Background Infrequently, femoral, or radial vascular access for thrombectomy or thrombaspiration for stroke patients is challenged by tortuosity. Direct carotid access (DCA) in the neck is a well-known technique that has been safely used for diagnostic angiography studies for > 60 years. The current limitation to performing endovascular procedures using a DCA is that it requires manual compression of the artery or open vascular surgery to close the access site. Off-label use of currently approved percutaneous closure devices has resulted in more than 20% of dissections, neck hematoma, stroke, and death.^1–5

Methods We have developed a percutaneous 8 Fr OD, 9 Fr ID, kink-resistance soft-tip super flexible thin-line access sheath for a 0.018’ microwire with a unique flush-through atraumatic dilator for angiography without the need to remove micro-guide wire and suture DCA closure system based on a single suture with an Auto-Knot feature. The one-step integrated access sheath and closure device eliminates external exchanges. The thin-line access sheath has a distal radiopaque and echogenic marker and a side port for an over-the-wire (OTW) deployment of suture, allowing constant preservation of the access to the carotid artery during closure.

Results In preparation for first-in-man (FIM), preclinical testing in-vitro (benchtop) and in-vivo (sheep animal model) using ultrasound for DCA and the access sheath and closure system, showed successful reliability of the single suture and Auto-Knot system and sealing of the 8Fr access. No dissections of the common carotid arteries were seen. A short learning curve for physicians of less than 5 minutes was observed with shortened procedural time to access the brain for EVT and minimal blood loss during the closure due to the ease of use of the closure device. We will report the FIM results with this novel system.

Conclusions A simplified direct carotid large bore access and closure system may eliminate delay in access for thrombectomy in acute ischemic stroke. It opens the opportunity to introduce a percutaneous temporary flow arrest and reversal for carotid stenting and enables the introduction of robotic-assisted direct access to the carotid artery.

References

1. Mokin M, et al. Direct carotid artery puncture access for endovascular treatment of acute ischemic stroke: technical aspects, advantages, and limitations. J Neurointervent Surg 2013;7:108–113.

2. Scoco AN, et al. Trans-carotid and trans-radial access for mechanical thrombectomy for acute ischemic stroke: a systematic review and meta-analysis. Cureus 2020;12:e8875.

3. Miszczuk M, et al. Direct puncture of the carotid artery as a bailout vascular access technique for mechanical thrombectomy in acute ischemic stroke - the revival of an old technique in a modern setting. Neuroradiology 2021;63:275–283.

4. Cord BJ, et al. Direct carotid puncture for mechanical thrombectomy in acute ischemic stroke patients with prohibitive vascular access. J Neurosurg 2021;135:53–63.

5. Allard J, et al. Rescue carotid puncture for ischemic stroke treated by endovascular therapy: a multicentric analysis and system review. J Neurointervent Surg 2021;13:809–815.

Disclosures A. Wakhloo: 4; C; Neurofine. 5; C; Neurofine. M. Litzenberg: 4; C; Neurofine. 5; C; Neurofine. B. Aurilia: 4; C; Neurofine. 5; C; Neurofine. Q. Wiebe: 5; C; Neurofine. N. Shattuck: 4; C; Neurofine. 5; C; Neurofine. D. Sierra: 4; C; Neurofine. 5; C; Neurofine.