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Impact of Implanted Sprint Fidelis Lead on Patient Mortality
Study Questions:
Is the Medtronic Fidelis lead (Medtronic, Minneapolis, MN) associated with an increased risk of death?
Methods:
The mortality rate during a mean of 34 months of follow-up in 1,030 patients (mean age 64 years) who received a Fidelis lead was compared to the mortality rate during a similar period of follow-up in 1,641 patients (mean age 65 years) who received a Medtronic Quattro lead, which is similar to the Fidelis lead, but not under advisory. Deaths were identified from medical records and the Social Security Death Index.
Results:
A nonfailed lead was prophylactically removed in 5.1% and 0.9% of patients in the Fidelis and Quattro groups, respectively. The failure rate of the Fidelis lead (13%) was significantly higher than that of the Quattro lead (1.3%). There were no deaths associated with the 85 Fidelis or 23 Quattro lead failures. Inappropriate shocks occurred in 45% of the patients with Fidelis lead failures. Four-year patient survival was 81% in the Fidelis group and 84% in the Quattro group. The Fidelis lead was not an independent predictor of mortality. The only independent predictors of mortality were low ejection fraction and fewer generator replacements.
Conclusions:
The authors concluded that the Fidelis lead is not associated with a higher risk of death.
Perspective:
The results of this study validate a conservative approach of removing a Fidelis lead only when there is evidence of lead failure. However, safe implementation of this strategy requires monitoring of lead function with the Lead Integrity Alert algorithm, which is possible only in patients who have a Medtronic generator. The case for prophylactic replacement of a Fidelis lead might be stronger in patients with another manufacturer’s generator, particularly if the patient is pacemaker-dependent.
Keywords: Follow-Up Studies, Pacemaker, Artificial, Social Security, Medical Records
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