Reuse of pacemakers and implantable cardioverter-defibrillators: systematic review, meta-analysis and quality assessment of the body of evidence

ABSTRACT

Background

Pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) have reduced mortality and improved the quality of life of cardiac patients. However, the high cost of these devices prevents their large-scale incorporation, particularly in low-income countries, where reusing explanted PMs/ICDs has become an alternative.

Methods

A systematic review and meta-analysis were conducted of studies that compare infection rates, device-related deaths, malfunction and premature battery depletion in patients with reused PM and ICD implants and those with new devices. The quality of the body of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework.

Results

The meta-analysis demonstrated no significant intergroup differences in infection rates (OR 0.98; 95% CI 0.60–1.60), device malfunction (OR 1.58; 95% CI 0.56–4.48) or premature battery depletion (OR 1.96; 95% CI 0.81–4.72) and no device-related deaths. Based on GRADE assessment, confidence in estimates for the outcomes infection rate and device-related death was rated as moderate.

Conclusion

The results of this analysis enabled us to conclude that PMs and ICDs can be safely and effectively reused. As such, every effort should be made to overcome regulatory, technical and ethical barriers to ensure implantation.

KEYWORDS:

• Pacemaker
• artificial
• cardiac pacemaker
• cardiac resynchronization therapy devices
• equipment reuse
• reusability
• equipment

Article highlights

• Lack of resources in the populations and health systems of low-income countries have caused inequalities in the treatment of cardiac patients due to the inadequate supply of artificial PMs and implantable cardioverter-defibrillators (ICDs).

• Reuse of these devices has been reported since the 1970s in several case series and cohort studies, but no randomized controlled trials.

• Published systematic reviews indicate no significant difference in clinical outcomes between patients implanted with reused PMs/ICDs and those with new devices. However, arguments and health restrictions against this practice remain in place.

• This systematic review and meta-analysis included recent studies that analyze infection rates, device-related deaths, malfunction and premature battery depletion. The findings corroborate those of previous meta-analyses and concluded that reusing PMs and ICDs is a safe and viable option when new devices are inaccessible.

• This study differs from previous research in that the body of evidence on the topic was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework, which made it possible to classify the confidence in estimates for infection rate and device-related death as moderate.

Acknowledgments

The authors are grateful to Dr. Rosana Evangelista Poderoso (Librarian and Director of the Medical Sciences School Library at Unicamp), Dr. Bernardo dos Santos (Statistician at the Research Support Center of the USP Nursing School) and Dr. Taís Freire Galvão (Pharmacist, Professor at the Faculty of Pharmaceutical Sciences at Unicamp).

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer Disclosures

One peer reviewer is a consultant to Medtronic Inc., and is a member of Speakers Bureau Abbott Labs (SJM). Peer reviewers on this manuscript have no other relevant financial relationships or otherwise to disclose.

Author contributions

Conceived and designed the experiments: EM Psaltikidis EAM Costa KU Graziano. Performed the experiments: EM Psaltikidis EAM Costa KU Graziano. Analyzed the data: EM Psaltikidis EAM Costa KU Graziano. Contributed reagents/materials/analysis tools: EM Psaltikidis EAM Costa KU Graziano. Wrote the paper: EM Psaltikidis EAM Costa KU Graziano. Provided editorial advice: EM Psaltikidis EAM Costa KU Graziano.

Websites

101. Open Science Framework (OSF). https://osf.io/?view_only=

102. GRADE working group. https://www.gradeworkinggroup.org/

103. World Bank Country and Lending Groups. https://datahelpdesk.worldbank.org/knowledgebase/articles/906,519

104. STIM développement. http://www.stim-developpement.org/index.php/fr/nous-connaitre

105. My Heart your Heart program. http://www.myheartyourheart.org/

Additional information

Funding

This paper was not funded.