Real‐World Data on the Lifespan of Implantable Cardioverter‐Defibrillators Depending on Manufacturers and the Amount of Ventricular Pacing

Horlbeck, Fritz; Mellert, Fritz; Kreuz, Jens; Nickenig, Georg; Schwab, Joerg O.

doi:10.1111/j.1540-8167.2012.02408.x

Cited by 62 publications

(62 citation statements)

References 38 publications

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“…The longevity of CRT and ICD devices is limited by their battery life, which is in the range of 4-7 years, depending on a number of factors including the pacing mode, pacing percentage and capacitor recharge interval. [31][32][33] Replacement of batteries alone is BACKGROUND NIHR Journals Library www.journalslibrary.nihr.ac.uk not feasible, so when the battery is due for renewal the pulse generator unit has to be replaced, in a minor surgical procedure. When possible the connecting leads are left in situ and only the generator unit itself is replaced, although eventually one or more of the connecting leads may also require replacement.…”

Section: Description Of the Technology Under Assessmentmentioning

confidence: 99%

“…In total, 8.5% of the HRQoL data were missing and summary reasons were provided. (77) 639 (76) 655 (77) Non-white race, n (%) 189 (23) 196 (23) 204 (24) LVEF ( NSVT, b n (%) 210 (25) 193 (23) 180 (21) Syncope, n (%) 52 (6) 54 (6) 56 (7) Systolic blood pressure (mmHg), median (IQR) 118 ( (83) 731 (87) 718 (85) ARB 114 (14) 118 (14) 132 (16) ACE inhibitor or ARB 783 (94) 822 (97) 827 (98) Beta-blocker 576 (69) 581 (69) 581 (69) Diuretic Loop 676 (82) 696 (82) 692 (82) Potassium sparing 168 (20) 174 (21) 165 (19) Thiazide 63 (8) 52 (6) 60 (7) Digoxin 552 (67) 614 (73) 589 (70) Acetylsalicylic acid (aspirin) 477 (58) 461 (55) 477 (56) Warfarin 266 (32) 310 (37) 281 (33) Statin 312 (38) 334 (40) 319 (38) Diabetes, n (%) 253 (31) 243 (29) 271 (32) Pulmonary disease, n (%) 175 …”

Section: Reference Listsmentioning

confidence: 99%

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Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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BackgroundThis assessment updates and expands on two previous technology assessments that evaluated implantable cardioverter defibrillators (ICDs) for arrhythmias and cardiac resynchronisation therapy (CRT) for heart failure (HF).ObjectivesTo assess the clinical effectiveness and cost-effectiveness of ICDs in addition to optimal pharmacological therapy (OPT) for people at increased risk of sudden cardiac death (SCD) as a result of ventricular arrhythmias despite receiving OPT; to assess CRT with or without a defibrillator (CRT-D or CRT-P) in addition to OPT for people with HF as a result of left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony despite receiving OPT; and to assess CRT-D in addition to OPT for people with both conditions.Data sourcesElectronic resources including MEDLINE, EMBASE and The Cochrane Library were searched from inception to November 2012. Additional studies were sought from reference lists, clinical experts and manufacturers’ submissions to the National Institute for Health and Care Excellence.Review methodsInclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Data were synthesised through narrative review and meta-analyses. For the three populations above, randomised controlled trials (RCTs) comparing (1) ICD with standard therapy, (2) CRT-P or CRT-D with each other or with OPT and (3) CRT-D with OPT, CRT-P or ICD were eligible. Outcomes included mortality, adverse events and quality of life. A previously developed Markov model was adapted to estimate the cost-effectiveness of OPT, ICDs, CRT-P and CRT-D in the three populations by simulating disease progression calculated at 4-weekly cycles over a lifetime horizon.ResultsA total of 4556 references were identified, of which 26 RCTs were included in the review: 13 compared ICD with medical therapy, four compared CRT-P/CRT-D with OPT and nine compared CRT-D with ICD. ICDs reduced all-cause mortality in people at increased risk of SCD, defined in trials as those with previous ventricular arrhythmias/cardiac arrest, myocardial infarction (MI) > 3 weeks previously, non-ischaemic cardiomyopathy (depending on data included) or ischaemic/non-ischaemic HF and left ventricular ejection fraction ≤ 35%. There was no benefit in people scheduled for coronary artery bypass graft. A reduction in SCD but not all-cause mortality was found in people with recent MI. Incremental cost-effectiveness ratios (ICERs) ranged from £14,231 per quality-adjusted life-year (QALY) to £29,756 per QALY for the scenarios modelled. CRT-P and CRT-D reduced mortality and HF hospitalisations, and improved other outcomes, in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT. The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar. CRT-P and CRT-D compared with OPT produced ICERs of £27,584 per QALY and £27,899 per QALY respectively. The ICER for CRT-D compared with CRT-P was £28,420 per QALY. In people with both conditions, CRT-D reduced the risk of all-cause mortality and HF hospitalisation, and improved other outcomes, compared with ICDs. Complications were more common with CRT-D. Initial management with OPT alone was most cost-effective (ICER £2824 per QALY compared with ICD) when health-related quality of life was kept constant over time. Costs and QALYs for CRT-D and CRT-P were similar. The ICER for CRT-D compared with ICD was £27,195 per QALY and that for CRT-D compared with OPT was £35,193 per QALY.LimitationsLimitations of the model include the structural assumptions made about disease progression and treatment provision, the extrapolation of trial survival estimates over time and the assumptions made around parameter values when evidence was not available for specific patient groups.ConclusionsIn people at risk of SCD as a result of ventricular arrhythmias and in those with HF as a result of LVSD and cardiac dyssynchrony, the interventions modelled produced ICERs of < £30,000 per QALY gained. In people with both conditions, the ICER for CRT-D compared with ICD, but not CRT-D compared with OPT, was < £30,000 per QALY, and the costs and QALYs for CRT-D and CRT-P were similar. A RCT comparing CRT-D and CRT-P in people with HF as a result of LVSD and cardiac dyssynchrony is required, for both those with and those without an ICD indication. A RCT is also needed into the benefits of ICD in non-ischaemic cardiomyopathy in the absence of dyssynchrony.Study registrationThis study is registered as PROSPERO number CRD42012002062.FundingThe National Institute for Health Research Health Technology Assessment programme.

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Section: Description Of the Technology Under Assessmentmentioning

confidence: 99%

Section: Reference Listsmentioning

confidence: 99%

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Colquitt¹,

Mendes²,

Clegg³

et al. 2014

Health Technology Assessment

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“…The three studies by Thijssen, Horlbeck, and Alam [12][13][14] were published after 2012 but included ICD implantations and follow-up over differently long time spans. Thijssen and coworkers [12] reported on 1072 device replacements for battery depletion, performed between 1996 and 2010.…”

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%

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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“…On an average, a modern pacemaker works for 7-10 years, 6,7 and the median longevity of an AICD is less than 5 years to 7.6 years, [8][9][10] depending on the rate of use. In comparison to the longevity of the pacemakers, that of ICDs is less predictable because of high individual variability of use.…”

Section: Basics Of Cardiac Rhythm Control Devicesmentioning

confidence: 99%

Reuse of Cardiac Rhythm Control Devices: A Review

et al. 2013

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Cardiac rhythm control devices i.e. pacemakers, implantable cardioverter-defibrillators (ICDs) and biventricular pacemakers are at times lifesaving treatment and prevention of arrhythmia. But, despite definite indications, many people in the developing countries cannot afford these devices due to high cost, and succumb to premature death. On the other hand, after implantation, pacemakers and ICDs are sometimes underutilized because of premature explantation due to death of the recipient, device infection, or upgradation, leaving a considerable extent of serviceable battery life unused. Majority of these explanted devices are simply thrown away. Though made for single use, a growing body of evidence indicates the safety, efficacy and feasibility of reimplantation of the prematurely explanted devices in patient in need who is otherwise unable to afford a new one. Patients, physicians, morticians, and even the general public support the idea of device donation and recycling. A number of organizations around the world have engaged themselves in this benevolent effort, and t he feasibility of device reutilization programme has already been established. However, some logistic, legal and ethical concerns are yet to be solved. The statutory bodies and professional organizations should address the issue of device recycling to solve the unsolved issues and formulate standard practice guidelines. In that case, such medical wastes may turn into invaluable resources, and help ensuring equitable medical care throughout the world. Cardiovascular Journal Volume 6, No. 1, 2013, Page 52-59 DOI: http://dx.doi.org/10.3329/cardio.v6i1.16116

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Real‐World Data on the Lifespan of Implantable Cardioverter‐Defibrillators Depending on Manufacturers and the Amount of Ventricular Pacing

Abstract: CRT-Ds and an elevated percentage of VP are associated with a significantly elevated risk for device replacement, while Medtronic ICDs showed the longest lifespans.

Cited by 62 publications

References 38 publications

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

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

Reuse of Cardiac Rhythm Control Devices: A Review

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