Assessing the safety of implantable cardioverter‐defibrillator reuse—A retrospective case‐control study

Abstract

Aims The safety of pacemaker reuse has been proven by numerous studies in the last two decades. With the exception of one research paper, the safety of reuse of implantable cardioverter‐defibrillators has not been properly investigated. Our aim was to establish whether resterilized implantable cardioverter‐defibrillators are as safe as new devices in relation to functionality and infection rates. Methods All the patients (n = 271) implanted with a new or a donated, used implantable cardioverter‐defibrillator (ICD) at the Institute of Cardiovascular Disease Timisoara Romania between January 2001 and December 2012 were included in the study. The patients had class I indication for ICD implantation. One hundred fifty‐seven patients received reused ICDs and 114 patients received new ICDs. Complications were defined as infections that required reintervention, device malfunction, and replacements due to untimely or unexpected battery depletion. Results Complications occurred in 4.38% of the patients in the new ICD group and in 1.91% of the reused ICD group. The difference was not considered statistically significant (odds ratio 0.28, 95% confidence interval 0.04‐1.82, P = .18). Conclusion According to our data, properly verified and resterilized ICDs are as safe as new devices, when risk of infection or malfunction rates are assessed. Due to the high costs of new ICDs, their safe reuse has profound humanitarian and financial implications.

Safety and Efficacy of Submuscular Implantation With Resterilized Cardiac Implantable Electronic Device in Patients With Device Infection: A Retrospective Observational Study in Taiwan

“…Our results are consistent with those of other studies that compared the clinical outcomes of new vs resterilized CIEDs [ 4 , 9 , 11–13 ]. The combined results provide persuasive evidence of the safety and efficacy of reimplantation of resterilized CIED.…”

“…Several recent studies have reported an infection rate of <5% with resterilized CIEDs, suggesting comparable risk with that of new devices ( Supplementary Table 3 ) [ 4 , 9 , 11–13 ]. In a multinational study that follows the infection outcomes of reused CIEDs that entered the prospective Heart to Heart registry, established in 2003, the rate of device infection at 2 years was 2.0% among the 1051 patients with reused CIEDs and 1.2% among 3153 patients with new devices [ 11 ].…”

“…Before being reimplanted, the resterilized CIED had to fulfill conditions, including no sign of device malfunction during initial implantation, no visual signs of physical damage, and estimated remaining running time of the battery greater than two-thirds of the theoretical total running time [ 9 , 10 ]. Biological residue was thoroughly removed, particularly in the device connector slots, which if still present excluded the device from further use.…”

“…In another meta-analysis, which identified 172 studies published between 2009 and 2017, the authors concluded that CIED resterilization did not significantly increase the risk of infection, malfunction, premature battery depletion, or device-related death [ 8 ]. More recently, a retrospective case–control study indicated that ICD reuse is not associated with increased risk of complications [ 9 ]. However, despite the satisfactory outcomes and established acceptance with resterilization of CIED, data of repeat infection after reimplantation of resterilized CIED are lacking.…”

Reuse of cardiac implantable electronic devices in developing countries perspectives: A literature review

“…Therefore, due to the high cost of new devices, the reuse of used CIEDs appears to be a feasible and safe option, especially when the alternative would be not having any device at all 18–20 . In the European Community there is no uniform policy regarding CIED reuse, while in Romania CIEDs are usually reused, the United Kingdom, France, Spain and Switzerland have published recommendations or prohibitions about reprocessing this type of products 21–23 . Reprocessing CIEDs for reimplantation is not allowed in the United States either, due to the risk of infection 24 .…”