Dataset Information

Use of healthcare claims to validate the Prevention of Arrhythmia Device Infection Trial cardiac implantable electronic device infection risk score.

ABSTRACT:

Aim

The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims.

Methods and results

Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76.

Conclusion

The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score.

SUBMITTER: Ahmed FZ

PROVIDER: S-EPMC8427456 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:OBJECTIVES:Initial management of cardiac implantable electronic device (CIED) infection requires removal of the infected CIED system and treatment with systemic antibiotics. However, the optimal timing to device reimplantation is unknown. The aim of this study was to quantify the incidence of reinfection after initial management of CIED infection, and to assess the effect of timing to reimplantation on reinfection rates. DESIGN:Systematic review and meta-analysis. INTERVENTIONS:A systematic review and meta-analysis was performed of studies published up to February 2018. Inclusion criteria were: (a) documented CIED infection, (b) studies that reported the timing to device reimplantation and (c) studies that reported the proportion of participants with device reinfection. A meta-analysis of proportions using a random effects model was performed to estimate the pooled device reinfection rate. PRIMARY AND SECONDARY OUTCOME MEASURES:The primary outcome measure was the rate of CIED reinfection. The secondary outcome was all-cause mortality. RESULTS:Of the 280 screened studies, 8 met inclusion criteria with an average of 96 participants per study (range 15-220 participants). The pooled incidence rate of device reinfection was 0.45% (95% CI, 0.02% to 1.23%) per person year. A longer time to device reimplantation >72 hours was associated with a trend towards higher rates of reinfection (unadjusted incident rate ratio 4.8; 95% CI 0.9 to 24.3, p=0.06); however, the meta-regression analysis was unable to adjust for important clinical covariates. There did not appear to be a difference in reinfection rates when time to reimplantation was stratified at 1 week. Heterogeneity was moderate (I2=61%). CONCLUSIONS:The incident rate of reinfection following initial management of CIED infection is not insignificant. Time to reimplantation may affect subsequent rates of device reinfection. Our findings are considered exploratory and significant heterogeneity limits interpretation. PROSERO REGISTRATION NUMBER:CRD4201810960.

Dataset Information

Use of healthcare claims to validate the Prevention of Arrhythmia Device Infection Trial cardiac implantable electronic device infection risk score.

Aim

Methods and results

Conclusion

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