Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve

TY - JOUR

T1 - Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve

AU - Webb, John

AU - Gerosa, Gino

AU - Lefèvre, Thierry

AU - Leipsic, Jonathon

AU - Spence, Mark

AU - Thomas, Martyn

AU - Thielmann, Matthias

AU - Treede, Hendrik

AU - Wendler, Olaf

AU - Walther, Thomas

N1 - Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2014/12/2

Y1 - 2014/12/2

N2 - 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).

AB - 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).

KW - Aged, 80 and over

KW - Aortic Valve/diagnostic imaging

KW - Aortic Valve Stenosis/mortality

KW - Cardiac Catheterization/instrumentation

KW - Echocardiography

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/instrumentation

KW - Humans

KW - Male

KW - Multidetector Computed Tomography

KW - Patient Outcome Assessment

KW - Prospective Studies

KW - Prosthesis Design

KW - Prosthesis Fitting

KW - Stroke/epidemiology

U2 - 10.1016/j.jacc.2014.09.026

DO - 10.1016/j.jacc.2014.09.026

M3 - SCORING: Journal article

C2 - 25456759

VL - 64

SP - 2235

EP - 2243

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 21

ER -