OBSERVANT II: Post TAVR 30-Day and 6-Month Stroke Predictors

Despite stroke rate has declined since the early days of transcatheter aortic valve replacement (TAVR), it remains significant, reaching 1% to 3% 30 days after procedure. Since TAVR has seen a progressive expansion to the low risk and young populations, identifying risk factors in patient selection and management is crucial for us to prevent stroke.

Estudio OBSERVANT II: Predictores de accidente cerebrovascular a 30 días y a 6 meses después del TAVI

Even though predictors of 30-day stroke have been described, such as the interaction between a calcified native valve and the device, hemodynamic instability and other patient-related factors are not taken into account as mid and long term predictors.

The aim of this analysis within the OBSERVANT II framework ─ a multicenter, observational and prospective study ─ was to look into 30-day and 6-month stroke incidence after TAVR, and to identify both procedure and patient related predictors.

Primary end point revolved around stroke and TAVR incidence at 30 days and 6 months.

This analysis included 2753 patients, mean age 81, mostly women. 61% presented EUROSCORE II over 4%. The transfemoral approach was used in most cases, and the most frequent device was EVOLUT R/PRO (53%), followed by SAPIEN 3 (27%), ACURATE Neo (10%) and PORTICO (8%). There were no significant differences between devices as regards stroke incidence.

Stroke incidence at 30 days resulted 1.3%, and 2.4% at 6 months. As regards predictors, logistic regression analysis revealed predilation (OR: 2.28, 95% CI: 1.12–4.65, p = 0.023), diabetes (OR: 3.10, 95% CI: 1.56–6.18, p = 0.001) and <50% ejection fraction (OR: 2.15, 95% CI: 1.04–4.47, p = 0.04) were independent predictors of 30-day stroke. The use of dual antiplatelet therapy (DAPT) and oral anticoagulation was inversely associated to stroke risk.

At 6 months, diabetes (HR: 2.07, 95% CI: 1.25–3.42, p = 0.004), neurological dysfunction (HR: 3.92, 95% CI: 1.52–10, p = 0.004) and critical status (HR: 3.05, 95% CI: 1.21–7.72, p = 0.018) resulted independent predictors. Bicuspid valve also resulted a significant predictor of 6-month stroke, but with ample confidence interval (HR: 4.75, 95% CI: 1.44–15.7 p = 0.011). Also, the use of simple/dual antiplatelet treatment and anticoagulation was inversely associated to stroke at 6 months.

Conclusion

To conclude, stroke rate after TAVR is generally low and has seen a decline since the early days of this strategy. This study reveals that most predictors of stroke at 30 days and 6 months after TAVR are patient related. This might contribute to improve risk stratification of patients before procedure.