Long-term superiority of steroid elution in atrial active fixation platinum leads

Steroid elution reduces the acute increase in stimulation threshold particularly in active fixation leads. The aim of this study was to investigate the long-term efficacy of steroid elution in atrial screw-in leads compared to conventional lead design. Two different bipolar active fixation platinum lead designs were implanted. Leads were similar except for the presence (group S, n = 66) or absence (group N, n = 68) of steroid elution. Patients received dual chamber pacemakers with the following atrial leads in consecutive order: Medtronic 4058 M (group N, n = 30), Medtronic 4068 (group S, n = 40), Vitatron IMS 13 (identical to 4058 M, group N, n = 38), and Vitatron IMX 13 (identical to 4068, group S, n = 26). The mean follow-up period was 40.7 +/- 16.1 months (range 10 to 84 months). Stimulation thresholds, pacing impedances, P wave potentials, and sensing threshold were assessed for both groups immediately, 10 days, 6 weeks, and 3 months after implantation followed by 6-months intervals. Energy thresholds, chronaxie-rheobase products, and energy consumption of atrial pacing were calculated. Chronic values were deduced from the most recent measurement performed in an individual patient. Within the first 10 days after implantation, atrial voltage threshold at pulse duration of 0.4 ms increased from 0.91 +/- 0.42 to 2.06 +/- 0.45 V in group N (P < 0.001). Less increase was observed in group S (0.83 +/- 0.39 to 1.08 +/- 0.53 V, P = 0.003). Atrial voltage thresholds remained markedly lower in steroid-eluting leads during whole follow-up (1.12 +/- 0.49 V in group S vs 1.58 +/- 0.71 V in group N, P < 0.001). Chronic energy consumption was markedly reduced in group S (4.0 +/- 2.7 microJ) compared to group N (9.8 +/- 7.5 microJ, P < 0.001). An atrial voltage threshold below 1.25 V at 0.4 ms was achieved in 92.3% of patients of group S allowing programming of an output of 2.5 V. Such low outputs were feasible in only 49.3% of patients in group N (P < 0.001). Chronic P wave amplitudes did not differ significantly between groups (3.27 +/- 1.81 mV in group N vs 3.24 +/- 1.18 mV in group S, P = 0.91). Steroid elution diminishes the increase of stimulation thresholds of nonsteroid atrial active fixation platinum leads resulting in a long-term reduction of energy consumption. Thus, use of steroids can be recommended for general use in atrial active fixation lead designs.