Abstract 16990: First In-Human Implantations of a New Fully Resorbable Antibiotic Envelope During Cardiac Implantable Electronic Device (CIED) Procedures
Background: Infection at time of CIED implantation or replacement is associated with significant morbidity, mortality and costs. The observed infection rate is 1.6% to 2.4% and increasing with major comorbidities. One strategy to reduce the infection risk is to use a non-resorbable envelope impregnated with antibiotics (rifampin and minocycline effective for ± 7-10 days). A previous small series reported a reduction in the infection rate from 3% to 0.4%. A new version of this envelope (AIGISRX R/TYRX, Inc.) is designed to be fully resorbable in ± 9 weeks, leaving no material behind. We therefore performed the first implants in humans.
Methods and Results: Eleven patients undergoing new CIED implants or replacements/upgrades were prospectively included in this validation period. The mean age of this cohort was 66.6 years, 3 were diabetics and 2 had renal failure. Four new CIED implants were included (2 ICDs and 2 pacemakers). Three CIED replacements (1 CRT, 1 DDD pacemaker, 1 ICD patient with mechanical valves) and 4 upgrades procedures (lead extraction, lead revision, new ICD and/or pacing leads) were performed. One procedure was a sub-pectoral implant. All patients were seen in the device clinic one month after implant. The mean follow-up was 73 days. No complication was seen and no infection was observed. This cohort is still being followed. One patient required a lead revision (lead dislodgement) 35 days after the implantation. No residual envelope material was seen in the pocket during the revision procedure.
Conclusions: This is the first human cohort implanted with a new fully resorbable antibacterial envelope. During this short follow-up, no complication and no CIED infection were observed. At 35 days, a revision procedure confirmed that no residual material was seen in the pocket. This new technology may prove to reduce the infection risk significantly, without leaving any residual foreign body in the pocket.
- © 2013 by American Heart Association, Inc.