CEREBRAL EMBOLIC PROTECTION FOR TRANSCATHETER AORTIC VALVE REPLACEMENT: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS

SESSION TITLE: Cardiothoracic Surgery Posters 2 SESSION TYPE: Original Investigation Posters PRESENTED ON: 10/11/2023 12:00 pm - 12:45 pm PURPOSE: Transcatheter Aortic-Valve Replacement (TAVR) is now considered the intervention of choice for aortic stenosis, but disseminated debris can significantly increase the risk of stroke which is a known complication of the procedure. (1) Cerebral Embolic Protection (CEP) devices were developed with the aim of capturing the debris and decreasing the risk of post-procedural stroke. (2) We performed a systematic review and meta-analysis of randomized controlled trials to assess the safety and efficacy of CEP devices in TAVR. METHODS: A search was performed on PubMed, Cochrane, and Web of Science and the Medical Subject Headings terms for "(cerebral embolic protection) AND (Transcatheter aortic-valve replacement)” were searched from the conception of data to 10/06/2022. A total of 308 articles were screened by two independent reviewers and 24 full length articles were evaluated for eligibility. We included a total of seven randomized controlled trials that compared any form of cerebral embolic protection device to placebo in adult patients undergoing TAVR. RESULTS: The total population of patients was 4321, with 2151 patients in the CEP group and 1848 in the placebo group. The mean age was 81 years and the follow-up period for most trials was 30 days. The primary outcomes assessed included all-cause mortality and stroke with secondary outcomes including disabling stroke and new ischemic lesions on magnetic resonance imaging. Mortality at 30 days in the CEP group was 0.83% (18/2151) compared to 0.59% (11/1848) in the placebo group. The random effects model meta-analysis showed a Mantel-Haenszel (MH) odds ratio of 1.15 (confidence interval 0.52-2.5, p value 0.72), with an I2 of 0.00, showing low heterogeneity. Stroke was noted in 3.77% (81/2148) compared to 3.81% (74/1941) in the CEP and placebo groups respectively, a random effects model meta-analysis showed a MH odds ratio of 0.89 (confidence interval 0.48-1.6; p value 0.72) with an I2 of 52.4. There was a small yet significant difference in the rate of disabling stroke between the two groups with the random effect model meta-analysis showing an MH odds ratio of 0.472 (confidence interval 0.23-0.95; p value 0.03), favoring the CEP group. Similarly, a fewer number of new MRI lesions were noted in the CEP group compared to placebo with an MH odds ratio of 0.40 (CI 0.22-0.74; p value 0.004). The most common adverse effects included acute kidney injury and vascular complications with meta-analyses showing no difference among the two groups. CONCLUSIONS: Cerebral embolic protection devices for transcatheter aortic-valve replacement have not been shown to be efficacious in terms of reducing mortality or risk of stroke, however, they may decrease the risk of development of disabling stroke or new lesions on MRI. Use of cerebral embolic protection device should be considered based on individual patient factors. CLINICAL IMPLICATIONS: Use of cerebral embolic protection device should be considered based on individual patient factors. DISCLOSURES: No relevant relationships by Rimsha Ali No relevant relationships by Khaldoon Aljassani No relevant relationships by Aslan Amirian No relevant relationships by Jessica Cunningham No relevant relationships by Anupam Halder No relevant relationships by Taaha Mirza No relevant relationships by Kripa Rajak No relevant relationships by Navitha Ramesh No relevant relationships by Bosky Soni