Infections can not push this 'envelope," as antimicrobial device protects cardiovascular implants

January 12th, 2015

An "antibacterial envelope" product used with implantable heart devices reduced major infection rates by more than 90%, researchers and the product manufacturers report. It’s always advisable to infuse a bit of skepticism in reviewing claims and study findings by medical corporations, but this sounds like a promising solution to the problem of infections in patients with cardiovascular implantable electronic device (CIEDs). (Use of brand names should not be considered as an endorsement.)

According to a press release, the use of TYRX, Inc.’s AIGISRx® Antibacterial Envelope reduced major infection rates by more than 90% in patients undergoing CIED replacement procedures compared to similar high-risk cohorts. The results of the CITADEL & CENTURION clinical study results were presented recently in Denver at the Late Breaking Clinical Trials session at Heart Rhythm 2013 , the Heart Rhythm Society’s 34th annual scientific meeting.

CITADEL / CENTURION is a prospective, multicenter clinical study to evaluate the major device infection and mechanical complication rates in the 12 months after implantation, in patients at high risk for CIED infection who have their CIED implanted with an AIGISRx Antibacterial Envelope. Study patients were enrolled at 55 US centers, and were at high-risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (CITADEL), or a cardiac resynchronization therapy (CRT) device (CENTURION). Key study findings include: • The CITADEL / CENTURION cohort at 90 days of follow-up had 95% fewer major CIED infections than the pre-defined published control cohort of 533 ICD and CRT replacement procedures (Gould et al. JAMA 2006, 295(16); 1907-1911) which had a major CIED infection rate of 1.88% at a mean follow-up of 81 days (0.1% vs. 1.88%; P0.001). • The CITADEL / CENTURION cohort at 90 days of follow-up had 94% fewer major infections than the 45-day major infection rate of 1.7% reported for the cohort of 1081 ICD/CRT replacement procedures in the Ontario ICD Database (Krahn et al. Circulation Arrhythmia and Electrophysiology 2011 4(2) 136-42 (0.1% vs. 1.7%; P0.001). • There was 1 major infection (0.1%), the primary efficacy endpoint of the study, after 90 days of follow-up. There were 11 minor infections (limited to the incision and skin) (1.1%). • The incidence of the most common mechanical complication, major hematomas (1.5%), was not significantly different than the pre-defined control cohort (2.3%; P = NS). • There were no unanticipated serious AIGISRx-related adverse events. There were 20 (2%) deaths, none related to the AIGISRx.