Benedikt Koell, Sebastian Ludwig, Jessica Weimann, Dhairya Patel, Lukas Stolz, Tetsu Tanaka, Teresa Trenkwalder, Felix Rudolph, Daryoush Samim, Philipp von Stein, Cristina Giannini, Julien Dreyfus, Andrea Scotti, Jean-Michel Paradis, Marianna Adamo, Nicole Karam, Yohann Bohbot, Anne Bernard, Bruno Melica, Yusuke Kobari, Yoan Lavie-Badie, Mirjam Kessler, Omar Chehab, Simon Redwood, Edith Lubos, Ole De Backer, Marco Metra, Azeem Latib, Chiara Primerano, Christos Iliadis, Fabien Praz, Muhammed Gerçek, Erion Xhepa, Marcel Weber, Raj Makkar, Juan Granada, Thomas Modine, Erwan Donal, Jörg Hausleiter, Augustin Coisne, Daniel Kalbacher, on behalf the OCEAN-Mitral investigators
BACKGROUND: The evolving landscape of mitral valve transcatheter edge-to-edge repair (M-TEER) for mitral regurgitation (MR) has seen continuous advancements, driving improvements in therapeutic efficacy. Particularly in primary MR (PMR), contemporary device iterations of M-TEER offer technical advantages for improved management of complex anatomies. However, data on temporal trends in M-TEER for PMR are limited. AIMS: The primary objective of our study was to analyse temporal trends in the safety, efficacy, and stability of M-TEER treatment. METHODS: The PRIME-MR registry, a retrospective multicentre study, enrolled consecutive patients undergoing M-TEER for PMR at 27 centres in Europe and North America. M-TEER procedures were categorised into four time periods (2009-2013, 2014-2016, 2017-2019, and 2020-2023), to align with major device updates. RESULTS: The analysis included 3,082 consecutive patients (median age 82 years [interquartile range 76.0-85.0], 45.1% female). Patients treated were highly symptomatic (New York Heart Association [NYHA] Class ≥III in 80.4%). Patient characteristics showed a decline in symptomatic severity (NYHA Class ≥III 85.9% in 2009-2013 vs 71.8% in 2020-2023), accompanied by lower mean Society of Thoracic Surgeons scores (5.6% [2009-2013] vs 4.6% [2020-2023]; p for trend<0.0001), and less severe MR. Over time, complication rates decreased (procedures with complications: 42.4% [2009-2013] vs 23.1% [2020-2023]; p for trend<0.0001), whereas technical efficacy increased (residual MR ≤1+: 54.0% [2009-2013] vs 68.4% [2020-2023]; p for trend<0.001). There was an increased occurrence of stable results without any deterioration at one-year follow-up (63.6% [2009-2013] vs 74.4% [2020-2023]; p for trend=0.03). CONCLUSIONS: Findings from the PRIME-MR registry highlight substantial reductions in residual MR severity and complication rates over time in PMR patients undergoing M-TEER.