Use of Antibacterial Envelopes for Prevention of Infection in Neuromodulation Implantable Pulse Generators.

Background: Neuromodulation unit placement carries a historic infection rate as high as 12%. Treatment of such requires surgical removal and a long course of systemic antibiotics. Antibiotic-impregnated envelopes have been effective in preventing infection in implantable cardiac devices. At our center, 1 surgeon uses these envelopes with all implanted neuromodulation units.

Objective: To assess the efficacy of antibacterial envelopes in prevention of infection in neuromodulation device placement.

Methods: We conducted a retrospective cohort study of consecutive implantable pulse generator (IPG) unit implantation with an antibacterial envelope at a single center between October 2014 and December 2019. We collected demographic data, including postoperative infections, reoperations, and complications, associated with the IPGs. This cohort was then compared with a historical cohort of consecutive patients undergoing surgery before envelope usage (October 2007-April 2014).

Results: In the pre-envelope cohort of 151 IPGs placed in 116 patients, there were 18 culture-confirmed infections (11.9%). In the antibacterial envelope cohort of 233 IPGs placed in 185 patients, there were 5 culture-confirmed infections (2.1%). The absolute risk reduction of the antibacterial envelope was 9.85% (95% CI 4.3%-15.4%, P < .01). The number needed to treat was 10.1 (95% CI 6.5-23.1, P < .01) envelopes to prevent 1 IPG infection.

Conclusion: We saw a reduced rate of infections in the antibacterial envelope cohort. Although this is likely multifactorial, our results suggest a benefit of antibacterial envelopes on infection after neuromodulation surgery.