Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings

Sung Han Yoon; Brian K. Whisenant; Sabine Bleiziffer; Victoria Delgado; Niklas Schofer; Lena Eschenbach; Buntaro Fujita; Rahul Sharma; Marco Ancona; Ermela Yzeiraj; Stefano Cannata; Colin Barker; James E. Davies; Antonio H. Frangieh; Florian Deuschl; Tomaz Podlesnikar; Masahiko Asami; Abhijeet Dhoble; Anthony Chyou; Jean Bernard Masson; Harindra C. Wijeysundera; Daniel J. Blackman; Rajiv Rampat; Maurizio Taramasso; Enrique Gutierrez-Ibanes; Tarun Chakravarty; Guiherme F. Attizzani; Tsuyoshi Kaneko; S. Chiu Wong; Horst Sievert; Fabian Nietlispach; David Hildick-Smith; Luis Nombela-Franco; Lenard Conradi; Christian Hengstenberg; Michael J. Reardon; Albert Markus Kasel; Simon Redwood; Antonio Colombo; Saibal Kar; Francesco Maisano; Stephan Windecker; Thomas Pilgrim; Stephan M. Ensminger; Bernard D. Prendergast; Joachim Schofer; Ulrich Schaefer; Jeroen J. Bax; Azeem Latib; Raj R. Makkar

doi:10.1016/j.jacc.2017.07.714

Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings

Sung Han Yoon, Brian K. Whisenant, Sabine Bleiziffer, Victoria Delgado, Niklas Schofer, Lena Eschenbach, Buntaro Fujita, Rahul Sharma, Marco Ancona, Ermela Yzeiraj, Stefano Cannata, Colin Barker, James E. Davies, Antonio H. Frangieh, Florian Deuschl, Tomaz Podlesnikar, Masahiko Asami, Abhijeet Dhoble, Anthony Chyou, Jean Bernard MassonHarindra C. Wijeysundera, Daniel J. Blackman, Rajiv Rampat, Maurizio Taramasso, Enrique Gutierrez-Ibanes, Tarun Chakravarty, Guiherme F. Attizzani, Tsuyoshi Kaneko, S. Chiu Wong, Horst Sievert, Fabian Nietlispach, David Hildick-Smith, Luis Nombela-Franco, Lenard Conradi, Christian Hengstenberg, Michael J. Reardon, Albert Markus Kasel, Simon Redwood, Antonio Colombo, Saibal Kar, Francesco Maisano, Stephan Windecker, Thomas Pilgrim, Stephan M. Ensminger, Bernard D. Prendergast, Joachim Schofer, Ulrich Schaefer, Jeroen J. Bax, Azeem Latib, Raj R. Makkar

Research output: Contribution to journal › Article › peer-review

173 Scopus citations

Abstract

Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

Original language	English (US)
Pages (from-to)	1121-1131
Number of pages	11
Journal	Journal of the American College of Cardiology
Volume	70
Issue number	9
DOIs	https://doi.org/10.1016/j.jacc.2017.07.714
State	Published - Aug 29 2017
Externally published	Yes

Keywords

annuloplasty ring
degenerated bioprostheses
mitral valve
transcatheter valve implantation

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jacc.2017.07.714

Cite this

Yoon, S. H., Whisenant, B. K., Bleiziffer, S., Delgado, V., Schofer, N., Eschenbach, L., Fujita, B., Sharma, R., Ancona, M., Yzeiraj, E., Cannata, S., Barker, C., Davies, J. E., Frangieh, A. H., Deuschl, F., Podlesnikar, T., Asami, M., Dhoble, A., Chyou, A., ... Makkar, R. R. (2017). Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings. Journal of the American College of Cardiology, 70(9), 1121-1131. https://doi.org/10.1016/j.jacc.2017.07.714

Yoon, SH, Whisenant, BK, Bleiziffer, S, Delgado, V, Schofer, N, Eschenbach, L, Fujita, B, Sharma, R, Ancona, M, Yzeiraj, E, Cannata, S, Barker, C, Davies, JE, Frangieh, AH, Deuschl, F, Podlesnikar, T, Asami, M, Dhoble, A, Chyou, A, Masson, JB, Wijeysundera, HC, Blackman, DJ, Rampat, R, Taramasso, M, Gutierrez-Ibanes, E, Chakravarty, T, Attizzani, GF, Kaneko, T, Wong, SC, Sievert, H, Nietlispach, F, Hildick-Smith, D, Nombela-Franco, L, Conradi, L, Hengstenberg, C, Reardon, MJ, Kasel, AM, Redwood, S, Colombo, A, Kar, S, Maisano, F, Windecker, S, Pilgrim, T, Ensminger, SM, Prendergast, BD, Schofer, J, Schaefer, U, Bax, JJ, Latib, A & Makkar, RR 2017, 'Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings', Journal of the American College of Cardiology, vol. 70, no. 9, pp. 1121-1131. https://doi.org/10.1016/j.jacc.2017.07.714

@article{074a1293789a42858433e1286b3bae00,

title = "Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings",

abstract = "Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.",

keywords = "annuloplasty ring, degenerated bioprostheses, mitral valve, transcatheter valve implantation",

author = "Yoon, {Sung Han} and Whisenant, {Brian K.} and Sabine Bleiziffer and Victoria Delgado and Niklas Schofer and Lena Eschenbach and Buntaro Fujita and Rahul Sharma and Marco Ancona and Ermela Yzeiraj and Stefano Cannata and Colin Barker and Davies, {James E.} and Frangieh, {Antonio H.} and Florian Deuschl and Tomaz Podlesnikar and Masahiko Asami and Abhijeet Dhoble and Anthony Chyou and Masson, {Jean Bernard} and Wijeysundera, {Harindra C.} and Blackman, {Daniel J.} and Rajiv Rampat and Maurizio Taramasso and Enrique Gutierrez-Ibanes and Tarun Chakravarty and Attizzani, {Guiherme F.} and Tsuyoshi Kaneko and Wong, {S. Chiu} and Horst Sievert and Fabian Nietlispach and David Hildick-Smith and Luis Nombela-Franco and Lenard Conradi and Christian Hengstenberg and Reardon, {Michael J.} and Kasel, {Albert Markus} and Simon Redwood and Antonio Colombo and Saibal Kar and Francesco Maisano and Stephan Windecker and Thomas Pilgrim and Ensminger, {Stephan M.} and Prendergast, {Bernard D.} and Joachim Schofer and Ulrich Schaefer and Bax, {Jeroen J.} and Azeem Latib and Makkar, {Raj R.}",

note = "Publisher Copyright: {\textcopyright} 2017 American College of Cardiology Foundation",

year = "2017",

month = aug,

day = "29",

doi = "10.1016/j.jacc.2017.07.714",

language = "English (US)",

volume = "70",

pages = "1121--1131",

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

issn = "0735-1097",

publisher = "Elsevier USA",

number = "9",

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TY - JOUR

T1 - Transcatheter Mitral Valve Replacement for Degenerated Bioprosthetic Valves and Failed Annuloplasty Rings

AU - Yoon, Sung Han

AU - Whisenant, Brian K.

AU - Bleiziffer, Sabine

AU - Delgado, Victoria

AU - Schofer, Niklas

AU - Eschenbach, Lena

AU - Fujita, Buntaro

AU - Sharma, Rahul

AU - Ancona, Marco

AU - Yzeiraj, Ermela

AU - Cannata, Stefano

AU - Barker, Colin

AU - Davies, James E.

AU - Frangieh, Antonio H.

AU - Deuschl, Florian

AU - Podlesnikar, Tomaz

AU - Asami, Masahiko

AU - Dhoble, Abhijeet

AU - Chyou, Anthony

AU - Masson, Jean Bernard

AU - Wijeysundera, Harindra C.

AU - Blackman, Daniel J.

AU - Rampat, Rajiv

AU - Taramasso, Maurizio

AU - Gutierrez-Ibanes, Enrique

AU - Chakravarty, Tarun

AU - Attizzani, Guiherme F.

AU - Kaneko, Tsuyoshi

AU - Wong, S. Chiu

AU - Sievert, Horst

AU - Nietlispach, Fabian

AU - Hildick-Smith, David

AU - Nombela-Franco, Luis

AU - Conradi, Lenard

AU - Hengstenberg, Christian

AU - Reardon, Michael J.

AU - Kasel, Albert Markus

AU - Redwood, Simon

AU - Colombo, Antonio

AU - Kar, Saibal

AU - Maisano, Francesco

AU - Windecker, Stephan

AU - Pilgrim, Thomas

AU - Ensminger, Stephan M.

AU - Prendergast, Bernard D.

AU - Schofer, Joachim

AU - Schaefer, Ulrich

AU - Bax, Jeroen J.

AU - Latib, Azeem

AU - Makkar, Raj R.

PY - 2017/8/29

Y1 - 2017/8/29

N2 - Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

AB - Background Limited data exist regarding transcatheter mitral valve replacement (TMVR) for patients with failed mitral valve replacement and repair. Objectives This study sought to evaluate the outcomes of TMVR in patients with failed mitral bioprosthetic valves (valve-in-valve [ViV]) and annuloplasty rings (valve-in-ring [ViR]). Methods From the TMVR multicenter registry, procedural and clinical outcomes of mitral ViV and ViR were compared according to Mitral Valve Academic Research Consortium criteria. Results A total of 248 patients with mean Society of Thoracic Surgeons score of 8.9 ± 6.8% underwent TMVR. Transseptal access and the balloon-expandable valve were used in 33.1% and 89.9%, respectively. Compared with 176 patients undergoing ViV, 72 patients undergoing ViR had lower left ventricular ejection fraction (45.6 ± 17.4% vs. 55.3 ± 11.1%; p < 0.001). Overall technical and device success rates were acceptable, at 92.3% and 85.5%, respectively. However, compared with the ViV group, the ViR group had lower technical success (83.3% vs. 96.0%; p = 0.001) due to more frequent second valve implantation (11.1% vs. 2.8%; p = 0.008), and lower device success (76.4% vs. 89.2%; p = 0.009) due to more frequent reintervention (16.7% vs. 7.4%; p = 0.03). Mean mitral valve gradients were similar between groups (6.4 ± 2.3 mm Hg vs. 5.8 ± 2.7 mm Hg; p = 0.17), whereas the ViR group had more frequent post-procedural mitral regurgitation moderate or higher (19.4% vs. 6.8%; p = 0.003). Furthermore, the ViR group had more frequent life-threatening bleeding (8.3% vs. 2.3%; p = 0.03), acute kidney injury (11.1% vs. 4.0%; p = 0.03), and subsequent lower procedural success (58.3% vs. 79.5%; p = 0.001). The 1-year all-cause mortality rate was significantly higher in the ViR group compared with the ViV group (28.7% vs. 12.6%; log-rank test, p = 0.01). On multivariable analysis, failed annuloplasty ring was independently associated with all-cause mortality (hazard ratio: 2.70; 95% confidence interval: 1.34 to 5.43; p = 0.005). Conclusions The TMVR procedure provided acceptable outcomes in high-risk patients with degenerated bioprostheses or failed annuloplasty rings, but mitral ViR was associated with higher rates of procedural complications and mid-term mortality compared with mitral ViV.

KW - annuloplasty ring

KW - degenerated bioprostheses

KW - mitral valve

KW - transcatheter valve implantation

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U2 - 10.1016/j.jacc.2017.07.714

DO - 10.1016/j.jacc.2017.07.714

M3 - Article

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SN - 0735-1097

VL - 70

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EP - 1131

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 9

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