TY - JOUR
T1 - 1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study
AU - Webb, John G.
AU - Hensey, Mark
AU - Szerlip, Molly
AU - Schäfer, Ulrich
AU - Cohen, Gideon N.
AU - Kar, Saibal
AU - Makkar, Raj
AU - Kipperman, Robert M.
AU - Spargias, Konstantinos
AU - O'Neill, William W.
AU - Ng, Martin K.C.
AU - Fam, Neil P.
AU - Rinaldi, Michael J.
AU - Smith, Robert L.
AU - Walters, Darren L.
AU - Raffel, Christopher O.
AU - Levisay, Justin
AU - Latib, Azeem
AU - Montorfano, Matteo
AU - Marcoff, Leo
AU - Shrivastava, Maithili
AU - Boone, Robert
AU - Gilmore, Suzanne
AU - Feldman, Ted E.
AU - Lim, D. Scott
N1 - Funding Information:
This study was funded by Edwards Lifesciences. Drs. Lim, Fam, Webb, and Schäfer have received speaking honoraria, travel support, or grant support from Edwards Lifesciences. Drs. O’Neill, Ng, and Smith have received grant support from Edwards Lifesciences. Drs. Szerlip, Spargias, and Marcoff are speakers or consultants for Edwards Lifesciences. Dr. Feldman, Dr. Shrivastava, and Ms. Gilmore are employees of Edwards Lifesciences. Dr. Rinaldi teaches courses and is a proctor, speaker, and consultant for Abbott Vascular; is an advisory board member, a consultant, and a speaker for Boston Scientific; has received a research grant from Boston Scientific; and teaches courses and is a consultant, proctor, and speaker for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 American College of Cardiology Foundation
PY - 2020/10/26
Y1 - 2020/10/26
N2 - Objectives: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). Background: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Methods: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. Results: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). Conclusions: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)
AB - Objectives: The authors report the CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) expanded experience, 1-year outcomes, and analysis by functional mitral regurgitation (FMR) and degenerative mitral regurgitation (DMR). Background: The 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported. Methods: Eligible patients had symptomatic MR ≥3+, were receiving optimal medical therapy, and were deemed candidates for transcatheter mitral repair by the local heart team. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days. Follow-up was continued to 1 year. Results: One hundred nine patients were treated (67% FMR, 33% DMR); the mean age was 75.5 years, and 57% were in New York Heart Association functional class III or IV. At 30 days, there was 1 cardiovascular death (0.9%), MR ≤1+ was achieved in 80% of patients (77% FMR, 86% DMR) and MR ≤2+ in 96% (96% FMR, 97% DMR), 88% of patients were in New York Heart Association functional class I or II, 6-min walk distance had improved by 28 m, and Kansas City Cardiomyopathy Questionnaire score had improved by 16 points (p < 0.001 for all). At 1 year, Kaplan-Meier survival was 92% (89% FMR 96% DMR) with 88% freedom from heart failure hospitalization (80% FMR, 100% DMR), MR was ≤1+ in 82% of patients (79% FMR, 86% DMR) and ≤2+ in 100% of patients, 88% of patients were in New York Heart Association functional class I or II, and Kansas City Cardiomyopathy Questionnaire score had improved by 14 points (p < 0.001 for all). Conclusions: The PASCAL transcatheter valve repair system demonstrated a low complication rate and high survival, with robust sustained MR reduction accompanied by significant improvements in functional status and quality of life at 1 year. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study [CLASP]; NCT03170349)
KW - CLASP
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.2020.06.019
DO - 10.1016/j.jcin.2020.06.019
M3 - Article
C2 - 33092709
AN - SCOPUS:85091198086
SN - 1936-8798
VL - 13
SP - 2344
EP - 2357
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 20
ER -