Real-Time ECG Monitoring for Patients With Implantable Pacemaker - A Review of Current Status.

Implantable pacemakers are widely used for managing patients with certain cardiac rhythm abnormalities to reduce mortality and morbidity while improving quality of life. However, for ECG devices that have to analyze the surface ECG signals, it has always been a major challenge to maintain a high level of performance. Several recent advances in pacemaker development have created even further challenges for the ECG devices. Earlier developments such as ventricular pacing, atrial pacing, dual-chamber pacing, unipolar vs. bipolar pacing are well understood. However, more recent advances such as: biventricular pacing, multipoint pacing, leadless pacemakers, device-specific algorithms for reducing frequency of right ventricle pacing and managing pacing output to improve battery life are much more complex and thus are more difficult to evaluate whether the ECG devices can still function effectively. To ensure continuous safe and effective monitoring, the basic requirements are: a) mandatory manufacture disclosure of device information required for monitoring algorithm design, b) development of up-to-date paced algorithm performance evaluation procedures, and c) a suitable paced database for algorithm development and testing. This would require the cooperation of pacemaker and ECG device manufactures, and regulatory agencies.