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 J 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 J Bax, Corrado Tamburino, Antonio Colombo, Lars Søndergaard, John G Webb, Seung-Jung Park

198 Citationer (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).

Originalsprog	Engelsk
Tidsskrift	Journal of the American College of Cardiology
Vol/bind	68
Udgave nummer	11
Sider (fra-til)	1195-205
Antal sider	11
ISSN	0735-1097
DOI	https://doi.org/10.1016/j.jacc.2016.06.041
Status	Udgivet - 13 sep. 2016

Adgang til dokumentet

10.1016/j.jacc.2016.06.041

Citationsformater

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), 1195-205. https://doi.org/10.1016/j.jacc.2016.06.041

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', Journal of the American College of Cardiology, bind 68, nr. 11, s. 1195-205. https://doi.org/10.1016/j.jacc.2016.06.041

@article{2a6e1ece180541df842650b35769517f,

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 = "Journal Article",

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",

year = "2016",

month = sep,

day = "13",

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

language = "English",

volume = "68",

pages = "1195--205",

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

issn = "0735-1097",

publisher = "Elsevier Inc.",

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 J

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 - Journal Article

U2 - 10.1016/j.jacc.2016.06.041

DO - 10.1016/j.jacc.2016.06.041

M3 - Journal article

C2 - 27609682

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

Abstract

Adgang til dokumentet

Fingeraftryk

Citationsformater