Why the study?
Does a fractally coated 1.3 mm2 high impedance pacing electrode improve pacing thresholds and impedance compared to a 10 mm2 titanium nitride coated electrode in patients requiring ventricular pacing?
Does a fractally coated 1.3 mm2 high impedance pacing electrode improve pacing thresholds and impedance compared to a 10 mm2 titanium nitride coated electrode in patients requiring ventricular pacing?
A fractally coated 1.3 mm2 pacing electrode significantly increases impedance and reduces pacing thresholds without compromising sensing compared to a standard 10 mm2 electrode.
May reduce device energy use in ventricular pacing; hypothesis-generating until randomized trials confirm outcomes.
Minimizing the geometric surface area of pacing electrodes increases impedance and reduces the current drain during stimulation, provided that voltage (pulse-width) thresholds remain unchanged. This may be feasible by coating the electrode surface to increase the capacity of the electrode tissue interface and to diminish polarization. Ten unipolar, tined leads with a surface area of 1.3 mm2 and a "fractal" coating of iridium (Biotronik SD-V137) were implanted in the ventricle, and electrogram amplitude (unfiltered), slew-rate, pacing threshold (0.5 ms), and impedance (2.5 V; 0.5 ms) were measured by the 5311 PSA (Medtronic). On days 0. 2. 5. 10, 28, 90, 180, 360 postimplant, sensing threshold (up to 7.0 mV, measuring range 1-14 mV on day 360 only) and the strength duration curve (0.5-4.0 V; 0.03-1.5 ms; steps: 0.5 V; 0.01 ms, respectively) were determined, the minimum charge delivered per pulse (charge threshold), and the impedance were taken from pacemaker telemetry (Intermedics 294-03). Data were compared with those of an earlier series of 20 unipolar, tined TIR-leads (Biotronik) with a surface area of 10 mm2 and a @actal" coating of titanium nitride. With the model SD-V137 versus TIR, intraoperative electrogram amplitudes were 15.1 +/- 6.1 versus 14.4 +/- 3.9 mV (NS), slew rates 3.45 +/- 1.57 versus 1.94 +/- 1.06 V/s (P < 0.05), pacing thresholds 0.16 +/- 0.05 versus 0.52 +/- 0.15 V (P < 0.01) and impedance measurements 1,136 +/- 175 versus 441 +/- 73 omega (P < 0.0001), respectively. During follow-up, sensing thresholds were the same with both leads. Differences in pulse width thresholds lost its significance on day 28 but resumed on day 360 (SD-V137; 0.08 +/- 0.04 ms; TIR: 0.16 +/- 0.06 ms at 2.5 V; P < 0.01). With an electrode surface of 1.3 mm2, charge per pulse and impedance consistently differed from control, being 0.15 +/- versus 0.66 +/- 0.20 microC (P < 0.001) and 1,344 +/- 376 versus 538 +/- 79 omega respectively, one year after implantation (P < 0.0001). In summary, "fractally" coated small surface electrodes do not compromise sensing; by more than doubling impedance against controls they offer pacing thresholds (mainly in terms of charge) that are significantly lower than with the reference electrode.
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Fröhlig et al. (1998) studied this question.
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