Transcatheter mitral repair in patients with symptomatic moderate functional mitral regurgitation: 1-year outcomes from the MiCLASP study

Philipp Lurz¹, MD, PhD; Volker Rudolph², MD; Tienush Rassaf³, MD; Peter Luedike³^,⁴, MD; Thomas Schmitz⁵, MD; Tobias Kister⁶, MD; Tobias Geisler⁷, MD; Edith Lubos⁸, MD; Ingo Eitel⁹, MD, PhD; Ralph Stephan von Bardeleben¹, MD, PhD; Nedy Brambilla¹⁰, MD; Sergio Berti¹¹, MD; Axel Linke¹², MD, PhD; Bernhard Unsöld¹³, MD; Christian Hengstenberg¹⁴, MD; Stephan Baldus¹⁵, MD; Konstantinos Spargias¹⁶, MD, PhD; Georg Nickenig¹⁷, MD; Paolo Denti¹⁸, MD; Helge Möllmann¹⁹, MD, PhD; Wolfgang Rottbauer²⁰, MD, PhD; Fabien Praz²¹, MD; Christian Butter²², MD, PhD; Markus Reinthaler²³, MD; Nicolas M. Van Mieghem²⁴, MD, PhD; Frank Edelmann²⁵, MD; Martin J. Swaans²⁶, MD, PhD; Adam Witkowski²⁷, MD; Mamta H. Buch²⁸, MD, PhD; Tim Seidler²⁹, MD; Andrés Iñiguez³⁰, MD; Leo Marcoff³¹, MD; Konstantinos Koulogiannis³¹, MD; Jörg Hausleiter³², MD, PhD; on behalf of the MiCLASP study investigators

1. Department of Cardiology, University Medical Center Mainz, Mainz, Germany; 2. Herz-und Diabeteszentrum NRW-Bad Oeynhausen, Bad Oeynhausen, Germany; 3. Department of Cardiology and Vascular Medicine, West German Heart and Vascular Center, University Hospital Essen, Essen, Germany; 4. Department of Cardiology and Intensive Care, Niels-Stensen-Kliniken, Marienhospital Osnabrück, Osnabrück, Germany and Heartcenter Osnabrück-Bad Rothenfelde GmbH, Osnabrück, Germany; 5. Contilia Herz- und Gefaszentrum, Elisabeth-Krankenhaus Essen, Essen, Germany; 6. Heart Center Leipzig at Leipzig University, Leipzig, Germany; 7. Department of Cardiology and Angiology, University Hospital Tubingen, Tubingen, Germany; 8. Marienkrankenhaus, Hamburg, Germany; 9. Universitatsklinikum Schleswig Holstein Lubeck, Lubeck, Germany and German Center for Cardiovascular Research (DZHK) partner site Hamburg/Kiel/Lubeck, Lubeck, Germany; 10. IRCCS Policlinico San Donato, San Donato Milanese, Italy; 11. Ospedale del Cuore, Fondazione C.N.R. Reg. Toscana, Massa, Italy; 12. Technische Universitat Dresden, Herzzentrum Universitatsklinik fur Innere Medizin/ Kardiologie, Dresden, Germany; 13. Medical Clinic I, Cardiology and Angiology, Justus-Liebig University, Giesen, Germany; 14. Universitatsklinikum AKH Wien, Medizinische Universitat Wien, Vienna, Austria; 15. Department of Cardiology, Heart Center, University Hospital Cologne, Cologne, Germany; 16. Hygeia Hospital, Athens, Greece; 17. University Hospital Bonn, Bonn, Germany; 18. IRCCS Ospedale San Raffaele, Milan, Italy; 19. St. Johannes Hospital, Dortmund, Germany; 20. Department of Cardiology, Ulm University Heart Center, Ulm, Germany; 21. Inselspital Bern, Bern, Switzerland; 22. Department of Cardiology, University Hospital Heart Centre Brandenburg, Brandenburg Medical School (MHB), Bernau, Germany; 23. Campus Benjamin Franklin Berlin, Berlin, Germany; 24. Erasmus University Medical Center, Rotterdam, the Netherlands; 25. Deutsches Herzzentrum der Charite-Campus Virchow Klinikum, Berlin, Germany; 26. St. Antonius Nieuwegein, Nieuwegein, the Netherlands; 27. National Institute of Cardiology, Warsaw, Poland; 28. Manchester University NHS Foundation Trust, Manchester, United Kingdom; 29. Herzzentrum Gottingen, Gottingen, Germany; 30. Hospital Alvaro Cunqueiro, Vigo, Spain; 31. Atlantic Health System Morristown Medical Center, Morristown, NJ, USA; 32. Medizinische Klinik und Poliklinik I, Ludwig-Maximilians University, Munich, Germany

Abstract

Background: Current clinical guidelines do not recommend mitral transcatheter edge-to-edge repair (M-TEER) for patients with moderate functional mitral regurgitation (FMR), and the implications of M-TEER in this population are not well documented.

Aims: We aimed to assess M-TEER outcomes in patients with symptomatic moderate FMR compared to those with FMR ≥3+ who were treated with the PASCAL system in the MiCLASP study.

Methods: Patients were stratified by baseline FMR grade (2+ or ≥3+). The echocardiographic core laboratory-assessed mitral regurgitation (MR) reduction, clinical events committee-adjudicated major adverse events (MAE) rate and functional and quality-of-life outcomes were evaluated up to 1 year after M-TEER.

Results: Of the 544 (FMR=322; degenerative MR=163; mixed/other=59) enrolled patients, 101 had baseline FMR 2+ and 197 FMR ≥3+. Both groups achieved significant MR reduction at discharge, which was sustained up to 1 year, with 89.8% of patients achieving MR ≤1+ in the FMR 2+ group and 77.8% in the FMR ≥3+ group (all p<0.001 vs baseline). At 1 year, significant improvements (all p<0.001 vs baseline) in functional capacity (New York Heart Association Class I/II: 67.1% FMR 2+; 70.1% FMR ≥3+) and quality of life (change in the Kansas City Cardiomyopathy Questionnaire overall score: +13.9 points FMR 2+; +13.9 points FMR ≥3+) were achieved in both groups, with high survival (90.0% FMR 2+; 84.2% FMR ≥3+; p=0.176) and low MAE rates (13.9% FMR 2+; 18.3% FMR ≥3+; p=0.413).

Conclusions: In the MiCLASP study, patients with moderate FMR experienced significant MR reduction at 1 year, resulting in clinical and symptomatic benefits comparable to those with ≥moderate-severe FMR, suggesting that select patients with symptomatic moderate FMR can benefit from M-TEER.

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