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German Multicenter Experience With a New Leaflet-Based Transcatheter Mitral Valve Repair System for Mitral
Victor Mauri1, Christian Besler2, Matthias Riebisch3
1Department of Cardiology, Heart Centre, Faculty of Medicine, University of Cologne, Cologne, Germany.
JACC. Cardiovascular Interventions
|December 11, 2020
Summary
The PASCAL system effectively repaired mitral regurgitation with high success and low adverse events. Patients experienced significant symptom improvement after the transcatheter mitral valve repair.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Medical Devices
Background:
- The PASCAL repair system offers percutaneous treatment for mitral regurgitation (MR).
- It features unique broad paddles and independent leaflet capture for enhanced repair.
- Mitral regurgitation affects numerous patients, necessitating effective treatment options.
Purpose of the Study:
- To assess the procedural safety and short-term efficacy of the PASCAL system for mitral valve repair.
- To evaluate outcomes in patients with symptomatic moderate-to-severe mitral regurgitation.
Main Methods:
- A prospective study of 309 patients with symptomatic MR (3+/4+) treated with the PASCAL system.
- Primary endpoints included technical success, residual MR at discharge, and major adverse events (MAE) at 30 days.
- Data collected from 10 participating clinical sites.
Main Results:
- High technical success rate (96%) with significant MR reduction (93.5% ≤2+ MR at discharge).
- Low 30-day MAE rate (4.1%) and all-cause mortality (2.0%).
- Significant improvement in functional status, with 72% of patients in NYHA class ≤II post-procedure.
Conclusions:
- Transcatheter mitral valve repair using the PASCAL system is safe and effective in the early post-approval period.
- The system demonstrates high procedural success and a favorable safety profile.
- Significant reduction in MR and improvement in patient functional status were observed.
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