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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Cost-Effectiveness of a Microvolt T-Wave Alternans Screening Strategy for Implantable Cardioverter-Defibrillator Placement in the MADIT-II–Eligible Population

Paul S. Chan, MD, MSc^_*,,1,_*, Kenneth Stein, MD, Theodore Chow, MD, FACC, Mark Fendrick, MD, J. Thomas Bigger, MD^|| and Sandeep Vijan, MD, MSc^_*,

^_* VA Center for Practice Management and Outcomes Research, Ann Arbor, Michigan
University of Michigan, Ann Arbor, Michigan
Weill Medical Center, Cornell University, New York, New York
The Lindner Clinical Trial Center at the Christ Hospital and the Ohio Heart and Vascular Center, Cincinnati, Ohio
^|| Columbia University Medical Center, New York, New York.

Manuscript received November 2, 2005; revised manuscript received January 31, 2006, accepted February 7, 2006.

^_* Reprint requests and correspondence: Dr. Paul S. Chan, VA Ann Arbor Healthcare System, Cardiology (111-A), 2215 Fuller Road, Ann Arbor, Michigan 48105. (Email: paulchan{at}umich.edu).

OBJECTIVES: This study was designed to compare the cost-effectiveness of implantable cardioverter-defibrillator (ICD) placement with and without risk stratification with microvolt T-wave alternans (MTWA) testing in the MADIT-II (Second Multicenter Automatic Defibrillator Implantation Trial) eligible population.

BACKGROUND: Implantable cardioverter-defibrillators have been shown to prevent mortality in the MADIT-II population. Microvolt T-wave alternans testing has been shown to be effective in risk stratifying MADIT-II–eligible patients.

METHODS: On the basis of published data, cost-effectiveness of three therapeutic strategies in MADIT-II–eligible patients was assessed using a Markov model: 1) ICD placement in all; 2) ICD placement in patients testing MTWA non-negative;, and 3) medical management. Outcomes of expected cost, quality-adjusted life-years (QALYs), and incremental cost-effectiveness were determined for patient lifetime.

RESULTS: Under base-case assumptions, providing ICDs only to those who test MTWA non-negative produced a gain of 1.14 QALYs at an incremental cost of $55,700 when compared to medical therapy, resulting in an incremental cost-effectiveness ratio (ICER) of $48,700/QALY. When compared with a MTWA risk-stratification strategy, placing ICDs in all patients resulted in an ICER of $88,700/QALY. Most (83%) of the potential benefit was achieved by implanting ICDs in the 67% of patients who tested MTWA non-negative. Results were most sensitive to the effectiveness of MTWA as a risk-stratification tool, MTWA negative screen rate, cost and efficacy of ICD therapy, and patient risk for arrhythmic death.

CONCLUSIONS: Risk stratification with MTWA testing in MADIT-II–eligible patients improves the cost-effectiveness of ICDs. Implanting defibrillators in all MADIT-II–eligible patients, however, is not cost-effective, with one-third of patients deriving little additional benefit at great expense.

Abbreviations and Acronyms   CMS = Centers for Medicare and Medicaid Services   ICD = implantable cardioverter-defibrillator   ICER = incremental cost-effectiveness ratio   MADIT-II = Second Multicenter Automatic Defibrillator Implantation Trial   MTWA = microvolt T-wave alternans   QALY = quality-adjusted life-year   SCD = sudden cardiac death

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