Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry.

Background and Purpose- Mechanical thrombectomy has been shown to improve clinical outcomes in patients with acute ischemic stroke. However, the impact of balloon guide catheter (BGC) use is not well established. Methods- STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter study of patients with large vessel occlusion treated with the Solitaire stent retriever as first-line therapy. In this study, an independent core laboratory, blinded to the clinical outcomes, reviewed all procedures and angiographic data to classify procedural technique, target clot location, recanalization after each pass, and determine the number of stent retriever passes. The primary clinical end point was functional independence (modified Rankin Scale, 0-2) at 3 months as determined on-site, and the angiographic end point was first-pass effect (FPE) success rate from a single device attempt (modified Thrombolysis in Cerebral Infarction, ≥2c) as determined by a core laboratory. Achieving modified FPE (modified Thrombolysis in Cerebral Infarction, ≥2b) was also assessed. Comparisons of clinical outcomes were made between groups and adjusted for baseline and procedural characteristics. All participating centers received institutional review board approval from their respective institutions. Results- Adjunctive technique groups included BGC (n=445), distal access catheter (n=238), and conventional guide catheter (n=62). The BGC group had a higher rate of FPE following first pass (212/443 [48%]) versus conventional guide catheter (16/62 [26%]; P=0.001) and distal access catheter (83/235 [35%]; P=0.002). Similarly, the BGC group had a higher rate of modified FPE (294/443 [66%]) versus conventional guide catheter (26/62 [42%]; P<0.001) and distal access catheter (129/234 [55%]; P=0.003). The BGC group achieved the highest rate of functional independence (253/415 [61%]) versus conventional guide catheter (23/55 [42%]; P=0.007) and distal access catheter (113/218 [52%]; P=0.027). Final revascularization and mortality rates did not differ across the groups. Conclusions- BGC use was an independent predictor of FPE, modified FPE, and functional independence, suggesting that its routine use may improve the rates of early revascularization success and good clinical outcomes. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02239640.

Interhospital Transfer Before Thrombectomy Is Associated With Delayed Treatment and Worse Outcome in the STRATIS Registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke).

BACKGROUND: Endovascular treatment with mechanical thrombectomy (MT) is beneficial for patients with acute stroke suffering a large-vessel occlusion, although treatment efficacy is highly time-dependent. We hypothesized that interhospital transfer to endovascular-capable centers would result in treatment delays and worse clinical outcomes compared with direct presentation. METHODS: STRATIS (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) was a prospective, multicenter, observational, single-arm study of real-world MT for acute stroke because of anterior-circulation large-vessel occlusion performed at 55 sites over 2 years, including 1000 patients with severe stroke and treated within 8 hours. Patients underwent MT with or without intravenous tissue plasminogen activator and were admitted to endovascular-capable centers via either interhospital transfer or direct presentation. The primary clinical outcome was functional independence (modified Rankin Score 0-2) at 90 days. We assessed (1) real-world time metrics of stroke care delivery, (2) outcome differences between direct and transfer patients undergoing MT, and (3) the potential impact of local hospital bypass. RESULTS: A total of 984 patients were analyzed. Median onset-to-revascularization time was 202.0 minutes for direct versus 311.5 minutes for transfer patients (P<0.001). Clinical outcomes were better in the direct group, with 60.0% (299/498) achieving functional independence compared with 52.2% (213/408) in the transfer group (odds ratio, 1.38; 95% confidence interval, 1.06-1.79; P=0.02). Likewise, excellent outcome (modified Rankin Score 0-1) was achieved in 47.4% (236/498) of direct patients versus 38.0% (155/408) of transfer patients (odds ratio, 1.47; 95% confidence interval, 1.13-1.92; P=0.005). Mortality did not differ between the 2 groups (15.1% for direct, 13.7% for transfer; P=0.55). Intravenous tissue plasminogen activator did not impact outcomes. Hypothetical bypass modeling for all transferred patients suggested that intravenous tissue plasminogen activator would be delayed by 12 minutes, but MT would be performed 91 minutes sooner if patients were routed directly to endovascular-capable centers. If bypass is limited to a 20-mile radius from onset, then intravenous tissue plasminogen activator would be delayed by 7 minutes and MT performed 94 minutes earlier. CONCLUSIONS: In this large, real-world study, interhospital transfer was associated with significant treatment delays and lower chance of good outcome. Strategies to facilitate more rapid identification of large-vessel occlusion and direct routing to endovascular-capable centers for patients with severe stroke may improve outcomes. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke: Primary Results of the STRATIS Registry.

BACKGROUND AND PURPOSE: Mechanical thrombectomy with stent retrievers has become standard of care for treatment of acute ischemic stroke patients because of large vessel occlusion. The STRATIS registry (Systematic Evaluation of Patients Treated With Neurothrombectomy Devices for Acute Ischemic Stroke) aimed to assess whether similar process timelines, technical, and functional outcomes could be achieved in a large real world cohort as in the randomized trials. METHODS: STRATIS was designed to prospectively enroll patients treated in the United States with a Solitaire Revascularization Device and Mindframe Capture Low Profile Revascularization Device within 8 hours from symptom onset. The STRATIS cohort was compared with the interventional cohort of a previously published SEER patient-level meta-analysis. RESULTS: A total of 984 patients treated at 55 sites were analyzed. The mean National Institutes of Health Stroke Scale score was 17.3. Intravenous tissue-type plasminogen activator was administered in 64.0%. The median time from onset to arrival in the enrolling hospital, door to puncture, and puncture to reperfusion were 138, 72, and 36 minutes, respectively. The Core lab-adjudicated modified Thrombolysis in Cerebral Infarction ≥2b was achieved in 87.9% of patients. At 90 days, 56.5% achieved a modified Rankin Scale score of 0 to 2, all-cause mortality was 14.4%, and 1.4% suffered a symptomatic intracranial hemorrhage. The median time from emergency medical services scene arrival to puncture was 152 minutes, and each hour delay in this interval was associated with a 5.5% absolute decline in the likelihood of achieving modified Rankin Scale score 0 to 2. CONCLUSIONS: This largest-to-date Solitaire registry documents that the results of the randomized trials can be reproduced in the community. The decrease of clinical benefit over time warrants optimization of the system of care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02239640.

Parent vessel occlusion for treatment of cerebral aneurysms: Is there still an indication? A series of 17 patients.

INTRODUCTION/PURPOSE: Flow diversion has allowed cerebrovascular neurosurgeons and neurointerventionalists to treat complex, large aneurysms, previously treated with trapping, bypass, and/or parent vessel sacrifice. However, a minority of aneurysms remain that cannot be treated endovascularly, and microsurgical treatment is too dangerous. However, balloon test occlusion (macro and micro), micro WADA testing, ICG, intra-angiography and intra-operative monitoring are all available to clinically test the hypothesis that vessel sacrifice is safe. We describe a dual-institution series of aneurysms successfully treated with parent vessel occlusion (PVO). MATERIALS/METHODS: Prospectively collected databases of all endovascular and open cerebrovascular cases performed at Maine Medical Center and Vanderbilt University Medical Center from 2011 to 2013 were screened for patients treated with primary vessel sacrifice. A total of 817 patients were screened and 17 patients were identified who underwent parent vessel sacrifice as primary treatment. RESULTS: All 17 patients primarily treated with PVO are described below. Nine patients presented with SAH, and 3/17 involved anterior circulation. Complete occlusion was achieved in 15/17 patients. In the remaining 2 patients, significant reduction in the aneurysm occurred. Modified Rankin Score (mRS) of 0, signifying complete independence, was achieved for 16/17 patients. One patient died due to an extracranial process. CONCLUSIONS: Parent vessel sacrifice remains a viable and durable solution in select ruptured and unruptured intracranial aneurysms. Many adjuncts are available to aid in the decision making. In this small series, patients naturally divided into vertebral dissecting aneurysms, giant aneurysms and small distal aneurysms. Outcomes were favorable in this highly selected group.

Decompressive craniectomy for severe traumatic brain injury: clinical study, literature review and meta-analysis.

OBJECTIVE: To examine the clinical and neurological outcome of patients who sustained a severe non-penetrating traumatic brain injury (TBI) and underwent unilateral decompressive craniectomy (DC) for refractory intracranial hypertension. DESIGN: Single center, retrospective, observational. SETTING: Level I Trauma Center in Portland, Maine. PATIENTS: 31 patients aged 16-72 of either sex who sustained a severe, non-penetrating TBI and underwent a unilateral DC for evacuation of parenchymal or extra-axial hematoma or for failure of medical therapy to control intracranial pressure (ICP). INTERVENTIONS: Review of the electronic medical record of patients undergoing DC for severe TBI and assessment of extended Glasgow Outcome Score (e-GOS) at 6-months following DC. MEASUREMENTS AND MAIN RESULTS: The mean age was 39.3y ± 14.5. The initial GCS was 5.8 ± 3.2, and the ISS was 29.7 ± 6.3. Twenty-two patients underwent DC within the first 24 h, two within the next 24 h and seven between the 3rd and 7th day post injury. The pre-DC ICP was 30.7 ± 10.3 and the ICP was 12.1 ± 6.2 post-DC. Cranioplasty was performed in all surviving patients 1-4 months post-DC. Of the 29 survivors following DC, the e-GOS was 8 in seven patients, and 7 in ten patients. The e-GOS was 5-6 in 6 others. Of the 6 survivors with poor outcomes (e-GOS = 2-4), five were the initial patients in the series. CONCLUSIONS: In patients with intractable cerebral hypertension following TBI, unilateral DC in concert with practice guideline directed brain resuscitation is associated with good functional outcome and acceptable-mortality.

Treatment of Distal Anterior Circulation Aneurysms With the Pipeline Embolization Device: A US Multicenter Experience.

BACKGROUND: Utilization of the Pipeline embolization device (PED) to treat distal carotid circulation aneurysms has not been well studied. OBJECTIVE: To report the collective experience of using PED to treat distal anterior circulation aneurysms. METHODS: We retrospectively reviewed clinical and radiographic records of all patients who underwent Pipeline embolization of distal anterior circulation aneurysms at 10 US neurosurgical centers between 2011 and 2013. RESULTS: Twenty-eight patients (mean age 51.7 years; 18 women) with 28 aneurysms were included in the analyses. Fifteen aneurysms were fusiform, 5 dissecting, and 8 saccular. Average aneurysm size was 12.3 mm; 7 were giant. Twenty aneurysms were located along the middle cerebral artery, 6 along the anterior cerebral artery, and 2 along the anterior communicating artery. PED deployment was successful in 27 patients, with coils utilized in 6 cases. Clinical follow-up was available for an average of 10.7 months (range 3-26). Twenty-seven patients had follow-up neurovascular imaging: 21 aneurysms had complete occlusion, 4 had residual neck filling, and 2 had residual dome filling. Periprocedural complications (<30 days) occurred in 3 patients (10.7%), including 1 case of device failure resulting in stroke. Outcomes were good (modified Rankin Scale score 0 to 2) in 27 patients (96.4%) and fair (modified Rankin Scale 3) in 1. CONCLUSION: PED can be utilized in the treatment of distal anterior circulation aneurysms with difficult anatomy for conventional surgical or endovascular techniques. Larger-scale studies with long-term follow-up are needed to further elucidate the durability of PED treatment and its effect on perforator-rich vascular segments. ABBREVIATIONS: ACA, anterior cerebral arteryAcomA, anterior communicating arteryDSA, digital subtraction angiographyMCA, middle cerebral arterymRS, modified Rankin scalePED, Pipeline embolization device.

Prospective series of two hours supine rest after 4fr sheath-based diagnostic cerebral angiography: Outcomes, productivity and cost.

There is no standard of care for catheter size or post-procedure supine time in cerebral angiography. Catheter sizes range from 4-Fr to 6-Fr with supine times ranging from two to over six hours. The objective of our study was to establish the efficacy, safety, and cost savings of two-hour supine time after 4-Fr elective cerebral angiography. A prospective, single arm study was performed on 107 patients undergoing elective cerebral angiography. All cerebral angiograms were performed with a 4-Fr sheath-based system without closure devices. Ten minutes of manual compression was applied to the femoral access site, with further compression held as clinically indicated. Patients were then monitored in a nursing unit for two hours supine and subsequently mobilized. Nursing discretion was allowed for earlier mobilization. Patients were called the next day to assess delayed hematoma and bleeding. Estimates of cost savings and productivity increases are provided. All patients ambulated in two hours or less. There were no strokes or vessel dissections. Five patients (4.7%) experienced a palpable hematoma, three patients (2.8%) experienced bleeding immediately following the procedure requiring further compression, and one patient (0.9%) experienced minor groin oozing at home. No patient required transfusion, thrombin injection, or endovascular/surgical management of a groin complication. A two-hour post-procedure supine time resulted in cost savings of $952 per angiogram and a total of $101,864. 4-Fr sheath based cerebral angiography with two-hour post-procedure supine time is safe and effective, and allows for a considerable increase in patient satisfaction, cost savings and productivity.

Aspirin allergy desensitization in cerebrovascular disease. A report of two cases, literature review and management guide for the neurointerventionalist.

Aspirin (ASA) is the mainstay of treatment in cerebrovascular and systemic vascular disease. ASA hypersensitivity can pose a challenge to achieving optimum medical management prior to and after neurointerventional treatment. Desensitization to ASA is well described in the allergy and cardiovascular literature, but there are no similar discussions specific to neurointervention. The purpose of our study was to describe our experience with ASA hypersensitivity management and review the relevant literature. Two cases of patients with symptomatic cerebrovascular disease requiring neurointervention who were successfully desensitized to their ASA hypersensitivity prior to treatment are described. The subsequent literature is reviewed. Several ASA desensitization protocols exist and have been proven to successfully treat ASA hypersensitivity and allow for ASA therapy to be safely initiated. We describe several previously published protocols. ASA desensitization is a safe and simple way to manage ASA hypersensitivity. We provide comprehensive management guidelines for the neurointerventionalist engaging in ASA desensitization.

Endovascular reconstruction of vertebral artery occlusion prior to basilar thrombectomy in a series of six patients presenting with acute symptomatic basilar thrombosis.

INTRODUCTION AND PURPOSE: Symptomatic acute basilar thrombosis is associated with a high mortality rate. Aggressive endovascular management has led to survival rates of 35-50%. We report the largest series of endovascular reconstruction of occluded dominant vertebral arteries prior to basilar thrombectomy. MATERIALS AND METHODS: A prospective database since August 2010 of all neuroendovascular interventions was mined for patients undergoing basilar artery thrombolysis from which a group with vertebral artery reconstruction was selected. Patient charts were retrospectively reviewed for relevant clinical, technical, and outcome data. RESULTS: From August 2010 to September 2012, six patients were identified who underwent vertebral reconstruction prior to basilar thrombectomy. Patients ranged in age from 42 to 57 years (mean 51 years). Mean time from symptoms until recanalization was approximately 6 h. Angiographic Thrombolysis in Cerebral Infarction IIB reconstitution of the basilar trunk was achieved in all cases. There were no technical complications. Two patients had care withdrawn secondary to massive completed brainstem infarction and poor neurological status post intervention. Three patients are now independent at 12, 14, and 31 months, respectively. One patient, after a follow-up of only 8 months, has achieved a modified Rankin Scale score of 3. CONCLUSIONS: Complete vertebral occlusion below a basilar thrombus can be recanalized prior to thrombectomy. In this case series, 100% of the acutely occluded vertebral arteries could be opened using either anterograde or retrograde access. However, basilar thrombosis continues to be a devastating illness, with one-third of the patients in this series dying of progressive infarction despite angiographic patency of the large conduit vessels with technical complications.

Hyperperfusion syndrome after stent/coiling of a ruptured carotid bifurcation aneurysm.

The authors report a syndrome of regional, symptomatic cerebral hyperperfusion, and edema mimicking infarction in a 54-year-old woman following coiling of a ruptured right carotid bifurcation aneurysm and stenting of the right middle cerebral artery. The patient presented with a Hunt and Hess grade III subarachnoid hemorrhage 7 days after developing thunderclap headache. She underwent successful coiling under general anesthesia of the 1.6 × 1.5 × 1.6 cm aneurysm, but immediately after the coil was placed occlusion of the proximal M1 segment was developed. This occlusion was stented after ~5-min delay, and flow restored without angiographic evidence of distal emboli. Following the procedure, she was extubated and noted to have left hemiparesis, neglect, and mutism without a CT correlate. Cerebral infarction was suspected, but urgent repeat angiography demonstrated patent cerebral vasculature. On the following day, symptoms persisted, and non-contrast head CT now showed cerebral edema localized to the right middle cerebral artery territory mimicking subacute infarction. CT perfusion imaging and angiography showed a widely patent MCA circulation, and suggested a regional hyperperfusion syndrome. The blood pressure was incrementally lowered, with rapid and sustained neurological improvement. Hyperperfusion events following aneurysm repair and related circumstances are reviewed.

Outcomes of 33 patients from the wars in Iraq and Afghanistan undergoing bilateral or bicompartmental craniectomy.

OBJECT: There are no published long-term data for patients with penetrating head injury treated with bilateral supratentorial craniectomy, or supra- and infratentorial craniectomy. The authors report their experience with 33 patients treated with bilateral or bicompartmental craniectomy from the ongoing conflicts in Iraq and Afghanistan. METHODS: An exploratory analysis of Glasgow Outcome Scale (GOS) scores at 6 months in 33 patients was performed. Follow-up lasting a median of more than 2 years was performed in 30 (91%) of these patients. The association of GOS score with categorical variables was explored using the Wilcoxon rank-sum test or Kruskal-Wallis analysis of variance. The Spearman correlation coefficient was used for ordinal/continuous data. To provide a clinically meaningful format to present GOS scores with categorical variables, patients with GOS scores of 1-3 were categorized as having a poor outcome and those with scores of 4 and 5 as having a good outcome. This analysis does not include the patients who died in theater or in Germany who underwent bilateral decompressive craniectomy because those figures have not been released due to security concerns. RESULTS: All patients were men with a median age of 24 years (range 19-46 years) and a median initial Glasgow Coma Scale (GCS) score of 5 (range 3-14). At 6 months, 9 characteristics were statistically significant: focus of the initial injury, systemic infection, initial GCS score, initial GCS score excluding patients with a GCS score of 3, GCS score on arrival to the US, GCS score on dismissal from the medical center, Injury Severity Score, and patients with cerebrovascular injury. Six factors were significant at long-term follow-up: focus of initial injury, systemic infection, initial GCS score excluding patients with a GCS score of 3, GCS score on arrival to the US, and GCS score on dismissal from the medical center. At long-term follow-up, 7 (23%) of 30 patients had died, 5 (17%) of 30 had a GOS score of 2 or 3, and 18 (60%) of 30 had a GOS score of 4 or 5. CONCLUSIONS: In this selected group of patients who underwent bilateral or bicompartmental craniectomy, 60% are independent at long-term follow-up. Patients with bifrontal injury fared best. Systemic infection and cerebrovascular injury corresponded with a worse outcome.

The evolution of the treatment of traumatic cerebrovascular injury during wartime.

The approach to traumatic craniocervical vascular injury has evolved significantly in recent years. Conflicts prior to Operations Iraqi and Enduring Freedom were characterized by minimal intervention in the setting of severe penetrating head injury, in large part due to limited far-forward resource availability. Consequently, sequelae of penetrating head injury like traumatic aneurysm formation remained poorly characterized with a paucity of pathophysiological descriptions. The current conflicts have seen dramatic improvements with respect to the management of severe penetrating and closed head injuries. As a result of the rapid field resuscitation and early cranial decompression, patients are surviving longer, which has led to diagnosis and treatment of entities that had previously gone undiagnosed. Therefore, in this paper the authors' purpose is to review their experience with severe traumatic brain injury complicated by injury to the craniocervical vasculature. Historical approaches will be reviewed, and the importance of modern endovascular techniques will be emphasized.

Variant of subclavian steal in the setting of ipsilateral common carotid artery occlusion: case report.

Subclavian steal is a well-described angiographic finding and clinical syndrome that rarely results in vertebrobasilar ischemic symptoms. In classic subclavian steal, left subclavian artery (SA) stenosis occurs proximal to the left vertebral artery (VA) origin. We report a symptomatic variant of this syndrome that occurred in the setting of left common carotid artery occlusion and anomalous origin of the left VA directly from the aortic arch. The steal and symptoms resolved after stenting of the left SA stenosis.

Current concepts in the management of intracranial atherosclerotic disease.

Medically refractory, symptomatic intracranial atherosclerotic disease has a poor prognosis. Based on the results of the Warfarin-Aspirin Symptomatic Intracranial Disease study, the risk of ipsilateral stroke at 1.8 years is between 13 and 14% in patients with symptomatic intracranial atherosclerosis. Synergistic advances in intracranial angioplasty and stenting, modern neuroimaging techniques, and periprocedural and postprocedural antithrombotic regimens are creating new models for the diagnosis and successful endovascular treatment of intracranial stenosis. In this article, the most recent clinical developments and concepts for the diagnosis and endovascular treatment of intracranial atherosclerotic disease are discussed.

Cerebral endovascular neurosurgery.

Cerebral endovascular neurosurgery has evolved rapidly in the past decade through advances in tools and techniques and as a result of the thrust toward evidence-based medicine. More patients with diseases traditionally treated via microsurgical approaches can now be treated with techniques that focus on endoluminal reconstruction. With the introduction of intracranial clot retrievers and appropriately sized stents, stroke care is being slowly revolutionized for those patients with salvageable brain tissue at the time of admission to the hospital. In this article, the recent history, current state, and possible future of cerebral endovascular neurosurgery are reviewed for the following diseases: stroke, intracranial atherosclerotic disease, brachiocephalic occlusive disease, cerebral aneurysms, central nervous system vascular malformations, and brain tumors. New concepts and applications for endovascular treatment of epilepsy and multiple sclerosis are mentioned. The potential for nanotechnology in this field and the future endovascular suite are envisioned.

Complications of carotid artery stenting at a high-volume teaching center: experience of University at Buffalo endovascular fellows from 2004 to 2006.

OBJECTIVE: Among neurosurgeons, cardiologists, neuroradiologists, vascular surgeons, and peripheral vascular radiologists, the metric of clinical competency in carotid artery angioplasty and stenting (CAS) continues to be debated. This review of fellowship experience with more than 200 CAS cases was undertaken to ascertain the 30-day morbidity and mortality rates at a high-volume endovascular training center with a well-established system for teaching CAS. METHODS: A prospectively collected database of more than 8000 endovascular cases was culled for all patients undergoing CAS from July 2004 through February 2006, in which the primary operator was one of the current senior fellows (RDE, ES). The operative reports, hospital charts, and office notes were then reviewed for morbidity and mortality within 30 days. RESULTS: At 30 days, the combined rates of morbidity and mortality for each fellow were nearly identical at 4.9 and 5.9%, respectively. There were two deaths, one of which resulted from reperfusion hemorrhage and one after cardiac surgery. During the study period, six strokes and two myocardial infarctions occurred; one of the patients who had a myocardial infarction underwent coronary stenting on an emergency basis. One patient had a femoral artery occlusion requiring operative repair. CONCLUSION: At a high-volume endovascular training center with a well-established teaching pathway for CAS, morbidity and mortality rates comparable to those reported in previously published series of carotid endarterectomy were obtained.