Background: The rapidly increasing number of elderly (>= 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with... Show moreBackground: The rapidly increasing number of elderly (>= 65 years old) with TBI is accompanied by substantial medical and economic consequences. An ASDH is the most common injury in elderly with TBI and the surgical versus conservative treatment of this patient group remains an important clinical dilemma. Current BTF guidelines are not based on high-quality evidence and compliance is low, allowing for large international treatment variation. The RESET-ASDH trial is an international multicenter RCT on the (cost-)effectiveness of early neurosurgical hematoma evacuation versus initial conservative treatment in elderly with a t-ASDHMethods: In total, 300 patients will be recruited from 17 Belgian and Dutch trauma centers. Patients >= 65 years with at first presentation a GCS >= 9 and a t-ASDH > 10 mm or a t-ASDH < 10 mm and a midline shift > 5 mm, or a GCS < 9 with a traumatic ASDH < 10 mm and a midline shift < 5 mm without extracranial explanation for the comatose state, for whom clinical equipoise exists will be randomized to early surgical hematoma evacuation or initial conservative management with the possibility of delayed secondary surgery. When possible, patients or their legal representatives will be asked for consent before inclusion. When obtaining patient or proxy consent is impossible within the therapeutic time window, patients are enrolled using the deferred consent procedure. Medical-ethical approval was obtained in the Netherlands and Belgium. The choice of neurosurgical techniques will be left to the discretion of the neurosurgeon. Patients will be analyzed according to an intention-to-treat design. The primary endpoint will be functional outcome on the GOS-E after 1 year. Patient recruitment starts in 2022 with the exact timing depending on the current COVID-19 crisis and is expected to end in 2024.Discussion: The study results will be implemented after publication and presented on international conferences. Depending on the trial results, the current Brain Trauma Foundation guidelines will either be substantiated by high-quality evidence or will have to be altered. Show less
Objective: Age is an independent risk factor for mortality after both elective open surgical repair (OSR) and endovascular aneurysm repair (EVAR). As a result of an ageing population, and the less... Show moreObjective: Age is an independent risk factor for mortality after both elective open surgical repair (OSR) and endovascular aneurysm repair (EVAR). As a result of an ageing population, and the less invasive nature of EVAR, the number of patients over 80 years (octogenarians) being treated is increasing. The mortality and morbidity following aneurysm surgery are increased for octogenarians. However, the mortality for octogenarians who have either low or high peri-operative risks remains unclear. The aim of this study was to provide peri-operative outcomes of octogenarians vs. non-octogenarians after OSR and EVAR for intact aneurysms, including separate subanalyses for elective and urgent intact repair, based on a nationwide cohort. Furthermore, the influence of comorbidities on peri-operative mortality was examined.Methods: All patients registered in the Dutch Surgical Aneurysm Audit (DSAA) undergoing intact AAA repair between 2013 and 2018, were included. Patient characteristics and peri-operative outcomes (peri-operative mortality, and major complications) of octogenarians vs. non-octogenarians for both OSR and EVAR were compared using descriptive statistics. Multivariable logistic regression analyses were used to examine whether age and the presence of cardiac, pulmonary, or renal comorbidities were associated with mortality.Results: This study included 12 054 EVAR patients (3 015 octogenarians), and 3 815 OSR patients (425 octogenarians). Octogenarians in both the EVAR and OSR treatment groups were more often female and had more comorbidities. In both treatment groups, octogenarians had significantly higher mortality rates following intact repair as well as higher major complication rates. Mortality rates of octogenarians were 1.9% after EVAR and 11.8% after OSR. Age >= 80 and presence of cardiac, pulmonary, and renal comorbidities were associated with mortality after EVAR and OSR.Conclusion: Because of the high peri-operative mortality rates of octogenarians, awareness of the presence of comorbidities is essential in the decision making process before offering aneurysm repair to this cohort, especially when OSR is considered. Show less
