Canadian Registry of Electronic Device outcomes (CREDO): the Abbott ICD Premature Battery Depletion Advisory, a multicentre cohort study

Abstract 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 with data from a Canadian registry. Methods/Results This is a prospective observational study including patients with an Abbott device subject to the Advisory from nine centres in Canada . The incidence and outcomes related to device revision due to premature battery depletion were identified and adjudicated by a committee. 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 patient request in 5 patients (0.2%). A total of 63 (2.4%) of 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 due 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 associated with the battery performance of devices under advisory.