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To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.ctim.2007.04.004 Byline: Christian Schneider (a), Berthold Schneider (b), Juergen Hanisch (c), Robbert van Haselen (d) Keywords: Traumeel; Homoeopathy; Primary care; Observational cohort study; Injury Abstract: To assess the use, effectiveness and safety of a homoeopathic preparation (Traumeel) compared with conventional therapies in the treatment of trauma and injuries. Author Affiliation: (a) Klinik fur Ganzheitsmedizin, Herrsching, Germany (b) Institut fur Biometrie, Hanover Medical School, Germany (c) IFAG Basel AG, Switzerland (d) International Institute for Integrated Medicine (INTMEDI), Suite 467, 22 Eden Street, Kingston KT1 1DN, United Kingdom Article Note: (footnote) [star] This study was supported by a grant from Biologische Heilmittel Heel GmbH.

Allen 3 Sportarten ist die grundsätzlich niedrige Verletzungshäufigkeit während des Sportbetriebs gemeinsam. Durch wiederkehrende Vibrationen und/oder direkten Kontakt des Helmes mit dem Eis oder dem Sportgerät können jedoch teils langfristige Beschwerden im Kontext einer Concussion auftreten. Die Symptome (u. a. Kopfschmerz, Unwohlsein, Desorientiertheit) müssen ernst genommen und weiter abgeklärt werden. Das Ausmaß der Beschwerden hängt dabei von vielen möglichen Faktoren ab – nach derzeitigem Erkenntnisstand von der körperlichen Fitness, der Halsmuskulatur und der Geometrie/Beschaffenheit der Bahn. Aktuell werden Untersuchungen und Studien zu diesem Thema, die sich mit der Anwendung der bekannten Testverfahren (u. a. SCAT oder ImPACT) beschäftigen, durchgeführt. So soll eine zu frühe Rückkehr in die Sportart und damit wiederholte Verletzungen ausgeschlossen werden. Information on all 3 sports, injury patterns and advices for supervision are given. Common to all 3 sports is the generally low frequency of injuries during sports activities. Recurring vibrations and/or direct contact of the helmet with the ice or sports equipment can lead to long-term complaints in the context of a concussion. The symptoms (including headache, malaise/discomfort and disorientation) must be taken seriously and further diagnosed. The extent of the discomfort depends on many possible factors - according to the current state of knowledge, on the physical fitness, the neck muscles and the geometry/state of the track. Examinations and studies on this topic are currently being carried out, which deal with the application of the known test procedures (including SCAT or ImPACT). In this way, an early return to the sport and thus repeated injuries should be ruled out. [ABSTRACT FROM AUTHOR]

Objectives: Ventricular assist devices (VAD) are increasingly implanted in patients with terminal heart failure. Here we describe the clinical course, management and outcome of VAD patients with S. aureus bloodstream infection (SAB).Methods: We conducted a post hoc analysis of data from 1073 patients who had been prospectively enrolled in two consecutive SAB bicenter cohort studies. Patients with VAD in situ at the onset of SAB were identified. Follow-up of patients was at least 90 days.Results: Twelve VAD patients with SAB were identified. Compared to the overall cohort, patients with VAD presented more often with fever (92% vs. 65%) and septic shock (33% vs. 23%) and showed higher C-reactive protein levels (mean 244 vs. 132 g/ml). The median time to onset of SAB after device implantation was 161 days (range 24-790 days). 30-day mortality was comparable to the whole cohort (17% vs. 19%). Infection-related surgical interventions were performed in six patients. Hematogenous dissemination to distant foci was not found in any patient. One out of nine surviving patients required continuous suppressive antibiotic therapy.Conclusions: Mortality rates for VAD patients with SAB were comparable to SAB without VAD. No hematogenous disssemination or persistent infections were recorded, which might be associated with the prompt and aggressive antibiotic and surgical management in VAD patients. SAB per se does not preclude successful transplantation. [ABSTRACT FROM AUTHOR]

Environmental degradation encompasses multiple processes that are rarely combined in analyses. This study refers to three types of environmental degradation resulting from agricultural activity: soil erosion, nutrient loss, and groundwater pollution. The research was conducted in seven distinct study areas in the Malopolska Province, Poland, each characterized by different environmental properties. Calculations were made on the basis of common models, i.e., USLE (soil erosion), InVEST (nutrient loss), and DRASTIC (groundwater pollution). Two scenarios were calculated to identify the areas contributing to potential and actual degradation. For the potential degradation scenario all study areas were treated as arable land. To identify the areas actually contributing to all three types of degradation, the de facto land use pattern was used for a second scenario. The results show that the areas most endangered by agricultural activity are located in the mountainous region, whereas most of the degraded zones were located in valley bottoms and areas with intensive agriculture. The different hazards rarely overlap spatially in the given study areas – meaning that different areas require different management approaches. The distribution of arable land was negatively correlated with soil erosion hazard, whereas no linkage was found between nutrient loss or groundwater pollution hazards and the proportion of arable land. This indicates that the soil erosion hazard is the most influential factor in the distribution of arable land, whereas nutrient loss and groundwater pollution is widely ignored during land use decision-making. Slope largely and most frequently influences all hazard types, whereas land use also played an important role in the case of soil and nutrient losses. In this study we presented a consistent methodology to capture complex degradation processes and provide robust indicators which can be included in existing impact assessment approaches like Life Cycle Assessments and Grey Water Footprint analyses. [ABSTRACT FROM AUTHOR]

Objectives: Patients with rheumatoid arthritis (RA) are considered to be at increased risk of severe infections. We here describe the clinical characteristics, course and outcome of RA patients with Staphylococcus aureus bacteremia (SAB).Methods: We conducted a post hoc analysis of data from a German bi-center prospective SAB cohort study (period 2006-2014). Patients were followed-up for one year. Primary and secondary outcomes were survival time and osteoarticular infection (OAI).Results: A total of 1069 patients with SAB were analyzed, with 31 patients suffering from RA. RA patients showed significantly more often OAI (15/31 patients, 48% vs. 152/1038, 15%), disseminated infection (12/31, 39% vs. 164/1038, 16%) and severe sepsis/septic shock (12/31, 39% vs. 235/1038, 23%). Day-30 mortality in RA patients was 36% (vs. 19% in non-RA patients, p = 0.034), and day 90 mortality was 58% (vs. 32%, p = 0.003). Multivariate analyses confirmed RA to be an independent risk factor for death (HR 2.3, 95% CI 1.4-3.7) and OAI (OR 4.2, 95% CI 1.8-9.8).Conclusions: Patients with RA exhibit a complicated SAB course and a high mortality, their management is challenging. Adequate antibiotic treatment, prompt invasive diagnostic and therapeutic procedures like joint lavage or surgery are of pivotal importance. Joint damage due to RA may confer a higher risk of acquiring OAI than immunosuppression. [ABSTRACT FROM AUTHOR]

Objectives To analyze the safety and feasibility of laparoscopic-assisted ventriculoperitoneal shunt (VPS) insertion in children younger than the age of 1 year and weighing less than 5 kg. Methods We performed a retrospective review of children receiving laparoscopic-assisted VPS. Patient characteristics, complications, operation and hospitalization time, blood loss, and conversion to the standard approach were noted and analyzed. Results Laparoscopic-assisted VPS was performed in 25 children. Mean age was 32 months (range 19 days to 18 years); 16 patients (64%) were younger than the age of 1 year and 10 patients (38%) weighed less than 5 kg at the time of surgery. In all cases laparoscopic insertion was possible without the need to convert to the standard approach. No intraoperative laparoscopy-associated complications occurred. Mean estimated blood volume lost was 4.52%, showing no significant difference between patients younger and older than 1 year. Mean operation time was 75.44 minutes (range 45–121 minutes), and mean hospitalization time was 37.1 days (range 4–142 days, median: 22 days). Patients younger than the age of 1 year showed significant shorter operation time ( P < 0.001) and longer hospitalization time ( P = 0.04). Complication rate within 30 days was 24% ( n = 6), and overall complication rate was 36% ( n = 9), whereas none were related to the abdominal placement of the catheter, and showed no difference between the 2 age groups. Conclusions Laparoscopic-assisted VPS insertion in children seems to be safe and feasible leading to very good results even in patients under the age of 1 and weighing less than 5 kg. [ABSTRACT FROM AUTHOR]

Background Multidetector CT (MDCT) is performed to evaluate patients before transcatheter aortic valve replacement (TAVR). MDCT can uncover relevant nonvascular incidental findings. The use of venous phase imaging (VPI) in MDCT before TAVR has not been evaluated. Objective To evaluate the incidence of nonvascular findings in MDCT before TAVR with effect on the TAVR procedure and the value of VPI in this setting. Methods Sixty-four-slice MDCT angiography with VPI (100 mL contrast agent with 370-mg iopromide per mL) in 76 patients was retrospectively evaluated by 2 readers. Nonvascular findings were separately assessed on arterial and venous phase images and categorized in consensus as nonsignificant (no effect on TAVR), intermediate (further workup or surveillance necessary, no effect on TAVR), or significant (effect on TAVR). Radiation dose was recorded as dose-length product (DLP) and effective dose was calculated. Results A total of 169 findings were detected, of which 155 (91.7%) were nonsignificant, 13 (7.7%) were intermediate, and 1 (0.6%) was significant. TAVR was canceled in 1 patient (1.3%) because of suspected pancreatic cancer. No significant finding was seen on VPI only. Mean total DLP was 1137.9 mGy·cm (16.07 mSv) and the proportional mean DLP of VPI was 403 mGy·cm (6.85 mSv). Conclusion The incidence of nonvascular significant findings in MDCT before TAVR is low and VPI in our series did not add value. However, it may be considered in selected patients. [ABSTRACT FROM AUTHOR]

Background When coronary calcium scoring is performed in patients with suspected coronary artery disease, a separate noncontrast scan is acquired before contrast-enhanced coronary CT angiography (CTA). Objective Our aim was to develop and validate an automated method for calculating the coronary calcium score (CCS) from coronary CTA. Methods We analyzed coronary CTA and noncontrast CT data sets of 84 patients (Agatston score >0). The CCS on noncontrast CT was measured using commercial methods. Coronary calcium volume was measured on coronary CTA using an automated standardized method with scan-specific calcium thresholds. Data sets were split into derivation (n = 40) and validation groups (n = 44). To calculate the CCS on coronary CTA, a conversion factor between calcium scores measured in noncontrast CT and the calcium volume measured on coronary CTA was derived by linear regression. Results In the validation group, the median calculated CCS derived from CTA was 277 and 244 on noncontrast images ( P = .12). This CCS showed an excellent correlation with the CCS from noncontrast images (Pearson, r = 0.95). In the validation group, 39 of 44 patients (88.6%) were classified into the same standard category (1–10, 11–100, 101–400, or >400) with an excellent agreement (weighted κ of 0.87). Conclusion CCSs can be accurately measured from contrast-enhanced coronary CTA by using an automated, standardized method, obviating the need for a noncontrast scan. [ABSTRACT FROM AUTHOR]

Copyright of Sport-Orthopadie - Sport-Traumatologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Sport-Orthopadie - Sport-Traumatologie is the property of Elsevier B.V. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Coronary CT angiography allows visualization of the coronary arteries. However, motion artifact can impair delineation of the coronary artery lumen and detection of coronary artery stenoses. Objective: We investigated the influence of heart rate and the segment of the cardiac cycle during which images are reconstructed on the occurrence of motion artifacts. Methods: We evaluated coronary CT angiography datasets obtained by 64-slice dual-source CT in 100 consecutive patients. Data were reconstructed at 13 time instants during the cardiac cycle and evaluated for the presence of motion artifact. Results: Mean heart rate was 66±14 beats/min. Overall, 98 of 100 patients had evaluable datasets. For heart rates ≤60 beats/min, optimal image quality was uniformly found during late diastole (100% of cases with evaluable image quality during a time window between 65% and 75% of the cardiac cycle). With increasing heart rates, images reconstructed during late systole more frequently provided best image quality. However, image reconstruction could not be restricted to a systolic time period. To achieve evaluable image quality in 95% of cases, data acquired between 25% and 75% of the cardiac cycle had to be available for patients with heart rates >60 beats/min. Conclusion: Dual-source CT provides high image quality across a wide range of heart rates. Although data acquisition may be limited to diastole for patients with heart rates ≤60 beats/min, the availability of data acquired both during systole and diastole is necessary for patients with higher heart rates. [ABSTRACT FROM AUTHOR]

Abstract: Purpose: We wanted to identify the importance of the duration of invasive ventilation and of renal replacement therapy for short-term prognosis of surgical patients treated in an intensive care unit (ICU). Methods: We analyzed adult patients (n = 1462) who had an ICU length of stay of more than 4 days and who were followed up until the end of the short-term phase after ICU admission. Duration of different invasive therapies was evaluated by constructing specific vectors that tested effects of time-dependent variables on outcome after a lag time of 7 days. Measurements and Main Results: Eight hundred eight patients (56.6%) were still alive at the end of the short-term phase. During the short-term phase, 85.3% of the 1462 patients required invasive ventilation, and 16.1%, a continuous renal replacement therapy. Besides the underlying disease and disease severity at ICU admission, the need for invasive ventilation or renal replacement therapy was associated with poorer outcome. Duration of invasive ventilation shortened survival if treatment lasted for more than 11 days (nonlinear association). In contrast, duration of renal replacement therapy was unimportant for short-term prognosis. Conclusion: Prolonged duration of invasive ventilation but not of renal replacement therapy is inversely related to short-term survival. [Copyright &y& Elsevier]

Summary: Objectives: To evaluate the relationship between mortality of bloodstream infection due to Staphylococcus aureus and infectious diseases specialist consultation and other factors potentially associated with outcomes. Methods: A 6-year cohort study was conducted at a 1600-bed university hospital. Consecutive adult patients with S. aureus bacteremia were assessed using a standardised data collection and review form. A new infectious diseases service increased its consultations for S. aureus bacteremia from 33% of cases in 2002 to >80% in 2007. Infectious disease consultation and other factors potentially associated with in-hospital mortality were analysed by multivariate logistic regression. Results: A total of 521 patients were studied. All-cause in-hospital mortality was 22%, 90-day mortality was 32%. Factors significantly associated with in-hospital mortality in multivariate analysis were ICU admission (OR 5.8, CI 3.5–9.7), MRSA (OR 2.6, CI 1.4–4.9), age ≥60 years (OR 2.4, CI 1.4–4.2), a diagnosis of endocarditis (OR 2.8, CI 1.4–5.7), a non-fatal underlying disease/comorbidity according to the McCabe classification (OR 0.2, CI 0.1–0.4), and infectious disease specialist consultation (OR 0.6, CI 0.4–1.0). Conclusions: These data suggest that outcome of S. aureus bacteremia may be improved by an expert consultation service. [Copyright &y& Elsevier]

Abstract: The use of cages of different material and shapes for cervical discectomy with fusion (ACDF) has increased during the last few years. The use of additional osteogenic material is controversial. We prospectively evaluated an empty, Plasmapore®-covered titanium cage (PCTC) in 45 patients undergoing 58 ACDFs. Patients were evaluated using standard clinical and radiological criteria. Good to excellent outcome was achieved in 93%, 78% and 75% after 3, 12 and 48 months, respectively. Sixty-five percent of patients could resume their prior work after 48 months. Disc space height and lordosis could be preserved in all cases. Two percent of the treated levels showed subsidence and 2% increased segmental motion. There were no procedure-related complications. Implantation of an empty PCTC after microsurgical anterior cervical discectomy is a safe procedure with good results and low incidence of complications. Disc height and lordosis can be preserved with low incidence of subsidence and good fusion rates. [Copyright &y& Elsevier]

Abstract: Objective: There is controversy whether the measurement of QT dispersion might provide information about the presence and extent of ischaemic myocardium. It was the aim to analyse the diagnostic value of QT dispersion for the detection of myocardial ischaemia in comparison to Tl-201-SPECT. Patients and methods: 100 patients were randomly selected from patients referred for Tl-201-SPECT. QT duration was measured in all 12 leads in the resting ECG and in the ECG either at maximal bicycle exercise or during peak dipyridamole stress. QT dispersion was calculated and correlated with parameters of ischaemia for all patients and for the bicycle exercise and the dipyridamole group separately. Results: 25 patients had to be excluded from the analysis because QT dispersion could not be measured. Regression analysis did not show significant correlation neither for all 75 patients nor for the bicycle exercise nor for the dipyridamole group correlating grade of myocardial ischaemia, number of ischaemic segments and summed ischaemic stress score with QT dispersion in the resting or the stress ECG and QTd and there was no significant difference between groups. Conclusion: QT dispersion could not be measured in 25/100 patients (25%). In the remaining patients QT dispersion did not correlate with the extent or grade of myocardial ischaemia. [Copyright &y& Elsevier]

Abstract: The effluent of four sewage treatment plants (STP) and eight surface water samples from the river Rhine in Germany and two smaller rivers were monitored for the hormones estradiol (E2) and ethinylestradiol (EE2). The studied STPs are using different treatment processes. Two facilities include an activated sludge treatment, one is a constructed wetland, and one is just an aerated lagoon. For analysis of E2 and EE2 in the aquatic environment two immunoassays have been developed allowing a very cost-effective screening for both hormones in environmental samples. Detection limits could be established at 0.05ngL−1 for E2 and 0.01ngL−1 for EE2, taking a 50-fold enrichment into account. Median concentrations for E2 and EE2 in effluent samples were 12 and 1.8ngL−1, in surface water 4.0 and 0.7ngL−1, respectively. The highest estrogen concentrations were found in the effluent of the lagoon, equipped with very basic means of wastewater treatment. [Copyright &y& Elsevier]

Context: The incidence of tendon injuries and tendinopathy has risen substantially in the past decades. Objective: To assess the noninferiority of therapy based on the homeopathic preparation Traumeel S ointment (Heel GmbH, Baden-Baden, Germany) compared with treatment based on diclofenac 1% gel in patients with tendinopathies of varying etiology. Design: Nonrandomized, observational study. Setting: Ninety-five homeopathy and conventional medical practices in Germany. Patients: Three hundred fifty-seven patients aged 18 to 93 years with tendinopathy of varying etiology based on excessive tendon load rather than inflammation. Interventions: Traumeel S ointment or diclofenac 1% gel for a maximum of 28 days. Main Outcome Measures: Efficacy was measured on a four-degree scale on pain-related variables, on variables related to motility, and on overall treatment outcome. Tolerability was monitored as adverse events. Compliance was assessed by practitioner and patient on a four-degree scale. Results: The patients groups were comparable at baseline. The changes in summary score of all pain-related variables were −5.3 ± 2.7 (all values means ± SD) in the Traumeel group and −5.0 ± 2.7 in the control group. Changes for all motility-related variables were −4.2 ± 3.8 with Traumeel and −3.7 ± 3.4 with control therapy. The summary scores for all clinical variables were reduced by −9.5 ± 5.7 with Traumeel therapy and by −8.7 ± 5.4 with diclofenac-based treatment. Homeopathic therapy was noninferior to diclofenac therapy on all variables. For motility-related variables, there was a trend toward superiority of Traumeel. Treatments were well tolerated with no treatment-related adverse events. Conclusions: The results suggest that Traumeel ointment is an effective alternative to nonsteroidal antiinflammatory drugs therapy for the acute symptomatic treatment of patients with tendinopathy. [Copyright &y& Elsevier]

Ethynylestradiol (EE2) is one of the most potent endocrine disrupting compounds capable to induce estrogenic effects even at trace level concentrations in the aquatic environment. Methods for detecting EE2 in such concentrations are generally based on GC or HPLC coupled to at least one mass spectrometer. Another approach are immunoassays and sensor systems but for most designs, derivatives of EE2 are required (e.g. for coupling to carrier proteins, enzyme or fluorescent labels, etc.). Here we present the straightforward synthesis and complete characterization of a new long-chain biotinylated EE2 derivative. The new EE2 derivative is used as tracer in a direct competitive enzyme-linked immunosorbent assay (ELISA) for the determination of EE2. With pure water, the limit of detection (LOD, signal-to-noise ratio, S/N=3) and the test midpoint were found to be 14 and 136 ng l-1, respectively. Cross reactivity (CR) was tested for 10 endogenous steroids and the BSA-conjugate used for immunization, as well as a synthetic precursor of the conjugate. Among the naturally occuring compounds, CR was determined to be maximum for metabolites of EE2 conjugated at ring-position 3 (17% and 37% for 3-glucuronide and 3-sulphate, respectively). Assay stability was tested against humic substances and organic solvents. Increasing amounts of organic solvents in the sample caused a clear decrease in sensitivity, presence of humic substances lead to an overestimation of EE2. [Copyright &y& Elsevier]

Ten patients with symptomatic coronary artery disease received oral azithromycin for 3 days and underwent directional atherectomy on the third day. Azithromycin was found in all plaque samples with a median concentration of 284 ng/ml (95% confidence interval 163 to 517 ng/ml). [ABSTRACT FROM AUTHOR]

In March 2006, 6 healthy volunteers experienced serious adverse reactions during a first-in-human clinical trial of the superagonistic anti-CD28 mAb TGN1412. A first investigation excluded contaminations of the drug product or protocol irregularities as the root cause. Later, an expert scientific group convened in the United Kingdom to develop recommendations pertinent to minimizing risks of first-in-human clinical trials. The expert scientific group concluded from in silico calculations that at the initial dose of 0.1 mg/kg, which was adjusted on the basis of the no observed adverse effect level, approximately 86.2% to 90.9% CD28 receptor occupancy was obtained. Here we developed a flow cytometric method that revealed receptor occupancy of approximately 45% to 80% under the above conditions. Thus we present a method to experimentally determine receptor occupancy that can be taken as one parameter to define the minimal anticipated biological effect level as the basis for calculating safer starting doses for first-in-human clinical trials for products in which a potential risk has been identified. Additional measures are being discussed that will help to significantly improve safety of first-in-human clinical trials. [Copyright &y& Elsevier]

Assessment of vancomycin-resistant Enterococcus faecium (VREfm) prevalence upon hospital admission and analysis of risk factors for colonization. From 2014 to 2018, patients were recruited within 72 hours of admission to seven participating German university hospitals, screened for VREfm and questioned for potential risk factors (prior multidrug-resistant organism detection, current/prior antibiotic consumption, prior hospital, rehabilitation or long-term care facility stay, international travel, animal contact and proton pump inhibitor [PPI]/antacid therapy). Genotype analysis was done using cgMLST typing. Multivariable analysis was performed. In 5 years, 265 of 17,349 included patients were colonized with VREfm (a prevalence of 1.5%). Risk factors for VREfm colonization were age (adjusted OR [aOR], 1.02; 95% CI, 1.01–1.03), previous (aOR, 2.71; 95% CI, 1.87–3.92) or current (aOR, 2.91; 95% CI, 2.60–3.24) antibiotic treatment, prior multidrug-resistant organism detection (aOR, 2.83; 95% CI, 2.21–3.63), prior stay in a long-term care facility (aOR, 2.19; 95% CI, 1.62–2.97), prior stay in a hospital (aOR, 2.91; 95% CI, 2.05–4.13) and prior consumption of PPI/antacids (aOR, 1.29; 95% CI, 1.18–1.41). Overall, the VREfm admission prevalence increased by 33% each year and 2% each year of life. 250 of 265 isolates were genotyped and 141 (53.2%) of the VREfm were the emerging ST117. Multivariable analysis showed that ST117 and non-ST117 VREfm colonized patients differed with respect to admission year and prior multidrug-resistant organism detection. Age, healthcare contacts and antibiotic and PPI/antacid consumption increase the individual risk of VREfm colonization. The VREfm admission prevalence increase in Germany is mainly driven by the emergence of ST117. [ABSTRACT FROM AUTHOR]

COVID-19 causes a wide range of symptoms, with particularly high risk of severe respiratory failure and death in patients with predisposing risk factors such as advanced age or obesity. Recipients of solid organ transplants, and in particular lung transplantation, are more susceptible to viral infection owing to immune suppressive medication. As little is known about the SARS-CoV-2 infection in these patients, this study was undertaken to describe outcomes and potential management strategies in early COVID-19 infection early after lung transplantation. We describe the incidence and outcome of COVID-19 in a cohort of recent lung transplant recipients in Munich. Six of 186 patients who underwent lung transplantation in the period between March 2019 and March 2021 developed COVID-19 within the first year after transplantation. We documented the clinical course and laboratory changes for all patients showing differences in the severity of the infection with COVID-19 and their outcomes. Three of 6 SARS-CoV-2 infections were hospital-acquired and the patients were still in inpatient treatment after lung transplantation. All patients suffered from symptoms. One patient did not receive antiviral therapy. Remdesivir was prescribed in 4 patients and the remaining patient received remdesivir, bamlanivimab and convalescent plasma. COVID-19 does not appear to cause milder disease in lung transplant recipients compared with the general population. Immunosuppression is potentially responsible for the delayed formation of antibodies and their premature loss. Several comorbidities and a general poor preoperative condition showed an extended hospital stay. [ABSTRACT FROM AUTHOR]

Abstract: Background: Since 1999 randomized controlled trials have shown that new therapeutic strategies, such as strict glycemic control, increased use of noninvasive ventilation and of lung-protective ventilation, and early goal-oriented shock therapy, may reduce mortality in selected groups of critically ill patients. Whether these benefits can be translated to a surgical clinical setting is unclear. We wanted to evaluate longitudinally the successive routine implementation of new therapeutic measures and its effect on postsurgical patients admitted to the intensive care unit. Methods: We performed a retrospective analysis on data collected prospectively from March 1, 1993 through February 28, 2005. Results: A cohort of 1,802 consecutive cases requiring intensive care therapy for more than 4 days was analyzed. A significant decrease in mortality was observed in the last years of the study. With adjustment for relevant covariates, treatment after the implementation of new therapeutic strategies was identified as an independent factor linked with a reduced risk of death (odds ratio [OR] .518; 95% confidence interval [CI] .337–.796), whereas older age (OR 1.030; 95% CI 1.015–1.045), a high severity score on admission (OR 1.155; 95% CI 1.113–1.198) or during intensive care unit stay (OR 1.187; 95% CI 1.145–1.231), a high number of failing organs (OR 1.918; 95% CI 1.635–2.250), and peritonitis (OR 3.277; 95% CI 2.046–5.246) were independently associated with death. Conclusions: Implementing of a variety of new therapeutic measures into routine care of critically ill surgical patients was associated with improved survival after 2001. [Copyright &y& Elsevier]

Identification of akinetic but viable myocardium is important for the selection of patients for coronary revascularization. In order to assess predictive values of end-diastolic wall thickness and dobutamine induced wall thickening obtained by magnetic resonance imaging (MRI) and [18F]Fluorodeoxyglucose uptake assessed by positron emission tomography (F-18-FDG-PET), these parameters were compared to recovery of left ventricular function after successful revascularization. Forty patients with chronic myocardial infarction and regional a- or dyskinesia by ventriculography underwent rest- and dobutamine-MRI studies (10 μg dobutamine/kg body weight/min) and F-18-FDG-PET. Viability of the infarct region was considered to be present if; 1) end-diastolic wall thickness was ≥ 5.5 mm; 2) dobutamine induced wall thickening ≥ 2 mm could be measured; and 3) normalized F-18-FDG-uptake was ≥ 50% in ≥ 50% of akinetic segments. Preserved end-diastolic wall thickness was found in 32/40 patients, functional improvement during dobutamine infusion in 26/40 patients and preserved F-18-FDG-uptake in 29/40 patients. After revascularization regional left ventricular function improved in 25/40 patients. Positive and negative predictive values and diagnostic accuracy were 78%, 100%, and 83% for preserved end-diastolic wall thickness, 92%, 93%, and 93% for dobutamine inducible contraction reserve and 86%, 100%, and 90% for preserved F-18-FDG-uptake. Quantitative assessment of dobutamine induced systolic wall thickening by MRI and F-18-FDG-uptake by PET are highly accurate techniques for the identification of viable myocardium and prediction of functional recovery after successful revascularization. Preserved end-diastolic wall thickness results in an overestimation of viable myocardium compared to functional improvement, but wall thickness <5.5 mm excludes recovery of regional function. [Copyright &y& Elsevier]

Thea authors discuss aspects of nonclinical scientific advice on advanced therapy medicinal products (ATMPs) comprising tissue-engineered products (TEPs), somatic cell therapy medicinal products (CTMPs) and gene therapy medicinal products (GTMPs). The authors provide a comprehensive analysis of the scientific advice from the Committee for Medicinal Products for Human Use (CHMP). Moreover, they comments on the use of a classic guideline-based approach on ATMP development.

Phenotyping chronic lung allograft dysfunction (CLAD) in single lung transplant (SLTX) recipients is challenging. The aim of this study was to assess the diagnostic and prognostic value of longitudinal lung function tests in SLTX recipients with CLAD. A total of 295 SLTX recipients were analyzed and stratified according to native lung physiology. In addition to spirometry, measurements of static lung volumes and lung capacities were used to phenotype patients and to assess their prognostic value. Outcome was survival after CLAD onset. Patients with insufficient clinical information were excluded (n = 71). Of 224 lung transplant recipients, 105 (46.9%) developed CLAD. Time to CLAD onset (hazard ratio [HR]: 0.82, 95% CI: 0.74–0.90; p < 0.001), severity of CLAD at onset (HR: 0.97, 95% CI: 0.94–0.99; p = 0.009), and progression after onset of CLAD (HR: 1.03, 95% CI: 1.00–1.05; p = 0.023) were associated with outcome. Phenotypes at onset were bronchiolitis obliterans syndrome (BOS) (59.1%), restrictive allograft syndrome (RAS) (12.4%), mixed phenotype (6.7%), and undefined phenotype (21.9%). Survival estimates differed significantly between phenotypes (p = 0.004), with RAS and mixed phenotype being associated with the worst survival, followed by BOS and undefined phenotype. Finally, a higher hazard for mortality was noticed for RAS (HR: 2.34, 95% CI: 0.99–5.52; p = 0.054) and mixed phenotype (HR: 3.30, 95% CI: 1.20–9.11; p = 0.021) while controlling for time to CLAD onset and severity of CLAD at onset. Phenotyping CLAD in SLTX remains challenging with a high number of patients with an undefined phenotype despite comprehensive lung function testing. However, phenotyping is of prognostic value. Furthermore, early, severe, and progressive CLADs are associated with worse survival. [ABSTRACT FROM AUTHOR]