A prospective multicenter study on the safety of a pacemaker with automatic energy control: influence of the electrical factor on chronic stimulation threshold. PEACE Investigators.

Abstract

The effectiveness and safety of a pacemaker with automatic control of capture was evaluated in 162 patients followed at 27 Spanish centers. The aim of our prospective, multicenter, and randomized trial was to determine the relationship between the voltage output of the pulse generator and the stimulation threshold. We randomized 162 patients (107 men, mean age 75 +/- 12 years). We implanted a ventricular pacemaker model Regency SR+ or SC+ with Pacesetter's low polarization bipolar leads Membrane E 1450. The patients were randomized to receive Autocapture or not; group I (81 patients) Autocapture On, pulse output automatically adjusted and group II (81 patients) Autocapture Off, fixed output parameters (3.9 V, 0.37 ms). We performed a 6-month follow-up measuring stimulation threshold by means of the VARIO test and Autocapture test, evoked response signal, and R wave signal. The mean R wave was 15.77 +/- 3.5 mV at the end of the follow-up for group I, and 14.91 +/- 6.8 mV for group II (P = NS). The measured evoked response at the end of the follow-up was 9.25 mV in Group I and 8.48 mV in Group II (P = NS). The stimulation threshold was not different between groups. The current density created with the voltage and pulse width used in this study (< or = 3.9 V and 0.37 ms) at the tip of this electrode during the maturation process had no influence on the development of the chronic detection and stimulation thresholds.