Original Investigation
Multicenter Evaluation of a Next-Generation Balloon-Expandable Transcatheter Aortic Valve

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Abstract

Background

The SAPIEN 3 (Edwards Lifesciences Inc., Irvine, California) transcatheter valve incorporates features designed to address the well-known deficiencies of transcatheter aortic valve replacement (TAVR). An ultra–low-profile delivery system facilitates safe, controlled, and accurate implantation and an external seal minimizes paravalvular regurgitation.

Objectives

The study evaluated whether TAVR with this third-generation valve would be a viable alternative to high- or intermediate-risk surgery for severe aortic stenosis.

Methods

The prospective study enrolled 150 patients at 16 sites in Europe and Canada. Clinical and echocardiographic outcomes were assessed at baseline, post-procedure, and 30 days. New sizing recommendations were developed during the course of the study.

Results

Patients were 83.6 ± 5.0 years of age, with multiple comorbidities reflected by a Society of Thoracic Surgeons score of 7.4 ± 4.5% and logistic EuroSCORE of 21.6 ± 12.3%. A transfemoral approach was chosen in 64.0% and alternative access (transapical/direct aortic) in the remainder. At 30 days, paravalvular regurgitation was none to mild in 96.4% and moderate in 3.5%. No patient had severe regurgitation. Transfemoral implantation was associated with low mortality (2.1%), no disabling stroke (0.0%), and fully percutaneous access and closure in 95.8%. Nontransfemoral alternative access was associated with higher rates of mortality (11.6%) and stroke (5.6%).

Conclusions

This third-generation device addresses major deficiencies of earlier valves in terms of ease of use, accuracy of positioning, and paravalvular sealing. The rates of mortality and stroke with transfemoral access are among the lowest reported and support further evaluation as an alternative to open surgery in intermediate-risk patients. (Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve [SAPIEN3]; NCT01808287)

Key Words

aortic stenosis
transcatheter aortic valve replacement

Abbreviations and Acronyms

CT
computed tomography
LVOT
left ventricular outflow tract
STS
Society of Thoracic Surgeons
TAVR
transcatheter aortic valve replacement
THV
transcatheter heart valve

Cited by (0)

Drs. Webb, Spence, and Thomas have received consulting fees from Edwards Lifesciences. Dr. Gerosa has received honoraria and consulting fees from Edwards Lifesciences, AstraZeneca, St. Jude Medical, Heartware, Jarvik, and Sorin; and has received research support from and is on the advisory board for Edwards Lifesciences. Dr. Lefèvre has served as a proctor and consultant for Edwards Lifesciences. Dr. Thomas has served as a consultant for and received research support from Edwards Lifesciences. Dr. Wendler has received speakers’ honoraria from, has been a proctor for, and has been a consultant for Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

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