Insight into the mechanism of failure of the Riata lead under advisory

BACKGROUND: Cable externalization and insulation abrasion are known to occur with the St Jude Medical Riata leads under advisory. The distribution of these abnormalities and how they relate to clinical presentation have not been well described. OBJECTIVE: In this study, we sought to determine the relationship between structural lead failure and clinical presentation by using the analysis of returned Riata products in Canada. METHODS: The analyses of returned Riata products in Canada were obtained from St Jude Medical, Sylmar, CA. These data were correlated with the clinical presentation of patients just before lead removal from service. RESULTS: As of May 1, 2013, there were 263 returned Riata leads in Canada. Of these, 43 (16.8%) were found to have insulation abrasion that was due to either lead-can or lead-other device interaction (70%) or inside-out abrasion (27.9%). The predilection of lead-to-can abrasion was seen in the Riata 7-F leads (84.2% vs 58.4%; P = .07), while inside-out abrasion was more common in the Riata 8-F leads (37.5% vs 15.8%; P = .12). Electrical abnormalities were frequent (20 of 31 [65.4%]) and most often due to electrical noise (45.2%), although inappropriate shocks were present (25.8%). Death occurred in 1 of 43 (2.3%) of those patients with an insulation defect in the lead-can abrasion group. CONCLUSION: Lead-can abrasion is the most common form of insulation defect in the Riata group of leads under advisory. Management of this group of leads under advisory should not neglect the issue of lead-can abrasion, in addition to detection of cable externalization.