Malek, Adel M.

Background Larger “macrowires” may facilitate microcatheter-free delivery of large-bore aspiration catheters (ACs) for intracranial endovascular mechanical thrombectomy. We examined the safety and efficacy of the Aristotle Colossus Guidewire for this use. Methods In this retrospective analysis of prospective data from 12 institutions, we identified anterior circulation endovascular mechanical thrombectomy cases involving the Aristotle Colossus guidewire over a 12-month period. The primary efficacy endpoint was successful delivery of the AC to the site without the use of adjunct devices. Multivariable logistic regression was performed with clinically relevant covariables. Results In 122 patients (median age 74 years (interquartile range (IQR) 63–82)), most intracranial occlusions were in the M1 segment of the middle cerebral artery (95/122, 78.0%). The primary endpoint of microcatheter-free AC delivery was met in 87.7% (107/122) of patients; 93/122 (76.2%) patients underwent microcatheter-free delivery with successful reperfusion via contact aspiration (modified thrombolysis in cerebral infarction grade ≥ 2B). The median number of passes was 1 (IQR 1–2). Multivariable regression demonstrated that severe internal carotid artery tortuosity or cervical loop presence (odds ratio (OR): 0.09, 95% confidence interval (CI): 0.01–0.54, p = 0.01) and presence of intracranial atherosclerotic disease (OR: 0.15, 95% CI: 0.03–0.83, p = 0.03) were significantly associated with lower odds of successful AC delivery over the guidewire. Intraprocedural vasospasm occurred in 4.9% (6/122) of cases; there were no reports of vessel dissection or perforation. Conclusions We demonstrate the favorable performance of the Aristotle Colossus guidewire for anterior circulation ischemic stroke intervention. The macrowire appears to safely facilitate navigation of the neurovasculature by large-bore ACs without the need for microcatheter and/or stentriever.

Background Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. Objective To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. Methods PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. Results A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study’s primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). Conclusions Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. Trial registration NCT02186561 .

Stimulated by a recent controversy regarding pressure drops predicted in a giant aneurysm with a proximal stenosis, the present study sought to assess variability in the prediction of pressures and flow by a wide variety of research groups. In phase I, lumen geometry, flow rates, and fluid properties were specified, leaving each research group to choose their solver, discretization, and solution strategies. Variability was assessed by having each group interpolate their results onto a standardized mesh and centerline. For phase II, a physical model of the geometry was constructed, from which pressure and flow rates were measured. Groups repeated their simulations using a geometry reconstructed from a micro-computed tomography (CT) scan of the physical model with the measured flow rates and fluid properties. Phase I results from 25 groups demonstrated remarkable consistency in the pressure patterns, with the majority predicting peak systolic pressure drops within 8% of each other. Aneurysm sac flow patterns were more variable with only a few groups reporting peak systolic flow instabilities owing to their use of high temporal resolutions. Variability for phase II was comparable, and the median predicted pressure drops were within a few millimeters of mercury of the measured values but only after accounting for submillimeter errors in the reconstruction of the life-sized flow model from micro-CT. In summary, pressure can be predicted with consistency by CFD across a wide range of solvers and solution strategies, but this may not hold true for specific flow patterns or derived quantities. Future challenges are needed and should focus on hemodynamic quantities thought to be of clinical interest.