Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry

Mayra Guerrero, Danny Dvir, Dominique Himbert, Marina Urena, Mackram Eleid, Dee Dee Wang, Adam Greenbaum, Vaikom S. Mahadevan, David Holzhey, Daniel O'Hair, Nicolas Dumonteil, Josep Rodés-Cabau, Nicolo Piazza, Jose H. Palma, Augustin DeLago, Enrico Ferrari, Adam Witkowski, Olaf Wendler, Ran Kornowski, Pedro Martinez-ClarkDaniel Ciaburri, Richard Shemin, Sami Alnasser, David McAllister, Martin Bena, Faraz Kerendi, Gregory Pavlides, Jose J. Sobrinho, Guilherme F. Attizzani, Isaac George, George Nickenig, Amir Ali Fassa, Alain Cribier, Vinnie Bapat, Ted Feldman, Charanjit Rihal, Alec Vahanian, John Webb, William O'Neill

Research output: Contribution to journalArticle

151 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1361-1371
Number of pages11
JournalJACC: Cardiovascular Interventions
Volume9
Issue number13
DOIs
StatePublished - Jul 11 2016

Keywords

  • calcific mitral stenosis
  • mitral annular calcification
  • mitral valve disease
  • mitral valve replacement
  • transcatheter valve replacement

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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    Guerrero, M., Dvir, D., Himbert, D., Urena, M., Eleid, M., Wang, D. D., Greenbaum, A., Mahadevan, V. S., Holzhey, D., O'Hair, D., Dumonteil, N., Rodés-Cabau, J., Piazza, N., Palma, J. H., DeLago, A., Ferrari, E., Witkowski, A., Wendler, O., Kornowski, R., ... O'Neill, W. (2016). Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry. JACC: Cardiovascular Interventions, 9(13), 1361-1371. https://doi.org/10.1016/j.jcin.2016.04.022