title: Long-Term Experience with First-Generation Implantable Neurostimulation Device in Central Sleep Apnea Treatment.
abstract: BACKGROUND
  Sleep-disordered breathing (SDB) and Cheyne-Stokes respiration (CSR) are associated with shorter survival in patients with heart failure. A novel treatment method for this patient group is unilateral phrenic nerve stimulation by the remedē® system (Respicardia Inc., Minnetonka, MN, USA), a transvenously implantable neurostimulation device, which has recently been studied in a large randomized, controlled trial. Previous literature has shown efficacy and safety of the treatment with this first-generation device, but hardly any data are available on long-term clinical parameters, the remedē® device's battery lifetime, device exchangeability, lead position stability, surgical accessibility, and manageability.
  
  
  METHODS
  We performed remedē® device replacements in consecutive patients for battery depletion, and documented clinical parameters, longevity, operation procedure, complications, and difficulties.
  
  
  RESULTS
  All patients were on neurostimulation treatment by phrenic nerve neurostimulation when device replacement became necessary. Apnea-hypopnea index (from 45 ± 4/h to 9 ± 4/h), oxygen-desaturation index (from 35 ± 7/h to 7 ± 6/h), and time spent with oxygen saturation of <90% (T < 90% from 5 ± 7% to 0 ± 0%) were improved and improvements remained constant throughout the 4-year follow-up. Mean battery life was 4.2 ± 0.2 years and mean replacement procedure time was 25 ± 5.1 minutes. Apart from conventional X-ray documentation of stable lead positions in a long-term setting, no radiation or contrast dye usage was needed and no major complications occurred. In addition, clinical exercise capacity and sleepiness symptoms improved.
  
  
  CONCLUSIONS
  Novel remedē® device shows sustained therapy efficacy and safety in terms of stable lead positions over 4 years. Long-term phrenic nerve neurostimulation therapy for central SDB/CSR appears feasible in a clinical routine setting.
authors.affiliation: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Henrik
authors.initials: H
authors.lastname: Fox
authors.affiliation: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bitter
authors.affiliation: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Horstkotte
authors.affiliation: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Olaf
authors.initials: O
authors.lastname: Oldenburg
authors.affiliation: Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Bad Oeynhausen, Germany.
authors.forename: Klaus-Jürgen
authors.initials: KJ
authors.lastname: Gutleben
mesh_terms: D000368:Aged; D002639:Cheyne-Stokes Respiration / Q000175:diagnosis* / Q000628:therapy*; D004599:Electric Stimulation Therapy / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D058542:Implantable Neurostimulators; D008137:Longitudinal Studies; D008297:Male; D010791:Phrenic Nerve; D020182:Sleep Apnea, Central / Q000175:diagnosis* / Q000628:therapy*; D016896:Treatment Outcome
keywords: Cheyne-Stokes respiration; heart failure; phrenic nerve stimulation; polysomnography; sleep-disordered breathing