植入型心脏电子装置感染的危险因素和预防进展

孙慧 综述 华伟 审校

(中国医学科学院 阜外医院，北京 100037)

1 背景

植入型心脏电子装置(cardiac implantable electronic device,CIED)指永久起搏器、植入型心脏转复除颤器(implantable cardioverter defibrillator,ICD)和心脏再同步化治疗除颤器，近年来手术量明显增加，随之而来的相关感染问题愈加引起重视。尽管花费逐年上升，CIED感染相关病死率仍高达4.5%，且在老年人中有上升趋势[1]。

CIED的1年感染发生率据报道总体为0.9%～2.4%[2-8]，某地区一项回顾了14年数据的调查研究显示每1 000 CIED年中有2.45例感染发生[9]。关于更加复杂的装置，ICD的感染发生率为0.6%～1.2%，心脏再同步化治疗除颤器为1.0%～3.5%[2,10]。

CIED感染导致患者再入院，医疗机构负担加重[7]，感染患者较植入后未发生感染者病死率至少增加40%，无论是否得到适当的处理[11]。CIED相关感染性心内膜炎的病死率为36%，从出现临床表现到死亡的中位数时间为95 d[12]。

2 CIED感染的危险因素

2.1 患者相关

统计学分析显示与患者临床特征相关的CIED感染危险因素包括：年龄、男性、非洲裔美洲人种、糖尿病[2,4]、肾功能不全、慢性阻塞性肺疾病、恶性肿瘤、心力衰竭、术前发热、皮肤异常状况、应用皮质类固醇药物、抗凝药物等[9,13-14]。

相较于肾功能正常的人群，慢性肾脏病患者更易发生CIED感染，无论是否透析。对于没有接受透析治疗的患者，应用皮质类固醇药物增加CIED感染风险；对于接受透析治疗者慢性阻塞性肺疾病则是危险因素[15]。

Mittal等[2]利用7项临床指标归纳总结出了一个评分系统，可能对预测CIED感染的风险分层有益。此外，年龄、转移性肿瘤、肾功能衰竭、射血分数减低和皮质类固醇药物使用是影响CIED感染再入院和病死率的独立危险因素[7,16-17]。

2.2 操作相关

导致CIED感染的常见病原体包括凝固酶阴性葡萄球菌和金黄色葡萄球菌[14,16]。有研究分别比较了氯己定乙醇和碘伏，水性碘伏和乙醇碘伏在皮肤消毒方面的效能，结果对比1年的感染发生率均未见显著性差异[4,18]。佩戴双层手套，先后应用乙醇和碘伏消毒皮肤、切口以及囊袋内面，并附以4 d的预防性抗生素应用，可使感染发生率降至0.26%[19]。一个由三步皮肤消毒法构成的预防措施也被证明有益，包括手术前晚应用乙醇消毒前胸，手术前10 min应用碘伏消毒，手术中在切开皮肤前再应用碘伏消毒[20]。

系统分析显示操作相关的感染危险因素包括：术后血肿、因导线脱位而再次切开、装置移除或更换、未预防性应用抗生素、临时起搏、缺乏经验的术者以及操作时间延长[3,9,13-14,18]。术前1 h预防性应用抗生素的措施已被广泛认可[21]，然而在切口缝合后局部应用抗生素却是无益的[14]。

在BRUISE CONTROL INFECTION研究中，植入术后出现有临床意义的血肿的患者11%发生了感染，而这一比例在术后未出现血肿的患者中为1.5%。血肿是CIED感染的独立预测因素，可使植入术后1年内的感染风险增加>7倍，无论是否经验性地应用了抗生素[5,20]。对于因装置升级或更换的再次手术，一项前瞻性随机单盲对照试验得出结论认为，囊袋剥脱不但对预防感染无益，还可显著增加血肿发生率[22]。

2.3 装置相关

CIED感染除了通过临床表现判断，还可以利用18氟-脱氧葡萄糖正电子发射/CT显像在囊袋区域高度敏感、特异地早期检出，尤其是最终需要移除的CIED囊袋感染[23]。

科学家和制造商针对CIED感染已研发出了数种应对方案。在抗感染生物材料方面，将由同种血浆和血小板配以利福平和米诺环素合成的一种生物材料包裹于CIED脉冲发生器周围，这一方法在体外实验和活体实验中均观察到了抗感染的效果[24]。

回顾性研究显示抗菌的CIED封膜对于预防感染在疗效和经济投入方面均有获益[2,25]，对比可吸收和不可吸收CIED封膜的抗菌效果并无显著性差异[26]；但是，目前正在进行中的WRAP-IT试验，一项前瞻性、多中心、随机、单盲试验，力图为可吸收的抗菌CIED封膜在预防感染方面的效能寻求更有力的证据[27]。

腹部囊袋、心外膜导线、留置2根或3根导线以及双腔系统均易导致装置感染[13]。对于经静脉植入ICD后感染的患者，改为植入皮下ICD可作为一个合理的选择[28]，植入皮下ICD不经中心静脉，因而可避免中心静脉狭窄和感染的风险，这对接受血液透析的慢性肾脏病患者是至关重要的[29]。

此外，在因感染而移除ICD后等待再次植入的间期，可穿戴式ICD可作为对心脏骤停的保护措施，此方法优于单纯地住院或医疗看护[30]。

3 总结

近年来CIED感染问题愈发突出，增加了医疗系统和政府的经济负担。对于此问题重在预防，谨慎地评估患者的手术适应证、临床特点和合并症，特别是具有CIED感染危险因素的患者。术前预防性应用抗生素和皮肤消毒必须严格执行，提高手术操作技术以避免组织损伤、血肿，缩短操作时间。旨在预防CIED感染的生物材料正在逐步开发中，其中抗菌性CIED封膜具有临床应用前景，针对其疗效的多中心随机对照试验正在进行中。

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