Analysis of STS/ACC TVT Registry Indicate EPD Use May Not Protect Against Stroke

David Cohen, MD

New research from an analysis of data within the STS/ACC Transcatheter Valve Therapy (TVT) Registry is questioning the effectiveness of cerebral embolic protection devices (EPDs) for mitigating stroke risk during transcatheter aortic valve replacement (TAVR).

While a secondary, propensity-matched analysis indicated an 18% lower odds of in-hospital stroke with EPD use, results of the primary analysis suggested EPD use resulted in an absolute difference of -0.15%, which led investigators to call for larger, randomized trials to assess safety and efficacy of use in TAVR patients.

“These findings provide a strong basis for large-scale randomized controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR,” wrote investigators. “More definitive data from ongoing randomized trials powered to detect differences in clinically-important endpoints are necessary to support use of EPDs in TAVR.”

Despite advances in techniques and technology, stroke remains a serious and persistent risk following TAVR. With this in mind, a team led by David Cohen, MD, director of Clinical and Outcomes Research of the Cardiovascular Research Foundation, sought to assess how use of EPDs might influence in-hospital stroke risk using data from the STS/ACC TVT Registry.

For the purpose of analysis, investigators included adults aged 18 years and older who underwent elective or urgent TAVR from January 2018-December 2019 for native aortic valve disease or a degenerated surgical bioprosthesis. Exclusion criteria for the study included undergoing TAVR at a surgery performing 20 or fewer procedures annually, repeat TAVR procedures, undergoing TAVR via non-transfemoral access, and missing data, among others.

In total, investigators identified 123,186 patients from 599 sites for inclusion in their study. Overall, use of EPD during TAVR increased over time, with rates of usage peaking in 2019 with use at 28% of sites and 13% of TAVR procedures. Investigators noted wide variation in EPD use across the sites included in the study with 8% of sites representing more than 50% of EPD use and 72% of sites reporting no EPD use.

The primary outcome of the analysis was in-hospital stroke. Investigators also included other events such as in-hospital stroke or death, 30-day stroke, and 30-day mortality. For the purpose of analysis, stroke was defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Of note, investigators designed their study to include an instrumental variable analysis, which was used as the primary analysis, and a propensity scored-based secondary analysis using overlap weighting.

In their primary analysis, which used an instrumental variable model, there was no association between EPD use and in-hospital stroke ([adjusted relative risk, 0.90 [95% CI, 0.68-1.13], absolute risk difference: -0.15% [95% CI, -0.49 to 0.20]). In a secondary analysis using a propensity-score based model results suggested EPD use was associated with 18% lower odds of in-hospital stroke (adjusted OR 0.82 [95% CI, 0.69-0.97], absolute risk difference -0.28% [95% CI: -0.52 to -0.03]). This secondary analysis also suggested EPD use was associated with a lower risk of in-hospital stroke or death, 30-day stroke, and 30-day mortality.

This study, “Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results from the TVT Registry,” was published in Circulation.