Key result
Advisory-affected Abbott ICDs and CRT devices show low ~1.6% battery failure rate without adverse events.
Why the study?
Premature or rapid battery depletion may compromise ICD performance and reliability, but real-world outcomes and clinical management of devices subject to the Abbott advisory required description.
Does exposure to Abbott ICD and CRT devices subject to the premature battery depletion advisory result in high rates of battery failure or adverse clinical events?
Cohort (n=2,678)
Yes
Does exposure to Abbott ICD and CRT devices subject to the premature battery depletion advisory result in high rates of battery failure or adverse clinical events?
Answers are grounded in this paper and cite their sources.
The low rate of premature battery depletion and absence of related adverse events support current recommendations for active surveillance and enhanced monitoring rather than early prophylactic device replacement.
BACKGROUND: Premature or rapid battery depletion may compromise the performance and reliability of an implantable cardioverter defibrillator (ICD), potentially resulting in harm or death to patients. We sought to describe the outcomes and clinical management of devices included in the Abbott ICD Premature Battery Depletion Advisory, using data from a Canadian registry. METHODS: This prospective observational study includes patients with an Abbott device subject to the advisory, from 9 centres in Canada. The incidence and outcomes related to device revision owing to premature battery depletion were identified and adjudicated by a committee. RESULTS: There were 2678 patients enrolled with a device subject to the advisory. Devices were implanted between 2010 and 2017; follow-up time was 5.7 ± 0.7 years. Device revision occurred in 222 patients (8.3%). Revision for premature battery depletion occurred in 43 patients (1.6%). Devices were revised at physician discretion on notice of the advisory in 16 patients (0.6%), and at patient request in 5 patients (0.2%). A total of 63 (2.4%) devices reached routine end of battery life. A further 95 (3.5%) patients underwent revision for other reasons. There were no reported major complications or adverse events with device revision owing to the advisory. There were no deaths attributed to premature battery depletion. CONCLUSIONS: The rate of premature battery depletion associated with the Abbott ICD Premature Battery Depletion Advisory is low. There were no clinically adverse events identified that were associated with the battery performance of devices under advisory.
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Davis et al. (2020) conducted a cohort in Abbott ICD or CRT devices subject to premature battery depletion advisory (n=2,678). Abbott ICD/CRT devices subject to Premature Battery Depletion Advisory was evaluated on Occurrence of premature battery depletion (PBD) (Annualized rate 0.36%, 95% CI 0.22-0.50). Exposure to Abbott ICD and CRT devices subject to the premature battery depletion advisory was associated with a low failure rate of 1.6% (annualized rate 0.36%) and no clinical adverse events.
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