Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry.
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Guerrero Mayra, Dvir Danny, Himbert Dominique, Urena Marina, Eleid Mackram, Wang Dee Dee, Greenbaum Adam, Mahadevan Vaikom S, Holzhey David, O'Hair Daniel, Dumonteil Nicolas, Rodés-Cabau Josep, Piazza Nicolo, Palma Jose H, DeLago Augustin, Ferrari Enrico, Witkowski Adam, Wendler Olaf, Kornowski Ran, Martinez-Clark Pedro, Ciaburri Daniel, Shemin Richard, Alnasser Sami, McAllister David, Bena Martin, Kerendi Faraz, Pavlides Gregory, Sobrinho Jose J, Attizzani Guilherme F, George Isaac, Nickenig George, Fassa Amir-Ali, Cribier Alain, Bapat Vinnie, Feldman Ted, Rihal Charanjit, Vahanian Alec, Webb John, O'Neill William
Аннотация
BACKGROUND: The risk of surgical mitral valve replacement in patients with severe MAC is high. There are isolated reports of successful TMVR with balloon-expandable valves in this patient population.
METHODS: We performed a multicenter retrospective review of clinical outcomes of patients with severe MAC undergoing TMVR.
RESULTS: From September 2012 to July of 2015, 64 patients in 32 centers underwent TMVR with compassionate use of balloon-expandable valves. Mean age was 73 ± 13 years, 66% were female, and mean Society of Thoracic Surgeons score was 14.4 ± 9.5%. The mean mitral gradient was 11.45 ± 4.4 mm Hg and the mean mitral area was 1.18 ± 0.5 cm(2). SAPIEN valves (Edwards Lifesciences, Irvine, California) were used in 7.8%, SAPIEN XT in 59.4%, SAPIEN 3 in 28.1%, and Inovare (Braile Biomedica, Brazil) in 4.7%. Access was transatrial in 15.6%, transapical in 43.8%, and transseptal in 40.6%. Technical success according to Mitral Valve Academic Research Consortium criteria was achieved in 46 (72%) patients, primarily limited by the need for a second valve in 11 (17.2%). Six (9.3%) had left ventricular tract obstruction with hemodynamic compromise. Mean mitral gradient post-procedure was 4 ± 2.2 mm Hg, paravalvular regurgitation was mild or absent in all. Thirty-day all-cause mortality was 29.7% (cardiovascular = 12.5% and noncardiac = 17.2%); 84% of the survivors with follow-up data available were in New York Heart Association functional class I or II at 30 days (n = 25).
CONCLUSIONS: TMVR with balloon-expandable valves in patients with severe MAC is feasible but may be associated with significant adverse events. This strategy might be an alternative for selected high-risk patients with limited treatment options.