Background: Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement. Objectives: This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis. Methods: AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure. Results: Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3 years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95% CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95% CI: 0.63-3.04; P = 0.421). At 30 days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95% CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95% CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95% CI 1.02-8.95; P = 0.045). Conclusions: Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.
Buono, A., Zito, A., Kim, W., Fabris, T., De Biase, C., Bellamoli, M., Montarello, N., Costa, G., Alfadhel, M., Koren, O., Fezzi, S., Bellini, B., Massussi, M., Scotti, A., Bai, L., Costa, G., Mazzapicchi, A., Giacomin, E., Gorla, R., Hug, K., Briguori, C., Bettari, L., Messina, A., Boiago, M., Villa, E., Renker, M., Garcia Gomez, M., Fraccaro, C., De Rosa, M. L., Patel, V., Trani, C., De Carlo, M., Laterra, G., Latini, A., Pellegrini, D., Ielasi, A., Orbach, A., Landes, U., Rheude, T., Testa, L., Amat Santos, I., Mangieri, A., Saia, F., Favero, L., Chen, M., Adamo, M., Latib, A., Sonia Petronio, A., Montorfano, M., Makkar, R. R., Mylotte, D., Blackman, D. J., Burzotta, F., Barbanti, M., De Backer, O., Tchètchè, D., Maffeo, D., Tarantini, G., Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis, <<JACC: CARDIOVASCULAR INTERVENTIONS>>, 2024; 17 (22): 2596-2608. [doi:10.1016/j.jcin.2024.07.031] [https://hdl.handle.net/10807/300820]
Balloon-Expandable vs Self-Expanding Valves for Transcatheter Treatment of Sievers Type 1 Bicuspid Aortic Stenosis
Zito, Andrea;Trani, Carlo;Saia, Francesco;Burzotta, Francesco;Tarantini, Giuseppe
2024
Abstract
Background: Balloon-expandable valves (BEVs) and self-expanding valves (SEVs) have different features that may impact the outcomes of patients with Sievers type 1 bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement. Objectives: This study sought to compare procedural and clinical outcomes of BEVs and SEVs in Sievers type 1 BAV stenosis. Methods: AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) is an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events, defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure. Results: Among 955 eligible patients, propensity score matching resulted in 301 pairs. At a median follow-up of 1.3 years, BEVs and SEVs had a similar risk of major adverse events (BEV vs SEV: HR: 0.75; 95% CI: 0.49-1.16; P = 0.200). Technical success was similar (OR: 1.38; 95% CI: 0.63-3.04; P = 0.421). At 30 days, BEVs were associated with a lower risk of new permanent pacemaker implantation (OR: 0.42; 95% CI: 0.24-0.72; P = 0.002) and moderate or greater paravalvular regurgitation (OR: 0.16; 95% CI: 0.05-0.48; P = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR: 3.03; 95% CI 1.02-8.95; P = 0.045). Conclusions: Current-generation BEVs and SEVs proved similar technical success and midterm clinical efficacy in Sievers type 1 BAV stenosis. Compared to SEVs, BEVs were associated with less permanent pacemaker implantation and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.
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