Patients with bicuspid aortic valve disease are increasingly undergoing transcatheter aortic valve implantation (TAVI), although long-term outcome data in higher-risk subgroups remain limited. A multicenter retrospective analysis presented at EuroPCR 2026 evaluated the impact of diabetes mellitus (DM) on procedural and long-term clinical outcomes in patients with raphe-type bicuspid aortic valves undergoing TAVI.

The analysis included 980 consecutive patients with severe aortic stenosis and raphe-type, or Sievers type 1, bicuspid aortic valves treated with TAVI at 24 international centers between 2016 and 2023. Among the cohort, 171 patients (17.4%) had DM. Outcomes were assessed according to Valve Academic Research Consortium-3 (VARC-3) criteria.

The primary endpoint was major adverse cardiovascular events (MACE), defined as a composite of all-cause death, cerebrovascular events including stroke or transient ischemic attack, and heart failure hospitalization at 1 and 3 years. Secondary endpoints included technical success, device success, early safety at 30 days, cardiovascular death, cerebrovascular events, and heart failure hospitalization.

Findings

• Procedural outcomes, including technical success, device success, and early safety at 30 days, were comparable between patients with and without DM.
• At 1 year, MACE occurred in 11.0% of patients with DM (17 events) and 7.5% of patients without DM (56 events). DM was not independently associated with higher 1-year MACE risk (adjusted hazard ratio [HR], 1.36; 95% confidence interval [CI], 0.76-2.43).
• DM was independently associated with higher 1-year cerebrovascular event risk (adjusted HR, 2.34; 95% CI, 1.08-5.07).
• At 3 years, MACE rates increased to 20.0% in patients with DM (31 events) and 14.0% in patients without DM (104 events), although the adjusted association did not reach statistical significance (adjusted HR, 1.47; 95% CI, 0.96-2.26).
• DM independently predicted higher 3-year cardiovascular death risk (adjusted HR, 3.32; 95% CI, 1.65-6.68) and cerebrovascular event risk (adjusted HR, 3.17; 95% CI, 1.57-6.41).
• Heart failure hospitalization risk was not significantly associated with DM status at either 1 or 3 years (adjusted HR, 0.84; 95% CI, 0.22-3.28).

Among patients with raphe-type bicuspid aortic valve undergoing TAVI, DM was associated with higher long-term cardiovascular and cerebrovascular risk despite comparable procedural success and early clinical outcomes. The findings identify DM as an independent predictor of adverse 3-year outcomes in this population.