Early U.S. Commercial Experience With a Novel Transcatheter Edge-to-Edge Repair System: Insights From Real-World Data.
Document Type
Article
Publication Title
JACC. Cardiovascular interventions
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
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.
First Page
2036
Last Page
2046
DOI
10.1016/j.jcin.2025.07.019
Publication Date
8-25-2025
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, 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 Aug 25;18(16):2036-2046. doi: 10.1016/j.jcin.2025.07.019. PMID: 40866033.