Clinical surveillance of a tined, bipolar, silicone-insulated ventricular pacing lead

Europace. 2006 Feb;8(2):118-21. doi: 10.1093/europace/euj029. Epub 2006 Jan 9.

Abstract

Aims: This study assesses short- and long-term performance of the S80TB ventricular lead manufactured by Sorin Biomedica, Italy.

Methods and results: Three hundred and thirty leads were implanted and had complete follow-up with us for a minimum of 60 months or up to failure, removal, and/or patient death (mean 40 months, range: 1 day to 81 months). Thirty-two patients (9.6%) had spontaneous lead-related complications: 7 (2.1%) occurred during the first week; 25 (7.6%) had chronic complications, of which 20 (6.1%) necessitated re-operations; 3 (0.9%) were lead material failures. Of the 110 re-operations (90 pacemaker replacements and 20 operations due to complications), 7 additional cases (6.4%) were complicated by unique connector damage that occurred during disconnection of the lead from the connector block. The Kaplan-Meier estimated 5-year lead survival free of lead material failure and free of any significant lead complication were 97.9 and 87%, respectively.

Conclusion: The S80TB lead demonstrates an acceptable rate of acute and chronic spontaneous complications and very few lead material failures over 5 years of follow-up. However, there seems to be a relatively high incidence of connector damage during disconnection from the connector block. Extra caution is required during those procedures in patients with this lead.

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Cardiac Pacing, Artificial*
  • Electrodes, Implanted
  • Equipment Design
  • Equipment Failure
  • Equipment Failure Analysis
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Pacemaker, Artificial / adverse effects*
  • Retrospective Studies
  • Survival Rate
  • Treatment Outcome
  • Ventricular Fibrillation / mortality
  • Ventricular Fibrillation / therapy*