JACC. Cardiovascular interventions · 2019
Transcatheter Valve Repair for Patients With Mitral Regurgitation: 30-Day Results of the CLASP Study.
СтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАКлиническое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Lim D Scott, Kar Saibal, Spargias Konstantinos, Kipperman Robert M, O'Neill William W, Ng Martin K C, Fam Neil P, Walters Darren L, Webb John G, Smith Robert L, Rinaldi Michael J, Latib Azeem, Cohen Gideon N, Schäfer Ulrich, Marcoff Leo, Vandrangi Prashanthi, Verta Patrick, Feldman Ted E
Аннотация
OBJECTIVES: The authors report the procedural and 30-day results of the PASCAL Transcatheter Valve Repair System (Edwards Lifesciences, Irvine, California) in patients with mitral regurgitation (MR) enrolled in the multicenter, prospective, single-arm CLASP study.
BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.
METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.
RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.
CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).
BACKGROUND: Severe MR may lead to symptoms, impaired quality of life, and reduced functional capacity when untreated.
METHODS: Eligible patients had grade 3+ or 4+ MR despite optimal medical therapy and were deemed appropriate for the study by the local heart team. All outcomes were assessed through 30 days post-procedure. Major adverse events (MAEs) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The primary safety endpoint was the rate of MAEs at 30 days.
RESULTS: Between June 2017 and September 2018, 62 patients with grade 3+ or 4+ MR were enrolled. The mean age was 76.5 years, and 51.6% of patients were in New York Heart Association functional class III or IV, with 56% functional, 36% degenerative, and 8% mixed MR etiology. At 30 days, the MAE rate was 6.5%, with an all-cause mortality rate of 1.6% and no occurrence of stroke; 98% had MR grade ≤2+, with 86% with MR grade ≤1+ (p < 0.0001); and 85% were in New York Heart Association functional class I or II (p < 0.0001). Six-minute walk distance improved by 36 m (p = 0.0018), and Kansas City Cardiomyopathy Questionnaire and EQ-5D scores improved by 17 (p < 0.0001) and 10 (p = 0.0004) points, respectively.
CONCLUSIONS: The PASCAL repair system showed feasibility and acceptable safety in the treatment of patients with grade 3+ or 4+ MR. MR severity, irrespective of etiology, was significantly reduced and accompanied by clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. (The CLASP Study Edwards PASCAL Transcatheter Mitral Valve Repair System Study; NCT03170349).
Предметные рубрики MeSH
AgedAged, 80 and overCardiac CatheterizationExercise ToleranceFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHemodynamicsHumansMaleMitral ValveMitral Valve InsufficiencyProspective StudiesProsthesis DesignQuality of LifeRecovery of FunctionRisk FactorsSeverity of Illness IndexTime FactorsTreatment OutcomeVentricular Function, Left