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Johannes Leiner,1,2 Vincent Pellissier,2 Sebastian König,1,2 Lars Stellmacher,2 Sven Hohenstein,2 Carolin Schanner,2 Stefan Kwast,2 Ralf Kuhlen,3,4 Andreas Bollmann1– 3 1Department of Electrophysiology, Heart Center Leipzig at University of Leipzig, Leipzig, Saxony, Germany; 2Real World Evidence and Health Technology Assessment, Helios Health Institute, Berlin, Germany; 3Helios Health Institute, Berlin, Germany; 4Helios Health, Berlin, GermanyCorrespondence: Johannes Leiner, Heart Centre Leipzig at University of Leipzig, Department of Electrophysiology, Struempellstrasse 39, Leipzig, 04289, Germany, Tel +49 341 865 251573, Email johannes.leiner@helios-gesundheit.deIntroduction: Type 2 diabetes mellitus (T2DM) is a leading cause of chronic kidney disease (CKD) globally. Both conditions substantially worsen patients’ prognosis. Current data on German in-hospital CKD cohorts are scarce. The multinational CaReMe study was initiated to evaluate the current epidemiology and healthcare burden of cardiovascular, renal and metabolic diseases. In this substudy, we share real-world data on CKD inpatients stratified for coexisting T2DM derived from a large German hospital network.Methods: This study used administrative data of inpatient cases from 89 Helios hospitals from 01/01/2016 to 28/02/2022. Data were extracted from ICD-10-encoded discharge diagnoses and OPS-encoded procedures. The first case meeting a previously developed CKD definition (defined by ICD-10- and OPS-codes) was considered the index case for a particular patient. Subsequent hospitalizations were analysed for readmission statistics. Patient characteristics and pre-defined endpoints were stratified for T2DM at index case.Results: In total, 48,011 patients with CKD were included in the present analysis (mean age ± standard deviation, 73.8 ± 13.1 years; female, 44%) of whom 47.9% had co-existing T2DM. Patients with T2DM were older (75 ± 10.6 vs 72.7 ± 14.9 years, p < 0.001), but gender distribution was similar to patients without T2DM. The burden of cardiovascular disease was increased in patients with T2DM, and index and follow-up in-hospital mortality rates were higher. Non-T2DM patients were characterised by more advanced CKD at baseline. Patients with T2DM had consistently higher readmission numbers for all events of interest, except for readmissions due to kidney failure/dialysis, which were more common in non-T2DM patients.Conclusion: In this study, we present recent data on hospitalized patients with CKD in Germany. In this CKD cohort, nearly half had T2DM, which substantially affected cardiovascular disease burden, rehospitalization frequency and mortality. Interestingly, non-diabetic patients had more advanced underlying renal disease, which affected renal outcomes. Keywords: chronic kidney disease, type 2 diabetes mellitus, administrative data, in-hospital mortality, kidney failure, rehospitalization

Johannes Leiner,1,2 Sven Hohenstein,2 Vincent Pellissier,2 Sebastian König,1,2 Claudia Winklmair,3 Irit Nachtigall,4 Andreas Bollmann,1,2,5 Ralf Kuhlen3,5,6 On behalf of the scientific advisory board of the Initiative of Quality Medicine (IQM)1Heart Centre Leipzig at University of Leipzig, Department of Electrophysiology, Leipzig, Germany; 2Real World Evidence and Health Technology Assessment at Helios Health Institute, Berlin, Germany; 3Initiative of Quality Medicine, Berlin, Germany; 4Department of Infectious Diseases and Infection Prevention, HELIOS Hospital Emil-von-Behring, Berlin, Germany and Charité - Universitaetsmedizin Berlin, Institute of Hygiene and Environmental Medicine, Berlin, Germany; 5Helios Health Institute, Berlin, Germany; 6Helios Health, Berlin, GermanyCorrespondence: Ralf Kuhlen, Initiative Qualitaetsmedizin e.V, Alt-Moabit 104, Berlin, 10559, Germany, Tel +49 30 7262 152 - 0, Email ralf.kuhlen@initiative-qualitaetsmedizin.deIntroduction: Reliable surveillance systems to monitor trends of COVID-19 case numbers and the associated healthcare burden play a central role in efficient pandemic management. In Germany, the federal government agency Robert-Koch-Institute uses an ICD-code-based inpatient surveillance system, ICOSARI, to assess temporal trends of severe acute respiratory infection (SARI) and COVID-19 hospitalization numbers. In a similar approach, we present a large-scale analysis covering four pandemic waves derived from the Initiative of Quality Medicine (IQM), a German-wide network of acute care hospitals.Methods: Routine data from 421 hospitals for the years 2019– 2021 with a “pre-pandemic” period (01– 01-2019 to 03– 03-2020) and a “pandemic” period (04– 03-2020 to 31– 12-2021) was analysed. SARI cases were defined by ICD-codes J09-J22 and COVID-19 by ICD-codes U07.1 and U07.2. The following outcomes were analysed: intensive care treatment, mechanical ventilation, in-hospital mortality.Results: Over 1.1 million cases of SARI and COVID-19 were identified. Patients with COVID-19 and additional codes for SARI were at higher risk for adverse outcomes when compared to non-COVID SARI and COVID-19 without any coding for SARI. During the pandemic period, non-COVID SARI cases were associated with 28%, 23% and 27% higher odds for intensive care treatment, mechanical ventilation and in-hospital mortality, respectively, compared to pre-pandemic SARI.Conclusion: The nationwide IQM network could serve as an excellent data source to enhance COVID-19 and SARI surveillance in view of the ongoing pandemic. Future developments of COVID-19/SARI case numbers and associated outcomes should be closely monitored to identify specific trends, especially considering novel virus variants.Graphical Abstract: Keywords: initiative of quality medicine, Germany, COVID-19, SARI, inpatient, hospital network

With the arrival of the R packages \fontencoding {T1}\texttt {nlme} and \fontencoding {T1}\texttt {lme4}, linear mixed models (LMMs) have come to be widely used in experimentally-driven areas like psychology, linguistics, and cognitive science. This tutorial provides a practical introduction to fitting LMMs in a Bayesian framework using the probabilistic programming language Stan. We choose Stan (rather than WinBUGS or JAGS) because it provides an elegant and scalable framework for fitting models in most of the standard applications of LMMs. We ease the reader into fitting increasingly complex LMMs, using a two-condition repeated measures self-paced reading study.

Aims: Heart failure (HF) and chronic kidney disease (CKD) place significant challenges on the healthcare system, and their co-existence is associated with shared adverse outcomes. The multinational CaReMe project was initiated to provide contemporary, real-world epidemiological data on cardiovascular and reno-metabolic diseases. Utilizing data from the German CaReMe cohort, we characterize a multicentric HF population and describe in-hospital outcomes stratified for co-morbid CKD., Methods and Results: This retrospective, observational study analysed administrative data from inpatient cases hospitalized in 87 German Helios hospitals between 1 January 2016 and 31 August 2022. The first hospitalization of patients aged ≥18 years with a primary discharge diagnosis of HF, based on ICD-10 codes, were considered the index cases, and subsequent hospitalizations were considered as readmissions. Baseline characteristics and outcomes were stratified for co-morbid CKD using ICD-10-encoding from the index cases. Cox regression was utilized for readmission endpoints and in-hospital mortality. In total, 174 829 index cases (mean age 79 ± 15 years, 49.9% female) were included; of these, 55.0% had coexisting CKD. Patients with CKD were older, suffered from worse HF-related symptoms, had a higher co-morbidity burden, and in-hospital mortality was increased at index and during follow-up. Prevalent CKD was associated with higher rehospitalization rates and was an independent predictor for in-hospital death., Conclusions: Within this HF inpatient cohort from a multicentric German database, CKD was diagnosed in more than half of the patients and was associated with increased in-hospital mortality at baseline and during follow-up. Rehospitalizations were observed earlier and more frequently in patients with HF and co-morbid CKD., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Objectives: The COVID-19 pandemic affected patients' access to health services, including patients with severe chronic pain. Since limited data on pandemic-caused changes in pain therapy is available, we analyzed its effect on hospital-based pain treatment., Methods: For this retrospective claims data analysis conducted in n  = 37 hospitals, we included patients treated for a chronic pain-related diagnosis. Discharge rates stratified by region and pain unit size were analyzed for different time periods between January 2019 and June 2022., Results: There was a significant decrease in day-care, inpatient interdisciplinary multimodal pain management, from a total of 5,533 hospital pre-pandemic treatments in 2019, to 3,942 in 2020 and 4,262 in 2021, with a slight increase in the first half of 2022. The extent of COVID-19-related changes differed depending on region and pain unit size., Conclusion: The decreased number of hospital pain treatments during the pandemic implies a relevant analgesic undertreatment. During future pandemics, the ethical dimension of potentially non-sufficient pain treatment should be weighted against social, medical and hygienic restrictions influencing the hospitalization rate., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Cegla, Hohenstein, Bollmann, Pellissier, Bencheva and Schmiedl.)

Purpose: Respiratory syncytial virus (RSV) infection is a major cause of childhood hospitalization. The COVID-19 pandemic has disrupted the usual seasonal pattern of RSV, resulting in high activity during the off-season. This study aims to evaluate the effects of the pandemic on the severity of RSV infections., Methods: Data from 11,915 children hospitalized due to RSV infection between 2016 and 2022 were analyzed. The hospitalized patients were categorized into two groups, from January 2016 to February 2020 (PreCoV19 group) and from March 2020 to December 2022 (CoV19 group). The hospitalization duration, intensive care unit (ICU) admissions, length of stay at ICU, mechanical ventilation requirement and duration, Elixhauser comorbidity index scores, and in-hospital mortality were analyzed., Results: Children in the PreCoV19 group had a mean age of 0.4 ± 0.7, whereas those in the CoV19 group had a mean age of 0.6 ± 1.0 years. Children during the pandemic had significantly shorter hospital stays (4.3 ± 2.6 days) compared to children of the pre-pandemic period (4.9 ± 3.3 days). Although ICU admission rates did not change, the duration of ICU stays decreased in the CoV19 group. Moreover, the in-hospital mortality did not differ between the groups. A multivariable analysis showed that younger age, regardless of the pandemic period, was associated with prolonged hospital stays, higher ICU admission rates, and an increased requirement for mechanical ventilation., Conclusion: Our findings highlight significant changes of the clinical characteristics of RSV infections during the pandemic, with implications for clinical management and public health strategies., (© 2024. The Author(s).)

Background:  The COVID-19 pandemic has significantly affected acute ischemic stroke (AIS) care. In this study, we examined the effects of the pandemic on neurosurgical AIS care by means of decompressive surgery (DS)., Methods:  In this retrospective observational study, we compared the characteristics, in-hospital processes, and in-hospital mortality rates among patients hospitalized for AIS during the first four waves of the pandemic (between January 1, 2020 and October 26, 2021) versus the corresponding periods in 2019 (prepandemic). We used administrative data from a nationwide hospital network in Germany., Results:  Of the 177 included AIS cases with DS, 60 were from 2019 and 117 from the first four pandemic waves. Compared with the prepandemic levels, there were no changes in weekly admissions for DS during the pandemic. The same was true for patient age (range: 51.7-60.4 years), the number of female patients (range: 33.3-57.1%), and the prevalence of comorbidity, as measured by the Elixhauser Comorbidity Index (range: 13.2-20.0 points). Also, no alterations were observed in transfer to the intensive care unit (range: 87.0-100%), duration of in-hospital stay (range: 14.6-22.7 days), and in-hospital mortality rates (range: 11.8-55.6%)., Conclusion:  In Germany, compared with the prepandemic levels, AIS patients undergoing DS during the first four waves of the pandemic showed no changes in demographics, rates of comorbidity, and in-hospital mortality rates. This is in contrast to previous evidence on patients with less critical types of AIS not requiring DS and underlines the uniqueness of the subgroup of AIS patients requiring DS. Our findings suggests that these patients, in contrast to AIS patients in general, were unable to forgo hospitalization during the COVID-19 pandemic. Maintaining the delivery of DS is an essential aspect of AIS care during a pandemic., Competing Interests: J.D. received funding through the Helios Center for Research and Innovation via a grant (HCRI ID 2021–0431). R.K. holds shares of Fresenius AG. Y.R. is a member of DWG Commissions (Science, Education, Quality Safety, Congress Program, Scientific Advisory Board publication “Die Wirbelsäule”), and Eurospine EduCom. All other authors declare no conflict of interest., (Thieme. All rights reserved.)

Objective: Cholecystectomy is one of the most frequently performed surgeries in Germany and is performed as a treatment of acute cholecystitis (guideline S3 IIIB.8) and after endoscopic retrograde cholangiopancreatography for choledocholithiasis with simultaneous cholecystolithiasis (guideline S3 IIIC.6). This article examines the effects of a guideline update from 2017, which recommends prompt cholecystectomy within 24 hours of admission due to cholecystitis or within 72 hours after bile duct repair. In addition, it aims to identify reasons (eg, financial disincentives) and potential for improvement for non-adherence to the guidelines., Design: Methodologically, a retrospective analysis based on routine billing data from 84 Helios Group hospitals from 2016 and 2022, with a total of 45 393 included cases, was applied. The guideline adherence rate is used as the main outcome measure., Results: Results show the guideline updates led to a statistically significant increase in the proportion of cholecystectomy performed in a timely manner (guideline S3 IIIB.8: increase from 43% to 49%, p<0.001; guideline S3 IIIC.6: increase from 7% to 20%, p<0.001). Medical, structural and financial reasons for non-adherence could be identified., Conclusion: As possible reasons for non-adherence, medical factors such as advanced age, multimorbidity and frailty could be identified. Analyses of structural factors revealed that hospitals in very rural regions are less likely to perform timely cholecystectomies, presumably due to infrastructural and personnel-capacity bottlenecks. A similar picture emerges for maximum-care hospitals, which might be explained by more severe and complex cases on average. Further evaluation indicates that an increase in and better hospital-internal participation of gastroenterologists in remuneration could lead to even greater adherence to the S3 IIIC.6 guideline., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: The intensive care unit (ICU) is a scarce resource in all health care systems, necessitating a well-defined utilization. Therefore, benchmarks are essential; and yet, they are limited due to heterogenous definitions of what an ICU is. This study analyzed the case distribution, patient characteristics, and hospital course and outcomes of 6,204,093 patients in the German Helios Hospital Group according to 10 derived ICU definitions. We aimed to set a baseline for the development of a nationwide, uniform ICU definition. Methods : We analyzed ten different ICU definitions: seven derived from the German administrative data set of claims data according to the German Hospital Remuneration Act, three definitions were taken from the Helios Hospital Group's own bed classification. For each ICU definition, the size of the respective ICU population was analyzed. Due to similar patient characteristics for all ten definitions, we selected three indicator definitions to additionally test statistically against IQM. Results : We analyzed a total of 5,980,702 completed hospital cases, out of which 913,402 referred to an ICU criterion (14.7% of all cases). A key finding is the significant variability in ICU population size, depending on definitions. The most restrictive definition of only mechanical ventilation (DOV definition) resulted in 111,966 (1.9%) cases; mechanical ventilation plus typical intensive care procedure codes (IQM definition) resulted in 210,147 (3.5%) cases; defining each single bed individually as ICU or IMC (ICUᴧIMC definition) resulted in 411,681 (6.9%) cases; and defining any coded length of stay at ICU (LOSi definition) resulted in 721,293 (12.1%) cases. Further testing results for indicator definitions are reported. Conclusions : The size of the population, utilization rates, outcomes, and capacity assumptions clearly depend on the definition of ICU. Therefore, the underlying ICU definition should be stated when making any comparisons. From previous studies, we anticipated that 25-30% of all ICU patients should be mechanically ventilated, and therefore, we conclude that the ICUᴧIMC definition is the most plausible approximation. We suggest a mandatory application of a clearly defined ICU term for all hospitals nationwide for improved benchmarking and data analysis.

Aims: Endemic SARS-CoV-2 infections still burden the healthcare system and represent a considerable threat to vulnerable patient cohorts, in particular immunocompromised (IC) patients. This study aimed to analyze the in-hospital outcome of IC patients with severe SARS-CoV-2 infection in Germany., Methods: This retrospective, observational study, analyzed administrative data from inpatient cases ( n = 146,324) in 84 German Helios hospitals between 1 January 2022 and 31 December 2022 with regard to in-hospital outcome and health care burden in IC patients during the first 12 months of Omicron dominance. As the primary objective, in-hospital outcomes of patients with COVID-19-related severe acute respiratory infection (SARI) were analyzed by comparing patients with ( n = 2037) and without IC diagnoses ( n = 14,772). Secondary analyses were conducted on IC patients with ( n = 2037) and without COVID-19-related SARI ( n = 129,515). A severe in-hospital outcome as a composite endpoint was defined per the WHO definition if one of the following criteria were met: intensive care unit (ICU) treatment, mechanical ventilation (MV), or in-hospital death., Results: In total, 12% of COVID-related SARI cases were IC patients, accounting for 15% of ICU admissions, 15% of MV use, and 16% of deaths, resulting in a higher prevalence of severe in-hospital courses in IC patients developing COVID-19-related SARI compared to non-IC patients (Odds Ratio, OR = 1.4, p < 0.001), based on higher in-hospital mortality (OR = 1.4, p < 0.001), increased need for ICU treatment (OR = 1.3, p < 0.001) and mechanical ventilation (OR = 1.2, p < 0.001). Among IC patients, COVID-19-related SARI profoundly increased the risk for severe courses (OR = 4.0, p < 0.001)., Conclusions: Our findings highlight the vulnerability of IC patients to severe COVID-19. The persistently high prevalence of severe outcomes in these patients in the Omicron era emphasizes the necessity for continuous in-hospital risk assessment and monitoring of IC patients.

Purpose: In spine care, frailty is associated with poor outcomes. The aim of this study was to describe changes in frailty in spine care during the coronavirus disease 2019 (COVID-19) pandemic and their relation to surgical management and outcomes., Methods: Patients hospitalized for spine pathologies between January 1, 2019, and May 17, 2022, within a nationwide network of 76 hospitals in Germany were retrospectively included. Patient frailty, types of surgery, and in-hospital mortality rates were compared between pandemic and pre-pandemic periods., Results: Of the 223,418 included patients with spine pathologies, 151,766 were admitted during the pandemic and 71,652 during corresponding pre-pandemic periods in 2019. During the pandemic, the proportion of high-frailty patients increased from a range of 5.1-6.1% to 6.5-8.8% (p < 0.01), while the proportion of low frailty patients decreased from a range of 70.5-71.4% to 65.5-70.1% (p < 0.01). In most phases of the pandemic, the Elixhauser comorbidity index (ECI) showed larger increases among high compared to low frailty patients (by 0.2-1.8 vs. 0.2-0.8 [p < 0.01]). Changes in rates of spine surgery were associated with frailty, most clearly in rates of spine fusion, showing consistent increases among low frailty patients (by 2.2-2.5%) versus decreases (by 0.3-0.8%) among high-frailty patients (p < 0.02). Changes in rates of in-hospital mortality were not associated with frailty., Conclusions: During the COVID-19 pandemic, the proportion of high-frailty patients increased among those hospitalized for spine pathologies in Germany. Low frailty was associated with a rise in rates of spine surgery and high frailty with comparably larger increases in rates of comorbidities., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Aims: The diagnostic application of artificial intelligence (AI)-based models to detect cardiovascular diseases from electrocardiograms (ECGs) evolves, and promising results were reported. However, external validation is not available for all published algorithms. The aim of this study was to validate an existing algorithm for the detection of left ventricular systolic dysfunction (LVSD) from 12-lead ECGs., Methods and Results: Patients with digitalized data pairs of 12-lead ECGs and echocardiography (at intervals of ≤7 days) were retrospectively selected from the Heart Center Leipzig ECG and electronic medical records databases. A previously developed AI-based model was applied to ECGs and calculated probabilities for LVSD. The area under the receiver operating characteristic curve (AUROC) was computed overall and in cohorts stratified for baseline and ECG characteristics. Repeated echocardiography studies recorded ≥3 months after index diagnostics were used for follow-up (FU) analysis. At baseline, 42 291 ECG-echocardiography pairs were analysed, and AUROC for LVSD detection was 0.88. Sensitivity and specificity were 82% and 77% for the optimal LVSD probability cut-off based on Youden's J. AUROCs were lower in ECG subgroups with tachycardia, atrial fibrillation, and wide QRS complexes. In patients without LVSD at baseline and available FU, model-generated high probability for LVSD was associated with a four-fold increased risk of developing LVSD during FU., Conclusion: We provide the external validation of an existing AI-based ECG-analysing model for the detection of LVSD with robust performance metrics. The association of false positive LVSD screenings at baseline with a deterioration of ventricular function during FU deserves a further evaluation in prospective trials., Competing Interests: Conflict of interest: none declared., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: Among brain tumor patients, frailty is associated with poor outcomes. The COVID-19 pandemic has led to increased frailty in the general population. To date, evidence on changes in frailty among brain tumor patients during the pandemic is lacking. We aimed to compare frailty among brain tumor patients in Germany during the COVID-19 pandemic to the pre-pandemic era and to assess potential effects on brain tumor care., Methods: In this retrospective observational study, we compared frailty among brain tumor patients hospitalized during the COVID-19 pandemic in years 2020 through 2022 to pre-pandemic years 2016 through 2019 based on administrative data from a nationwide network of 78 hospitals in Germany. Using the Hospital Frailty Risk Score (HFRS), frailty was categorized as low, intermediate, or high. We examined changes in frailty, patient demographics, the burden of comorbidity, rates of surgery, and mortality rates for different frailty groups during the pandemic and compared them to pre-pandemic levels., Results: Of the 20,005 included hospitalizations for brain tumors, 7979 were during the pandemic (mean age 60.0 years (± 18.4); females: 49.8%), and 12,026 in the pre-pandemic period (mean age: 59.0 years [± 18.4]; females: 49.2%). Average daily admissions decreased from 8.2 (± 5.1) during pre-pandemic years to 7.3 (± 4.5) during the pandemic (p < 0.01). The overall median HFRS decreased from 3.1 (IQR: 0.9-7.3) during the pre-pandemic years to 2.6 (IQR: 0.3-6.8) during the pandemic (p < 0.01). At the same time, the Elixhauser Comorbidity Index (ECI) decreased from 17.0 (± 12.4) to 16.1 (± 12.0; p < 0.01), but to a larger degree among high compared to low frailty cases (by 1.8 vs. 0.3 points; p = 0.04). In the entire cohort, the mean length of stay was significantly shorter in the pandemic period (9.5 days [± 10.7]) compared with pre-pandemic levels (10.2 days [± 11.8]; p < 0.01) with similar differences in the three frailty groups. Rates of brain tumor resection increased from 29.9% in pre-pandemic years to 36.6% during the pandemic (p < 0.001) without differences between frailty levels. Rates of in-hospital mortality did not change during the pandemic (6.1% vs. 6.7%, p = 0.07), and there was no interaction with frailty., Conclusion: Even though our findings are limited in that the HFRS is validated only for patients ≥ 75 years of age, our study among patients of all ages hospitalized for brain tumors in Germany suggests a marked decrease in levels of frailty and in the burden of comorbidities during the COVID-19 pandemic., (© 2023. The Author(s).)

Background: The necessary number of intensive care beds has been under debate in recent years. This study aims to provide a descriptive analysis of postoperative intensive care for visceral surgery patients based on three indicator procedures, with particular attention to the frequency and duration of intensive care among these patients, trends in the occupancy of intensive care units, and the course during the COVID-19 pandemic., Methods: Routine data from inpatient cases of the Helios group (24 888 cases from 71 acute care hospitals) from 01.01.2016 to 31.12.2021 were analyzed retrospectively. The indicator procedures were colorectal resection, surgery for gastric carcinoma, and left pancreatic resection., Results: Routine data reveal a decline in the utilization of intensive care by these patients over the years, e.g., after colorectal resection, from 84.2% in 2016 to 63.1% in 2021. The percentage of patients requiring mechanical ventilation declined to a small extent as well (2016: 10.3%; 2021: 8.9%). In-hospital mortality remained stable in the range of 4.1% to 5.2%. The number of gastric carcinomas operated on fell from 355 in 2016 to 239 in 2021, while the number of left pancreatic resections remained stable in the range of 147 to 172 per year., Conclusion: In the hospitals studied, visceral surgery patients still commonly undergo intensive care postoperatively, at a rate that is declining slowly over the years. No adjustments were made for age, sex, or Elixhauser comorbidity index.

Background: Even though several therapeutic options are available, COVID-19 is still lacking a specific treatment regimen. One potential option is dexamethasone, which has been established since the early beginnings of the pandemic. The aim of this study was to determine its effects on the microbiological findings in critically ill COVID-19 patients., Methods: A multi-center, retrospective study was conducted, in which all the adult patients who had a laboratory-confirmed (PCR) SARS-CoV-2 infection and were treated on intensive care units in one of twenty hospitals of the German Helios network between February 2020-March 2021 were included. Two cohorts were formed: patients who received dexamethasone and those who did not, followed by two subgroups according to the application of oxygen: invasive vs. non-invasive., Results: The study population consisted of 1.776 patients, 1070 of whom received dexamethasone, and 517 (48.3%) patients with dexamethasone were mechanically ventilated, compared to 350 (49.6%) without dexamethasone. Ventilated patients with dexamethasone were more likely to have any pathogen detection than those without ( p < 0.026; OR = 1.41; 95% CI 1.04-1.91). A significantly higher risk for the respiratory detection of Klebsiella spp. ( p = 0.016; OR = 1.68 95% CI 1.10-2.57) and for Enterobacterales ( p = 0.008; OR = 1.57; 95% CI 1.12-2.19) was found for the dexamethasone cohort. Invasive ventilation was an independent risk factor for in-hospital mortality ( p < 0.01; OR = 6.39; 95% CI 4.71-8.66). This risk increased significantly in patients aged 80 years or older by 3.3-fold ( p < 0.01; OR = 3.3; 95% CI 2.02-5.37) when receiving dexamethasone., Conclusion: Our results show that the decision to treat COVID-19 patients with dexamethasone should be a matter of careful consideration as it involves risks and bacterial shifts.

Background: Reports about the influence of the COVID-19 pandemic on the number of hospital admissions and in-hospital mortality during the first wave between March and May 2020 showed conflicting results and are limited by single-center or limited regional multicenter datasets. Aim of this analysis covering all German federal states was the comprehensive description of hospital admissions and in-hospital mortality during the first wave of the COVID-19 pandemic., Methods and Results: We conducted an observational study on hospital routine data (§21 KHEntgG) and included patients with the main diagnosis of acute myocardial infarction (ICD 21 and ICD 22). A total of 159 hospitals included 36,329 patients in the database, with 12,497 patients admitted with ST-elevation myocardial infarction (STEMI) and 23,832 admitted with non-ST-elevation myocardial infarction (NSTEMI). There was a significant reduction in the number of patients admitted with STEMI (3748 in 2020, 4263 in 2019 and 4486 in 2018; p < 0.01) and NSTEMI (6957 in 2020, 8437 in 2019 and 8438 in 2020; p < 0.01). These reductions were different between the Federal states of Germany. Percutaneous coronary intervention was performed more often in 2020 than in 2019 (odds ratio 1.13, 95% confidence interval [CI] 1.06-1.21) and 2018 (odds ratio 1.20, 95% CI 1.12-1.29) in NSTEMI and more often than in 2018 (odds ratio 1.26, 95% CI 1.10-1.43) in STEMI. The in-hospital mortality did not differ between the years for STEMI and NSTEMI, respectively., Conclusions: In this large representative sample size of hospitals in Germany, we observed significantly fewer admissions for NSTEMI and STEMI during the first COVID-19 wave, while quality of in-hospital care and in-hospital mortality were not affected. Admissions for STEMI and NSTEMI during the months March to May over 3 years and corresponding in-hospital mortality for patients with STEMI and NSTEMI in 159 German hospitals. (p-value for admissions 2020 versus 2019 and 2018: < 0.01; p-value for mortality: n.s.)., (© 2022. The Author(s).)

Background: Little is known about delivery of neurosurgical care, complication rate and outcome of patients with high-grade glioma (HGG) during the coronavirus disease 2019 (Covid-19) pandemic., Methods: This observational, retrospective cohort study analyzed routine administrative data of all patients admitted for neurosurgical treatment of an HGG within the Helios Hospital network in Germany. Data of the Covid-19 pandemic (March 1, 2020-May 31, 2022) were compared to the pre-pandemic period (January 1, 2016-February 29, 2020). Frequency of treatment and outcome (in-hospital mortality, length of hospital stay [LOHS], time in intensive care unit [TICU] and ventilation outside the operating room [OR]) were separately analyzed for patients with microsurgical resection (MR) or stereotactic biopsy (STBx)., Results: A total of 1763 patients underwent MR of an HGG (648 patients during the Covid-19 pandemic; 1115 patients in the pre-pandemic period). 513 patients underwent STBx (182 [pandemic]; 331 patients [pre-pandemic]). No significant differences were found for treatment frequency (MR: 2.95 patients/week [Covid-19 pandemic] vs. 3.04 patients/week [pre-pandemic], IRR 0.98, 95% CI: 0.89-1.07; STBx (1.82 [Covid-19 pandemic] vs. 1.86 [pre-pandemic], IRR 0.96, 95% CI: 0.80-1.16, P  > .05). Rates of in-hospital mortality, infection, postoperative hemorrhage, cerebral ischemia and ventilation outside the OR were similar in both periods. Overall LOHS was significantly shorter for patients with MR and STBx during the Covid-19 pandemic., Conclusions: The Covid-19 pandemic did not affect the frequency of neurosurgical treatment of patients with an HGG based on data of a large nationwide hospital network in Germany. LOHS was significantly shorter but quality of neurosurgical care and outcome was not altered during the Covid-19 pandemic., Competing Interests: None., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Society for Neuro-Oncology and the European Association of Neuro-Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Mobile health (mHealth) approaches are already having a fundamental impact on clinical practice in cardiovascular medicine. A variety of different health apps and wearable devices for capturing health data such as electrocardiograms (ECGs) exist. However, most mHealth technologies focus on distinct variables without integrating patients' quality of life, and the impact on clinical outcome measures of implementing those digital solutions into cardiovascular health care is still to be determined., Objective: Within this document, we describe the TeleWear project, which was recently initiated as an approach for contemporary patient management integrating mobile-collected health data and the standardized mHealth-guided measurement of patient-reported outcomes (PROs) in patients with cardiovascular disease., Methods: The specifically designed mobile app and clinical frontend form the central elements of our TeleWear infrastructure. Because of its flexible framework, the platform allows far-reaching customization with the possibility to add different mHealth data sources and respective questionnaires (patient-reported outcome measures)., Results: With initial focus on patients with cardiac arrhythmias, a feasibility study is currently carried out to assess wearable-recorded ECG and PRO transmission and its evaluation by physicians using the TeleWear app and clinical frontend. First experiences made during the feasibility study yielded positive results and confirmed the platform's functionality and usability., Conclusions: TeleWear represents a unique mHealth approach comprising PRO and mHealth data capturing. With the currently running TeleWear feasibility study, we aim to test and further develop the platform in a real-world setting. A randomized controlled trial including patients with atrial fibrillation that investigates PRO- and ECG-based clinical management based on the established TeleWear infrastructure will evaluate its clinical benefits. Widening the spectrum of health data collection and interpretation beyond the ECG and use of the TeleWear infrastructure in different patient subcohorts with focus on cardiovascular diseases are further milestones of the project with the ultimate goal to establish a comprehensive telemedical center entrenched by mHealth., (©Johannes Leiner, Sebastian König, Konstantinos Mouratis, Igor Kim, Pia Schmitz, Tanvi Joshi, Carolin Schanner, Lisa Wohlrab, Sven Hohenstein, Vincent Pellissier, Anne Nitsche, Ralf Kuhlen, Gerhard Hindricks, Andreas Bollmann. Originally published in JMIR Formative Research (https://formative.jmir.org), 03.03.2023.)

Purpose: At the beginning of the COVID-19 pandemic, SARS-CoV-2 was often compared to seasonal influenza. We aimed to compare the outcome of hospitalized patients with cancer infected by SARS-CoV-2 or seasonal influenza including intensive care unit admission, mechanical ventilation and in-hospital mortality., Methods: We analyzed claims data of patients with a lab-confirmed SARS-CoV-2 or seasonal influenza infection admitted to one of 85 hospitals of a German-wide hospital network between January 2016 and August 2021., Results: 29,284 patients with COVID-19 and 7442 patients with seasonal influenza were included. Of these, 360 patients with seasonal influenza and 1625 patients with COVID-19 had any kind of cancer. Cancer patients with COVID-19 were more likely to be admitted to the intensive care unit than cancer patients with seasonal influenza (29.4% vs 24.7%; OR 1.31, 95% CI 1.00-1.73 p < .05). No statistical significance was observed in the mechanical ventilation rate for cancer patients with COVID-19 compared to those with seasonal influenza (17.2% vs 13.6% OR 1.34, 95% CI 0.96-1.86 p = .09). 34.9% of cancer patients with COVID-19 and 17.9% with seasonal influenza died (OR 2.45, 95% CI 1.81-3.32 p < .01). Risk factors among cancer patients with COVID-19 or seasonal influenza for in-hospital mortality included the male gender, age, a higher Elixhauser comorbidity index and metastatic cancer., Conclusion: Among cancer patients, SARS-CoV-2 was associated with a higher risk for in-hospital mortality than seasonal influenza. These findings underline the need of protective measurements to prevent an infection with either COVID-19 or seasonal influenza, especially in this high-risk population., (© 2022. The Author(s).)

Background:  The full impact of the COVID-19 pandemic on surgical spine care is difficult to assess due to a lack in nationwide evidence from more recent phases of the pandemic. We aimed to describe changes in in-hospital processes associated with spinal fusion procedures in the treatment of spinal infections (SI) during different phases of the pandemic., Methods:  In this retrospective observational study, we examined the in-hospital prevalence and outcomes of spinal fusion procedures for SI (along with patient characteristics, rates of transfer to intensive care units, and mortality rates) during the first four waves of the pandemic compared with the corresponding prepandemic periods in 2019. We used administrative data from a nationwide network of 76 hospitals managing 7% of all in-hospital cases in Germany., Results:  We observed no significant change in the prevalence of SI fusion procedures during the pandemic, neither in total numbers (349 vs. 373) nor for each wave separately. On a patient level, we found no differences in age, sex, and the prevalence of paresis, and no relevant differences in associated comorbidities. The rate of mechanical ventilation did not change during any of the examined pandemic waves: it ranged between 9.5 and 18.6% during the pandemic and 3.1 and 16.0% during the corresponding prepandemic control periods. The rate of transfer to intensive care changed only during wave 4 (from 70.4 to 54.8%; p  = 0.046) but not in any other pandemic phases. We observed no changes in in-hospital mortality rates (range: 2.9-9.7% vs. 6.2-11.3%) or in duration of hospital stay (range: 26.2-30.8 days vs. 20.8-29.2 days)., Conclusions:  The main finding of our study is that within this nationwide network of spine care centers in Germany, the delivery of surgical treatment of SI by means of spinal fusion procedures was maintained throughout the first four waves of the pandemic. Furthermore, there were no relevant changes in patient demographics, in-hospital processes, and mortality rates., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Fast-track concepts have fundamentally changed the perioperative care of patients in the last 30 years. Sufficient evidence is available for these concepts., Objective: The aim of this article is to evaluate the dissemination of fast-track concepts in Germany based on routine data., Material and Methods: A retrospective analysis of all colorectal resections performed at the Helios Clinics in 2016-2021 was carried out. These were analyzed with respect to the length of hospital stay, intensive care unit occupancy, ventilation proportion, mortality, complication rate and access approach., Results and Discussion: A transfer to the intensive medical care unit is still the standard in Germany after colorectal resection. For oncological colorectal resection, in particular, two thirds of the patients are still perioperatively treated on the intensive care unit. The duration of inpatient hospital stay for colorectal resection is still excessively long in international comparisons and has also only diminished slowly in recent years (e.g. colon cancer 2016: 18.6 ± 11.9 days and 2021: 13.8 ± 9.3 days). The proportion of open surgical interventions is declining but still accounts for a relevant proportion even 30 years after the implementation of laparoscopy (e.g. colon cancer 2016: 71.10% and 2021: 56.44%). Therefore, the care of patients with colorectal resection still does not seem to be implemented according to the fast-track principle., (© 2022. The Author(s), under exclusive licence to Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

Background: This study compared patient profiles and clinical courses of SARS-CoV-2 infected inpatients over different pandemic periods., Methods: In a retrospective cross-sectional analysis, we examined administrative data of German Helios hospitals using ICD-10-codes at discharge. Inpatient cases with SARS-CoV-2 infection admitted between 03/04/2020 and 07/19/2022 were included irrespective of the reason for hospitalization. All endpoints were timely assigned to admission date for trend analysis. The first pandemic wave was defined by change points in time-series of incident daily infections and compared with different later pandemic phases according to virus type predominance., Results: We included 72,459 inpatient cases. Patients hospitalized during the first pandemic wave (03/04/2020-05/05/2020; n = 1,803) were older (68.5 ± 17.2 vs. 64.4 ± 22.6 years, p < 0.01) and severe acute respiratory infections were more prevalent (85.2 vs. 53.3%, p < 0.01). No differences were observed with respect to distribution of sex, but comorbidity burden was higher in the first pandemic wave. The risk of receiving intensive care therapy was reduced in all later pandemic phases as was in-hospital mortality when compared to the first pandemic wave. Trend analysis revealed declines of mean age and Elixhauser comorbidity index over time as well as a decline of the utilization of intensive care therapy, mechanical ventilation and in-hospital mortality., Conclusion: Characteristics and outcomes of inpatients with SARS-CoV-2 infection changed throughout the observational period. An ongoing evaluation of trends and care pathways will allow for the assessment of future demands., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2022 König, Hohenstein, Pellissier, Leiner, Hindricks, Nachtigall, Kuhlen and Bollmann.)

Background: The SARS-CoV-2 variant B.1.1.529 (Omicron) was first described in November 2021 and became the dominant variant worldwide. Existing data suggests a reduced disease severity with Omicron infections in comparison to B.1.617.2 (Delta). Differences in characteristics and in-hospital outcomes of COVID-19 patients in Germany during the Omicron period compared to Delta are not thoroughly studied. ICD-10-code-based severe acute respiratory infections (SARI) surveillance represents an integral part of infectious disease control in Germany., Methods: Administrative data from 89 German Helios hospitals was retrospectively analysed. Laboratory-confirmed SARS-CoV-2 infections were identified by ICD-10-code U07.1 and SARI cases by ICD-10-codes J09-J22. COVID-19 cases were stratified by concomitant SARI. A nine-week observational period between December 6, 2021 and February 6, 2022 was defined and divided into three phases with respect to the dominating virus variant (Delta, Delta to Omicron transition, Omicron). Regression analyses adjusted for age, gender and Elixhauser comorbidities were applied to assess in-hospital patient outcomes., Results: A total cohort of 4,494 inpatients was analysed. Patients in the Omicron dominance period were younger (mean age 47.8 vs. 61.6; p < 0.01), more likely to be female (54.7% vs. 47.5%; p < 0.01) and characterized by a lower comorbidity burden (mean Elixhauser comorbidity index 5.4 vs. 8.2; p < 0.01). Comparing Delta and Omicron periods, patients were at significantly lower risk for intensive care treatment (adjusted odds ratio 0.72 [0.57-0.91]; p = 0.005), mechanical ventilation (adjusted odds ratio 0.42 [0.31-0.57]; p < 0.001), and in-hospital mortality (adjusted odds ratio 0.42 [0.32-0.56]; p < 0.001). This also applied mostly to the separate COVID-SARI group. During the Delta to Omicron transition, case numbers of COVID-19 without SARI exceeded COVID-SARI for the first time in the pandemic's course., Conclusion: Patient characteristics and outcomes differ during the Omicron dominance period as compared to Delta suggesting a reduced disease severity with Omicron infections. SARI surveillance might play a crucial role in assessing disease severity of future SARS-CoV-2 variants., (© 2022. The Author(s).)

Background: Severe acute respiratory infections (SARI) are the most common infectious causes of death. Previous work regarding mortality prediction models for SARI using machine learning (ML) algorithms that can be useful for both individual risk stratification and quality of care assessment is scarce. We aimed to develop reliable models for mortality prediction in SARI patients utilizing ML algorithms and compare its performances with a classic regression analysis approach., Methods: Administrative data (dataset randomly split 75%/25% for model training/testing) from years 2016-2019 of 86 German Helios hospitals was retrospectively analyzed. Inpatient SARI cases were defined by ICD-codes J09-J22. Three ML algorithms were evaluated and its performance compared to generalized linear models (GLM) by computing receiver operating characteristic area under the curve (AUC) and area under the precision-recall curve (AUPRC)., Results: The dataset contained 241,988 inpatient SARI cases (75 years or older: 49%; male 56.2%). In-hospital mortality was 11.6%. AUC and AUPRC in the testing dataset were 0.83 and 0.372 for GLM, 0.831 and 0.384 for random forest (RF), 0.834 and 0.382 for single layer neural network (NNET) and 0.834 and 0.389 for extreme gradient boosting (XGBoost). Statistical comparison of ROC AUCs revealed a better performance of NNET and XGBoost as compared to GLM., Conclusion: ML algorithms for predicting in-hospital mortality were trained and tested on a large real-world administrative dataset of SARI patients and showed good discriminatory performances. Broad application of our models in clinical routine practice can contribute to patients' risk assessment and quality management., (© 2022. The Author(s).)

Purpose: To determine effects on admission, treatment, and outcome for acute cholecystitis during the course of the COVID-19 pandemic in 2020 and 2021., Methods: Retrospective analysis of claims data from 74 German hospitals. Study periods were defined from March 5, 2020 (start of first wave) to June 20, 2021 (end of third wave) and compared to corresponding control periods (March 2018 to February 2020). All in-patients with acute cholecystitis were included. Distribution of cases, type of surgery, comorbidities, surgical outcome, and length of stay of all cases with acute cholecystitis and cholecystectomy were compared. In addition, we analyzed the type of treatment (non-surgical, cholecystostomy, or cholecystectomy) for all cases with main diagnosis of acute cholecystitis., Results: We could not demonstrate differences in daily admissions over the course of the pandemic (11.2-12.7 patients vs. 11.9-12.6 patients for control periods). Proportion of patients with non-surgical treatment was low and not increased (11.7-17.3% vs. 14.5-18.4%). Cholecystostomy was rare throughout all periods (0-0.5% of all patients). We did not observe an increase in open surgery (proportion of open cholecystectomies 3.4-5.5%). Mortality was generally low (1.5-1.9%) with no differences between periods. Median length of stay was 4 days throughout all periods., Conclusion: The numerous restrictions during the COVID-19 pandemic did not result in an increase of admissions or surgery for acute cholecystitis. Laparoscopic cholecystectomy has been safely applied during the pandemic. Our results may assure the ability to maintain high quality of surgical care even in times of disruptions to the health care system., (© 2022. The Society for Surgery of the Alimentary Tract.)

Objective: The impact of the COVID-19 year on the number of daily psychiatric emergency admissions and length of stay was compared with previous years., Methods: In a retrospective study, the four quarters of 2020 of several psychiatric hospitals in Germany were statistically compared with the respective quarters of 2018 and 2019., Results: A total of 73,412 cases was analyzed. In the 2 nd quarter of 2020, the number of daily admissions was significantly lower as compared to the control period (59.1 vs. 70.7; incidence rate ratio [95 % confidence interval] 0.81 [0.69; 0.96]; p = 0.012). Length of stay was numerically but not significantly different as compared to the control periods., Conclusion: The COVID-19 pandemic had a strong impact on inpatient psychiatric care. In the future, multimodal care structures must ensure the care of severely mentally ill people in crisis situations., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Introduction: In the early stages of the global COVID-19 pandemic hospital admissions for acute ischemic stroke (AIS) decreased substantially. As health systems have become more experienced in dealing with the pandemic, and as the proportion of the population vaccinated rises, it is of interest to determine whether the prevalence of AIS hospitalization and outcomes from hospitalization have returned to normal., Patients and Methods: In this observational, retrospective cohort study, we compared the prevalence and outcomes of AIS during the first four waves of the pandemic to corresponding pre-pandemic periods in 2019 using administrative data collected from a nationwide network of 76 hospitals that manages 7% of all in-hospital cases in Germany., Results: We included 25,821 AIS cases in the study period (2020/2021) and used 26,295 AIS cases as controls (2019). Compared to pre-pandemic numbers, mean daily AIS admissions decreased only during wave 1 (from 39.6 to 34.1; p < 0.01) and wave 2 (from 39.9 to 38.3; p = 0.03) and returned to normal levels during waves 3 and 4. AIS case fatality increased in wave 1 only (from 6.0% to 7.6%; p = 0.03). We observed a consistent decrease in the prevalences of arterial hypertension, diabetes, and obesity among AIS cases throughout the pandemic and no changes in rates of systemic thrombolysis, mechanical thrombectomy, or decompressive craniectomy. The rate of transfer to stroke units increased only during waves 2 (by 4.6%; p < 0.01) and 3 (by 3.0%; p < 0.01). The proportion of patients with coinciding SARS-CoV-2 and AIS was low, peaking at 3.4% in wave 2 and subsequently decreasing to 0.4% in wave 4., Conclusion: In Germany, the COVID-19 pandemic seems to have had a larger effect on nationwide in-hospital AIS care during the early pandemic stages, in which AIS case numbers decreased and case fatality rose. This may reflect a nationwide "learning curve" within health care systems in providing AIS care in times of a pandemic., Competing Interests: Declaration of conflicting interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JD, KP, FP, SH, VP, MS, BH, AMH, RK, AB, and SR are employees of Helios. RK holds shares in Fresenius AG., (© European Stroke Organisation 2022.)

Aims: Utilizing administrative data may facilitate risk prediction in heart failure inpatients. In this short report, we present different machine learning models that predict in-hospital mortality on an individual basis utilizing this widely available data source., Methods and Results: Inpatient cases with a main discharge diagnosis of heart failure hospitalized between 1 January 2016 and 31 December 2018 in one of 86 German Helios hospitals were examined. Comorbidities were defined by ICD-10 codes from administrative data. The data set was randomly split into 75/25% portions for model development and testing. Five algorithms were evaluated: logistic regression [generalized linear models (GLMs)], random forest (RF), gradient boosting machine (GBM), single-layer neural network (NNET), and extreme gradient boosting (XGBoost). After model tuning, the receiver operating characteristics area under the curves (ROC AUCs) were calculated and compared with DeLong's test. A total of 59 074 inpatient cases (mean age 77.6 ± 11.1 years, 51.9% female, 89.4% NYHA Class III/IV) were included and in-hospital mortality was 6.2%. In the test data set, calculated ROC AUCs were 0.853 [95% confidence interval (CI) 0.842-0.863] for GLM, 0.851 (95% CI 0.840-0.862) for RF, 0.855 (95% CI 0.844-0.865) for GBM, 0.836 (95% CI 0.823-0.849) for NNET, and 0.856 (95% CI 9.846-0.867) for XGBoost. XGBoost outperformed all models except GBM., Conclusion: Machine learning-based processing of administrative data enables the creation of well-performing prediction models for in-hospital mortality in heart failure patients., (© The Author(s) 2022. Published by Oxford University Press on behalf of European Society of Cardiology.)

Background: The aim of our study was to assess the impact the impact of gender and age on reactogenicity to three COVID-19 vaccine products: Biontech/Pfizer (BNT162b2), Moderna (mRNA-1273) and AstraZeneca (ChAdOx). Additional analyses focused on the reduction in working capacity after vaccination and the influence of the time of day when vaccines were administered., Methods: We conducted a survey on COVID-19 vaccinations and eventual reactions among 73,000 employees of 89 hospitals of the Helios Group. On May 19th, 2021 all employees received an email, inviting all employees who received at least 1 dose of a COVID-19 to participate using an attached link. Additionally, the invitation was posted in the group's intranet page. Participation was voluntary and non-traceable. The survey was closed on June 21st, 2021., Results: 8375 participants reported on 16,727 vaccinations. Reactogenicity was reported after 74.6% of COVID-19 vaccinations. After 23.0% vaccinations the capacity to work was affected. ChAdOx induced impairing reactogenicity mainly after the prime vaccination (70.5%), while mRNA-1273 led to more pronounced reactions after the second dose (71.6%). Heterologous prime-booster vaccinations with ChAdOx followed by either mRNA-1273 or BNT162b2 were associated with the highest risk for impairment (81.4%). Multivariable analyses identified the factors older age, male gender and vaccine BNT162b as independently associated with lower odds ratio for both, impairing reactogenicity and incapacity to work. In the comparison of vaccine schedules, the heterologous combination ChAdOx + BNT162b or mRNA-1273 was associated with the highest and the homologue prime-booster vaccination with BNT162b with the lowest odds ratios. The time of vaccination had no significant influence., Conclusions: Around 75% of the COVID-19 vaccinations led to reactogenicity and nearly 25% of them led to one or more days of work loss. Major risk factors were female gender, younger age and the administration of a vaccine other than BNT162b2. When vaccinating a large part of a workforce against COVID-19, especially in professions with a higher proportion of young and women such as health care, employers and employees must be prepared for a noticeable amount of absenteeism. Assuming vaccine effectiveness to be equivalent across the vaccine combinations, to minimize reactogenicity, employees at risk should receive a homologous prime-booster immunisation with BNT162b2., Trial Registration: The study was approved by the Ethic Committee of the Aerztekammer Berlin on May 27th, 2021 (Eth-37/21) and registered in the German Clinical Trials Register (DRKS 00025745). The study was supported by the Helios research grant HCRI-ID 2021-0272., (© 2022. The Author(s).)

Purpose: The COVID-19 pandemic has led to global changes in healthcare systems. The purpose of this study was to investigate the effects on surgical care of patients., Methods: We performed a retrospective analysis of routine data from the largest hospital group in Germany (68 acute hospitals). Included were inpatients who underwent cholecystectomy between March 19, 2020 (beginning of the first lockdown in Germany) and September 22, 2020. These patients were compared with those treated in the same interval in 2019., Results: In the 2020 study period, 4035 patients met the inclusion criteria (2019: 4526 patients). During the first lockdown, there was a significant reduction in the number of cholecystectomies performed (51.1% decrease). More patients with a higher risk profile underwent urgent operations, which were accompanied by a significant increase in conversion from laparoscopic to open cholecystectomy. The patients were treated as inpatients for a longer duration than 2019, and the mortality rate increased significantly to 1.3% (2019: 0.1%). The complication rate also showed a significant increase. After the end of the first lockdown, daily admission rates normalized very quickly. However, it was not possible to fully address the backlog of operations., Conclusion: There is still a "patient stagnation" 6 months after the first German lockdown. Extrapolated to the national level, this corresponds to almost 21,000 fewer cholecystectomies performed in Germany in 2020. It remains to be seen whether surgical rates will return to pre-pandemic levels and whether complications will arise in the future due to the lack of operations., (© 2021. The Society for Surgery of the Alimentary Tract.)

Importance: Throughout the ongoing SARS-CoV-2 pandemic, it has been critical to understand not only the viral disease itself but also its implications for the overall health care system. Reports about excess mortality in this regard have mostly focused on overall death counts during specific pandemic phases., Objective: To investigate hospitalization rates and compare in-hospital mortality rates with absolute mortality incidences across a broad spectrum of diseases, comparing 2020 data with those of prepandemic years., Design, Setting, and Participants: Retrospective, cross-sectional, multicentric analysis of administrative data from 5 821 757 inpatients admitted from January 1, 2016, to December 31, 2020, to 87 German Helios primary to tertiary care hospitals., Exposures: Exposure to SARS-CoV-2., Main Outcomes and Measures: Administrative data were analyzed from January 1, 2016, to March 31, 2021, as a consecutive sample for all inpatients. Disease groups were defined according to International Statistical Classification of Diseases and Related Health Problems, 10th Revision (ICD-10; German modification) encoded main discharge diagnoses. Incidence rate ratios (IRRs) for hospital admissions and hospital mortality counts, as well as relative mortality risks (RMRs) comparing 2016-2019 with 2020 (exposure to the SARS-CoV-2 pandemic), were calculated with Poisson regression with log-link function., Results: Data were examined for 5 821 757 inpatients (mean [SD] age, 56.4 [25.3] years; 51.5% women), including 125 807 in-hospital deaths. Incidence rate ratios for hospital admissions were associated with a significant reduction for all investigated disease groups (IRR, 0.82; 95% CI, 0.79-0.86; P < .001). After adjusting for age, sex, the Elixhauser Comorbidity Index score, and SARS-CoV-2 infections, RMRs were associated with an increase in infectious diseases (RMR, 1.28; 95% CI, 1.21-1.34; P < .001), musculoskeletal diseases (RMR, 1.19; 95% CI, 1.04-1.36; P = .009), and respiratory diseases (RMR, 1.09; 95% CI, 1.05-1.14; P < .001) but not for the total cohort (RMR, 1.00; 95% CI, 0.99-1.02; P = .66). Regarding in-hospital mortality, IRR was associated with an increase within the ICD-10 chapter of respiratory diseases (IRR, 1.28; 95% CI, 1.13-1.46; P < .001) in comparing 2020 with 2016-2019, in contrast to being associated with a reduction in IRRs for the overall cohort and several other subgroups. After exclusion of patients with SARS-CoV-2 infections, IRRs were associated with a reduction in absolute in-hospital mortality for the overall cohort (IRR, 0.78; 95% CI, 0.72-0.84; P < .001) and the subgroup of respiratory diseases (IRR, 0.83; 95% CI, 0.74-0.92; P < .001)., Conclusions and Relevance: This cross-sectional study of inpatients from a multicentric German database suggests that absolute in-hospital mortality for 2020 across disease groups was not higher compared with previous years. Higher IRRs of in-hospital deaths observed in patients with respiratory diseases were likely associated with individuals with SARS-CoV-2 infections.

Background: Transcatheter aortic valve replacement is an established treatment option for patients with severe symptomatic aortic stenosis and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce., Methods: The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure during Transfemoral Transcatheter Aortic Valve Implantation) is an investigator-initiated, multicenter study, in which patients undergoing transfemoral transcatheter aortic valve replacement were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular) potentially complemented by a small plug. The primary end point consisted of access site- or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary end points included the rate of access site- or access-related bleeding, VCD failure, and time to hemostasis., Results: A total of 516 patients were included and randomly assigned. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary end point occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk, 1.61 [95% CI, 1.07-2.44], P =0.029). Access site- or access-related bleeding occurred in 11.6% versus 7.4% (relative risk, 1.58 [95%CI: 0.91-2.73], P =0.133) and device failure in 4.7% versus 5.4% (relative risk, 0.86, [95% CI, 0.40-1.82], P =0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32-180] versus 240 [174-316] seconds, P <0.001)., Conclusions: Among patients treated with transfemoral transcatheter aortic valve replacement, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access site- or access-related vascular complications but a shorter time to hemostasis compared with a primary suture-based technique using the ProGlide VCD. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04459208.

Background: Reduced hospital admission rates for heart failure (HF) and evidence of increased in-hospital mortality were reported during the COVID-19 pandemic. The aim of this study was to apply a machine learning (ML)-based mortality prediction model to examine whether the latter is attributable to differing case mixes and exceeds expected mortality rates., Methods and Results: Inpatient cases with a primary discharge diagnosis of HF non-electively admitted to 86 German Helios hospitals between 01/01/2016 and 08/31/2020 were identified. Patients with proven or suspected SARS-CoV-2 infection were excluded. ML-based models were developed, tuned, and tested using cases of 2016-2018 (n = 64,440; randomly split 75%/25%). Extreme gradient boosting showed the best model performance indicated by a receiver operating characteristic area under the curve of 0.882 (95% confidence interval [CI]: 0.872-0.893). The model was applied on data sets of 2019 and 2020 (n = 28,556 cases) and the hospital standardized mortality ratio (HSMR) was computed as the observed to expected death ratio. Observed mortality rates were 5.84% (2019) and 6.21% (2020), HSMRs based on an individual case-based mortality probability were 100.0 (95% CI: 93.3-107.2; p = 1.000) for 2019 and 99.3 (95% CI: 92.5-106.4; p = .850) for 2020. Within subgroups of age or hospital volume, there were no significant differences between observed and expected deaths. When stratified for pandemic phases, no excess death during the COVID-19 pandemic was observed., Conclusion: Applying an ML algorithm to calculate expected inpatient mortality based on administrative data, there was no excess death above expected event rates in HF patients during the COVID-19 pandemic., (© 2021 The Authors. Clinical Cardiology published by Wiley Periodicals, LLC.)

COVID-19 has led to profound changes in the world as we have known it. Due to the sharp increase in intensive care, COVID patients, elective admissions and interventions have been postponed. But emergencies such as myocardial infarction have also decreased. The present study deals with the effects of the COVID pandemic on visceral surgical emergencies on the basis of 5 indicator operations. Routine data from 73 acute hospitals of the Helios Group were evaluated for this purpose. The interventions that were carried out between March 13, 2020 and March 12, 2021 were included. The data was compared with the period from March 13, 2019 to March 12, 2020. The number of interventions in serious emergencies (ileus, mesenteric ischemia and ulcer perforation) has remained constant. However, the length of stay in hospital in the pandemic year 2020 was significantly shorter than in the reference year 2019. The number of cholecystectomies and appendectomies in the pandemic year was significantly lower than in the reference year 2019. The outcome parameters intensive care, invasive ventilation and hospital mortality were comparable for the two periods for these interventions., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)