Maternal anemia and red blood cell requirements in 72 women undergoing ex-utero intrapartum treatment (EXIT) procedure.

Background: The ex-utero intrapartum treatment (EXIT) allows to ensure fetal airway while keeping uteroplacental circulation. However, EXIT may become a life-threatening procedure due to the increased risk of uterine atony or placenta abruption with increased peripartum blood losses and increased transfusion rates. We aim to review maternal anemia prevalence and transfusion requirements in women undergoing EXIT procedure. Methods: Using data from the Federal German Statistical Office hospitalized women undergoing EXIT procedure between January 1st 2006 and December 31st 2021 were included. The prevalence of anemia, peripartum hemorrhage, comorbidities and administration of red blood cells (RBC) were analyzed. Results: In total, 72 women underwent EXIT procedure with a median age of 31 years (26;33.5). In 43.1% EXIT was conducted at 34-36 weeks of gestational age. "Anemia during pregnancy" was present in 47.2%, "anemia due to acute bleeding" in 25.0% and "iron deficiency anemia" in 15.3%. Postpartum hemorrhage occurred in 11.1%. RBCs were transfused in 15.3% of all women. Most women required 1-5 units of RBCs. Conclusion: Despite the rarity of this procedure, anemia management and blood conservation strategies in order to reduce the need for RBC transfusion are highly important in women undergoing EXIT procedure.

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.

Lessons Learned from Model-based Economic Evaluations of COVID-19 Drug Treatments Under Pandemic Circumstances: Results from a Systematic Review.

BACKGROUND: Following clinical research of potential coronavirus disease 2019 (COVID-19) treatments, numerous decision-analytic models have been developed. Due to pandemic circumstances, clinical evidence was limited and modelling choices were made under great uncertainty. This study aimed to analyse key methodological characteristics of model-based economic evaluations of COVID-19 drug treatments, and specifically focused on modelling choices which pertain to disease severity levels during hospitalisation, model structure, sources of effectiveness and quality of life and long-term sequelae. METHODS: We conducted a systematic literature review and searched key databases (including MEDLINE, EMBASE, Web of Science, Scopus) for original articles on model-based full economic evaluations of COVID-19 drug treatments. Studies focussing on vaccines, diagnostic techniques and non-pharmaceutical interventions were excluded. The search was last rerun on 22 July 2023. Results were narratively synthesised in tabular form. Several aspects were categorised into rubrics to enable comparison across studies. RESULTS: Of the 1047 records identified, 27 were included, and 23 studies (85.2%) differentiated patients by disease severity in the hospitalisation phase. Patients were differentiated by type of respiratory support, level of care management, a combination of both or symptoms. A Markov model was applied in 16 studies (59.3%), whether or not preceded by a decision tree or an epidemiological model. Most cost-utility analyses lacked the incorporation of COVID-19-specific health utility values. Of ten studies with a lifetime horizon, seven adjusted general population estimates to account for long-term sequelae (i.e. mortality, quality of life and costs), lasting for 1 year, 5 years, or a patient's lifetime. The most often reported parameter influencing the outcome of the analysis was related to treatment effectiveness. CONCLUSION: The results illustrate the variety in modelling approaches of COVID-19 drug treatments and address the need for a more standardized approach in model-based economic evaluations of infectious diseases such as COVID-19. TRIAL REGISTRY: Protocol registered in PROSPERO under CRD42023407646.

The value of artificial intelligence for the treatment of mechanically ventilated intensive care unit patients: An early health technology assessment.

PURPOSE: The health and economic consequences of artificial intelligence (AI) systems for mechanically ventilated intensive care unit patients often remain unstudied. Early health technology assessments (HTA) can examine the potential impact of AI systems by using available data and simulations. Therefore, we developed a generic health-economic model suitable for early HTA of AI systems for mechanically ventilated patients. MATERIALS AND METHODS: Our generic health-economic model simulates mechanically ventilated patients from their hospitalisation until their death. The model simulates two scenarios, care as usual and care with the AI system, and compares these scenarios to estimate their cost-effectiveness. RESULTS: The generic health-economic model we developed is suitable for estimating the cost-effectiveness of various AI systems. By varying input parameters and assumptions, the model can examine the cost-effectiveness of AI systems across a wide range of different clinical settings. CONCLUSIONS: Using the proposed generic health-economic model, investors and innovators can easily assess whether implementing a certain AI system is likely to be cost-effective before an exact clinical impact is determined. The results of the early HTA can aid investors and innovators in deployment of AI systems by supporting development decisions, informing value-based pricing, clinical trial design, and selection of target patient groups.

No Sequestration of Commonly Used Anti-Infectives in the Extracorporeal Membrane Oxygenation (ECMO) Circuit-An Ex Vivo Study.

Patients undergoing extracorporeal membrane oxygenation (ECMO) often require therapy with anti-infective drugs. The pharmacokinetics of these drugs may be altered during ECMO treatment due to pathophysiological changes in the drug metabolism of the critically ill and/or the ECMO therapy itself. This study investigates the latter aspect for commonly used anti-infective drugs in an ex vivo setting. A fully functional ECMO device circulated an albumin-electrolyte solution through the ECMO tubes and oxygenator. The antibiotic agents cefazolin, cefuroxim, cefepime, cefiderocol, linezolid and daptomycin and the antifungal agent anidulafungin were added. Blood samples were taken over a period of four hours and drug concentrations were measured via high-pressure liquid chromatography (HPLC) with UV detection. Subsequently, the study analyzed the time course of anti-infective concentrations. The results showed no significant changes in the concentration of any tested anti-infectives throughout the study period. This ex vivo study demonstrates that the ECMO device itself has no impact on the concentration of commonly used anti-infectives. These findings suggest that ECMO therapy does not contribute to alterations in the concentrations of anti-infective medications in severely ill patients.

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.

Mechanical ventilation as a major driver of COVID-19 hospitalization costs: a costing study in a German setting.

BACKGROUND: While COVID-19 hospitalization costs are essential for policymakers to make informed health care resource decisions, little is known about these costs in western Europe. The aim of the current study is to analyze these costs for a German setting, track the development of these costs over time and analyze the daily costs. METHODS: Administrative costing data was analyzed for 598 non-Intensive Care Unit (ICU) patients and 510 ICU patients diagnosed with COVID-19 at the Frankfurt University hospital. Descriptive statistics of total per patient hospitalization costs were obtained and assessed over time. Propensity scores were estimated for length of stay (LOS) at the general ward and mechanical ventilation (MV) duration, using covariate balancing propensity score for continuous treatment. Costs for each additional day in the general ward and each additional day in the ICU with and without MV were estimated by regressing the total hospitalization costs on the LOS and the presence or absence of several treatments using generalized linear models, while controlling for patient characteristics, comorbidities, and complications. RESULTS: Median total per patient hospitalization costs were €3,010 (Q1 - Q3: €2,224-€5,273), €5,887 (Q1 - Q3: €3,054-€10,879) and €21,536 (Q1 - Q3: €7,504-€43,480), respectively, for non-ICU patients, non-MV and MV ICU patients. Total per patient hospitalization costs for non-ICU patients showed a slight increase over time, while total per patient hospitalization costs for ICU patients decreased over time. Each additional day in the general ward for non-ICU COVID-19 patients costed €463.66 (SE: 15.89). Costs for each additional day in the general ward and ICU without and with mechanical ventilation for ICU patients were estimated at €414.20 (SE: 22.17), €927.45 (SE: 45.52) and €2,224.84 (SE: 70.24). CONCLUSIONS: This is, to our knowledge, the first study examining the costs of COVID-19 hospitalizations in Germany. Estimated costs were overall in agreement with costs found in literature for non-COVID-19 patients, except for higher estimated costs for mechanical ventilation. These estimated costs can potentially improve the precision of COVID-19 cost effectiveness studies in Germany and will thereby allow health care policymakers to provide better informed health care resource decisions in the future.

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.

Microvascular Leakage as Therapeutic Target for Ischemia and Reperfusion Injury.

Reperfusion injury is a very common complication of various indicated therapies such as the re-opening of vessels in the myocardium or brain as well as reflow in hemodynamic shutdown (cardiac arrest, severe trauma, aortic cross-clamping). The treatment and prevention of reperfusion injury has therefore been a topic of immense interest in terms of mechanistic understanding, the exploration of interventions in animal models and in the clinical setting in major prospective studies. While a wealth of encouraging results has been obtained in the lab, the translation into clinical success has met with mixed outcomes at best. Considering the still very high medical need, progress continues to be urgently needed. Multi-target approaches rationally linking interference with pathophysiological pathways as well as a renewed focus on aspects of microvascular dysfunction, especially on the role of microvascular leakage, are likely to provide new insights.

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.

Expectations of Anesthesiology and Intensive Care Professionals Toward Artificial Intelligence: Observational Study.

BACKGROUND: Artificial intelligence (AI) applications offer numerous opportunities to improve health care. To be used in the intensive care unit, AI must meet the needs of staff, and potential barriers must be addressed through joint action by all stakeholders. It is thus critical to assess the needs and concerns of anesthesiologists and intensive care physicians related to AI in health care throughout Europe. OBJECTIVE: This Europe-wide, cross-sectional observational study investigates how potential users of AI systems in anesthesiology and intensive care assess the opportunities and risks of the new technology. The web-based questionnaire was based on the established analytic model of acceptance of innovations by Rogers to record 5 stages of innovation acceptance. METHODS: The questionnaire was sent twice in 2 months (March 11, 2021, and November 5, 2021) through the European Society of Anaesthesiology and Intensive Care (ESAIC) member email distribution list. A total of 9294 ESAIC members were reached, of whom 728 filled out the questionnaire (response rate 728/9294, 8%). Due to missing data, 27 questionnaires were excluded. The analyses were conducted with 701 participants. RESULTS: A total of 701 questionnaires (female: n=299, 42%) were analyzed. Overall, 265 (37.8%) of the participants have been in contact with AI and evaluated the benefits of this technology higher (mean 3.22, SD 0.39) than participants who stated no previous contact (mean 3.01, SD 0.48). Physicians see the most benefits of AI application in early warning systems (335/701, 48% strongly agreed, and 358/701, 51% agreed). Major potential disadvantages were technical problems (236/701, 34% strongly agreed, and 410/701, 58% agreed) and handling difficulties (126/701, 18% strongly agreed, and 462/701, 66% agreed), both of which could be addressed by Europe-wide digitalization and education. In addition, the lack of a secure legal basis for the research and use of medical AI in the European Union leads doctors to expect problems with legal liability (186/701, 27% strongly agreed, and 374/701, 53% agreed) and data protection (148/701, 21% strongly agreed, and 343/701, 49% agreed). CONCLUSIONS: Anesthesiologists and intensive care personnel are open to AI applications in their professional field and expect numerous benefits for staff and patients. Regional differences in the digitalization of the private sector are not reflected in the acceptance of AI among health care professionals. Physicians anticipate technical difficulties and lack a stable legal basis for the use of AI. Training for medical staff could increase the benefits of AI in professional medicine. Therefore, we suggest that the development and implementation of AI in health care require a solid technical, legal, and ethical basis, as well as adequate education and training of users.

Prevalence of acute neurological complications and pathological neuroimaging findings in critically ill COVID-19 patients with and without VV-ECMO treatment.

Acute brain injuries such as intracerebral hemorrhage (ICH) and ischemic stroke have been reported in critically ill COVID-19 patients as well as in patients treated with veno-venous (VV)-ECMO independently of their COVID-19 status. The purpose of this study was to compare critically ill COVID-19 patients with and without VV-ECMO treatment with regard to acute neurological symptoms, pathological neuroimaging findings (PNIF) and long-term deficits. The single center study was conducted in critically ill COVID-19 patients between February 1, 2020 and June 30, 2021. Demographic, clinical and laboratory parameters were extracted from the hospital's databases. Retrospective imaging modalities included head computed tomography (CT) and magnetic resonance imaging (MRI). Follow-up MRI and neurological examinations were performed on survivors > 6 months after the primary occurrence. Of the 440 patients, 67 patients received VV-ECMO treatment (15%). Sixty-four patients (24 with VV-ECMO) developed acute neurological symptoms (pathological levels of arousal/brain stem function/motor responses) during their ICU stay and underwent neuroimaging with brain CT as the primary modality. Critically ill COVID-19 patients who received VV-ECMO treatment had a significantly lower survival during their hospital stay compared to those without (p < 0.001). Among patients treated with VV-ECMO, 10% showed acute PNIF in one of the imaging modalities during their ICU stay (vs. 4% of patients in the overall COVID-19 ICU cohort). Furthermore, 9% showed primary or secondary ICH of any severity (vs. 3% overall), 6% exhibited severe ICH (vs. 1% overall) and 1.5% were found to have non-hemorrhagic cerebral infarctions (vs. < 1% overall). There was a weak, positive correlation between patients treated with VV-ECMO and the development of acute neurological symptoms. However, the association between the VV-ECMO treatment and acute PNIF was negligible. Two survivors (one with VV-ECMO-treatment/one without) showed innumerable microhemorrhages, predominantly involving the juxtacortical white matter. None of the survivors exhibited diffuse leukoencephalopathy. Every seventh COVID-19 patient developed acute neurological symptoms during their ICU stay, but only every twenty-fifth patient had PNIF which were mostly ICH. VV-ECMO was found to be a weak risk factor for neurological complications (resulting in a higher imaging rate), but not for PNIF. Although logistically complex, repeated neuroimaging should, thus, be considered in all critically ill COVID-19 patients since ICH may have an impact on the treatment decisions and outcomes.

Potential of FX06 to prevent disease progression in hospitalized non-intubated COVID-19 patients - the randomized, EU-wide, placebo-controlled, phase II study design of IXION.

BACKGROUND: More than 2.7 million hospitalizations of COVID-19-infected patients have occurred in Europe alone since the outbreak of the coronavirus in 2020. Interventions against SARS-CoV-2 are still in high need to prevent admissions to ICUs worldwide. FX06, a naturally occurring peptide in humans and other mammals, has the potential to reduce capillary leak by improving endothelial dysfunction and thus preventing the deterioration of patients. With IXION, we want to investigate the potential of FX06 to prevent disease progression in hospitalized, non-intubated COVID-19 patients. METHODS: IXION is an EU-wide, multicentre, placebo-controlled, double-blinded, parallel, randomized (2:1) phase II clinical study. Patient recruitment will start in September 2022 (to Q2/2023) in Germany, Italy, Lithuania, Spain, Romania, Portugal, and France. A total of 306 hospitalized patients (≥ 18 years and < 75 years) with a positive SARS-CoV-2 PCR test and a COVID-19 severity of 4-6 according to the WHO scale will be enrolled. After randomization to FX06 or placebo, patients will be assessed until day 28 (and followed up until day 60). FX06 (2 × 200 mg per day) or placebo will be administered intravenously for 5 consecutive days. The primary endpoint is to demonstrate a difference in the proportion of patients with progressed/worsened disease state in patients receiving FX06 compared to patients receiving placebo. Secondary endpoints are lung function, oxygen saturation and breathing rate, systemic inflammation, survival, capillary refill time, duration of hospital stay, and drug accountability. DISCUSSION: With IXION, the multidisciplinary consortium aims to deliver a new therapy in addition to standard care against SARS-CoV-2 for the clinical management of COVID-19 during mild and moderate stages. Potential limitations might refer to a lack of recruiting and drop-out due to various possible protocol violations. While we controlled for drop-outs in the same size estimation, recruitment problems may be subject to external problems difficult to control for. TRIAL REGISTRATION: EudraCT 2021-005059-35 . Registered on 12 December 2021. Study Code TMP-2204-2021-47.

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.

Insight into ECMO, mortality and ARDS: a nationwide analysis of 45,647 ECMO runs.

BACKGROUND: Extracorporeal life support (ECLS) has become an integral part of modern intensive therapy. The choice of support mode depends largely on the indication. Patients with respiratory failure are predominantly treated with a venovenous (VV) approach. We hypothesized that mortality in Germany in ECLS therapy did not differ from previously reported literature METHODS: Inpatient data from Germany from 2007 to 2018 provided by the Federal Statistical Office of Germany were analysed. The international statistical classification of diseases and related health problems codes (ICD) and process keys (OPS) for extracorporeal membrane oxygenation (ECMO) types, acute respiratory distress syndrome (ARDS) and hospital mortality were used. RESULTS: In total, 45,647 hospitalized patients treated with ECLS were analysed. In Germany, 231 hospitals provided ECLS therapy, with a median of 4 VV-ECMO and 9 VA-ECMO in 2018. Overall hospital mortality remained higher than predicted in comparison to the values reported in the literature. The number of VV-ECMO cases increased by 236% from 825 in 2007 to 2768 in 2018. ARDS was the main indication for VV-ECMO in only 33% of the patients in the past, but that proportion increased to 60% in 2018. VA-ECMO support is of minor importance in the treatment of ARDS in Germany. The age distribution of patients undergoing ECLS has shifted towards an older population. In 2018, the hospital mortality decreased in VV-ECMO patients and VV-ECMO patients with ARDS to 53.9% (n = 1493) and 54.4% (n = 926), respectively. CONCLUSIONS: ARDS is a severe disease with a high mortality rate despite ECLS therapy. Although endpoints and timing of the evaluations differed from those of the CESAR and EOLIA studies and the Extracorporeal Life Support Organization (ELSO) Registry, the reported mortality in these studies was lower than in the present analysis. Further prospective analyses are necessary to evaluate outcomes in ECMO therapy at the centre volume level.

Quantification of Intraoperative Blood Loss in a Simulated Scenario Using a Novel Device.

BACKGROUND: Particularly for protracted bleeding situations, the realization of a relevant blood loss is necessary for early initiation of therapy to avoid hemodynamic instability and shock. The frequently used visual assessment of blood loss is known to be incorrect. An innovative option to address this problem is a mobile application using colorimetric image correction and analysis. METHODS: The objective of this study was to evaluate the clinical applicability and accuracy of a novel mobile device application using colorimetric image correction and analysis for blood loss estimation. Scenarios of blood-filled surgical sponges were created to evaluate the accuracy of colorimetric-based blood loss estimation and visual and gravimetric blood loss estimation. RESULTS: Fifty-three anesthesiologists ran through the scenarios. The estimated blood loss correlated the least with the reference blood loss in the visual technique (Rho: 0.52; P < 3.7×10-16), followed by the gravimetric technique (Rho: 0.73; P = 2.8×10-05). The best correlation was found in the colorimetric blood loss measurement (Rho: 0.77; P = 3.53×10-06). A median overestimation per scenario of 133.0 mL (interquartile range [IQR] 33.0 mL-283.0 mL) was observed when using the visual method, whereas 32.5 mL (IQR 10.8 mL-44.0 mL) was overestimated with the gravimetric method and 31 mL (IQR 17.0 mL-42.8 mL) with the colorimetric method. Especially in the case of blood loss underestimation, the application has the least deviation from the reference. CONCLUSION: The blood loss measured in the sponges correlated strong with the reference blood loss, showing the smallest median overestimation and the smallest deviation in underestimation. The visual estimation shows serious errors, where the gravimetric method is prone to errors, especially in dilution. The colorimetric method offers an easily implementable possibility to monitor blood loss in real time and to initiate early diagnostic and therapeutic measures in case of persistent blood loss. The influence of real-time estimation of colorimetric blood loss on transfusion decisions should be the subject of future studies.