Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems

Biffi, Mauro; Ziacchi, Matteo; Bertini, Matteo; Sangiorgi, Diego; Corsini, Daniela; Martignani, Cristian; Diemberger, Igor; Boriani, Giuseppe

doi:10.1093/europace/eun240

Cited by 51 publications

(58 citation statements)

References 36 publications

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“…In agreement with previous reports, 12,26 device replacements for battery depletion started to occur after 3 years of follow-up and involved 50% of CRT-D patients after 4 years at Kaplan-Meier analysis. Previous data from a large US registry showed that 53% of normally performing ICDs and, specifically, only 4% of CRT-D were in service 4 years after implantation.…”

Section: Device Longevitysupporting

confidence: 91%

“…27 In our series, battery depletion represented the main cause of earlier surgical revision in patients with CRT-D. Indeed, it has been shown that CRT-D are the most demanding antiarrhythmic devices in terms of battery consumption because of the need for continuous biventricular pacing, although device longevity may differ significantly among manufacturers 12,26 and modern algorithms for pacing output reduction have been demonstrated to improve longevity. 28 Nevertheless, the risk of earlier surgical revision for battery depletion in CRT-D should be considered not only per se, but also in relationship with the observed higher risk of infection following replacement.…”

Section: Device Longevitymentioning

confidence: 90%

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Long-Term Complications Related to Biventricular Defibrillator Implantation

et al. 2011

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on behalf of the Cardiovascular Centers Participating in the ClinicalService ProjectBackground-Long-term data on device-related untoward events in patients receiving defibrillators for resynchronization therapy (CRT-D) are lacking. We quantified the frequency of repeat invasive procedures and the nature of long-term complications in current clinical practice and examined possible predictors of device-related events and their association with long-term patient outcome. Methods and Results-We analyzed data from 3253 patients who underwent de novo successful implantation of CRT-D and were followed up for a median of 18 months (25th to 75th percentiles: 9 to 30) in 117 Italian centers. Device-related events were reported in 416 patients, and, specifically, surgical interventions for system revision were described in 390 patients. Four years after the implantation procedure, 50% of patients underwent surgical revision for battery depletion and 14% for unanticipated events. For comparison, at 4 years battery depletion occurred in 10% and 13% of patients who received single-and dual-chamber defibrillators at the study centers, and unanticipated events were reported as 4% and 9%, respectively. In CRT-D, infections occurred at a rate of 1.0%/y, and the risk of infections increased after device replacement procedures (hazard ratio, 2.04; 95% confidence interval, 1.01 to 4.09; Pϭ0.045). Left ventricular lead dislodgements were reported at a rate of 2.3%/y and were predicted by longer fluoroscopy time and higher pacing threshold on implantation. Device-related events were not associated with a worse clinical outcome; indeed, the risk of death was similar in patients with and without surgical revision (hazard ratio, 0.90; 95% confidence interval, 0.56 to 1.47; Pϭ0.682). Conclusions-In current clinical practice device-related events are more frequent in CRT-D than in single-or dual-chamber defibrillators, and are frequently managed by surgical intervention for system revision. However, a worse clinical outcome is not associated with these events. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01007474.

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Section: Device Longevitysupporting

confidence: 91%

Section: Device Longevitymentioning

confidence: 90%

Long-Term Complications Related to Biventricular Defibrillator Implantation

et al. 2011

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“…According to our modelling results, extending longevity translates into a reduction in device replacements, hospitalizations, and complications, as well as reduced costs. Admittedly, these data are derived from a model based on data from other studies, 9,27 which is no replacement to validation and confirmation in the real-world setting, where other factors, such as co-morbidities, lead failure, and device recalls add to the complexity of device therapy. It is worth to promote the institution of registries for collecting independent data on actual device longevity, thus avoiding the obvious limitation of data obtained from single institutions.…”

Section: Discussionmentioning

confidence: 99%

“…Our analysis probably underestimated another source of saving, that is, the potential lengthening of follow-up visits due to longer-lasting devices. 27,34 In fact, independently from device longevity we assumed a background number of two follow-up visits per year after the first implant. This amount was considered to rise to three follow-up visits during the year of replacement (one more follow-up visit).…”

Section: Discussionmentioning

confidence: 99%

Impact of extending device longevity on the long-term costs of implantable cardioverter-defibrillator therapy: a modelling study with a 15-year time horizon

Boriani

Braunschweig

Deharo³

et al. 2013

EP Europace

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AimsTo determine the long-term costs of extending device longevity in four patient populations requiring a single-chamber implantable cardioverter-defibrillator (ICD) or requiring cardiac resynchronization therapy with defibrillation (CRT-D) device over a 15-year time window. Methods and resultsWe considered patient populations with an accepted indication for a single-chamber ICD for prevention of sudden cardiac death in the context of preserved (Population A) or impaired (Population B) left ventricular function; or with indication for a CRT-D device in the context of heart failure in New York Heart Association class II (Population C) or III (Population D). Expected patient survival and a cost analysis, including the cost of complications, was undertaken from a hospital perspective. Extended device longevity of 5 vs. 9 years for ICDs (Populations A and B); 4 vs. 7 years for CRT-Ds (Populations C and D) were considered. Over a 15-year time horizon, total, yearly, and per diem savings, per patient, from extending ICD longevity to 9 years were E10 926.91, E728.46, and E1.99 for Population A, and E7661.32, E510.75, and E1.40 for Population B. Total, yearly, and per diem savings from extending CRT-D longevity to 7 years were E13 630.38, E908.69, and E2.49 for Population C, and E10 968.29, E731.22, and E2.00 for Population D. Avoidance of a generator replacement amounted up to 46.6-62.5% of the saving. ConclusionExtending device longevity has an important effect on the long-term cost of device therapy, both for ICD and CRT-D. This has important implications for device choice.--

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“…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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Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems

Abstract: Battery longevity is significantly different among manufacturers. ICD cost is strictly dependent on device longevity, whereas device up-front cost is of limited clinical meaning. Appropriate assessment of cost-effectiveness should be based on ICD longevity in the real-life scenario.

Cited by 51 publications

References 36 publications

Long-Term Complications Related to Biventricular Defibrillator Implantation

Long-Term Complications Related to Biventricular Defibrillator Implantation

Impact of extending device longevity on the long-term costs of implantable cardioverter-defibrillator therapy: a modelling study with a 15-year time horizon

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

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