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Published on: August 8, 2025
Sentinel Cerebral Embolic Protection in Patients with Transcatheter Aortic Valve Replacement: A Meta-analysis of
Dhruvi Kalpesh Joshi1, Najwaa Kirmani2, Juan Pinilia3
1From the Department of Internal Medicine, Narendra Modi Medical College and Sheth L.G. Hospital, Ahmedabad, India.
Insights
The Sentinel cerebral embolic protection (CEP) device during transcatheter aortic valve replacement (TAVR) did not significantly reduce stroke, neurological complications, or mortality in a meta-analysis of five trials. Further research is needed for high-risk patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Neurology
Background:
- Transcatheter aortic valve replacement (TAVR) is a primary treatment for severe aortic stenosis.
- Stroke is a significant complication following TAVR procedures.
- Cerebral embolic protection (CEP) devices aim to mitigate stroke risk during TAVR.
Purpose of the Study:
- To evaluate the efficacy of the Sentinel cerebral embolic protection (CEP) device in reducing stroke, death, and neurological complications in patients undergoing TAVR.
- To synthesize evidence from randomized controlled trials comparing CEP use versus no device during TAVR.
Main Methods:
- Systematic literature search of PubMed, Embase, and Cochrane Central for relevant randomized controlled trials.
- Meta-analysis of five randomized controlled trials involving 11,006 patients (50.0% received CEP, 50.0% did not).
- Primary outcomes included stroke within 72 hours, disabling stroke, any stroke, transient ischemic attack, and all-cause mortality.
Main Results:
- No significant reduction in stroke within 72 hours was observed with Sentinel CEP use (2.3% vs. 2.5%; RR: 0.88, 95% CI: 0.69-1.12).
- Rates of transient ischemic attack (0.4% vs. 0.3%; RR: 1.28, 95% CI: 0.66-2.50) and all-cause mortality (0.7% vs. 0.7%; RR: 1.08, 95% CI: 0.69-1.69) were comparable between groups.
- Low heterogeneity (I2=0%) was noted across all analyzed outcomes.
Conclusions:
- The Sentinel CEP device during TAVR is not associated with a significant reduction in neurological complications or mortality.
- The current evidence does not support a clear overall clinical benefit of routine CEP use in the general TAVR population.
- Further investigation is warranted to identify potential benefits in specific high-risk patient subgroups.
Abstract:
Transcatheter aortic valve replacement (TAVR) is widely used to treat severe aortic stenosis, and stroke remains a serious complication. The Sentinel cerebral embolic protection (CEP) device is designed to reduce this risk. However, it is still unclear if it truly improves patient outcomes. This meta-analysis evaluates whether the Sentinel device reduces stroke, death, or neurological complications. We searched PubMed, Embase, and Cochrane Central for randomized controlled trials comparing the use of the Sentinel CEP versus no device in patients undergoing TAVR. Outcomes included stroke within 72 hours, disabling stroke, any stroke, transient ischemic attack, and mortality. Statistical analysis was performed using R version 4.4.2. Heterogeneity was assessed using the I2 statistic. Five randomized controlled trials with 11,006 patients were included; 50.0% (n = 5502) received the CEP device and 50.0% (n = 5504) did not. Lower risk of stroke within 72 hours was observed with Sentinel CEP, although the difference was nonsignificant [2.3% vs 2.5%; risk ratio (RR): 0.88, 95% confidence interval (CI): 0.69-1.12; P = 0.292; I2 = 0%]. No significant difference was observed in the incidence of transient ischemic attack between both groups (0.4% vs 0.3%; RR: 1.28, 95% CI: 0.66-2.50; P = 0.465; I2 = 0%). All-cause mortality rates were comparable between both groups (0.7% vs 0.7%; RR: 1.08, 95% CI: 0.69-1.69; P = 0.748; I2 = 0%). CEP during TAVR was not associated with a significant reduction in neurological or mortality outcomes, indicating no clear overall clinical benefit in the studied population. Further studies are needed to determine its potential role in selected high-risk patients.
