title: Cost of a recall of a single-center experience managing the Riata defibrillator lead.
abstract: Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, California) were recalled in 2011 due to increased risk of insulation failure leading to externalized cables. Fluoroscopic screening can identify insulation failure, although the relation between mechanical failure and electrical failure is unclear. At the time of the recall, the University of Virginia developed a screening program, including fluoroscopic evaluation, education sessions, device interrogation, and remote monitoring for patients with this defibrillator lead. The aim of this study was to review the outcomes of the screening program, including costs, which were absorbed by our institution. Costs were calculated using Medicare reimbursement estimates. Forty-eight patients participated in the screening program. At initial screening, 31% were found to have evidence of insulation failure but electrical function was normal in all leads. The cost of this program was $35,358.72. The cost per diagnosis of mechanical lead failure was $2,357.25. During 2 years of follow-up, 1 patient experienced Riata lead electrical failure without fluoroscopic evidence of insulation failure. Patients were more likely to have a lead revision if there was evidence of insulation failure. Lead revisions occurred at the time of generator change in 88% of patients with insulation failure but in only 14% of patients with a fluoroscopically normal lead (p = 0.04). The cost of recall-related defibrillator lead revisions was $81,704.55. In conclusion, our Riata screening program added expense without clear benefit to patients. In fact, patients may have been put at more risk by undergoing defibrillator lead revisions based solely on the results of the fluoroscopic screening.
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Sarah
authors.initials: S
authors.lastname: Hussain
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Liza
authors.initials: L
authors.lastname: Moorman
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: J Randall
authors.initials: JR
authors.lastname: Moorman
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: John P
authors.initials: JP
authors.lastname: DiMarco
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Rohit
authors.initials: R
authors.lastname: Malhotra
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Darby
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: Kenneth
authors.initials: K
authors.lastname: Bilchick
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: J Michael
authors.initials: JM
authors.lastname: Mangrum
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia.
authors.forename: John D
authors.initials: JD
authors.lastname: Ferguson
authors.affiliation: Division of Cardiology, Department of Medicine, University of Virginia Health System, Charlottesville, Virginia. Electronic address: pkm5f@virginia.edu.
authors.forename: Pamela K
authors.initials: PK
authors.lastname: Mason
mesh_terms: D003365:Costs and Cost Analysis; D017147:Defibrillators, Implantable / Q000191:economics*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration