Updated 30-Day Outcomes for the U.S. Early Feasibility Study of the SAPIEN M3 Transcatheter Mitral Valve Replacement System
Makkar R, O'Neill W, Whisenant B, Guerrero M, Feldman T, Rihal C, Gorelick J, and Webb J. Updated 30-Day Outcomes for the U.S. Early Feasibility Study of the SAPIEN M3 Transcatheter Mitral Valve Replacement System. J Am Coll Cardiol 2019; 74(13):B8.
J Am Coll Cardiol
Background: Our aim was to determine the initial technical feasibility, clinical safety, and efficacy of the SAPIEN M3 System in patients with severe mitral regurgitation (MR). Mitral valve surgery is currently recommended in patients with severe, symptomatic MR. The SAPIEN M3 System is a novel, transvenous, transseptal mitral valve (Edwards Lifesciences) that may provide a minimally invasive alternative to surgery for high-risk patients with severe mitral valve disease. The SAPIEN M3 system comprises 2 components: 1) a transseptal, transcatheter docking system that is introduced via the medial mitral commissure into the left ventricle to encircle the mitral chordae; and 2) a modified SAPIEN3 valve deployed into the dock. Methods: A total of 4 U.S. sites participated in this early feasibility study of 35 high-surgical-risk patients with severe, symptomatic MR. Key inclusion criteria included MR ≥3+, New York Heart Association functional class ≥II, and high risk for cardiovascular surgery as determined by the heart team. The primary endpoint was technical success, defined by Mitral Valve Academic Research Consortium criteria at exit from the cardiac catheterization laboratory. Follow-up visits are scheduled for 30 days, 6 months, 1 year, and annually to 5 years. Results: Technical success was achieved in 88.6% of patients (31 of 35; 1 patient underwent percutaneous paravalvular leak closure during the index procedure, 1 patient had separate transseptal punctures for deployment of the docking system and valve, and 2 patients had transseptal punctures but no valve deployment). One patient experienced disabling stroke 30 days post-procedure. The 30-day all-cause mortality rate was 2.9% (n = 1). Echocardiographic data at 30 days was available in 33 of 34 patients: 87.9% had ≤1+ MR and 12.1% had ≥2+ MR. Mean mitral valve gradient was 3.20 ± 1.88 mm Hg at baseline and 5.36 ± 0.33 mm Hg at 30 days. Conclusion: The use of the SAPIEN M3 System for treating high-risk patients with severe MR is technically feasible, safe, and effective in reducing MR. These early data suggest that application of this modified SAPIEN 3 valve in the treatment of native MR warrants investigation in a large clinical trial setting.