Arrhythmias & electrophysiology
Randomized Trial of Stand-Alone Use of the Antimicrobial Envelope in High-Risk Cardiac Device Patients
Authors' conclusion
The use of antibiotic pocket irrigation and postoperative oral antibiotics provides no additional benefit to the prophylactic measures of chlorhexidine skin preparation, preoperative intravenous antibiotics, and an antibiotic envelope in reducing CIED infection.
Study context
- Population
- Patients undergoing cardiac implantable electronic device (CIED) procedures with ≥2 risk factors for infection
- Participants
- 1,010 patients
- Comparison
- Antibiotic pocket wash and postoperative antibiotics plus standard prophylaxis vs standard prophylaxis (chlorhexidine, IV antibiotics, TYRX-a envelope)
- Studyn = 505
- Controln = 505reference
- Primary endpoint
- CIED infection and system removal
- Follow-up
- 6 months
Methodological detailsprospective, multicentre, In-person wound check with digital photo 2 weeks postimplant and at 3 and 6 months
- Prospective
- Multicentre
- In-person wound check with digital photo 2 weeks postimplant and at 3 and 6 months
Primary result
As reported in the abstract
CIED infection
P = 0.74
Further findings
| Outcome | OR | P value |
|---|---|---|
| Predictor of CIED system removal at 6 months: prior CIED infection (all subjects)Independent predictor | 9.77 | P = 0.004 |
Subjects with infection and system removal (n = 11)
- Time to study end point (days)
- 107±92
- PADIT score
- 7.4
- 1-year mortality
- 64%
- Infections requiring removal in setting of pocket hematoma
- 5 of 11
Original publication
Randomized Trial of Stand-Alone Use of the Antimicrobial Envelope in High-Risk Cardiac Device Patients. Circ Arrhythm Electrophysiol. Published 24 March 2023. doi:10.
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