Dataset Information

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

ABSTRACT:

Aims

Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings.

Methods and results

A previously published decision-tree-based cost-effectiveness model was used to compare the costs per quality-adjusted life year (QALY) associated with adjunctive use of an antibacterial envelope for infection prevention compared to standard-of-care intravenous antibiotics. The model was adapted using data from a Danish observational two-centre cohort study that investigated infection-risk patients undergoing cardiac resynchronization therapy (CRT) reoperations with and without an antibacterial envelope (n = 1943). We assumed a cost-effectiveness threshold of €34 125/QALY gained, based on the upper threshold used by the National Institute for Health and Care Excellence (£30 000). An antibacterial envelope was associated with an incremental cost-effectiveness ratio (ICER) of €12 022 per QALY in patients undergoing CRT reoperations, thus indicating that the envelope is cost-effective when compared with standard of care. A separate analysis stratified by device type showed ICERS of €6227 (CRT defibrillator) and €29 177 (CRT pacemaker) per QALY gained.

Conclusions

Cost-effectiveness ratios were favourable for patients undergoing CRT reoperations in the Danish healthcare system, and thus are in line with previous studies. Results from this study can contribute to making the technology available to Danish patients and align preventive efforts in the pacemaker and ICD area.

SUBMITTER: Frausing MHJP

PROVIDER: S-EPMC10286568 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

Frausing Maria Hee Jung Park MHJP Johansen Jens Brock JB Afonso Daniela D Jørgensen Ole Dan OD Olsen Thomas T Gerdes Christian C Johansen Mette Lundsby ML Wolff Claudia C Mealing Stuart S Nielsen Jens Cosedis JC Kronborg Mads Brix MB

Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology 20230601 6

<h4>Aims</h4>Use of an absorbable antibacterial envelope during implantation prevents cardiac implantable electronic device infections in patients with a moderate-to-high infection risk. Previous studies demonstrated that an envelope is cost-effective in high-risk patients within German, Italian, and English healthcare systems, but these analyses were based on limited data and may not be generalizable to other healthcare settings.<h4>Methods and results</h4>A previously published decision-tree-b ...[more]

PMID: 37345858

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Project description:BackgroundIn the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system.MethodsA decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature.ResultsThe base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost.ConclusionsThe absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Project description:BackgroundInclusion of 12-lead electrocardiography (ECG) in preparticipation screening of young athletes is controversial because of concerns about cost-effectiveness.ObjectiveTo evaluate the cost-effectiveness of ECG plus cardiovascular-focused history and physical examination compared with cardiovascular-focused history and physical examination alone for preparticipation screening.DesignDecision-analysis, cost-effectiveness model.Data sourcesPublished epidemiologic and preparticipation screening data, vital statistics, and other publicly available data.Target populationCompetitive athletes in high school and college aged 14 to 22 years.Time horizonLifetime.PerspectiveSocietal.InterventionNonparticipation in competitive athletic activity and disease-specific treatment for identified athletes with heart disease.Outcome measureIncremental health care cost per life-year gained.Results of base-case analysisAddition of ECG to preparticipation screening saves 2.06 life-years per 1000 athletes at an incremental total cost of $89 per athlete and yields a cost-effectiveness ratio of $42 900 per life-year saved (95% CI, $21 200 to $71 300 per life-year saved) compared with cardiovascular-focused history and physical examination alone. Compared with no screening, ECG plus cardiovascular-focused history and physical examination saves 2.6 life-years per 1000 athletes screened and costs $199 per athlete, yielding a cost-effectiveness ratio of $76 100 per life-year saved ($62 400 to $130 000).Results of sensitivity analysisResults are sensitive to the relative risk reduction associated with nonparticipation and the cost of initial screening.LimitationsEffectiveness data are derived from 1 major European study. Patterns of causes of sudden death may vary among countries.ConclusionScreening young athletes with 12-lead ECG plus cardiovascular-focused history and physical examination may be cost-effective.Primary funding sourceStanford Cardiovascular Institute and the Breetwor Foundation.

Project description:ObjectivesThe objective of this study was to evaluate the cost-effectiveness of quadripolar versus bipolar cardiac resynchronization defibrillator therapy systems.BackgroundQuadripolar left ventricular (LV) leads for cardiac resynchronization therapy reduce phrenic nerve stimulation (PNS) and are associated with reduced mortality compared with bipolar leads.MethodsA total of 606 patients received implants at 3 UK centers (319 Q, 287 B), between 2009 and 2014; mean follow-up was 879 days. Rehospitalization episodes were costed at National Health Service national tariff rates, and EQ-5D utility values were applied to heart failure admissions, acute coronary syndrome events, and mortality data, which were used to estimate quality-adjusted life-year differences over 5 years.ResultsGroups were matched with regard to age and sex. Patients with quadripolar implants had a lower rate of hospitalization than those with bipolar implants (42.6% vs. 55.4%; p = 0.002). This was primarily driven by fewer hospital readmissions for heart failure (51 [16%] vs. 75 [26.1%], respectively, for quadripolar vs. bipolar implants; p = 0.003) and generator replacements (9 [2.8%] vs. 19 [6.6%], respectively; p = 0.03). Hospitalization for suspected acute coronary syndrome, arrhythmia, device explantation, and lead revisions were similar. This lower health-care utilization cost translated into a cumulative 5-year cost saving for patients with quadripolar systems where the acquisition cost was <£932 (US $1,398) compared with bipolar systems. Probabilistic sensitivity analysis results mirrored the deterministic calculations. For the average additional price of £1,200 (US $1,800) over a bipolar system, the incremental cost-effective ratio was £3,692 per quality-adjusted life-year gained (US $5,538), far below the usual willingness-to-pay threshold of £20,000 (US $30,000).ConclusionsIn a UK health-care 5-year time horizon, the additional purchase price of quadripolar cardiac resynchronization defibrillator therapy systems is largely offset by lower subsequent event costs up to 5 years after implantation, which makes this technology highly cost-effective compared with bipolar systems.

Project description:IntroductionExcessive alcohol consumption increases the risk of many diseases and injuries, and the Global Burden of Disease 2010 study estimated that 6% of the burden of disease in Denmark is due to alcohol consumption. Alcohol consumption thus places a considerable economic burden on society.MethodsWe analysed the cost-effectiveness of six interventions aimed at preventing alcohol abuse in the adult Danish population: 30% increased taxation, increased minimum legal drinking age, advertisement bans, limited hours of retail sales, and brief and longer individual interventions. Potential health effects were evaluated as changes in incidence, prevalence and mortality of alcohol-related diseases and injuries. Net costs were calculated as the sum of intervention costs and cost offsets related to treatment of alcohol-related outcomes, based on health care costs from Danish national registers. Cost-effectiveness was evaluated by calculating incremental cost-effectiveness ratios (ICERs) for each intervention. We also created an intervention pathway to determine the optimal sequence of interventions and their combined effects.ResultsThree of the analysed interventions (advertising bans, limited hours of retail sales and taxation) were cost-saving, and the remaining three interventions were all cost-effective. Net costs varied from € -17 million per year for advertisement ban to € 8 million for longer individual intervention. Effectiveness varied from 115 disability-adjusted life years (DALY) per year for minimum legal drinking age to 2,900 DALY for advertisement ban. The total annual effect if all interventions were implemented would be 7,300 DALY, with a net cost of € -30 million.ConclusionOur results show that interventions targeting the whole population were more effective than individual-focused interventions. A ban on alcohol advertising, limited hours of retail sale and increased taxation had the highest probability of being cost-saving and should thus be first priority for implementation.

Project description:AimsMulti-organ dysfunction was recently reported to be a common condition in patients with heart failure (HF). The Model for End-stage Liver Disease eXcluding International normalized ratio (MELD-XI) score reflects liver and kidney function. The prognostic relevance of this score has been reported in patients with a variety of cardiovascular diseases who are undergoing interventional therapies. However, the relationship between the severity of hepatorenal dysfunction assessed by the MELD-XI score and the long-term clinical outcomes of HF patients receiving cardiac resynchronization therapy (CRT) has not been evaluated.Methods and resultsClinical records of 283 patients who underwent CRT implantation between March 2003 and October 2020 were retrospectively evaluated (mean age 67 ± 12, 22.6% female). Blood samples were collected before CRT implantation. Patients were divided into three groups based on tertiles of the MELD-XI score: first tertile (MELD-XI = 9.44, n = 95), second tertile (9.44 < MELD-XI < 13.4, n = 94), and third tertile (MELD-XI ≥ 13.4, n = 94). The primary endpoint was all-cause mortality. Compared with the other groups, the third tertile group exhibited significantly older age, higher prevalence of diabetes mellitus and hypertension, lower haemoglobin level, and higher N-terminal pro-brain natriuretic peptide level (all P < 0.05). The functional CRT response rate was also significantly lower in the third tertile group (P = 0.011). During a median follow-up of 30 months (inter-quartile range, 9-67), 105 patients (37.1%) died. Kaplan-Meier analysis revealed that patients with a higher MELD-XI score had a greater risk of all-cause mortality (log-rank test: P < 0.001). Even after adjustment for clinically relevant factors and a conventional risk score, the MELD-XI score was still associated with mortality (adjusted hazard ratio: 1.04, 95% confidence interval: 1.00-1.07, P = 0.014, and adjusted hazard ratio: 1.04, 95% confidence interval: 1.01-1.09, P = 0.005, respectively). A higher MELD-XI score was associated with a greater risk of all-cause mortality than a lower MELD-XI score regardless of whether a pacemaker or defibrillator was implanted (log-rank test: P = 0.010 and P < 0.001, respectively).ConclusionsImpaired hepatorenal function assessed by the MELD-XI score was associated with older age, higher prevalence of multiple co-morbidities, severity of HF, lower CRT response rates, and subsequent all-cause mortality in HF patients undergoing CRT implantation. These results suggest that the MELD-XI score can provide additional prognostic information and may be useful for improving risk stratification in this population.

Dataset Information

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

Aims

Methods and results

Conclusions

Publications

Cost-effectiveness of an antibacterial envelope for infection prevention in patients undergoing cardiac resynchronization therapy reoperations in Denmark.

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