease. Other concomitant cardiovascular morbidities, including atrial fibrillation or flutter (65%), prior MI (39%), and prior stroke or transient ischemic attach (> 10%) were well represented.

When those with device success were compared with those with device failure, the risk profile was comparable. The predicted STS (Society of Thoracic Surgeons) mortality for mitral valve repair among these two groups was 14.8% versus 15% (P = 0.97), respectively.

However, those with device failure did have a lower baseline left ventricular ejection fraction (40.7% vs. 42.9%; P = .009) and a greater prevalence of moderate-to-severe or severe MR (96.1% vs. 84.9%; P < 0.001).

The growing experience with TEER means that benefit has now been shown in several complicated MR groups, such as those with severe ventricular dysfunction, renal insufficiency, and obstructive lung disease. This was a rationale for looking at the impact or repairing MR in patients with cardiogenic shock.

It is a pressing question, according to Dr. Alkhouli. He cited studies suggesting that up to 20% of patients hospitalized for cardiogenic shock have at least moderate-to-severe MR. Conversely, cardiogenic shock is not an uncommon finding in patients with MR.

While Dr. Alkhouli acknowledged that the many variables influencing outcome in patients with MR and cardiogenic shock will make a randomized trial “challenging,” many experts echoed this concern and even expressed some skepticism about the potential for an unbiased trial.
 

Data confirm MR repair is safe during shock

“These data do show that repair of MR is safe in patients safe in patients with cardiogenic shock,” said Anita W. Asgar, MD, an interventional cardiologist associated with the Montreal Heart Institute. She noted that there was a 5- to 6-day delay among the cardiogenic shock patients prior to undergoing MR repair in this analysis, potentially reflecting an elimination of those at very high risk. Similarly, she suggested that many interventionalists are likely to consider multiple variables before proceeding.

As a result, MR repair may not be amenable to randomization in a cardiogenic shock population, given that this decision is not typically undertaken out of the context of multiple variables.

“I am not sure that a clinical trial is ethical,” she said. She would expect that clinicians enrolling patients would only do so on a selective basis.

Alexandra J. Lansky, MD, Director of the Yale Heart and Vascular Research Program, Yale University, New Haven, Conn., also emphasized the difficulty of controlling for variables, such as the duration of cardiogenic shock, that influence decision-making.

Nevertheless, she called the data “very important” in that they at least lend some objective data for deciding whether to intervene a group of “challenging” patients not uncommonly faced in clinical practice.

Dr. Alkhouli reports financial relationships with Abbott Vascular, Boston Scientific, Johnson & Johnson, and Phillips. Dr. Asgar reports financial relationships with Abbott Vascular, Edwards Lifesciences, W.L. Gore & Associates, and Medtronic. Dr. Lasky reports no potential conflicts of interest.

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

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.
 

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.
 

The design improvements introduced in the fourth-generation device for transcatheter mitral valve repair, called the MitraClip G4 (Abbott), appears to yield better outcomes than previous iterations, according to a multinational postapproval study with more than 1,000 patients.

Not least, the 1.3% all-cause mortality at 30 days in this series, called EXPAND G4, “is the lowest that has been reported to date,” reported Ralph Stephan von Bardeleben, MD, at the Transcatheter Cardiovascular Therapeutics annual meeting, sponsored by the Cardiovascular Research Foundation.

Ted Bosworth/MDedge News

The evidence of relative advantages was based on comparisons with historical data and a similar study of the previous-generation device. That previous study, called EXPAND, evaluated the MitraClip NTR and ETR systems.

Device times shorter with new device

“There were shorter device times with MitraClip G4,” said Dr. von Bardeleben, referring to a more than 10-minute advantage over the previous generation device (35 minutes in EXPAND G4 vs. 46 min in EXPAND). Although the reduction in overall median procedure time was more modest (77 vs. 80 minutes), Dr. von Bardeleben said these are “the shortest device and procedural times reported to date.”

He also reported what appeared to be incremental advantages across multiple other endpoints, such as procedural success (96.2% vs. 95.8%) and a reduction in the mean clip rate (1.4 vs. 1.5).

Compared with historical outcomes with other devices employed in transcatheter edge-to-edge repair (TEER) of mitral valves, Dr. von Bardeleben contended that the results support the premise that the MitraClip G4 system is a meaningful advance by incorporating such features as an expanded choice of clip sizes, a greater coaptation area, and a more advanced gripper actuation for leaflet grasping.
 

Over 90% achieve MR 1+

Not least, it appears to increase the proportion of patients who achieve a mitral regurgitation grade of 1+ (MR1+) or lower, which is increasingly recognized as the goal of TEER, said Dr. von Bardeleben, head of the Centre of Structure Heart Disease Interventions, Heart Valve Centre, Mainz, Germany.

He said the rates of 91% achieving MR1+ or less and 98% achieved 2+ or lower compare favorably with most other series and exceeds levels achieved with surgery.

Dr. von Bardeleben also contended that, because of its design features, the MitraClip G4 “expands the spectrum of TEER-suitable patients.” He noted that 5% of the patients in this real-world series had a high risk of stenosis owing to such issues as severe annular or leaflet calcification and another 5% had factors that would predict inadequate MR reduction, such as Barlow’s disease, bi-leaflet prolapse, and severe leaflet degeneration.

The 1,164 patients in EXPAND G4 were enrolled from sites in the United States, Europe, Canada, and Japan. For the key outcome measure of procedural success, echocardiograms were assessed by an independent core laboratory. Of the 1,164 patients enrolled, 1,044 (91%) had complete follow-up data at 30 days.

The procedural success rates were reflected in improvements in New York Heart Association (NYHA) functional classes and in the Kansas City Cardiomyopathy Questionnaire (KCCQ), a quality of life instrument. Prior to treatment, 69% were in NYHA class III or greater. Following treatment, the proportion was 17% (P < .0001). The 18-point improvement in the KCCQ was characterized by Dr. von Bardeleben as “both clinically and statistically significant [P < .0001].”

There were no strokes in this series, and the 30-day incidence of myocardial infarction was 0.2%. The proportion requiring cardiovascular surgery within 30 days was less than 1%. The rate of bleeding episodes, all of which were nonserious, was 7%.

The “EXPAND G4 study confirms the safety and effectiveness of the next generation MitraClip G4 system,” according to Dr. von Bardeleben, and it did so “in a contemporary real-world setting.”
 

Outcome data characterized as ‘excellent’

Several invited panelists participating in a discussion following the presentation agreed.

“These results are excellent,” said Raj Makkar, MD, associate director of interventional technologies at Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles. While he was impressed with the fact that only 2% missed the primary endpoint of MR 2+ or lower, he indicated that the 91% achieving MR 1+ or lower might be an even more apt signal that newer-generation devices are improving.

This was echoed by other panelists who appeared to form a general consensus over the premise that the target in TEER should no longer be MR 2+ for most patients.

“We should now be aiming for MR grade of 0-1,” stated panelist Stephan Windecker, MD, chairman, department of cardiology, University of Bern (Switzerland). He indicated that this goal is increasingly reasonable given the advances in device design and greater operator experience.

Dr. von Bardeleben reported financial relationships with Abbott Vascular, Edwards Lifesciences, Medtronic, and Neochord. Dr. Makkar reported financial relationships with Abbott Vascular, Cordis, Edwards Lifesciences, and Medtronic. Dr. Windecker reported financial relationships with more than 30 pharmaceutical companies, including Abbott Vascular, which manufactures MitraClip G4.
 

An anesthesiologist is under arrest and facing criminal charges related to alleged tampering with patient IV bags at Baylor Scott & White Surgicare, a North Dallas surgical center. Raynaldo Rivera Ortiz Jr., MD, 59, is accused of injecting nerve-blocking and bronchodilating drugs into patient IV bags, resulting in at least one death and multiple cardiac emergencies.

In June, an anesthesiologist identified by Dallas ABC affiliate WFAA as Melanie Kaspar, MD, a colleague of Dr. Ortiz’s at the outpatient center, was ill and treated herself for dehydration using an IV bag of saline she had taken home from work. She died immediately after injecting the contents of the bag. According to the autopsy report, she died from a lethal dose of bupivacaine, a nerve-blocking agent often used during the administration of anesthesia. According to WFAA, Dr. Kaspar’s death was initially ruled accidental, but the Dallas County Medical Examiner has since reopened the case. 

Then in August, an 18-year-old male patient, identified in court documents as J.A., experienced a cardiac emergency during a scheduled surgery at the clinic. The teen, who according to local press coverage was undergoing nose surgery after a dirt bike accident, was transferred to a local ICU. A chemical analysis of the fluid from the saline bag that was used during his surgery found epinephrine (a stimulant that could have caused his symptoms), bupivacaine, and lidocaine.

According to court documents, an investigation by the surgical center identified about 10 additional unexpected cardiac emergencies that occurred during what should have been unremarkable surgeries, an exceptionally high rate of complications, suggesting a pattern of intentional adulteration of IV bags. These surgeries were performed between May and August.

In addition, the complaint alleges that none of the cardiac incidents occurred during Dr. Ortiz’s surgeries; however, all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while he was on vacation. The incidents began 2 days after Dr. Ortiz had been notified that he was the subject of a disciplinary inquiry stemming from an incident in which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency, according to federal officials.

The complaint also alleges that Dr. Ortiz had a history of disciplinary actions against him, including at the facility, and he complained that the center was trying to “crucify” him.

Surveillance video from the hallway of the center’s operating room shows Dr. Ortiz placing IV bags in the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies, according to the complaint. In the description of one instance captured on video, Dr. Ortiz was observed walking quickly from an operating room to the bag warmer, placing a single IV bag inside, visually scanning the empty hallway, and quickly walking away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.

The complaint alleges that in another instance, Dr. Ortiz was observed exiting his operating room carrying an IV bag concealed in what appeared to be a paper folder, swapping the bag with another bag from the warmer, and walking away. Roughly 30 minutes later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. 

“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic Oath,” said Chad E. Meacham, U.S. Attorney for the Northern District of Texas. “A single incident of seemingly intentional patient harm would be disconcerting; multiple incidents are truly disturbing. At this point, however, we believe that the problem is limited to one individual, who is currently behind bars. We will work tirelessly to hold him accountable.”

Dr. Ortiz is charged with tampering with a consumer product and with intentionally adulterating drugs. If convicted, he faces a maximum penalty of life in prison. Dr. Ortiz will make his initial appearance before U.S. Magistrate Judge Renee Toliver in Dallas Sept. 16.

On Sept. 9, the Texas Medical Board suspended Dr. Ortiz’s license in connection with this investigation, noting that the panel found “an imminent peril to the public health, safety, or welfare” and that Dr. Ortiz’s “continuation in the practice of medicine poses a continuing threat to public welfare.”

“It is astounding, stunning [for the victims] to think that anyone did this intentionally,” said Bruce W. Steckler, an attorney for some of the victims, in an interview with WFAA.

Baylor Scott & White Health, which operates the surgical center, said in a statement that the North Dallas facility will remain closed as the investigation continues.

“We actively assisted authorities in their investigation and will continue to do so. We also remain focused on communicating with patients,” the health system said.

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

An anesthesiologist is under arrest and facing criminal charges related to alleged tampering with patient IV bags at Baylor Scott & White Surgicare, a North Dallas surgical center. Raynaldo Rivera Ortiz Jr., MD, 59, is accused of injecting nerve-blocking and bronchodilating drugs into patient IV bags, resulting in at least one death and multiple cardiac emergencies.

In June, an anesthesiologist identified by Dallas ABC affiliate WFAA as Melanie Kaspar, MD, a colleague of Dr. Ortiz’s at the outpatient center, was ill and treated herself for dehydration using an IV bag of saline she had taken home from work. She died immediately after injecting the contents of the bag. According to the autopsy report, she died from a lethal dose of bupivacaine, a nerve-blocking agent often used during the administration of anesthesia. According to WFAA, Dr. Kaspar’s death was initially ruled accidental, but the Dallas County Medical Examiner has since reopened the case. 

Then in August, an 18-year-old male patient, identified in court documents as J.A., experienced a cardiac emergency during a scheduled surgery at the clinic. The teen, who according to local press coverage was undergoing nose surgery after a dirt bike accident, was transferred to a local ICU. A chemical analysis of the fluid from the saline bag that was used during his surgery found epinephrine (a stimulant that could have caused his symptoms), bupivacaine, and lidocaine.

According to court documents, an investigation by the surgical center identified about 10 additional unexpected cardiac emergencies that occurred during what should have been unremarkable surgeries, an exceptionally high rate of complications, suggesting a pattern of intentional adulteration of IV bags. These surgeries were performed between May and August.

In addition, the complaint alleges that none of the cardiac incidents occurred during Dr. Ortiz’s surgeries; however, all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while he was on vacation. The incidents began 2 days after Dr. Ortiz had been notified that he was the subject of a disciplinary inquiry stemming from an incident in which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency, according to federal officials.

The complaint also alleges that Dr. Ortiz had a history of disciplinary actions against him, including at the facility, and he complained that the center was trying to “crucify” him.

Surveillance video from the hallway of the center’s operating room shows Dr. Ortiz placing IV bags in the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies, according to the complaint. In the description of one instance captured on video, Dr. Ortiz was observed walking quickly from an operating room to the bag warmer, placing a single IV bag inside, visually scanning the empty hallway, and quickly walking away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.

The complaint alleges that in another instance, Dr. Ortiz was observed exiting his operating room carrying an IV bag concealed in what appeared to be a paper folder, swapping the bag with another bag from the warmer, and walking away. Roughly 30 minutes later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. 

“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic Oath,” said Chad E. Meacham, U.S. Attorney for the Northern District of Texas. “A single incident of seemingly intentional patient harm would be disconcerting; multiple incidents are truly disturbing. At this point, however, we believe that the problem is limited to one individual, who is currently behind bars. We will work tirelessly to hold him accountable.”

Dr. Ortiz is charged with tampering with a consumer product and with intentionally adulterating drugs. If convicted, he faces a maximum penalty of life in prison. Dr. Ortiz will make his initial appearance before U.S. Magistrate Judge Renee Toliver in Dallas Sept. 16.

On Sept. 9, the Texas Medical Board suspended Dr. Ortiz’s license in connection with this investigation, noting that the panel found “an imminent peril to the public health, safety, or welfare” and that Dr. Ortiz’s “continuation in the practice of medicine poses a continuing threat to public welfare.”

“It is astounding, stunning [for the victims] to think that anyone did this intentionally,” said Bruce W. Steckler, an attorney for some of the victims, in an interview with WFAA.

Baylor Scott & White Health, which operates the surgical center, said in a statement that the North Dallas facility will remain closed as the investigation continues.

“We actively assisted authorities in their investigation and will continue to do so. We also remain focused on communicating with patients,” the health system said.

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

An anesthesiologist is under arrest and facing criminal charges related to alleged tampering with patient IV bags at Baylor Scott & White Surgicare, a North Dallas surgical center. Raynaldo Rivera Ortiz Jr., MD, 59, is accused of injecting nerve-blocking and bronchodilating drugs into patient IV bags, resulting in at least one death and multiple cardiac emergencies.

In June, an anesthesiologist identified by Dallas ABC affiliate WFAA as Melanie Kaspar, MD, a colleague of Dr. Ortiz’s at the outpatient center, was ill and treated herself for dehydration using an IV bag of saline she had taken home from work. She died immediately after injecting the contents of the bag. According to the autopsy report, she died from a lethal dose of bupivacaine, a nerve-blocking agent often used during the administration of anesthesia. According to WFAA, Dr. Kaspar’s death was initially ruled accidental, but the Dallas County Medical Examiner has since reopened the case. 

Then in August, an 18-year-old male patient, identified in court documents as J.A., experienced a cardiac emergency during a scheduled surgery at the clinic. The teen, who according to local press coverage was undergoing nose surgery after a dirt bike accident, was transferred to a local ICU. A chemical analysis of the fluid from the saline bag that was used during his surgery found epinephrine (a stimulant that could have caused his symptoms), bupivacaine, and lidocaine.

According to court documents, an investigation by the surgical center identified about 10 additional unexpected cardiac emergencies that occurred during what should have been unremarkable surgeries, an exceptionally high rate of complications, suggesting a pattern of intentional adulteration of IV bags. These surgeries were performed between May and August.

In addition, the complaint alleges that none of the cardiac incidents occurred during Dr. Ortiz’s surgeries; however, all of the incidents occurred around the time Dr. Ortiz performed services at the facility, and no incidents occurred while he was on vacation. The incidents began 2 days after Dr. Ortiz had been notified that he was the subject of a disciplinary inquiry stemming from an incident in which he allegedly “deviated from the standard of care” during an anesthesia procedure when a patient experienced a medical emergency, according to federal officials.

The complaint also alleges that Dr. Ortiz had a history of disciplinary actions against him, including at the facility, and he complained that the center was trying to “crucify” him.

Surveillance video from the hallway of the center’s operating room shows Dr. Ortiz placing IV bags in the stainless-steel bag warmer shortly before other doctors’ patients experienced cardiac emergencies, according to the complaint. In the description of one instance captured on video, Dr. Ortiz was observed walking quickly from an operating room to the bag warmer, placing a single IV bag inside, visually scanning the empty hallway, and quickly walking away. Just over an hour later, according to the complaint, a 56-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure.

The complaint alleges that in another instance, Dr. Ortiz was observed exiting his operating room carrying an IV bag concealed in what appeared to be a paper folder, swapping the bag with another bag from the warmer, and walking away. Roughly 30 minutes later, a 54-year-old woman suffered a cardiac emergency during a scheduled cosmetic surgery after a bag from the warmer was used during her procedure. 

“Our complaint alleges this defendant surreptitiously injected heart-stopping drugs into patient IV bags, decimating the Hippocratic Oath,” said Chad E. Meacham, U.S. Attorney for the Northern District of Texas. “A single incident of seemingly intentional patient harm would be disconcerting; multiple incidents are truly disturbing. At this point, however, we believe that the problem is limited to one individual, who is currently behind bars. We will work tirelessly to hold him accountable.”

Dr. Ortiz is charged with tampering with a consumer product and with intentionally adulterating drugs. If convicted, he faces a maximum penalty of life in prison. Dr. Ortiz will make his initial appearance before U.S. Magistrate Judge Renee Toliver in Dallas Sept. 16.

On Sept. 9, the Texas Medical Board suspended Dr. Ortiz’s license in connection with this investigation, noting that the panel found “an imminent peril to the public health, safety, or welfare” and that Dr. Ortiz’s “continuation in the practice of medicine poses a continuing threat to public welfare.”

“It is astounding, stunning [for the victims] to think that anyone did this intentionally,” said Bruce W. Steckler, an attorney for some of the victims, in an interview with WFAA.

Baylor Scott & White Health, which operates the surgical center, said in a statement that the North Dallas facility will remain closed as the investigation continues.

“We actively assisted authorities in their investigation and will continue to do so. We also remain focused on communicating with patients,” the health system said.

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

In 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.

Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.

Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.

Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.

“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.

She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.

The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.

A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.

However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.

Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.

Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”

However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.

Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”

Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.

Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.

“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.

For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.

In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.

Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.

When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.

“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”

Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.

One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.

Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.

Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.

“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”

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 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.

Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.

Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.

Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.

“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.

She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.

The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.

A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.

However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.

Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.

Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”

However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.

Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”

Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.

Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.

“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.

For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.

In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.

Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.

When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.

“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”

Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.

One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.

Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.

Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.

“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”

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 2021, Tim Chevalier received the first of many coverage denials from his insurance company for the hair-removal procedure he needed as part of a phalloplasty, the creation of a penis.

Electrolysis is a common procedure among transgender people like Mr. Chevalier, a software developer in Oakland, Calif.. In some cases, it’s used to remove unwanted hair from the face or body. But it’s also required for a phalloplasty or a vaginoplasty, the creation of a vagina, because all hair must be removed from the tissue that will be relocated during surgery.

Mr. Chevalier’s insurer, Anthem Blue Cross, told him he needed what’s known as a prior authorization for the procedure. Even after Mr. Chevalier received the authorization, he said, his reimbursement claims kept getting denied. According to Mr. Chevalier, Anthem said the procedure was considered cosmetic.

Many trans patients have trouble getting their insurers to cover gender-affirming care. One reason is transphobia within the U.S. health care system, but another involves how medical diagnoses and procedures are coded for insurance companies. Nationwide, health care providers use a list of diagnostic codes provided by the ICD-10. And many of those, advocates for transgender people say, haven’t caught up to the needs of patients. Such diagnostic codes provide the basis for determining which procedures, such as electrolysis or surgery, insurance will cover.

“It’s widely regarded that the codes are very limited in ICD-10,” said Johanna Olson-Kennedy, MD, medical director of the Center for Transyouth Health and Development at Children’s Hospital Los Angeles.

She advocates for a move to the 11th edition of the coding system, which was endorsed by the World Health Organization in 2019 and began to be adopted around the globe in February. Today, more than 34 countries use ICD-11.

The new edition has replaced outdated terms like “transsexualism” and “gender identity disorder” with “gender incongruence,” which is no longer classified as a mental health condition, but as a sexual health one. This is crucial in reducing the stigmatization of trans people in health care, said Dr. Olson-Kennedy.

A move away from the mental health classification may also mean more coverage of gender-affirming care by insurance companies, which sometimes question mental health claims more rigorously than those for physical illnesses. WHO officials have said they hope that adding gender incongruence to a sexual health chapter will “help increase access to care for health interventions” and “destigmatize the condition,” according to the WHO website.

However, history suggests that ICD-11 likely won’t be implemented in the United States for years. The WHO first endorsed ICD-10 in 1990, but the United States didn’t implement it for 25 years.

Meanwhile, patients who identify as transgender and their doctors are spending hours trying to get coverage – or using crowdfunding to cover big out-of-pocket bills. Mr. Chevalier estimated he has received 78 hours of electrolysis at $140 per hour, costing $10,920.

Anthem spokesperson Michael Bowman wrote in an email that “there has been no medical denials or denial of coverage” because Anthem “preapproved coverage for these services.”

However, even after the preapproval was given, Anthem responded to Mr. Chevalier’s claims by stating the electrolysis would not be reimbursed because the procedure is considered cosmetic, rather than medically necessary. This is regardless of Mr. Chevalier’s diagnosis of gender dysphoria – the psychological distress felt when someone’s biological sex and gender identity don’t match – which many doctors consider a medically legitimate reason for hair removal.

Bowman wrote that “once this issue was identified, Anthem implemented an internal process which included a manual override in the billing system.”

Still, Mr. Chevalier filed a complaint with the California Department of Managed Health Care, and the state declared Anthem Blue Cross out of compliance. Additionally, after KHN started asking Anthem questions about Chevalier’s bills, two claims that had not been addressed since April were resolved in July. So far, Anthem has reimbursed Chevalier around $8,000.

Some procedures that trans patients receive can also be excluded from coverage because insurance companies consider them “sex specific.” For example, a transgender man’s gynecological visit may not be covered because his insurance plan covers those visits only for people enrolled as women.

“There is always this question of: What gender should you tell the insurance company?” said Nick Gorton, MD, an emergency medicine physician in Davis, Calif. Dr. Gorton, who is trans, recommends his patients with insurance plans that exclude trans care calculate the out-of-pocket costs that would be required for certain procedures based on whether the patient lists themselves as male or female on their insurance paperwork. For example, Dr. Gorton said, the question for a trans man becomes “what’s more expensive – paying for testosterone or paying for a Pap smear?” – since insurance likely won’t cover both.

For years, some physicians helped trans patients get coverage by finding other medical reasons for their trans-related care. Dr. Gorton said that if, for instance, a transgender man wanted a hysterectomy but his insurance didn’t cover gender-affirming care, Dr. Gorton would enter the ICD-10 code for pelvic pain, as opposed to gender dysphoria, into the patient’s billing record. Pelvic pain is a legitimate reason for the surgery and is commonly accepted by insurance providers, Dr. Gorton said. But some insurance companies pushed back, and he had to find other ways to help his patients.

In 2005, California passed a first-of-its-kind law that prohibits discrimination by health insurance on the basis of gender or gender identity. Now, 24 states and Washington, D.C., forbid private insurance from excluding transgender-related health care benefits.

Consequently, Dr. Gorton no longer needs to use different codes for patients seeking gender-affirming care at his practice in California. But physicians in other states are still struggling.

When Eric Meininger, MD, MPH, an internist and pediatrician at Indiana University Health’s gender health program in Indianapolis, treats a trans kid seeking hormone therapy, he commonly uses the ICD-10 code for “medication management” as the primary reason for the patient’s visit. That’s because Indiana has no law providing insurance protections for LGBTQ+ people, and when gender dysphoria is listed as the primary reason, insurance companies have denied coverage.

“It’s frustrating,” Dr. Meininger said. In a patient’s billing record, he sometimes provides multiple diagnoses, including gender dysphoria, to increase the likelihood that a procedure will be covered. “It’s not hard usually to come up with five or seven or eight diagnoses for someone because there’s lots of vague ones out there.”

Implementing ICD-11 won’t fix all the coding problems, as insurance companies may still refuse to cover procedures related to gender incongruence even though it is listed as a sexual health condition. It also won’t change the fact that many states still allow insurance to exclude gender-affirming care. But in terms of reducing stigma, it’s a step forward, Dr. Olson-Kennedy said.

One reason the United States took so long to switch to ICD-10 is that the American Medical Association strongly opposed the move. It argued the new system would put an incredible burden on doctors. Physicians would have to “contend with 68,000 diagnosis codes – a fivefold increase from the approximately 13,000 diagnosis codes in use today,” the AMA wrote in a 2014 letter. Implementing software to update providers’ coding systems would also be costly, dealing a financial blow to small medical practices, the association argued.

Unlike past coding systems, ICD-11 is fully electronic, with no physical manual of codes, and can be incorporated into a medical facility’s current coding system without requiring a new rollout, said Christian Lindmeier, a WHO spokesperson.

Whether these changes will make the adoption of the new edition easier in the United States is yet to be seen. For now, many trans patients in need of gender-affirming care must pay their bills out of pocket, fight their insurance company for coverage, or rely on the generosity of others.

“Even though I did get reimbursed eventually, the reimbursements were delayed, and it burned up a lot of my time,” Mr. Chevalier said. “Most people would have just given up.”

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.

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

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

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

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

The European Society of Cardiology guidelines on cardiovascular assessment and management of patients undergoing noncardiac surgery have seen extensive revision since the 2014 version.

They still have the same aim – to prevent surgery-related bleeding complications, perioperative myocardial infarction/injury (PMI), stent thrombosis, acute heart failure, arrhythmias, pulmonary embolism, ischemic stroke, and cardiovascular (CV) death.

lyosha_nazarenko/Thinkstock

Cochairpersons Sigrun Halvorsen, MD, PhD, and Julinda Mehilli, MD, presented highlights from the guidelines at the annual congress of the European Society of Cardiology and the document was simultaneously published online in the European Heart Journal.

The document classifies noncardiac surgery into three levels of 30-day risk of CV death, MI, or stroke. Low (< 1%) risk includes eye or thyroid surgery; intermediate (1%-5%) risk includes knee or hip replacement or renal transplant; and high (> 5%) risk includes aortic aneurysm, lung transplant, or pancreatic or bladder cancer surgery (see more examples below).

It classifies patients as low risk if they are younger than 65 without CV disease or CV risk factors (smoking, hypertension, diabetes, dyslipidemia, family history); intermediate risk if they are 65 or older or have CV risk factors; and high risk if they have CVD.  

In an interview, Dr. Halvorsen, professor in cardiology, University of Oslo, zeroed in on three important revisions:

First, recommendations for preoperative ECG and biomarkers are more specific, he noted.

The guidelines advise that before intermediate- or high-risk noncardiac surgery, in patients who have known CVD, CV risk factors (including age 65 or older), or symptoms suggestive of CVD:

• It is recommended to obtain a preoperative 12-lead ECG (class I).
• It is recommended to measure high-sensitivity cardiac troponin T (hs-cTn T) or high-sensitivity cardiac troponin I (hs-cTn I). It is also recommended to measure these biomarkers at 24 hours and 48 hours post surgery (class I).
• It should be considered to measure B-type natriuretic peptide or N-terminal of the prohormone BNP (NT-proBNP).

However, for low-risk patients undergoing low- and intermediate-risk noncardiac surgery, it is not recommended to routinely obtain preoperative ECG, hs-cTn T/I, or BNP/NT-proBNP concentrations (class III).

Troponins have a stronger class I recommendation, compared with the IIA recommendation for BNP, because they are useful for preoperative risk stratification and for diagnosis of PMI, Dr. Halvorsen explained. “Patients receive painkillers after surgery and may have no pain,” she noted, but they may have PMI, which has a bad prognosis.

Second, the guidelines recommend that “all patients should stop smoking 4 weeks before noncardiac surgery [class I],” she noted. Clinicians should also “measure hemoglobin, and if the patient is anemic, treat the anemia.”

Third, the sections on antithrombotic treatment have been significantly revised. “Bridging – stopping an oral antithrombotic drug and switching to a subcutaneous or IV drug – has been common,” Dr. Halvorsen said, “but recently we have new evidence that in most cases that increases the risk of bleeding.”

“We are [now] much more restrictive with respect to bridging” with unfractionated heparin or low-molecular-weight heparin, she said. “We recommend against bridging in patients with low to moderate thrombotic risk,” and bridging should only be considered in patients with mechanical prosthetic heart valves or with very high thrombotic risk.
 

More preoperative recommendations

In the guideline overview session at the congress, Dr. Halverson highlighted some of the new recommendations for preoperative risk assessment.  

If time allows, it is recommended to optimize guideline-recommended treatment of CVD and control of CV risk factors including blood pressure, dyslipidemia, and diabetes, before noncardiac surgery (class I).

Patients commonly have “murmurs, chest pain, dyspnea, and edema that may suggest severe CVD, but may also be caused by noncardiac disease,” she noted. The guidelines state that “for patients with a newly detected murmur and symptoms or signs of CVD, transthoracic echocardiography is recommended before noncardiac surgery (class I).

“Many studies have been performed to try to find out if initiation of specific drugs before surgery could reduce the risk of complications,” Dr. Halvorsen noted. However, few have shown any benefit and “the question of presurgery initiation of beta-blockers has been greatly debated,” she said. “We have again reviewed the literature and concluded ‘Routine initiation of beta-blockers perioperatively is not recommended (class IIIA).’ “

“We adhere to the guidelines on acute and chronic coronary syndrome recommending 6-12 months of dual antiplatelet treatment as a standard before elective surgery,” she said. “However, in case of time-sensitive surgery, the duration of that treatment can be shortened down to a minimum of 1 month after elective PCI and a minimum of 3 months after PCI and ACS.”
 

Patients with specific types of CVD

Dr. Mehilli, a professor at Landshut-Achdorf (Germany) Hospital, highlighted some new guideline recommendations for patients who have specific types of cardiovascular disease.

Coronary artery disease (CAD). “For chronic coronary syndrome, a cardiac workup is recommended only for patients undergoing intermediate risk or high-risk noncardiac surgery.”

“Stress imaging should be considered before any high risk, noncardiac surgery in asymptomatic patients with poor functional capacity and prior PCI or coronary artery bypass graft (new recommendation, class IIa).”

Mitral valve regurgitation. For patients undergoing scheduled noncardiac surgery, who remain symptomatic despite guideline-directed medical treatment for mitral valve regurgitation (including resynchronization and myocardial revascularization), consider a valve intervention – either transcatheter or surgical – before noncardiac surgery in eligible patients with acceptable procedural risk (new recommendation).

Cardiac implantable electronic devices (CIED). For high-risk patients with CIEDs undergoing noncardiac surgery with high probability of electromagnetic interference, a CIED checkup and necessary reprogramming immediately before the procedure should be considered (new recommendation).

Arrhythmias. “I want only to stress,” Dr. Mehilli said, “in patients with atrial fibrillation with acute or worsening hemodynamic instability undergoing noncardiac surgery, an emergency electrical cardioversion is recommended (class I).”

Peripheral artery disease (PAD) and abdominal aortic aneurysm. For these patients “we do not recommend a routine referral for a cardiac workup. But we recommend it for patients with poor functional capacity or with significant risk factors or symptoms (new recommendations).”

Chronic arterial hypertension. “We have modified the recommendation, recommending avoidance of large perioperative fluctuations in blood pressure, and we do not recommend deferring noncardiac surgery in patients with stage 1 or 2 hypertension,” she said.
 

Postoperative cardiovascular complications

The most frequent postoperative cardiovascular complication is PMI, Dr. Mehilli noted.

“In the BASEL-PMI registry, the incidence of this complication around intermediate or high-risk noncardiac surgery was up to 15% among patients older than 65 years or with a history of CAD or PAD, which makes this kind of complication really important to prevent, to assess, and to know how to treat.”

“It is recommended to have a high awareness for perioperative cardiovascular complications, combined with surveillance for PMI in patients undergoing intermediate- or high-risk noncardiac surgery” based on serial measurements of high-sensitivity cardiac troponin.

The guidelines define PMI as “an increase in the delta of high-sensitivity troponin more than the upper level of normal,” Dr. Mehilli said. “It’s different from the one used in a rule-in algorithm for non-STEMI acute coronary syndrome.”

Postoperative atrial fibrillation (AFib) is observed in 2%-30% of noncardiac surgery patients in different registries, particularly in patients undergoing intermediate or high-risk noncardiac surgery, she noted.

“We propose an algorithm on how to prevent and treat this complication. I want to highlight that in patients with hemodynamic unstable postoperative AF[ib], an emergency cardioversion is indicated. For the others, a rate control with the target heart rate of less than 110 beats per minute is indicated.”

In patients with postoperative AFib, long-term oral anticoagulation therapy should be considered in all patients at risk for stroke, considering the anticipated net clinical benefit of oral anticoagulation therapy as well as informed patient preference (new recommendations).

Routine use of beta-blockers to prevent postoperative AFib in patients undergoing noncardiac surgery is not recommended.

The document also covers the management of patients with kidney disease, diabetes, cancer, obesity, and COVID-19. In general, elective noncardiac surgery should be postponed after a patient has COVID-19, until he or she recovers completely, and coexisting conditions are optimized.

The guidelines are available from the ESC website in several formats: pocket guidelines, pocket guidelines smartphone app, guidelines slide set, essential messages, and the European Heart Journal article.
 

Noncardiac surgery risk categories

The guideline includes a table that classifies noncardiac surgeries into three groups, based on the associated 30-day risk of death, MI, or stroke:

• Low (< 1%): breast, dental, eye, thyroid, and minor gynecologic, orthopedic, and urologic surgery.
• Intermediate (1%-5%): carotid surgery, endovascular aortic aneurysm repair, gallbladder surgery, head or neck surgery, hernia repair, peripheral arterial angioplasty, renal transplant, major gynecologic, orthopedic, or neurologic (hip or spine) surgery, or urologic surgery
• High (> 5%): aortic and major vascular surgery (including aortic aneurysm), bladder removal (usually as a result of cancer), limb amputation, lung or liver transplant, pancreatic surgery, or perforated bowel repair.

The guidelines were endorsed by the European Society of Anaesthesiology and Intensive Care. The guideline authors reported numerous disclosures.

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

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

Patients who undergo lung cancer surgery and who receive long-term opioids for pain relief have an elevated risk of all-cause mortality at 2 years, a new study suggests. That risk was 40% higher than among patients who did not receive opioids.

“This is the first study to identify the association of new long-term opioid use with poorer long-term survival outcomes after lung cancer surgery using real-world data based on a national registration database,” said the authors, led by In-Ae Song, MD, Seoul National University Bundang Hospital, Seongnam, South Korea.

“New long-term opioid use may be associated with poor long-term survival outcomes, especially in potent opioid users,” they concluded.

Long-term opioid use might promote protumor activity secondary to immunosuppression along with migration of tumor cells and angiogenesis, the authors suggested.

The study was published online in Regional Anesthesia and Pain.

The finding comes from a study that used the South Korean National Health Insurance database as a nationwide registration data source. “All patients undergoing lung cancer surgery between 2011 and 2018 were included,” the authors noted.

In total, 54,509 patients were included in the final analysis. Six months after undergoing the procedure, 3,325 patients (6.1%) had been prescribed opioids continuously and regularly. These patients constituted the new long-term opioid user group.

This finding fits in with those from past studies that have suggested that new long-term postoperative pain is reported in 4%-12% of patients who undergo lung cancer surgeries, the authors commented.

The new study found that all-cause mortality at 2 years was significantly higher in the new long-term opioid user group than it was in the non–opioid user group (17.3% vs. 9.3%; P < .001).

Moreover, the new long-term opioid user group were at 43% higher risk of 2-year lung cancer mortality and 29% higher risk of 2-year non–lung cancer mortality.

The investigators divided the patients who had received long-term opioids into two subgroups – those who received more potent opioids (1.6%), and those who received less potent opioids (4.5%).

There was a big difference in the results for all-cause mortality.

Compared with nonopioid users, long-term use of less potent opioids was associated with a 2-year mortality risk of only 22% (P < .001), whereas the patients who used potent opioids were at a 92% increased risk of all-cause mortality.

A number of risk factors were associated with an increased rate of new long-term opioid use. These included older age, being male, length of stay in hospital, and comorbidities.

In addition, patients who were more likely to receive long-term opioids included those who had received neoadjuvant and adjuvant chemotherapy and those who had experienced preoperative anxiety disorder or insomnia disorder.

In contrast, patients who underwent video-assisted thoracoscopic surgery were less likely to receive long-term opioids, the authors noted.

The authors disclosed no relevant financial relationships.

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

BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.

The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
 

Moving beyond transvenous and subcutaneous ICDs

Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.

Medtronic

This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
 

A 98.7% rate of arrhythmia termination at implant

The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.

The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.

Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.

Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
 

Short follow-up; questions remain

“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.

“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.

Implantation ‘is not difficult’

The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.

Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.

All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.

Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.

During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
 

A 10% rate of inappropriate shocks

However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.

“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.

Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.

The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.

Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.

“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.

The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.

BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.

The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
 

Moving beyond transvenous and subcutaneous ICDs

Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.

Medtronic

This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
 

A 98.7% rate of arrhythmia termination at implant

The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.

The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.

Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.

Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
 

Short follow-up; questions remain

“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.

“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.

Implantation ‘is not difficult’

The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.

Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.

All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.

Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.

During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
 

A 10% rate of inappropriate shocks

However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.

“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.

Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.

The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.

Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.

“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.

The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.

BARCELONA – A novel “extravascular” implantable cardioverter defibrillator (ICD) that uses substernally placed electrodes surpassed its prespecified efficacy and safety targets in the device’s pivotal trial with 299 patients who received an implant.

The results showed that the extravascular ICD “provides antitachycardia pacing and low energy defibrillation while avoiding the vascular space” for lead placement, Ian Crozier, MD, said at the annual congress of the European Society of Cardiology.

Mitchel L. Zoler/MDedge News

“The results are fantastic; they exceeded our expectations,” said Dr. Crozier in an interview, adding that he expects the new device to receive marketing approval from regulatory agencies based on the findings. “This will be the next generation of ICD going forward,” predicted Dr. Crozier, an electrophysiologist cardiologist at Christchurch (New Zealand) Hospital.
 

Moving beyond transvenous and subcutaneous ICDs

Traditional ICDs use transvenous leads, which can cause vascular injury, are prone to lead fracture over time, and can produce serious infections as well as other potential complications. The U.S. Food and Drug Administration first approved an alternative-design, subcutaneous ICD in 2012 that avoids the need for transvenous leads and the risks they pose. But subcutaneous ICDs have their own limitations: an inability to provide antitachycardia pacing or chronic pacing; a limited ability to provide bradycardia pacing; and an increased device size with shorter battery life, because of the high shock power needed for effective performance. These drawbacks have collectively hindered uptake, Dr. Crozier said.

Medtronic

This led to development of the extravascular ICD – 10 years in the making – which uses substernally placed leads that allow antitachycardia pacing and backup pacing in a device with the size of and the anticipated battery longevity of a transvenous ICD device, noted Dr. Crozier.
 

A 98.7% rate of arrhythmia termination at implant

The pivotal trial’s primary efficacy endpoint was successful defibrillation based on terminating an induced, sustained, shockable ventricular arrhythmia at the time of implantation. The rate was 98.7%, compared with a prespecified target of 88%. All patients had a class I or IIa indication for an ICD.

The primary safety endpoint was freedom from major system- or procedure-related complications at 6 months, which occurred at a rate of 92.6%, compared with the study’s prespecified target rate of 79%. Both targets were derived from the historical rates of ICDs with transvenous leads.

Simultaneously with Dr. Crozier’s report at the congress, the results also appeared online in the New England Journal of Medicine.

Although the pivotal study met both prespecified endpoints, the evidence has limitations that make it likely that regulatory bodies will seek additional data, commented Fred Kusumoto, MD, director of heart rhythm services for the Mayo Clinic in Jacksonville, Fla.
 

Short follow-up; questions remain

“Follow-up was relatively short, less than a year,” and “questions remain” about the extravascular ICD’s performance, Dr. Kusumoto said in an interview. “Inappropriate shocks occurred in nearly 10% of patients after 11 month follow-up,” he noted, and also cited the 29 patients who needed revisions including two cases with lead fractures.

“The extravascular lead strategy has an advantage over transvenous systems because of the lower risk for extraction or explant,” and it also provides the antitachycardia pacing that’s not available with subcutaneous ICDs, he granted. But in the new study, antitachycardia termination was delivered to only 10 patients and had “reasonable” effectiveness by resolving 70% of these episodes. “Wide adoption by clinicians will depend on results from larger studies with longer follow-up,” Dr. Kusumoto maintained. He also wanted to see confirmation of the ease of lead removal after longer periods of implantation.

Implantation ‘is not difficult’

The trial ran at 46 sites in 17 countries during September 2019 to October 2021. It enrolled patients with a class I or IIa indication for an ICD, excluding patients with a prior sternotomy or need for chronic pacing, and those unable to undergo defibrillation testing.

Clinicians attempted an implantation in 316 patients and had successful placement in 299 (314 had successful placement of their substernal leads), with 292 having a functional device after 6 months, and 284 completing their planned 6-month follow-up. The median procedure time was 66 minutes, including the time for defibrillation testing.

All of the cardiologists who did the implants had received a full day of training prior to performing the procedure. “This is not a difficult procedure, but it is not a region [the substernal space] that cardiologists are familiar working in,” noted Dr. Crozier, explaining the rationale behind a policy of required implantation training.

Twenty-five adverse events occurred in 23 patients. Eighteen of these events required a system revision, including nine lead dislodgments and five infections. The seven adverse events that did not require a revision included three wound-related episodes and three hospitalizations for inappropriate shock. No patients died, nor were there any cardiac injuries as result of the implant.

During average follow-up of 10.6 months, the implanted devices delivered antitachycardia pacing to 10 patients, successfully terminating 32 of 46 episodes (70%), a rate that Dr. Crozier called “very good, and very comparable to transvenous devices.” The devices also delivered 18 appropriate shocks that successfully converted all 18 episodes.
 

A 10% rate of inappropriate shocks

However, 29 patients (10% of the study cohort) received inappropriate shocks in 81 episodes, with a total of 118 inappropriate shocks delivered, including 34 episodes (42%) triggered by oversensing of a P wave.

“We fully acknowledge that the inappropriate shock rate is higher than what’s seen with transvenous ICDs, but the rate is comparable to what was seen in the early trials with subcutaneous ICDs,” said Dr. Crozier. “We have a number of strategies to reduce the inappropriate shock rate to what we’d expect with conventional devices,” such as making sure that P waves are not detected by the device at the time of implantation, using new algorithms to mitigate P wave sensing, and other programming changes, he added.

Two patients had lead fractures that Dr. Crozier attributed to atypical lead locations and that are likely avoidable in the future. He expressed optimism that the extravascular ICD will avoid the high lead fracture rate over time that remains a problem for ICDs with transvenous leads.

The study also followed a subgroup of 36 patients who underwent a prespecified protocol of chronic defibrillation testing that was successful in all 36.

Dr. Crozier conceded that the extravascular ICD cannot currently deliver chronic pacing, but he expressed optimism that this capability will be available in the future.

“This innovative [extravascular] ICD system would be particularly beneficial for patients with ventricular arrhythmias that can be reliably pace terminated and avoid a transvenous endocardial lead, but more information is required,” concluded Dr. Kusumoto.

The study was sponsored by Medtronic, the company that is developing the extravascular ICD. Dr. Crozier is a consultant to and has received research funding from Medtronic. Dr. Kusumoto had no disclosures.

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

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

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

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

BARCELONA – For patients with emphysema who are suitable candidates for lung volume reduction surgery, there were no differences at 1 year in either lung function, dyspnea, or exercise capacity between patients who were assigned to undergo standard lung volume reduction surgery (LVRS) or bronchoscopic lung volume reduction with endobrachial valves (BLVR-EBV) in a randomized trial.

Among patients with emphysema amenable to surgery, there were similar improvements between the treatment groups at 12-month follow-up as assessed by the iBODE score, a composite disease severity measure incorporating body mass index, airflow obstruction, dyspnea, and exercise capacity (incremental shuttle walk test), reported Sara Buttery, BSc, a research physiotherapist and PhD candidate at the National Heart and Lung Institute at Imperial College London.

“Until now there had been no direct comparison of the two to inform decision-making when a person seems to be suitable for either. Bronchoscopic lung volume reduction is a less invasive option and is thought to be ‘less risky’ but, until now, there has not been substantial research to support this,” she said at the annual congress of the European Respiratory Society.

Ms. Buttery and colleagues conducted a randomized, controlled, single-blinded superiority trial to see whether LVRS could be superior to BLVR with valves. They enrolled 88 patients (52% male) with a mean age of 64, and randomly assigned them to receive either LVRS (41 patients) or the less-invasive BLVR (47 patients).

As noted before, there were no significant differences in outcomes at 1 year, with similar degrees of improvement between the surgical techniques for both the composite iBODE score (–1.10 for LVRS vs. –0.82 for BLVR, nonsignificant), and for the individual components of the score.

In addition, the treatments were associated with similar reductions in gas trapping, with residual volume percentage predicted –36.1 with LVRS versus –30.5 with BLVR (nonsignificant).

One patient in each group died during the 12 months of follow-up. The death of the patient in the BLVR group was deemed to be treatment related; the death of the patient in the LVRS group was related to a noninfective exacerbation of chronic obstructive pulmonary disease.

Invited discussant Isabelle Opitz, MD, from University Hospital Zürich told Ms. Buttery: “I have to congratulate you for this very first randomized controlled trial comparing both procedures in a superiority design.”

She pointed out, however, that the number of patients lost to follow-up and crossover of some patients randomized to bronchoscopy raised questions about the powering of the study.

“We did a sensitivity analysis to have a look to see if there was any difference between the patients who did return and the ones who didn’t, and there was no difference at baseline between those patients.” Ms. Buttery said.

She noted that follow-up visits were hampered by the COVID-19 pandemic and the inability of many patients to come into the clinic.

Dr. Opitz also asked about COPD Assessment Test (CAT) scores that were included in the trial design but not reported in the presentation. Ms. Buttery said that the CAT results favored the LVRS group, and that the results would be included in a future economic analysis.

“The results from this first randomized controlled trial suggest that BLVR may be a good therapeutic option for those patients for whom either procedure is suitable,” said Alexander Mathioudakis, MD, PhD, from the University of Manchester (England), who was not involved with this study but commented on it in a press statement. “Lung volume reduction surgery is an invasive operation as it requires a small incision to be made in the chest, which is stitched up after the procedure. As such, it has risks associated with surgery and it takes longer to recover from than bronchoscopic lung volume reduction. On the other hand, endobronchial valves placement is also associated with side effects, such as pneumonia, or valve displacement. Therefore, both the safety and effectiveness of the two procedures need to be investigated further, in larger groups of patients, but the results from this trial are very encouraging.”

The study is supported by the U.K. National Institute of Health Research. Ms. Buttery, Dr. Opitz, and Dr. Mathioudakis reported no relevant financial relationships.

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