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

John G Webb1, Mark Hensey1, Molly Szerlip2

  • 1St. Paul's Hospital, Vancouver, British Columbia, Canada.

JACC. Cardiovascular Interventions
|October 23, 2020
PubMed

Insights

The PASCAL transcatheter valve repair system shows excellent 1-year outcomes for mitral regurgitation, with high survival and significant quality of life improvements in patients with functional and degenerative mitral regurgitation.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • The CLASP study previously reported 30-day outcomes for the PASCAL transcatheter valve repair system.
  • This study extends the experience to 1-year outcomes and analyzes results based on mitral regurgitation type.

Purpose of the Study:

  • To evaluate the expanded experience and 1-year outcomes of the Edwards PASCAL Transcatheter Mitral Valve Repair System.
  • To analyze the system's effectiveness in patients with functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR).

Main Methods:

  • The study included 109 patients with symptomatic moderate to severe mitral regurgitation (MR) receiving optimal medical therapy.
  • Patients underwent transcatheter mitral repair using the PASCAL system.
  • Primary endpoints included procedural and clinical success, and major adverse events at 30 days, with follow-up to 1 year.

Main Results:

  • At 1 year, Kaplan-Meier survival was 92% (89% FMR, 96% DMR).
  • 82% of patients achieved MR ≤1+ (79% FMR, 86% DMR), and 100% achieved MR ≤2+.
  • Significant improvements were observed in New York Heart Association functional class (88% I or II), 6-minute walk distance, and Kansas City Cardiomyopathy Questionnaire scores.

Conclusions:

  • The PASCAL system demonstrated a low complication rate and high survival at 1 year.
  • Robust and sustained MR reduction was achieved, leading to significant improvements in functional status and quality of life.
  • The findings support the use of the PASCAL transcatheter valve repair system for patients with significant mitral regurgitation.
Abstract

Keywords:
CLASPPASCALdegenerative mitral regurgitationfunctional mitral regurgitationmitral regurgitationmitral repair

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