Focus on Transcatheter Aortic Valve Replacement
5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves: Results From the CHOICE Randomized Clinical Trial

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Abstract

Objectives

The purpose of this study was to evaluate clinical and echocardiographic outcome data of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients with Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial at 5 years.

Background

The CHOICE trial was designed to compare device performance of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV.

Methods

The CHOICE trial is an investigator-initiated trial that randomized 241 high-risk patients with severe symptomatic aortic stenosis and an anatomy suitable for treatment with both BE and SE THVs to transfemoral transcatheter aortic valve replacement with either device. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, and echocardiographic evaluation of valve function and THV durability.

Results

After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%; p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%; p = 0.12), all strokes (17.5% vs. 16.5%; p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%; p = 0.75). SE patients had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in 7 BE patients (7.3%) and 1 SE patient (0.8%; p = 0.06), and moderate or severe structural valve deterioration in 6 BE patients (6.6%) and no SE patient (0%; p = 0.018). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%; p = 0.63).

Conclusions

Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral transcatheter aortic valve replacement with early-generation BE and SE valves that were not statistically significantly different, with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve. (A Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: The CHOICE Trial [CHOICE]; NCT01645202)

Key Words

aortic stenosis
balloon-expandable
durability
self-expanding
TAVR

Abbreviations and Acronyms

AR
aortic regurgitation
AS
aortic stenosis
BE
balloon-expandable
BVD
bioprosthetic valve dysfunction
BVF
bioprosthetic valve failure
CI
confidence interval
EACTS
European Association for Cardio-Thoracic Surgery
EAPCI
European Association of Percutaneous Cardiovascular Interventions
EOA
effective orifice area
ESC
European Society of Cardiology
MI
myocardial infarction
NSVD
nonstructural valve deterioration
PPM
patient–prosthesis mismatch
PVL
paravalvular leak
SAVR
surgical aortic valve replacement
SE
self-expanding
SVD
structural valve deterioration
TAVR
transcatheter aortic valve replacement
THV
transcatheter heart valve
VARC
Valve Academic Research Consortium

Cited by (0)

Funded by the Heart Center, Segeberger Kliniken GmbH, Bad Segeberg, Germany. Dr. Abdel-Wahab has been a proctor and consultant for Boston Scientific and Medtronic. Dr. Neumann has received institutional research grants, consultancy fees, and speaker honoraria from Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, Sanofi, Bayer, The Medicines Company, Bristol-Myers Squibb, Novartis, Roche, Boston Scientific, Biotronik, Ferrer, and Medtronic. Dr. Frerker has received speaker honoraria from Edwards Lifesciences. Dr. Richardt has received an institutional research grant from Biotronik, St. Jude Medical, and Medtronic; and is an advisory board member for Abbott Vascular and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.