RESEARCHERS have investigated if a cerebral protection device could prevent stroke after TAVI, but a major new analysis suggests that while the Sentinel system may lower short-term mortality, it does not significantly reduce the risk of stroke after TAVI.
Protecting the Brain During TAVI Procedures
Transcatheter aortic valve implantation (TAVI) has revolutionised treatment for severe aortic stenosis, but stroke after TAVI remains one of its most feared complications. The Sentinel cerebral embolic protection (CEP) system, designed to capture debris dislodged during valve implantation, was developed to address this risk. However, uncertainty has persisted regarding its effectiveness in reducing neurological events. This new meta-analysis updates previous evidence, assessing whether Sentinel truly delivers on its promise to prevent stroke after TAVI and improve patient outcomes.
Study Design and Key Findings on Stroke After TAVI
Researchers performed a comprehensive meta-analysis of eight studies, including five randomised controlled trials (RCTs) and three propensity score-matched (PSM) studies, covering 33,111 patients undergoing TAVI. Among them, 50.1% received the Sentinel protection device. Pooled data revealed that Sentinel significantly reduced 30-day mortality (risk ratio [RR] 0.75, 95% confidence interval [CI] 0.58–0.97; p=0.03) and acute kidney injury (RR 0.90, 95% CI 0.82–0.98; p=0.01). However, the device did not show a statistically significant benefit for periprocedural ischaemic stroke (RR 0.92, CI 0.79–1.07; p=0.28), total stroke (RR 0.79, CI 0.59–1.05; p=0.10), or disabling stroke. In-hospital mortality and major vascular complications were also unaffected. Importantly, RCT-only analyses confirmed no significant effect of Sentinel CEP on stroke-related outcomes.
Clinical Implications and Future Research
Although the Sentinel system may confer benefits for short-term survival and kidney protection, its inability to significantly lower stroke after TAVI highlights a gap between mechanical embolic capture and true neurological protection. For clinicians, these findings stress the need for better patient selection and more targeted research, particularly in high-risk populations. Future trials should explore next-generation protection devices or adjunctive pharmacological strategies that could more effectively reduce the risk of stroke after TAVI while maintaining procedural safety.
Reference
Braite M et al. Sentinel cerebral protection system in TAVI: an updated meta-analysis of randomized and propensity-matched studies. Catheterization and Cardiovascular Interventions. 2025;DOI:10.1002/ccd.70236.
