PASCAL Precision System Outcomes by Implant Location and Lesion Location in Degenerative Mitral Regurgitation Patients From the STS/ACC TVT Registry

Department

Cardiology

Document Type

Article

Publication Title

Journal of the American Heart Association

Abstract

Background: Mitral valve transcatheter edge-to-edge repair can be more challenging in noncentral regions of the valve and in anterior or bileaflet lesions. We assess effect of implant location and leaflet lesion location on safety and effectiveness of PASCAL Precision system in degenerative mitral regurgitation (MR).

Methods: Mitral valve transcatheter edge-to-edge repair outcomes in patients with degenerative MR treated with PASCAL Precision system (September 2022-October 2024), from the US STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) Registry, were analyzed by implant location (A2P2/non-A2P2) and leaflet lesion location (anterior/posterior/bileaflet). Procedural, clinical, and echocardiographic outcomes to 30 days were assessed.

Results: At 30 days, both A2P2 (n=1526) and non-A2P2 (n=299) groups had low event rates (cardiovascular mortality: 1.1% versus 1.0%, mitral valve reintervention: 0.4% versus 0.0% and single leaflet device attachment: 0.5% versus 0.3%; all P> 0.05) and demonstrated significant MR reduction (P< 0.001 versus baseline) with no significant difference between groups (P=0.750) (MR ≤ 2+: 93.4% versus 95.4%; MR ≤ 1+: 72.0% versus 73.3%). Kansas City Cardiomyopathy Questionnaire Overall Summary scores improved significantly in both groups (∆19.3, ∆17.7 points; P=0.741). The anterior (n=250), posterior (n=902), and bileaflet (n=192) disease groups also had low event rates (cardiovascular mortality: 0.4%, 1.1%, 0.0%; mitral valve reintervention: 0.8%, 0.1%, 0.5%; and single leaflet device attachment: 0.8%, 0.2%, 0.5%; all P> 0.05), and demonstrated significant MR reduction (P< 0.001 versus baseline) with no significant difference across groups (P=0.459) (MR ≤ 2+: 94.1%, 93.1%, and 94.5%; MR ≤ 1+: 79.0%, 69.2%, and 72.4%). All groups experienced significant improvement in Kansas City Cardiomyopathy Questionnaire Overall Summary scores (∆21.4, ∆18.8, ∆12.0 points; P=0.087).

Conclusion: In real-world patients with degenerative mitral regurgitation, treatment with the PASCAL Precision system was associated with favorable safety and effectiveness at 30 days, regardless of implant location or leaflet lesion location.

First Page

e052158

DOI

10.1161/JAHA.125.052158

Volume

15

Issue

21

Publication Date

11-3-2026

Medical Subject Headings

Humans; Mitral Valve Insufficiency; Registries; Female; Mitral Valve; Male; Aged; Treatment Outcome; Heart Valve Prosthesis; Transcatheter Mitral Valve Replacement; Aged, 80 and over; Prosthesis Design; United States; Time Factors

PubMed ID

42924766

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