title: Transvenous extraction profile of Riata leads: procedural outcomes and technical complexity of mechanical removal.
abstract: BACKGROUND
  Riata (RT) and Sprint Fidelis (SF) leads were recalled by the United States Food and Drug Administration because of an increased rate of failure mainly due to conductor fracture or insulation abrasion. According to lead design and type of failure, extraction complexity may be different, potentially affecting procedural outcomes and indications.
  
  
  OBJECTIVE
  The purpose of this study was to assess the extraction profile of RT leads with and without cable externalization in comparison to SF leads.
  
  
  METHODS
  From January 1997 to April 2014, all consecutive RT and SF leads extracted transvenously were analyzed. Among 661 consecutive patients with 705 ventricular implantable cardioverter-defibrillator (ICD) leads extracted, 194 patients with 134 RT leads (RT group) and 61 SF leads (SF group) were identified. Removal indications often were infective (64%), and extracted leads had a prevalence of dual-coil design (89%). Baseline patients and lead characteristics were comparable between groups.
  
  
  RESULTS
  Success rate was high in both groups (97.8% RT vs 100% SF) without major complications. Mechanical dilation was comparable between groups, but RT leads often required larger sheaths (11.7 ± 1.4 vs 11.3 ± 1.4), a more frequent crossover to the internal transjugular approach (14% vs 3%), and a longer procedural time (23 ± 33 minutes vs 12 ± 16 minutes). Implantation time (odds ratio 4.84, 95% confidence interval 1.05-22.2, P = .042) and RT leads (odds ratio 1.04, 95% confidence interval 1.02-1.06, P <.001) were independent predictors of the internal transjugular approach.
  
  
  CONCLUSIONS
  Extraction of RT leads is feasible and effective. However, extraction of RT leads is more complex than that of SF leads. Lack of coil backfilling and cable externalization in RT group may account for these differences.
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bongiorni
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Di Cori
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy. Electronic address: lucasegreti@gmail.com.
authors.forename: Luca
authors.initials: L
authors.lastname: Segreti
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Giulio
authors.initials: G
authors.lastname: Zucchelli
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Viani
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Paperini
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: De Lucia
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Dianora
authors.initials: D
authors.lastname: Levorato
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Adriano
authors.initials: A
authors.lastname: Boem
authors.affiliation: Second Division of Cardiology, Cardiothoracic and Vascular Department, University Hospital of Pisa, Pisa, Italy.
authors.forename: Ezio
authors.initials: E
authors.lastname: Soldati
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000009:adverse effects*; D004867:Equipment Design / Q000009:adverse effects* / Q000295:instrumentation; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D008297:Male; D057052:Medical Device Recalls; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome; D014481:United States
keywords: Jugular vein; Lead extraction; Mechanical dilation; Riata; Sprint Fidelis