Elsevier

Heart Rhythm

Volume 18, Issue 12, December 2021, Pages 2061-2069
Heart Rhythm

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

https://doi.org/10.1016/j.hrthm.2021.08.026Get rights and content

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.

Introduction

More than 1 million pacemakers are implanted worldwide every year.1 Modern bipolar pacemaker leads are expected to have a 10-year survival of 94%–98%.2 Manufacturer product performance reports suggest 97%–99% 5-year survival.3, 4, 5, 6 However, product performance reports are subject to reporting bias and may underestimate the true lead malfunction rate.7 The pacing lead has long been considered to be the weakest aspect of the implantable pacing system, and percutaneous lead extraction of chronic pacemaker leads can be challenging and occasionally require surgical removal.8 Desire to remove the lead, and its attendant risks, from the pacing system has lead to the development and increasing expansion of leadless pacemakers.9

Current surveillance databases with long-term follow-up are currently limited to manufacturer product performance reports as well as some health system databases, such as the National Surveillance Center through the Veterans Administration. Pacemaker lead recalls are less common than implantable cardioverter-defibrillator (ICD) lead recalls, but have still occurred—notably with the Telectronics Accufix active fixation lead and the Medtronic 4004/4004M pacing lead.10, 11, 12

There have been recent reports that the Tendril family of pacemaker leads (Abbott Laboratories, Chicago, IL) may have higher than expected rates of lead abnormalities, primarily manifesting as lead noise, compared with other contemporary pacemaker leads.13 However, it has been suggested that the increased noise detection may be due to different sensing algorithms in the Abbott generators, which do not represent actual lead malfunction.14 Many of the published studies have been small, and based on the currently available data, it is not clear whether the increased lead noise results in increased lead extraction or revision or can be managed with device reprogramming and monitoring alone.

To investigate this further, we performed a systematic review and meta-analysis of available data to examine the incidence of lead abnormalities and lead extraction or revision for the current commercially available active fixation pacemaker leads.

Section snippets

Search strategy

We performed an electronic search of MEDLINE/PubMed, Embase, and Scopus databases to identify studies that examined pacemaker lead longevity and lead abnormality or malfunction. Specific search terms are in Online Supplemental Table 1. The search was limited to humans, English language, and adults from inception to March 2021. Two reviewers (R.V.K. and E.M.) independently performed the title, abstract, and full-text review. Conflicts were settled by a third reviewer (A.O.). Studies were

Search results

The electronic search resulted in 3263 unique studies, 581 full-text papers were examined for eligibility, and 8 studies were included for the analysis (Online Supplemental Figure 1).20, 21, 22, 23, 24, 25, 26, 27 Study characteristics are in summarized Table 1. Details on the included pacemaker leads are provided in Table 2. All the included studies were at a moderate or severe risk of bias, but none were critical (Online Supplemental Figure 2). The total number of pacemaker leads examined was

Discussion

The main findings of this meta-analysis are as follows:

  • 1.

    Abbott pacing leads have higher abnormality rates than do leads of other manufacturers.

  • 2.

    Abbott lead abnormalities are not completely related to device/generator algorithms.

  • 3.

    Abbott leads have a higher rate of lead revision or extraction than do leads of other manufacturers.

To our knowledge, this is the first meta-analysis to examine contemporary pacemaker leads. There have now been multiple reports of increased lead abnormalities for Abbott

Conclusion

Abbott pacemaker leads are associated with an increased rate of electrical abnormalities compared with other manufacturers, which is not completely explained by generator detection algorithms. In most cases, conservative management with monitoring or reprogramming is effective. Abbott leads are also associated with an increased risk of reprogramming and lead revision or extraction. It remains unclear whether many of the lead revisions or extractions could have been avoided with reprogramming

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  • Cited by (5)

    Funding sources: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

    Disclosures: Dr Dhruva has received funding from the National Heart, Lung, and Blood Institute of the National Institutes of Health (K12HL138046), Food and Drug Administration, the National Evaluation System for Health Technology Coordinating Center, Greenwall Foundation, Arnold Ventures, and the National Institute for Health Care Management. The rest of the authors report no conflicts of interest.

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