Cleary Daniel R, Palan Mihir J, Useinovic Nemanja, Burchiel Kim J
1Department of Neurological Surgery and.
2School of Medicine, Oregon Health & Science University, Portland, Oregon.
J Neurosurg. 2025 Jan 31;142(6):1589-1598. doi: 10.3171/2024.9.JNS241705. Print 2025 Jun 1.
Implanted neuromodulatory devices are important for the surgical management of pain, epilepsy, movement disorders, and spasticity. These devices are surgically implanted, but many must be periodically explanted and replaced as batteries deplete or devices fail. Replacement surgery risks further infections that require device explantation, incur large financial costs, and reduce patient quality of life. To reduce infection rates, a single surgeon began using vancomycin-impregnated absorbable calcium sulfate delayed-response beads with neuromodulatory device and intrathecal pump primary implantations and replacements. The infection rates when using vancomycin-impregnated beads were compared with previously published rates from the same surgeon.
Patients were identified who underwent primary placement or replacement of an implanted neuromodulatory control device (pumps, generators, and stimulators) with vancomycin-impregnated absorbable calcium sulfate beads between 2019 and 2022. Control data were obtained from patients who underwent surgery prior to the start of using antibiotic beads (2016-2019). Postoperative infection status as well as de-identified demographic and clinical data were extracted from electronic health records. Patients were stratified by use of antibiotic beads, device type, and whether they had an infection within 1 year requiring explantation. Statistical comparisons were made using independent t-tests, Fisher's exact test, and the chi-square test, with α set at 0.05. Effect size was calculated using Cohen's h statistic.
A total of 665 surgeries were included for 611 patients who received antibiotic beads with device implantation, compared to 393 surgeries for 379 patients without antibiotic beads. The postoperative wound infection rate was 1.5% (n = 10 patients) versus 3.6% (n = 14 patients) for antibiotic beads versus controls (p = 0.03). When stratified by device type, a significant reduction in infection rate was found only with deep brain stimulation (DBS) generators (3.4% for controls vs 0.2% for beads, p = 0.002), which corresponds to a small to medium effect size (h = 0.27).
The use of vancomycin-impregnated absorbable calcium sulfate beads was associated with a reduced rate of postoperative infection rates with implantable devices, and specifically for DBS primary implantation and replacement surgeries.
植入式神经调节装置对于疼痛、癫痫、运动障碍和痉挛的外科治疗至关重要。这些装置通过手术植入，但许多装置必须在电池耗尽或出现故障时定期取出并更换。更换手术有导致进一步感染的风险，这需要取出装置，会产生高昂的经济成本，并降低患者的生活质量。为降低感染率，一位外科医生开始在神经调节装置和鞘内泵初次植入及更换手术中使用万古霉素浸渍的可吸收硫酸钙延迟反应珠。将使用万古霉素浸渍珠时的感染率与该外科医生之前公布的感染率进行比较。
确定2019年至2022年间接受植入式神经调节控制装置（泵、发生器和刺激器）初次植入或更换手术并使用万古霉素浸渍可吸收硫酸钙珠的患者。对照数据来自在开始使用抗生素珠之前接受手术的患者（2016 - 2019年）。从电子健康记录中提取术后感染状况以及去识别化的人口统计学和临床数据。患者按是否使用抗生素珠、装置类型以及是否在1年内发生需要取出装置的感染进行分层。使用独立t检验、Fisher精确检验和卡方检验进行统计学比较，α设定为0.05。使用Cohen's h统计量计算效应大小。
共有611例接受装置植入并使用抗生素珠的患者进行了665次手术，相比之下，379例未使用抗生素珠的患者进行了393次手术。抗生素珠组的术后伤口感染率为1.5%（n = 10例患者），对照组为3.6%（n = 14例患者）（p = 0.03）。按装置类型分层时，仅在脑深部刺激（DBS）发生器方面发现感染率显著降低（对照组为3.4%，珠组为0.2%，p = 0.002），这对应于小到中等效应大小（h = 0.27）。
使用万古霉素浸渍的可吸收硫酸钙珠与植入式装置术后感染率降低相关，特别是对于DBS初次植入和更换手术。
