Physician Transfer Versus Patient Transfer for Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis.

BACKGROUND: Physician transfer is an alternate option to patient transfer for expedient performance of mechanical thrombectomy in patients with acute ischemic stroke. METHODS AND RESULTS: We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechanical thrombectomy. A search of PubMed, Scopus, and Web of Science was undertaken, and data were extracted. A statistical pooling with random-effects meta-analysis was performed to examine the odds of reduced time interval between stroke onset and recanalization, functional independence, death, and angiographic recanalization. A total of 12 studies (11 nonrandomized observational studies and 1 nonrandomized controlled trial) were included, with a total of 1894 patients. Physician transfer was associated with a significantly shorter time interval between stroke onset and recanalization with a pooled mean difference estimate of -62.08 (95% CI, -112.56 to -11.61]; P=0.016; 8 studies involving 1419 patients) with high between-study heterogeneity in the estimates (I2=90.6%). The odds for functional independence at 90 days were significantly higher (odds ratio, 1.29 [95% CI, 1.00-1.66]; P=0.046; 7 studies with 1222 patients) with physician transfer with low between-study heterogeneity (I2=0%). Physician transfer was not associated with higher odds of near-complete or complete angiographic recanalization (odds ratio, 1.18 [95% CI, 0.89-1.57; P=0.25; I2=2.8%; 11 studies with 1856 subjects). CONCLUSIONS: Physician transfer was associated with a significant reduction in the mean of time interval between symptom onset and recanalization and increased odds for functional independence at 90 days with physician transfer compared with patient transfer among patients who undergo mechanical thrombectomy.

Self-expanding versus balloon expandable stent for intracranial arterial stenosis: A systematic review and meta-analysis.

BACKGROUND AND PURPOSE: There are limited data regarding the comparison of balloon expandable stents (BES) and self-expanding stents (SES) for the treatment of intracranial arterial stenosis. METHODS: We conducted a systematic review to identify studies that compared SES and BES in patients with symptomatic intracranial arterial stenosis. Data were extracted from relevant studies found through a search of PubMed, Scopus, and Web of Science until from January 1, 2010 to September 28, 2023. Statistical pooling with random-effects meta-analysis was undertaken to compare the rates/severity of postprocedure stenosis, technical success, 30-day stroke and/or death, cumulative clinical endpoints, and restenosis rates. RESULTS: A total of 20 studies were included. The standardized mean difference (SMD) for postprocedure stenosis (%) was significantly lower (SMD: -0.52, 95% confidence interval [CI]: -0.79 to -0.24, p < .001, 10 studies involving 1515 patients) with BES. The odds for 30-day stroke and/or death were significantly lower (odds ratio [OR] 0.68, 95% CI: 0.50-0.94, p = .019, 15 studies involving 2431 patients), and cumulative clinical endpoints on follow-up were nonsignificantly lower (OR 0.64, 95% CI: 0.30-1.37, p = .250, 10 studies involving 947 patients) with BES. The odds for restenosis during follow-up were significantly lower (OR 0.50, 95% CI: 0.31-0.80, p = .004, 13 studies involving 1115 patients) with BES. CONCLUSIONS: Compared with SES, BES were associated with lower rates of postprocedure 30-day stroke and/or death with lower rates of restenosis during follow up and the treatment of symptomatic intracranial arterial stenosis.

Acute ischemic stroke patients admitted to hospitals that perform percutaneous coronary interventions in the United States.

BACKGROUND: We explored the potential of mechanical thrombectomy (MT) for acute ischemic stroke patients at hospitals that perform percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) in the United States. METHODS: We analyzed nationally representative data between 2017 and 2020 to determine the numbers, characteristics, and outcomes of acute ischemic stroke patients admitted to hospitals that perform both primary PCI and MT, hospitals that perform primary PCI but not MT and hospitals that perform neither PCI or MT. Multiple logistic regressions were performed to evaluate the effect of hospital type on in-hospital mortality and discharge home (without palliative care). RESULTS: A total of 1,210,415, 1,002,950, and 488,845 acute ischemic stroke patients were admitted to hospitals that performed both primary PCI and MT, performed primary PCI but not MT, or performed neither PCI nor MT, respectively. Compared with hospitals that performed both PCI and MT, the odds of in-hospital mortality were lower in hospitals that performed PCI only (odds ratio (OR) 0.88 95 % confidence interval (CI) 0.86-0.91, p<0.001) and hospitals that performed neither PCI or MT (OR 0.85 95 %CI 0.82-0.89, p<0.0010). There was no significant difference in the odds of discharge home between the three types of hospitals. CONCLUSIONS: Almost 37 % the patients with acute ischemic stroke are admitted to hospitals that perform primary PCI (but not MT) supporting strategies to increase the performance of MT in such hospitals as an option to increase rapid availability of MT in the United States.

New cardiovascular events in the convalescent period among survivors of SARS-CoV-2 infection.

BACKGROUND: Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection may have an increased risk of acute cardiovascular events in the convalescent period. AIMS: To determine whether patients with SARS-CoV-2 infection have an increased risk of cardiovascular events during the convalescent period. METHODS: We analyzed 10,691 hospitalized adult pneumonia patients with SARS-CoV-2 infection and contemporary matched controls of pneumonia patients without SARS-CoV-2 infection. The risk of new cardiovascular events following >30 days pneumonia admission (convalescent period) was ascertained using Cox proportional hazards regression analysis to adjust for potential confounders. RESULTS: Among 10,691 pneumonia patients with SARS-CoV-2 infection, 697 patients (5.8%; 95% CI, 5.4-6.2%) developed new cardiovascular events (median time interval of 218 days post pneumonia admission; interquartile range Q1 = 117 days, Q3 = 313 days). The risk of new cardiovascular events was not significantly higher among pneumonia patients with SARS-CoV-2 infection compared with those with pneumonia without SARS-CoV-2 infection (hazard ratio (HR), 0.90, 95% CI, 0.80-1.02) after adjustment for potential confounders. In addition, no significant difference in the rate of a new ischemic stroke (HR, 0.84; 95% CI, 0.70-1.02) or ischemic heart disease (HR, 1.00; 95% CI, 0.87-1.15) was observed between the pneumonia patients with and without SARS-CoV-2 infection. CONCLUSION: Our study suggests that new cardiovascular events rate in the convalescent period among pneumonia patients with SARS-CoV-2 infection was not significantly higher than the rate seen with other pneumonias.

Annual Direct Cost of Dysphagia Associated with Acute Ischemic Stroke in the United States.

BACKGROUND: Dysphagia after acute ischemic stroke is frequent and increases the risk of pneumonia, insertion of feeding tube, hospital length-of-stay and rates of discharge to institutional care. However, the financial impact of dysphagia after acute ischemic stroke is not well understood. METHODS: Estimates were derived from published medical and economic literature to provide a range of estimates for the annual direct hospital cost of dysphagia associated with acute ischemic stroke in the United States. We also estimated the cost savings associated with a hypothetical new therapeutic intervention under a variety of assumptions. RESULTS: The 1-year costs per patient of acute hospital and post hospitalization care were $67,100 to $112,400 in acute ischemic stroke patient with dysphagia and $54,0310 to $51,979.8 in acute ischemic stroke patient without dysphagia in the two models. The estimated incremental cost in United States for ischemic stroke patients with dysphagia was $ 4,610,038,961.13 (95% confidence interval [CI] $3,796,502,674-$5,423,575,248) according to assumptions of Model 1. The estimated incremental cost in United States for ischemic stroke patients with dysphagia was $ 20,114,218,586.23 (95% CI $16564650600.42-$23663786572.04) according to assumptions of Model 2. The cost savings per year with a new therapeutic intervention ranged from $509,444,886.6 to $3,601,651,036 depending upon the magnitude of benefit. CONCLUSION: Our analysis provides additional justification using financial basis for a much larger investment in research and development for treatment of dysphagia associated with ischemic stroke.

Acute Ischemic Stroke and COVID-19: An Analysis of 27 676 Patients.

BACKGROUND AND PURPOSE: Acute ischemic stroke may occur in patients with coronavirus disease 2019 (COVID-19), but risk factors, in-hospital events, and outcomes are not well studied in large cohorts. We identified risk factors, comorbidities, and outcomes in patients with COVID-19 with or without acute ischemic stroke and compared with patients without COVID-19 and acute ischemic stroke. METHODS: We analyzed the data from 54 health care facilities using the Cerner deidentified COVID-19 dataset. The dataset included patients with an emergency department or inpatient encounter with discharge diagnoses codes that could be associated to suspicion of or exposure to COVID-19 or confirmed COVID-19. RESULTS: A total of 103 (1.3%) patients developed acute ischemic stroke among 8163 patients with COVID-19. Among all patients with COVID-19, the proportion of patients with hypertension, diabetes, hyperlipidemia, atrial fibrillation, and congestive heart failure was significantly higher among those with acute ischemic stroke. Acute ischemic stroke was associated with discharge to destination other than home or death (relative risk, 2.1 [95% CI, 1.6-2.4]; P<0.0001) after adjusting for potential confounders. A total of 199 (1.0%) patients developed acute ischemic stroke among 19 513 patients without COVID-19. Among all ischemic stroke patients, COVID-19 was associated with discharge to destination other than home or death (relative risk, 1.2 [95% CI, 1.0-1.3]; P=0.03) after adjusting for potential confounders. CONCLUSIONS: Acute ischemic stroke was infrequent in patients with COVID-19 and usually occurs in the presence of other cardiovascular risk factors. The risk of discharge to destination other than home or death increased 2-fold with occurrence of acute ischemic stroke in patients with COVID-19.

Early mandated social distancing is a strong predictor of reduction in peak daily new COVID-19 cases.

OBJECTIVES: Mandated social distancing has been applied globally to reduce the spread of coronavirus disease 2019 (COVID-19). However, the beneficial effects of this community-based intervention have not been proven or quantified for the COVID-19 pandemic. STUDY DESIGN: This is a regional population-level observational study. METHODS: Using publicly available data, we examined the effect of timing of mandated social distancing on the rate of COVID-19 cases in 119 geographic regions, derived from 41 states within the United States and 78 other countries. The highest number of new COVID-19 cases per day recorded within a geographic unit was the primary outcome. The total number of COVID-19 cases in regions where case numbers had reached the tail end of the outbreak was an exploratory outcome. RESULTS: We found that the highest number of new COVID-19 cases per day per million persons was significantly associated with the total number of COVID-19 cases per million persons on the day before mandated social distancing (ß = 0.66, P < 0.0001). These findings suggest that if mandated social distancing is not initiated until the number of existing COVID-19 cases has doubled, the eventual peak would result in 58% more COVID-19 cases per day. Subgroup analysis on those regions where the highest number of new COVID-19 cases per day has peaked showed increase in ß values to 0.85 (P < 0.0001). The total number of cases during the outbreak in a region was strongly predicted by the total number of COVID-19 cases on the day before mandated social distancing (ß = 0.97, P < 0.0001). CONCLUSIONS: Initiating mandated social distancing when the numbers of COVID-19 cases are low within a region significantly reduces the number of new daily COVID-19 cases and perhaps also reduces the total number of cases in the region.

Changes in Neuroendovascular Procedural Volume During the COVID-19 Pandemic: An International Multicenter Study.

BACKGROUND AND PURPOSE: The effect of coronavirus disease 2019 (COVID-19) pandemic on performance of neuroendovascular procedures has not been quantified. METHODS: We performed an audit of performance of neuroendovascular procedures at 18 institutions (seven countries) for two periods; January-April 2019 and 2020, to identify changes in various core procedures. We divided the region where the hospital was located based on the median value of total number of COVID-19 cases per 100,00 population-into high and low prevalent regions. RESULTS: Between 2019 and 2020, there was a reduction in number of cerebral angiograms (30.9% reduction), mechanical thrombectomy (8% reduction), carotid artery stent placement for symptomatic (22.7% reduction) and asymptomatic (43.4% reduction) stenoses, intracranial angioplasty and/or stent placement (45% reduction), and endovascular treatment of unruptured intracranial aneurysms (44.6% reduction) and ruptured (22.9% reduction) and unruptured brain arteriovenous malformations (66.4% reduction). There was an increase in the treatment of ruptured intracranial aneurysms (10% increase) and other neuroendovascular procedures (34.9% increase). There was no relationship between procedural volume change and intuitional location in high or low COVID-19 prevalent regions. The procedural volume reduction was mainly observed in March-April 2020. CONCLUSIONS: We provided an international multicenter view of changes in neuroendovascular practices to better understand the gaps in provision of care and identify individual procedures, which are susceptible to change.

Development, behaviour and sensory processing in Marshall-Smith syndrome and Malan syndrome: phenotype comparison in two related syndromes.

BACKGROUND: Ultrarare Marshall-Smith and Malan syndromes, caused by changes of the gene nuclear factor I X (NFIX), are characterised by intellectual disability (ID) and behavioural problems, although questions remain. Here, development and behaviour are studied and compared in a cross-sectional study, and results are presented with genetic findings. METHODS: Behavioural phenotypes are compared of eight individuals with Marshall-Smith syndrome (three male individuals) and seven with Malan syndrome (four male individuals). Long-term follow-up assessment of cognition and adaptive behaviour was possible in three individuals with Marshall-Smith syndrome. RESULTS: Marshall-Smith syndrome individuals have more severe ID, less adaptive behaviour, more impaired speech and less reciprocal interaction compared with individuals with Malan syndrome. Sensory processing difficulties occur in both syndromes. Follow-up measurement of cognition and adaptive behaviour in Marshall-Smith syndrome shows different individual learning curves over time. CONCLUSIONS: Results show significant between and within syndrome variability. Different NFIX variants underlie distinct clinical phenotypes leading to separate entities. Cognitive, adaptive and sensory impairments are common in both syndromes and increase the risk of challenging behaviour. This study highlights the value of considering behaviour within developmental and environmental context. To improve quality of life, adaptations to environment and treatment are suggested to create a better person-environment fit.

Mandated societal lockdown and road traffic accidents.

BACKGROUND: The effect of mandated societal lockdown to reduce the transmission of coronavirus disease 2019 (COVID-19) on road traffic accidents is not known. For this reason, we performed an in-depth analysis using data from Statewide Traffic Accident Records System. MATERIALS AND METHODS: We reviewed data on total 2292 road traffic accident records in Missouri from January 1, 2020 through May 15, 2020. We treated March 23 as the first day of mandated societal lockdown and May 3 as the first day of re-opening. RESULTS: We have found that there was a significant reduction in road traffic accidents resulting in minor or no injuries (mean 14.5 versus 10.8, p < 0.0001) but not in accidents resulting in serious or fatal injuries (mean 3.4 versus 3.7, p = 0.42) after mandated societal lockdown. Furthermore, there was a significant reduction in road traffic accidents resulting in minor or no injuries after the mandated social lockdown (parameter estimate -5.9, p = 0.0028) in the time series analysis. There was an increase in road traffic accidents resulting in minor or no injuries after expiration of mandatory societal lockdown (mean 10.8 versus 13.7, p = 0.04). CONCLUSION: The mandated societal lockdown policies led to reduction in road traffic accidents resulting in non-serious or no injuries but not those resulting in serious or fatal injuries.

Hyperglycemia, duration of diabetes, and intracranial atherosclerotic stenosis by magnetic resonance angiography: The ARIC-NCS study.

AIMS: The association of hyperglycemia and duration of diabetes with intracranial atherosclerotic stenosis (ICAS) in the general population is not well documented. We examined whether elevated glucose and longer diabetes duration is independently associated with ICAS in a community-based sample. METHODS: We cross-sectionally analyzed 1644 participants (age 67-90 years) of the Atherosclerosis Risk in Communities Study who underwent cerebrovascular magnetic resonance angiography in 2011-13. We applied multivariable ordinal logistic regression to evaluate the association of ICAS category ("no stenosis", "stenosis <50%", or "stenosis ≥50%") with glucose or diabetes duration (<10, 10 to 20, and ≥20 years). We also obtained the corresponding odds ratios applying inverse-probability weighting to account for potential selection bias due to attrition. RESULTS: Compared to non-diabetic participants in the lowest glucose quartile, the weighted odds ratios (95% confidence interval) of higher ICAS category were 1.88 (1.18, 3.00) and 2.01 (1.08, 3.72) for non-diabetic and diabetic participants in the corresponding highest glucose quartile, respectively. We observed significant positive trends of ICAS across diabetes duration categories in unweighted, but not in weighted, analyses. CONCLUSIONS: Hyperglycemia and longer duration of diabetes were independently associated with ICAS, suggesting the importance of maintaining glycemic control to prevent stroke.

Management of acute ischemic stroke in patients with COVID-19 infection: Report of an international panel.

BACKGROUND AND PURPOSE: On 11 March 2020, World Health Organization (WHO) declared the COVID-19 infection a pandemic. The risk of ischemic stroke may be higher in patients with COVID-19 infection similar to those with other respiratory tract infections. We present a comprehensive set of practice implications in a single document for clinicians caring for adult patients with acute ischemic stroke with confirmed or suspected COVID-19 infection. METHODS: The practice implications were prepared after review of data to reach the consensus among stroke experts from 18 countries. The writers used systematic literature reviews, reference to previously published stroke guidelines, personal files, and expert opinion to summarize existing evidence, indicate gaps in current knowledge, and when appropriate, formulate practice implications. All members of the writing group had opportunities to comment in writing on the practice implications and approved the final version of this document. RESULTS: This document with consensus is divided into 18 sections. A total of 41 conclusions and practice implications have been developed. The document includes practice implications for evaluation of stroke patients with caution for stroke team members to avoid COVID-19 exposure, during clinical evaluation and performance of imaging and laboratory procedures with special considerations of intravenous thrombolysis and mechanical thrombectomy in stroke patients with suspected or confirmed COVID-19 infection. CONCLUSIONS: These practice implications with consensus based on the currently available evidence aim to guide clinicians caring for adult patients with acute ischemic stroke who are suspected of, or confirmed, with COVID-19 infection. Under certain circumstances, however, only limited evidence is available to support these practice implications, suggesting an urgent need for establishing procedures for the management of stroke patients with suspected or confirmed COVID-19 infection.

AQURE PASSPORT Intracranial Catheter for Mechanical Thrombectomy in Acute Ischemic Stroke Patients.

OBJECTIVE: We report the first experience with a new intracranial catheter as an adjunct to mechanical thrombectomy in acute ischemic stroke patients. METHODS: We prospectively determined technical success, intended procedure (device delivery at target lesion) completion without a need for a different catheter, technical ease, and intended procedure completion without the occurrence of ≥3 unsuccessful attempts in acute ischemic stroke patients with intracranial occlusion. The initial site of occlusion and recanalization was graded based on Qureshi grading scheme. Grade 0 was used to define complete recanalization. RESULTS: A total of four procedures were performed in four patients with a mean age of 63.5 years (range 50-81 years). The occlusion was in the proximal middle cerebral artery in two patients, and posterior cerebral artery and basilar artery in one patient each. The procedures were technically successful and met the definition of technical ease in all patients. The distal-most segment where AQURE PASSPORT intracranial catheter was placed was in the supraclinoid internal carotid artery, proximal posterior cerebral artery, proximal middle cerebral artery, and proximal basilar artery in the four patients. Stent retrievers were used in three patients and primary angioplasty was performed in two patients. Complete recanalization was achieved in all four patients. The primary operator rated the performance of guide catheter as superior in all cases. CONCLUSION: The present study demonstrates the feasibility of performing mechanical thrombectomy for intracranial arterial occlusion with a new intracranial catheter having superior performance.

A Bayesian hierarchical model estimating CACE in meta-analysis of randomized clinical trials with noncompliance.

Noncompliance to assigned treatment is a common challenge in analysis and interpretation of randomized clinical trials. The complier average causal effect (CACE) approach provides a useful tool for addressing noncompliance, where CACE is defined as the average difference in potential outcomes for the response in the subpopulation of subjects who comply with their assigned treatments. In this article, we present a Bayesian hierarchical model to estimate the CACE in a meta-analysis of randomized clinical trials where compliance may be heterogeneous between studies. Between-study heterogeneity is taken into account with study-specific random effects. The results are illustrated by a re-analysis of a meta-analysis comparing the effect of epidural analgesia in labor versus no or other analgesia in labor on the outcome cesarean section, where noncompliance varied between studies. Finally, we present simulations evaluating the performance of the proposed approach and illustrate the importance of including appropriate random effects and the impact of over- and under-fitting.

Reliability and validity of clinical tests to assess posture, pain location, and cervical spine mobility in adults with neck pain and its associated disorders: Part 4. A systematic review from the cervical assessment and diagnosis research evaluation (CADRE) collaboration.

PURPOSE: To determine the reliability and validity of clinical tests to assess posture, pain location, and cervical spine mobility in adults with grades I-IV neck pain and associated disorders (NAD). METHODS: We systematically searched electronic databases to update the systematic review of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders. Eligible reliability and validity studies were critically appraised using modified versions of the QAREL and QUADAS-2 instruments, respectively. Evidence from low risk of bias studies were synthesized following best evidence synthesis principles. RESULTS: We screened 14302 articles, critically appraised 46 studies, and found 32 low risk of bias articles (14 reliability and 18 validity studies). We found preliminary evidence of: 1) reliability of visual inspection, aided with devices (CROM and digital caliper) to assess head posture; 2) reliability and validity of soft tissue palpation to locate tender/trigger points in muscles; 3) reliability and validity of joint motion palpation to assess stiffness and pain provocation in combination; and 4) range of motion tests using visual estimation (in cervical extension only) or devices (digital caliper, goniometer, inclinometer) to assess cervical mobility. CONCLUSIONS: We found little evidence to support the reliability and validity of clinical tests to assess head posture, pain location and cervical mobility in adults with NAD grades I-III. More advanced validity studies are needed to inform the clinical utility of tests used to evaluate patients with NAD.

Cognitive impairment and intracranial atherosclerotic stenosis in general population.

OBJECTIVE: To investigate the association between asymptomatic intracranial atherosclerosis and cognitive impairment in the Atherosclerosis Risk in Communities (ARIC) cohort. METHODS: ARIC participants underwent high-resolution 3T magnetic resonance angiography and a neuropsychology battery and neurologic examination adjudicated by an expert panel to detect mild cognitive impairment (MCI) and dementia. We adjusted for demographic and vascular risk factors in weighted logistic regression analysis, accounting for stratified sampling design and attrition, to determine the association of intracranial atherosclerotic stenosis (ICAS) with cognitive impairment. RESULTS: In 1,701 participants (mean age 76 ± 5.3, 41% men, 71% whites, 29% blacks) with adequate imaging quality and no history of stroke, MCI was identified in 578 (34%) and dementia in 79 (4.6%). In white participants, after adjustment for demographic and vascular risk factors, ICAS ≥50% (vs no ICAS) was strongly associated with dementia (odds ratio [OR] 4.1, 95% confidence interval [CI] 1.7-10.0) and with any cognitive impairment (OR 1.7, 95% CI 1.1-2.8). In contrast, no association was found between ICAS ≥50% and MCI or dementia in blacks, although the sample size was limited and estimates were imprecise. CONCLUSION: Our results suggest that asymptomatic ICAS is independently associated with cognitive impairment and dementia in whites.

A Population-Based Study of the Incidence of Acute Spinal Cord Infarction.

BACKGROUND: There is a paucity of reliable data regarding incidence of acute spinal cord infarction in population-based studies. OBJECTIVES: To determine the incidence of acute spinal cord infarction using a population-based design. METHODS: Medical records and neuroimaging data of all patients with acute spinal cord infarction from Stearns and Benton Counties, Minnesota, between January 1, 2010 and May 31, 2014 were reviewed. Patients with a first-time diagnosis of spinal cord infarction were categorized as primary or secondary depending upon underlying etiology identified. We calculated the incidences of primary and secondary spinal cord infarction adjusted for age and sex based on the 2010 US census (189,093 resident populations). RESULTS: The age- and sex-adjusted incidence of spinal cord infarction was 3.1 [95% confidence interval (CI) 1.6-7.2] per100,000 person-years. The age- and sex-adjusted incidence of primary and secondary spinal cord infarction was 1.5 [95% CI 0.6-3.6] and 1.6 [95% CI 0.6-3.6] per 100,000 person-years, respectively. The age-adjusted incidences among men and women were 1.5 [95%CI 0.6-3.7] and 4.6 [95% CI 2.2-8.7] per 100,000 person-years, respectively. No case fatality was observed at one month. CONCLUSION: We provide incidence rates for acute spinal cord infarction to assist in future studies and resource allocation.

Phantom-based standardization of CT angiography images for spot sign detection.

PURPOSE: The CT angiography (CTA) spot sign is a strong predictor of hematoma expansion in intracerebral hemorrhage (ICH). However, CTA parameters vary widely across centers and may negatively impact spot sign accuracy in predicting ICH expansion. We developed a CT iodine calibration phantom that was scanned at different institutions in a large multicenter ICH clinical trial to determine the effect of image standardization on spot sign detection and performance. METHODS: A custom phantom containing known concentrations of iodine was designed and scanned using the stroke CT protocol at each institution. Custom software was developed to read the CT volume datasets and calculate the Hounsfield unit as a function of iodine concentration for each phantom scan. CTA images obtained within 8 h from symptom onset were analyzed by two trained readers comparing the calibrated vs. uncalibrated density cutoffs for spot sign identification. ICH expansion was defined as hematoma volume growth >33%. RESULTS: A total of 90 subjects qualified for the study, of whom 17/83 (20.5%) experienced ICH expansion. The number of spot sign positive scans was higher in the calibrated analysis (67.8 vs 38.9% p < 0.001). All spot signs identified in the non-calibrated analysis remained positive after calibration. Calibrated CTA images had higher sensitivity for ICH expansion (76 vs 52%) but inferior specificity (35 vs 63%) compared with uncalibrated images. CONCLUSION: Normalization of CTA images using phantom data is a feasible strategy to obtain consistent image quantification for spot sign analysis across different sites and may improve sensitivity for identification of ICH expansion.

Open-Label Phase I Clinical Study to Assess the Safety and Efficacy of Cilostazol in Patients Undergoing Internal Carotid Artery Stent Placement.

BACKGROUND: One-month dual antiplatelet treatment, with aspirin and clopidogrel, following internal carotid artery stent placement is the current standard of care to prevent in-stent thrombosis. Cilostazol, an antiplatelet drug, has been demonstrated to have a safety profile comparable to aspirin and clopidogrel. OBJECTIVE: To evaluate the safety and clinical efficacy of cilostazol and aspirin therapy following internal carotid artery stent placement up to 1 month postprocedure. METHODS: A phase I open-label, nonrandomized two-center prospective study was conducted. All subjects received aspirin (325 mg/day) and cilostazol (200 mg/day) 3 days before extracranial stent placement. Two antiplatelet agents were continued for 1 month postprocedure followed by aspirin daily monotherapy. The primary efficacy end point was the 30-day composite occurrence of death, cerebral infarction, transient ischemic attack, and in-stent thrombosis. The primary safety end point was bleeding. RESULTS: Twelve subjects (mean age ± SD, 66 ± 12 years; 9 males) were enrolled and underwent internal carotid artery angioplasty and stent placement. None of the subjects who successfully followed the study protocol experienced any complications at the 1- and 3-month follow-ups. One patient had a protocol deviation due to concurrent use of enoxaparin (1 mg/kg twice daily) in addition to aspirin and cilostazol, resulting in a fatal symptomatic intracerebral hemorrhage following successful stent placement on postprocedure day 1. One patient discontinued cilostazol after the first dose secondary to dizziness. CONCLUSION: The use of cilostazol and aspirin for internal carotid artery stent placement appears to be safe, but protocol compliance needs to be emphasized.