Journal of Vascular and Interventional Neurology

Preclinical safety and efficacy of the NeVa NET™: A novel thrombectomy device with integrated embolic distal protection

Vania Anagnostakou — 2022-12-02

Background

High quality reperfusion is linked to better clinical outcomes during thrombectomy for large vessel occlusion in acute ischemic stroke. A novel stent-retriever device with an integrated microfilter for embolic distal protection has been developed to improve first pass full reperfusion.

Objective

Compare the safety and effectiveness of the NeVa NET^™ versus the standard stent-retriever thrombectomy devices.

Materials and methods

Radial force measurements were performed on 10 NeVa NET™ and 4 Solitaire™ 6x30mm. Animal studies involving three Yorkshire pigs were performed comparing NeVa NET™ to Solitaire™ 6x40mm and 4x40mm to assess for acute vascular injury, vasospasm and thrombogenicity during thrombectomy. A randomized comparison in a closed loop vascular model was performed to quantify first pass effect and distal emboli generated during twenty MCA thrombectomies.

Results

Radial force curves were similar between the NeVa NET™ and Solitaire™ 6x30mm. Below 2.5mm the Solitaire™ demonstrated higher radial force compared to NeVa NET™. Vasospasm scores were nearly identical after four thrombectomies in multiple similar sized swine arteries. The addition of the internal filter did not result in increased thrombogenicity in the non-heparinized swine model. In the randomized flow model study, NeVa NET™ required less passes than Solitaire™ to achieve TICI 3 reperfusion (p=0.0344). Solitaire™ generated 4-fold more clot fragments >1mm in size compared to NeVa Net™ (p=0.037, Wilcoxan rank sum). For fragments between 0.2-1mm, Solitaire™ generated 91 whereas NeVa™ generated a total of 20 fragments. Overall, more clot fragments were generated during Solitaire™ as compared to NeVa NET™ thrombectomy (p=0.048).

Conclusions

Our pre-clinical results support the use of the NeVa NET^TM device in a clinical trial to determine if this novel design improves first pass full reperfusion.

Rescue Intracranial Stenting during Endovascular Thrombectomy in Patients with Large Vessel Occlusion Stroke

Mais Al-Kawaz — 2022-12-03

Introduction:

Rescue treatment for failed thrombectomy in patients with acute ischemic stroke (AIS) from large vessel occlusion (LVO) remains controversial. We report our institutional experience with using intracranial stenting of occlusion refractory to aspiration and stent retriever thrombectomy.

Methods:

We performed a retrospective review of our prospectively maintained thrombectomy database to identify the LVO AIS patients who underwent intracranial stenting during endovascular thrombectomy between 1/2015-7/2021. Modified Rankin scale (mRS) at 90 days was used as primary outcome. Secondary outcomes included symptomatic intracerebral hemorrhage (sICH), and mortality at 90days.

Results:

We identified 47 acute ischemic stroke patients who underwent intracranial stenting acutely. Median age was 66 years (Interquartile range (IQR 58-75), median baseline mRS was 0 (IQR 0-1), median NIHSS score was 13.5 (IQR 7-18), and median ASPECTS was 9 (IQR 8-10). The median number of thrombectomy passes prior to stenting was 3 (IQR 2-4). In 48% of patients, a combination of aspiration and stent retriever techniques were used prior to intracranial stenting. Majority of the patients (93%) were loaded with anti-thrombotics intraoperatively. Successful recanalization (TICI 2 B or better) was achieved in 96% of the patients. Fourty nine percent of our cohort had good outcome at 90 days. A total of 4 patients (8.5%) developed a sICH, with a 90 day mortality of rate of 17.0% (8/47).

Conclusion:

Rescue intracranial stenting is a safe and effective approach in patients with emergent large vessel occlusion refractory to aspiration and stent retriever thrombectomy.

The Endovascular Stroke Treatment Only (ESTO) Trial. A Phase 2 Open Label Multicenter Trial

Adnan. Qureshi — 2023-02-20

Background and Aims— We performed a phase 2 trial to determine whether mechanical thrombectomy (MT) alone in acute ischemic stroke patients demonstrates “promise” or a lack thereof (“futility”) compared with those treated with intravenous (IV) recombinant tissue plasminogen activator (rt-PA) (historical controls).

Methods— Subjects with a baseline National Institutes of Health Stroke Scale (NIHSS) score ≥6 who presented within 4.5 hours of symptom onset with documented occlusion of intracranial internal carotid artery, or M1 or M2 segment of the middle cerebral artery on computed tomographic angiography were treated with MT alone. The primary outcome was functional independence defined by a modified Rankin scale (mRS) of 0-2 at 90 days post recruitment.

Results— The 72 subjects (median baseline NIHSS score of 17) were treated with MT with a median time from symptom onset of 180 minutes with complete and partial angiographic recanalization observed in 45 and 27 patients, respectively. Symptomatic intracerebral hemorrhage (≥4 points NIHSS score increase) within 24 hours was observed in none of the 72 subjects. Overall, functional independence at 90 days was observed in 38 (52.8%) of 72 subjects. The rate was higher than the rate of functional independence in a comparable historical cohort of patients treated with IV rt-PA (52.8% versus 35.9%, p=0.032) enabling us to reject the futility hypothesis.

Conclusions— Due to the relatively high rates of functional independence at 90 days observed in this phase 2 trial, a randomized phase 3 comparing standard intravenous rt-PA followed by MT with primary MT is being planned.

The Standards of Training in Vascular Neurology, Interventional Management of Stroke and Neuroendovascular Surgery for the Middle East and North Africa region

Syed Irteza Hussain — 2022-12-01

Abstract:

There is a dearth of standardized training in the Middle East and North African region within the field of stroke medicine and neurointerventional surgery. The Middle East and North Africa Stroke and Interventional Neurotherapies Organization (MENA- SINO). has formally outlined the training requirements and program structure required to train practitioners locally within the region. A more Flexible pathways to accommodate both need and quality assurance were included. Three tracks of Training were outlined; where track 1 was outlined to deliver the requirement for vascular neurology training, track 2 to fulfill the required standards for straining in Stroke neurointervention while track 3 was outlined to cover the standards to create neuroendovascular surgery training program.

Bilateral Duplication of the Cervical Internal Carotid Artery

Nozomi Sasaki — 2022-12-04

Duplicated cervical internal carotid artery (ICA) is a very rare variant. The frequency is unknown and there are few reports so far. We report a case of bilateral duplicated ICA pointed out incidentally. The ICA is embryologically divided into segments by primitive blood vessels, and partial regression or agenesis in these segment results in variant of ICA that use alternative blood vessels. The duplicated ICA is likely to occur distal portion of cervical ICA and reaches inside of the carotid canal. The carotid branch of the pharyngeal branch of the ascending pharyngeal artery runs around the ICA and anastomoses with the artery of foramen lacerum of ICA in the carotid canal. The duplicated ICA may be embryologically involved in the carotid branch of ascending pharyngeal artery.

Scepter Mini for the Treatment of an Anterior Ethmoidal Artery Dural Arteriovenous Fistula: Technical Case Report

Sharon Bossert — 2022-12-02

Background: Dural arteriovenous fistulas of the anterior skull base pose a particular challenge for interventionalists; thus, these lesions have historically been addressed surgically. The Scepter Mini dual-lumen balloon microcatheter is the smallest dual-lumen liquid embolic compatible catheter on the market and has the potential to revolutionize the treatment of these lesions. We present the treatment and cure of an anterior cranial fossa dural arteriovenous fistula treated trans-arterially through the ophthalmic artery using the Scepter mini microcatheter.

Methods: A 77-year-old male was incidentally found to have an anterior cranial fossa dural arteriovenous fistula fed by bilateral anterior ethmoidal arteries. Primary drainage was via a subfrontal cortical vein draining into a sylvian vein and then into the right Vein of Labbe. The patient underwent transarterial embolization of the dural arteriovenous fistula via the right ophthalmic artery with Onyx 18 via the Scepter Mini dual-lumen balloon microcatheter.

Results: The fistula was angiographically cured, and the proximal ophthalmic artery and central retinal artery were preserved. The patient was intact after the procedure and at follow up.

Conclusion: Anterior cranial fossa dural arteriovenous fistulas were classically thought to be surgical lesions due to the challenging endovascular anatomy; however, the Scepter Mini allows for safe access of distal vasculature and immediate flow arrest for optimal safe delivery of liquid embolic agents. This case, along with others, suggest the remarkable value of this new dual-lumen balloon microcatheter.

A Rare Case of Vertebral Artery Dissection in Both Limbs of Fenestration

kojiro ishikawa — 2022-12-02

We present a rare case of dissection of both limbs of a vertebral artery fenestration, with a ruptured dissecting aneurysm in one limb. A 54-year-old man was diagnosed subarachnoid hemorrhage. An emergency digital subtraction angiography revealed a fenestration in the intracranial region of the left vertebral artery. The limb of the ventral side showed a fusiform dilation in the proximal and the limb of the dorsal side showed irregular stenosis. These were characteristic of arterial dissection. We diagnosed dissection of both limbs of the vertebral artery fenestration, and a ruptured dissecting aneurysm of the ventral limb. Endovascular trapping of the ventral limb was performed. A follow-up image showed that the stenosis of the dorsal limb had completely resolved to normal, suggesting spontaneous remodeling of the dissection. The vascular fragility inherent in the fenestration may have contributed to the dissection, suggesting dissections occurring simultaneously in both limbs of the fenestration.

First Report of Optical Coherence Tomography (OCT) to Evaluate Extracranial Vertebral Artery Dissection Caused by Drug-Coated Balloon Angioplasty

Zhongjun Chen — 2022-12-03

Background: Optical Coherence Tomography (OCT) in a new technology with potential neurointerventional applications. We report the use of OCT to detect intraluminal dissection secondary to angioplasty in the extracranial vertebral artery.

Methods: OCT were acquired using Dragonfly imaging catheter (Dragonfly Duo;LightLab Imaging, Inc.,St.Jude Medical.) and data were analyzed by the ILUMIEN OPTIS Imaging System (Abbott Medical,Westfort,USA) in cervical vertebral artery in an adult patient presented with a 7-day history of dizziness, vertigo and right limb weakness associated with a long stenotic segment of the proximal right vertebral artery segment.

Results: Angiogram showed good patency and no proximal dissection after drug eluting balloon dilation of the stenosis. However, OCT showed two distinct dissections and a 3.5*35 mm RQES drug eluting stent was placed. OCT showed resolution of dissection and new high signals distributed unevenly on the initial surface, presumably drug particles released from the drug eluting balloon.

Conclusions: The first reported case suggests that OCT is feasible for imaging proximal vertebral artery lesion and may be more sensitive than angiogram in detecting post angioplasty vertebral artery dissection.