Cerebrovascular events occurring 30 days within transcatheter aortic valve replacement (TAVR) were closely tied with several patient and operator factors, according to a systematic review of the literature.
Strokes and transient ischemic attacks were reported at a median rate of 4% across single-center and multicenter studies (range 1-11%), Josep Rodés-Cabau, MD, of Quebec Lung & Heart Institute in Canada, and colleagues reported online in the Journal of the American College of Cardiology.
On multivariable adjustment, while men had fewer events in the short term (RR 0.82, 95% CI 0.70-0.97), they were more common for patients:
With chronic kidney disease (RR 1.29, 95% 1.03-1.63)
Suffering from new-onset atrial fibrillation (Afib) after TAVR (RR 1.85, 95% CI 1.20-2.84)
Whose procedures were performed in the first half of a center’s TAVR experience (RR 1.55, 95% CI 1.16-2.08)
“Importantly, transcatheter valve type and approach do not seem to influence the incidence of cerebrovascular events,” the authors wrote.
Calling this finding “reassuring,” Anthony A. Bavry, MD, MPH, and Islam Y. Elgendy, MD, both of the University of Florida in Gainesville, noted that approximately 90% of present-day TAVR procedures are performed via the transfemoral approach.
“There was no observed difference among the studies that adjudicated for cerebrovascular events versus those without adjudication, indicating that outside of randomized trials, operators have been clinically adjudicating events well,” they added in an accompanying editorial.
The predictors that Rodés-Cabau and colleagues found represent a first step to implementing further preventive measures for patients at highest risk. These may include the use of embolic protection devices and optimizing antithrombotics after TAVR, the investigators suggested, concluding: ”Because TAVR is set to expand its indication to lower surgical-risk patients, cerebrovascular events remain an ongoing problem, and future efforts should aim at identifying patients who would benefit from tailored therapies.”
Regarding new-onset Afib, the strongest predictor of stroke, “our findings support the need for continuous rhythm monitoring during hospitalization post-TAVR to detect otherwise silent episodes of new-onset Afib,” the authors suggested. “Because no clear guidelines exist regarding anticoagulation therapy post-TAVR, the present study along with others urges the consideration of prompt anticoagulation in these patients after diagnosing Afib regardless of the episode duration.”
Bavry and Elgendy agreed: “As this procedure is expanded to involve patients with lower surgical risk, minimizing cerebrovascular events is of critical importance.” Embolic protection devices “add to procedural complexity and potential risk” and remain under investigation, they commented.
The investigators pulled data from 64 studies for their meta-analysis. In total, there were 72,318 patients included, 2,385 of whom had an early cerebrovascular event.
Use of balloon post-dilation trended towards a relationship with events (RR 1.43, 0.97-2.10), leading Rodés-Cabau and colleagues to conclude: “The trend we showed supports further research about the exact role of balloon post-dilation in cerebrovascular event occurrence.”
“Careful planning of the procedure with proper imaging and optimal device sizing is of vital importance to limit the risk of paravalvular regurgitation and need for subsequent balloon post-dilation,” Bavry and Elgendy wrote in their editorial.
Moreover, among the limitations of the study were the variable definition of “cerebrovascular event” across the studies included and the low statistical power for some analyses, the authors acknowledged. “Our overall results should be regarded as hypothesis-generating, supporting the need for uniform and exhaustive reporting of events in the field of TAVR.”
Additionally, “the vast majority of included studies are observational in nature, which can be prone to bias,” the editorial noted.
“Although the primary focus of this meta-analysis was clinically manifest cerebrovascular events, it is important to mention that a considerable number (up to 80%) of patients encounter clinically silent cerebral emboli detected by diffusion-weighted magnetic resonance imaging, which have controversial prognostic implications.”
Rodés-Cabau reported receiving research grants from Edwards Lifesciences, Keystone, Medtronic, and St. Jude Medical.
Bavry disclosed receiving an honorarium from the American College of Cardiology; Elgendy disclosed having no relationships relevant to the editorial.
Journal of the American College of Cardiology
Auffret V, et al “Predictors of early cerebrovascular events in patients with aortic stenosis undergoing transcatheter aortic valve replacement” J Am Coll Cardiol 2016; DOI: 10.1016/j.jacc.2016.05.065.
Journal of the American College of Cardiology
Bavry AA and Elgendy IY “Cerebrovascular events with transcatheter aortic valve replacement: can we identify those who are at risk?” J Am Coll Cardiol 2016; DOI: 10.1016/j.jacc.2016.05.066.