Introduction: Riata (R) and Sprint Fidelis (S) leads were recalled by the Food and Drug Administration because of an increased rate of failure due to conductor fracture or insulation abrasion. Treatment options include intensifying monitoring and possible recalled lead replacement, with or without extraction. According to lead design and type of failure, procedural extraction complexity may be different. Aim of this study was to assess the extraction profile of R leads with and without cable exteriorization in comparison to S Leads. Methods: From January 1997 to December 2012, we included in the analysis all the consecutive R and S extracted transvenously. Results: Among 545 consecutive patients with 582 ventricular ICD leads extracted, we identified 51 S (S Group) and 102 R (R Group). Indications to removal were infective in the majority of cases (70%) and with a prevalence of dual coil leads (90%). Baseline patients and lead characteristics resulted comparable between groups. Results: Success rate was very high in both groups (100% S leads vs 99% R leads, p=NS) without major complications. R leads required more often MD (98% vs 92%, p=0.05) and larger sheaths, a more frequent crossover to the transjugular approach (ITA) (8% vs 2%, p=0.10), and a final longer extraction time (11±18 vs 18±23 min) Overall, the rate of complex extraction procedures (CEP) resulted higher in the R Group (32% vs 14%, p= 0.02). Presence of cable externalization was a major independent predictor of difficult extraction and necessity of ITA. Conclusions: Extraction of R leads is feasible and effective. However, extraction of R leads is more complex than S 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 carefully individualized.

Riata lead extraction: technical approach and procedural implications of transvenous removal

M G. Bongiorni;A. Di Cori;L. Segreti;G. Zucchelli;L. Paperini;SL. Romano
2014-01-01

Abstract

Introduction: Riata (R) and Sprint Fidelis (S) leads were recalled by the Food and Drug Administration because of an increased rate of failure due to conductor fracture or insulation abrasion. Treatment options include intensifying monitoring and possible recalled lead replacement, with or without extraction. According to lead design and type of failure, procedural extraction complexity may be different. Aim of this study was to assess the extraction profile of R leads with and without cable exteriorization in comparison to S Leads. Methods: From January 1997 to December 2012, we included in the analysis all the consecutive R and S extracted transvenously. Results: Among 545 consecutive patients with 582 ventricular ICD leads extracted, we identified 51 S (S Group) and 102 R (R Group). Indications to removal were infective in the majority of cases (70%) and with a prevalence of dual coil leads (90%). Baseline patients and lead characteristics resulted comparable between groups. Results: Success rate was very high in both groups (100% S leads vs 99% R leads, p=NS) without major complications. R leads required more often MD (98% vs 92%, p=0.05) and larger sheaths, a more frequent crossover to the transjugular approach (ITA) (8% vs 2%, p=0.10), and a final longer extraction time (11±18 vs 18±23 min) Overall, the rate of complex extraction procedures (CEP) resulted higher in the R Group (32% vs 14%, p= 0.02). Presence of cable externalization was a major independent predictor of difficult extraction and necessity of ITA. Conclusions: Extraction of R leads is feasible and effective. However, extraction of R leads is more complex than S 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 carefully individualized.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11568/1147808
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