Transcatheter Mitral Valve Therapy: STS-ACC TVT Registry Report

Quick Takes

  • This in-depth review of trends in transcatheter mitral valve therapies (transcatheter edge-to-edge repair [TEER] and transcatheter mitral valve replacement [TMVR]) in the US shows a 10-fold increase in procedural volumes from 2014–2020 (Q1).
  • Primary mitral regurgitation (MR) remains the most common indication for TEER; however, there has been a doubling of procedural volume for secondary MR since 2018. Valve-in-valve therapy remains the most common indication for TMVR followed by valve-in-MAC and valve-in-ring.
  • Procedural outcomes for both TMVR and TEER including length of stay and reduction in functional class have improved, and complication rates remain low.

Study Questions:

What are trends in transcatheter mitral valve therapies in the United States from 2014–2020?

Methods:

All patients undergoing transcatheter edge-to-edge repair (TEER) and transcatheter mitral valve replacement (TMVR) with an approved device in the United States are enrolled in the STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry. All data submitted for TEER or TMVR between 2014 and March 31, 2020, are reported.

Results:

A total of 37,475 patients underwent a mitral transcatheter procedure, including 33,878 TEER and 3,597 TMVR. Annual procedure volumes for TEER have increased from 1,152 per year in 2014 to 10,460 per year in 2019 at 403 sites, and for TMVR, from 84 per year to 1,120 per year at 301 centers. Mortality rates have decreased for TEER at 30 days (5.6%-4.1%) and 1 year (27.4%-22.0%). Early off-label use data on TMVR in mitral valve-in-valve therapy led to approval by the US Food and Drug Administration (FDA) in 2017, and the 2019 30-day mortality rate was 3.9%.

Conclusions:

The STS/ACC TVT Registry was formed by the professional societies in collaboration with the FDA to assess the introduction of innovative transcatheter valve therapy in the United States. With patient-level data from >30,000 procedures from 2014 through the first quarter of 2020, important insights can be discerned into the current state of transcatheter mitral valve therapies. With the growth of transcatheter mitral valve repair and replacement and improved outcomes for both procedures, substantial variations in effectiveness and safety of these technologies are apparent.

Perspective:

This in-depth review of trends in transcatheter mitral valve therapies (TEER and TMVR) in the United States shows a 10-fold increase in procedural volumes from 2014–2020 (Q1). Primary mitral regurgitation (MR) remains the most common indication for TEER; however, there has been a doubling of procedural volume for secondary MR since 2018. Valve-in-valve therapy remains the most common indication for TMVR followed by valve–in–mitral annular calcification (MAC) and valve-in-ring. Procedural outcomes for both TMVR and TEER including length of stay and reduction in functional class have improved, and complication rates remain low. Although 30-day and 1-year mortality rates remain significant, the reliability of this finding is hampered by baseline high-risk patient cohorts being offered these therapies and missing data variables.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Cardiac Surgical Procedures, Heart Failure, Heart Valve Diseases, Length of Stay, Mitral Valve, Mitral Valve Insufficiency, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement


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