Showing papers by "David Fiorella published in 2019"
Greenville Health System1, University at Buffalo2, Icahn School of Medicine at Mount Sinai3, Stony Brook University4, Medical University of South Carolina5, West Virginia University6, Abbott Northwestern Hospital7, University of Saskatchewan8, University of Tennessee9, California Pacific Medical Center10, Wake Forest Baptist Medical Center11
TL;DR: This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy and assesses whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retrievers as first line.
265 citations
TL;DR: The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer.
Abstract: Introduction The Woven EndoBridge Intrasaccular Therapy (WEB-IT) Study is a pivotal, prospective, single-arm, investigational device exemption study designed to evaluate the safety and effectiveness of the WEB device for the treatment of wide-neck bifurcation aneurysms. Methods One-hundred and fifty patients with wide-neck bifurcation aneurysms were enrolled at 21 US and six international centers. Angiograms from the index procedure, and 6-month and 1-year follow-up visits were all reviewed by a core laboratory. All adverse events were reviewed and adjudicated by a clinical events adjudicator. A data monitoring committee provided oversight during the trial to ensure subject safety. Results One-hundred and forty-eight patients received the WEB implant. One (0.7%) primary safety event occurred during the study—a delayed ipsilateral parenchymal hemorrhage—on postoperative day 22. No primary safety events occurred after 30 days through 1 year. At the 12-month angiographic follow-up, 77/143 patients (53.8%) had complete aneurysm occlusion. Adequate occlusion was achieved in 121/143 (84.6%) subjects. Conclusions The prespecified safety and effectiveness endpoints for the aneurysms studied in the WEB-IT trial were met. The results of this trial suggest that the WEB device provides an option for patients with wide-neck bifurcation aneurysms that is as effective as currently available therapies and markedly safer. Trial registration number NCT02191618
200 citations
TL;DR: The potential role for the endovascular management of cSDH is reviewed within the context of a discussion of the epidemiology, pathophysiology, and conventional management of this disease.
Abstract: Chronic subdural hematoma (cSDH) is one of the most common neurosurgical diagnoses in adults. The disease is fundamentally a disorder of the meningeal blood vessels, and options exist for the minimally invasive neuroendovascular management. We review the potential role for the endovascular management of cSDH within the context of a discussion of the epidemiology, pathophysiology, and conventional management of this disease.
90 citations
Medical University of South Carolina1, Veterans Health Administration2, University of Iowa Hospitals and Clinics3, State University of New York System4, Emory University5, University of California, Los Angeles6, Barrow Neurological Institute7, Oregon Health & Science University8, National Institutes of Health9
TL;DR: Borderzone infarcts and impaired collateral flow identify a subgroup of patients with intracranial stenosis who are at particularly high risk of recurrent stroke on medical treatment.
Abstract: Background and Purpose- Although aggressive medical therapy was superior to stenting in the SAMMPRIS trial (Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis), the stroke rate in the medical arm was still high. The aim of this study was to determine the association between hemodynamic markers (borderzone infarct pattern and impaired collateral flow on baseline imaging) and rates of recurrent stroke in patients treated medically in SAMMPRIS. Methods- This was a post hoc analysis of patients whose qualifying event for SAMMPRIS was an infarct in the territory of a stenotic middle cerebral artery or intracranial carotid artery. Infarcts were adjudicated as involving primarily internal or cortical borderzone territories, the core middle cerebral artery territory, or perforator territories, and collateral flow was assessed according to a standard scale (American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology). Log-rank tests and χ2 tests were performed to assess associations of infarct patterns and collateral flow with rates of recurrent stroke. Results- Of 101 patients who qualified, 14 of 53 (26.4%) with borderzone infarcts, 2 of 24 (8.3%) with core middle cerebral artery infarcts, and 3 of 24 (12.5%) with perforator infarcts had a recurrent stroke in the territory ( P=0.14 for comparing the 3 groups, P=0.052 for borderzone versus nonborderzone). Of 82 patients with collateral flow assessment, 30 of 43 (70%) with borderzone infarcts, 7 of 19 (37%) with core middle cerebral artery infarcts, and 11 of 20 (55%) with perforator infarcts had impaired collateral flow distal to the stenosis ( P=0.049). Patients with borderzone infarcts and impaired collateral flow had the highest risk of recurrent stroke (37%). Conclusions- Borderzone infarcts and impaired collateral flow identify a subgroup of patients with intracranial stenosis who are at particularly high risk of recurrent stroke on medical treatment. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT00576693.
73 citations
TL;DR: The LVIS stent system allows safe and highly effective coil embolization of WNAs and is evaluated to evaluate the safety and effectiveness of this device.
Abstract: Introduction The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. Methods The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. Results One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion– 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. Conclusion The LVIS stent system allows safe and highly effective coil embolization of WNAs. Clinical registration number NCT01793792.
46 citations
43 citations
TL;DR: The aim of this article is to provide an overview of these devices and to summarize the evidence in the literature pertaining to the treatment of intracranial aneurysms with them.
Abstract: Endosaccular flow disruption is an innovative method of treating wide-necked complex aneurysms. Currently four types of devices have obtained the CE mark for use within Europe. These are the Woven EndoBridge device (WEB), the Luna Aneurysm Embolization System, the Medina Embolic Device (Medtronic), and the Contour Neurovascular System. The aim of this article is to provide an overview of these devices and to summarize the evidence in the literature pertaining to the treatment of intracranial aneurysms with them.
38 citations
TL;DR: There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers, and the type of stents was associated with immediate and long-term angiographic outcomes.
Abstract: Introduction The endovascular stent-assisted coiling approach for the treatment of cerebral aneurysms is evolving rapidly with the availability of new stent devices. It remains unknown how each type of stent affects the safety and efficacy of the stent-coiling procedure. Methods This study compared the outcomes of endovascular coiling of cerebral aneurysms using Neuroform (NEU), Enterprise (EP), and Low-profile Visualized Intraluminal Support (LVIS) stents. Patient characteristics, treatment details and angiographic results using the Raymond–Roy grade scale (RRGS), and procedural complications were analyzed in our study. Results Our study included 659 patients with 670 cerebral aneurysms treated with stent-assisted coiling (NEU, n=182; EP, n=158; LVIS, n=330) that were retrospectively collected from six academic centers. Patient characteristics included mean age 56.3±12.1 years old, female prevalence 73.9%, and aneurysm rupture on initial presentation of 18.8%. We found differences in complete occlusion on baseline imaging, defined as RRGS I, among the three stents: LVIS 64.4%, 210/326; NEU 56.2%, 95/169; EP 47.6%, 68/143; P=0.008. The difference of complete occlusion on 10.5 months (mean) and 8 months (median) angiographic follow-up remained significant: LVIS 84%, 251/299; NEU 78%, 117/150; EP 67%, 83/123; P=0.004. There were 7% (47/670) intra-procedural complications and 11.5% (73/632) post-procedural-related complications in our cohort. Furthermore, procedure-related complications were higher in the braided-stents vs laser-cut, P=0.002. Conclusions There was a great variability in techniques and choice of stent type for stent-assisted coiling among the participating centers. The type of stent was associated with immediate and long-term angiographic outcomes. Randomized prospective trials comparing the different types of stents are warranted.
38 citations
TL;DR: Minimally invasive endoscopic hematoma evacuation was associated with lower rates of in-hospital mortality in patients with spontaneous basal-ganglia ICH, which support a randomized controlled trial of MIS versus medical management for ICH.
Abstract: Background We conducted a case-control study to assess the relative safety and efficacy of minimally invasive endoscopic surgery (MIS) for clot evacuation in patients with basal-ganglia intracerebral hemorrhage (ICH). Methods We evaluated consecutive patients with acute basal-ganglia ICH at a single center over a 42-month period. Patients received either best medical management according to established guidelines (controls) or MIS (cases). The following outcomes were compared before and after propensity-score matching (PSM): in-hospital mortality; discharge National Institutes of Health Stroke Scale score; discharge disposition; and modified Rankin Scale scores at discharge and at 3 months. Results Among 224 ICH patients, 19 (8.5%) underwent MIS (mean age, 50.9±10.9; 26.3% female, median ICH volume, 40 (IQR, 25–51)). The interventional cohort was younger with higher ICH volume and stroke severity compared with the medically managed cohort. After PSM, 18 MIS patients were matched to 54 medically managed individuals. The two cohorts did not differ in any of the baseline characteristics. The median ICH volume at 24 hours was lower in the intervention group (40 cm3 (IQR, 25–50) vs 15 cm3 (IQR, 5–20); P Conclusions Minimally invasive endoscopic hematoma evacuation was associated with lower rates of in-hospital mortality in patients with spontaneous basal-ganglia ICH. These findings support a randomized controlled trial of MIS versus medical management for ICH.
31 citations
Icahn School of Medicine at Mount Sinai1, Mount Sinai Health System2, Medical University of South Carolina3, State University of New York System4, Stony Brook University5, Woodward, Inc.6, West Virginia University Hospitals7, Abbott Northwestern Hospital8, University of Saskatchewan9, University of California, San Francisco10
TL;DR: Data show similar adequate revascularization rates and 90-day functional outcomes for first-line direct aspiration and stent retrievers for anterior large vessel occlusion in a real-world setting, which support the findings of other prospective trials evaluating the two techniques.
Abstract: Background Thrombectomy for anterior large vessel occlusion less than 24 hours since last known well is now standard of care. Certain aspects of clinical trials may limit generalizability to ’real-world9 practice. Objective To compare revascularization rates and outcomes for direct aspiration (ADAPT) and stent retriever thrombectomy following anterior acute ischemic stroke (AIS) in a real-life setting. Methods Data from the most recent 20 consecutive patients with AIS treated with mechanical thrombectomy between 2015 and 2016 were collected from 15 high-volume stroke centers across North America for a total of 300 cases. Patients with proximal anterior large vessel occlusions were dichotomized by primary treatment technique. Ordinal logistic regression assessed the effects of clinical variables on patient disability using 90-day modified Rankin Scale (mRS) scores. Results Adequate revascularization (Thrombolysis in Cerebral Infarction ≥2b) was ultimately achieved in 91.2% of first-line direct aspiration (ADAPT) cases with an average of 1.9±1.9 passes and in 87.5% of stent retriever cases with an average of 1.7±1.0 passes. Time from groin puncture to revascularization was shorter for ADAPT cases. The mean 90-day mRS score for both groups was 3.0±2.4. Number of passes using primary technique, and postintervention intracranial hemorrhage, were significant predictors of 90-day mRS scores after ADAPT, while age and preprocedure mRS score were predictive of outcomes following first-line stent retriever. Conclusions Our data show similar adequate revascularization rates and 90-day functional outcomes for first-line direct aspiration and stent retrievers for anterior large vessel occlusion in a real-world setting. These results support the findings of other prospective trials evaluating the two techniques.
15 citations
TL;DR: Device-induced intra-aneurysmal flow alterations quantified by simple aneurysmal time–density curves can potentially be used to predict long-term outcomes of flow diversion.
Abstract: BackgroundThe recent growth of neuro-endovascular treatment has rekindled interest in the use of angiographic techniques for flow assessment. Aneurysm treatment with flow diverters is particularly ...
TL;DR: The MISTIE III trial did not reach its primary endpoint of improved functional outcome at 1 year, but it did generate a wealth of high-quality data that provide invaluable insight into this devastating disease.
Abstract: On February 7 the results of phase 3 of the Minimally Invasive Surgery Plus rt-PA for Intracerebral Hemorrhage Evacuation (MISTIE III) trial were published in the Lancet .1 The trial did not reach its primary endpoint of improved functional outcome at 1 year. It did, however, generate a wealth of high-quality data that provide invaluable insight into this devastating disease.
MISTIE III was an open-label blinded endpoint trial performed at 78 hospitals in the USA, Canada, Europe, Australia, and Asia that randomized (1:1) 506 patients to minimally invasive surgery or standard medical treatment. Eligible patients presented with a hematoma measuring ≥30 mL, a National Institutes of Health Stroke Scale score ≥6, good baseline status, a CT angiogram negative for an underlying lesion, and a repeat CT demonstrating clot volume stability for at least 6 hours.
Average time to randomization was 47 hours in the surgical group and 46 hours in the medical group. The average time to surgery was 58.3 hours with an average procedural duration of 1 hour. Clinical deterioration led to craniotomy or craniectomy in four patients …
TL;DR: Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis and physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.
Abstract: Background: Cerebrovascular disease is an important cause of cognitive impairment. The aim of this study is to report the relationship between cognitive function and risk factors at baseline and during follow-up in the Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) trial. Methods: Subjects in the SAMMPRIS trial were included in this study. In order to have an assessment of cognitive function independent of stroke, patients with a stroke as a qualifying event whose deficits included aphasia or neglect were excluded from these analyses as were those with a cerebrovascular event during follow-up. The Montreal Cognitive Assessment (MoCA) score was used to assess cognitive impairment at baseline, 4 months, 12 months and closeout. Cognitive impairment was defined as MoCA < 26. A multivariate analysis was performed to determine what risk factors were independent predictors of cognitive function at baseline, 12 months and closeout. Among patients randomized to aggressive medical management only, the percentage of patients with cognitive impairment was compared between patients in versus out of target for each risk factor at 12 months and closeout. Results: Of the 451 patients in SAMMPRIS, 371 patients met the inclusion criteria. MoCA < 26 was present in 55% at baseline. Older age and physical inactivity were associated with cognitive impairment at baseline. Older age, non-white race, lower baseline body mass index, and baseline cognitive impairment were associated with cognitive impairment at 12 months. In the aggressive medical management group, at 12 months, physical inactivity during follow-up was the strongest risk factor associated with cognitive impairment. Conclusion: Cognitive impairment is common in patients with severe symptomatic intracranial atherosclerosis. Physical inactivity at baseline and during follow-up is a strong predictor of cognitive impairment.
TL;DR: The Thrombolysis in Cerebral Infarction (TICI) grading system was first described by Higashida in 20031 and later modified and has been adopted widely but loses relevance when this is not the case.
Abstract: The Thrombolysis in Cerebral Infarction (TICI) grading system was first described by Higashida in 20031 and later modified.2 More recently a 2C grade (near complete, >90%) has been adopted widely (table 1).3 However, this grading system is based on the assumption that the emergent large vessel occlusion (ELVO) involves the M1 segment (or carotid terminus) and loses relevance when this is not the case. Consider a superior division M2 occlusion, for example. Assuming codominant M2 divisions, from the onset of the procedure the TICI grade would be a 2B: an endpoint indicating successful recanalization in the historical literature. If partial M2 recanalization was achieved it may still be graded as a 2B at the conclusion, rendering it impossible to decipher if progress had been made. An alternative approach would be to grade the M2 occlusion a ‘target vessel TICI’ 0. In this manner, at the procedure conclusion, whether it remained a 0 or if it were recanalized …
TL;DR: In this paper, an analysis from the Stenting and Aggressive Medical management for prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial showed that good control of vascular risk factors (systolic blood pressure, low-density lipoprotein, and exercise) was associated with fewer vascular e
Abstract: Background:Analyses from the Stenting and Aggressive Medical management for prevention of Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) trial showed that good control of vascular risk factors (systolic blood pressure, low-density lipoprotein, and exercise) was associated with fewer vascular e