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Published on: June 3, 2018
Safety and Efficacy of Cerebral Embolic Protection Device During Transcatheter Aortic Valve Implantation: An Updated
Vinicius Bittar de Pontes1, Sebastian Jaramillo2, Thierry Trevisan1
1University Centre of Associated Colleges for Education, Boa Vista, São João da, Brazil.
Insights
Cerebral embolic protection (CEP) devices, like the Sentinel, may reduce stroke and mortality risks during transcatheter aortic-valve implantation (TAVI). This meta-analysis found CEP use associated with lower stroke and death rates without increasing complications.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Neurosurgery
Background:
- Cerebral embolic protection (CEP) devices aim to reduce stroke risk during transcatheter aortic-valve implantation (TAVI).
- The safety and efficacy of CEP devices, specifically the Sentinel device, during TAVI remain subjects of ongoing research and debate.
Purpose of the Study:
- To evaluate the safety and efficacy of utilizing the Sentinel cerebral embolic protection device during TAVI procedures.
- To synthesize evidence from randomized controlled trials and observational studies to assess the impact of Sentinel CEP on stroke and mortality rates.
Main Methods:
- A systematic literature search was conducted across PubMed, Embase, and the Cochrane Library up to April 2025.
- Included studies comprised randomized controlled trials (RCTs) and observational cohorts comparing TAVI with and without the Sentinel CEP device.
- Pooled risk ratios (RRs) and odds ratios (ORs) were calculated using a random-effects model to analyze outcomes.
Main Results:
- The meta-analysis included 17 studies with 752,164 patients, 11.5% of whom received the Sentinel device.
- CEP use was linked to significantly lower rates of early stroke, any stroke, 30-day stroke, disabling stroke, and all-cause mortality.
- No significant differences were found in major vascular complications, bleeding events, or acute kidney injury (AKI); however, RCT analysis showed similar stroke and mortality outcomes.
Conclusions:
- The Sentinel CEP device appears to be associated with reduced risks of stroke and mortality following TAVI.
- The use of the Sentinel device did not increase the incidence of vascular complications, bleeding, or AKI.
- Subgroup analysis indicated potential benefits for patients with prior stroke, but not for those with bicuspid aortic valves.
Background:
Cerebral embolic protection (CEP) devices may mitigate the risk of embolization and stroke during transcatheter aortic-valve implantation (TAVI), yet their safety and efficacy remain debated.
Aims:
To evaluate the safety and efficacy of CEP during TAVI.
Methods:
We conducted a systematic search of PubMed, Embase, and the Cochrane Library from inception through April 2025 for randomized controlled trials (RCTs) and observational studies comparing TAVI performed with versus without the Sentinel CEP device. Pooled risk ratios (RRs), odds ratios (ORs), and 95% confidence intervals (CIs) were calculated using a random-effects model.
Results:
Seventeen studies (4 RCTs and 13 observational cohorts) involving 752,164 patients were included; among them, 86,916 (11.5%) received the Sentinel device. CEP use was associated with significantly lower rates of early stroke (within 72 h; RR 0.61; 95% CI 0.40-0.94), any stroke (RR 0.78; 95% CI 0.65-0.94), 30-day stroke (RR 0.47; 95% CI 0.26-0.85), disabling stroke (RR 0.49; 95% CI 0.29-0.84), and all-cause mortality (RR 0.66; 95% CI 0.49-0.89). No significant differences were observed in transient major vascular complications, bleeding events, or acute kidney injury (AKI). In the analysis restricted to RCTs, stroke and mortality outcomes were similar between groups, with no significant differences across safety endpoints. In prespecified subgroup analyses, patients with bicuspid aortic valves derived no significant benefit from CEP (OR O.80; 95% CI 0.40-1.61), whereas those with prior stroke experienced a reduced risk of recurrent stroke (RR 0.61; 95% CI 0.45-0.82).
Conclusion:
This meta-analysis suggests that the Sentinel CEP device is associated with lower risks of stroke and mortality following TAVI, without increasing the incidence of vascular complications, bleeding, or AKI.
