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Original Investigation
July 29, 2020

One-Year Outcomes of Mitral Valve-in-Valve Using the SAPIEN 3 Transcatheter Heart Valve

Author Affiliations
  • 1Intermountain Medical Center, Salt Lake City, Utah
  • 2Cleveland Clinic, Cleveland, Ohio
  • 3Mayo Clinic Hospital, Rochester, Minnesota
  • 4Columbia University, New York, New York
  • 5University of Washington Medical Center, Seattle
  • 6Saint Thomas Hospital, Nashville, Tennessee
  • 7Memorial Hermann Heart and Vascular Institute, University of Texas/McGovern Medical School, Houston
  • 8Heart Hospital Baylor Plano, Plano, Texas
  • 9Henry Ford Hospital, Detroit, Michigan
  • 10Cedar Sinai Medical Center, Los Angeles, California
JAMA Cardiol. 2020;5(11):1245-1252. doi:10.1001/jamacardio.2020.2974
Key Points

Question  What are the contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) transcatheter mitral valve-in-valve (MViV) replacement?

Findings  In this cohort study of 1529 high-risk patients who received SAPIEN 3 MViV, procedural technical success was 96.8% and all-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access

Meaning  In this study, the transseptal SAPIEN 3 MViV was associated with rare procedural complications and low mortality and should be considered an option for most patients with failed surgical bioprosthetic mitral valves.

Abstract

Importance  Bioprosthetic mitral valves are implanted with increasing frequency but inevitably degenerate, leading to heart failure. Reoperation is associated with high morbidity and mortality. Transcatheter mitral valve-in-valve (MViV) using balloon-expandable transcatheter valves has emerged as an alternative for high–surgical risk patients.

Objective  To assess contemporary outcomes of SAPIEN 3 (Edwards Lifesciences) MViV replacement.

Design, Setting, and Participants  In this registry-based prospective cohort study of SAPIEN 3 MViV, patients entered in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from June 2015 to July 2019 were analyzed. US Centers for Medicare and Medicaid linkage ensured comprehensive collection of death and stroke data.

Exposures  Mitral valve-in-valve for degenerated bioprosthetic mitral valves.

Main Outcomes and Measures  The primary efficacy end point was 1-year mortality. The primary safety end point was procedural technical success as defined by the Mitral Valve Academic Research Consortium criteria. Secondary end points included 30-day mortality, New York Heart Association–defined heart failure, and mitral valve performance.

Results  A total of 1529 patients (mean [SD] age, 73.3 [11.84] years; 904 women [59.1%]) underwent transseptal or transapical MViV implant at 295 hospitals between June 2015 and July 2019. The mean (SD) Society of Thoracic Surgeons predicted risk of mortality was 11.1% (8.7%). Procedural technical success was achieved for 1480 of 1529 patients (96.8%). All-cause mortality was 5.4% at 30 days and 16.7% at 1 year. Transseptal access was associated with lower 1-year all-cause mortality than transapical access (15.8% vs 21.7%; P = .03). Transcatheter MViV led to early, sustained, and clinically meaningful improvements in heart failure (class III/IV New York Heart Association heart failure of 87.1% at baseline vs 9.7% at 1 year). The mean (SD) mitral valve gradient at 1 year was 7 (2.89) mm Hg.

Conclusions and Relevance  Transcatheter MViV using the SAPIEN 3 transcatheter heart valve is associated with high technical success, low 30-day and 1-year mortality, significant improvement of heart failure symptoms, and sustained valve performance. Transseptal MViV should be considered an option for most patients with failed surgical bioprosthetic valves and favorable anatomy.

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