A Permanent Common Carotid Filter for Stroke Prevention in Atrial Fibrillation: Ex Vivo and In Vivo Pre-Clinical Testing

Abstract

Background and purposeA novel, permanent, bilateral, common carotid artery (CCA) coil filter implant was designed to capture stroke-producing emboli in atrial fibrillation patients. Under ultrasound guidance, it is automatically deployed through a 24-guage needle and is retrievable up to 4 h post-procedure. We assessed the feasibility, safety, and effectiveness of the CCA filter in pre-clinical testing. MethodsIn a pulsatile flow simulator, the filter's embolic capture efficiency and integrity of simulated (1.2 mm diameter nylon balls) and actual thromboemboli were tested. Implant insertion, retrieval, and chronic safety were tested in sheep by ultrasound and X-ray. At termination, the CCAs were explanted and examined by pathology, histopathology and scanning electron microscopy. The fate of captured emboli was evaluated in sheep 3 weeks after upstream injection of autologous thromboemboli. ResultsIn the flow simulator, 10 filters captured 29 of 29 (100%) 1.2 mm diameter nylon balls. In the thromboemboli integrity test, all captured thromboemboli (99 of 99) were adherent to the filter, without fragmentation. All sheep (n = 30/60 implants) underwent successful CCA filter implantation. During follow-ups at 4, 12, 13, 23, and 31 weeks (6 sheep/12 implants at each follow-up), there were no (0%) major bleeds, CCA damage/stenosis, implant migration, flow obstruction, or thrombi detected by ultrasound. Two organized microthrombi (<100 μm) were observed by histopathology at the puncture site. After 3 weeks, autologous captured thromboemboli (n = 10) either completely regressed (5 of 5) or did not progress (5 of 5). ConclusionThese favorable pre-clinical results prompt clinical testing of the CCA filter in stroke prevention clinical trials.