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

S. Ludwig (Hamburg)¹, A. Coisne (Lille)², A. Scotti (New York)³, W. Ben Ali (Montreal)⁴, J. Weimann (Hamburg)¹, A. Duncan (London)⁵, J. Webb (Vancouver)⁶, D. Kalbacher (Hamburg)⁷, B. Köll (Hamburg)¹, T. K. Rudolph (Bad Oeynhausen)⁸, G. Nickenig (Bonn)⁹, J. Hausleiter (München)¹⁰, H. Ruge (München)¹¹, M. Adam (Köln)¹², A. S. Petronio (Pisa)¹³, N. Dumonteil (Toulouse)¹⁴, L. Sondergaard (Kopenhagen)¹⁵, M. Adamo (Brescia)¹⁶, D. Regazzoli (Mailand)¹⁷, A. Garatti (Mailand)¹⁸, T. Schmidt (Hamburg)¹⁹, G. Dahle (Oslo)²⁰, M. Taramasso (Zürich)²¹, T. Walther (Frankfurt am Main)²², J. Kempfert (Berlin)²³, J.-F. Obadia (Lyon)²⁴, S. Redwood (London)²⁵, S. Goel (Houston)²⁶, N. Fam (Toronto)²⁷, M. Metra (Brescia)¹⁶, M. Andreas (Wien)²⁸, D. Muller (Sydney)²⁹, P. Denti (Milan)³⁰, F. Praz (Bern)³¹, R. S. von Bardeleben (Mainz)³², A. Latib (Ney York)³³, J. Granada (New York)³⁴, T. Modine (Bordeaux)³⁵, L. Conradi (Köln)^36
1Universitäres Herz- und Gefäßzentrum Hamburg Klinik für Kardiologie Hamburg, Deutschland; ²Heart Valve Clinic, CHU Lille Department of Clinical Physiology and Echocardiography Lille, Frankreich; ³Montefiore Medical Center, Albert Einstein College of Medicine Montefiore-Einstein Center for Heart and Vascular Care New York, USA; ⁴Montreal Heart Institute Montreal, Kanada; ⁵Royal Brompton and Harefield Hospital Consultant Cardiologist London, Großbritannien; ⁶St. Paul's Hospital Vancouver, Kanada; ⁷Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland; ⁸Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; ⁹Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; ¹⁰LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; ¹¹Deutsches Herzzentrum München Klinik für Herz- und Gefäßchirurgie München, Deutschland; ¹²Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; ¹³University of Pisa Pisa, Italien; ¹⁴Clinique Pasteur Toulouse, Frankreich; ¹⁵Rigshospitalet Kopenhagen, Dänemark; ¹⁶University of Brescia Department of Medical and Surgical Specialties, Radiological Sciences, and Public Health Brescia, Italien; ¹⁷Humanitas Hospital Milan Mailand, Italien; ¹⁸San Donato Hospital Mailand, Italien; ¹⁹Asklepios Westklinikum Rissen Abteilung für Kardiologie Hamburg, Deutschland; ²⁰Rikshospitalet Oslo, Norwegen; ²¹HerzZentrum Hirslanden Cardiology Zürich, Schweiz; ²²Universitätsklinikum Frankfurt Klinik für Thorax-, Herz- und Thorakale Gefäßchirurgie Frankfurt am Main, Deutschland; ²³Deutsches Herzzentrum der Charite (DHZC) Klinik für Herz-, Thorax- und Gefäßchirurgie Berlin, Deutschland; ²⁴Civils Hospices of Lyon Lyon, Frankreich; ²⁵St. Thomas' Hospital Department of Cardiology London, Deutschland; ²⁶Houston Methodist Hospital Houston, USA; ²⁷St. Michael's Hospital Toronto, Kanada; ²⁸Medical University Vienna Wien, Österreich; ²⁹St. Vincent's Hospital Sydney, Australien; ³⁰San Raffaele Hospital IRCCS Ospedale San Raffaele Milan, Italien; ³¹Inselspital - Universitätsspital Bern Universitätsklinik für Kardiologie Bern, Schweiz; ³²Universitätsmedizin der Johannes Gutenberg-Universität Mainz Zentrum für Kardiologie im Herz- und Gefäßzentrum Mainz, Deutschland; ³³Montefiore Medical Center, Albert Einstein College of Medicine Montefiore-Einstein Center for Heart and Vascular Care Ney York, USA; ³⁴Cardiovascular Research Foundation New York, Deutschland; ³⁵Centre Hospitalier Universitaire Bordeaux Service Médico-Chirurgical: Valvulopathies-Chirurgie Cardiaque-Cardiologie Interventionelle Structurelle Bordeaux, Frankreich; ³⁶Universitätsklinikum Köln Klinik und Poliklinik für Herzchirurgie Köln, 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.