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

120 Citations (Scopus)

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

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Mitral Valve
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Brazil
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Mortality
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Keywords

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

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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

In: JACC: Cardiovascular Interventions, Vol. 9, No. 13, 11.07.2016, p. 1361-1371.

Research output: Contribution to journalArticle

Guerrero, M, Dvir, D, Himbert, D, Urena, M, Eleid, M, Wang, DD, Greenbaum, A, Mahadevan, VS, Holzhey, D, O'Hair, D, Dumonteil, N, Rodés-Cabau, J, Piazza, N, Palma, JH, DeLago, A, Ferrari, E, Witkowski, A, Wendler, O, Kornowski, R, Martinez-Clark, P, Ciaburri, D, Shemin, R, Alnasser, S, McAllister, D, Bena, M, Kerendi, F, Pavlides, G, Sobrinho, JJ, Attizzani, GF, George, I, Nickenig, G, Fassa, AA, Cribier, A, Bapat, V, Feldman, T, Rihal, C, Vahanian, A, Webb, J & 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, vol. 9, no. 13, pp. 1361-1371. https://doi.org/10.1016/j.jcin.2016.04.022
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. / Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification : Results From the First Multicenter Global Registry. In: JACC: Cardiovascular Interventions. 2016 ; Vol. 9, No. 13. pp. 1361-1371.
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title = "Transcatheter Mitral Valve Replacement in Native Mitral Valve Disease With Severe Mitral Annular Calcification: Results From the First Multicenter Global Registry",
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.",
keywords = "calcific mitral stenosis, mitral annular calcification, mitral valve disease, mitral valve replacement, transcatheter valve replacement",
author = "Mayra Guerrero and Danny Dvir and Dominique Himbert and Marina Urena and Mackram Eleid and Wang, {Dee Dee} and Adam Greenbaum and Mahadevan, {Vaikom S.} and David Holzhey and Daniel O'Hair and Nicolas Dumonteil and Josep Rod{\'e}s-Cabau and Nicolo Piazza and Palma, {Jose H.} and Augustin DeLago and Enrico Ferrari and Adam Witkowski and Olaf Wendler and Ran Kornowski and Pedro Martinez-Clark and Daniel Ciaburri and Richard Shemin and Sami Alnasser and David McAllister and Martin Bena and Faraz Kerendi and Gregory Pavlides and Sobrinho, {Jose J.} and Attizzani, {Guilherme F.} and Isaac George and George Nickenig and Fassa, {Amir Ali} and Alain Cribier and Vinnie Bapat and Ted Feldman and Charanjit Rihal and Alec Vahanian and John Webb and William O'Neill",
year = "2016",
month = "7",
day = "11",
doi = "10.1016/j.jcin.2016.04.022",
language = "English (US)",
volume = "9",
pages = "1361--1371",
journal = "JACC: Cardiovascular Interventions",
issn = "1936-8798",
publisher = "Elsevier Inc.",
number = "13",

}

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

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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