Background Eight randomized trials have evaluated whether theprophylactic use of an implantable cardioverter–defibrillator(ICD) improves survival among patients who are at risk for suddendeath due to left ventricular systolic dysfunction but who havenot had a life-threatening ventricular arrhythmia. We assessedthe cost-effectiveness of the ICD in the populations representedin these primary-prevention trials.
Methods We developed a Markov model of the cost, quality oflife, survival, and incremental cost-effectiveness of the prophylacticimplantation of an ICD, as compared with control therapy, amongpatients with survival and mortality rates similar to thosein each of the clinical trials. We modeled the efficacy of theICD as a reduction in the relative risk of death on the basisof the hazard ratios reported in the individual clinical trials.
Results Use of the ICD increased lifetime costs in every trial.Two trials — the Coronary Artery Bypass Graft (CABG) PatchTrial and the Defibrillator in Acute Myocardial Infarction Trial(DINAMIT) — found that the prophylactic implantation ofan ICD did not reduce the risk of death and thus was both moreexpensive and less effective than control therapy. For the othersix trials — the Multicenter Automatic Defibrillator ImplantationTrial (MADIT) I, MADIT II, the Multicenter Unsustained TachycardiaTrial (MUSTT), the Defibrillators in Non-Ischemic CardiomyopathyTreatment Evaluation (DEFINITE) trial, the Comparison of MedicalTherapy, Pacing, and Defibrillation in Heart Failure (COMPANION)trial, and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)— the use of an ICD was projected to add between 1.01and 2.99 quality-adjusted life-years (QALY) and between $68,300and $101,500 in cost. Using base-case assumptions, we foundthat the cost-effectiveness of the ICD as compared with controltherapy in these six populations ranged from $34,000 to $70,200per QALY gained. Sensitivity analyses showed that this cost-effectivenessratio would remain below $100,000 per QALY as long as the ICDreduced mortality for seven or more years.
Conclusions Prophylactic implantation of an ICD has a cost-effectivenessratio below $100,000 per QALY gained in populations in whicha significant device-related reduction in mortality has beendemonstrated.
The implantable cardioverter–defibrillator (ICD) can convertepisodes of ventricular fibrillation and ventricular tachycardiato sinus rhythm, thus potentially averting sudden death fromcardiac causes. Randomized trials clearly demonstrate that theimplantation of an ICD reduces the subsequent risk of deathamong patients who have been resuscitated from a cardiac arrest.1,2,3However, because very few patients in the United States survivean out-of-hospital cardiac arrest, a strategy of implantingan ICD in patients at high risk for sudden death from cardiaccauses has been proposed.
Eight clinical trials have randomly assigned patients at riskfor sudden death due to left ventricular systolic dysfunctionwho have not had life-threatening ventricular arrhythmias toreceive an ICD or an alternative therapy: the Defibrillatorin Acute Myocardial Infarction Trial (DINAMIT), the MulticenterAutomatic Defibrillator Implantation Trial I and II (MADIT Iand MADIT II, respectively), the Defibrillators in Non-IschemicCardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparisonof Medical Therapy, Pacing, and Defibrillation in Heart Failure(COMPANION) trial, the Multicenter Unsustained Tachycardia Trial(MUSTT), the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT),and the Coronary Artery Bypass Graft (CABG) Patch Trial.4,5,6,7,8,9,10,11Several of these trials, most notably MADIT II and SCD-HeFT,have shown that prophylactic implantation of an ICD significantlyreduced overall mortality.6,9 No such advantage was found inthe DINAMIT and CABG Patch Trial, however.4,10
The Centers for Medicare and Medicaid Services estimate thatas many as 500,000 Medicare beneficiaries might be eligibleto receive a prophylactic ICD in the United States.12 Giventhe substantial cost of the ICD, the economic effect of thisstrategy must be considered. In this analysis, we evaluatedthe benefits, costs, and cost-effectiveness of the prophylacticimplantation of an ICD in patients meeting the inclusion criteriaof each of the eight primary-prevention trials.
Methods
Design of the Study
We used a decision model to estimate costs and survival amongpatients who received either an ICD for the primary preventionof sudden death from cardiac causes or control therapy (Figure 1).We adhered to recommendations for the conduct of cost-effectivenessanalyses by using a societal perspective on health benefitsand costs and applying a 3 percent annual discount rate.13 Althoughsome of the individual trials from which we obtained data weresupported by device manufacturers, none of the authors of thisarticle had any association with the manufacturers of ICD devices.
The square on the left represents a choice between alternative treatments: the implantation of an ICD or control therapy. Circles represent chance nodes. Patients who receive an ICD are at risk for death from the implantation procedure. Patients who do not die from the procedure and patients assigned to conventional (control) treatment enter the Markov tree (denoted by rectangles containing circles and an arrow). The Markov tree represents the clinical events that can occur during each one-month period as a patient is followed until death: a patient may die (from arrhythmia, nonarrhythmic cardiac causes, or noncardiac causes). If the patient survives, he or she remains well for the one-month period. Patients who have an ICD may have a lead infection or failure that may (or may not) cause them to discontinue treatment (and to switch to the control therapy).
Decision Model
We adapted a Markov model14,15 developed to assess the cost-effectivenessof the ICD16,17,18 (Figure 1) using Decision Maker software(version 2002.7.2, Pratt Medical Group). The model tracked acohort of patients who received either a prophylactic ICD orcontrol therapy. Each month, patients in this Markov tree wereat risk for sudden death from cardiac causes, nonsudden deathfrom cardiac causes, and death from noncardiac causes.
We assumed that the probability of death was constant and matchedthe total rate of death from any cause among the control patientsduring the average follow-up period (range, 16 to 41 months).For extrapolation beyond the trial period, we assumed the annualrate of death from any cause observed during the trial periodcontinued, but we also incorporated data from the U.S. generalpopulation to account for the increase in the age- and sex-specificrate of death from noncardiac causes as the cohort aged.19 Additionalinformation is provided in the Supplementary Appendix, availablewith the full text of this article at www.nejm.org.4,5,6,7,8,9,10,11
Efficacy of the ICD
We modeled the efficacy of ICD therapy as a reduction in therelative risk of death from any cause on the basis of the hazardratios reported by each clinical trial (provided in the Supplementary Appendix).4,5,6,7,8,9,10,11,16,20,21,22,23,24,25,26,27,28,29,30The effectiveness of the ICD, as compared with control therapy,in reducing the hazard ratio for death varied among the trialsin relation to their annual rate of death from any cause (correlationcoefficient, –0.76) (Figure 2). For our base-case analysis,we assumed that the benefit of the ICD would continue throughoutthe patient's lifetime and that the generator would be replacedevery five years.21
Figure 2. Hazard Ratios for the Risk of Death after the Implantation of an ICD, as Compared with Control Therapy, in Eight Primary-Prevention Trials.
The eight trials were as follows: the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), the Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Coronary Artery Bypass Graft (CABG) Patch Trial.4,5,6,7,8,9,10,11
Quality of Life
The Markov model incorporated adjustments for the quality oflife associated with age-specific current health, a historyof myocardial infarction, and with implantation of an ICD withthe use of utilities. Utilities are a measure of the qualityof life rated on a scale from 0 to 1, where 0 represents deathand 1 ideal health. The model assumed that one year of lifewith left ventricular dysfunction equaled 0.88 year of optimalhealth on the basis on data from previous studies.27,29,31 Thisfigure was then multiplied by age-specific weights based ondata from the Beaver Dam Health Outcomes Study.28 In our base-caseanalysis, we assumed that the quality of life did not changeas a result of the implantation of an ICD. We assumed that patientswho were hospitalized for lead infections received a quality-of-lifedecrement of 3.5 days (as shown in the Supplementary Appendix).
Costs
Our analysis included the direct costs of medical care associatedwith inpatient and outpatient treatment (provided in the Supplementary Appendix).We included the costs of the initial ICD implantation;of ongoing therapy for both the control and ICD groups, includingvisits to physicians, laboratory tests, and rehospitalization;and of ICD generator or lead replacement. We updated all coststo 2005 U.S. dollars using the gross domestic product deflator.32,33We based the cost of ICD implantation ($27,975) and replacement($18,390) on the fiscal-year 2005 Medicare Inpatient ProspectiveHospital Payment system (diagnosis-related groups 515 and 115)and professional fees (Current Procedural Terminology codes33249 and 33240). We assumed that single-chamber ICDs were usedin terms of both costs and complications. We obtained follow-uphospitalization costs unrelated to ICD implantation for bothstrategies from the Myocardial Infarction Triage and Interventionpatient registry.34,35
Sensitivity Analyses
We performed sensitivity analyses to account for important modelassumptions and uncertainties. For clinical variables, our rangesfor sensitivity analyses represent our judgment of the variationlikely to be encountered in clinical practice on the basis ofboth the literature and discussion with experts. In sensitivityanalyses that included all model variables, the incrementalcost-effectiveness of the ICD as compared with control therapywas most sensitive to variation in five factors: the efficacyof the ICD in reducing mortality, the cost of ICD implantation,the frequency of generator replacement, the quality of life,and the time horizon used in the analysis. We therefore exploredthese variables more extensively and assessed the range of potentialeffects.
Results
Validation of the Model
For the trial period, our Markov model predicted mortality ratesassociated with control therapy that were within 0.3 percentagepoint of those found in the individual trials. For the ICD strategy,our model matched the trial results within 1.6 percentage pointsexcept for those of MADIT I, for which our estimated mortalityrate was 20 percent at 27 months, rather than the actual rateof 15.8 percent. The cause of this discrepancy is not clear.
Base-Case Analysis
The health and economic outcomes varied greatly among the trialpopulations (Table 1). In each population, prophylactic implantationof an ICD was more expensive than control therapy, with theincrease in estimated lifetime discounted costs ranging from$55,700 in the CABG Patch Trial to $101,500 in MUSTT. In sixof the eight populations, implantation of the ICD improved lifeexpectancy relative to control therapy, with the discountedincrement ranging from 1.40 to 4.14 years (undiscounted range,2.12 to 6.21) or from 1.01 to 2.99 quality-adjusted life-years(QALY) (undiscounted range, 1.53 to 4.47). The incremental cost-effectivenessratios based on these trials ranged from $24,500 to $50,700per life-year added and from $34,000 to $70,200 per QALY added(Table 1). In two trials (DINAMIT and CABG Patch), the lifeexpectancy of the patients who received an ICD was less thanthat of the patients who received control therapy, so the ICDwas both more expensive and less effective than control therapy.
Table 1. Health and Economic Outcomes of the Prophylactic Implantation of an ICD as Compared with Control Therapy.
Sensitivity Analyses
The incremental cost-effectiveness of the ICD as compared withcontrol therapy became more favorable as the efficacy of theICD increased within the 95 percent confidence interval forthe reduction in the risk of death from any cause that was calculatedin each trial (Table 1 and Figure 3A). Since the efficacy ofthe ICD is, in general, related to the estimated annual mortalityrate in the patient population studied (Figure 2), the incrementalcost-effectiveness of the ICD tended to be more favorable inhigher-risk patients.
Figure 3. Sensitivity Analysis of the Incremental Cost-Effectiveness of Prophylactic Implantation of an ICD, as Compared with Control Therapy, with Respect to Efficacy (Panel A), the Frequency of Generator Replacement (Panel B), and the Quality of Life (Panel C).
Eight trials were analyzed: the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), the Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Coronary Artery Bypass Graft (CABG) Patch Trial.4,5,6,7,8,9,10,11 Panel A reflects the efficacy of the ICD in reducing the risk of death from any cause. The arrows indicate the efficacy of the ICD in reducing the risk of death from any cause in the individual trials. The arrow in Panel B indicates the base-case estimate of replacing the generator every five years. The arrow in Panel C indicates the base-case estimate of the quality of life with an ICD of 0.88. For this analysis, the assumed quality of life with control therapy remains constant at 0.88. QALY denotes quality-adjusted life-year.
Lowering the estimated cost of the ICD improved cost-effectiveness.If the cost of the ICD were reduced from $27,975 to $10,000,the incremental cost-effectiveness of ICD therapy would improvefrom $70,200 to $52,400 per QALY gained in SCD-HeFT and from$34,000 to $27,900 per QALY gained in MUSTT. Conversely, ifthe cost of the device were increased to $60,000, the incrementalcost-effectiveness of the ICD would be less favorable, rangingfrom $44,700 per QALY gained in MUSTT to $101,800 per QALY gainedin SCD-HeFT.
If ICD generators were replaced more frequently than every fiveyears, the cost-effectiveness of ICD therapy would be less economicallyfavorable (replacement every three years yields an incrementalcost-effectiveness of between $41,200 and $88,600 per QALY gainedfor the clinical trials in which prophylactic implantation ofan ICD was found to be better than control therapy). However,if the generators were replaced every seven years, the cost-effectivenessof ICD implantation relative to control therapy would improveto between $30,800 and $62,300 per QALY gained (Figure 3B).
We initially assumed that the prophylactic implantation of anICD would not further change the patients' quality of life,but if the patients' quality of life were decreased by prophylacticICD implantation, the cost-effectiveness of this approach wouldbe much less favorable (Figure 3C). For example, in SCD-HeFT,if a patient in the control group has a utility of 0.88 anda patient with an ICD has a utility of 0.72 or less, then thecontrol therapy is associated with both lower costs and betteroutcomes than the implantation of an ICD. Such an ICD-associateddecrease in the quality of life might be anticipated, for example,in a patient who received numerous shocks from the device.36However, as long as the utility associated with having an ICDexceeded 0.84, the cost-effectiveness would be less than $100,000per QALY gained. Recent clinical trials suggest that the implantationof an ICD may in fact improve the average quality of life.36,37In SCD-HeFT, if the ICD utility were increased to 0.95 (base-caseutility, 0.88), then the cost-effectiveness of the implantationof an ICD would improve to less than $50,000 per QALY gained.
Because patients with nonischemic cardiomyopathy might havea lower quality of life than those with ischemic heart disease,we also explored the effect of decreasing patients' utilityon the basis of the presence of left ventricular dysfunction(for both the ICD and control strategies) from our base-casevalue of 0.88 to 0.75, as suggested in one study.38 In the clinicaltrials in which prophylactic implantation of an ICD was foundto be better than control therapy, the cost-effectiveness ofthe ICD would range from $39,800 to $82,400 per QALY gained.Because such patients might also have higher inpatient costs,we also explored increasing monthly inpatient costs. Our resultswere not sensitive to these changes; increasing these monthlyinpatient costs by 50 percent (for both treatment strategies)would change the incremental cost-effectiveness of the implantationof an ICD from $70,200 to $73,500 per QALY gained in SCD-HeFTand from $34,000 to $37,300 per QALY gained in MUSTT.
Extrapolation and the Time Horizon
Our base-case analyses used a time horizon that encompassedthe lifetime of the patient, and we assumed that the costs andbenefits associated with the ICD in reducing the risk of suddendeath from cardiac causes would continue for the entire period.If we used a lifelong horizon but assumed that ICD efficacyceased after the first three years, the cost-effectiveness ofthe ICD as compared with control treatment became much lessfavorable, ranging from $70,200 per QALY gained in MUSTT to$171,800 per QALY gained in SCD-HeFT (Figure 4A). As long asthe ICD retained its effectiveness for at least seven years,the cost-effectiveness of this approach as compared with controltherapy was less than $100,000 per QALY gained in all trialsin which prophylactic implantation of an ICD was found to bebetter than control therapy (Figure 4A).
Figure 4. Incremental Cost-Effectiveness of the Prophylactic Implantation of an ICD, as Compared with Control Therapy, with Respect to the Duration of the ICD-Associated Reduction in the Risk of Sudden Death from Cardiac Causes (Panel A) and the Time Horizon (Panel B).
The analysis included the six trials in which prophylactic implantation of an ICD was found to be better than control therapy: the Multicenter Automatic Defibrillator Implantation Trial I (MADIT I), MADIT II, the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial, the Multicenter Unsustained Tachycardia Trial (MUSTT), and the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT). In Panel A, the x axis indicates the duration of the ICD-associated benefit in years; after this time it is assumed that the ICD provides no additional benefit and the survival curves of both groups are parallel. In this analysis, the costs for both treatment strategies continue through the patient's projected lifetime. The base-case assumption is that the benefit lasts a lifetime (arrow). In Panel B, both costs and benefits are assumed to stop at the specified time. QALY denotes quality-adjusted life-year.
We also evaluated the costs and benefits of the implantationof an ICD as compared with control therapy for various timehorizons (Figure 4B). In these analyses, both costs and benefitswere included in the simulation through the use of a specifiedtime horizon (for example, three years), and neither costs norbenefits that occurred after that time frame were included.Cost-effectiveness became substantially more favorable as thetime horizon increased (Figure 4B). Therefore, a cost-effectivenessanalysis limited to a shorter time horizon would result in aless favorable estimate of cost-effectiveness than would ananalysis with a longer time horizon.
Discussion
Our analysis demonstrates that under most assumptions, the prophylacticimplantation of an ICD has a cost-effectiveness ratio below$100,000 per QALY gained in patients at increased risk for suddendeath as the result of a reduced left ventricular ejection fraction.The weight of evidence from eight randomized trials is thatthe prophylactic implantation of an ICD reduces the rate ofdeath from any cause; in the six trials that showed a mortalitybenefit, we project that the implantation of an ICD adds between2.12 and 6.21 undiscounted years of life. This increment inlife expectancy is substantial as compared with that providedby many other medical interventions, and the incremental cost-effectivenessof the ICD, in appropriately selected patients, is similar tothat of other interventions often accepted as cost-effective.
In the six randomized trials that showed a reduction in mortalityassociated with the implantation of an ICD,5,6,7,8,9,11 we founda cost-effectiveness ratio of less than $51,000 per additionallife-year and less than $71,000 per QALY gained. In the twostudies that found a higher mortality rate among patients whoreceived an ICD than among patients who received control therapy,the ICD strategy was associated with higher costs and worseoutcomes.
A quantitative overview20 of the eight primary-prevention ICDtrials showed a significant degree of heterogeneity among thesetrials in the effectiveness of the ICD in reducing the rateof death from any cause. The disparity in results among thesestudies is probably a consequence of several factors, includingthe differing characteristics of the populations, the differingquality of the non-ICD medical therapy given to the controlgroups, and the differing competing risks of death from causesnot affected by ICD implantation. The two trials in which patientsassigned to ICD therapy had a higher mortality rate were composedof patients who were undergoing concomitant bypass surgery (CABGPatch) or who had had an acute myocardial infarction (DINAMIT).Prophylactic implantation of an ICD in such patients may havereduced efficacy owing to the specific characteristics of thepatient population, competing causes of death, or both. Whateverthe reason, this heterogeneity in the effectiveness of prophylacticimplantation of an ICD highlights the need for appropriate,evidence-based selection of patients.
Because the clinical results of the prophylactic implantationof an ICD vary substantially depending on the patient population,we did not pool the results of available trials to estimatean overall cost-effectiveness ratio. Indeed, cost-effectivenessis not an inherent property of any particular therapy but dependson the patient population in which the therapy is used. Whenthe clinical effectiveness of a therapy varies according tothe population selected, its cost-effectiveness will vary aswell.39
Prophylactic implantation of an ICD poses a difficult challengeto health policymakers owing to the high cost of the deviceand the large patient population in which it may be applied.40Even if this approach is used only in patient populations inwhich it has been shown to be cost-effective, the aggregateexpenditure in the United States for ICDs could easily exceedseveral billion dollars per year. If clinicians extend the prophylacticuse of ICDs to lower-risk patients in whom the efficacy is lowerand cost-effectiveness less favorable, the societal cost willrise further. On the other hand, within the population of patientswith low ejection fractions, it may be possible to identifysubgroups that have a characteristically greater or lesser benefit.The Center for Medicare and Medicaid Services has announcedplans for the prospective collection of data to assist in identifyingsuch subgroups.12 There is not yet, however, a consensus asto how such patients might be identified.
Recently, the SCD-HeFT investigators presented results fromtheir trial-specific cost-effectiveness analysis.41 Their base-caseanalysis estimates that the ICD costs $33,200 per life-yearmore than does medical management (as compared with our estimateof $50,700 per life-year). Although we do not have access toall their assumptions, incorporating into our model the lowerICD-implantation cost used in their analysis ($17,500) wouldresult in a cost-effectiveness ratio of $43,200 per life-year.
Our study has several limitations. We used only summary datafrom each trial, so our projections may not match the more detailedresults of prospective economic studies that may have been donewithin the individual trials. We also made lifetime projectionsof the clinical and economic outcomes of the prophylactic implantationof an ICD — an approach that required some assumptions.Our analysis demonstrates that as long as the mortality benefitassociated with the prophylactic implantation of the ICD (ascompared with control therapy) exceeds seven years, the ICDcosts less than $100,000 per QALY gained in the trials showingthat the ICD implantation reduced the risk of death. We cannot,however, be certain that longer-term follow-up of the trialsmight indicate the need for some adjustments in our analyses.Nevertheless, in view of the substantial reductions in mortalityseen during medium-term follow-up in these trials, these adjustmentsare not likely to change our major conclusions.
Our analysis is limited to ICDs and cannot be extrapolated tothe newer devices that include a cardiac-resynchronization capability.The added cost and complexity of these combined devices suggestthat their cost-effectiveness may be quite different from thatof ICDs alone. By contrast, our findings are probably applicableto lower-cost ICDs that may omit noncritical features to reduceexpense. Future price competition that lowers the costs of thesedevices would also enhance the cost-effectiveness of ICDs. Inconclusion, our analysis suggests that the prophylactic implantationof an ICD has a cost-effectiveness ratio below $100,000 perQALY gained in populations in which a significant device-associatedreduction in mortality has been demonstrated.
Supported by the Blue Cross Blue Shield Association TechnologyEvaluation Center, the Department of Veterans Affairs, and theAgency for Healthcare Research and Quality.
Drs. Sanders, Hlatky, and Owens report having served as consultantsto the Blue Cross Blue Shield Association Technology EvaluationCenter.
Source Information
From Duke Clinical Research Institute, Duke University, Durham, N.C. (G.D.S.); the Department of Health Research and Policy, School of Medicine (M.A.H.), and the Center for Primary Care and Outcomes Research, Department of Medicine (M.A.H., D.K.O.), Stanford University, Stanford, Calif.; and the Veterans Affairs Palo Alto Health Care System, Palo Alto, Calif. (D.K.O.).
Address reprint requests to Dr. Sanders at Duke Clinical Research Institute, P.O. Box 17969, Duke University, Durham, NC 27715, or at gillian.sanders{at}duke.edu.
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Cost-Effectiveness of ICDs
Anderson K. P., Stevenson L. W., Stevenson W. G., Fauchier L., Babuty D., Sanders G. D., Hlatky M. A., Owens D. K.
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