Abstract 1585: Medtronic Sprint Fidelis Lead Recall: Determining the 5-Year Cost to Medicare
Background: The Medtronic Sprint Fidelis defibrillator lead has a high failure rate and was recalled in October 2007. The purpose of this study was to determine the cost of the management of this lead to Medicare.
Methods: Real hospital cost data in US dollars were collected from a single university medical center on 11 patients who underwent lead revision either electively (n= 2) or after being hospitalized for multiple shocks caused by a lead fracture (n= 9). 82% of the patients underwent extraction of the Fidelis lead at the time of lead revision. A decision model was made that outlines the potential management of the lead recall over time. The existing literature and Medtronic data were reviewed for parameters included in the decision model. The model assumed that 175,000 patients were alive with an implanted Fidelis lead at the time of the recall and that the annual failure rate will be 1.5% over the next 5 years. It was also assumed that 1% of patients without a lead fracture would also undergo lead revision electively each year, and that the proportion of patients who would have the Fidelis lead extracted rather than abandoned would be 9:100. Estimates were used for parameters for which no data is available. A sensitivity analysis was performed on cost estimates to arrive at a cost range.
Results: The cost of lead revision was higher, but not significantly, when the Fidelis lead was extracted rather than abandoned ($46,535±8,125 vs. $33,802±33, p= 0.06), and when the patient was hospitalized for inappropriate shocks before the lead revision ($46,329±8126 vs. $34,728±6701, p= 0.09). All patients except one (n=10) had a new generator implanted at the time of lead revision. In five years, the estimated cost impact of the Medtronic Sprint Fidelis lead recall to Medicare will be $269,000,000 (Range $135,000,000–$709,000,000; October 2007 USD).
Conclusion: The cost impact of managing a defibrillator lead with a high failure rate to Medicare will be substantial, at approximately $269,000,000.