Do small (6.6 Fr.) active and passive fixation defibrillation leads perform as well as larger sized leads? A multi-centre analysis.
OBJECTIVE
The 6.6 Fr. Sprint Fidelis lead family may allow multiple lead implantation procedures with reduced risk of venous obstruction.


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((R)) 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.


CONCLUSIONS
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.
Küpper
Bernhard
B
Schüchtermann Klinik, Bad Rothenfelde, Germany. b.kuepper@elisabeth-essen.de
Yee
Raymond
R
O'Hara
Gilles
G
Simpson
Chris S
CS
Della Bella
Paolo
P
Workel
Martin
M
Hull
Michael
M
Heuer
H
H
D002170:Canada / Q000453:epidemiology; D018572:Disease-Free Survival; D004554:Electric Countershock / Q000295:instrumentation* / Q000379:methods / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000145:classification / Q000706:statistics & numerical data*; D005060:Europe / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D015995:Prevalence; D018570:Risk Assessment / Q000379:methods; D012307:Risk Factors; D016896:Treatment Outcome; D014693:Ventricular Fibrillation / Q000453:epidemiology* / Q000517:prevention & control*