Infections Down With Antibacterial Envelope for ICD/CRT Implants

June 07, 2017

WASHINGTON, DC — Placing a cardiovascular implantable electronic device (CIED) into an antibiotic-impregnated mesh envelope before implantation may entail a lower risk of major infection related to the device than is presented by standard implantation procedures, suggest a combined analysis of two prospective study populations[1].

The reduction in infection risk wasn't accompanied by increases in device-related complications. The two cohorts included patients who received replacement or upgraded cardiac resynchronization therapy (CRT) and implantable cardioverter-defibrillator (ICD) devices that were implanted while inside the TYRX Antibacterial Envelope (previously TYRX, now Medtronic). They were compared with control groups taken from the literature, Medicare claims data, and site-matched historical cases.

In the combined cohorts totaling 1129 patients from 55 centers in the US, the rate of major CIED-related infection was 0.4% at 1 year, compared with the prespecified benchmark of 2.2% (P<0.003) taken from the literature, observe the authors, led by Dr Charles A Henrikson (Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR).

Their observational analysis on the TYRX device, long approved in the US but untested in a completed randomized trial, was published May 31, 2017 in JACC: Clinical Electrophysiology.

The rate of major infection was 0.2% in the ICD group (n=459) and 0.7% in the CRT group (n=670), not a significant difference. The 0.2% ICD rate was significantly lower than the 2.2% rate among controls based on the literature.

A 0.7% major-infection rate for a subset of 578 CRT patients for whom there were comorbidity-matched controls (n=21,434 Medicare cases) was significantly lower than for those controls (1.3%, P=0.02) but not compared with a site-matched control cohort (n=578) (1.0%, P=0.38).

A contemporary absorbable version is currently under evaluation in the prospective World-Wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT) randomized trial, with a projected enrollment of >7700 patients receiving ICD or CRT upgrades or replacements.

The combined studies were sponsored by TYRX, from which Henrikson discloses receiving support. Disclosures for the coauthors are listed in the paper.

Follow Steve Stiles on Twitter: @SteveStiles2. For more from, follow us on Twitterand Facebook.


Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.