More antibiotics may not benefit high-risk patients undergoing cardiac device implantation
Click Here to Manage Email Alerts
Key takeaways:
- Chlorhexidine skin preparation, IV antibiotics and an antibiotic envelope may be enough to prevent infection.
- Additional antibiotic measures did not improve infection risk after cardiac device implantation.
Antibiotic irrigation and oral antibiotics on top of chlorhexidine skin preparation, IV antibiotics and antibiotic envelope did not provide additional benefit for high-risk patients after cardiac device implantation, researchers reported.
The results of the ENVELOPE trial were published in Circulation: Arrhythmia and Electrophysiology.
Image: Adobe Stock
“The TYRX-a antimicrobial envelope has been shown to reduce cardiac implantable electronic device infections in the WRAP-IT trial” Christopher R. Ellis, MD, FACC, associate professor of cardiac electrophysiology and director of the cardiac electrophysiology laboratory and the left atrial appendage closure program at Vanderbilt University Medical Center, and colleagues wrote. “Intensified antibiotic prophylaxis in a predominate pacemaker population did not provide meaningful cardiac implantable electronic device infection reduction in the PADIT trial. The combination has not been tested.”
The ENVELOPE trial
The ENVELOPE trial was a prospective, randomized controlled trial that enrolled 1,010 patients at six global sites (mean age, 70.4 years; 73% men) with at least two risk factors for infection who underwent cardiac implantable electronic device (CIED) procedures.
Infection risk factors included diabetes, chronic kidney disease, therapeutic systemic anticoagulation, chronic HF, chronic corticosteroid use, fever or leukocytosis within 24 hours of implant, device revision, more than three leads in situ, pocket reentry within 2 weeks after prior procedure or previous CIED infection, according to the study.
Participants were randomly assigned to the study arm or control arm. The study arm received pocket wash with 500 mL antibiotic solution and postoperative antibiotics for 3 days on top of prophylactic control measures. The control arm received standard chlorhexidine skin preparation, IV antibiotics and the antibiotic envelope (TYRX-a, Medtronic).
Participants attended an in-person wound check with digital photography at 2 weeks, 3 months and 6 months after device implantation, the researchers wrote.
The primary endpoint was CIED infection and system removal at 6 months.
Additional antibiotics not beneficial
The most frequent device type was cardiac resynchronization therapy-defibrillator followed by dual-chamber implantable cardioverter defibrillator system and dual-chamber pacemaker.
Overall, the rate of infection requiring device removal was low in both arms and was not significantly different (1% in the control arm vs. 1.2% in the study arm; P = .74). A total of 11 patients required device removal, the researchers reported.
Among those who required device removal due to infection, time from implant to removal was 107 days on average.
Overall, the average Prevention of Arrhythmia Device Infection Trial (PADIT) score was 7.4 and the 1-year mortality rate was 64%, according to the study.
PADIT score was 8.4 in the control group and 6.7 among patients who received antibiotic pocket wash and postoperative antibiotics (P = .32).
Moreover, prior CIED infection was independently associated with device removal at 6 months in all patients (OR = 9.77; P = .004). Three of the 11 patients requiring device removal had a prior CIED infection, and all three died of sepsis before study completion, the researchers wrote.
“Patients undergoing cardiac implantable electronic device procedures who are high risk for infection and receive a TYRX-a envelope derive no benefit from additional antibiotics (oral, or pocket irrigation),” they wrote. “The anecdotal practice of irrigating a cardiac implantable electronic device pocket with antibiotics or sending a patient home with oral antibiotics post-procedure should be abandoned.”
Collapse
Click Here to Manage Email Alerts