Data Sharing: A New Editorial Initiative of the International Committee of Medical Journal Editors. Implications for the Editors' Network.

The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship- emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.

An echo-guided case report of rapid regression of unstable mobile thrombus aortic atheroma after aggressive statin and antiplatelet combination therapy.

We describe a case report that documented the efficacy and safety of medical therapy in stabilizing and resolving a complex and unstable aortic atheroma after a relatively short period. The patient had a large protruding, mobile, calcified nonulcerated atheroma involving the descending aorta and was therefore treated with aggressive combination therapy with high statin dosages (atorvastatin = 80 mg) and dual antiplatelet treatment (clopidogrel = 75 mg and aspirin = 100 mg). At follow-up, the echocardiogram showed a significant regression in the atheroma volume, with no signs suggestive of ulceration on its surface with the complete mobile component resolution.

The role of the kidney in heart failure.

Renal dysfunction is common in patients with heart failure and is associated with high morbidity and mortality. Cardiac and renal dysfunction may worsen each other through multiple mechanisms such as fluid overload and increased venous pressure, hypo-perfusion, neurohormonal and inflammatory activation, and concomitant treatment. The interaction between cardiac and renal dysfunction may be critical for disease progression and prognosis. Renal dysfunction is conventionally defined by a reduced glomerular filtration rate, calculated from serum creatinine levels. This definition has limitations as serum creatinine is dependent on age, gender, muscle mass, volume status, and renal haemodynamics. Changes in serum creatinine related to treatment with diuretics or angiotensin-converting enzyme inhibitors are not necessarily associated with worse outcomes. New biomarkers might be of additional value to detect an early deterioration in renal function and to improve the prognostic assessment, but they need further validation. Thus, the evaluation of renal function in patients with heart failure is important as it may reflect their haemodynamic status and provide a better prognostic assessment. The prevention of renal dysfunction with new therapies might also improve outcomes although strong evidence is still lacking.

n-3 polyunsaturated fatty acids in the prevention of atrial fibrillation recurrences after electrical cardioversion: a prospective, randomized study.

BACKGROUND: n-3 polyunsaturated fatty acids (n-3 PUFAs) exert antiarrhythmic effects and reduce sudden cardiac death. However, their role in the prevention of atrial fibrillation remains controversial. We aimed to determine the effect of n-3 PUFAs in addition to amiodarone and a renin-angiotensin-aldosterone system inhibitor on the maintenance of sinus rhythm after direct current cardioversion in patients with persistent atrial fibrillation. METHODS AND RESULTS: We conducted a randomized, double-blind, placebo-controlled, parallel-arm trial in patients with persistent atrial fibrillation, with at least 1 relapse after cardioversion, and treated with amiodarone and a renin-angiotensin-aldosterone system inhibitor. Participants were assigned to placebo or n-3 PUFAs 2 g/d and then underwent direct current cardioversion 4 weeks later. The primary end point was the probability of maintenance of sinus rhythm at 1 year after cardioversion. Of 254 screened patients, 199 were found to be eligible and randomized. At the 1-year follow up, the probability of maintenance of sinus rhythm was significantly higher in the n-3 PUFAs-treated patients compared with the placebo group (hazard ratio, 0.62 [95% confidence interval, 0.52 to 0.72] and 0.36 [95% confidence interval, 0.26 to 0.46], respectively; P=0.0001). CONCLUSIONS: In patients with persistent atrial fibrillation on amiodarone and a renin-angiotensin-aldosterone system inhibitor, the addition of n-3 PUFAs 2 g/d improves the probability of the maintenance of sinus rhythm after direct current cardioversion. Our data suggest that n-3 PUFAs may exert beneficial effects in the prevention of atrial fibrillation recurrence. Further studies are needed to confirm and expand our findings. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01198275.

Long-term prognostic value of CA 125 serum levels in mild to moderate heart failure patients.

BACKGROUND: Plasma levels of tumor marker carbohydrate 125 antigen (CA 125) have been found elevated among patients with advanced heart failure (HF). We evaluated the prognostic value of CA125 in a population of patients with mild to moderate HF. METHODS AND RESULTS: Serum levels of CA 125 were obtained in 102 patients with mild to moderate HF from idiopathic (48%) or ischemic (52%) dilated cardiomyopathy (age 64 ± 10.4 years, left ventricular ejection fraction: 34.4 ± 8.5%), under optimized medical therapy. During follow-up (43 ± 15 months), 16 (15.7%) cardiovascular deaths and 23 (22.5%) cardiovascular deaths + HF hospitalizations were recorded. Considering cardiac death, comparison of Kaplan-Meier survival curves by the log-rank test showed that patients with CA 125 levels higher than the cut-off value (30 U/mL) had a worse survival (P < .0001). This was observed also when considering cardiovascular death+ HF hospitalizations as the secondary end point (P = .0003). Event-free survival was assessed by Kaplan-Meier method and log-rank test. Multivariable Cox proportional stepwise hazards regression analysis was performed and showed that CA 125 and systolic pulmonary artery pressure (sPAP) were significantly associated with the risk of cardiovascular deaths + HF hospitalizations (HR 1.01, 95% CI 1.02-1.06, and HR 1.07, 95% CI 1.02-1.1, P < .001, respectively). CONCLUSIONS: In mild-to-moderate HF patients under optimized therapy, higher plasma CA 125 levels are an effective long-term prognostic marker in forecasting cardiovascular events and HF hospitalization and may contribute to a better risk stratification.

Renal dysfunction in acute heart failure: epidemiology, mechanisms and assessment.

Renal dysfunction is often present and/or worsens in patients with heart failure and this is associated with increased costs of care, complications and mortality. The cardiorenal syndrome can be defined as the presence or development of renal dysfunction in patients with heart failure. Its mechanisms are likely related to low cardiac output, increased venous congestion and renal venous pressure, neurohormonal and inflammatory activation and local changes, such as adenosine release. Many drugs, including loop diuretics, may contribute to worsening renal function through the activation of some of these mechanisms. Renal damage is conventionally defined by the increase in creatinine and blood urea nitrogen blood levels. However, these changes may be not related with renal injury or prognosis. New biomarkers of renal injury seem promising but still need to be validated. Thus, despite the epidemiological evidence, we are still lacking of satisfactory tools to assess renal injury and function and its prognostic significance.

Can we prevent or treat renal dysfunction in acute heart failure?

Most patients with heart failure (HF) already have or develop renal dysfunction; this might contribute to their poor outcome. Current treatment for HF can also contribute to worsen renal function. High furosemide doses are traditionally associated with worsening renal function (WRF), but patients with fluid overload may benefit of aggressive fluid removal. Unfortunately, promising therapies like vasopressin antagonists and adenosine antagonists have not been demonstrated to improve outcomes. Likewise, correction of low renal blood flow through dopamine, inotropic agents, or vasodilators does not seem to be associated with a clear benefit. However, transient WRF associated with acute HF treatment may not necessarily portend a poor prognosis. In this review, we focus on the strategies to detect renal dysfunction in acute HF, the underlying pathophysiological mechanisms, and the potential treatments.

Preoperative cardiac evaluation and perioperative cardiac therapy in patients undergoing open surgery for abdominal aortic aneurysms: effects on cardiovascular outcome.

BACKGROUND: Cardiovascular complications, such as death, myocardial infarction, or heart failure, are the leading causes of morbidity and mortality in adult patients undergoing major noncardiac surgery. OBJECTIVE: To evaluate the effects of an accurate preoperative cardiac evaluation, together with optimized perioperative drug therapy, in reducing cardiovascular events in patients undergoing open aortic surgery for abdominal aneurysm. METHODS: Between January 2000 and December 2008, we considered all consecutive patients undergoing elective abdominal aortic open surgery at the Vascular Surgery Unit of the University of Study-Spedali Civili (Italy). Since January 2003, we have used an intensive cardiac preoperative evaluation: patients with at least one cardiac risk factor received a preoperative cardiac evaluation; all non-invasive and invasive tests were performed preoperatively when indicated by the consultant cardiologist, that also optimized the pharmacological perioperative therapy. The outcome of the 418 patients undergoing surgery between 2003 and 2008 was compared with those of the 204 patients in the previous triennium 2000 to 2002, when only patients with positive history for cardiac disease received a standard preoperative cardiological clinical or instrumental evaluation. RESULTS: Patients enrolled in the 2003 to 2008 interval were slightly older and with a higher prevalence of comorbidities compared with those observed in the previous triennium; furthermore, the number of noninvasive tests performed before surgery increased significantly. Nevertheless, the number of major cardiac perioperative complications decreased over time: particularly, in-hospital mortality rate was 0.9% in the latter period, compared with 3.4% in the years 2000 to 2002. Also, the long-term mortality was significantly reduced in patients operated on between 2003 and 2008 compared with those operated on in the previous triennium. CONCLUSION: These data suggest a significant benefit of an intensive cardiac preoperative evaluation in reducing the incidence of perioperative and postoperative cardiac morbidity and mortality.

Long-term prognostic value of the right ventricular myocardial performance index compared to other indexes of right ventricular function in patients with moderate chronic heart failure.

BACKGROUND: The ventricular myocardial performance index (MPI) is a feasible echocardiographic parameter for the evaluation of patients with chronic heart failure (CHF). The long-term prognostic role of right ventricular MPI (RV MPI) has been already assessed in patients with more advanced CHF but data are lacking in moderate CHF. The aim of the study is to evaluate the possible prognostic role of RV MPI in moderate CHF patients compared to others traditional RV parameters. METHODS: From 2003 to 2004 we enrolled 95 consecutive NYHA class II CHF patients (65 males and 30 females), with the mean age of 66 ± 11 years with left ventricular ejection fraction (LVEF) <40%, on optimal medical treatment. All patients were evaluated clinically and by echocardiography with a follow-up of 5 years (combined end point: cardiovascular mortality and hospitalization for HF). RESULTS: RV MPI was 0.45 ± 0.36, tricuspid annular plane systolic excursion was 21 ± 8 mm, RV fractional area change was 42 ± 12%, systolic pulmonary artery pressure was 33 ± 9 mmHg, and acceleration time of pulmonic flow was 115.5 + 22.62 msec. After the 5 year follow-up the total mortality was 24.2% and HF hospitalization rate was 33%. At Cox multivariate analysis only an RV MPI superior to median value (>0.38) and tricuspid annular plane systolic excursion inferior to median value (<18 mm) had shown a significant prognostic role. CONCLUSION: The RV MPI in a population of moderate CHF showed to have a more long-term powerful prognostic value than other conventional and traditional echocardiographic right ventricular functional parameters.

The link between intracranial haemorrhage and cardiogenic shock: a case of Takotsubo cardiomyopathy.

Myocardial dysfunction occurs frequently during subarachnoid haemorrhage (SAH) and it is often referred to as neurogenic stunned myocardium (NSM). Takotsubo cardiomyopathy (TTC), which can lead to life-threatening acute heart failure, has been considered a possible complication of SAH. Actually, NSM and TTC are believed to share the same pathophysiological mechanisms and are likely a manifestation of the same disease. We report a case of a 64-year-old woman with SAH and cardiogenic shock due to acute left ventricular dysfunction. Echocardiography and ventriculography showed the typical pattern of TTC. Angiography excluded coronary artery disease or coronary spasm. Short-term inotropic support was necessary. Rapid recovery of left ventricular function was observed after 8 days. Acute myocardial dysfunction due to TTC in the setting of SAH may lead to cardiogenic shock which is difficult to treat. Patients with SAH and haemodynamic instability warrant a careful assessment of ventricular function on admission to rule out TTC