Implant experience with unipolar polyurethane pacing leads

Abstract

A total of 905 unipolar polyurethane pacing leads have been implanted by the first author's group, between April 1978 and February 1982, with a mean implant of 1.4 years. Twelve leads were explanted and analyzed. Eleven of the explanted leads exhibited some degree of surface damage or "frosting." Of the 11, five atrial (Medtronic 6991 U) and one ventricular (Medtronic 6971) lead suffered complete insulation failure. One lead was completely free from surface damage. Clinically, insulation failure presented as muscle stimulation and/or battery depletion. Surface damage appears to be due to an environmental stress cracking (ESC) mechanism. ESC requires both a surface active agent from the hostile biological environment, and stress in excess of a threshold value. The minor surface damage or "frosting" of the eleven explanted leads was typically 10 to 15 microns deep on leads implanted about one year, although one device (15 months) had 30 micron cracks. No lead failures in this series were attributed to this shallow cracking mechanism. The severe cracking of the six Medtronic leads leading to insulin failure was thought to be due to the unusually high tensile stresses imposed by manufacturing processes and ligatures. The incidence of failure was 7% (5/74) for the Medtronic 6991 U and 0.2% (1/454) for the Medtronic 6971. Medtronic lead manufacturing processes have been modified to reduce the high residual tensile stresses and a fixation sleeve has been added to reduce ligature stress.