TCT CONNECT-5 Six-Month and One-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study
Smith R, Szerlip M, Lim S, Makkar R, Kar S, Kipperman R, Spargias K, O'Neill W, Ng M, Fam N, Rinaldi M, Raffel O, Walters D, Levisay J, Montorfano M, Latib A, Cohen G, Schäfer U, Marcoff L, and Webb J. TCT CONNECT-5 Six-Month and One-Year Outcomes for Transcatheter Repair in Patients With Mitral Regurgitation From the CLASP Study. Journal of the American College of Cardiology 2020; 76(17):B3.
Journal of the American College of Cardiology
Background: Transcatheter mitral valve repair has emerged as a viable option for treating mitral regurgitation (MR). We report results from the multicenter, prospective, single-arm CLASP study with the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, California).
Methods: 109 intent to treat and roll-in patients with clinically significant MR ≥3+ and deemed candidates for transcatheter repair by the local heart team were treated in the CLASP study. The study outcomes were evaluated by an independent clinical events committee and echocardiographic core laboratory. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications.
Results: Mean age was 76 years, 54% male, 57% New York Heart Association (NYHA) functional class III/IV, 100% MR grade ≥3+ with 67% functional, 33% degenerative etiology. Successful implantation was achieved in 95% of patients. At 30 days, the MAE rate was 8.3% including 1 cardiovascular mortality, 1 stroke, and 1 conversion to mitral valve replacement surgery. 88% of patients were in NYHA functional class I/II (p < 0.001); MR grade was ≤1+ in 80% of patients and ≤2+ in 96% of patients. Significant improvements in 6-minute walk distance (+28 m; p < 0.001) and KCCQ (+16 points; p < 0.001) were observed. These outcomes were sustained at 6 months. We report 1-year follow-up of the first 62 intent to treat patients: 92% 1-year survival rate (KM estimate), no stroke, no late reintervention, and one late myocardial infarction. MR grade was ≤1+ in 82% of patients and ≤2+ in 100% of patients. 88% of patients were in NYHA functional class I/II (p < 0.001), 6-minute walk distance improved by 21 m (p = 0.124), and KCCQ improved by 14 points (p < 0.001).
Conclusion: This study demonstrates the PASCAL transcatheter valve repair system is safe and resulted in significant MR reduction at 30 days and 6 months and was sustained at 1 year with 100% of patients achieving MR ≤2+ and 82% MR ≤1+. Results show a high survival and low complication rates with sustained improvements in functional status, exercise capacity, and quality of life at 1 year.