Evidence map›Paper›PMID 32915063›Full record

ArticleCirculation. Arrhythmia and electrophysiology2020

Cost-Effectiveness of an Antibacterial Envelope for Cardiac Implantable Electronic Device Infection Prevention in the US Healthcare System From the WRAP-IT Trial.

Bruce L Wilkoff, Giuseppe Boriani, Suneet Mittal, Jeanne E Poole, Charles Kennergren, G Ralph Corey, Andrew D Krahn, Edward J Schloss, Jose L Gallastegui, Robert A Pickett and 16 more

Registry-linked trialOpen access · bronzeAbstract readComparative Study
In one paragraph

Article in Circulation. Arrhythmia and electrophysiology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02277990 (Cardiac Implantable Electronic Device), which is not on this map. Cited by 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
5.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02277990 phase4completednot on this map

Cardiac Implantable Electronic Device (CIED) Antibiotic Envelope Infection Prevention Trial

TypeinterventionalSponsorMedtronic Cardiac Rhythm and Heart FailureRan2015 to 2018Enrolled7,075ConditionsCIED Related InfectionArmsTYRX™ Absorbable Antibacterial Envelope
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Cost-effectiveness of an intraoperative antibacterial envelope in preventing cardiac implantable device-associated infections: a systematic review.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 · 2025
    Pooled it
  2. Antibiotic eluting envelopes: evidence, technology, and defining high-risk populations.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 · 2021
    Trial
  3. Article
  4. Article
  5. Article
  6. Review
  7. Validation of the PADIT (prevention of arrhythmia device infection trial) risk score for infection and infection subtypes.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 · 2026
    Article
  8. Article
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  10. Review
  11. Article
  12. Review
  13. Cardiac implantable electronic device upgrades and downgrades: a Clinical Consensus Statement of the European Heart Rhythm Association (EHRA) of the ESC, the Asia Pacific Heart Rhythm Association (APHRS), Canadian Heart Rhythm Society (CHRS), Heart Rhythm Society (HRS), and the Latin American Heart Rhythm Society (LAHRS).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 · 2025
    Article
  14. Article
  15. Article
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  18. Device infection in patients undergoing pacemaker or defibrillator surgery: risk stratification using the PADIT score.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2024
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 6 countries.

Bruce L WilkoffCleveland Clinic, OH (B.L.W., K.G.T.).
Giuseppe BorianiUniversity of Modena and Reggio Emilia, Modena, Italy (G.B.).
Suneet MittalValley Health System, Ridgewood, NJ (S.M.).
Jeanne E PooleUniversity of Washington School of Medicine, Seattle (J.E.P.).
Charles KennergrenSahlgrenska University Hospital, Göteborg, Sweden (C.K.).
G Ralph CoreyDuke Clinical Research Institute, Durham, NC (G.R.C.).
Andrew D KrahnUniversity of British Colombia, Canada (A.D.K.).
Edward J SchlossThe Christ Hospital, Cincinnati, OH (E.J.S.).
Jose L GallasteguiClearwater Cardiovascular and Interventional Consultants, Safety Harbor, FL (J.L.G.).
Robert A PickettSaint Thomas Research Institute, LLC, Nashville, TN (R.A.P.).
Rudolph F EvonichUpper Michigan Cardiovascular Associates, Marquette (R.F.E.).
Steven F RoarkCardiology Associates of Gainesville, FL (S.F.R.).
Denise M SorrentinoIowa Heart Center, Ames (D.M.S.).
Darius P SholevarVirtua Health System, Camden, NJ (D.P.S.).
Edmond M CroninTemple University Hospital, Philadelphia, PA (E.M.C.).
Brett J BermanChula Vista Cardiac Center, CA (B.J.B.).
David W RiggioArizona Arrhythmia Consultants, Scottsdale (D.W.R.).
Hafiza H KhanBaylor Research Institute, Plano, TX (H.H.K.).
Marc T SilverWakeMed Heart and Vascular, WakeMed Health and Hospitals, Raleigh, NC (M.T.S.).
Jack CollierOklahoma Heart Hospital (J.C.).
Zayd EldadahMedStar Heart and Vascular Institute, Washington, DC (Z.E.).
Reece HolbrookMedtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).
Jeff D LandeMedtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).
Daniel R LexcenMedtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).
Swathi SeshadriMedtronic, Inc, Mounds View, MN (R.H., J.D.L., D.R.L., S.S.).
Khaldoun G TarakjiCleveland Clinic, OH (B.L.W., K.G.T.).
Medtronic (Ireland) · IECleveland Clinic · USAmes National Laboratory · USBritish Academy · GBChrist Hospital · USClinical Research Institute · USFlorida Urology Associates · USGeorgia Arrhythmia Consultants · USHeart Hospital Baylor Plano · USMedStar Heart & Vascular Institute · USNorthern Michigan University · USOklahoma Heart Hospital · USPrecision Research Institute · USSahlgrenska University Hospital · SESaint Thomas West Hospital · USSociety of Interventional Radiology · USTemple University Hospital · USUniversity of Modena and Reggio Emilia · ITUniversity of Washington · USValley Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Drug CostsAbsorbable ImplantsAnti-Bacterial AgentsAntibiotic ProphylaxisCardiac Resynchronization Therapy DevicesClinical Decision-MakingCost-Benefit AnalysisCost SavingsDecision TreesDefibrillators, ImplantableHumansModels, EconomicMulticenter Studies as TopicProsthesis ImplantationProsthesis-Related InfectionsQuality-Adjusted Life YearsAnti-Bacterial Agentsdefibrillatorsincidenceinfectionsmortalitypopulation

Identifiers

PMID32915063
PMCPMC7566304
OpenAlexW3084981742

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.