Introduction:
Stroke is still a major complication that is reported in 2-5% of patients at 30 days, after a transcatheter aortic valve replacement (TAVR). The Sentinel Cerebral Protection System (CPS) (Claret Medical Inc., Santa Rosa, CA. USA) is the only FDA approved cerebral embolic protection device (CEPD). This meta-analysis aims to assess the potential benefits of the routine use of CPS after TAVR.
Methods:
The Cochrane library, PubMed and Web of science were searched for relevant studies. Two authors independently screened and included studies that were randomized controlled trials or controlled observational studies comparing the use of Sentinel CPS with no CEPD in TAVR. Data was extracted and the risk of bias assessed using the Cochrane Collaboration tools (RoB2.0 and ROBINS-I).
Results:
Four studies (3 randomized controlled trials and 1 quasi experimental study) comparing 847 patients in whom sentinel CPS was used to 483 in whom it was not used. Two of the studies had low risk of bias and 2 had some concerns for risk of bias. The primary outcomes were the number or size of ischemic lesions on brain MRI in 2 studies, major cardiac and cerebrovascular events in 1 study and a composite of mortality or stroke in 1 study. Patients in whom Sentinel CPS was used had lower rates of 30-day clinical stroke (3.5% vs 6.1%; RR 0.51 [95% CI 0.29, 0.90] I
2
= 0%), 30-day mortality (0.8% vs 2.7%; RR 0.34 [95% CI 0.12, 0.92] I
2
= 0%) and major or life-threatening bleeding (3.3% vs 6.6%; RR 0.50 [95% CI 0.26, 0.98] I
2
= 16%). There was no significant difference between the two arms in the incidence of acute kidney injury (0.8% vs 1%; RR 0.85 [95% CI 0.22, 3.24] I
2
= 0%) and major vascular complications (5.1% vs 6%; RR 0.74 [95% CI 0.33, 1.67] I
2
= 45%).
Conclusion:
Sentinel CPS use in TAVR can be helpful in reducing the risk of stroke, mortality and major or life-threatening bleeding at 30 days.
Cerebral protection devices in transcatheter aortic valve replacement: a clinical meta-analysis of randomized controlled trials
