ClinicalElectrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis
Graphical abstract
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
References (34)
- et al.
The 11th world survey of cardiac pacing and implantable cardioverter-defibrillators: calendar year 2009—a World Society of Arrhythmia’s project
Pacing Clin Electrophysiol
(2011) - et al.
Updated appraisal of pacing lead performance from the Danish Pacemaker Register: the reliability of bipolar pacing leads has improved
Pacing Clin Electrophysiol
(2000) - Product Performance Report. 2nd Edition 2020. Biotronik Web site....
Cardiac Rhythm & Heart Failure Product Performance Report. 1st Edition, Issue 84. 2021
Abbott Web site
Boston Scientific Web site
- et al.
Defibrillator lead survival: where is the threshold?
Circ Cardiovasc Qual Outcomes
(2020) - et al.
Late manifestation of coronary sinus and left atrial perforation of a left ventricular pacemaker lead at extraction
Pacing Clin Electrophysiol
(2016) - et al.
Early performance of a miniaturized leadless cardiac pacemaker: the Micra Transcatheter Pacing Study
Eur Heart J
(2015) - et al.
Cardiac perforation due to a fracture of a recalled Accufix bipolar active fixation pacing lead 29 years after implantation: a case report
J Cardiovasc Electrophysiol
(2021)
Pacemaker recall highlights security concerns for implantable devices
Circulation
Multicenter experience with a bipolar tined polyurethane ventricular lead
Pacing Clin Electrophysiol
The saga of tendril leads continues: should we continue to bury our heads in the sand?
J Cardiovasc Electrophysiol
Detection of high-frequency artifact as a function of pulse generator algorithms and outer-insulation material
Heart Rhythm
2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction
Heart Rhythm
Pacing inhibition after biventricular implantable cardioverter defibrillator upgrade: what is the mechanism?
Pacing Clin Electrophysiol
Imputing missing standard deviations in meta-analyses can provide accurate results
J Clin Epidemiol
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.