Antibacterial envelope lowers major CIED infections
Infections related to Cardiac Implantable Electronic Devices (CIED) cause significant morbidity and mortality. Till now, only preoperative antibiotics have been shown to be a useful preventive strategy. A new study published in NEJM  and presented at the Annual Conference of the American College of Cardiology 2019 assessed the preventive role of an antibacterial envelope against CIED related infections. It was a randomized controlled clinical trial to assess the safety and efficacy of an absorbable antibiotic eluting envelope in reducing CIED associated infections. Those undergoing a new implant as well as those undergoing generator replacement, pocket revision or system upgrade were included in a 1:1 ratio to receive the envelope or not.
Primary endpoint; Infection resulting in system extraction, revision or long term antibiotic or death within a year of CIED implantation.
Secondary endpoint for safety: Procedure related or system related complications in a year.
Nearly seven thousands patients were randomized into the two groups. Primary endpoint occurred in 25 of the study group and 42 of the control group, giving a hazard ratio, 0.60. Safety endpoint occurred in 201 of the study group and 236 of the control group (hazard ratio 0.87).
Mean follow up was 20.7±8.5 months. Major CIED-related infections occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63).
The absorbable multifilament mesh envelope (TYRX Absorbable Antibacterial Envelope, Medtronic) is used to improve CIED stabilization in the subcutaneous pocket and to elute the antibiotics minocycline and rifampin.
The trial was supported by Medtronic.
Tarakji KG, Mittal S, Kennergren C, Corey R, Poole JE, Schloss E, Gallastegui J, Pickett RA, Evonich R, Philippon F, McComb JM, Roark SF, Sorrentino D, Sholevar D, Cronin E, Berman B, Riggio R, Biffi M, Khan H, Silver MT, Collier J, Eldadah Z, Wright DJ, Lande JD, Lexcen DR, Cheng A, Wilkoff BL, for the WRAP-IT Investigators. Antibacterial Envelope to Prevent Cardiac Implantable Device Infection. March 17, 2019. DOI: 10.1056/NEJMoa1901111