Why the study?
Does a new bipolar, steroid-eluting, high impedance epimyocardial lead design maintain stable pacing and sensing characteristics over 6 months in growing dogs?
Does a new bipolar, steroid-eluting, high impedance epimyocardial lead design maintain stable pacing and sensing characteristics over 6 months in growing dogs?
A new bipolar, steroid-eluting, high impedance epimyocardial pacing lead demonstrated excellent chronic pacing and sensing characteristics with negligible fibrotic capsule formation in a canine model.
Supports stable performance in growing dogs; leaves open translation to pediatric patients.
Epicardial pacing typically is associated with decreased pacing and sensing capabilities compared with the endocardial approach. Since endocardial pacing is neither appropriate nor possible in all instances, this study was conducted to evaluate a new concept in a chronic epimyocardial lead design in six 3-month-old growing dogs. The new bifurcated lead (Medtronic model 10401) is a low current drain, high impedance, steroid-eluting, bipolar design. The implant is facilitated by a suture attached with an atraumatic needle. Twelve ventricular leads were implanted (2 per animal) and followed for 6 months with weekly analysis of pacing and sensing capabilities. Results at explant were compared with implant values. There were no significant differences between implant and explant in sensed R waves, or in the slew rate of the R wave in unipolar or bipolar modes. Lead impedances at explant remained high in both modes: bipolar, 1550 +/- 223; unipolar, 1234 +/- 262 omega (P < 0.05). Chronic voltage (v) threshold at 0.5 msec showed no significant change from implant values during the study: unipolar, 0.4 +/- 0.2 vs 0.7 +/- 0.3; bipolar, 0.5 +/- 0.4 vs 1 +/- 0.5. Histologic evaluations of the electrode tissue interface demonstrated negligible fibrotic capsule formation. This study introduces a new, easily implanted, high impedance, low threshold, bipolar epimyocardial pacing lead design with excellent chronic pacing and sensing characteristics.
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Karpawich et al. (1994) studied this question.
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