Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study.

Spargias, Konstantinos; Lim, D Scott; 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, Christopher O; Walters, Darren L; Levisay, Justin; Montorfano, Matteo; Latib, Azeem; Carroll, John D; Nickenig, Georg; Windecker, Stephan; Marcoff, Leo; Cohen, Gideon N; ... (2023). Three-year outcomes for transcatheter repair in patients with mitral regurgitation from the CLASP study. Catheterization and cardiovascular interventions: official journal of the Society for Cardiac Angiography & Interventions, 102(1), pp. 145-154. Wiley 10.1002/ccd.30686

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BACKGROUND

Mitral valve transcatheter edge-to-edge repair (M-TEER) is an effective option for treatment of mitral regurgitation (MR). We previously reported favorable 2-year outcomes for the PASCAL transcatheter valve repair system.

OBJECTIVES

We report 3-year outcomes from the multinational, prospective, single-arm CLASP study with analysis by functional MR (FMR) and degenerative MR (DMR).

METHODS

Patients with core-lab determined MR ≥ 3+ were deemed candidates for M-TEER by the local heart team. Major adverse events were assessed by an independent clinical events committee to 1 year and by sites thereafter. Echocardiographic outcomes were evaluated by the core laboratory to 3 years.

RESULTS

The study enrolled 124 patients, 69% FMR; 31% DMR (60% NYHA class III-IVa, 100% MR ≥ 3+). The 3-year Kaplan-Meier estimate for survival was 75% (66% FMR; 92% DMR) and freedom from heart failure hospitalization (HFH) was 73% (64% FMR; 91% DMR), with 85% reduction in annualized HFH rate (81% FMR; 96% DMR) (p < 0.001). MR ≤ 2+ was achieved and maintained in 93% of patients (93% FMR; 94% DMR) and MR ≤ 1+ in 70% of patients (71% FMR; 67% DMR) (p < 0.001). The mean left ventricular end-diastolic volume (181 mL at baseline) decreased progressively by 28 mL [p < 0.001]. NYHA class I/II was achieved in 89% of patients (p < 0.001).

CONCLUSIONS

The 3-year results from the CLASP study demonstrated favorable and durable outcomes with the PASCAL transcatheter valve repair system in patients with clinically significant MR. These results add to the growing body of evidence establishing the PASCAL system as a valuable therapy for patients with significant symptomatic MR.

Item Type:	Journal Article (Original Article)
Division/Institute:	04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology
UniBE Contributor:	Windecker, Stephan
Subjects:	600 Technology > 610 Medicine & health
ISSN:	1522-726X
Publisher:	Wiley
Language:	English
Submitter:	Pubmed Import
Date Deposited:	15 May 2023 08:53
Last Modified:	04 Jul 2023 00:15
Publisher DOI:	10.1002/ccd.30686
PubMed ID:	37178388
Uncontrolled Keywords:	3-year outcomes CLASP DMR FMR TEER mitral repair
URI:	https://boris.unibe.ch/id/eprint/182544