Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

Sung Han Yoon; Tobias Schmidt; Sabine Bleiziffer; Niklas Schofer; Claudia Fiorina; Antonio J. Munoz-Garcia; Ermela Yzeiraj; Ignacio J. Amat-Santos; Didier Tchetche; Christian Jung; Buntaro Fujita; Antonio Mangieri; Marcus Andre Deutsch; Timm Ubben; Florian Deuschl; Shingo Kuwata; Chiara De Biase; Timothy Williams; Abhijeet Dhoble; Won Keun Kim; Enrico Ferrari; Marco Barbanti; E. Mara Vollema; Antonio Miceli; Cristina Giannini; Guiherme F. Attizzani; William K.F. Kong; Enrique Gutierrez-Ibanes; Victor Alfonso Jimenez Diaz; Harindra C. Wijeysundera; Hidehiro Kaneko; Tarun Chakravarty; Moody Makar; Horst Sievert; Christian Hengstenberg; Bernard D. Prendergast; Flavien Vincent; Mohamed Abdel-Wahab; Luis Nombela-Franco; Miriam Silaschi; Giuseppe Tarantini; Christian Butter; Stephan M. Ensminger; David Hildick-Smith; Anna Sonia Petronio; Wei Hsian Yin; Federico De Marco; Luca Testa; Nicolas M. Van Mieghem; Brian K. Whisenant; Karl Heinz Kuck; Antonio Colombo; Saibal Kar; Cesar Moris; Victoria Delgado; Francesco Maisano; Fabian Nietlispach; Michael J. Mack; Joachim Schofer; Ulrich Schaefer; Jeroen J. Bax; Christian Frerker; Azeem Latib; Raj R. Makkar

doi:10.1016/j.jacc.2017.10.006

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

Sung Han Yoon, Tobias Schmidt, Sabine Bleiziffer, Niklas Schofer, Claudia Fiorina, Antonio J. Munoz-Garcia, Ermela Yzeiraj, Ignacio J. Amat-Santos, Didier Tchetche, Christian Jung, Buntaro Fujita, Antonio Mangieri, Marcus Andre Deutsch, Timm Ubben, Florian Deuschl, Shingo Kuwata, Chiara De Biase, Timothy Williams, Abhijeet Dhoble, Won Keun KimEnrico Ferrari, Marco Barbanti, E. Mara Vollema, Antonio Miceli, Cristina Giannini, Guiherme F. Attizzani, William K.F. Kong, Enrique Gutierrez-Ibanes, Victor Alfonso Jimenez Diaz, Harindra C. Wijeysundera, Hidehiro Kaneko, Tarun Chakravarty, Moody Makar, Horst Sievert, Christian Hengstenberg, Bernard D. Prendergast, Flavien Vincent, Mohamed Abdel-Wahab, Luis Nombela-Franco, Miriam Silaschi, Giuseppe Tarantini, Christian Butter, Stephan M. Ensminger, David Hildick-Smith, Anna Sonia Petronio, Wei Hsian Yin, Federico De Marco, Luca Testa, Nicolas M. Van Mieghem, Brian K. Whisenant, Karl Heinz Kuck, Antonio Colombo, Saibal Kar, Cesar Moris, Victoria Delgado, Francesco Maisano, Fabian Nietlispach, Michael J. Mack, Joachim Schofer, Ulrich Schaefer, Jeroen J. Bax, Christian Frerker, Azeem Latib, Raj R. Makkar

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

200 Scopus citations

Abstract

Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

Original language	English (US)
Pages (from-to)	2752-2763
Number of pages	12
Journal	Journal of the American College of Cardiology
Volume	70
Issue number	22
DOIs	https://doi.org/10.1016/j.jacc.2017.10.006
State	Published - Dec 5 2017
Externally published	Yes

Keywords

aortic regurgitation
transcatheter valve implantation

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

Access to Document

10.1016/j.jacc.2017.10.006

Cite this

Yoon, S. H., Schmidt, T., Bleiziffer, S., Schofer, N., Fiorina, C., Munoz-Garcia, A. J., Yzeiraj, E., Amat-Santos, I. J., Tchetche, D., Jung, C., Fujita, B., Mangieri, A., Deutsch, M. A., Ubben, T., Deuschl, F., Kuwata, S., De Biase, C., Williams, T., Dhoble, A., ... Makkar, R. R. (2017). Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation. Journal of the American College of Cardiology, 70(22), 2752-2763. https://doi.org/10.1016/j.jacc.2017.10.006

Yoon, SH, Schmidt, T, Bleiziffer, S, Schofer, N, Fiorina, C, Munoz-Garcia, AJ, Yzeiraj, E, Amat-Santos, IJ, Tchetche, D, Jung, C, Fujita, B, Mangieri, A, Deutsch, MA, Ubben, T, Deuschl, F, Kuwata, S, De Biase, C, Williams, T, Dhoble, A, Kim, WK, Ferrari, E, Barbanti, M, Vollema, EM, Miceli, A, Giannini, C, Attizzani, GF, Kong, WKF, Gutierrez-Ibanes, E, Jimenez Diaz, VA, Wijeysundera, HC, Kaneko, H, Chakravarty, T, Makar, M, Sievert, H, Hengstenberg, C, Prendergast, BD, Vincent, F, Abdel-Wahab, M, Nombela-Franco, L, Silaschi, M, Tarantini, G, Butter, C, Ensminger, SM, Hildick-Smith, D, Petronio, AS, Yin, WH, De Marco, F, Testa, L, Van Mieghem, NM, Whisenant, BK, Kuck, KH, Colombo, A, Kar, S, Moris, C, Delgado, V, Maisano, F, Nietlispach, F, Mack, MJ, Schofer, J, Schaefer, U, Bax, JJ, Frerker, C, Latib, A & Makkar, RR 2017, 'Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation', Journal of the American College of Cardiology, vol. 70, no. 22, pp. 2752-2763. https://doi.org/10.1016/j.jacc.2017.10.006

@article{860e01a20a1a428baf260c23679cd703,

title = "Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation",

abstract = "Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.",

keywords = "aortic regurgitation, transcatheter valve implantation",

author = "Yoon, {Sung Han} and Tobias Schmidt and Sabine Bleiziffer and Niklas Schofer and Claudia Fiorina and Munoz-Garcia, {Antonio J.} and Ermela Yzeiraj and Amat-Santos, {Ignacio J.} and Didier Tchetche and Christian Jung and Buntaro Fujita and Antonio Mangieri and Deutsch, {Marcus Andre} and Timm Ubben and Florian Deuschl and Shingo Kuwata and {De Biase}, Chiara and Timothy Williams and Abhijeet Dhoble and Kim, {Won Keun} and Enrico Ferrari and Marco Barbanti and Vollema, {E. Mara} and Antonio Miceli and Cristina Giannini and Attizzani, {Guiherme F.} and Kong, {William K.F.} and Enrique Gutierrez-Ibanes and {Jimenez Diaz}, {Victor Alfonso} and Wijeysundera, {Harindra C.} and Hidehiro Kaneko and Tarun Chakravarty and Moody Makar and Horst Sievert and Christian Hengstenberg and Prendergast, {Bernard D.} and Flavien Vincent and Mohamed Abdel-Wahab and Luis Nombela-Franco and Miriam Silaschi and Giuseppe Tarantini and Christian Butter and Ensminger, {Stephan M.} and David Hildick-Smith and Petronio, {Anna Sonia} and Yin, {Wei Hsian} and {De Marco}, Federico and Luca Testa and {Van Mieghem}, {Nicolas M.} and Whisenant, {Brian K.} and Kuck, {Karl Heinz} and Antonio Colombo and Saibal Kar and Cesar Moris and Victoria Delgado and Francesco Maisano and Fabian Nietlispach and Mack, {Michael J.} and Joachim Schofer and Ulrich Schaefer and Bax, {Jeroen J.} and Christian Frerker and Azeem Latib and Makkar, {Raj R.}",

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

year = "2017",

month = dec,

day = "5",

doi = "10.1016/j.jacc.2017.10.006",

language = "English (US)",

volume = "70",

pages = "2752--2763",

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

issn = "0735-1097",

publisher = "Elsevier USA",

number = "22",

}

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

AU - Yoon, Sung Han

AU - Schmidt, Tobias

AU - Bleiziffer, Sabine

AU - Schofer, Niklas

AU - Fiorina, Claudia

AU - Munoz-Garcia, Antonio J.

AU - Yzeiraj, Ermela

AU - Amat-Santos, Ignacio J.

AU - Tchetche, Didier

AU - Jung, Christian

AU - Fujita, Buntaro

AU - Mangieri, Antonio

AU - Deutsch, Marcus Andre

AU - Ubben, Timm

AU - Deuschl, Florian

AU - Kuwata, Shingo

AU - De Biase, Chiara

AU - Williams, Timothy

AU - Dhoble, Abhijeet

AU - Kim, Won Keun

AU - Ferrari, Enrico

AU - Barbanti, Marco

AU - Vollema, E. Mara

AU - Miceli, Antonio

AU - Giannini, Cristina

AU - Attizzani, Guiherme F.

AU - Kong, William K.F.

AU - Gutierrez-Ibanes, Enrique

AU - Jimenez Diaz, Victor Alfonso

AU - Wijeysundera, Harindra C.

AU - Kaneko, Hidehiro

AU - Chakravarty, Tarun

AU - Makar, Moody

AU - Sievert, Horst

AU - Hengstenberg, Christian

AU - Prendergast, Bernard D.

AU - Vincent, Flavien

AU - Abdel-Wahab, Mohamed

AU - Nombela-Franco, Luis

AU - Silaschi, Miriam

AU - Tarantini, Giuseppe

AU - Butter, Christian

AU - Ensminger, Stephan M.

AU - Hildick-Smith, David

AU - Petronio, Anna Sonia

AU - Yin, Wei Hsian

AU - De Marco, Federico

AU - Testa, Luca

AU - Van Mieghem, Nicolas M.

AU - Whisenant, Brian K.

AU - Kuck, Karl Heinz

AU - Colombo, Antonio

AU - Kar, Saibal

AU - Moris, Cesar

AU - Delgado, Victoria

AU - Maisano, Francesco

AU - Nietlispach, Fabian

AU - Mack, Michael J.

AU - Schofer, Joachim

AU - Schaefer, Ulrich

AU - Bax, Jeroen J.

AU - Frerker, Christian

AU - Latib, Azeem

AU - Makkar, Raj R.

PY - 2017/12/5

Y1 - 2017/12/5

N2 - Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

AB - Background Limited data exist about safety and efficacy of transcatheter aortic valve replacement (TAVR) in patients with pure native aortic regurgitation (AR). Objectives This study sought to compare the outcomes of TAVR with early- and new-generation devices in symptomatic patients with pure native AR. Methods From the pure native AR TAVR multicenter registry, procedural and clinical outcomes were assessed according to VARC-2 criteria and compared between early- and new-generation devices. Results A total of 331 patients with a mean STS score of 6.7 ± 6.7 underwent TAVR. The early- and new-generation devices were used in 119 patients (36.0%) and 212 patients (64.0%), respectively. STS score tended to be lower in the new-generation device group (6.2 ± 6.7 vs. 7.6 ± 6.7; p = 0.08), but transfemoral access was more frequently used in the early-generation device group (87.4% vs. 60.8%; p < 0.001). Compared with the early-generation devices, the new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%; p < 0.001) due to lower rates of second valve implantation (12.7% vs. 24.4%; p = 0.007) and post-procedural AR ≥ moderate (4.2% vs. 18.8%; p < 0.001). There were no significant differences in major 30-day endpoints between the 2 groups. The cumulative rates of all-cause and cardiovascular death at 1-year follow-up were 24.1% and 15.6%, respectively. The 1-year all-cause mortality rate was significantly higher in the patients with post-procedural AR ≥ moderate compared with those with post-procedural AR ≤ mild (46.1% vs. 21.8%; log-rank p = 0.001). On multivariable analysis, post-procedural AR ≥ moderate was independently associated with 1-year all-cause mortality (hazard ratio: 2.85; 95% confidence interval: 1.52 to 5.35; p = 0.001). Conclusions Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR. In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.

KW - aortic regurgitation

KW - transcatheter valve implantation

UR - http://www.scopus.com/inward/record.url?scp=85034023722&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85034023722&partnerID=8YFLogxK

U2 - 10.1016/j.jacc.2017.10.006

DO - 10.1016/j.jacc.2017.10.006

M3 - Article

C2 - 29191323

AN - SCOPUS:85034023722

SN - 0735-1097

VL - 70

SP - 2752

EP - 2763

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 22

ER -

Transcatheter Aortic Valve Replacement in Pure Native Aortic Valve Regurgitation

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this