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J Am Coll Cardiol, 2008; 51:1357-1365, doi:10.1016/j.jacc.2007.09.073
© 2008 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: HEART RHYTHM DISORDER

Inappropriate Implantable Cardioverter-Defibrillator Shocks in MADIT II

Frequency, Mechanisms, Predictors, and Survival Impact

James P. Daubert, MD*,*, Wojciech Zareba, MD, PhD*, David S. Cannom, MD{dagger}, Scott McNitt, MS*, Spencer Z. Rosero, MD*, Paul Wang, MD{ddagger}, Claudio Schuger, MD§, Jonathan S. Steinberg, MD||, Steven L. Higgins, MD, David J. Wilber, MD#, Helmut Klein, MD**, Mark L. Andrews, BBA*, W. Jackson Hall, PhD{dagger}{dagger}, Arthur J. Moss, MD* for the MADIT II Investigators

* Cardiology Division, Department of Medicine, University of Rochester Medical Center, Rochester, New York
{dagger} Good Samaritan Hospital, Los Angeles, California
{ddagger} Stanford University Medical Center, Stanford, California
§ Henry Ford Health System, Detroit, Michigan
|| St. Luke’s-Roosevelt Hospital Center, New York, New York
Scripps Memorial Hospital, La Jolla, California
# Loyola University Medical Center, Maywood, Illinois
** University Hospital, Magdeburg, Germany
{dagger}{dagger} Department of Biostatistics, University of Rochester Medical Center, Rochester, New York.

Manuscript received February 21, 2007; revised manuscript received September 19, 2007, accepted September 23, 2007.

* Reprint requests and correspondence: Dr. James P. Daubert, Box 679-URMC, Rochester, New York 14642. (Email: James_Daubert{at}URMC.Rochester.edu).

Objectives: This study sought to identify the incidence and outcome related to inappropriate implantable cardioverter-defibrillator (ICD) shocks, that is, those for nonventricular arrhythmias.

Background: The MADIT (Multicenter Automatic Defibrillator Implantation Trial) II showed that prophylactic ICD implantation improves survival in post-myocardial infarction patients with reduced ejection fraction. Inappropriate ICD shocks are common adverse consequences that may impair quality of life.

Methods: Stored ICD electrograms from all shock episodes were adjudicated centrally. An inappropriate shock episode was defined as an episode during which 1 or more inappropriate shocks occurred; another inappropriate ICD episode occurring within 5 min was not counted. Programmed parameters for patients with and without inappropriate shocks were compared.

Results: One or more inappropriate shocks occurred in 83 (11.5%) of the 719 MADIT II ICD patients. Inappropriate shock episodes constituted 184 of the 590 total shock episodes (31.2%). Smoking, prior atrial fibrillation, diastolic hypertension, and antecedent appropriate shock predicted inappropriate shock occurrence. Atrial fibrillation was the most common trigger for inappropriate shock (44%), followed by supraventricular tachycardia (36%), and then abnormal sensing (20%). The stability detection algorithm was programmed less frequently in patients receiving inappropriate shocks (17% vs. 36%, p = 0.030), whereas other programming parameters did not differ significantly from those without inappropriate shocks. Importantly, patients with inappropriate shocks had a greater likelihood of all-cause mortality in follow-up (hazard ratio 2.29, p = 0.025).

Conclusions: Inappropriate ICD shocks occurred commonly in the MADIT II study, and were associated with increased risk of all-cause mortality.

Abbreviations and Acronyms
  AF = atrial fibrillation or atrial flutter
  ATP = antitachycardia pacing
  CHF = congestive heart failure
  HR = hazard ratio
  ICD = implantable cardioverter-defibrillator
  SVT = supraventricular tachycardia
  VF = ventricular fibrillation
  VT = ventricular tachycardia


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