Objectives: We sought to investigate the nature of terminal events and potential contributory clinical and nonclinical (e.g., device-related) factors associated with sudden death (SD) in recipients of an implantable cardioverter-defibrillator (ICD).
Background: The ICD is very effective in terminating ventricular tachycardia (VT) or ventricular fibrillation (VF), but protection against SD is not absolute. Little is known about the nature and potential causes of SD in patients with ICDs.
Methods: We analyzed 25 cases of out-of-hospital SD among patients enrolled in the clinical investigation of the Cadence Tiered-Therapy Defibrillator System.
Results: All patients (24 men and 1 woman, mean age 62+/-10 years) received epicardial lead systems. The majority (92%) had coronary artery disease and a previous myocardial infarction (MI), with a mean left ventricular ejection fraction 0.25+/-0.07. At device implantation, the mean defibrillation threshold was 13+/-5 J. Sudden death occurred 13+/-11 months later. Twenty patients (80%) had received appropriate ICD therapies before death, and 18 (72%) were receiving > or = 1 antiarrhythmic drugs at the time of death. Sudden death was tachyarrhythmia-associated in 16 patients (64%), non-tachyarrhythmia-associated in 7 (28%) and indeterminate in 2 (8%). In the 16 patients with tachyarrhythmia-associated SD, the overall first therapy success rate in tachycardia and fibrillation zones was 60% and 67%, respectively. However, despite protracted therapies (> or = 2 shocks) in 7 (66%) of 12 patients who received fibrillation therapies, the final tachyarrhythmic episode was ultimately terminated by the ICD in 15 (94%) of the 16 patients, whereas 1 patient died after multiple (initially successful) internal and external shocks for intractable VT/VF during exercise. In 10 patients (40%) one or more, primarily clinical, factors potentially contributory to SD were identified: heart failure (n=8), angina (n=2), hypokalemia (n=1), adverse antiarrhythmic drug treatment (n=1) and acute MI (n=1). An additional 10 patients (40%) had experienced an increase in frequency of ICD shocks within 3 months of SD. Appropriate battery voltages and normal circuitry function were found in all devices interrogated and analyzed after death.
Conclusions: In this select group of patients receiving a third-generation ICD, SD was associated with VT or VF events in nearly two-thirds of patients, and death occurred despite ultimately successful, although often protracted, device therapies. These observations, along with evidence of recent worsening clinical status, suggest acute cardiac mechanical dysfunction as a frequent terminal factor. In recipients with ICDs, SD directly attributable to device failure seems to be rare.