Cerebral embolic protection is a strategy to prevent embolization of thrombotic or calcific debris during transcatheter aortic valve replacement (TAVR). A number of randomized and controlled studies have tested the safety and efficacy of various devices, though none of them have enough statistical power to show significant differences in end points.
While preliminary evidence suggests these devices may reduce cerebral infarction markers or improve post procedural cognitive function, their effect on hard clinical events remains unknown.
This is a meta-analysis of randomized studies evaluating cerebral embolic protection devices. Primary end point was death risk or stroke, according to the intention-to-treat principle.
It included a total of 5 randomized studies with 625 patients; 376 receiving some kind of cerebral embolic protection device and 249 control patients receiving no protection device.
Cerebral embolic protection devices showed lower death risk and stroke compared to the control group (6.4% vs. 10.8%; RR: 0.57; CI 95%: 0.33 to 0.98; p=0.04). The number needed to treat to avoid death or stroke was 22.
Outcomes were consistent when stratifying by device type, and magnitude and direction were also consistent with sequential exclusion of each of the studies (basically, no study or device tilted the scales).
When considering all cause death and stroke separately, there was a difference in favor of embolic protection devices, though not significant.
These findings suggest that cerebral embolic protection devices could be an adjunctive strategy in patients undergoing TAVR.
They seem to be particularly effective in patients at high risk of neurological events. However, for younger patients at lower risk, it is also important to prevent silent cerebral lesions, since they have been long associated to time related cognitive deterioration.
Conclusion
All data on cerebral embolic protection during transcatheter aortic valve replacement procedures (TAVR) appear to show they are associated to a significant lower risk of death or stroke.
Original Title: Cerebral Embolic Protection During TAVR. A Clinical Event Meta-Analysis.
Reference: Gennaro Giustino et al. J Am Coll Cardiol. 2017 Jan 31;69(4):465-466.
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