A prospective, randomized, controlled, interventional clinical trial to evaluate the safety and efficacy of the medical monopoint reperfusion system for aspiration thrombectomy in acute ischemic stroke patients (SUMMIT MAX): Trial rationale and design.

BACKGROUND: Treatment of large vessel occlusion (LVO) using mechanical thrombectomy with or without intravenous thrombolysis has demonstrated better outcomes compared to medical treatment alone. Large-bore aspiration catheters have been recently introduced. Their effectiveness and safety have not been demonstrated in a randomized trial. The SUMMIT MAX study is designed to address this question. METHODS: SUMMIT MAX is a randomized controlled trial where the effectiveness and safety of the large-bore Monopoint Reperfusion system (Route 92 Medical, San Mateo, CA), will be compared to the currently largest available FDA-cleared aspiration thrombectomy device the AXS Vecta Aspiration system (Stryker Neurovascular, Fremont, CA). The study is a multi-center, prospective, randomized, controlled, interventional, open label clinical trial. The hypothesis is that the effectiveness measured by the recanalization rate (modified thrombolysis in cerebrovascular infarction - mTICI) and safety measured by symptomatic intracranial hemorrhage rate (sICH) of the medical monopoint reperfusion system is non-inferior to the AXS Vecta Aspiration system. RESULTS: Up to 250 subjects are enrolled with at least 50% of subjects enrolled by US sites. The primary effectiveness endpoint is successful arterial revascularization defined as an mTICI score ≥ 2b after use of the assigned device adjudicated by an independent core lab. The primary safety endpoint is defined as sICH within 24 h (-8/+24) post-procedure. Secondary endpoints include successful arterial revascularization defined as a mTICI score ≥ 2b after use of the assigned device with or without adjunctive therapy; device-related serious adverse events; all asymptomatic hemorrhages; time from groin puncture to final angiogram; and rate of first pass effect defined as mTICI 2b after first pass with the assigned device stratified by age (≤85, ≥ 86). CONCLUSION: SUMMIT MAX is a randomized controlled trial comparing the effectiveness and safety of a new large bore class of aspiration devices to the currently largest FDA-cleared aspiration device available.

Early Experience With Artificial Intelligence Software to Detect Intracranial Occlusive Stroke in Trauma Patients.

Objective Identifying ischemic stroke is a diagnostic challenge in the trauma subpopulation. We describe our early experience with artificial intelligence-assisted image analysis software for automatically identifying acute ischemic stroke in trauma patients.  Methods Patients were retrospectively screened for (i) admission to the trauma service at a level one trauma center between 2020 and 2022, (ii) radiologist-confirmed intracranial occlusion, (iii) occlusion identified on computed tomography angiography performed within 24 hours of admission, (iv) no intracranial hemorrhage, and (v) contemporaneous analysis with the large vessel occlusion (LVO) detection program. Baseline characteristics, stroke detection, response-activation, and outcome data were summarized.  Results Of 9893 trauma patients admitted, 88 (0.89%) patients had a cerebral stroke diagnosis, of which 10 patients (10/88; 11.4%) met inclusion criteria. Most patients were admitted following a fall (8/10; 80%). Six (6/10; 60.0%) patients had LVOs. The program correctly detected 83.3% (5/6) of patients, and these patients were triaged in less than one hour from arrival on average. The program did not falsely identify non-LVOs as LVOs for any patients. Conclusions Identifying adjunct tools to aid timely identification and treatment of ischemic stroke in trauma patients is necessary to increase the chances for meaningful neurological recovery. Our early experience exhibited potential for using automated software to aid occlusion identification and subsequent stroke team mobilization. Future studies in larger cohorts will expand upon these preliminary findings to establish the accuracy and clinical benefit of automated stroke detection tool integration for the trauma population.

Correlating Age and Hematoma Volume with Extent of Midline Shift in Acute Subdural Hematoma Patients: Validation of an Artificial Intelligence Tool for Volumetric Analysis.

OBJECTIVE: Decision for intervention in acute subdural hematoma patients is based on a combination of clinical and radiographic factors. Age has been suggested as a factor to be strongly considered when interpreting midline shift (MLS) and hematoma volume data for assessing critical clinical severity during operative intervention decisions for acute subdural hematoma patients. The objective of this study was to demonstrate the use of an automated volumetric analysis tool to measure hematoma volume and MLS and quantify their relationship with age. METHODS: A total of 1789 acute subdural hematoma patients were analyzed using qER-Quant software (Qure.ai, Mumbai, India) for MLS and hematoma volume measurements. Univariable and multivariable regressions analyzed association between MLS, hematoma volume, age, and MLS:hematoma volume ratio. RESULTS: In comparison to young patients (≤ 70 years), old patients (>70 years) had significantly higher average hematoma volume (old: 62.2 mL vs. young 46.8 mL, P < 0.0001), lower average MLS (old: 6.6 mm vs. young: 7.4 mm, P = 0.025), and lower average MLS:hematoma volume ratio (old: 0.11 mm/mL vs. young 0.15 mm/mL, P < 0.0001). Young patients had an average of 1.5 mm greater MLS for a given hematoma volume in comparison to old patients. With increasing age, the ratio between MLS and hematoma volume significantly decreases (P = 0.0002). CONCLUSIONS: Commercially available, automated, artificial intelligence (AI)-based tools may be used for obtaining quantitative radiographic measurement data in patients with acute subdural hematoma. Our quantitative results are consistent with the qualitative relationship previously established between age, hematoma volume, and MLS, which supports the validity of using AI-based tools for acute subdural hematoma volume estimation.

Factors Affecting Selection of TraineE for Neurointervention (FASTEN).

BACKGROUND AND IMPORTANCE: Neurointervention is a very competitive specialty in the United States due to the limited number of training spots and the larger pool of applicants. The training standards are continuously updated to ensure solid training experiences. Factors affecting candidate(s) selection have not been fully established yet. Our study aims to investigate the factors influencing the selection process. METHODS: A 52-question survey was distributed to 93 program directors (PDs). The survey consisted of six categories: (a) Program characteristics, (b) Candidate demographics, (c) Educational credentials, (d) Personal traits, (e) Research and extracurricular activities, and (f) Overall final set of characteristics. The response rate was 59.1%. As per the programs' characteristics, neurosurgery was the most involved specialty in running the training programs (69%). Regarding demographics, the need for visa sponsorship held the greatest prominence with a mean score of 5.9 [standard deviation (SD) 2.9]. For the educational credentials, being a graduate from a neurosurgical residency and the institution where the candidate's residency training is/was scored the highest [5.4 (SD = 2.9), 5.4 (SD = 2.5), respectively]. Regarding the personal traits, assessment by faculty members achieved the highest score [8.9 (SD = 1)]. In terms of research/extracurricular activities, fluency in English had the highest score [7.2 (SD = 1.9)] followed by peer-reviewed/PubMed-indexed publications [6.4 (SD = 2.2)]. CONCLUSION: Our survey investigated the factors influencing the final decision when choosing the future neurointerventional trainee, including demographic, educational, research, and extracurricular activities, which might serve as valuable guidance for both applicants and programs to refine the selection process.

COManeci MechANical Dilation for vasospasm (COMMAND): multicenter experience.

BACKGROUND: We report the largest multicenter experience to date of utilizing the Comaneci device for endovascular treatment of refractory intracranial vasospasm. METHODS: Consecutive patients undergoing Comaneci mechanical dilatation for vasospasm were extracted from prospectively maintained registries in 11 North American centers (2020-2022). Intra-arterial vasodilators (IAV) were allowed, with the Comaneci device utilized after absence of vessel dilation post-infusion. Pre- and post-vasospasm treatment scores were recorded for each segment, with primary radiological outcome of score improvement post-treatment. Primary clinical outcome was safety/device-related complications, with secondary endpoints of functional outcomes at last follow-up. RESULTS: A total of 129 vessels in 40 patients (median age 52 years; 67.5% females) received mechanical dilation, 109 of which (84.5%) exhibited pre-treatment severe-to-critical vasospasm (ie, score 3/4). Aneurysmal subarachnoid hemorrhage was the most common etiology of vasospasm (85%), with 65% of procedures utilizing Comaneci-17 (92.5% of patients received IAV). The most treated segments were anterior cerebral artery (34.9%) and middle cerebral artery (31%). Significant vasospasm drop (pre-treatment score (3-4) to post-treatment (0-2)) was achieved in 89.9% of vessels (96.1% of vessels experienced ≥1-point drop in score post-treatment). There were no major procedural/post-procedural device-related complications. Primary failure (ie, vessel unresponsive) was encountered in one vessel (1 patient) (1/129; 0.8%) while secondary failure (ie, recurrence in previously treated segment requiring retreatment in another procedure) occurred in 16 vessels (7 patients) (16/129; 12.4%), with median time-to-retreatment of 2 days. Favorable clinical outcome (modified Rankin Scale 0-2) was noted in 51.5% of patients (median follow-up 6 months). CONCLUSIONS: The Comaneci device provides a complementary strategy for treatment of refractory vasospasm with reasonable efficacy/favorable safety. Future prospective trials are warranted.

An Oropharyngeal Obstructive Lesion in a Neonate.

Neonatal HNT in the pharynx is a rare cause of respiratory distress and poor feeding in the newborn, but must be differentiated from teratoma, encephalocele, and nasal glioma. While surgical resection is the preferred treatment modality, we posit there is a role for sclerosis of the glial heterotopic cyst if complete surgical excision is not possible or carries risk of high morbidity. Here, we present a case of a 7-day-old neonate presenting with acute respiratory distress found to have a nasopharyngeal/oropharyngeal mass ultimately treated with sclerotherapy at 9 months of age.

Case report: Utilization and efficacy of large-bore catheters in mechanical thrombectomies.

Thrombotic strokes are caused by occlusion of flow in a blood vessel by a clot or thrombus, resulting in disruption of oxygen and nutrients to the brain that can result in neurological deficits. There are many devices now available for safe and effective removal of thrombi from large blood vessels. This report focuses on the Zoom 0.088" large-bore catheter, which has the potential to be navigated into a large vessel for thrombus removal via aspiration, and weigh the risks and benefits of its utilization in thrombectomy patients. In this case, we discuss the use of this device for thrombectomy of a left M1 middle cerebral artery occlusion that resulted in a distal left MCA dissection and eventual loss of access to the site of the thrombus. Ultimately, the patient died from a large stroke in the left MCA territory. In light of this occurrence, we seek to explore the utility and feasibility of large-bore catheters and their risks in thrombectomy candidates.

Treatment of cerebral vasospasm secondary to subarachnoid hemorrhage utilizing the Comaneci device.

Delayed cerebral ischemia due to vasospasm following subarachnoid hemorrhage continues to have high morbidity and mortality despite current treatments. This report highlights the use of the Comaneci (Rapid Medical, Yokneam, Israel), a device FDA approved for temporary coil embolization assistance, for the treatment of symptomatic vasospasm. Ten days post subarachnoid hemorrhage, a patient developed acute left-sided hemiparesis with angiographic vasospasm. Through a Headway 17 microcatheter, a Comaneci 17 was deployed in the right ICA terminus, M1, M2, A1, and, A2 segments resulting in improvement of angiographic vasospasm and the patient's left-sided hemiparesis. On the following day, a repeat angiogram demonstrated no recurrence of vasospasm. The patient had complete return on neurologic function by post bleed day 18 continuing to her four-week follow-up appointment. This case demonstrates the feasibility of the Comaneci device as an effective tool in the treatment of vasospasm following subarachnoid hemorrhage.