1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study

John G. Webb, Mark Hensey, Molly Szerlip, Ulrich Schäfer, Gideon N. Cohen, Saibal Kar, Raj Makkar, Robert M. Kipperman, Konstantinos Spargias, William W. O'Neill, Martin K.C. Ng, Neil P. Fam, Michael J. Rinaldi, Robert L. Smith, Darren L. Walters, Christopher O. Raffel, Justin Levisay, Azeem Latib, Matteo Montorfano, Leo MarcoffMaithili Shrivastava, Robert Boone, Suzanne Gilmore, Ted E. Feldman, D. Scott Lim

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

Abstract

Objectives: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). Background: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Methods: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. Results: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). Conclusions: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)

Original languageEnglish (US)
Pages (from-to)2344-2357
Number of pages14
JournalJACC: Cardiovascular Interventions
Volume13
Issue number20
DOIs
StatePublished - Oct 26 2020
Externally publishedYes

Keywords

  • CLASP
  • PASCAL
  • degenerative mitral regurgitation
  • functional mitral regurgitation
  • mitral regurgitation
  • mitral repair

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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