HFSA 2019: A Transcatheter Valve Repair System Reduces Grade of Mitral Regurgitation Significantly
Reduction was linked to improvement in functional status, exercise capacity, and quality of life.
September 13, 2019—Philadelphia, Pennsylvania—A transcatheter mitral valve repair device has been shown to lead to a significant grade reduction in mitral regurgitation. The device was associated with clinically and statistically significant improvements in functional status, exercise capacity, and quality of life.
This 6-month result of the single-arm, multicenter, prospective PASCAL trAnScatheter mitral valve rePair (CLASP) study was reported at the 23rd Annual Scientific Meeting of the Heart Failure Society of America (HFSA), from September 13 – 16.
Sula Mazimba, MD, of the University of Virginia, Charlottesville, and colleagues enrolled eligible patients with clinically significant mitral regurgitation despite optimal medical therapy. All were deemed candidates for transcatheter mitral repair.
Major adverse events and echocardiographic images were assessed. The rate of major adverse events was defined as the composite of cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and reintervention for study device-related complications.
A total of 62 patients were enrolled worldwide for transcatheter mitral valve reconstruction using the PASCAL system. Mean patient age was 76.5 years. All patients exhibited grade ≥3+ mitral regurgitation and 51.6% of patients suffered from in New York Heart Association class III/IV heart failure.
Overall, 95% of patients experienced successful implantation of the device. At discharge, 95% of patients exhibited grade ≤2+; 81%, grade ≤1+ mitral regurgitation. The rate of major adverse events was 4.8%.
At 30-day follow-up, 98% of patients exhibited grade ≤2+; 81% grade ≤1+ mitral regurgitation. In all, 88% were classified as suffering from New York Heart Association class I/II heart failure (P < .01).
Results of the 6-minute walk test had improved by 38.9 m (P < .01). This improvement was accompanied by average improvement in Kansas City Cardiomyopathy Questionnaire and EuroQol 5D scores by 14.1 (P < .01) and 8.3 points (P < .01), respectively.
Dr. Mazimba explained that severe mitral regurgitation can lead to an impaired prognosis if left untreated. Transcatheter treatment options have emerged as an alternative to surgery and an adjunct to medical therapy.
The PASCAL system is leaflet repair therapy that employs clasps and paddles to place a woven Nitinol spacer between the native valve leaflets to fill the regurgitant orifice via a transseptal approach.
The estimated primary completion date of the CLASP study is December 2019. The estimated study completion date is January 2024.
Primary outcome measures are a composite of major adverse events defined as cardiovascular mortality, stroke, myocardial infarction, new need for renal replacement therapy, severe bleeding, and reintervention for study device-related complications at 30 days. The primary endpoint was assessed after 30 days.
Secondary outcome measures are:
- Mitral regurgitation reduction after 30 days, 6 months, and 1 year
- All-cause mortality after 30 days, 6 months, and 1 year
- Recurrent heart failure hospitalization after 30 days, 6 months, and 1 year
- Change in 6-minute walk test distance after 6 months and 1 year
Dr. Mazimba concluded that, in this early device experience, the PASCAL device resulted in a significant reduction in mitral regurgitation grade.
This reduction was associated with clinically and statistically significant improvements in functional status, exercise capacity, and quality of life. Continued follow-up is warranted to validate these initial promising results.
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