Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial (WRAP-IT)

Tarakji, Khaldoun G.; Mittal, Suneet; Kennergren, Charles; Corey, Ralph; Poole, Jeanne E.; Stromberg, Kurt; Lexcen, Daniel R.; Wilkoff, Bruce L.

doi:10.1016/j.ahj.2016.06.010

Cited by 60 publications

(67 citation statements)

References 40 publications

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“…There was no statistical difference between the two arms. 31 More recently, WRAP-IT, 32,33 a large global randomized CIED trial, reported a 40% reduction in major CIED infections and 61% reduction in pocket infections within 12 months of the procedure with the use of the TYRX envelope. The use of the antibacterial envelope was recently recommended in the 2019 European Heart Rhythm Association (EHRA) International Consensus document, endorsed by a number of professional societies/associations comprised of cardiology experts.…”

Section: Discussionmentioning

confidence: 99%

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Eby

Bengtson

Johnson

et al. 2020

Journal of Medical Economics

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Aims: Cardiac device infections (CDIs) are serious adverse events associated with morbidity and mortality, significant costs and increased healthcare utilization. The objective of the current study was to characterize the CDI rate by device type, risk factors for infection and healthcare costs from a large U.S. health insurer perspective. Materials and Methods: A retrospective analysis of a large U.S. health insurer database identified commercial and Medicare Advantage with Part D (MAPD) members !18 years with !1 claim for a cardiac implantable electronic device (CIED) procedure between 01 October 2011 and 31 October 2015. CIEDs included pacemakers (IPG), implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapypacemakers without (CRT-P) and with defibrillation (CRT-D). Probabilities of CDI through one-year post implant were estimated using the Kaplan-Meier method. A regression model with stepwise variable selection was used to select risk factors associated with CDIs. Results: A total of 63,406 patients were included with an overall CDI rate of 1.28% (1.0% de novo and 1.74% replacement devices), varying by device type: IPG ¼ 0.91%; ICD ¼ 1.63%; CRT-p ¼ 1.50%; CRT-D ¼ 2.22%. The average adjusted annual medical costs were 2.4 times greater [95% confidence interval (CI) ¼ 2.1-2.7] for those with an infection compared to those without, and the incremental cost difference was estimated to be $57,322 [95% CI $46,572-$70,484]. Observed risk factors of CDIs included prior device infection [Odds ratio (OR) ¼ 11.356; 95% CI ¼ 7.923-16.276], undergoing a CIED replacement procedure (OR ¼ 1.644; 95% CI ¼ 1.361-1.987), implantation of a high-power device (OR ¼ 1.354; 95% CI ¼ 1.115-1.643), and younger age (age < 65) (OR ¼ 1.607; 95% CI ¼ 1.307-1.976). Conclusions: The CDI rate at one year ranged from 0.91%-2.22% depending on device type. Management of CDIs among commercial and MAPD members is associated with high healthcare expenditures.

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Section: Discussionmentioning

confidence: 99%

Economic impact of cardiac implantable electronic device infections: cost analysis at one year in a large U.S. health insurer

Eby

Bengtson

Johnson

et al. 2020

Journal of Medical Economics

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“…We noted that the infection rate in our study is slightly lower than the reported infection rate in more recent studies (>1%); however, we felt this occurred secondary to the timeframe of follow‐up used (i.e., 60 days instead of 6 or 12 months in more recent studies). Our data collection for this study predates WRAP‐IT and related trials, so we did not have that standard to adhere to. For the purposes of this study, if an elevated WBC confers an elevated risk of infection, presumably this risk would be related to early infection (the same mechanism/infection that caused the elevated WBC) and this would be apparent shortly after the procedure and certainly by 60 days.…”

Section: Discussionmentioning

confidence: 99%

“…Our data collection for this study predates WRAP-IT 18 and related trials, so we did not have that standard to adhere to. For the purposes of this study, if an elevated WBC confers an elevated risk of infection, presumably this risk would be related to early infection (the same mechanism/infection that caused the elevated WBC) and this would be apparent shortly after the procedure and certainly by 60 days.…”

Section: Although Not Specifically Indicated Preoperative Laboratorymentioning

confidence: 99%

Significance of leukocytosis prior to cardiac device implantation

Kumar

Tompkins

Veenhuyzen

et al. 2018

Pacing Clinical Electrophis

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“…Ongoing studies will hopefully provide further clarity on the utility of infection prophylaxis strategies (6,10), our study suggests that current practice is diffuse and greatly in need of standardization.…”

mentioning

confidence: 91%