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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<\/i> to coincide with the annual meeting of the American College of Cardiology, held from March 16 to 18 in New Orleans.<\/p>\n
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).<\/p>\n
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).<\/p>\n
“These results add to the existing body of literature on the safety and efficacy of the envelope in reducing CIED infections,” the authors write.<\/p>\n
The study was funded by Medtronic.<\/p>\n
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