Multi-centric study for development and validation of a CT head rule for mild traumatic brain injury in direct oral anticoagulants: the HERO-M nomogram.

BACKGROUND: Nomograms are easy-to-handle clinical tools which can help in estimating the risk of adverse outcome in certain population. This multi-center study aims to create and validate a simple and usable clinical prediction nomogram for individual risk of post-traumatic Intracranial Hemorrhage (ICH) after Mild Traumatic Brain Injury (MTBI) in patients treated with Direct Oral Anticoagulants (DOACs). METHODS: From January 1, 2016 to December 31, 2019, all patients on DOACs evaluated for an MTBI in five Italian Emergency Departments were enrolled. A training set to develop the nomogram and a test set for validation were identified. The predictive ability of the nomogram was assessed using AUROC, calibration plot, and decision curve analysis. RESULTS: Of the 1425 patients in DOACs in the study cohort, 934 (65.5%) were included in the training set and 491 (34.5%) in the test set. Overall, the rate of post-traumatic ICH was 6.9% (7.0% training and 6.9% test set). In a multivariate analysis, major trauma dynamic (OR: 2.73, p = 0.016), post-traumatic loss of consciousness (OR: 3.78, p = 0.001), post-traumatic amnesia (OR: 4.15, p < 0.001), GCS < 15 (OR: 3.00, p < 0.001), visible trauma above the clavicles (OR: 3. 44, p < 0.001), a post-traumatic headache (OR: 2.71, p = 0.032), a previous history of neurosurgery (OR: 7.40, p < 0.001), and post-traumatic vomiting (OR: 3.94, p = 0.008) were independent risk factors for ICH. The nomogram demonstrated a good ability to predict the risk of ICH (AUROC: 0.803; CI95% 0.721-0.884), and its clinical application showed a net clinical benefit always superior to performing CT on all patients. CONCLUSION: The Hemorrhage Estimate Risk in Oral anticoagulation for Mild head trauma (HERO-M) nomogram was able to predict post-traumatic ICH and can be easily applied in the Emergency Department (ED).

Arterial intracranial thrombosis as the first manifestation of vaccine-induced immune thrombotic thrombocytopenia (VITT): a case report.

OBJECTIVE: We describe a severe case of vaccine-induced immune thrombotic thrombocytopenia (VITT) after the first dose of the ChAdOx1 nCoV-19 vaccine leading to massive ischemic stroke. METHODS: A 42-year-old woman developed acute left hemiparesis (NIHSS 12) 9 days after the first vaccine dose. RESULTS: The blood tests revealed low platelets (70 103/µL) and severe increment of D-dimer (70,745 ng/mL FEU). Brain non-contrast computed tomography and multiphasic CT angiography demonstrated a right middle cerebral artery occlusion. The patient was treated with primary thrombectomy, steroids, immunoglobulin, and fondaparinux. Despite the treatment, the neurological status deteriorated and underwent decompressive hemicraniectomy. She was transferred to the rehab's unit 52 days after the onset. DISCUSSION: Healthcare providers should be aware of the possibility of ischemic stroke as a manifestation of VITT. Awareness on this very rare and possibly fatal complication should be reinforced on both the vaccine recipients and general practitioners.

Risk of delayed intracranial haemorrhage after an initial negative CT in patients on DOACs with mild traumatic brain injury.

BACKGROUND: Repeat head CT in patients on direct oral anticoagulant therapy (DOACs) with minor traumatic brain injury (MTBI) after an initial CT scan without injury on arrival in the Emergency Department (ED) is a common clinical practice but is not based on clear evidence. AIM: To assess the incidence of delayed intracranial haemorrhage (ICH) in patients taking DOACs after an initial negative CT and the association of clinical and risk factors presented on patient arrival in the ED. METHODS: This retrospective multicentre observational study considered patients taking DOACs undergoing repeat CT after a first CT free of injury for the exclusion of delayed ICH after MTBI. Timing between trauma and first CT in the ED and pre- or post-trauma risk factors were analysed to assess a possible association with the risk of delayed ICH. RESULTS: A total of 1426 patients taking DOACs were evaluated in the ED for an MTBI. Of these, 68.3% (916/1426) underwent a repeat CT after an initial negative CT and 24 h of observation, with a rate of delayed ICH of 1.5% (14/916). Risk factors associated with the presence of a delayed ICH were post-traumatic loss of consciousness, post-traumatic amnesia and the presence of a risk factor when the patient presented to the ED within 8 h of the trauma. None of the patients with delayed ICH at 24-h repeat CT required neurosurgery or died within 30 days. CONCLUSIONS: Delayed ICH is an uncommon event at the 24-h control CT and does not affect patient outcome. Studying the timing and characteristics of the trauma may indicate patients who may benefit from more in-depth management.

"Decision tree analysis for assessing the risk of post-traumatic haemorrhage after mild traumatic brain injury in patients on oral anticoagulant therapy".

BACKGROUND: The presence of oral anticoagulant therapy (OAT) alone, regardless of patient condition, is an indication for CT imaging in patients with mild traumatic brain injury (MTBI). Currently, no specific clinical decision rules are available for OAT patients. The aim of the study was to identify which clinical risk factors easily identifiable at first ED evaluation may be associated with an increased risk of post-traumatic intracranial haemorrhage (ICH) in OAT patients who suffered an MTBI. METHODS: Three thousand fifty-four patients in OAT with MTBI from four Italian centers were retrospectively considered. A decision tree analysis using the classification and regression tree (CART) method was conducted to evaluate both the pre- and post-traumatic clinical risk factors most associated with the presence of post-traumatic ICH after MTBI and their possible role in determining the patient's risk. The decision tree analysis used all clinical risk factors identified at the first ED evaluation as input predictor variables. RESULTS: ICH following MTBI was present in 9.5% of patients (290/3054). The CART model created a decision tree using 5 risk factors, post-traumatic amnesia, post-traumatic transitory loss of consciousness, greater trauma dynamic, GCS less than 15, evidence of trauma above the clavicles, capable of stratifying patients into different increasing levels of ICH risk (from 2.5 to 61.4%). The absence of concussion and neurological alteration at admission appears to significantly reduce the possible presence of ICH. CONCLUSIONS: The machine-learning-based CART model identified distinct prognostic groups of patients with distinct outcomes according to on clinical risk factors. Decision trees can be useful as guidance in patient selection and risk stratification of patients in OAT with MTBI.

Safe chest tube placement in a patient with tension pneumothorax receiving rivaroxaban therapy for non-valvular atrial fibrillation.

The number of patients treated with direct oral anticoagulants is increasing worldwide. Although bleeding complications associated with direct oral anticoagulants are lower than those associated with vitamin K antagonists, the increased number of patients treated with these anticoagulants suggests that a higher absolute number of patients are at risk. Tube thoracostomy is an invasive procedure with a high risk of bleeding. To date, among direct oral anticoagulants, only dabigatran has a well-studied antidote to reverse its effects during emergency procedure or surgery. This report describes a case in which emergency placement of a tube thoracostomy, in a patient with type 2 respiratory failure due to left tension pneumothorax and receiving the anticoagulant rivaroxaban, in the pharmacokinetics phase with greater anticoagulant effect, did not result in bleeding greater than that typically encountered during such interventions. The procedure ended successfully with no acute complications.

Electrocardiographic characteristics, anthropometric features, and cardiovascular risk factors in a large cohort of adolescents.

Aims: The characteristics of electrocardiographic (ECG) patterns in the general population of adolescents are insufficiently defined. The purpose of this study is to report ECG patterns and their association with anthropometric characteristics. Methods and results: Twenty-four thousand and sixty-two students of Roman schools, aged 12-19, were screened with ECG and physical examinations. Electrocardiographic abnormalities were classified as either minor/non-clinically relevant or major, and anthropometric measures were evaluated per age class. Obesity prevalence was 20.9%, with a higher rate in younger students (P < 0.008 for all comparisons, except for the pair 16-17 vs. 18-19 years). Stage 1 hypertension was found in 3.14% of adolescents, Stage 2 hypertension in 0.45% of adolescents, and isolated systolic hypertension in 11.7% of adolescents. Heart rate and QT interval corrected for heart rate (QTc) decreased with increasing age. The QTc was longer in females than in males over 14 years. A higher rate of incomplete right bundle branch block (RBBB) was observed in underweight students (21.58% vs. 15.10% in non-underweight students, P < 0.0001). Complete RBBB was the most common major ECG abnormality (1.6%). It was associated with height irrespective of age, sex, and body mass index (odds ratio 17.9; 95% confidence interval 5.0-64.6) and more frequent in students regularly practicing physical activity (1.80% vs. 1.02%, P = 0.0009). Conclusion: Heart rate and QTc decreased with increasing age. The QTc was longer in females than in males over 14 years. RBBB was the most common major abnormality and was associated with higher stature. The prevalence of some cardiovascular risk factors in adolescents is provided.

Exploring PTSD in emergency operators of a major University Hospital in Italy: a preliminary report on the role of gender, age, and education.

BACKGROUND: Emergency services personnel face frequent exposure to potentially traumatic events, with the potential for chronic symptomatic distress. The DSM-5 recently recognized a particular risk for post-traumatic stress disorder (PTSD) among first responders (criterion A4) but data are still scarce on prevalence rates and correlates. OBJECTIVE: The aim of the present study was to explore the possible role of age, gender, and education training in a sample of emergency personnel diagnosed with DSM-5 PTSD. METHODS: The Trauma and Loss Spectrum-Self-Report (TALS-SR) and the Work and Social Adjustment Scale (WSAS) were administered to 42 between nurses and health care assistants, employed at the emergency room of a major University Hospital (Pisa) in Italy. RESULTS: 21.4% of the sample reported DSM-5 PTSD with significantly higher scores in the TALS-SR domain exploring the acute reaction to trauma and losses among health care assistants, older, and non-graduated subjects. A significant correlation between the number of the TALS-SR symptoms endorsed, corresponding to DSM-5 PTSD diagnostic criteria emerged in health care assistants. CONCLUSIONS: Despite further studies are needed in larger samples, our data suggest a high risk for PTSD and post-traumatic stress spectrum symptoms in nurses and health care workers operating in an emergency department, particularly among health care assistants, women, older, and non-graduated operators.

Short and long-term mortality of patients presenting with bleeding events to the Emergency Department.

BACKGROUND: Death of patients presenting with bleeding events to the Emergency Department still represent a major problem. We sought to analyze clinical characteristics associated with worse outcomes including short- and long-term death, beyond antithombotic treatment strategy. METHODS: Patients presenting with any bleeding events during 2016-2017years were enrolled. Clinical parameters, site of bleeding, major bleeding, ongoing anti-thrombotic treatment strategy and death were collected. Hard 5:1 propensity score matching was performed to adjust dead patients in baseline characteristics. Endpoints were one-month and one-year death. RESULTS: Out of 166,000 visits to the Emergency Department, 3.050 patients (1.8%) were enrolled and eventually 429 were analyzed after propensity. Overall, anticoagulants or antiplatelets were given to 234(54%). Major bleeding account for 111(26%) patients, without differences between those taking anticoagulants or antiplatelets versus others. Death at one-month and one-year was 26(6%) and 72(17%), respectively. Independent predictors of one-month death were major bleeding (Odds Ratio, OR 26, p<0.001), female gender (OR 7, p<0.001) and white blood cells (OR 1.2, p=0.01); of one-year were major bleeding (OR 7, p<0.001), age (OR 1.1, p<0.001) and female gender (OR 2.3, p=0.043). Of note, death rate of gastrointestinal and intracranial bleeding where higher than others (p<0.001). Overall mortality was approximately 40% on one-month; 60% in older patients and 80% in female gender with CHA2D2VASC-score≥2. Receiver operator characteristics analysis showed larger areas for major bleeding and age (0.75 and 0.72, respectively) over others; p<0.05 on C-statistic. CONCLUSIONS: In patients with bleeding events, death rate was driven by major bleeding on short-term and older age on long-term. Among dead patients mortality was approximately 40% on one-month; 60% in older patients, and 80% in female gender.

Direct oral anticoagulants in patients undergoing cardioversion: insight from randomized clinical trials.

Anticoagulation, reducing the risk of thromboembolic events in patients undergoing cardioversion, is a cornerstone of peri-cardioversion management in patients with atrial fibrillation. We aimed to analyse published data on the efficacy and safety of direct oral anticoagulants (DOACs) in patients undergoing cardioversion. We performed a systematic review of randomized prospective clinical trials (RCTs) comparing DOACs with warfarin and reporting data on post-cardioversion outcomes of interest. Outcomes of interest were stroke, systemic thromboembolic events and major bleeding. We reviewed a total of six RCTs including 3900 cardioversions performed using a DOAC for thromboembolic prophylaxis. These studies reported a low incidence overall of adverse outcomes associated with the use of DOACs (around 1% in all studies, except the ROCKET post-hoc study which included ablation procedures). The incidence rate of adverse events during DOAC treatment was found to be very similar to that observed with warfarin anticoagulation. In RCTs DOAC treatment in patients undergoing cardioversion appears to be effective and safe. However, because evidence in this clinical setting is still weak, observational reports could be useful in providing further data about peri-procedural outcomes.

Prevalence and predictor factors of severe venous obstruction after cardiovascular electronic device implantation.

AIMS: Despite not being uncommon, limited evidence exists about predisposing factors for venous obstruction in patients with implantable electronic devices. We aimed to assess the prevalence of severe venous obstruction in patients with intravenous devices and identify predictor factors. METHODS AND RESULTS: A total of 184 patients underwent venography to detect venous obstruction associated with the inserted lead. Vessel obstruction was graded as venous occlusion (complete flow interruption), severe obstruction (narrowing >90%), or mild-moderate obstruction (narrowing 50-90%). Severe venous obstruction/occlusion prevalence was 11.4% (n = 21) and was always asymptomatic. Collateral circulation was found in 80.9% of patients with severe obstruction/occlusion. Twelve patients (6.5%) had 3 leads. The rates of patients with secondary prevention of sudden cardiac death as indication for implantable devices and of those of patients with 3 leads were significantly greater in the group with severe obstruction/occlusion than in the non-severe obstruction/occlusion group (respectively, P = 0.004 and P = 0.03). Logistic analysis adjusted for venous thromboembolic risk factors confirmed that secondary prevention of sudden cardiac death as indication for implantable devices [odds ratio (OR), 7.1; 95% confidence interval (CI): 1.4-35.3; P = 0.017] and the presence of 3 leads (OR, 8.5; 95% CI: 1.75-41.35; P = 0.008) were predictors of severe obstruction/occlusion. CONCLUSION: In patients with implantable devices, severe venous obstruction prevalence is not negligible and the lack of symptoms does not exclude it. The presence of three leads and sudden cardiac death as indication for implantable devices seem to be associated with the presence of severe venous obstruction/occlusion.

Access to emergency room for hypoglycaemia in people with diabetes.

BACKGROUND: Hypoglycaemia is a major burden of the pharmacological therapy of diabetes and is associated with increased morbidity, mortality and treatment costs. METHODS: We screened all admissions to the emergency room of the Pisa University Hospital from 1 January 2009 to 31 December 2013, selecting individuals with a discharge diagnosis of hypoglycaemia. We retrieved 500 admissions involving adult diabetic patients: age 71 ± 16 years; M/F 50.2/49.8%; 70.2% type 2 diabetes (T2DM). RESULTS: Among T2DM, 42.2% were on insulin, 10.8% on insulin plus oral anti-diabetes drugs and 38.2% on oral anti-diabetes drugs alone (92% sulphonylureas/glinides ± insulin-sensitizers). Glibenclamide was the most frequently used sulphonylurea (69%). Individuals treated with oral anti-diabetes drugs were older than those on insulin (79 ± 11 versus 74 ± 12 years; p < 0.0001). Among patients taking sulphonylurea, 47% had estimated glomerular filtration rate <60 mL/min/1.73 m(2) and 13.5% had <30 mL/min/1.73 m(2) . In-hospital admission occurred in 20% of cases. Hospitalized patients with T2DM were older than those discharged (80 ± 10 versus 76 ± 12 years, p < 0.01) and were on oral antidiabetic drugs in 54.8% of the cases, whereas 35.7% were on insulin (χ(2) , p < 0.0001) and 8.3% on combined therapy. Notably, 93.5% of those on oral anti-diabetic drugs were taking a secretagogue. Insulin-treated subjects were younger than those treated with oral anti-diabetic drugs alone (77 ± 12 versus 82 ± 7 years; p < 0.02). The mean in-hospital annual mortality rate was 85 deaths per 1000 patients-year. CONCLUSIONS: Our results support the recommendation that the risk associated with insulin and insulin-secretagogues should be carefully assessed, particularly when prescribed in vulnerable patients with T2DM.

Regional differences in presentation and treatment of patients with atrial fibrillation in Europe: a report from the EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry.

AIMS: Country differences in management practices are evident, and the publication of management guidelines by the European Society of Cardiology (ESC) and other learned societies has tried to recommend a uniform evidence-based approach to management. Despite the availability of guidelines and efforts to improve implementation, differences in guideline adherence are evident, and differences between countries and regions within Europe are therefore likely. METHODS AND RESULTS: In this analysis from the baseline dataset of the EORP-AF Pilot survey, we examined regional differences in presentation and treatment of contemporary patients with atrial fibrillation (AF) in Europe, as managed by European cardiologists. We focused on a subgroup of 902 hospital admitted patients in whom no rhythm control was performed or planned. Chronic heart failure was more common in East countries (P < 0.0001) while hypertension and peripheral artery disease were more common in South countries (both P < 0.0001). Previous bleeding and chronic kidney disease were more common in South countries (both P < 0.0001). A CHA2DS2-VASc score of ≥2 was highest in East and South countries (93.0 and 95.3%, respectively) compared with 80.8% in West countries (P < 0.0001). A HAS-BLED score of ≥3 was also highest in East and South countries (18.0 and 29.2% respectively) compared with 4.8% in West countries (P < 0.0001). Oral anticoagulation (OAC) use (either as OAC or OAC plus antiplatelet therapy) in West, East, and South countries was 72.0, 74.7, and 76.2%, respectively. Only antiplatelet therapy was used in 13.6, 15.4, and 12.4%, respectively. An initial rate control strategy only was most common in South countries (77.8%) (P < 0.0001). CONCLUSION: From the systematic collection of contemporary data regarding the management and treatment of AF in nine participating member ESC countries, we provide hypothesis-generating insights into regional management practices in Europe with regard to patient characteristics and treatment options.

Sex-related differences in presentation, treatment, and outcome of patients with atrial fibrillation in Europe: a report from the Euro Observational Research Programme Pilot survey on Atrial Fibrillation.

AIMS: Sex differences in the epidemiology and clinical management of AF are evident. Of note, females are more symptomatic and if age >65, are at higher risk of thromboembolism if incident AF develops, compared with males. METHODS AND RESULTS: In an analysis from the dataset of the Euro Observational Research Programme on Atrial Fibrillation (EORP-AF) Pilot survey (n = 3119), we examined sex-related differences in presentation, treatment, and outcome of contemporary patients with AF in Europe.Female subjects were older (P < 0.0001), with a greater proportion aged ≥75 years, with more heart failure and hypertension. Heart failure with preserved ejection fraction was more common in females (P < 0.0001), as was valvular heart disease (P = 0.0003). Females were more symptomatic compared with males with a higher proportion being EHRA Class III and IV (P = 0.0012). The more common symptoms that were more prevalent in females were palpitations (P < 0.0001) and fear/anxiety (P = 0.0007). Other symptoms (e.g. dyspnoea, chest pain, fatigue, etc.) were not different between males and females. Health status scores were significantly lower for females overall, specifically for the psychological and physical domains (both P < 0.0001) but not for the sexual activity domain (P = 0.9023). Females were less likely to have electrical cardioversion (18.9 vs. 25.5%, P < 0.0001), and more likely to receive rate control (P = 0.002). Among patients recruited in hospital and discharged alive (n = 2009), documented contraindications to vitamin K antagonist (VKA) were evident in 23.8% of females. A CHA2DS2-VASc score ≥2 was found in 94.7% of females and 74.6% of males (P < 0.0001), with oral anticoagulants being used in 95.3 and 76.2%, respectively (P < 0.0001). A HAS-BLED score of ≥3 was found in 12.2% of females and 14.5% of males. Independent predictors of VKA use in females on multivariate analysis were CHA2DS2-VASc score (P = 0.0007), lower HAS-BLED score (P = 0.0284), and prosthetic mechanical valves (P = 0.0276). CONCLUSION: The EORP-AF Pilot survey provides contemporary data on sex differences in clinical features and management of AF patients participating in the EORP-AF Pilot registry. Female subjects were older and more symptomatic, compared with males, and were more likely to receive rate control. Also, female patients were at higher stroke risk overall, but oral anticoagulation was used in a high proportion of patients.

Device-detected atrial fibrillation and risk for stroke: an analysis of >10,000 patients from the SOS AF project (Stroke preventiOn Strategies based on Atrial Fibrillation information from implanted devices).

OBJECTIVE: The aim of this study was to assess the association between maximum daily atrial fibrillation (AF) burden and risk of ischaemic stroke. BACKGROUND: Cardiac implanted electronic devices (CIEDs) enhance detection of AF, providing a comprehensive measure of AF burden. DESIGN, SETTING, AND PATIENTS: A pooled analysis of individual patient data from five prospective studies was performed. Patients without permanent AF, previously implanted with CIEDs, were included if they had at least 3 months of follow-up. A total of 10 016 patients (median age 70 years) met these criteria. The risk of ischaemic stroke associated with pre-specified cut-off points of AF burden (5 min, 1, 6, 12, and 23 h, respectively) was assessed. RESULTS: During a median follow-up of 24 months, 43% of 10 016 patients experienced at least 1 day with at least 5 min of AF burden and for them the median time to the maximum AF burden was 6 months (inter-quartile range: 1.3-14). A Cox regression analysis adjusted for the CHADS2 score and anticoagulants at baseline demonstrated that AF burden was an independent predictor of ischaemic stroke. Among the thresholds of AF burden that we evaluated, 1 h was associated with the highest hazard ratio (HR) for ischaemic stroke, i.e. 2.11 (95% CI: 1.22-3.64, P = 0.008). CONCLUSIONS: Device-detected AF burden is associated with an increased risk of ischaemic stroke in a relatively unselected population of CIEDs patients. This finding may add to the basis for timely and clinically appropriate decision-making on anticoagulation treatment.

Atrial antitachycardia pacing and managed ventricular pacing in bradycardia patients with paroxysmal or persistent atrial tachyarrhythmias: the MINERVA randomized multicentre international trial.

AIMS: Atrial fibrillation (AF) is a common comorbidity in bradycardia patients. Advanced pacemakers feature atrial preventive pacing and atrial antitachycardia pacing (DDDRP) and managed ventricular pacing (MVP), which minimizes unnecessary right ventricular pacing. We evaluated whether DDDRP and MVP might reduce mortality, morbidity, or progression to permanent AF when compared with standard dual-chamber pacing (Control DDDR). METHODS AND RESULTS: In a randomized, parallel, single-blind, multi-centre trial we enrolled 1300 patients with bradycardia and previous atrial tachyarrhythmias, in whom a DDDRP pacemaker had recently been implanted. History of permanent AF and third-degree atrioventricular block were exclusion criteria. After a 1-month run-in period, 1166 eligible patients, aged 74 ± 9 years, 50% females, were randomized to Control DDDR, DDDRP + MVP, or MVP. Analysis was intention-to-treat. The primary outcome, i.e. the 2-year incidence of a combined endpoint composed of death, cardiovascular hospitalizations, or permanent AF, occurred in 102/385 (26.5%) Control DDDR patients, in 76/383 (19.8%) DDDRP + MVP patients [hazard ratio (HR) = 0.74, 95% confidence interval 0.55-0.99, P = 0.04 vs. Control DDDR] and in 85/398 (21.4%) MVP patients (HR = 0.89, 95% confidence interval 0.77-1.03, P = 0.125 vs. Control DDDR). When compared with Control DDDR, DDDRP + MVP reduced the risk for AF longer than 1 day (HR = 0.66, 95% CI 0.52-0.85, P < 0.001), AF longer than 7 days (HR = 0.52, 95% CI 0.36-0.73, P < 0.001), and permanent AF (HR = 0.39, 95% CI 0.21-0.75, P = 0.004). CONCLUSION: In patients with bradycardia and atrial tachyarrhythmias, DDDRP + MVP is superior to standard dual-chamber pacing. The primary endpoint was significantly lowered through the reduction of the progression of atrial tachyarrhythmias to permanent AF. CLINICALTRIALSGOV IDENTIFIER: NCT00262119.

A prospective survey in European Society of Cardiology member countries of atrial fibrillation management: baseline results of EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry.

AIMS: Given the advances in atrial fibrillation (AF) management and the availability of new European Society of Cardiology (ESC) guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in ESC member countries. METHODS AND RESULTS: We conducted a registry of consecutive in- and outpatients with AF presenting to cardiologists in nine participating ESC countries. All patients with an ECG-documented diagnosis of AF confirmed in the year prior to enrolment were eligible. We enroled a total of 3119 patients from February 2012 to March 2013, with full data on clinical subtype available for 3049 patients (40.4% female; mean age 68.8 years). Common comorbidities were hypertension, coronary disease, and heart failure. Lone AF was present in only 3.9% (122 patients). Asymptomatic AF was common, particularly among those with permanent AF. Amiodarone was the most common antiarrhythmic agent used (∼20%), while beta-blockers and digoxin were the most used rate control drugs. Oral anticoagulants (OACs) were used in 80% overall, most often vitamin K antagonists (71.6%), with novel OACs being used in 8.4%. Other antithrombotics (mostly antiplatelet therapy, especially aspirin) were still used in one-third of the patients, and no antithrombotic treatment in only 4.8%. Oral anticoagulants were used in 56.4% of CHA2DS2-VASc = 0, with 26.3% having no antithrombotic therapy. A high HAS-BLED score was not used to exclude OAC use, but there was a trend towards more aspirin use in the presence of a high HAS-BLED score. CONCLUSION: The EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot Registry has provided systematic collection of contemporary data regarding the management and treatment of AF by cardiologists in ESC member countries. Oral anticoagulant use has increased, but novel OAC use was still low. Compliance with the treatment guidelines for patients with the lowest and higher stroke risk scores remains suboptimal.

The influence of gender on heart rhythm disease.

This paper deals with cardiac arrhythmias, focusing on differences between genders. We sought to examine the potential effect of gonadal hormones on heart rhythm disorders, and sex-related differences in incidence and clinical course of arrhythmias--differences that may require specific approaches to detection and management of heart rhythm disease.

Development and validation of an integrated diagnostic algorithm derived from parameters monitored in implantable devices for identifying patients at risk for heart failure hospitalization in an ambulatory setting.

BACKGROUND: We developed and validated a heart failure (HF) risk score combining daily measurements of multiple device-derived parameters. METHODS: Heart failure patients from clinical studies with implantable devices were used to form two separate data sets. Daily HF scores were estimated by combining changes in intra-thoracic impedance, atrial fibrillation (AF) burden, rapid rate during AF, %CRT pacing, ventricular tachycardia, night heart rate, heart rate variability, and activity using a Bayesian model. Simulated monthly follow-ups consisted of looking back at the maximum daily HF risk score in the preceding 30 days, categorizing the evaluation as high, medium, or low risk, and evaluating the occurrence of HF hospitalizations in the next 30 days. We used an Anderson-Gill model to compare survival free from HF events in the next 30 days based on risk groups. RESULTS: The development data set consisted of 921 patients with 9790 patient-months of data and 91 months with HF hospitalizations. The validation data set consisted of 1310 patients with 10 655 patient-months of data and 163 months with HF hospitalizations. In the validation data set, 10% of monthly evaluations in 34% of the patients were in the high-risk group. Monthly diagnostic evaluations in the high-risk group were 10 times (adjusted HR: 10.0; 95% CI: 6.4-15.7, P < 0.001) more likely to have an HF hospitalization (event rate of 6.8%) in the next 30 days compared with monthly evaluations in the low-risk group (event rate of 0.6%). CONCLUSION: An HF score based on implantable device diagnostics can identify increased risk for HF hospitalization in the next 30 days.

Trauma Center model application in the University Hospital of Pisa: a single-center comparative study.

The Trauma Center, Hub, is a highly specialized hospital indicated for complex major trauma management after stabilization at a 1st level hospital, Spoke. Although in the United States this organization demonstrated its effectiveness in mortality, in the Italian context, data available are limited. On 30 September 2018, the University Hospital of Pisa formalized the introduction of the Trauma Center, optimizing Emergency Department (ED) organization to guarantee the highest standard of care. The aim of this study was to demonstrate that the new model led better outcomes. We conducted a comparative retrospective study on 1154 major traumas over 24 months: the first 12 months (576 patients) correspond to the period before Trauma Center introduction, and the following 12 (457 patients) to the subsequent period. Results showed increase in greater dynamics and primary centralization by helicopter (p < 0.001, p 0.006). A systematic assessment with ABCDE algorithm was performed in a higher number of patients in the most recent period, from 38.4% to 80.3% (p < 0.001). Focused Assessment with Sonography for Trauma (FAST) performed by the emergency doctor increased after Trauma Center introduction, p value < 0.001. The data show an increase of ATLS certification among staff from 51.9 to 71.4% and a reduction in early and late mortality after the Trauma Center introduction (p value 0.05 and < 0.01). Fewer patients required intensive and surgical treatments, with a shorter hospital stay. The results demonstrate the advantage in terms of outcomes in the organization of the Trauma Center in the Italian context.

The hemorrhagic risk: how to evaluate it.

This issue addresses the evaluation of hemorrhagic risk during antithrombotic treatment in atrial fibrillation patients. It illustrates the relevance of bleeding complications in the management of anticoagulation therapy and demonstrates the size of the problem among patients taking old and novel oral anticoagulant drugs. A survey of the main factors affecting the bleeding risk with pertinent supporting evidence is performed. Finally the paper discusses how to estimate the individual bleeding risk focusing on the HAS-BLED score, whose use is recommended by international guidelines.