DOI: 10.1161/jaha.123.031881 ISSN: 2047-9980

One‐Year Outcomes According to Mitral Regurgitation Etiology Following Transcatheter Edge‐to‐Edge Repair With the PASCAL System: Results From a Multicenter Registry

Philipp von Stein, Christian Besler, Matthias Riebisch, Osamah Al‐Hammadi, Tobias Ruf, Muhammed Gerçek, Christina Grothusen, Michael Mehr, Marc Ulrich Becher, Kai Friedrichs, Can Öztürk, Stephan Baldus, Henning Guthoff, Tienush Rassaf, Holger Thiele, Georg Nickenig, Jörg Hausleiter, Helge Möllmann, Patrick Horn, Malte Kelm, Volker Rudolph, Ralph‐Stephan von Bardeleben, Holger M. Nef, Peter Luedike, Philipp Lurz, Roman Pfister, Victor Mauri
  • Cardiology and Cardiovascular Medicine
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Background

We previously reported procedural and 30‐day outcomes of a German early multicenter experience with the PASCAL system for severe mitral regurgitation (MR). This study reports 1‐year outcomes of mitral valve transcatheter edge‐to‐edge repair with the PASCAL system according to MR etiology in a large all‐comer cohort.

Methods and Results

Clinical and echocardiographic outcomes up to 1‐year were investigated according to MR etiology (degenerative [DMR], functional [FMR], or mixed [MMR]) in the first 282 patients with symptomatic MR 3+/4+ treated with the PASCAL implant at 9 centers in 2019. A total of 282 patients were included (33% DMR, 50% FMR, 17% MMR). At discharge, MR reduction to ≤1+/2+ was achieved in 58%/87% of DMR, in 75%/97% of FMR, and in 78%/98% of patients with MMR ( P =0.004). MR reduction to ≤1+/2+ was sustained at 30 days (50%/83% DMR, 67%/97% FMR, 74%/100% MMR) and at 1 year (53%/78% DMR, 75%/97% FMR, 67%/91% MMR) with significant differences between etiologies. DMR patients with residual MR 3+/4+ at 1‐year had at least complex valve morphology in 91.7%. Valve‐related reintervention was performed in 7.4% DMR, 0.7% FMR, and 0.0% MMR ( P =0.010). At 1‐year, New York Heart Association Functional Class was significantly improved irrespective of MR etiology ( P <0.001).

Conclusions

In this large all‐comer cohort, mitral valve transcatheter edge‐to‐edge repair with the PASCAL system was associated with an acute and sustained MR reduction at 1‐year in all causes. However, in patients with DMR, MR reduction was less pronounced, reflecting the high incidence of complex or very complex anatomies being referred for mitral valve transcatheter edge‐to‐edge repair.

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