Background

Limited evidence is available to determine the efficacy of an antibacterial enveloped (AE) cardiovascular implantable electronic device (CIED).

Objective

To assess if the use of antibacterial enveloped devices in high-risk patients are associated with lower chances of major CIED infections and mortality compared to non-enveloped devices.

Methods

A comprehensive literature search on multiple databases was performed. The relative odds ratio (OR) of major CIED infection and mortality was calculated using a random-effect model.

Results

A total of six studies consisting of 11,897 patients, were included; 5844 with an AE-CIED and 6053 with conventional CIED. In the pooled cohort, patients with AE-CIED had a 66% lower odds of major CIED infection (OR 0.34, 0.13, 0.86, CI 95%, p = 0.02) compared to CIED. Propensity matched analysis showed a 71% lower odds of major infection in the AE-CIED group (OR 0.29, 95% CI 0.10–0.82, p = 0.02). Stratified analysis based on the type of study (retrospective vs. prospective) and duration of follow up (6 months vs. greater than six months) also showed numerically lower infection odds in the AE-CIED. Similarly, the relative odds of mortality were lower in patients with AE-CIED (OR 0.55, 95% CI 0.16–1.91, p = 0.34) compared to CIED patients; however, this difference was statistically non-significant.

Conclusion

In high-risk patients, AE-CIED might offer lower odds of CIED infections. It has numerically lower (45%) but statistically non-significant odds of mortality if used in conjunction with the standard infection prevention protocol. More large scale studies and long-term follow-ups are required to validate our findings.

中文翻译：

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抗菌包膜在高危患者中预防心血管可植入电子设备感染的功效：系统评价和荟萃分析。

背景

有限的证据可用于确定抗菌包膜（AE）心血管可植入电子设备（CIED）的功效。

目的

为了评估在高风险患者中使用抗菌包膜器械是否与非包膜器械相比具有更低的发生重大CIED感染的机会和死亡率。

方法

在多个数据库上进行了全面的文献检索。使用随机效应模型计算主要CIED感染和死亡率的相对优势比（OR）。

结果

总共包括6项研究，包括11,897例患者；带有AE-CIED的5844和带有常规CIED的6053。在合并队列中，与CIED相比，AE-CIED患者发生重大CIED感染的几率降低了66％（OR 0.34、0.13、0.86，CI 95％，p = 0.02）。倾向匹配分析显示，AE-CIED组发生重大感染的几率降低了71％（OR 0.29，95％CI 0.10-0.82，p = 0.02）。根据研究类型（回顾性与前瞻性）和随访时间（6个月对大于6个月）进行的分层分析也显示，AE-CIED的感染几率较低。同样，与CIED患者相比，AE-CIED患者的相对死亡率更低（OR 0.55，95％CI 0.16-1.91，p = 0.34）。但是，这种差异在统计学上不显着。

结论

在高危患者中，AE-CIED可能会降低CIED感染的几率。如果与标准的感染预防方案结合使用，它的死亡率较低（45％），但统计上的死亡率没有统计学意义。需要更大规模的研究和长期的随访来验证我们的发现。