Implantable cardioverter defibrillator therapy in patients with prior coronary revascularization in the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Introduction: We conducted this study to examine the effect of the ICD on the outcomes of patients with prior coronary revascularization enrolled in the Sudden Cardiac Death in Heart Failure Trial (SCD‐HeFT) and to assess the association of time from coronary revascularization to enrollment with death and sudden cardiac death (SCD). Methods and Results: We included in this analysis patients with ischemic heart disease not randomized to the amiodarone arm. Cox proportional hazards models were used to examine the association of prior CABG and of prior PCI with each outcome. Interactions between randomized treatment and each revascularization type and time were tested in each model. Of the 882 patients who met these inclusion criteria, 255 (29%) had no prior revascularization, 178 (20%) had prior PCI only, 284 (32%) had prior CABG only, and 165 (19%) had prior PCI and CABG. There was no significant difference in ICD benefit across the revascularization subgroups (all P > 0.1). There was a trend toward improved survival with an ICD in patients who had their CABG > 2 years before randomization (HR [CI]= 0.71 [0.49, 1.04]) that was not observed in patients who had their CABG ≤ 2 years before randomization (HR [CI]= 1.40 [0.61, 3.24]). Conclusion: In SCD‐HeFT, there was no significant difference in ICD benefit across the revascularization subgroups. Patients who had their CABG > 2 years before randomization showed a trend toward improved survival with an ICD that was not observed in patients who had their CABG ≤ 2 years before randomization.     

Primary prevention with defibrillator therapy in women: results from the Sudden Cardiac Death in Heart Failure Trial

Introduction: The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) demonstrated that implantable cardioverter defibrillator (ICD) therapy reduced overall mortality in patients with class II or III heart failure and left ventricular ejection fraction (LVEF) ≤ 35%, while amiodarone had no effect on survival. There are limited data regarding the influence of gender on outcome of patients receiving ICDs for primary prevention.
Methods: We examined gender differences in response to treatment and outcome in this cohort.
Results: Women comprised 23% of the SCD-HeFT cohort, with similar percentages in the amiodarone, ICD, and placebo groups. Compared with men, women were more likely to be non-Caucasian, to have class III heart failure, and nonischemic heart disease. After adjustment for baseline differences, overall mortality risk was lower in women than in men. The gender difference in overall mortality was seen in the placebo group, while no gender difference in overall mortality was seen in the ICD group. There was a significantly lower absolute risk of death in the placebo arm women, compared with the placebo arm men (annual mortality rate approximately 4% vs. 6%).
Conclusions: The impact of ICD therapy appears to differ between men and women in this trial, with a smaller ICD benefit among women. However, the test for an interaction between gender and therapy was not significant. The lower overall mortality risk in women in the placebo group and the smaller number of women enrolled may help to explain why treatment differences in women were much smaller and difficult to detect.     

Digoxin use and heart failure outcomes: results from the Valsartan Heart Failure Trial (Val-HeFT)

Several retrospective studies have raised concerns regarding digoxin therapy in select subgroups of heart failure patients. To assess the impact of digoxin therapy on outcomes in the current era of heart failure therapy, the authors analyzed data representing 5010 patients enrolled in the Valsartan Heart Failure Trial (Val-HeFT) to examine the relationship of baseline digoxin use and all-cause mortality, first morbid event, and heart failure hospitalizations. At baseline, 3374 patients (67%) were receiving digoxin therapy and 1636 (33%) were not. Patients receiving digoxin had features of worse heart failure with higher New York Heart Association class and lower blood pressure, ejection fraction, and β-blocker use (32.1% vs 40.8%). Digoxin use was associated with worse mortality (21.1 vs 15.0%, P<.001), first morbid event (34.6 vs 21.7, P<.001), and HF hospitalization rate (19.1 vs 10.1%, P<.001). After adjustment for baseline group differences including medical therapy and baseline rhythm, patients receiving digoxin remained at a higher risk for all-cause mortality (hazard ratio [HR], 1.28; 95% confidence interval [CI], 1.05-1.57), first morbid event (HR, 1.35; 95% CI, 1.15-1.59), and heart failure hospitalization (HR, 1.41; 95% CI, 1.12-1.78). These results remained materially unchanged with propensity matched analysis. No benefit with digoxin use was observed in this study, underscoring the need to reassess the role of digoxin in the contemporary management of heart failure.     

Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)

Background

The Valsartan Heart Failure Trial (Val-HeFT) compared valsartan versus placebo in 5010 patients taking prescribed background therapy for New York Heart Association class II to IV heart failure. Valsartan reduced the risk of heart failure hospitalization and improved clinical signs and symptoms of heart failure. We sought to compare resource use, costs, and health outcomes among patients taking prescribed therapy for heart failure and randomly assigned to receive valsartan or placebo.

Methods

Measures of resource use were based on data collected during the trial. Unit cost estimates were collected from individual countries and converted to 1999 US dollars. Total costs were estimated for hospitalizations, inpatient and outpatient physician services, ambulance transportation, deaths outside the hospital, and outpatient cardiovascular medications.

Results

Mean follow-up was 23 months. Mean costs for heart failure hospitalizations were $423 lower among patients receiving valsartan (95% CI, −706 to −146). Mean total costs were $9008 for patients receiving valsartan and $8464 for patients receiving placebo, a net incremental cost of $545 (95% CI, −149 to 1148), including the cost of valsartan. There was an overall reduction in total costs of $929 (95% CI, −3243 to 1533) among patients not receiving an ACE inhibitor at baseline but a slight increase in costs of $334 (95% CI, −497 to 1199) among those receiving an ACE inhibitor without a β-blocker and a $1246 increase (95% CI, 54 to 2230) in patients receiving both an ACE inhibitor and a β-blocker at baseline.

Conclusions

Valsartan provided clinical benefits at a mean incremental cost of $285 per year during the trial. In patients not taking ACE inhibitors, valsartan was economically attractive, increasing survival while reducing or marginally increasing overall costs.     

心衰患者心源性猝死的一级预防

心衰患者SCD平均发生率约40％。 本文综述SCD发生率、原因、高危病人的识别及药物治疗对SCD的影响。并且概述ICD在SCD一级预防中的重要性。     

心力衰竭患者心源性猝死的预警和治疗策略

重点探讨心力衰竭患者发生心源性猝死的预测方法和治疗策略,旨在为心源性猝死的预防及治疗提供客观依据。     

Continuous hemodynamic monitoring in patients with mild to moderate heart failure: results of The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCEhf) trial

Clinical trial results support the hypothesis that implantable hemodynamic monitoring (IHM) systems may reduce hospitalizations among patients with chronic heart failure (HF). The Reducing Decompensation Events Utilizing Intracardiac Pressures in Patients With Chronic Heart Failure (REDUCE hf ) study was a prospective, randomized, multicenter, single-blinded trial that enrolled patients with New York Heart Association class II or III symptoms, an indication for an implantable cardioverter-defibrillator (ICD), and a previous HF hospitalization. A combination IHM-ICD was implanted and patients were randomly assigned to a treatment group in which hemodynamic information was used or a control group in which hemodynamic information was not available. Patients were followed for 12 months to evaluate the primary efficacy end point of HF hospitalizations, emergency department visits, or urgent clinic visits. The trial was designed to enroll 1300 patients, but stopped at 400 patients because of IHM lead failures experienced from previous trials. A total of 202 treatment patients and 198 controls were randomized for 12-month follow-up. The primary safety end point was met, but the rate of HF equivalents was not different between groups. REDUCE hf was unable to test clinical efficacy end points adequately. The device combining IHM-ICD technology was safe and functioned appropriately. Patients at high risk for decompensated HF have high baseline filling pressures and demonstrate consistent increases as the process of congestion worsens to the time of hospitalization.