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Implementation of Lead Safety Recommendations
Author(s) -
VAN REES JOHANNES B.,
BORLEFFS C. JAN WILLEM,
BAX JEROEN J.,
NAGTEGAAL ELS M.,
VAN DER VELDE ENNO T.,
VAN ERVEN LIESELOT,
SCHALIJ MARTIN J.
Publication year - 2010
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.1540-8159.2009.02622.x
Subject(s) - medicine , lead (geology) , confidence interval , implantable cardioverter defibrillator , sprint , incidence (geometry) , emergency medicine , physical therapy , physics , geomorphology , optics , geology
Background: The Medtronic Sprint Fidelis (SF) implantable cardioverter defibrillator (ICD; Medtronic Inc., Minneapolis, MN, USA) lead has a higher than expected failure rate. Because of patient safety, Medtronic announced two advisories consisting of (1) adjustments in device settings (October 2007) and (2) installation of a lead integrity algorithm (May 2008). The objective of this study was to evaluate the effect of Medtronic's announcements on patient safety.Methods: To comply with the advisories, two clinical evaluations were conducted. The effect of the advisories was assessed by the lead failure rate and the occurrence of inappropriate shocks due to lead failure. Three periods were distinguished in the comparison of event rates: lead implantation to advisory 1 (period A), in‐between both advisories (period B), and advisory 2 to follow‐up (period C).Results: Since 2004, 372 patients received a Medtronic ICD and SF lead and were followed from first implant (December 2004) to April 2009. Cumulative incidence rate of lead failure was 3.6%[95% confidence interval (CI) 1.6–5.6] at 21 months and increased to 11.0% (95% CI 6.1–15.9) at 42 months. After implementation of both advisories, the occurrence of inappropriate shocks due to lead failure decreased from 1.5 (95% CI 0.59, 3.00) per 100 lead‐years in period A to 0.8 (95% CI 0.02, 4.25) per 100 lead‐years in period C.Conclusion: The current study demonstrates that despite an increasing risk for SF lead failure, implementation of the advisories decreased the occurrence of inappropriate shocks due to lead failure. (PACE 2010; 431–436)