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Europace Advance Access originally published online on September 3, 2008
Europace 2008 10(11):1288-1295; doi:10.1093/europace/eun240
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Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2008. For permissions please email: journals.permissions@oxfordjournals.org


Implantable cardioverter-defibrillators

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

Mauro Biffi1,*, Matteo Ziacchi1, Matteo Bertini1, Diego Sangiorgi1, Daniela Corsini2, Cristian Martignani1, Igor Diemberger1 and Giuseppe Boriani1

1 Institute of Cardiology Policlinico S. Orsola-Malpighi, University of Bologna, Via Massarenti 9, 40138 Bologna, Italy; 2 Department of Pharmacy, Policlinico S. Orsola-Malpighi, University of Bologna, Bologna, Italy

Manuscript submitted 1 June 2008. Accepted after revision 6 August 2008.

* Corresponding author. Tel: +39 (0) 51 6363531; fax: +39 (0) 51 344859. E-mail address: mauro.biffi{at}aosp.bo.it


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Aims: Comparative studies on the longevity of implantable cardioverter-defibrillators (ICDs) among different manufacturers have never been reported. Longevity of ICD devices implanted from 1 January 2000 to 31 December 2002 was prospectively investigated according to their type and manufacturer.

Methods and results: Longevity of single-chamber (SC), double-chamber (DC), and biventricular (CRT-D) ICDs from Medtronic (MDT), Guidant (GDT), and St Jude Medical (SJM) was measured in all the patients who required device replacement. The observation follow-up ended on 31 December 2007; patients who died prematurely or were transplanted before battery exhaustion were excluded from the analysis. Factors associated with longevity (number of delivered shocks, pacing activity) were researched. One hundred and fifty-three patients received an ICD in the abovementioned period. Six underwent heart transplantation, and 23 died before device replacement; 80 had an SC device, 59 had DC device, and 14 had CRT-D device. Longevity of MDT was superior to GDT and SJM, replacement rates being, respectively, 42%, 95.3%, and 97.2%. Only MDT manufacturers and SC type were associated with greater ICD longevity. Longevity had an impact on the cost/month of treatment of replaced ICDs.

Conclusion: 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.

Key Words: Implantable cardioverter-defibrillator, Battery longevity, Device cost


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Implantable cardioverter-defibrillators (ICD) are an effective treatment to prevent sudden death in selected patients.1Go–5Go ICD longevity is a very important aspect for clinical practice as far as patients' comfort and safety are concerned, as device replacement carries a substantial risk of serious complications,6Go,7Go and for health-care systems, when cost-effectiveness of ICD therapy is being evaluated. Formerly published observations on ICD longevity suffered some limitations, as they did not allow comparisons based on device activity as obtained by a similar programming strategy, or based on the different manufacturers' technology.8Go–10Go

We observed the longevity of ICDs from three different manufacturers used in our centre, to understand whether a significant difference exists among technologies.


    Methods
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
All the patients implanted with an ICD from 1 January 2000 up to 31 December 2002 were followed-up to 31 December 2007. Patients who underwent heart transplantation or died before battery replacement were excluded from the analysis. Longevity was calculated up to the day of ICD replacement. To achieve comparisons, all capacitor charges were counted for each device, whether appropriate (ventricular arrhythmias), inappropriate (supraventricular arrhythmias), or diverted (self-terminated arrhythmias, with charge delivered into the internal load of the device). Periodic capacitor reform was left unchanged according to the manufacturer's recommendations: these charges were not counted for longevity evaluation. Device programming followed the strategy of shock therapy minimization: ventricular fibrillation (VF) detection was always set faster than 220 bpm, ventricular tachycardia (VT) detection was also programmed in each patient. At least two attempts to terminate VT by anti-tachycardia therapy (ATP) were programmed. Inappropriate capacitor charge owing to non-sustained VT was avoided by programming an appropriate detection. Sinus tachycardia discriminators were programmed in all devices; AF and 1:1 supraventricular arrhythmias discriminators were programmed when clinically indicated. Intracardiac electrogram (EGM) collection at arrhythmia onset was minimized whenever possible.

Cardiac stimulation also affects device longevity, hence the amount of pacing was retrieved from the devices at each follow-up, and the pacing output was reported. In patients without pacing indications, devices were programmed at the lowest programmable rate and with the longest attainable atrioventricular delay [double-chamber (DC) ICDs only] in order to minimize the delivery of stimulation. The lower rate of biventricular ICDs was programmed at 40 bpm to minimize atrial pacing, unless atrial stimulation was indicated.


    Statistical analysis
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Continuous variables were expressed as mean ± standard deviation (median and range if not normally distributed), while categorical data were expressed as absolute and relative frequency.

Comparisons between continuous variables were made by t-test or non-parametric test, for independent or paired samples. Categorical data were compared using {chi}2 or Fisher's exact test, as appropriate.

Owing to non-normality of distribution, ICD longevities and costs were expressed as median and range.

Comparisons between groups were made by Kruskal–Wallis test.

ICD type and manufacturer were analysed by the Kaplan–Meier method and differences between groups were analysed with the log-rank test.

Independent predictors were detected using Cox proportional hazards regression model.

Variables included in the model were type of ICD, manufacturer, maximum device output (≤ or >31J), arrhythmia storm (yes/no), amount of paced activity (≤ or >50%), number of delivered shocks per year divided into four subgroups (0, 1–2, 3–5, ≥6), coronary artery disease.

The proportional hazard assumption was assessed by Schoenfeld residuals. A P-value <0.05 was considered statistically significant. All analyses were performed with Stata for Windows 10 statistical software (StataCorp, TX, USA).


    Results
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
In this 3-year period, 153 patients received an ICD. Eighty (52%) had coronary artery disease, whereas 73 (48%) had several different arrhythmogenic diseases; 38 (24.8%) had idiopathic dilated cardiomyopathy (IDCM), 15 (9.8%) had hypertrophic cardiomyopathy, 10 (6.5%) had right ventricular arrhythmogenic cardiomyopathy, 7 (4.5%) had valvular heart disease, 2 (1.3%) with idiopathic VF, and 1 (0.6%) with Brugada's syndrome. The mean age was 64 ± 12 years, the male:female ratio was 125:28, LV ejection fraction (EF) was 39.7 ± 16.5 (range 17–88). Twenty-eight patients had an LVEF >60% (hypertrophic cardiomyopathy, ARVD, idiopathic VF, Brugada syndrome), and some valvular and IDCM patients had an EF >35%. Primary prevention of sudden death was the indication for 105 (68%) patients, whereas secondary prevention accounted for 48 (32%) ICD implants. The indication to ICD implantation because of primary prevention of sudden death was: sustained VT inducibility according to the MADIT and MUSTT criteria for patients with previous myocardial infarction; bridge to heart transplantation in patients with severe heart failure and syncopal or recurrent symptomatic NSVT; unexplained syncope and inducible VT/VF, or recurrent near syncopal NSVT and inducible sustained VT/VF in those with IDCM or moderate heart failure; syncope and family history of sudden death and/or symptomatic NSVT in patients with hypertrophic cardiomyopathy; syncope and inducible monomorphic VT/VF or documented symptomatic NSVT and inducible VT/VF in ARVD patients.

Six patients underwent heart transplantation (1 MDT, 2 GDT, 3 SJM), and 23 died before ICD replacement (6 MDT, 5 GDT, 12 SJM), hence are excluded from analysis; 124 completed the follow-up period. None of the devices were subjected to alerts or corrective actions that could cause a more frequent automatic capacitor reforming or premature device replacement.

Table 1 reports the devices implanted in the study period according to type (single chamber, dual chamber, biventricular), model, and manufacturer. The average service life of replaced ICDs within each model subgroup, the devices still in service, and the number of paced patients is also reported in Table 1. No ICD/lead failure occurred during the follow-up period. Devices were replaced within 30 days after the elective replacement interval had been reached, depending on the recent arrhythmia history and the clinical setting.


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Table 1 Devices employed during the study period

 
Cardiac stimulation was minimized (<1%) by ICD programming, except in patients with pacing indications: three with a SC device, six with a DC device, and all 10 CRT-D patients (Table 1).

All the patients with CRT-Ds devices were >99% paced in both ventricles; atrial pacing was <1% in all the patients. Six patients had devices with a common ventricular output (MDT), so that both ventricles were paced by the same strength, whereas four patients had devices capable of independent programmability of the LV output (2 GDT, 2 SJM).

These latter four devices paced at the same output (RV = 2 V at 0.5 ms, LV = 3 V at 0.5 ms), and had the same longevity (Table 1). The four MDT devices pacing below battery voltage (2 V at 0.8 ms) are still in service (Table 1), whereas those pacing at high output (3 V at 1.0 ms and 6 V at 1.0 ms) because of a high LV pacing threshold (2 V at 0.8 ms and 4.2 V at 1.0 ms) were replaced after 63 and 35 months, respectively. Lead repositioning to achieve a lower pacing threshold was not feasible in these two patients (lack of another suitable coronary vein in the former, unwillingness to undergo tunnelling from the right side or thoracotomy because of left subclavian thrombosis in the latter).

Shock delivery for VF or VT refractory to ATP occurred in 55 of 124 patients (44%). Overall, therapy for VT/VF (ATP and shock) was delivered to 88 of 124 patients (70%). Eleven arrhythmia storms (>3 shocks in the same day) occurred in 4 of 124 patients (3.2%). No capacitor charge owing to non-sustained VT was observed. Inappropriate shocks were delivered to 14 of 124 patients (11%); these were also counted as charges into the Cox regression model.

Implantable cardioverter-defibrillator longevity
At the end of the follow-up period, replacement rates were: 56 of 57 (97.2%) for SJM, 41 of 43 (95.3%) for GDT, and 10 of 24 (42%) for MDT (P = 0.0001 (Figure 1A). Among these 124 patients, 17 still had the device in service: 11 SC (8 MDT, 2 GDT, 1 SJM), 2 DC (MDT), 4 CRT-D (MDT).


Figure 1
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Figure 1 Implantable cardioverter-defibrillator (ICD) replacement according to manufacturer (A) and ICD type (B). GDT, Guidant; MDT, Medtronic; SJM, St Jude Medical; SC, single chamber; DC, double chamber; CRT-D, biventricular.

 
When the duration of replaced devices is analysed, SC ICDs are superior to DC and CRT-D, although this is mainly due to SJM devices (Figure 1B, Table 2). Moreover, four biventricular MDT devices are still in service >6 years after implantation (Table 1). The replacement rate per implantation year is consistent with the Kaplan–Meier curve and the longevity analysis (Table 3).


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Table 2 Longevity of 107 implantable cardioverter-defibrillators (ICDs) replaced in the follow-up period

 


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Table 3 Rate of implantable cardioverter-defibrillator (ICD) replacement per implantation year

 
As reported in Table 1, different longevity among models by the same manufacturer was observed, mainly among GDT who had an intense model turnover in those years. Twenty Photon DR by SJM had the same battery model (9610) as the Angstrom series,8Go whereas two Photon DR and two Atlas DR had a different battery (2150). Median longevity of these latter four ICDs was 54 months, although the longest lasting SJM ICDs (64, 62, and 60 months, respectively) were powered by the 9610 battery model.

The median number of device charges is reported in Figure 2: it was slightly (not significantly) higher in MDT DC devices.


Figure 2
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Figure 2 Number of delivered shocks according to device type and manufacturer. GDT, Guidant; MDT, Medtronic; SJM, St Jude Medical; SC, single chamber; DC, double chamber; CRT-D, biventricular; shock/Pat/yr denotes number of shocks/patient/year.

 
SC devices and MDT manufacturer were associated with a superior longevity at Cox regression analysis, whereas the number of capacitor charges had no effect (Table 4). Devices delivering pacing therapy to two cardiac chambers (a single DC and six CRT-D) at a high stimulation strength had a shorter longevity (35–63 months).


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Table 4 Factors associated with implantable cardioverter-defibrillator (ICD) replacement

 
Implantable cardioverter-defibrillator cost
Owing to the observed difference in ICD longevity (Table 2), the cost/service life of replaced ICDs was different among manufacturers, longer-lasting devices being on average 38% less expensive than the others.


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Implantable cardioverter-defibrillator longevity
Our observation is a comparative report on ICD longevity among manufacturers in clinical practice, aside from the area of device recall/malfunction: all the ICDs in our observation were normally performing. In the literature, data on ICD longevity were often triggered by unexpected technical failures,8Go whereas insight on the longevity of ICDs exhibiting ‘regular’ performance in the ‘true’ clinical scenario may be gained by registries.9Go,10Go Hauser report9Go from a large US registry shows that 5 years after implantation, only 26% of normally performing devices are in service: differently from our study, no analysis based on device activity or on manufacturer has ever been reported.

Longevity of an implanted device is pivotal in the evaluation of its cost, on which studies of cost-effectiveness should be based.10Go–13Go In our study we observed important differences among manufacturers in terms of device longevity, unrelated to the amount of delivered high-voltage therapy (Table 4). Although a straight comparison cannot be made as in randomized controlled trials, because of unique characteristics of the individual patients and of their clinical course, substantial differences among technologies seem to exist. Five years ago, Ellinor et al.8Go reported a shorter than expected life of service in Angstrom and Profile devices by SJM, largely because of a poor interaction of a downsized battery and a dedicated safety circuit. The same battery model in our Photon devices could last as long as 64 months, meaning that an unpredictable behaviour of the battery power source and of circuitry–battery interplay may heavily affect device longevity. In fact, in the Photon series a new platform and the incorporation of ROM and RAM consuming 24% less current allowed an increased device longevity when compared with Angstrom and Profile. Ellinor et al.8Go claimed that attention should be paid to ICD longevity in the future, as the market forces driving towards device downsizing and increased ICD monitoring and diagnostic functions could lead to unpredictable battery behaviour. Our study covers a subset of devices free from recalls and corrective actions in a defined observation period: it thus represents a faithful picture of ICD technology in that time-frame. In our study, MDT devices had a superior longevity. Not surprisingly, similar findings have been recently reported by another European centre:14Go nearly 50% of MDT devices lasted ≥7 years, compared with none by all other manufacturers. In the Basel experience, Medtronic technology showed superior longevity over a 12-year period in 679 devices, although a detailed analysis was not reported.14Go According to clinical practice in our centre, we followed the strategy of minimization of shock therapy in favour of painless VT termination, by programming ATP schemes as the first-line therapy. This strategy is actually supported by strong clinical evidence.15Go,16Go Accordingly, the shock rate was low, and comparable among the three manufacturers. For this reason, the amount of shock therapy was not predictive of a poorer longevity, as in Hauser's report.10Go

It appears from our data that SJM and GDT device longevity (55 months) is quite comparable with the recently reported US registry.10Go As in Hauser's report,10Go SC ICDs had a superior longevity with respect to DC devices, except for the MDT manufacturer, whose SC and DC devices had the same performance. Moreover, the four CRT-Ds with pacing output below battery voltage and less-sophisticated features had a median longevity beyond 6 years.

A small battery saving may have been conferred to MDT by minimization of EGM collection before arrhythmia onset and by less frequent capacitor reforming. Indeed, the latter suggests a possible technological advantage in manufacturing, as it implies that less internal dissipation of energy occurs in the battery, and that less reversible degradation of the dielectric layer occurs in the capacitor along time. Indeed, SJM and GDT used Wilson Greatbatch batteries, MDT used proprietary batteries; from GEM II onward, MDT capacitors are also proprietary. The continuous research in battery and capacitor technology has achieved the development of power sources with both a high capacity density and a high power density, suitable for high current drain (capacitor charge for the delivery of high voltage therapy) in a uniformly low charge time throughout the entire service life, as well as for lasting endurance during customary activities.17Go–20Go Two major developments in the chemistry of batteries have supported these improvements: the use of ‘combination’ silver vanadium oxide (CSVO) in the cathode and balancing the cell to an appropriate electron reduction allowed a reduced growth of internal battery impedance over time, which also contributes to the uniformly short capacitor charge time;18Go the development of hybrid cathode batteries (lithium/silver vanadium oxide blended with carbon monofluoride, Li/CFx-SVO) has allowed an increased service life coupled to a short charge time throughout the device service life, with an improved battery predictability.19Go,20Go Because of these improvements, Boston Scientific also changed ICDs power supply in Confient/Livian ICDs with Li/CFx-SVO hybrid batteries performing superior to Prizm/Vitality series. Another step towards superior ICD longevity is the recent release of lithium/manganese dioxide-(LiMnO2) powered devices by Boston Scientific. LiMnO2 batteries have stable voltage for most of the service life with a gradual decay towards replacement, irrespective of the rate of energy usage (high or low), no midlife impedance rise (reforming needed only to measure charge), very high capacity, and stable charge time. This chemistry allows reliable predictability of charge remaining in the battery by the measurement of power consumption (weighing of historical usage and current programming).

Beyond battery technology, the availability of ‘improved’ stacked-plate electrolytic capacitors has reduced the energy losses related to reforming the dielectric layer while allowing short capacitor charge time.18Go Over years, the increased energy and capacity density in the battery, the shorter charge times, and a better packaging efficiency allowed ICD downsizing at no compromise for longevity when compared with old ICD releases.21Go In fact, the devices with improved technology employed in our study had a superior longevity compared with older ICD releases21Go or to bigger abdominal and epicardiac devices, despite an increased amount of EGM collection and additional features.

The improvements in battery and capacitor technology have increased ICD efficiency over time, but some trade-off because of the additional monitoring, diagnostic, and pacing features may occur, as reported in pacemaker technology.22Go For instance, the same battery model (WG 2150) powered several SJM devices, from SC to CRT-D (Table 1): longevity decreased, being DC33J > SC35J > DC35J > CRT D30J (Table 1).

The management of the pacing burden also plays a role in technologies. In our CRT-D patients, longevity decreased when pacing at high outputs was required (Tables 1 and 2). Indeed, very little effort has been made to save battery longevity in the setting of a high pacing threshold, which may occur in DC and CRT-D.23Go As reported by Hauser,9Go CRT-D and DC replacement rates are, respectively, 87% at 3 years and 67% at 4 years.

Despite the improvement in steroid-eluting pacing leads, pacing threshold may unpredictably increase at long-term: in a recent study, right ventricular pacing threshold increased beyond 1.5 V at 0.5 ms in 25% of patients 1 year after implantation.24Go Use of voltage multipliers then occurs to ensure a 100% safety margin, possibly wasting device longevity.25Go Late variability of pacing threshold was largely ignored until the development of algorithms for stimulation by automatic verification of capture, which provide details of the pacing threshold over time.26Go,27Go The automatic adjustment of pacing output according to the measured threshold allows to increase device longevity by avoiding the use of voltage multipliers, the benefit being greater at high pacing thresholds.25Go Despite successful feasibility studies,27Go–30Go these algorithms have only recently been implemented in CRT-Ds.31Go A benefit in terms of longevity can be expected by the use of such algorithms in all paced chambers so as to minimize the use of voltage multipliers.

On a different perspective, when ventricular pacing is not needed, an SC or a DC ICD capable of minimizing ventricular stimulation32Go should be mandatory to improve longevity. In fact, ICD longevity is the priority with respect to size not only for health systems, but also for the patients themselves. In a recent survey 90% of patients preferred a larger long-lasting device, the result being independent of patient sex, age, body size, and clinical status.33Go Thus, the ideal ICD to cover a hypothetical 10-year life span should be appropriately sized and capable of minimizing battery drain in routine operation.

Implantable cardioverter-defibrillator cost
ICD therapy is considered a cost-effective treatment, and cost-effectiveness estimates are sensitive to variations in device longevity.34Go–37Go Indeed, in the analysis reported by Sanders et al.34Go and by Al-Khatib et al.,35Go extension of device longevity from 5 to 7 years and up to 10 years yielded a substantial improvement of cost-effectiveness estimates. Moreover, increased device longevity would translate into reduction of ICD replacements. Based on Hauser's report,10Go a 10-year lasting device would save most ICD replacements, as only 40% of ICD carriers with LV dysfunction are likely to survive longer then 10 years. This figure may be somewhat different when patients with primary arrhythmogenic diseases, hypertrophic, or right ventricular arrhythmogenic cardiomyopathy are considered; nonetheless, it reinforces the concept that health system expenditures would be largely reduced by long-lasting ICDs.10Go From the patients' point of view, it would translate into a decreased risk of severe complications related to repeated replacements, which cause costly hospitalizations and interventions. In the large Danish registry7Go complications were more likely at device replacement (2%) than at implantation (0.75%). In Gould's report6Go on ICD replacement following advisories, pocket infection requiring lead extraction occurred in 2% of patients, and mortality related to lead extraction was 0.4%.

The implant of a device with extended longevity would also imply the possibility of lengthening the time between follow-up visits, thus obtaining a combined effect on patient comfort and cost-effectiveness improvement.34Go,37Go

In our study, longevity impacted the cost per service life of ICDs, meaning that the up-front cost is of limited value. Indeed, this is very important, as Camm et al.37Go recently highlighted that cost perception and misleading cost-effectiveness studies have negative drawbacks on clinical practice. Fitzpatrick et al.38Go claimed that, based on an expected service life of 7–11 years and on ICD discounting through suppliers competition, ICD therapy should be made available to all the patients currently being denied this treatment because of misleading cost-effectiveness computations.


    Conclusion
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Significant differences were observed in the past years among American ICD manufacturers. Extensive technological research is needed to improve ICD longevity, matching clinical requirements. Cost-effectiveness studies should be based on actual ICD longevity.


    Study limitations
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
Our study related to a relatively small number of devices, hence a per-model analysis would have been meaningless. Such an analysis has never been performed in the large report by Hauser.9Go On the other hand, our single-centre experience allowed comparable ICD programming, so that an analysis based on ICD activity was possible.

In any study of actual device longevity, the devices under investigation are outdated at their replacement owing to the continuing technological improvements and device releases turnover. Our results may not apply to current or future devices, nonetheless our observations may be helpful, where they represent a milestone for comparison with future ICD releases.


    Acknowledgement
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
The authors thank Jessica Frisoni for her valuable help in data collection.

Conflict of interest: none declared.


    References
 Top
 Abstract
 Introduction
 Methods
 Statistical analysis
 Results
 Discussion
 Conclusion
 Study limitations
 Acknowledgement
 References
 
[1] Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter Automatic Defibrillator Implantation Trial Investigators. N Engl J Med (1996) 335:1933–40.[Abstract/Free Full Text]

[2] The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med (1997) 337:1576–83.[Abstract/Free Full Text]

[3] Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med (1999) 341:1882–90.[Abstract/Free Full Text]

[4] Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med (2002) 346:877–83.[Abstract/Free Full Text]

[5] Bardy G, Lee KL, Mark DB, et al, for the SCD-HeFT Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med (2005) 352:225–37.[Abstract/Free Full Text]

[6] Gould PA, Krahn AD. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA (2006) 295:1907–11.[Abstract/Free Full Text]

[7] Johansen JB, Nielsen JC, Arnsbo P, Moller M, Pedersen AK, Mortensen PT. Higher incidence of pacemaker infection after replacement than after first implantation: experiences from 36076 consecutive patients. Heart Rhythm (2006) 3:S102–S103. AB 49-5.

[8] Ellinor PT, Guy ML, Ruskin JN, McGovern BA. Variability in implantable cardioverter defibrillator pulse generator longevity between manufacturers. Pacing Clin Electrophysiol (2003) 26:71–5.[CrossRef][Medline]

[9] Hauser RG, Hayes DL, Epstein AE, Cannom DS, Vlay SC, Song SL, et al. Multicenter experience with failed and recalled implantable cardioverter-defibrillator pulse generators. Heart Rhythm (2006) 3:640–4.[CrossRef][Web of Science][Medline]

[10] Hauser RG. The growing mismatch between patient longevity and the service life of implantable cardioverter-defibrillators. J Am Coll Cardiol (2005) 45:2022–5.[Abstract/Free Full Text]

[11] Morgan JM. Cost-effectiveness of implantable cardioverter defibrillator therapy. J Cardiovasc Electrophysiol (2002) 13:S114–S117.[Web of Science][Medline]

[12] Hauer RN, Derksen R, Wever EF. Can implantable cardioverter-defibrillator therapy reduce healthcare costs? Am J Cardiol (1996) 78:134–9.[CrossRef][Web of Science][Medline]

[13] Crossley GH, Fitzgerald DM. Estimating defibrillator longevity: a need for an objective comparison. Pacing Clin Electrophysiol (1997) 20:1897–901.[CrossRef][Medline]

[14] Schaer BA, Joerg L, Sticherling C, Osswald S. Marked differences in ICD longevity among different manufacturers. Eur Heart J (2007) 28:38. Abstract.

[15] Sweeney MO, Wathen MS, Volosin K, Abdalla I, DeGroot PJ, Otterness MF, et al. Appropriate and inappropriate ventricular therapies, quality of life, and mortality among primary and secondary prevention implantable cardioverter defibrillator patients: results from the Pacing Fast VT REduces Shock ThErapies (PainFREE Rx II) trial. Circulation (2005) 111:2898–905.[Abstract/Free Full Text]

[16] Wilkoff BL, Ousdigian KT, Sterns LD, Wang ZJ, Wilson RD, Morgan JM, EMPIRIC Trial Investigators. A comparison of empiric to physician-tailored programming of implantable cardioverter-defibrillators: results from the prospective randomized multicenter EMPIRIC trial. J Am Coll Cardiol (2006) 48:330–9.[Abstract/Free Full Text]

[17] Crespi AM, Somdahl SK, Schmidt CL, Skarstad PM. Evolution of power sources for implantable cardioverter-defibrillators. J Power Source (2001) 96:33–8.[CrossRef]

[18] Skarstad PM. Battery and capacitor technology for uniform charge time in implantable cardioverter-defibrillators. J Power Source (2004) 136:263–7.[CrossRef]

[19] Chen K, Merritt DR, Howard WG, Schmidt CL, Skarstad PM. Hybrid cathode lithium batteries for implantable medical applications. J Power Source (2006) 162:837–40.[CrossRef]

[20] Gomadam PM, Merritt DR, Scott ER, Schmidt CL, Skarstad PM, Weidner JW. Modeling Li/CFx-SVO hybrid-cathode batteries. J Electrochem Soc (2007) 154:A1058–64.[CrossRef]

[21] Hauser R, Hayes D, Parsonnet V, Furman S, Epstein A, Hayes J, et al. Feasibility and initial results of an internet-based pacemaker and ICD pulse generator and lead registry. PACE (2001) 24:82–7.[Medline]

[22] Senaratne J, Irwin ME, Senaratne MP. Pacemaker longevity: are we getting what we are promised? Pacing Clin Electrophysiol (2006) 29:1044–54.[CrossRef][Medline]

[23] Epstein AE, Plumb VJ, Kirk KA, Kay GN. Pacing threshold increase in nonthoracotomy implantable defibrillator leads: implications for battery longevity and margin of safety. J Interv Card Electrophysiol (1997) 1:131–4.[CrossRef][Medline]

[24] Boriani G, Rusconi L, Biffi M, Pavia L, Sassara M, Malfitano D, et al. Role of ventricular autocapture function in increasing longevity of DDDR pacemakers: a prospective study. Europace (2006) 8:216–20.[Abstract/Free Full Text]

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