Early Postmarket Results with EmboTrap II Stent Retriever for Mechanical Thrombectomy: A Multicenter Experience.

BACKGROUND AND PURPOSE: EmboTrap II is a novel stent retriever with a dual-layer design and distal mesh designed for acute ischemic stroke emergent large-vessel occlusions. We present the first postmarket prospective multicenter experience with the EmboTrap II stent retriever. MATERIALS AND METHODS: A prospective registry of patients treated with EmboTrap II at 7 centers following FDA approval was maintained with baseline patient characteristics, treatment details, and clinical/radiographic follow-up. RESULTS: Seventy patients were treated with EmboTrap II (mean age, 69.9 years; 48.6% women). Intravenous thrombolysis was given in 34.3%, and emergent large-vessel occlusions were located in the ICA (n = 18), M1 (n = 38), M2 or M3 (n = 13), and basilar artery (n = 1). The 5 × 33 mm device was used in 88% of cases. TICI ≥ 2b recanalization was achieved in 95.7% (82.3% in EmboTrap II-only cases), and first-pass efficacy was achieved in 35.7%. The NIHSS score improved from a preoperative average of 16.3 to 12.1 postprocedure and to 10.5 at discharge. An average of 2.5 [SD, 1.8] passes was recorded per treatment, including non-EmboTrap attempts. Definitive treatment was performed with an alternative device (aspiration or stent retriever) in 9 cases (12.9%). Some hemorrhagic conversion was noted in 22.9% of cases, of which 4.3% were symptomatic. There were no device-related complications. CONCLUSIONS: Initial postmarket results with the EmboTrap II stent retriever are favorable and comparable with those of other commercially available stent retrievers. Compared with EmboTrap II, the first-generation EmboTrap may have a higher first-pass efficacy; however, data are limited by retrospective case analysis, incomplete clinical follow-up, and small sample size, necessitating future trials.

Impact of Time on Thrombolysis in Cerebral Infarction Score Results.

PURPOSE: Extended thrombolysis in cerebral infarction (eTICI) score results of 2b or higher are known to be predictors for favorable outcome after acute stroke. Additionally, time is a major factor influencing outcome after ischemic stroke. Until today only little is known about the impact of time on angiographic results regarding the outcome after mechanical thrombectomy; however, this impact might be of interest if an initially unfavorable angiographic result has to be improved. METHODS: Retrospective study of 164 patients with large vessel occlusion of the anterior circulation treated by mechanical thrombectomy. Multiple logistic regression analysis of relevant periprocedural and procedural times in respect to the probability of achieving functional independence at 90 days in respect to different eTICI results was performed to build a time and TICI score-dependent model for outcome prediction in which the influence of time was assumed to be steady among the TICI grades. RESULTS: The probability of achieving a favorable outcome is significantly different between eTICI2b-50, 67, TICI2c and TICI3 results (p < 0.001). The odds for achieving a favorable outcome decrease over time and differ for each TICI category and time point. The individual odds for each patient, time point and TICI grade can be calculated based on this model. CONCLUSION: The impact of periprocedural and procedural times and eTICI reperfusion results adds a new dimension to the decision-making process in patients with primary unfavorable angiographic results.

One-Stop Management with Perfusion for Transfer Patients with Stroke due to a Large-Vessel Occlusion: Feasibility and Effects on In-Hospital Times.

BACKGROUND AND PURPOSE: In-hospital time delays lead to a relevant deterioration of neurologic outcomes in patients with stroke with large-vessel occlusions. At the moment, CT perfusion is relevant in the triage of late-window patients with stroke. We conducted this study to determine whether one-stop management with perfusion is feasible and leads to a reduction of in-hospital times. MATERIALS AND METHODS: In this observational study, we report the first 15 consecutive transfer patients with stroke with externally confirmed large-vessel occlusions who underwent flat panel detector CT perfusion and thrombectomy in the same room. Preinterventional imaging consisted of noncontrast flat panel detector CT and flat panel detector CT perfusion, acquired with a biplane angiography system. The flat panel detector CT perfusion was used to reconstruct a flat panel detector CT angiography to confirm the large-vessel occlusions. After confirmation of the large-vessel occlusion, the patient underwent mechanical thrombectomy. We recorded time metrics and safety parameters prospectively and compared them with those of transfer patients whom we treated before the introduction of one-stop management with perfusion. RESULTS: Fifteen transfer patients underwent flat panel detector CT perfusion and were treated with mechanical thrombectomy from June 2017 to January 2019. The median time from symptom onset to admission was 241 minutes. Median door-to-groin time was 24 minutes. Compared with 23 transfer patients imaged with multidetector CT, it was reduced significantly (24 minutes; 95% CI, 19-37 minutes, versus 53 minutes; 95% CI, 44-66 minutes; P < .001). Safety parameters were comparable between groups. CONCLUSIONS: In this small series, one-stop management with perfusion led to a significant reduction of in-hospital times compared with our previous workflow.

The problem of strict image-based inclusion criteria for mechanical thrombectomy - an analysis of stroke patients with an initial low CBV-ASPECTS score.

INTRODUCTION: Endovascular treatment for acute ischaemic stroke with large artery occlusion has become the standard of care. However, the question if a subgroup of patients, with a low cerebral blood volume Alberta Stroke Program Early CT score (CBV-ASPECTS) ≤ 7 should be excluded from endovascular treatment remains open. Therefore; we investigated the difference of outcome between patients who were treated by endovascular treatment vs patients who did not receive endovascular treatment. METHODS: We retrospectively analysed our stroke database for all patients who presented within six hours of onset with unfavourable imaging findings and who received endovascular treatment or best medical treatment alone. Unfavourable imaging was defined as a CBV-ASPECTS ≤ 7, which was an exclusion criterion for endovascular treatment at our institution before 2015. RESULTS: From 60 patients with an initial CBV-ASPECTS ≤ 7, 40 received best medical treatment and 20 were treated with endovascular treatment. Arterial hypertension and atrial fibrillation was more present in patients without endovascular treatment, the other baseline characteristics and percentage of patients treated with intravenous recombinant tissue plasminogen activator were not significantly different in both groups. At discharge, 40% of the interventional treated patients had a favourable outcome (eight of 20 (40%) vs six of 40 (15%; p = 0.031). The median values of the National Institute of Health Stroke Score and modified Rankin Scale at discharge were significantly lower in the treated cohort (6.5 (2.5-10.5) vs 16 (9.5-22.5); p = 0.006; 3 (0-5.5) vs 5 (4.5-5.5); p = 0.003). CONCLUSION: Patients with a CBV-ASPECTS ≤ 7 are likely to benefit from therapy and therefore may not be excluded from endovascular treatment. Further randomised trials are warranted to validate the data.

Diagnosing Early Ischemic Changes with the Latest-Generation Flat Detector CT: A Comparative Study with Multidetector CT.

BACKGROUND AND PURPOSE: One-stop management of mechanical thrombectomy-eligible patients with large-vessel occlusion represents an innovative approach in acute stroke treatment. This approach reduces door-to-reperfusion times by omitting multidetector CT, using flat detector CT as pre-mechanical thrombectomy imaging. The purpose of this study was to compare the diagnostic performance of the latest-generation flat detector CT with multidetector CT. MATERIALS AND METHODS: Prospectively derived data from patients with ischemic stroke with large-vessel occlusion and mechanical thrombectomy were analyzed in this monocentric study. All included patients underwent multidetector CT before referral to our comprehensive stroke center and flat detector CT in the angiography suite before mechanical thrombectomy. Diagnosis of early ischemic signs, quantified by the ASPECTS, was compared between modalities using cross tables, the Pearson correlation, and Bland-Altman plots. The predictive value of multidetector CT- and flat detector CT-derived ASPECTS for functional outcome was investigated using area under the receiver operating characteristic curve analysis. RESULTS: Of 25 patients, 24 (96%) had flat detector CT with sufficient diagnostic quality. Median multidetector CT and flat detector CT ASPECTSs were 7 (interquartile range, 5.5-9 and 4.25-8, respectively) with a mean period of 143.6 ± 49.5 minutes between both modalities. The overall sensitivity was 85.1% and specificity was 83.1% for flat detector CT ASPECTS compared with multidetector CT ASPECTS as the reference technique. Multidetector CT and flat detector CT ASPECTS were strongly correlated (r = 0.849, P < .001) and moderately predicted functional outcome (area under the receiver operating characteristic curve, 0.738; P = .007 and .715; P = .069, respectively). CONCLUSIONS: Determination of ASPECTS on flat detector CT is feasible, showing no significant difference compared with multidetector CT ASPECTS and a similar predictive value for functional outcome. Our findings support the use of flat detector CT for emergency stroke imaging before mechanical thrombectomy to reduce door-to-groin time.

[Psychometric Testing of a New Scale Assessing the Reasons for Non-Utilisation of Health Care Services by People with Migration Backgrounds]. / Psychometrische Überprüfung eines Fragebogens zur Erfassung der Barrieren der Inanspruchnahme von Gesundheitsleistungen durch Personen mit Migrationshintergrund.

BACKGROUND: In Germany live a lot of migrants. Cultural and migration specific aspects seem to have an effect on utilisation of health care. There are no instruments that measure such factors of influence. METHODS: A systematic literature research or article that identify the difficulties of the migrants in using the health care system, was made. The relevant aspects were explored during a health related opinion survey of migrants from former USSR, Turkey, Italy and Spain. The psychometric qualities of this questionnaire were investigated with factor and reliability analyses. RESULTS: There were 24 reasons identified for non-utilisation health care. They were combined in a questionnaire. The factor analysis showed 2-factor structure ("janguage und information related Reasons" Chronbach's α=0.928 and "experience with/attitude toward health care system", Chronbach's α=0.879). Furthermore, there was a total scale with Chronbach's α=0.945. The acceptance was between 80.0 and 96.3%. CONCLUSIONS: The results confirm the psychometric quality of this measuring instrument. For further generalisability more verification will be necessary.

Risk prediction of very early recurrence, death and progression after acute ischaemic stroke.

BACKGROUND AND PURPOSE: Early recurrent strokes lead to extended hospitalization and high number of complications. We investigated three stroke scores, the Essen Stroke Risk Score (ESRS), the ABCD(2) and the Recurrence Risk Estimator at 90 days (RRE-90) for their prognostic value to predict early recurrent stroke, death and progressive stroke. METHODS: Clinical and radiological data from 1727 consecutive patients with ischaemic stroke, being admitted to the stroke unit, were evaluated retrospectively. Predictive value of stroke scores was tested for early recurrence within 7 days, death and progressive stroke expressed as observational risk and area under the receiver operator curve (AUROC). RESULTS: Early recurrent stroke occurred in 56 patients (3.2%), 40 patients (2.3%) died within the first 7 days and 125 patients (7.2%) had a progressive stroke. ESRS was not predictive for early recurrence, death or progressive stroke. ABCD(2) score was predictive for death (P<0.01; χ(2); AUROC, 0.65; 0.58-0.72), and progressive stroke (P<0.001; χ(2); AUROC, 0.70; 0.66-0.74). RRE-90 predicted early recurrent stroke (P<0.001; χ(2); AUROC, 0.65; 0.58-0.73), early death (P<0.001; χ(2); AUROC, 0.72; 0.66-0.78) and progressive stroke (P<0.001; χ(2); AUROC, 0.66; 0.61-0.71). CONCLUSIONS: RRE-90 bears high potential to not only predict early recurrence but also death and progression after ischaemic stroke. ABCD(2) appears to be useful to predict risk of death and progression. These findings have relevant clinical implications for early triage of patients being admitted to stroke units.

[Frequency of decubitus ulcer in patients of a university medical center. Combination of routine documentation and cross-sectional study]. / Häufigkeit des Dekubitus in einem Universitätsklinikum. Kombination von Routinedokumentation und Querschnittstudie.

BACKGROUND AND OBJECTIVE: Pressure ulcer is a relevant issue for quality management and cost containment of hospitals. Cross-sectional studies are the typical design to estimate the frequency of pressure ulcers. The derived point prevalence rate is not as good for a case related reference value as the period prevalence rate. The interdisciplinary pressure ulcer project at the University Clinics in Essen combined a routine documentation with a cross-sectional survey, thus providing both measurements for the first time. PATIENTS AND METHODS: The routine and computer-based collection of information about pressure ulcers started in March 2003, using the patient administration system medico//s from Siemens. Findings are presented from 49,904 admissions, starting on 91/03/2004, discharged by 31/03/2004. The mean age was 48.7 +/- 22.4 years; 51.2 % were males, 48.8 % females. Additionally, a decubitus team examined patients from randomly selected wards each work-day. The real period prevalence rate was calculated using the observed period prevalence rate, the sensitivity and the point prevalence rate. RESULTS: In the routine documentation, 700 pressure ulcers had been recorded from 49,904 inpatient cases (period prevalence rate 1.4 %). The decubitus team did 5,415 examinations and 294 times detected at least one pressure ulcer (point prevalence rate 5.4 %). Estimated results in three different period prevalence rates: 3.0 % using sensitivity of the routine documentation, 3.7 % using sensitivity stratified for departments, and 2.3 % using the point prevalence rate for cases with short, medium, and long length of stay. CONCLUSIONS: The project presents for the first time reference values for pressure ulcer frequency in university clinics. A comparison with international rates is hindered by unpublished sensitivity values. In view of the higher point prevalence rate of 10 % present in the literature, a period prevalence rate of 5 % is a realistic reference value.

A sensitive homologous radioimmunoassay for human relaxin-2 (h-RLX-2) based on antibodies characterized by epitope mapping studies.

We present a sensitive homologous radioimmunoassay (RIA) for the quantitative determination of human relaxin (hRLX) in human serum, plasma, seminal plasma, and urine. This assay is based on a rabbit antiserum which was generated using recombinant hRLX-2 as immunogen. Using 125I-hRLX-2 as tracer and a total incubation time of 20 - 24 hours the radioimmunoassay showed linearity in a range of 60 - 4000 ng/l, a lower detection limit of 38 ng/l and a mean recovery rate of 98.5%. Intraassay variation was 4.0% (mean = 526 ng/l) and 11.9% (mean = 2368 ng/l), and interassay variation 10.7% (mean = 256 ng/l) and 13.1% (mean = 2368 ng/l). Using hRLX-2 hexapeptides on polystyrene pins, epitopes recognized by the hRLX-2 specific rabbit antiserum were determined experimentally, and compared to predicted epitopes. Both methods led to comparable results. The antiserum, recognizing different epitopes, showed no cross-reactivity with human insulin, hZn-insulin, hIGF-I, hIGF-II, human inhibin alpha-subunit, two different forms of seminal plasma inhibin like peptide, spermolaxin, ubiquitin, prolactin, LH, FSH and hCG.

Maullinia ectocarpii gen. et sp. nov. (Plasmodiophorea), an intracellular parasite in Ectocarpus siliculosus (Ectocarpales, Phaeophyceae) and other filamentous brown algae.

An obligate intracellular parasite infecting Ectocarpus spp. and other filamentous marine brown algae is described. The pathogen forms an unwalled multinucleate syncytium (plasmodium) within the host cell cytoplasm and causes hypertrophy. Cruciform nuclear divisions occur during early development. Mature plasmodia become transformed into single sporangia, filling the host cell completely, and then cleave into several hundred spores. The spores are motile with two unequal, whiplash-type flagella inserted subapically and also show amoeboid movement. Upon settlement, cysts with chitinous walls are formed. Infection of host cells is accomplished by means of an adhesorium and a stachel apparatus penetrating the host cell wall, and injection of the cyst content into the host cell cytoplasm. The parasite is characterized by features specific for the plasmodiophorids and is described as a new genus and species, Maullinia ectocarpii.

Vascular endothelial growth factor A (VEGF-A) mRNA expression levels decrease after menopause in normal breast tissue but not in breast cancer lesions.

We hypothesized that the regulation of microvascular functions and angiogenesis in breast tissue, a well known target of ovarian steroid action, is dependent on the hormonal exposure of the breast. Relative expression levels of VEGF-A (vascular endothelial growth factor A), a putative key regulator of angiogenesis in breast cancer, were analysed in the tumour and the adjacent non-neoplastic breast tissue of 19 breast cancer patients by quantitative reverse transcriptase polymerase chain reaction. In non-neoplastic breast specimens the expression levels of all detected VEGF-A-isoforms (189, 165, 121) were significantly higher in premenopausal compared to post-menopausal women (P = 0.02) and were inversely correlated with the patient's age (P = 0.006). In contrast, in cancerous tissues menopausal status had no influence on VEGF-A-expression levels. Benign and malignant tissues exhibited a similar expression pattern of VEGF-A-isoforms relative to each other. Thus, the regulation of the vasculature in normal breast tissue, as opposed to breast cancer tissue, appears to be hormonally dependent. Endogenous and therapeutically used hormonal steroids might, therefore, cause clinically relevant changes of the angiogenic phenotype of the human breast.

Persistent virus integration into the genome of its algal host, Ectocarpus siliculosus (Phaeophyceae).

The brown alga Ectocarpus siliculosus frequently carries an endogenous virus, E. siliculosus virus (EsV-1), the genome of which is a circular, double-stranded DNA molecule of about 320 kbp. After infection, which occurs in the unicellular spores or gametes, the virus is present latently in all somatic cells of the host. Virus multiplication is restricted to cells of the reproductive organs. It has been an open question whether the latent viral DNA occurs as a free episome or becomes integrated into the host genome. PCR studies showed that viral DNA co-migrates with high molecular mass DNA in pulsed-field gel electrophoresis, which confirms that latent viral DNA is integrated into the host genome.

Urinary and plasma urodilatin measured by a direct RIA using a highly specific antiserum.

Urodilatin (95-126) (URO) appears to play a major physiologic role in fluid homeostasis and produces major changes when administered intravenously. Here we describe a monospecific, high-affinity antiserum against URO with no cross-reactivity (<0.01%) against the structural highly homologous atrial natriuretic peptide 99-126 (ANP-99-126), ANP analogs, and related peptides such as brain natriuretic peptide. A competitive RIA was developed, based on this antiserum. Urine samples with or without ethanol extraction and plasma samples without pretreatment were analyzed by the RIA, which had a detection limit of 10.5 ng/L, a linear measuring range between 10.5 and 1000 ng/L, and recoveries of 93-102% in urine and 90-104% in plasma. The intraassay CVs were 8.2% and 8.1% for urine samples with 269 and 669 ng/L URO; the interassay CV was 9.7% at 839 ng/L. Using this assay, we present URO data for urine from healthy volunteers receiving low and routine sodium diets and from clinical urine specimens; we also present pharmacokinetic data for URO in plasma from patients suffering from bronchial asthma and treated by URO infusion.

Improved purification of human bone sialoprotein and development of a homologous radioimmunoassay.

Bone sialoprotein (BSP) is a phosphorylated skeletal glycoprotein. Here we describe a new procedure for the purification of BSP involving wide-pore reversed-phase HPLC, and the development of a homologous RIA for human BSP. The immunoassay showed linearity between 3 and 120 micrograms/L, a lower detection limit of 0.7 micrograms/L, and a mean recovery rate of 99.4%. Intraassay variation was 7.0% (mean = 10.9 micrograms/L) and 6.1% (mean = 38.8 micrograms/L), and interassay variation was 9.2% (mean = 11.1 micrograms/L) and 9.4% (mean = 39.0 micrograms/L). No cross-reactivity was detected with osteocalcin, osteonectin, or bone alkaline phosphatase. Preliminary clinical evaluation in healthy controls (n = 90) showed a mean serum BSP concentration on 12.1 +/- 5.0 micrograms/L (+/- SD). BSP was significantly increased in patients with Paget disease of bone, primary and secondary hyperparathyroidism, and also in subjects with renal failure without skeletal involvement. Impairment of hepatic function did not affect serum BSP concentrations.

Carcass and tissue fat content in the pregnant rat.

The present study in rats was aimed at determining the specific day of pregnancy on which maternal body fat accumulation starts and which tissues are involved. Most of the body weight increase at day 12 of gestation corresponded to conceptus-free maternal weight which progressively increased until the 19th day of gestation after which maternal weight stabilized and the rate of conceptus weight gain became maximal. Maternal carcass fat content progressively increased until day 18 of gestation, increased very markedly on day 19, stabilized between day 19 and 20 and then decreased on day 21. These changes were the opposite of the course of the specific-gravity values. The fresh weight of lumbar fat-pads and mesenteric adipose tissue reflected the changes in carcass fat content throughout gestation. Periuterine adipose-tissue mass declined on day 12 of gestation to be recuperated later, subcutaneous adipose tissue increased on day 12 to decline progressively thereafter and interscapular brown adipose tissue remained stable until day 20 and increased on day 21. With only a few exceptions, the lipid concentration in all these adipose tissues remained stable throughout gestation. Mammary glands and liver weights increased intensely from day 12 and, whereas the lipid concentration in the former was stable, in the latter it decreased on day 12 and increased on days 18 and 19. These results show that in the rat (a) maternal carcass fat accumulation during gestation is not paralleled by the size of the different fat-storing tissues and (b) mammary-gland fat accumulation also contributes to maternal fat storage.

Detection of human autoantibody against intercalated cells of kidney-collecting tubule.

Serum from a 24-year-old woman with a history of habitual abortions was examined for autoantibodies by indirect immunofluorescence microscopy. Fluorochrome-labelled antibodies to IgG revealed cytoplasmic staining of single cells in rat kidney collecting and connecting tubules. An identical staining pattern was reproducibly obtained in human and rabbit kidney, pointing to a cytoplasmic antigen concentrated in the apical pole of these cells. Lectin-binding histochemistry and immunohistochemical experiments using markers for different cell populations of the renal collecting tubule by double immunofluorescence technique, identified the cells recognized by the autoantibody as intercalated cells (ICC). Remarkably, this autoantibody reacted with a different antigen from those described to date in ICC, as evidenced by distribution and intracellular localization. The pattern of immunostaining suggests that all ICC are recognized in total rather than only one subpopulation. The connection between habitual abortions and this novel autoantibody are discussed.

Role of lipoprotein lipase activity on lipoprotein metabolism and the fate of circulating triglycerides in pregnancy.

The mechanism that induces maternal hypertriglyceridemia in late normal pregnancy, and its physiologic significance are reviewed as a model of the effects of sex steroids on lipoprotein metabolism. In the pregnant rat, maternal carcass fat content progressively increases up to day 19 of gestation, then declines at day 21. The decline may be explained by the augmented lipolytic activity in adipose tissue that is seen in late pregnancy in the rat. This change causes maternal circulating free fatty acids and glycerol levels to rise. Although the liver is the main receptor organ for these metabolites, liver triglyceride content is reduced. Circulating triglycerides and very-low-density lipoprotein (VLDL)-triglyceride levels are highly augmented in the pregnant rat, indicating that liver-synthesized triglycerides are rapidly released into the circulation. Similar increments in circulating VLDL-triglycerides are seen in pregnant women during the third trimester of gestation. This increase is coincident with a decrease in plasma postheparin lipoprotein lipase activity, indicating a reduced removal of circulating triglycerides by maternal tissues or a redistribution in their use among the different tissues. During late gestation in the rat, tissue lipoprotein lipase activity varies in different directions; it decreases in adipose tissue, the liver, and to a smaller extent the heart, but increases in placental and mammary gland tissue. These changes play an important role in the fate of circulating triglycerides, which are diverted from uptake by adipose tissue to uptake by the mammary gland for milk synthesis, and probably by the placenta for hydrolysis and transfer of released nonesterified fatty acids to the fetus. After 24 hours of starvation, lipoprotein lipase activity in the liver greatly increases in the rat in late pregnancy; this change is not seen in virgin animals. This alteration is similar to that seen in liver triglyceride content and plasma ketone body concentration in the fasted pregnant rat. In the fasting condition during late gestation, heightened lipoprotein lipase activity is the proposed mechanism through which the liver becomes an acceptor of circulating triglycerides, allowing their use as ketogenic substrates, so that both maternal and fetal tissues may indirectly benefit from maternal hypertriglyceridemia. Changes in the magnitude and direction of lipoprotein lipase activity in different tissues during gestation actively contribute both to the development of hypertriglyceridemia and to the metabolic fate of circulating triglycerides.(ABSTRACT TRUNCATED AT 400 WORDS)