1-Year Outcomes From the Multicenter, Prospective Study With the Novel PASCAL Transcatheter Valve Repair System for Patients With Mitral Regurgitation in the CLASP Study
Kar S, Ng M, Lim S, Walters D, Webb J, Fam N, Rinaldi M, Kipperman R, Latib A, Cohen G, Smith R, Spargias K, O'Neill W, Schäfer U, and Feldman T. 1-Year Outcomes From the Multicenter, Prospective Study With the Novel PASCAL Transcatheter Valve Repair System for Patients With Mitral Regurgitation in the CLASP Study. J Am Coll Cardiol 2019; 74(13):B91.
J Am Coll Cardiol
Background: Severe mitral regurgitation (MR) may lead to an impaired prognosis if left untreated. Transcatheter treatment options have emerged as alternatives to surgery and an adjunct to medical therapy. We report the 1-year results of the first 30 patients in the multicenter, prospective, single-arm CLASP study treating patients with MR with the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, California). Methods: Eligible patients had clinically significant MR despite optimal medical therapy and were deemed candidates for transcatheter mitral repair by the local heart team. Safety, performance, and clinical outcomes were assessed up to 1-year post-procedure. All major adverse events (MAE) were adjudicated by an independent clinical events committee, and echocardiographic images were assessed by a core laboratory. The MAE rate at 30 days was the primary safety endpoint, defined as the composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and reintervention for study device–related complications. Results: From June 2017 to September 2018, 62 patients were enrolled (mean age 77 years, 63% men) with MR grade ≥3+ (55% functional, 37% degenerative, 8% mixed etiology), and 52% of patients were in New York Heart Association (NYHA) functional class III/IV. Successful implantation of the PASCAL device was achieved in 95% of patients. The primary safety endpoint was 6.5%, with 1 cardiovascular mortality. At 6-month follow-up, paired analyses showed 98% of patients with grade ≤2+ MR, 81% with grade ≤1+ MR, and 88% in NYHA functional class I/II (p < 0.0001). The 6MWT improved by 21 m (p = 0.1525) and was accompanied by average improvements in Kansas City Cardiomyopathy Questionnaire and EQ5D scores by 17 points (p < 0.0001) and 11 points (p < 0.0001), respectively. The 1-year results in the first 30 patients will be available for presentation. Conclusion: In this early device experience, the PASCAL repair system showed an acceptable safety profile in treating patients with mitral regurgitation. The PASCAL device resulted in substantial MR grade reduction, which was associated with clinically significant improvements in functional status, exercise capacity, and quality of life.