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Assessing the safety of implantable cardioverter-defibrillator reuse-A retrospective case-control study
Bogdan Enache1,2, Raluca Șoșdean1,2, Răzvan Macarie2
1University of Medicine and Pharmacy "Victor Babes" Timisoara, Timisoara, Romania.
Insights
Properly resterilized implantable cardioverter-defibrillators (ICDs) are as safe as new devices, showing no significant difference in infection or malfunction rates. This finding has significant humanitarian and financial implications due to the high cost of new ICDs.
Area of Science:
- Cardiovascular Medicine
- Biomedical Engineering
- Infectious Disease
Background:
- Pacemaker reuse is well-established, but safety data for implantable cardioverter-defibrillators (ICDs) is limited.
- Previous research on reused ICD safety is scarce, necessitating further investigation.
- High costs of new ICDs prompt exploration of safe reuse options.
Purpose of the Study:
- To evaluate the safety of resterilized implantable cardioverter-defibrillators (ICDs) compared to new devices.
- To assess infection and device malfunction rates in patients receiving new versus reused ICDs.
- To determine if reused ICDs are a safe alternative to new devices.
Main Methods:
- A study included 271 patients receiving new or reused ICDs between 2001 and 2012.
- Complications were defined as infections requiring reintervention, device malfunction, or premature battery depletion.
- Statistical analysis compared complication rates between the new and reused ICD groups.
Main Results:
- Complication rates were 4.38% for new ICDs and 1.91% for reused ICDs.
- The difference in complication rates was not statistically significant (P = .18).
- No significant difference was found in infection or malfunction rates between the two groups.
Conclusions:
- Properly verified and resterilized ICDs are as safe as new devices regarding infection and malfunction.
- The safe reuse of ICDs presents significant humanitarian and financial benefits.
- Further research supports the safe and cost-effective use of reused ICDs.
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.
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