J Am Coll Cardiol, doi:10.1016/j.jacc.2006.02.051 (Published online 7 June 2006)
© 2006 by the American College of Cardiology Foundation

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CLINICAL RESEARCH: HEART RHYTHM DISORDERS

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*,{dagger},*, Kenneth Stein, MD{ddagger}, Theodore Chow, MD, FACC§, Mark Fendrick, MD{dagger}, J. Thomas Bigger, MD|| and Sandeep Vijan, MD, MSc*,{dagger}

* VA Center for Practice Management and Outcomes Research, Ann Arbor, Michigan
{dagger}University of Michigan, Ann Arbor, Michigan
{ddagger}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@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