Do small (6.6 Fr.) active and passive fixation defibrillation leads perform as well as larger sized leads? A multi-centre analysis

Bernhard Küpper, Raymond Yee, Gilles O'Hara, Chris S. Simpson, Paolo Della Bella, Martin Workel, Michael Hull, H. Heuer

Research output: Contribution to journalArticle

Abstract

Aims: The 6.6 Fr. Sprint Fidelis® lead family may allow multiple lead implantation procedures with reduced risk of venous obstruction. Methods and results: Two prospective, historically controlled, multi-centre studies were conducted in Europe (80 patients) and Canada (79 patients). The purpose was to assess the ventricular lead-related adverse events (LRAEs) and performance of the small Models 6948 and 6949 defibrillation leads, respectively, in patients with a standard indication for an ICD implant. Safety was assessed by demonstrating equivalence of the LRAE free rate at 1 month to comparable but larger leads (Models 6942, 6943, 6944, 6947and 4074). Seventy-five of 80 patients with a 6948 lead (93.8%) remained free of LRAEs. Seventy-four out of 79 patients (93.7%) with the 6949 lead remained free of LRAEs. The 95% lower confidence bounds were above the critical difference limits. Thus, safety of the Sprint Fidelis® leads is similar to that of larger leads. Electrical performance through 1-month follow-up proved to be acceptable in comparison with other established leads. Conclusion: These multi-centre studies confirm that smaller defibrillation leads offer similar safety and efficacy features to widely used larger leads; they have low LRAE rates and defibrillation thresholds, while providing the advantage of a smaller introducer size and reduced venous obstruction.

Original languageEnglish
Pages (from-to)657-661
Number of pages5
JournalEuropace
Volume9
Issue number8
DOIs
Publication statusPublished - Aug 2007

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Keywords

  • Defibillation lead
  • Dual coil
  • Electrical performance
  • ICD
  • Lead handling
  • Safety

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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