Stroke prevention devices for TAVR fail to make an impact
Cerebral embolic protection devices (CEPDs) do not significantly reduce the risk of stroke after transcatheter aortic valve replacement (TAVR), according to a new meta-analysis published in Clinical Cardiology.[1]
The use of CEPDs—small devices designed to catch debris during heart procedures and reduce the patient’s risk of stroke—has been a major story in recent years. While some cardiologists use the devices during every TAVR they perform, others have remained skeptical. The devices certainly work, regularly filtering out debris during treatment, but randomized trials have yet to identify a consistent benefit in terms of patient outcomes. In addition, the devices are associated with increased healthcare costs, and many care teams are hesitant about making TAVR even more expensive than it already is.
Hoping to settle this question once and for all, the team behind this study performed a meta-analysis of eight randomized controlled trials (RCTs). More than 11,000 TAVR patients participated in those trials, and 51% were treated with a CEPD.
Overall, “no significant difference” was observed in the overall stroke rates, disabling stroke rates or non-disabling stroke rates of patients who did and did not undergo TAVR with a CEPD. Also, all-cause mortality, transient ischemic attacks, bleeding events, acute kidney injury, delirium and pacemaker implantation occurred at similar rates for the two groups. This trend persisted for separate subgroup analyses focused on specific CEPD types.
“While the mechanistic rationale for CEPDs is compelling, their clinical utility remains debated,” wrote first author Mohamed Ibrahim Gbreel, a researcher with October 6 University in Egypt, and colleagues. “This meta-analysis synthesized the current evidence from eight RCTs to provide the most comprehensive evaluation to date on the impact of CEPD use on clinical outcomes.”
The group also emphasized that CEPDs “should not be viewed as a homogeneous intervention.” Each device has its own safety profile, for example, and any decisions to use a CEPD should be based on that individual patient’s anatomy more than anything else.
The authors also called for additional research into the use of CEPDs during TAVR.
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Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.