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

JACC Cardiovasc Interv. 2021 Jul 26;14(14):1538-1548. doi: 10.1016/j.jcin.2021.04.001. Epub 2021 May 18.


Objectives: This study reports 2-year outcomes from the multicenter, prospective, single-arm CLASP study with functional mitral regurgitation (FMR) and degenerative MR (DMR) analysis.

Background: Transcatheter repair is a favorable option to treat MR. Long-term prognostic impact of the PASCAL transcatheter valve repair system in patients with clinically significant MR remains to be established.

Methods: Patients had clinically significant MR ≥3+ as evaluated by the echocardiographic core laboratory and were deemed candidates for transcatheter repair by the heart team. Assessments were performed by clinical events committee to 1 year (site-reported thereafter) and core laboratory to 2 years.

Results: A total of 124 patients (69% FMR, 31% DMR) were enrolled with a mean age of 75 years, 56% were male, 60% were New York Heart Association functional class III to IVa, and 100% had MR ≥3+. At 2 years, Kaplan-Meier estimates showed 80% survival (72% FMR, 94% DMR) and 84% freedom from heart failure (HF) hospitalization (78% FMR, 97% DMR), with 85% reduction in annualized HF hospitalization rate (81% FMR, 98% DMR). MR ≤1+ was achieved in 78% of patients (84% FMR, 71% DMR) and MR ≤2+ was achieved in 97% (95% FMR, 100% DMR) (all p < 0.001). Left ventricular end-diastolic volume decreased by 33 ml (p < 0.001); 93% of patients were in New York Heart Association functional class I to II (p < 0.001).

Conclusions: The PASCAL repair system demonstrated sustained favorable outcomes at 2 years in FMR and DMR patients. Results showed high survival and freedom from HF rehospitalization rates with a significantly reduced annualized HF hospitalization rate. Durable MR reduction was achieved with evidence of left ventricular reverse remodeling and significant improvement in functional status. The CLASP IID/IIF randomized pivotal trial is ongoing.

Keywords: CLASP study; PASCAL; degenerative mitral regurgitation; functional mitral regurgitation; mitral regurgitation; mitral repair.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Heart Valve Prosthesis Implantation* / adverse effects
  • Humans
  • Male
  • Mitral Valve / diagnostic imaging
  • Mitral Valve / surgery
  • Mitral Valve Insufficiency* / diagnostic imaging
  • Mitral Valve Insufficiency* / surgery
  • Prospective Studies
  • Treatment Outcome