Key result
Cerebral embolic protection overall did not reduce any stroke (RR 0.95; 95% CI 0.50-1.81), but the SENTINEL device reduced disabling stroke (RR 0.46; 95% CI 0.22-0.95) in patients undergoing TAVI.
Why the study?
New evidence emerged to evaluate whether capturing embolized debris with cerebral embolic protection devices reduces stroke risk in TAVI, overall and stratified by device type and baseline surgical risk.
Does cerebral embolic protection reduce stroke and mortality in patients undergoing TAVI?
Meta-Analysis (n=3,921)
Does cerebral embolic protection reduce stroke and mortality in patients undergoing TAVI?
Effect estimate: RR 0.95 (95% CI 0.50-1.81)
While overall cerebral embolic protection did not significantly reduce any stroke or mortality at 30 days in TAVI patients, the SENTINEL device specifically may reduce disabling stroke, particularly in high and intermediate surgical risk patients.
Background: Transcatheter aortic valve intervention (TAVI) can lead to the embolization of debris. Capturing the debris by cerebral embolic protection (CEP) devices may reduce the risk of stroke. New evidence has allowed us to examine the effects of CEP in patients undergoing TAVI. We aimed to assess the effects of CEP overall and stratified by the device used (SENTINEL or TriGuard) and the surgical risk of the patients. Methods: We selected randomized controlled trials using electronic databases through September 17, 2022. We estimated random-effects risk ratios (RR) with (95% confidence interval) and calculated absolute risk differences at 30 days across baseline surgical risks derived from the TAVI trials for any stroke (disabling and nondisabling) and all-cause mortality. Results: Among 6 trials (n = 3921), CEP vs. control did not reduce any stroke [RR: 0.95 (0.50-1.81)], disabling [RR: 0.75 (0.18-3.16)] or nondisabling [RR: 0.99 (0.65-1.49)] strokes, or all-cause mortality [RR: 1.23 (0.55-2.77)]. However, when analyzed by device, SENTINEL reduced disabling stroke [RR: 0.46 (0.22-0.95)], translating into 6 fewer per 1000 in high-risk, 3 fewer per 1000 in intermediate-risk, and 1 fewer per 1000 in low surgical-risk patients. CEP vs. control did not reduce the risk of any bleeding [RR: 1.03 (0.44-2.40)], major vascular complications [RR: 1.41 (0.57-3.48)], or acute kidney injury [RR: 1.36 (0.57-3.28)]. Conclusions: This updated meta-analysis showed that SENTINEL CEP might reduce disabling stroke in patients undergoing TAVI. Patients with high and intermediate surgical risks were most likely to derive benefits.
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Khan et al. (2023) conducted a meta-analysis in Transcatheter Aortic Valve Intervention (TAVI) (n=3,921). Cerebral embolic protection (CEP) vs. Control was evaluated on Any stroke (disabling and nondisabling) (RR 0.95, 95% CI 0.50-1.81). Cerebral embolic protection overall did not reduce any stroke (RR 0.95; 95% CI 0.50-1.81), but the SENTINEL device reduced disabling stroke (RR 0.46; 95% CI 0.22-0.95) in patients undergoing TAVI.
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