Web-based Dashboard on ECMO Utilization in Germany: An Interactive Visualization, Analyses, and Prediction Based on Real-life Data.

In Germany, a comprehensive reimbursement policy for extracorporeal membrane oxygenation (ECMO) results in the highest per capita use worldwide, although benefits remain controversial. Public ECMO data is unstructured and poorly accessible to healthcare professionals, researchers, and policymakers. In addition, there are no uniform policies for ECMO allocation which confronts medical personnel with ethical considerations during health crises such as respiratory virus outbreaks.Retrospective information on adult and pediatric ECMO support performed in German hospitals was extracted from publicly available reimbursement data and hospital quality reports and processed to create the web-based ECMO Dashboard built on Open-Source software. Patient-level and hospital-level data were merged resulting in a solid base for ECMO use analysis and ECMO demand forecasting with high spatial granularity at the level of 413 county and city districts in Germany.The ECMO Dashboard ( https://www.ecmo-dash.de/ ), an innovative visual platform, presents the retrospective utilization patterns of ECMO support in Germany. It features interactive maps, comprehensive charts, and tables, providing insights at the hospital, district, and national levels. This tool also highlights the high prevalence of ECMO support in Germany and emphasizes districts with ECMO surplus - where patients from other regions are treated, or deficit - origins from which ECMO patients are transferred to other regions. The dashboard will evolve iteratively to provide stakeholders with vital information for informed and transparent resource allocation and decision-making.Accessible public routine data could support evidence-informed, forward-looking resource management policies, which are urgently needed to increase the quality and prepare the critical care infrastructure for future pandemics.

Preoperative hemoglobin thresholds for survival equity in women and men.

Anemia affects humans throughout life, and is linked to higher morbidity and mortality. Unclear is whether hemoglobin values are equivalent between women and men. This study evaluates the association of preoperative hemoglobin levels with in-hospital mortality and estimates thresholds for survival equity between men and women. All adult patients undergoing surgery between 2010 and 2019 from 14 German hospitals were included in the study. Thresholds for survival equity were determined with generalized additive models. In total, 842,130 patients with a median in-hospital follow-up time of 7 days were analyzed. During follow-up 20,370 deaths occurred. Preoperative hemoglobin stratified in-hospital mortality (log-rank test p < 0.001) and was associated with mortality independently of demographic risk, surgical risk and health status. For each 1 g/dL reduction in preoperative hemoglobin, the odds of mortality increased by a factor of 1.22 (95% CI 1.21-1.23, p < 0.001). A preoperative hemoglobin threshold of 10.5 g/dL reflected equivalent risk for both male and female patients. Hemoglobin levels below 10.5 g/dL had higher risk of mortality for women than for men. The findings from this study aid evidence-based thresholds, inform anemia management and promote equitable care, thus enhancing patient outcomes.

Anaemia and red blood cell transfusion in women with placenta accreta spectrum: an analysis of 38,060 cases.

Placenta accreta spectrum (PAS) has become a significant life-threatening issue due to its increased incidence and associated morbidity and mortality. Pregnancy is often associated with states of anaemia, and severe maternal haemorrhage represents a major risk factor for red blood cell (RBC) transfusion. The present study retrospectively analyzed the prevalence of anaemia, transfusion requirements and outcome in women with PAS. Using data from the German Statistical Office pregnant patients with deliveries hospitalized between January 2012 and December 2021 were included. Primary outcome was the prevalence of anemia and administration of RBCs. Secondary outcome were complications in women with PAS who received RBC transfusion. In total 6,493,606 pregnant women were analyzed, of which 38,060 (0.59%) were diagnosed with PAS. The rate of anaemia during pregnancy (60.36 vs. 23.25%; p < 0.0001), postpartum haemorrhage (47.08 vs. 4.41%; p < 0.0001) and RBC transfusion rate (14.68% vs. 0.72%; p < 0.0001) were higher in women with PAS compared to women without PAS. Women with PAS who had bleeding and transfusion experienced significantly more peripartum complications than those who did not. A multiple logistic regression revealed that the probability for RBC transfusion in all pregnant women was positively associated with anaemia (OR 21.96 (95% CI 21.36-22.58)). In women with PAS, RBC transfusion was positively associated with the presence of renal failure (OR 11.27 (95% CI 9.35-13.57)) and congestive heart failure (OR 6.02 (95% CI (5.2-7.07)). Early anaemia management prior to delivery as well as blood conservation strategies are crucial in women diagnosed with PAS.

Use of cell salvage in obstetrics in Germany: analysis of national database of 305 610 cases with peripartum haemorrhage.

BACKGROUND: One of the leading causes of maternal death worldwide is severe obstetric haemorrhage after childbirth. Use of intraoperative cell salvage is strongly recommended by international guidelines on patient blood management. Recent data provide strong evidence that use of cell salvage in obstetrics is effective and safe in women with postpartum haemorrhage resulting in fewer transfusion-related adverse events and shorter hospital stay. We retrospectively analysed the use of cell salvage in bleeding women during delivery for a period of 10 yr in German hospitals. METHODS: Data from the German Federal Statistical Office were used that covers all in-hospital birth deliveries from 2011 to 2020. Prevalence of peripartum haemorrhage (pre-, intra-, and post-partum haemorrhage), comorbidities, peripartum complications, administration of blood products, and use of cell salvage were analysed. RESULTS: Of 6 356 046 deliveries in Germany, 305 610 women (4.8%) suffered from peripartum haemorrhage. Of all women with peripartum haemorrhage, postpartum haemorrhage was the main cause for major obstetric haemorrhage (92.33%). Cell salvage was used in only 228 (0.07%) of all women with peripartum haemorrhage (cell salvage group). In women undergoing Caesarean delivery with postpartum haemorrhage, cell salvage was used in only 216 out of 70 450 women (0.31%). CONCLUSION: Cell salvage during peripartum haemorrhage is rarely used in Germany. There is tremendous potential for the increased use of cell salvage in peripartum haemorrhage nationwide.

Anemia, red blood cell transfusion and administration of blood products in obstetrics: a nationwide analysis of more than 6 million cases from 2011-2020.

BACKGROUND: The prevalence of anemia is high, especially in obstetrics. There is large evidence, that anemia during pregnancy is associated with increased maternal morbidity and mortality. Anemia and peripartum hemorrhage remain the main causes for transfusion of red blood cells (RBC). Patient Blood Management (PBM) reduces the need for RBC transfusion significantly. The present study retrospectively analyzed the impact and prevalence of anemia and RBC transfusion on pregnant women. MATERIALS AND METHODS: Data were retrieved from the German Statistical Office on pregnant women who delivered in hospital between January 1st 2011 and December 31st 2020. The prevalence of anemia, peripartum hemorrhage, comorbidities, administration of blood products and complications were analyzed. RESULTS: A total of 6,356,046 pregnant women were analyzed of whom 78,257 (1.23%) received RBC transfusion (RBC transfusion group) and 6,277,789 (98.77%) did not receive RBC transfusion (non-RBC transfusion group). In all women analyzed anemia rate was 23.74%. The rates of anemia during pregnancy (70.39 vs 23.15%; p<0.0001), postpartum hemorrhage (41.42 vs 4.35%; p<0.0001), hospital length of stay (127.5 vs 87.08 hours; p<0.0001) and single complications were higher in women with RBC transfusion compared to women without RBC transfusion. DISCUSSION: The prevalence of anemia and the increased risk for RBC transfusion show that there is great potential for effective implementation of PBM in obstetrics. The treatment of anemia during pregnancy and reduction of RBC transfusions will decrease maternal morbidity and mortality.

Results from 237 extracorporeal membrane oxygenation runs with drowned patients: a nationwide retrospective study.

BACKGROUND: Drowning is one of the leading causes of death worldwide and presents with a wide range of symptoms, from simple coughing to cardiac or pulmonary failure. In severe cases, extracorporeal membrane oxygenation (ECMO) should be considered as a rescue therapy. Therefore, we sought to analyse ECMO usage, outcomes and predictive factors in drowned patients. METHODS: The Federal Statistical Office of Germany provided the study data. The patients included experienced drowning (ICD T75.1) and ECMO (OPS 8-852.0, 8-852.3) between 2007 and 2020. All age groups were included. Mortality was calculated for the total population and for ECMO patients. A multiple logistic regression model for ECMO patients was applied to account for predefined patient characteristics and complications. RESULTS: Of 12,354 patients who were hospitalised due to drowning, 237 patients (1.9%) received ECMO. Hospital mortality was 14.1% (n = 1741) overall and 74.7% (n = 177) for ECMO patients. In-hospital mortality was positively associated with cardiopulmonary resuscitation (CPR) before admission (odds ratio [OR] 4.49, 1.31-15.39) and in-hospital CPR (OR 6.28, 2.76-14.31). Stroke (OR 0.14, 0.02-0.96) and drug abuse (OR 0.05, 0.01-0.45) were negatively associated with in-hospital mortality. Neither the ECMO mode nor the patient's age and sex had statistically significant effects on survival. CONCLUSION: This study indicates that survival in drowned patients who receive ECMO is lower than previously reported. The proportion of paediatric patients was also smaller than expected. As the effects of different ECMO modes on mortality remain unclear, the need for further study remains great.

German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients.

BACKGROUND: Patient Blood Management (PBM) is a patient-centred, systematic, evidence-based approach to improve patient outcomes by managing and preserving a patient's own blood whilst promoting patient safety and empowerment. The effectiveness and safety of PBM over a longer period have not yet been investigated. METHODS: We performed a prospectively designed, multicentre follow-up study with non-inferiority design. Data were retrospectively extracted case-based from electronic hospital information systems. All in-hospital patients (≥18 yr) undergoing surgery and discharged between January 1, 2010 and December 31, 2019 were included in the analysis. The PBM programme focused on three domains: preoperative optimisation of haemoglobin concentrations, blood-sparing techniques, and guideline adherence/standardisation of allogeneic blood product transfusions. The outcomes were utilisation of blood products, composite endpoint of in-hospital mortality and postoperative complications (myocardial infarction/ischaemic stroke/acute renal failure with renal replacement therapy/sepsis/pneumonia), anaemia rate at admission and discharge, and hospital length of stay. RESULTS: A total of 1 201 817 (pre-PBM: n=441 082 vs PBM: n=760 735) patients from 14 (five university/nine non-university) hospitals were analysed. Implementation of PBM resulted in a substantial reduction of red blood cell utilisation. The mean number of red blood cell units transfused per 1000 patients was 547 in the PBM cohort vs 635 in the pre-PBM cohort (relative reduction of 13.9%). The red blood cell transfusion rate was significantly lower (P<0.001) with odds ratio 0.86 (0.85-0.87). The composite endpoint was 5.8% in the PBM vs 5.6% in the pre-PBM cohort. The non-inferiority aim (safety of PBM) was achieved (P<0.001). CONCLUSIONS: Analysis of >1 million surgical patients showed that the non-inferiority condition (safety of Patient Blood Management) was fulfilled, and PBM was superior with respect to red blood cell transfusion. CLINICAL TRIAL REGISTRATION: NCT02147795.

[Implementation of Patient Blood Management as Standard-of-Care]. / Etablierung eines Patient Blood Managements als Behandlungsstandard.

Anaemia is among the most common co-morbidity in surgical patients. However, it often remains unrecognized and untreated, which results in an increased requirement for allogeneic blood products and complications. Patient Blood Management offers patient-centred and evidence-based therapies and preventive measures for anaemia. Patient Blood Management is composed of 3 main pillars: pre-operative anaemia management, blood loss reduction and the rational use of allogeneic blood products. The World Health Organization demands the implementation of Patient Blood Management measures since 2010. However, a comprehensive implementation of Patient Blood Management as a standard-of-care is still not achieved. Here, we describe the need for a comprehensive Patient Blood Management implementation and highlight several specific Patient Blood Management measures.

How do I/we forecast tomorrow's transfusion? A focus on recipients' profiles.

Red blood cell (RBC) transfusion is a life-saving medical intervention and has an essential role in the management of surgical patients. However, blood donations and supply levels are decreasing, therefore there is an unmet need for the accurate prediction of the transfusion probability for surgical patients. Multiple methods have been established to predict the need for RBC transfusion. Maximum surgical blood order schedules are widely used in the clinical setting. However, these lists are not designed to accurately predict RBC utilization for an individual case as factors such as preoperative haemoglobin level, total body blood volume, comedications are not considered. Artificial intelligence and related technologies based on machine learning modelling are valuable alternatives to predict transfusion probability taking into account patient individual risk factors including among others comorbidities, laboratory parameters, use of oral anticoagulation, ASA score, surgeon's ID or applied blood saving measures. Overall, forecasting the need for a RBC transfusion can facilitate personalized medicine, quality assurance, decrease blood wastage, decrease costs, and increase patient safety. Furthermore, transfusion prediction models could facilitate blood management strategies before surgery.

Routine Use of Esophago-gastro-duodenoscopy (EGD) in Bariatric Surgery-an International Survey of Our Current Practice.

INTRODUCTION: The role of esophago-gastro-duodenoscopy (EGD) in bariatric surgery has been widely discussed. In 2020, the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) issued recommendations on the routine use of EGD before and after bariatric surgery. However, little is known of our current practice and the guidance uptake. METHODS: We conducted an international survey assessing bariatric surgeons' practice on the use of EGD. The survey aimed to identify whether surgeons offer EGD in the following settings: pre-operative, post-operative at 1 year, every 2-3 years following longitudinal sleeve gastrectomy (LSG) or one-anastomosis gastric bypass (OAGB). Data was analyzed using descriptive statistics. RESULTS: Among 121 respondents, 72% are aware of the IFSO recommendations. The commonly performed bariatric procedures were LSG, Roux-en-Y gastric bypass (RYGB), and OAGB. 53.7% surgeons routinely offer pre-operative EGD and 14.3% routinely offer post-operative EGD for bariatric patients at 1 year after surgery. Majority do not routinely offer EGD after LSG (74.8%) or OAGB (79.7%) every 2-3 years as proposed by IFSO. CONCLUSION: The uptake of IFSO recommendation is variable according to each recommendation with better compliance among surgeons with regard to pre-operative EGD. Further research is necessary to develop robust evidence-base for the role of endoscopy after bariatric surgery with the inclusion of patient and public involvement.

Characteristics and mortality of 561,379 hospitalized COVID-19 patients in Germany until December 2021 based on real-life data.

The ongoing SARS-CoV-2 pandemic is characterized by poor outcome and a high mortality especially in the older patient cohort. Up to this point there is a lack of data characterising COVID-19 patients in Germany admitted to intensive care (ICU) vs. non-ICU patients. German Reimbursement inpatient data covering the period in Germany from January 1st, 2020 to December 31th, 2021 were analyzed. 561,379 patients were hospitalized with COVID-19. 24.54% (n = 137,750) were admitted to ICU. Overall hospital mortality was 16.69% (n = 93,668) and 33.36% (n = 45,947) in the ICU group. 28.66% (n = 160,881) of all patients suffer from Cardiac arrhythmia and 17.98% (n = 100,926) developed renal failure. Obesity showed an odds-ratio ranging from 0.83 (0.79-0.87) for WHO grade I to 1.13 (1.08-1.19) for grade III. Mortality-rates peaked in April 2020 and January 2021 being 21.23% (n = 4539) and 22.99% (n = 15,724). A third peak was observed November and December 2021 (16.82%, n = 7173 and 16.54%, n = 9416). Hospitalized COVID-19 patient mortality in Germany is lower than previously shown in other studies. 24.54% of all patients had to be treated in the ICU with a mortality rate of 33.36%. Congestive heart failure was associated with a higher risk of death whereas low grade obesity might have a protective effect on patient survival. High admission numbers are accompanied by a higher mortality rate.

Extracorporeal membrane oxygenation in coronavirus disease 2019: A nationwide cohort analysis of 4279 runs from Germany.

BACKGROUND: In the context of the coronavirus disease 2019 (COVID-19) pandemic, many retrospective single-centre or specialised centre reports have shown promising mortality rates with the use of extracorporeal membrane oxygenation (ECMO) therapy. However, the mortality rate of an entire country throughout the COVID-19 pandemic remains unknown. OBJECTIVES: The primary objective is to determine the hospital mortality in COVID-19 patients receiving venovenous ECMO (VV-ECMO) and veno-arterial ECMO (VA-ECMO) therapy. Secondary objectives are the chronological development of mortality during the pandemic, the analysis of comorbidities, age and complications. DESIGN: Cohort study. SETTING: Inpatient data from January 2020 to September 2021 of all hospitals in Germany were analysed. PARTICIPANTS: All COVID-19-positive patients who received ECMO therapy were analysed according to the appropriate international statistical classification of diseases and related health problem codes (ICDs) and process key codes (OPSs). MAIN OUTCOME MEASURES: The primary outcome was the hospital mortality. RESULTS: In total, 4279 COVID-19-positive patients who received ECMO therapy were analysed. Among 404 patients treated with VA-ECMO and 3875 treated with VV-ECMO, the hospital mortality was high: 72% (n = 291) for VA-ECMO and 65.9% (n = 2552) for VV-ECMO. A total of 43.2% (n = 1848) of all patients were older than 60 years with a hospital mortality rate of 72.7% (n = 172) for VA-ECMO and 77.6% (n = 1301) for VV-ECMO. CPR was performed in 44.1% (n = 178) of patients with VA-ECMO and 16.4% (n = 637) of patients with VV-ECMO. The mortality rates widely varied from 48.1 to 84.4% in individual months and worsened from March 2020 (59.2%) to September 2021 (78.4%). CONCLUSION: In Germany, a large proportion of elderly patients with COVID-19 were treated with ECMO, with an unacceptably high hospital mortality. Considering these data, the unconditional use of ECMO therapy in COVID-19 must be carefully considered and advanced age should be considered as a relative contraindication.

Use of routinely collected health data in randomised clinical trials: comparison of trial-specific death data in the BOSS trial with NHS Digital data.

BACKGROUND: A promising approach to reduce the increasing costs of clinical trials is the use of routinely collected health data as participant data. However, the quality of this data could limit its usability as trial participant data. METHODS: The BOSS trial is a randomised controlled trial comparing regular endoscopies versus endoscopies at need in patients with Barrett's oesophagus with primary endpoint death. Data on death and cancer collected every 2 years after randomisation (trial-specific data) were compared to data received annually (all patients on one date) from the routinely collected health data source National Health Service (NHS) Digital. We investigated completeness, agreement and timeliness and looked at the implications for the primary trial outcome. Completeness and agreement were assessed by evaluating the number of reported and missing cases and any disparities between reported dates. Timeliness was considered by graphing the year a death was first reported in the trial-specific data against that for NHS Digital data. Implications on the primary trial outcome, overall survival, of using one of the data sources alone were investigated using Kaplan-Meier graphs. To assess the utility of cause of death and cancer diagnoses, oesophageal cancer cases were compared. RESULTS: NHS Digital datasets included more deaths and often reported them sooner than the trial-specific data. The number reported as being from oesophageal cancer was similar in both datasets. Due to time lag in reporting and missing cases, the event rate appeared higher using the NHS Digital data. CONCLUSION: NHS Digital death data is useful for calculating overall survival where trial-specific follow-up is only every 2 years from randomisation and the follow-up requires patient response. The cancer data was not a large enough sample to assess usability. We suggest that this assessment of registry data is done for more phase III RCTs and for more registry data to get a more complete picture of when RCHD would be useful in phase III RCT. TRIAL REGISTRATION: ISRCTN54190466 (BOSS) 1 Oct 2009.

Automated cytological detection of Barrett's neoplasia with infrared spectroscopy.

BACKGROUND: Development of a nonendoscopic test for Barrett's esophagus would revolutionize population screening and surveillance for patients with Barrett's esophagus. Swallowed cell collection devices have recently been developed to obtain cytology brushings from the esophagus: automated detection of neoplasia in such samples would enable large-scale screening and surveillance. METHODS: Fourier transform infrared (FTIR) spectroscopy was used to develop an automated tool for detection of Barrett's esophagus and Barrett's neoplasia in esophageal cell samples. Cytology brushings were collected at endoscopy, cytospun onto slides and FTIR images were measured. An automated cell recognition program was developed to identify individual cells on the slide. RESULTS: Cytology review and contemporaneous histology was used to inform a training dataset containing 141 cells from 17 patients. A classification model was constructed by principal component analysis fed linear discriminant analysis, then tested by leave-one-sample-out cross validation. With application of this training model to whole slide samples, a threshold voting system was used to classify samples according to their constituent cells. Across the entire dataset of 115 FTIR maps from 66 patients, whole samples were classified with sensitivity and specificity respectively as follows: normal squamous cells 79.0% and 81.1%, nondysplastic Barrett's esophagus cells 31.3% and 100%, and neoplastic Barrett's esophagus cells 83.3% and 62.7%. CONCLUSIONS: Analysis of esophageal cell samples can be performed with FTIR spectroscopy with reasonable sensitivity for Barrett's neoplasia, but with poor specificity with the current technique.

Cancer screening via infrared spectral cytopathology (SCP): results for the upper respiratory and digestive tracts.

Instrumental advances in infrared micro-spectroscopy have made possible the observation of individual human cells and even subcellular structures. The observed spectra represent a snapshot of the biochemical composition of a cell; this composition varies subtly but reproducibly with cellular effects such as progression through the cell cycle, cell maturation and differentiation, and disease. The aim of this summary is to provide a synopsis of the progress achieved in infrared spectral cytopathology (SCP) - the combination of infrared micro-spectroscopy and multivariate methods of analysis - for the detection of abnormalities in exfoliated human cells of the upper respiratory and digestive tract, namely the oral and nasopharyngeal cavities, and the esophagus.

Barrett's Oesophagus Surveillance versus endoscopy at need Study (BOSS): protocol and analysis plan for a multicentre randomized controlled trial.

OBJECTIVES: The absolute annual risk of patients with Barrett's oesophagus (BO) developing oesophageal adenocarcinoma (OAC) is ≤ 0.5%. Screening BO patients for malignant progression using endoscopic surveillance is widely practised. To assess the efficacy and cost-effectiveness of this, we developed a protocol for a randomized controlled trial of surveillance versus 'at need' endoscopy. METHODS: In a multicentre trial, 3400 BO patients randomized to either 2-yearly endoscopic surveillance or 'at need' endoscopy will be followed up for 10 years. Urgent endoscopy will be offered to all patients who develop symptoms of dysphagia, unexplained weight loss > 7lb (3.2 kg), iron deficiency anaemia, recurrent vomiting, or worsening upper gastrointestinal symptoms. Participants must have endoscopically and histologically confirmed BO, with circumferential BO ≥ 1 cm or maximal tongue/island length ≥ 2 cm. Candidates with existing oesophageal high-grade dysplasia or cancer, or previous upper gastrointestinal cancer will be excluded. Primary outcome will be overall survival. Secondary outcomes will be cost effectiveness (cost per life year saved and quality adjusted life years); cancer-specific survival; time to OAC diagnosis and stage at diagnosis; morbidity and mortality related to any interventions; and frequency of endoscopy. CONCLUSIONS: This randomized trial will provide data to evaluate the efficacy and cost-effectiveness of screening BO patients for OAC.

Infrared micro-spectroscopy for cyto-pathological classification of esophageal cells.

We report results from a study utilizing infrared spectral cytopathology (SCP) to detect abnormalities in exfoliated esophageal cells. SCP has been developed over the past decade as an ancillary tool to classical cytopathology. In SCP, the biochemical composition of individual cells is probed by collecting infrared absorption spectra from each individual, unstained cell, and correlating the observed spectral patterns, and the variations therein, against classical diagnostic methods to obtain an objective, machine-based classification of cells. In the past, SCP has been applied to the analysis and classification of cells exfoliated from the cervix and the oral cavity. In these studies, it was established that SCP can distinguish normal and abnormal cell types. Furthermore, SCP can differentiate between truly normal cells, and cells with normal morphology from the vicinity of abnormalities. Thus, SCP may be a valuable tool for the screening of early stages of dysplasia and pre-cancer.

Strategies for the prevention of oesophageal adenocarcinoma.

The incidence of oesophageal adenocarcinoma has increased by 500% over the past 30 years [1]. Improved understanding of the mechanisms of neoplastic progression provides an opportunity to reverse this trend. A thorough review of emerging strategies aiming to prevent the formation of oesophageal malignancy is presented. These include dietary modification, chemoprevention, early endoscopic identification and treatment of premalignant disease, and the potential for a non-endoscopic screening test. Oesophageal adenocarcinoma has become a major public health problem in the West and it is essential that clinicians are fully informed of risk reduction strategies so that they can be actively promoted in the community.