1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves: Results From the CHOICE Randomized Clinical Trial.
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.


OBJECTIVE
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 = 0.37) and of cardiovascular causes (12.4% vs. 9.4%; RR: 1.32; 95% CI: 0.63 to 2.75; p = 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 = 0.11) and repeat hospitalization for heart failure (7.4% vs. 12.8%; RR: 0.58; 95% CI: 0.26 to 1.27; p = 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 = 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 = 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).
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany. Electronic address: mohamed.abdel-wahab@segebergerkliniken.de.
Mohamed
M
Abdel-Wahab
University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany.
Franz-Josef
FJ
Neumann
Munich University Clinic, Munich, Germany.
Julinda
J
Mehilli
Cardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany.
Christian
C
Frerker
Cardiosurgery Department, Lübeck University Hospital, Lübeck, Germany.
Doreen
D
Richardt
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
Martin
M
Landt
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
John
J
Jose
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
Ralph
R
Toelg
Cardiology Department, Asklepios Clinic St. Georg, Hamburg, Germany.
Karl-Heinz
KH
Kuck
Munich University Clinic, Munich, Germany.
Steffen
S
Massberg
Mathematics Department, University of Sussex, Brighton, United Kingdom.
Derek R
DR
Robinson
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
Mohamed
M
El-Mawardy
Heart Center, Segeberger Kliniken, Bad Segeberg, Germany.
Gert
G
Richardt
D000368:Aged; D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000175:diagnosis* / Q000601:surgery*; D063126:Balloon Valvuloplasty / Q000592:standards / Q000639:trends*; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis / Q000592:standards / Q000639:trends*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design / Q000592:standards / Q000639:trends*; D013997:Time Factors; D065467:Transcatheter Aortic Valve Replacement / Q000592:standards / Q000639:trends*; D016896:Treatment Outcome
TAVR; aortic stenosis; balloon-expandable; self-expandable