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, Vol. 68, No. 11, 13.09.2016, p. 1195-1205.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -