TY - JOUR
T1 - Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification
T2 - Results From the First Multicenter Global Registry
AU - Guerrero, Mayra
AU - Dvir, Danny
AU - Himbert, Dominique
AU - Urena, Marina
AU - Eleid, Mackram
AU - Wang, Dee Dee
AU - Greenbaum, Adam
AU - Mahadevan, Vaikom S.
AU - Holzhey, David
AU - O'Hair, Daniel
AU - Dumonteil, Nicolas
AU - Rodés-Cabau, Josep
AU - Piazza, Nicolo
AU - Palma, Jose H.
AU - DeLago, Augustin
AU - Ferrari, Enrico
AU - Witkowski, Adam
AU - Wendler, Olaf
AU - Kornowski, Ran
AU - Martinez-Clark, Pedro
AU - Ciaburri, Daniel
AU - Shemin, Richard
AU - Alnasser, Sami
AU - McAllister, David
AU - Bena, Martin
AU - Kerendi, Faraz
AU - Pavlides, Gregory
AU - Sobrinho, Jose J.
AU - Attizzani, Guilherme F.
AU - George, Isaac
AU - Nickenig, George
AU - Fassa, Amir Ali
AU - Cribier, Alain
AU - Bapat, Vinnie
AU - Feldman, Ted
AU - Rihal, Charanjit
AU - Vahanian, Alec
AU - Webb, John
AU - O'Neill, William
N1 - Publisher Copyright:
© 2016 American College of Cardiology Foundation
PY - 2016/7/11
Y1 - 2016/7/11
N2 - Objectives This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. 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 cm2. 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.
AB - Objectives This study sought to evaluate the outcomes of the early experience of transcatheter mitral valve replacement (TMVR) with balloon-expandable valves in patients with severe mitral annular calcification (MAC) and reports the first large series from a multicenter global registry. 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 cm2. 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.
KW - calcific mitral stenosis
KW - mitral annular calcification
KW - mitral valve disease
KW - mitral valve replacement
KW - transcatheter valve replacement
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U2 - 10.1016/j.jcin.2016.04.022
DO - 10.1016/j.jcin.2016.04.022
M3 - Article
C2 - 27388824
AN - SCOPUS:84990842066
SN - 1936-8798
VL - 9
SP - 1361
EP - 1371
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 13
ER -