Why the study?
The comparative efficacy and safety of balloon-expandable valves and self-expandable valves in transcatheter aortic valve replacement for bicuspid aortic stenosis remain a topic of debate.
Do balloon-expandable valves compared to self-expandable valves improve clinical and procedural outcomes in patients with bicuspid aortic stenosis undergoing TAVR?
Do balloon-expandable valves compared to self-expandable valves improve clinical and procedural outcomes in patients with bicuspid aortic stenosis undergoing TAVR?
In TAVR for bicuspid aortic stenosis, balloon-expandable valves carry a higher risk of annular rupture but a lower risk of new pacemaker implantation compared to self-expandable valves.
Comparable safety/efficacy of BEVs and SEVs in bicuspid AS supports individualized choice; leaves open dedicated RCTs for optimization.
The comparative efficacy and safety of balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in transcatheter aortic valve replacement for bicuspid aortic stenosis remain a topic of debate. This systematic review and meta-analysis aim to synthesize available evidence to guide clinical decision-making. A systematic search of PubMed, Embase, and Web of Science was conducted. Risk ratios (RRs) and mean differences were pooled using a random-effects model. Thirteen studies comprising 2174 patients were included. BEVs were associated with a significantly higher risk of annulus rupture (RR = 3.00, 95% CI, 1.13-7.94, P = 0.03), while procedural and 30-day mortality rates were comparable between BEVs and SEVs. The need for new pacemaker implantation at 30 days was significantly lower in the BEV group (RR = 0.64, 95% CI, 0.49-0.83, P = 0.0009). Postdilation was reduced considerably with BEVs following sensitivity analysis (RR = 0.35, 95% CI, 0.24-0.52, P < 0.0001). In summary, both BEVs and SEVs demonstrated acceptable safety profiles, with BEVs carrying a higher risk of annular rupture but potential advantages in device success and postdilation rates. Large-scale randomized trials remain essential to refine patient selection and procedural strategies.
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Bacha et al. (2025) studied this question.
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