Thrombectomy for acute ischemic stroke with the new Sofia 6-French PLUS distal access reperfusion catheter: A single-center experience.

INTRODUCTION: The Sofia 6-French PLUS catheter is a recently approved aspiration catheter for use in neuro-endovascular procedures. The description of Sofia 6-French PLUS use in acute ischemic stroke is limited. OBJECTIVE: The purpose of this article is to describe our initial experience with the new Sofia 6-French PLUS catheter for treatment of acute ischemic stroke and to report on its safety and efficacy. METHODS: We performed a retrospective study of 54 thrombectomy cases treated with the Sofia 6-French PLUS catheter. Mean patient age and admission National Institutes of Health Stroke Scale score were 65.30 (1.92) and 15.98 (0.89), respectively. The most common sites of vessel occlusion included the M1 segment (50%) and internal carotid artery (31%). Thrombectomy was performed using the direct aspiration first pass technique and/or aspiration in conjunction with a stent retriever. RESULTS: Successful navigation of the Sofia 6-French PLUS catheter to the site of thromboembolus was achieved in 94% of cases. Revascularization was achieved in a total of 47 cases (87%). Mean time from groin access to revascularization was 42.79 (3.23) min. There were no catheter-related complications. Final outcome data was available for 44 patients (81%). Of these patients, 41% achieved a good outcome (modified Rankin scale score of 0-2) at 60-90 day follow-up, 41% had a poor outcome (modified Rankin 3-5) and eight patients died (18%). CONCLUSIONS: We demonstrate the safe and effective use of the Sofia 6-French PLUS catheter for treatment of acute ischemic stroke. Future studies in the form of a randomized clinical trial or multicenter registry are warranted to further evaluate its comparative safety and efficacy.

Thick and diffuse cisternal clot independently predicts vasospasm-related morbidity and poor outcome after aneurysmal subarachnoid hemorrhage.

OBJECTIVE: Aneurysmal subarachnoid hemorrhage (aSAH) is associated with significant morbidity and mortality. The presence of thick, diffuse subarachnoid blood may portend a worse clinical course and outcome, independently of other known prognostic factors such as age, aneurysm size, and initial clinical grade. METHODS: In this post hoc analysis, patients with aSAH undergoing surgical clipping (n = 383) or endovascular coiling (n = 189) were pooled from the placebo arms of the Clazosentan to Overcome Neurological Ischemia and Infarction Occurring After Subarachnoid Hemorrhage (CONSCIOUS)-2 and CONSCIOUS-3 randomized, double-blind, placebo-controlled phase 3 studies, respectively. Patients without and with thick, diffuse SAH (≥ 4 mm thick and involving ≥ 3 basal cisterns) on admission CT scans were compared. Clot size was centrally adjudicated. All-cause mortality and vasospasm-related morbidity at 6 weeks and Glasgow Outcome Scale-Extended (GOSE) scores at 12 weeks after aSAH were assessed. The effect of the thick and diffuse cisternal aSAH on vasospasm-related morbidity and mortality, and on poor clinical outcome at 12 weeks, was evaluated using logistic regression models. RESULTS: Overall, 294 patients (51.4%) had thick and diffuse aSAH. Compared to patients with less hemorrhage burden, these patients were older (median age 55 vs 50 years) and more often had World Federation of Neurosurgical Societies (WFNS) grade III-V SAH at admission (24.1% vs 16.5%). At 6 weeks, all-cause mortality and vasospasm-related morbidity occurred in 36.1% (95% CI 30.6%-41.8%) of patients with thick, diffuse SAH and in 14.7% (95% CI 10.8%-19.5%) of those without thick, diffuse SAH. Individual event rates were 7.5% versus 2.5% for all-cause death, 19.4% versus 6.8% for new cerebral infarct, 28.2% versus 9.4% for delayed ischemic neurological deficit, and 24.8% versus 10.8% for rescue therapy due to cerebral vasospasm, respectively. Poor clinical outcome (GOSE score ≥ 4) was observed in 32.7% (95% CI 27.3%-38.3%) and 16.2% (95% CI 12.1%-21.1%) of patients with and without thick, diffuse SAH, respectively. CONCLUSIONS: In a large, centrally adjudicated population of patients with aSAH, WFNS grade at admission and thick, diffuse SAH independently predicted vasospasm-related morbidity and poor 12-week clinical outcome. Patients with thick, diffuse cisternal SAH may be an important cohort to target in future clinical trials of treatment for vasospasm.

Efficacy of Ultra-Early (< 12 h), Early (12-24 h), and Late (>24-138.5 h) Surgery with Magnetic Resonance Imaging-Confirmed Decompression in American Spinal Injury Association Impairment Scale Grades A, B, and C Cervical Spinal Cord Injury.

In cervical traumatic spinal cord injury (TSCI), the therapeutic effect of timing of surgery on neurological recovery remains uncertain. Additionally, the relationship between extent of decompression, imaging biomarker evidence of injury severity, and outcome is incompletely understood. We investigated the effect of timing of decompression on long-term neurological outcome in patients with complete spinal cord decompression confirmed on postoperative magnetic resonance imaging (MRI). American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade conversion was determined in 72 AIS grades A, B, and C patients 6 months after confirmed decompression. Thirty-two patients underwent decompressive surgery ultra-early (< 12 h), 25 underwent decompressive surgery early (12-24 h), and 15 underwent decompressive surgery late (> 24-138.5 h) after injury. Age, gender, injury mechanism, intramedullary lesion length (IMLL) on MRI, admission ASIA motor score, and surgical technique were not statistically different among groups. Motor complete patients (p = 0.009) and those with fracture dislocations (p = 0.01) tended to be operated on earlier. Improvement of one grade or more was present in 55.6% of AIS grade A, 60.9% of AIS grade B, and 86.4% of AIS grade C patients. Admission AIS motor score (p = 0.0004) and pre-operative IMLL (p = 0.00001) were the strongest predictors of neurological outcome. AIS grade improvement occurred in 65.6%, 60%, and 80% of patients who underwent decompression ultra-early, early, and late, respectively (p = 0.424). Multiple regression analysis revealed that IMLL was the only significant variable predictive of AIS grade conversion to a better grade (odds ratio, 0.908; confidence interval [CI], 0.862-0.957; p < 0.001). We conclude that in patients with post-operative MRI confirmation of complete decompression following cervical TSCI, pre-operative IMLL, not the timing of surgery, determines long-term neurological outcome.

Use of Pipeline Flex is associated with reduced fluoroscopy time, procedure time, and technical failure compared with the first-generation Pipeline embolization device.

BACKGROUND: Flow diversion with the Pipeline embolization device is a well-established method of intracranial aneurysm treatment. However, deployment of the first-generation device (Pipeline Classic) can be technically challenging. The Pipeline Flex contains the same flow-diverting stent with a modified delivery system. OBJECTIVE: To compare procedural outcomes between the first-generation device (Pipeline Classic) and the Pipeline Flex. METHODS: Thirty-eight of the first 40 consecutive patients who underwent intracranial aneurysm treatment with the Pipeline Flex and 58 of the most recent 60 consecutive patients who underwent treatment with the Pipeline Classic at our institution were evaluated. Patient demographics, aneurysm characteristics, technical procedural details, and early outcomes were analyzed. RESULTS: The two groups were comparable for age, gender, and location of target aneurysms. Use of Pipeline Flex decreased procedure time by 44.2 min (p≤0.001) and fluoroscopy time by 22.0 min (p=0.001) compared with the Pipeline Classic. Similarly, radiation exposure was less in the Flex group with a mean difference of 3473.5 Gy cm2 (p=0.002), while contrast usage was decreased with a mean difference of 22.3 mL (p=0.007). These differences remained significant in multivariate regression analysis. Finally, the rate of device deployment failure was lower in the Flex group (7.1%) than in the Classic group (23.9%) (p=0.034). CONCLUSIONS: Use of Pipeline Flex significantly reduces the total procedure and fluoroscopy time, contrast usage, patient radiation exposure, and proportion of recaptured devices in comparison with the Pipeline Classic, probably owing to an enhanced delivery system that allows for more reliable and controlled deployment.