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

Molly Szerlip, Konstantinos S. Spargias, Raj Makkar, Saibal Kar, Robert M. Kipperman, William W. O'Neill, Martin K.C. Ng, Robert L. Smith, Neil P. Fam, Michael J. Rinaldi, O. Christopher Raffel, Darren L. Walters, Justin Levisay, Matteo Montorfano, Azeem Latib, John D. Carroll, Georg Nickenig, Stephan Windecker, Leo Marcoff, Gideon N. CohenUlrich Schäfer, John G. Webb, D. Scott Lim

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1538-1548
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume14
Issue number14
DOIs
StatePublished - Jul 26 2021

Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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