Summary Background Early results of the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis trial showed that, by 30 days, 33 (14·7%) of 224 patients ...in the stenting group and 13 (5·8%) of 227 patients in the medical group had died or had a stroke (percentages are product limit estimates), but provided insufficient data to establish whether stenting offered any longer-term benefit. Here we report the long-term outcome of patients in this trial. Methods We randomly assigned (1:1, stratified by centre with randomly permuted block sizes) 451 patients with recent transient ischaemic attack or stroke related to 70–99% stenosis of a major intracranial artery to aggressive medical management (antiplatelet therapy, intensive management of vascular risk factors, and a lifestyle-modification programme) or aggressive medical management plus stenting with the Wingspan stent. The primary endpoint was any of the following: stroke or death within 30 days after enrolment, ischaemic stroke in the territory of the qualifying artery beyond 30 days of enrolment, or stroke or death within 30 days after a revascularisation procedure of the qualifying lesion during follow-up. Primary endpoint analysis of between-group differences with log-rank test was by intention to treat. This study is registered with ClinicalTrials.gov , number NCT 00576693. Findings During a median follow-up of 32·4 months, 34 (15%) of 227 patients in the medical group and 52 (23%) of 224 patients in the stenting group had a primary endpoint event. The cumulative probability of the primary endpoints was smaller in the medical group versus the percutaneous transluminal angioplasty and stenting (PTAS) group (p=0·0252). Beyond 30 days, 21 (10%) of 210 patients in the medical group and 19 (10%) of 191 patients in the stenting group had a primary endpoint. The absolute differences in the primary endpoint rates between the two groups were 7·1% at year 1 (95% CI 0·2 to 13·8%; p=0·0428), 6·5% at year 2 (–0·5 to 13·5%; p=0·07) and 9·0% at year 3 (1·5 to 16·5%; p=0·0193). The occurrence of the following adverse events was higher in the PTAS group than in the medical group: any stroke (59 26% of 224 patients vs 42 19% of 227 patients; p=0·0468) and major haemorrhage (29 13%of 224 patients vs 10 4% of 227 patients; p=0·0009). Interpretation The early benefit of aggressive medical management over stenting with the Wingspan stent for high-risk patients with intracranial stenosis persists over extended follow-up. Our findings lend support to the use of aggressive medical management rather than PTAS with the Wingspan system in high-risk patients with atherosclerotic intracranial arterial stenosis. Funding National Institute of Neurological Disorders and Stroke (NINDS) and others.
Atherosclerotic intracranial arterial stenosis is an important cause of stroke that is increasingly being treated with percutaneous transluminal angioplasty and stenting (PTAS) to prevent recurrent ...stroke. However, PTAS has not been compared with medical management in a randomized trial.
We randomly assigned patients who had a recent transient ischemic attack or stroke attributed to stenosis of 70 to 99% of the diameter of a major intracranial artery to aggressive medical management alone or aggressive medical management plus PTAS with the use of the Wingspan stent system. The primary end point was stroke or death within 30 days after enrollment or after a revascularization procedure for the qualifying lesion during the follow-up period or stroke in the territory of the qualifying artery beyond 30 days.
Enrollment was stopped after 451 patients underwent randomization, because the 30-day rate of stroke or death was 14.7% in the PTAS group (nonfatal stroke, 12.5%; fatal stroke, 2.2%) and 5.8% in the medical-management group (nonfatal stroke, 5.3%; non-stroke-related death, 0.4%) (P=0.002). Beyond 30 days, stroke in the same territory occurred in 13 patients in each group. Currently, the mean duration of follow-up, which is ongoing, is 11.9 months. The probability of the occurrence of a primary end-point event over time differed significantly between the two treatment groups (P=0.009), with 1-year rates of the primary end point of 20.0% in the PTAS group and 12.2% in the medical-management group.
In patients with intracranial arterial stenosis, aggressive medical management was superior to PTAS with the use of the Wingspan stent system, both because the risk of early stroke after PTAS was high and because the risk of stroke with aggressive medical therapy alone was lower than expected. (Funded by the National Institute of Neurological Disorders and Stroke and others; SAMMPRIS ClinicalTrials.gov number, NCT00576693.).
Enrollment in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial was halted due to the high risk of stroke or death within 30 ...days of enrollment in the percutaneous transluminal angioplasty and stenting arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with periprocedural cerebrovascular events in the trial.
Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed periprocedural) in the percutaneous transluminal angioplasty and stenting arm.
Of 224 patients randomized to percutaneous transluminal angioplasty and stenting, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs within the periprocedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (P ≤ 0.05) with hemorrhagic stroke. Nonsmoking, basilar artery stenosis, diabetes, and older age were associated (P ≤ 0.05) with ischemic events.
Periprocedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for periprocedural strokes could be identified, excluding patients with these features from undergoing percutaneous transluminal angioplasty and stenting to lower the procedural risk would limit percutaneous transluminal angioplasty and stenting to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. Clinical Trial Registration Information- URL: http://clinicaltrials.gov. Unique Identifier: NCT00576693.
Advanced magnetic resonance imaging (MRI) acquisition methods such as 4D phase contrast magnetic resonance imaging (4D pcMRI) have found widespread applications in assessing hemodynamics in cerebral ...aneurysms. One of the goals is the identification of a hemodynamic scenario predictive of aneurysm rupture. Because of the technical complexity the 4D pcMRI technology, challenges exist in extracting and communicating the wealth of information contained in the MRI image data, in particular, to a multidisciplinary team of health professionals and basic scientists.
Here we introduce a new resource in the form of a commercially available optical see-through head-mounted display, which allows augmenting the real world by computer-generated virtual objects.
An image processing algorithm was presented for integrating 3D surface models derived from 3D rotational angiography data, 3D time-of-flight MRI data, and 4D pcMRI data into the augmented reality environment. This new approach was successfully evaluated on blood flow data acquired before and after flow diverter treatment in 6 patients harboring a cerebral aneurysm.
Augmented reality may become an additional means for visualizing complex medical data, in particular complex flows as illustrated here.
•Design of an AR algorithm for displaying complex medical vascular image data .•Using different kinds of image data (MRI, 3D RSA, and 4D pcMRI), the application of the device was successful.•Natural interaction with complex 3D medical image data that seemed to exist in the actual real space.
Background Mechanical thrombectomy is established for large‐vessel occlusions in acute ischemic stroke, but the potential role in distal vessel occlusions of medium arteries is less well established. ...Such medium or distal arterial segments have not been assessed with respect to thrombectomy devices used during endovascular therapy. We conducted an analysis of arterial size, segmental anatomy, and stent‐retriever device performance with respect to vessel size during thrombectomy. Methods The STRATIS registry angiography core laboratory adjudicated the exact location of the occlusion, proximal, and distal device deployment, relationship to arterial bifurcations, and anatomic nomenclature. Arterial diameters were measured at all these sites. Statistical analyses examined the relationship between vessel and stent size, and arterial recanalization using expanded Thrombolysis in Cerebral Infarction reperfusion score. Results Overall, 665 patients with stroke were included following thrombectomy using various Solitaire device sizes, including Solitaire 4×40, Solitaire 6×30, Solitaire 4×20, Solitaire 6×20, and Solitaire 4×15. Arterial diameter at the occlusion site was a median of 2.17 mm (interquartile range IQR, 1.88–2.60 mm) in the distal M1, 1.67 mm (IQR, 1.47–2.06 mm) in the proximal M2 middle cerebral artery, 1.50 mm (IQR, 1.15–1.61 mm) in the distal M2 middle cerebral artery, 1.24 mm (IQR, 1.11–1.24 mm) in the M3 middle cerebral artery, and 1.88 mm (IQR, 1.49–1.94 mm) in the P1 posterior cerebral artery. Expanded Thrombolysis in Cerebral Infarction 2b to 3 reperfusion was achieved in all M3 or P1 segment occlusions. The rate of first‐pass recanalization was significantly higher in patients with medium (0.75–2 mm) versus large (>2 mm) vessel occlusion (69.5% versus 57.1%; P = 0.003). Conclusion Considerable overlap was noted between arterial sizes at occlusion sites carrying different segmental arterial nomenclature or vessel names. Substantial reperfusion may be achieved with currently available mechanical thrombectomy devices in medium arteries.
Spinal extradural (epidural) arteriovenous fistulas (AVFs) are uncommon vascular lesions of the spine with arteriovenous shunting located primarily in the epidural venous plexus. Understanding the ...complex anatomical variations of these uncommon lesions is important for management. The authors describe the different types of spinal extradural AVFs and their endovascular management using Onyx.
Eight spinal extradural AVFs in 7 patients were studied using MR imaging, spinal angiography, and dynamic CT (DynaCT) between 2005 and 2009. Special consideration was given to the anatomy, pattern of venous drainage, and mass effect upon the nerve roots, spinal cord, and vertebrae.
The neuroaxial location of the 8 spinal extradural AVFs was lumbosacral in 1 patient, lumbar in 4 patients, thoracic in 2 patients, and cervical in 1 patient. Spinal extradural AVFs were divided into 3 types. In Type A spinal extradural AVFs, arteriovenous shunting occurs in the epidural space and these types have an intradural draining vein causing venous hypertension and spinal cord edema with associated myelopathy or cauda equina syndrome. Type B1 malformations are confined to the epidural space with no intradural draining vein, causing compression of the spinal cord and/or nerve roots with myelopathy and/or radiculopathy. Type B2 malformations are also confined to the epidural space with no intradural draining vein and no mass effect, and are asymptomatic. There were 4 Type A spinal extradural AVFs, 3 Type B1s, and 1 Type B2. Onyx was used in all cases for embolization. Follow-up at 6-24 months showed that 4 patients experienced excellent recovery. Three patients with Type A spinal extradural AVFs attained good motor recovery but experienced persistent bladder and/or bowel problems.
The current description of the different types of spinal extradural AVFs can help in understanding their pathophysiology and guide management. DynaCT was found to be useful in understanding the complex anatomy of these lesions. Endovascular treatment with Onyx is a good alternative for spinal extradural AVF management.
Little is currently known about the effects of the coronavirus (COVID-19) pandemic on neurointerventional (NI) procedural volumes or its toll on physician wellness.
A 37-question online survey was ...designed and distributed to physician members of three NI physician organizations.
A total of 151 individual survey responses were obtained. Reduced mechanical thrombectomy procedures compared with pre-pandemic were observed with 32% reporting a greater than 50% reduction in thrombectomy volumes. In concert with most (76%) reporting at least a 25% reduction in non-mechanical thrombectomy urgent NI procedures and a nearly unanimous (96%) cessation of non-urgent elective cases, 68% of physicians reported dramatic reductions (>50%) in overall NI procedural volume compared with pre-pandemic. Increased door-to-puncture times were reported by 79%. COVID-19-positive infections occurred in 1% of physician respondents: an additional 8% quarantined for suspected infection. Sixty-six percent of respondents reported increased career stress, 56% increased personal life/family stress, and 35% increased career burnout. Stress was significantly increased in physicians with COVID-positive family members (P<0.05).
This is the first study designed to understand the effects of the COVID-19 pandemic on NI physician practices, case volumes, compensation, personal/family stresses, and work-related burnout. Future studies examining these factors following the resumption of elective cases and relaxing of social distancing measures will be necessary to better understand these phenomena.
The legislative branch of government took many by surprise when it announced the Medicare Access and CHIP Reauthorization Act of 2015. Once the Act was passed, President Obama quickly signed this ...bipartisan, bicameral effort into law. A foundational element of this legislation was the permanent repeal of the sustainable growth rate formula. Physicians and their patients were appropriately enthusiastic about this development. The Medicare Access and CHIP Reauthorization Act of 2015 included additional elements of considerable interest to neurointerventional specialists.
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