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; Tamburino, Corrado; Colombo, Antonio; Søndergaard, Lars; Webb, John G; Park, Seung Jung.
I: Journal of the American College of Cardiology, Bind 68, Nr. 11, 13.09.2016, s. 1195-1205.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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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
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
VL - 68
SP - 1195
EP - 1205
JO - Journal of the American College of Cardiology
JF - Journal of the American College of Cardiology
SN - 0735-1097
IS - 11
ER -
ID: 180758958