Cerebrovascular Events Post-Transcatheter Aortic Valve Replacement in a Large Cohort of Patients: A FRANCE 2 Registry Substudy
What are the frequency, patterns, and predictors of cerebrovascular events (CVEs) following transcatheter aortic valve replacement (TAVR)?
Using data from the French Aortic Nation CoreValve and Edwards 2 (FRANCE 2) prospective registry, investigators examined 3,191 patients treated with TAVR at 34 sites using balloon-expandable (66.9%) or self-expanding (33.1%) devices. The frequency, patterns, and predictors of CVEs were examined over a follow-up of 6 months, and CVEs were defined using Valve Academic Research Consortium 1 definitions.
Mean follow-up was 5.2 ± 4.7 months, and CVEs occurred in 127 patients (4.0%), with major stroke, minor stroke, and transient ischemic attacks observed in 2.2%, 0.6%, and 1.2%, respectively. Events were observed within 48 hours in 48.5%, between 2 and 30 days in 36.9%, and after 1 month in 14.6% of individuals. Access route (p = 0.13) and valve type (p = 0.90) were not associated with risk of CVE. Implantation of two valves (vs. one valve) (5.5% vs. 2.1%, p = 0.01) and new-onset paroxysmal atrial fibrillation (13.6 vs. 7.6%, p = 0.02) were associated with increased risk of CVE. On multivariable analysis, predictors of CVEs included increased age (odds ratio [OR], 1.05; 95% confidence interval [CI], 1.02-1.08; p = 0.002) and implantation of a second valve (OR, 3.13; 95% CI, 1.40-7.05; p = 0.006).
CVEs after TAVR were observed in 4% of patients. Increased age and implantation of a second valve are associated with a greater risk of CVE.
CVEs were observed in 4% of patients after TAVR in this multicenter prospective registry, and most commonly occurred early after the procedure. This frequency may be underestimated if complete neurologic exams were not uniformly performed or patients under-reported neurologic symptoms on follow-up, although this likely represents the majority of clinically significant events. On multivariable analysis, only one modifiable risk factor – implantation of a second valve – was associated with an increased risk of CVE. However, this study did not examine whether balloon post-dilation following valve deployment was associated with increased risk of stroke as has been previously reported. These findings will be helpful when weighing the risks and benefits of deploying a second valve, and highlight the need for improved devices and delivery techniques to minimize the need for additional procedures after device deployment.
Keywords: Stroke, Ischemic Attack, Transient, Risk Assessment
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