This paper is only available as a PDF. To read, Please Download here.
Transcatheter mitral valve repair has emerged as a viable option for treating functional mitral regurgitation (FMR). We report results for the FMR cohort from the multicenter, prospective, single arm CLASP study with the PASCAL transcatheter valve repair system (Edwards Lifesciences, Irvine, CA).
Eligible patients had clinically significant and symptomatic MR ≥3+ and were deemed candidates for transcatheter repair by the local heart team. The study outcomes were evaluated by an independent clinical events committee and echocardiographic core lab. The primary safety endpoint was a composite MAE rate at 30 days of cardiovascular mortality, stroke, MI, new need for renal replacement therapy, severe bleeding, and re-intervention for study device-related complications.
Of the 109 patients enrolled (intent to treat/ITT and roll-in), 73 (67%) had FMR as determined by the core lab. Mean age was 73 years, 55% male, 60% NYHA Class III/IV with 100% MR grade ≥3+. Successful implantation was achieved in 96% of patients. At 30 days, the MAE rate was 11.0% including one cardiovascular mortality, one stroke, and one conversion to mitral valve replacement surgery. At 30 days, 88% of patients were in NYHA Class I/II (p<0.001), MR grade was ≤1+ in 77% of patients and ≤2+ in 96% of patients. Improvements in 6MWD (+23 m, p=0.009) and KCCQ (+15 points, p<0.001) were observed. These outcomes were sustained at six-months. In addition, we report one-year follow up of the first 38 FMR patients (ITT): 89% one-year survival rate (KM estimate) with 80% freedom from HF hospitalization and no late strokes. At 1 year, MR grade was ≤1+ in 79% of patients and ≤2+ in 100% of patients. 83% of patients were in NYHA Class I/II (p<0.001), 6MWD improved by 24 m (p=0.261) and KCCQ improved by 13 points (p=0.002).
This study demonstrates that the PASCAL repair system is safe and results in remarkable MR reduction in patients with FMR. 100% of patients achieved MR ≤2+, and ∼ 80% achieved MR ≤1+, sustained at one year. Results show a high survival rate, low complications, and sustained improvements in functional status, exercise capacity, and quality of life at one year.
To read this article in full you will need to make a payment
Purchase one-time access:Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
One-time access price info
- For academic or personal research use, select 'Academic and Personal'
- For corporate R&D use, select 'Corporate R&D Professionals'
Subscribe:Subscribe to Journal of Cardiac Failure
Already a print subscriber? Claim online access
Already an online subscriber? Sign in
Register: Create an account
Institutional Access: Sign in to ScienceDirect
© 2020 Published by Elsevier Inc.