Correspondence
Cost-Effectiveness of ICDs
N Engl J Med 2006; 354:205-207January 12, 2006
- Article
To the Editor:
The cost-effectiveness of implantable cardioverter–defibrillator (ICD) therapy reported by Sanders et al. (Oct. 6 issue)1 is overly optimistic, because it does not fully account for several factors that raise the costs and lower the effectiveness of this therapy. The authors assumed a constant benefit of the ICD during the patient's lifetime, whereas in previous investigations, the benefit declined, with a convergence of survival curves by seven to eight years.2 The assumed probability of lead-related complications (2.4 percent over 20 months) underestimates the spectrum and frequency of serious complications (up to 14 percent in the Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]).3 The high frequency of recalls of devices and the consequent interventions are not accounted for.4 The base-case assumption of an equivalent quality of life among patients who received an ICD and the control patients does not account for the adverse effect of ICD shocks (31 percent in SCD-HeFT)3 or for the discomfort, inconvenience, and the loss of time and income due to the implantation procedure and the need for replacement of the device, the checking and programming of the device before and after many forms of surgery, and, because of the presence of the device, the exclusion of several types of diagnostic procedures, treatments, employment, and recreation. The inclusion of these factors, in addition to those noted by Goldman in his editorial,5 would unfavorably affect the cost-effectiveness of ICDs.
5 ReferencesKelley P. Anderson, M.D.
Marshfield Clinic, Marshfield, WI 54449
kpand@att.net 1
Sanders GD ,Hlatky MA ,Owens DK . Cost-effectiveness of implantable cardioverter-defibrillators. N Engl J Med 2005;353:1471-1480
Full Text | Web of Science | Medline2
Weiss JP ,Saynina O ,McDonald KM ,McClellan MB ,Hlatky MA . Effectiveness and cost-effectiveness of implantable cardioverter defibrillators in the treatment of ventricular arrhythmias among Medicare beneficiaries. Am J Med 2002;112:519-527
CrossRef | Web of Science | Medline3
Bardy GH ,Lee KL ,Mark DB , et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225-237[Erratum, N Engl J Med 2005;352:2146.]
Full Text | Web of Science | Medline4
Maisel WH ,Sweeney MO ,Stevenson WG ,Ellison KE ,Epstein LM . Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001;286:793-799
CrossRef | Web of Science | Medline5
Goldman L . Cost-effectiveness in a flat world -- can ICDs help the United States get rhythm? N Engl J Med 2005;353:1513-1515
Full Text | Web of Science | Medline
To the Editor:
The study by Sanders et al. of the cost-effectiveness of ICDs exemplifies the skilled analyses that are crucial as the choices become explicit between technologies and between technology and disease management, which is traditionally judged more harshly according to cost savings. However, the conclusions of the study may be less applicable to patients with heart failure, who are most often considered for ICDs, than to those who do not have heart failure, because the assumptions of stable risks and quality of life for seven years extend beyond the median survival of patients with symptomatic heart failure. Future models should include patients with New York Heart Association (NYHA) class III symptoms of heart failure and could use a Markov model similar to that previously used to study candidates for heart transplantation.1 Patients with class III symptoms of heart failure face a higher risk of both death from any cause, death from causes other than arrhythmias, and diminished quality of life,2 with utility closer to 0.50 than the 0.88 year used for this analysis. Patients with NYHA class III heart failure in SCD-HeFT had no survival benefit with ICDs, and the benefit attributable to ICDs in the Comparison of Medical Therapy, Pacing, and Defibrillation in Heart Failure (COMPANION) trial ended after two quality-adjusted life-years (QALYs) gained.3 The transition rate to class III heart failure may be a critical determinant of cost-effectiveness, making ICDs acceptably cost-effective only when follow-up after implantation is linked with management of heart failure that is focused on preventing disease progression.
Lynne W. Stevenson, M.D.
William G. Stevenson, M.D.
Brigham and Women's Hospital, Boston, MA 02115Dr. L.W. Stevenson reports having received consulting fees and honoraria from Medtronic; and Dr. W.G. Stevenson, honoraria from Medtronic, Guidant, and St. Jude Medical.
3 References1
Stevenson LW ,Warner SL ,Hamilton MA , et al. Modeling distribution of donor hearts to maximize early candidate survival. Circulation 1992;86:Suppl II:II-2242
Lewis EF ,Johnson PA ,Johnson W ,Collins C ,Griffin L ,Stevenson LW . Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant 2001;20:1016-1024
CrossRef | Web of Science | Medline3
Bristow MR ,Saxon LA ,Boehmer J , et al. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N Engl J Med 2004;350:2140-2150
Full Text | Web of Science | Medline
To the Editor:
In their analysis, Sanders et al. found that prophylactic implantation of an ICD has a cost-effectiveness ratio below $100,000 per QALY gained in populations in which a significant reduction in device-related mortality has been demonstrated. It may be disappointing to note that the cost-effectiveness of the ICD seems to decrease from the first studies to the later ones: $34,000 per QALY gained in the Multicenter Automatic Defibrillator Implantation Trial (MADIT), $54,100 in MADIT II, and $70,200 in the SCD-HeFT. The more recent studies defined high risk more broadly (entirely on the basis of a decrease in left ventricular ejection fraction). It is a challenge for future studies to identify properly subgroups of patients who may derive a greater benefit from a prophylactic ICD (with the use of quantitative electrocardiography, for example), particularly those with heart failure in whom there are competing risks between death as a result of worsening pump failure and sudden death.1,2 Such definition of a subgroup is likely to improve markedly the cost-effectiveness of the prophylactic ICD.
2 ReferencesLaurent Fauchier, M.D.
Dominique Babuty, M.D.
Centre Hospitalier Universitaire Trousseau, 37044 Tours, France1
McClellan MB ,Tunis SR . Medicare coverage of ICDs. N Engl J Med 2005;352:222-224
Full Text | Web of Science | Medline2
Kadish A . Prophylactic defibrillator implantation -- toward an evidence-based approach. N Engl J Med 2005;352:285-287
Full Text | Web of Science | Medline
Author/Editor Response
We thank Dr. Anderson for his careful review of our model's structure and assumptions. We believe that these assumptions reflect the best available current evidence, but we also checked to see whether changes in the assumptions would have affected the cost-effectiveness of the ICD. We did find that the cost-effectiveness of the ICD became much less favorable if its efficacy ceased after a short time period (Figure 4A in our report).1 We found that the ICD cost less than $100,000 per QALY as long as it reduced mortality for no less than 7 years. Lead complications had less effect on the cost-effectiveness of the ICD. Increasing this rate to 14 percent over the median 45.5 months follow-up, as Dr. Anderson suggests, would change the cost-effectiveness of the ICD in the SCD-HeFT population from $70,200 per QALY to $74,300 per QALY. Our model captured the effects of complications that resulted in therapy crossover by adopting an intention-to-treat analysis of the efficacy of the ICD. We agree that the quality of life is important to consider (as done in Figure 3C of our article).1 Quality-of-life outcomes may vary among individual patients, however, so we used the anticipated effect on the quality of life in the entire population of patients.
Drs. Stevenson and Stevenson raise important points about the patient populations considered for prophylactic ICD implantation and emphasize that patients with severe heart failure were not generally enrolled in the randomized, controlled trials we studied. We agree, and we caution readers not to extrapolate our results beyond the populations of patients in whom the ICD has been proved to be effective by clinical trials.
Drs. Fauchier and Babuty accurately point out the influence of risk stratification among patients on the cost-effectiveness of the ICD. We agree that there is a need to identify patients who are at increased risk for sudden death but whose competing risks of death would allow them to realize the greatest benefit from receipt of an ICD.1 The effectiveness and cost-effectiveness of the ICD will improve if further studies can identify the clinical characteristics or diagnostic tests that will enable clinicians to select patients who will gain the most benefit from the ICD.
1 ReferencesGillian D. Sanders, Ph.D.
Duke University, Durham, NC 27715
gillian.sanders@duke. edu Mark A. Hlatky, M.D.
Stanford University, Stanford, CA 94305Douglas K. Owens, M.D.
Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 943041
Owens DK ,Sanders GD ,Heidenreich PA ,McDonald KM ,Hlatky MA . Effect of risk stratification on cost-effectiveness of the implantable cardioverter defibrillator. Am Heart J 2002;144:440-448
CrossRef | Web of Science | Medline
- Citing Articles (2)
Citing Articles
1
Garrick C. Stewart, Joanne R. Weintraub, Parakash P. Pratibhu, Marc J. Semigran, Janice M. Camuso, Kimberly Brooks, Sui W. Tsang, Mary Susan Anello, Viviane T. Nguyen, Eldrin F. Lewis, Anju Nohria, Akshay S. Desai, Michael M. Givertz, Lynne W. Stevenson. (2010) Patient Expectations From Implantable Defibrillators to Prevent Death in Heart Failure. Journal of Cardiac Failure 16:2, 106-113
CrossRef2
James N. Kirkpatrick, Bradley P. Knight. (2008) The management of implantable cardiac devices at the end of life. Progress in Palliative Care 16:5, 250-256
CrossRef
