Incidence and predictors of 30‐day and 6‐month stroke after TAVR: Insights from the multicenter OBSERVANT II study

Abstract

BackgroundThe incidence and predictors of 30‐day stroke after transcatheter aortic valve replacement (TAVR) were derived from early studies investigating first‐generation devices. The incidence of 6‐month stroke and its related predictors are unknown.AimsTo investigate the incidence and to identify procedural and patient‐related predictors of 30‐day and 6‐month stroke after TAVR.MethodsData from 2753 consecutive patients with severe aortic stenosis undergoing TAVR were obtained from the OBSERVANT‐II study, an observational, prospective, multicenter cohort study. The study endpoints were symptomatic 30‐day and 6‐month stroke after TAVR.ResultsThe occurrence of a 30‐day and 6‐month stroke was low (1.3% and 2.4%, respectively) but with significant impact on survival. Aortic valve predilatation (odds ratio [OR]: 2.28, 95% confidence interval [CI]: 1.12–4.65, p = 0.023), diabetes (OR: 3.10, 95% CI: 1.56–6.18, p = 0.001), and left ventricle ejection fraction < 50% (OR: 2.15, 95% CI: 1.04–4.47, p = 0.04) were independent predictors of 30‐day stroke, whereas diabetes (sub‐distribution hazard ratio [SHR]: 2.07, 95% CI: 1.25–3.42, p = 0.004), pre‐existing neurological dysfunction (SHR: 3.92, 95% CI: 1.54–10, p = 0.004), bicuspid valve (SHR: 4.75, 95% CI: 1.44–15.7, p = 0.011), and critical status (SHR: 3.05, 95% CI: 1.21–7.72, p = 0.018) were predictive of 6‐month stroke. Conversely, antiplatelet therapy and anticoagulation were protective factors at both 30 days and 6 months.ConclusionsStroke after TAVR was rare. Predilatation was the only procedural factor predictive of 30‐day stroke, whereas the remaining were patient‐related risk factors, suggesting appropriate risk stratification preoperatively.

Stroke prevention in TAVR: A patient‐tailored approach may be needed

“…Unfortunately, some important variables such as AV leaflet calcification, new-onset atrial fibrillation, heparin/activated clotting time, or use of CEP devices could not be collected in this multicenter observational study. Despite these limitations, this study by Gorla et al 1 has worth because it reports observations in an unselected all-comers population and offers valuable insight in the real-world incidence, predictors, and protective factors of TAVR-related stroke.…”

“…In this issue of Catheterization & Cardiovascular Interventions, Gorla et al 1 report on the incidence and predictors of 30-day and 6month stroke after TAVR in 2753 patients, which were consecutively enrolled in the Italian multicenter, observational, prospective OBSERVANT-II cohort study. Stroke occurred in 1.3% and 2.4% of patients within 30 days and 6 months after TAVR, respectively.…”