Effects of anti-osteoporosis therapy on the risk of secondary fractures and surgical complications following surgical fixation of proximal humerus fracture in older people.

BACKGROUND: age-related fragility fractures cause significant burden of disease. Within an ageing society, fracture and complication prevention will be essential to balance health expenditure growth. OBJECTIVE: to assess the effect of anti-osteoporotic therapy on surgical complications and secondary fractures after treatment of fragility fractures. PATIENTS AND METHODS: retrospective health insurance data from January 2008 to December 2019 of patients ≥65 years with proximal humeral fracture (PHF) treated using locked plate fixation (LPF) or reverse total shoulder arthroplasty were analysed. Cumulative incidences were calculated by Aalen-Johansen estimates. The influence of osteoporosis and pharmaceutical therapy on secondary fractures and surgical complications were analysed using multivariable Fine and Gray Cox regression models. RESULTS: a total of 43,310 patients (median age 79 years, 84.4% female) with a median follow-up of 40.9 months were included. Five years after PHF, 33.4% of the patients were newly diagnosed with osteoporosis and only 19.8% received anti-osteoporotic therapy. A total of 20.6% (20.1-21.1%) of the patients had at least one secondary fracture with a significant reduction of secondary fracture risk by anti-osteoporotic therapy (P < 0.001). An increased risk for surgical complications (hazard ratio: 1.35, 95% confidence interval: 1.25-1.47, P < 0.001) after LPF could be reversed by anti-osteoporotic therapy. While anti-osteoporotic therapy was more often used in female patients (35.3 vs 19.1%), male patients showed significantly stronger effects reducing the secondary fracture and surgical complication risk. CONCLUSIONS: a significant number of secondary fractures and surgical complications could be prevented by consequent osteoporosis diagnosis and treatment particularly in male patients. Health-politics and legislation must enforce guideline-based anti-osteoporotic therapy to mitigate burden of disease.

Increased complication rates of salvage reverse total shoulder arthroplasty (RTSA) after failed locked plate fixation compared with primary RTSA in the treatment of proximal humeral fractures in elderly patients.

HYPOTHESIS: Common surgical treatment options for proximal humeral fractures in elderly patients include locked plate fixation (LPF) and reverse total shoulder arthroplasty (RTSA). It was hypothesized that secondary RTSA after LPF would be associated with higher complication rates and costs compared with primary RTSA. METHODS: We analyzed the health insurance data of patients aged ≥65 years who received RTSA for the treatment of a proximal humeral fracture between January 2013 and September 2019 with a pre-study phase of 5 years. Multivariable Cox, logistic, and linear regression models were used to evaluate the association between treatment group and complications, hospital length of stay, charges, and mortality rate during a 34-month follow-up period. RESULTS: A total of 14,220 patients underwent primary RTSA and 1282 patients underwent secondary RTSA after prior surgery using LPF for the treatment of proximal humeral fractures. After adjustment for patient characteristics, more surgical complications were observed after secondary RTSA during index hospitalization (odds ratio, 4.62; 95% confidence interval [CI], 4.00-5.34; P < .001) and long-term follow-up (hazard ratio, 1.52; 95% CI, 1.27-1.81; P < .001). Moreover, secondary RTSA was associated with an increased cumulative total cost of €6638.1 (95% CI, €6229.9-€7046.5; P < .001). If conversion from LPF to secondary RTSA occurred during index hospitalization, more major adverse events, more thromboembolic events, and a higher mortality rate were found in the short and long term (all P < .05). CONCLUSION: Secondary RTSA is associated with higher total costs and more complications. Hence, if surgical treatment of a proximal humeral fracture in an elderly patient is needed, prognostic factors for LPF need to be evaluated carefully. If in doubt, the surgeon should opt to perform primary RTSA as patients will benefit in the long term.

Current use and safety of novel oral anticoagulants in adults with congenital heart disease: results of a nationwide analysis including more than 44 000 patients.

AIMS: To evaluate the use of novel oral anticoagulants (NOACs) compared with vitamin K antagonists (VKAs) in adult congenital heart disease (ACHD) and assess outcome in a nationwide analysis. METHODS AND RESULTS: Using data from one of Germany's largest Health Insurers, all ACHD patients treated with VKAs or NOACs were identified and changes in prescription patterns were assessed. Furthermore, the association between anticoagulation regimen and complications including mortality was studied. Between 2005 and 2018, the use of oral anticoagulants in ACHD increased from 6.3% to 12.4%. Since NOACs became available their utilization increased constantly, accounting for 45% of prescribed anticoagulants in ACHD in 2018. Adult congenital heart disease patients on NOACs had higher thromboembolic (3.8% vs. 2.8%), MACE (7.8% vs. 6.0%), bleeding rates (11.7% vs. 9.0%), and all-cause mortality (4.0% vs. 2.8%; all P < 0.05) after 1 year of therapy compared with VKAs. After comprehensive adjustment for patient characteristics, NOACs were still associated with increased risk of MACE (hazard rate-HR 1.22; 95% CI 1.09-1.36) and increased all-cause mortality (HR 1.43; 95% CI 1.24-1.65; both P < 0.001), but also bleeding (HR 1.16; 95% CI 1.04-1.29; P = 0.007) during long-term follow-up. CONCLUSION: Despite the lack of prospective studies in ACHD, NOACs are increasingly replacing VKAs and now account for almost half of all oral anticoagulant prescriptions. Particularly, NOACs were associated with excess long-term risk of MACE, and mortality in this nationwide analysis, emphasizing the need for prospective studies before solid recommendations for their use in ACHD can be provided.

Mortality after use of paclitaxel-based devices in peripheral arteries: a real-world safety analysis.

AIMS: Drug-eluting devices (DED) represent a well-established therapy being widely used for endovascular revascularization (EVR) of peripheral vessels. Recent data indicate a two-fold increased long-term mortality in patients treated with paclitaxel-based DED. The subsequent safety concerns affected international regulatory authorities to enunciate several alerts for further application of DED. METHODS AND RESULTS: In 9.2 million insurants of the German BARMER Health Insurance, data on the application of paclitaxel-based drug-eluting stents (DES) and drug-coated balloons (DCB) were retrieved from their introduction on the market in 2007 until present. All patients with first EVR between 2007 and 2015 were indexed and followed until 31 December 2017. Each subsequently applied DES, DCB, bare-metal stent, and uncoated balloon was included in further analyses. Multivariable Cox regression analysis considered potential non-linear time-dependent hazard ratios (HRs) of DES and DCB over 11 years. We identified 64 771 patients who underwent 107 112 EVR procedures using 23 137 DED. Multivariable Cox regression analysis showed paclitaxel-based DES not to be associated with increased long-term mortality for over 11 years past application (all P > 0.057). DCB was associated with decreased long-term mortality for the first year past application (HR 0.92; P < 0.001), and indifferent correlation in the years thereafter (all P > 0.202). CONCLUSION: Our real-world analysis showed no evidence for increased mortality associated with paclitaxel-based DED for over 11 years.

COVID-19 rapid molecular point-of-care testing is effective and cost-beneficial for the acute care of trauma patients.

PURPOSE: To evaluate the accuracy and cost benefit of a rapid molecular point-of-care testing (POCT) device detecting COVID-19 within a traumatological emergency department. BACKGROUND: Despite continuous withdrawal of COVID-19 restrictions, hospitals will remain particularly vulnerable to local outbreaks which is reflected by a higher institution-specific basic reproduction rate. Patients admitted to the emergency department with unknown COVID-19 infection status due to a- or oligosymptomatic COVID-19 infection put other patients and health care workers at risk, while fast diagnosis and treatment is necessary. Delayed testing results in additional costs to the health care system. METHODS: From the 8th of April 2021 until 31st of December 2021, all patients admitted to the emergency department were tested with routine RT-PCR and rapid molecular POCT device (Abbott ID NOW™ COVID-19). COVID-19-related additional costs for patients admitted via shock room or emergency department were calculated based on internal cost allocations. RESULTS: 1133 rapid molecular tests resulted in a sensitivity of 83.3% (95% CI 35.9-99.6%), specificity of 99.8% (95% CI 99.4-100%), a positive predictive value of 71.4% (95% CI 29-96.3%) and a negative predictive value of 99.9% (95% CI 99.5-100%) as compared to RT-PCR. Without rapid COVID-19 testing, each emergency department and shock room admission with subsequent surgery showed additional direct costs of 2631.25€, without surgery of 729.01€. CONCLUSION: Although rapid molecular COVID-19 testing can initially be more expensive than RT-PCR, subsequent cost savings, improved workflows and workforce protection outweigh this effect by far. The data of this study support the use of a rapid molecular POCT device in a traumatological emergency department.

Sex disparities in guideline-recommended therapies and outcomes after ST-elevation myocardial infarction in a contemporary nationwide cohort of patients over an eight-year period.

BACKGROUND AND AIMS: Acute myocardial infarction (AMI) is the leading cause of death worldwide. Outcome has improved during the last decades due to secondary prevention and widespread coronary interventions, but recent studies still show sex differences and insufficient drug adherence. We aimed to determine differences in the treatment strategies and outcomes between women and men with ST-elevation myocardial infarction (STEMI) in Germany. METHODS: From the Federal Association of the Local Health Insurance Funds (Allgemeine Ortskrankenkasse), 175,187 patients were identified who were hospitalized due to STEMI in Germany between January 1, 2010 and December 31, 2017. RESULTS: Compared to men, women were older (median 76 vs. 64 years) and had more often diabetes, hypertension, chronic heart failure, and chronic kidney disease (all p <0.001). Women suffered from higher rates of in-hospital complications such as bleeding (9.3 vs. 6.6%), longer hospitalizations (12.2 vs. 11.7 days) and were less likely to undergo percutaneous coronary intervention (75.5 vs. 85.2%). After adjustment for patient's risk profile, female sex was associated with decreased overall survival (HR 1.02, 95% confidence interval (CI) 1.00-1.04; p=0.036). Notably, more men received all four guideline-recommended drugs after STEMI (women 65.7% vs. men 69.8% after 90 days; p <0.001). With increasing number of prescribed drugs, patients benefit even more. This concerned both sexes, but was more pronounced in men (with 4 prescribed drugs: women HR 0.52, 95%CI 0.50-0.55; men HR 0.48, 95% CI 0.47-0.50, pint = 0.014). CONCLUSIONS: In a contemporary nationwide analysis, women with STEMI were older, had more comorbidities, underwent revascularization less often and had an increased risk for major complications as well as overall survival. Guideline-recommended drug therapy was applied less frequently in women although associated with an improved overall-survival.

Admission Rates, Time Trends, Risk Factors, and Outcomes of Ischemic and Hemorrhagic Stroke From German Nationwide Data.

BACKGROUND AND OBJECTIVES: In the last decade, there have been major improvements in the control of risk factors, acute stroke therapies and rehabilitation following the availability of high-quality evidence and guidelines on best practices in the acute phase. In this changing landscape, we aimed to investigate the stroke admission rates, time-trends, risk factors, and outcomes during the period of 2014-2019 using German nationwide data. METHODS: We obtained data of all acute stroke hospitalizations by the Federal Statistical Office. All hospitalized cases of adults (age ≥ 18 years) with acute stroke from the years 2014-2019 were analyzed regarding time trends, risk factors, treatments, morbidity and in-hospital mortality according to stroke subtype (all-cause/ischaemic/haemorrhagic). RESULTS: Between 2014 and 2019, overall stroke hospitalizations in adults (median age = 76 years, [IQR: 65-83 years]) initially increased from 306,425 in 2014 to peak at 318,849 in 2017 before falling to again to 312,692 in 2019, whereas percentage stroke hospitalizations that resulted in death remained stable during this period at 8.5% in 2014 and 8.6% in 2019. In a multivariate model of 1,882,930 cases, the strongest predictors of in-hospital stroke mortality were haemorrhagic subtype (Adjusted OR [aOR] = 3.06, 95% CI 3.02-3.10; p<0.001), cancer (aOR = 2.11, 2.06-2.16; p<0.001), congestive heart failure (aOR = 1.70, 1.67-1.73; p<0.001), and lower extremity arterial disease (aOR =1.76, 1.67-1.84; p<0.001). DISCUSSION: Despite recent advances in acute stroke care over the last decade, the percentage of stroke hospitalizations resulting in death remained unchanged. Further research is needed to determine how best to optimize stroke care pathways for multimorbid patients.

Blunt Chest Trauma in Polytraumatized Patients: Predictive Factors for Urgent Thoracotomy.

PURPOSE: Current guidelines on urgent thoracotomy of polytraumatized patients are based on data from perforating chest injuries. We aimed to identify predictive factors for urgent thoracotomy after chest-tube placement for blunt chest trauma in a civilian setting. METHODS: Polytraumatized patients (Injury Severity Score ≥16) with blunt chest trauma, submitted to a level I trauma centre during a period of 12 years that received at least one chest tube were included. Trauma mechanism, chest-tube output, haemoglobin values, need for cellular blood products, coagulopathies, rib fracture pattern, thoracotomy, and mortality were retrospectively analysed. RESULTS: 235 polytraumatized patients were included. Patients that received urgent thoracotomy (UT, n = 10) showed a higher mean chest-tube output within 24 h with a median (Mdn) of 3865 (IQR 2423-5156) mL compared to the group with no additional thoracic surgery (NT, n = 225) with Mdn 185 (IQR 50-463) mL (p < 0.001). The cut-off 24-h chest-tube output value for recommended thoracotomy was 1270 mL (ROC-Curve). UT showed an initial haemoglobin of Mdn 11.7 (IQR 9.2-14.3) g/dL and an INR value of Mdn 1.27 (IQR 1.11-1.69) as opposed to Mdn 12.3 (IQR 10-13.9) g/dL and Mdn 1.13 (IQR 1.05-1.34) in NT (haemoglobin: p = 0.786; INR: p = 0.215). There was an average number of 7.1(±3.4) rib fractures in UT and 6.7(±4.8) in NT (p = 0.649). CONCLUSIONS: Chest-tube output remains the single most important predictive factor for urgent thoracotomy also after blunt chest trauma. Patients with a chest-tube output of more than 1300 mL within 24 h after trauma should be considered for transfer to a level I trauma centre with standby thoracic surgery.

Gender differences in acute myocardial infarction-A nationwide German real-life analysis from 2014 to 2017.

BACKGROUND: Female sex was reported to be associated with an unfavorable outcome in acute myocardial infarction (AMI). In this nationwide analysis we assessed sex differences in acute outcomes of AMI and recent trends in patient healthcare. METHODS: We analyzed 875 735 German cases hospitalized with a main diagnosis of ST- (STEMI) and non ST-elevation myocardial infarction (NSTEMI) between January 01 2014 and December 31 2017 regarding morbidity, in-hospital mortality and treatments. A multivariable logistic regression model was designed to evaluate the use of interventions and their impact on in-hospital mortality. RESULTS: STEMI cases decreased from 72 894 in 2014 to 68 213 in 2017, with 70% assignable to men. Female sex was associated with older age (74 vs. 62 years), and higher prevalence of cardiovascular risk factors such as chronic kidney disease (19.2% vs. 12.5%), hypertension (69.0% vs. 65.0%) and left ventricular heart failure (36.0% vs. 32.1%). In NSTEMI, female sex was also associated with older age (78 vs. 71 years), and higher prevalence of cardiovascular risk factors such as chronic kidney disease (29.7% vs. 23.9%), hypertension (77.4% vs. 74.5%) and left ventricular heart failure (40.5% vs. 36.4%). Overall, 74.3% of female and 81.3% of male STEMI cases received percutaneous coronary intervention (PCI, p < 0.001). In NSTEMI, PCI was performed in 40.8% of female and 52.0% of male cases (p < 0.001). In-hospital mortality was notably increased in female patients with STEMI (15.0% vs. 9.6%; p < 0.001; OR 1.07; 95% CI 1.03-1.10) and NSTEMI (8.3% vs. 6.3%; p < 0.001; OR 0.91; 95% CI 0.89-0.93) compared to males. CONCLUSIONS: Our nationwide real-world data document that in-patient STEMI cases continue to decrease in women and men. The observed higher in-hospital mortality in women was largely attributed to a more unfavorable risk and age distribution rather than to female-intrinsic factors. Women with AMI continue to be less likely to receive revascularization therapies.

Male Sex Is Associated with Higher Mortality and Increased Risk for Complications after Surgical Treatment of Proximal Humeral Fractures.

AIMS: The best surgical treatment of multi-fragmentary proximal humeral fractures in the elderly is a highly controversial topic. The aim of this study is to assess for sex-related differences regarding mortality and complications after reverse total shoulder arthroplasty (RTSA) and locking plate fixation (LPF). PATIENTS AND METHODS: All patients from the largest German healthcare insurance (26.5 million policy holders) above the age of 65 years that were treated with LPF or RTSA after a multi-fragmentary proximal humerus fracture between January 2010 and September 2018 were included. Multivariable Cox regression models were used to assess the association of sex with overall survival, major adverse events and surgical complications. RESULTS: A total of 8264 (15%) men and 45,707 (85%) women were followed up for a median time of 52 months. After 8 years, male patients showed significantly higher rates for death (65.8%; 95% CI 63.9-67.5% vs. 51.1%; 95% CI 50.3-51.9%; p < 0.001) and major adverse events (75.5%; 95% CI 73.8-77.1% vs. 61.7%; 95% CI 60.9-62.5%; p < 0.001). With regard to surgical complications, after adjustment of patient risk profiles, there were no differences between females and males after LPF (p > 0.05), whereas men showed a significantly increased risk after RTSA (HR 1.86; 95% CI 1.56-2.22; p < 0.001) with more revision surgeries performed (HR 1.76, 95% CI 1.46-2.12; p < 0.001) compared to women. CONCLUSION: The male sex is an independent risk factor for death and major adverse events after both LPF and RTSA. An increased risk for surgical complications after RTSA suggests that male patients benefit more from LPF. Sex should be considered before making treatment decisions.