TY - JOUR
T1 - 2-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study
AU - Szerlip, Molly
AU - Spargias, Konstantinos S.
AU - Makkar, Raj
AU - Kar, Saibal
AU - Kipperman, Robert M.
AU - O'Neill, William W.
AU - Ng, Martin K.C.
AU - Smith, Robert L.
AU - Fam, Neil P.
AU - Rinaldi, Michael J.
AU - Raffel, O. Christopher
AU - Walters, Darren L.
AU - Levisay, Justin
AU - Montorfano, Matteo
AU - Latib, Azeem
AU - Carroll, John D.
AU - Nickenig, Georg
AU - Windecker, Stephan
AU - Marcoff, Leo
AU - Cohen, Gideon N.
AU - Schäfer, Ulrich
AU - Webb, John G.
AU - Lim, D. Scott
N1 - Funding Information:
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.
Publisher Copyright:
© 2021 American College of Cardiology Foundation
PY - 2021/7/26
Y1 - 2021/7/26
N2 - 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.
AB - 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.
KW - CLASP study
KW - PASCAL
KW - degenerative mitral regurgitation
KW - functional mitral regurgitation
KW - mitral regurgitation
KW - mitral repair
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U2 - 10.1016/j.jcin.2021.04.001
DO - 10.1016/j.jcin.2021.04.001
M3 - Article
C2 - 34020928
AN - SCOPUS:85110238674
SN - 1936-8798
VL - 14
SP - 1538
EP - 1548
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 14
ER -