Results from the CITADEL/CENTURION study have shown 95% fewer major cardiovascular implantable electronic device (CIED) infections in patients undergoing CIED replacement procedures using an antibacterial envelope (AIGISRx, Tyrx). Charles Henrikson, chief of Electrophysiology, Oregon Health Sciences University, USA, presented the prospective data on 1,000 patients at a Late Breaking Clinical Trials session at Heart Rhythm 2013 (8–11 May, Denver, USA).
CITADEL (AIGISRx envelope for prevention of infection following replacement with an implantable cardioverter defibrillator) / CENTURION (AIGISRx envelope for prevention of infection following replacement with a cardiac resynchronisation therapy device) was a prospective, multicentre clinical study designed 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 centres, and were at high-risk for infection because they were undergoing a CIED replacement procedure with an implantable cardioverter-defibrillator (ICD), (the CITADEL arm), or a cardiac resynchronisation therapy (CRT) device (the CENTURION arm).
The endpoints of the study were major and minor CIED infections and mechanical complication.
The key findings of the trials, according to Henrikson, were:
- 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) which had a major CIED infection rate of 1.88% at a mean follow-up of 81 days (0.1% vs. 1.88%; p<0.001).
- 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 , 0.1% vs. 1.7%, p<0.001).
- There was one 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 antibacterial envelope-related adverse events. There were 20 (2%) deaths, none related to the antibacterial envelope.
In the presentation Henrikson said that 1,000 patients showed 95% fewer major CIED infections in patients undergoing CIED replacement procedures using the antibacterial envelope compared to similar high-risk cohorts.
“CIED infections are increasing in frequency, are associated with substantial morbidity, mortality, and cost, and present significant challenges to patients and for the physicians who provide care for them,” said Henrikson.
“The use of an antibacterial envelope in CIED procedures at higher risk for device infection was associated with very low 90-day CIED infection rates. Use of the antibacterial envelope was not associated with unanticipated serious, device-related adverse events,” he concluded.