Embolic protection devices (EPDs) are unable to consistently reduce the risk of death or stroke among transcatheter aortic valve replacement (TAVR) patients, according to a new meta-analysis published in the American Journal of Cardiology.
The authors explored data from six randomized trials designed to assess the effectiveness of using EPDs during TAVR procedures. A total of 839 patients were included in the team’s analysis.
Overall, EPDs were found to have “no significant influence” on the primary outcome of death or stroke.
The FDA has cleared one EPD based on research that suggests it may reduce ischemic brain injury detected by diffusion weighted magnetic resonance imaging (DW-MRI). However, the authors noted, “the clinical significance of embolic debris and new brain lesions on DW-MRI in patients undergoing TAVR is not firmly established.”
“In this meta-analysis of six randomized controlled trials, we found no significant difference with regards to death or stroke in patients undergoing TAVR with or without EPDs,” wrote lead author Salik Nazir, MD, division of cardiology at the University of Toledo Medical Center in Toledo, Ohio, and colleagues. “In a previous real-world observational study, involving more than 400 U.S. academic centers, no difference in stroke rates was observed in patients undergoing TAVR with or without EPDs.”
Nazir et al. hoped that an ongoing trial, expected to enroll approximately 3,000 TAVR patients by the time it is complete, will provide additional evidence related to EPDs and TAVR outcomes in the near future.
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.