One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study

BACKGROUND: Studies on mitral transcatheter edge-to-edge repair for atrial functional mitral regurgitation (AFMR) and ventricular functional mitral regurgitation (VFMR) are limited. METHODS: We report 1-year outcomes of mitral transcatheter edge-to-edge repair for AFMR and VFMR using the PASCAL transcatheter valve repair system in the MiCLASP multicenter European postmarket clinical follow-up study (REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04430075). RESULTS: Analysis included 295 patients with functional mitral regurgitation (75.5±9.93 years old, 59.3% male) from the first 600 enrolled in the MiCLASP study, with AFMR in 17.6% (52) and VFMR in 82.4% (243). Patients with AFMR were older (79.7±6.67 versus 74.6±10.30 years), majority female (75.0% versus 33.3%), and had higher rates of hypertension (98.1% versus 82.3%) and atrial fibrillation (82.7% versus 60.1%) than patients with VFMR (all P <0.05). Patients with VFMR had higher NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels (3350.0 [1720.0–6564.0] versus 1562.0 [790.0–2286.0]; P <0.001) and more severe mitral regurgitation (≥3+) at baseline (71.9% versus 46.2%; P <0.001). Procedural success was high (AFMR, 96.2%; VFMR, 97.1%; P =0.661), and patients with AFMR had shorter procedure duration (73.5 versus 85.5 minutes; P =0.044). One-year Kaplan-Meier estimate of freedom from all-cause mortality or heart failure hospitalizations was 79.3% in AFMR and 70.9% in VFMR ( P =0.267). Both AFMR and VFMR groups demonstrated significant mitral regurgitation reduction (mitral regurgitation ≤1+, 93.1% and 81.3%), low mean transmitral gradients (3.5 and 3.1 mm Hg), significant proportional reductions in left ventricular end-diastolic volume (−12.9% and −16.4%) and left atrial volume (−9.6% and −10.9%), high proportions at New York Heart Association class I/II (76.5% and 64.6%), and significant increases in Kansas City Cardiomyopathy Questionnaire Overall Summary score (+18.0 and +11.6 points), respectively (all P <0.05 from baseline). CONCLUSIONS: One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.

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Journal
Circulation Cardiovascular Interventions
Published
2026-08-25
DOI
https://doi.org/10.1161/circinterventions.126.016563
Primary Topic
Cardiac Valve Diseases and Treatments
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article
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article

One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study

Nicolas M. Van Mieghem, Christian Hengstenberg, Adam Witkowski, Volker Rudolph et al.
Circulation Cardiovascular Interventions
Cardiac Valve Diseases and Treatments
article

One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study

Nicolas M. Van Mieghem, Christian Hengstenberg, Adam Witkowski, Volker Rudolph, Frank Edelmann, Leo Marcoff, Helge Möllmann, Paolo Denti, Christian Butter, Fabien Praz, Jörg Hausleiter, Amir A. Mahabadi, Tobias Kister, Stephan Baldus, Sérgio Berti, Bernhard Unsöld, Ralph Stephan von Bardeleben, Martin J. Swaans, Ingo Eitel, Philipp Lurz, Frieder Wolf, Konstantinos Koulogiannis, Tobias Geisler, Edith Lubos, Georg Nickenig, Thomas Schmitz, Axel Linke, Konstantinos Spargias, Mamta Buch, on behalf of the MiCLASP Study Investigators, Nedy Brambilla, Wolfgang Rottbauer, Tienush Rassaf, Markus Reinthaler
article en

Abstract

BACKGROUND: Studies on mitral transcatheter edge-to-edge repair for atrial functional mitral regurgitation (AFMR) and ventricular functional mitral regurgitation (VFMR) are limited. METHODS: We report 1-year outcomes of mitral transcatheter edge-to-edge repair for AFMR and VFMR using the PASCAL transcatheter valve repair system in the MiCLASP multicenter European postmarket clinical follow-up study (REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04430075). RESULTS: Analysis included 295 patients with functional mitral regurgitation (75.5±9.93 years old, 59.3% male) from the first 600 enrolled in the MiCLASP study, with AFMR in 17.6% (52) and VFMR in 82.4% (243). Patients with AFMR were older (79.7±6.67 versus 74.6±10.30 years), majority female (75.0% versus 33.3%), and had higher rates of hypertension (98.1% versus 82.3%) and atrial fibrillation (82.7% versus 60.1%) than patients with VFMR (all P <0.05). Patients with VFMR had higher NT-proBNP (N-terminal pro-B-type natriuretic peptide) levels (3350.0 [1720.0–6564.0] versus 1562.0 [790.0–2286.0]; P <0.001) and more severe mitral regurgitation (≥3+) at baseline (71.9% versus 46.2%; P <0.001). Procedural success was high (AFMR, 96.2%; VFMR, 97.1%; P =0.661), and patients with AFMR had shorter procedure duration (73.5 versus 85.5 minutes; P =0.044). One-year Kaplan-Meier estimate of freedom from all-cause mortality or heart failure hospitalizations was 79.3% in AFMR and 70.9% in VFMR ( P =0.267). Both AFMR and VFMR groups demonstrated significant mitral regurgitation reduction (mitral regurgitation ≤1+, 93.1% and 81.3%), low mean transmitral gradients (3.5 and 3.1 mm Hg), significant proportional reductions in left ventricular end-diastolic volume (−12.9% and −16.4%) and left atrial volume (−9.6% and −10.9%), high proportions at New York Heart Association class I/II (76.5% and 64.6%), and significant increases in Kansas City Cardiomyopathy Questionnaire Overall Summary score (+18.0 and +11.6 points), respectively (all P <0.05 from baseline). CONCLUSIONS: One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.

Circulation Cardiovascular Interventions
University of Vienna (AT), Johannes Gutenberg University Mainz (DE), Justus-Liebig-Universität Gießen (DE), University Hospital Bonn (DE), Heart and Diabetes Center North Rhine-Westphalia (DE), University Hospital of Bern (CH), Erasmus MC (NL), Morristown Medical Center (US), LMU Klinikum (DE), Hochschule Campus Wien (AT), Elisabeth-Krankenhaus Essen (DE), University Medical Center of the Johannes Gutenberg University Mainz (DE), Universitätsklinikum Tübingen (DE), Universitäres Kinderwunschzentrum Lübeck (DE), IRCCS Policlinico San Donato (IT), St. Antonius Ziekenhuis (NL), Universitätsmedizin Göttingen (DE), Hygeia Hospital (GR), Marienkrankenhaus Hamburg (DE), IRCCS Ospedale San Raffaele (IT), Klinik Donaustauf (DE), Medizinische Hochschule Brandenburg Theodor Fontane (DE), St.-Johannes-Hospital Dortmund (DE), Centrum für Integrierte Onkologie (DE), Wythenshawe Hospital (GB), Universitätszahnklinik Wien (AT), Fondazione Toscana Gabriele Monasterio (IT), Universitätsklinikum Brandenburg an der Havel (DE), West German Heart and Vascular Center Essen (DE), Klinik und Poliklinik für Psychotherapie und Psychosomatik (DE), Atlantic Health System (US), Cardinal Stefan Wyszynski University in Warsaw (PL), Charité - Universitätsmedizin Berlin (DE), Ludwig-Maximilians-Universität München (DE), Leipzig University (DE)
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