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René Chapot

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DOI: 10.1016/s0140-6736(20)30258-0
2020
Cited 413 times
Efficacy and safety of nerinetide for the treatment of acute ischaemic stroke (ESCAPE-NA1): a multicentre, double-blind, randomised controlled trial
Background Nerinetide, an eicosapeptide that interferes with post-synaptic density protein 95, is a neuroprotectant that is effective in preclinical stroke models of ischaemia-reperfusion. In this trial, we assessed the efficacy and safety of nerinetide in human ischaemia-reperfusion that occurs with rapid endovascular thrombectomy in patients who had an acute ischaemic stroke. Methods For this multicentre, double-blind, randomised, placebo-controlled study done in 48 acute care hospitals in eight countries, we enrolled patients with acute ischaemic stroke due to large vessel occlusion within a 12 h treatment window. Eligible patients were aged 18 years or older with a disabling ischaemic stroke at the time of randomisation, had been functioning independently in the community before the stroke, had an Alberta Stroke Program Early CT Score (ASPECTS) greater than 4, and vascular imaging showing moderate-to-good collateral filling, as determined by multiphase CT angiography. Patients were randomly assigned (1:1) to receive intravenous nerinetide in a single dose of 2·6 mg/kg, up to a maximum dose of 270 mg, on the basis of estimated or actual weight (if known) or saline placebo by use of a real-time, dynamic, internet-based, stratified randomised minimisation procedure. Patients were stratified by intravenous alteplase treatment and declared endovascular device choice. All trial personnel and patients were masked to sequence and treatment allocation. All patients underwent endovascular thrombectomy and received alteplase in usual care when indicated. The primary outcome was a favourable functional outcome 90 days after randomisation, defined as a modified Rankin Scale (mRS) score of 0–2. Secondary outcomes were measures of neurological disability, functional independence in activities of daily living, excellent functional outcome (mRS 0–1), and mortality. The analysis was done in the intention-to-treat population and adjusted for age, sex, baseline National Institutes of Health Stroke Scale score, ASPECTS, occlusion location, site, alteplase use, and declared first device. The safety population included all patients who received any amount of study drug. This trial is registered with ClinicalTrials.gov, NCT02930018. Findings Between March 1, 2017, and Aug 12, 2019, 1105 patients were randomly assigned to receive nerinetide (n=549) or placebo (n=556). 337 (61·4%) of 549 patients with nerinetide and 329 (59·2%) of 556 with placebo achieved an mRS score of 0–2 at 90 days (adjusted risk ratio 1·04, 95% CI 0·96–1·14; p=0·35). Secondary outcomes were similar between groups. We observed evidence of treatment effect modification resulting in inhibition of treatment effect in patients receiving alteplase. Serious adverse events occurred equally between groups. Interpretation Nerinetide did not improve the proportion of patients achieving good clinical outcomes after endovascular thrombectomy compared with patients receiving placebo. Funding Canadian Institutes for Health Research, Alberta Innovates, and NoNO.
DOI: 10.1159/000094831
2006
Cited 381 times
Recommendations for the Management of Intracranial Haemorrhage – Part I: Spontaneous Intracerebral Haemorrhage
This article represents the recommendations for the management of spontaneous intracerebral haemorrhage of the European Stroke Initiative (EUSI). These recommendations are endorsed by the 3 European societies which are represented in the EUSI: the European Stroke Council, the European Neurological Society and the European Federation of Neurological Societies.
DOI: 10.1161/strokeaha.113.001232
2013
Cited 245 times
Prospective, Multicenter, Single-Arm Study of Mechanical Thrombectomy Using Solitaire Flow Restoration in Acute Ischemic Stroke
Background and Purpose— Mechanical thrombectomy using stent retriever devices have been advocated to increase revascularization in intracranial vessel occlusion. We present the results of a large prospective study on the use of the Solitaire Flow Restoration in patients with acute ischemic stroke. Methods— Solitaire Flow Restoration Thrombectomy for Acute Revascularization was an international, multicenter, prospective, single-arm study of Solitaire Flow Restoration thrombectomy in patients with large vessel anterior circulation strokes treated within 8 hours of symptom onset. Strict criteria for site selection were applied. The primary end point was the revascularization rate (thrombolysis in cerebral infarction ≥2b) of the occluded vessel as determined by an independent core laboratory. The secondary end point was the rate of good functional outcome (defined as 90-day modified Rankin scale, 0–2). Results— A total of 202 patients were enrolled across 14 comprehensive stroke centers in Europe, Canada, and Australia. The median age was 72 years, 60% were female patients. The median National Institute of Health Stroke Scale was 17. Most proximal intracranial occlusion was the internal carotid artery in 18%, and the middle cerebral artery in 82%. Successful revascularization was achieved in 79.2% of patients. Device and procedure-related severe adverse events were found in 7.4%. Favorable neurological outcome was found in 57.9%. The mortality rate was 6.9%. Any intracranial hemorrhagic transformation was found in 18.8% of patients, 1.5% were symptomatic. Conclusions— In this single-arm study, treatment with the Solitaire Flow Restoration device in intracranial anterior circulation occlusions results in high rates of revascularization, low risk of clinically relevant procedural complications, and good clinical outcomes in combination with low mortality at 90 days. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01327989.
DOI: 10.1161/strokeaha.120.028956
2020
Cited 216 times
Thrombectomy for Distal, Medium Vessel Occlusions
Endovascular thrombectomy (EVT) is well established as a highly effective treatment for acute ischemic stroke (AIS) due to proximal, large vessel occlusions (PLVOs). With iterative further advances in catheter technology, distal, medium vessel occlusions (DMVOs) are now emerging as a promising next potential EVT frontier. This consensus statement integrates recent epidemiological, anatomic, clinical, imaging, and therapeutic research on DMVO-AIS and provides a framework for further studies. DMVOs cause 25% to 40% of AISs, arising as primary thromboemboli and as unintended consequences of EVT performed for PLVOs, including emboli to new territories (ENTs) and emboli to distal territories (EDTs) within the initially compromised arterial field. The 6 distal medium arterial arbors (anterior cerebral artery [ACA], M2–M4 middle cerebral artery [MCA], posterior cerebral artery [PCA], posterior inferior cerebellar artery [PICA], anterior inferior cerebellar artery [AICA], and superior cerebellar artery [SCA]) typically have 25 anatomic segments and give rise to 34 distinct arterial branches nourishing highly differentiated, largely superficial cerebral neuroanatomical regions. DMVOs produce clinical syndromes that are highly heterogenous but frequently disabling. While intravenous fibrinolytics are more effective for distal than proximal occlusions, they fail to recanalize one-half to two-thirds of DMVOs. Early clinical series using recently available, smaller, more navigable stent retriever and thromboaspiration devices suggest EVT for DMVOs is safe, technically efficacious, and potentially clinically beneficial. Collaborative investigations are desirable to enhance imaging recognition of DMVOs; advance device design and technical efficacy; conduct large registry studies using harmonized, common data elements; and complete formal randomized trials, improving treatment of this frequent mechanism of stroke.
DOI: 10.1159/000446503
2016
Cited 164 times
Aneurysm Study of Pipeline in an Observational Registry (ASPIRe)
<b><i>Background and Objective:</i></b> Few prospective studies exist evaluating the safety and efficacy of the Pipeline Embolization Device (PED) in the treatment of intracranial aneurysms. The Aneurysm Study of Pipeline In an observational Registry (ASPIRe) study prospectively analyzed rates of complete aneurysm occlusion and neurologic adverse events following PED treatment of intracranial aneurysms. <b><i>Materials and Methods:</i></b> We performed a multicenter study prospectively evaluating patients with unruptured intracranial aneurysms treated with PED. Primary outcomes included (1) spontaneous rupture of the Pipeline-treated aneurysm; (2) spontaneous nonaneurysmal intracranial hemorrhage (ICH); (3) acute ischemic stroke; (4) parent artery stenosis, and (5) permanent cranial neuropathy. Secondary endpoints were (1) treatment success and (2) morbidity and mortality at the 6-month follow-up. Vascular imaging was evaluated at an independent core laboratory. <b><i>Results:</i></b> One hundred and ninety-one patients with 207 treated aneurysms were included in this registry. The mean aneurysm size was 14.5 ± 6.9 mm, and the median imaging follow-up was 7.8 months. Twenty-four aneurysms (11.6%) were small, 162 (78.3%) were large and 21 (10.1%) were giant. The median clinical follow-up time was 6.2 months. The neurological morbidity rate was 6.8% (13/191), and the neurological mortality rate was 1.6% (3/191). The combined neurological morbidity/mortality rate was 6.8% (13/191). The most common adverse events were ischemic stroke (4.7%, 9/191) and spontaneous ICH (3.7%, 7/191). The complete occlusion rate at the last follow-up was 74.8% (77/103). <b><i>Conclusions:</i></b> Our prospective postmarket study confirms that PED treatment of aneurysms in a heterogeneous patient population is safe with low rates of neurological morbidity and mortality. Patients with angiographic follow-up had complete occlusion rates of 75% at 8 months.
DOI: 10.1177/1747493016681020
2016
Cited 160 times
e-ASPECTS software is non-inferior to neuroradiologists in applying the ASPECT score to computed tomography scans of acute ischemic stroke patients
Background The Alberta Stroke Program Early Computed Tomography Score (ASPECTS) is an established 10-point quantitative topographic computed tomography scan score to assess early ischemic changes. We performed a non-inferiority trial between the e-ASPECTS software and neuroradiologists in scoring ASPECTS on non-contrast enhanced computed tomography images of acute ischemic stroke patients. Methods In this multicenter study, e-ASPECTS and three independent neuroradiologists retrospectively and blindly assessed baseline non-contrast enhanced computed tomography images of 132 patients with acute anterior circulation ischemic stroke. Follow-up scans served as ground truth to determine the definite area of infarction. Sensitivity, specificity, and accuracy for region- and score-based analysis, receiver-operating characteristic curves, Bland-Altman plots and Matthews correlation coefficients relative to the ground truth were calculated and comparisons were made between neuroradiologists and different pre-specified e-ASPECTS operating points. The non-inferiority margin was set to 10% for both sensitivity and specificity on region-based analysis. Results In total 2640 (132 patients × 20 regions per patient) ASPECTS regions were scored. Mean time from onset to baseline computed tomography was 146 ± 124 min and median NIH Stroke Scale (NIHSS) was 11 (6-17, interquartile range). Median ASPECTS for ground truth on follow-up imaging was 8 (6.5-9, interquartile range). In the region-based analysis, two e-ASPECTS operating points (sensitivity, specificity, and accuracy of 44%, 93%, 87% and 44%, 91%, 85%) were statistically non-inferior to all three neuroradiologists (all p-values <0.003). Both Matthews correlation coefficients for e-ASPECTS were higher (0.36 and 0.34) than those of all neuroradiologists (0.32, 0.31, and 0.3). Conclusions e-ASPECTS was non-inferior to three neuroradiologists in scoring ASPECTS on non-contrast enhanced computed tomography images of acute stroke patients.
DOI: 10.1016/s0140-6736(22)00537-2
2022
Cited 158 times
Thrombectomy alone versus intravenous alteplase plus thrombectomy in patients with stroke: an open-label, blinded-outcome, randomised non-inferiority trial
Whether thrombectomy alone is equally as effective as intravenous alteplase plus thrombectomy remains controversial. We aimed to determine whether thrombectomy alone would be non-inferior to intravenous alteplase plus thrombectomy in patients presenting with acute ischaemic stroke.In this multicentre, randomised, open-label, blinded-outcome trial in Europe and Canada, we recruited patients with stroke due to large vessel occlusion confirmed with CT or magnetic resonance angiography admitted to endovascular centres. Patients were randomly assigned (1:1) via a centralised web server using a deterministic minimisation method to receive stent-retriever thrombectomy alone or intravenous alteplase plus stent-retriever thrombectomy. In both groups, thrombectomy was initiated as fast as possible with any commercially available Solitaire stent-retriever revascularisation device (Medtronic, Irvine, CA, USA). In the combined treatment group, intravenous alteplase (0·9 mg/kg bodyweight, maximum dose 90 mg per patient) was administered as early as possible after randomisation for 60 min with 10% of the calculated dose given as an initial bolus. Personnel assessing the primary outcome were masked to group allocation; patients and treating physicians were not. The primary binary outcome was a score of 2 or less on the modified Rankin scale at 90 days. We assessed the non-inferiority of thrombectomy alone versus intravenous alteplase plus thrombectomy in all randomly assigned and consenting patients using the one-sided lower 95% confidence limit of the Mantel-Haenszel risk difference, with a prespecified non-inferiority margin of 12%. The main safety endpoint was symptomatic intracranial haemorrhage assessed in all randomly assigned and consenting participants. This trial is registered with ClinicalTrials.gov, NCT03192332, and is closed to new participants.Between Nov 29, 2017, and May 7, 2021, 5215 patients were screened and 423 were randomly assigned, of whom 408 (201 thrombectomy alone, 207 intravenous alteplase plus thrombectomy) were included in the primary efficacy analysis. A modified Rankin scale score of 0-2 at 90 days was reached by 114 (57%) of 201 patients assigned to thrombectomy alone and 135 (65%) of 207 patients assigned to intravenous alteplase plus thrombectomy (adjusted risk difference -7·3%, 95% CI -16·6 to 2·1, lower limit of one-sided 95% CI -15·1%, crossing the non-inferiority margin of -12%). Symptomatic intracranial haemorrhage occurred in five (2%) of 201 patients undergoing thrombectomy alone and seven (3%) of 202 patients receiving intravenous alteplase plus thrombectomy (risk difference -1·0%, 95% CI -4·8 to 2·7). Successful reperfusion was less common in patients assigned to thrombectomy alone (182 [91%] of 201 vs 199 [96%] of 207, risk difference -5·1%, 95% CI -10·2 to 0·0, p=0·047).Thrombectomy alone was not shown to be non-inferior to intravenous alteplase plus thrombectomy and resulted in decreased reperfusion rates. These results do not support omitting intravenous alteplase before thrombectomy in eligible patients.Medtronic and University Hospital Bern.
DOI: 10.1161/strokeaha.120.030620
2020
Cited 131 times
Challenging the Ischemic Core Concept in Acute Ischemic Stroke Imaging
Endovascular treatment is a highly effective therapy for acute ischemic stroke due to large vessel occlusion and has recently revolutionized stroke care. Oftentimes, ischemic core extent on baseline imaging is used to determine endovascular treatment-eligibility. There are, however, 3 fundamental issues with the core concept: First, computed tomography and magnetic resonance imaging, which are mostly used in the acute stroke setting, are not able to precisely determine whether and to what extent brain tissue is infarcted (core) or still viable, due to variability in tissue vulnerability, the phenomenon of selective neuronal loss and lack of a reliable gold standard. Second, treatment decision-making in acute stroke is multifactorial, and as such, the relative importance of single variables, including imaging factors, is reduced. Third, there are often discrepancies between core volume and clinical outcome. This review will address the uncertainty in terminology and proposes a direction towards more clarity. This theoretical exercise needs empirical data that clarify the definitions further and prove its value.
DOI: 10.1001/jamaneurol.2019.3403
2020
Cited 112 times
Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke
<h3>Importance</h3> Randomized clinical trials have shown the efficacy of thrombectomy of large intracranial vessel occlusions in adults; however, any association of therapy with clinical outcomes in children is unknown. <h3>Objective</h3> To evaluate the use of endovascular recanalization in pediatric patients with arterial ischemic stroke. <h3>Design, Setting, and Participants</h3> This retrospective, multicenter cohort study, conducted from January 1, 2000, to December 31, 2018, analyzed the databases from 27 stroke centers in Europe and the United States. Included were all pediatric patients (&lt;18 years) with ischemic stroke who underwent endovascular recanalization. Median follow-up time was 16 months. <h3>Exposures</h3> Endovascular recanalization. <h3>Main Outcomes and Measures</h3> The decrease of the Pediatric National Institutes of Health Stroke Scale (PedNIHSS) score from admission to day 7 was the primary outcome (score range: 0 [no deficit] to 34 [maximum deficit]). Secondary clinical outcomes included the modified Rankin scale (mRS) (score range: 0 [no deficit] to 6 [death]) at 6 and 24 months and rate of complications. <h3>Results</h3> Seventy-three children from 27 participating stroke centers were included. Median age was 11.3 years (interquartile range [IQR], 7.0-15.0); 37 patients (51%) were boys, and 36 patients (49%) were girls. Sixty-three children (86%) received treatment for anterior circulation occlusion and 10 patients (14%) received treatment for posterior circulation occlusion; 16 patients (22%) received concomitant intravenous thrombolysis. Neurologic outcome improved from a median PedNIHSS score of 14.0 (IQR, 9.2-20.0) at admission to 4.0 (IQR, 2.0-7.3) at day 7. Median mRS score was 1.0 (IQR, 0-1.6) at 6 months and 1.0 (IQR, 0-1.0) at 24 months. One patient (1%) developed a postinterventional bleeding complication and 4 patients (5%) developed transient peri-interventional vasospasm. The proportion of symptomatic intracerebral hemorrhage events in the HERMES meta-analysis of trials with adults was 2.79 (95% CI, 0.42-6.66) and in Save ChildS was 1.37 (95% CI, 0.03-7.40). <h3>Conclusions and Relevance</h3> The results of this study suggest that the safety profile of thrombectomy in childhood stroke does not differ from the safety profile in randomized clinical trials for adults; most of the treated children had favorable neurologic outcomes. This study may support clinicians’ practice of off-label thrombectomy in childhood stroke in the absence of high-level evidence.
DOI: 10.1001/jamaneurol.2021.0001
2021
Cited 91 times
Thrombectomy for Primary Distal Posterior Cerebral Artery Occlusion Stroke
Clinical evidence of the potential treatment benefit of mechanical thrombectomy for posterior circulation distal, medium vessel occlusion (DMVO) is sparse.To investigate the frequency as well as the clinical and safety outcomes of mechanical thrombectomy for isolated posterior circulation DMVO stroke and to compare them with the outcomes of standard medical treatment with or without intravenous thrombolysis (IVT) in daily clinical practice.This multicenter case-control study analyzed patients who were treated for primary distal occlusion of the posterior cerebral artery (PCA) of the P2 or P3 segment. These patients received mechanical thrombectomy or standard medical treatment (with or without IVT) at 1 of 23 comprehensive stroke centers in Europe, the United States, and Asia between January 1, 2010, and June 30, 2020. All patients who met the inclusion criteria were matched using 1:1 propensity score matching.Mechanical thrombectomy or standard medical treatment with or without IVT.Clinical end point was the improvement of National Institutes of Health Stroke Scale (NIHSS) scores at discharge from baseline. Safety end point was the occurrence of symptomatic intracranial hemorrhage and hemorrhagic complications were classified based on the Second European-Australasian Acute Stroke Study (ECASSII). Functional outcome was evaluated with the modified Rankin Scale (mRS) score at 90-day follow-up.Of 243 patients from all participating centers who met the inclusion criteria, 184 patients were matched. Among these patients, the median (interquartile range [IQR]) age was 74 (62-81) years and 95 (51.6%) were female individuals. Posterior circulation DMVOs were located in the P2 segment of the PCA in 149 patients (81.0%) and in the P3 segment in 35 patients (19.0%). At discharge, the mean NIHSS score decrease was -2.4 points (95% CI, -3.2 to -1.6) in the standard medical treatment cohort and -3.9 points (95% CI, -5.4 to -2.5) in the mechanical thrombectomy cohort, with a mean difference of -1.5 points (95% CI, 3.2 to -0.8; P = .06). Significant treatment effects of mechanical thrombectomy were observed in the subgroup of patients who had higher NIHSS scores on admission of 10 points or higher (mean difference, -5.6; 95% CI, -10.9 to -0.2; P = .04) and in the subgroup of patients without IVT (mean difference, -3.0; 95% CI, -5.0 to -0.9; P = .005). Symptomatic intracranial hemorrhage occurred in 4 of 92 patients (4.3%) in each treatment cohort.This study suggested that, although rarely performed at comprehensive stroke centers, mechanical thrombectomy for posterior circulation DMVO is a safe, and technically feasible treatment option for occlusions of the P2 or P3 segment of the PCA compared with standard medical treatment with or without IVT.
DOI: 10.1148/radiol.2222010432
2002
Cited 177 times
Endovascular Treatment of Cerebral Mycotic Aneurysms
To evaluate the endovascular treatment (EVT) of mycotic aneurysms (MAs).Clinical and radiologic data of 18 MAs treated with EVT were retrospectively reviewed. There were 14 patients (11 men, three women), ranging in age from 28 to 64 (mean age, 44 years). All patients had endocarditis and positive blood culture. The aneurysms were located within the distal cerebral circulation (n = 13) or in the circle of Willis (n = 5). There were 12 ruptured aneurysms and six unruptured aneurysms. Distal or fusiform aneurysms were treated by means of parent vessel occlusion. Proximal saccular aneurysms were selectively treated.Endovascular treatment was successful for all aneurysms. No aneurysm bled after embolization during clinical follow-up. Follow-up angiograms obtained in 11 of 14 patients 6 months to 2 years after the procedures showed stable occlusions. Transient complications occurred in two cases, with worsening of hemiparesis and quadrantanopia. Five patients underwent surgical cardiac valve replacement within 1 week of EVT without neurologic complications. The late clinical outcome was normal neurologic status (n = 9) or permanent disability that was related to the initial stroke (n = 5).EVT is a reliable and safe technique that should be considered at the time of diagnosis of cerebral mycotic aneurysms.
DOI: 10.1097/00005537-199901000-00027
1999
Cited 171 times
Long‐term follow‐up of juvenile nasopharyngeal angiofibromas: Analysis of recurrences
Abstract Objectives : Juvenile nasopharyngeal angiofibroma often recurs if the tumor is large. This report is a long‐term follow‐up of these cases. It establishes the prognostic values of tumor extensions, analyzes the anatomic factors involved in recurrences, describes the spontaneous evolution of remnants based on a radiographic follow‐up, and evaluates the pertinence of complex combined surgical approaches for invasive tumors and the value of complementary endoscopy. Study Design : Retrospective review of 44 cases treated between 1985 and 1996. Methods : Statistical analysis of the correlation between recurrence and tumor extension as evaluated by systematic analysis of 18 putative tumor extensions on preoperative computed tomography scans. Results : Invasion of the skull base affected two‐thirds of the patients, and the rate of recurrence was 27.5%. Extensions to the infratemporal fossa, sphenoid sinus, base of pterygoids and clivus, the cavernous sinus (medial), foramen lacerum, and anterior fossa were correlated with more frequent recurrence. Long‐term radiographic follow‐up revealed putative residual disease in nine asymptomatic patients: these remnants gradually involuted. Conclusions : The data in the current study emphasize the prognostic value of skull base invasion and the difficulty of complete resection of extended lesions. Tumor remnants detected in symptom‐free patients should be kept under surveillance by repeated computed tomography scan, since involution may occur. Recurrent symptoms may be treated by radiotherapy (30 Gy) rather than by extended combined procedures. Endoscopic surgery should be combined with surgery for better control of skull base extensions.
DOI: 10.1161/strokeaha.112.663328
2012
Cited 169 times
Retrospective Multicenter Study of Solitaire FR for Revascularization in the Treatment of Acute Ischemic Stroke
Background and Purpose— The purpose of this study was to evaluate safety and efficacy of the Solitaire FR device in the treatment of patients with acute ischemic stroke secondary to large artery occlusion. Methods— We conducted a retrospective study of consecutive patients presenting with acute ischemic stroke treated with Solitaire FR as the first-line device to restore blood flow in 6 experienced European centers. This study was entirely funded and supported by Coviden Neurovascular. An independent Corelab determined modified Thrombolysis in Cerebral Infarction scores on the preprocedure and postprocedure angiograms. Complete revascularization was defined as modified Thrombolysis in Cerebral Infarction 2b or 3 post-Solitaire FR device use. Symptomatic intracranial hemorrhage was defined as parenchymal hemorrhage Type 2 associated with a decline of ≥4 points in the National Institutes of Health Stroke Scale score within 24 hours or causing death. Favorable functional outcome was considered as modified Rankin Scale score ≤2 at Day 90. Results— We studied 141 patients (mean age, 66 years; median National Institutes of Health Stroke Scale, 18); 74 patients received intravenous tissue-type plasminogen activator before endovascular treatment. Complete revascularization was achieved in 120 of 142 occlusion sites (85%) and good outcome in 77 of 141 (55%) patients. Good outcome was more frequent in patients treated with intravenous tissue-type plasminogen activator than in those without (66% versus 42%; P &lt;0.01). Symptomatic intracranial hemorrhage was reported in 5 patients (4%) and 29 of 141 (20%) patients died or were lost during follow-up (3 cases). Conclusions— This retrospective study with centralized evaluation shows that the use of Solitaire FR is safe and achieves good revascularization rates and functional outcomes in patients with acute ischemic stroke and large artery occlusion.
DOI: 10.1016/j.neurad.2013.10.001
2014
Cited 156 times
The Pressure Cooker Technique for the treatment of brain AVMs
Arteriovenous malformations (AVMs) may be cured by injecting liquid embolic agents such as Onyx. Reflux, however, can sometimes be difficult to control and may jeopardize a complete embolization. The pressure cooker technique (PCT) was designed to create an anti-reflux plug by trapping the detachable part of an Onyx-compatible microcatheter with coils and glue in order to obtain wedge-flow conditions, thereby enabling a better understanding of macrofistulous AVMs and a more comprehensive, forceful and controlled Onyx embolization. The PCT might enlarge the range of AVMs amenable to endovascular cure. Three illustrative cases are presented.
DOI: 10.1017/cbo9780511722073
2007
Cited 150 times
Color Atlas of Vascular Tumors and Vascular Malformations
Hemangiomas and superficial vascular malformations are disfiguring birthmarks that can occur over 65% of a child's body. This atlas will focus on the classification, multidisciplinary approach, recognition and identification, and treatment options for this class of pathology. Vascular malformations, composed of malformed vessels, never regress and sometimes expand rapidly. They occur in any body part including viscera. They cause cosmetic problems, functional disability and can be life threatening and require radiologic imaging and pathology to recognize and perform differential diagnosis on various vascular anomalies. In addition, new techniques, including molecular biology procedures, have evolved allowing less invasive and a more effective approach to diagnosis and treatment.
DOI: 10.1161/strokeaha.114.005050
2014
Cited 136 times
Optimal Workflow and Process-Based Performance Measures for Endovascular Therapy in Acute Ischemic Stroke
We report on workflow and process-based performance measures and their effect on clinical outcome in Solitaire FR Thrombectomy for Acute Revascularization (STAR), a multicenter, prospective, single-arm study of Solitaire FR thrombectomy in large vessel anterior circulation stroke patients.Two hundred two patients were enrolled across 14 centers in Europe, Canada, and Australia. The following time intervals were measured: stroke onset to hospital arrival, hospital arrival to baseline imaging, baseline imaging to groin puncture, groin puncture to first stent deployment, and first stent deployment to reperfusion. Effects of time of day, general anesthesia use, and multimodal imaging on workflow were evaluated. Patient characteristics and workflow processes associated with prolonged interval times and good clinical outcome (90-day modified Rankin score, 0-2) were analyzed.Median times were onset of stroke to hospital arrival, 123 minutes (interquartile range, 163 minutes); hospital arrival to thrombolysis in cerebral infarction (TICI) 2b/3 or final digital subtraction angiography, 133 minutes (interquartile range, 99 minutes); and baseline imaging to groin puncture, 86 minutes (interquartile range, 24 minutes). Time from baseline imaging to puncture was prolonged in patients receiving intravenous tissue-type plasminogen activator (32-minute mean delay) and when magnetic resonance-based imaging at baseline was used (18-minute mean delay). Extracranial carotid disease delayed puncture to first stent deployment time on average by 25 minutes. For each 1-hour increase in stroke onset to final digital subtraction angiography (or TICI 2b/3) time, odds of good clinical outcome decreased by 38%.Interval times in the STAR study reflect current intra-arterial therapy for patients with acute ischemic stroke. Improving workflow metrics can further improve clinical outcome.http://www.clinicaltrials.gov. Unique identifier: NCT01327989.
DOI: 10.1161/strokeaha.117.017208
2017
Cited 116 times
Direct Mechanical Thrombectomy Versus Combined Intravenous and Mechanical Thrombectomy in Large-Artery Anterior Circulation Stroke
Arguments in Favor of Bridging Thrombolysis Early ReperfusionIVT can be started earlier than MT, and in some patients, IV tPA might completely lyse proximal occlusions before MT starts.A recent meta-analysis found a complete recanalization within 3 hours after application of IV tPA in 21% of M1 occlusions, in 38% of M2 occlusions, and in 4% of internal carotid artery (ICA) occlusions. 18However, in clinical practice, recanalization may not occur early enough to obviate the need for subsequent MT.A recent study analyzed early recanalization rates after IVT
DOI: 10.1161/strokeaha.117.020125
2018
Cited 114 times
Primary Results of the Multicenter ARISE II Study (Analysis of Revascularization in Ischemic Stroke With EmboTrap)
EmboTrap is a novel stent retriever designed to achieve rapid and substantial flow restoration in acute ischemic stroke secondary to large-vessel occlusions. Here, we evaluated EmboTrap's safety and efficacy compared with established stent retrievers.ARISE II (Analysis of Revascularization in Ischemic Stroke With EmboTrap) was a single-arm, prospective, multicenter study, comparing the EmboTrap device to a composite performance goal criterion derived using a Bayesian meta-analysis from the pivotal SWIFT (Solitaire device) and TREVO 2 (Trevo device) trials. Patients at 11 US and 8 European sites were eligible for inclusion if they had large-vessel occlusions and moderate-to-severe neurological deficits within 8 hours of symptom onset. The primary efficacy end point was achievement of modified Thrombolysis in Cerebral Ischemia (mTICI) reperfusion scores of ≥2b within 3 EmboTrap passes as adjudicated by the core laboratory. The primary safety end point was a composite of symptomatic intracerebral hemorrhage and serious adverse device effects. Secondary end points included functional independence (modified Rankin Scale, 0-2) and all-cause mortality at 90 days.Between October 2015 and February 2017, 227 patients were enrolled and treated with the EmboTrap device. The primary efficacy end point (mTICI ≥2b within 3 passes) was achieved in 80.2% (95% confidence interval, 74%-85% versus 56% performance goal criterion; P value, <0.0001), and mTICI 2c/3 was 65%. After all interventions, mTICI 2c/3 was achieved in 76%, and mTICI ≥2b was 92.5%. The rate of first pass (mTICI ≥2b following a single pass) was 51.5%. The primary safety end point composite rate of symptomatic intracerebral hemorrhage or serious adverse device effects was 5.3%. Functional independence and all-cause mortality at 90 days were 67% and 9%, respectively.The EmboTrap stent-retriever mechanical thrombectomy device demonstrated high rates of substantial reperfusion and functional independence in patients with acute ischemic stroke secondary to large-vessel occlusions.URL: http://www.clinicaltrials.gov. Unique identifier: NCT02488915.
DOI: 10.1148/radiol.2015150575
2016
Cited 106 times
Comparison of a Balloon Guide Catheter and a Non–Balloon Guide Catheter for Mechanical Thrombectomy
Purpose To evaluate the effectiveness of mechanical thrombectomy with the use of a stent retriever in acute ischemic stroke, performed by using a balloon guide catheter or non–balloon guide catheter. Materials and Methods In accordance with the institutional review board approval obtained at the two participating institutions, retrospective analysis was performed in 183 consecutive patients treated between 2013 and 2014 for occlusions in the middle cerebral artery or carotid terminus by using a stent retriever with a balloon guide catheter (n = 102) at one center and a non–balloon guide catheter (n = 81) at the other center. Data on procedure duration, number of passes, angiographic findings, type of stent retriever used, and expertise of the operators were collected. Successful recanalization was defined as grade 3 or 2b modified Treatment in Cerebral Ischemia recanalization accomplished in up to three passes. Univariate and multivariate subgroup analyses were conducted to control for the confounding variables of prior thrombolysis, location of occlusion, and operator expertise. Results Successful recanalization with the balloon guide catheter was achieved in 89.2% of thrombectomies (91 of 102) versus 67.9% (55 of 81) achieved with the non–balloon guide catheter (P = .0004). The one-pass thrombectomy rate with the balloon guide catheter was significantly higher than for that with the non–balloon guide catheter (63.7% [65 of 102] vs 35.8% [29 of 81], respectively; P = .001). The procedure duration was significantly shorter by using the balloon guide catheter than the non–balloon guide catheter (median, 20.5 minutes vs 41.0 minutes, respectively; P < .0001). Conclusion The effectiveness of mechanical thrombectomy with stent retrievers in acute ischemic stroke in the anterior circulation in terms of angiographic results and procedure duration was improved when performed in combination with the balloon guide catheter. © RSNA, 2016
DOI: 10.1161/strokeaha.113.003798
2014
Cited 98 times
Acute Ischemic Stroke
HomeStrokeVol. 45, No. 2Acute Ischemic Stroke Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplemental MaterialFree AccessResearch ArticlePDF/EPUBAcute Ischemic StrokeTime, Penumbra, and Reperfusion Nathan W. Manning, MBBS, FRANZCR, Bruce C.V. Campbell, MBBS, BMedSc, PhD, FRACP, Thomas J. Oxley, MBBS, BMedSc and René Chapot, MD Nathan W. ManningNathan W. Manning From the Florey Institute of Neuroscience and Mental Health (N.W.M., B.C.V.C., T.J.O.) and Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital (B.C.V.C., T.J.O.), University of Melbourne, Parkville, Australia; and Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany (R.C.). , Bruce C.V. CampbellBruce C.V. Campbell From the Florey Institute of Neuroscience and Mental Health (N.W.M., B.C.V.C., T.J.O.) and Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital (B.C.V.C., T.J.O.), University of Melbourne, Parkville, Australia; and Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany (R.C.). , Thomas J. OxleyThomas J. Oxley From the Florey Institute of Neuroscience and Mental Health (N.W.M., B.C.V.C., T.J.O.) and Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital (B.C.V.C., T.J.O.), University of Melbourne, Parkville, Australia; and Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany (R.C.). and René ChapotRené Chapot From the Florey Institute of Neuroscience and Mental Health (N.W.M., B.C.V.C., T.J.O.) and Department of Medicine and Neurology, Melbourne Brain Centre at the Royal Melbourne Hospital (B.C.V.C., T.J.O.), University of Melbourne, Parkville, Australia; and Department of Intracranial Endovascular Therapy, Alfried-Krupp Krankenhaus Hospital, Essen, Germany (R.C.). Originally published7 Jan 2014https://doi.org/10.1161/STROKEAHA.113.003798Stroke. 2014;45:640–644Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2014: Previous Version 1 IntroductionCurrent guidelines advocate intravenous thrombolysis for patients with ischemic stroke <4.5 hours from onset without additional imaging beyond noncontrast computed tomography (CT) of the brain.1 Rapid administration of intravenous tissue-type plasminogen activator (IV-tPA) will reduce disability. Treatment of patients within 3 hours has an odds ratio of 1.53 (95% confidence interval, 1.26–1.86) for a favorable outcome (modified Rankin scale [mRS], 0–2) at 3 months.2 However, this represents an absolute increase of 9% compared with placebo and is available to a minority of patients with ischemic stroke because of the rigid time constraints.3 Modern stroke imaging grants unprecedented access to the pathophysiology in individual patients with stroke. Time remains of key importance with respect to patient outcomes. However, it is now possible to not only routinely visualize the causative occlusion, but also estimate the ischemic core, the penumbral tissue at risk if reperfusion does not occur, and the state of the collateral blood supply. The current focus of Acute Ischemic Stroke (AIS) intervention should be to achieve reperfusion of the penumbra. Recent trials point to potential avenues to improve patient access by imaging-based patient selection and the importance of rapid and complete reperfusion of the penumbra.Penumbral Imaging for Patient SelectionThree parenchymal vascular states exist in varying proportions in each AIS patient. These are the ischemic core, the penumbra, and a region of benign oligemia.4,5 Separating the penumbra from the ischemic core is of critical importance in guiding stroke therapy. So too is separating the penumbra from the region of benign oligemia. By definition, the penumbra is the region of tissue that is at risk of being recruited into the ischemic core. Thus, the penumbra is the principal target for reperfusion and, therefore, should dictate patient selection. Given the progressive nature of ischemic stroke, establishing the continued existence of the penumbra becomes particularly pertinent in extended time windows. Poor sensitivity or specificity in penumbral selection will lead to patients being inappropriately included for or excluded from therapy with obvious consequences.A key question is to what extent current imaging approaches can accurately achieve this. An association between reperfusion and improved clinical outcome in patients with a penumbral imaging pattern has been demonstrated.6–8 Observational series have demonstrated feasibility of imaging selection for IV-tPA treatment beyond 4.5 hours and suggested reasonable safety.9,10 A small randomized trial successfully used penumbral imaging to demonstrate improved outcomes in patients treated with tenecteplase versus tPA.11 However, there has not yet been a large randomized trial to establish penumbral imaging definitively as an effective means to identify patients who will benefit from a treatment.The noncontrast CT and clinical selection used in traditional IV-tPA trials allow considerable heterogeneity in pathophysiology, which may dilute the apparent effectiveness of treatment. Some patients eligible using these criteria have already reperfused or never had a major vessel occlusion in the first place. These individuals have a high likelihood of good outcome, regardless of treatment. Others have poor collaterals and a large ischemic core at baseline, with no potential benefit from thrombolysis and potentially increased risk of hemorrhagic transformation.12 In addition, tPA has limited success in rapidly recanalizing large-vessel occlusions, even within current time guidelines, further diluting the effect of treatment.13,14The DEFUSE (Diffusion and Perfusion Imaging Evaluation For Understanding Stroke Evolution) study delivered the first sophisticated analysis of the role of perfusion imaging in AIS management.6 Patients with a target mismatch profile showed a substantial effect of reperfusion on clinical outcome (odds ratio, 5.4; P=0.039).6 The Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET)7 of IV-tPA versus placebo also demonstrated a clear association of reperfusion with improved clinical and radiological outcomes in those patients with a target mismatch. Much was learned from these studies, and penumbral criteria were refined, leading to the DEFUSE-2 prospective cohort study in patients undergoing intra-arterial (IA) therapy.8 This trial used a fully automated postprocessing system (RApid processing of PerfusIon and Diffusion [RAPID])15 to accelerate interpretation and improve reproducibility. Patients were treated 3 to 12 hours after symptom onset using IA-tPA and older generation endovascular devices. In this study, patients with a target mismatch who achieved reperfusion had an adjusted odds ratio of 4.0 (95% confidence interval, 1.3–12.2) for good functional outcome. The most exciting result of DEFUSE-2 was that imaging dispensed with time from symptom onset as the principal determinant of success. Mismatch patients treated early (≤6 hours) or late (>6 hours) showed no significant difference in favorable clinical response to reperfusion.8 This suggests that patients who are able to maintain a penumbra longer, presumably relating to good collateral vessels, represent a subpopulation who will benefit the most from reperfusion. A similar finding has also been demonstrated in functional outcomes using CT perfusion–based selection.16 The significance of this time-insensitive patient selection with respect to improving access to therapy for patients presenting beyond the current time limits or with unclear symptom onset cannot be overstated.Recently, the first randomized controlled trial using penumbral imaging before IA therapy has been published, MR-RESCUE (Mechanical Retrieval and Recanalization of Stroke Clots Using Embolectomy).17 Both MRI and CT perfusion were used to screen patients again with automated postprocessing software, RescueOnSite. Disappointingly, MR-RESCUE failed to demonstrate a favorable response to endovascular therapy based on penumbral patterns.17Significant differences in imaging protocols between DEFUSE-2 and MR-RESCUE may explain the contrasting outcomes. Patients in DEFUSE-2 had a median time from imaging to femoral puncture of 42 minutes. A median time from imaging to completion of intervention and therefore reperfusion of 90 minutes was reported. Reperfusion assessment was performed acutely, with median time from baseline MRI to follow-up MRI being 222 minutes.18 In contrast, MR-RESCUE reported a mean time from imaging to femoral puncture of 120 minutes. Unfortunately, no indication of procedure times has been given. The long time delay likely relates, in part, to randomization in MR-RESCUE. However, stroke is a dynamic condition, and penumbral status could have changed significantly during that time delay. Furthermore, reperfusion was not assessed until day 7, by which time spontaneous reperfusion is common but may have occurred too late to save brain.The mismatch criteria used by the RAPID software in DEFUSE-2 were optimized based on DEFUSE6 and EPITHET7 data. In this work, determinants of the ischemic core and penumbra were based on longitudinal MRI studies in the presence or absence of reperfusion. Critically, reperfusion was assessed by perfusion imaging at a relatively early time point.19 Although the analysis was rigorous, the determinants were relatively simple. Ischemic core was defined using MR diffusion (apparent diffusion coefficient <600×10–6 mm2/s). Penumbra was identified using a Tmax >6-second threshold based on analysis of the best baseline perfusion lesion threshold to predict follow-up infarction in patients who did not reperfuse.8 These seemed to be robust on analysis of the DEFUSE-2 data set.18 MR-RESCUE used a remarkably complex multiparametric algorithm to estimate ischemic core that even included baseline National Institutes of Health Stroke Scale (NIHSS) in the case of CT perfusion.20 Maximum core volume for penumbral pattern was 90 mL in contrast to 70 mL in DEFUSE-2, and the penumbra in MR-RESCUE was estimated using Tmax >4 seconds (which generates significantly larger volumes than Tmax >6 seconds). These 2 factors would increase the likelihood of patients being classified as having mismatch in MR-RESCUE versus DEFUSE-2.The primary analysis of DEFUSE-2 was reperfusion versus no reperfusion, whereas in MR-RESCUE it was embolectomy versus standard care. This meant that, although similar endovascular techniques were used in both trials, the low thrombolysis in cerebral infarction (TICI) 2b/3 successful revascularization rate of 27% in MR-RESCUE made it difficult to show benefit of treatment. MR-RESCUE did show trends toward improved functional outcomes in patients who achieved revascularization in both penumbral and nonpenumbral groups, but numbers were too small for detailed statistical comparison. Only 13.6% of patients achieved good functional outcomes (mRS, 0–2) in the absence of revascularization at day 7, all of which were from the penumbral group. In patients achieving revascularization, 28.4% also achieved good functional outcomes. The relatively small difference in good outcome between those with a penumbral pattern versus those without (34% versus 21%)17 suggests that the algorithm used in this trial had only modest success in identifying treatment responders.In both DEFUSE-2 and MR-RESCUE, lack of investigator equipoise seems to be an issue. In DEFUSE-2, an average of 5.1 patients per site per year were enrolled versus 0.8 patients per site per year in MR-RESCUE. In contradistinction to DEFUSE-2, MR-RESCUE had larger initial ischemic core volumes despite a narrower time window (≤8 versus ≤12 hours). The low rate of enrollment and the larger ischemic cores imply that investigators, possibly because of personal convictions about the efficacy of IA therapy, did not randomize patients with smaller cores. Whereas the converse may be true for DEFUSE-2, investigators may have deemed reperfusion futile in patients with larger cores and not enrolled them. In fact, MR-RESCUE penumbral patients had similar cores to nontarget DEFUSE-2 patients (36 versus 45 mL). This likely explains the similarities in the functional outcomes in these 2 apparently contradictory groups (mRS, 0–2; ≈19% in both).6,17The significance of baseline ischemic core volume has only recently been refined.21–23 Current generation trials give this issue considerably greater emphasis (SWIFT-PRIME [ClinicalTrials.gov NCT01657461] <50mL and EXTEND-IA24 [NCT01492725] <70 mL). The results of MR-RESCUE and DEFUSE-2, which at first seem to be contradictory, highlight the significance of ischemic core volume and its importance in patient selection. Furthermore, they highlight the importance of appropriate penumbral selection, particularly in patients treated later. Current trials are in a position to benefit from this experience, and this is reflected in their design.Endovascular Reperfusion TherapyRapid and complete reperfusion is the goal of AIS intervention.25–27 Although the rates of reperfusion achieved with IV-tPA are modest in major vessel occlusion,6,7 particularly compared with more aggressive modern techniques,28,29 it remains the only treatment with proven clinical benefit. The results of Prolyse in Acute Cerebral Thromboembolism Trial II (PROACT II)30 propelled intra-arterial thrombolysis forward and may be responsible for the developments in endovascular intervention today. PROACT II reported marked benefit compared with heparin control with a 15% treatment effect, surpassing even the National Institutes of Neurological Disorders and Stroke (NINDS) trial.31 At the time, it was felt that IA-tPA would lead to significantly improved reperfusion and thus better outcomes. Recently, 2 large multicenter randomized controlled trials have reported results comparing intravenous with IA thrombolysis. Both failed to demonstrate an advantage of an IA approach. These trials highlight the importance of patient selection, the need for speed, and the shortcomings of thrombolysis-based reperfusion.The Italian SYNTHESIS trial32 compared endovascular therapy (the majority of patients receiving IA-tPA) with IV-tPA. It failed to show an advantage of IA compared with IV-tPA (odds ratio, 0.71; 95% confidence interval, 0.44–1.14).32 There was considerable delay in IA treatment (225 versus 165 minutes; P<0.001) and concerns about the intention-to-treat analysis and patient crossover. More significantly, the trial design underestimated the relevance of imaging-based patient selection. Patients were randomized based only on noncontrast CT brain to exclude hemorrhage. Noninvasive angiography was not performed to determine the presence of a vascular occlusion, and the absence of an occlusion on digital subtraction angiography was not a contraindication to IA-tPA. Furthermore, no attempt was made to exclude patients unlikely to have a target lesion clinically. Consequently, patients randomized to endovascular therapy had NIHSS of only 13 (median) with mild strokes (NIHSS as low as 2) included. In PROACT II, there was no significant difference between IA thrombolysis and heparin-treated controls in patients with NIHSS <11.30 The issue is well illustrated by the original SYNTHESIS pilot trial.33 In this study, patients more likely to have a target lesion were enrolled. The NIHSS of endovascular patients was 17 (median), with a range of 7 to 23 indicating exclusion of patients with mild strokes unlikely to have vascular occlusions. In this small study (n=54), 3-month good functional outcomes (mRS, 0–2) were achieved in 56% of patients treated with IA-tPA compared with 31% of those treated with IV-tPA.33 The selection of patients more likely to have a vascular occlusion allows the effect of timely reperfusion to be demonstrated.The Interventional Management of Stroke III study (IMS III)34 tested a bridging approach of IV-tPA followed by IA therapy. The trial was stopped early because it crossed the prespecified boundary for futility. Two major criticisms of IMS III are the delay to endovascular treatment (mean 249 minutes after onset) and that patients were almost exclusively treated with either IA-tPA or older mechanical devices. As was shown for IV tPA,35 in the absence of penumbral imaging, time remains the most critical determinant of success in reperfusion therapy.36 This would be expected to be of even greater significance in an AIS patient population selected based on severity (NIHSS ≥10 or >7 with a defined vessel occlusion).34 Obviously, the critical factor is time to reperfusion rather than time to starting intervention. No direct indication of procedural times is available for IMS III; however, relatively lengthy procedures can be inferred given the use of IA-tPA in 80% of patients. The IMS III protocol allowed for IA-tPA infusions ≤120 minutes, and in DEFUSE-2, the median IA-tPA procedure time was 90 minutes.8 In comparison, in the largest series published on the current-generation stentriever devices, procedure times are reported at 40 minutes (median).28 Furthermore, an endovascular bypass is often achieved, at least temporarily, at the time of first deployment, which was reported at only 26 minutes (median).28IMS III illustrates the absolute importance of quality reperfusion, building on reperfusion data from the previous IMS trials.37 Partial or complete reperfusion (TICI, 2–3) was achieved in 65% of internal carotid artery, 81% of M1, and 70% of M2 occlusions. On the surface, this would seem to compare with success rates using stentrievers.28,38 However, these figures include patients who achieved reperfusion of less than half the affected vascular territory (TICI 2a). If TICI 2a patients are excluded, the IMS III rates of TICI 2b-3 reperfusion are 38% for internal carotid artery, 44% for M1, and 44% for M2 occlusions.34 This effectively halves the quoted reperfusion rate and is in stark contrast to stentrievers that achieve TICI 2b-3 in >75% of patients in less than half the time.28,38The prognostic relevance of quantifying the degree of reperfusion was investigated in DEFUSE-2. In patients with favorable penumbral imaging, the degree of reperfusion, assessed on early follow-up MRI, was divided into quartiles. A strong relationship between favorable clinical response and the degree of reperfusion was seen with rates increasing across each successive quartile: Q1 29%, Q2 44%, Q3 65%, and Q4 94%.8 Similar results were seen on analysis of IMS III reperfusion data.34 The degree of reperfusion (TICI) achieved directly correlated with good functional outcomes at 90 days (Figure). It seems that too few patients achieved quality reperfusion fast enough to save brain. In line with this interpretation, several recent studies have demonstrated that clinical outcomes after TICI 2a align closely with TICI 0 to 1 and that good outcomes usually require TICI 2b or preferably TICI 3.39,40 Subsequently, a recent position statement has recommended that procedures be performed with a view to a minimum reperfusion of TICI 2b.41 The hope for the future is that modern devices may more than double the rate of quality reperfusion in less than half the time.Download figureDownload PowerPointFigure. Rates of good functional outcome (modified Rankin scale [mRS], 0–2) at day 90 stratified by thrombolysis in cerebral infarction (TICI) reperfusion grade. Data derived from IMS-III.Currently, stentrievers are the most appropriate first-line endovascular intervention supported by the literature, with technical results that seem superior to most other techniques and devices.42–45 Recently, stentrievers have been demonstrated to improve functional outcomes compared with either IA-tPA or Merci Retriever.46 This suggests a direct translation from technical success to clinical success. The recent Solitaire Flow Restoration Thrombectomy for Acute Revascularization registry has demonstrated compelling technical success rates.29 Quality reperfusion was achieved, with 79.2% achieving TICI 2b-3 as adjudicated by the core laboratory. Significantly, the majority of these patients achieved TICI 3 reperfusion (54.7%). These results were achieved with a maximum of 3 Solitaire passes and a mean procedure time of 32 minutes from puncture to reperfusion. The importance of shaving off minutes once a patient reaches the site of care has already been well demonstrated for thrombolysis.47,48 Although there was no control group, the 58% rate of mRS 0 to 2, 7% mortality, and 1.5% symptomatic hemorrhage rate are impressive. It compares favorably with a recent study of IV-tPA in a similarly severe stroke population (median NIHSS=17) in which the rate of mRS 0 to 2 was 35%.14 Certainly, this is encouraging for current randomized trials involving stentrievers that use more sophisticated imaging selection strategies.ConclusionsRapid reperfusion of the penumbra should be at the core of all AIS interventions. The highly individualized nature of the pathophysiology in AIS patients and the variability in achieving quality reperfusion among the various noninvasive and invasive interventions are becoming apparent. Technical advances in clot retrieval offer exciting prospects when combined with thoughtful patient selection and highly organized systems of care to expedite therapy. The current generation of randomized trials appear to acknowledge this complexity and will hopefully demonstrate clear advantages to aggressive strategies able to achieve timely, high-quality reperfusion to the ischemic penumbra.DisclosuresDr Campbell, Co-PI EXTEND-IA, received speakers' honoraria from Boehringer Ingelheim and is a consultant for Lundbeck; Dr Chapot is a consultant for Covidien, Microvention, and Balt. The other authors report no conflicts.FootnotesCorrespondence to Nathan Manning, MBBS, FRANZCR, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Grattan St, Parkville, Victoria 3010, Australia. E-mail [email protected]References1. Jauch EC, Saver JL, Adams HP, Bruno A, Connors JJB, Demaerschalk BM, et al. Guidelines for the early management of patients with acute ischemic stroke.Stroke. 2013; 44:870–947.LinkGoogle Scholar2. Wardlaw JM, Murray V, Berge E, del Zoppo G, Sandercock P, Lindley RL, et al. Recombinant tissue plasminogen activator for acute ischaemic stroke.Lancet. 2012; 379:2364–2372.CrossrefMedlineGoogle Scholar3. Donnan GA, Davis SM, Parsons MW, Ma H, Dewey HM, Howells DW. How to make better use of thrombolytic therapy in acute ischemic stroke.Nat Rev Neurol. 2011; 7:400–409.CrossrefMedlineGoogle Scholar4. Astrup J, Siesjö BK, Symon L. Thresholds in cerebral ischemia—the ischemic penumbra.Stroke. 1981; 12:723–725.LinkGoogle Scholar5. Kaufmann AM, Firlik AD, Fukui MB, Wechsler LR, Jungries CA, Yonas H. Ischemic core and penumbra in human stroke.Stroke. 1999; 30:93–99.LinkGoogle Scholar6. Albers GW, Thijs VN, Wechsler L, Kemp S, Schlaug G, Skalabrin E, et al. Magnetic resonance imaging profiles predict clinical response to early reperfusion (DEFUSE).Ann Neurol.2006; 60:508–517.CrossrefMedlineGoogle Scholar7. Davis SM, Donnan GA, Parsons MW, Levi C, Butcher KS, Peeters A, et al. Effects of alteplase beyond 3 h after stroke in the Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET).Lancet Neurol. 2008; 7:299–309.CrossrefMedlineGoogle Scholar8. Lansberg MG, Straka M, Kemp S, Mlynash M, Wechsler LR, Jovin TG, et al. MRI profile and response to endovascular reperfusion after stroke (DEFUSE-2).Lancet Neurol. 2012; 11:860–867.CrossrefMedlineGoogle Scholar9. Thomalla G, Schwark C, Sobesky J, Bluhmki E, Fiebach JB, Fiehler J, et al. Outcome and symptomatic bleeding complications of intravenous thrombolysis within 6 hours in MRI-selected stroke patients.Stroke. 2006; 37:852–858.LinkGoogle Scholar10. Köhrmann M, Jüttler E, Fiebach JB, Huttner HB, Siebert S, Schwark C, et al. MRI versus CT-based thrombolysis treatment within and beyond the 3h time window after stroke onset.Lancet Neurol. 2006; 5:661–667.CrossrefMedlineGoogle Scholar11. Parsons M, Spratt N, Bivard A, Campbell B, Chung K, Miteff F, et al. A randomized trial of tenecteplase versus alteplase for acute ischemic stroke.N Engl J Med. 2012; 366:1099–1107.CrossrefMedlineGoogle Scholar12. Campbell BCV, Christensen S, Butcher KS, Gordon I, Parsons MW, Desmond PM, et al. Regional very low cerebral blood volume predicts hemorrhagic transformation better than DWI volume and thresholded ADC in acute ischemic stroke.Stroke. 2010; 41:82–88.LinkGoogle Scholar13. Porelli S, Leonardi M, Stafa A, Barbara C, Procaccianti G, Simonetti L. CT angiography in an acute stroke protocol: correlation between occlusion site and outcome of intravenous thrombolysis.Interv Neuroradiol. 2013; 19:87–96.CrossrefMedlineGoogle Scholar14. González RG, Furie KL, Goldmacher GV, Smith WS, Kamalian S, Payabvash S, et al. Good outcome rate of 35% in IV-tPA–treated patients with computed tomography angiography confirmed severe anterior circulation occlusive stroke.Stroke. 2013; 44:3109–3113.LinkGoogle Scholar15. Straka M, Albers GW, Bammer R. Real-time diffusion-perfusion mismatch analysis in acute stroke.J Magn Reson Imaging. 2010; 32:1024–1037.CrossrefMedlineGoogle Scholar16. Turk A, Magarik JA, Chaudry I, Turner RD, Nicholas J, Holmstedt CA, et al. CT perfusion-guided patient selection for endovascular treatment of acute ischemic stroke is safe and effective.J Neurointerv Surg. 2012; 4:261–265.CrossrefMedlineGoogle Scholar17. Kidwell CS, Jahan R, Gornbein J, Alger JR, Nenov V, Ajani Z, et al;MR RESCUE Investigators. A trial of imaging selection and endovascular treatment for ischemic stroke.N Engl J Med. 2013; 368:914–923.CrossrefMedlineGoogle Scholar18. Wheeler HM, Mlynash M, Inoue M, Tipirneni A, Liggins J, Zaharchuk G, et al. Early DWI and perfusion-weighted imaging lesion volumes forecast final infarct size in DEFUSE-2.Stroke. 2013; 44:681–685.LinkGoogle Scholar19. Lansberg MG, Lee J, Christensen S, Straka M, De Silva DA, Mlynash M, et al. RAPID automated patient selection for reperfusion therapy.Stroke. 2011; 42:1608–1614.LinkGoogle Scholar20. Kidwell CS, Wintermark M, De Silva DA, Schaewe TJ, Jahan R, Starkman S, et al. Multiparametric MRI and CT models of infarct core and favorable penumbral imaging patterns in acute ischemic stroke.Stroke. 2013; 44:73–79.LinkGoogle Scholar21. Lev MH, Segal AZ, Farkas J, Hossain ST, Putman C, Hunter GJ, et al. Utility of perfusion-weighted CT imaging in acute middle cerebral artery stroke treated with intra-arterial thrombolysis.Stroke. 2001; 32:2021–2028.LinkGoogle Scholar22. Yoo AJ, Verduzco LA, Schaefer PW, Hirsch JA, Rabinov JD, Gonzalez RG. MRI-based selection for intra-arterial stroke therapy.Stroke. 2009; 40:2046–2054.LinkGoogle Scholar23. Parsons MW, Christensen S, McElduff P, Levi CR, Butcher KS, De Silva DA, et al. Pretreatment diffusion-and perfusion-MR lesion volumes have a crucial influence on clinical response to stroke thrombolysis.J Cereb Blood Flow Metab. 2010; 30:1214–1225.CrossrefMedlineGoogle Scholar24. Campbell BCV, Mitchell PJ, Yan B, Parsons MW, Christensen S, Churilov L, et al. A multicenter, randomized, controlled study to investigate EXtending the time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial therapy (EXTEND-IA).Int J Stroke. November 10, 2013. doi: 10.1111/ijs.12206.: http://onlinelibrary.wiley.com/doi/10.1111/ijs.12206/abstract. Accessed November 10, 2013.Google Scholar25. De Silva DA, Fink JN, Christensen S, Ebinger M, Bladin C, Levi CR, et al;Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) Investigators. Assessing reperfusion and recanalization as markers of clinical outcomes after intravenous thrombolysis in the echoplanar imaging thrombolytic evaluation trial (EPITHET).Stroke. 2009; 40:2872–2874.LinkGoogle Scholar26. Soares BP, Chien JD, Wintermark M. MR and CT monitoring of recanalization, reperfusion, and penumbra salvage.Stroke. 2009; 40:S24–S27.LinkGoogle Scholar27. Soares BP, Tong E, Hom J, Cheng S-C, Bredno J, Boussel L, et al. Reperfusion is a more accurate predictor of follow-up infarct volume than recanalization.Stroke. 2010; 41:e34–e40.LinkGoogle Scholar28. Dávalos A, Pereira VM, Chapot R, Bonafé A, Andersson T, Gralla J; Solitaire Group. Retrospective multicenter study of Solitaire FR for revascularization in the treatment of acute ischemic stroke.Stroke. 2012; 43:2699–2705.LinkGoogle Scholar29. Pereira VM, Gralla J, Davalos A, Bonafé A, Castaño C, Chapot R, et al. Prospective, multicenter, single-arm study of mechanical thrombectomy using Solitaire Flow Restoration in acute ischemic stroke.Stroke. 2013; 44:2802–2807.LinkGoogle Scholar30. Furlan A, Higashida R, Wechsler L, Gent M, Rowley H, Kase C, et al. Intra-arterial prourokinase for acute ischemic stroke. The PROACT II study.JAMA. 1999; 282:2003–2011.CrossrefMedlineGoogle Scholar31. NINDS tPA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke.N Engl J Med. 1995; 333:1581–1587.CrossrefMedlineGoogle Scholar32. Ciccone A, Valvassori L, Nichelatti M, Sgoifo A, Ponzio M, Sterzi R, et al;SYNTHESIS Expansion Investigators. Endovascular treatment for acute ischemic stroke.N Engl J Med. 2013; 368:904–913.CrossrefMedlineGoogle Scholar33. Ciccone A, Valvassori L, Ponzio M, Ballabio E, Gasparotti R, Sessa M, et al;SYNTHESIS Investigators. Intra-arterial or intravenous thrombolysis for acute ischemic stroke? The SYNTHESIS pilot trial.J Neurointerv Surg. 2010; 2:74–79.CrossrefMedlineGoogle Scholar34. Broderick JP
DOI: 10.1136/neurintsurg-2015-012236
2016
Cited 95 times
Comparison of outcome and interventional complication rate in patients with acute stroke treated with mechanical thrombectomy with and without bridging thrombolysis
Background No randomized trial has investigated the effect of mechanical thrombectomy (MT) alone in patients with acute stroke. There are conflicting results as to whether prior intravenous thrombolysis (IVT) facilitates subsequent MT, and data in patients treated with MT alone owing to contraindications to IVT are limited. Objective To compare consecutive patients treated with MT alone or with preceding IVT in a large tertiary neurointerventional center, with special emphasis on contraindications to IVT. Methods Retrospective analysis of 283 consecutive patients with acute ischemic stroke treated with MT in a tertiary neurovascular center over 14 months. Data on characteristics of periprocedural times, recanalization rate, complications, and long-term functional outcome were collected prospectively. Results Information on prior IVT and functional outcome was available in 250 patients. Mean (SD) follow-up period was 5.7 (5.1) months and 105 (42%) patients received both IVT and MT. No significant differences were found in successful recanalization rates (Thrombolysis in Cerebral Infarction (TICI) 2b/3, 73.8% vs 73.1, p=0.952), complication rates, and long-term favorable outcome (modified Rankin Scale 0–2, 35.2% vs 40%, p=0.444) between patients receiving MT plus IVT and those receiving MT alone. A favorable outcome in patients directly treated with MT alone who were eligible for IVT was achieved in 48.2%. Thrombectomy was safe and resulted in a favorable outcome in 32% of patients with absolute contraindications to IVT. Conclusions Preceding use of IVT was not an independent predictor of favorable outcome in patients with acute stroke treated with MT and complication rates did not differ whether or not IVT was used. MT is safe and achieved a favorable outcome in one-third of patients with stroke ineligible for IVT.
DOI: 10.1161/strokeaha.116.012619
2016
Cited 87 times
Outcome After Thrombectomy and Intravenous Thrombolysis in Patients With Acute Ischemic Stroke
In patients with ischemic stroke, randomized trials showed a better functional outcome after endovascular therapy with new-generation thrombectomy devices compared with medical treatment, including intravenous thrombolysis. However, effects on mortality and the generalizability of results to routine clinical practice are uncertain.In a prospective observational register-based study patients with ischemic stroke treated either with thrombectomy, intravenous thrombolysis, or their combination were included. Primary outcome was the modified Rankin scale score (0 [no symptoms] to 6 [death]) at 3 months. Ordinal logistic regression was used to estimate the common odds ratio as treatment effects (shift analysis). Propensity score matching was applied to compare patients treated either with intravenous thrombolysis alone or with intravenous thrombolysis plus thrombectomy.Among 2650 recruited patients, 1543 received intravenous thrombolysis, 504 underwent thrombectomy, and 603 received intravenous thrombolysis in combination with thrombectomy. Later time-to-treatment was associated with worse outcomes among patients treated with thrombectomy plus thrombolysis. In 241 pairs of propensity score-matched patients with a proximal intracranial occlusion, thrombectomy plus thrombolysis was associated with improved functional outcome (common odds ratio, 1.84; 95% confidence interval, 1.32-2.57), and reduced mortality (15% versus 33%; P<0.0001) compared with intravenous thrombolysis alone. Results were similar in various sensitivity analyses accounting for missing outcome data and different analytic methods.Results from this large prospective registry show that also in routine clinical care thrombectomy plus thrombolysis compared with thrombolysis alone improved functional outcome and reduced mortality in patients with ischemic stroke. Earlier treatment was associated with better outcomes.
DOI: 10.1161/strokeaha.117.018459
2017
Cited 73 times
Direct Mechanical Intervention Versus Bridging Therapy in Stroke Patients Eligible for Intravenous Thrombolysis
Randomized controlled trials have shown that mechanical thrombectomy (MT) plus best medical treatment improves outcome in stroke patients with large-vessel occlusion in the anterior circulation. Whether direct MT is equally effective as bridging thrombolysis (intravenous thrombolysis plus MT) in intravenous thrombolysis eligible patients remains unclear.We compared clinical and radiological outcomes at 3 months in 249 bridging patients with 111 patients receiving direct MT for large-vessel occlusion anterior circulation stroke from 2 prospective registries (study period Essen: June 2012 to August 2013, Bern February 2009 to August 2014). We matched all patients from the direct MT group who would have qualified for intravenous thrombolysis with controls from the bridging group, using multivariate and propensity score methods. Subgroup analyses for internal carotid artery occlusions were performed.Baseline characteristics did not differ between the direct MT group and bridging cohort, except for higher rates of coronary heart disease (P=0.029) and shorter intervals from onset to endovascular therapy (P<0.001) in the MT group. Functional outcome, mortality, and intracerebral hemorrhage did not differ, neither in univariate nor after multivariate and propensity score matching. However, in patients with internal carotid artery occlusion, mortality in the direct cohort was significantly lower.In this matched-pair analysis, there was no difference in outcome in patients with large-vessel occlusion anterior circulation stroke treated with direct MT compared with those treated with bridging thrombolysis; however, mortality in patients with internal carotid artery occlusion treated with direct MT was significantly lower than after bridging thrombolysis. Randomized trials comparing direct MT with bridging therapy are needed.
DOI: 10.1136/neurintsurg-2018-014204
2018
Cited 70 times
Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up
The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs.The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year.Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment.Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs.NCT02390037.
DOI: 10.1007/s00062-021-01066-6
2021
Cited 69 times
Glue, Onyx, Squid or PHIL? Liquid Embolic Agents for the Embolization of Cerebral Arteriovenous Malformations and Dural Arteriovenous Fistulas
Endovascular embolization is an effective treatment option for cerebral arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs). A variety of liquid embolic agents have been and are currently used for embolization of AVMs and DAVFs. Knowledge of the special properties of the agent which is used is crucial for an effective and safe embolization procedure.This article describes the properties and indications of the liquid embolic agents which are currently available: cyanoacrylates (also called glues), and the copolymers Onyx, Squid and PHIL, as well as their respective subtypes.Cyanoacrylates were the predominantly used agents in the 1980s and 1990s. They are currently still used in specific situations, for example for the occlusion of macro-shunts, for the pressure cooker technique or in cases in which microcatheters are used that are not compatible with dimethyl-sulfoxide. The first broadly used copolymer-based embolic agent Onyx benefits from a large amount of available experience and data, which demonstrated its safety and efficacy in the treatment of cerebral vascular malformations, while its drawbacks include temporary loss of visibility during longer injections and artifacts in cross-sectional imaging. The more recently introduced agents Squid and PHIL aim to overcome these shortcomings and to improve the success rate of endovascular embolization. Novelties of these newer agents with potential advantages include extra-low viscosity versions, more stable visibility, and a lower degree of imaging artifacts.All the available liquid embolic agents feature specific potential advantages and disadvantages over each other. The choice of the most appropriate embolic agent must be made based on the specific material characteristics of the agent, related to the specific anatomical characteristics of the target pathology.
DOI: 10.1136/neurintsurg-2020-017035
2021
Cited 41 times
Effectiveness of very low profile thrombectomy device in primary distal medium vessel occlusion, as rescue therapy after incomplete proximal recanalization or following iatrogenic thromboembolic events
Recent progress with smaller retrievers has expanded the ability to reach distal brain arteries. We herein report recanalization, bleeding complications and short-term clinical outcomes with the smallest currently known low profile thrombectomy device in patients with primary or secondary distal medium vessel occlusion (DMVO).We performed a retrospective analysis of 115 patients receiving mechanical thrombectomy (MT) in DMVO using the extended Thrombolysis in Cerebral Infarction (eTICI), European Cooperative Acute Stroke Study (ECASS) II classification, The National Institutes of Health Stroke Scale (NIHSS) and modified Rankin Scale (mRS) scores at admission and discharge to evaluate outcomes. Patients were stratified into three groups: (1) primary isolated distal occlusion (n=34), (2) secondary distal occlusion after MT of a proximal vessel occlusion (n=71), or (3) during endovascular treatment of aneurysms or arteriovenous malformations (AVMs) (n=10).Successful distal recanalization, defined as an eTICI score of 2b67, 2c and 3, was achieved in 74.7% (86/115) of patients. More specifically, it was 70.5% (24/34), 73.2% (52/71), and 100% (10/10) of primary DMVO, secondary DMVO after proximal MT, and rescue MT during aneurysm or AVM embolization, respectively. Symptomatic intraparenchymal bleeding occurred in 6.9% (eight patients). In-hospital mortality occurred in 18.1% (19/105) of patients with stroke. The most common cause of death was large infarct, old age, and therapy limitation.Direct or rescue MT of DMVO using a very low profile thrombectomy device is associated with a high rate of successful recanalization and a reasonable rate of symptomatic hemorrhagic complication, despite a risk of 18.1% hospital mortality in elderly patients. Further trials are needed to confirm our results and assess long-term clinical outcomes.
DOI: 10.1148/radiol.220229
2023
Cited 15 times
Thrombectomy versus Medical Management for Isolated Anterior Cerebral Artery Stroke: An International Multicenter Registry Study
Background Evidence supporting a potential benefit of thrombectomy for distal medium vessel occlusions (DMVOs) of the anterior cerebral artery (ACA) is, to the knowledge of the authors, unknown. Purpose To compare the clinical and safety outcomes between mechanical thrombectomy (MT) and best medical treatment (BMT) with or without intravenous thrombolysis for primary isolated ACA DMVOs. Materials and Methods Treatment for Primary Medium Vessel Occlusion Stroke, or TOPMOST, is an international, retrospective, multicenter, observational registry of patients treated for DMVO in daily practice. Patients treated with thrombectomy or BMT alone for primary ACA DMVO distal to the A1 segment between January 2013 and October 2021 were analyzed and compared by one-to-one propensity score matching (PSM). Early outcome was measured by the median improvement of National Institutes of Health Stroke Scale (NIHSS) scores at 24 hours. Favorable functional outcome was defined as modified Rankin scale scores of 0-2 at 90 days. Safety was assessed by the occurrence of symptomatic intracerebral hemorrhage and mortality. Results Of 154 patients (median age, 77 years; quartile 1 [Q1] to quartile 3 [Q3], 66-84 years; 80 men; 94 patients with MT; 60 patients with BMT) who met the inclusion criteria, 110 patients (median age, 76 years; Q1-Q3, 67-83 years; 50 men; 55 patients with MT; 55 patients with BMT) were matched. DMVOs were in A2 (82 patients; 53%), A3 (69 patients; 45%), and A3 (three patients; 2%). After PSM, the median 24-hour NIHSS point decrease was -2 (Q1-Q3, -4 to 0) in the thrombectomy and -1 (Q1-Q3, -4 to 1.25) in the BMT cohort (P = .52). Favorable functional outcome (MT vs BMT, 18 of 37 [49%] vs 19 of 39 [49%], respectively; P = .99) and mortality (MT vs BMT, eight of 37 [22%] vs 12 of 39 [31%], respectively; P = .36) were similar in both groups. Symptomatic intracranial hemorrhage occurred in three (2%) of 154 patients. Conclusion Thrombectomy appears to be a safe and technically feasible treatment option for primary isolated anterior cerebral artery occlusions in the A2 and A3 segment with clinical outcomes similar to best medical treatment with and without intravenous thrombolysis. © RSNA, 2023 Supplemental material is available for this article. See also the editorial by Zhu and Wang in this issue.
DOI: 10.1148/radiology.210.3.r99mr40651
1999
Cited 154 times
Percutaneous Gastrostomy with Fluoroscopic Guidance: Single-Center Experience in 500 Consecutive Cancer Patients
To evaluate the feasibility, complications, adequacy of feeding support, and tolerability of fluoroscopically guided gastrostomy in cancer patients.Five hundred cancer patients were referred for fluoroscopically guided gastrostomy, among whom percutaneous endoscopic gastrostomy was contraindicated or had been unsuccessful in approximately one-fourth. Five hundred eight fluoroscopically guided gastrostomies with T-fastener gastropexy were performed in 496 patients. The procedure was unsuccessful in four patients, and 12 patients needed a second gastrostomy.Fluoroscopically guided gastrostomy was feasible in 99% of patients. During the first 30 postprocedure days, there were seven major complications (1.4%): cardiac failure (n = 1), hemorrhage (n = 1), and peritonitis (n = 5); one patient died of peritonitis. No major complications occurred after the 30th postprocedure day. There were 27 minor complications (5.4%) during the first 30 postprocedure days and 88 (17.6%) thereafter. Long-term minor complications mainly involved the disturbances and nearly always resolved once the tube was exchanged. Such exchanges were easily performed under fluoroscopic guidance except in two patients, who required repeat fluoroscopically guided gastrostomy.Fluoroscopically guided gastrostomy is highly feasible and safe and provides adequate feeding support, even when percutaneous endoscopic gastrostomy is impossible. Long-term complications, which are mainly tube disturbances, are easily treated.
DOI: 10.3171/jns.2002.97.2.0280
2002
Cited 135 times
Transcranial approach for venous embolization of dural arteriovenous fistulas
Object. Transvenous embolization is effective in the treatment of an intracranial dural arteriovenous fistula (DAVF). Access to the fistula via the internal jugular vein (IJV) may be limited by associated dural sinus thrombosis; a transcranial approach has been developed for venous embolization in such a situation. The authors report their experiences with the use of a transcranial approach for venous embolization of DAVFs. Methods. Ten patients with DAVFs underwent craniectomy and embolization procedures in which direct sinus puncture was performed. The DAVFs were located inside the dura mater that constituted the walls of the transverse sinus in five cases, the superior sagittal sinus in four cases, and the superior petrosal sinus in one case. All DAVFs drained directly into a sinus with secondary reflux into leptomeningeal veins. In all cases, the fistula could not be accessed from the IJVs. Craniectomy was performed in an operating room and, in seven cases, subsequent enlargement of the craniectomy was required. Sinus catheterization was performed after the patient had been transferred to the angiography room. The DAVFs were embolized using coils only in five patients, glue only in two patients, and both coils and glue in three patients. Angiographic confirmation that embolization of the fistula was successful was obtained in all cases. A transient complication occurred during the first case after sinus catheterization was attempted in the operating room. Conclusions. The transcranial approach allows straightforward access to DAVFs located on superficial dural sinuses that are inaccessible from the IJVs. The effectiveness of this approach is similar to that of the standard retrograde venous approach. The correct location and adequate extent of the craniectomy are essential for success to be achieved using this technique.
DOI: 10.1136/neurintsurg-2016-012896
2017
Cited 65 times
Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study
Background and purpose The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer. Materials and methods The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes. Results Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (&lt;10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period. Conclusions The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods. Clinical trial registration NCT02390037 .
DOI: 10.1007/s00701-017-3154-8
2017
Cited 62 times
European consensus conference on unruptured brain AVMs treatment (Supported by EANS, ESMINT, EGKS, and SINCH)
In December of 2016, a Consensus Conference on unruptured AVM treatment, involving 24 members of the three European societies dealing with the treatment of cerebral AVMs (EANS, ESMINT, and EGKS) was held in Milan, Italy. The panel made the following statements and general recommendations: (1) Brain arteriovenous malformation (AVM) is a complex disease associated with potentially severe natural history; (2) The results of a randomized trial (ARUBA) cannot be applied equally for all unruptured brain arteriovenous malformation (uBAVM) and for all treatment modalities; (3) Considering the multiple treatment modalities available, patients with uBAVMs should be evaluated by an interdisciplinary neurovascular team consisting of neurosurgeons, neurointerventionalists, radiosurgeons, and neurologists experienced in the diagnosis and treatment of brain AVM; (4) Balancing the risk of hemorrhage and the associated restrictions of everyday activities related to untreated unruptured AVMs against the risk of treatment, there are sufficient indications to treat unruptured AVMs grade 1 and 2 (Spetzler–Martin); (5) There may be indications for treating patients with higher grades, based on a case-to-case consensus decision of the experienced team; (6) If treatment is indicated, the primary strategy should be defined by the multidisciplinary team prior to the beginning of the treatment and should aim at complete eradication of the uBAVM; (7) After having considered the pros and cons of a randomized trial vs. a registry, the panel proposed a prospective European Multidisciplinary Registry.
DOI: 10.3174/ajnr.a3855
2014
Cited 59 times
Impact of Age and Baseline NIHSS Scores on Clinical Outcomes in the Mechanical Thrombectomy Using Solitaire FR in Acute Ischemic Stroke Study
Age and stroke severity are inversely correlated with the odds of favorable outcome after ischemic stroke. A previously proposed score for Stroke Prognostication Using Age and NIHSS Stroke Scale (SPAN) indicated that SPAN-100-positive patients (ie, age + NIHSS score = 100 or more) do not benefit from IV-tPA. If this finding holds true for endovascular therapy, this score can impact patient selection for such interventions. This study investigated whether a score combining age and NIHSS score can improve patients' selection for endovascular stroke therapy.The SPAN index was calculated for patients in the prospective Solitaire FR Thrombectomy for Acute Revascularization study: an international single-arm multicenter cohort for anterior circulation stroke treatment by using the Solitaire FR. The proportion with favorable outcome (90-day mRS score ≤2) was compared between SPAN-100-positive versus-negative patients.Of the 202 patients enrolled, 196 had baseline NIHSS scores. Fifteen (7.7%) patients were SPAN-100-positive. There was no difference in the rate of successful reperfusion (Thrombolysis In Cerebral Infarction 2b or 3) between SPAN-100-positive versus -negative groups (93.3% versus 82.8%, respectively; P = .3). Stroke SPAN-100-positive patients had a significantly lower proportion of favorable clinical outcomes (26.7% versus 60.8% in SPAN-100-negative, P = .01). In a multivariable analysis, SPAN-100-positive status was associated with lower odds of favorable outcome (OR, 0.3; 95% CI, 0.1-0.9; P = .04). A higher baseline Alberta Stroke Program Early CT Score and a short onset to revascularization time also predicted favorable outcome in the multivariable analysis.A significantly lower proportion of patients with a positive SPAN-100 achieved favorable outcome in this cohort. SPAN-100 was an independent predictor of favorable outcome after adjusting for time to treatment and the extent of preintervention tissue damage according to the Alberta Stroke Program Early CT Score.
DOI: 10.1136/neurintsurg-2019-014770
2019
Cited 53 times
Periprocedural safety and technical outcomes of the new Silk Vista Baby flow diverter for the treatment of intracranial aneurysms: results from a multicenter experience
Purpose The aim of our study was to assess the technical success and the safety of this new low-profile flow diverter Silk Vista Baby (SVB) by evaluating the intraprocedural and periprocedural complication rate. Material/methods Clinical, procedural, and angiographic data were analyzed. Results: 41 consecutive patients (28 women; age average 50.5 years) with 43 aneurysms were treated with SVB. Aneurysm sizes were classified by their maximum diameter, with an average size of 9.5 mm (range 2–30 mm). Thirty-four cases were unruptured. five aneurysms previously ruptured, had recurrence after the initial coiling. There were two ruptured cases. Aneurysms' locations were: M1 segment (five cases), M2 segment (three cases), M3 segment (one case), middle cerebral artery (MCA) bifurcation (six cases), carotid-T (two cases), anterior communicating artery/A1/A2 (11 cases), pericallosal artery (four cases), supraclinoid ICA (two cases), PCom (one case), V4 segment (three cases), PCA (three cases), SCA (one case), and PICA (one case). We had five intraprocedural complications which resolved without clinical consequences and three events postprocedural events. Initial occlusion rates were: eight aneurysms (18.6%) were completely occluded, five aneurysms (11.6%) showed near-complete occlusion, four cases (9.3%) showed incomplete filling, and 26 cases (60.4%) showed persisting filling. The mRS score at discharge from the hospital did not change from the admission mRS score. Conclusion Our study demonstrated that the use of the new low-profile flow diverter, SVB device, for the treatment of intracranial aneurysms is feasible and technically safe.
DOI: 10.3174/ajnr.a6814
2020
Cited 42 times
Antiplatelet Management for Stent-Assisted Coiling and Flow Diversion of Ruptured Intracranial Aneurysms: A DELPHI Consensus Statement
<h3>BACKGROUND AND PURPOSE:</h3> There is a paucity of data regarding antiplatelet management strategies in the setting of stent-assisted coiling/flow diversion for ruptured intracranial aneurysms. This study aimed to identify current challenges in antiplatelet management during stent-assisted coiling/flow diversion for ruptured intracranial aneurysms and to outline possible antiplatelet management strategies. <h3>MATERIALS AND METHODS:</h3> The modified DELPHI approach with an on-line questionnaire was sent in several iterations to an international, multidisciplinary panel of 15 neurointerventionalists. The first round consisted of open-ended questions, followed by closed-ended questions in the subsequent rounds. Responses were analyzed in an anonymous fashion and summarized in the final manuscript draft. The statement received endorsement from the World Federation of Interventional and Therapeutic Neuroradiology, the Japanese Society for Neuroendovascular Therapy, and the Chinese Neurosurgical Society. <h3>RESULTS:</h3> Data were collected from December 9, 2019, to March 13, 2020. Panel members achieved consensus that platelet function testing may not be necessary and that antiplatelet management for stent-assisted coiling and flow diversion of ruptured intracranial aneurysms can follow the same principles. Preprocedural placement of a ventricular drain was thought to be beneficial in cases with a high risk of hydrocephalus. A periprocedural dual, intravenous, antiplatelet regimen with aspirin and a glycoprotein IIb/IIIa inhibitor was preferred as a standard approach. The panel agreed that intravenous medication can be converted to oral aspirin and an oral P2Y12 inhibitor within 24 hours after the procedure. <h3>CONCLUSIONS:</h3> More and better data on antiplatelet management of patients with ruptured intracranial aneurysms undergoing stent-assisted coiling or flow diversion are urgently needed. Panel members in this DELPHI consensus study preferred a periprocedural dual-antiplatelet regimen with aspirin and a glycoprotein IIb/IIIa inhibitor.
DOI: 10.1136/neurintsurg-2020-015943
2020
Cited 39 times
Periprocedural to 1-year safety and efficacy outcomes with the Pipeline Embolization Device with Shield technology for intracranial aneurysms: a prospective, post-market, multi-center study
Background The first and second generations of the Pipeline Embolization Device (PED) have been widely adopted for the treatment of intracranial aneurysms (IAs) due to their high associated occlusion rates and low morbidity and mortality. The objective of this study was to evaluate the safety and effectiveness of the third- generation Pipeline Shield device (PED-Shield) for the treatment of IAs. Methods The SHIELD study was a prospective, single-arm, multicenter, post-market, observational study evaluating the PED-Shield device for the treatment of IAs. The primary efficacy endpoint was complete aneurysm occlusion without significant parent artery stenosis or retreatment at 1-year post-procedure and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurological death. Results Of 205 subjects who consented across 21 sites, 204 subjects with 204 target aneurysms were ultimately treated (mean age 54.8±12.81 years, 81.4% [166/204] female). Technical success (ie, deployment of the PED-Shield) was achieved in 98.0% (200/204) of subjects with a mean number of 1.1±0.34 devices per subject and a single device used in 86.8% (177/204) of subjects. The primary effectiveness endpoint was met in 71.7% (143/200) of subjects while the primary safety endpoint occurred in six (2.9%) subjects, two (1.0%) of which led to neurological death. Conclusions The findings of the SHIELD study support the safety and effectiveness of the PED-Shield for IA treatment, evidenced by high occlusion rates and low rates of neurological complications in the study population. Clinical trial registration-URL http://www.clinicaltrials.gov . Unique identifier: NCT02719522 .
DOI: 10.1177/17474930211048768
2021
Cited 30 times
SWIFT DIRECT: Solitaire™ With the Intention For Thrombectomy Plus Intravenous t-PA Versus DIRECT Solitaire™ Stent-retriever Thrombectomy in Acute Anterior Circulation Stroke: Methodology of a randomized, controlled, multicentre study
Whether treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in acute ischemic stroke patients with large vessel occlusion is beneficial remains unclear.To determine whether patients experiencing acute ischemic stroke due to occlusion of the intracranial internal carotid artery or the M1 segment of the middle cerebral artery who are referred to an endovascular stroke center and who are candidates for intravenous alteplase will have non-inferior functional outcome at 90 days when treated with MT alone (direct MT) with stent retrievers compared to patients treated with combined intravenous thrombolysis (IVT) with alteplase plus MT (IVT + MT) with stent retrievers.To randomize 404 patients 1:1 to direct MT or combined IVT+MT.A multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial utilizing an adaptive statistical design.The primary efficacy endpoint is functional independence (modified Rankin Scale 0-2) at 90 days. Secondary clinical efficacy outcomes include change in National Institutes of Health Stroke Scale score from baseline to day 1 and health-related quality of life at 90 days. Secondary technical efficacy outcomes include successful reperfusion prior to start of MT and time from randomization to successful reperfusion. Safety outcomes include all serious adverse events, symptomatic intracranial hemorrhage, and mortality up to 90 days.SWIFT DIRECT will inform physicians whether direct MT in acute ischemic stroke patients with large vessel occlusion is equally or more efficacious than combined treatment with intravenous alteplase and MT.ClinicalTrials.gov Identifier: NCT03192332.
DOI: 10.1161/strokeaha.121.037792
2022
Cited 22 times
Aspiration Versus Stent Retriever Thrombectomy for Distal, Medium Vessel Occlusion Stroke in the Posterior Circulation: A Subanalysis of the TOPMOST Study
The optimal endovascular strategy for reperfusing distal medium-vessel occlusions (DMVO) remains unknown. This study evaluates angiographic and clinical outcomes of thrombectomy strategies in DMVO stroke of the posterior circulation.TOPMOST (Treatment for Primary Medium Vessel Occlusion Stroke) is an international, retrospective, multicenter, observational registry of patients treated for DMVO between January 2014 and June 2020. This study analyzed endovascularly treated isolated primary DMVO of the posterior cerebral artery in the P2 and P3 segment. Technical feasibility was evaluated with the first-pass effect defined as a modified Thrombolysis in Cerebral Infarction Scale score of 3. Rates of early neurological improvement and functional modified Rankin Scale scores at 90 days were compared. Safety was assessed by the occurrence of symptomatic intracranial hemorrhage and intervention-related serious adverse events.A total of 141 patients met the inclusion criteria and were treated endovascularly for primary isolated DMVO in the P2 (84.4%, 119) or P3 segment (15.6%, 22) of the posterior cerebral artery. The median age was 75 (IQR, 62-81), and 45.4% (64) were female. The initial reperfusion strategy was aspiration only in 29% (41) and stent retriever in 71% (100), both achieving similar first-pass effect rates of 53.7% (22) and 44% (44; P=0.297), respectively. There were no significant differences in early neurological improvement (aspiration: 64.7% versus stent retriever: 52.2%; P=0.933) and modified Rankin Scale rates (modified Rankin Scale score 0-1, aspiration: 60.5% versus stent retriever 68.6%; P=0.4). In multivariable logistic regression analysis, the time from groin puncture to recanalization was associated with the first-pass effect (adjusted odds ratio, 0.97 [95% CI, 0.95-0.99]; P<0.001) that in turn was associated with early neurological improvement (aOR, 3.27 [95% CI, 1.16-9.21]; P<0.025). Symptomatic intracranial hemorrhage occurred in 2.8% (4) of all cases.Both first-pass aspiration and stent retriever thrombectomy for primary isolated posterior circulation DMVO seem to be safe and technically feasible leading to similar favorable rates of angiographic and clinical outcome.
DOI: 10.1097/01202412-200411000-00001
2004
Cited 103 times
Vascular anomalies and the growth of limbs: a review
Growth of the limb in a child can be impaired, with the coexistence of a vascular malformation. In these vascular bone syndromes, altered growth is manifest as overgrowth or hypotrophy. The vascular malformation is usually complex and gets progressively worse with time. The two types of vascular anomalies in limbs, fast-flow and slow-flow, can be associated with limb length discrepancies. The fast-flow vascular malformations together with arteriovenous fistulae are part of Parkes Weber syndrome, characterized by congenital red cutaneous staining, hypertrophy in girth and increasing of limb length, lymphedema, increasing skin alterations due to a distal vascular steal, and pain, all of which develop during childhood. Treatment is generally conservative. An affected lower extremity can be complicated by pelvic tilting and scoliosis because leg length discrepancy may reach 10 cm. To avoid such a course, stapling epiphysiodesis of the knee cartilages is often performed, but this orthopedic procedure may augment the worsening of the arterial venous malformation in the limb. Therefore, less aggressive orthopedic management is preferable. Slow-flow vascular anomalies associated with limb growth alteration include (1) a diffuse capillary malformation (port-wine stain) with congenital hypertrophy of the involved extremity which is non-progressive; (2) purely venous malformations invading skin, muscles and joints, with pain, functional impairment, a chronic localized intravascular coagulopathy requiring distinctive management, and usually a slight undergrowth of the affected extremity and progressing amyotrophy; (3) the triad of a port-wine stain, anomalous veins and overgrowth of the limb, often known as Klippel–Trenaunay syndrome, which requires orthopedic management to decide the optimal timing for epiphysiodesis (i.e. when leg length discrepancy is >2.5 cm). Varicose veins are sometimes surgically removed after ultrasonographic and Doppler evaluation has confirmed a normal deep venous system. Capillary malformations can be effectively treated with pulsed dye laser, but results are usually poor in distal extremities.
DOI: 10.1161/01.str.32.1.118
2001
Cited 90 times
Carotid Stenting for Radiation-Induced Stenoses
Radiation-induced stenoses of the carotid artery are associated with fibrosis of the arterial layers and tissue planes that renders their surgical treatment difficult. We present our clinical experience in carotid angioplasty stenting (CAS) of patients harboring such stenoses.Seven patients underwent transfemoral CAS of 10 radiation-induced stenoses located on either the common or the internal carotid artery. Six patients presented neurological symptoms. Four patients had undergone previous radical neck dissection, and 3 had permanent tracheostomies. Stenoses were primarily covered with a self-expandable stent before carotid dilation.All interventions were successful, with residual stenoses <20%. No permanent complication occurred. The mean follow-up was 8 months. Patients were symptom free at the last clinical examination, and Doppler control showed no evidence of restenosis.Carotid stenting appears very attractive for such "hostile neck" patients and seems a safe and efficient treatment for radiation-induced stenoses.
DOI: 10.3174/ajnr.a3552
2013
Cited 58 times
Stent Retriever Use for Retrieval of Displaced Microcoils: A Consecutive Case Series
Coil displacement during endovascular coiling procedures may require coil retrieval in the context of flow limitation or thromboembolic risk. No standard recommended method of coil retrieval exists. We present a consecutive series of 14 patients with displaced coil during aneurysm coiling in whom the complication was effectively managed with the use of a stent retriever system. Two illustrative cases from the 14 are described, and technical notes are detailed regarding use of the technique. The use of stent retrievers presents a simple, safe, and effective choice for removal of prolapsed coils during aneurysm coiling.
DOI: 10.3174/ajnr.a4766
2016
Cited 48 times
Training Guidelines for Endovascular Ischemic Stroke Intervention: An International Multi-Society Consensus Document
Ischemic stroke is a leading cause of death and disability worldwide. Much of the long-term disability occurs in patients with Emergent Large Vessel Occlusion (ELVO). In fact, in these patients, occlusion of a major intracerebral artery results in a large area of brain injury often resulting in
2014
Cited 46 times
Acute Ischemic Stroke: Time, Penumbra, and Reperfusion
Current guidelines advocate intravenous thrombolysis for patients with ischemic stroke <4.5 hours from onset without additional imaging beyond noncontrast computed tomography (CT) of the brain.1 Rapid administration of intravenous tissue-type plasminogen activator (IV-tPA) will reduce disability. Treatment of patients within 3 hours has an odds ratio of 1.53 (95% confidence interval, 1.26–1.86) for a favorable outcome (modified Rankin scale [mRS], 0–2) at 3 months.2 However, this represents an absolute increase of 9% compared with placebo and is available to a minority of patients with ischemic stroke because of the rigid time constraints.3 Modern stroke imaging grants unprecedented access to the pathophysiology in individual patients with stroke. Time remains of key importance with respect to patient outcomes. However, it is now possible to not only routinely visualize the causative occlusion, but also estimate the ischemic core, the penumbral tissue at risk if reperfusion does not occur, and the state of the collateral blood supply. The current focus of Acute Ischemic Stroke (AIS) intervention should be to achieve reperfusion of the penumbra. Recent trials point to potential avenues to improve patient access by imaging-based patient selection and the importance of rapid and complete reperfusion of the penumbra. Three parenchymal vascular states exist in varying proportions in each AIS patient. These are the ischemic core, the penumbra, and a region of benign oligemia.4,5 Separating the penumbra from the ischemic core is of critical importance in guiding stroke therapy. So too is separating the penumbra from the region of benign oligemia. By definition, the penumbra is the region of tissue that is at risk of being recruited into the ischemic core. Thus, the penumbra is the principal target for reperfusion and, therefore, should dictate patient selection. Given the progressive nature of ischemic stroke, establishing the continued existence of …
DOI: 10.1161/strokeaha.117.018707
2018
Cited 45 times
Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms
Background and Purpose— Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils. Methods— A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized. Results— Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils—adjusted for rupture status—of 8.4% (95% confidence interval, 0.5–16.2; P =0.036). Adverse and serious adverse events were evenly distributed between groups. Conclusions— Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms. Clinical Trial Registration— URL: https://www.drks.de/drks_web/ . Unique identifier: DRKS00003132.
DOI: 10.3389/fneur.2019.00127
2019
Cited 40 times
Treatment Methods and Early Neurologic Improvement After Endovascular Treatment of Tandem Occlusions in Acute Ischemic Stroke
Background and Purpose: A tandem occlusion of the intracranial circulation and the extracranial carotid artery (ICA) occurs in 10-20% of all strokes based on large vessel occlusion (LVO). The optimal treatment strategy for those patients is unknown. We report our management strategy and the outcome in these patients in a large single-center cohort. Materials and Methods: We retrospectively analyzed all patients treated by Mechanical Thrombectomy (MT) for an intracranial LVO associated to an occlusion of the extracranial ICA between April 2009 and May 2016. The following data were collected: Recanalization rate (mTICI IIb and III), clinical result including early neurological improvement (ENI, NIHSS score improvement of ≥ 8 points after 24 hours or NIHSS score of 0 or 1 after 3 days) and functional outcome during long term follow up. Secondary endpoints were the patency of the internal carotid artery at 24 hours and the rate of symptomatic hemorrhage. Patient demographics and antiaggregation regimen were recorded as co-variables. Results: 163/1645 (9.9%) MT patients had a tandem occlusion. All thrombectomy procedures were performed with stent retrievers. PTA without additional placement of a stent was achieved in 14 patients, additional placement of a stent was achieved in 149 patients. The overall rate of mTICI IIB/III recanalization was 91.4%. An early neurological improvement was found in 79 of 163 patients (48.4%), respectively 51% (76/149) and 21% (3/14) in the Stent vs non Stent group. 120/163 patients (73.6 %) had a late favorable outcome (mRS 0-2). The ICA reocclusion rate at 24 hours was respectively 5.4 % (8/149) and 42% (6/14) in the Stent vs non Stent group. The rate of symptomatic hemorrhage was 4.9%. Younger age (p=0.002) and shorter recanalization times (p=0.017) were associated with good outcome. Conclusion: Stent-PTA of the ICA in addition to MT with a stent retriever was safe and effective in tandem occlusion of the anterior brain circulation. PTA and MT without stenting in tandem lesions showed a higher early re-occlusion rate and lower rate of early neurological improvement. The technical approach should aim the fastest possible recanalization of the intracranial vessels, either with stenting first or last.
DOI: 10.1159/000445449
2016
Cited 39 times
Endovascular Stroke Management: Key Elements of Success
&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; In the last 12 months, treatment of acute ischaemic stroke secondary to large vessel occlusion has undergone a paradigm shift. The success of endovascular surgery, and in particular, the use of stent-retrievers, is remarkable. &lt;b&gt;&lt;i&gt;Summary:&lt;/i&gt;&lt;/b&gt; Beyond percentages and p values, the endovascular trials demonstrated, in their similarities and their differences, the critical elements of successful intervention in acute ischaemic stroke. Patient selection based on non-invasive neuroimaging has emerged as a critical step in acute ischaemic stroke management. The more sophisticated imaging-based selection, those assessing collateral blood flow or ischaemic penumbra appear to be associated with better outcomes and possibly fewer complications. The importance of achieving effective, quality reperfusion is also demonstrated, in a remarkably linear fashion, across the 5 published trials. This may emerge as the single most important determinant of functional outcomes. While reperfusion may succeed time as the preeminent modifiable variable, it remains clear that achieving quality reperfusion in a timely manner should remain the goal of all acute stroke programs. &lt;b&gt;&lt;i&gt;Key Message:&lt;/i&gt;&lt;/b&gt; Comparing the recent successful endovascular stroke trials, both between one another, and to their unsuccessful predecessors, emphasizes the importance of patient selection, time and reperfusion. Highlighting these factors allows for a better understanding of the challenges facing clinicians and the changes required to be made in hospital systems in order to achieve a new standard of care in treating acute ischaemic stroke.
DOI: 10.1136/neurintsurg-2020-016566
2020
Cited 37 times
The transvenous retrograde pressure cooker technique for the curative embolization of high-grade brain arteriovenous malformations
Background Transvenous embolization of brain arteriovenous malformations (AVMs) can be curative. We aimed to evaluate the cure rate and safety of the transvenous retrograde pressure cooker technique (RPCT) using coils and n-butyl-2-cyanoacrylate as a venous plug. Methods All AVM patients treated via transvenous embolization between December 2004 and February 2017 in a single center were extracted from our database. Inclusion criteria were: inability to achieve transarterial cure alone; AVM &lt; 3 cm; and single main draining vein. Outcome measures were immediate and 90 days' angiographic AVM occlusion rate, and morbidity and mortality at 30 days and 12 months, according to the modified Rankin Scale (mRS) score. Results Fifty-one patients (20 women; median age 47 years) were included. A majority (71%) were high grade (3 to 5 in the Spetzler–Martin classification). AVMs were deeply seated in 30 (59%) and cortical in 21 patients (41%). Thirty-three patients were previously embolized transarterially (65%). All patients but one were cured within a single session with the RPCT (96%). Cure was confirmed on follow-up digital subtraction angiography at 3 months in 82% of patients. Three patients experienced intracranial hemorrhage (6%), one requiring surgical evacuation. There were no deaths. One treatment-related major permanent deficit was observed (2.0%). Mean mRS before treatment, at 30 days, and 12 months after RPCT was 1.5, 1.5, and 1.3, respectively. Conclusions The retrograde pressure cooker technique can be curative in carefully selected high-grade AVMs. Long-term follow-up and prospective studies are needed to confirm our results.
DOI: 10.1161/jaha.119.012795
2020
Cited 34 times
Emergency Intracranial Stenting in Acute Stroke: Predictors for Poor Outcome and for Complications
Background Stent‐retriever thrombectomy is the first‐line therapy in acute stroke with intracranial large vessel occlusion. In case of failure of stent‐retriever thrombectomy, rescue stent angioplasty might be the only treatment option to achieve permanent recanalization. This study aims at identifying predictors for poor outcome and complications in a large, multicenter cohort receiving rescue stent angioplasty. Methods and Results We performed a retrospective analysis of patients with large vessel occlusion who were treated with rescue stent angioplasty after stent‐retriever thrombectomy between 2012 and 2018 in 7 neurovascular centers. We defined 2 binary outcomes: (1) functional clinical outcome (good modified Rankin Scale, 0–2; and poor modified Rankin Scale, 4–6) and (2) early symptomatic intracerebral hemorrhage. Impacts of clinical, radiological, and interventional parameters on outcomewere assessed in uni‐ and multivariable logistic regression models. Two hundred ten patients were included with target vessels located within the anterior circulation (136 of 210; 64.8%) and posterior circulation (74 of 210; 35.2%). Symptomatic intracerebral hemorrhage occured in 22 patients, 86.4% (19 of 22) after anterior and 13.6% (3 of 22) after posterior circulation large vessel occlusion. Good functional outcome was observed in 44.8% (73 of 163). A higher National Institutes of Health Stroke Scale on admission (adjusted odds ratio, 1.10; P= 0.002), a higher premorbid modified Rankin Scale (adjusted odds ratio, 2.02; P =0.049), and a modified Thrombolysis in Cerebral Infarction score of 0 to 2a after stenting (adjusted odds ratio, 23.24; P &lt;0.001) were independent predictors of poor functional outcome. Conclusions Use of rescue stent angioplasty can be considered for acute intracranial large vessel occlusion in cases after unsuccessful stent‐retriever thrombectomy. Likelihood of symptomatic intracerebral hemorrhage is higher in anterior circulation stroke.
DOI: 10.1136/neurintsurg-2020-016115
2020
Cited 34 times
First clinical multicenter experience with the new Scepter Mini microballoon catheter
Background Balloon-assisted techniques can improve the endovascular treatment of cerebrospinal vascular malformations. The aim of this study was to report the first clinical multicenter experience with the new Scepter Mini dual-lumen microballoon catheter. Methods Patients with cerebral or spinal vascular malformations treated with the Scepter Mini at seven European neurovascular centers were retrospectively reviewed. Clinical data, angiographic features of the vascular malformations, procedural parameters including the type of application, navigability, technical failures, complications and embolization success were assessed. Results The usage of 34 Scepter Mini microballoon catheters in 20 patients was analyzed. Most treated malformations (80.0%) were cerebral arteriovenous malformations. Four different applications were reported: embolization via Scepter Mini (n=23, 67.6%), balloon-occlusion with simultaneous embolization via a second microcatheter (n=3, 8.8%), diagnostic angiography with simultaneous balloon-inflation for flow arrest (n=4, 11.8%), and navigation support (n=4, 11.8%). The mean diameter of the blood vessels in which the Scepter Mini was inflated was 1.9±0.5 mm. The navigability of the Scepter Mini was rated as ‘easy’ or ‘very easy’ in 88.2% of cases. Complete occlusion of the malformation was achieved in 60.9% of cases. Technical failures occurred in 4/23 embolization procedures, and all were related to insufficient stability of the balloon within the vessel. No complications related to the Scepter Mini were observed, while unrelated complications occurred in three patients (15.0%). Conclusions The Scepter Mini is a promising new device for balloon-assisted embolization of cerebrospinal vascular malformations via small feeders. Beyond embolization, the Scepter Mini can also be used for other applications, such as superselective flow arrest and navigation support.
DOI: 10.3171/2019.9.jns191733
2021
Cited 26 times
Long-term outcomes of wide-necked intracranial bifurcation aneurysms treated with T-stent–assisted coiling
The endovascular treatment of complex bifurcation aneurysms possessing a neck that incorporates multiple side branches remains a surgical challenge. Double-stent-assisted coiling techniques, such as those with stents in an X and Y configuration, enable the endovascular treatment of wide-necked complex intracranial bifurcation aneurysms. However, the intraluminal struts at the intersection point in X- and Y-stents are not amenable to endothelialization, which may lead to thromboembolic complications. Stenting in the T configuration is a relatively new double-stent coiling technique. T-stenting differs from X- or Y-stenting in that there are no overlapping or intersecting stent segments. Promising short-term results of T-stent-assisted coiling were recently reported. However, the long-term results have not yet been demonstrated. This retrospective study investigated the long-term angiographic and clinical results in patients with wide-necked complex intracranial bifurcation aneurysms treated with T-stent-assisted coiling.A retrospective review was performed to identify patients with wide-necked complex intracranial bifurcation aneurysms treated with T-stent-assisted coiling at 4 institutions. The technical success and the initial and follow-up clinical and angiographic outcomes were assessed. Aneurysm filling status was assessed according to the Raymond classification. Periprocedural and delayed complications were reviewed. The neurological status of the patients was evaluated using the modified Rankin Scale (mRS).One hundred two aneurysms in 102 patients (54 females), whose mean age was 57.9 ± 13.0 years, were included in the study. T-stenting was performed successfully in all patients. Immediate postprocedural angiography revealed complete occlusion in 83.3% of patients. Periprocedural complications developed in 13.7%, resulting in permanent morbidity in 1.9% and death in 1%. Eighty patients (78.4%) had at least one follow-up DSA examination performed at 6 months or later following the endovascular procedure. The mean duration of angiographic follow-up was 30.0 ± 16.3 months. The last follow-up examinations showed complete occlusion in 90.0% of patients. During the follow-up period, only 1 patient (1.3%) required retreatment. Delayed thromboembolic complications were observed in 4 patients (3.9%) without permanent morbidity. The mRS scores of all patients at the last clinical follow-up were between 0 and 2.The short-term angiographic findings showed that T-stent-assisted coiling is a feasible and effective endovascular method to treat wide-necked complex bifurcation aneurysms. The long-term angiographic follow-up results suggest that T-stent-assisted coiling provides a durable treatment for wide-necked complex bifurcation aneurysms with favorable clinical outcomes, demonstrating the long-term safety of T-stent-assisted coiling.
DOI: 10.1001/archotol.132.1.86
2006
Cited 60 times
Aberrant Internal Carotid Artery in the Temporal Bone
To describe the clinical and radiological features of the vascular anomaly aberrant internal carotid artery (ICA) in the temporal bone and to discuss management strategies.Retrospective study.Sixteen cases of aberrant ICA were diagnosed between 1982 and 2003.Of 16 cases, 11 were recognized by imaging assessment, 4 were recognized during middle ear surgery, and 1 was recognized clinically. Among the 11 cases, 8 malformations were diagnosed because of otologic symptoms related to the abnormal ICA or chronic otitis, while the other 3 were identified incidentally because of an underlying accompanying disease. In 4 cases, the diagnosis was made during surgery related to chronic otitis media (n = 2) or conductive hearing loss (n = 2). In these 4 cases, massive bleeding resulted from surgical injury to the vessel. Packing the external auditory canal and the middle ear first controlled the bleeding. Endovascular procedure was required in 2 cases to exclude an aneurysm or to control bleeding but was followed by anterior cerebral stroke in 1 case. The aberrant ICA could be identified on computed tomographic scan by the following features: intratympanic mass, enlarged inferior tympanic canaliculus, absence of the vertical segment of the ICA canal, and absence of bone covering the tympanic portion of the ICA. Conventional angiography was mandatory when intervention was planned to control bleeding or aneurysm.This study highlights that aberrant ICA has to be identified before any middle ear surgery because misdiagnosis may lead to dramatic surgical complications, whereas diagnosis with computed tomographic scan is easy. Bleeding is a minor complication compared with the putative neurologic deficit due to endovascular occlusion.
DOI: 10.1007/s10792-012-9550-4
2012
Cited 42 times
Ophthalmologic outcome of direct and indirect carotid cavernous fistulas
DOI: 10.3174/ajnr.a5037
2016
Cited 36 times
Embolization of Intracranial Dural Arteriovenous Fistulas Using PHIL Liquid Embolic Agent in 26 Patients: A Multicenter Study
<h3>BACKGROUND AND PURPOSE:</h3> The introduction of liquid embolic agents has revolutionized endovascular approach to cranial vascular malformations. The aim of the study was to retrospectively assess the efficacy and safety of Precipitating Hydrophobic Injectable Liquid (PHIL), a new nonadhesive liquid embolic agent, in the treatment of patients with cranial dural arteriovenous fistulas. The primary end point was the rate of complete occlusion of dural arteriovenous fistulas. Secondary end points included the incidence of adverse events and clinical status at 3-month follow-up. <h3>MATERIALS AND METHODS:</h3> This was a retrospective multicenter study. Twenty-six consecutive patients with dural arteriovenous fistulas (de novo or previously treated) treated by injection of PHIL only or with PHIL in combination with other embolization products (such as Onyx or detachable coils) were included in the study. Recruitment started in August 2014 and ended in September 2015. <h3>RESULTS:</h3> Twenty-two (85%) patients were treated with PHIL only, with 3 patients treated with both PHIL and Onyx, and 1, with both PHIL and coils. Immediate complete angiographic occlusion was achieved in 20 (77%) patients. Of the 6 patients with residual fistulas, 3 were retreated with PHIL and 1 achieved angiographic cure. An adverse event was seen in 1 patient who developed worsening of preexisting ataxia due to acute thrombosis of the draining vein. <h3>CONCLUSIONS:</h3> PHIL appears to be safe and effective for endovascular treatment of cranial dural arteriovenous fistulas. Short-term angiographic and clinical results are comparable with those of Onyx, with the added advantage of easier preparation and improved homogeneous cast visualization. The use of iodine as a radio-opacifier also produces considerably less artifacts on CT compared with tantalum-based embolic materials.
DOI: 10.23736/s0390-5616.18.04421-1
2018
Cited 34 times
Contemporary endovascular techniques for the curative treatment of cerebral arteriovenous malformations and review of neurointerventional outcomes
Since the first landmark randomized trials on unruptured bAVMs were published, there has been emerging concerns about the role of endovascular therapy. For bAVMs considered inoperable, embolization remains an option worth considering, especially in young patients presenting with a rupture. We aimed to review the curative potential of contemporary stand-alone embolization techniques enabling high occlusion rates and their respective short and long term safety profile.We performed a PubMed search with the terms "curative embolization of brain arteriovenous malformations" and "endovascular cure of brain arteriovenous malformations" focusing on the last ten years (2008-2018) and compliant to the PRISMA reporting guidelines. We then screened the prospective and retrospective studies of pediatric or adult populations that contained patient demographics, ruptured or unruptured presentation, and bAVM grade according to the Spetzler-Martin (SM) classification, exclusive or stand-alone endovascular treatment without previous embolization, micro-, radio- or stereotactic surgery, number of sessions, type of access, technique(s) and embolic agents used, rate of angiographically confirmed complete occlusion at least 3 months after obliteration stratified by AVM grade or subtype, as well as neurological status and treatment-associated outcome based on the modified Rankin scale at admission, discharge and within 12 months following curative embolization, rated by an independent observer.Given the heterogeneity of the reported data, multiple confounding factors, overwhelming number of unpowered studies, lack of homogenous control groups and poor compliance to PRISMA reporting guidelines in most of the interventional literature, we were unable to obtain solid data and perform a statistical meta-analysis on the safety and effectiveness of curative embolization. Consequently, we decided to cover a selection of salient topics.Stand-alone curative embolization, as well as exclusive microsurgery or radiosurgery each play complementary roles. Hemorrhagic, deep-seated lesions are an interesting subtype of surgically unfavorable bAVMs that may benefit from exclusive transvenous embolization, when carefully selected. Larger randomized trials and prospective registries are needed to establish the place of stand-alone or neoadjuvant endovascular treatment.
DOI: 10.1212/wnl.0000000000011107
2021
Cited 22 times
Clinical Diffusion Mismatch to Select Pediatric Patients for Embolectomy 6 to 24 Hours After Stroke
To determine whether thrombectomy is safe in children up to 24 hours after onset of symptoms when selected by mismatch between clinical deficit and infarct.A secondary analysis of the Save ChildS Study (January 2000-December 2018) was performed, including all pediatric patients (<18 years) diagnosed with arterial ischemic stroke who underwent endovascular recanalization at 27 European and United States stroke centers. Patients were included if they had a relevant mismatch between clinical deficit and infarct.Twenty children with a median age of 10.5 (interquartile range [IQR] 7-14.6) years were included. Of those, 7 were male (35%), and median time from onset to thrombectomy was 9.8 (IQR 7.8-16.2) hours. Neurologic outcome improved from a median Pediatric NIH Stroke Scale score of 12.0 (IQR 8.8-20.3) at admission to 2.0 (IQR 1.2-6.8) at day 7. Median modified Rankin Scale (mRS) score was 1.0 (IQR 0-1.6) at 3 months and 0.0 (IQR 0-1.0) at 24 months. One patient developed transient peri-interventional vasospasm; no other complications were observed. A comparison of the mRS score to the mRS score in the DAWN and DEFUSE 3 trials revealed a higher proportion of good outcomes in the pediatric compared to the adult study population.Thrombectomy in pediatric ischemic stroke in an extended time window of up to 24 hours after onset of symptoms seems safe and neurologic outcomes are generally good if patients are selected by a mismatch between clinical deficit and infarct.This study provides Class IV evidence that for children with acute ischemic stroke with a mismatch between clinical deficit and infarct size, thrombectomy is safe.
DOI: 10.1186/s12883-022-02707-0
2022
Cited 12 times
Stroke-derived neutrophils demonstrate higher formation potential and impaired resolution of CD66b + driven neutrophil extracellular traps
Abstract Background Recent evidence suggests a merging role of immunothrombosis in the formation of arterial thrombosis. Our study aims to investigate its relevance in stroke patients. Methods We compared the peripheral immunological profile of stroke patients vs. healthy controls. Serum samples were functionally analyzed for their formation and clearance of Neutrophil-Extracellular-Traps. The composition of retrieved thrombi has been immunologically analyzed. Results Peripheral blood of stroke patients showed significantly elevated levels of DNAse-I ( p &lt; 0.001), LDG ( p = 0.003), CD4 ( p = 0.005) as well as the pro-inflammatory cytokines IL-17 ( p &lt; 0.001), INF-γ ( p &lt; 0.001) and IL-22 ( p &lt; 0.001) compared to controls, reflecting a T H 1/T H 17 response. Increased counts of DNAse-I in sera ( p = 0.045) and Neutrophil-Extracellular-Traps in thrombi ( p = 0.032) have been observed in patients with onset time of symptoms longer than 4,5 h. Lower values of CD66b in thrombi were independently associated with greater improvement of NIHSS after mechanical thrombectomy ( p = 0.045). Stroke-derived neutrophils show higher potential for Neutrophil-Extracellular-Traps formation after stimulation and worse resolution under DNAse-I treatment compared to neutrophils derived from healthy individuals. Conclusions Our data provide new insight in the role of activated neutrophils and Neutrophil-Extracellular-Traps in ischemic stroke. Future larger studies are warranted to further investigate the role of immunothrombosis in the cascades of stroke. Trial registration DRKS, DRKS00013278, Registered 15 November 2017, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&amp;TRIAL_ID=DRKS00013278
DOI: 10.1002/1531-8249(200010)48:4<669::aid-ana16>3.0.co;2-6
2000
Cited 70 times
Aneurysm of a dural sigmoid sinus: A novel vascular cause of pulsatile tinnitus
We report a newly evidenced cause of venous pulsatile tinnitus—the aneurysm of a dural sigmoid sinus. A 33-year-old patient presented with an incapacitating pulsatile tinnitus of 6 months' duration in the left ear. The radiological workup evidenced an aneurysm of the left sigmoid sinus. Selective endovascular coil occlusion of the aneurysm was followed by complete resolution of the tinnitus. Ann Neurol 2000;48:669–671
DOI: 10.1097/01.rvi.0000124952.24134.8b
2004
Cited 64 times
Location of Vessel Occlusion of Calibrated Tris-acryl Gelatin Microspheres for Tumor and Arteriovenous Malformation Embolization
To evaluate (i). the presence and number of calibrated tris-acryl gelatin microspheres (TGMS) in targeted organs after embolization of tumors or arteriovenous malformations (AVMs) and (ii). the possible correlations among the size of TGMS used for embolization, the size of TGMS found in specimens, and the size of the occluded vessels.Histologic slides were reviewed of 92 specimens from 80 patients with primarily head and neck tumors or AVMs operatively treated after embolization with TGMS of various sizes (40-120 microm, 100-300 microm, 300-500 microm, 500-700 microm, 700-900 microm, and 900-1200 microm). The diameters of the vessels containing TGMS, the size of TGMS, and the thickness of the inflammatory reactions developed around them were measured, and the location of the microspheres was recorded.TGMS were found in 88% of the specimens; 1985 embolized vessels containing TGMS were analyzed. The median number of TGMS per vessel was one (mean +/- SD, 3.1 +/- 6.9). The diameter of the occluded vessels increased significantly (P <.0001) with increased size of TGMS used for embolization. In tumors, 92% of the occluded vessels were located inside the tumor.There is an obvious correspondence between the size of the TGMS used for embolization and the diameter of the occluded vessels. This correlation confirms the possibility that the vessels to be occluded can be precisely targeted with the use of a proper TGMS size range.
DOI: 10.1007/s00234-016-1693-y
2016
Cited 30 times
GREAT—a randomized controlled trial comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment: procedural safety and core-lab-assessedangiographic results
Hybrid hydrogel-platinum coils (HydroCoil) have proven effective for endovascular aneurysm treatment. To overcome technical limitations (coil stiffness, time restriction for placement), a second generation of softer hydrogel coils has been brought to clinical practice (HydroSoft, HydroFrame). We report on procedural safety and core-lab-assessed angiographic results from an open-label multicenter randomized controlled trial. Web-based randomization occurred in 15 medical centers in France and seven in Germany between coil embolization with second-generation hydrogel coils and treatment with any bare platinum coil. Assist devices could be used as clinically required. Primary endpoint is a composite outcome including major aneurysm recurrence and poor clinical outcome at 18 months follow-up. Five hundred thirteen patients were randomized (hydrogel n = 256, bare platinum n = 257). Twenty patients were excluded for missing informed consent and nine patients for treatment related criteria. Four hundred eighty-four patients were analyzed as randomized (hydrogel n = 243, bare platinum n = 241). Two hundred eight had ruptured aneurysms (43 %). Prespecified procedural complications occurred in 58 subjects (hydrogel n = 28, bare platinum n = 30, p = 0.77). The 14-day mortality rate was 2.1 % in both arms of the study. The median calculated packing densities for aneurysms assigned to hydrogel and bare platinum were 39 and 31 % respectively (p < 0.001). No statistically significant differences were found between arms in the post procedural angiographic occlusion rate (p = 0.8). Second-generation hydrogel coils can be used in a wide spectrum of aneurysms with a risk profile equivalent to bare platinum. Packing density was significantly higher in aneurysms treated with hydrogel coils. http://www.germanctr.de , DRKS00003132
DOI: 10.1161/strokeaha.119.028221
2020
Cited 22 times
Does Device Selection Impact Recanalization Rate and Neurological Outcome?
Background and Purpose— The recent Save ChildS study provides multicenter evidence for the use of mechanical thrombectomy in children with large vessel occlusion arterial ischemic stroke. However, device selection for thrombectomy may influence rates of recanalization, complications, and neurological outcomes, especially in pediatric patients of different ages. We, therefore, performed additional analyses of the Save ChildS data to investigate a possible association of different thrombectomy techniques and devices with angiographic and clinical outcome parameters. Methods— The Save ChildS cohort study (January 2000–December 2018) analyzed data from 27 European and United States stroke centers and included all pediatric patients (&lt;18 years), diagnosed with arterial ischemic stroke who underwent endovascular recanalization. Patients were grouped into first-line contact aspiration (A Direct Aspiration First Pass Technique [ADAPT]) and non-ADAPT groups as well as different stent retriever size groups. Associations with baseline characteristics, recanalization rates (modified Treatment in Cerebral Infarction), complication rates, and neurological outcome parameters (Pediatric National Institutes of Health Stroke Scale after 24 hours and 7 days; modified Rankin Scale and Pediatric Stroke Outcome Measure at discharge, after 6 and 24 months) were investigated. Results— Seventy-three patients with a median age of 11.3 years were included. Currently available stent retrievers were used in 59 patients (80.8%), of which 4×20 mm (width×length) was the most frequently chosen size (36 patients =61%). A first-line ADAPT approach was used in 7 patients (9.6%), and 7 patients (9.6%) were treated with first-generation thrombectomy devices. In this study, a first-line ADAPT approach was neither associated with the rate of successful recanalization (ADAPT 85.7% versus 87.5% No ADAPT) nor with the complication rate or the neurological outcome. Moreover, there were no associations of stent retriever sizes with rates of recanalization, complication rates, or outcome parameters. Conclusions— Our study suggests that neurological outcomes are generally good regardless of any specific device selection and suggests that it is important to offer thrombectomy in eligible children regardless of technique or device selection. Registration— URL: https://www.drks.de/ ; Unique identifier: DRKS00016528.
DOI: 10.1212/wnl.0000000000013081
2022
Cited 11 times
Cerebrovascular Collateral Integrity in Pediatric Large Vessel Occlusion
<h3>Background and Objectives</h3> Robust cerebrovascular collaterals in adult patients with large vessel occlusion stroke have been associated with longer treatment windows, better recanalization rates, and improved outcomes, but the role of collaterals in pediatric stroke is not known. The primary aim was to determine whether favorable collaterals correlated with better radiographic and clinical outcomes in children with ischemic stroke who underwent thrombectomy. <h3>Methods</h3> This study analyzed a subset of children enrolled in SaveChildS, a retrospective, multicenter, observational cohort study of 73 pediatric patients with stroke who underwent thrombectomy between 2000 and 2018 at 27 US and European centers. Included patients had baseline angiographic imaging and follow-up modified Rankin Scale scores available for review. Posterior circulation occlusions were excluded. Cerebrovascular collaterals were graded on acute neuroimaging by 2 blinded neuroradiologists according to the Tan collateral score, in which favorable collaterals are defined as &gt;50% filling and unfavorable collaterals as &lt;50% filling distal to the occluded vessel. Collateral status was correlated with clinical and neuroimaging characteristics and outcomes. Between-group comparisons were performed with the Wilcoxon rank-sum test for continuous variables or Fisher exact test for binary variables. <h3>Results</h3> Thirty-three children (mean age 10.9 [SD ±4.9]) years were included; 14 (42.4%) had favorable collaterals. Median final stroke volume as a percent of total brain volume (TBV) was significantly lower in patients with favorable collaterals (1.35% [interquartile range (IQR) 1.14%–3.76%] vs 7.86% [IQR 1.54%–11.07%], <i>p</i> = 0.049). Collateral status did not correlate with clinical outcome, infarct growth, or final Alberta Stroke Program Early CT Score (ASPECTS) in our cohort. Patients with favorable collaterals had higher baseline ASPECTS (7 [IQR 6–8] vs 5.5 [4–6], <i>p</i> = 0.006), smaller baseline ischemic volume (1.57% TBV [IQR 1.09%–2.29%] vs 3.42% TBV [IQR 1.26%–5.33%], <i>p</i> = 0.035), and slower early infarct growth rate (2.4 mL/h [IQR 1.5–5.1 mL/h] vs 10.4 mL/h [IQR 3.0–30.7 mL/h], <i>p</i> = 0.028). <h3>Discussion</h3> Favorable collaterals were associated with smaller final stroke burden and slower early infarct growth rate but not with better clinical outcome in our study. Prospective studies are needed to determine the impact of collaterals in childhood stroke. <h3>Classification of Evidence</h3> This study provides Class II evidence that in children with ischemic stroke undergoing thrombectomy, favorable collaterals were associated with improved radiographic outcomes but not with better clinical outcomes.
DOI: 10.1007/s00062-022-01161-2
2022
Cited 10 times
First-line Double Stentriever Thrombectomy for M1/TICA Occlusions
Mechanical thrombectomy is the standard of care for acute ischemic stroke due to large-vessel occlusion; however, mechanical thrombectomy fails to achieve adequate recanalization in nearly one third of these cases. Rescue therapy using two stentrievers simultaneously yields good results in clots refractory to single stentriever treatment. We aimed to determine the safety and efficacy of first-line double stentriever thrombectomy for acute occlusion of the M1 segment of the middle cerebral artery and/or terminal internal carotid artery (TICA).This single-center study prospectively enrolled consecutive patients with a single M1/TICA occlusion to undergo double stentriever thrombectomy between May and October 2020. Outcomes included successful recanalization (modified thrombolysis in cerebral infarction, TICI 2b/3), first-pass effect, procedure times, number of device passes, symptomatic intracerebral hemorrhage, National Institutes of Health Stroke Scale Score (NIHSS) at discharge, 90-day functional independence (modified Rankin scale 0-2), and 90-day mortality.We analyzed 39 patients median age 79 years (range 42-96 years); 23 (58.9%) female; 19 (48.7%) with TICA occlusions; 5 (12.8%) with mRS 3-5 at admission; mean NIHSS at admission, 17 ± 4.39). Mean time from symptom onset to final angiogram was 238.0 ± 94.6 min; mean intervention duration was 36.0 ± 24.2 min. The mean number of device passes was 1.5 ± 1.07. All patients had final TICI 2b/3, and 27 (69%) had TICI 2c/3 after the first pass. We observed 3 (7.9%) cases of intracerebral symptomatic hemorrhages. At 90 days, 16 (41%) patients were functionally independent and 9 (23%) had died. The percentage of patients with good clinical outcome at 90 days was 55.5% in the first-pass subgroup.Our findings suggest that first-line double stentriever thrombectomy is safe and effective for M1/TICA occlusions.
DOI: 10.1161/strokeaha.122.042200
2023
Cited 4 times
Infarcts in a New Territory: Insights From the ESCAPE-NA1 Trial
Background: Infarct in a new territory (INT) is a known complication of endovascular stroke therapy. We assessed the incidence of INT, outcomes after INT, and the impact of concurrent treatments with intravenous thrombolysis and nerinetide. Methods: Data are from ESCAPE-NA1 trial (Safety and Efficacy of Nerinetide [NA-1] in Subjects Undergoing Endovascular Thrombectomy for Stroke), a multicenter, international randomized study that assessed the efficacy of intravenous nerinetide in subjects with acute ischemic stroke who underwent endovascular thrombectomy within 12 hours from onset. Concurrent treatment and outcomes were collected as part of the trial protocol. INTs were identified on core lab imaging review of follow-up brain imaging and defined by the presence of infarct in a new vascular territory, outside the baseline target occlusion(s) on follow-up brain imaging (computed tomography or magnetic resonance imaging). INTs were classified by maximum diameter (&lt;2, 2–20, and &gt;20 mm), number, and location. The association between INT and clinical outcomes (modified Rankin Scale and death) was assessed using standard descriptive techniques and adjusted estimates of effect were derived from Poisson regression models. Results: Among 1092 patients, 103 had INT (9.3%, median age 69.5 years, 49.5% females). There were no differences in baseline characteristics between those with versus without INT. Most INTs (91/103, 88.3%) were not associated with visible occlusions on angiography and 39 out of 103 (37.8%) were &gt;20 mm in maximal diameter. The most common INT territory was the anterior cerebral artery (27.8%). Almost half of the INTs were multiple (46 subjects, 43.5%, range, 2–12). INT was associated with poorer outcomes as compared to no INT on the primary outcome of modified Rankin Scale score of 0 to 2 at 90 days (adjusted risk ratio, 0.71 [95% CI, 0.57–0.89]). Infarct volume in those with INT was greater by a median of 21 cc compared with those without, and there was a greater risk of death as compared to patients with no INT (adjusted risk ratio, 2.15 [95% CI, 1.48–3.13]). Conclusions: Infarcts in a new territory are common in individuals undergoing endovascular thrombectomy for acute ischemic stroke and are associated with poorer outcomes. Optimal therapeutic approaches, including technical strategies, to reduce INT represent a new target for incremental quality improvement of endovascular thrombectomy. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02930018.
DOI: 10.1136/jnis-2023-020210
2023
Cited 4 times
Effect of anesthetic strategies on distal stroke thrombectomy in the anterior and posterior cerebral artery
Numerous questions regarding procedural details of distal stroke thrombectomy remain unanswered. This study assesses the effect of anesthetic strategies on procedural, clinical and safety outcomes following thrombectomy for distal medium vessel occlusions (DMVOs).Patients with isolated DMVO stroke from the TOPMOST registry were analyzed with regard to anesthetic strategies (ie, conscious sedation (CS), local (LA) or general anesthesia (GA)). Occlusions were in the P2/P3 or A2-A4 segments of the posterior and anterior cerebral arteries (PCA and ACA), respectively. The primary endpoint was the rate of complete reperfusion (modified Thrombolysis in Cerebral Infarction score 3) and the secondary endpoint was the rate of modified Rankin Scale score 0-1. Safety endpoints were the occurrence of symptomatic intracranial hemorrhage and mortality.Overall, 233 patients were included. The median age was 75 years (range 64-82), 50.6% (n=118) were female, and the baseline National Institutes of Health Stroke Scale score was 8 (IQR 4-12). DMVOs were in the PCA in 59.7% (n=139) and in the ACA in 40.3% (n=94). Thrombectomy was performed under LA±CS (51.1%, n=119) and GA (48.9%, n=114). Complete reperfusion was reached in 73.9% (n=88) and 71.9% (n=82) in the LA±CS and GA groups, respectively (P=0.729). In subgroup analysis, thrombectomy for ACA DMVO favored GA over LA±CS (aOR 3.07, 95% CI 1.24 to 7.57, P=0.015). Rates of secondary and safety outcomes were similar in the LA±CS and GA groups.LA±CS compared with GA resulted in similar reperfusion rates after thrombectomy for DMVO stroke of the ACA and PCA. GA may facilitate achieving complete reperfusion in DMVO stroke of the ACA. Safety and functional long-term outcomes were comparable in both groups.
DOI: 10.1212/wnl.52.4.883
1999
Cited 54 times
Thrombotic carotid megabulb: Fibromuscular dysplasia, septae, and ischemic stroke
<b><i>Article abstract</i></b> The proximal internal carotid artery is most commonly spared in cerebral fibromuscular dysplasia. The authors report the cases of three young black patients with stroke and carotid megabulbs with fibrous components, two of whom had superimposed thrombi.
DOI: 10.1007/s00062-010-0020-y
2010
Cited 33 times
Retrieval of Displaced Coil Using a Solitaire® Stent
DOI: 10.1136/neurintsurg-2014-011417
2014
Cited 28 times
Retrograde access to the posterior inferior cerebellar artery in balloon-assisted coiling of posterior inferior cerebellar artery aneurysms
Balloon-assisted coil embolization of proximal posterior inferior cerebellar artery (PICA) aneurysms may be limited by the inferiorly oriented, acutely angulated origin of the PICA from the vertebral artery. The aim of this study is to evaluate retrograde access to the PICA via the contralateral vertebral artery or the posterior communicating artery.Twenty-nine proximal PICA aneurysms treated by balloon remodeling with navigation of the balloon in the PICA via the contralateral vertebral artery or posterior communicating artery were found in our database between January 2007 and December 2013 and were reviewed.Access to the PICA was made via the contralateral vertebral artery in 26 patients (90%), six of them (23%) with a hypoplastic V4 segment. In three patients (10%) the retrograde approach was made via the posterior communicating artery. After balloon remodeling, additional stenting was performed in 16 patients (55%). The complication rate was 3% (1 acute stent thrombosis). Grade 0 or 1 occlusion was obtained in all patients at completion angiography. No recurrence was found during follow-up.Retrograde access to the PICA to perform balloon-assisted coil embolization of proximal PICA aneurysms with or without additional stenting after coiling is safe and effective. Hypoplastic V4 segment of the contralateral vertebral artery is not a contraindication.
DOI: 10.1136/neurintsurg-2019-014957
2019
Cited 20 times
Intracranial bailout stenting with the Acclino (Flex) Stent/NeuroSpeed Balloon Catheter after failed thrombectomy in acute ischemic stroke: a multicenter experience
Background and purpose To report on the feasibility, safety, and outcome of acute intracranial stenting (ICS) with the Acclino (Flex) Stent and NeuroSpeed Balloon Catheter in cases of failed mechanical thrombectomy (MT) for acute ischemic stroke (AIS). Methods We retrospectively reviewed the data of patients treated with acute bailout stenting after failed MT in three large neurointerventional centers using exclusively the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter. Functional outcome was assessed by the rate of major early neurological recovery (mENR) at 24 hours and at 90 days with the modified Rankin Scale (mRS). Safety evaluation included symptomatic intracranial hemorrhage (sICH), mortality, and intervention-related serious adverse events (SAEs). Results 50 patients with a median age of 71 years met the inclusion criteria and 52% (26/50) of the occluded vessels were located within the anterior circulation. mENR was observed in 38.8% and 90-day favorable outcome (mRS ≤2) was 40.6% (13/32). Higher NIH Stroke Scale scores on admission were significantly associated with poor functional outcome (mRS ≥3) at 90 days (adjusted OR 1.28; 95% CI 1.07 to 1.53; p=0.007). sICH occurred in two cases of the study population. There were no intervention-related SAEs. Conclusion Intracranial bailout stenting with the Acclino (Flex) Stent and the NeuroSpeed Balloon Catheter after failed MT is a feasible and effective recanalization method for atherosclerotic stenosis-based stroke that is associated especially with low rates of sICH.
DOI: 10.3389/fneur.2020.00097
2020
Cited 20 times
Intracranial Stenting After Failed Thrombectomy in Patients With Moderately Severe Stroke: A Multicenter Cohort Study
Background & Purpose: Recently, acute intracranial stenting (ICS) has gained more interest as a potential bailout strategy for large vessel occlusions (LVO) that are refractory to thrombectomy. However, there are currently no reports on ICS in patients with moderately severe stroke discussing the question if implementing a permanent stent is feasible and leads to improved recanalization after failed thrombectomy. Methods: We analyzed a large multicenter database of patients receiving ICS for anterior circulation LVO after failed thrombectomy. Inclusion criteria were defined as: Moderately severe stroke ( National Institute Health Stroke Scale (NIHSS) ≤9 on admission), anterior circulation LVO, acute ICS after failed stent retriever MT. Primary endpoint was the rate of improved successful recanalization after ICS defined as a modified Thrombolysis In cerebral Infarction (mTICI) score ≥2b. Favorable neurological outcome was defined as an early neurological improvement (ENI) of 4 points or reaching 0 with respect to baseline NIHSS. Results: Forty-one patients met the inclusion criteria. A median of 2 retrievals were performed (IQR 1-4) prior decision-making for ICS. ICS led in 90.2% (37/41) of cases to a final mTICI≥2b with significant improvement (p<0.001) after the last retrieval attempt. The median NIHSS decreased (p=0.178) from 7 (IQR 3.5-8) on admission to 2.5 (IQR 0-8.25) at discharge. ENI was observed in 47.4% (18/38). sICH occurred in 4.8% (2/41). Conclusion: ICS after failed thrombectomy appears to effectively improve recanalization rates in patients with moderately severe strokes. Thus, ICS should be considered also for patients with baseline NIHSS ≤9 if thrombectomy fails.
DOI: 10.1136/neurintsurg-2020-016059
2020
Cited 20 times
Feasibility and safety of thrombectomy for isolated occlusions of the posterior cerebral artery: a multicenter experience and systematic literature review
Background Substantial clinical evidence supporting the benefit of mechanical thrombectomy (MT) for distal occlusions within the posterior circulation is still missing. This study aims to investigate the procedural feasibility and safety of MT for isolated occlusions of the posterior cerebral artery. Methods We retrospectively reviewed patients from three stroke centers with acute ischemic stroke attributed to isolated posterior cerebral artery occlusion (IPCAOs) who underwent MT between January 2014 and December 2019. Procedural and safety assessment included successful recanalization rates (defined as Thrombolysis in Cerebral Infarction Scale (TICI) ≥2b), number of MT attempts and first-pass effect (TICI 3), intracranial hemorrhage (ICH), mortality, and intervention-related serious adverse events. Treatment effects were evaluated by the rate of early neurological improvement (ENI) and early functional outcome was assessed with the modified Rankin Scale (mRS) at discharge. A systematic literature review was conducted to identify and summarize previous reports on MT for IPCAOs. Results Forty-three patients with IPCAOs located in the P1 (55.8%, 24/43), P2 (37.2%, 16/43), and P3 segment (7%, 3/43) were analyzed. The overall rate of successful recanalization (TICI ≥2b) was 86% (37/43), including a first pass-effect of 48.8% (21/43) leading to TICI 3. sICH occurred in 7% (3/43) and there were two cases with iatrogenic vessel dissection and one perforation. ENI was observed in 59% (23/39) and excellent functional outcome (mRS ≤1) in 46.2% (18/39) of patients who were discharged. The in-hospital mortality rate was 9.3% (4/43). Conclusion Our study suggests the technical feasibility and safety of thrombectomy for IPCAOs. Further studies are needed to investigate safety and long-term functional outcomes with posterior circulation stroke-adjusted outcome assessment.
DOI: 10.1136/neurintsurg-2020-016303
2020
Cited 19 times
Derivo embolization device in the treatment of unruptured intracranial aneurysms: a prospective multicenter study
Background Flow diverters (FD) are used regularly for the endovascular treatment of unruptured intracranial aneurysms. We aimed to assess the safety and effectiveness of the Derivo embolization device (DED) with respect to long-term clinical and angiographic outcomes. Methods A prospective multicenter trial was conducted at 12 centers. Patients presenting with modified Rankin Score (mRS) of 0–1, treated for unruptured intracranial aneurysms with DED were eligible. Primary endpoint was the mRS assessed at 18 months with major morbidity defined as mRS 3–5. Satisfactory angiographic occlusion was defined as 3+4 on the Kamran scale. Results Between July 2014 and February 2018, 119 patients were enrolled. Twenty-three patients were excluded. Ninety-six patients, 71 (74%) female, mean age 54±12.0 years, were included in the analysis. Mean aneurysm size was 14.2±16.9 mm. The mean number of devices implanted per patient was 1.2 (range 1–3). Clinical follow-up at 18 months was available in 90 (94%) patients, resulting in a mean follow-up period of 14.8±5.2 months. At last available follow-up of 96 enrolled patients, 91 (95%) remained mRS 0–1. The major morbidity rate (mRS 3–5) was 3.1% (3/96), major stroke rate was 4.2% (4/96), and mortality was 0%. Follow-up angiographies were available in 89 (93%) patients at a median of 12.4±5.84 months with a core laboratory adjudicated satisfactory aneurysm occlusion in 89% (79/89). Conclusion Our results suggest that DED is a safe and effective treatment for unruptured aneurysms with high rates of satisfactory occlusion and comparably low rates of permanent neurological morbidity and mortality. Trial registration DRKS00006103
DOI: 10.1007/s00415-021-10684-6
2021
Cited 15 times
The angiographic presentation of European Moyamoya angiopathy
Little is known about the angiographic presentation of Moyamoya angiopathy (MMA) in non-Asian patients.Conventional cerebral angiograms from 155 Caucasian patients diagnosed as MMA were analyzed with respect to extracranial champagne bottle neck sign, Suzuki stages, collateral status, as well as presence of aneurysms and posterior cerebral artery stenosis.In 84 of 155 angiograms, the extracranial carotid artery was visualized, in 65 of them (77.4%), a champagne bottle neck sign was noted. Of the 278 analyzable hemispheres, 13.7%,11.2%, 37.8%, 27.3%, 8.6%, and 1.4% were classified as Suzuki stage I, stage II, stage III, stage IV, stage V, and stage VI, respectively. Among 280 hemispheres, in 53 hemispheres (18.9%) isolated basal collaterals (pathway I) and in 104 hemispheres (37.1%) choroidal and pericallosal collaterals (including basal collaterals, pathway II) were found. In 74 hemispheres (26.4%) ethmoidal collaterals (pathways III), and in 17 hemispheres (6.1%) vault collaterals were visualized. Patients with higher Suzuki stages IV-VI (p = 0.008) and ethmoidal collaterals (p < 0.001) suffered more often from cerebral hemorrhage. Transient ischemic attacks occurred more frequently in patients with Suzuki stage I to III (p < 0.001). In 10 of 155 patients (6.5%), the angiogram revealed a cerebral aneurysm. In 13 patients (8.4%), a stenotic P1 segment of the posterior cerebral artery was found.This is so far the largest observational study about angiography in Caucasian European MMA patients. A comparison with Asian data indicates similarity of disease in Caucasian and Asian patients.
DOI: 10.1136/jnis-2022-019207
2022
Cited 9 times
Time to treatment with bridging intravenous alteplase before endovascular treatment:subanalysis of the randomized controlled SWIFT-DIRECT trial
We hypothesized that treatment delays might be an effect modifier regarding risks and benefits of intravenous thrombolysis (IVT) before mechanical thrombectomy (MT).We used the dataset of the SWIFT-DIRECT trial, which randomized 408 patients to IVT+MT or MT alone. Potential interactions between assignment to IVT+MT and expected time from onset-to-needle (OTN) as well as expected time from door-to-needle (DTN) were included in regression models. The primary outcome was functional independence (modified Rankin Scale (mRS) 0-2) at 3 months. Secondary outcomes included mRS shift, mortality, recanalization rates, and (symptomatic) intracranial hemorrhage at 24 hours.We included 408 patients (IVT+MT 207, MT 201, median age 72 years (IQR 64-81), 209 (51.2%) female). The expected median OTN and DTN were 142 min and 54 min in the IVT+MT group and 129 min and 51 min in the MT alone group. Overall, there was no significant interaction between OTN and bridging IVT assignment regarding either the functional (adjusted OR (aOR) 0.76, 95% CI 0.45 to 1.30) and safety outcomes or the recanalization rates. Analysis of in-hospital delays showed no significant interaction between DTN and bridging IVT assignment regarding the dichotomized functional outcome (aOR 0.48, 95% CI 0.14 to 1.62), but the shift and mortality analyses suggested a greater benefit of IVT when in-hospital delays were short.We found no evidence that the effect of bridging IVT on functional independence is modified by overall or in-hospital treatment delays. Considering its low power, this subgroup analysis could have missed a clinically important effect, and exploratory analysis of secondary clinical outcomes indicated a potentially favorable effect of IVT with shorter in-hospital delays. Heterogeneity of the IVT effect size before MT should be further analyzed in individual patient meta-analysis of comparable trials.URL: https://www.gov ; Unique identifier: NCT03192332.
DOI: 10.1136/jnis-2022-019859
2023
Cited 3 times
LIQUID - Treatment of high-grade dural arteriovenous fistulas with Squid liquid embolic agent: a prospective, observational multicenter study
Endovascular embolization is a feasible treatment for cranial dural arteriovenous fistulas (DAVFs). New embolic agents aim to improve the success of DAVF embolization.To assess the safety, efficacy, and short-term outcome of the treatment of DAVFs using the new liquid embolic agent Squid.The LIQUID study is a prospective, observational multicenter study on the treatment of high-grade (Cognard type ≥3) DAVFs with the embolic agent Squid. The primary outcome measures were safety (ie, morbidity and mortality), as well as the occlusion rate 90 to 180 days after treatment.In eight centers, 53 patients (mean age 59.8 years, 22.6% female) were treated in 55 treatment sessions. Of the DAVFs, 56.6% were Cognard type III, 41.5% type IV, and 18.9% were ruptured. Squid 18 was used in 83.6% and Squid 12 in 32.7% of the treatments. The overall rate of intraprocedural or postprocedural adverse events (AEs) was 18.2%. Procedure-related AEs resulting in permanent morbidity were observed in 3.6%. One patient (1.8%) died unrelated to the procedure due to pulmonary embolism. The final complete occlusion rate at 90 to 180 days was 93.2%. After a mean follow-up of 5.5 months, the modified Rankin Scale (mRS) score was stable or improved in 93.0%. In one of the patients, worsening of the mRS score was related to the procedure (1.8%).Squid is a safe and effective liquid embolic agent for the treatment of high-grade DAVFs.
2006
Cited 37 times
Cerebroprotective effect of angiotensin IV in experimental ischemic stroke in the rat mediated by AT(4) receptors.
Recent studies have reported potential roles of angiotensins in an adaptative physiological mechanism of protection against cerebral ischemia-induced neurological damages. In the present study, we examined the protective role of angiotensin IV (AngIV) in a rat model of embolic stroke induced by intracarotid injection of calibrated microspheres (50 microm). Internal carotid infusions of increasing doses of AngIV (0.01, 0.1 and 1 nmol/0.1 mL saline) dose dependently decreased mortality, neurological deficit and cerebral infarct size at 24 hours. With the highest dose of AngIV, mortality was reduced from 55 % in saline infused controls to 10 % (p=0.003), neurological deficit was reduced from 3.8 +/- 0.3 to 1.4 +/- 0.3 , (p<0.0001) and cerebral infarct size at 24 hours was decreased from 432 +/- 26 mm(3) to 185 +/- 19, (p=0.0001). The AT(4) antagonist divalinal-AngIV (10(-9) mol/0.1 mL), or pretreatment with L-NAME (10(-7) mol/0.1 mL), both completely abolished the protective effect of AngIV (1 nmol). The AT(2) antagonist PD123319 (10(-7) mol/0.1 mL) partially prevented the protective effect of AngIV on the neurological score. Sequential cerebral arteriographies revealed that AngIV induced a redistribution of blood flow to the ischemic areas within minutes. These results suggest that pharmacological doses of AngIV are protective against acute cerebral ischemia by triggering an AT(4)-mediated, NO-dependent intracerebral hemodynamic mechanism.
DOI: 10.1016/j.jvs.2010.04.026
2010
Cited 27 times
Early side effects after embolization of a carotid body tumor using Onyx
The case of a 20-year-old woman with a carotid body tumor of Shamblin class III is reported. Ten hours after preoperative direct intralesional embolization with 20 mL Onyx (ethylene-vinyl alcohol copolymer; Micro Therapeutics, Irvine, Calif), the patient showed symptoms of Horner syndrome and deficits of the hypoglossal and glossopharyngeal nerves. Intraoperative examination 12 hours after Onyx embolization revealed a massive swelling of the hypoglossal and glossopharyngeal nerves. The patient's tongue motility and glossopharyngeal function improved after surgery, but Horner syndrome was still present. Owing to the delayed occurrence of these adverse effects, the optimal time of surgical intervention after Onyx embolization should be discussed and perhaps expedited.
DOI: 10.1016/j.neurad.2016.12.009
2017
Cited 22 times
The association between collateral status, recanalization and long term outcome in stroke patients treated with stent retrievers – Are there indications not to perform thrombectomy based on CT angiography?
To investigate the association between baseline pial collateral status on computed tomography angiography (CTA) with recanalization and functional outcome in patients with acute anterior circulation stroke treated with stent retriever thrombectomy.Retrospective analysis of 87 patients from a prospective thrombectomy registry. Collateral status on CTA source images was categorized into good, moderate, and poor with the Tan and Miteff scores by two-blinded readers. Association between CTA collateral status and successful recanalization was investigated with univariate regression analysis. Multivariate logistic regression was used to analyse the association between collateral score and favourable clinical outcome (mRS 0-2) and death at follow-up.Mean age was 72.5 years and baseline median NIHSS score was 15. Patients with poor collaterals on Tan score had a significant higher mortality compared with moderate or good collaterals during a mean follow-up period of 5.2 months (85.7% vs. 30.6% vs. 25.7%, P<0.001). Univariate logistic regression analysis did not show a significant association between Tan score (OR 1.681, 95% CI 0.683-4.140) and successful recanalization. Higher age (OR 1.067, 95% CI 1.013-1.124; P=0.015) and lower Tan score (OR 0.421, 95% CI 0.192-0.922; P=0.031) were independent predictors of death at follow-up on multivariate analysis. The Miteff collateral score could be assessed only in 65 of the 87 patients and the Tan collateral score had a higher interrater reliability.Poor collaterals on CTA were associated with a very high rate of fatal outcome in anterior circulation stroke patients despite a high rate of successful recanalization with stent retrievers.
DOI: 10.3389/fneur.2018.00533
2018
Cited 19 times
Angioplasty and Stenting of Intracranial Arterial Stenosis in Perforator-Bearing Segments: A Comparison Between the Anterior and the Posterior Circulation
Background and Purpose: Subgroup analysis of the SAMMPRIS trial showed a higher rate of periprocedural perforator strokes with the Wingspan stent in the basilar artery in patients with symptomatic intracranial atherosclerotic stenosis (ICAS). It remains unclear whether angioplasty (PTA) alone or in combination with other stent types (PTAS) will yield similar results in perforator-bearing segments of the anterior and posterior circulation. Methods: We retrospectively analyzed the periprocedural complication rate, long term outcome and stroke etiology in 59 consecutive patients with ICAS of the middle cerebral artery (79 treatments) and 67 patients with ICAS of the intracranial vertebral and basilar artery (76 treatments) treated with PTA or PTAS from 2007 to 2015 in a high-volume neuro-interventional center. Results: Periprocedural symptomatic ischemic strokes occurred significantly more often in patients with posterior vs. anterior ICAS treatment (14.5 vs. 5.1%, p = 0.048). During a mean follow-up period of 19 (±23.7) months, 5 recurrent ischemic and 2 hemorrhagic strokes (10.4%) occurred in the territory of the treated artery in posterior circulation compared to 2 ischemic strokes in the anterior circulation (3.4%, p = 0.549). Overall, significantly more patients treated for a posterior ICAS suffered a periprocedural or follow-up stroke [25% vs. 11.4%, p = 0.024]. Periprocedural ischemic strokes were predominantly perforator strokes (73.3%), while all ischemic strokes during follow-up were caused by distal embolization (57.1%) or delayed stent occlusion (42.9%). There was no difference between PTA alone and PTAS. Conclusion: The periprocedural and long-term symptomatic stroke rate was significantly higher in the treatment of perforator-bearing arteries in the posterior circulation. There was no difference between PTA alone or PTAS.
DOI: 10.1177/1591019918821738
2019
Cited 18 times
Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM): Study protocol of a randomised controlled trial
Transvenous embolisation is a promising technique but the benefits remain uncertain. We hypothesised that transvenous embolisation leads to a higher rate of arteriovenous malformation angiographic occlusion than transarterial embolisation.The Transvenous Approach for the Treatment of cerebral Arteriovenous Malformations (TATAM) is an investigator initiated, multicentre, prospective, phase 2, randomised controlled clinical trial. To test the hypothesis that transvenous embolisation is superior to transarterial embolisation for arteriovenous malformation obliteration, 76 patients with arteriovenous malformations considered curable by up to two sessions of endovascular therapy will be randomly allocated 1:1 to treatment with either transvenous embolisation (with or without transarterial embolisation) (experimental arm) or transarterial embolisation alone (control arm). The primary endpoint of the trial is complete arteriovenous malformation occlusion, assessed by catheter cerebral angiography. Complete occlusions will be confirmed at 3 months, while incompletely occluded arteriovenous malformations, considered treatment failures, will then be eligible for complementary treatments by surgery, radiation therapy, or even transvenous embolisation. Standard procedural safety outcomes will also be assessed. Patient selection will be validated by a case selection committee, and participating centres with limited experience in transvenous embolisation will be proctored.The TATAM trial is a transparent research framework designed to offer a promising but still unvalidated treatment to selected arteriovenous malformation patients. Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03691870.
DOI: 10.1186/s42466-022-00173-0
2022
Cited 8 times
Intra-arterial application of nimodipine in reversible cerebral vasoconstriction syndrome: a neuroradiological method to help differentiate from primary central nervous system vasculitis
Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by a prolonged, but self-limiting segmental cerebral vasoconstriction. Neurological outcomes vary, but can be severe. The clinical hallmark of RCVS is thunderclap headache, which might come along with further neurological symptoms. Distinguishing RCVS from other entities, such as primary angiitis of the central nervous system (PACNS), is of utmost importance for appropriate therapy. The angiographic response to intra-arterial nimodipine application has been suggested as an additional diagnostic criterion for RCVS but confirmatory studies are limited. We aimed to evaluate the angiographic nimodipine test.We reviewed retrospectively the clinical and imaging data of 13 RCVS patients, who were admitted to a single German neurological department between January 2013 and December 2020.Out of 13 patients diagnosed with RCVS, 4 patients underwent an angiographic nimodipine test. In all 4 patients cerebral vasoconstriction completely resolved during nimodipine application. Among the four patients with a positive test, there was one individual, in whom a response was detected after a delay of 60 min. In all patients, we found a complete resolution of cerebral vasoconstriction within 12 weeks.Our findings support the usefulness of the application of nimodipine in diagnosing RCVS. Prolonged angiographic observation of the vascular response after nimodipine injection is important.
DOI: 10.1136/jnis-2022-019096
2022
Cited 8 times
Clinical experience with the Bendit steerable microcatheter: a new paradigm for endovascular treatment
Vessel tortuosity poses a challenge during endovascular treatment of neurovascular lesions. Bendit Technologies (Petah Tikva, Israel) has developed flexible, steerable microcatheters designed with unique bending and torquing capabilities.To describe our first-in-human trial of Bendit21.Bendit21 was used in our exploratory, prospective, multicenter, open-label, single-arm clinical study, and in two compassionate use cases. Procedures were conducted at four centers in Austria, Germany, Israel, and the United States between May 2021 and March 2022, in patients with neurovascular conditions. The primary endpoints were device-related safety events, successful navigation through the neurovasculature, and, when intended, successful delivery of contrast or therapy.Two patients with giant aneurysms were treated successfully under compassionate use approval. The clinical study included 25 patients (mean age: 63.4±11.8 years; 32.0% female). Fourteen patients (56.0%) had aneurysms, two had arteriovenous malformations/fistulas (8.0%), one had a stroke (4.0%), four (16.0%) had intracranial stenosis, and four (16.0%) had other conditions. Bendit21 was used without a guidewire in 12/25 (48.0%) procedures. Bendit21 was successfully navigated through the vasculature without delays or spasms in all cases (100%). Contrast was delivered as intended in 7/7 (100%) cases. Therapeutic devices were delivered successfully with Bendit as intended in 14/18 (77.8%) cases; four deficiencies occurred in three patients with aneurysms, in whom delivery of coils, an intrasaccular device, or a flow diverter was attempted. There were no device-related safety events or mortalities.Our initial clinical experience with the Bendit21 microcatheter demonstrates its usefulness in achieving technical success in patients with challenging neurovascular conditions.
DOI: 10.1177/159101990200800314
2002
Cited 37 times
Fatal Cardiovascular Collapse during Ethanol Sclerotherapy of a Venous Malformation
We report a case of fatal cardiovascular collapse that occurred during Ethanol sclerotherapy of a venous malformation in a 21-year-old woman. The malformation was located on the anterior part of the thigh. Fifty ml of a mixture of Ethanol, Ethibloc and Lipiodol containing 35 ml of Ethanol (0.52 ml/kg) were injected under fluoroscopy. A major drop in arterial pressure was recorded after release of the tourniquet placed at the thigh root. The patient died after four hours of intensive cardiac reanimation. Her blood alcohol level was 0.4 g/l one hour after the end of the intervention. The cardiac toxicity of ethanol depends more on the potential acute venous contamination than on the blood alcohol concentration. The currently admitted "safety limit" of 1 ml/kg of bodyweight for ethanol sclerotherapy of venous malformations is certainly unsafe and must be redefined.
DOI: 10.1097/01.rvi.0000150038.99488.01
2005
Cited 34 times
Partition of Calibrated Tris-acryl Gelatin Microspheres in the Arterial Vasculature of Embolized Nasopharyngeal Angiofibromas and Paragangliomas
PURPOSE: To determine the location of calibrated tris-acryl gelatin microspheres (TGMs) in the arterial vasculature of nasopharyngeal angiofibromas (NAFs) and paragangliomas (PGs). MATERIALS AND METHODS: Forty-nine specimens (25 PGs and 24 NAFs) treated operatively after embolization with TGMs of various sizes (100–300 μm to 900–1200 μm) were stained with hematoxylin and eosin saffron and analyzed at an objective magnification of 10 or 20 with a micrometric eyepiece (magnification, ×12.5). The diameter of occluded vessels, their localization (intraor extratumoral), and the number and diameter of TGMs they contained were determined. RESULTS: Embolized vessels (N = 1125) were measured: 440 in PGs and 685 in NAFs. Vessels were 89% intratumoral and 11% extratumoral. The diameter of the occluded vessels increased significantly with the size range of TGMs used for embolization for each tumor type (P < .0001). Intratumoral occluded vessels were significantly smaller than extratumoral vessels (P < .0001). Distribution of TGMs within the vascular network (intratumoral or extratumoral location) were similar for NAFs and PGs. The intratumoral and extratumoral dissemination of TGMs was different when comparing 100–300-μm TGMs versus 500–700-μm TGMs (P = .0006) as well as 300–500-μm TGMs versus 500–700-μm TGMs (P = .0001). CONCLUSIONS: The size of the vessels occluded by TGMs and their intraor extratumoral location directly depend on the size of the injected TGMs. The vessels located inside the tumors were smaller than those located outside the tumors. A threshold for the intratumoral penetration of TGMs in the vasculature can be proposed from these data. There was no evidence of different behavior of TGMs in NAFs versus PGs. To determine the location of calibrated tris-acryl gelatin microspheres (TGMs) in the arterial vasculature of nasopharyngeal angiofibromas (NAFs) and paragangliomas (PGs). Forty-nine specimens (25 PGs and 24 NAFs) treated operatively after embolization with TGMs of various sizes (100–300 μm to 900–1200 μm) were stained with hematoxylin and eosin saffron and analyzed at an objective magnification of 10 or 20 with a micrometric eyepiece (magnification, ×12.5). The diameter of occluded vessels, their localization (intraor extratumoral), and the number and diameter of TGMs they contained were determined. Embolized vessels (N = 1125) were measured: 440 in PGs and 685 in NAFs. Vessels were 89% intratumoral and 11% extratumoral. The diameter of the occluded vessels increased significantly with the size range of TGMs used for embolization for each tumor type (P < .0001). Intratumoral occluded vessels were significantly smaller than extratumoral vessels (P < .0001). Distribution of TGMs within the vascular network (intratumoral or extratumoral location) were similar for NAFs and PGs. The intratumoral and extratumoral dissemination of TGMs was different when comparing 100–300-μm TGMs versus 500–700-μm TGMs (P = .0006) as well as 300–500-μm TGMs versus 500–700-μm TGMs (P = .0001). The size of the vessels occluded by TGMs and their intraor extratumoral location directly depend on the size of the injected TGMs. The vessels located inside the tumors were smaller than those located outside the tumors. A threshold for the intratumoral penetration of TGMs in the vasculature can be proposed from these data. There was no evidence of different behavior of TGMs in NAFs versus PGs.
2005
Cited 32 times
Early Postoperative CT Scanning for Juvenile Nasopharyngeal Angiofibroma: Detection of Residual Disease
BACKGROUND AND PURPOSE: High recurrence rates and early recurrence have been reported for juvenile nasopharyngeal angiofibroma (JNA) involving the skull base. The purpose of this study was to evaluate the diagnostic accuracy of contrast-enhanced CT scanning for the detection of residual disease (RD) in the early postoperative course after surgical excision of JNA. METHODS: We retrospectively reviewed data in 20 male patients (mean age ± SD, 15.4 ± 5 years; range, 10–32 years) who underwent enhanced helical CT in the days after apparent complete surgical excision of JNA with initial expansion in the skull base. Four independent, blinded readers evaluated the occurrence of RD. Final diagnoses were rendered on the basis of histologic examination of excised specimens of RD or clinical and radiologic follow-up. The Cohen κ test was performed to examine interreader agreement. RESULTS: Postoperative contrast-enhanced CT had a sensitivity of 75%, a specificity of 83%, a positive predictive value of 75% and a negative predictive value of 83% for the detection of RD. The prevalence of RD was 40%. The base of pterygoids was the most frequent location of RD. Interreader agreement was high for the detection of putative RD (κ = 0.83). Variabilities in readers’ interpretations were encountered for false-positive results and for disease in the foramen lacerum. False-negative results involved the base of pterygoids. Early postoperative CT scanning was well tolerated by all patients. CONCLUSION: Contrast-enhanced helical CT is an accurate tool to evaluate excision of JNA in the days after surgery.
DOI: 10.1016/j.jvir.2007.07.015
2007
Cited 29 times
MR Imaging Detection of Superparamagnetic Iron Oxide–loaded Tris-acryl Embolization Microspheres
To assess by magnetic resonance (MR) imaging the detectability of superparamagnetic iron oxide (SPIO)-labeled microspheres (MSs) in vitro on gelose, ex vivo in kidneys from embolized sheep, and in vivo in kidneys from embolized pigs.With various sizes of SPIO-labeled MSs, common neck and pelvic spin-echo and gradient-echo sequences were acquired on a 1.5-T MR unit. SPIO-labeled MSs of four sizes were embedded in a hydrogel as single MSs or in multiple units, or multiplets. Detection rate on MR imaging was assessed according to the real size and number of MSs. SPIO-loaded and unloaded MSs of four sizes were injected into eight sheep kidneys, which underwent MR and pathologic examinations. For each size, the location of MSs in renal vasculature was determined and compared according to the technique used. Kidneys were embolized in pigs with various amounts of MSs in three sizes. MR was performed immediately after embolization and SPIO-labeled MS detection was assessed according to size, organ, and amount injected. Results SPIO-labeled MSs provide a low signal intensity on T1-weighted sequences, without distortion. In vitro, 28% of 100-300-microm single MSs were detected and more than 80% were detected for larger sizes. MS multiplets were all detected in all sizes. Ex vivo, all sizes of MSs were detected by MR imaging in kidneys, whereas control MSs were not observed. Histologic analysis showed that there was no difference in vascular distribution between SPIO-labeled MS and control MSs, and therefore for each caliber (P > .05). Arterial location of SPIO-labeled MSs was the same on MR imaging and histologic analysis. In vivo, SPIO-labeled MS were detected in the kidney vasculature when volumes greater than 1 mL of 100-300-microm or 500-700-microm MSs were injected. Volumes lower than 1 mL SPIO-labeled MSs were hardly detected in kidneys, regardless of MS size. Conclusions SPIO-labeled MSs are detected by MR imaging with common gradient-echo sequences in vitro in gelose and ex vivo and in vivo in kidneys. SPIO-labeled MSs could allow better control of embolization and thereby enhance efficacy and safety of the procedure.
DOI: 10.1007/s00234-013-1197-y
2013
Cited 21 times
The sheeping technique or how to avoid exchange maneuvers
DOI: 10.1161/jaha.119.014418
2020
Cited 14 times
Incidence of Acute Kidney Injury After Computed Tomography Angiography±Computed Tomography Perfusion Followed by Thrombectomy in Patients With Stroke Using a Postprocedural Hydration Protocol
Background The risk of contrast‐induced acute kidney injury (AKI) in patients with stroke receiving both computed tomography (CT) angiography and mechanical thrombectomy has been investigated only in small case series. No studies have investigated whether additional CT perfusion or chronic kidney disease (CKD) are associated with higher rates of AKI. Methods and Results Retrospective analysis of the AKI incidence in 1089 consecutive patients receiving CT angiography and mechanical thrombectomy from 2015 to 2017 and in subgroups with CKD (n=99) and CT perfusion (n=104) was performed. Patients received a standardized hydration protocol. Data on kidney function after mechanical thrombectomy were available in 1017 patients. A total of 59 (5.8%) patients developed AKI, and only 4 (6.8%) patients needed hemodialysis, all with known CKD. Patients with AKI significantly more often had known CKD (20.3% versus 8.4%, P =0.002), diabetes mellitus (33.9% versus 20.9%, P =0.018), and tandem occlusion (32.2% versus 16.2%, P =0.003) and a significantly higher in‐hospital mortality (20.3% versus 7.0%, P &lt;0.001) compared with patients without AKI. However, there were no significant independent predictors for AKI in multivariable logistic regression analysis. Sex (odds ratio [OR], 2.03; 95% CI, 1.17–3.52 [ P =0.012]), higher National Institutes of Health Stroke Scale (OR, 1.10; 95% CI, 1.05–1.14 [ P &lt;0.001]), AKI (OR, 3.52; 95% CI, 1.63–7.64 [ P =0.001]), diuretic use (OR, 1.80; 95% CI, 1.02–3.19), futile or incomplete recanalization (OR, 0.19; 95% CI, 0.09–0.40 [ P &lt;0.001]), and total volume of contrast agent volume (OR, 1.007; 95% CI, 1.002–1.011 [ P =0.004]) were independently associated with in‐hospital death. Two thirds of the patients with AKI died of severe brain damage and not AKI itself. Conclusions Post‐contrast AKI rarely occurs in patients with stroke receiving a contrast agent for CT angiography/CT perfusion and subsequent mechanical thrombectomy. Patients with known CKD had higher rates of AKI and only these patients needed hemodialysis, but CKD was not independently associated with AKI or in‐hospital mortality.
DOI: 10.3174/ajnr.a6888
2020
Cited 14 times
Considerations for Antiplatelet Management of Carotid Stenting in the Setting of Mechanical Thrombectomy: A Delphi Consensus Statement
There are only few data and lack of consensus regarding antiplatelet management for carotid stent placement in the setting of endovascular stroke treatment. We aimed to develop a consensus-based algorithm for antiplatelet management in acute ischemic stroke patients undergoing endovascular treatment and simultaneous emergent carotid stent placement.We performed a literature search and a modified Delphi approach used Web-based questionnaires that were sent in several iterations to an international multidisciplinary panel of 19 neurointerventionalists from 7 countries. The first round included open-ended questions and formed the basis for subsequent rounds, in which closed-ended questions were used. Participants continuously received feedback on the results from previous rounds. Consensus was defined as agreement of ≥70% for binary questions and agreement of ≥50% for questions with >2 answer options. The results of the Delphi process were then summarized in a draft manuscript that was circulated among the panel members for feedback.A total of 5 Delphi rounds were performed. Panel members preferred a single intravenous aspirin bolus or, in jurisdictions in which intravenous aspirin is not available, a glycoprotein IIb/IIIa receptor inhibitor as intraprocedural antiplatelet regimen and a combination therapy of oral aspirin and a P2Y12 inhibitor in the postprocedural period. There was no consensus on the role of platelet function testing in the postprocedural period.More and better data on antiplatelet management for carotid stent placement in the setting of endovascular treatment are urgently needed. Panel members preferred intravenous aspirin or, alternatively, a glycoprotein IIb/IIIa receptor inhibitor as an intraprocedural antiplatelet agent, followed by a dual oral regimen of aspirin and a P2Y12 inhibitor in the postprocedural period.
DOI: 10.1227/ons.0000000000000679
2023
Clinical and Simulated Experiences With the Bendit Articulating/Steerable Microcatheter in Endovascular Treatment: 2-Dimensional Operative Video
Berenstein, Alejandro MD*; Chapot, Rene MD‡; Orion, David MD§; Barr, John D. MD‖; Cabiri, Oz MI¶; Killer-Oberpfalzer, Monika MD# Author Information
DOI: 10.3390/jcm13020388
2024
A Giant Stent for Giant Cerebral Aneurysms—The Accero®-Rex-Stent
Until now, giant intracranial aneurysms (GIAs) have in many cases been a vascular disease that was difficult or impossible to treat, not least due to the lack of availability of a large-format stent. In this multicentre study, we report on the first five clinical applications of the Accero®-Rex-Stents (Acandis, Pforzheim, Germany) in the successful treatment of fusiform cerebral giant aneurysms.The Accero®-Rex-Stents are self-expanding, braided, fully radiopaque Nitinol stents designed for aneurysm treatment. The stent is available in three different sizes (diameter 7-10 mm, length 30-60 mm) and intended for endovascular implantation in vessels with diameters of 5.5-10 mm.Five patients (all male, age 54.4 ± 8.1 years) with large fusiform aneurysms of the posterior circulation were treated endovascularly using the Accero®-Rex-Stents. There were no technical complications. One major ischemic complication occurred. A significant remodeling and reduction in the size of the stent-covered aneurysms was already seen in the short-term post-interventional course.The Accero®-Rex-Stents were successfully and safely implanted in all five patients with fusiform giant aneurysms, showing technical feasibility with promising initial results and significant aneurysm size reduction in already available follow-up imaging.With the Accero-Rex-Stents, a new device is available that offers another treatment option for rare cerebral fusiform giant aneurysms with very large parent vessels.
DOI: 10.1136/jnis-2023-021218
2024
Connecting the DOTs: a novel imaging sign on flat-panel detector CT indicating distal vessel occlusions after thrombectomy
Immediate non-contrast post-interventional flat-panel detector CT (FPDCT) has been suggested as an imaging tool to assess complications after endovascular therapy (EVT). We systematically investigated a new imaging finding of focal hyperdensities correlating with remaining distal vessel occlusion after EVT.A single-center retrospective analysis was conducted for all acute ischemic stroke patients admitted between July 2020 and December 2022 who underwent EVT and immediate post-interventional FPDCT. A blinded core lab performed reperfusion grading on post-interventional digital subtraction angiography (DSA) images and evaluated focal hyperdensities on FPDCT (here called the distal occlusion tracker (DOT) sign). DOT sign was defined as a tubular or punctiform, vessel confined, hyperdense signal within the initial occlusion target territory. We assessed sensitivity and specificity of the DOT sign when compared with DSA findings.The median age of the cohort (n=215) was 74 years (IQR 63-82) and 58.6% were male. The DOT sign was positive in half of the cohort (51%, 110/215). The DOT sign had high specificity (85%, 95% CI 72% to 93%), but only moderate sensitivity (63%, 95% CI 55% to 70%) for detection of residual vessel occlusions. In comparison to the core lab, operators overestimated complete reperfusion in a quarter of the entire cohort (25%, 53/215). In more than half of these cases (53%, 28/53) there was a positive DOT sign, which could have mitigated this overestimation.The DOT sign appears to be a frequent finding on immediate post-interventional FPDCT. It correlates strongly with incomplete reperfusion and indicates residual distal vessel occlusions. In the future, it may be used to complement grading of reperfusion success and may help mitigating overestimation of reperfusion in the acute setting.
DOI: 10.1007/s00234-010-0803-5
2010
Cited 22 times
Ethanol threshold doses for systemic complications during sclerotherapy of superficial venous malformations: a retrospective study
DOI: 10.1007/s00234-011-0899-2
2011
Cited 19 times
Unique sacral location of an arteriovenous fistula of the filum terminale associated with diastematomyelia and lowered spinal cords
DOI: 10.1007/s00234-015-1501-0
2015
Cited 15 times
GREAT—a randomized aneurysm trial. Design of a randomized controlled multicenter study comparing HydroSoft/HydroFrame and bare platinum coils for endovascular aneurysm treatment
The effectiveness of a hybrid hydrogel platinum detachable coil (HydroCoil; MicroVention Inc., Tustin, CA) for endovascular aneurysm treatment has been proven in a recently published RCT. Due to technical restrictions (coil stiffness, time restriction for placement), the HydroSoft coil as well as a corresponding 3D framing coil, the HydroFrame coil (MicroVention Inc., Tustin, CA), a class of new softer coils containing less hydrogel and swelling more slowly than the HydroCoil, have been developed and brought to clinical practice. The present study aims to compare the effectiveness of endovascular aneurysm treatment with coil embolization between patients allocated HydroSoft/HydroFrame versus bare platinum coiling. GREAT is a randomized, controlled, multicentre trial in patients bearing cerebral aneurysms to be treated by coil embolization. Eligible patients were randomized to either coil embolization with HydroSoft/HydroFrame coils (>50 % of administered coil length), or bare platinum coils. Inclusion criteria were as follows: age 18–75, ruptured aneurysm (WFNS 1–3) and unruptured aneurysm with a diameter between 4 and 12 mm. Anatomy such that endovascular coil occlusion deemed possible and willingness of the neurointerventionalist to use either HydroSoft/HydroFrame or bare platinum coils. Exclusion criteria were as follows: aneurysms previously treated by coiling or clipping. Primary endpoint is a composite of major aneurysm recurrence on follow-up angiography and poor clinical outcome (modified Rankin scale 3 or higher), both assessed at 18 months post treatment. Risk differences for poor outcomes will be estimated in a modified intention-to-treat analysis stratified by rupture status (DRKS-ID: DRKS00003132).
DOI: 10.1007/s00234-016-1667-0
2016
Cited 15 times
Training guidelines for endovascular stroke intervention: an international multi-society consensus document
We, as a group of international multi-disciplinary neurointerventional societies involved in the endovascular management of acute ischemic stroke, have put forth these training guidelines. We believe that a neuroscience background, dedicated neurointerventional training, and stringent peer review and quality assurance processes are critical to ensuring the best possible patient outcomes. Well-trained neurointerventionalists are a critical component of an organized and efficient team needed to deliver clinically effective mechanical thrombectomy for acute ischemic stroke patients.
DOI: 10.1007/s00234-018-2088-z
2018
Cited 15 times
Low rates of recanalization for wide-necked aneurysms treated with stenting after balloon-assisted coiling: combination of techniques delivers stable and improved results during follow-up
DOI: 10.1136/neurintsurg-2019-015474
2020
Cited 13 times
Removal of distal fragments of liquid embolic agents during arteriovenous malformation embolization using the TIGERTRIEVER 13: a technical report
Arteriovenous malformations (AVMs) are vascular lesions that may be treated by an endovascular approach using liquid embolic agents but the control of the liquid embolic agent remains poor and a potential complication may be distal migration of embolic material. The TIGERTRIEVER 13 is a new stent retriever designed for stroke thrombectomy and has a version ideal for distal occlusions. We report our experience in the removal of embolic agent which had migrated into the distal vessels using the TIGERTRIEVER during PHIL/Onyx embolization of AVMs.Three patients with brain and spinal AVMs underwent endovascular embolization. During trans-arterial embolization of the AVM with PHIL/Onyx, retrograde filling of distal arterial feeders was followed by migration into the normal arterial branches (cortical middle cerebral artery, distal posterior cerebral artery, and anterior spinal artery). This resulted in occlusion or sluggish distal flow in these branches with potential significant neurological deficits. In all three cases, a Headway Duo microcatheter was navigated distally in the occluded vessel beyond the embolic material using a Traxcess microwire. The TIGERTRIEVER 13 was deployed with recanalization of the vessel after a single attempt. In all three patients there were no complications related to the retrieval of embolic agent.Distal migrated embolic agents such as PHIL or Onyx can be removed from various arterial vascular territories using stent retrievers dedicated to small vessels.
DOI: 10.1136/neurintsurg-2019-015744
2020
Cited 13 times
Stenting with Acclino (flex) for symptomatic intracranial stenosis as secondary stroke prevention
Background and purpose Stroke recurrence is high in patients with symptomatic intracranial stenosis despite best medical treatment. Based on evidence from past studies using previous stent generations, elective intracranial stenting (eICS) is considered in a minority of patients. This study aims to report on experience performing eICS with a novel device combination. Methods We retrospectively reviewed data from three high volume stroke centers and analyzed patients that were treated with eICS for symptomatic intracranial stenosis using the Acclino (flex) stent and the NeuroSpeed balloon catheter (Acandis GmbH, Pforzheim, Germany). Study endpoints were periprocedural rates of stroke regardless of territory or death at discharge and at the time of follow-up after eICS. Safety evaluation included asymptomatic and symptomatic intracranial hemorrhage, serious adverse events related to the intervention, and evaluation of stent patency at the time of follow-up. Results The median age of patients that met the inclusion criteria (n=76) was 69 years. Target vessels were located in the anterior circulation in 55.3% (42/76) of patients. The periprocedural stroke rate was 6.5% (fatal stroke 2.6%; non-fatal stroke 3.9%) at discharge after eICS. Asymptomatic intracranial hemorrhage was observed in 5.2% (4/76) of patients. Follow-up DSA revealed in-stent restenosis of 25% (15/60), and percutaneous transluminal angioplasty was performed again in 11.6% (7/60) of patients. Conclusion Stenting for symptomatic intracranial stenosis with the Acclino (flex)/NeuroSpeed balloon catheter seemed to be safe and reinforces eICS as an endovascular therapy option for secondary stroke prevention. Future studies are warranted to confirm these findings and investigate antithrombotic strategies and in-stent restenosis to minimize periprocedural complications and guarantee long term stent patency.
DOI: 10.1136/neurintsurg-2020-015902
2020
Cited 13 times
Workflow patterns and potential for optimization in endovascular stroke treatment across the world: results from a multinational survey
Background The benefit of endovascular treatment (EVT) is highly time-dependent, and treatment delays reduce patients’ chances to achieve a good outcome. In this survey-based study, we aimed to evaluate current in-hospital EVT workflow characteristics across different countries and hospital settings, and to quantify the time-savings that could be achieved by optimizing particular workflow steps. Methods In a multinational survey, neurointerventionalists were asked to provide specific information about EVT workflows in their current working environment. Workflow characteristics were summarized using descriptive statistics and stratified by country and physician characteristics, such as age, career stage, personal and institutional caseload. Results Among 248 respondents from 48 countries, pre-notification of the neurointerventional team was used in 70% of cases. The emergency department (ED) and CT scanner, and the CT scanner and neuroangiography suite, were on different floors in 23% and 38%, respectively. Redundant procedures in the ED were often routinely performed, such as chest x-rays (in 6%). General anesthesia was the most frequently used anesthesia protocol for EVT (42%), and an anesthesiologist was available in 82% for this purpose. 52% of the participants used a pre-prepared EVT kit. Conclusion The current structure of EVT workflows offers possibilities for improvement. While some bottlenecks, such as the spatial department set-up, cannot easily be resolved, pre-notification tools and pre-prepared EVT kits are more straightforward to implement and could help to reduce treatment delays, and thereby improve patient outcomes.
DOI: 10.1136/neurintsurg-2020-016619
2020
Cited 13 times
Retreatments must be included in the evaluation of device performance
We would like to comment on the conclusions of the recent paper reporting the 3 year follow-up results of the Webcast studies1: ‘This analysis confirms the high safety profile of WEB…the great stability of aneurysm occlusion in 83.6% of aneurysms’. It is not easy to criticize a manuscript written by 17 experts, including many prominent leaders of the neurovascular field and several close friends, particularly one where superlatives (‘high safety’ and ‘great stability’) and ‘GCP’ (n=8) are used repeatedly. Yet, as true friends, we must tell the ‘ugly truth’: 10 years after its introduction, the evidence supporting the use of WEB in the treatment of aneurysms (mainly small unruptured aneurysms) is weak; a case series of 100 or so highly selected patients, recruited in …
DOI: 10.1136/neurintsurg-2022-018723
2022
Cited 6 times
Mechanical thrombectomy for acute ischemic stroke in COVID-19 patients: multicenter experience in 111 cases
Data on the frequency and outcome of mechanical thrombectomy (MT) for large vessel occlusion (LVO) in patients with COVID-19 is limited. Addressing this subject, we report our multicenter experience.A retrospective cohort study was performed of consecutive acute stroke patients with COVID-19 infection treated with MT at 26 tertiary care centers between January 2020 and November 2021. Baseline demographics, angiographic outcome and clinical outcome evaluated by the modified Rankin Scale (mRS) at discharge and 90 days were noted.We identified 111 out of 11 365 (1%) patients with acute or subsided COVID-19 infection who underwent MT due to LVO. Cardioembolic events were the most common etiology for LVO (38.7%). Median baseline National Institutes of Health Stroke Scale score and Alberta Stroke Program Early CT Score were 16 (IQR 11.5-20) and 9 (IQR 7-10), respectively. Successful reperfusion (mTICI ≥2b) was achieved in 97/111 (87.4%) patients and 46/111 (41.4%) patients were reperfused completely. The procedure-related complication rate was 12.6% (14/111). Functional independence was achieved in 20/108 (18.5%) patients at discharge and 14/66 (21.2%) at 90 days follow-up. The in-hospital mortality rate was 30.6% (33/108). In the subgroup analysis, patients with severe acute COVID-19 infection requiring intubation had a mortality rate twice as high as patients with mild or moderate acute COVID-19 infection. Acute respiratory failure requiring ventilation and time interval from symptom onset to groin puncture were independent predictors for an unfavorable outcome in a logistic regression analysis.Our study showed a poor clinical outcome and high mortality, especially in patients with severe acute COVID-19 infection undergoing MT due to LVO.