The research, led by Dr. Daniele Giacoppo and colleagues from Azienda Ospedaliero-Universitaria Policlinico Rodolico-San Marco, University of Catania, assessed 1,443 consecutive BAV patients treated with TAVR across 29 centers. Of these, 860 received BE-THVs, while 583 were treated with SE-THVs. Patients were followed for up to three years.
Based on the study, the researchers reported the following findings:
- No significant difference was observed in the composite endpoint of death or stroke between balloon-expandable (BE-THV) and self-expanding transcatheter heart valves (SE-THV) after propensity score matching and adjustment for confounders.
- In-hospital and 30-day event rates were 5.1% for BE-THV and 6.1% for SE-THV (HR 1.02).
- At three years, mortality or stroke occurred in 23.7% of the BE-THV group and 26.2% of the SE-THV group (HR 0.99).
- These findings remained consistent across subgroups and statistical models, including inverse probability weighting and multivariable adjustment.
- Balloon-expandable valves were associated with a higher mean transvalvular gradient and an increased risk of annulus rupture.
- Self-expanding valves had a higher incidence of moderate-to-severe paravalvular regurgitation, need for additional valve implantation, and permanent pacemaker insertion.
- Pacemaker implantation within 30 days was significantly lower in the BE-THV group compared to SE-THV (11.9% vs. 18.6%; HR 0.58).
“These data suggest that both balloon-expandable and self-expanding THVs offer similar long-term safety and efficacy for BAV patients undergoing TAVR,” the authors noted, emphasizing that device selection should consider anatomical features and procedural risks rather than anticipated survival differences.
Bicuspid aortic valve anatomy poses unique challenges in TAVR due to asymmetric calcification and elliptical annuli, raising concerns about procedural complications. Despite these challenges, the findings underscore the progress in treating BAV with transcatheter approaches and the feasibility of both valve types for this patient population.
The authors concluded that while the choice between BE-THV and SE-THV does not affect major long-term outcomes like death or stroke, clinicians should weigh trade-offs in terms of procedural complications, including annular rupture risk with BE-THV and conduction disturbances with SE-THV.
"The study reinforces the need for individualized decision-making in BAV interventions and highlights the importance of continuous device innovation to optimize outcomes in this anatomically complex group," the authors concluded.
Reference:
Giacoppo D, Alvarez-Covarrubias H, Xhepa E, et al. Transcatheter aortic valve replacement with balloon- versus self-expandable bioprostheses for the treatment of bicuspid aortic valve stenosis. Circulation. 2025;Epub ahead of print.
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