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Purpose: The MacNew Heart Disease Health-Related Quality of Life Instrument (MacNew) is a validated, clinically sensitive, 27-item disease-specific questionnaire. This study aimed to develop a new heart disease-specific classification system for the MacNew amenable for use in health state valuation., Methods: Patients with heart disease attending outpatient clinics and inpatient wards in Brisbane, Australia, completed MacNew. The development of the new disease-specific classification system included three stages. First, a principal component analysis (PCA) established dimensionality. Second, Rasch analysis was used to select items for each dimension. Third, Rasch analysis was used to explore response-level reduction. In addition, clinician and patient judgement informed item selection., Results: Participants included 685 patients (acute coronary 6%, stable coronary 41%, chronic heart failure 20%). The PCA identified 4 dimensions (restriction, emotion, perception of others, and symptoms). The restriction dimension was divided into physical and social dimensions. One item was selected from each to be included in the classification system. Three items from the emotional dimension and two symptom items were also selected. The final classification system had seven dimensions with four severity levels in each: physical restriction; excluded from doing things with other people; worn out or low in energy; frustrated, impatient or angry; unsure and lacking in self-confidence; shortness of breath; and chest pain., Conclusion: This study generated a brief heart disease-specific classification system, consisting of seven dimensions with four severity levels in each. The classification system is amenable to valuation to enable the generation of utility value sets to be developed for use in economic evaluation., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: The objective of this study was to assess the cost-effectiveness of a long-term, nurse-led, multidisciplinary programme of home/clinic visits in preventing progressive cardiac dysfunction in patients at risk of developing de novo chronic heart failure (CHF)., Methods: A trial-based analysis was conducted alongside a pragmatic, single-centre, open-label, randomized controlled trial of 611 patients (mean age: 66 years) with subclinical cardiovascular diseases (without CHF) discharged to home from an Australian tertiary referral hospital. A nurse-led home and clinic-based programme (NIL-CHF intervention, n = 301) was compared with standard care ( n=310) in terms of life-years, quality-adjusted life-years (QALYs) and healthcare costs. The uncertainty around the incremental cost and QALYs was quantified by bootstrap simulations and displayed on a cost-effectiveness plane., Results: During a median follow-up of 4.2 years, there were no significant between-group differences in life-years (-0.056, p=0.488) and QALYs (-0.072, p=0.399), which were lower in the NIL-CHF group. The NIL-CHF group had slightly lower all-cause hospitalization costs (AUD$2943 per person; p=0.219), cardiovascular-related hospitalization costs (AUD$1142; p=0.592) and a more pronounced reduction in emergency/unplanned hospitalization costs (AUD$4194 per person; p=0.024). When the cost of intervention was added to all-cause, cardiovascular and emergency-related readmissions, the reductions in the NIL-CHF group were AUD$2742 ( p=0.313), AUD$941 ( p=0.719) and AUD$3993 ( p=0.046), respectively. At a willingness-to-pay threshold of AUD$50,000/QALY, the probability of the NIL-CHF intervention being better-valued was 19%., Conclusions: Compared with standard care, the NIL-CHF intervention was not a cost-effective strategy as life-years and QALYs were slightly lower in the NIL-CHF group. However, it was associated with modest reductions in emergency/unplanned readmission costs.

Background: The EQ-5D-3L, a generic multi-attribute utility instrument (MAUI), is widely employed to assist in economic evaluations in health care. The EQ-5D-3L lacks sensitivity when used in conditions such as cardiovascular disease (CVD). Although there are number of CVD specific quality of life instruments, currently, there are no CVD specific MAUIs. The aim of this study is to investigate the discriminative ability and responsiveness of the EQ-5D-3L and the Minnesota Living with Heart Failure Questionnaire (MLHF), a CVD specific quality of life instrument in a group of heart failure patients., Methods: The psychometric performance of the EQ-5D-3L and the MLHF was assessed using data from a randomised trial for a heart failure management intervention. The two instruments were compared for discrimination, responsiveness and agreement. The severity groups were defined using New York Heart Association functional classes., Results: The effect sizes for severe classes were generally similar showing good discrimination. The MLHF recorded better responsiveness between the time points than the EQ-5D-3L which was indicated by higher effect sizes and standardised response means. The change in MLHF summary scores between the time points was significant (p<0.005; paired t-test). The overall agreement between the two measures was low., Conclusion: The low correlation indicates that the two classification systems cover different aspects of health space. Comparison of CVD specific instruments with other generic MAUIs such as EQ-5D-3L and AQOL-8D is recommended for further research., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Background: The cost-effectiveness of heart failure management programs (HF-MPs) is highly variable. We explored intervention and clinical characteristics likely to influence cost outcomes., Methods: A systematic review of economic analyses alongside randomized clinical trials comparing HF-MPs and usual care. Electronic databases were searched for English peer-reviewed articles published between 1990 and 2013., Results: Of 511 articles identified, 34 comprising 35 analyses met the inclusion criteria. Eighteen analyses (51%) reported a HF-MP as more effective and less costly; four analyses (11%), and five analyses (14%) also reported they were more effective but with no significant or an increased cost difference, respectively. Alternatively, five analyses (14%) reported no statistically significant difference in effects or costs, and one analysis (3%) reported no statistically significant effect difference but was less costly. Finally, two analyses (6%) reported no statistically significant effect difference but were more costly. Interventions that reduced hospital admissions tended to result in favorable cost outcomes, moderated by increased resource use, intervention cost and/or the durability of the intervention effect. The reporting quality of economic evaluation assessed by the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist varied substantially between 5% and 91% (median 45%; 34 articles) of the checklist criteria adequately addressed. Overall, none of the study, patient or intervention characteristics appeared to independently influence the cost-effectiveness of a HF-MP., Conclusion: The extent that HF-MPs reduce hospital readmissions appears to be associated with favorable cost outcomes. The current evidence does not provide a sufficient evidence base to explain what intervention or clinical attributes may influence the cost implications., (© The European Society of Cardiology 2014.)

Objective: To assess the long-term cost-effectiveness of two multidisciplinary management programs for elderly patients hospitalized with chronic heart failure (CHF) and how it is influenced by patient characteristics., Methods: A trial-based analysis was conducted alongside a randomized controlled trial of 280 elderly patients with CHF discharged to home from three Australian tertiary hospitals. Two interventions were compared: home-based intervention (HBI) that involved home visiting with community-based care versus specialized clinic-based intervention (CBI). Bootstrapped incremental cost-utility ratios were computed based on quality-adjusted life-years (QALYs) and total healthcare costs. Cost-effectiveness acceptability curves were constructed based on incremental net monetary benefit (NMB). We performed multiple linear regression to explore which patient characteristics may impact patient-level NMB., Results: During median follow-up of 3.2 years, HBI was associated with slightly higher QALYs (+0.26 years per person; p=0.078) and lower total healthcare costs (AU$ -13,100 per person; p=0.025) mainly driven by significantly reduced duration of all-cause hospital stay (-10 days; p=0.006). At a willingness-to-pay threshold of AU$ 50,000 per additional QALY, the probability of HBI being better-valued was 96% and the incremental NMB of HBI was AU$ 24,342 (discounted, 5%). The variables associated with increased NMB were HBI (vs. CBI), lower Charlson Comorbidity Index, no hyponatremia, fewer months of HF, fewer prior HF admissions <1 year and a higher patient's self-care confidence. HBI's net benefit further increased in those with fewer comorbidities, a lower self-care confidence or no hyponatremia., Conclusions: Compared with CBI, HBI is likely to be cost-effective in elderly CHF patients with significant comorbidity., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Background: Patients with end-stage heart failure possess many attributes that place them at risk for prolonged mechanical ventilation (MV). However, there are only limited data on MV support among children after ventricular assist device (VAD) implantation. We report the duration of MV after VAD placement, indications for respiratory support in the postimplantation period, and associated patient factors., Methods: This single-center retrospective study included 43 consecutive children (aged <18 years) with end-stage heart failure who were supported with a VAD as a bridge to transplantation from January 2005 to December 2011. Multivariable analysis was performed using the multiple Poisson regression model for the duration of MV., Results: Overall, 33% (n = 14) remained on MV until heart transplant or death. Of those requiring pre-VAD extracorporeal membrane oxygenation (ECMO) support, 63% (n = 12 of 19) remained on MV until heart transplant or death compared with 8% (n = 2 of 24) among those not on ECMO before VAD (p < 0.001). Patients with moderate or severe mitral regurgitation while on VAD support had 1.7-times more MV days compared with those with none or trivial on-VAD mitral regurgitation. In addition, previous support on ECMO, those with moderate or severe tricuspid regurgitation, and those with only left VAD implants had an increased risk of prolonged MV., Conclusions: Our results suggest that VAD recipients previously supported on ECMO, those with moderate or severe mitral regurgitation, moderate or severe tricuspid regurgitation, and those with only left VAD implants had an increased risk of prolonged MV. Future studies in larger cohorts are necessary to confirm the findings from this single-institutional experience., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Extracorporeal membrane oxygenation (ECMO) is a lifesaving therapy, which has been used for the support of children with a broad range of diseases. Two pumps of differing mechanisms have been used to generate the extracorporeal flow: roller-head pumps and centrifugal pumps. Seven patients supported during ECMO with Levitronix Centrimag (Centrimag group [CG]) were matched to 14 patients supported with Stockert-Shiley SIII (Stockert-Shiley group [SSG]) at a single institution from July 2007 to July 2009. We hypothesized that hemolysis as measured by plasma-free hemoglobin (PFH) is elevated in the SSG versus the CG during cardiac ECMO. Categorical data were analyzed using Fisher's exact test. Plasma-free hemoglobin differences between groups were analyzed using both Wilcoxon rank sum and beta regression. Overall, SSG patients had two times the odds of having a higher PFH than CG patients adjusting for repeated measures (odds ratio [OR] = 1.96, 95% confidence interval [CI]: [1.15-3.34], p < 0.014). Differences between circuit failure in the first 168 hours did not reach statistical significance (1/7 CG vs. 7/14 SSG; p = 0.174). In this population of cardiac patients requiring ECMO support, more hemolysis occurred in the SSG, a roller-head pump supported group, when compared with the CG, a centrifugal pump supported group. Differences in circuit life did not reach statistical significance. This pilot study contrasts with past studies, which have demonstrated more hemolysis occurring with centrifugal pumps when compared with roller-head pumps.

Although there is tremendous interest in stem cell (SC)-based therapies for cardiomyopathy caused by chronic myocardial infarction, many unanswered questions regarding the best approach remain. The TAC-HFT study is a phase I/II randomized, double-blind, placebo-controlled trial designed to address several of these questions, including the optimal cell type, delivery technique, and population. This trial compares autologous mesenchymal SCs (MSCs) and whole bone marrow mononuclear cells (BMCs). In addition, the study will use a novel helical catheter to deliver cells transendocardially. Although most trials have used intracoronary delivery, the optimal method is unknown and data suggest that the transendocardial approach may have important advantages. Several trials support the benefit of SCs in patients with chronic ischemic cardiomyopathy (ICMP), although the sample sizes have been small and the number of trials sparse. After a pilot phase of 8 patients, 60 patients with ICMP (left ventricular ejection fraction 15%-50%) will be randomized to group A (30 patients further randomized to receive MSC injection or placebo in a 2:1 fashion) or group B (30 patients further randomized to BMCs or placebo in a 2:1 fashion). All patients will undergo bone marrow aspiration and transendocardial injection of SCs or placebo. The primary and secondary objectives are, respectively, to demonstrate the safety and efficacy (determined primarily by cardiac magnetic resonance imaging) of BMCs and MSCs administered transendocardially in patients with ICMP., (Copyright © 2011 Mosby, Inc. All rights reserved.)

Background: Elders with heart failure (HF) are at risk for frequent hospitalizations for symptom management. Repeated admissions are partly related to delay in responding to HF symptoms. Contextual factors such as prior illness experiences and social/emotional factors may affect symptom interpretation and response. The Self-Regulation Model of Illness guided this study as it acknowledges the dynamic nature of illness and influence of contextual factors and social environment on the interpretation and response to symptoms., Objective: The purpose of this study was to describe contextual factors related to symptom recognition and response among elders hospitalized with decompensated HF., Methods: A mixed-methods design was used. The HF Symptom Perception Scale (physical factors), Specific Activity Scale (functional performance), and Response to Symptoms Questionnaire (cognitive/emotional factors) were administered to participants aged >or=65 years. Symptom duration and clinical details were collected by interview and chart review. Open-ended questions addressing the symptom experience, including the context in which symptoms occurred, were audiotaped, transcribed, analyzed, and compared across cases to inform the quantitative data., Results: The convenience sample (n = 77) was 48% female, 85.7% were non-Hispanic White, and mean age was 75.9 years (SD = 7.7 years). Functional performance was low (81% class III/IV). The most frequently reported symptoms were dyspnea, dyspnea on exertion, and fatigue. Median duration of early symptoms of HF decompensation was 5 to 7 days, but dyspnea duration ranged from 30 minutes to 90 days before action was taken. Longer dyspnea duration was associated with higher physical symptom distress (r = .30) and lower anxiety (r = -.31). Sensing and attributing meaning to early symptoms of HF decompensation were problematic., Discussion: The physical symptom experience and the cognitive and emotional response to HF symptoms were inadequate for timely care seeking for most of this older aged sample.