Background
The Medtronic Sprint Fidelis defibrillator lead is prone to fracture and was recalled
in 2007 after 665 failures and five reported deaths. Approximately 150,000 patients
at risk for sudden death in the United States have Sprint Fidelis leads. The rate
of Sprint Fidelis lead failure may be increasing, and physicians are confronted with
the decision to replace the lead prophylactically.
Objective
The purpose of this study was to determine if the hazard of Sprint Fidelis lead failure
is changing and to compare its performance to other contemporary implantable cardioverter-defibrillator
(ICD) leads.
Methods
Transvenous ICD leads implanted and followed at our two tertiary-care referral centers
between January 2004 and December 2008 were included in the study. Lead failure data
were entered prospectively by both centers via the Multicenter Registry. Clinical
data were collected prospectively by each center and merged for the purpose of this
study.
Results
During 5,700 implant years of follow-up (average 1.9 ± 1.3 years), 94 of 3,037 defibrillator
leads failed (1.65%/year), including 72 (8.5%) of 848 Sprint Fidelis leads. The cumulative
hazard of Sprint Fidelis failure was significantly greater compared to 2,189 other
defibrillator leads (P <.0001), and the hazard of Sprint Fidelis failure accelerated after the first year
and continued to increase during the study. In contrast to other defibrillator leads,
the Sprint Fidelis failure rate was significantly higher (3.75%/year vs 0.58%/year)
and the 3-year estimated survival was significantly lower (87.9% [95% CI 84.8, 90.9]
vs 98.5% [95% CI 97.8, 99.3]; P <.0001). The chance that a Sprint Fidelis lead would survive another year decreased
progressively during the study. Most Sprint Fidelis failures were caused by pace-sense
conductor fracture (n = 63 [87.5%]), which caused inappropriate shocks in 36 of 72
patients.
Conclusion
The hazard of Sprint Fidelis lead failure is increasing, whereas the failure rates
of other defibrillator leads are low and stable. Physicians should consider these
data when managing patients who have Sprint Fidelis leads.
Keywords
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Article info
Publication history
Published online: February 23, 2009
Accepted:
February 11,
2009
Received:
January 23,
2009
Footnotes
Dr. Hayes has received honoraria from Medtronic, Boston Scientific [Guidant], St. Jude Medical, Sorin/ELA, and Blackwell/Wiley; has served and/or is serving on an Advisory Board of Boston Scientific (Guidant), St. Jude Medical, Sorin/ELA, and AI-Semi; serves on a Steering Committee of St. Jude (DSMB); and has received royalties from Blackwell/Futura.
Identification
Copyright
© 2009 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
