Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02087-y

Transcatheter mitral valve replacement versus edge-to-edge repair in patients with secondary mitral regurgitation: Outcomes according to the COAPT eligibility criteria
S. Ludwig1, D. Kalbacher2, W. Ben Ali3, F. Praz4, R. Pfister5, G. Nickenig6, A. Coisne7, D. Muller8, R. S. von Bardeleben9, A. Duncan10, J. Webb11, A. S. Petronio12, M. Metra13, S. Massberg14, M. Neuß15, H. Thiele16, T. K. Rudolph17, T. Walther18, H. Ruge19, J. Kempfert20, N. Schofer2, M. Orban14, H. Reichenspurner21, S. Blankenberg22, J. Granada23, T. Modine24, J. Hausleiter14, L. Conradi21, für die Studiengruppen: CHOICE-MI, EuroSMR
1Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 2Allgemeine und Interventionelle Kardiologie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 3Montreal Heart Institute, Montreal, CA; 4Inselspital - Universitätsspital Bern, Bern, CH; 5Klinik III für Innere Medizin, Herzzentrum der Universität zu Köln, Köln; 6Medizinische Klinik und Poliklinik II, Universitätsklinikum Bonn, Bonn; 7CHU de Lille, Lille, FR; 8St Vincent's Private Hospital Sydney, Darlinghurst, NSW, AU; 9Zentrum für Kardiologie im Herz- und Gefäßzentrum, Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz; 10Royal Brompton Hospital, London, UK; 11St. Paul's Hospital, Vancouver, BC, CA; 12University of Pisa, Pisa, IT; 13ASST Spedali Civili and University of Brescia, Brescia, IT; 14Medizinische Klinik und Poliklinik I, LMU Klinikum der Universität München, München; 15Herzzentrum Brandenburg / Kardiologie, Immanuel Klinikum Bernau, Bernau bei Berlin; 16Klinik für Innere Medizin/Kardiologie, Herzzentrum Leipzig - Universität Leipzig, Leipzig; 17Allgemeine und Interventionelle Kardiologie/Angiologie, Herz- und Diabeteszentrum NRW, Bad Oeynhausen; 18Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie, Universitätsklinikum Frankfurt, Frankfurt am Main; 19Deutsches Herzzentrum München, München; 20Klinik für Herz-, Thorax- und Gefäßchirurgie, Deutsches Herzzentrum Berlin, Berlin; 21Klinik und Poliklinik für Herz- und Gefäßchirurgie, Universitäres Herz- und Gefäßzentrum Hamburg GmbH, Hamburg; 22Klinik für Kardiologie, Universitäres Herz- und Gefäßzentrum UKE Hamburg GmbH, Hamburg; 23Cardiovascular Research Foundation, New York City, US; 24CHU de Bordeaux, Bordeaux, FR;
Background: The COAPT eligibility criteria have been proven to identify patients with secondary mitral regurgitation (SMR) that benefit from mitral valve transcatheter edge-to-edge repair (M-TEER) treatment. Transcatheter mitral valve replacement (TMVR) is a novel therapeutic option for surgical high-risk patients with SMR. The future role of TMVR among established SMR therapies is yet to be defined.

Aims: In this study we aimed to compare the clinical outcomes of TMVR versus M-TEER among patients with SMR according to the adapted COAPT eligibility criteria.
 
Methods: This study included SMR patients undergoing TMVR from the CHOICE-MI registry and M-TEER from the EuroSMR registry. The CHOICE-MI registry included 153 SMR patients treated with ten different TMVR devices (90.0% transapical access) between 05/2014 and 03/2021. Among others, a main indication for TMVR was non-eligibility for M-TEER. The EuroSMR registry included 1,383 SMR patients treated with M-TEER between 11/2008 and 09/2019. Propensity score (PS)-matching was performed for 12 demographic, clinical and echocardiographic parameters. Matched patients were subdivided into COAPT-eligible and COAPT-ineligible patients according to previously published adapted COAPT inclusion criteria. The primary endpoint was defined as all-cause mortality at 2 years.

Results: After PS-matching, a total of 145 TMVR patients (75.1 years [70.3, 80.0], EuroSCORE II 6.3% [IQR 3.7, 13.4]) were compared to 488 M-TEER patients (76.6 years [70.0, 80.7], EuroSCORE II 7.6% [3.9, 14.1]). In the TMVR group, 41 patients were COAPT-eligible (28.3%) and 104 patients were COAPT-ineligible (71.7%). In the M-TEER group, 156 patients were COAPT-eligible (32.0%) and 332 patients were COAPT-ineligible (66.0%). In COAPT-eligible patients, all-cause mortality after 2 years was significantly lower in patients undergoing M-TEER (23.3%) compared to those undergoing TMVR (43.7%, p=0.0021). This difference was mainly driven by higher procedural mortality (4.9% [TMVR] vs. 0.0% [TEER], p=0.056) and 30-day mortality (13.0% [TMVR] vs. 2.5% [M-TEER], p=0.0078) in patients undergoing TMVR. In contrast, all-cause mortality was comparable between TMVR and M-TEER in the group of COAPT-ineligible patients (TMVR: 37.7%, M-TEER: 37.5%, p=0.80). TMVR was associated with superior reduction of MR in both COAPT-eligible (MR ≤1+ at discharge: 95.1% [TMVR] vs. 66.8% [M-TEER], p<0.0026) and COAPT-ineligible patients (96.6% [TMVR] vs. 62.2% [M-TEER], p<0.001). At 1-year follow-up, functional improvement did not differ between TMVR and M-TEER in COAPT-eligible patients (NYHA functional class I/II: 81.5% [TMVR] vs. 59.3% [M-TEER], p=0.20), while in COAPT-ineligible patients functional improvement was greater in patients undergoing TMVR (85.6% [TMVR] vs. 66.5% [M-TEER], p=0.0071).

Conclusion: In our analysis, M-TEER in COAPT-eligible patients appears to be associated with a survival benefit over TMVR treated patients, while TMVR is associated with a better symptomatic improvement and comparable survival rates compared to M-TEER in COAPT-ineligible patients. MR resolution was higher in TMVR compared to M-TEER. These results must be considered as hypothesis-generating and warrant a prospective randomised study comparing different procedures as well as medical therapy in COAPT-ineligible patients.

https://dgk.org/kongress_programme/ht2022/aPP263.html