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

• Published in: Journal of the American College of Cardiology 2015-08, Vol.66 (7), p.791-800
• Main Authors: 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, Richardt, Gert
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Aortic Valve Stenosis - diagnosis; Aortic Valve Stenosis - surgery; Balloon Valvuloplasty - standards; Balloon Valvuloplasty - trends; Female; Follow-Up Studies; Heart Valve Prosthesis - standards; Heart Valve Prosthesis - trends; Humans; Male; Middle Aged; Prospective Studies; Prosthesis Design - standards; Prosthesis Design - trends; Time Factors; Transcatheter Aortic Valve Replacement - standards; Transcatheter Aortic Valve Replacement - trends; Treatment Outcome
• ISSN: 1558-3597
• DOI: 10.1016/j.jacc.2015.06.026

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. The aim of this study was to evaluate clinical and echocardiographic outcome data at longer term follow-up. 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. 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). 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).