Hospital Epidemiology Department - Hospital Infection Control and Health Technology Assessment Department, Clinical Hospital of the University of Campinas - Unicamp, Campinas, SP, Brazil.
Life Sciences Department, Bahia State University, Salvador, BA, Brazil.
Expert Rev Med Devices. 2021 Jun;18(6):553-567. doi: 10.1080/17434440.2021.1927706. Epub 2021 Jun 17.
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.
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.
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.
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.
起搏器（PMs）和植入式心律转复除颤器（ICDs）降低了心脏患者的死亡率并提高了生活质量。然而，这些设备的高成本阻碍了它们的大规模应用，尤其是在低收入国家，重新使用已植入的 PM 和 ICD 已成为一种替代方案。
对比较重新使用的 PM 和 ICD 植入患者与新设备患者的感染率、与设备相关的死亡率、故障和电池过早耗尽的发生率的研究进行了系统评价和荟萃分析。使用推荐评估、制定与评价（GRADE）框架评估证据体的质量。
荟萃分析显示，感染率（OR 0.98；95%CI 0.60-1.60）、设备故障（OR 1.58；95%CI 0.56-4.48）或电池过早耗尽（OR 1.96；95%CI 0.81-4.72）以及与设备相关的死亡方面，组间无显著差异。基于 GRADE 评估，对感染率和与设备相关的死亡这两个结局的估计的置信度被评为中度。
这项分析的结果使我们能够得出结论，PM 和 ICD 可以安全有效地重复使用。因此，应尽一切努力克服监管、技术和伦理障碍，以确保植入。
