Five trials that investigated the efficacy of modern endovascular therapies for stroke--MR CLEAN, ESCAPE, SWIFT PRIME, EXTEND IA and REVASCAT--have been published within the past year, changing the ...landscape of acute stroke management. The trials used a variety of imaging modalities and combinations of treatment approaches, including the mandatory use of intravenous thrombolysis before the initiation of endovascular therapy. All five trials provided strong evidence to support the use of thrombectomy that is initiated within 6 h of stroke onset, prompting worldwide changes in the guidelines for management of acute stroke by endovascular treatment. The benefits of endovascular therapy were observed irrespective of a patient's age, their NIH Stroke Scale score, or whether they received intravenous thrombolysis. In this article, we review the main findings of these recent trials, focusing on key aspects of their designs, and discuss their impact on the future management of patients with acute stroke that results from large-vessel occlusion. We discuss the values of noncontrast CT ASPECTS, perfusion imaging and angiography for selecting patients to receive endovascular interventions. We also consider the role of thrombectomy beyond 6 h after stroke onset, and in patients with posterior circulation strokes.
Mechanical thrombectomy (MT) became the "gold-standard" treatment for most patients with acute ischemic stroke due to anterior circulation large vessel occlusion. With such a remarkable paradigm ...shift, it is important that this modality of treatment becomes widely and homogeneously available throughout the United States and other countries. Although the time window for MT is large (24 hours in selected patients), time is still a major determinant of outcome. Several variables are involved in achieving timely access of MT for the majority of the population: prehospital management systems, transportation models, in-hospital workflow organization, accreditation and infrastructure of centers, training of neurointervention professionals, and geographic distribution of centers. The current situation in the United States regarding MT access is marked by geographic and socioeconomic disparities. We provide an overview of current challenges and solutions in achieving more universal access to MT for the population.
OBJECTIVE The long-term effectiveness of endovascular treatment of large and giant wide-neck aneurysms using traditional endovascular techniques has been disappointing, with high recanalization and ...re-treatment rates. Flow diversion with the Pipeline Embolization Device (PED) has been recently used as a stand-alone therapy for complex aneurysms, showing significant improvement in effectiveness while demonstrating a similar safety profile to stent-supported coil treatment. However, relatively little is known about its long-term safety and effectiveness. Here the authors report on the 3-year safety and effectiveness of flow diversion with the PED in a prospective cohort of patients with large and giant internal carotid artery aneurysms enrolled in the Pipeline for Uncoilable or Failed Aneurysms (PUFS) trial. METHODS The PUFS trial is a prospective study of 107 patients with 109 aneurysms treated with the PED. Primary effectiveness and safety end points were demonstrated based on independently monitored 180-day clinical and angiographic data. Patients were enrolled in a long-term follow-up protocol including 1-, 3-, and 5-year clinical and imaging follow-up. In this paper, the authors report the midstudy (3-year) effectiveness and safety data. RESULTS At 3 years posttreatment, 74 subjects with 76 aneurysms underwent catheter angiography as required per protocol. Overall, complete angiographic aneurysm occlusion was observed in 71 of these 76 aneurysms (93.4% cure rate). Five aneurysms were re-treated, using either coils or additional PEDs, for failure to occlude, and 3 of these 5 were cured by the 3-year follow-up. Angiographic cure with one or two treatments of Pipeline embolization alone was therefore achieved in 92.1%. No recanalization of a previously completely occluded aneurysm was noted on the 3-year angiograms. There were 3 (2.6%) delayed device- or aneurysm-related serious adverse events, none of which led to permanent neurological sequelae. No major or minor late-onset hemorrhagic or ischemic cerebrovascular events or neurological deaths were observed in the 6-month through 3-year posttreatment period. Among 103 surviving patients, 85 underwent functional outcome assessment in which modified Rankin Scale scores of 0-1 were demonstrated in 80 subjects. CONCLUSIONS Pipeline embolization is safe and effective in the treatment of complex large and giant aneurysms of the intracranial internal carotid artery. Unlike more traditional endovascular treatments, flow diversion results in progressive vascular remodeling that leads to complete aneurysm obliteration over longer-term follow-up without delayed aneurysm recanalization and/or growth. Clinical trial registration no.: NCT00777088 (clinicaltrials.gov).
To critically review and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type ...plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning these eligibility criteria, which could potentially expand the safe and judicious use of alteplase and improve outcomes after stroke.
Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association Stroke Council's Scientific Statement Oversight Committee and the American Heart Association's Manuscript Oversight Committee. The writers used systematic literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge and, when appropriate, formulated recommendations using standard American Heart Association criteria. All members of the writing group had the opportunity to comment on and approved the final version of this document. The document underwent extensive American Heart Association internal peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the American Heart Association Science Advisory and Coordinating Committee.
After a review of the current literature, it was clearly evident that the levels of evidence supporting individual exclusion criteria for intravenous alteplase vary widely. Several exclusionary criteria have already undergone extensive scientific study such as the clear benefit of alteplase treatment in elderly stroke patients, those with severe stroke, those with diabetes mellitus and hyperglycemia, and those with minor early ischemic changes evident on computed tomography. Some exclusions such as recent intracranial surgery are likely based on common sense and sound judgment and are unlikely to ever be subjected to a randomized, clinical trial to evaluate safety. Most other contraindications or warnings range somewhere in between. However, the differential impact of each exclusion criterion varies not only with the evidence base behind it but also with the frequency of the exclusion within the stroke population, the probability of coexistence of multiple exclusion factors in a single patient, and the variation in practice among treating clinicians.
Studies have begun investigating grit (continued fortitude in the face of hardship) and resilience (ability to recover from a setback) and their relationship to burnout (emotional exhaustion EE ...caused by prolonged stress or frustration) within medicine. We investigated the prevalence of burnout among neurosurgery residents and aimed to determine the relationship among burnout, grit, and resilience.
We surveyed U.S. neurosurgical residents to perform a discretional analysis of prevalence of burnout. Multivariate analysis was performed to determine which variables were associated with higher and lower levels of EE, depersonalization (DP), personal accomplishment (PA), burnout, grit, and resilience.
Of 1385 U.S. neurosurgery residents, 427 (30.8%) responded to our survey. Burnout prevalence was 33.0% (95% confidence interval, 28.6%–37.7%). High grit was associated with U.S. graduates (P = 0.006), married residents (P = 0.025), and fewer social/personal stressors (P = 0.003). Lower resilience was associated with female sex (P = 0.006), whereas higher resilience was associated with international medical graduates (P = 0.017) and fewer social/personal stressors (P = 0.005). High burnout was associated with greater social/personal stressors (P = 0.002), clinical rotations (P = 0.001), and lack of children (P = 0.016). There were positive correlations between EE and DP and among PA, grit, and resilience. There were negative correlations for EE and DP with PA, grit, and resilience and between grit/resilience and burnout.
There is an inverse relationship between grit/resilience and burnout. Increased social/personal stressors are associated with increased levels of burnout and decreased grit and resilience. Grit and resilience are higher when social and personal stressors are decreased, indicating that these characteristics may fluctuate over time.
Flow diversion for posterior circulation aneurysms performed using the Pipeline embolization device (PED) constitutes an increasingly common off-label use for otherwise untreatable aneurysms. The ...safety and efficacy of this treatment modality has not been assessed in a multicenter study.
A retrospective review of prospectively maintained databases at 8 academic institutions was performed for the years 2009 to 2016 to identify patients with posterior circulation aneurysms treated with PED placement.
A total of 129 consecutive patients underwent 129 procedures to treat 131 aneurysms; 29 dissecting, 53 fusiform, and 49 saccular lesions were included. At a median follow-up of 11 months, complete and near-complete occlusion was recorded in 78.1%. Dissecting aneurysms had the highest occlusion rate and fusiform the lowest. Major complications were most frequent in fusiform aneurysms, whereas minor complications occurred most commonly in saccular aneurysms. In patients with saccular aneurysms, clopidogrel responders had a lower complication rate than did clopidogrel nonresponders. The majority of dissecting aneurysms were treated in the immediate or acute phase following subarachnoid hemorrhage, a circumstance that contributed to the highest mortality rate in those aneurysms.
In the largest series to date, fusiform aneurysms were found to have the lowest occlusion rate and the highest frequency of major complications. Dissecting aneurysms, frequently treated in the setting of subarachnoid hemorrhage, occluded most often and had a low complication rate. Saccular aneurysms were associated with predominantly minor complications, particularly in clopidogrel nonresponders.
Abstract
BACKGROUND
A simple dimensionless aneurysm number ($An$), which depends on geometry and flow pulsatility, was previously shown to distinguish the flow mode in intracranial aneurysms (IA): ...vortex mode with a dynamic vortex formation/evolution if $An > 1$, and cavity mode with a steady shear layer if $An < 1$.
OBJECTIVE
To hypothesize that $An\ > \ 1$ can distinguish rupture status because vortex mode is associated with high oscillatory shear index, which, in turn, is statistically associated with rupture.
METHODS
The above hypothesis is tested on a retrospective, consecutively collected database of 204 patient-specific IAs. The first 119 cases are assigned to training and the remainder to testing dataset. $An$ is calculated based on the pulsatility index (PI) approximated either from the literature or solving an optimization problem (denoted as$\ \widehat {PI}$). Student's t-test and logistic regression (LR) are used for hypothesis testing and data fitting, respectively.
RESULTS
$An$
can significantly discriminate ruptured and unruptured status with 95% confidence level (P < .0001). $An$ (using PI) and $\widehat {An}$ (using $\widehat {PI}$) significantly predict the ruptured IAs (for training dataset $An\!:\ $AUC = 0.85, $\widehat {An}\!:\ $AUC = 0.90, and for testing dataset $An\!:\ $sensitivity = 94%, specificity = 33%, $\widehat {An}\!:\ $sensitivity = 93.1%, specificity = 52.85%).
CONCLUSION
$An > 1$
predicts ruptured status. Unlike traditional hemodynamic parameters such as wall shear stress and oscillatory shear index, $An$ has a physical threshold of one (does not depend on statistical analysis) and does not require time-consuming flow simulations. Therefore, $An$ is a simple, practical discriminator of IA rupture status.
We aimed to evaluate how predefined candidate cerebral perfusion parameters correlate with collateral circulation status and to assess their capacity to predict infarct growth in patients with acute ...ischemic stroke (AIS) eligible for endovascular therapy. Patients enrolled in the SWIFT PRIME trial with baseline computed tomography perfusion (CTP) scans were included. RAPID software was used to calculate mean relative cerebral blood volume (rCBV) in hypoperfused regions, and hypoperfusion index ratio (HIR). Blind assessments of collaterals were performed using CT angiography in the whole sample and cerebral angiogram in the endovascular group. Reperfusion was assessed on 27-h CTP; infarct volume was assessed on 27-h magnetic resonance imaging/CT scans. Logistic and rank linear regression models were conducted. We included 158 patients. High rCBV (p = 0.03) and low HIR (p = 0.03) were associated with good collaterals. A positive association was found between rCBV and better collateral grades on cerebral angiography (p = 0.01). Baseline and 27-h follow-up CTP were available for 115 patients, of whom 74 (64%) achieved successful reperfusion. Lower rCBV predicted a higher infarct growth in successfully reperfused patients (p = 0.038) and in the endovascular treatment group (p = 0.049). Finally, rCBV and HIR may serve as markers of collateral circulation in AIS patients prior to endovascular therapy.
Clinical Trial Registration: Unique identifier: NCT0165746.
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.
Patients with posterior circulation strokes have been excluded from recent randomized endovascular stroke trials. We reviewed the recent multicenter experience with endovascular treatment of ...posterior circulation strokes to identify the clinical, radiographic, and procedural predictors of successful recanalization and good neurological outcomes.
We performed a multicenter retrospective analysis of consecutive patients with posterior circulation strokes, who underwent thrombectomy with stent retrievers or primary aspiration thrombectomy (including A Direct Aspiration First Pass Technique ADAPT approach). We correlated clinical and radiographic outcomes with demographic, clinical, and technical characteristics.
A total of 100 patients were included in the final analysis (mean age, 63.5±14.2 years; mean admission National Institutes of Health Stroke Scale score, 19.2±8.2). Favorable clinical outcome at 3 months (modified Rankin Scale score ≤2) was achieved in 35% of patients. Successful recanalization and shorter time from stroke onset to the start of the procedure were significant predictors of favorable clinical outcome at 90 days. Stent retriever and aspiration thrombectomy as primary treatment approaches showed comparable procedural and clinical outcomes. None of the baseline advanced imaging modalities (magnetic resonance imaging, computed tomographic perfusion, or computed tomography angiography assessment of collaterals) showed superiority in selecting patients for thrombectomy.
Time to the start of the procedure is an important predictor of clinical success after thrombectomy in patients with posterior circulation strokes. Both stent retriever and aspiration thrombectomy as primary treatment approaches are effective in achieving successful recanalization.
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