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CLINICAL RESEARCH: CARDIAC RHYTHM DISORDER

Factors Influencing Appropriate Firing of the Implanted Defibrillator for Ventricular Tachycardia/Fibrillation

Findings From the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II)

Jagmeet P. Singh, MD, PhD^_*,_*, W. Jackson Hall, PhD, Scott McNitt, MS, Hongyue Wang, MA, James P. Daubert, MD, Wojciech Zareba, MD, Jeremy N. Ruskin, MD^_*, Arthur J. Moss, MD and the MADIT-II Investigators

^_* Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
Department of Biostatistics and Computational Biology, University of Rochester Medical Center, Rochester, New York
Cardiology Unit, Department of Medicine, University of Rochester Medical Center, Rochester, New York

Manuscript received February 2, 2005; revised manuscript received April 11, 2005, accepted May 10, 2005.

^_* Reprint requests and correspondence: Dr. Jagmeet P. Singh, GRB 109, Cardiac Arrhythmia Service, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, Massachusetts 02114 (Email: jsingh{at}partners.org).

OBJECTIVES: The purpose of this study was to prospectively examine the role of clinical, laboratory, echocardiographic, and electrophysiological variables as predictors of appropriate initial implantable cardioverter-defibrillator (ICD) therapy for ventricular tachycardia (VT) or ventricular fibrillation (VF) or death in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II) population.

BACKGROUND: There is limited information regarding the determinants of appropriate ICD therapy in patients with reduced ventricular function after a myocardial infarction.

METHODS: We used secondary analysis in one arm of a multicenter randomized clinical trial in patients with a previous myocardial infarction and reduced left ventricular function.

RESULTS: We analyzed baseline and follow-up data on 719 patients enrolled in the ICD arm of the MADIT-II study. Appropriate ICD therapy was observed in 169 subjects. Clinical, laboratory, echocardiographic, and electrophysiological variables, along with measures of clinical instability such as interim hospitalization for congestive heart failure (IH-CHF) and interim hospitalization for coronary events (IH-CE), were examined with proportional hazards models and Kaplan-Meier time-to-event curves before and after first interim hospitalization. Interim hospitalization-CHF, IH-CE, no beta-blockers, digitalis use, blood urea nitrogen (BUN) >25, body mass index (BMI) 30 kg/m², and New York Heart Association functional class >II were associated with increased risk for appropriate ICD therapy for VT, VF, or death. In a multivariate (stepwise selection) analysis, IH-CHF was associated with an increased risk for the end point of either VT or VF (hazard ratio [HR] 2.52, 95% confidence interval [CI] 1.69 to 3.74, p < 0.001) and for the combined end point of VT, VF, or death (HR 2.97, 95% CI 2.15 to 4.09, p < 0.001). Interim hospitalization-CE was associated with an increased risk for VT, VF, or death (HR 1.66, 95% CI 1.09 to 2.52, p = 0.02).

CONCLUSIONS: These results provide important mechanistic information, suggesting that worsening clinical condition and cardiac instability, as reflected by an IH-CHF or IH-CE, are subsequently associated with a significant increase in the risk for appropriate ICD therapy (for VT/VF) and death.

Abbreviations and Acronyms   BMI = body mass index   BUN = blood urea nitrogen   CE = coronary events   CHF = congestive heart failure   CI = confidence interval   HR = hazard ratio   ICD = implantable cardioverter-defibrillator   IH = interim hospitalization   LVEF = left ventricular ejection fraction   MADIT-II = Multicenter Automatic Defibrillator Implantation Trial II   MI = myocardial infarction   NYHA = New York Heart Association   VF = ventricular fibrillation   VT = ventricular tachycardia

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