Use of a Dual-Filter Cerebral Embolic Protection Device in Thoracic Endovascular Aortic Repair

BACKGROUND:The risk of periprocedural stroke after thoracic endovascular aortic repair (TEVAR) ranges from 3% to 8%. Although cerebral embolic protection devices (CEPD) are widely utilized in transcatheter aortic valve replacement, there are currently no Food and Drug Administration approved CEPDs for use in TEVAR. We report our initial experience with the off-label use of a dual-filter CEPD in patients undergoing TEVAR. METHODS:Two patients at high risk for embolic stroke underwent TEVAR for descending thoracic aortic aneurysms (DTAAs) at a single institution. A dual-filter CEPD (Sentinel; Boston Scientific, Marlborough, MA) was used in an off-label fashion in both cases. Patient 1 was a 62-year-old woman with a 6.2-cm DTAA, extending from the left subclavian artery (LSCA) to the diaphragm (Zones 3-5) and associated with extensive atherosclerotic disease of the aortic arch. Patient 2 was a 78-year-old woman with a 6.3-cm DTAA, extending from the LSCA (Zone 2) to the sixth intercostal space (Zone 4) with associated mural thrombus. Given the proximity of the aneurysm to the LSCA, a left carotid-subclavian bypass was performed for planned LSCA coverage. RESULTS:Through a percutaneous right radial artery approach using a 6F sheath, the Sentinel dual-filter CEPD was delivered over a 0.014″ guidewire into the thoracic aorta. Under fluoroscopic guidance, the 2 filters were sequentially deployed in the innominate and left common carotid arteries, respectively. Appropriately sized devices were successfully delivered and deployed in the proximal and distal landing zones, respectively. Two devices were used for each patient. Completion angiograms showed successful exclusion of the DTAAs in both cases, without evidence of endoleak. The CEPD filters were retrieved in standard fashion without difficulty. Pathology demonstrated successful capture of embolic debris and fibrin clot in both patients. Neither patient exhibited neurological deficits or device-related complications. Both patients remained neurologically intact at 1- and 2-month follow-up, respectively. Surveillance angiograms revealed successful exclusion of the aneurysm without any evidence of endoleak. CONCLUSIONS:We report the novel off-label use of a dual-filter CEPD in 2 patients undergoing TEVAR. Pathological confirmation of embolic debris in the filters makes this a potential tool for stroke prevention during TEVAR in high-risk patients.