Shawcross James, Bakhai Ameet, Ansaripour Ali, Armstrong James, Lewis David, Agg Philip, De Godoy Roberta, Blunn Gordon
Accentus Medical Ltd, Didcot, UK.
Department of Cardiology, Royal Free London NHS Trust, London, UK.
Open Heart. 2017 Apr 11;4(1):e000357. doi: 10.1136/openhrt-2015-000357. eCollection 2017.
Evidence suggests that the rate of cardiovascular implantable electronic device (CIED) infections is increasing more rapidly than the rates of CIED implantation and is associated with considerable mortality, morbidity and health economic impact. Antimicrobial surface treatments are being developed for CIEDs to reduce the risk of postimplantation infection within the subcutaneous implant pocket.
The feasibility of processing cardiac pacemakers with the Agluna antimicrobial silver ion surface technology and in vivo biocompatibility were evaluated. Antimicrobially processed (n=6) and control pacemakers (n=6) were implanted into subcutaneous pockets and connected to a part of the muscle using an ovine model for 12 weeks. Pacemaker function was monitored preimplantation and postimplantation.
Neither local infection nor systemic toxicity were detected in antimicrobial or control devices, and surrounding tissues showed no abnormal pathology or over-reactivity. Semiquantitative scores of membrane formation, cellular orientation and vascularity were applied over five regions of the pacemaker capsule and average scores compared. Results showed no significant difference between antimicrobially processed and control pacemakers. Silver analysis of whole blood at 7 days found that levels were a maximum of 10 parts per billion (ppb) for one sample, more typically ≤2 ppb, compared with <<2 ppb for preimplantation levels, well below reported toxic levels.
There was no evidence of adverse or abnormal pathology in tissue surrounding antimicrobially processed pacemakers, or deleterious effect on basic pacing capabilities and parameters at 12 weeks. This proof of concept study provides evidence of basic biocompatibility and feasibility of applying this silver ion-based antimicrobial surface to a titanium pacemaker surface.
有证据表明，心血管植入式电子设备（CIED）感染率的增长速度比CIED植入率更快，且与相当高的死亡率、发病率及健康经济影响相关。目前正在研发用于CIED的抗菌表面处理技术，以降低皮下植入囊袋内植入后感染的风险。
评估了采用Agluna抗菌银离子表面技术处理心脏起搏器的可行性及体内生物相容性。将经过抗菌处理的起搏器（n = 6）和对照起搏器（n = 6）植入皮下囊袋，并使用绵羊模型连接到部分肌肉上，持续12周。在植入前和植入后监测起搏器功能。
在抗菌或对照设备中均未检测到局部感染或全身毒性，周围组织也未显示出异常病理或过度反应。在起搏器囊膜的五个区域应用膜形成、细胞取向和血管形成的半定量评分，并比较平均评分。结果显示，经过抗菌处理的起搏器与对照起搏器之间无显著差异。在第7天对全血进行银分析发现，一个样本中的银含量最高为十亿分之十（ppb），更常见的是≤2 ppb，而植入前水平<<2 ppb，远低于报告的毒性水平。
没有证据表明经过抗菌处理的起搏器周围组织存在不良或异常病理，也没有证据表明在12周时对基本起搏能力和参数有有害影响。这项概念验证研究提供了基本生物相容性的证据，以及将这种基于银离子的抗菌表面应用于钛制起搏器表面的可行性。
