(Circulation. 1996;93:489-496.)
© 1996 American Heart Association, Inc.
Articles |
Cost-effectiveness of Implantable Defibrillator as First-Choice Therapy Versus Electrophysiologically Guided, Tiered Strategy in Postinfarct Sudden Death Survivors
A Randomized Study
Presented in part at the 67th Scientific Sessions of the American Heart Association, Dallas, Tex, November 14-17, 1994, and published in abstract form in Circulation (1994;90[pt 2]:I-654).
From the Heart-Lung Institute (E.F.D.W., R.N.W.H., H.R., P.F.A.B., E.O.R. de M.), the Department of Health Sciences (G.S.), and the Clinical Epidemiology Unit (A.A.), University Hospital and University of Utrecht; the Department of Experimental Cardiology (F.J.L. van C.), and the Department of Epidemiology (J.G.P.T.), University Hospital and University of Amsterdam; the Thoraxcenter (H.J.G.M.C.), University Hospital and University of Groningen; and the Interuniversity Cardiology Institute of the Netherlands, Utrecht.
Correspondence to Eric F.D. Wever, MD, Department of Cardiology, Heart-Lung Institute, University Hospital Utrecht, 100 Heidelberglaan, PO Box 85500, 3508 GA Utrecht, Netherlands.
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Abstract |
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 Top Abstract IntroductionMethods Results Discussion References |
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Background Rising costs of health care, partly as a result of costly therapeutic innovations, are of concern to both the medical profession and healthcare authorities. The implantable cardioverter-defibrillator (ICD) is still not remunerated by Dutch healthcare insurers. The aim of this study was to evaluate the cost-effectiveness of early implantation of the ICD in postinfarct sudden death survivors.
Methods and Results Sixty consecutive postinfarct survivors of cardiac arrest caused by ventricular tachycardia or fibrillation were randomly assigned either ICD as first choice (n=29) or a tiered therapy starting with antiarrhythmic drugs and guided by electrophysiological (EP) testing (n=31). Median follow-up was 729 days (range, 3 to 1675 days). Fifteen patients died, 4 in the early ICD group and 11 in the EP-guided strategy group (P=.07). For quantitative assessment, the cost-effectiveness ratio was calculated for both groups and expressed as median total costs per patient per day alive. Because effectiveness aspects other than mortality are not incorporated in this ratio, other factors related to quality of life were used as qualitative measures of cost-effectiveness. The cost-effectiveness ratios were $63 and $94 for the early ICD and EP-guided strategy groups, respectively, per patient per day alive. This amounts to a net cost-effectiveness of $11 315 per patient per year alive saved by early ICD implantation. Costs in the early ICD group were higher only during the first 3 months of follow-up, but as a result of the high proportion of therapy changes, including arrhythmia surgery and late ICD implantation, costs in the EP-guided strategy group became higher after that. Patients discharged with antiarrhythmic drugs as sole therapy had the lowest total costs. This subset, however, showed extremely high mortality, resulting in a poor cost-effectiveness ratio ($196 per day). Invasive therapies and hospitalization were the major contributors to costs. If quality-of-life measures are taken into account, the cost-effectiveness of early ICD implantation was even more favorable. Recurrent cardiac arrest and cardiac transplantation occurred in the EP-guided strategy group only, whereas exercise tolerance, total hospitalization duration, number of invasive procedures, and antiarrhythmic therapy changes were significantly in favor of early ICD implantation.
Conclusions In terms of cost-effectiveness, early ICD implantation is superior to the EP-guided therapeutic strategy in postinfarct sudden death survivors.
Key Words: death, sudden • cost-benefit analysis • defibrillation • electrophysiology • trials
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Introduction |
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TopAbstractIntroductionMethods Results Discussion References |
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Antiarrhythmic drug therapy has long been considered the cornerstone in the management of patients with life-threatening ventricular tachyarrhythmias.1 2 3 4 5 However, recent reports suggest that the ICD may be superior to drug therapy in terms of both clinical effectiveness6 7 8 9 and cost-effectiveness.10 11 12 13 Because these studies were retrospective and did not directly compare similar patient groups, the ICD has remained a "last-resort" therapy in many clinical practices. In a recent randomized study of postinfarct sudden death survivors, however, we found higher effectiveness of ICD implantation as first-choice therapy compared with a tiered treatment strategy guided by EP testing (EP-guided strategy), including antiarrhythmic drugs as first choice and, when they fail, nonpharmacological treatment modalities.14 15 16
Uncertainties still remain regarding the cost-effectiveness of ICD therapy.17 18 Rising costs of health care, caused partly by costly therapeutic innovations, are of concern to both the medical profession and healthcare authorities. For this reason, the ICD currently is not reimbursed by the healthcare system in the Netherlands.19 Although ICDs are expensive, this high cost does not necessarily mean that ICD therapy is associated with higher overall expenditures compared with established therapeutic modalities. The EP-guided therapeutic strategy, starting with antiarrhythmic drugs, is in most cases very expensive.11 20 21 22 Antiarrhythmic drug treatment fails in a considerable proportion of patients.4 11 This means that many patients will eventually have nonpharmacological therapy after multiple drug trials and a lengthy hospitalization with multiple EP studies and other diagnostic procedures. In particular, ablative surgery with frequently prolonged postoperative intensive care and/or last-resort ICD implantation has a major effect on total costs. Another reason for high costs may be readmissions and, in the case of repeated resuscitations, potentially long-lasting neurological sequelae. In addition, the EP-guided strategy may have an unfavorable psychological impact on the patients and their relatives. Moreover, in subgroups of patients without an ICD, a high sudden death rate persists.
We performed a cost-effectiveness analysis of ICD implantation as first-choice therapy versus the tiered, EP-guided strategy, as practiced in many centers, in a randomized study design.
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Methods |
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TopAbstractIntroductionMethods Results Discussion References |
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Patients, Treatment Allocation, and Effectiveness Assessment
The study was approved by the Institutional Review Boards of our institutions and carried out in postinfarct survivors of out-of-hospital cardiac arrest caused by documented VT or VF. Patients were recruited at the University Hospitals of Utrecht and Groningen between April 1989 and April 1993. Details on inclusion and exclusion criteria and the predefined study protocol were described previously.16 19 All patients had baseline inducibility of ventricular tachyarrhythmia. The programmed electric stimulation protocol was described previously.23 Randomization was stratified according to the number of normokinetic segments by use of left ventricular cineangiography.16 19 24 25 Fig 1
provides a flowchart of the study. After
randomization, therapy was started as soon as possible. Patients
allocated to the EP-guided strategy were consequently treated according
to the lower branch of the flowchart (see Fig 1), with
antiarrhythmic
drug therapy always the first step. Patients who failed drug therapy
were subjected to VT surgery only if they had mappable VT and were
anticipated to have an acceptable perioperative risk.
This was judged primarily from analysis of the systolic
function of the noninfarcted part of the left
ventricle.16 19 24 25
Patients were discharged when
antiarrhythmic therapy was considered effective and safe. Effectiveness
of an intended therapy was guided by both noninvasive tests (continuous
telemetry, Holter monitoring, and exercise testing) and repeated
programmed electric stimulation.16 23 All patients
were
meticulously followed, and the study ended on January 1, 1994.
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The cost-effectiveness analysis reported in the present study is based on the comparative effectiveness of the two treatment strategies published previously.16 Total mortality in the two groups was compared by use of the hazard ratio, which may be interpreted as relative risk; the precision of hazard ratio estimates was described by means of 95% CIs obtained from the Cox proportional-hazards model. The ICD used for this study was the Ventak P (Cardiac Pacemakers Inc).
Cost-effectiveness Analysis
Total Costs
Starting on the day of randomization, total costs incurred
during initial hospitalization, readmissions, and follow-up were
analyzed. We kept an account of all medical costs per patient,
ie, hospitalization; visits to outpatient clinics; all
diagnostic investigations; and all therapeutic procedures,
including drug treatment and domiciliary care. For all studied
patients, calculation of costs of diagnostic and
therapeutic procedures (including physicians' fees) was based on the
lowest class scale rates of Dutch private healthcare insurance used by
the billing department of the University Hospital Utrecht.
Table 1 shows the costs of hospitalization and
diagnostic and therapeutic cardiac procedures at the
University Hospital of Utrecht and the costs of devices
according to January 1990 and December 1993 cost scenarios. The
in-hospital charges per day varied from $313 in January 1990 to
$497 in December 1993, with a median of $426 in January 1992,
regardless of the type of ward (all costs are given in US dollars). A
sensitivity analysis of cost estimates was performed according
to these three different levels of hospitalization charges. We did not
use a discount rate because the median follow-up was only 2 years.
Medians of total costs per patient in both study groups were compared.
In the EP-guided group, total costs per patient in the subgroups of
patients who remained on antiarrhythmic drugs as sole therapy, had
map-guided arrhythmia surgery, or underwent late ICD
implantation also were calculated separately. The development of
expenses in survivors was estimated by both absolute and median values
of total costs at consecutive 1-, 3-, and 6-month intervals after
randomization and for the entire study period.
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Cost-effectiveness
For the assessment of the
cost-effectiveness, we used total
mortality as the only primary end point of effectiveness.
Cost-effectiveness of each strategy was expressed as a
cost-effectiveness ratio. This ratio was estimated in two ways.
First, it was estimated as the median of total costs per patient per
day alive. This ratio was calculated by dividing total costs for each
patient by the number of days the patient was alive. Subsequently, the
median of these ratios per strategy was assessed. In the same way, the
cost-effectiveness ratio was determined for the subgroups of the
EP-guided treatment arm. Second, cost-effectiveness ratios per
strategy were calculated by dividing total costs in absolute values by
the total number of patient days alive at consecutive 1-, 3-, and
6-month intervals after randomization.
Quality-of-Life
Aspects
Because effectiveness aspects other than mortality are not
expressed in the cost-effectiveness ratio, the following factors
reflecting quality of life (secondary end points) were used for
additional description: major nonfatal events (recurrent cardiac arrest
and cardiac transplantation), functional NYHA class, exercise
tolerance, left ventricular ejection fraction, duration of
hospitalization (initial and readmissions), number of invasive
procedures, and changes of antiarrhythmic therapy. NYHA class and
exercise duration were compared at randomization and 3 and 12 months
after discharge; left ventricular ejection fraction, at
randomization and 3 months after discharge.16 Differences
in quality-of-life variables were assessed with the
Mann-Whitney U test, with values of P
.05
considered significant.
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Results |
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TopAbstractIntroductionMethods Results Discussion References |
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Patients, Treatment Allocation, and Effectiveness Assessment
Sixty consecutive patients were included. Twenty-nine were allocated to early ICD implantation and 31 to the EP-guided strategy. The two groups showed no differences in baseline characteristics.16 The mean ejection fraction of the included patients was approximately 0.30. The mean number of antiarrhythmic drug trials used in the EP-guided arm was 2.2 (median, 2; range, 1 to 5).16 Of the 31 EP-guided strategy patients, 24 (77%) had a trial with a class III antiarrhythmic agent. More than two drug trials were used in 9 patients in whom drugs had to be discontinued owing to adverse effects. Inferred from persistent inducibility, drug therapy was considered a failure in 20 of 31 patients. Table 2
shows additional follow-up results
for both strategies and for subgroups of the EP-guided arm. Median
follow-up duration for all patients was 729 days (mean, 802 days;
range, 3 to 1675 days); for the early ICD group, 871 days (mean, 881
days; range, 8 to 1675 days); and for the EP-guided group, 676 days
(mean, 728 days; range, 3 to 1537 days). Longer follow-up for the
early ICD group compared with the EP-guided group was attributable to
the higher survival rate in the former (see Table 2). No
patient was
lost to follow-up.
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By the end of the study, about one half of the EP-guided patients (52%) ended up with a late ICD. In this study population, no patient was considered a suitable candidate for catheter ablation, and only a minority (6 patients, 19%) of highly selected patients underwent VT surgery.
Fifteen patients died, 4 in the early ICD group and 11 in the
EP-guided
group (see Table 2
). There was a strong trend toward better
survival in
the early ICD group, but the difference was not statistically
significant (hazard ratio, 0.34; 95% CI, 0.11 to 1.08;
P=.07). Of the 11 patients of the EP-guided arm treated with
antiarrhythmic drugs as sole therapy, 7 died.16
Cost-effectiveness Analysis
Total Costs
Table
2 shows medians of total costs per patient for both
strategies with calculations according to the three levels of hospital
charges. Median total costs were similar for both strategies ($47 000
versus $47 500, 1992 scenario). These amounts, however, were
uncorrected for the difference in follow-up duration between the
two strategy arms, which was shorter for the EP-guided group because of
higher mortality (often at an early stage). To correct for these
factors, the development of expenditure in survivors was assessed by
use of median values of total costs per patient at consecutive monthly
intervals. Fig 2 shows that compared with the overall
EP-guided group, median total costs per patient in the early ICD group
were higher only during the first 3 months of follow-up; after
that, the EP-guided strategy was more costly. The difference in cost
development is due to the costs associated with therapy changes,
including arrhythmia surgery and late ICD implantation in the
EP-guided group within this early 3-month period and to longer
hospitalization.16 Table 3 shows absolute
values of total costs at consecutive 1-, 3-, and 6-month intervals
after randomization. Total costs per patient over the entire study
period were less for the early ICD group compared with the EP-guided
strategy ($56 067 versus $63 032 per patient according to the 1992
scenario).
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In both strategy arms, there was some unavoidable delay of surgical therapy (map-guided surgery and ICD implantation) due to logistics. The median duration of (in-hospital) delay was 12 days (range, 4 to 47 days) in the early ICD group and 5 days (range, 0 to 16 days) in the EP-guided strategy arm.
Patients remaining on antiarrhythmic drugs as
sole therapy had the
lowest total costs ($23 500 per patient) but the highest mortality (7
patients). The ICD device, surgery (including ICD implantation), and
hospitalization were the primary contributors to total costs per
patient for both strategies, as shown in Fig 3.
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Cost-effectiveness
Table 2 shows
cost-effectiveness ratios based on median values
for both strategies and for the subgroups of the EP-guided arm. The
early ICD strategy was more cost-effective than the EP-guided
strategy, regardless of whether it is calculated according to the 1990,
1992, or 1993 scenario. Although patients remaining on antiarrhythmic
drugs as sole therapy had the lowest total costs, this subset of
patients, because of the extremely high mortality early during
follow-up, showed the worst cost-effectiveness ratio ($196
according to the 1992 scenario). Table 3 shows an estimation of
the
cost-effectiveness ratios of both strategies based on absolute
values (1992 scenario) at consecutive 1-, 3-, and 6-month intervals
after randomization and for the entire study period. When calculated in
this way, cost-effectiveness of the early ICD strategy also appears
to be better than that of the EP-guided strategy ($64 versus $87 per
day alive).
Quality-of-Life Aspects
When
quality-of-life aspects also are taken into account,
cost-effectiveness of early ICD implantation appears even more
favorable. Recurrent cardiac arrest and cardiac transplantation
occurred in the EP-guided group only, whereas better exercise
tolerance, shorter total hospitalization duration, and fewer invasive
procedures and antiarrhythmic therapy changes were all significantly in
favor of early ICD implantation. In contrast, NYHA classification and
left ventricular ejection fraction were not significantly
different between the two groups.16
Pulse
Generator Replacement
Replacement of pulse generators because of
end-of-life
situations in 6 ICD patients (4 in the early ICD group) and replacement
of the whole ICD system because of infection in 1 patient from the
EP-guided group did not affect the cost-effectiveness ratio
substantially (see Table 3, months 19 to 22 and 23 to end). The
cost-effectiveness ratios of the 4 early ICD patients who
underwent pulse generator replacement were $44, $48, $63, and
$120 for the entire study period. The poor cost-effectiveness ratio
of the last patient was due to lengthy institutionalization for
psychiatric illness. The cost-effectiveness ratios of the two
patients from the EP-guided strategy group who underwent pulse
generator replacement were $55 and $100; the ratio for the patient
whose entire ICD system was replaced was $178. The last patient also
was readmitted twice for noncardiac surgery.
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Discussion |
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TopAbstractIntroductionMethods Results Discussion References |
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This is the first randomized trial to estimate the cost-effectiveness of ICD implantation as first-choice therapy. Cost-effectiveness was compared with the tiered therapeutic strategy guided by EP testing for life-threatening ventricular tachyarrhythmia. In the present study, this comparison was made in patients at high risk for recurrent life-threatening events after surviving an episode of cardiac arrest caused by VT or VF associated with chronic-stage myocardial infarction.4 26
The results of this cost-effectiveness study clearly favor early
ICD implantation in this patient category. The cost-effectiveness
ratio based on median values was $63 and $94 per patient per day alive
in the early ICD and EP-guided groups, respectively (1992 scenario, see
Table 2). The difference would account for a net
cost-effectiveness
ratio of $11 300 (saved costs) per patient per life-year saved.
The ICD device, surgery (including ICD implantation), and
hospitalization were the major contributors to total costs in both
strategies (see Fig 3).
Costs of diagnostic and therapeutic procedures did not
change substantially during the study period, whereas charges for
hospitalization differed (see Table 1). Therefore, we performed
a
sensitivity analysis to estimate the extremes of costs and
cost-effectiveness ratios exclusively according to the three
different scenarios of hospitalization charges: the 1990, the 1992, and
the 1993 scenarios. However, this did not result in major shifts (see
Table 2).
Anticipating a wide range in costs per day alive, we decided to use
median values to compare both strategies. Nevertheless, when
cost-effectiveness for both strategies was defined as total costs
in absolute values divided by total number of patient days alive (see
Table 3), findings were comparable, ie, better for the early
ICD
strategy.
Effectiveness measures other than life expectancy, such as
quality-of-life aspects, were not used for quantitative
determination of the cost-effectiveness ratio. When such measures
are taken into account, cost-effectiveness of early ICD
implantation appears even more favorable. Recurrent cardiac arrest
occurred in the EP-guided group only, whereas exercise tolerance, total
hospitalization duration, number of invasive procedures, and
antiarrhythmic therapy changes were all significantly in favor of early
ICD implantation. One patient in the EP-guided group ended up with
cardiac transplantation.16 Because quality-of-life
testing has not generally been routine in cost-effectiveness
analyses,27 28 we did not adjust the
cost-effectiveness ratios for quality of life. We arbitrarily
decided not to include ICD discharges in quality-of-life
aspects. As Jung et al,29 reported, the
delivery of multiple (more than five) shocks in a relatively short
period (12 months) may have a negative impact on quality of life in
ICD patients. However, except for 5 (3 early and 2 late ICD) patients,
this was absent in our study. In addition, the proportion of patients
with shocks in the early ICD group (62%) was not different from that
in the subgroup with late ICD implants in the EP-guided group
(63%).16
Costs in the early ICD group were higher only during the first 3 months
of follow-up (see Fig 2). Thereafter, the EP-guided strategy
was
more expensive. The difference in cost development was due to costs
associated with therapy changes, including arrhythmia surgery
and late ICD implantation, within the early 3-month period in the
EP-guided group. This finding should be taken into account in the
continuing discussion on mortality benefits of the
ICD.18 30 31
In both strategy arms, there was some unavoidable delay of
surgical therapy. If this delay could have been avoided, median total
costs would have been lower for both strategies, $40 300 instead of
$47 000 per patient for the early ICD group and $46 900 instead of
$47 500 per patient for the EP-guided strategy group (see Table
2).
According to the 1992 scenario, the costs for early ICD implantation would be $23 000 (63x365) per patient per year of life saved. This is well within the range of costs of other accepted therapies, such as coronary artery bypass surgery ($7700 to $44 200), treatment of hypertension ($11 100 to $23 200), and nefrodialysis ($57 300 to $59 500).10
In the EP-guided arm of our study, the high mortality (7 patients, 64%) in the subgroup of patients who were discharged with antiarrhythmic drugs as sole therapy was remarkable.16 Of these 7 patients, 4 died suddenly despite the fact that drug treatment was thought to be effective from both noninvasive and invasive efficacy tests. This mortality rate is higher than that reported in some previous studies for suppression of inducibility with antiarrhythmic drug treatment.4 32 The methods used to assess therapy efficacy, including the programmed electric stimulation protocol, were current and in agreement with the methods described by others.4 16 19 23 32 33 34 In our present study of postinfarct sudden death survivors, however, these methods appeared unreliable in predicting long-term outcome. During the last 5 years, other reports have evolved that expressed doubt about the reliability of EP-guided drug testing.5 35 36 37 In addition to the results of our randomized study, we analyzed the influence on cost-effectiveness (1992 cost scenario) of three assumptions in the EP-guided strategy group: lower sudden death rate, therapy efficacy assessment without EP testing, and exclusion of VT surgery as a therapeutic option.
To study the effect of the poor outcome in patients with antiarrhythmic
drugs as sole therapy on the cost-effectiveness ratio of the
EP-guided strategy, we assumed an outcome similar to that reported
previously for such patients.4 32 We estimated the
cost-effectiveness ratio of the EP-guided arm if 3 patients who
died suddenly would have stayed alive without readmissions until the
end of the study. This would have resulted in a median
cost-effectiveness ratio of the EP-guided strategy of $86 instead
of $94 per patient per day alive (see Table 2) and a mean
cost-effectiveness ratio of $81 instead of $87 per patient day
alive (see Table 3).
Although in our opinion the results of the Electrophysiologic Study Versus Electrocardiographic Monitoring Study38 do not necessarily apply to our patient population, we have analyzed the influence on cost-effectiveness assuming a similar approach to therapy efficacy assessment. Therefore, cost-effectiveness ratios were estimated with the costs of EP studies in the patients of the EP-guided arm ignored. Then, the median and mean cost-effectiveness ratios in the EP-guided arm would have been $91 and $81 per patient per day alive, respectively.
Although we think that VT surgery may be a suitable therapy in selected patients and with appropriate surgical experience,24 25 39 we have also studied the effect of arrhythmia surgery on the cost-effectiveness ratio. For that purpose, we estimated the EP-guided cost-effectiveness ratio by disregarding the costs of surgery in the 6 patients with arrhythmia surgery and assuming that they would have had ICD implantation after drug failure and stayed alive without further costs until the end of the study. This resulted in median and mean cost-effectiveness ratios of the EP-guided arm of $89 and $86 per patient per day alive, respectively.
Thus, according to these assumptions, the median and mean
cost-effectiveness ratios varied between $86 and $91 and between
$81 and $86 per patient per day alive, respectively. These values are
lower than those obtained in the EP-guided arm of the randomized study
(see Tables 2 and 3) but remain much higher than
obtained with ICD
implantation as first-choice treatment. It should be stressed,
however, that such calculations are purely hypothetical and may
therefore be different from those obtained from ongoing prospective
comparative
studies.40 41 42 43 44
Cost-effectiveness analyses of ICD implantation to date have been performed retrospectively.10 11 13 Kuppermann et al10 compared one group of patients discharged with ICDs implanted as a last resort with a group of patients treated with antiarrhythmic drugs. Other therapeutic options were not considered. They calculated a net cost-effectiveness ratio of $17 100 per life-year saved as extra costs for the ICD according to a 1986 scenario. They expected scenarios later than 1986 to be less costly on the basis of assumptions of increased longevity of the device and a transvenous approach to implantation. A similar expectation was expressed in the model study by Anderson and Camm13 in a 1993 report. Costs were also expected to be lower if the decision to implant the ICD had been made earlier. This latter aspect was retrospectively studied by O'Donoghue et al,11 who suggested a trend toward lower costs for such a strategy. The studies by Kuppermann et al10 and O'Donoghue et al11 were hampered by their retrospective characters and heterogeneous patient populations. In contrast, the present study involved comparable patient groups that were randomized after stratification according to left ventricular function and followed prospectively according to the intention-to-treat principle.16 In addition, important alternatives to drug therapy (eg, map-guided ablative techniques) that are part of the EP-guided therapeutic approach were not considered in the above retrospective analyses. By studying total mortality of a well-defined patient population in a randomized design, this study has overcome objections against comparisons of ICD therapy with "historical" controls, as recently raised by Zipes.41
In our study, all but three ICDs were implanted by transthoracic approach, which was the standard approach at the beginning of the study.16 At that time, there was limited experience with transvenous implantation. We later agreed that patients with previous cardiac surgery could have the transvenous approach. The transvenous approach has become the approach of choice in most patients, and morbidity and mortality are expected to decrease.28 45 46 47 48 49 50 This approach will rarely require postoperative care in an intensive care unit.51 Hence, these factors will result in shorter hospitalization, lower costs, and better cost-effectiveness. Technological advances, eg, devices of smaller size that may be implanted subpectorally in the EP laboratory,51 and increased longevity are further expected to add to superior cost-effectiveness of early ICD therapy.
Study Limitations
Within the context of our study design and
the type of
antiarrhythmic drugs chosen, ICD as first-choice therapy appears to
be the most cost-effective approach. However, we cannot exclude
that other strategies not investigated in our study may have similar or
even better cost-effectiveness. Further studies comparing different
scenarios (eg, empirical amiodarone or other EP-guided drugs)
must be performed to confirm or complement the findings of our study.
Such studies should be done before a definitive answer can be given as
to whether an ICD as first-choice therapy should be routinely
recommended in these patients. This issue may be solved by ongoing
studies.40 41 42 43 44
The cost-effectiveness analysis did not include a consideration of nonmedical costs, eg, those created by patients' reduction of professional activities. For all studied patients, calculation of costs of diagnostic and therapeutic procedures was done according only to the lowest class scale rates of Dutch private healthcare insurance as used by the billing department of the University Hospital of Utrecht, which may not always have covered all costs incurred. During the study period, six pulse generators had to be replaced because of end-of-life situations with no effect on the cost-effectiveness ratio. The relatively short duration of the study did not allow an appropriate estimation of the influence of more replacements over time.
Conclusions
Data from this randomized study demonstrate that
in terms of
cost-effectiveness early ICD implantation is superior to serial
drug testing and subsequent EP-guided, nonpharmacological therapy as
used in this study in postinfarct sudden death survivors. This is in
accordance with the expectation expressed in retrospective studies.
Immediate implantation after judicious decision making, use of
transvenous leads, and refinement of ICD technology may add to improve
cost-effectiveness of ICD therapy. Finally, results of this study
originate from a first attempt at a synthesis between clinical,
scientific, and economic data. Cooperative efforts in these three
fields may contribute to political decision making and reimbursement
policy.
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Selected Abbreviations and Acronyms |
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Acknowledgments |
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This work was supported by the Dutch Sick-Fund Council and Cardiac Pacemakers Inc. We are indebted to Fred Wittkampf, PhD, Ans Wiesfeld, MD, Alice Ester, MD, and Erik Buskens, MD, for their support in data analysis and to Judith van Gestel and Barbara Holderbusch for their help in preparing the manuscript.
Received May 22, 1995; revision received September 11, 1995; accepted September 17, 1995.
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References |
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TopAbstractIntroductionMethods Results Discussion References |
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