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. 

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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. 

Dr. Andrés Rodríguez

Dr. Andrés Rodríguez.
Member of the Editorial Board of SOLACI.org.

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

Reference: Riccardo Gorla MD, PhD et al Catheter Cardiovasc Interv. 2023;1–10.


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