Longitudinal follow-up of externalized Riata leads

Riata family of implantable cardioverter defibrillator leads have demonstrated in situ conductor externalization, prompting a class I recall and the Food and Drug Administration recommendation for fluoroscopic screening. The natural history of externalized Riata leads, however, remains unclear. In this study, we examined the rate of electrical failure in Riata leads with externalized cables. We reviewed medical and implantable cardioverter defibrillator records of all 329 patients with Riata leads who underwent fluoroscopic screening from December 2011 to March 2012 at the University of Pittsburgh Medical Center hospitals. Externalization was present in 76 patients (23%); of whom, 24 (32%) had the Riata lead replaced shortly after screening. The remaining 52 patients were followed for 7.9 ± 2.9 months, during which 5 patients were lost to follow-up and 2 patients exhibited electrical lead failure resulting in lead replacement, an electrical failure rate of 6.4% per year in externalized leads. In conclusion, prospective follow-up data on externalized Riata leads suggest an electrical failure rate in excess of 6% per year. This high failure rate warrants consideration of prophylactic replacement of externalized Riata leads. Further studies examining the natural history of Riata leads are warranted.