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Electrical Abnormalities with St. Jude/Abbott Pacing Leads: A Systematic Review and Meta-analysis.

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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 others. OBJECTIVE To determine… Click to show full abstract

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 others. OBJECTIVE 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 2,510 (17%), Boston Scientific 849 (6%), and Microport 382 (3%) of the leads. The weighted mean follow up was 3.6 years. Lead abnormalities occurred in 5.0% of all leads; 6.1% for Abbott leads, 1.1% for Medtronic, 1.4% for Boston Scientific, and 5.5% for Microport. The most common lead abnormality was lead noise with normal impedance. Abbott leads were associated with an increased risk of abnormalities (RR 7.81; 95% CI 3.21 - 19.04), reprogramming (RR 7.95; 95% CI 3.55-17.82), and lead revision/extraction (RR 8.91; 95% CI 3.36-23.60). Abbott leads connected to an Abbott generator 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 to other manufacturers, primarily manifesting as lead noise with a normal impedance, and are associated with an increased risk of lead reprogramming and lead revision or extraction.

Keywords: malfunction rates; abbott leads; abbott; meta analysis

Journal Title: Heart rhythm
Year Published: 2021

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