Cerebral embolic protection during TAVI safe, but has no clear benefits

Cerebral embolic protection during transcatheter aortic valve implantation (TAVI) is safe, but it does not seem to be particularly beneficial in terms of clinical or neuroimaging outcomes, reports a recent meta-analysis.

Accessing the databases of Embase, Medline, and the Cochrane central Register of Controlled Trials, the researchers retrieved six trials (n=856). A total of 488 patients were given cerebral embolic protection, while 368 received controls.

The risk of stroke was not significantly different between the intervention arms (relative risk [RR], 0.88, 95 percent confidence interval [CI], 0.57–1.36; p=0.566). The same was true for nondisabling (RR, 0.81, 95 percent CI, 0.50–1.32; p=0.396) and disabling (RR, 0.85, 95 percent CI, 0.21–3.41; p=0.818) stroke. No heterogeneity of evidence was reported for any of the three outcomes.

In addition, the researchers also saw no significant risk of death associated with the use of cerebral embolic protection (RR, 0.56, 95 percent CI, 0.21–1.51; p=0.255).

Despite no clear benefit, there were also no associated significant safety concerns. The risk of all bleeding, for instance, was not significantly elevated (RR, 0.84, 95 percent CI, 0.55–1.29; p=0.431), as was that for life-threatening o disabling bleeding (RR, 0.71, 95 percent CI, 0.21–2.40; p=0.587).

Risks of major vascular complications (RR, 1.04, 95 percent CI, 0.62–1.74; p=0.877) and acute kidney injury (RR, 0.75, 95 percent CI, 0.21–2.76; p=0.668) were also not significantly elevated.

“The use of cerebral embolic protection during TAVI should be restricted to randomized clinical trials, or in selected high-risk cases where clinical judgement suggests a role,” the researchers said.