• N. Engl. J. Med. · May 2020

    Multicenter Study

    Infections Associated with Resterilized Pacemakers and Defibrillators.

    • Thomas F Khairy, Marie-Andrée Lupien, Santiago Nava, Frank Valdez Baez, Fernando Solares Ovalle, Nery E Linarez Ochoa, Gerardo Sosa Mendoza, Cesar A Carrazco, Christine Villemaire, Richard Cartier, Denis Roy, Mario Talajic, Marc Dubuc, Bernard Thibault, Peter G Guerra, Lena Rivard, Katia Dyrda, Blandine Mondésert, Rafik Tadros, Julia Cadrin-Tourigny, Laurent Macle, and Paul Khairy.
    • From the Montreal Heart Institute, Université de Montréal, Montreal (T.F.K., M.-A.L., C.V., R.C., D.R., M.T., M.D., B.T., P.G.G., L.R., K.D., B.M., R.T., J.C.-T., L.M., P.K.); Instituto Nacional de Cardiologia, Ignacio Chavez, Mexico City (S.N.); the Dominican Institute of Cardiology, Santo Domingo, Dominican Republic (F.V.B.); Clínicas Médicas las Américas, Guatemala City, Guatemala (F.S.O.); and Cardiología Hospital General del Sur, Choluteca (N.E.L.O.), and Instituto Nacional Cardiopulmonar (G.S.M.) and Medicina Interna-Programación de Marcapaso Definitivo, Instituto Nacional Cardiopulmonar, Tegucigalpa (C.A.C.) - all in Honduras.
    • N. Engl. J. Med. 2020 May 7; 382 (19): 1823-1831.

    BackgroundAccess 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.MethodsA 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.ResultsResterilized 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.ConclusionsAmong 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.Copyright © 2020 Massachusetts Medical Society.

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