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Background
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).
Methods
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.
Results
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).
Conclusions
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.
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Copyright
© 2020 Published by Elsevier Inc.
