Abdel-Wahab, Mohamed, Neumann, Franz-Josef, Mehilli, Julinda, Frerker, Christian, Richardt, Doreen, Landt, Martin, Jose, John, Toelg, Ralph, Kuck, Karl-Heinz, Massberg, Steffen, Robinson, Derek R, El-Mawardy, Mohamed and Richardt, Gert (2015) 1-Year outcomes after transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves. Journal of the American College of Cardiology, 66 (7). pp. 791-800. ISSN 0735-1097

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Abstract

BACKGROUND The use of a balloon-expandable transcatheter heart valve previously resulted in a greater rate of
device success compared with a self-expandable transcatheter heart valve.
OBJECTIVES The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term
follow-up.
METHODS The investigator-initiated trial randomized 241 high-risk patients with symptomatic severe aortic stenosis
and anatomy suitable for treatment with both balloon- and self-expandable transcatheter heart valves to transfemoral
transcatheter aortic valve replacement with either device. Patients were followed-up for 1 year, with assessment of
clinical outcomes and echocardiographic evaluation of valve function.
RESULTS At 1 year, the rates of death of any cause (17.4% vs. 12.8%; relative risk [RR]: 1.35; 95% confidence interval
[CI]: 0.73 to 2.50; p ¼ 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p ¼ 0.54) were
not statistically significantly different in the balloon- and self-expandable groups, respectively. The frequencies of all
strokes (9.1% vs. 3.4%; RR: 2.66; 95% CI: 0.87 to 8.12; p ¼ 0.11) and repeat hospitalization for heart failure (7.4% vs.
12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p ¼ 0.19) did not statistically significantly differ between the 2 groups. Elevated
transvalvular gradients during follow-up were observed in 4 patients in the balloon-expandable group (3.4% vs. 0%;
p ¼ 0.12); all were resolved with anticoagulant therapy, suggesting a thrombotic etiology. More than mild paravalvular
regurgitation was more frequent in the self-expandable group (1.1% vs. 12.1%; p ¼ 0.005).
CONCLUSIONS Despite the higher device success rate with the balloon-expandable valve, 1-year follow-up of patients
in CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis:
Medtronic CoreValve Versus Edwards SAPIEN XT Trial), with limited statistical power, revealed clinical outcomes after
transfemoral transcatheter aortic valve replacement with both balloon- and self-expandable prostheses that were not
statistically significantly different. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic
Stenosis: The CHOICE Trial; NCT01645202) (J Am Coll Cardiol 2015;66:791–800) © 2015 by the American College of
Cardiology Foundation.

Item Type:	Article
Keywords:	transcatheter heart valve, balloon-expandable, self-expandable
Schools and Departments:	School of Mathematical and Physical Sciences > Mathematics
Subjects:	R Medicine > RD Surgery > RD0032 Operative surgery. Technique of surgical operations
Depositing User:	Derek Robinson
Date Deposited:	11 Sep 2015 12:58
Last Modified:	02 Jul 2019 14:32
URI:	http://sro.sussex.ac.uk/id/eprint/56652

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