Long-term follow-up of pacemakers with an Autocapture pacing system.

Abstract

The aim of this study was to evaluate the safety and performance of the Autocapture pacing system during a 5-year follow-up period. The study was conducted retrospectively between May 1996 and May 2001. Sixty consecutive patients who had undergone VVI pacemaker implantation using an Autocapture program with leads 1402T (n: 31) and 1452T (n: 29) were included in the study. Intraoperative measurements including a ventricular stimulation threshold test, sensing of intrinsic R wave (mV), and lead impedance (W) were done by a standard pacing system analyzer. Evoked responses (ER, mV) and polarization signals (PS, mV) were measured after the pocket was closed. Pacing thresholds by Autocapture (AC thrd, V) and Vario (Vario thrd, V), battery current (mA), and battery impedance (kW) were also repeated during predischarge and 1, 6, 12, 18, 24, 30, 40, 50, and 60 months after discharge. According to the ER and PS values an Autocapture algorithm could be activated in 49 patients (88%). The Autocapture algorithm remained active during the follow-up in all of these patients. In patients with inappropriate ER and PS values (11 patients, 12%), pacemakers were programmed to a VVIR pacing mode and Autocapture algorithm was inactivated. ER and PS values did not reach appropriate values to activate the Autocapture algorithm in any of these patients in consecutive follow-ups. Twenty-four-hour Holter monitoring could be conducted in 32 patients (53%). In all recordings, when the loss of capture occurred, it was confirmed that back-up pacing continued. When the first measurements recorded during implantation were compared to approximately the 5th year measurements; ER (9.2 mV vs 9.6 mV), PS signal (1.13 +/- 0.30 mV vs 1.15 +/- 0.72 mV), AC thrd (0.4 V vs 1.2 V), Vario thrd (0.7 V vs 1.3 V), and lead impedance (502 ohm vs 620 ohm) were not changed significantly. Battery impedance increased 1 kOhm between 30-40 months of the implantation. Seven deaths occurred during follow-up. Three patients had fatal myocardial infarction, one died due to a non-cardiac event, and the remaining three died due to progressive heart failure. ER, R wave amplitude, and PS, which are the main parameters for the continuation of Autocapture function, did not change significantly during long-term follow-up. High output back up pacing provided additional safety for sudden rises in threshold. The Autocapture pacing algorithm was found to be effective and reliable during long-term follow-up.