Impact of Implanted Recalled Sprint Fidelis Lead on Patient Mortality: Heart Rhythm Disorder

Objectives This study sought to compare all-cause mortality in patients with Fidelis leads (Medtronic, Minneapolis, Minnesota) to those with a nonadvisory lead. Background Although Fidelis leads are prone to fracture, and rare deaths due to lead failure have been reported, it is unclear whether the...

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Veröffentlicht in:Journal of the American College of Cardiology 2011-07, Vol.58 (3), p.278-283
Hauptverfasser: Morrison, Thomas B, Friedman, Paul A, Kallinen, Linda M, Hodge, David O, Crusan, Daniel, Kumar, Kapil, Hayes, David L, Rea, Robert F, Hauser, Robert G
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Sprache:eng
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Zusammenfassung:Objectives This study sought to compare all-cause mortality in patients with Fidelis leads (Medtronic, Minneapolis, Minnesota) to those with a nonadvisory lead. Background Although Fidelis leads are prone to fracture, and rare deaths due to lead failure have been reported, it is unclear whether the presence of a Fidelis lead is associated with increased mortality. This study compares all-cause mortality in a large cohort of patients with Fidelis and Quattro implantable cardioverter-defibrillator (ICD) leads. Methods All patients with Fidelis (Medtronic models 6931, 6948, and 6949) and Quattro (Medtronic model 6947) leads followed at 3 tertiary care centers were identified from the medical records (implant dates: November 19, 2001, to December 23, 2008). Clinical and device-specific data were collected into a common database. Deaths were identified from medical records and the Social Security Death Index. Survival was estimated using the Kaplan-Meier method. Results A total of 2,671 patients (1,030 Fidelis and 1,641 Quattro) were identified. There were 398 deaths: 147 in the Fidelis group (mean follow-up: 34.4 months) and 251 in the Quattro group (mean follow-up: 39.9 months). No deaths were associated with 85 Fidelis and 23 Quattro failures. At 4 years, survival was diminished in patients with Fidelis compared with Quattro leads (80.7% vs. 83.9%, p = 0.025). After adjustment for factors associated with mortality, survival was similar between groups. One hundred percent pacing was not associated with mortality. Elective removal of nonfailed leads was performed in 5.1% of Fidelis and 0.9% of Quattro patients. Conclusions In a conservatively managed cohort, in whom observation was predominantly utilized, adjusted survival is similar between patients with Fidelis and Quattro ICD leads.
ISSN:0735-1097
DOI:10.1016/j.jacc.2011.03.027