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Antibacterial envelope helps prevent cardiac implantable device infection

Stephen Padilla
16 Apr 2019

A recent study has shown that the adjunctive use of an antibacterial envelope significantly reduces incidence of major cardiac implantable electronic device (CIED) infections, without a higher incidence of complications, compared with standard-of-care infection-prevention strategies alone.

“Infections after placement of CIEDs are associated with substantial morbidity and mortality,” researchers said. “There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections.”

This randomized, controlled clinical trial evaluated the safety and efficacy of an absorbable, antibiotic-eluting envelope in lowering the incidence of infection associated with CIED implantations. Researchers randomly assigned patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator, in a 1:1 ratio, to receive envelope or not. All patients received standard-of-care strategies to prevent infection.

Infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months following CIED implantation procedure, was the primary endpoint. Procedure- or system-related complications within 12 months were the secondary endpoints for safety.

Of the patients, 3,495 were randomized to the envelope group and 3,488 to the control group, with a mean follow-up of 20.7±8.5 months. The primary endpoint occurred in 25 and 42 patients in the envelope and control groups, respectively (12-month Kaplan–Meier estimated event rate, 0.7 percent and 1.2 percent, respectively; hazard ratio [HR], 0.60; 95 percent CI, 0.36–0.98; p=0.04). [N Engl J Med 2019;doi:10.1056/NEJMoa1901111]

The secondary endpoints occurred in 201 and 236 patients in the envelope and control groups, respectively (12-month Kaplan–Meier estimated event rate, 6.0 percent and 6.9 percent, respectively; HR, 0.87; 0.72–1.06; pnoninferiority<0.001). Thirty-two patients in the envelope group developed major CIED-related infections over the entire follow-up period, while 51 patients in the control group did (HR, 0.63; 0.40–0.98).

These findings are consistent with those of an earlier study, which found that the use of TYRX antibacterial envelope correlated with a lower rate of major CIED infection rate. [JACC Clin Electrophysiol 2017;3:1158-1167]

Major CIED infection occurred in only five of 1,129 patients treated with TYRX (0.4 percent; 0.0–0.9 percent), significantly lower than the 12-month benchmark rate of 2.2 percent (p=0.0023). Additionally, pocket haematoma was the most common CIED mechanical complication, occurring in 18 of 1,129 patients (1.6 percent; 0.8–2.5).

“TYRX is a monofilament polypropylene mesh impregnated with minocycline and rifampin specifically designed to hold a CIED in place and elute antimicrobials over time,” the authors said.

The last two decades saw a significant increase in the number of patients receiving CIED. CIED-related infection represents a serious complication following CIED implantation and is associated with morbidity and mortality. [J Arrhythm 2016;32:297-302]

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