Early Experience With New Transcatheter Mitral Valve Replacement

Vinayak Bapat, Vivek Rajagopal, Christopher Meduri, R Saeid Farivar, Antony Walton, Stephen J Duffy, Robert Gooley, Aubrey Almeida, Michael J Reardon, Neal S Kleiman, Konstantinos Spargias, Stratis Pattakos, Martin K Ng, Michael Wilson, David H Adams, Martin Leon, Michael J Mack, Sharla Chenoweth, Paul Sorajja, Intrepid Global Pilot Study Investigators

Research output: Contribution to journalArticlepeer-review

221 Scopus citations

Abstract

Background Transcatheter mitral valve replacement (TMVR) is a potential therapy for patients with symptomatic, severe mitral regurgitation (MR). The feasibility of this therapy remains to be defined. Objectives The authors report their early experience with TMVR using a new valve system. Methods The valve is a self-expanding, nitinol valve with bovine pericardial leaflets that is placed using a transapical delivery system. Patients with symptomatic MR who were deemed high or extreme risk by the local heart teams were enrolled in a global pilot study at 14 sites (United States, Australia, and Europe). Results Fifty consecutively enrolled patients (mean age: 73 ± 9 years; 58.0% men; 84% secondary MR) underwent TMVR with the valve. The mean Society for Thoracic Surgery score was 6.4 ± 5.5%; 86% of patients were New York Heart Association functional class III or IV, and the mean left ventricular ejection fraction was 43 ± 12%. Device implant was successful in 48 patients with a median deployment time of 14 min (interquartile range: 12 to 17 min). The 30-day mortality was 14%, with no disabling strokes, or repeat interventions. Median follow-up was 173 days (interquartile range: 54 to 342 days). At latest follow-up, echocardiography confirmed mild or no residual MR in all patients who received implants. Improvements in symptom class (79% in New York Heart Association functional class I or II at follow-up; p < 0.0001 vs. baseline) and Minnesota Heart Failure Questionnaire scores (56.2 ± 26.8 vs. 31.7 ± 22.1; p = 0.011) were observed. Conclusions TMVR with the valve was feasible in a study group at high or extreme risk for conventional mitral valve replacement.

Original languageEnglish (US)
Pages (from-to)12-21
Number of pages10
JournalJournal of the American College of Cardiology
Volume71
Issue number1
DOIs
StatePublished - Jan 2 2018

Keywords

  • Journal Article
  • transcatheter mitral valve replacement
  • prosthesis
  • mitral valve regurgitation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Early Experience With New Transcatheter Mitral Valve Replacement'. Together they form a unique fingerprint.

Cite this