Cerebral Embolic Protection Devices: How Useful are they in TAVR?

During TAVR, we often fear the possibility of a stroke, which occurs in approximately 1 – 2% of cases. In general, this phenomenon is caused by thrombi stemming from atherosclerotic or calcified plaque, depending on the etiology. Even though its incidence has declined with technology development and the increasing expertise of operators, it is still a challenge to overcome.

¿Cuán útiles son los sistemas de protección cerebral en el TAVI?

In order to tackle this problem, several cerebral protection systems (CEPS) have been designed. However, studies, randomized or not, offer diverging results as to their associated complications.

This meta-analysis incorporated 8 randomized studies totaling 4,043 patients; 53.8% (2,175) undergoing TAVR with CEPS. Primary end point was risk of stroke.

Among the used CEPS were the Sentinel (Boston Scientific), the Montage (Claret Medical), the TriGUARD (Keystone Heart) and the EMBOL-X (Edwards Lifesciences).

There were no significant differences in primary end point (relative risk [RR], 0.88; CI 95%, 0.65-1.18; p = 0.39; I2 = 0%). Neither were there differences in disabling stroke (RR, 0.67; CI 95%, 0.31-1.46; p = 0.32; I2 = 8.6%) or non-disabling stroke (RR, 0.99; CI 95%, 0.71-1.40; p = 0.97; I2 = 0%), all-cause mortality (RR, 0.87; CI 95%, 0.43-1.78; p = 0.71; I2 = 2.3%), bleeding, vascular complications, or renal injury.

The MRI did not show significant differences in total lesion volume or the number of ischemic lesions.

The Sentinel CEPS, unlike its counterparts, did show a reduction in disabling stroke (RR, 0.42; CI 95%, 0.20-0.88; p = 0.022; I2 = 0%), even though there were no differences in stroke (total), non-disabling or all-cause mortality rates.

Conclusion

Data from randomized studies on cerebral embolic protection systems did not reveal safety issues in clinical primary end points or on neuro-imaging. Specific analysis of the Sentinel CEPS showed a significant reduction in disabling stroke. Ongoing studies might contribute to validate these outcomes.