1-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study |
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| Affiliation: | 1. St. Paul’s Hospital, Vancouver, British Columbia, Canada;2. Baylor Scott and White The Heart Hospital Plano, Plano, Texas;3. Marienkrankenhaus, Hamburg, Germany;4. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada;5. Los Robles Regional Medical Center, Thousand Oaks, California;6. Cedars-Sinai Medical Center, Los Angeles, California;7. Atlantic Health System Morristown Medical Center, Morristown, New Jersey;8. Hygeia Hospital, Athens, Greece;9. Henry Ford Hospital, Detroit, Michigan;10. Royal Prince Alfred Hospital, Camperdown, Australia;11. St. Michael’s Hospital, Toronto, Ontario, Canada;12. Sanger Heart & Vascular Institute, Charlotte, North Carolina;13. The Prince Charles Hospital, Chermside, Australia;14. NorthShore University Health System, Evanston Hospital, Evanston, Illinois;15. Montefiore Medical Center, Bronx, New York;p. San Raffaele Institute, Milan, Italy;q. Edwards Lifesciences, Irvine, California;r. University of Virginia Health System Hospital, Charlottesville, Virginia |
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| Abstract: | ObjectivesThe 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).BackgroundThe 30-day results from the CLASP study of the PASCAL transcatheter valve repair system for clinically significant mitral regurgitation (MR) have been previously reported.MethodsEligible 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.ResultsOne 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).ConclusionsThe 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) |
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| Keywords: | CLASP degenerative mitral regurgitation functional mitral regurgitation mitral regurgitation mitral repair PASCAL 6MWD" },{" #name" :" keyword" ," $" :{" id" :" kwrd0045" }," $$" :[{" #name" :" text" ," _" :" 6-min walk distance DMR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0055" }," $$" :[{" #name" :" text" ," _" :" degenerative mitral regurgitation FMR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0065" }," $$" :[{" #name" :" text" ," _" :" functional mitral regurgitation LV" },{" #name" :" keyword" ," $" :{" id" :" kwrd0075" }," $$" :[{" #name" :" text" ," _" :" left ventricular MAE" },{" #name" :" keyword" ," $" :{" id" :" kwrd0085" }," $$" :[{" #name" :" text" ," _" :" major adverse event MI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0095" }," $$" :[{" #name" :" text" ," _" :" myocardial infarction MR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0105" }," $$" :[{" #name" :" text" ," _" :" mitral regurgitation NYHA" },{" #name" :" keyword" ," $" :{" id" :" kwrd0115" }," $$" :[{" #name" :" text" ," _" :" New York Heart Association |
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