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Cardiovascular Hospitalization (cardiovascular + hospitalization)

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Rationale and Design of ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg Bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in PatiENts with Atrial Fibrillation/Atrial Flutter

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 1 2008
STEFAN H. HOHNLOSER M.D.
Background: Atrial fibrillation (AF) is the most commonly encountered clinical arrhythmia, predominantly affecting elderly patients. There is a continued need for new antiarrhythmic drugs to treat the ever-increasing number of patients with this arrhythmia. Dronedarone is a new antiarrhythmic compound currently being developed for treatment of AF. Methods: The ATHENA trial (A placebo-controlled, double-blind, parallel arm Trial to assess the efficacy of dronedarone 400 mg bid for the prevention of cardiovascular Hospitalization or death from any cause in patiENts with Atrial fibrillation/atrial flutter) is the largest single antiarrhythmic drug trial ever conducted. More than 4,600 patients with a history of AF or atrial flutter (AFL) have been randomized to receive dronedarone 400 mg bid or matching placebo. The primary study endpoint is time to first cardiovascular hospitalization or death from any cause. The study has completed patient enrollment in December 2006 and is expected to end follow-up 1 year later. Conclusion: ATHENA will be the largest efficacy and safety trial of dronedarone, a multichannel blocker compound with properties from class I, II, III, and IV antiarrhythmic drugs developed to treat patients with AF. [source]

Clustering of Ventricular Tachyarrhythmias in Heart Failure Patients Implanted with a Biventricular Cardioverter Defibrillator

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 12 2006
MAURIZIO LUNATI M.D.
Background: Temporal patterns of ventricular tachyarrhythmia (VT/VF) have been studied only in patients who have received implantable cardioverter defibrillators (ICD) for secondary prevention of sudden death, and mainly in ischemic patients. The aim of this study was to evaluate VT/VF recurrence patterns in heart failure (HF) patients with biventricular ICD and to stratify results according to HF etiology and ICD indication. Methods and Results: We studied 421 patients (91% male, 66 ± 9 years). HF etiology was ischemic in 292 patients and nonischemic in 129. ICD indication was for primary prevention in 227 patients and secondary prevention in 194. Baseline left ventricular ejection fraction (LVEF) was 26 ± 7%, QRS duration 168 ± 32 msec, and NYHA class 2.9 ± 0.6. In a follow-up of 19 ± 11 months, 1,838 VT/VF in 110 patients were appropriately detected. In 59 patients who had ,4 episodes, we tried to determine whether VT/VF occurred randomly or rather tended to cluster by fitting the frequency distribution of tachycardia interdetection intervals with exponential functions: VT/VF clusters were observed in 46 patients (78% of the subgroup of patients with ,4 episodes and 11% of the overall population). On multivariate logistic analysis, VT/VF clusters were significantly (P < 0.01) associated with ICD indication for secondary prevention (odds ratio [OR]= 3.12; confidence interval [CI]= 1.56,6.92), nonischemic HF etiology (OR = 4.34; CI = 2.02,9.32), monomorphic VT (OR = 4.96; CI = 2.28,10.8), and LVEF < 25% (OR = 3.34; CI = 1.54,7.23). Cardiovascular hospitalizations and deaths occurred more frequently in cluster (21/46 [46%]) than in noncluster patients (63/375 (17%), P < 0.0001). Conclusions: In HF patients with biventricular ICDs, VT/VF clusters may be regarded as the epiphenomenon of HF deterioration or as a marker of suboptimal response to cardiac resynchronization therapy. [source]

Rationale and Design of ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg Bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in PatiENts with Atrial Fibrillation/Atrial Flutter

Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2010
M.H.S., SANA M. AL-KHATIB M.D.
ICD: Remote Monitoring Versus Clinic Interrogations.,Introduction: Remote monitoring is increasingly becoming the new standard of care for implantable cardioverter defibrillator (ICD) follow-up. We sought to determine whether remote monitoring of ICDs improves patient outcomes compared with quarterly device interrogations in clinic. Methods and Results: In this single-center pilot clinical trial, adult patients with an ICD were randomly assigned to remote monitoring versus quarterly device interrogations in clinic. The primary endpoint was a composite of cardiovascular hospitalization, emergency room visit for a cardiac cause, and unscheduled visit to the electrophysiology clinic for a device-related issue at 1 year. We also examined health-related quality of life, costs, and patient satisfaction with their ICD care. Of 151 patients enrolled in this trial, 76 were randomized to remote monitoring and 75 to quarterly device interrogations in clinic. There was no significant difference in the primary endpoint (32% in the remote monitoring arm vs 34% in the control arm; P = 0.8), mortality, or cost between the 2 arms. Quality of life and patient satisfaction were significantly better in the control arm than in the remote monitoring arm at 6 months (83 [25th, 75th percentiles 70, 90] vs 75 [50, 85]; P = 0.002 and 88 [75, 100] vs 75 [75, 88]; P = 0.03, respectively), but not at 12 months. Conclusion: We showed no significant reduction in cardiac-related resource utilization with remote monitoring of ICDs. However, given the small number of patients in our study, the real clinical and health economics impact of remote monitoring needs to be verified by a large, multicenter, randomized clinical trial. (J Cardiovasc Electrophysiol, Vol. 21, pp. 545-550, May 2010) [source]

Effect of Left Ventricular Lead Concordance to the Delayed Contraction Segment on Echocardiographic and Clinical Outcomes after Cardiac Resynchronization Therapy

JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY, Issue 5 2009
JEFFREY W.H. FUNG M.D.
Introduction: The optimal left ventricular (LV) pacing site for cardiac resynchronization therapy (CRT) is unclear. The current study aims to explore the clinical significance of LV lead concordance to delayed contraction segment in CRT. Methods and Results: Concordant LV lead position was defined as the lead tip located by fluoroscopy at or immediately adjacent to the LV segment with latest contraction determined by tissue Doppler imaging. Echocardiographic and clinical outcomes among 101 consecutive patients with or without concordant LV lead positions were compared. There was no significant difference in changes in LV volumes and clinical parameters between patients with concordant (n = 46) or nonconcordant (n = 55) LV lead positions at 3 and 6 months. In multivariate analysis, the baseline asynchrony index (,= 1.092, 95% CI: 1.050,1.114; P < 0.001), but not LV lead concordance, was the only independent predictor of LV reverse remodeling. By Cox regression analysis, ischemic etiology, and LV reverse remodeling, but not LV lead concordance, were independent predictors of mortality (,= 2.475, 95% CI: 1.183,5.178; P = 0.016, and ,= 0.272, 95% CI: 0.130,0.567; P < 0.001, respectively), cardiovascular hospitalization (,= 1.551, 95% CI: 1.032,2.333; P = 0.035, and ,= 0.460, 95% CI: 0.298,0.708; P < 0.001, respectively), and heart failure hospitalization (,= 0.486, 95% CI: 0.320,0.738; P = 0.001 for LV reverse remodeling). Conclusion: LV lead concordance to the delayed contraction segment may not be a major determining factor for favorable echocardiographic and clinical outcomes after CRT. [source]

Rationale and Design of ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg Bid for the Prevention of Cardiovascular Hospitalization or Death from Any Cause in PatiENts with Atrial Fibrillation/Atrial Flutter

Prognostic value of interleukin-6, plasma viscosity, fibrinogen, von Willebrand factor, tissue factor and vascular endothelial growth factor levels in congestive heart failure

EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 11 2003
B. S. P. Chin
Abstract Background, Congestive heart failure (CHF) carries a poor prognosis with a high mortality rate, frequent hospitalizations and increased risk of thrombotic complications such as stroke. Cytokines may contribute to the progression and prothrombotic state of CHF, including the pro-inflammatory interleukin-6 (IL-6) and the pro-angiogenic vascular endothelial growth factor (VEGF), both of which are raised in CHF. The procoagulant properties of both cytokines may be mediated via tissue factor (TF), a potent clotting activator. We hypothesized that plasma levels of these markers, as well as levels of plasma viscosity, fibrinogen, soluble P-selectin and von Willebrand factor (markers of abnormal rheology, clotting, platelet activation, and endothelial damage, respectively) will be useful in predicting morbidity and mortality in chronic stable CHF. Methods and results, One hundred and twenty consecutive out-patients with chronic stable CHF (92 males; mean [SD] age 64 [11] years, mean [SD] left ventricular ejection fraction of 29 [6]%) were recruited and followed for 2 years during which 42 patients reached a clinical end-point of all-cause mortality and cardiovascular hospitalizations, including stroke and myocardial infarction. Plasma IL-6 (P = 0·003) and TF (P = 0·013) levels, but not other research indices, were higher in those who suffered events compared with those without events. Predictors of end-points were high (, median) TF (P = 0·011), and IL-6 (P = 0·023) levels, as well as the lowest quartile of a left ventricular ejection fraction (P = 0·007). A strong correlation was present between TF and IL-6 levels (r = 0·59; P < 0·0001) and with VEGF levels (r = 0·43; P < 0·0001). Conclusion, IL-6 and TF are predictors of poor prognosis in chronic CHF, raising the hypothesis that IL-6 may contribute to the progression and thrombotic complications of CHF via its actions on TF expression. Although VEGF did not independently predict outcome in chronic CHF, the possibility arises that it may act with IL-6 to induce TF expression. [source]