Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study

Philipp von Stein; Lukas Stolz; Jean Marc Haurand; Matthias Gröger; Felix Rudolph; Donika Mustafa; Jannik Jobst; Christoph Alexander Mues; Amir Abbas Mahabadi; Isabel A Hörbrand; Carl Schulz; Atsushi Sugiura; Tobias Ruf; Philipp Lurz; Muhammed Gerçek; Patrick Horn; Mirjam Kessler; Tienush Rassaf; Marcel Weber; Tobias Kister; Niklas Schofer; Mathias Konstandin; Florian Schindhelm; Helge Möllmann; Bernhard Unsöld; Stephan Baldus; Wolfgang Rottbauer; Volker Rudolph; Jörg Hausleiter; Roman Pfister; Victor Mauri; REPAIR Investigators

doi:10.1016/j.jcin.2024.11.016

Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair: The REPAIR Study

JACC Cardiovasc Interv. 2024 Nov 25:S1936-8798(24)01712-6. doi: 10.1016/j.jcin.2024.11.016. Online ahead of print.

Authors

Philipp von Stein¹, Lukas Stolz², Jean Marc Haurand³, Matthias Gröger⁴, Felix Rudolph⁵, Donika Mustafa⁶, Jannik Jobst⁷, Christoph Alexander Mues⁸, Amir Abbas Mahabadi⁹, Isabel A Hörbrand¹⁰, Carl Schulz¹¹, Atsushi Sugiura¹², Tobias Ruf¹³, Philipp Lurz¹³, Muhammed Gerçek⁵, Patrick Horn³, Mirjam Kessler⁴, Tienush Rassaf⁹, Marcel Weber¹², Tobias Kister¹⁴, Niklas Schofer¹¹, Mathias Konstandin¹⁰, Florian Schindhelm⁹, Helge Möllmann⁸, Bernhard Unsöld⁷, Stephan Baldus⁶, Wolfgang Rottbauer⁴, Volker Rudolph⁵, Jörg Hausleiter¹⁵, Roman Pfister⁶, Victor Mauri¹⁶; REPAIR Investigators

Affiliations

¹ Department of Cardiology, Heart Center, Faculty of Medicine, University of Cologne, Cologne, Germany; Cardiovascular Research Foundation, New York, New York, USA.
² Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität München, Munich, Germany.
³ Department of Cardiology, Pulmonology and Vascular Medicine, University Hospital Düsseldorf, Medical Faculty of the Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
⁴ Department of Internal Medicine II, Ulm University Heart Center, Ulm, Germany.
⁵ Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
⁶ Department of Cardiology, Heart Center, Faculty of Medicine, University of Cologne, Cologne, Germany.
⁷ Department of Cardiology and Angiology, Justus-Liebig-University Giessen, Giessen, Germany.
⁸ Medical Clinic I, Department of Cardiology, St. Johannes Hospital, Dortmund, Germany.
⁹ Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, University of Duisburg Essen, Essen, Germany.
¹⁰ Department of Internal Medicine III, Division of Cardiology, University Hospital Heidelberg, Ruprecht-Karls University Heidelberg, Heidelberg, Germany.
¹¹ Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹² Department of Internal Medicine II, Heart Center Bonn, University Hospital Bonn, Bonn, Germany.
¹³ Department of Cardiology, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
¹⁴ Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Science, Leipzig, Germany.
¹⁵ Medizinische Klinik und Poliklinik I, Ludwig-Maximilians-Universität München, Munich, Germany; Munich Heart Alliance, Partner Site German Center for Cardiovascular Disease, Munich, Germany.
¹⁶ Department of Cardiology, Heart Center, Faculty of Medicine, University of Cologne, Cologne, Germany. Electronic address: [email protected].

PMID: 39745410
DOI: 10.1016/j.jcin.2024.11.016

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: The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations.

Methods: The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10_only, P10/Ace_Gen1 (introduction of Ace), and P10/Ace_Prec (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: A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10_only, 945 P10/Ace_Gen1, and 560 P10/Ace_Prec. Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10_only: 66% [n = 422 of 638], P10/Ace_Gen1: 73% [n = 661 of 906], P10/Ace_Prec: 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.

Keywords: M-TEER; PASCAL; REPAIR; mitral regurgitation; mitral valve transcatheter edge-to-edge repair; real world.