Initial experience with fractal coated atrial and ventricular leads.

Abstract

We entered patients with usual indications to cardiac pacing in a prospective non randomized clinical investigation with an aim to follow up for twelve months. The Polyrox PX 60 BP and PX 53 JBP pacing lead with an iridium fractal surface were implanted. This was conducted over a study of 17 patients (12 atrial leads and 17 ventricular leads) who required either a dual or single chamber pacing, to 12 months follow-up. The results showed an average atrial threshold of 0.6 V and an average ventricular threshold of 0.6 V at implant and 0.6 V and 0.6 V respectively at 12 months. An averaged sensed amplitude P-wave of 3.6 mV and R-wave of 12.0 mV where recorded at implant and 3.1 mV and 11.2 mV respectively at 12 months. Our results showed that the leads exhibited low acute and chronic pacing and sensing thresholds due to the fractal coating available on these pacing leads.