Predictors of permanent pacemaker implantation in patients with raphe-type bicuspid aortic valve stenosis undergoing TAVR.

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.