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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, Scott McNitt, MS^_*, Spencer Z. Rosero, MD^_*, Paul Wang, MD, 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, Arthur J. Moss, MD^_* for the MADIT II Investigators

^_* Cardiology Division, Department of Medicine, University of Rochester Medical Center, Rochester, New York
Good Samaritan Hospital, Los Angeles, California
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
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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