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Infections Associated with Resterilized Pacemakers and Defibrillators.
The New England Journal of Medicine ( IF 158.5 ) Pub Date : 2020-05-07 , DOI: 10.1056/nejmoa1813876
Thomas F Khairy 1 , Marie-Andrée Lupien 1 , Santiago Nava 1 , Frank Valdez Baez 1 , Fernando Solares Ovalle 1 , Nery E Linarez Ochoa 1 , Gerardo Sosa Mendoza 1 , Cesar A Carrazco 1 , Christine Villemaire 1 , Richard Cartier 1 , Denis Roy 1 , Mario Talajic 1 , Marc Dubuc 1 , Bernard Thibault 1 , Peter G Guerra 1 , Lena Rivard 1 , Katia Dyrda 1 , Blandine Mondésert 1 , Rafik Tadros 1 , Julia Cadrin-Tourigny 1 , Laurent Macle 1 , Paul Khairy 1
Affiliation  

BACKGROUND Access to pacemakers and defibrillators is problematic in places with limited resources. Resterilization and reuse of implantable cardiac devices obtained post mortem from patients in wealthier nations have been undertaken, but uncertainty around the risk of infection is a concern. METHODS A multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices in this program were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk. RESULTS Resterilized devices were implanted in 1051 patients (mean [±SD] age, 63.2±18.5 years; 43.6% women) in Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97 to 2.83; P = 0.06); there were no device-related deaths. The most common implicated pathogens were Staphylococcus aureus and S. epidermidis. CONCLUSIONS Among patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.

中文翻译:

与消毒的起搏器和除颤器相关的感染。

背景技术在资源有限的地方使用起搏器和除颤器是有问题的。已经从较富裕国家的患者进行了验尸后对可植入心脏设备进行了再消毒和再利用,但是人们担心感染的风险仍存在不确定性。方法1983年发起了一个跨国计划,向服务水平低下的国家提供经过测试和消毒的起搏器和除颤器。我们在2003年建立了前瞻性注册表。在该计划中,接受了重复使用设备的患者与在加拿大接受新设备植入的对照组患者的比例为1:3。主要结果是感染或与设备有关的死亡,其他原因造成的死亡被建模为竞争风险。结果1051例患者(平均[±SD]年龄,63.2±18.5岁; 43。墨西哥(36.0%),多米尼加共和国(28.1%),危地马拉(26.6%)和洪都拉斯(9.3%)的女性为6%。总体而言,有85%的患者使用了起搏器,而15%的患者使用了除颤器,其中有一个(55.5%),两个(38.8%)或三个(5.7%)的导线。这些患者和3153名匹配的对照患者之间的基线特征没有差异。在随访的2年中,有21例患者(2.0%)使用了重复使用的器械,38例(1.2%)使用了新器械的患者发生了感染(危险比,1.66; 95%置信区间,0.97至2.83; P = 0.06) ; 没有设备相关的死亡事件。最常见的病原体是金黄色葡萄球菌和表皮葡萄球菌。结论在服务不足的国家/地区接受了重新消毒和重复使用的起搏器或除颤器的患者中,感染或设备相关死亡的发生率在2年为2.0%,
更新日期:2020-05-07
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