Sentinel Cerebral Protection System in TAVI: An Updated Meta-Analysis of Randomized and Propensity-Matched Studies.

Abstract

Backgrounds: Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI). The Sentinel cerebral embolic protection (CEP) system is designed to mitigate this risk by capturing embolic debris, but its clinical benefit remains uncertain.

Aims: This meta-analysis evaluated the impact of Sentinel CEP on stroke and related outcomes in TAVI.

Methods: PubMed, Embase, and Cochrane were searched for randomized controlled trials (RCTs) and propensity score-matched (PSM) studies comparing TAVI with and without Sentinel CEP. The outcomes were periprocedural ischemic stroke, total stroke, disabling stroke, 30-day mortality, in-hospital mortality, composite death or stroke, acute kidney injury (AKI), and major vascular complications. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model.

Results: Eight studies (five RCTs, three PSM studies) encompassing 33,111 patients were analyzed, with 50.1% receiving Sentinel. In pooled analysis, Sentinel CEP significantly reduced 30-day mortality (RR 0.75, 95% CI 0.58-0.97; p = 0.03) and AKI (RR 0.90, 95% CI 0.82-0.98; p = 0.01). No significant effect was observed for periprocedural ischemic 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), in-hospital mortality (RR 0.86, CI 0.57-1.31; p = 0.47), composite death or stroke, or major vascular complications. RCT-only analyses confirmed no significant effect on any outcome.

Conclusions: Sentinel CEP was associated with lower 30-day mortality and AKI in pooled cohorts, but did not reduce stroke. The absence of benefit in RCTs underscores the need for further studies in high-risk TAVI populations.