Stroke and Transient Ischaemic Attack within 30 Days of Transcatheter Aortic Valve Implantation: Insights from a contemporary real-world all-comers registry (Preprint)

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BACKGROUND Transcatheter aortic valve implantation (TAVI) has become a potential treatment modality for symptomatic patients with severe aortic stenosis (AS) across all surgical risk profiles. However, peri-procedural stroke remains a persistent and serious complication with significant implications for patient outcomes and healthcare systems. Reported incidence ranges between 2-7%. As the benefit of cerebral protection devices and the optimal antithrombotic regime following TAVI remain unclear, understanding contemporary risks and timings of stroke are important in order to tailor peri/post procedural stroke risk reduction strategies. OBJECTIVE To evaluate the incidence, timing, and predictors of stroke and transient ischaemic attack (TIA) within 30 days post TAVI in a contemporary real-world all-comers registry. METHODS Consecutive patients undergoing TAVI (n=980) between January 2020 and February 2024 were included in this retrospective study. A stroke diagnosis was made based on the Valve Academic Research Consortium-2 (VARC-2), defined as a focal or global neurological deficit >24 hours or <24 hours if haemorrhage or infarct was found on neuroimaging. TIA was defined as the duration of a focal or global neurological deficit <24 hours. Those with documented evidence of stroke or TIA were sub-divided into acute (<24 hours post procedure) and subacute (1-30 days post procedure). Patients from outside our catchment area were excluded (n=46) due to the lack of access to patient records. Two patients were excluded as no valve was deployed. RESULTS A total of 932 patients (41% female, mean age 81.6±6.9 years) were included in the study. TAVI was performed for severe AS in the context of degenerative calcific disease of native valves in 94% (n=873), 6% (n=57) of TAVIs were valve-in-valve procedures, and only one patient was treated for severe stenosis of a congenital (Bicuspid) aortic valve. 84% (n=779) had no prior history of stroke and 26% had a history of diabetes mellitus. 60% (n=555) of patients were in sinus rhythm prior to TAVI, 35% (n=326) were in atrial fibrillation or flutter and 5% (n=51) were in a paced rhythm. Self-expanding valves were implanted in 58% (n=542) of cases and Balloon-expanding valves were used in the remainder. The majority of cases were performed transfemorally (96%). Pre-dilatation balloon aortic valvuloplasty was performed in 16% (n=150) of cases and the median procedure time was 76 mins [IQR 66.0, 89.0]. Vascular closure device successfully achieved haemostasis in 94% (n=877) of procedures. The thirty-day incidence of stroke/TIA was 3.2% (n=30), with 35% (n=11) occurring within 24 hours and the majority occurring within the first 48 hours (58%, n=18). The median number of days of stroke/TIA post-TAVI was 1.0 [0.0, 3.0]. Most (80%, n=24) were ischaemic strokes and of these one had a haemorrhagic transformation. Diabetes is the only variable predictive of stroke at 30 days HR 2.14 (95% CI 1.01 – 4.56), p=.049 using logistic regression. CONCLUSIONS Most cerebrovascular events occurred early post TAVI. Effective stroke prevention strategies, including optimized antithrombotic regimens and the role of cerebral protection devices, warrant further evaluation. CLINICALTRIAL n/a

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