心臟植入式電子裝置感染之相關危險因素探討-以北部某醫學中心為例

Abstract

研究動機 心臟植入式電子裝置(Cardiovascular Implantable Electronic Device, CIED)術後併發的囊袋感染與心內膜炎，皆會影響病患心臟疾病的預後，甚至死亡。本研究描述單一醫學中心五年內CIED術後感染的發生率和CIED感染的相關因素。 研究方法 本研究為病歷回溯性研究，以病歷查核方式連續收案五年(2010年1月至2014年12月)在台北某醫學中心接受CIED手術的1890位患者。以描述性統計、獨立樣本檢定，及卡方檢定比較CIED感染組與未感染組，並依據感染發生的時間分為早期感染（＜30天）、晚期感染（1-12個月），與延遲感染（＞12個月），比較早期、晚期，與延遲感染的差異並分析感染相關因素。 研究結果 根據1686位有效樣本，52.8%為男性，年齡約74 ± 17歲，70.8%為首次植入手術，術後3.2%有囊袋血腫，2.8%有早期再手術，平均追蹤3.2 ± 1.7年CIED感染發生率為2.4%，92.7%為局部囊袋感染，高手術量組（n > 200）的感染發生率較低（1.8%）。感染時間分布，以延遲感染最多，佔16人(39%)、晚期感染15人(36.6%)，早期感染10人(24.4%)。 CIED感染的相關因素，比較感染組（n = 41）與未感染組（n = 1645），感染組較年輕（71 ± 21 vs. 74 ± 17, p = 0.03），男性較多（68.3 % vs. 52.4%, p = 0.04），12.2%有CIED感染病史（p < 0.01），12.2%有活動性癌症（p < 0.01），較高比例為第二次以上手術（46.3% vs. 28.8%, p = 0.01），平均手術次數較多（2.4 ± 1.9 vs. 1.4 ± 0.6, p < 0.01），術後有22%出現囊袋血腫（p < 0.01），及19.5%接受早期再介入治療（P < 0.01）。比較早期、晚期，與延遲感染組的差異，早期感染組除了體重過重(Body Mass Index, BMI：26.8 ± 7, p = 0.01)外，有50%病患有術後囊袋血腫(p = 0.03)，並有50%病患接受過早期再介入治療(p < 0.01)。感染個案分析發現29.4%（n = 12）患者有局部囊袋的皮膚問題，其中有2/3（n = 8）為延遲感染組患者，12.2%（n = 5）患者體內有感染源存在，19.6%（n = 8）有術後囊袋血腫，而有22%（n = 9）接受過早期或再次手術。 結論 CIED感染的發生率2.4%，高於國際平均的感染發生率1.3%。建議應及早確認感染相關危險因素、減少非必要的CIED手術、預防囊袋血腫發生及系統性感染，並積極處理皮膚問題，以降低感染發生率。

Background: Cardiovascular Implantable Electronic Device (CIED) related pocket infection and endocarditis affect patients’ prognosis and even caused death. This study described the incidence of 5-year CIED infection and to explore the risk factors and symptom presentation of CIED infection at a single medical center in Northern Taiwan. Methods: A retrospective study using medical chart reviews included 1890 consecutive patients who underwent CIED surgery from January 2010 to December 2014 at a medical center in Taipei. Descriptive and bivariate statistics were used to describe and compare the differences between infected and non-infected groups. The CIED infection was further stratified by time of infection occurred: early-infection (< 30 days of surgery), late-infection (1-12 months), and delayed-infection (>12 months). Risk factors and symptom presentation were also explored by comparing these three stratified infected groups. Results: In total, 1686 qualified subjects were included in this study with 52.8% were males. With a median age of 74 ± 17 years, 70.8% of subjects were first implants, 3.2% had pocket hematoma after operation, and 2.8% had early re-intervention. With the average follow-up years of 3.2 ± 1.7, the CIED infection incidence was 2.4%. Among those, 92.7% had local pocket infections. Stratified by surgeons’ operation volume, incidences varied with only 1.8% in the high-volume (>200 surgeries performed) group. Stratified by time of infection occurred, 39% (n=16) had delayed infection, 36.6% (n=15) had late infection, and 24.4% (n=10) had early infection. Comparing the infected (n=41) and non-infected (n=1645) groups, the infected group was younger, (median age 71 ± 21 vs. 74 ± 17 years for non-infected; p = 0.03), had more males (68.3 % vs. 52.4%; p = 0.04) and higher rates of comorbidities (i.e., 12.2% had a history of CIED infection, and 12.2% had active cancer). They were also more likely to have reoperation (46.3% vs. 28.8%; p = 0.01), received more operations (2.4 ± 1.9 vs. 1.4 ± 0.6 operations; p < 0.01), experienced a high rate of pocket hematoma (22%; p < 0.01), and up to 19.5% (n = 8) had received early re-intervention (p < 0.01). Stratified by time of infection occurred, the early-infected group was more likely be overweight (Body Mass Index, BMI: 26.8 ± 7, p = 0.01), more highly to have pocket hematoma (50%; p = 0.03), and more likely to receive early re-intervention (50%; p < 0.01). As to the presentation of infection, 19.5%（n=8）had pocket hematoma and 29.4% (n=12）had local skin problems with two-third of these subjects (n=8) were in the delay-infected group. On the other end, 12.2% had identifiable infective source in the body. As to the clinical intervention, 22%（n=9）received re-intervention. Conclusion: The incidence of CIED infection in this study was 2.4%, which is higher than the international benchmark of 1.3%. To reduce the incidence of CIED infection, risk factors should be further identified; unnecessary CIED procedures should be avoided; pocket hematoma, systemic infection, and local skin problems should be actively managed.