Lars-Åke Levin

Nurse-led heart failure clinics improve survival and self-care behaviour in patients with heart failure - Results from a prospective, randomised trial

AIM The aim of this trial was to prospectively evaluate the effect of follow-up at a nurse-led heart failure clinic on mortality, morbidity and self-care behaviour for patients hospitalised due to heart failure for 12 months after discharge. METHODS A total of 106 patients were randomly assigned to either follow-up at a nurse-led heart failure clinic or to usual care. The nurse-led heart failure clinic was staffed by specially educated and experienced cardiac nurses, delegated the responsibility for making protocol-led changes in medications. The first follow-up visit was 2-3 weeks after discharge. During the visit the nurse evaluated the heart failure status and the treatment, gave education about heart failure and social support to the patient and his family. RESULTS There were fewer patients with events (death or admission) after 12 months in the intervention group compared to the control group (29 vs 40, p=0.03) and fewer deaths after 12 months (7 vs 20, p=0.005). The intervention group had fewer admissions (33 vs 56, p=0.047) and days in hospital (350 vs 592, p=0.045) during the first 3 months. After 12 months the intervention was associated with a 55% decrease in admissions/patient/month (0.18 vs 0.40, p=0.06) and fewer days in hospital/patient/month (1.4 vs 3.9, p=0.02). The intervention group had significantly higher self-care scores at 3 and 12 months compared to the control group (p=0.02 and p=0.01). CONCLUSIONS Follow up after hospitalisation at a nurse-led heart failure clinic can improve survival and self-care behaviour in patients with heart failure as well as reduce the number of events, readmissions and days in hospital.

Swedish experience-based value sets for EQ-5D health states

AbstractPurposeTo estimate Swedish experience-based value sets for EQ-5D health states using general population health survey data.MethodsApproximately 45,000 individuals valued their current health status by means of time trade off (TTO) and visual analogue scale (VAS) methods and answered the EQ-5D questionnaire, making it possible to model the association between the experience-based TTO and VAS values and the EQ-5D dimensions and severity levels. The association between TTO and VAS values and the different severity levels of respondents’ answers on a self-rated health (SRH) question was assessed.ResultsAlmost all dimensions (except usual activity) and severity levels had less impact on TTO valuations compared with the UK study based on hypothetical values. Anxiety/depression had the greatest impact on both TTO and VAS values. TTO and VAS values were consistently related to SRH. The inclusion of age, sex, education and socioeconomic group affected the main effect coefficients and the explanatory power modestly.ConclusionsA value set for EQ-5D health states based on Swedish valuations has been lacking. Several authors have recently advocated the normative standpoint of using experience-based values. Guidelines of economic evaluation for reimbursement decisions in Sweden recommend the use of experience-based values for QALY calculations. Our results that anxiety/depression had the greatest impact on both TTO and VAS values underline the importance of mental health for individuals’ overall HRQoL. Using population surveys is in line with recent thinking on valuing health states and could reduce some of the focusing effects potentially appearing in hypothetical valuation studies.

Screening for Atrial Fibrillation A Report of the AF-SCREEN International Collaboration

Approximately 10% of ischemic strokes are associated with atrial fibrillation (AF) first diagnosed at the time of stroke. Detecting asymptomatic AF would provide an opportunity to prevent these strokes by instituting appropriate anticoagulation. The AF-SCREEN international collaboration was formed in September 2015 to promote discussion and research about AF screening as a strategy to reduce stroke and death and to provide advocacy for implementation of country-specific AF screening programs. During 2016, 60 expert members of AF-SCREEN, including physicians, nurses, allied health professionals, health economists, and patient advocates, were invited to prepare sections of a draft document. In August 2016, 51 members met in Rome to discuss the draft document and consider the key points arising from it using a Delphi process. These key points emphasize that screen-detected AF found at a single timepoint or by intermittent ECG recordings over 2 weeks is not a benign condition and, with additional stroke factors, carries sufficient risk of stroke to justify consideration of anticoagulation. With regard to the methods of mass screening, handheld ECG devices have the advantage of providing a verifiable ECG trace that guidelines require for AF diagnosis and would therefore be preferred as screening tools. Certain patient groups, such as those with recent embolic stroke of uncertain source (ESUS), require more intensive monitoring for AF. Settings for screening include various venues in both the community and the clinic, but they must be linked to a pathway for appropriate diagnosis and management for screening to be effective. It is recognized that health resources vary widely between countries and health systems, so the setting for AF screening should be both country- and health system-specific. Based on current knowledge, this white paper provides a strong case for AF screening now while recognizing that large randomized outcomes studies would be helpful to strengthen the evidence base.

Population screening of 75- and 76-year-old men and women for silent atrial fibrillation (STROKESTOP)

Atrial fibrillation (AF) is important because it is common and is a major cause of stroke unless treated with oral anticoagulant. The prevalence of AF increases with age as does the risk of stroke. At 75 years the risk from age alone is so high that current guidelines recommend anticoagulation even in the absence of other risk factors. Atrial fibrillation is often asymptomatic and only discovered by chance or when a stroke already has occurred. We have launched a major screening study for silent AF in which 25,000 Swedes aged 75 and 76 years are randomized to either participate in a screening programme using ambulant intermittent electrocardiogram (ECG) recording to detect silent AF, or act as a control group. Patients in whom AF is detected are offered cardiological examination and anticoagulant treatment according to current guidelines. The cohort and the controls will be followed prospectively for 5 years after the inclusion of the first participant. An interim analysis will be made after 3 years. Our hypothesis is that screening for AF will reduce stroke incidence in the screened population, and that this screening will prove to be cost effective. Secondary endpoints are: any thromboembolic event, intracranial bleeding, other major bleeding, first ever diagnosis of dementia, death from any cause, and a composite of these endpoints.

Cost-effectiveness of dabigatran compared with warfarin for patients with atrial fibrillation in Sweden.

AIMS Patients with atrial fibrillation have a significantly increased risk of thromboembolic events such as ischaemic stroke, and patients are therefore recommended to be treated with anticoagulation treatment. The most commonly used anticoagulant consists of vitamin K antagonist such as warfarin. A new oral anticoagulation treatment, dabigatran, has recently been approved for stroke prevention among patients with atrial fibrillation. The purpose of this study was to estimate the cost-effectiveness of dabigatran as preventive treatment of stroke and thromboembolic events compared with warfarin in 65-year-old patients with atrial fibrillation in Sweden. METHODS AND RESULTS A decision analytic simulation model was used to estimate the long-term (20-year) costs and effects of the different treatments. The outcome measures are the number of strokes prevented, life years gained, and quality-adjusted life years (QALYs) gained. Costs and effect data are adjusted to a Swedish setting. Patients below 80 years of age are assumed to start with dabigatran 150 mg twice a day and switch to 110 mg twice a day at the age of 80 years due to higher bleeding risk. The price of dabigatran in Sweden is €2.82 (Swedish kronor 25.39) per day for both doses. The cost per QALY gained for dabigatran compared with warfarin is estimated at €7742, increasing to €12 449 if dabigatran is compared with only well-controlled warfarin treatment. CONCLUSION Dabigatran is a cost-effective treatment in Sweden, as its incremental cost-effectiveness ratio is below the normally accepted willingness to pay limit.

Cost-effectiveness of mass screening for untreated atrial fibrillation using intermittent ECG recording

AIMS The aim of this study was to estimate the cost-effectiveness of 2 weeks of intermittent screening for asymptomatic atrial fibrillation (AF) in 75/76-year-old individuals. METHODS AND RESULTS The cost-effectiveness analysis of screening in 75-year-old individuals was based on a lifelong decision analytic Markov model. In this model, 1000 hypothetical individuals, who matched the population of the STROKESTOP study, were simulated. The population was analysed for different parameters such as prevalence, AF status, treatment with oral anticoagulation, stroke risk, utility, and costs. In the base-case scenario, screening of 1000 individuals resulted in 263 fewer patient-years with undetected AF. This implies eight fewer strokes, 11 more life-years, and 12 more quality-adjusted life years (QALYs) per 1000 screened individuals. The screening implies an incremental cost of €50 012, resulting in a cost of €4313 per gained QALY and €6583 per avoided stroke. CONCLUSIONS With the use of a decision analytic simulation model, it has been shown that screening for asymptomatic AF in 75/76-year-old individuals is cost-effective.

The long-term cost-effectiveness of fetal monitoring during labour : a comparison of cardiotocography complemented with ST analysis versus cardiotocography alone

Objective  To assess the cost‐effectiveness of the use of cardiotocography (CTG) complemented with fetal electrocardiography and ST analysis compared with the use of CTG alone in term deliveries when a decision has been made to use fetal monitoring with a scalp electrode.

Cost-effectiveness of endovascular thrombectomy in patients with acute ischemic stroke

Objective: To evaluate the cost-effectiveness of adding endovascular thrombectomy to standard care in patients with acute ischemic stroke. Methods: The cost-effectiveness analysis of endovascular thrombectomy in patients with acute ischemic stroke was based on a decision-analytic Markov model. Primary outcomes from ESCAPE, Extending the Time for Thrombolysis in Emergency Neurological Deficits–Intra-Arterial (EXTEND-IA), Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN), Endovascular Revascularization With Solitaire Device Versus Best Medical Therapy in Anterior Circulation Stroke Within 8 Hours (REVASCAT), and Solitaire with the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) along with data from published studies and registries were used in this analysis. We used a health care payer perspective and a lifelong time horizon to estimate costs and effects. Results: The model showed that adding thrombectomy with stent retrievers to guideline-based care (including IV thrombolysis) resulted in a gain of 0.40 life-years and 0.99 quality-adjusted life-years along with a cost savings of approximately

Cost effectiveness of local collagen-gentamicin as prophylaxis for sternal wound infections in different risk groups

221 per patient. The sensitivity analysis showed that the results were not sensitive to changes in uncertain parameters or assumptions. Conclusions: Adding endovascular treatment to standard care resulted in substantial clinical benefits at low costs. The results were consistent throughout irrespective of whether data from ESCAPE, EXTEND-IA, MR CLEAN, REVASCAT, or SWIFT PRIME were used in this model.

Cost and health outcome of primary percutaneous coronary intervention versus thrombolysis in acute ST-segment elevation myocardial infarction-Results of the Swedish Early Decision reperfusion Study (SWEDES) trial.

Objectives. In a randomized trial addition of local collagen-gentamicin in the sternal wound reduced the rate of sternal wound infection (SWI) to about 50% compared to intravenous prophylaxis alone. The aim of the present study was to evaluate the economic rationale for its use in every-day clinical practice. This includes the question whether high-risk groups that may have particular benefit should be identified. Design. For each patient with SWI in the trial the costs attributable to the SWI were calculated. Risk factors for SWI were identified and any heterogeneity of the effect of the prophylaxis examined. Results. The mean cost of a SWI was about 14500 Euros. A cost effectiveness analysis showed that the prophylaxis was cost saving. The positive net balance was even higher in risk groups. Assignment to the control group, overweight, diabetes, younger age, mammarian artery use, left ventricular ejection fraction < 35% and longer operation time were independent risk factors for infection. Conclusion. The addition of local collagen-gentamicin to intravenous antibiotic prophylaxis was dominant, i.e. resulted in both lower costs and fewer wound infections.