Safety of cardioversion in atrial fibrillation lasting less than 48 h without post-procedural anticoagulation in patients at low cardioembolic risk.

Currently, there is no unified consensus on short-term anticoagulation after cardioversion of atrial fibrillation lasting less than 48 h in low-cardioembolic-risk patients. The aim of this study is to evaluate the rate of transient ischemic attacks, stroke and death in this subset of patients after cardioversion without post-procedural anticoagulation. In a prospective observational study, patients with recent-onset AF undergoing cardioversion attempts in the Emergency Department were evaluated over the past 3 years. Inclusion criteria were conversion to sinus rhythm, low thromboembolic risk defined by a CHA2DS2VASc score of 0-1 points for males (0-2 points for females aged over 65 years), and hospital discharge without anticoagulant treatment. Patients with severe valvular heart disease, underlying systemic causes of AF, and those discharged with anticoagulant therapy were excluded. The main outcomes measured were TIA, stroke and death at thirty days' follow-up after discharge. During the study period, 218 successful cardioversions, obtained both electrically and pharmacologically, were performed on 157 patients. One hundred and eleven patients were males (71%), the mean age was 55.2 years (±standard deviation 10.7), 99 patients (63%) reported a CHA2DS2VASc score of 0, and the remaining 58 (37%) had a risk profile of 1 point. Of these, latter 8 were females (5%) older than 65 years (risk score 2 points). At the thirty days outcome, none of the 150 enrolled patients who completed a follow-up visit has reported TIA or stroke, nor died, in the overall 211 successful cardioversions evaluated. In our study, the rate of thromboembolic events after cardioversion of recent-onset AF of less than 48 h duration, in patients with a 0-1 CHA2DS2VASc risk profile (females 0-2), appeared to be extremely low even in absence of post-procedural anticoagulation. These findings seem to confirm data from previous studies, and suggest that routine post-procedural short-term anticoagulation may be considered as an overtreatment in this very low-risk subset of patients.

Early goal-directed therapy vs usual care in the treatment of severe sepsis and septic shock: a systematic review and meta-analysis.

Sepsis is a common and high-burden healthcare problem with a mortality exceeding 20 % in severe sepsis and nearly 50 % when septic shock is present. Early goal-directed therapy (EGDT) is recommended by sepsis guidelines as the standard of care following a landmark study by Rivers et al. alongside other observational studies. Three recent randomized controlled trials have questioned the Rivers' results. The objective of our systematic review was to assess the effectiveness of EGDT in reducing the mortality of severe sepsis or septic shock. Relevant primary studies were identified by searching the MEDLINE and EMBASE databases and the Cochrane Central Register of Controlled Clinical Trials to identify randomized controlled trials assessing the effectiveness of EGDT for sepsis. Data from all trials were combined and analyzed using a random effects model. Five studies, enrolling a total of 4033 patients, were included in the meta-analysis. In-hospital mortality did not differ between the two treatment groups (RR 0.93, 95 % CI 0.77-1.11, P = 0.42), although moderate heterogeneity between studies was noted (I (2) = 48 %). A non-significant trend toward reduction in 60-day mortality in the EGDT group was noted (RR 0.93, 95 % CI 0.82-1.05, P = 0.22, I (2) = 24 %). Heterogeneity between trials precludes a definitive conclusion on the utility of EGDT in severe sepsis. Until further evidence is available, it is reasonable to consider EGDT in the care of patients with severe sepsis and septic shock.

Safety and feasibility of intravenous rt-PA in the Emergency Department without a neurologist-based stroke unit: an observational study.

Early intravenous thrombolysis has proven to be a safe and effective therapy for selected patients with acute ischemic stroke (AIS). Nowadays, thrombolysis is usually delivered by neurologists in "hub" referral centers. However, only a few among eligible patients actually receive treatment. Barriers to early administration of thrombolysis are represented by delays in presentation to referral centers, in-hospital and transfer delays, as well as changes in symptoms during assessment time. The aim of this study is to evaluate the safety and rate of thrombolysis provided in Emergency Department (ED) of a district hospital without neurological stroke team. Consecutive patients with AIS treated with intravenous thrombolysis were prospectively enrolled in this observational study, conducted between May 2010 and December 2013. The main outcomes evaluated were: mortality, symptomatic intracerebral hemorrhage (ICH), systemic adverse events, and neurological recovery. Secondly, all patients admitted with ischemic stroke were retrospectively screened to assess the reasons for exclusion to treatment and the rate of thrombolysis delivered. During the study period, 43 patients with AIS received intravenous rt-PA treatment. The mortality rate at three months was 9.5 % (4/43; 95 % CI 2.6-22.1) and total ICH at any-time CT scan imaging was 18.6 % (8/43; 8.4-33.4). At seven days or at discharge, 35/43 patients (81.4 %; 66.6-91.6) presented a neurological improvement and 46.5 % (20/43; 31.2-62.3) a complete neurological recovery presenting a normal NIHSS, while 9.5 % of patients remained in steady conditions and other 9.5 % worsened (4/43; 2.6-22.1). Outcomes do not appear to be very different from those reported in SITS-MOST study cohort. Among the overall 732 patients with AIS, 117 (16.0 %; 13.4-18.8) were eligible for age and arrived within the three-hour window of time, and the thrombolysis rate was 5.9 % (43/732; 4.3-7.8). Administration of rt-PA in an ED setting without neurological specialized stroke unit seems to be feasible and safe after adequate training. Thrombolysis rate found seems to be favorably comparable with the national average in specialist stroke units. If such data were confirmed by studies of greater dimension, this may imply the ability to perform thrombolysis even in smaller centers without the neurologist, thus being able to treat a greater number of patients in the times proven effective for thrombolysis.

Syncope recurrence and mortality: a systematic review.

AIMS: Data on adverse events and death rates following syncope are heterogeneous among studies, and knowledge of syncope prognosis could help to better define the correct management of patients. METHODS AND RESULTS: We performed a systematic review of literature by searching for prospective observational studies enrolling consecutive patients presenting to the Emergency Department because of syncope. The outcomes considered were syncope recurrence and short- and long-term mortality. Morbidity and a composite of morbidity and mortality were also assessed. Pooled event rates and 95% confidence intervals (CI) were calculated for each outcome using the random effects model. Twenty-five studies (11 158 patients) were included. The incidence of syncope relapse linearly increased from 0.3% at 30 days to 22% at 2 years follow-up. One-year mortality rate varied between 5.7 and 15.5%; the pooled estimate was 8.4% (95% CI: 6.7-10.2%). The incidence of adverse events (morbidity) varied between 6.1 and 25.2% at 10 days and 2 years, respectively. The short-term (10 days) pooled incidence of the composite of morbidity and mortality was 9.1% (95% CI: 6.6-12.5%). We found a high statistical heterogeneity between studies. CONCLUSION: This meta-analysis of prospective observational studies shows that the chance of being asymptomatic linearly progressively decreased over time after the first syncope. Short-term (10-30 days) mortality after syncope was <2% and that the overall 10-day rate of the composite endpoint of death and major events was ∼9%. The knowledge of syncope prognosis could help clinicians to understand syncope patients' prognosis and researchers to design future studies.

Cardioversion in atrial fibrillation. Focus on recent-onset atrial fibrillation.

Atrial fibrillation is the most common sustained arrhythmia encountered in clinical practice. Its prevalence is rising due to an increasing elderly population and the improvement in management of life-threatening diseases such as myocardial infarction and heart failure. Over the past few years effective non-pharmacological treatments, new antiarrhythmics drugs, and anticoagulants have been introduced. Regardless of rate-control or rhythm control strategy, adequate stroke prevention still remains a cornerstone in the treatment of this arrhythmia. This review aims to illustrate the main practical issues in the management of atrial fibrillation, focusing on patients with recent-onset and hemodynamically stable atrial fibrillation.

Bleeding risk during treatment of acute thrombotic events with subcutaneous LMWH compared to intravenous unfractionated heparin; a systematic review.

BACKGROUND: Low Molecular Weight Heparins (LMWH) are at least as effective antithrombotic drugs as Unfractionated Heparin (UFH). However, it is still unclear whether the safety profiles of LMWH and UFH differ. We performed a systematic review to compare the bleeding risk of fixed dose subcutaneous LMWH and adjusted dose UFH for treatment of venous thromboembolism (VTE) or acute coronary syndromes (ACS). Major bleeding was the primary end point. METHODS: Electronic databases (MEDLINE, EMBASE, and the Cochrane Library) were searched up to May 2010 with no language restrictions. Randomized controlled trials in which subcutaneous LMWH were compared to intravenous UFH for the treatment of acute thrombotic events were selected. Two reviewers independently screened studies and extracted data on study design, study quality, incidence of major bleeding, patients' characteristics, type, dose and number of daily administrations of LMWH, co-treatments, study end points and efficacy outcome. Pooled odds ratios (OR) and 95% confidence intervals (CI) were calculated using the random effects model. RESULTS: Twenty-seven studies were included. A total of 14,002 patients received UFH and 14,635 patients LMWH. Overall, no difference in major bleeding was observed between LMWH patients and UFH (OR = 0.79, 95% CI 0.60-1.04). In patients with VTE LMWH appeared safer than UFH, (OR = 0.68, 95% CI 0.47-1.00). CONCLUSION: The results of our systematic review suggest that the use of LMWH in the treatment of VTE might be associated with a reduction in major bleeding compared with UFH. The choice of which heparin to use to minimize bleeding risk must be based on the single patient, taking into account the bleeding profile of different heparins in different settings.

Interobserver agreement in the interpretation of computed tomography in acute pulmonary embolism.

Multidetector computed tomography (MDCT) is one of the best diagnostic tools for the diagnosis of pulmonary embolism (PE). However, differences in MDCT interpretation, depending on the operator personal expertise, is an important factor that could interfere with the right diagnosis and, consequently, with the more adequate and well-timed therapy. The aim of the present study was to evaluate the interobserver agreement in the interpretation of MDCT for the diagnosis of acute PE. On a blind basis, 4 radiologists with different expertise in CT interpretation evaluated 46 different MDCT executed for acute PE. They had to verify the presence or absence of PE and, in the positive case, localize (right-left) and quantify (massive, segmentarian or subsegmentarian) it. The interobserver concordance was expressed using the Cohen K statistic. The mean concordance between the 4 operators was high (0.82; range, 0.68-0.95). Ruling out the massive PE cases, the mean concordance over the other cases was only moderate (0.47; range, 0.16-0.84). We found a very good interobserver agreement in MDCT evaluation for the diagnosis of massive PE, whereas we observed a lower concordance in regard to segmentarian and subsegmentarian PE. In the case of negative or nonmassive PE diagnosis, a second evaluation of the CT performed by an expert CT radiologist would probably be effective to decrease the CT evaluation error.

Eligibility criteria in heart failure randomized controlled trials: a gap between evidence and clinical practice.

The aim of the present study was to compare the characteristics of patients referred to our heart failure outpatient clinic with those of patients enrolled in clinical trials on heart failure pharmacological treatment. Thus, we estimated the proportion of patients admitted to our heart failure outpatient clinic who would have been included in randomized controlled trials evaluating the effects of medical treatments on heart failure mortality, published over a 10 years period (1993-2003). Sixteen studies (n = 45276) and 299 consecutive outpatients, were included. On average, only 34% of the outpatients would have been included in at least one of the 16 trials (8-71%). The main reasons for exclusion were: NYHA class (70% were in NYHA class II), ejection fraction (29% had EF > 35%), co-morbidity (51% had co-morbidity, mainly renal failure, COPD, and disthyroidism), age (22% were older than 80 years), and occurrence of a recent acute event (50% experienced an ischemic coronary syndrome, revascularization, pulmonary edema, or stroke in the prior 6 months). These results underline the crucial role of patient selection in clinical trials, raising uncertainties about the complete applicability of trial results to clinical practice.