Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

Sung Han Yoon; Thierry Lefèvre; Jung Ming Ahn; Gidon Y. Perlman; Danny Dvir; Azeem Latib; Marco Barbanti; Florian Deuschl; Ole De Backer; Philipp Blanke; Thomas Modine; Gregor Pache; Franz-Josef Neumann; Philipp Ruile; Takahide Arai; Yohei Ohno; Hidehiro Kaneko; Edgar Tay; Niklas Schofer; Erik W. Holy; Ngai H V Luk; Gerald Yong; Qingsheng Lu; William K F Kong; Jimmy Hon; Hsien Li Kao; Michael Lee; Wei Hsian Yin; Duk Woo Park; Soo Jin Kang; Seung Whan Lee; Young Hak Kim; Cheol Whan Lee; Seong Wook Park; Hyo Soo Kim; Christian Butter; Omar K. Khalique; Ulrich Schaefer; Fabian Nietlispach; Susheel K. Kodali; Martin B Leon; Jian Ye; Bernard Chevalier; Jonathon Leipsic; Victoria Delgado; Jeroen Bax; Corrado Tamburino; Antonio Colombo; Lars Søndergaard; John G Webb; Seung Jung Park

doi:10.1016/j.jacc.2016.06.041

Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

Sung Han Yoon, Thierry Lefèvre, Jung Ming Ahn^*, Gidon Y. Perlman, Danny Dvir, Azeem Latib, Marco Barbanti, Florian Deuschl, Ole De Backer, Philipp Blanke, Thomas Modine, Gregor Pache, Franz-Josef Neumann, Philipp Ruile, Takahide Arai, Yohei Ohno, Hidehiro Kaneko, Edgar Tay, Niklas Schofer, Erik W. HolyNgai H V Luk, Gerald Yong, Qingsheng Lu, William K F Kong, Jimmy Hon, Hsien Li Kao, Michael Lee, Wei Hsian Yin, Duk Woo Park, Soo Jin Kang, Seung Whan Lee, Young Hak Kim, Cheol Whan Lee, Seong Wook Park, Hyo Soo Kim, Christian Butter, Omar K. Khalique, Ulrich Schaefer, Fabian Nietlispach, Susheel K. Kodali, Martin B Leon, Jian Ye, Bernard Chevalier, Jonathon Leipsic, Victoria Delgado, Jeroen Bax, Corrado Tamburino, Antonio Colombo, Lars Søndergaard, John G Webb, Seung Jung Park

^*Corresponding author for this work

Department of Clinical Medicine

125 Citations (Scopus)

Abstract

Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices.

Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices.

Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015.

Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99).

Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184)

Original language	English
Journal	Journal of the American College of Cardiology
Volume	68
Issue number	11
Pages (from-to)	1195-1205
Number of pages	11
ISSN	0735-1097
DOIs	https://doi.org/10.1016/j.jacc.2016.06.041
Publication status	Published - 13 Sept 2016

Keywords

mortality
new device
paravalvular leak

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Yoon, S. H., Lefèvre, T., Ahn, J. M., Perlman, G. Y., Dvir, D., Latib, A., Barbanti, M., Deuschl, F., De Backer, O., Blanke, P., Modine, T., Pache, G., Neumann, F-J., Ruile, P., Arai, T., Ohno, Y., Kaneko, H., Tay, E., Schofer, N., ... Park, S. J. (2016). Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. Journal of the American College of Cardiology, 68(11), 1195-1205. https://doi.org/10.1016/j.jacc.2016.06.041

Yoon, SH, Lefèvre, T, Ahn, JM, Perlman, GY, Dvir, D, Latib, A, Barbanti, M, Deuschl, F, De Backer, O, Blanke, P, Modine, T, Pache, G, Neumann, F-J, Ruile, P, Arai, T, Ohno, Y, Kaneko, H, Tay, E, Schofer, N, Holy, EW, Luk, NHV, Yong, G, Lu, Q, Kong, WKF, Hon, J, Kao, HL, Lee, M, Yin, WH, Park, DW, Kang, SJ, Lee, SW, Kim, YH, Lee, CW, Park, SW, Kim, HS, Butter, C, Khalique, OK, Schaefer, U, Nietlispach, F, Kodali, SK, Leon, MB, Ye, J, Chevalier, B, Leipsic, J, Delgado, V, Bax, J, Tamburino, C, Colombo, A, Søndergaard, L, Webb, JG & Park, SJ 2016, 'Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis', Journal of the American College of Cardiology, vol. 68, no. 11, pp. 1195-1205. https://doi.org/10.1016/j.jacc.2016.06.041

@article{5edf953d473b4f1d88ca650529a9f46c,

title = "Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis",

abstract = "Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184)",

keywords = "mortality, new device, paravalvular leak",

author = "Yoon, {Sung Han} and Thierry Lef{\`e}vre and Ahn, {Jung Ming} and Perlman, {Gidon Y.} and Danny Dvir and Azeem Latib and Marco Barbanti and Florian Deuschl and {De Backer}, Ole and Philipp Blanke and Thomas Modine and Gregor Pache and Franz-Josef Neumann and Philipp Ruile and Takahide Arai and Yohei Ohno and Hidehiro Kaneko and Edgar Tay and Niklas Schofer and Holy, {Erik W.} and Luk, {Ngai H V} and Gerald Yong and Qingsheng Lu and Kong, {William K F} and Jimmy Hon and Kao, {Hsien Li} and Michael Lee and Yin, {Wei Hsian} and Park, {Duk Woo} and Kang, {Soo Jin} and Lee, {Seung Whan} and Kim, {Young Hak} and Lee, {Cheol Whan} and Park, {Seong Wook} and Kim, {Hyo Soo} and Christian Butter and Khalique, {Omar K.} and Ulrich Schaefer and Fabian Nietlispach and Kodali, {Susheel K.} and Leon, {Martin B} and Jian Ye and Bernard Chevalier and Jonathon Leipsic and Victoria Delgado and Jeroen Bax and Corrado Tamburino and Antonio Colombo and Lars S{\o}ndergaard and Webb, {John G} and Park, {Seung Jung}",

year = "2016",

month = sep,

day = "13",

doi = "10.1016/j.jacc.2016.06.041",

language = "English",

volume = "68",

pages = "1195--1205",

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

issn = "0735-1097",

publisher = "Elsevier",

number = "11",

}

TY - JOUR

T1 - Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

AU - Yoon, Sung Han

AU - Lefèvre, Thierry

AU - Ahn, Jung Ming

AU - Perlman, Gidon Y.

AU - Dvir, Danny

AU - Latib, Azeem

AU - Barbanti, Marco

AU - Deuschl, Florian

AU - De Backer, Ole

AU - Blanke, Philipp

AU - Modine, Thomas

AU - Pache, Gregor

AU - Neumann, Franz-Josef

AU - Ruile, Philipp

AU - Arai, Takahide

AU - Ohno, Yohei

AU - Kaneko, Hidehiro

AU - Tay, Edgar

AU - Schofer, Niklas

AU - Holy, Erik W.

AU - Luk, Ngai H V

AU - Yong, Gerald

AU - Lu, Qingsheng

AU - Kong, William K F

AU - Hon, Jimmy

AU - Kao, Hsien Li

AU - Lee, Michael

AU - Yin, Wei Hsian

AU - Park, Duk Woo

AU - Kang, Soo Jin

AU - Lee, Seung Whan

AU - Kim, Young Hak

AU - Lee, Cheol Whan

AU - Park, Seong Wook

AU - Kim, Hyo Soo

AU - Butter, Christian

AU - Khalique, Omar K.

AU - Schaefer, Ulrich

AU - Nietlispach, Fabian

AU - Kodali, Susheel K.

AU - Leon, Martin B

AU - Ye, Jian

AU - Chevalier, Bernard

AU - Leipsic, Jonathon

AU - Delgado, Victoria

AU - Bax, Jeroen

AU - Tamburino, Corrado

AU - Colombo, Antonio

AU - Søndergaard, Lars

AU - Webb, John G

AU - Park, Seung Jung

PY - 2016/9/13

Y1 - 2016/9/13

N2 - Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184)

AB - Background Few studies have evaluated the clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve stenosis (AS). Particularly, limited data exist comparing the results of TAVR with new-generation devices versus early-generation devices. Objectives This study sought to evaluate the clinical outcomes of TAVR for bicuspid AS with early- and new-generation devices. Methods The Bicuspid TAVR Registry is an international multicenter study enrolling consecutive patients with bicuspid AS undergoing TAVR between April 2005 and May 2015. Results Of 301 patients, 199 patients (71.1%) were treated with early-generation devices (Sapien XT [Edwards Lifesciences Corporation, Irvine, California]: n = 87; CoreValve [Medtronic, Minneapolis, Minnesota]: n = 112) and 102 with new-generation devices (Sapien 3 [Edwards Lifesciences Corporation]: n = 91; Lotus [Boston Scientific Corporation, Marlborough, Massachusetts]: n = 11). The mean Society of Thoracic Surgeons score was 4.7 ± 5.2 without significant differences between groups (4.6 ± 5.1 vs. 4.9 ± 5.4; p = 0.57). Overall, all-cause mortality rates were 4.3% at 30 days and 14.4% at 1 year. Moderate or severe paravalvular leak was absent and significantly less frequent with new-generation compared to early-generation devices (0.0% vs. 8.5%; p = 0.002), which resulted in a higher device success rate (92.2% vs. 80.9%; p = 0.01). There were no differences between early- and new-generation devices in stroke (2.5% vs. 2.0%; p > 0.99), life-threatening bleeding (3.5% vs. 2.9%; p > 0.99), major vascular complication (4.5% vs. 2.9%; p = 0.76), stage 2 to 3 acute kidney injury (2.5% vs. 2.9%; p > 0.99), early safety endpoints (15.1% vs. 10.8%; p = 0.30), and 30-day all-cause mortality (4.5% vs. 3.9%; p > 0.99). Conclusions The clinical outcomes of TAVR in patients with bicuspid AS were favorable. New-generation devices were associated with less paravalvular leak and, hence, a higher device success rate than early-generation devices. (The Bicuspid Aortic Stenosis Following Transcatheter Aortic Valve Replacement Registry [Bicuspid TAVR]; NCT02394184)

KW - mortality

KW - new device

KW - paravalvular leak

U2 - 10.1016/j.jacc.2016.06.041

DO - 10.1016/j.jacc.2016.06.041

M3 - Journal article

C2 - 27609682

AN - SCOPUS:84994910749

SN - 0735-1097

VL - 68

SP - 1195

EP - 1205

JO - Journal of the American College of Cardiology

JF - Journal of the American College of Cardiology

IS - 11

ER -

Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis

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