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A New Single Chamber Implantable Defibrillator with Atrial Sensing: A Practical Demonstration of Sensing and Ease of Implantation
Published on: February 28, 2012
Cost-effectiveness of implantable cardioverter-defibrillators
Gillian D Sanders1, Mark A Hlatky, Douglas K Owens
1Duke Clinical Research Institute, Duke University, Durham, NC 27715, USA. gillian.sanders@duke.edu
Insights
Prophylactic implantable cardioverter-defibrillator (ICD) use is cost-effective for preventing sudden cardiac death in select high-risk patients. The ICD improves survival and quality of life, with a cost-effectiveness ratio below $100,000 per QALY gained when mortality benefits are significant.
Area of Science:
- Cardiology
- Health Economics
- Medical Technology
Background:
- Eight randomized trials investigated prophylactic implantable cardioverter-defibrillator (ICD) use for patients at risk of sudden cardiac death due to left ventricular systolic dysfunction.
- The study assessed the cost-effectiveness of ICDs in primary prevention populations from these trials.
Purpose of the Study:
- To evaluate the cost-effectiveness of prophylactic implantable cardioverter-defibrillator (ICD) implantation compared to standard care.
- To determine the impact of ICDs on survival, quality of life, and healthcare costs in patients with left ventricular systolic dysfunction.
Main Methods:
- A Markov model was developed to simulate costs, quality of life, survival, and incremental cost-effectiveness.
- The model incorporated survival and mortality rates from eight primary prevention clinical trials.
- ICD efficacy was modeled as a reduction in the relative risk of death based on trial hazard ratios.
Main Results:
- Prophylactic ICD implantation increased lifetime costs in all evaluated trials.
- Two trials (CABG Patch, DINAMIT) showed no mortality benefit, making ICDs less effective and more costly.
- For six trials (MADIT I, MADIT II, MUSTT, DEFINITE, COMPANION, SCD-HeFT), ICDs added 1.01–2.99 QALYs and $68,300–$101,500 per patient.
- Cost-effectiveness ranged from $34,000 to $70,200 per QALY gained in these six populations.
- Sensitivity analyses indicated cost-effectiveness remained below $100,000/QALY if mortality benefits persisted for at least seven years.
Conclusions:
- Prophylactic ICD implantation is cost-effective (below $100,000/QALY) in patient populations where a significant, device-related reduction in mortality is demonstrated.
- The economic value of ICDs is contingent on their proven ability to reduce mortality over a sustained period.
Background:
Eight randomized trials have evaluated whether the prophylactic use of an implantable cardioverter-defibrillator (ICD) improves survival among patients who are at risk for sudden death due to left ventricular systolic dysfunction but who have not had a life-threatening ventricular arrhythmia. We assessed the cost-effectiveness of the ICD in the populations represented in these primary-prevention trials.
Methods:
We developed a Markov model of the cost, quality of life, survival, and incremental cost-effectiveness of the prophylactic implantation of an ICD, as compared with control therapy, among patients with survival and mortality rates similar to those in each of the clinical trials. We modeled the efficacy of the ICD as a reduction in the relative risk of death on the basis of 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) Patch Trial and the Defibrillator in Acute Myocardial Infarction Trial (DINAMIT)--found that the prophylactic implantation of an ICD did not reduce the risk of death and thus was both more expensive and less effective than control therapy. For the other six trials--the Multicenter Automatic Defibrillator Implantation Trial (MADIT) I, MADIT II, the Multicenter Unsustained Tachycardia Trial (MUSTT), the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) trial, the Comparison of Medical Therapy, 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 1.01 and 2.99 quality-adjusted life-years (QALY) and between 68,300 dollars and 101,500 dollars in cost. Using base-case assumptions, we found that the cost-effectiveness of the ICD as compared with control therapy in these six populations ranged from 34,000 dollars to 70,200 dollars per QALY gained. Sensitivity analyses showed that this cost-effectiveness ratio would remain below 100,000 dollars per QALY as long as the ICD reduced mortality for seven or more years.
Conclusions:
Prophylactic implantation of an ICD has a cost-effectiveness ratio below 100,000 dollars per QALY gained in populations in which a significant device-related reduction in mortality has been demonstrated.
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