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

doi:10.1016/j.jcin.2020.06.019

JACC: Cardiovascular Interventions

Volume 13, Issue 20, 26 October 2020, Pages 2344-2357

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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)

Central Illustration

Key Words

CLASP

degenerative mitral regurgitation

functional mitral regurgitation

mitral regurgitation

mitral repair

PASCAL

Abbreviations and Acronyms

6MWD

6-min walk distance

DMR

degenerative mitral regurgitation

FMR

functional mitral regurgitation

left ventricular

MAE

major adverse event

myocardial infarction

mitral regurgitation

NYHA

New York Heart Association

Cited by (0)

: This study was funded by Edwards Lifesciences. Drs. Lim, Fam, Webb, and Schäfer have received speaking honoraria, travel support, or grant support from Edwards Lifesciences. Drs. O’Neill, Ng, and Smith have received grant support from Edwards Lifesciences. Drs. Szerlip, Spargias, and Marcoff are speakers or consultants for Edwards Lifesciences. Dr. Feldman, Dr. Shrivastava, and Ms. Gilmore are employees of Edwards Lifesciences. Dr. Rinaldi teaches courses and is a proctor, speaker, and consultant for Abbott Vascular; is an advisory board member, a consultant, and a speaker for Boston Scientific; has received a research grant from Boston Scientific; and teaches courses and is a consultant, proctor, and speaker for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

: The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.