title: Multicenter experience with extraction of the Sprint Fidelis implantable cardioverter-defibrillator lead.
abstract: OBJECTIVE
  This study was undertaken to determine the safety and feasibility of extraction of the Sprint Fidelis (Medtronic, Minneapolis, Minnesota) lead.
  
  
  BACKGROUND
  The reported failure rate of the Sprint Fidelis defibrillator lead has increased to a range greater than initially appreciated with emerging evidence of an accelerating rate of fracture. At present, consensus guidelines continue to recommend against prophylactic extraction of the lead, citing major complication rates between 1.4% and 7.3%. However, data regarding the safety and feasibility of extraction of small-diameter, backfilled implantable cardioverter-defibrillator leads such as the Sprint Fidelis are limited.
  
  
  METHODS
  We performed a retrospective cohort study of consecutive patients undergoing extraction of Sprint Fidelis (models 6930, 6931, 6948, 6949) leads at 5 high-volume centers. Patient characteristics, indications for extraction, and use of countertraction sheath (CTS) assistance are reported. The risk of major and minor complications was determined. A multivariable logistic regression model was developed to predict factors associated with the use of CTS assistance.
  
  
  RESULTS
  Between May 2005 and August 2009, 349 Sprint Fidelis leads were extracted from 348 patients. All leads were removed completely. The average duration of the implanted lead was 27.5 months (range 0.03 to 58.8 months). Approximately one-half of the extracted leads were fractured (49.4%), and 26.5% were extracted prophylactically. The other major indication for extraction was infection (22.8%). Extraction was achieved with simple traction in 49.4% leads; CTS assistance was required in 174 cases (50.6%). In multivariable models, length of time since implantation was directly related to the need for CTS assistance (odds ratio per month since implantation: 1.035; 95% confidence interval: 1.010 to 1.061; p=0.006). There were no major procedural complications or deaths.
  
  
  CONCLUSIONS
  Extraction of the Sprint Fidelis lead can be performed safely by experienced operators at high-volume centers with a complication rate lower than that reported for older generation leads. However, leads with longer implant durations are associated with the use of CTS assistance. Recommendations regarding prophylactic Sprint Fidelis lead extraction may warrant reconsideration.
authors.affiliation: Brigham and Women's Hospital, Boston, Massachusetts 02115, USA. mmaytin@partners.org
authors.forename: Melanie
authors.initials: M
authors.lastname: Maytin
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Love
authors.forename: Avi
authors.initials: A
authors.lastname: Fischer
authors.forename: Roger G
authors.initials: RG
authors.lastname: Carrillo
authors.forename: Juan D
authors.initials: JD
authors.lastname: Garisto
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Bongiorni
authors.forename: Luca
authors.initials: L
authors.lastname: Segreti
authors.forename: Roy M
authors.initials: RM
authors.lastname: John
authors.forename: Gregory F
authors.initials: GF
authors.lastname: Michaud
authors.forename: Christine M
authors.initials: CM
authors.lastname: Albert
authors.forename: Laurence M
authors.initials: LM
authors.lastname: Epstein
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000379:methods; D004868:Equipment Failure; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged