Transvenous removal of recalled ICD leads: riata vs sprint fidelis

Abstract

Introduction: Sprint Fidelis (S) and Riata (R) ICD leads were recalled by the Food and Drug Administration because of an increased rate of failure due to conductor fracture (S) or insulation abrasion (R). Treatment options include intensifying monitoring and intervening replacing recalled lead, with or without extraction. However, because of its mechanical separation, R leads may be challenging to extract. Aim of this study is a comparison between S and R lead extraction. Methods: Since January 1997 to June 2012, we managed 513 consecutive patients with 545 ventricular ICD leads; among these, 45 were S and 94 R. There were no significative difference in patients and lead characteristics in the two groups. Indications to removal were infective in the majority of cases (73%). Mean pacing period was 39.1±22.1 months in S group and 36.1±23.4 months in R group. 91% of ICD leads in both groups were dual coil. In case of manual traction failure, we performed mechanical dilatation using a single polypropylene sheath technique (Cook Vascular - Leechburg PA, USA) and if necessary, other intravascular tools (Catchers and Lassos, Osypka, Grentzig-Whylen, G); an Approach through the Internal Jugular Vein (JA) was performed in case of failure of the standard approach. Results: Success rate was achieved in all 45 (100%) S leads and in 93/94 (98.9%) R leads. No major complications occurred. Manual traction effectiveness was higher in S leads (9 vs 2%) while JA was required more frequently in R leads (8 vs 2%) (p<0.01). Extraction time and mean sheath size used were significantly higher in R group. Comparing binding sites locations, R leads exhibited higher incidence in superior vena cava, right atrium and tricuspid valve as compared to S leads (p<0.01). In R group presence of cable externalization was a predictor of difficult procedure and need for JA. Conclusions: Our experience shows that the extraction of recalled S and R ICD leads is feasible and effective. However, extraction of R leads is more complex than F leads. Lack of coil backfilling and cable externalization in R group may account for these differences. The decision to extract or not to extract R leads should be individualized.