Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation Using the Sentinel Cerebral Protection System:...

Area of Science:

• Cardiovascular Medicine
• Interventional Cardiology
• Neurology

Background:

• Transcatheter aortic valve implantation (TAVI) is crucial for symptomatic aortic stenosis.
• Embolic stroke is a significant complication despite TAVI's mortality benefits.
• Transcatheter cerebral embolic protection (TCEP) devices aim to mitigate stroke risk during TAVI.

Purpose of the Study:

• To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs).
• To evaluate the effectiveness of the Sentinel™ cerebral protection system (CPS) in reducing periprocedural stroke during TAVI.

Main Methods:

• Systematic review and meta-analysis of RCTs identified via MEDLINE, Cochrane, and Scopus databases (until 12/2023).
• Primary outcome: periprocedural stroke. Secondary outcomes included disabling stroke, mortality, and other complications.
• Risk ratios (RR) calculated using Mantel-Haenszel method with fixed analysis; heterogeneity assessed using chi-squared and I² tests.

Main Results:

• Four RCTs involving 3528 patients were analyzed; SAPIEN 3 was the most common valve.
• No significant difference in overall periprocedural stroke between TAVI with Sentinel™ CPS and no TCEP (RR 0.75, P=0.12).
• A significant reduction in periprocedural disabling strokes was observed with Sentinel™ CPS (RR 0.41, P=0.02), with a Number Needed to Treat (NNT) of 123.

Conclusions:

• TAVI with Sentinel™ CPS did not alter the overall risk of periprocedural stroke.
• The Sentinel™ CPS was associated with a reduced risk of disabling periprocedural strokes in TAVI patients.
• Further research may clarify the role of TCEP in TAVI procedures.