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Transcatheter Mitral Valve Replacement for Patients with Mitral Annular Calcification: Results from the CHOICE-MI Registry

https://doi.org/10.1007/s00392-024-02406-5

Sebastian Ludwig (Hamburg)1, A. Coisne (Lille)2, A. Scotti (New York)3, W. Ben Ali (Montreal)4, J. Weimann (Hamburg)5, A. Duncan (London)6, J. Webb (Vancouver)7, D. Kalbacher (Hamburg)8, B. Köll (Hamburg)1, T. K. Rudolph (Bad Oeynhausen)9, G. Nickenig (Bonn)10, J. Hausleiter (München)11, H. Ruge (München)12, M. Adam (Köln)13, A. S. Petronio (Pisa)14, N. Dumonteil (Toulouse)15, L. Sondergaard (Kopenhagen)16, M. Adamo (Brescia)17, D. Regazzoli (Mailand)18, A. Garatti (Mailand)19, T. Schmidt (Lübeck)20, G. Dahle (Oslo)21, M. Taramasso (Zürich)22, T. Walther (Frankfurt am Main)23, J. Kempfert (Berlin)24, J.-F. Obadia (Lyon)25, S. Redwood (London)26, S. Goel (Houston)27, N. Fam (Toronto)28, M. Metra (Brescia)17, M. Andreas (Wien)29, D. Muller (Sydney)30, P. Denti (Mailand)31, F. Praz (Bern)32, R. S. von Bardeleben (Mainz)33, A. Latib (New York)3, J. Granada (New York)34, T. Modine (Bordeaux)35, L. Conradi (Hamburg)36

1Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; 2CHU Lille Lille, Frankreich; 3Montefiore Medical Center New York, USA; 4Montreal Heart Institute Montreal, Kanada; 5Universitäres Herz- und Gefäßzentrum Hamburg Hamburg, Deutschland; 6Royal Brompton and Harefield Hospital Consultant Cardiologist London, Großbritannien; 7St. Paul's Hospital Vancouver, Kanada; 8Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland; 9Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 10Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; 11LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; 12Deutsches Herzzentrum München München, Deutschland; 13Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 14University of Pisa Pisa, Italien; 15Clinique Pasteur Toulouse, Frankreich; 16Rigshospitalet Kopenhagen, Dänemark; 17Civil Hospital of Brescia Brescia, Italien; 18Humanitas Hospital Milan Mailand, Italien; 19San Donato Hospital Mailand, Italien; 20Universitätsklinikum Schleswig-Holstein Medizinische Klinik II / Kardiologie, Angiologie, Intensivmedizin Lübeck, Deutschland; 21Rikshospitalet Oslo, Norwegen; 22HerzZentrum Hirslanden Zürich Zürich, Schweiz; 23Universitätsklinikum Frankfurt Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie Frankfurt am Main, Deutschland; 24Deutsches Herzzentrum der Charite (DHZC) Klinik für Herz-, Thorax- und Gefäßchirurgie Berlin, Deutschland; 25Civils Hospices of Lyon Lyon, Frankreich; 26St. Thomas Hospital London, Großbritannien; 27Houston Methodist Hospital Houston, USA; 28St. Michael's Hospital Toronto, Kanada; 29Medical University Vienna Wien, Österreich; 30St. Vincent's Hospital Sydney, Australien; 31San Raffaele Hospital Mailand, Italien; 32Inselspital Bern Bern, Schweiz; 33Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie im Herz- und Gefäßzentrum Mainz, Deutschland; 34Cardiovascular Research Foundation New York, USA; 35CHU Bordeaux Bordeaux, Frankreich; 36Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Herz- und Gefäßchirurgie Hamburg, Deutschland

 

Background. Patients with mitral valve disease related to mitral annulus calcification (MAC) represent a challenging, high-risk patient subset with limited treatment options. Transcatheter mitral valve replacement (TMVR) using dedicated devices represents a novel treatment alternative for these patients.

Objectives. We aimed to assess the feasibility of transcatheter mitral valve replacement (TMVR) using dedicated devices for the treatment of patients with MAC using data from a large international TMVR registry.

Methods. The CHOICE-MI registry included consecutive patients with symptomatic MR treated with dedicated TMVR devices at 31 international centers. For this study, only patients with available computed tomography data on MAC severity, were included. Procedural and 30-day MVARC outcomes as well as long-term clinical outcomes were compared between patients with low (i.e., none or mild) MAC and high (i.e., moderate or severe) MAC. MR elimination was defined as no or trace residual MR.

Results. Among 279 eligible patients (age 76.0 [IQR 71.0, 81.0], EuroSCORE II 6.2% [IQR 3.9, 12.1]), 57 patients presented with high MAC and 222 with low MAC. There were no differences between both groups regarding age, sex, and surgical risk scores. Patients in the high MAC group had a higher prevalence of primary MR, extracardiac arteriopathy, and prior aortic valve replacement. Compared to the low MAC group, left ventricular ejection fraction (55% [IQR 41-60] vs. 45% [IQR 36-56], p=0.005) and mean transvalvular gradient (4.0mmHg [3.0-6.0] vs. 3.0mmHg [2-4], p<0.001) were higher in the high MAC group. Technical success was achieved in 94.7% in the high MAC group and in 95.0% in the low MAC group (p=1.00), but the rate of valve malposition, migration or embolization was higher in the high MAC group (11.3% vs. 1.4%, p=0.002). In high MAC patients, TMVR was associated with a higher rate of major bleeding complications (21.6% vs. 8.8%, p=0.02) and renal failure AKIN ≥2 (26.8% vs. 8.2%, p<0.001). The extent of complete MR elimination did not differ between patients with high MAC (85.9%) and low MAC (80.8%, p=0.77) with durable results out to 2-year follow-up. Likewise, there were no differences between the rates of patients at NYHA functional class I or II at 1- and 2-year follow up. No differences between the high and low MAC groups were observed for the 2-year endpoints of all-cause mortality (37.7% vs. 38.5%, p=0.76) and all-cause mortality or heart failure hospitalization (52.4% vs. 46.7%, p=0.28).

Conclusions. Despite higher rates of post-procedural complications, TMVR in patients with moderate or severe MAC is associated with similar technical success, MR elimination, functional improvement and survival compared to low MAC patients. Further studies are necessary to define the future role of TMVR for the treatment of patients with severe MAC.

 

 

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