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Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study.

JACC. Cardiovascular interventions

Authors: Philipp Lurz, Thomas Schmitz, Tobias Geisler, Jörg Hausleiter, Ingo Eitel, Volker Rudolph, Edith Lubos, Ralph Stephan von Bardeleben, Nedy Brambilla, Federico De Marco, Sergio Berti, Holger Nef, Axel Linke, Christian Hengstenberg, Stephan Baldus, Konstantinos Spargias, Paolo Denti, Georg Nickenig, Helge Möllmann, Wolfgang Rottbauer, Fabien Praz, Christian Butter, Markus Reinthaler, Nicolas M Van Mieghem, Mohammad Sherif, Martin Swaans, Adam Witkowski, Mamta Buch, Tim Seidler, Andrés Iñiguez, Holger Thiele, Mareike Eißmann, Juergen Schreieck, Michael Näbauer, Leo Marcoff, Konstantinos Koulogiannis, Tienush Rassaf, Peter Luedike

BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established.

OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study.

METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year.

RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline).

CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.

Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.

PMID: 38599692

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