Using an antibacterial envelope can significantly lower the risk of infection among patients who develop hematomas after receiving a cardiac implantable electronic device (CIED), according to new findings published in Heart Rhythm.
“Implant site hematoma is a known complication of CIED procedures,” wrote lead author Khaldoun G. Tarakji, MD, associate section head for cardiac electrophysiology at the Cleveland Clinic’s Heart and Vascular Institute, and colleagues. “The overall incidence of hematoma has been reported to be in the range of 1.2% to 9.5% and is associated with other serious consequences such as device infection, cessation of oral anticoagulant therapy, prolonged hospitalization, increased healthcare costs, morbidity and mortality. Many patients that require CIED procedures have comorbidities that necessitate the use of anticoagulation therapy and balancing the risks of interrupted therapy vs. bleeding due to continued therapy presents additional challenges.”
This analysis represented a 36-month update of data originally gathered by Tarakji’s team for the WRAP-IT study in 2019. The group tracked data from more than 3,300 patients treated with Medtronic’s Tyrx Absorbable Antibacterial Envelope during the implantation of a CIED and more than 3,400 control patients who were not treated with the envelope during their implantation.
Overall, the authors found patients treated with and without the envelope experienced comparable rates of hematomas. However, use of the envelope was associated with an 82% reduction in the risk of a major CIED infection.
“Major CIED infections, the endpoint used for this analysis, were defined as infections that resulted in CIED system removal, an invasive CIED procedure, treatment with long-term antibiotic therapy with infection recurrence after discontinuation of antibiotic therapy or death,” the authors explained.
Additional findings from this analysis are scheduled to be presented at Heart Rhythm 2021, the annual scientific sessions of the Heart Rhythm Society.
The study, which was funded by Medtronic, can be read in full here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.