Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report

Paul Sorajja, Sreekanth Vemulapalli, Ted Feldman, Michael Mack, David Holmes, Amanda Stebbins, Saibal Kar, Vinod Thourani, Gorav Ailawadi

Research output: Contribution to journalArticle

102 Scopus citations

Abstract

Background Post-market surveillance is needed to evaluate the real-world clinical effectiveness and safety of U.S. Food and Drug Administration–approved devices. Objectives The authors examined the commercial experience with transcatheter mitral valve repair for the treatment of mitral regurgitation. Methods Data from the Society of Thoracic Surgery/American College of Cardiology Transcatheter Valve Therapy Registry on patients commercially treated with transcatheter mitral valve repair were analyzed. The study population consisted of 2,952 patients treated at 145 hospitals between November 2013 and September 2015. In 1,867 patients, data were linked to patient-specific Centers for Medicare and Medicaid Services administrative claims for analyses. Results The median age was 82 years (55.8% men), with a median Society of Thoracic Surgery predicted risk of mortality of 6.1% (interquartile range: 3.7% to 9.9%) and 9.2% (interquartile range: 6.0% to 14.1%) for mitral repair and replacement, respectively. Overall, in-hospital mortality was 2.7%. Acute procedure success occurred in 91.8%. Among the patients with Centers for Medicare and Medicaid Services linkage data, the mortality at 30 days and at 1 year was 5.2% and 25.8%, respectively, and repeat hospitalization for heart failure at 1 year occurred in 20.2%. Variables associated with mortality or rehospitalization for heart failure after multivariate adjustment were increasing age, lower baseline left ventricular ejection fraction, worse post-procedural mitral regurgitation, moderate or severe lung disease, dialysis, and severe tricuspid regurgitation. Conclusions Our findings demonstrate that commercial transcatheter mitral valve repair is being performed in the United States with acute effectiveness and safety. Our findings may help determine which patients have favorable long-term outcomes with this therapy.

Original languageEnglish (US)
Pages (from-to)2315-2327
Number of pages13
JournalJournal of the American College of Cardiology
Volume70
Issue number19
DOIs
StatePublished - Nov 7 2017

Keywords

  • mitral regurgitation
  • outcomes
  • transcatheter

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Sorajja, P., Vemulapalli, S., Feldman, T., Mack, M., Holmes, D., Stebbins, A., Kar, S., Thourani, V., & Ailawadi, G. (2017). Outcomes With Transcatheter Mitral Valve Repair in the United States: An STS/ACC TVT Registry Report. Journal of the American College of Cardiology, 70(19), 2315-2327. https://doi.org/10.1016/j.jacc.2017.09.015