1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification

Mayra Guerrero; Marina Urena; Dominique Himbert; Dee Dee Wang; Mackram Eleid; Susheel Kodali; Isaac George; Tarun Chakravarty; Moses Mathur; David Holzhey; Ashish Pershad; H. Kenith Fang; Daniel O'Hair; Noah Jones; Vaikom S. Mahadevan; Nicolas Dumonteil; Josep Rodés-Cabau; Nicolo Piazza; Enrico Ferrari; Daniel Ciaburri; Mohammed Nejjari; Augustin DeLago; Paul Sorajja; Firas Zahr; Vivek Rajagopal; Brian Whisenant; Pinak Bipin Shah; Jan Malte Sinning; Adam Witkowski; Helene Eltchaninoff; Danny Dvir; Bena Martin; Guilherme F. Attizzani; Diego Gaia; Nagela S.V. Nunes; Amir Ali Fassa; Faraz Kerendi; Gregory Pavlides; Vijay Iyer; Georges Kaddissi; Christian Witzke; James Wudel; Gregory Mishkel; Bryan Raybuck; Chi Wang; Ron Waksman; Igor Palacios; Alain Cribier; John Webb; Vinnie Bapat; Mark Reisman; Raj Makkar; Martin Leon; Charanjit Rihal; Alec Vahanian; William O'Neill; Ted Feldman

doi:10.1016/j.jacc.2018.02.054

1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification

Mayra Guerrero, Marina Urena, Dominique Himbert, Dee Dee Wang, Mackram Eleid, Susheel Kodali, Isaac George, Tarun Chakravarty, Moses Mathur, David Holzhey, Ashish Pershad, H. Kenith Fang, Daniel O'Hair, Noah Jones, Vaikom S. Mahadevan, Nicolas Dumonteil, Josep Rodés-Cabau, Nicolo Piazza, Enrico Ferrari, Daniel CiaburriMohammed Nejjari, Augustin DeLago, Paul Sorajja, Firas Zahr, Vivek Rajagopal, Brian Whisenant, Pinak Bipin Shah, Jan Malte Sinning, Adam Witkowski, Helene Eltchaninoff, Danny Dvir, Bena Martin, Guilherme F. Attizzani, Diego Gaia, Nagela S.V. Nunes, Amir Ali Fassa, Faraz Kerendi, Gregory Pavlides, Vijay Iyer, Georges Kaddissi, Christian Witzke, James Wudel, Gregory Mishkel, Bryan Raybuck, Chi Wang, Ron Waksman, Igor Palacios, Alain Cribier, John Webb, Vinnie Bapat, Mark Reisman, Raj Makkar, Martin Leon, Charanjit Rihal, Alec Vahanian, William O'Neill, Ted Feldman

Research output: Contribution to journal › Article

83 Scopus citations

Abstract

Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. Objectives: The goal of this study was to evaluate 1-year outcomes in this registry. Methods: This study was a multicenter retrospective review of clinical outcomes. Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm², mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

Original language	English (US)
Pages (from-to)	1841-1853
Number of pages	13
Journal	Journal of the American College of Cardiology
Volume	71
Issue number	17
DOIs	https://doi.org/10.1016/j.jacc.2018.02.054
State	Published - May 1 2018

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Keywords

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

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Cite this

Guerrero, M., Urena, M., Himbert, D., Wang, D. D., Eleid, M., Kodali, S., George, I., Chakravarty, T., Mathur, M., Holzhey, D., Pershad, A., Fang, H. K., O'Hair, D., Jones, N., Mahadevan, V. S., Dumonteil, N., Rodés-Cabau, J., Piazza, N., Ferrari, E., ... Feldman, T. (2018). 1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification. Journal of the American College of Cardiology, 71(17), 1841-1853. https://doi.org/10.1016/j.jacc.2018.02.054

1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification. / Guerrero, Mayra; Urena, Marina; Himbert, Dominique; Wang, Dee Dee; Eleid, Mackram; Kodali, Susheel; George, Isaac; Chakravarty, Tarun; Mathur, Moses; Holzhey, David; Pershad, Ashish; Fang, H. Kenith; O'Hair, Daniel; Jones, Noah; Mahadevan, Vaikom S.; Dumonteil, Nicolas; Rodés-Cabau, Josep; Piazza, Nicolo; Ferrari, Enrico; Ciaburri, Daniel; Nejjari, Mohammed; DeLago, Augustin; Sorajja, Paul; Zahr, Firas; Rajagopal, Vivek; Whisenant, Brian; Shah, Pinak Bipin; Sinning, Jan Malte; Witkowski, Adam; Eltchaninoff, Helene; Dvir, Danny; Martin, Bena; Attizzani, Guilherme F.; Gaia, Diego; Nunes, Nagela S.V.; Fassa, Amir Ali; Kerendi, Faraz; Pavlides, Gregory; Iyer, Vijay; Kaddissi, Georges; Witzke, Christian; Wudel, James; Mishkel, Gregory; Raybuck, Bryan; Wang, Chi; Waksman, Ron; Palacios, Igor; Cribier, Alain; Webb, John; Bapat, Vinnie; Reisman, Mark; Makkar, Raj; Leon, Martin; Rihal, Charanjit; Vahanian, Alec; O'Neill, William; Feldman, Ted.

In: Journal of the American College of Cardiology, Vol. 71, No. 17, 01.05.2018, p. 1841-1853.

Research output: Contribution to journal › Article

Guerrero, M, Urena, M, Himbert, D, Wang, DD, Eleid, M, Kodali, S, George, I, Chakravarty, T, Mathur, M, Holzhey, D, Pershad, A, Fang, HK, O'Hair, D, Jones, N, Mahadevan, VS, Dumonteil, N, Rodés-Cabau, J, Piazza, N, Ferrari, E, Ciaburri, D, Nejjari, M, DeLago, A, Sorajja, P, Zahr, F, Rajagopal, V, Whisenant, B, Shah, PB, Sinning, JM, Witkowski, A, Eltchaninoff, H, Dvir, D, Martin, B, Attizzani, GF, Gaia, D, Nunes, NSV, Fassa, AA, Kerendi, F, Pavlides, G, Iyer, V, Kaddissi, G, Witzke, C, Wudel, J, Mishkel, G, Raybuck, B, Wang, C, Waksman, R, Palacios, I, Cribier, A, Webb, J, Bapat, V, Reisman, M, Makkar, R, Leon, M, Rihal, C, Vahanian, A, O'Neill, W & Feldman, T 2018, '1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification', Journal of the American College of Cardiology, vol. 71, no. 17, pp. 1841-1853. https://doi.org/10.1016/j.jacc.2018.02.054

Guerrero, Mayra ; Urena, Marina ; Himbert, Dominique ; Wang, Dee Dee ; Eleid, Mackram ; Kodali, Susheel ; George, Isaac ; Chakravarty, Tarun ; Mathur, Moses ; Holzhey, David ; Pershad, Ashish ; Fang, H. Kenith ; O'Hair, Daniel ; Jones, Noah ; Mahadevan, Vaikom S. ; Dumonteil, Nicolas ; Rodés-Cabau, Josep ; Piazza, Nicolo ; Ferrari, Enrico ; Ciaburri, Daniel ; Nejjari, Mohammed ; DeLago, Augustin ; Sorajja, Paul ; Zahr, Firas ; Rajagopal, Vivek ; Whisenant, Brian ; Shah, Pinak Bipin ; Sinning, Jan Malte ; Witkowski, Adam ; Eltchaninoff, Helene ; Dvir, Danny ; Martin, Bena ; Attizzani, Guilherme F. ; Gaia, Diego ; Nunes, Nagela S.V. ; Fassa, Amir Ali ; Kerendi, Faraz ; Pavlides, Gregory ; Iyer, Vijay ; Kaddissi, Georges ; Witzke, Christian ; Wudel, James ; Mishkel, Gregory ; Raybuck, Bryan ; Wang, Chi ; Waksman, Ron ; Palacios, Igor ; Cribier, Alain ; Webb, John ; Bapat, Vinnie ; Reisman, Mark ; Makkar, Raj ; Leon, Martin ; Rihal, Charanjit ; Vahanian, Alec ; O'Neill, William ; Feldman, Ted. / 1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification. In: Journal of the American College of Cardiology. 2018 ; Vol. 71, No. 17. pp. 1841-1853.

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title = "1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification",

abstract = "Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. Objectives: The goal of this study was to evaluate 1-year outcomes in this registry. Methods: This study was a multicenter retrospective review of clinical outcomes. Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.",

keywords = "calcific mitral valve stenosis, mitral annular calcification, mitral valve disease, mitral valve replacement, transcatheter valve replacement",

author = "Mayra Guerrero and Marina Urena and Dominique Himbert and Wang, {Dee Dee} and Mackram Eleid and Susheel Kodali and Isaac George and Tarun Chakravarty and Moses Mathur and David Holzhey and Ashish Pershad and Fang, {H. Kenith} and Daniel O'Hair and Noah Jones and Mahadevan, {Vaikom S.} and Nicolas Dumonteil and Josep Rod{\'e}s-Cabau and Nicolo Piazza and Enrico Ferrari and Daniel Ciaburri and Mohammed Nejjari and Augustin DeLago and Paul Sorajja and Firas Zahr and Vivek Rajagopal and Brian Whisenant and Shah, {Pinak Bipin} and Sinning, {Jan Malte} and Adam Witkowski and Helene Eltchaninoff and Danny Dvir and Bena Martin and Attizzani, {Guilherme F.} and Diego Gaia and Nunes, {Nagela S.V.} and Fassa, {Amir Ali} and Faraz Kerendi and Gregory Pavlides and Vijay Iyer and Georges Kaddissi and Christian Witzke and James Wudel and Gregory Mishkel and Bryan Raybuck and Chi Wang and Ron Waksman and Igor Palacios and Alain Cribier and John Webb and Vinnie Bapat and Mark Reisman and Raj Makkar and Martin Leon and Charanjit Rihal and Alec Vahanian and William O'Neill and Ted Feldman",

year = "2018",

month = may,

day = "1",

doi = "10.1016/j.jacc.2018.02.054",

language = "English (US)",

volume = "71",

pages = "1841--1853",

journal = "Journal of the American College of Cardiology",

issn = "0735-1097",

publisher = "Elsevier USA",

number = "17",

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TY - JOUR

T1 - 1-Year Outcomes of Transcatheter Mitral Valve Replacement in Patients With Severe Mitral Annular Calcification

AU - Guerrero, Mayra

AU - Urena, Marina

AU - Himbert, Dominique

AU - Wang, Dee Dee

AU - Eleid, Mackram

AU - Kodali, Susheel

AU - George, Isaac

AU - Chakravarty, Tarun

AU - Mathur, Moses

AU - Holzhey, David

AU - Pershad, Ashish

AU - Fang, H. Kenith

AU - O'Hair, Daniel

AU - Jones, Noah

AU - Mahadevan, Vaikom S.

AU - Dumonteil, Nicolas

AU - Rodés-Cabau, Josep

AU - Piazza, Nicolo

AU - Ferrari, Enrico

AU - Ciaburri, Daniel

AU - Nejjari, Mohammed

AU - DeLago, Augustin

AU - Sorajja, Paul

AU - Zahr, Firas

AU - Rajagopal, Vivek

AU - Whisenant, Brian

AU - Shah, Pinak Bipin

AU - Sinning, Jan Malte

AU - Witkowski, Adam

AU - Eltchaninoff, Helene

AU - Dvir, Danny

AU - Martin, Bena

AU - Attizzani, Guilherme F.

AU - Gaia, Diego

AU - Nunes, Nagela S.V.

AU - Fassa, Amir Ali

AU - Kerendi, Faraz

AU - Pavlides, Gregory

AU - Iyer, Vijay

AU - Kaddissi, Georges

AU - Witzke, Christian

AU - Wudel, James

AU - Mishkel, Gregory

AU - Raybuck, Bryan

AU - Wang, Chi

AU - Waksman, Ron

AU - Palacios, Igor

AU - Cribier, Alain

AU - Webb, John

AU - Bapat, Vinnie

AU - Reisman, Mark

AU - Makkar, Raj

AU - Leon, Martin

AU - Rihal, Charanjit

AU - Vahanian, Alec

AU - O'Neill, William

AU - Feldman, Ted

PY - 2018/5/1

Y1 - 2018/5/1

N2 - Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. Objectives: The goal of this study was to evaluate 1-year outcomes in this registry. Methods: This study was a multicenter retrospective review of clinical outcomes. Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

AB - Background: The risk of surgical mitral valve replacement in patients with severe mitral annular calcification (MAC) is high. Several patients worldwide with severe MAC have been treated successfully with transcatheter mitral valve replacement (TMVR) using balloon-expandable aortic transcatheter valves. The TMVR in MAC Global Registry is a multicenter registry that collects data on outcomes of these procedures. Objectives: The goal of this study was to evaluate 1-year outcomes in this registry. Methods: This study was a multicenter retrospective review of clinical outcomes. Results: A total of 116 extreme surgical risk patients with severe MAC underwent TMVR; 106 had a procedure date >1 year before data-lock and were included in the analysis. Their mean age was 73 ± 12 years, and 68% were female. The mean Society of Thoracic Surgeons score was 15.3 ± 11.6%, and 90% were in New York Heart Association functional class III or IV. Thirty-day and 1-year all-cause mortality was 25% and 53.7%, respectively. Most patients who survived 30 days were alive at 1 year (49 of 77 [63.6%]), and the majority (71.8%) were in New York Heart Association functional class I or II. Echocardiography data at 1 year were available in 34 patients. Mean left ventricular ejection fraction was 58.6 ± 11.2%, mean mitral valve area was 1.9 ± 0.5 cm2, mean mitral gradient was 5.8 ± 2.2 mm Hg, and 75% had zero or trace mitral regurgitation. Conclusions: TMVR with balloon-expandable aortic valves in extreme surgical risk patients with severe MAC is feasible but associated with high 30-day and 1-year mortality. Most patients who survive the 30-day post-procedural period are alive at 1 year and have sustained improvement of symptoms and transcatheter valve performance. The role of TMVR in patients with MAC requires further evaluation in clinical trials.

KW - calcific mitral valve stenosis

KW - mitral annular calcification

KW - mitral valve disease

KW - mitral valve replacement

KW - transcatheter valve replacement

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10.1016/j.jacc.2018.02.054