Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data

Abstract

Background: The PASCAL Precision transcatheter valve repair system provides a new option for treating prohibitive surgical risk patients with significant, symptomatic degenerative mitral regurgitation (DMR). Objectives: The authors report early U.S. commercial experience with the PASCAL Precision system. Methods: Patients with DMR treated with the PASCAL Precision system in the United States were analyzed from the STS/ACC TVT Registry. Procedural, clinical, echocardiographic, functional, and quality-of-life outcomes to 30 days were assessed. All outcomes, including echocardiographic assessments, were site-assessed. Results: In 1,995 DMR patients, the median age was 81.6 years, and 57.0% were male. Median STS-PROM for mitral valve repair was 3.6%, and 69.4% were in NYHA functional class III/IV. Mixed etiology (DMR + other etiology) was present in 11.4%, and 66.9% had complex anatomy (annular/leaflet calcification, mitral valve area <4 cm2, bileaflet flail/prolapse/tethering, or mitral stenosis). The device was successfully implanted in 97.7%. MR reduction was significant at 30 days with 94.2% achieving ≤moderate MR and 72.6% ≤mild MR (P < 0.001 vs baseline). Patients experienced significant functional and quality-of-life improvements with a mean 21.0-point increase in Kansas City Cardiomyopathy Questionnaire score and 84.6% in NYHA functional class I/II (all P < 0.001). Mitral valve reintervention and single-leaflet device attachment rates were 0.4% and 0.5%, respectively, and all-cause mortality, cardiovascular mortality, and heart failure readmission rates were 2.2%, 1.2%, and 2.6%, respectively, at 30 days. Conclusions: Early U.S. STS/ACC TVT Registry commercial experience confirms the safety and effectiveness of the novel PASCAL Precision system in the treatment of a broad population of real-world DMR patients.