Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair
Philipp von Stein, Lukas Stolz, Jean Marc Haurand, Matthias Gröger, Felix Rudolph, Donika Mustafa, Jannik Jobst, Christoph Alexander Mues, Amir A. Mahabadi, Isabel A Hörbrand, Carl Schulz, Atsushi Sugiura, T. Ruf, Philipp Lurz, Muhammed Gerçek, Patrick Horn, Mirjam Keßler, Tienush Rassaf, Marcel Weber, Tobias Kister, Niklas Schofer, Mathias H. Konstandin, Florian Schindhelm, Helge Möllmann, Bernhard Unsöld, Stephan Baldus, Wolfgang Rottbauer, Volker Rudolph, Jörg Hausleiter, Roman Pfister, Victor Mauri
Abstract
BACKGROUND: The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system. OBJECTIVES: This study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations. METHODS: (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years). RESULTS: : 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations. CONCLUSIONS: Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation.