Development and preliminary clinical tests of an impedance sensing VDD recording pacemaker for diagnosis and research.

Episodes of serious but infrequently occurring cardiac arrhythmias can be difficult to detect and analyse, even with modern Holter monitoring. A previous diagnostic pacemaker developed by this group provided VVI pacing therapy and recorded intracardiac ECG signals but had no atrial sensing or impedance measuring capability. A new external diagnostic pacemaker system is described that has been developed to assist in diagnosing intermittent arrhythmias by selectively recording intracardiac signals. Unlike other ambulatory monitors, in addition to recording ECG, the device combines VDD pacing therapy with the capability of monitoring and recording intracardiac impedance and pressure waveforms through a temporary intracardiac lead. A PCMCIA memory card allows storage of 48 arrhythmic events of 21 seconds each. Twelve seconds of waveform are retained before the event occurs and nine seconds after. Data retrieval and processing is performed with a PC which reconstructs each waveform for display. The ECG provides data on cardiac rhythm while cardiac function is inferred from the haemodynamic signals. During simulated trials, 14 event types were presented to the system. All events were successfully detected and recorded. During in vivo clinical tests 83 waveform recordings were made. Impedance fluctuations with typical peak-to-peak values of 64 ohms were successfully recorded.