Patients undergoing cardiac implantable electronic device (CIED) implantation with TYRX, Inc.'s FDA-cleared AIGISRx Antibacterial Envelope enjoyed a 99.5 percent rate of successful implantation with an overall infection rate of 0.48 percent in the first 1.9 months following the procedure, as reported in newly published results of TYRX's COMMAND Clinical Study. There were no infections in patients receiving initial implantations of pacemakers, implantable cardioverter-defibrillators, or cardiac resynchronization therapy devices. The infection rate within the highest risk cohort, ICD/CRT-D replacements/revisions, demonstrated 70 percent fewer infections than some previous studies.
Results of the COMMAND Study included data from 642 consecutive CIED implantation or revision/replacement procedures utilizing the AIGISRx Antibacterial Envelope at 10 U.S. medical centers. The results were published in the October online issue of Pacing and Clinical Electrophysiology, the journal of the International Cardiac Pacing and Electrophysiology Society. "The COMMAND Study provides additional evidence that the AIGISRx Antibacterial Envelope offers physicians an effective means for addressing the significant unmet clinical need for additional CIED infection prophylaxis as described in the American Heart Association and Heart Rhythm Society CRM Infection Guidelines published earlier this year," says Heather Bloom, MD, director of electrophysiology at the Atlanta VA Medical Center, assistant professor of medicine at Emory University, and lead author on the COMMAND Study report.
The COMMAND Study, the first clinical study of patients undergoing CIED implantation with the AIGISRx Antibacterial Envelope, was a retrospective cohort study in patients receiving implantation of a pacemaker, implanted cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device. The primary endpoints of the study were successful CIED implantation and CIED infection. The study enrolled a high proportion of patients with established risk factors for CIED infection: 67.5 percent underwent revision or replacement procedures, and 36.5 percent had procedures with a CRT- defibrillator (CRT-D). Currently, more than 500,000 CIEDs are implanted in the United States each year. CIED infections occur in association with 1 percent to 7 percent of these devices and are associated with significant morbidity, mortality, and expense. The AIGISRx Antibacterial Envelope is designed to reduce infection risk by eluting the antibiotics minocycline and rifampin for seven to 10 days after implantation with the CIED. This antibiotic combination has been shown to reduce infections associated with medical devices in multiple randomized controlled trials.
TYRX chief medical officer, Daniel Lerner, MD, commented, "Previous studies have demonstrated that coating or impregnating medical devices with the antibiotics minocycline and rifampin significantly reduces device-related infections. The COMMAND Study is important because it generated data on the clinical performance of an FDA-cleared device that provides sustained local delivery of these antibiotics in the generator pocket after CIED implantation, in a population at high risk for CIED infection."