Bacterial infections on the surface of medical devices are a significant problem in therapeutic approach, especially when implants are used in the living. In cardiology, pacemaker generator pocket surfaces, made in ti...Bacterial infections on the surface of medical devices are a significant problem in therapeutic approach, especially when implants are used in the living. In cardiology, pacemaker generator pocket surfaces, made in titanium alloy can be colonized by pathogen microorganism. This contamination represents a major risk of sepsis, endocarditis and localized infections for patients. A way to limit this bacterial contamination is to modify the surface topography using nano-structuration process of the titanium alloy surface of the implanted devices. The aim of this study is to evaluate the influence of TiO<sub>2</sub> nanotube layers on bacterial infection in the living, considering the feasibility of an animal model of chronic foreign body infection. TiO<sub>2</sub> nanotube layers prepared by electrochemical anodization of Ti foil in 0.4 wt% hydrofluoric acid solution were implanted subcutaneously in Wistar rats. Three weeks after implantation, TiO<sub>2</sub> implants were contaminated by a Staphylococcus epidermilis strain using two different concentrations at 10<sup>6</sup> and 10<sup>8</sup> colony forming unit (CFU) in order to induce a sufficient infection level and to avoid unwanted over infection consequences on rats health during the experiments. After 28 days in the living, 75% of nanotube layers initially submitted to the 10<sup>8</sup> CFU inoculum were contaminated while only 25% nanotube layers initially submitted to the 10<sup>6</sup> CFU inoculum remained infected. This significant result underlines the influence of TiO<sub>2</sub> nanotube layers in decreasing the infection level. Our in vitro experiments showed that the synthesized TiO<sub>2</sub> nanotubes indeed decreased the Staphylococcus epidermilis adhesion compared to unanodized Ti foil.展开更多
Background Many recipients of implantable cardiac electronic devices have atrial fibrillation （AF） occurrences after device implantation, even if there is no previous history of AF, and some of the episodes are asym...Background Many recipients of implantable cardiac electronic devices have atrial fibrillation （AF） occurrences after device implantation, even if there is no previous history of AF, and some of the episodes are asymptomatic. The purpose of this study was to evaluate trends in AF burden following early AF detection in patients treated with pacemakers equipped with automatic, daily Home Monitoring function. Methods Between February 2009 and December 2010, the registry recruited 701 pacemaker patients （628 dual-chamber, 73 biventricular devices） at 97 clinical centers in China. Daily Home Monitoring data transmissions were analyzed to screen for the AF burden. In-office follow-ups were scheduled for 3 and 6 months after implantation. Upon first AF （i.e., mode-switch） detection in a patient, screening olAF burden by Home Monitoring was extended for the next 180 days. Results At least one episode of AF was observed in 22.9% of patients with dual-chamber pacemakers and in 28.8% of patients with biventricular pacemakers. The first AF detection in a patient occurred, on average, about 2 months before scheduled follow-up visits. In both pacemaker groups, mean AF burden decreased significantly （P〈0.05） over 180 days following first AF detection： from 12.0% to 2.5% in dual-chamber and from 12.2% to 0.5% in biventricular pacemaker recipients. The number of patients with an AF burden 〉10% per month was significantly reduced over 6 months of implantation in both dual chamber （38 patients in the first month vs. 21 patients in month 6, P〈0.05） and biventricular （7 patients in the first month vs. 0 patient in months 4-6, P〈0.05） pacemaker recipients. Conclusions Automatic, daily Home Monitoring of patients treated with cardiac pacemakers allows early detection of AF, and there is a gradual and significant decrease in AF burden.展开更多
目的:系统评价心脏植入式电子设备(CIED)植入术后设备感染(DRI)的风险预测模型。方法:通过计算机检索PubMed、Embase、Web of Science、Cochrane图书馆、CINAHL、中国生物医学文献数据库、中国知网、维普网、万方数据库中与CIED植入术后...目的:系统评价心脏植入式电子设备(CIED)植入术后设备感染(DRI)的风险预测模型。方法:通过计算机检索PubMed、Embase、Web of Science、Cochrane图书馆、CINAHL、中国生物医学文献数据库、中国知网、维普网、万方数据库中与CIED植入术后DRI风险预测模型相关的文献,检索时间为从建库至2023年12月2日。由2名研究者独立筛选文献、提取资料并完成纳入文献的偏倚风险与适用性评价。结果:共纳入16项研究,模型总体适用性较好,但偏倚风险较高,ROC曲线的AUC为0.67~0.96。11项研究完成了内部验证,5项研究进行了外部验证。囊袋和(或)电极重置/装置升级、肾功能不全或肾功能衰竭、年龄、植入埋藏式心脏复律除颤器或心脏再同步化治疗、使用抗凝药是DRI的预测因子。结论:目前CIED植入术后DRI风险预测模型整体性能较好,适用性较好,但偏倚风险较高。需在数据来源、变量筛选、模型评价等方面提高研究质量,开展前瞻性队列研究,完善现有模型的外部验证,并积极研发适用于我国人群的预测模型。展开更多
文摘Bacterial infections on the surface of medical devices are a significant problem in therapeutic approach, especially when implants are used in the living. In cardiology, pacemaker generator pocket surfaces, made in titanium alloy can be colonized by pathogen microorganism. This contamination represents a major risk of sepsis, endocarditis and localized infections for patients. A way to limit this bacterial contamination is to modify the surface topography using nano-structuration process of the titanium alloy surface of the implanted devices. The aim of this study is to evaluate the influence of TiO<sub>2</sub> nanotube layers on bacterial infection in the living, considering the feasibility of an animal model of chronic foreign body infection. TiO<sub>2</sub> nanotube layers prepared by electrochemical anodization of Ti foil in 0.4 wt% hydrofluoric acid solution were implanted subcutaneously in Wistar rats. Three weeks after implantation, TiO<sub>2</sub> implants were contaminated by a Staphylococcus epidermilis strain using two different concentrations at 10<sup>6</sup> and 10<sup>8</sup> colony forming unit (CFU) in order to induce a sufficient infection level and to avoid unwanted over infection consequences on rats health during the experiments. After 28 days in the living, 75% of nanotube layers initially submitted to the 10<sup>8</sup> CFU inoculum were contaminated while only 25% nanotube layers initially submitted to the 10<sup>6</sup> CFU inoculum remained infected. This significant result underlines the influence of TiO<sub>2</sub> nanotube layers in decreasing the infection level. Our in vitro experiments showed that the synthesized TiO<sub>2</sub> nanotubes indeed decreased the Staphylococcus epidermilis adhesion compared to unanodized Ti foil.
文摘Background Many recipients of implantable cardiac electronic devices have atrial fibrillation （AF） occurrences after device implantation, even if there is no previous history of AF, and some of the episodes are asymptomatic. The purpose of this study was to evaluate trends in AF burden following early AF detection in patients treated with pacemakers equipped with automatic, daily Home Monitoring function. Methods Between February 2009 and December 2010, the registry recruited 701 pacemaker patients （628 dual-chamber, 73 biventricular devices） at 97 clinical centers in China. Daily Home Monitoring data transmissions were analyzed to screen for the AF burden. In-office follow-ups were scheduled for 3 and 6 months after implantation. Upon first AF （i.e., mode-switch） detection in a patient, screening olAF burden by Home Monitoring was extended for the next 180 days. Results At least one episode of AF was observed in 22.9% of patients with dual-chamber pacemakers and in 28.8% of patients with biventricular pacemakers. The first AF detection in a patient occurred, on average, about 2 months before scheduled follow-up visits. In both pacemaker groups, mean AF burden decreased significantly （P〈0.05） over 180 days following first AF detection： from 12.0% to 2.5% in dual-chamber and from 12.2% to 0.5% in biventricular pacemaker recipients. The number of patients with an AF burden 〉10% per month was significantly reduced over 6 months of implantation in both dual chamber （38 patients in the first month vs. 21 patients in month 6, P〈0.05） and biventricular （7 patients in the first month vs. 0 patient in months 4-6, P〈0.05） pacemaker recipients. Conclusions Automatic, daily Home Monitoring of patients treated with cardiac pacemakers allows early detection of AF, and there is a gradual and significant decrease in AF burden.
文摘目的:系统评价心脏植入式电子设备(CIED)植入术后设备感染(DRI)的风险预测模型。方法:通过计算机检索PubMed、Embase、Web of Science、Cochrane图书馆、CINAHL、中国生物医学文献数据库、中国知网、维普网、万方数据库中与CIED植入术后DRI风险预测模型相关的文献,检索时间为从建库至2023年12月2日。由2名研究者独立筛选文献、提取资料并完成纳入文献的偏倚风险与适用性评价。结果:共纳入16项研究,模型总体适用性较好,但偏倚风险较高,ROC曲线的AUC为0.67~0.96。11项研究完成了内部验证,5项研究进行了外部验证。囊袋和(或)电极重置/装置升级、肾功能不全或肾功能衰竭、年龄、植入埋藏式心脏复律除颤器或心脏再同步化治疗、使用抗凝药是DRI的预测因子。结论:目前CIED植入术后DRI风险预测模型整体性能较好,适用性较好,但偏倚风险较高。需在数据来源、变量筛选、模型评价等方面提高研究质量,开展前瞻性队列研究,完善现有模型的外部验证,并积极研发适用于我国人群的预测模型。
