title: Clinical experience and procedural outcomes associated with the DF4 implantable cardioverter defibrillator system: the SJ4 postapproval study.
abstract: BACKGROUND
  Current implantable cardioverter defibrillators (ICDs) employ two or three low- and high-voltage lead connectors, adding complexity and bulk, sometimes resulting in incorrect connections and adverse events. The SJ4 study evaluates the performance of a novel integrated single-lead DF4 connection system by characterizing lead measurements, handling characteristics, and outcomes.
  
  
  METHODS
  Patients with standard guidelines-based ICD indications were enrolled and implanted with a St. Jude Medical™ DF4 system (St. Jude Medical, Sylmar, CA, USA; right ventricular high-voltage DF4 lead models 7120Q, 7121Q, 7122Q, or 7170Q with compatible ICD). Device electrical measurements, handling characteristics, and any adverse events were collected at implant and during each scheduled 6-month follow-up.
  
  
  RESULTS
  Among 1,701 patients (65 ± 13 years, 72% male, left ventricular ejection fraction 29 ± 12%) enrolled at 58 centers, there were 1,697 successful implants (99.8% implant success; ICD; n = 999, cardiac resynchronization therapy-defibrillator n = 698). Implanting physicians reported that implantation of the DF4 lead was normal or easier than normal in 94% of cases with successful implant. These patients have been followed for 1.7 ± 0.5 years with a maximum follow-up of 2.5 years. The complication rate was 0.017 per patient year of follow-up (95% confidence interval: 0.013-0.023), which included abnormal defibrillation impedance, elevated pacing thresholds, failure to detect ventricular tachycardia/ventricular fibrillation, lead dislodgement, lead fracture, loss of capture, and lead perforation. There were no set screw-related complications at implant or during follow-up.
  
  
  CONCLUSIONS
  The DF4 system overall performed very well with few complications at implant and in follow-up.
authors.affiliation: Section of Cardiac Electrophysiology and Pacing, Heart and Vascular Institute, The Cleveland Clinic Foundation, Cleveland, Ohio, USA. cantild@ccf.org
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Cantillon
authors.forename: Kieu
authors.initials: K
authors.lastname: Ha
authors.forename: Robert
authors.initials: R
authors.lastname: Styperek
authors.forename: Pitayadet
authors.initials: P
authors.lastname: Jumrussirikul
authors.forename: Michael
authors.initials: M
authors.lastname: Mirro
authors.forename: Wilson
authors.initials: W
authors.lastname: Wong
authors.forename: Bruce L
authors.initials: BL
authors.lastname: Wilkoff
mesh_terms: D000368:Aged; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data*; D004567:Electrodes, Implanted / Q000706:statistics & numerical data*; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data*; D019544:Equipment Failure Analysis; D005260:Female; D006333:Heart Failure / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008297:Male; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
keywords: DF4; connectors; implantable cardioverter defibrillator leads