Clinical testing of a new pacemaker function to monitor ventricular capture

Automatic beat-by-beat capture functions are designed to minimize the pacing energy delivered, while maintaining the highest safety by delivering an immediate back-up stimulus in case of loss of capture. The objective of this study was to estimate the lowering of ventricular pacing amplitude allowed by such a function, compared to amplitudes usually set manually in routine practice. An automatic ventricular pacing threshold test is launched every 6 hours to measure the automatic capture threshold (AT). From AT the function calculates: (1) the"capture amplitude"(V(c)) = AT + 0.5 V at a minimum output of 1 V and (2) the"safety amplitude" (V(s)) = twice AT at a minimum output of 2.5 V. The function preferentially uses V(c) and verifies capture after each paced beat. In case of loss of capture, a back-up spike is delivered and V(s) is implemented until the next threshold measurement. We estimated the ventricular amplitude delivered by the pacemaker from data stored in the pacemaker memory. We compared these values with the pacing amplitude typically programmed manually (MPA) by physicians at twice AT and a minimum of 2.5 V. Data from 57 recipients of Talent 3 DR pacemakers were analyzed. Complete data sets were available in 25 patients at 1 day, 28 at 1 month, and 39 between 1 day and 1 month. No loss of capture or ventricular pause was observed on 53 ambulatory electrocardiograms (ECG); and pulse amplitude automatically delivered by the device was significantly lower than the MPA at each of the three time points analyzed. This new beat-by-beat capture function allows a significant lowering of the pacing amplitude compared to manual settings, while preserving a 100% safety.