Does the PASCAL transcatheter valve repair system improve tricuspid regurgitation severity and functional status in patients with symptomatic severe TR?
The PASCAL transcatheter valve repair system demonstrated early feasibility, safety, and significant reduction in tricuspid regurgitation severity and symptoms at 30 days.
BACKGROUND Tricuspid regurgitation (TR) is a prevalent disease with limited treatment options. OBJECTIVES This is the first 30-day report of the U.S. single-arm, multicenter, prospective CLASP TR early feasibility study of the PASCAL transcatheter valve repair system in the treatment of TR. METHODS Patients with symptomatic TR despite optimal medical therapy, reviewed by the local heart team and central screening committee, were eligible for the study. Data were collected at baseline, discharge, and the 30-day follow-up and were reviewed by an independent clinical events committee and echocardiographic core laboratory. Feasibility endpoints included safety (composite major adverse event MAE rate), echocardiographic, clinical, and functional endpoints. RESULTS Of the 34 patients enrolled in the study, the mean age was 76 years, 53% were women, the mean Society of Thoracic Surgeons score was 7.3%, 88% had atrial fibrillation/flutter, 97% had severe or greater TR, and 79% had New York Heart Association (NYHA) functional class III/IV symptoms. Twenty-nine patients (85%) received implants; at 30 days, 85% of them achieved a TR severity reduction of at least 1 grade, with 52% with moderate or less TR (p < 0.001). The MAE rate was 5.9%, and none of the patients experienced cardiovascular mortality, stroke, myocardial infarction, renal complication, or reintervention. Eighty-nine percent of the patients improved to NYHA functional class I/II (p < 0.001), the mean 6-min walk distance improved by 71 m (p < 0.001), and the mean Kansas City Cardiomyopathy Questionnaire score improved by 15 points (p < 0.001). CONCLUSIONS In this early experience, the repair system performed as intended, with substantial TR reduction, favorable safety results with a low MAE rate, no mortality or reintervention, and significant improvements in functional status, exercise capacity, and quality of life. (Edwards CLASP TR EFS CLASP TR EFS; NCT03745313).
“These results are encouraging and consistent with those reported following the initial commercial approval of PASCAL in Europe. Without directly comparing different devices and studies, the safety and effectiveness of TEER observed in the CLASP TR EFS have generally been in line with previous studies using the TriClip Tricuspid Valve Repair System”
Kodali et al. (Mon,) studied this question.