Unstructured abstract: There are limited data regarding predictors and impact of permanent pacemaker implantation (PPI) among patients with raphe-type bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement (TAVR). The aim is to evaluate the incidence, predictors and clinical impact of PPI among patient with raphe-type BAV treated with TAVR. The AD-HOC is an international registry enrolling patients with raphe-type BAV stenosis undergoing TAVR. We investigated the incidence of PPI; clinical, anatomical and procedural predictors of PPI were assessed. The impact of PPI on overall survival and on the Valve Academic Research Consortium-3 (VARC-3) clinical efficacy endpoint, defined as freedom from death, heart failure (HF) hospitalizations or TIA/stroke, was evaluated. Among the 912 patients, PPI after TAVR was required in 141 cases (15.5%). The VARC-3 technical success and device success endpoints were met in 94.7% and 85.2% of patients with no differences between those with and without PPI. Independent predictors of PPI included peripheral vascular disease (OR: 2.05, 95% CI: 1.09-3.87, p=0.026), chronic kidney disease (OR: 1.53, 95% CI: 1.04-2.26), right bundle branch block (RBBB - OR: 5.88, 05% CI: 3.33-10.38), R-L raphe localization (OR: 2.51, 95% CI: 1.24, 5.10) and use of Evolut R/Pro/Pro+ (OR: 1.68, 95% CI: 1.18-2.68, p=0.006). At follow-up, VARC-3 clinical efficacy endpoint was similar (log-rank p=0.579). In conclusions, PPI following TAVR in BAV is relatively common but without impact on mid-term clinical outcome. Beyond pre-procedural RBBB and the use of Evolut valves, PPI had unique anatomical predictors within this population, such as the R-L raphe localization. Condensed abstract: The AD-HOC is an observational, international, multicenter registry enrolling patients with raphe-type 1 BAV stenosis undergoing TAVR at 24 Institutions from 2016 to 2023. Among the 912 included patients, new PPI was required in 141 cases (15.5%). The VARC-3 technical success and device success endpoints were met in 94.7% and 85.2% of patients, respectively, with no differences between those with and without PPI. At multivariable logistic regression analysis, independent predictors of PPI after TAVR included peripheral vascular disease, chronic kidney disease, pre-procedural RBBB, the R-L raphe localization and the use of Evolut R/Pro/Pro+ valves. No differences were noticed between PPI and no-PPI recipients in terms of the VARC-3 efficacy endpoint at the 3-year follow-up.
Mangieri, A., Gitto, M., Tarantini, G., 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., Renker, M., Gomez, M. G., Fraccaro, C., De Rosa, M. L., Zito, A., Trani, C., Laterra, G., Pellegrini, D., Ielasi, A., Orbach, A., Landes, U., Rheude, T., Testa, L., Santos, I. A., Saia, F., Favero, L., Chen, M., Adamo, M., Latib, A., Petronio, A. S., Montorfano, M., Makkar, R. R., Mylotte, D., Blackman, D. J., Burzotta, F., Barbanti, M., De Backer, O., Tchètchè, D., Maffeo, D., Buono, A., Predictors of permanent pacemaker implantation in patients with raphe-type bicuspid aortic valve stenosis undergoing TAVR, <<THE AMERICAN JOURNAL OF CARDIOLOGY>>, 2025; (Sept 27): N/A-N/A. [doi:10.1016/j.amjcard.2025.09.042] [https://hdl.handle.net/10807/322736]
Predictors of permanent pacemaker implantation in patients with raphe-type bicuspid aortic valve stenosis undergoing TAVR
Tarantini, Giuseppe;Zito, Andrea;Trani, Carlo;Saia, Francesco;Burzotta, Francesco;Buono, Andrea
2025
Abstract
Unstructured abstract: There are limited data regarding predictors and impact of permanent pacemaker implantation (PPI) among patients with raphe-type bicuspid aortic valve (BAV) stenosis undergoing transcatheter aortic valve replacement (TAVR). The aim is to evaluate the incidence, predictors and clinical impact of PPI among patient with raphe-type BAV treated with TAVR. The AD-HOC is an international registry enrolling patients with raphe-type BAV stenosis undergoing TAVR. We investigated the incidence of PPI; clinical, anatomical and procedural predictors of PPI were assessed. The impact of PPI on overall survival and on the Valve Academic Research Consortium-3 (VARC-3) clinical efficacy endpoint, defined as freedom from death, heart failure (HF) hospitalizations or TIA/stroke, was evaluated. Among the 912 patients, PPI after TAVR was required in 141 cases (15.5%). The VARC-3 technical success and device success endpoints were met in 94.7% and 85.2% of patients with no differences between those with and without PPI. Independent predictors of PPI included peripheral vascular disease (OR: 2.05, 95% CI: 1.09-3.87, p=0.026), chronic kidney disease (OR: 1.53, 95% CI: 1.04-2.26), right bundle branch block (RBBB - OR: 5.88, 05% CI: 3.33-10.38), R-L raphe localization (OR: 2.51, 95% CI: 1.24, 5.10) and use of Evolut R/Pro/Pro+ (OR: 1.68, 95% CI: 1.18-2.68, p=0.006). At follow-up, VARC-3 clinical efficacy endpoint was similar (log-rank p=0.579). In conclusions, PPI following TAVR in BAV is relatively common but without impact on mid-term clinical outcome. Beyond pre-procedural RBBB and the use of Evolut valves, PPI had unique anatomical predictors within this population, such as the R-L raphe localization. Condensed abstract: The AD-HOC is an observational, international, multicenter registry enrolling patients with raphe-type 1 BAV stenosis undergoing TAVR at 24 Institutions from 2016 to 2023. Among the 912 included patients, new PPI was required in 141 cases (15.5%). The VARC-3 technical success and device success endpoints were met in 94.7% and 85.2% of patients, respectively, with no differences between those with and without PPI. At multivariable logistic regression analysis, independent predictors of PPI after TAVR included peripheral vascular disease, chronic kidney disease, pre-procedural RBBB, the R-L raphe localization and the use of Evolut R/Pro/Pro+ valves. No differences were noticed between PPI and no-PPI recipients in terms of the VARC-3 efficacy endpoint at the 3-year follow-up.
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