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

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

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

Journal

JACC. Cardiovascular interventions

ISSN: 1876-7605

Titre abrégé: JACC Cardiovasc Interv

Pays: United States

ID NLM: 101467004

Informations de publication

Date de publication:
26 07 2021

Historique:

received: 22 02 2021

revised: 01 04 2021

accepted: 06 04 2021

pubmed: 23 5 2021

medline: 30 10 2021

entrez: 22 5 2021

Statut: ppublish

Résumé

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

Sections du résumé

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.

Identifiants

DOI: 10.1016/j.jcin.2021.04.001 PMID: 34020928

pubmed: 34020928

pii: S1936-8798(21)00675-0

doi: 10.1016/j.jcin.2021.04.001

pii:

doi:

Types de publication

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

Langues

eng

Sous-ensembles de citation

Pagination

1538-1548

Commentaires et corrections

Type : CommentIn

Type : ErratumIn

Informations de copyright

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures This work was supported by Edwards Lifesciences. Drs. Szerlip, Spargias, O’Neill, Ng, Smith, Fam, Rinaldi, Nickenig, Schäfer, Webb, and Lim have served as speakers, served as consultants, or received travel/grant support from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.