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Ofer Yodfat l Guy Shinar l Avraham Neta l Sagit Broder l Yair Dan l Eyal Kaufman l Vivek Y. Reddy

Abstract: Background and purpose: A 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-gauge 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. Methods: In 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. Results: In 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 (b100 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). Conclusion: These favorable pre-clinical results prompt clinical testing of the CCA filter in stroke prevention clinical trials

Vivek Y. Reddy l Petr Neuzil l Tom de Potter l Jan van der Heyden l Selma C. Tromp l Benno Rensingl Eva Jiresova l Libor Dujka l Veronika Lekesova

Abstract:
BACKGROUND
Patients with high stroke risk and atrial fibrillation who are unsuitable to oral anticoagulants (OACs)require other stroke prevention strategies. A novel permanent coil filter directly placed into both common carotid arteries(CCAs) was designed to capture emboli >1.4 mm in diameter.

OBJECTIVES
The multicenter, nonrandomized, first-in-human clinical CAPTURE (Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients) trial sought to determine the feasibility and safety of bilateral CCA filter placement.

METHODS
Eligible patients had atrial fibrillation, CHA2DS2-VASc (Congestive heart failure, Hypertension, Age 75 years, Diabetes, Stroke/transient ischemic attack, Vascular disease, Age 65 to 74 years, Sex category) $2, OAC unsuitability, CCA size 4.8 to 9.8 mm, and no carotid stenosis >30%. Under ultrasound guidance, after direct transcutaneous carotid puncture with a 24-gauge needle, a motorized unit expels the filter to unfurl in the artery. Patients received aspirin/clopidogrel for3 months, and aspirin thereafter. Primary endpoints were: 1) procedural success—bilateral, properly positioned CCA filters; and 2) 30-day incidence of major adverse events—death, stroke, major bleeding, filter migration, CCA thrombus, or stenosis. Carotid ultrasounds were conducted post-procedure, pre-discharge, at 1 week, and at 1, 3, 6, and 12 months.

RESULTS
At 3 centers, 25 patients were enrolled: age 71 9 years, CHA 2 DS2-VASc ¼ 4.4 1.0, prior embolism in 48%.Procedure success was 92% (23 of 25 patients); 1 patient had unilateral deployment. There were no device/procedure-related major adverse events; minor puncture site hematomas/edema occurred in 5 of 25 (20%). After 6-month mean follow-up, asymptomatic thrombi were detected in 4 patients (1 bilateral, 4 unilateral), adjudicated as captured (n ¼ 3)unclassified (n ¼ 2), or in situ (n ¼ 0). In all patients, the thrombi dissolved with subcutaneous heparin. In 1 patient,2 device/procedure-unrelated minor strokes occurred.

CONCLUSIONS
Permanent carotid filter placement for stroke prophylaxis is technically feasible and safe.(Carotid Artery Implant for Trapping Upstream Emboli for Preventing Stroke in Atrial Fibrillation Patients [CAPTURE];NCT03571789) (J Am Coll Cardiol 2019;74:829–39) © 2019 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/) .

Michael S. Lee l Justin Hayase l David R. Holmes