TY - JOUR
T1 - Transcatheter Valve Repair for Patients With Mitral Regurgitation
T2 - 30-Day Results of the CLASP Study
AU - Lim, D. Scott
AU - Kar, Saibal
AU - Spargias, Konstantinos
AU - Kipperman, Robert M.
AU - O'Neill, William W.
AU - Ng, Martin K.C.
AU - Fam, Neil P.
AU - Walters, Darren L.
AU - Webb, John G.
AU - Smith, Robert L.
AU - Rinaldi, Michael J.
AU - Latib, A.
AU - Cohen, Gideon N.
AU - Schäfer, Ulrich
AU - Marcoff, Leo
AU - Vandrangi, Prashanthi
AU - Verta, Patrick
AU - Feldman, T. E.
N1 - Publisher Copyright:
© 2019
PY - 2019/7/22
Y1 - 2019/7/22
N2 - 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.
AB - 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.
KW - CLASP
KW - PASCAL
KW - mitral regurgitation
KW - mitral repair
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U2 - 10.1016/j.jcin.2019.04.034
DO - 10.1016/j.jcin.2019.04.034
M3 - Article
C2 - 31255562
AN - SCOPUS:85068431590
SN - 1936-8798
VL - 12
SP - 1369
EP - 1378
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 14
ER -