U.S. experience with the AddVent VDD(R) pacing system. AddVent Phase I Investigators

The AddVent pacemaker generator and model 1328C AV single-pass lead is a new pacemaker system capable of VDD or VDDR modes. The purpose of this study was to present the initial experience with AddVent in the United States and Canada. Between May 10, 1995 and May 3, 1996, 53 devices were implanted in 52 patients and followed for a mean of 217 (+/- 39) days. At the predischarge, 1-, 3-, and 6-month follow-up evaluations, atrial sensing thresholds and ventricular sensing and capture thresholds were measured in the supine, sitting, and standing positions to evaluate stability of atrial sensing with respect to body posture at rest. At the 1-month follow-up, a treadmill exercise test was performed to evaluate atrial sensing during exercise and to evaluate two new features of the AddVent called "sensor-mediated rate smoothing" and "preferential P wave sensing." Atrial sensing thresholds were not significantly different (P > 0.05) among body postures for any follow-up period or among follow-up periods for each posture. At rest, the percentage of appropriately tracked P waves observed was > 99% at each follow-up period. During treadmill exercise, the percentage of appropriately tracked P waves was > 98.7%. Appropriate preferential P wave sensing and sensor-mediated rate smoothing (VDDR mode) was observed. The AddVent pacing system provides safe and effective pacing therapy. Several features of VDDR pacing offer advantages over standard VDD pacing.