Clinical Pearls & Morning Reports
Published May 15, 2019
It is estimated that 1.5 million patients receive cardiac implantable electronic devices (CIEDs) worldwide every year. Tarakji et al. conducted a randomized, controlled, postmarketing, interventional clinical trial that assessed whether adjunctive therapy with an absorbable, antibiotic-eluting mesh envelope, designed to hold a CIED, was more effective at preventing infection associated with CIED implantations than standard infection-control strategies alone. Read the Original Article here.
Q: How common is CIED infection?
A: CIED infection is a rare but serious event, and its management requires prolonged hospitalization, which involves device and lead extraction with adjunctive antibiotic therapy. The risk of major complications with lead extraction is low, approximately 1 to 2%, but these can be fatal. Despite proper management of CIED infection, morbidity and both short- and long-term mortality remain high.
Q: What antibiotics are eluted from the envelope designed to reduce CIED infections?
A: The envelope is constructed from a multifilament knitted mesh and coated with an absorbable polymer mixed with minocycline and rifampin, which elutes the antibiotics into the local tissue for a minimum of 7 days. The envelope is fully absorbed in approximately 9 weeks.
A: The trial by Tarakji et al. showed that in a population of patients who were at increased risk for CIED pocket infection, the envelope was significantly more effective at preventing infection than standard infection-control strategies alone. The efficacy objective was met, with 40% fewer patients in the envelope group than in the control group having a major infection through 12 months of follow-up. The envelope was successfully implanted in 99.7% of procedure attempts, and the safety objective was met, because the envelope group did not have a higher incidence of CIED procedure-related or system-related complications than the control group.
A: Although the use of the envelope may require dissection to create a slightly larger CIED pocket, Tarakji et al. did not observe a significant difference in the rate of complications (e.g., hematoma) or procedure time that could be attributed to this. There were fewer system revisions in the envelope group than in the control group and no complications due to allergy to the envelope mesh, polymer, or antibiotics.