植入型心臟電子裝置感染的危險因素和預防進展

孫慧 綜述 華偉 審校

(中國醫學科學院 阜外醫院，北京 100037)

1 背景

植入型心臟電子裝置(cardiac implantable electronic device,CIED)指永久起搏器、植入型心臟轉復除顫器(implantable cardioverter defibrillator,ICD)和心臟再同步化治療除顫器，近年來手術量明顯增加，隨之而來的相關感染問題愈加引起重視。盡管花費逐年上升，CIED感染相關病死率仍高達4.5%，且在老年人中有上升趨勢[1]。

CIED的1年感染發生率據報道總體為0.9%～2.4%[2-8]，某地區一項回顧了14年數據的調查研究顯示每1 000 CIED年中有2.45例感染發生[9]。關于更加復雜的裝置，ICD的感染發生率為0.6%～1.2%，心臟再同步化治療除顫器為1.0%～3.5%[2,10]。

CIED感染導致患者再入院，醫療機構負擔加重[7]，感染患者較植入后未發生感染者病死率至少增加40%，無論是否得到適當的處理[11]。CIED相關感染性心內膜炎的病死率為36%，從出現臨床表現到死亡的中位數時間為95 d[12]。

2 CIED感染的危險因素

2.1 患者相關

統計學分析顯示與患者臨床特征相關的CIED感染危險因素包括：年齡、男性、非洲裔美洲人種、糖尿病[2,4]、腎功能不全、慢性阻塞性肺疾病、惡性腫瘤、心力衰竭、術前發熱、皮膚異常狀況、應用皮質類固醇藥物、抗凝藥物等[9,13-14]。

相較于腎功能正常的人群，慢性腎臟病患者更易發生CIED感染，無論是否透析。對于沒有接受透析治療的患者，應用皮質類固醇藥物增加CIED感染風險；對于接受透析治療者慢性阻塞性肺疾病則是危險因素[15]。

Mittal等[2]利用7項臨床指標歸納總結出了一個評分系統，可能對預測CIED感染的風險分層有益。此外，年齡、轉移性腫瘤、腎功能衰竭、射血分數減低和皮質類固醇藥物使用是影響CIED感染再入院和病死率的獨立危險因素[7,16-17]。

2.2 操作相關

導致CIED感染的常見病原體包括凝固酶陰性葡萄球菌和金黃色葡萄球菌[14,16]。有研究分別比較了氯己定乙醇和碘伏，水性碘伏和乙醇碘伏在皮膚消毒方面的效能，結果對比1年的感染發生率均未見顯著性差異[4,18]。佩戴雙層手套，先后應用乙醇和碘伏消毒皮膚、切口以及囊袋內面，并附以4 d的預防性抗生素應用，可使感染發生率降至0.26%[19]。一個由三步皮膚消毒法構成的預防措施也被證明有益，包括手術前晚應用乙醇消毒前胸，手術前10 min應用碘伏消毒，手術中在切開皮膚前再應用碘伏消毒[20]。

系統分析顯示操作相關的感染危險因素包括：術后血腫、因導線脫位而再次切開、裝置移除或更換、未預防性應用抗生素、臨時起搏、缺乏經驗的術者以及操作時間延長[3,9,13-14,18]。術前1 h預防性應用抗生素的措施已被廣泛認可[21]，然而在切口縫合后局部應用抗生素卻是無益的[14]。

在BRUISE CONTROL INFECTION研究中，植入術后出現有臨床意義的血腫的患者11%發生了感染，而這一比例在術后未出現血腫的患者中為1.5%。血腫是CIED感染的獨立預測因素，可使植入術后1年內的感染風險增加>7倍，無論是否經驗性地應用了抗生素[5,20]。對于因裝置升級或更換的再次手術，一項前瞻性隨機單盲對照試驗得出結論認為，囊袋剝脫不但對預防感染無益，還可顯著增加血腫發生率[22]。

2.3 裝置相關

CIED感染除了通過臨床表現判斷，還可以利用18氟-脫氧葡萄糖正電子發射/CT顯像在囊袋區域高度敏感、特異地早期檢出，尤其是最終需要移除的CIED囊袋感染[23]。

科學家和制造商針對CIED感染已研發出了數種應對方案。在抗感染生物材料方面，將由同種血漿和血小板配以利福平和米諾環素合成的一種生物材料包裹于CIED脈沖發生器周圍，這一方法在體外實驗和活體實驗中均觀察到了抗感染的效果[24]。

回顧性研究顯示抗菌的CIED封膜對于預防感染在療效和經濟投入方面均有獲益[2,25]，對比可吸收和不可吸收CIED封膜的抗菌效果并無顯著性差異[26]；但是，目前正在進行中的WRAP-IT試驗，一項前瞻性、多中心、隨機、單盲試驗，力圖為可吸收的抗菌CIED封膜在預防感染方面的效能尋求更有力的證據[27]。

腹部囊袋、心外膜導線、留置2根或3根導線以及雙腔系統均易導致裝置感染[13]。對于經靜脈植入ICD后感染的患者，改為植入皮下ICD可作為一個合理的選擇[28]，植入皮下ICD不經中心靜脈，因而可避免中心靜脈狹窄和感染的風險，這對接受血液透析的慢性腎臟病患者是至關重要的[29]。

此外，在因感染而移除ICD后等待再次植入的間期，可穿戴式ICD可作為對心臟驟停的保護措施，此方法優于單純地住院或醫療看護[30]。

3 總結

近年來CIED感染問題愈發突出，增加了醫療系統和政府的經濟負擔。對于此問題重在預防，謹慎地評估患者的手術適應證、臨床特點和合并癥，特別是具有CIED感染危險因素的患者。術前預防性應用抗生素和皮膚消毒必須嚴格執行，提高手術操作技術以避免組織損傷、血腫，縮短操作時間。旨在預防CIED感染的生物材料正在逐步開發中，其中抗菌性CIED封膜具有臨床應用前景，針對其療效的多中心隨機對照試驗正在進行中。

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