Six-month Outcomes from the Multicenter, Prospective Study with the Novel PASCAL Transcatheter Valve Repair System for Patients with Mitral Regurgitation in the CLASP Study

Abstract

Severe mitral regurgitation (MR) may lead to an impaired prognosis if left untreated. Transcatheter treatment options have emerged as an alternative to surgery and an adjunct to medical therapy. We report the six-month results of the PASCAL transcatheter valve repair system in treating patients with MR enrolled in the multicenter, prospective, single arm CLASP study. The PASCAL system is a leaflet repair therapy that uses clasps and paddles to place a woven Nitinol spacer between the native valve leaflets to fill the regurgitant orifice via a transseptal approach. Eligible patients had clinically significant MR despite optimal medical therapy and were deemed candidates for transcatheter mitral repair by the local Heart Team. All major adverse events (MAE) were adjudicated by an independent clinical events committee and echocardiographic images were assessed by a core lab. The MAE rate was defined as the composite of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications. 62 patients were enrolled worldwide for transcatheter mitral valve reconstruction using the PASCAL system. The mean age was 76.5 years. All patients had MR grade ≥3+ and 51.6% of patients were in NYHA Class III/IV. Successful implantation of the PASCAL device was achieved in 95% of patients. At discharge, 95% of patients had MR grade ≤2+ with 81% grade ≤1+. The MAE rate was 4.8%. At 30-day follow-up, 98% of patients had MR grade ≤2+ with 81% grade ≤1+ and 88% were in NYHA Class I/II (p