Does the Guardian ATP 4210 effectively and safely treat ventricular tachyarrhythmias and provide bradycardia support?
The Guardian ATP 4210 successfully treated VT/VF and provided bradycardia support in a Phase I trial, but a critical design flaw causing device shutdown upon safety check failure requires modification for long-term safety.
Guardian antitachycardia pacing (ATP) 4210 is a third generation, multi-programmable cardioverter defibrillator undergoing Phase I clinical trials. The tiered response includes ATP, low energy cardioversion or defibrillation, and bradycardia support. Extensive telemetry is available, including an episode log and details of all episode events. Five patients underwent the implantation of Guardian ATP 4210 as part of a Phase I trial at the University of Louisville. Two of the five patients had multiple VT episodes that were reverted successfully using ATP pacing (slow VT) and defibrillation (fast VT) and VF episodes, which resulted in defibrillation therapy over a follow-up period of 6 to 8 months. Four of the five patients required bradycardia support for bradyarrhythmias unassociated with ATP therapy or defibrillation and one patient required bradycardia support postdefibrillation therapy. The device design is microprocessor based and requires continuous interrogation of the microprocessor memory and checks of the validity of programmed parameters to continue its operation. When the safety check fails, the device is designed to shut down its antitachycardia and defibrillator functions. This design feature has a potential for leaving the patient unprotected if the device shuts down. Modification of this feature is required to ensure the device's long-term safety.
Singer et al. (Mon,) studied this question.