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Update on Small‐Diameter Implantable Cardioverter‐Defibrillator Leads Performance
Author(s) -
VAN REES JOHANNES B.,
VAN WELSENES GUIDO H.,
BORLEFFS C. JAN WILLEM,
THIJSSEN JOEP,
VAN DER VELDE ENNO T.,
VAN DER WALL ERNST E.,
VAN ERVEN LIESELOT,
SCHALIJ MARTIN J.
Publication year - 2012
Publication title -
pacing and clinical electrophysiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.686
H-Index - 101
eISSN - 1540-8159
pISSN - 0147-8389
DOI - 10.1111/j.1540-8159.2011.03338.x
Subject(s) - medicine , implantable cardioverter defibrillator , hazard ratio , sprint , cohort , confidence interval , cardiology , lead (geology) , cardiac resynchronization therapy , perforation , heart failure , ejection fraction , physical therapy , materials science , geomorphology , geology , punching , metallurgy
Background:The performance of small diameter implantable cardioverter defibrillator (ICD) leads is questionable. However, data on performance during long‐term follow‐up are scarce. The aim of this study is to provide an update for the lead failure and cardiac perforation rate of Medtronic's Sprint Fidelis ICD lead (Medtronic Inc., Minneapolis, MN, USA) and St. Jude Medical's Riata ICD lead (St. Jude Medical Inc., St. Paul, MN, USA).Methods:Since 1996, all ICD system implantations at the Leiden University Medical Center, the Netherlands, are registered. For this study, data up to February 2011 on 396 Sprint Fidelis leads (follow‐up 3.4 ± 1.5 years), 165 8‐French (F) Riata leads (follow‐up 4.6 ± 2.6 years), and 30 7‐F Riata leads (follow‐up 2.9 ± 1.3 years) were compared with a benchmark cohort of 1,602 ICD leads (follow‐up 3.4 ± 2.7 years) and assessed for the occurrence of lead failure and cardiac perforation.Results:During follow‐up, the yearly lead failure rate of the Sprint Fidelis lead, 7‐F Riata lead, 8‐F Riata lead, and the benchmark cohort was 3.54%, 2.28%, 0.78%, and 1.14%, respectively. In comparison to the benchmark cohort, the adjusted hazard ratio of lead failure was 3.7 (95% confidence interval [CI] 2.4–5.7, P < 0.001) for the Sprint Fidelis lead and 4.2 (95% CI 1.0–18.0, P < 0.05) for the 7‐F Riata lead. One cardiac perforation was observed (3.3%) in the 7‐F Riata group versus none in the 8‐F Riata and Sprint Fidelis lead population.Conclusion:The current update demonstrates that the risk of lead failure during long‐term follow‐up is significantly increased for both the Sprint Fidelis and the 7‐F Riata lead in comparison to the benchmark cohort. Only one cardiac perforation occurred.(PACE 2012; 35:652–658)