Clinical Surveillance of a Thin Bipolar Pacing Lead

Abstract

A total number of 415 co-radial, bipolar pacing leads (189 atrial leads; 226 ventricular leads) were implanted in 228 patients between November 1994 and July 1999. Mean pacing thresholds at the implantation were normal at 0.6 V in the atrium and at 0.4 V in the ventricle with a pulse duration of 0.4-0.5 ms. Lead impedance was relatively low (337-447 ohms for atrial leads; 369-459 ohms for ventricular leads) at the implantation and during the follow-up periods. No definite failure in lead materials was observed in either atrial or ventricular leads (mean follow-up of 19.7 and 19.2 months, respectively: up to 52.9 months for both leads). Predicted clinical surveillance up to 10 years calculated statistically showed that the upper 95% confidence limit was a constant of 100%. The lower 95% confidence limits at 5, 7, and 10 years were estimated to be 98.0%, 97.2%, and 96.0%, respectively. From the present study, the ThinLine lead is reliable for both sensing and pacing thresholds, and has excellent predicted lead longevity. Nevertheless, further observation is required regarding cost performance, such as early replacement of the pacemaker generator, because of the lower pacing lead impedance.