title: Longevity of the Subcutaneous Implantable Defibrillator: Long-Term Follow-Up of the European Regulatory Trial Cohort.
abstract: BACKGROUND
  The recent advent of subcutaneous implantable cardioverter defibrillators (S-ICDs) has provided investigators with a safe and effective new therapy in patients at risk of sudden cardiac death. At present, no data are available with regard to the longevity of these new devices. This study evaluated the longevity of the S-ICD system.
  
  
  RESULTS
  All patients enrolled in the European Regulatory Trial were included in the analysis. During follow-up, time and causes of device replacement or explantation were assessed and categorized. Device longevity was estimated using Kaplan-Meier analysis. Fifty-five patients were followed for a median of 5.8 years. During follow-up, 26 (47%) patients underwent device replacement and 5 (9%) underwent device explantation. Median time to replacement was 5.0 years (Q1-Q3, 4.4-5.6 years). Replacement was caused by battery depletion in 25 patients (92%), of which 5 within 1.5 years because of premature battery depletion, and by infection in 1 patient (2%). Replacement for a transvenous ICD system was required in 4 patients (7%) because of ineffective defibrillation in 1 (0.003 per patient-year), need for resynchronization therapy in 2 (0.01 per patient-year), and for antibradycardia pacing in 1 (0.003 per patient-year). At 5 years follow-up, 71% of devices were still in service.
  
  
  CONCLUSIONS
  This study provides the first estimate of S-ICD system longevity since its introduction in clinical practice. Median longevity of the first generation S-ICD system was 5.0 years. The majority of devices were replaced because of battery depletion.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT01117792.
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.). d.theuns@erasmusmc.nl.
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Ian G
authors.initials: IG
authors.lastname: Crozier
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Craig S
authors.initials: CS
authors.lastname: Barr
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Margaret A
authors.initials: MA
authors.lastname: Hood
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Riccardo
authors.initials: R
authors.lastname: Cappato
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Reinoud E
authors.initials: RE
authors.lastname: Knops
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Alexander H
authors.initials: AH
authors.lastname: Maass
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Lucas V A
authors.initials: LV
authors.lastname: Boersma
authors.affiliation: From the Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands (D.A.M.J.T., L.J.); Department of Cardiology, Christchurch Hospital, Christchurch, New Zealand (I.G.C.); Department of Cardiology, Russell's Hall Hospital, Dudley, United Kingdom (C.S.B.); Department of Cardiology, Auckland City Hospital, Auckland, New Zealand (M.A.H.); Department of Cardiology, Humanitas Research Hospital Rozzano, Milan, Italy (R.C.); Department of Cardiology, Humanitas Gavazenni Hospital, Bergamo, Italy (R.C.); Department of Cardiology, Academic Medical Center, Amsterdam, The Netherlands (R.E.K.); Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands (A.H.M.); Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands (L.V.A.B.); and Department of Cardiology, University Medical Centre, Ghent, Belgium (L.J.).
authors.forename: Luc
authors.initials: L
authors.lastname: Jordaens
mesh_terms: D017147:Defibrillators, Implantable; D020878:Device Removal; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D013997:Time Factors
keywords: arrhythmias, cardiac; bradycardia; death, sudden, cardiac; defibrillators, implantable; longevity