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

Suneet Mittal1, Bruce L Wilkoff2, Charles Kennergren3

  • 1Department of Cardiology, Valley Health System, Ridgewood New Jersey.

Heart Rhythm
|February 23, 2020
PubMed
Summary

The antibacterial-eluting envelope significantly reduced cardiac implantable electronic device infections long-term. This safety profile was maintained without increasing procedure or system-related complications.

Keywords:
Cardiac resynchronization therapyComplicationGenerator replacementImplantable cardioverter-defibrillatorInfectionPacemakerReplacement

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Area of Science:

  • Cardiology
  • Infectious Diseases
  • Biomaterials

Background:

  • The World-wide Randomized Antibiotic Envelope Infection Prevention trial showed a 40% reduction in CIED infections within 12 months using an antibacterial-eluting envelope.
  • The TYRX Absorbable Antibacterial Envelope is designed to prevent infections associated with cardiac implantable electronic devices.

Purpose of the Study:

  • To evaluate the longer-term (>12 months) efficacy of the antibacterial-eluting envelope in reducing CIED infections.
  • To assess the safety and complication profile of the envelope beyond the first year post-implantation.

Main Methods:

  • A randomized trial involving 6800 patients undergoing CIED procedures (replacement, upgrade, revision, or CRT-D implantation).
  • Patients received standard infection prophylaxis and were randomized 1:1 to receive the envelope or not.
  • Infection incidence and complications were tracked for up to 36 months using Cox proportional hazards regression.

Main Results:

  • Major CIED infections occurred in 1.3% of envelope recipients versus 1.9% of controls (HR 0.64; P = .046).
  • Any CIED infection occurred in 2.1% of envelope recipients versus 2.8% of controls (HR 0.69; P = .030).
  • System- or procedure-related complications were similar between groups (8.0% vs 8.2%), with no increased risk observed with the envelope.

Conclusions:

  • The infection risk reduction associated with the antibacterial-eluting envelope is sustained beyond one year post-procedure.
  • The use of the envelope does not increase the risk of CIED-related complications.
  • The antibacterial-eluting envelope offers a safe and effective long-term solution for preventing CIED infections.