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Objective: There has been a decline in hospital admission rates in many countries since the beginning of the COVID-19 pandemic. Patient selection differed from episodes before the pandemic. This study investigated changes in baseline characteristics as well as the short term mortality rate and probability of receiving an invasive procedure while considering sex disparities., Methods: Claims data provided by Germany's second largest insurance fund, BARMER, were used. Patients without COVID-19 who were treated for ST segment elevation myocardial infarction (STEMI), non-ST segment elevation myocardial infarction (NSTEMI), acute limb ischaemia (ALI), and stroke between 1 January 2018 and 31 December 2021 were included. Outcomes were compared separately for both sexes between the years before the pandemic (2018/2019) and during the pandemic (2020/2021). Propensity scores with exact matching were used to balance confounders including age, drug prescriptions in the previous year, federal state, month of admission, domiciliary care, and the Elixhauser comorbidities. Short term death and probability of invasive procedures were determined using cumulative incidence functions and Cox regressions., Results: The cohort consisted of 140 989 hospitalisations of 122 340 individual patients (48.3% female) with 102 960 matched cases. Baseline characteristics were similar between episodes in the unmatched cohort. Earlier discharge was observed for all strata except for males with ALI or STEMI, where the probability of early discharge was unchanged. The probability of receiving an invasive procedure was increased for both sexes with ALI, NSTEMI, and STEMI but not for stroke. The analyses suggested neither a statistically significant increase of the in hospital mortality rate nor the 30 day mortality rate after the pandemic started., Conclusion: There was no evidence for a direct or indirect impact of the pandemic on major short term hospital outcomes. While the probability of receiving an invasive procedure increased for STEMI, NSTEMI, and ALI, the overall short term mortality rate was unaffected for both sexes., (Copyright © 2024 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: There is a paucity of data on the relationship between hospital procedure volume and outcomes after inpatient treatment of symptomatic peripheral arterial disease (PAD). This study aimed to generate meaningful hypotheses to support the ongoing discussion., Methods: Data derived from BARMER, Germany's second largest insurance provider, were linked with nationwide hospital procedure volumes from mandatory hospital quality reports. All endovascular (EVR) and open surgical revascularisations (OSR) provided to patients (≥ 40 years) with symptomatic PAD between 1 January 2013 and 31 December 2018 were included. Hospital volume was defined as the number of procedures performed by a hospital in the previous calendar year (in quartiles). Freedom from re-intervention, amputation, and overall mortality rate within 12 months after discharge were analysed using multivariable Cox proportional hazards models. In hospital mortality was determined by generalised estimating equations logistic regression models., Results: There were 88 187 revascularisations (72.4% EVR; EVR: 72.7 years and 45.2% females; OSR: 71.9 years and 41.9% females) registered by 668 hospitals. No statistically significant association was found between 12 month freedom from re-intervention and hospital volume (EVR: 4; quartile HR 1.05; 95% CI 0.94 - 1.16. OSR: 4; quartile HR 1.05; 95% CI 0.92 - 1.21). Patients with OSR had a decreased hazard of 12 month mortality in a high volume hospital compared with a low volume hospital (HR 0.85; 95% CI 0.73 - 0.98), but not with EVR (HR 1.03; 95% CI 0.91 - 1.16). Patients who were treated in hospitals with highest volumes showed decreased hazards of 12 month freedom from amputation when compared with low volume hospitals (EVR: HR 0.72; 95% CI 0.52 - 0.99. OSR: HR 0.61; 95% CI 0.44 - 0.85)., Conclusion: This large retrospective analysis of insurance claims suggests that higher procedure volume is associated with lower major amputation rates, although there is a need for standardisation of the definition of volume stratification. Future studies should address the impact of subsequent outpatient care and surveillance to further examine the complex interaction between treatment and outcomes., (Copyright © 2022 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objectives: Molar incisor hypomineralization (MIH) has become a major oral health problem of widely unknown origin. Besides genetic predisposition, exposure to certain drugs in early childhood are suspected to be associated with MIH. Aim of this routine data analysis was to examine associations of MIH and exposure to medication as well as perinatal factors., Methods: Individuals with MIH were identified in claims data using a validated predefined specific treatment pattern. The database was a comprehensive routine data set of a major national health insurance company (BARMER, Germany). Based on this treatment pattern a MIH group and an unaffected control group were formed for analysis. Various medical data including medical diagnoses and prescriptions were available. Associations were examined comparing results for a set of variables in both groups. Differences between the groups were tested for significance using T-tests (P<0.01)., Results: Between 2010 to 2019, a total of 298,502 children between 6 and 9 years of age were included in this analysis. 22,947 were assigned to the MIH group. For individuals in this group, significantly larger prescription quantities in the main ATC (Anatomical, Therapeutic, Chemical) groups J (antiinfectives for systemic use), R (respiratory system) and S (sensory organs) were found in the first 4 years of life compared to MIH unaffected individuals. With antibiotics, there were both significantly larger prescription quantities and significantly higher numbers of respective prescriptions in the first 4 years of life. The differences amounted up to about 10.62% in frequently used antibiotics to be found in ATC J01D (other beta-lactam antibacterials) for the number of prescriptions in the 4th year of life. No association was found for premature birth, mode of delivery or the use of antipyretic or anti-inflammatory medication., Conclusions: While perinatal factors do not seem to be associated with MIH development, early life exposure to antibiotics might play a role., Clinical Significance Statement: Although causal relations can still not be proven, a responsible use of the unquestionably beneficial antibiotics is encouraged from a clinical point of view., Competing Interests: Declaration of Competing Interest The authors declare no competing interests., (Copyright © 2022. Published by Elsevier Ltd.)

Objective: There is a paucity of evidence concerning the risk of bleeding after hospitalisation for symptomatic peripheral artery disease (PAD) in everyday clinical practice, as randomised clinical trials commonly exclude patients with heightened risk. The current study aimed to develop a pragmatic risk score that enables prediction of major bleeding during the first year after index discharge., Methods: Unselected retrospective data from the second largest insurance fund in Germany, BARMER, were used to identify patients with a first hospitalisation for PAD registered between 1 January 2010 and 31 December 2018. Within a separate training cohort, final predictors were selected using penalised Cox regression (least absolute shrinkage and selection operator with ten fold cross validation) with one year major bleeding requiring hospitalisation as outcome. The risk score was internally validated. Four different risk groups were constructed., Results: A total of 81 930 patients (47.2% female, 72.3 years) underwent hospitalisation for symptomatic PAD. After one year, 1 831 (2.2%) of the patients had a major bleeding event. Independent predictors were previous oral anticoagulation, age over 80, chronic limb threatening ischaemia, congestive heart failure, severe chronic kidney disease, previous bleeding event, anaemia, and dementia. The OAC 3 -PAD risk score exhibited adequate calibration and discrimination between four risk groups (c = 0.69, 95% confidence interval 0.67 - 0.71) from low risk (1.3%) to high risk (6.4%)., Conclusion: A pragmatic risk score was developed to predict the individual major bleeding risk classifying a fifth of the cohort as high risk patients. Individual prediction scores such as the one proposed here may help to inform the risk and benefit of intensified antithrombotic strategies., (Copyright © 2021 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: To assess the association between long term risk of hospitalisation for heart failure (HHF) and lower extremity minor and major amputation (LEA) in patients initiating sodium glucose cotransporter 2 inhibitors (SGLT2i) suffering from type 2 diabetes and peripheral arterial disease (PAD). Outcomes were compared with patients without PAD and evaluated separately for the time periods before and after the official warning of the European Medicines Agency (EMA) in early 2017., Methods: This study used BARMER German health claims data including all patients suffering from type 2 diabetes initiating SGLT2i therapy between 1 January 2013 and 31 December 2019 with follow up until the end of 2020. New users of glucagon like peptide 1 receptor agonists (GLP1-RAs) were used as active comparators. Inverse probability weighting with truncated stabilised weights was used to adjust for confounding, and five year risks of HHF and LEA were estimated using Cox regression. Periods before and after the EMA warning were analysed separately and stratified by presence of concomitant PAD., Results: In total, 44 284 (13.6% PAD) and 56 878 (16.3% PAD) patients initiated SGLT2i or GLP1-RA, respectively. Before the EMA warning, initiation of SGLT2i was associated with a lower risk of HHF in patients with PAD (hazard ratio, HR, 0.85, 95% confidence interval, CI, 0.73 - 0.99) and a higher risk of LEA in patients without PAD (HR 1.79, 95% CI 1.04 - 2.92). After the EMA warning, the efficacy and safety endpoints were no longer statistically different between groups., Conclusion: The results from this large nationwide real world study highlight that PAD patients exhibit generally high amputation risks. This study refutes the idea that the presence of PAD explains the excess LEA risk associated with initiation of SGLT2i. The fact that differentials among study groups diminished after the EMA warning in early 2017 emphasises that regulatory surveillance measures worked in everyday clinical practice., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Limited data exist on the impact of gender and specialized care on the requirement of repeat treatment of supraventricular tachycardia (SVT) in adult patients with congenital heart disease (ACHDs)., Objective: The study aimed to assess independent predictors of a combined end point of re-catheter ablation (CA) or cardioversion at 3 years of follow-up, including the impact of gender and specialized ACHD care., Methods: All ACHDs registered in a database of one of the largest German health insurers (≈9.2 million members) who underwent CA for SVT were analyzed., Results: Of 38,892 ACHDs 16 years or older, 485 (49.5% women; median age 58.4 years; interquartile range 42.1-70.8 years) underwent CA for SVT. Over 3-year follow-up, the number of yearly CA procedures increased significantly, particularly for atrial fibrillation (+195%) and atrial flutter (+108%). Moderate to severe complexity heart disease (odds ratio [OR] 1.66; P = .01), advanced age (OR 1.85 per year; P = .02), chronic kidney disease (OR 1.70; P = .01), and atrial fibrillation (OR 2.02; P = .002) emerged as independent predictors of retreatment. Retreatment was significantly less often performed if primary CA was carried out at a specialized CHD center (P = .009) in patients with moderate to severe complexity heart disease. Women treated in specialist centers had a 1.6-fold reduced risk of undergoing retreatment (P = .01)., Conclusion: CA for SVT is increasingly performed in ACHDs, especially for atrial flutter and atrial fibrillation. Patients with moderate and severe complexity congenital heart defects and female ACHDs benefit from upfront referral to specialized CHD centers for CA. Centralization of care for ACHD arrhythmias should thus be advocated., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objective: Several reports have addressed sex disparities in peripheral arterial occlusive disease (PAOD) treatment with inconclusive or even conflicting results. However, most previous studies have neither been sufficiently stratified nor used matching or weighting methods to address severe confounding. In the present study, we aimed to determine the disparities between sexes after percutaneous endovascular revascularization (ER) for symptomatic PAOD., Methods: Health insurance claims data from the second-largest insurance fund in Germany, BARMER, were used. A large cohort of patients who had undergone index percutaneous ER of symptomatic PAOD from January 1, 2010 to December 31, 2018 were included in the present study. The study cohort was stratified by the presence of intermittent claudication, ischemic rest pain, and wound healing disorders. Propensity score matching was used to adjust for confounding through differences in age, treated vessel region, comorbidities, and pharmacologic treatment. Sex-related differences regarding cardiovascular event-free survival, amputation-free survival, and overall survival within 5 years of surgery were determined using Kaplan-Meier time-to-event curves, log-rank test, and Cox regression analysis., Results: In the present study, 50,051 patients (47.2% women) were identified and used to compose a matched cohort of 35,232 patients. Among all strata, female patients exhibited lower mortality (hazard ratio [HR], 0.69-0.90), fewer amputations or death (HR, 0.70-0.89), and fewer cardiovascular events or death (HR, 0.78-0.91). The association between female sex and improved long-term outcomes was most pronounced for the patients with intermittent claudication., Conclusions: In the present propensity score-matched analysis of health insurance claims, we observed superior cardiovascular event-free survival, amputation-free survival, and overall survival during 5 years of follow-up after percutaneous ER in women with symptomatic PAOD. Future studies should address sex disparities in the open surgical treatment of PAOD to illuminate whether the conflicting data from previous reports might have resulted from insufficient stratification of the studies., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: Several studies suggest a disadvantage for women in peri-operative morbidity and mortality after open surgery in peripheral arterial occlusive disease. In addition to their heterogeneity regarding design and analysed cohorts, long term data are mostly missing. This study aimed to determine sex disparities in outcomes after open revascularisation in chronic limb threatening ischaemia (CLTI)., Methods: Using health insurance claims data of the second largest insurance fund in Germany, BARMER, a large cohort of patients was sampled consecutively for analysis including index open surgical revascularisations of CLTI performed between 1 January 2010, and 31 December 2018. Propensity score matching was used to adjust for confounding. Sex related differences regarding overall survival, amputation free survival (AFS), and cardiovascular event free survival (CVEFS) during the five years after surgery were determined using Kaplan-Meier time to event curves, log rank test, logistic, and Cox regression., Results: Among 9 526 patients (49.5% women) in the entire cohort, 6 502 patients were matched. Before matching, women were older at presentation (78.0 vs. 71.8 years, p < .001) and suffered more often from multiple comorbidities (van Walraven score > 9, 55.5% vs. 50.6%, p < .001). During the hospital stay, there were 692 (7.3%) deaths, while 4 631 deaths (48.6%) occurred during the follow up. In the matched cohort, the median follow up was 746 days for women and 871 days for men. In the matched analyses, female sex was significantly associated with better overall survival (hazard ratio, HR, 0.80, log rank p < .001), AFS (HR 0.81, log rank p < .0001), and CVEFS (HR 0.84, log rank p < .001) five years after the index treatment., Conclusion: In this largest propensity score matched analysis of health insurance claims to date from Germany, evidence was found for better long term outcomes in women after open surgical revascularisations for chronic limb threatening ischaemia. Future guidelines and studies should address the impact of sex on patient selection practice and outcomes to determine the underlying reasons for existing disparities., (Copyright © 2021 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Patients with peripheral arterial occlusive disease (PAOD) face an increased risk of both lower limb amputation and death. To date, it has been challenging to predict the long term outcomes for PAOD. The aim was to develop a risk score to predict worse five year amputation free survival (AFS)., Methods: In this retrospective analysis of claims data, symptomatic PAOD patients were split into training and validation sets. Variables in the model were patient age and sex, Elixhauser comorbidities, and the 190 most common secondary diagnoses. Penalised Cox regression (least absolute shrinkage and selection operator [LASSO]) with tenfold cross validation for variable selection was performed and patients were categorised into five risk groups using the ten most important variables. All analyses were stratified by intermittent claudication (IC) and chronic limb threatening ischaemia (CLTI)., Results: In total, 87 293 patients with PAOD (female 45.3%, mean age 71.4 ± 11.1 years) were included in the analysis. The most important variable predicting worse five year AFS was patient age >80 years. The GermanVasc score exhibited good predictive accuracy both for IC (c statistic = 0.70, 95% confidence interval [CI] 0.69-0.71) and CLTI (c statistic = 0.69, 95% CI 0.68-0.70) with adequate calibration due largely to alignment of observed and expected risk. Depending on the cumulative point score, the five year risk of amputation or death ranged from 9% (low risk) to 48% (high risk) for IC, and from 25% to 88% for CLTI., Conclusion: The GermanVasc score predicts worse five year AFS stratified for inpatients suffering from IC and CLTI, with good predictive accuracy. By separating low from high risk patients, the GermanVasc score may support patient centred consent., (Copyright © 2020 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: Endovascular revascularisation has become a standard approach for below knee lesions and paclitaxel coated devices have been widely used in patients with chronic limb threatening ischaemia. A recent meta-analysis reported higher mortality in paclitaxel coated devices compared with uncoated devices in femoropopliteal lesions. This study aimed to determine long term outcomes in below the knee interventions using paclitaxel coated devices in routine vascular care using a large and contemporary cohort., Methods: A large cohort was created using all inclusive health insurance claims data of patients covered by the second largest insurance fund in Germany. The cohort included patients with index revascularisation of arteries below the knee performed from 1 January 2010, to 31 December 2018. Only patients with first paclitaxel coated device exposure were included. The study cohort was stratified into balloon vs. stent treatment and patients with paclitaxel coated devices were matched with uncoated devices using propensity score. Outcomes were evaluated using the Kaplan-Meier method and Cox regression., Results: There were 14 738 patients (mean age 77.6 years, 43.6% female) and 6 568 matched patients included in the study. Increasing use of paclitaxel coated devices was observed during the study period (6% in 2010 vs. 31% in 2018, p < .001), and a total of 2 611 (39.8%) deaths occurred within five years of follow up. In the propensity score matched Cox model, a paclitaxel related reduction of five year mortality (hazards ratio, HR 0.84, 95% confidence interval, CI 0.78-0.91), amputation or death (HR 0.87, 95% CI 0.81-0.94), and cardiovascular event or death (HR 0.86, 95% CI 0.80-0.92) were observed., Conclusion: In this propensity score matched cohort, reduced long term all cause mortality, reduced rates of amputation or death and cardiovascular event or death were observed at five years after the use of paclitaxel coated devices when compared with uncoated devices for the treatment of chronic limb threatening ischaemia., (Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: Optimal pharmacological treatment (OPT) for peripheral arterial occlusive disease (PAOD) includes prescription of lipid lowering drugs, antithrombotics, and antihypertensives to symptomatic patients affected by intermittent claudication or chronic limb threatening ischaemia. This study sought to determine sex disparities and time trends in prescription of OPT in this population (clinicaltrials.gov NCT03909022)., Methods: Using data from the second largest insurance fund in Germany, BARMER, data on patients with an index admission for symptomatic PAOD between 1 January 2010 and 30 June 2018 with follow up until the end of 2018 were analysed. Sex disparities in post-discharge prescription status six months after index admission were tested and adjusted for patient and healthcare variables using bivariable tests and logistic regression analysis. Time trends in the prescription prevalence of OPT were analysed and tested., Results: There were 83 867 patients (mean age 71.9 years and 45.8% women) eligible for inclusion in the study. When compared with men, women had lower rates of prior outpatient care for PAOD (39.8% vs. 47.0%), were admitted more often with ischaemic rest pain (13.9% vs. 10.4%) and were older (74 vs. 70 y). After discharge, women had a lower rate of prescriptions for lipid lowering drugs (52.4% vs. 59.9%), while they received antihypertensive drugs more often (86.7% vs. 84.1%). We found evidence for a lower prescription prevalence of OPT in females (37.0% vs. 42.7%). Differences in patient and healthcare variables (e.g. demographics, comorbidities, prior treatment) between women and men explained 56% of this gap. The sex prescription gap did not narrow over time despite an overall upward trend in prescription prevalence for both women and men., Conclusion: Although presenting older and with more severe symptoms at the index admission for PAOD, women have a lower prescription prevalence of OPT compared with men, particularly with respect to lipid lowering drugs., (Copyright © 2020 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: Patients suffering from peripheral arterial occlusive disease (PAOD) are a central target population for multidisciplinary vascular medicine. This study aimed to highlight trends in treatment patterns and comorbidities using up to date longitudinal patient related data from Germany., Methods: This study is a retrospective health insurance claims data analysis of patients insured by the second largest health insurance provider in Germany, BARMER. All PAOD patient hospitalisations between 2008 and 2016 were included. The comorbidities were categorised with Elixhauser groups using WHO ICD-10 codes and summarised as the linear van Walraven score (vWS). A trend analysis of the comorbidities was performed after standardisation by age and sex., Results: A total of 156 217 patients underwent 202 961 hospitalisations (49.4% for chronic limb threatening ischaemia in 2016) with PAOD during the study period. Although the estimated annual incidence of PAOD among the BARMER cohort decreased slightly (- 4.4%), an increase was observed in the prevalence of PAOD (+ 23.1%), number of hospitalisations (+ 25.1%), peripheral vascular interventions (PVI, + 61.1%), and disease related reimbursement costs (+ 31%) from 2008 to 2016. Meanwhile, the number of major amputations decreased (- 15.1%). The proportion of patients aged 71-80 years increased about +10% among PAOD patients and the mean vWS also increased by two points during the study period. Considerable increases were found in the rates of hypertension, renal failure, and hypothyroidism, whereas the rates of diabetes and congestive heart failure decreased over time., Conclusion: Increasing numbers of PVI performed on these ageing and sicker patients lead to rising costs but correlate with decreasing major amputation rates., (Copyright © 2019 The Author(s). Published by Elsevier B.V. All rights reserved.)