title: High failure rate of the 5 French Sorin Hepta 4B pacemaker lead.
abstract: OBJECTIVE
  The 5 French Sorin Hepta 4B lead is a bipolar transvenous pacemaker lead with a passive fixation mechanism. From 2003 to 2008, a total of 98 Sorin Hepta 4B right ventricular pacemaker leads were implanted in our hospital. We observed an unexpected high failure rate of this pacemaker lead. The aim of this study is to determine the performance of the Hepta 4B lead.
  
  
  RESULTS
  A retrospective single-centre survey was conducted on the performance of all implanted Hepta 4B leads in our high-volume tertiary hospital. Information on all implants was stored in a database. Analysis of this database and patients' charts was performed to assess the rate of complications of all implanted Hepta 4B leads. Median time of follow-up was 5.49 (4.15-6.44) years. Of the 98 implanted Hepta 4B leads, 21 (21%) were replaced. A total of 18 (18%) leads showed electrical malfunction, leading to symptoms in five (5%) patients. Electrical malfunction included impedance change, threshold rise, and sensing problems.
  
  
  CONCLUSIONS
  In this single-centre retrospective observation we report an extreme and unexpected failure rate of the Sorin Hepta lead. The most common complication was electrical dysfunction. The reason for this phenomenon has to be analysed, but the co-radial multifilar design, allowing a smaller diameter of the lead, may explain this finding.
authors.affiliation: Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, PO Box 50000, 7500 KA Enschede, The Netherlands.
authors.forename: H G
authors.initials: HG
authors.lastname: Reinhart Dorman
authors.forename: Jurren M
authors.initials: JM
authors.lastname: Van Opstal
authors.forename: Jeroen
authors.initials: J
authors.lastname: Stevenhagen
authors.forename: Marcoen F
authors.initials: MF
authors.lastname: Scholten
mesh_terms: D000368:Aged; D004553:Electric Conductivity; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009426:Netherlands; D010138:Pacemaker, Artificial / Q000706:statistics & numerical data*; D012189:Retrospective Studies
keywords: Lead failure; Pacemaker therapy