Medical Technology

Transcatheter Mitral Valve Procedures Increase Tenfold Since 2014.

A new Society of Thoracic Surgeons–American College of Cardiology Transcatheter Valve Therapy (STS-ACC-TVT) Registry offers an up-to-date systematic review of transcatheter mitral valve therapy in the United States.

Registry data show significant annual growth in both transcatheter mitral valve repair and replacement with improving outcomes over time. The report was published online in the Journal of the American College of Cardiology.

Transcatheter edge to edge repair of the mitral valve (TEER) and transcatheter mitral valve replacement (TMVR) with the MitraClip system (Abbott, Inc) were approved by the US Food and Drug Administration as a reasonable alternative to surgery in patients who have severe mitral regurgitation with severe symptoms in New York Heart Association (NYHA) Class III or IV and other comorbidities that put them at high surgical risk.

The registry captures data for nearly all patients undergoing TEER and TMVR in the US between 2014 and March 2020.

In all, 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3597 TMVR.

TEER volumes increased from 1152 per year in 2014 to 10,460 per year in 2019 at 403 sites.

TMVR volumes increased from 84 per year to 1120 per year at 301 centers.

Mortality rates for TEER at 30 days decreased from 5.6% to 4.1%, and 1-year mortality decreased from 27.4% to 22.0%.

“The results in this registry are in high-risk patients, because that is all these procedures are approved for, but there are now two trials in the US in intermediate- and low-risk patients, comparing it to surgery,” Michael Mack, MD, Baylor, Scott and White Health, Dallas, Texas, and first author on the report, told | Medscape Cardiology.

“This registry report serves as the baseline of what current outcomes are, and this will be very useful going forward,” Mack said.

Useful Information, Impressive Increase

“This is very useful information,” Catherine M. Otto, MD, J. Ward Kennedy-Hamilton Endowed Chair in Cardiology at the University of Washington, Seattle, told | Medscape Cardiology, commenting on the findings.

“It’s impressive that there has been this tenfold increase in TEER, which is only a 2A indication, which means it is reasonable, rather than recommended. TEER is reasonable in people who are high surgical risk, and in people who are lower surgical risk, we’re still recommending surgery, particularly mitral valve repair. I think that’s an important angle for patients to understand,” Otto said.

“The registry shows what it should and that people are following the recent AHA/ACC guidelines. The median age of patients was 80, they were all high risk, and so the mortality rate at a year might be considered not exactly low, but these were elderly patients,” she said.

Transcatheter therapies for such high-risk individuals may not prolong life, but if they will make patients feel better, patients should have that information to help them make informed decisions, Otto added.

“I would want to know if having TEER or TMVR will make me feel better.”

Mack reports the following relationships: Edwards Lifesciences (Co-PI Partner 3 Trial), Medtronic (Study Chair Apollo Trial), Abbott (Co-PI Coapt Trial). Uncompensated. Travel expenses paid for trial related meetings. Otto reports no relevant financial relationships.

J Am Coll Cardiol. Published online October 25, 2021. Abstract

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