基于生物标志物的起搏器和植入式心律转复除颤器囊袋感染诊断：一项前瞻性、多中心、病例对照评估。
Biomarker-based diagnosis of pacemaker and implantable cardioverter defibrillator pocket infections: A prospective, multicentre, case-control evaluation.
作者信息
Lennerz Carsten, Vrazic Hrvoje, Haller Bernhard, Braun Siegmund, Petzold Tobias, Ott Ilka, Lennerz Agnes, Michel Jonathan, Blažek Patrick, Deisenhofer Isabel, Whittaker Peter, Kolb Christof
机构信息
Klinik für Herz- und Kreislauferkrankungen, Abteilung für Elektrophysiologie, Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
Department of Internal Medicine, Division of Cardiology, University Hospital Dubrava, School of Medicine, University of Zagreb, Zagreb, Croatia.
出版信息
PLoS One. 2017 Mar 6;12(3):e0172384. doi: 10.1371/journal.pone.0172384. eCollection 2017.
BACKGROUND
The use of cardiac implantable electronic devices (CIED) has risen steadily, yet the rate of cardiac device infections (CDI) has disproportionately increased. Amongst all cardiac device infections, the pocket infection is the most challenging diagnosis. Therefore, we aimed to improve diagnosis of such pocket infection by identifying relevant biomarkers.
METHODS
We enrolled 25 consecutive patients with invasively and microbiologically confirmed pocket infection. None of the patients had any confounding conditions. Pre-operative levels of 14 biomarkers were compared in infected and control (n = 50) patients. Our selected biomarkers included white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), lipopolysaccharide binding protein, high-sensitivity C-reactive protein (HS-CRP), polymorphonuclear-elastase, presepsin, various interleukins, tumor necrosis factor α (TNF-α), and granulocyte macrophage colony-stimulating factor (GM-CSF).
RESULTS
Of the 25 patients with isolated pocket infection (70±13years, 76% male, 40% ICDs), none presented with leukocytosis. In contrast, they had higher serum levels of HS-CRP (p = 0.019) and PCT (p = 0.010) than control patients. Median PCT-level was 0.06 ng/mL (IQR 0.03-0.07 ng/mL) in the study group versus 0.03 ng/mL (IQR 0.02-0.04 ng/mL) in controls. An optimized PCT cut-off value of 0.05 ng/mL suggests pocket infection with a sensitivity of 60% and specificity of 82%. In addition TNF-α- and GM-CSF-levels were lower in the study group. Other biomarkers did not differ between groups.
CONCLUSION
Diagnosis of isolated pocket infections requires clinical awareness, physical examination, evaluation of blood cultures and echocardiography assessment. Nevertheless, measurement of PCT- and HS-CRP-levels can aid diagnosis. However, no conclusion can be drawn from normal WBC-values.
CLINICAL TRIAL REGISTRATION
clinicaltrials.gov identifier: NCT01619267.
背景
心脏植入式电子设备（CIED）的使用量稳步上升，但心脏设备感染（CDI）的发生率却不成比例地增加。在所有心脏设备感染中，囊袋感染是最具挑战性的诊断。因此，我们旨在通过识别相关生物标志物来改善此类囊袋感染的诊断。
方法
我们连续纳入了25例经侵入性和微生物学确诊的囊袋感染患者。所有患者均无混杂情况。比较了感染患者和对照组（n = 50）患者术前14种生物标志物的水平。我们选择的生物标志物包括白细胞计数（WBC）、C反应蛋白（CRP）、降钙素原（PCT）、脂多糖结合蛋白、高敏C反应蛋白（HS-CRP）、多形核弹性蛋白酶、可溶性髓系细胞触发受体-1、各种白细胞介素、肿瘤坏死因子α（TNF-α）和粒细胞巨噬细胞集落刺激因子（GM-CSF）。
结果
在25例孤立性囊袋感染患者中（70±13岁，76%为男性，40%植入植入式心律转复除颤器），无一例出现白细胞增多。相比之下，他们的血清HS-CRP（p = 0.019）和PCT（p = 0.010）水平高于对照组患者。研究组的PCT中位数水平为0.06 ng/mL（四分位间距0.03 - 0.07 ng/mL），而对照组为0.03 ng/mL（四分位间距0.02 - 0.04 ng/mL）。优化后的PCT临界值为0.05 ng/mL，提示囊袋感染的敏感性为60%，特异性为82%。此外，研究组的TNF-α和GM-CSF水平较低。其他生物标志物在两组之间无差异。
结论
孤立性囊袋感染的诊断需要临床意识、体格检查、血培养评估和超声心动图检查。尽管如此，PCT和HS-CRP水平的测量有助于诊断。然而，白细胞计数正常无法得出结论。
临床试验注册
clinicaltrials.gov标识符：NCT01619267。
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