The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients.
BACKGROUND
Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events.


OBJECTIVES
This study sought to determine the timing and causes of clinically relevant neurological events after self-expandable TAVR.


METHODS
We enrolled 1,015 patients, of whom 996 underwent TAVR with a self-expandable system at 44 TAVR-experienced centers in Europe, Colombia, and Israel. Neurological events were evaluated for 3 distinct time periods: periprocedural (0 to 1 days post TAVR); early (2 to 30 days); and late (31 to 730 days). In this real-world study, neurological events were first referred to the site neurologist and then reviewed by an independent neurologist.


RESULTS
The overall stroke rate was 1.4% through the first day post-procedure, 3.0% at 30 days, and 5.6% at 2 years. There were no significant predictors of periprocedural stroke or stroke/transient ischemic attack (TIA) combined. Significant predictors of early stroke were acute kidney injury (p = 0.03), major vascular complication (p = 0.04), and female sex (p = 0.04). For stroke/TIA combined, prior atrial fibrillation (p = 0.03) and major vascular complication (p = 0.009) were predictive. Coronary artery bypass graft surgery was the only significant predictor of late stroke (p = 0.007) or late stroke/TIA (p = 0.06).


CONCLUSIONS
Treatment of high-risk patients with aortic stenosis using a self-expandable system was associated with a low stroke rate at short- and long-term follow-up. Multivariable predictors of clinically relevant neurological events differed on the basis of the timing after TAVR. (CoreValve Advance International Post Market Study; NCT01074658).
['Bosmans|Johan|J|', 'Bleiziffer|Sabine|S|', 'Gerckens|Ulrich|U|', 'Wenaweser|Peter|P|', 'Brecker|Stephen|S|', 'Tamburino|Corrado|C|', 'Linke|Axel|A|', '|||']
D000368:Aged D000369:Aged, 80 and over D001021:Aortic Valve D001024:Aortic Valve Stenosis D001281:Atrial Fibrillation D001026:Coronary Artery Bypass D005260:Female D006350:Heart Valve Prosthesis D006801:Humans D015994:Incidence D002546:Ischemic Attack, Transient D053208:Kaplan-Meier Estimate D008297:Male D011183:Postoperative Complications D018570:Risk Assessment D012307:Risk Factors D012720:Severity of Illness Index D020521:Stroke D013997:Time Factors D065467:Transcatheter Aortic Valve Replacement
aortic stenosis stroke transient ischemic attack self-expanding transcatheter aortic valve