Cerebral Embolic Protection during TAVR - Is it Appropriate for Routine Use?

Objective: There is a growing use of cerebral embolic protection devices in patients undergoing transcatheter aortic valve replacement (TAVR). Recent data showed convincing results in reducing ischemic brain lesions. However, there is only scarce data about the additional exposure to radiation or risk of vascular complications from the use of cerebral protection devices.

Method: Between 02/2016 and 07/2017, 391 patients underwent transfemoral TAVR procedure with Medtronic CoreValve/Evolut R (n = 196) or Edwards Sapien 3 (n = 195), respectively. In 39 patients, cerebral embolic protection was applied, using the dual filter-based Claret Sentinel™ Device (CSD). Prospectively collected data were retrospectively analyzed, comparing fluoroscopy/operation time, amount of contrast used, vascular events and influence on renal function in TAVR patients with (n = 39) and without (n = 352) CSD.

Results: The CSD was placed via the right radial (n = 35) or brachial (n = 4) artery. Procedural success rate with correct positioning, deployment and retraction of both filters was 94.9% (n = 37). In 2 cases, the filters could not be deployed due to severe tortuosity of the brachiocephalic trunk. Intraoperatively, no device related vascular events occurred. TAVI patients with CSD showed significantly higher total operation time, total fluoroscopy time and amount of contrast used (85.4 ± 39.3 versus 64.0 ± 29.8 minute, p = 0.002; 20.7 ± 9.3 versus 13.7 ± 7.0 minute, p =< 0.001; 133.7 ± 42.6 versus 109.7 ± 44.5 ml; p = 0.001). Comparing the first TAVR patients receiving a CSD (n = 20) with the last CSD cases (n = 19), total operation and fluoroscopy time had come down (95.4 ± 33.1 versus 75.00 ± 43.3 minute, p = 0.10; 22.9 ± 11.0 versus 18.4 ± 6.6. min, p = 0.13). There were no differences in postprocedure acute kidney injury (AKIN) between TAVI patients with and without a CSD (p = 0.80).

Conclusion: Our data adds evidence that the application of the CSD system is not associated with additional risks for the patient. Although procedural time and amount of contrast is higher when using the CSD, there were no device related intraoperative complications or increased incidence of postprocedural acute kidney injury.