Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports

Alam, Mian Bilal; Munir, Muhammad Bilal; Rattan, Rishi; Adelstein, Evan; Jain, Sandeep; Saba, Samir

doi:10.1093/europace/euw044

Cited by 15 publications

(29 citation statements)

References 16 publications

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“…The median survival of these implanted devices, published in the latest SJM product performance report, is around 6 years . Several recent studies have reported median longevity of around 5 years for this family of SJM CRT‐Ds . In our study, the median (and mean) longevity of the Promote CRT‐D devices was 5.5 years, which is consistent with these reports.…”

Section: Discussionsupporting

confidence: 92%

“…CRT‐ICDs are known to have lower longevity than SC or DC ICDs. Prior studies have shown that the median longevity of recent CRT‐Ds is around 5 years . Despite significant discrepancy between estimated and actual longevity, the overall longevity of the CRT‐Ds in this study matched expectations based on manufacturer specifications and published data.…”

Section: Discussionsupporting

confidence: 68%

“…Discrepancy was seen during all 18 months prior to ERI and was more marked in SC/DC devices compared to CRT devices. Though there have been several studies comparing the overall device longevity of different models of ICDs of various manufacturers, to the best of our knowledge this is the first study that looked at the correlation between patient‐specific real‐time longevity estimate (longevity gauge) and actual longevity in ICDs …”

Section: Discussionmentioning

confidence: 99%

“…Various factors affect the actual longevity of implanted ICDs (device survival) including bradycardia parameters such as pacing mode, outputs, lead impedances, and pacing percentage and tachycardia therapies such as number of high‐voltage charges and shocks. Several recent studies have reported on the real‐life longevity of different types of ICDs of various manufacturers …”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter‐Defibrillators

Doppalapudi

Barrios

Cuellar³

et al. 2017

Cardiovasc electrophysiol

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Section: Discussionsupporting

confidence: 92%

Section: Discussionsupporting

confidence: 68%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter‐Defibrillators

Doppalapudi

Barrios

Cuellar³

et al. 2017

Cardiovasc electrophysiol

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“…Technological advances in device circuitry, programming, and battery capacity have contributed to significant extensions in the longevity of commercially available CRT-Ds 16. However, the increase in battery longevity is not consistent across all manufacturers, with some manufacturers showing superior battery longevity over others for a variety of complex reasons 16,19–23. In Sweden, procedures for replacement of ICDs and CRT-Ds, respectively, represent 32.0% and 37.7% of the total number of procedures in 2015 11.…”

Section: Introductionmentioning

confidence: 99%

Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden

Gadler

Ding

Verin

et al. 2016

CEOR

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ObjectiveThe objective of this study was to quantify the impact that longer battery life of cardiac resynchronization therapy defibrillator (CRT-D) devices has on reducing the number of device replacements and associated costs of these replacements from a Swedish health care system perspective.MethodsAn economic model based on real-world published data was developed to estimate cost savings and avoided device replacements for CRT-Ds with longer battery life compared with devices with industry-standard battery life expectancy. Base-case comparisons were performed among CRT-Ds of three manufacturers – Boston Scientific Corporation, St. Jude Medical, and Medtronic – over a 6-year time horizon, as per the available clinical data. As a sensitivity analysis, we evaluated CRT-Ds as well as single-chamber implantable cardioverter defibrillator (ICD-VR) and dual-chamber implantable cardioverter defibrillator (ICD-DR) devices over a longer 10-year period. All costs were in 2015 Swedish Krona (SEK) discounted at 3% per annum.ResultsBase-case analysis results show that up to 603 replacements and up to SEK 60.4 million cumulative-associated costs could be avoided over 6 years by using devices with extended battery life. The pattern of savings over time suggests that savings are modest initially but increase rapidly beginning in the third year of follow-up with each year’s cumulative savings two to three times the previous year. Evaluating CRT-D, ICD-VR, and ICD-DR devices together over a longer 10-year period, the sensitivity analysis showed 2,820 fewer replacement procedures and associated cost savings of SEK 249.3 million for all defibrillators with extended battery life.ConclusionExtended battery life is likely to reduce device replacements and associated complications and costs, which may result in important cost savings and a more efficient use of health care resources as well as a better quality of life for heart failure patients in Sweden.

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“Real life” longevity of implantable cardioverter‐defibrillator devices

Manolis¹,

Maounis

Koulouris

et al. 2017

Clinical Cardiology

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Background Manufacturers of implantable cardioverter‐defibrillators (ICDs) promise a 5‐ to 9‐year projected longevity; however, real‐life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. Hypothesis Real‐life longevity of ICDs may differ from that stated by the manufacturers. Methods The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single‐ (n = 292) or dual‐chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). Results Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single‐chamber devices and shortest for CRT devices. Latest‐generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. Conclusions ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical therapy.

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Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports

Abstract: Large differences in CRT-D battery longevity exist between manufacturers. Industry-published PPRs significantly overestimate device longevity. These data have important implications to patients, healthcare professionals, hospitals, and third-party payers.

Cited by 15 publications

References 16 publications

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter‐Defibrillators

Significant Discrepancy Between Estimated and Actual Longevity in St. Jude Medical Implantable Cardioverter‐Defibrillators

Economic impact of longer battery life of cardiac resynchronization therapy defibrillators in Sweden

“Real life” longevity of implantable cardioverter‐defibrillator devices

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