MONDAY, March 18, 2019 (HealthDay News) -- An antibacterial envelope can reduce the incidence of major cardiac implantable electronic device (CIED) infections, according to a study published online March 17 in the New England Journal of Medicine to coincide with the annual meeting of the American College of Cardiology, held from March 16 to 18 in New Orleans.
Khaldoun G. Tarakji, M.D., M.P.H., from the Cleveland Clinic, and colleagues examined the safety and efficacy of an absorbable, antibiotic-eluting envelope for reducing the incidence of CIED implantation-associated infection. A total of 6,983 patients undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned to either receive the envelope (3,495 patients) or not (3,488 controls).
The researchers found that the primary end point (infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death within 12 months after implantation) occurred in 25 and 42 patients in the envelope and control groups, respectively (12-month Kaplan-Meier estimated event rate, 0.7 versus 1.2 percent; hazard ratio, 0.60; 95 percent confidence interval, 0.36 to 0.98; P = 0.04). The safety end point (procedure-related or system-related complications within 12 months) occurred in 201 and 236 patients in the envelope and control groups, respectively (12-month Kaplan-Meier estimated event rate, 6.0 versus 6.9 percent; hazard ratio, 0.87; 95 percent confidence interval, 0.72 to 1.06; P < 0.001 for noninferiority). Major CIED-related infections occurred in 32 and 51 patients in the envelope and control groups, respectively (hazard ratio, 0.63; 95 percent confidence interval, 0.40 to 0.98).
"These results add to the existing body of literature on the safety and efficacy of the envelope in reducing CIED infections," the authors write.
The study was funded by Medtronic.