Department of Cardiovascular Medicine, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Center for Cardiovascular Innovation, Division of Cardiology, University of British Columbia Vancouver, British Columbia, Canada.
JACC Clin Electrophysiol. 2022 Jan;8(1):101-111. doi: 10.1016/j.jacep.2021.08.009. Epub 2021 Sep 29.
This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures.
Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies.
This analysis included 2,803 control patients from the WRAP-IT trial who received standard preoperative antibiotics but not the envelope (44 patients with major infections through all follow-up). A multivariate least absolute shrinkage and selection operator machine learning model, controlling for patient characteristics and procedural variables, was used for risk factor selection and identification. Risk factors consistently retaining predictive value in the model (appeared >10 times) across 100 iterations of imputed data were deemed significant.
Of the 81 variables screened, 17 were identified as risk factors with 6 being patient/device-related (nonmodifiable) and 11 begin procedure-related (potentially modifiable). Patient/device-related factors included higher number of previous CIED procedures, history of atrial arrhythmia, geography (outside North America and Europe), device type, and lower body mass index. Procedural factors associated with increased risk included longer procedure time, implant location (non-left pectoral subcutaneous), perioperative glycopeptide antibiotic versus nonglycopeptide, anticoagulant, and/or antiplatelet use, and capsulectomy. Factors associated with decreased risk of infection included chlorhexidine skin preparation and antibiotic pocket wash.
In WRAP-IT patients, we observed that several procedural risk factors correlated with infection risk. These results can help guide infection prevention strategies to minimize infections associated with secondary CIED procedures.
本研究旨在确定二次心脏植入式电子设备（CIED）手术后感染的危险因素。
CIED 感染的危险因素尚未明确，且缺乏支持最小化感染的技术。WRAP-IT（全球随机抗生素包裹感染预防试验）是一项评估抗菌包裹物降低 CIED 感染安全性和有效性的大型研究，该研究提供了有关手术细节和感染预防策略的深入了解。
本分析纳入了 WRAP-IT 试验中的 2803 例接受标准术前抗生素但未使用包裹物的对照患者（所有随访期间有 44 例出现重大感染）。使用多变量最小绝对收缩和选择算子机器学习模型，控制患者特征和手术变量，进行危险因素选择和识别。在 100 次数据插补迭代中，在模型中始终保留预测价值（出现>10 次）的危险因素被认为具有统计学意义。
在筛选的 81 个变量中，有 17 个被确定为危险因素，其中 6 个与患者/设备相关（不可改变），11 个与手术相关（可能改变）。与患者/设备相关的因素包括先前 CIED 手术次数较多、心房颤动史、地理位置（北美和欧洲以外）、设备类型和较低的体重指数。与感染风险增加相关的手术因素包括手术时间较长、植入部位（非左侧胸壁皮下）、围手术期糖肽类抗生素与非糖肽类抗生素、抗凝剂和/或抗血小板药物的使用以及包膜切除术。与感染风险降低相关的因素包括洗必泰皮肤准备和抗生素囊袋冲洗。
在 WRAP-IT 患者中，我们观察到几个手术相关的危险因素与感染风险相关。这些结果可以帮助指导感染预防策略，以尽量减少与二次 CIED 手术相关的感染。
