title: Evaluation of the need of elective implantable cardioverter-defibrillator generator replacement in primary prevention patients without prior appropriate ICD therapy.
abstract: OBJECTIVE
  It is not clear whether patients who received an implantable cardioverter-defibrillator (ICD) for primary prevention should undergo device replacement if they never experienced an appropriate ICD therapy during the first generator longevity. This study evaluated the incidence and predictors of appropriate ICD therapy after device replacement in this specific population.
  
  
  METHODS
  From two large prospective ICD registries, we identified all primary prevention patients who had a first ICD replacement without previous appropriate ICD therapy. Cox regression analysis was used to identify predictors of appropriate ICD therapy.
  
  
  RESULTS
  Of 403 primary prevention patients needing first ICD replacement, 275 patients (68%) had not received previous appropriate ICD therapy. Patients without previous appropriate ICD therapy before first ICD replacement (mean age at replacement 62 ± 12 years, 75% male) had a mean follow-up of 86 ± 24 months after the initial implantation and 30 ± 24 months after device replacement. Following replacement, 3-year cumulative incidence of appropriate ICD therapy was 13.7% (95% CI 8.6 to 18.8%). No predictive factors associated with appropriate ICD therapy after replacement could be identified in spite of including seven clinically relevant factors.
  
  
  CONCLUSIONS
  A considerable number of primary prevention patients without previous appropriate ICD therapy before first ICD replacement received appropriate ICD therapy after replacement. As there were no predictors of appropriate ICD therapy after replacement, replacing an ICD is still recommended in all primary prevention patients despite the lack of appropriate ICD therapy during first battery service life.
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Sing-Chien
authors.initials: SC
authors.lastname: Yap
authors.affiliation: Division of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Beat A
authors.initials: BA
authors.lastname: Schaer
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Rohit E
authors.initials: RE
authors.lastname: Bhagwandien
authors.affiliation: Division of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Michael
authors.initials: M
authors.lastname: Kühne
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Lara
authors.initials: L
authors.lastname: Dabiri Abkenari
authors.affiliation: Division of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Stefan
authors.initials: S
authors.lastname: Osswald
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Tamas
authors.initials: T
authors.lastname: Szili-Torok
authors.affiliation: Division of Cardiology, University Hospital Basel, Basel, Switzerland.
authors.forename: Christian
authors.identifier: http://orcid.org/0000-0001-8428-7050
authors.initials: C
authors.lastname: Sticherling
authors.affiliation: Department of Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
mesh_terms: D016757:Death, Sudden, Cardiac / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D011322:Primary Prevention / Q000379:methods*; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D015996:Survival Rate / Q000639:trends; D013557:Switzerland / Q000453:epidemiology; D014693:Ventricular Fibrillation / Q000150:complications / Q000453:epidemiology / Q000628:therapy*