Electrophysiological performance of a bipolar membrane-coated titanium nitride electrode: a randomized comparison of steroid and nonsteroid lead designs.
The aim of this multicenter study was to investigate the performance of a new cardiac pacemaker lead with a titanium nitride cathode coated with a copolymer membrane. In particular, the electrophysiological effect of steroid dissolved in this ion-exchange membrane was evaluated by randomized comparison. Ninety-five patients were randomized either to the 1450 T (n = 51) or the 1451 T ventricular lead (n = 45) and received telemeteral VVI(R) pacemakers with identical diagnostic features. Both leads were bipolar, were passively affixed, and had a porous titanium nitride tip with a surface area of 3.5 mm2. The only difference between the two electrodes was 13 micrograms of dexamethasone added to the 1450 Ts membrane coating. Voltage thresholds (VTH) at pulse durations of 0.25, 0.37, and 0.5 ms, lead impedance, and sensing thresholds were measured at discharge, 2 weeks, 1 month, 3 months, and 6 months after implantation. Mean amplitude and the slew rate from three telemetered intracardiac electrograms, chronaxie-rheobase product, and minimum energy consumption were calculated. After a 6-month follow-up, mean voltage thresholds of 0.65 +/- 0.20 V and 0.63 +/- 0.34 were achieved for the 1450 T lead and 1451 T lead, respectively. As a result, a VTH < 1.0 V was obtained in all patients with 1450 T electrodes and in 97.7% of patients with 1451 T leads after 6 months follow-up. In both electrodes, stable VTH was reached 2 weeks after implantation, and no transient rise in threshold was observed. No differences were observed between the steroid and the nonsteroid group in respect to VTH, chronaxie-rheobase product, minimum energy consumption, and potential amplitude and slew rate. In conclusion, safe and efficient pacing at low pulse amplitudes were achieved with both leads. The tip design, independently of the steroid additive, prevented any energy-consuming increases in the voltage threshold.
Medical University of Luebeck, Department of Internal Medicine, Germany.
U K
UK
Wiegand
A
A
Zhdanov
E
E
Stammwitz
I
I
Crozier
R J
RJ
Claessens
J
J
Meier
R J
RJ
Bos
F
F
Bode
J
J
Potratz
D020099:Coated Materials, Biocompatible; D003907:Dexamethasone / Q000008:administration & dosage*; D004562:Electrocardiography / Q000187:drug effects / Q000295:instrumentation; D004566:Electrodes; D004867:Equipment Design; D006801:Humans; D010138:Pacemaker, Artificial; D012815:Signal Processing, Computer-Assisted / Q000295:instrumentation; D013686:Telemetry / Q000295:instrumentation; D014025:Titanium; D016896:Treatment Outcome
D020099:Coated Materials, Biocompatible; C041500:titanium nitride; D003907:Dexamethasone; D014025:Titanium