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使用再消毒的起搏器和除颤器不会增加感染率
作者:小柯机器人 发布时间:2020/5/8 13:07:42

加拿大蒙特利尔心脏研究所Paul Khairy团队取得新进展。他们分析了植入再消毒起搏器和除颤器相关的感染。2020年5月7日,该成果发表在《新英格兰医学杂志》上。

在资源有限的地方,使用起搏器和除颤器存在一些问题。有人将富裕国家死亡患者的植入式心脏装置进行再消毒和再利用,但感染风险的不确定性令人担忧。

1983年一个多国计划启动,向服务不足的国家提供经过检测和再消毒的起搏器和除颤器;2003年建立了前瞻性注册。在该项目中接受重复使用设备的患者与在加拿大接受新设备植入的对照患者的比例为1:3。主要结果是感染或与器械相关的死亡。

共有1051名患者被植入了再消毒的装置,平均年龄为63.2岁,43.6%为女性。其中36.0%的患者来自墨西哥,28.1%来自多米尼加共和国,26.6%来自危地马拉,9.3%来自洪都拉斯。总体而言,有85%的患者使用了起搏器,15%的患者使用了除颤器,其中一导联占55.5%,二导联占38.8%,三导联占5.7%。

这些患者和3153名匹配的对照患者间的基线特征没有差异。在2年的随访中,重复使用装置组中有21例患者(2.0%)发生感染,而新装置组中有38例(1.2%),风险比为1.66。两组均未发生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。

总之,在服务不足的国家/地区接受再消毒和再利用的起搏器或除颤器的患者中,2年内感染或设备相关死亡率为2.0%,与在加拿大使用新设备的匹配对照组患者相比,并没有显著差异。

附:英文原文

Title: Infections Associated with Resterilized Pacemakers and Defibrillators

Author: Thomas F. Khairy,, Marie-Andrée Lupien, B.Sc.,, Santiago Nava, M.D.,, Frank Valdez Baez, M.D.,, Fernando Solares Ovalle, M.D.,, Nery E. Linarez Ochoa, M.D.,, Gerardo Sosa Mendoza, M.D.,, Cesar A. Carrazco, M.D.,, Christine Villemaire, M.Sc.,, Richard Cartier, M.Sc.,, Denis Roy, M.D.,, Mario Talajic, M.D.,, Marc Dubuc, M.D.,, Bernard Thibault, M.D.,, Peter G. Guerra, M.D.,, Lena Rivard, M.D.,, Katia Dyrda, M.D.,, Blandine Mondésert, M.D.,, Rafik Tadros, M.D., Ph.D.,, Julia Cadrin-Tourigny, M.D.,, Laurent Macle, M.D.,, and Paul Khairy, M.D., Ph.D.

Issue&Volume: 2020-05-07

Abstract: Abstract

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.

DOI: 10.1056/NEJMoa1813876

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1813876

 

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home