Efficacy of steroid elutin: early follow-up experience with a new lead

In order to evaluate the performance of a new steroid bipolar ventricular lead Stelid BT46D (Ela Medical), 50 patients have been implanted with an Era Medical pacemaker connected to 36 Steroid Stelid BT46D and 14 control Stela BT46. The two leads showed similar acute sensing and pacing performances (Stelid 648 +/- 111ohms, 8 +/- 3 mV vs Stela 670 +/- 80 ohms, 11+/-3 mV). At implant, both pacing threshold at 0.5 ms were low with no significant difference (Stelid 0.37 +/- 0.09 V vs Stela 0.44 +/- 0.10 V). After day 3, a difference was observed with a slight increase for the Stela BT46, The difference between the two models became significant at 2 weeks (Stelid 0.73 +/- 0.34 V vs Stela 1.08 +/- 0.35, p<0.05) and was confirmed at one month (Stelid 0.67 +/- 0.18 V vs Stela 1 +/- 0.24 V, p<0.01). The Stelid BT46D provided a 33% reduction of pacing threshold. The impedance and the R wave amplitude remained similar between the two leads and no significant difference was observed during the follow-up (at one month: Stelid 625 +/- 100ohms, 9 mV vs Stela 653 +/- 113 ohms, 10 mV). No major averse event (perforation, exit block...) was reported. A Stelid BT46D dislodgement has however required a repositionning at day 3. With the association of vitreous carbon and steroid elution, the Stelid BT46D has a great potential for low energy stimulation.