Strokes After TAVR
What is the real-world rate of neurologic events in patients treated with a self-expanding transcatheter aortic valve replacement (TAVR)?
This prospective, multicenter, nonrandomized study enrolled 1,015 patients planned for TAVR at 44 experienced sites. A total of 996 subjects had an attempted TAVR, and patients were evaluated for clinically relevant neurologic events over a follow-up of 2 years. Only patients with suspected neurologic events were referred by their TAVR team to an on-site neurologist for evaluation.
Mean age was 81 ± 6 years, and 51% were female. The cumulative rate of stroke was 1.4% during the initial post-procedure day, 3.0% at 30 days, and 5.6% at 2 years; rates of major stroke during these time periods were 0.5%, 1.2%, and 2.9%, respectively. No variables were significantly associated with risk of stroke within 1 day post-procedure. On multivariable analysis, male gender was associated with reduced risk of stroke within 2-30 days (hazard ratio [HR], 0.3; 95% confidence interval [CI], 0.1-0.9; p = 0.04), while acute kidney injury (HR, 4.3; 95% CI, 1.2-15.6; p = 0.03) and major vascular complications (HR, 3.1; 95% CI, 1.0-9.3, p = 0.04) were associated with an increased risk. The only independent predictor of late stroke (31-730 days) was prior coronary artery bypass graft surgery (HR, 3.3; 95% CI, 1.4-7.7; p = 0.01). Any stroke within 30 days of TAVR was associated with increased all-cause mortality (p = 0.002).
The authors concluded that there was a low reported rate of strokes in this registry of patients treated with a self-expanding TAVR.
This study reports a lower rate of strokes than prior studies of self-expanding or balloon-expandable valves, and the reasons for this are not entirely clear. It is notable that this registry was limited to experienced sites with relatively high volumes, which may have had an impact on these findings, as experienced sites may experience lower rates of adverse events. But it is also important to recognize that patients were only evaluated by a neurologist when a neurologic event was suspected by the management team. It is possible that some patients were incompletely interviewed or examined regarding neurologic changes, and some patients may not have reported or noticed their neurologic symptoms. In the CoreValve US Pivotal trial, the rate of strokes at 1 year was 8.8%, but this study included a neurologic assessment at baseline and at follow-up, and any change prompted a complete neurologic workup. The real-world risk of stroke with this self-expanding valve is probably somewhere between the estimates provided by these two studies.
Keywords: Acute Kidney Injury, Cardiac Surgical Procedures, Coronary Artery Bypass, Heart Valve Diseases, Incidence, Registries, Risk, Stroke, Transcatheter Aortic Valve Replacement
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