Riata and Riata ST defibrillator leads failure: cable externalization is one problem, but other electrical failures seem more preoccupant

Abstract

Purpose: Riata and Riata ST leads (St Jude Medical, Sylmar, CA) are recalled insulation failure and cable externalization since 2010. The consequences of this insulation damage are not yet established. We aimed to determine the overall failures and their mechanism in 2 tertiary centres. Methods: All patients with Riata and Riata ST leads implanted and followed between 2003 and 2012, were evaluated with an annual biplane chest x-ray and ICD interrogation every 3 months. Results: 181 patients have been implanted with Riata (94 single-coil and 46 double-coil) and Riata ST (36 single-coil and 5 double-coil) leads. 86 patients have completed a follow-up of 74 months, 22 had heart transplant, 41 died, and 34 patients were referred to other centres or lost. Overall failure rate was 32.5% (28 patients); all were observed in 8-French leads except for one patient. We report 10 oversensing including 5 related to insulation damages and 5 without, none of them have shown cable externalization, 8 conductor fractures, 7 conductor externalizations without electrical abnormality, and 3 other isolated electrical problem such as impedance increase (11.6%, 9.3%, 8.1%, and 3.5% respectively). Mean time to failure was 62 months. Conclusions: Riata lead failure mostly concerns 8-French leads. Attention is especially paid to conductor externalization risk, but global failure rate with electrical complications seems more preoccupant and needs to be emphasised.