Pacing Threshold Trends and Variability in Modern Tined Leads Assessed Using High Resolution Automatic Measurements: Conversion of Pulse Width into Voltage Thresholds

Abstract

With the aid of an algorithm for automatic pacing threshold (T) measurement in the atrium and ventricle, downloadable into implanted Thera pacemakers (Medtronic Inc.), we studied T evolution during lead maturation, T variation during activities of daily living, and various types of beat-to-beat T variations in three tined bipolar leads: 5.6-mm2 steroid-eluting (Medtronic Inc. models 4524 atrial-J [n = 8] and 4024 ventricular [n = 8]), 1.2-mm2 steroid-eluting (Medtronic Inc. models 5534 atrial-J [n = 9] and 5034 ventricular [n = 9]), and 8-mm2 without steroid (Intermedics models 432-04 atrial-J [n = 7] and 430-10 ventricular [n = 7]). The leads were implanted in 24 consecutive patients with intact AV conduction (required by the algorithm) and followed for up to 13-25 months after implantation. Since the algorithm determined pulse width Ts at different amplitudes that, depending upon T level, could range from 0.5 to 5.0 V, we invented a methodology for conversion of pulse width Ts into voltage Ts at 0.5 ms, to pool and present T data on a universal scale. Frequent, high resolution T measurements revealed details on the lead maturation process that we divided into three stages: initial T subsiding, first wave of T peaking, and a new, quicker or slower, T rise. Although there were notable differences in duration and magnitude of T peaking on the individual basis, differences between the three lead types and between the atrium and ventricle were demonstrable. The 1.2-mm2 leads exhibited less T peaking than their predecessors 5.6-mm2 leads and excellent positional stability, whereas 8-mm2 leads demonstrated the most intensive T peaking and highest mean chronic T values. T changes during activities of daily living showed some tendencies-higher T during night and lower T during exercise--yet with a number of exceptions. The overall magnitude of daily T fluctuations was < 0.2 V in all but one lead, and 50% daily voltage safety margin would be sufficient. A 100% voltage safety margin may be inadequate for a 1-year period during the chronic phase (after 6 months of implantation). A scheme for calculation of pulse width safety margins equivalent to voltage safety margins is given. Some leads can exhibit very large beat-to-beat T variations before, during, and after T peaking, and prospective algorithms for automatic T measurement should verify T values through more than 1-2 captured beats to obviate a great underestimation of the T providing consistent capture. T dependence upon pacing rate was negligible. Consistent-capture hysteresis may, in conjunction with lead instability, be as much as 0.25 V. Therefore, it is better to use an incremental approach from below to T level during automatic T measurements.