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BackgroundTandem occlusions of the extracranial carotid and intracranial carotid or middle cerebral artery have a particularly poor prognosis without treatment. Several management strategies have been used with no clear consensus recommendations. We examined subjects with tandem occlusions enrolled in the ESCAPE trial and their outcomes.MethodsData are from the ESCAPE trial. Additional data were sought on interventions for each subject.ResultsThere were 54 (17%) subjects with tandem extracranial and intracranial occlusions. Patients in the endovascular treatment arm (n=30) were more likely to be younger (median age 66 years, p<0.01), male (66.7%, p=0.03), diabetic, and without atrial fibrillation. Subjects with tandem occlusions were more likely to have intracranial internal carotid artery occlusions than M1 occlusions (p<0.01). Of the 30 intervention-arm subjects, 17 (57%) underwent emergency endovascular treatment of the extracranial disease, 10 subjects before and seven subjects after intracranial thrombectomy. Of the remaining 13 subjects, only four required staged carotid revascularization due to persistent severe carotid stenosis; four had cervical pseudo-occlusions with no residual stenosis after large distal carotid thrombus burden aspiration/retrieval. Outcomes were similar between subjects with and without tandem lesions. The use of antithrombotic agents after acute carotid artery stenting was variable but no symptomatic intracerebral hemorrhage was seen in subjects who underwent emergency endovascular treatment of extracranial carotid artery.ConclusionsTandem occlusions occurred in one-sixth of patients and were treated highly variably within the ESCAPE trial. While outcomes were similar, the best method to treat the carotid artery in patients with tandem occlusion awaits further randomized data.Trial registration numberNCT01778335.

Abstract BACKGROUND Heterogeneous effect of endovascular aneurysm therapy has been observed across different anatomic locations. There is a paucity of data for stent-assisted coiling of middle cerebral artery (MCA) aneurysms. OBJECTIVE To present the results of the MCA aneurysm group from the Neuroform Atlas (Stryker Neurovascular) investigational device exemption (IDE) trial. METHODS The Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of wide-neck aneurysms (neck ≥ 4 mm or dome-to-neck ratio < 2) in the anterior circulation treated with the Neuroform Atlas Stent and approved coils. Follow-up was obtained immediately postprocedure and 2, 6, and 12 mo postoperatively. We herein describe safety and efficacy outcomes, and functional independence of the subjects with aneurysms from all segments of MCA. RESULTS A total of 35 patients were included (27 MCA bifurcation, 5 M1, 3 M2). The mean aneurysm size was 6.0 ± 1.8 mm, and the mean neck was 4.4 ± 1.2 mm. Technical procedural success was achieved in all patients. A total of 26 patients had follow-up digital subtraction angiography available at 12 mo, with 80.8% (21/26) having complete aneurysm occlusion. Twelve-month safety data were collected for 91.4% (32/35), 8.5% (3/35) had primary safety endpoint, all 3 major ischemic strokes. Mortality occurred in 2 patients beyond 30 d unrelated to procedure (1 gallbladder cancer and 1 fentanyl intoxication). At 1 yr, modified Rankin Score was 0 to 2 in 84.4% (27/32), 3 in 9.4%, and 3 patients were missing. Approximately 5.7% (2/35) of patients were retreated at 12 mo. CONCLUSION Stent-assisted coiling with the Neuroform Atlas Stent is a viable alternative to clipping for selected MCA aneurysms. Complete aneurysm occlusion rates have improved compared to historical data. Proper case selection can lead to acceptable endovascular results. Graphical Abstract Graphical Abstract

Background and objectiveStent-assisted coil embolization is a well-established treatment of intracranial wide-necked aneurysms. The Neuroform Atlas Stent System is a new generation microstent designed to enhance coil support, conformability, deliverability, and improve deployment accuracy. We present the 1-year efficacy and angiographic results of the Humanitarian Device Exemption (HDE) cohort from the Atlas Investigational Device Exemption (IDE) clinical trial.MethodThe Atlas IDE trial is a prospective, multicenter, single-arm, open-label study of unruptured wide-necked intracranial aneurysms treated with the Neuroform Atlas stent and approved coils. The primary efficacy endpoint was the rate of 12-month complete aneurysm angiographic occlusion (Raymond class I) without target aneurysm retreatment or significant parent artery stenosis (>50%) at the target location. The primary safety endpoint was the rate of major ipsilateral stroke or neurological death within 12 months. Imaging core laboratory and Clinical EventsCommittee adjudicated the primary endpoints.Results30 patients were enrolled at eight US centers, with 27 patients completing the 12-month angiographic follow-up. The mean age was 59.4±11.8 years and 24/30 patients (80%) were women. The mean aneurysm size was 5.3±1.7 mm and the dome:neck ratio was 1.1±0.2. Procedural technical success of Neuroform Atlas Stent deployment was 100%. 27 patients completed 12-month angiographic follow-up and 30 patients completed their 6-month follow-up. When applying the last observation carried forward method, the primary efficacy endpoint was observed in 26/30 patients (86.7%, 95% CI 69.3% to 96.2%) compared with 25/27 patients (92.6%, 95% CI 75.7% to 99.1%) who completed the 12-month angiographic follow-up. The primary safety endpoint of stroke occurred in one patient (3.3%), who made a complete clinical recovery at discharge. There were no neurological deaths.ConclusionThe Neuroform Atlas stent in conjunction with coils demonstrated a high rate of complete aneurysm occlusion at 12-month angiographic follow-up, with an improved safety profile in the HDE cohort.Clinical trial.gov registration number NCT0234058;Results

To assess cost-effectiveness of late time-window endovascular treatment (EVT) in a clinical trial setting and a \"real-world\" setting. Data are from the randomized ESCAPE trial and a prospective cohort study (ESCAPE-LATE). Anterior circulation large vessel occlusion patients presenting > 6 hours from last-known-well were included, whereby collateral status was an inclusion criterion for ESCAPE but not ESCAPE-LATE. A Markov state transition model was built to estimate lifetime costs and quality-adjusted life-years (QALYs) for EVT in addition to best medical care vs. best medical care only in a clinical trial setting (comparing ESCAPE-EVT to ESCAPE control arm patients) and a \"real-world\" setting (comparing ESCAPE-LATE to ESCAPE control arm patients). We performed an unadjusted analysis, using 90-day modified Rankin Scale(mRS) scores as model input and analysis adjusted for baseline factors. Acceptability of EVT was calculated using upper/lower willingness-to-pay thresholds of 100,000 USD/50,000 USD/QALY. Two-hundred and forty-nine patients were included (ESCAPE-LATE: = 200, ESCAPE EVT-arm: = 29, ESCAPE control-arm: = 20). Late EVT in addition to best medical care was cost effective in the unadjusted analysis both in the clinical trial and real-world setting, with acceptability 96.6%-99.0%. After adjusting for differences in baseline variables between the groups, late EVT was marginally cost effective in the clinical trial setting (acceptability:49.9%-61.6%), but not the \"real-world\" setting (acceptability:32.9%-42.6%). EVT for LVO-patients presenting beyond 6 hours was cost effective in the clinical trial setting and \"real-world\" setting, although this was largely related to baseline patient differences favoring the \"real-world\" EVT group. After adjusting for these, EVT benefit was reduced in the trial setting, and absent in the real-world setting.

BackgroundBetter reperfusion status results in smaller infarct volumes and better outcomes after thrombectomy. However, if large tissue volumes are already infarcted at baseline, reperfusion might also increase the risk of intracranial hemorrhage. This study aims to investigate the interaction between reperfusion status, baseline ischemic changes, and intracranial hemorrhage following thrombectomy.MethodsRetrospective analysis of the ESCAPE-NA1 randomized trial. Unadjusted and adjusted logistic regression models were used to estimate the associations of Alberta Stroke Program Early CT Score (ASPECTS) and expanded Treatment In Cerebral Infarction (eTICI) score on post-treatment hemorrhage. Treatment effect modification was assessed by including multiplicative interaction terms (ASPECTS*eTICI) in these models.ResultsA total of 1077 patients were included. Median age was 70.8 (IQR 60.7–79.7) and 543 (50.4%) were female. Any intracranial hemorrhage on 24-hour follow-up imaging occurred in 368/1077 (34.2%) patients. There was evidence of modification of the effect of final angiogram eTICI score on any intracranial hemorrhage by baseline ASPECTS (P=0.008). Marginal probabilities showed increased hemorrhage risk for patients with low ASPECTS with increasing final eTICI scores. This association was reversed in patients with small baseline ischemic changes and successful reperfusion. There was no association with symptomatic intracranial hemorrhage or parenchymal hematoma.ConclusionThe association of post-thrombectomy reperfusion status and post-treatment hemorrhage may be modified by the extent of baseline ischemia. Reperfusion is associated with reduced risk of hemorrhage in patients with small baseline infarcts, but increased hemorrhage risk in patients with extensive ischemic changes at baseline. However, no significant association was found with symptomatic intracranial hemorrhage or parenchymal hematoma.Trial registration numberNCT02930018.

ObjectiveThe safety and efficacy of intra-arterial treatment (IAT) in patients with acute ischemic stroke (AIS) due to cervical artery dissection (CeAD) has not been formally studied. The purpose of this study was twofold: first, describe a large series with CeAD treated with IAT; second, analyze outcomes with CeAD receiving IAT versus (a) CeAD not treated with IAT, (b) CeAD receiving intravenous thrombolysis (IVT) alone, and (c) non-CeAD mechanism of AIS receiving IAT.DesignDemographics, clinical characteristics, treatment, and outcomes were summarized for all CeAD patients treated with IAT from January 2010 to May 2015. Outcomes included favorable 90 day modified Rankin Scale (mRS) score of 0–2, symptomatic intracerebral hemorrhage (sICH), recanalization (Thrombolysis in Cerebral Infarction 2b-3), procedural complications, and mortality. Outcomes were analyzed with χ2 tests and multivariate logistic regression.ResultsThere were 161 patients with CeAD: 24 were treated with IAT and comprised our target population. Dissections were more common in the internal carotid (n=18) than in the vertebral arteries (n=6). All but one patient had intracranial embolus. IAT techniques included thrombectomy (n=19), IA thrombolysis (n=17), stent (n=14), and angioplasty (n=7). Outcomes included favorable 90 day mRS score of 0–2 in 63%, 4 deaths, 1 sICH, and 3 procedural complications. After adjustment, favorable mRS in our target population was similar to comparison populations: (a) in CeAD, IAT versus no IAT (OR 0.62, p=0.56); (b) In CeAD, IAT versus IVT alone (OR 1.32, p=0.79); and (c) IAT in CeAD versus non-CeAD mechanism of AIS (OR 0.58, p=0.34).ConclusionsIAT is a valid alternative therapeutic option for AIS caused by CeAD due to the low complication rate and excellent outcomes observed in this study.

Background and purposeIntra-arterial therapy (IAT) is most effective when performed rapidly after ischemic stroke onset. However, there are limited performance benchmarks in IAT and there is a scarcity of information on how to structure an effective IAT protocol and its impact on time to treatment. The objective of our study was to detail a standardized IAT protocol, and to assess its influence on time to treatment in ischemic stroke.MethodsThis was a retrospective observational study over 4 years at a comprehensive stroke center. A standardized IAT protocol was implemented in June 2013 that included pre-notifying the stroke team before hospital arrival, defining clinician roles, processing tasks in parallel, and standardizing IAT procedures. Three time metrics were examined and reported as median (IQR) minutes: arrival to CT imaging, CT to groin puncture, and puncture to recanalization. We compared these metrics in patients admitted before implementation (January 2012–May 2013) to patients admitted after (June 2013–December 2015) using Wilcoxon Mann–Whitney tests.Results380 patients were included. After the protocol was implemented, there were significant reductions in time from arrival to CT (17 (14–21) vs 13 (11–19) min, p<0.001), CT to puncture (46 (30–82) vs 31 (23–54) min, p<0.001), and puncture to recanalization (65 (33–90) vs 37 (22–65) min, p<0.001). 60% of time was saved during puncture to recanalization. Significant reductions in time were observed during both normal working hours and off-hours.ConclusionsImplementation of a standardized protocol resulted in a significant reduction in time to recanalization for patients with an ischemic stroke. A standardized IAT protocol decreases time to recanalization when team roles are clearly defined, tasks are processed in parallel, and procedures are standardized.

Background and purposeThe purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application.MethodsA retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial.ResultsA total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not.ConclusionInitial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

Stent retriever thrombectomy of large-vessel occlusion results in better outcomes than medical therapy alone. Alternative thrombectomy strategies, particularly a direct aspiration as first pass technique, while promising, have not been rigorously assessed for clinical efficacy in randomised trials. We designed COMPASS to assess whether patients treated with aspiration as first pass have non-inferior functional outcomes to those treated with a stent retriever as first line. We did a multicentre, randomised, open label, blinded outcome, core lab adjudicated non-inferiority trial at 15 sites (ten hospitals and four specialty clinics in the USA and one hospital in Canada). Eligible participants were patients presenting with acute ischaemic stroke from anterior circulation large-vessel occlusion within 6 h of onset and an Alberta Stroke Program Early CT Score of greater than 6. We randomly assigned participants (1:1) via a central web-based system without stratification to either direct aspiration first pass or stent retriever first line thrombectomy. Those assessing primary outcomes via clinical examinations were masked to group assignment as they were not involved in the procedures. Physicians were allowed to use adjunctive technology as was consistent with their standard of care. The null hypothesis for this study was that patients treated with aspiration as first pass achieve inferior outcomes compared with those treated with a stent retriever first line approach. The primary outcome was non-inferiority of clinical functional outcome at 90 days as measured by the percentage of patients achieving a modified Rankin Scale score of 0–2, analysed by intent to treat; non-inferiority was established with a margin of 0·15. All randomly assigned patients were included in the safety analyses. This trial is registered at ClinicalTrials.gov, number: NCT02466893. Between June 1, 2015, and July 5, 2017, we assigned 270 patients to treatment: 134 to aspiration first pass and 136 to stent retriever first line. A modified Rankin score of 0–2 at 90 days was achieved by 69 patients (52%; 95% CI 43·8–60·3) in the aspiration group and 67 patients (50%; 41·6–57·4) in the stent retriever group, showing that aspiration as first pass was non-inferior to stent retriever first line (pnon-inferiority=0·0014). Intracranial haemorrhage occurred in 48 (36%) of 134 in the aspiration first pass group, and 46 (34%) of 135 in the stent retriever first line group. All-cause mortality at 3 months occurred in 30 patients (22%) in both groups. A direct aspiration as first pass thrombectomy conferred non-inferior functional outcome at 90 days compared with stent retriever first line thrombectomy. This study supports the use of direct aspiration as an alternative to stent retriever as first-line therapy for stroke thrombectomy. Penumbra.

In a large meta-analysis of 27 MI trials, 4 a strong relationship between PCI-related time delay and benefits from primary angioplasty was observed in high-risk patients (r=-0.50, [beta]=-0.075 (95% CI -0.189 to 0.04)), with 131 min as the equipoint between PCI and medical therapies. [...]for every 10 min reduction in time to PCI, MI mortality was also reduced. 4 In a prospective PCI trial investigating the relationship between time and outcome, patients randomized <2 h after symptom onset demonstrated a strong trend towards a lower 30-day death rate with PCI than with medical treatment (2.2% vs 5.7%, p=0.058), with no difference observed in those randomized after 2 h. 5 A similar emphasis on time to treatment in AIS studies has also been demonstrated. 6-9 In a collaborative pooled analysis of seven AIS endovascular therapy databases, the impact of onset-to-reperfusion time (in large artery occlusions) on outcomes was assessed. [...]comprehensive studies, guidelines and recommendations are lacking for endovascular therapy time intervals. 13 Hence, considerable effort is needed to streamline the complex organization of personnel and resources involved in delivering endovascular therapy, which poses an even greater challenge in identifying benchmark times. 11 Insight to improving our processes can be borrowed from other industries.