Key result
Use of an antibacterial envelope during neuromodulation device placement reduced culture-confirmed infections compared to a historical cohort (2.1% vs 11.9%; ARR 9.85%, 95% CI 4.3-15.4; P<.01).
Why the study?
Neuromodulation unit placement carries a high infection rate, and although antibiotic-impregnated envelopes prevent infections in implantable cardiac devices, their efficacy in neuromodulation device placement needed assessment.
Does the use of antibacterial envelopes reduce the rate of culture-confirmed infections in patients undergoing neuromodulation implantable pulse generator placement?
Cohort (n=301)
No
Does the use of antibacterial envelopes reduce the rate of culture-confirmed infections in patients undergoing neuromodulation implantable pulse generator placement?
The use of antibacterial envelopes during neuromodulation implantable pulse generator placement is associated with a significant reduction in culture-confirmed infections compared to a historical cohort.
May support envelope use in neuromodulation implants; hypothesis-generating and requires randomized confirmation before practice change.
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.
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Persad et al. (2022) conducted a cohort in Neuromodulation device placement (n=301). Antibacterial envelope vs. Historical cohort without envelope usage was evaluated on Culture-confirmed infections (ARR 9.85%, 95% CI 4.3-15.4, p=<.01). Use of an antibacterial envelope during neuromodulation device placement reduced culture-confirmed infections compared to a historical cohort (2.1% vs 11.9%; ARR 9.85%, 95% CI 4.3-15.4; P<.01).
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