Europace Advance Access published online on June 26, 2007
Europace, doi:10.1093/europace/eum123
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Do small (6.6 Fr.) active and passive fixation defibrillation leads perform as well as larger sized leads? a multi-centre analysis
1 Schüchtermann Klinik, Bad Rothenfelde, Germany; 2 London Health Sciences Centre, London, Ontario, Canada; 3 Hôpital Laval, Sainte-Foy, Québec, Canada; 4 Kingston General Hospital, Kingston, Ontario, Canada; 5 Centro Cardiologico Monzino, Milan, Italy; 6 Medtronic, Bakken Research Center BV, Maastricht, The, Netherlands; 7 Medtronic Inc., Minneapolis, MN, USA; 8 St. Johannes Hospital, Dortmund, Germany
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.
Key Words: Defibrillation lead, Dual coil, ICD, Lead handling, Safety, Electrical performance
* Corresponding author: Abteilung Kardiologie/Angiologie, Elisabeth-Krankenhaus, Klara-Kopp-Weg 1, D-45138 Essen, Germany. Tel: +49 201 897 3201; fax: +49 201 288 525. E-mail address: b.kuepper{at}elisabeth-essen.de
Manuscript submitted 12 December 2006. Accepted after revision 24 May 2007.
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