Key result
Abbott leads linked to ~9.2-fold higher electrical abnormalities vs. Medtronic leads.
Why the study?
Electrical lead abnormalities can cause device malfunction and significant morbidity, but their prevalence and management in CIED patients needed determination.
Do Abbott CIED leads have a higher rate of electrical lead abnormalities compared to Medtronic leads in patients with CIEDs?
Cohort (n=2,996)
No
Do Abbott CIED leads have a higher rate of electrical lead abnormalities compared to Medtronic leads in patients with CIEDs?
Answers are grounded in this paper and cite their sources.
Abbott CIED leads are associated with a significantly higher risk of electrical lead abnormalities compared to Medtronic leads, leading to increased clinic visits and lead revisions.
BackgroundElectrical lead abnormalities (ELAs) can result in device malfunction, leading to significant morbidity in patients with cardiac implantable electronic devices (CIEDs).ObjectiveWe sought to determine the prevalence and management of ELAs in patients with CIEDs.MethodsThis was a retrospective cohort study of patients implanted with a CIED between 2012 and 2019 at a tertiary care center. The primary outcome was ELA defined as increased capture threshold (≥2× implantation value), decreased sensing (≤0.5 implantation value), change in impedance (>50% over 3 months), or nonphysiologic potentials. A secondary outcome of device clinic utilization was also collected.ResultsThere were 2996 unique patients (35% female) included with 4600 leads (57% Abbott, 43% Medtronic). ELAs were observed in 135 (3%) leads, including 124 (92%) Abbott and 10 (7%) Medtronic leads (hazard ratio 9.25, P < .001). Mean follow-up was 4.5 ± 2.2 years. ELAs were associated smaller lead French size, atrial location, and Abbott leads. Lead revision was required in 28% of cases. Patients with lead abnormalities had 38% more in-clinic visits per patient year of follow-up compared with those without (P < .001).ConclusionELAs were more frequent in certain models, which increased rates of revision and follow-up. Identification of factors that mitigate these abnormalities to improve lead performance are required to improve care for these devices and provide efficient healthcare. Electrical lead abnormalities (ELAs) can result in device malfunction, leading to significant morbidity in patients with cardiac implantable electronic devices (CIEDs). We sought to determine the prevalence and management of ELAs in patients with CIEDs. This was a retrospective cohort study of patients implanted with a CIED between 2012 and 2019 at a tertiary care center. The primary outcome was ELA defined as increased capture threshold (≥2× implantation value), decreased sensing (≤0.5 implantation value), change in impedance (>50% over 3 months), or nonphysiologic potentials. A secondary outcome of device clinic utilization was also collected. There were 2996 unique patients (35% female) included with 4600 leads (57% Abbott, 43% Medtronic). ELAs were observed in 135 (3%) leads, including 124 (92%) Abbott and 10 (7%) Medtronic leads (hazard ratio 9.25, P < .001). Mean follow-up was 4.5 ± 2.2 years. ELAs were associated smaller lead French size, atrial location, and Abbott leads. Lead revision was required in 28% of cases. Patients with lead abnormalities had 38% more in-clinic visits per patient year of follow-up compared with those without (P < .001). ELAs were more frequent in certain models, which increased rates of revision and follow-up. Identification of factors that mitigate these abnormalities to improve lead performance are required to improve care for these devices and provide efficient healthcare.
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Roberts et al. (2023) conducted a cohort in Cardiac implantable electronic devices (CIEDs) (n=2,996). Abbott leads vs. Medtronic leads was evaluated on Electrical lead abnormality (ELA) (HR 9.25, 95% CI 4.93-17.36, p=<0.001). Abbott manufactured leads were associated with a significantly higher incidence of electrical lead abnormalities compared with Medtronic leads (4.8% vs 0.5%, HR 9.25).
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