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

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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)

Key Words

mortality
new device
paravalvular leak

Abbreviations and Acronyms

AS
aortic valve stenosis
CI
confidence interval
CT
computed tomography
EuroSCORE
European System for Cardiac Operative Risk Evaluation
HR
hazard ratio
PVL
paravalvular leak
STS
Society of Thoracic Surgeons
TAVR
transcatheter aortic valve replacement
VARC
Valve Academic Research Consortium

Cited by (0)

This study was supported by a grant from the CardioVascular Research Foundation, Seoul, Republic of Korea. The Department of Cardiology at the Leiden University Medical Center received research grants from Edwards Lifesciences, Biotronik, Medtronic, and Boston Scientific. Drs. Lefèvre, Tay, and Yong have served as proctors for Edwards Lifesciences. Drs. Dvir, Modine, and Kodali have served as consultants for Edwards Lifesciences and Medtronic. Dr. Latib has served on the Medtronic advisory board; and has served as a consultant for Direct Flow Medical. Dr. De Backer has served as a proctor for St. Jude Medical. Drs. Barbanti, Blanke, Pache, Ye, and Webb have served as consultants for Edwards Lifesciences. Dr. Neumann has received grant support from Medtronic, Boston Scientific, and Edwards Lifesciences. Dr. Ohno has served as a proctor for Medtronic. Dr. Schofer has received travel support from Edwards Lifesciences and Boston Scientific. Dr. Holy has been awarded a training grant sponsored by Edwards Lifesciences. Dr. Khalique has served as a consultant for Edwards Lifesciences and Boston Scientific. Dr. Nietlispach has served as a consultant for Edwards Lifesciences, St. Jude Medical, Direct Flow Medical, and Medtronic. Dr. Leon has served as a nonpaid member of the Scientific Advisory Board of Edwards Lifesciences. Dr. Chevalier has served as a consultant for Medtronic. Dr. Leipsic has served as a consultant and provides the core laboratory for Edwards Lifesciences. Dr. Delgado has received speaking fees from Abbott Vascular. Dr. Søndergaard has served as a proctor for, received research contracts from, and served on the advisory board for Medtronic, St. Jude Medical, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Yoon and Lefèvre contributed equally to this work.

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