Abstract

The role of cerebral embolic protection (CEP) in patients undergoing transcatheter aortic valve replacement (TAVR remains a topic of debate despite multiple randomized controlled trials (RCTs). Recently, the PROTECTED TAVR trial was published. The current meta-analysis aimed to aggregate RCTs that examined all available forms of CEP devices to date. PubMed, Cochrane Central, and EMBASE were searched for RCTs comparing CEP versus no CEP in patients undergoing TAVR. The primary outcome was 30-day stroke. The secondary outcome was 30-day all-cause mortality. Search and reporting were according to PRISMA guidelines. Random effects model with DL tau estimator were used for pooled effect. Heterogeneity was assessed using I2 test. All analyses were performed by R studio. Six studies with a total of 3621 patients (CEP n= 1874, no CEP n= 1747) met our inclusion criteria (mean age 79.5 years, 58.6% male, average STS score 3.76). CEP was not associated with a significant reduction of stroke at 30 days (Relative risk RR: 0.75; 95% CI: 0.52, 1.08; P= 0.12; Absolute Risk Difference ARD: -0.75%; 95% CI: -1.8%, 0.3%). No difference in 30-day all-cause mortality with CEP vs no CEP use, RR: 0.93; 95% CI: 0.41, 2.11; P= 0.86. No change in pooled estimate when limiting analysis to trials that utilized Sentinel device. In this meta-analysis of all RCTs to date, use of CEP devices in patients undergoing TAVR was not associated with a significant reduction in 30-day stroke or all-cause mortality.

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