Key result
Self-expanding valves linked to ~2.6-fold higher odds of in-hospital stroke vs Sapien 3 Ultra RESILIA.
Why the study?
Stroke remains a serious complication after TAVR with contemporary devices, but incidence, predictors, and prognosis require further evaluation.
Does the incidence of in-hospital stroke and 1-year survival differ among patients undergoing TAVR with contemporary valve platforms (Sapien 3 Ultra RESILIA, Evolut FX, or Navitor)?
Cohort (n=5,123)
Yes
Does the incidence of in-hospital stroke and 1-year survival differ among patients undergoing TAVR with contemporary valve platforms (Sapien 3 Ultra RESILIA, Evolut FX, or Navitor)?
In contemporary TAVR, in-hospital stroke incidence varies by valve type (higher with self-expanding Evolut FX) and is independently associated with worse 1-year survival.
May warrant valve-specific stroke vigilance in TAVR; hypothesis-generating and should not yet change practice without randomized confirmation.
Background Stroke remains a serious complication after transcatheter aortic valve replacement (TAVR), even with contemporary devices. Objectives To evaluate the incidence, predictors, and prognosis of in-hospital stroke in patients undergoing TAVR with contemporary valve platforms. Methods We analyzed 5,123 patients from the multicenter OCEAN-TAVI registry who underwent TAVR with Sapien 3 Ultra RESILIA, Evolut FX, or Navitor between May 2022 and December 2024. Stroke incidence across valve types was compared using inverse probability of treatment weighting (IPTW). Predictors were assessed using multivariable Firth penalized logistic regression. Results In-hospital stroke occurred in 2.5% of patients. After IPTW adjustment, stroke incidence differed among valve types: 1.7% of patients treated with Sapien 3 Ultra RESILIA, 4.5% with Evolut FX, and 2.4% with Navitor (p = 0.044). Disabling stroke was more frequent with Evolut FX (2.5%) compared with Sapien 3 Ultra RESILIA (0.4%) and Navitor (0.7%; p < 0.001). Self-expanding valve use (adjusted odds ratio [aOR] 2.64, 95% confidence interval [CI] 1.67–4.16 for Evolut FX; aOR 2.37, 95% CI 1.35–4.18 for Navitor; both vs. S3UR), prior stroke (aOR 1.83, 95% CI 1.19–2.73), reduced renal function, and nontransfemoral access (aOR 2.11, 95% CI 1.29–3.45) were independently associated with in-hospital stroke. One-year survival was significantly lower among patients with stroke than among those without stroke (73.0% vs. 90.3%; p < 0.001). Conclusions In-hospital stroke remains an important complication after contemporary TAVR and is associated with worse clinical outcomes. Differences in stroke incidence across valve types were observed, highlighting the need for improved risk assessment.
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Watanabe et al. (2026) conducted a cohort in Transcatheter aortic valve replacement (n=5,123). Evolut FX (self-expanding valve) vs. Sapien 3 Ultra RESILIA was evaluated on In-hospital stroke (aOR 2.64, 95% CI 1.67-4.16, p=0.044). Self-expanding valves like Evolut FX were associated with a higher risk of in-hospital stroke compared to Sapien 3 Ultra RESILIA (4.5% vs 1.7%; aOR 2.64, 95% CI 1.67-4.16).
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