First outline and baseline data of a randomized, controlled multicenter trial to evaluate the health economic impact of home telemonitoring in chronic heart failure - CardioBBEAT.

BACKGROUND: Evidence that home telemonitoring for patients with chronic heart failure (CHF) offers clinical benefit over usual care is controversial as is evidence of a health economic advantage. METHODS: Between January 2010 and June 2013, patients with a confirmed diagnosis of CHF were enrolled and randomly assigned to 2 study groups comprising usual care with and without an interactive bi-directional remote monitoring system (Motiva®). The primary endpoint in CardioBBEAT is the Incremental Cost-Effectiveness Ratio (ICER) established by the groups' difference in total cost and in the combined clinical endpoint "days alive and not in hospital nor inpatient care per potential days in study" within the follow-up of 12 months. RESULTS: A total of 621 predominantly male patients were enrolled, whereof 302 patients were assigned to the intervention group and 319 to the control group. Ischemic cardiomyopathy was the leading cause of heart failure. Despite randomization, subjects of the control group were more often in NYHA functional class III-IV, and exhibited peripheral edema and renal dysfunction more often. Additionally, the control and intervention groups differed in heart rhythm disorders. No differences existed regarding risk factor profile, comorbidities, echocardiographic parameters, especially left ventricular and diastolic diameter and ejection fraction, as well as functional test results, medication and quality of life. While the observed baseline differences may well be a play of chance, they are of clinical relevance. Therefore, the statistical analysis plan was extended to include adjusted analyses with respect to the baseline imbalances. CONCLUSIONS: CardioBBEAT provides prospective outcome data on both, clinical and health economic impact of home telemonitoring in CHF. The study differs by the use of a high evidence level randomized controlled trial (RCT) design along with actual cost data obtained from health insurance companies. Its results are conducive to informed political and economic decision-making with regard to home telemonitoring solutions as an option for health care. Overall, it contributes to developing advanced health economic evaluation instruments to be deployed within the specific context of the German Health Care System. TRIAL REGISTRATION: ClinicalTrials.gov NCT02293252 ; date of registration: 10 November 2014.

Cost-effectiveness analysis of coronary artery disease screening in HIV-infected men.

BACKGROUND: HIV-infected patients are at increased risk of coronary artery disease (CAD). We evaluated the cost-effectiveness of cardiac screening for HIV-positive men at intermediate or greater CAD risk. DESIGN: We developed a lifetime microsimulation model of CAD incidence and progression in HIV-infected men. METHODS: Input parameters were derived from two HIV cohort studies and the literature. We compared no CAD screening with stress testing and coronary computed tomography angiography (CCTA)-based strategies. Patients with test results indicating 3-vessel/left main CAD underwent invasive coronary angiography (ICA) and received coronary artery bypass graft surgery. In the stress testing + medication and CCTA + medication strategies, patients with 1-2-vessel CAD results received lifetime medical treatment without further diagnostics whereas in the stress testing + intervention and CCTA + intervention strategies, patients with these results underwent ICA and received percutaneous coronary intervention. RESULTS: Compared to no screening, the stress testing + medication, stress testing + intervention, CCTA + medication, and CCTA + intervention strategies resulted in 14, 11, 19, and 14 quality-adjusted life days per patient and incremental cost-effectiveness ratios of 49,261, 57,817, 34,887 and 56,518 Euros per quality-adjusted life year (QALY), respectively. Screening only at higher CAD risk thresholds was more cost-effective. Repeated screening was clinically beneficial compared to one-time screening, but only stress testing + medication every 5 years remained cost-effective. At a willingness-to-pay threshold of 83,000 €/QALY (∼ 100,000 US$/QALY), implementing any CAD screening was cost-effective with a probability of 75-95%. CONCLUSIONS: Screening HIV-positive men for CAD would be clinically beneficial and comes at a cost-effectiveness ratio comparable to other accepted interventions in HIV care.

A simulation model of clinical and economic outcomes of cardiac CT triage of patients with acute chest pain in the emergency department.

OBJECTIVE: Uncertainty exists as to whether coronary CT angiography (CTA) compared with standard of care (SOC) is more effective and efficient in the triage of low-risk emergency department (ED) patients with acute chest pain. Our objective was to construct a simulation model to estimate clinical and economic outcomes. MATERIALS AND METHODS: We constructed a microsimulation model comparing SOC to coronary CTA-based triage of 1000 55-year-old patients (50% men) with acute chest pain, nonsignificant ECG changes, and initial negative cardiac markers. In SOC, patients were reevaluated with serial cardiac markers after 6-8 hours, followed by either nuclear stress imaging (SPECT) or stress echocardiography. In coronary CTA-based triage, patients were imaged immediately and, depending on the results, discharged, held for SPECT or stress echocardiography, or referred directly to invasive coronary angiography. RESULTS: Compared with SOC, coronary CTA-based triage reduced the number of patients referred for invasive coronary angiography from 406 (SPECT) or 370 (stress echocardiography) to 255 per 1000 and resulted in fewer "missed" cases of acute coronary syndrome overall (5 vs 18). Coronary CTA-based triage also resulted in fewer deaths (4 vs 6). Coronary CTA led to immediate discharge of 706 patients and produced average cost-savings in the ED of $851 (SPECT) or $462 (stress echocardiography) per patient. At 30 days after initial ED triage, coronary CTA-based management produced average savings of $283 (SPECT) and average costs of $292 (stress echocardiography) per patient triaged. CONCLUSION: Our model suggests that coronary CTA-based triage of low-risk patients with acute chest pain in the ED might reduce invasive catheterizations, could improve survival, and may save money.

[Influence of the demographic change on hospital admissions and costs in Germany]. / Einfluss der demographischen Entwicklung auf die stationären Fallzahlen und Kosten deutscher Krankenhäuser.

BACKGROUND: In the next years the population of most western countries will age rapidly. Beside socioeconomic and social problems sustainable consequences on the health care system are expected. Ageing of the population will place a corresponding growth in demand of health care services and relating expenditures. The following analysis assesses the impact of demographic factors on hospital admissions and related costs over the next 30 years. METHOD: German Federal Statistical Office 12th coordinated population projection, diagnosis statistics and cost of illness data were used to develop a projection of future hospital admissions and associated economic burden. The model considers age- and sex-specific differences. RESULTS: Ageing will increase all-cause hospital admissions by 12% between 2010 and 2040. Diseases of the circulatory system will have one of the most tremendous increases with an expected rise of 34% until 2040. In contrast, hospital stays because of mental and behavioural disorders will decrease by 9%. As hospital admissions rise we expect a further increase in overall expenditures for hospitalisations. DISCUSSION: Ageing of the population will further increase the demand for inpatient hospital services during the coming years. Nevertheless, the increase of hospital admissions will differ concerning single illness groups. The development of new care strategies should take these aspects into consideration.

Heart failure: the commonest reason for hospital admission in Germany: medical and economic perspectives.

BACKGROUND: Heart failure is now the commonest reason for hospitalization in Germany (German Federal Statistical Office, 2008). Heart failure will continue to be a central public health issue in the future as the population ages. This article focuses on regional differences, the costs of the disease, and the expected rate of increase in cases in the near future. METHODS: This analysis is based on diagnosis statistics, cause-of-death statistics, and cost of illness data, as reported by the German Federal Statistical Office. Age- and sex-specific differences are taken into account. RESULTS: 2006 was the first year in which heart failure led to more hospital admissions in Germany (317 000) than any other diagnosis. At present, about 141 000 persons in Germany aged 80 and over have heart failure; by the year 2050, it is predicted that more than 350 000 persons in this age group will be affected. The rate of diagnosis of heart failure, its frequency as a cause of death, and the costs associated with it all vary across the individual states of the Federal Republic of Germany. The nationwide cost of heart failure in 2006 was estimated at 2.9 billion euros. CONCLUSIONS: These findings reveal that heart failure has become more common as an admission diagnosis of hospitalized patients in Germany. Because the population is aging, new concepts for prevention and treatment will be needed in the near future so that the affected patients can continue to receive adequate care.

[New models to improve supply in patients with chronic heart failure]. / Neue Versorgungsstrukturen für Patienten mit chronischer Herzinsuffizienz.

Frequency of chronic heart failure still increases. More and more resources have been required for the diagnosis and therapy of this disease. This burden for health-care systems will grow in the near future. In particular, clinical treatment has a major impact. New approaches are essential to ensure an efficient supply of patients with chronic heart failure in the next years. Models to improve the supply give the opportunity to optimize the medical workflow and involve the patient into the concept of care. Therefore, a variety of models have been developed and up to now tested concerning benefit and applicability in western industrial countries. The present article focuses on the fundamental models to improve the supply of patients with chronic heart failure.

[Assessment of the natural history of coronary artery calcification and identification of its determinants. Rationale of the 2nd part of the Heinz Nixdorf Recall Study]. / Analyse des natürlichen Verlaufs der Koronargefässverkalkung und Identifizierung ihrer Determinanten. Rationale des 2. Teils der Heinz Nixdorf Recall Studie.

The Heinz Nixdorf Recall Study, which was inaugurated in 2000, is an ongoing population-based study to evaluate the prediction of cardiovascular events by integrating new imaging and nonimaging modalities in risk assessment. A focus is the additional prognostic value of coronary artery calcification (CAC). Currently used risk stratification algorithms often describe the individuals' risk based on few established risk factors only inaccurately. Using noninvasive quantification of CAC progression, the natural history of atherosclerosis with its repetitive, frequently subclinical plaque ruptures, may detect an unstable course of the disease long before the disease irreversibly manifests in sudden death or myocardial infarction. While the independent additional prognostic value of CAC quantification has been shown in asymptomatic patients at intermediate risk, only few studies provided evidence for an independent prognostic value of serial CAC measurements. In the Heinz Nixdorf Recall Study, the impact of established and new risk factors, e.g., the metabolic syndrome, psychosocial and environmental risk factors, or genetic variables, can be assessed. Further, the association of CAC progression with the incidence of other cardiovascular diseases such as heart failure or aortic or aortic valve calcification can be described. Since April 2006, the participants of the study return to the study center 5 years after baseline recruitment to assess health status and to determine the risk factor profile. Based on recently published data, serial CAC measurements have been granted allowing for (1) characterization of the natural history of CAC progression, and (2) identification of its determinants. The rationale of serial CAC quantification is discussed in this article.The Heinz Nixdorf Recall Study will contribute to the appraisal of new imaging modalities in risk stratification.