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The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up

Mittal S 1 , Wilkoff BL 2 , Kennergren C 3 , Poole JE 4 , Corey R 5 , Bracke FA 6 Show all authors , Curnis A 7 , Addo K 8 , Martinez-Arraras J 9 , Issa ZF 10 , Redpath C 11 , Moubarak J 12 , Khelae SK 13 , Boersma LVA 14 , Korantzopoulos P 15 , Krueger J 16 , Lande JD 16 , Morss GM 16 , Seshadri S 16 , Tarakji KG 2

Affiliations 

  • 1 Department of Cardiology, Valley Health System, Ridgewood New Jersey. Electronic address: [email protected]
  • 2 Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio
  • 3 Sahlgrenska Medical Faculty, University of Göteborg, Göteborg, Sweden
  • 4 Division of Cardiology, University of Washington School of Medicine, Seattle, Washington
  • 5 Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina
  • 6 Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands
  • 7 Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy
  • 8 Cardiology Division, Mount Carmel Health System, Columbus, Ohio
  • 9 Department of Cardiology, Amarillo Heart Clinical Research Institute, Amarillo, Texas
  • 10 Department of Cardiology, Prairie Education & Research Cooperative, Springfield, Illinois
  • 11 Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada
  • 12 Division of Cardiology, UPMC, Hamot Medical Center, Erie, Pennsylvania
  • 13 Department of Electrophysiology, Institute Jantung Negara, Kuala Lumpur, Malaysia
  • 14 Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands; Amsterdam University Medical Centers, Amsterdam, The Netherlands
  • 15 First Department of Cardiology, University of Ioannina Medical School, Ioannina, Greece
  • 16 Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota
Heart Rhythm, 2020 07;17(7):1115-1122.
PMID: 32087357 DOI: 10.1016/j.hrthm.2020.02.011

Abstract

BACKGROUND: The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN).

OBJECTIVE: The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications.

METHODS: All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling.

RESULTS: In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics).

CONCLUSION: The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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