Analysis of Implantable Defibrillator Longevity Under Clinical Circumstances: Implications for Device Selection

Knops, Paul; Theuns, Dominic; C.J., Jan; Jordaens, Luc

doi:10.1111/j.1540-8159.2009.02482.x

Cited by 25 publications

(25 citation statements)

References 45 publications

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“…Despite impressive overall technologic improvements, the reported SCD-HeFT [5] 71 % \10 % (standard battery)-92 %large battery Hauser [1] MADIT-II [6] 68 % 12-50 % Biffi [9] RAFT [7] 72 % 45-72 % Knops [10] MADIT-CRT [8] 88 % 0-75 % Schaer [11] 40-70 % Thijssen [12] 20-65 % Horlbeck [13] Clin Res Cardiol service life of ICD devices, estimated in real-life scenarios, were not clinically significantly prolonged over the past 10 years. Technical improvements were preferentially transformed into device miniaturization but not into prolonging device service life.…”

Section: Discussionmentioning

confidence: 97%

“…The mean service life of ICD ranged from 40 to 84 months with significant differences among manufacturers (single-chamber ICD: 55-72 months; dual-chamber ICD: 40-84 months; CRT-D 45-49 months). Knops and coworkers [10] analyzed 154 ICD replacements for battery depletion from 1996 to 2006 (32 single chamber, 98 dual chamber, 24 CRT) of 5 different manufacturers. The average service life in singlechamber ICD was 54 ± 19 months and in dual chamber and CRT devices 42 ± 15 months.…”

Section: Icd Device Technologymentioning

confidence: 99%

“…Between 2008 and 2014 several studies had been published on the problem of ICD longevity in clinical scenarios. These analyses included ''older'' and currently used ICD devices [9][10][11][12][13][14][15]. In the study by Biffi et al [9] 153 ICD replacements of three different brands were analyzed.…”

Section: Icd Device Technologymentioning

confidence: 99%

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The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries

Neuzner

2015

Clin Res Cardiol

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In 2005, Bob Hauser published a paper in the Journal of the American College of Cardiology entitled "The growing mismatch between patient longevity and the service life of Implantable Cardioverter-Defibrillators". Now, nearly a decade later, I would like to perform a second look on the problem of a mismatching between ICD device service life and the survival of ICD recipients. Since 2005, the demographics of the ICD population has changed significantly. Primary prevention has become the dominant indication in defibrillator therapy and device implantation is indicated more and more in earlier stages of cardiac diseases. In former larger scale ICD trials, the patient average 5-year survival probability was in a range of 68-71%; in newer CRT-D trials in a range of 72-88%. Due to a progressively widened ICD indication and implantation preferentially performed in patients with better life expectancy, the problem of inadequate device service life is of growing importance. The early days of defibrillator therapy started with a generator volume of 145 ccm and a device service life <18 months. In this early period, the device miniaturization and extension of service life were similar challenges for the technicians. Today, we have reached a formerly unexpected extent of device miniaturization. However, technologic improvements were often preferentially translated in further device miniaturization and not in prolonging device service life. In his analysis, Bob Hauser reported a prolonged device service life of 2.3 years in ICD models with a larger battery capacity of 0.54 up to 0.69 Ah. Between 2008 and 2014, several studies had been published on the problem of ICD longevity in clinical scenarios. These analyses included "older" and currently used single chamber, dual chamber and CRT devices. The reported average 5-year device service life ranged from 0 to 75%. Assuming today technology, larger battery capacities will only result in minimal increase in device volume. Selected ICD patients may further benefit from device miniaturization-but the vast majority may much more benefit from a significant prolongation in device service life. All published cost-effectiveness analyses in ICD therapy show that device costs and device service life are the dominant determinants of the results. The performed "second look-nearly a decade later" revealed that there are still relevant limitations regarding the device service life in current defibrillator therapy. Technical improvements were preferentially transformed into device miniaturization but not into prolonging device service life. But this optimization is strongly enforced. The most feasible solution might be the use of device batteries with larger capacities. The economic burden, mainly caused by non-adequate device service life, may limit the future realization of ICD therapy in a progressively growing patient population. In the former years, physicians and device manufacturers have ignored the patient perspective in defibrillator therapy. However, it is the patient viewpoint that...

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Section: Discussionmentioning

confidence: 97%

Section: Icd Device Technologymentioning

confidence: 99%

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The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries

Neuzner

2015

Clin Res Cardiol

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“…While there are known to be differences in battery performance among device manufacturers, unusual behavior must be identified and reported, as pre-market surveillance for many technologies can be insufficient. [6][7][8] There are many potential explanations for premature battery depletion. Devices in the St. Jude Fortify s and Unify s families make use of lithium silver vanadium oxide batteries (Greatbatch Medical, Clarence, NY).…”

Section: Discussionmentioning

confidence: 99%

Premature Battery Depletion in St. Jude Fortify® and Unify® Cardiac Implanted Electronic Devices

Richardson¹,

Parvez²,

Shen³

et al. 2016

JICRM

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ABSTRACT. The predictability of battery performance in pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) is necessary for safe clinical management. Unpredictable performance can have life-threatening implications. The aim was to describe the behavior of devices in the St. Jude Fortify s and Unify s device (St. Jude Medical, Minnetonka, MN) families exhibiting premature battery depletion. Five cases of very rapid battery depletion were identified. All available device data from 1 year prior to generator change were reviewed for trend in battery capacity, percent pacing, tachycardia therapies, and remote transmissions. All cases demonstrated rapid and unpredictable depletion of battery capacity and the presence of lithium clusters on device analysis. In the 12 months prior to generator change there were no significant changes in pacing burden or transmissions. None of the patients received either anti-tachycardia pacing or shocks in the 12 months prior to generator change. In two of the five cases the device reached the elective replacement indicator and end of service within 24 hours. In two cases emergent generator change was necessary due to PM dependence. Devices in the St. Jude Fortify s and Unify s families may exhibit precipitous battery depletion. Lithium cluster formation leading to battery depletion has been previously described. These data suggest this may be more common than previously thought. Owing to the unpredictable nature of battery performance in these devices, careful monitoring and potentially generator change for any abnormal battery behavior is indicated.

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“…According to several studies, device longevity increased from a mean of 19 months in the late 1980s to ≈60 months at present. [17][18][19][20] When analyzed per type of contemporary transvenous ICD, single-chamber ICDs have a mean longevity of 5.5 years and dual-chamber ICDs 5.8 years. 20 Compared with contemporary transvenous ICD systems, longevity of the first generation S-ICD is slightly shorter with a median longevity of 5.0 years.…”

Section: Discussionmentioning

confidence: 99%

Longevity of the Subcutaneous Implantable Defibrillator

Theuns

Crozier

Barr

et al. 2015

Circ: Arrhythmia and Electrophysiology

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Background— The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system. Methods and Results— All patients enrolled in the European Regulatory Trial were included in the analysis. During follow-up, time and causes of device replacement or explantation were assessed and categorized. Device longevity was estimated using Kaplan–Meier analysis. Fifty-five patients were followed for a median of 5.8 years. During follow-up, 26 (47%) patients underwent device replacement and 5 (9%) underwent device explantation. Median time to replacement was 5.0 years (Q1–Q3, 4.4–5.6 years). Replacement was caused by battery depletion in 25 patients (92%), of which 5 within 1.5 years because of premature battery depletion, and by infection in 1 patient (2%). Replacement for a transvenous ICD system was required in 4 patients (7%) because of ineffective defibrillation in 1 (0.003 per patient-year), need for resynchronization therapy in 2 (0.01 per patient-year), and for antibradycardia pacing in 1 (0.003 per patient-year). At 5 years follow-up, 71% of devices were still in service. Conclusions— This study provides the first estimate of S-ICD system longevity since its introduction in clinical practice. Median longevity of the first generation S-ICD system was 5.0 years. The majority of devices were replaced because of battery depletion. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01117792.

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Analysis of Implantable Defibrillator Longevity Under Clinical Circumstances: Implications for Device Selection

Abstract: (PACE 2009; 32:1276-1285 implantable cardioverter defibrillator, replacement, longevity, device selection

Cited by 25 publications

References 45 publications

The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries

The mismatch between patient life expectancy and the service life of implantable devices in current cardioverter-defibrillator therapy: a call for larger device batteries

Premature Battery Depletion in St. Jude Fortify® and Unify® Cardiac Implanted Electronic Devices

Longevity of the Subcutaneous Implantable Defibrillator

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