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

Szerlip, Molly; Spargias, Konstantinos S; Makkar, Raj; Kar, Saibal; Kipperman, Robert M; O'Neill, William W; Ng, Martin K C; Smith, Robert L; Fam, Neil P; Rinaldi, Michael J; Raffel, O Christopher; Walters, Darren L; Levisay, Justin; Montorfano, Matteo; Latib, Azeem; Carroll, John D; Nickenig, Georg; Windecker, Stephan; Marcoff, Leo; Cohen, Gideon N; ... (2021). 2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. JACC. Cardiovascular Interventions, 14(14), pp. 1538-1548. Elsevier 10.1016/j.jcin.2021.04.001

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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.

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