Changing trends in therapy delivery with a third generation noncommitted implantable defibrillator: results of a large single center clinical trial.

Thirty-four patients underwent implantation of a third generation ICD, the 4210 ATP, for sudden cardiac death or ventricular tachycardia. This device incorporates significant telemetry logs as well as a detailed analysis of each arrhythmia episode detected. During the period of clinical follow-up, a mean of 12.2 months, a total of 26,569 VT or VF detections were made. The vast majority of these were either due to atrial fibrillation, nonsustained VT, or "noise" detection, and only 6% led to device therapy. ATP was successful in 86.3% of episodes, with 3.5% accelerations and 2.4% failure of ATP trains. The majority of inappropriate therapy episodes were clustered in seven patients, and all were easily diagnosed with the aid of the extensive telemetry logs and sense histories. Of five late deaths, three were from congestive heart failure, one from cerebrovascular accident, and one unknown. These data reveal that this "tiered" therapy noncommitted ICD performs to expectations; the stored data is of significant value in diagnosing the cause of ICD therapy. In addition, ATP is an effective modality for termination of VT.

Improved patient surveillance and data acquisition with a third generation implantable cardioverter defibrillator.

Thirteen patients were implanted with the Telectronics 4210 ATP implantable cardioverter defibrillator (ICD) for ventricular tachycardia or ventricular fibrillation. This device has multiprogrammable antitachycardia pacing, bradycardia pacing, and shock therapies. In addition, there is extensive data logging and ECG snapshot capability for arrhythmia confirmation and response to therapy. These features permit easy retrieval of all detected and treated events, whatever the eventual outcome. In this study, the data logged at predischarge electrophysiological testing was compared to the data recorded in a standard manner. The bulk of the data, however, was derived from long-term follow-up of spontaneous events over a mean period of 203 days (range 154-257). During this period, a total of 6,193 arrhythmia detections were made: 20 were classified as ventricular fibrillation, and 6,173 as ventricular tachycardia. The vast majority of these (93%) terminated spontaneously without ICD intervention (5,738), underscoring the benefit of a standard second confirmation prior to therapy delivery (noncommitted system). There were 394 arrhythmia episodes treated with antitachycardia pacing; of these a total of 8.3% accelerated to either more rapid ventricular tachycardia or ventricular fibrillation (4.3% and 4.0%, respectively). Events were reported in an "episode log" format, listing all arrhythmia detections with time/date annotation; or in a "sense history" format, detailing each episode from start to conclusion. These data demonstrate that this advanced, "tiered" ICD with data recall contributes to better patient management, and permits a more tailored termination prescription for the individual patient.