Impact of unfavorable aortic anatomy on transcatheter aortic valve replacement outcomes

BACKGROUND: Despite device improvements for transcatheter aortic valve replacement (TAVR) and increased operator expertise, unfavorable aortic root anatomy might subtend worse procedural and clinical outcomes. The aim of the study is to assess procedural and clinical outcomes of transfemoral TAVR in patients with and without unfavorable aortic root anatomy and receiving Evolut PRO/PRO+ or SAPIEN 3 Ultra devices in contemporary clinical practice. METHODS: Patients enrolled in the multicenter OPERA-TAVI registry were considered. Patients were compared using propensity score matching according to the presence or absence of unfavorable anatomical characteristics of the aortic root [bicuspid aortic valve (BAV), moderate-to-severe left ventricular outflow tract calcifications, horizontal aorta]. Primary endpoints were Valve Academic Research Consortium (VARC)-3 device success and early safety. The secondary endpoint was a composite of 1-year all-cause death, disabling stroke and heart failure rehospitalization. RESULTS: Among a total of 1815 patients, 629 patients (34.7%) had at least one unfavorable characteristic. After adjustment, 624 matched pairs of patients were compared.VARC-3 device success (85.3% vs. 92.0%, P < 0.001) and early safety (72.9% vs. 79.6%, P = 0.006) were lower in patients with unfavorable characteristics. The secondary composite endpoint was higher in patients with unfavorable anatomical characteristics (Kaplan-Meier estimates 15.3 vs. 12.0%; Plogrank = 0.019). Among patients with unfavorable anatomical characteristics, BAV alone was associated with early safety [odds ratio 2.15, 95% confidence interval 1.04-4.70, P = 0.05]. CONCLUSIONS: Patients undergoing transfemoral TAVR had lower rates of device success and early safety in the presence of unfavorable anatomical characteristics, along with worse 1-year clinical outcomes. However, BAV was associated with higher early safety in this context.