Clinical surveillance of an active fixation, bipolar, polyurethane insulated pacing lead, Part II: The ventricular lead.

Since 1989, 72 Telectronics 330-201 active fixation, polyurethane insulated ventricular leads (Accufix) have been implanted at the Mayo Clinic. There were four (5.6%) acute lead related complications (perforation, microdislodgment, and macrodislodgment), three of which led to early reoperation. Over a follow-up time of up to 2.7 years (median 9.4 months), there were six (8.3%) chronic lead related complications but no failures of lead material. Most of these complications developed during the first month, and half of them were transient, with documented improvement later. Two patients (2.8%) required reoperation for chronic complications. At follow-up examination of the pacing thresholds, usually performed about 3 months after implantation, 14.3% of the examined patients had high pacing thresholds necessitating high-output programming. The mechanisms and later evolution of this phenomenon should be further evaluated.