PASCAL transcatheter valve repair system for mitral regurgitation has shown feasibility and safety to treat patients with grade 3+ or 4+, regardless etiology. Regurgitation grade was significantly reduced, and this was accompanied by clinical improvement in functional class, exercise capacity and quality of life.
This study soon to be published in J Am Coll Cardiol Intv is just a 30-day report on the new transcatheter mitral valve repair system PASCAL (Edwards Lifesciences, Irvine, California), but it is a promising tool that increases our arsenal to treat the mitral valve.
Eligible patients should have mitral valve regurgitation grade 3+ or 4+ and be symptomatic, despite optimal medical treatment. Major adverse events were adjudicated by an independent committee and echocardiographic images assessed by a central laboratory. Primary safety end points were major events at 30 days.
Between 2017 and 2018, 62 patients were enrolled, mean age 76.5, more than half (51.6%) were in functional class III-IV. Etiology was 56% functional, 36% degenerative and 8% mixed.
At 30 days, major event rate was 6.5% with 1.6% all-cause mortality and no stroke. 98% reached ≤2+ regurgitation grade and 86% ≤1+ grade (p=0.0001). As regards symptoms, 85% reached functional class I or II (p=0.0001).
6-minute walk test improved 36 meters (p=0.0018) and quality of life questionnaires improved, the Kansas City Cardiomyopathy Questionnaire improved 17 points (p<0.0001) and the score EQ-5D 10 points (p=0.0004).
The transcatheter mitral valve repair system PASCAL showed feasibility and safety to treat patients with mitral valve regurgitation 3+ to 4+, regardless etiology.
Clinical improvement was significant, as was functional class, exercise capacity and quality of life.
Original Title: Transcatheter Valve Repair for Patients With Mitral Regurgitation 30-Day Results of the CLASP Study.
Reference: D. Scott Lim et al. J Am Coll Cardiol Intv 2019, article in press.
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