Association of stroke unit certification with process quality in acute ischemic stroke: a registry-based study

Abstract Background Certification of primary and comprehensive Stroke Units (pSU, cSU) was established in Germany to ensure standardized, guideline-adherent and quality-assured care for patients with acute ischemic stroke. However, real-world evidence remains limited that treatment quality is different in certified institutions. In this analysis we focused on potential differences between certified and non-certified institutions concerning various aspects of intravenous thrombolysis. Methods We conducted a retrospective registry-based observational analysis of patients with acute ischemic stroke in Hesse, Germany, between 2021 and 2024. Associations between stroke unit certification, intravenous thrombolysis (IVT), and process quality indicators were assessed using multivariable generalized linear mixed-effects models accounting for hospital-level clustering. Results A total of 59,514 patients with acute ischemic stroke were included. IVT within 4.5 h after symptom onset was performed significantly more often in certified stroke units than in non-certified hospitals (pSUs: OR 2.32, 95% CI 1.65–3.27; cSUs: OR 2.19, 95% CI 1.57–3.07). In the extended treatment window (> 4.5–24 h), higher odds of IVT were also observed in pSUs (OR 2.41, 95% CI 1.16–5.00) and cSUs (OR 4.20, 95% CI 2.07–8.50). Certified stroke units achieved guideline-recommended targets more often, including a door-to-needle time ≤ 60 min (pSUs: OR 3.13, 95% CI 2.13–4.61; cSUs: OR 2.60, 95% CI 1.80–3.75) and ≤ 30 min (pSUs: OR 1.85, 95% CI 1.04–3.28; cSUs: OR 2.84, 95% CI 1.62–4.99). No significant differences were observed between pSUs and cSUs. Conclusions Stroke unit certification was associated with a more frequent use of IVT and shorter door-to-needle times.