981-52 Six-minute Walk Compared to Peak and Low-level Aerobic Capacity in 302 Patients with Heart Failure

Distances walked spontaneously during 6 min may reflect peak exerc capacity, the ability to sustain 6 min of low exercise without anaerobic metabolism, and non-metabolic factors such as stride. To determine how well 6-min walks in 302 heart failure patients reflected aerobic capacity at peak exercise (pkVO2) and/or R (VCO2/VO2) after 6min of low-level exercise similar to walking, 6-min walks were measured within 48 hrs of bicycle exercise with gas exchange during 6min 20-watt riding and then during incremental exercise.Although 6 min walk correlated with extremes of pkVO2, it varied widely (r=0.25) when pkVO2 was 10–20ml/kg/min (generally Class II-III). Although 6 min 20W ride required VO2 9 ±2ml/kg/min, similar to 3 METS estimated for walking, 6-min 20W R did not correlate well inversely with 6 min walk distance except at very short and long walks.In moderate heart failure, 6 min walk reflects factors other than aerobic capacity at peak or during 6 min of sustained low-level exercise

Buckle up safely: a cluster randomised trial to evaluate the effectiveness of a pre-school based program to increase appropriate use of child restraints

BACKGROUND: Road traffic crashes for car occupants are a leading cause of death and serious injury in children from high and middle income countries globally. Correct use of appropriate child restraints can significantly reduce death and serious injury but there is a need for well powered trials to examine effectiveness of programs to increase optimal child restraint practices. The aim of this trial is to examine the effectiveness of a comprehensive intervention to increase the use of appropriate child restraints, and decrease incorrect use of child restraints in pre-school aged children traveling in cars. METHODS AND DESIGN: A cluster randomised controlled trial will be conducted, involving 28 pre-school or childcare centres in low income areas of Sydney, Australia, over one calendar year. The intervention is an educational program involving an in-service for centre staff, distribution of educational materials to parents, a parent workshop demonstrating restraint use, subsidised restraints for parents in need, and vouchers for a free restraint checking service. Blinded assessors will observe restraint use at all centres at the end of the calendar year. Data will be analysed on an intention-to-treat basis; the primary analysis will compare the proportion of each of the two outcome measures (use of appropriate restraints, and incorrect use of restraints) at each centre between intervention and control groups. Detailed process evaluation will be conducted, including examination of implementation and utilisation of various elements of the program by both centres and families. DISCUSSION: This assessor blinded cluster randomised trial is powered to provide credible evidence about the efficacy of an education and distribution program in a pre-school setting to increase appropriate use, and decrease incorrect use of child restraints. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12609000612213

CardioMEMS Implantation Using Gadolinium-based Contrast Agent: A Case Report

A 57-year-old woman with New York Heart Association Class III heart failure requiring multiple hospitalisations over the previous year presented for CardioMEMS implantation. Because of the patient’s allergy history of anaphylaxis to iodine-based contrast agent she underwent the device implantation with gadolinium-based contrast agent (Magnevist), which was successful

Buckle-Up Safely (Shoalhaven): a process and impact evaluation of a pragmatic multifaceted preschool based pilot program to increase correct use of age appropriate child restraints

Objective: To conduct a process and impact evaluation of a multifaceted education-based pilot program targeting correct use of age-appropriate restraints in a regional setting with a high proportion of Aboriginal and Torres Strait Islander families. Methods: The program was delivered in 2010 in 3 early learning centers where 31 percent of the children were of Aboriginal and Torres Strait Islander descent. Each component of the program was assessed for message consistency and uptake. To measure program effectiveness, participating children were matched 1:1 by age, language spoken at home, and annual household income with 71 children from the control arm of a contemporaneous trial. The outcome measure in the control and program centers (a 4-category ordinal scale of restraint use) was compared using ordinal logistic regression accounting for age of the parent. Results: Process evaluation found that though program components were delivered with a consistency of message, uptake was affected by turnover of all staff at one center and by parents experiencing difficulty in paying for subsidized restraints at each of the centers. Impact evaluation found that children from the centers receiving the program had nearly twice the odds of being in a better restraint category than children matched from the control group (adjusted odds ratio [ORadj] = 2.06, 95% confidence interval [CI], 1.09-3.90). Conclusions: This was a pragmatic study reflecting the real-life issues of implementing a program in preschools where 57 percent of families had a low income and turnover of staff was high. Despite these issues, impact evaluation showed that the integrated educational program showed promise in increasing correct use of age-appropriate restraints. The findings from this pilot study support the use of an integrated educational program that includes access to subsidized restraints to promote best practice child restraint use among communities that include a high proportion of Aboriginal and Torres Strait Islander families in New South Wales. Future trials in similar settings should consider offering more support in centers with high turnover of staff and offering alternative methods of payment when families experience financial difficulties in purchasing the subsidized restraints. If proven in larger trials, this approach could reduce death and injuries in child passengers in this vulnerable group

Impact of Baseline Heart Failure Burden on Post-Implantable Cardioverter-Defibrillator Mortality Among Medicare Beneficiaries

ObjectivesThis study sought to assess the impact of baseline heart failure (HF) burden on survival with primary implantable cardioverter-defibrillator (ICD) among Medicare recipients.BackgroundSurvival after primary ICD implantation may differ between trial and Medicare populations.MethodsLinking data from the CMS (Centers for Medicare and Medicaid Services) ICD registry and the Medicare files (2005 to 2009), we identified primary ICD recipients age ≥66 years with ejection fraction ≤35%. Number of previous HF hospitalizations (prev-HF-hosp) and length of hospitalization prior to implantation were used to define HF burden. Crude all-cause mortality was estimated. Adjusted hazard ratios (HR) were derived from Cox models.ResultsOf 66,974 ICD recipients (73% men, 88% white, mean age 75 years), 11,876 died (average follow-up = 1.4 years), with 3-year mortality of 31%. Among patients with no prev-HF-hosp, 3-year mortality was 27% compared with 63% in those with ≥3 prev-HF-hosp (adjusted HR: 1.8). Among patients with same-day implantation, 3-year mortality was 25% compared with 53% in those with >1-week hospitalization days prior to implantation (adjusted HR: 1.9). Mortality at 3-year follow-up among the 31,685 ICD recipients with no prev-HF-hosp and same-day implantation (low HF burden) was similar to that in trials (22%).ConclusionsNearly one-third of Medicare ICD recipients died within 3 years, reflecting a population with more advanced age and disease than seen in trial populations for primary prevention ICD. Nearly one-half of Medicare recipients had a low HF burden and had a survival similar to trial ICD recipients. Future research is warranted to understand the effectiveness of primary ICD implantation among Medicare beneficiaries with heavy HF burdens

Influence of healthy candidate bias in assessing clinical effectiveness for implantable cardioverter-defibrillators: cohort study of older patients with heart failure

Objective: To assess the potential contribution of unmeasured general health status to patient selection in assessments of the clinical effectiveness of implantable cardioverter-defibrillator (ICD) therapy. Design: Retrospective cohort study. Setting: Linked data from an ICD registry, heart failure registry, and Medicare claims data for ICDs implanted in 2005 through 2009. Participants: 29 426 patients admitted to hospital with heart failure aged 66 years or older and eligible for ICD therapy for primary prevention. Main outcome measures Non-traumatic hip fracture, admission to a skilled nursing facility, and 30 day mortality—outcomes unlikely to be improved by ICD therapy. Results: Compared with 17 853 patients without ICD therapy, 11 573 patients with ICD therapy were younger and had lower ejection fraction and more cardiac admissions to hospital but fewer non-cardiac admissions to hospital and comorbid conditions. Patients with ICD therapy had greater freedom from unrelated events after adjusting for age and sex: hip fracture (hazard ratio 0.77, 95% confidence interval 0.64 to 0.92), skilled nursing facility admission (0.53, 0.50 to 0.55), and 30 day mortality (0.12, 0.10 to 0.15). Conclusions: Lower risks of measured outcomes likely reflect unmeasured differences in comorbidity and frailty. The findings highlight potential pitfalls of observational comparative effectiveness research and support physician consideration of general health status in selecting patients for ICD therapy

Improving survival for patients with advanced heart failure: A study of 737 consecutive patients

Objectives.This study sought to determine whether survival and risk of sudden death have improved for patients with advanced heart failure referred for consideration for heart transplantation as advances in medical therapy were systematically implemented over an 8-year period.Background.Recent survival trials in patients with mild to moderate heart failure and patients after a myocardial infarction have shown that angiotensin-converting enzyme inhibitors are beneficial, type I antiarrhythmic drugs can be detrimental, and amiodarone may be beneficial in some groups. The impact of advances in therapy may be enhanced or blunted when applied to severe heart failure.Methods.One-year mortality and sudden death were determined in relation to time, baseline variables and therapeutics for 737 consecutive patients referred for heart transplantation and discharged home on medical therapy from 1986 to 1988, 1989 to 1990 and 1991 to 1993. Medical care was directed by a single team of physicians with policies established by consensus. From 1986 to 1990, the hydralazine/isosorbide dinitrate combination or angiotensin-converting enzyme inhibitors were the initial vasodilators, and class I antiarrhythmic drugs were allowed. After 1990, captopril was the initial vasodilator, given to 86% of patients compared with 46% of patients before 1989. After mid-1989, class I agents were routinely withdrawn, and amiodarone was used for frequent ventricular ectopic beats or atrial fibrillation (53% of patients after 1990 vs. 10% before 1989).Results.The total 1-year mortality rate decreased from 33% before 1989 to 16% after 1990 (p = 0.0001), and sudden death decreased from 20% to 8% (p = 0.0006). Adjusted for clinical and hemodynamic variables in multivariate proportional hazards models, total mortality and sudden death were lower after 1990.Conclusions.The large reduction in mortality, particularly in sudden death, from advanced heart failure since 1990 may reflect an enhanced impact of therapeutic advances shown in large randomized trials when they are incorporated into a comprehensive approach in this population. This improved survival supports the growing practice of maintaining potential heart transplant candidates on optimal medical therapy until clinical decompensation mandates transplantation

Decreasing survival benefit from cardiac transplantation for outpatients as the waiting list lengthens

AbstractMany patients are accepted for cardiac transplantation during a period of clinical instability associated with a high risk of death, even though most can be discharged home to await transplantation. As the waiting lists lengthen, priority is awarded solely on the basis of the waiting time of outpatients, who now usually undergo transplantation after they have already survived a major period of jeopardy. To determine the impact of the current waiting times and priority system on the previously expected benefit offered by transplantation, 1-year actuarial survival without transplantation was recalculated after each month without transplantation for 214 potential candidates with an ejection fraction of 0.17 ± 0.05 discharged on tailored medical therapy after evaluation. These data were compared with the 1-year survival data of 88 outpatients who underwent transplantation.Actuarial survival after 1 year was 67% on tailored therapy compared with 88% after transplantation (p = 0.009). Death without transplantation was sudden in 43 of 51 patients, resulting from hemodynamic decompensation in 8. For outpatients already surviving 6 months without transplantation, actuarial survival over the next 12 months was 83% without transplantation. Thus, the expected improvement in survival after transplantation would be only 5% over the subsequent year for patients waiting 6 months, which is the waiting time for many outpatients. Such patients should be reevaluated to determine whether transplantation remains indicated during the next year