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.

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.

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.

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

How should we measure left atrium size and function?

Echocardiographic assessment of left atrial size from M-mode or 2D echocardiography measurements has been used in clinical and research studies for years, but its accuracy is now questioned. New techniques, such as 3D and tissue Doppler imaging, assessing velocities, strain and strain rate, provide improved prognostic value in a wide range of diseases. 2D strain imaging using speckle tracking on B-mode images may yield even better, angle-independent, results than tissue Doppler imaging-derived strain echocardiography. Finally, velocity vector imaging is a novel image analysis technique that may be used to quantify left atrial volume.

Jugular pacing lead extraction with laser sheath: a case report.

Over the past 20 years, the number of patients with pacemakers (PM) or implantable cardioverter defibrillators has risen markedly; consequently, an increasing number of lead-removal procedures have become necessary. A 64-year-old woman presenting with an infected device pocket and positive bacterial cultures (Staphylococcus aureus) was admitted to our department for lead removal; in 1991, she underwent VVI PM implantation for atrioventricular II degree Mobitz 1 block, and a unipolar lead was introduced via the left jugular vein. The procedure was performed in our Electrophysiology Lab with a cardiac surgeon on standby, using an excimer laser system emitting the energy at the tip of a flexible, fibre-optic 12 F sheath, developed by Spectranetics, Inc., Colorado Springs, CO, USA.

Role of beta-adrenergic receptor gene polymorphisms in the long-term effects of beta-blockade with carvedilol in patients with chronic heart failure.

BACKGROUND: Beta-blockers are mainstay of current treatment of heart failure (HF). Beta-adrenergic receptors (AR) single nucleotide gene polymorphisms (SNPs) may influence the sensitivity and density of beta-AR. We assessed the relation between three common beta-AR SNPs and the response to carvedilol administration. METHODS AND RESULTS: We studied 183 consecutive patients with chronic HF due to ischemic or nonischemic cardiomyopathy, a LV ejection fraction (LVEF) < or = 0.35, not previously treated with beta-blockers. Each patient underwent gated-SPECT radionuclide ventriculography, cardiopulmonary exercise testing and invasive hemodynamic monitoring at baseline and after 12 months of carvedilol administration at maintenance dosages. The beta1-AR gene Arg389Gly and the beta2-AR gene Arg16Gly SNPs were not related to the response to carvedilol administration. Homozygotes for the Glu27Glu allele showed a greater increase in the LVEF, compared to the other patients (+13.0 +/- 12.2% versus +7.1 +/- 8.1% in the Gln27Gln homozygotes, and 8.3 +/- 11.4% units in the Gln27Glu heterozygotes; p = 0.022 by ANOVA). Glu27Glu homozygotes also showed a greater decline in the pulmonary wedge pressure both at rest and at peak exercise. Gln27Glu SNP was selected amongst the determinants of the LVEF response to carvedilol at multivariable analysis, in addition to the cause of cardiomyopathy, baseline systolic blood pressure and the dose of carvedilol administered. CONCLUSION: Beta1-AR Arg389Gly and beta2-AR Arg16Gly SNPs are not related to the response to carvedilol therapy. In contrast, the Gln27Glu SNP is a determinant of the LVEF response to this agent in patients with chronic HF.

Psoriasis and cardiovascular diseases.

Psoriasis is a chronic immune-mediated disorder that affects about 2% to 3% of the adult population. Several reports have demonstrated an association between psoriasis and cardiovascular diseases such as myocardial infarction, hypertension, valvular disease and arrhythmia. In this review we analysed the link between psoriasis and cardiovascular disease and the possible physiopathologic mechanism of this correlation.

The role of n-3 PUFAs in preventing the arrhythmic risk in patients with idiopathic dilated cardiomyopathy.

BACKGROUND: N-3 polyunsaturated fatty acids (n-3 PUFAs) intake is associated with a reduction in sudden cardiac death in patients with ischemic heart disease. Their effects in patients with heart failure caused by idiopathic dilated cardiomyopathy (IDC) are unknown. METHODS: We compared with placebo the effects of n-3 PUFAs administration in 44 patients with IDC and with frequent or repetitive ventricular arrhythmias at Holter monitoring using a randomized, double-blind design. Arrhythmic risk was assessed by microvolt T-wave analysis (MTWA), signal averaged ECG (SAECG), Holter monitoring, power spectral analysis of heart rate (HR) variability, catecholamine and cytokine plasma levels, at baseline and after 6 months. RESULTS: At MTWA, 7/12 patients (58%) initially positive became negative after n-3 PUFAs while one patient became positive after placebo (p = 0.019). N-3 PUFAs administration was also associated to normalization of SAECG (11/15 patients, p < 0.0015), decrease in non-sustained ventricular tachycardia (NSVT) episodes (p = 0.0002) and NSVT HR (p = 0.0003), improvement in HR variability and decrease in catecholamine and cytokine plasma levels. The ratio of plasma n-6 PUFAs to n-3 PUFAs decreased from 12.01 to 3.48 after n-3 PUFAs. CONCLUSIONS: N-3 PUFAs administration is associated with favorable effects on parameters related to arrhythmic risk in patients with idiopathic dilated cardiomyopathy. These results are consistent with antiarrhythmic activity independent from their antiischemic effects.

[The study of left ventricular diastolic function by Doppler echocardiography: the essential for the clinician]. / Lo studio ecocardiografico-Doppler della funzione diastolica: cosa il clinico deve sapere.

The study of diastolic function by Doppler-echocardiography is complex and demanding. The cardiologist/echocardiographist must have a systematic approach to the study of left ventricular diastolic function, not only based on the Doppler index, but integrating Doppler patterns with other echo-parameters (chamber dimensions, wall thicknesses, systolic function, valve function and morphology) and clinical information. A rational interpretation of clinical and instrumental data can allow a correct diagnosis, which is essential for clinical decision-making.

A giant interatrial mass: an unusual presentation of primary amyloidosis.

We report a patient with primary systemic amyloidosis who had a very unusual form of clinical and instrumental presentation.

Authorship: From credit to accountability - Reflections from the Editors' network.

The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

La Red de Editores de la Sociedad Europea de Cardiología (SEC) proporciona un foro dinámico para debates editoriales y respalda las recomendaciones del Comité Internacional de Editores de Revistas Médicas (ICMJE) para mejorar la calidad científica de las revistas biomédicas. La autoría confiere crédito e importantes recompensas académicas. Recientemente, sin embargo, el ICMJE enfatizó que la autoría también requiere responsabilidad y compromiso. Estos problemas ahora están cubiertos por el nuevo (cuarto) criterio de autoría. Los autores deben aceptar ser responsables y garantizar que las preguntas sobre la precisión y la integridad de todo el trabajo será abordado adecuadamente. Esta revisión discute las implicaciones de este cambio de paradigma en requisitos de autoría con el objetivo de aumentar la conciencia sobre las buenas prácticas científicas y editoriales.

Authorship: From credit to accountability - Reflections from the Editors' network.

The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.

Worsening renal function in patients hospitalised for acute heart failure: clinical implications and prognostic significance.

BACKGROUND: Renal function is a powerful prognostic variable in patients with heart failure (HF). Hospitalisations for acute HF (AHF) may be associated with further worsening of renal function (WRF). METHODS AND RESULTS: We analysed the clinical significance of WRF in 318 consecutive patients admitted at our institute for AHF. WRF was defined as the occurrence, at any time during the hospitalisation, of both a > or =25% and a > or =0.3 mg/dL increase in serum creatinine (s-Cr) from admission (WRF-Abs-%). RESULTS: Patients were followed for 480+/-363 days. Fifty-three patients (17%) died and 132 (41%) were rehospitalised for HF. WRF-Abs-% occurred in 107 (34%) patients. At multivariable survival analysis, WRF-Abs-% was an independent predictor of death or HF rehospitalisation (adjusted HR, 1.47; 95%CI, 1.13-1.81; p=0.024). The independent predictors of WRF-Abs-%, evaluated using multivariable logistic regression, were history of chronic kidney disease (p=0.002), LV ejection fraction (p=0.012), furosemide daily dose (p=0.03) and NYHA class (p=0.05) on admission. CONCLUSION: WRF is a frequent finding in patients hospitalised for AHF and is associated with a poor prognosis. Severity of HF and daily furosemide dose are the most important predictors of the occurrence of WRF.