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Transcatheter mitral valve repair system safe, effective at 6 months
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PHILADELPHIA — Six-month data from the CLASP study showed a transcatheter mitral valve repair system for patients with functional mitral regurgitation conferred acceptable safety and statistically significant improvements in functional status and quality of life.
At 6 months, the device (Pascal Transcatheter Valve Repair System, Edwards Lifesciences) was associated with high rates of freedom from mortality (94%) and HF hospitalization (89%) as well as significant reduction in mitral regurgitation severity (baseline, 100% moderate or severe; 6 months, 3% moderate or severe; P < .0001), Sula Mazimba, MD, MPH, assistant professor of medicine at the University of Virginia Health System, said in a presentation at the Heart Failure Society of America Annual Scientific Meeting.
Kansas City Cardiomyopathy Questionnaire overall summary score improved by 17 points between baseline and 6 months, and NYHA class significantly improved during that time (P < .0001 for both). according to the researchers.
Left ventricular end-diastolic volume was reduced by 19 mL at 6 months (P = .0044) and health status as measured by EQ-5D improved by 12 during that time (P = .0004), Mazimba said.
Researchers implanted the transcatheter valve repair system in 62 patients. The present analysis focused on the 38 patients who had predominantly functional mitral regurgitation (mean age, 74 years; 63% men; 79% with atrial fibrillation; 68% with hypertension) despite optimal medical therapy.
“We find that the PASCAL transcatheter valve repair system was safe and performed as intended for patients with mitral regurgitation and that 6 months we saw a low rate of cardiovascular mortality and heart failure hospitalization,” Mazimba said. “MR reduction was significant at 6 months and significant improvements were noted in the functional status and quality of life. We still need to see how these results will pan out as we continue this clinical trial.” – by Scott Buzby
Reference:
Mazimba S, et al. Abstract 014. Presented at: Heart Failure Society of America Annual Scientific Meeting; Sept. 13-16, 2019; Philadelphia.
Disclosure: Mazimba reports no relevant financial disclosures.