Looking for a lead after recalls
In March, Robert G. Hauser, MD, of the Minneapolis Heart Institute Foundation and colleagues published a study that looked at deaths related to Riata and Riata ST leads after the FDA issued a Class 1 recall of the leads, citing potential risk of serious injury or patient death if affected devices malfunctioned. Hauser et al concluded that high-voltage failures and not externalized conductors may be the greater concern if they fail to provide life-saving therapy.
St. Jude Medical called for a retraction of the study, a move that caught the attention of the New York Times and shifted the controversy into the public domain. The journal editors refused. In news speak, the story “had legs,” meaning it would retain reader interest, at least as long as there was perceived controversy.
That controversy overshadowed the larger issue: how to manage patients implanted with possibly failing devices?
Among the many interesting presentations at HRS.12 was a poster session by Jamil Bashir, MD, of the division of cardiovascular surgery at the University of British Columbia in Vancouver. Bashir and colleagues analyzed the costs of elective or urgent lead procedures based on whether the patient presented with lead dysfunction.
The leads in this study were Sprint Fidelis ICD leads (Medtronic), which were recalled in 2007 due to a high fracture rate. Using five-year data from two centers in British Columbia, the researchers identified 346 Sprint Fidelis leads placed in 342 patients, with 47 fractures and 80 operations (46 urgent procedures and 34 elective procedures). They found that the average cost for lead fracture cases was double that of an elective procedure to revise the lead.
Based on the high fracture rate, they recommended that physicians use elective surgery for a generator change as an opportunity to revise Fidelis leads. Do the findings illuminate cost and care strategies for Riata patients? Perhaps not exactly, but like a beacon they may help guide physicians who are wrestling with these issues toward a solution.
Editor, Cardiovascular Business