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

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

in: J AM COLL CARDIOL, Jahrgang 68, Nr. 11, 13.09.2016, S. 1195-1205.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Yoon, S-H, Lefèvre, T, Ahn, J-M, 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, H-L, Lee, M, Yin, W-H, Park, D-W, Kang, S-J, Lee, S-W, Kim, Y-H, Lee, CW, Park, S-W, Kim, H-S, Butter, C, Khalique, OK, Schaefer, U, Nietlispach, F, Kodali, SK, Leon, MB, Ye, J, Chevalier, B, Leipsic, J, Delgado, V, Bax, JJ, Tamburino, C, Colombo, A, Søndergaard, L, Webb, JG & Park, S-J 2016, 'Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis', J AM COLL CARDIOL, Jg. 68, Nr. 11, S. 1195-1205. https://doi.org/10.1016/j.jacc.2016.06.041

APA

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. J AM COLL CARDIOL, 68(11), 1195-1205. https://doi.org/10.1016/j.jacc.2016.06.041

Vancouver

Yoon S-H, Lefèvre T, Ahn J-M, Perlman GY, Dvir D, Latib A et al. Transcatheter Aortic Valve Replacement With Early- and New-Generation Devices in Bicuspid Aortic Valve Stenosis. J AM COLL CARDIOL. 2016 Sep 13;68(11):1195-1205. https://doi.org/10.1016/j.jacc.2016.06.041

Bibtex

@article{a67a43634ba044d595fdc99db66fac36,
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 = "Aged, Aortic Valve/abnormalities, Aortic Valve Stenosis/etiology, Bicuspid Aortic Valve Disease, Equipment Design, Female, Heart Valve Diseases/complications, Humans, Male, Transcatheter Aortic Valve Replacement/instrumentation",
author = "Sung-Han Yoon and Thierry Lef{\`e}vre and Jung-Ming Ahn 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 Hsien-Li Kao and Michael Lee and Wei-Hsian Yin and Duk-Woo Park and Soo-Jin Kang and Seung-Whan Lee and Young-Hak Kim and Lee, {Cheol Whan} and Seong-Wook Park and Hyo-Soo Kim 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 Bax, {Jeroen J} and Corrado Tamburino and Antonio Colombo and Lars S{\o}ndergaard and Webb, {John G} and Seung-Jung Park",
note = "Copyright {\textcopyright} 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.",
year = "2016",
month = sep,
day = "13",
doi = "10.1016/j.jacc.2016.06.041",
language = "English",
volume = "68",
pages = "1195--1205",
journal = "J AM COLL CARDIOL",
issn = "0735-1097",
publisher = "Elsevier USA",
number = "11",

}

RIS

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 J

AU - Tamburino, Corrado

AU - Colombo, Antonio

AU - Søndergaard, Lars

AU - Webb, John G

AU - Park, Seung-Jung

N1 - Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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 - Aged

KW - Aortic Valve/abnormalities

KW - Aortic Valve Stenosis/etiology

KW - Bicuspid Aortic Valve Disease

KW - Equipment Design

KW - Female

KW - Heart Valve Diseases/complications

KW - Humans

KW - Male

KW - Transcatheter Aortic Valve Replacement/instrumentation

U2 - 10.1016/j.jacc.2016.06.041

DO - 10.1016/j.jacc.2016.06.041

M3 - SCORING: Journal article

C2 - 27609682

VL - 68

SP - 1195

EP - 1205

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 11

ER -