1. An absorbable, antibiotic-eluting envelope covering cardiac implantable electronic devices (CIEDs) significantly lowered the incidence of major infection within 12 months of the procedure compared to devices without the covering.
2. Procedure- or system-related complications occurring within 12 months of device implantation did not differ between the groups.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Despite the use of systemic antibiotics and sterile surgical procedure, infections after the placement of CIEDs occur and have significant health and economic consequences. Besides perioperative antibiotic strategy, little innovation on alternative means of reducing CIED associated infections has been done. An absorbable, minocycline and rifampin eluting envelope covering CIEDs has recently been developed. The Worldwide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) compared infection rates in patients who had an CIED procedure with or without the envelope. At 12 months following a CIED procedure, significant infection related complications occurred at a significantly higher rate in the group without the envelope than in the envelope covered group. Procedure related complications did not differ between groups.
This study provides strong efficacy justification for the use of antibiotic covering material when patients undergo a CIED procedure. Its strengths include the large number of patients studied, randomized design, and extensive subgroup analysis. Limitations included more patients with immunosuppression being randomized to the no-envelope group and no evaluation of envelopes with varied antibiotic combinations and/or dosing.
In-Depth [randomized controlled trial]: This single-blind, multi-center, postmarketing, randomized controlled trial enrolled patients between 2015 and 2017. Eligible patients were undergoing CIED placement procedures including initial placement, replacement, or lead changes. Patients were randomized to have their implanted device covered with an absorbable antibiotic (minocycline and rifampin)-eluting envelope (n=3495) or without (n=3488). The envelope eluted antibiotics into tissue for at least 7 days and was expected to absorb into tissue by 9 weeks. Patients were followed for a mean of 20.7 months, with 89.4% completing 12 months of follow-up. The primary end point was major CIED infection within 12 months following the procedure, which occurred 30 times in the envelope group and 45 times in the control group (12-month Kaplan– Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.36 to 0.98; P = 0.04). Data on antibiotic susceptibility from infections was not collected. Complications occurring within 12 months of the CIED procedure and were related to the procedure occurred in 201 and 236 patients in the envelope and control groups, respectively (12-month Kaplan–Meier estimated event rate, 6.0% and 6.9%, respectively; HR, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). Major or minor infections occurring within 12 months of the procedure occurred in 50 and 75 patients in the envelope and control groups, respectively (12-month Kaplan–Meier estimated event rate, 1.5% and 2.2%, respectively; HR, 0.67; 95% CI, 0.47 to 0.96).
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