1-Year Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves
Key result
Balloon-expandable TAVR shows no difference in 1-year mortality versus self-expandable valves.
- RR 1.35
- 95% CI 0.73 to 2.50
- P=0.37
- n=241
Why the study?
Balloon-expandable transcatheter heart valves previously showed higher device success than self-expandable valves, but clinical and echocardiographic outcomes required evaluation at longer-term follow-up.
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?
Key Points
- To evaluate the clinical and echocardiographic outcomes of balloon-expandable versus self-expandable transcatheter heart valves over one year.
- Randomized trial involving 241 high-risk patients with symptomatic severe aortic stenosis.
- Patients underwent transfemoral transcatheter aortic valve replacement with either balloon- or self-expandable valves.
- Follow-up included clinical assessments and echocardiographic evaluations for one year.
- At 1 year, death rates were 17.4% for balloon-expandable and 12.8% for self-expandable valves (RR: 1.35, p=0.37).
- Rates of all strokes were 9.1% (balloon) vs. 3.4% (self-expandable) (RR: 2.66, p=0.11).
- More than mild paravalvular regurgitation occurred in 12.1% of self-expandable patients versus 1.1% of the balloon group (p=0.005).
Study Design
Type
RCT (n=241)
Randomization
randomized
Structured PICO
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?
P
Population
241 high-risk patients with symptomatic severe aortic stenosis and anatomy suitable for both balloon- and self-expandable valves, followed for 1 year.
I
Intervention
Transfemoral transcatheter aortic valve replacement with balloon-expandable valve
C
Comparator
Transfemoral transcatheter aortic valve replacement with self-expandable valve
O
Outcome
Clinical outcomes (death of any cause, cardiovascular death, stroke, repeat hospitalization for heart failure) and echocardiographic evaluation of valve function at 1 yearhard clinical
Main Result
Relative Risk: 1.35 (95% CI 0.73–2.5)
Absolute Event Rate: 17.4% vs 12.8%
p-value: p=0.37
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.
Limitations
- limited statistical power
Key expert perspectives
Captured external expert commentary on this paper, strongest first. Original sources are linked where available.
“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.”
SPSue PeschinMHS, president and CEO
“The proposed updates to Medicare's national TAVR coverage policy represent a transformative milestone for heart-valve disease patients and their families. The TAVR procedure is often preferred by patients with severe AS because it avoids open-heart surgery and allows quicker treatment and recovery. By lifting the 14-year CED requirement, CMS is formally recognizing that TAVR is reasonable and necessary for the treatment of severe, symptomatic AS.”
DVDr. Vinod BadhwarCardiothoracic Surgeon
“Cardiothoracic surgeons bring essential expertise to the heart team. The quality and safety standards built into the prior NCD are critical evidence-based protections for patients, particularly for complex patients and evolving indications.”
Implication
No mortality difference observed by valve type; leaves open optimal selection pending larger randomized data.
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 = 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).
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Cite This Study
Abdel‐Wahab et al. (2015) conducted an 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).