Transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves resulted in no significant difference in 1-year all-cause death (17.4% vs. 12.8%; RR 1.35; P=0.37).
RCT (n=241)
randomized
Does a balloon-expandable valve improve 1-year clinical and echocardiographic outcomes compared to a self-expandable valve in high-risk patients undergoing transfemoral transcatheter aortic valve replacement for severe aortic stenosis?
At 1 year, balloon-expandable and self-expandable TAVR valves showed no significant differences in mortality or stroke, though self-expandable valves had higher rates of paravalvular regurgitation.
Relative Risk: 1.35 (95% CI 0.73–2.5)
Absolute Event Rate: 17.4% vs 12.8%
p-value: p=0.37
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 = 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).
“As TAVR continues to expand and as we begin to consider strategies for lifetime management of our younger and lower-risk patients, there remains a critical unmet need for more and better data regarding transcatheter heart valve durability, and I think that these current studies are an important step forward in that regard.”
Abdel‐Wahab et al. (Sat,) conducted a rct in symptomatic severe aortic stenosis (n=241). Balloon-expandable transcatheter heart valve vs. Self-expandable transcatheter heart valve was evaluated on Death of any cause (RR 1.35, 95% CI 0.73 to 2.50, p=0.37). Transcatheter aortic valve replacement with balloon-expandable versus self-expandable valves resulted in no significant difference in 1-year all-cause death (17.4% vs. 12.8%; RR 1.35; P=0.37).