Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data
Recommended Citation
Waggoner T, Garcia S, Chakravarty T, Makar M, Latib A, Kipperman RM, Zahr F, Hanson I, Sinha AK, Sharma RP, Depta JP, Castellanos JA, Kodali S, Krishnaswamy A, Whisenant B, Menees D, Lim DS, Gilani F, Sanchez CE, Gheewala N, Gada H, Kapadia S, Ramanathan PK, Shah PB, Renard B, Theodos G, Yaryura R, Gardner B, Steinberg DH, Gnall E, Kaddissi G, Chhatriwalla AK, Frangieh AH, Eleid MF, Géneréux P, Saxon JT, Villablanca P, Matar F, Agarwal H, Chetcuti S, Frisoli T, and Makkar R. Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data. JACC Cardiovasc Interv 2025;18(16):2036-2046.
Document Type
Article
Publication Date
8-25-2025
Publication Title
JACC Cardiovasc Interv
Keywords
Humans, Male, Female, Aged, Treatment Outcome, United States, Mitral Valve Insufficiency, Registries, Time Factors, Mitral Valve, Heart Valve Prosthesis, Cardiac Catheterization, Aged, 80 and over, Heart Valve Prosthesis Implantation, Recovery of Function, Quality of Life, Prosthesis Design, Risk Factors, Postoperative Complications
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 cm(2), 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.
Medical Subject Headings
Humans; Male; Female; Aged; Treatment Outcome; United States; Mitral Valve Insufficiency; Registries; Time Factors; Mitral Valve; Heart Valve Prosthesis; Cardiac Catheterization; Aged, 80 and over; Heart Valve Prosthesis Implantation; Recovery of Function; Quality of Life; Prosthesis Design; Risk Factors; Postoperative Complications
PubMed ID
40866033
Volume
18
Issue
16
First Page
2036
Last Page
2046
