BAV anatomy poses distinctive challenges for transcatheter aortic valve replacement (TAVR), driven by marked anatomical variability and procedural complexity. Although TAVR has emerged as an alternative to surgery in patients with elevated surgical risk and favorable anatomy, the optimal choice of transcatheter heart valve (THV) remains debated.
Despite continuous technological refinements aimed at improving deployment accuracy and reducing complications, uncertainty persists regarding which device type may better accommodate bicuspid morphology. The absence of randomized evidence leaves a critical knowledge gap; thus, the present study attempts to provide comparative evidence to guide decision-making in a scenario where device selection may meaningfully influence clinical trajectories.
To address this question, the investigators conducted an observational analysis across 29 centers, enrolling 1443 consecutive patients with computed tomography–confirmed BAV stenosis who underwent TAVR with either a balloon-expandable THV (BE-THV; n=860) or a self-expandable THV (SE-THV; n=583). Patients were categorized by prosthesis type and followed for up to 3 years. The primary endpoint was a composite of death or stroke across several time points (in-hospital, 30 days, 1 year, 2 years, and 3 years). Secondary outcomes included all-cause mortality, cardiac death, vascular complications, bleeding, acute kidney injury, need for repeat valve implantation, thrombosis, endocarditis, pacemaker implantation, and valve-related rehospitalization. To minimize bias in this nonrandomized comparison, advanced statistical approaches such as weighting techniques and multivariable adjustments were applied.
In-hospital and 30-day death or stroke rates did not significantly differ between BE-THV and SE-THV groups (5.1% vs 6.1%). At 3 years—consistent with findings at 1 and 2 years—the composite of death or stroke remained comparable (23.7% vs 26.2%). These findings persisted after weighting and multivariable adjustment.
Regarding complications, BE-THV was associated with a higher incidence of annular rupture and with higher mean transvalvular gradients during follow-up, whereas SE-THV was linked to increased need for repeat THV implantation and a greater frequency of moderate-to-severe paravalvular aortic regurgitation.
Pacemaker implantation at 30 days was less frequent in the BE-THV group (11.9% vs 18.6%), irrespective of the statistical method used.
Overall, the study shows that in patients with BAV stenosis undergoing TAVR, the choice between BE-THV and SE-THV does not influence the risk of death or stroke at 3 years, although each THV type presents a distinct pattern of complications that bears clinical relevance
𝗖𝗢𝗠𝗠𝗘𝗡𝗧𝗔𝗥𝗬:
This study provides valuable evidence in a clinical scenario historically marked by uncertainty: the use of TAVR in patients with bicuspid aortic valve (BAV) stenosis. Because randomized clinical trials in this population are difficult to conduct—given its relatively low prevalence and substantial anatomical heterogeneity—robust observational studies such as this one help fill a critical evidence gap. Its major strength lies in the inclusion of a large, multicenter cohort and the systematic application of advanced statistical techniques specifically designed to minimize confounding in nonrandomized comparisons.
The analysis shows that selecting a balloon-expandable THV (BE-THV) versus a self-expandable THV (SE-THV) does not translate into differences in major long-term outcomes. Still, the two devices demonstrate distinct patterns of complications that must be weighed carefully in clinical practice. This allows more informed discussions within the Heart Team and with patients, especially when anticipating device-specific risks. Of particular relevance is the higher incidence of moderate-to-severe aortic regurgitation with SE-THV, a finding that may carry long-term consequences and deserves dedicated future investigation.
Limitations extend beyond the observational design. Consecutive enrollment introduces the possibility that anatomical or clinical characteristics influenced THV selection. Nearly 20% of patients received early-generation devices, which could act as confounders. Diagnostic assessments were not performed by a core laboratory, and about 6% of computed tomography scans were unavailable—although multiple imputation partially mitigated this shortfall. Finally, clinical outcomes were site-reported, a factor inherent to real-world multicenter studies.
This work also raises forward-looking questions. One is whether ongoing innovations in THV design—particularly regarding sealing technologies, radial force, or recapturability—may shift the complication landscape observed with current devices. Another is whether increasingly sophisticated imaging-based phenotyping will ultimately allow for more personalized prosthesis selection. Furthermore, how these findings apply to younger, higher-risk patients remains uncertain, especially in relation to durability and the likelihood of future interventions.
Overall, this study advances clinical practice toward a more individualized approach for patients with BAV stenosis undergoing TAVR. Rather than settling the debate, it reframes it in a more evidence-driven and nuanced space.
𝗥𝗘𝗙𝗘𝗥𝗘𝗡𝗖𝗘:
Giacoppo D, A Alvarez-Covarrubias H, Xhepa E, Matsuda Y, Cangemi S, Michel JM, et al. Transcatheter Aortic Valve Replacement With Balloon- Versus Self-Expandable Bioprostheses for the Treatment of Bicuspid Aortic Valve Stenosis. Circulation. 2025 Sep 9;152(10):639-657. doi: 10.1161/CIRCULATIONAHA.124.069323.
