Cerebral Embolic Protection Device Use, Stroke, and Disabling Stroke in TAVR Before and After PROTECTED-TAVR

Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of severe aortic stenosis.However, periprocedural stroke remains a significant concern largely due to embolic debris released during valve deployment.Cerebral embolic protection devices (CEPD), such as the Sentinel device, aim to mitigate this risk by capturing debris.Early adoption grew steadily, 1 but the PROTECTED-TAVR trial, published on September 17, 2022, reported no significant reduction in overall stroke incidence (2.3% with CEPD vs 2.9% without; P .30).However, it suggested a decrease in disabling strokes (0.5% vs 1.3%), indicating possible benefit of CEPD use. 2 This data raised questions about CEPD efficacy, potentially influencing clinical uptake.We sought to investigate trends in CEPD utilization, stroke, and disabling stroke in TAVR from 2018 to 2024, focusing on the PROTECTED-TAVR trial's impact on uptake.We used the TriNetX platform, a federated health research network, to extract deidentified data on CEPD use during TAVR procedures from January 1, 2018 to December 31, 2024.CEPD deployment and stroke in TAVR patients was identified via International Classification of Diseases, Tenth Revision codes.Disabling stroke was defined as stroke leading to death, discharge to a nursing facility or home health, or significant remaining sequalae from the index stroke.Trends were calculated annually, with 2022 split into pre-trial (January 1 through September 17) and post-trial (September 18 through December 31) periods.Logistic regression was performed in Excel (Microsoft Corp), calculating P values to evaluate statistical significance, with P < .05 as the threshold.The study was exempt from ethical approval because TriNetX contains deidentified patient information.A total of 54,278 patients aged 18 years who underwent TAVR from January 1, 2018 through December 31, 2024 were identified.CEPD use rose steadily from 7.84% in 2018 to a peak of 12.10% in 2021, reflecting increasing adoption prior to the trial.However, in 2022, CEPD use declined from 12.07% pretrial to 10.01% post-trial, with a slight increase to 11.45% in 2023 and