Only a Minority of Thrombectomy Candidates Are Admitted During Night Shift: A Rationale for Diurnal Stroke Care Planning.

Background: Widespread quick access to mechanical thrombectomy (MT) for acute ischemic stroke (AIS) is one of the main challenges in stroke care. It is unclear if newly established MT units are required 24 h/7 d. We explored the diurnal admission rate of patients with AIS potentially eligible for MT to provide a basis for discussion of daytime-adapted stroke care concepts. Methods: Data collected from the Baden-Württemberg Stroke Registry in Germany were assessed (2008-2012). We analyzed the admission rate of patients with AIS stratified by the National Institutes of Health Stroke Scale (NIHSS) score at admission in 3-h intervals. An NIHSS score ≥10 was considered a predictor of large vessel occlusion. The average annual admission number of patients with severe AIS were stratified by stroke service level and calculated for a three-shift model and working/non-working hours. Results: Of 91,864, 22,527 (21%) presented with an NIHSS score ≥10. The average admission rates per year for a hospital without Stroke Unit (SU), with a local SU, with a regional SU and a stroke center were 8, 52, 90 and 178, respectively. Approximately 61% were admitted during working hours, 54% in the early shift, 36% in the late shift and 10% in the night shift. Conclusions: A two-shift model, excluding the night shift, would cover 90% of the patients with severe AIS. A model with coverage during working hours would miss ~40% of the patients with severe AIS. To achieve a quick and area-wide MT, it seems preferable for newly implemented MT-units to offer MT in a two-shift model at a minimum.

Outcomes of patients with stroke treated with thrombolysis according to prestroke Rankin Scale scores.

BACKGROUND: It is common practice to withhold IV thrombolysis (IVT) for acute ischemic stroke in patients with preexisting disabilities. To test the hypothesis of an association of IVT and good clinical outcome also in patients with preexisting disabilities without an increase in mortality, we analyzed data from 52,741 patients (15,317 treated with IVT) depending on prestroke Rankin Scale (pRS) score. METHODS: We performed an observational study based on a consecutive stroke registry covering 10.8 million inhabitants. The outcome at discharge of patients with stroke admitted in the time window of potential eligibility for IVT (<4.5 hours after stroke onset) was compared between patients treated and those not treated with thrombolysis, stratified by pRS score. Logistic regression analysis was used to estimate adjusted odds ratios (ORs) along with 95% confidence intervals (CIs) for favorable clinical outcome, defined as returning to the baseline pRS score or a score of 0 or 1 and mortality. Sensitivity analyses for subgroups of mildly and severely affected patients with stroke were performed, and the influence of treatment duration was assessed. RESULTS: Among included patients, IVT rates were 32% for patients with pRS scores of 0 to 1 and 20% for patients with pRS scores of 2 to 5. IVT in patients with pRS scores of 0 to 4 was associated with a higher chance of returning to the baseline pRS score (or a modified Rankin Scale score of 0/1), with ORs ranging between 1.42 (pRS score 2; 95% CI 1.16-1.73) and 1.73 (pRS score 0; 95% CI 1.61-1). The OR observed in patients with a pRS score of 5 was 0.65 (95% CI 0.25-1.70). Observed associations remained consistent in sensitivity analyses. Subgroup analyses revealed no evidence of bias due to potential floor and ceiling effects. No evidence of elevated in-hospital mortality of patients treated with thrombolysis was observed. CONCLUSIONS: Our study suggests that IVT can be effective even in patients with severe preexisting disabilities, provided that they were not bedridden before stroke onset. Withholding IVT on the sole ground of prestroke disabilities may not be justified.

Risk-adjusted mortality of VLBW infants in high-volume versus low-volume NICUs.

OBJECTIVE: To examine whether the number of very low birthweight (VLBW) infants treated annually in neonatal intensive care units (NICUs) (hospital volume) has an effect on their in-hospital mortality under the regulatory conditions in Germany. SETTING: The study included VLBW infants with <33 weeks of gestational age and birth weight below 1500 g admitted to NICUs in the state of Baden-Wüerttemberg, Germany, from 2003 to 2008. Cases were extracted from the compulsory German neonatal quality assurance programme with variables essential for calculation of the Clinical Risk Index for Babies (CRIB) and PREM birth model (PREM(bm)) scores. The cohort was divided into four subgroups corresponding to their disease severity (low, intermediate, high and very high) according to each score. Low-volume NICUs (LV-NICUs) were defined as treating up to 50 cases per year, while high-volume NICUs >50 cases. RESULTS: After exclusion of infants with lethal malformations, 5340 cases from 32 units were analysed. While raw mortality was comparable, infants in LV-NICUs had an increased mortality after risk adjustment with the CRIB and PREM(bm) scores (OR 1.48 (95% CI 1.16 to 1.90), p=0.002 with CRIB; and OR 1.39 (95% CI 1.11 to 1.76), p=0.005 with PREM(bm)). In a subgroup analysis mortality was significantly higher for LV-NICUs in the intermediate disease severity group (OR 1.49 (95% CI 1.02 to 2.17), p=0.037 with CRIB) and in the high-risk group (OR 1.70 (95% CI 1.16 to 1.90), p=0.002 with CRIB; and OR 1.39 (95% CI 1.11 to 1.76), p=0.005 with PREM(bm)), but not in the low-risk and very high-risk subgroups. CONCLUSION: Depending on the severity of the disease, the risk-adjusted mortality in German NICUs with 50 or less annual cases of VLBW infants may be significantly increased.

Diurnal Variation of Intravenous Thrombolysis Rates for Acute Ischemic Stroke and Associated Quality Performance Parameters.

INTRODUCTION: Based on data from the Baden-Wuerttemberg stroke registry, we aimed to explore the diurnal variation of acute ischemic stroke (IS) care delivery. MATERIALS AND METHODS: 92,530 IS patients were included, of whom 37,471 (40%) presented within an onset-to-door time ≤4.5 h. Daytime was stratified in 3-h time intervals and working vs. non-working hours. Stroke onset and hospital admission time, rate of door-to-neurological examination time ≤30 min, onset-/door-to-imaging time IV thrombolysis (IVT) rates, and onset-/door-to-needle time were determined. Multivariable regression models were used stratified by stroke onset and hospital admission time to assess the relationship between IVT rates, quality performance parameters, and daytime. The time interval 0:00 h to 3:00 h and working hours, respectively, were taken as reference. RESULTS: The IVT rate of the whole study population was strongly associated with the sleep-wake cycle. In patients presenting within the 4.5-h time window and potentially eligible for IVT stratification by hospital admission time identified two time intervals with lower IVT rates. First, between 3:01 h and 6:00 h (IVT rate 18%) and likely attributed to in-hospital delays with the lowest diurnal rate of door-to-neurological examination time ≤30 min and the longest door-to-needle time Second, between 6:01 h and 15:00 h (IVT rate 23-25%) compared to the late afternoon and evening hours (IVT rate 27-29%) due to a longer onset-to-imaging time and door-to-imaging time. No evidence for a compromised stroke service during non-working hours was observed. CONCLUSION: The analysis provides evidence that acute IS care is subject to diurnal variation which may affect stroke outcome. An optimization of IS care aiming at constantly high IVT rates over the course of the day therefore appears desirable.

Stroke unit care in germany: the german stroke registers study group (ADSR).

BACKGROUND: Factors influencing access to stroke unit (SU) care and data on quality of SU care in Germany are scarce. We investigated characteristics of patients directly admitted to a SU as well as patient-related and structural factors influencing adherence to predefined indicators of quality of acute stroke care across hospitals providing SU care. METHODS: Data were derived from the German Stroke Registers Study Group (ADSR), a voluntary network of 9 regional registers for monitoring quality of acute stroke care in Germany. Multivariable logistic regression analyses were performed to investigate characteristics influencing direct admission to SU. Generalized Linear Mixed Models (GLMM) were used to estimate the influence of structural hospital characteristics (percentage of patients admitted to SU, year of SU-certification, and number of stroke and TIA patients treated per year) on adherence to predefined quality indicators. RESULTS: In 2012 180,887 patients were treated in 255 hospitals providing certified SU care participating within the ADSR were included in the analysis; of those 82.4% were directly admitted to a SU. Ischemic stroke patients without disturbances of consciousness (p < .0001), an interval onset to admission time ≤3 h (p < .0001), and weekend admission (p < .0001) were more likely to be directly admitted to a SU. A higher proportion of quality indicators within predefined target ranges were achieved in hospitals with a higher proportion of SU admission (p = 0.0002). Quality of stroke care could be maintained even if certification was several years ago. CONCLUSIONS: Differences in demographical and clinical characteristics regarding the probability of SU admission were observed. The influence of structural characteristics on adherence to evidence-based quality indicators was low.

Access, timing and frequency of very early stroke rehabilitation - insights from the Baden-Wuerttemberg stroke registry.

BACKGROUND: While the precise timing and intensity of very early rehabilitation (VER) after stroke onset is still under discussion, its beneficial effect on functional disability is generally accepted. The recently published randomized controlled AVERT trial indicated that patients with severe stroke might be more susceptible to harmful side effects of VER, which we hypothesized is contrary to current clinical practice. We analyzed the Baden-Wuerttemberg stroke registry to gain insight into the application of VER in acute ischemic stroke (IS) and intracerebral hemorrhage (ICH) in clinical practice. METHODS: 99,753 IS patients and 8824 patients with ICH hospitalized from January 2008 to December 2012 were analyzed. Data on the access to physical therapy (PT), occupational therapy (OT), and speech therapy (ST), the time from admission to first contact with a therapist and the average number of therapy sessions during the first 7 days of admission are reported. Multiple logistic regression models adjusted for patient and treatment characteristics were carried out to investigate the influence of VER on clinical outcome. RESULTS: PT was applied in 90/87% (IS/ICH), OT in 63/57%, and ST in 70/65% of the study population. Therapy was mostly initiated within 24 h (PT 87/82%) or 48 h after admission (OT 91/89% and ST 93/90%). Percentages of patients under therapy and also the average number of therapy sessions were highest in those with a discharge modified Rankin Scale score of 2 to 5 and lowest in patients with complete recovery or death during hospitalization. The outcome analyses were fundamentally hindered due to biases by individual decision making regarding the application and frequency of VER. CONCLUSIONS: While most patients had access to PT we noticed an undersupply of OT and ST. Only little differences were observed between patients with IS and ICH. The staff decisions for treatment seem to reflect attempts to optimize resources. Patients with either excellent or very unfavorable prognosis were less frequently assigned to VER and, if treated, received a lower average number of therapy sessions. On the contrary, severely disabled patients received VER at high frequency, although potentially harmful according to recent indications from the randomized controlled AVERT trial.

Restriction of therapy mainly explains lower thrombolysis rates in reduced stroke service levels.

OBJECTIVE: To assess the influence of preexisting disabilities, age, and stroke service level on standardized IV thrombolysis (IVT) rates in acute ischemic stroke (AIS). METHODS: We investigated standardized IVT rates in a retrospective registry-based study in 36,901 patients with AIS from the federal German state Baden-Wuerttemberg over a 5-year period. Patients admitted within 4.5 hours after stroke onset were selected. Factors associated with IVT rates (patient-level factors and stroke service level) were assessed using robust Poisson regression modeling. Interactions between factors were considered to estimate risk-adjusted mortality rates and potential IVT rates by service level (with stroke centers as benchmark). RESULTS: Overall, 10,499 patients (28.5%) received IVT. The IVT rate declined with service level from 44.0% (stroke center) to 13.1% (hospitals without stroke unit [SU]). Especially patients >80 years of age and with preexisting disabilities had a lower chance of being treated with IVT at lower stroke service levels. Interactions between stroke service level and age group, preexisting disabilities, and stroke severity (all p < 0.0001) were observed. High IVT rates seemed not to increase mortality. Estimated potential IVT rates ranged between 41.9% and 44.6% depending on stroke service level. CONCLUSIONS: Differences in IVT rates among stroke service levels were mainly explained by differences administering IVT to older patients and patients with preexisting disabilities. This indicates considerable further potential to increase IVT rates. Our findings support guideline recommendations to admit acute stroke patients to SUs.

Intravenous Thrombolysis is Effective in Young Adults: Results from the Baden-Wuerttemberg Stroke Registry.

BACKGROUND: The efficacy of intravenous thrombolysis (IVT) is sufficiently proven in ischemic stroke patients of middle and older age by means of randomized controlled trials and large observational studies. However, data in young stroke patients ≤50 years are still scarce. In this study, we aimed to evaluate the effectiveness and safety of IVT in young adults aged 18-50 years. Data from a consecutive and prospective stroke registry was analyzed that covers a federal state with 10.8 million inhabitants in southwest Germany. METHODS: Our analysis comprises 51,735 ischemic stroke patients aged 18-80 years and hospitalized from January 2008 to December 2012. Of these, 4,140 (8%) were aged 18-50 years and 7,529 (15%) underwent IVT. Data on 8,439 patients (16% of the study population) were missing for National Institutes of Health stroke severity score at admission and/or modified Rankin Scale (mRS) at discharge and were excluded from outcome analysis. In sensitivity analysis, patients with incomplete data were also examined. Binary logistic regression models were used adjusted for patient, hospital, and procedural parameters and stratified by age group (18-50 and 51-80 years, subgroup analyses 18-30, 31-40, and 41-50 years) to assess the relationship between IVT and mRS at discharge. RESULTS: IVT appears equally effective in young adults 18-50 years (adjusted odds ratio 1.40, 95% confidence interval 1.12-1.75; p = 0.003), compared to patients 51-80 years of age (1.33, 1.23-1.43; p < 0.001). Age-stratified analyses suggest an inverse relation of age and effectiveness, which appears to be highest in very young patients 18-30 years of age (2.78, 1.10-7.05; p = 0.03). DISCUSSION: Ischemic stroke etiology, vascular dynamics, and recovery in young patients differ from those of middle and older age. The evidence from routine hospital care in Germany indicates that IVT in young stroke patients appears to be at least equally effective as in the elderly.

Auditing Neonatal Intensive Care: Is PREM a Good Alternative to CRIB for Mortality Risk Adjustment in Premature Infants?

BACKGROUND: Comparing outcomes at different neonatal intensive care units (NICUs) requires adjustment for intrinsic risk. The Clinical Risk Index for Babies (CRIB) is a widely used risk model, but it has been criticized for being affected by therapeutic decisions. The Prematurity Risk Evaluation Measure (PREM) is not supposed to be prone to treatment bias, but has not yet been validated. OBJECTIVES: We aimed to validate the PREM, compare its accuracy to that of the original and modified versions of the CRIB and CRIB-II, and examine the congruence of risk categorization. METHODS: Very-low-birth-weight (VLBW) infants with a gestational age (GA) <33 weeks, who were admitted to NICUs in Baden-Württemberg from 2003 to 2008, were identified from the German neonatal quality assurance program. CRIB, CRIB-II and PREM scores were calculated and modified. Omitting variables that directly reflected therapeutic decisions [the applied fraction of inspired oxygen (FiO2)] or that may have been prone to early-treatment bias (base excess and temperature), non-NICU-therapy-influenced scores were obtained. Score performance was assessed by the area under their ROC curve (AUC). RESULTS: The CRIB showed the largest AUC (0.89), which dropped significantly (to 0.85) after omitting the FiO2. The PREM birth condition model, PREM(bcm) (AUC 0.86), and the PREM birth model, PREM(bm) (AUC 0.82), also demonstrated good discrimination. PREM(bm) was superior to other non-therapy-affected scores and to GA, particularly in infants with <750 g birth weight. Congruence of risk categorization was low, especially among higher-risk cases. CONCLUSIONS: The CRIB score had the largest AUC, resulting from its inclusion of FiO2. PREM(bm), as the most accurate score among those unaffected by early treatment, seems to be a good alternative for strict risk adjustment in NICU auditing. It could be useful to combine scores.

Time to treatment with recombinant tissue plasminogen activator and outcome of stroke in clinical practice: retrospective analysis of hospital quality assurance data with comparison with results from randomised clinical trials.

OBJECTIVE: To study the time dependent effectiveness of thrombolytic therapy for acute ischaemic stroke in daily clinical practice. DESIGN: A retrospective cohort study using data from a large scale, comprehensive population based state-wide stroke registry in Germany. SETTING: All 148 hospitals involved in acute stroke care in a large state in southwest Germany with 10.4 million inhabitants. PARTICIPANTS: Data from 84,439 patients with acute ischaemic stroke were analysed, 10,263 (12%) were treated with thrombolytic therapy and 74,176 (88%) were not treated. MAIN OUTCOME MEASURES: Primary endpoint was the dichotomised score on a modified Rankin scale at discharge ("favourable outcome" score 0 or 1 or "unfavourable outcome" score 2-6) analysed by binary logistic regression. Patients treated with recombinant tissue plasminogen activator (rtPA) were categorised according to time from onset of stroke to treatment. Analogous analyses were conducted for the association between rtPA treatment of stroke and in-hospital mortality. As a co-primary endpoint the chance of a lower modified Rankin scale score at discharge was analysed by ordinal logistic regression analysis (shift analysis). RESULTS: After adjustment for characteristics of patients, hospitals, and treatment, rtPA was associated with better outcome in a time dependent pattern. The number needed to treat ranged from 4.5 (within first 1.5 hours after onset; odds ratio 2.49) to 18.0 (up to 4.5 hours; odds ratio 1.26), while mortality did not vary up to 4.5 hours. Patients treated with rtPA beyond 4.5 hours (including mismatch based approaches) showed a significantly better outcome only in dichotomised analysis (odds ratio 1.25, 95% confidence interval 1.01 to 1.55) but the mortality risk was higher (1.45, 1.08 to 1.92). CONCLUSION: The effectiveness of thrombolytic therapy in daily clinical practice might be comparable with the effectiveness shown in randomised clinical trials and pooled analysis. Early treatment was associated with favourable outcome in daily clinical practice, which underlines the importance of speeding up the process for thrombolytic therapy in hospital and before admission to achieve shorter time from door to needle and from onset to treatment for thrombolytic therapy.

Necrotizing enterocolitis and focal intestinal perforation in neonatal intensive care units in the state of baden-württemberg, Germany.

In preterm infants with very low birth weight (VLBW) <1500 g the most important acquired intestinal diseases are necrotising enterocolitis (NEC) and focal intestinal perforation (FIP). We analyzed data of the neonatology module of national external comparative quality assurance for inpatients in the state of Baden-Württemberg, Germany. Between 2010 and 2012, 59 of 3549 VLBW infants developed FIP (1.7%), 128 of them NEC (3.6%). In approximately 3% of infants with BW<1000 g FIP was diagnosed, which was nearly 9 times more often than in infants with BW between 1250 and 1499 g (FIP frequency 0.36%). NEC frequency increased with decreasing BW and was more than 10 times higher in the smallest infants (BW<750 g: 7.87%) compared to those with BW between 1250 and 1499 g (0.72%). The BW limit of 1250 g differentiates between groups of patients with distinguished risks for NEC and FIP.

Optoacoustic imaging for optimization of laser cyclophotocoagulation.

Optoacoustic imaging was used for ophthalmic imaging, especially of the ciliary body region, which is of interest in the treatment of glaucoma. The different tissue structures below the sclera of porcine and rabbit eyes in vitro could be differentiated up to a depth of more than 1.5 mm. Based on the optoacoustic signals, two-dimensional tomographic images could be generated for visualization of this region in a B-scan mode. In addition, changes during the coagulation process could be measured in real time, allowing the development of online control mechanisms for cyclophotocoagulation, which is an important therapy of glaucoma.