Clinical evaluation of a thin bipolar pacing lead.

Abstract

The main disadvantages of bipolar pacing leads have traditionally been related to their relative thickness and stiffness compared to unipolar leads. In a new "drawn filled tube" plus "coated wire" technology, each conductor strand is composed of MP35N tubing filled with silver core and coated with a thin ETFE polymer insulation material. This and parallel winding of single anode and cathode conductors into a single bifilar coil resulted in a bipolar lead (ThinLine, Intermedics) with a body diameter and flexibility similar to unipolar leads. The lead is tined, polyurethane, with the cathode and the anode made of iridium-oxide-coated titanium (IROX). The slotted 8-mm2 cathode tip is coated with polyethylene glycol, a blood soluble material. We present the clinical evaluation results from four pacemaker clinics, where 47 leads (23 atrial-J model 432-04 and 24 ventricular model 430-10) were implanted in 25 patients and followed for up to 2 years. The lead handling characteristics were found to be very satisfactory. Electrical parameters of the leads were measured at implant and noninvasively on postoperative days 1, 2, 21, 42, and months 3, 6, 12, and 24. Mean chronic pulse width thresholds at 2.5 V were 0.14 +/- 0.05 ms in the atrium and 0.10 +/- 0.02 ms in the ventricle, pacing impedances 443 +/- 104 omega and 520 +/- 241 omega, while median electrogram amplitudes were > or = 3.5 mV and > or = 7 mV, respectively. Pacing impedances and thresholds were found to be slightly but statistically significantly higher in unipolar than in bipolar configuration--the findings are explainable by the lead construction. One of 47 leads failed 3 weeks after implant; the conductors were short circuited due to an error during the manufacturing process. We conclude that the new lead thus far has demonstrated appropriate mechanical and electrical characteristics.