Ritvij Bowry

Benefits of Stroke Treatment Using a Mobile Stroke Unit Compared With Standard Management The BEST-MSU Study Run-In Phase

Background and Purpose— Faster treatment with intravenous tissue-type plasminogen activator (tPA) is likely to improve outcomes. Optimizing prehospital triage by mobile stroke units (MSUs) may speed treatment times. The Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit (BEST-MSU) study was launched in May 2014 using the first MSU in the United States to compare stroke management using an MSU versus standard management (SM). Herein, we describe the results of the prespecified, nonrandomized run-in phase designed to obtain preliminary data on study logistics. Methods— The run-in phase consisted of 8 MSU weeks when all-patient care occurred on the MSU and 2 SM weeks when the MSU nurse met personnel on scene or at the emergency department to ensure comparability with MSU patients. Telemedicine was independently performed in 9 MSU cases. Results— Of 130 alerts, 24 MSU and 2 SM patients were enrolled. Twelve of 24 MSU patients received tPA on board; 4 were treated within 60 minutes of last seen normal, and 4 went on to endovascular treatment. There were no hemorrhagic complications. Four had primary intracerebral hemorrhage. Agreement on tPA eligibility between the onsite and telemedicine physician was 90%. Conclusions— The run-in phase provided a tPA treatment rate of 1.5 patients per week, assured us that treatment within 60 minutes of onset is possible, and enabled enrollment of patients on SM weeks. We also recognized the opportunity to assess the effect of the MSU on endovascular treatment and intracerebral hemorrhage. Challenges include the need to control biased patient selection on MSU versus SM weeks and establish inter-rater agreement for tPA treatment using telemedicine.

Establishing the First Mobile Stroke Unit in the United States

Background and Purpose— Recently, the Mobile Stroke Unit (MSU) concept was introduced in Germany demonstrating prehospital treatment of more patients within the first hour of symptom onset. However, the details and complexities of establishing such a program in the United States are unknown. We describe the steps involved in setting up the first MSU in the United States. Methods— Implementation included establishing leadership, fund-raising, purchase and build-out, knitting a collaborative consortium of community stakeholders, writing protocols to ensure accountability, radiation safety, purchasing supplies, licensing, insurance, establishing a base station, developing a communication plan with city Emergency Medical Services, Emergency Medical Service training, staffing, and designing a research protocol. Results— The MSU was introduced after ≈1 year of preparation. Major obstacles to establishing the MSU were primarily obtaining funding, licensure, documenting radiation safety protocols, and establishing a smooth communication system with Emergency Medical Services. During an 8 week run-in phase, ≈2 patients were treated with recombinant tissue-type plasminogen activator per week, one-third within 60 minutes of symptom onset, with no complications. A randomized study to determine clinical outcomes, telemedicine reliability and accuracy, and cost effectiveness was formulated and has begun. Conclusion— The first MSU in the United States has been introduced in Houston, TX. The steps needed to accomplish this are described.

Telemedicine Can Replace the Neurologist on a Mobile Stroke Unit.

Background and Purpose— The BEST-MSU study (Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit) is a comparative effectiveness trial in patients randomized to mobile stroke unit or standard management. A substudy tested interrater agreement for tissue-type plasminogen activator eligibility between a telemedicine vascular neurologist and onboard vascular neurologist. Methods— On scene, both the telemedicine vascular neurologist and onboard vascular neurologist independently evaluated the patient, documenting their tissue-type plasminogen activator treatment decision, National Institutes of Health Stroke Scale score, and computed tomographic interpretation. Agreement was determined using Cohen &kgr; statistic. Telemedicine-related technical failures that impeded remote assessment were recorded. Results— Simultaneous and independent telemedicine vascular neurologist and onboard vascular neurologist assessment was attempted in 174 patients. In 4 patients (2%), the telemedicine vascular neurologist could not make a decision because of technical problems. The telemedicine vascular neurologist agreed with the onboard vascular neurologist on 88% of evaluations (&kgr;=0.73). Conclusions— Remote telemedicine vascular neurologist assessment is reliable and accurate, supporting either telemedicine vascular neurologist or onboard vascular neurologist assessment on our mobile stroke unit. Clinical Trial Registration— URL: http://www.clinicaltrials.gov. Unique identifier: NCT02190500.

Benefits of stroke treatment delivered using a mobile stroke unit trial

Rationale Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration NCT02190500.

CTP infarct core may predict poor outcome in stroke patients treated with IV t-PA

BACKGROUND Computerized tomography perfusion (CTP) has been widely studied in assessing physiological brain tissue parameters in patients with acute ischemic stroke (AIS). The utility of CTP to predict clinical outcome in patients with AIS treated with intravenous tissue plasminogen activator (IV t-PA) is controversial. We reviewed CTP data in AIS patients treated with IV t-PA to uncover potential predictors of clinical outcome. METHODS We retrospectively identified AIS patients from our stroke registry (7/07 to 2/10) who underwent CTP on arrival and then received IV t-PA. A neuroradiologist blinded to outcome performed all CTP parameter measurements on a commercially available Siemens Neuro PCT workstation. Tissue at risk (TAR) was defined as the area of infarct territory with a relative time to peak (rTTP) greater than 4s. Non-viable tissue (NVT) was defined as the area of infarct territory with absolute cerebral blood volume (CBV) less than 2 ml/100g and cerebral blood flow (CBF) less than 12.7 ml/100g/min. Penumbra was defined as the area of (TAR) minus the area of (NVT). Excellent clinical outcome was defined as mRS (0-1), good clinical outcome was defined as mRS (0-2), and poor clinical outcome was defined as mRS (4-6), all measured at hospital discharge and 90 days if available. Recanalization data was obtained when available by comparing pre-thrombolytic CTA data and post-treatment MRA/CTA images by a single blinded radiologist. RESULTS We identified 61 patients that met our inclusion criteria with a mean age of 68 (29-94), median NIHSS on admission of 13 (1-40), and median discharge mRS of 4 (0-6). Using multivariate logistic regression and ordinal logistic regression controlling for age and admission NIHSS, none of the CTP parameters were statistically associated with excellent or good clinical outcome (mRS<2). Using multivariate analysis controlling for age and admission NIHSS, NVT area>30 cm(2) (OR=5.12, CI: 0.95-27, p=0.05) was statistically associated with poor clinical outcome at discharge. NVT area ≥ 30 cm(2) was a potential predictor of poor outcome at discharge even when controlling for age and NIHSS. CONCLUSION CTP parameters derived from commercially available software and published thresholds yield little predictive value for good clinical outcomes for AIS patients treated with IV t-PA but may be useful in predicting poor clinical outcome especially if the area of non-viable tissue is greater than 30 cm(2).

Abstract TP267: Uncertainty-Based Individual Health Preferences for Patients With Primary Intracerebral Hemorrhage

Introduction: Value-based care and patient-perceived outcomes are increasingly important. Standard Gamble (SG) derived utilities directly measure patients’ preferences for health states and form the basis of health economic analyses. We describe distribution of and factors associated with SG utilities (SGU) in a cohort of intracerebral hemorrhage (ICH) patients, and explore changes in SGU over 90 days post-discharge. Methods: Our study is a multisite cohort aiming to evaluate the comparative effectiveness of ICH patient management at various levels of care across Texas. Consented patients undergo assessments including SG in-hospital, and 30 and 90 days post-discharge. The SG assesses patients’ risk-taking behavior toward achieving a perfect health status, and outputs utility on a scale of 0 - 1 (Figure 1). Median and interquartile range (IQR) are reported for inpatient and day-90 SGU. Quantile regression was used to evaluate factors associated with SGU. Difference in median (DIM) and 95% confidence interv...

Abstract TMP73: Rehabilitation for Patients With Primary Intracerebral Hemorrhage is Associated With Reduced 30-Day Hospital Readmissions

Introduction: Readmission (RA) after stroke is an established quality of care metric and is tied to reimbursements. Administrative databases lack stroke-specific severity indicators and information...

Abstract TP276: Health-Related Quality of Life Indices for Patients with Primary Intracerebral Hemorrhage

Introduction: Assessments of health-related quality of life (QoL) are increasingly important for stroke patients; however, such data are lacking for patients with intracerebral hemorrhage (ICH). Us...

Time to Decision and Treatment With tPA (Tissue-Type Plasminogen Activator) Using Telemedicine Versus an Onboard Neurologist on a Mobile Stroke Unit

Background and Purpose— Mobile stroke units (MSUs) can speed treatment with intravenous tPA (tissue-type plasminogen activator). We previously showed substantial agreement between a telemedicine-based vascular neurologist (TM-VN) and an onboard vascular neurologist (OB-VN) for the evaluation of patients with stroke for tPA eligibility on an MSU. However, the time efficiency of the telemedicine-based evaluation remained uncertain. In this study, we examined the speed of decision and treatment from MSU arrival for the TM-VN compared with an OB-VN. Methods— In 50 consecutive situations, the TM-VN served as the primary decision maker. Times from MSU arrival to tPA decision and tPA bolus were compared with the same metrics for when the OB-VN served as the primary decision maker. Results— Time to tPA decision for the TM-VN was 21 minutes (interquartile range, 16.25–26) versus 18 minutes (interquartile range, 14–22) for the OB-VN (P=0.01). Initiation of tPA bolus was 24 minutes (interquartile range, 19.75–30) for the TM-VN versus 24 minutes (interquartile range, 19–27.75) for the OB-VN (P=0.5). Conclusions— Assessment by a TM-VN is comparable with an OB-VN in making decisions about tPA administration on an MSU and does not lead to treatment delays. Clinical Trial Registration— URL: https://www.clinicaltrials.gov. Unique identifier: NCT02190500.

Intraosseous Administration of Tissue Plasminogen Activator on a Mobile Stroke Unit

Abstract Objective: Mobile stroke units offer improved time to administration of thrombolytics for ischemic stroke patients. Acquisition of intravenous (IV) access, however, can be challenging in the prehospital environment leading to treatment delays. Intraosseous (IO) access is commonly used in the prehospital setting for a variety of conditions and may serve as a viable means for tPA (tissue plasminogen activator) administration. Methods/Results: We describe 3 cases in which tPA was administered via IO access on a mobile stroke unit as part of the Benefits of Stroke Treatment Delivered Using a Mobile Stroke Unit Compared to Standard Management by Emergency Medical Services (BEST-MSU) trial. Conclusion: No adverse events were observed in the process of obtaining IO access or administering tPA.