Key result
Premature battery depletion occurred in 5.7% of patients with Boston Scientific devices under advisory compared to 1.1% of those not under advisory, with no instances of compromised therapy.
Why the study?
Certain Boston Scientific ICDs and CRT-Ds manufactured between 2008 and 2014 are subject to premature battery depletion from low-voltage capacitor malfunction, but device lifespan remains generally long and not all at-risk devices are under advisory.
What is the rate of premature battery depletion in Boston Scientific ICDs and CRT-Ds manufactured between 2008 and 2014?
Observational (n=838)
Yes
What is the rate of premature battery depletion in Boston Scientific ICDs and CRT-Ds manufactured between 2008 and 2014?
Answers are grounded in this paper and cite their sources.
Premature battery depletion in specific Boston Scientific ICDs/CRT-Ds occurs in 2.3% of patients, but risk of therapy loss can be mitigated with remote monitoring and regular follow-up without prophylactic generator replacement.
BACKGROUND: Boston Scientific (Marlborough, MA, USA) implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured between 2008 and 2014 are potentially subject to premature battery depletion through a low-voltage capacitor malfunction occurring as a result of hydrogen buildup within the device. Although some of these devices are currently under advisory, other devices manufactured during this timeframe carry a lower risk of the same malfunction. These same devices are known to have superior longevity in general, and the overall mean lifespan of the devices remains long. METHODS: All patients implanted or followed at our two centers who experienced premature battery depletion and had a Boston Scientific ICD or CRT-D potentially at risk for low-voltage capacitor malfunction were studied retrospectively. RESULTS: Nineteen out of 838 patients (2.3%) with devices potentially at risk have had premature battery depletion: 5.7% of those under advisory and 1.1% of those not under advisory. None of our patients had compromised therapy, and all had >27 days of projected battery longevity remaining. CONCLUSIONS: Undetected premature battery depletion in this population of ICDs has the potential to expose a patient to an interval of time where the device is unable to provide therapy. However, with enrollment in remote monitoring, regular follow-up, and attention to audible alerts, the risk of therapy loss due to low-voltage state can be effectively mitigated. For these reasons, prophylactic generator replacement is not recommended.
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Montgomery et al. (2019) conducted an observational in Patients with Boston Scientific ICDs or CRT-Ds potentially at risk for low-voltage capacitor malfunction (n=838). Boston Scientific ICDs or CRT-Ds under advisory vs. Devices not under advisory was evaluated on Premature battery depletion. Premature battery depletion occurred in 5.7% of patients with Boston Scientific devices under advisory compared to 1.1% of those not under advisory, with no instances of compromised therapy.
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