title: Clinical experience with a novel subcutaneous implantable defibrillator system in a single center.
abstract: BACKGROUND
  Implantable cardioverter-defibrillators (ICDs) reduce mortality in both primary and secondary prevention, but are associated with substantial short- and long-term morbidity. A totally subcutaneous ICD (S-ICD) system has been developed. We report the initial clinical experience of the first 31 patients implanted at our hospital.
  
  
  METHODS
  All patients had an ICD indication according to the ACC/AHA/ESC guidelines. The first 11 patients were part of the reported CE trial. The implantation was performed without fluoroscopy. The device was implanted subcutaneously in the anterior axillary line, with a parasternal lead tunneled from the xiphoid to the manubrial-sternal junction. Ventricular fibrillation (VF) was induced to assess detection accuracy and defibrillation efficacy using 65 J shocks.
  
  
  RESULTS
  Post-implant, 52 sustained episodes of VF were induced. Sensitivity was 100% and induced conversion efficacy was 100% (with standard polarity in 29 patients). Mean time to therapy was 13.9 ± 2.5 s (range 11-21.6 s). Late procedure-related complications were observed in 2 of the first 11 implantations (lead migration). During follow-up, spontaneous ventricular arrhythmias occurred in four patients, with accurate detection of all episodes. Inappropriate therapy was observed in five patients. Recurrences were prevented with reprogramming.
  
  
  CONCLUSIONS
  The S-ICD system can be implanted without the use of fluoroscopy by using anatomical landmarks only. Episodes of VF were accurately detected using subcutaneous signals, and all induced and clinical episodes were successfully converted. The S-ICD system is a viable alternative to conventional ICD systems for selected patients.
authors.affiliation: Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands.
authors.forename: Lara
authors.initials: L
authors.lastname: Dabiri Abkenari
authors.forename: Dominic A M J
authors.initials: DA
authors.lastname: Theuns
authors.forename: Suzanne D A
authors.initials: SD
authors.lastname: Valk
authors.forename: Yves
authors.initials: Y
authors.lastname: Van Belle
authors.forename: Natasja M
authors.initials: NM
authors.lastname: de Groot
authors.forename: David
authors.initials: D
authors.lastname: Haitsma
authors.forename: Agnes
authors.initials: A
authors.lastname: Muskens-Heemskerk
authors.forename: Tamas
authors.initials: T
authors.lastname: Szili-Torok
authors.forename: Luc
authors.initials: L
authors.lastname: Jordaens
mesh_terms: D000328:Adult; D000368:Aged; D001145:Arrhythmias, Cardiac / Q000503:physiopathology / Q000628:therapy; D017147:Defibrillators, Implantable / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D006331:Heart Diseases / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D055502:Secondary Prevention; D013997:Time Factors; D014693:Ventricular Fibrillation / Q000503:physiopathology / Q000628:therapy*