Electrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis,Heart Rhythm

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Electrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis
Heart Rhythm ( IF 5.6 ) Pub Date : 2021-08-28 , DOI: 10.1016/j.hrthm.2021.08.026
Roshni V Khatiwala ₁ , Elizabeth Mullins ₁ , Dali Fan ₂ , Uma N Srivatsa ₂ , Sanket S Dhruva ₃ , Adam Oesterle ₃

Affiliation

Background

Although there is a paucity of contemporary data on pacemaker lead survival rates, small studies suggest that some leads may have higher malfunction rates than do others.

Objective

The purpose of this study was to determine the malfunction rates of current pacemaker leads.

Methods

A meta-analysis including studies that examined the non–implant-related lead malfunction rates of current commercially available active fixation pacemaker leads was performed. An electronic search of MEDLINE/PubMed, Scopus, and Embase was performed. DerSimonian and Laird random effects models were used.

Results

Eight studies with a total of 14,579 leads were included. Abbott accounted for 10,838 (74%), Medtronic 2510 (17%), Boston Scientific 849 (6%), and MicroPort 382 (3%) leads. The weighted mean follow-up period was 3.6 years. Lead abnormalities occurred in 5.0% of all leads, 6.1% of Abbott leads, 1.1% of Medtronic, 1.4% of Boston Scientific, and 5.5% of MicroPort. The most common lead abnormality was lead noise with normal impedance. Abbott leads were associated with an increased risk of abnormalities (relative risk [RR] 7.81; 95% confidence interval [CI] 3.21–19.04), reprogramming (RR 7.95; 95% CI 3.55–17.82), and lead revision or extraction (RR 8.91; 95% CI 3.36–23.60). Abbott leads connected to an Abbott generator had the highest abnormality rate (8.0%) followed by Abbott leads connected to a non-Abbott generator (4.7%) and non-Abbott leads connected to an Abbott generator (0.4%).

Conclusions

Abbott leads are associated with an increased risk of abnormalities compared with leads of other manufacturers, primarily manifesting as lead noise with normal impedance, and are associated with an increased risk of lead reprogramming and lead revision or extraction.

中文翻译：

St. Jude/Abbott 起搏导联的电异常：系统评价和荟萃分析

背景

尽管目前关于起搏器导线存活率的数据很少，但小型研究表明，某些导线的故障率可能高于其他导线。

客观的

本研究的目的是确定当前起搏器导联的故障率。

方法

进行了一项荟萃分析，其中包括检查当前市售有源固定起搏器导线的非植入相关导线故障率的研究。对 MEDLINE/PubMed、Scopus 和 Embase 进行了电子检索。使用了 DerSimonian 和 Laird 随机效应模型。

结果

共纳入 8 项研究，共有 14,579 条线索。雅培占 10,838 (74%)、美敦力 2510 (17%)、波士顿科学 849 (6%) 和微创 382 (3%) 领先。加权平均随访时间为 3.6 年。5.0% 的导联、6.1% 的 Abbott 导联、1.1% 的 Medtronic、1.4% 的 Boston Scientific 和 5.5% 的 MicroPort 导联出现异常。最常见的导线异常是阻抗正常的导线噪声。Abbott 引线与异常风险增加相关（相对风险 [RR] 7.81；95% 置信区间 [CI] 3.21–19.04）、重新编程（RR 7.95；95% CI 3.55–17.82）和引线修正或拔除（RR 8.91；95% CI 3.36–23.60)。连接到 Abbott 发生器的 Abbott 导联异常率最高 (8.0%)，其次是连接到非 Abbott 发生器的 Abbott 导联 (4.