title: Spinal cord stimulation is safe and feasible in patients with advanced heart failure: early clinical experience.
abstract: OBJECTIVE
  Pre-clinical work suggests that upper thoracic spinal cord stimulation (SCS) may have therapeutic effects in the treatment of heart failure (HF). We therefore aim to assess the safety and feasibility of SCS in HF patients.
  
  
  RESULTS
  A prospective, randomized, double-blind, crossover pilot study was conducted in symptomatic HF patients receiving optimal medical therapy. Patients were implanted with an SCS system and randomized to an SCS-ACTIVE, delivered at 90% paraesthesia threshold, or an SCS-INACTIVE phase for 3 months, followed by a 1-month washout period and crossover to the alternative phase. The safety of SCS therapy was assessed by death and cardiac events. Implantable cardioverter defibrillator (ICD) function in the presence of SCS was tested by defibrillation testing during SCS system implant and review of real-time and stored electrograms during follow-up. The efficacy of SCS therapy was assessed by changes in patient symptoms, LV function, and BNP level. Nine patients were investigated. In all cases, ICD sensing, detection, and therapy delivery were unaffected by SCS. During follow-up, one patient died and one was hospitalized for HF while in the SCS-INACTIVE phase, and two patients had HF hospitalizations during the SCS-ACTIVE phase. Symptoms were improved in the majority of patients with SCS, while markers of cardiac structure and function were, in aggregate, unchanged.
  
  
  CONCLUSIONS
  This study shows that an SCS system can be safely implanted in patients with advanced HF and that the SCS system does not interfere with ICD function.
authors: Catedra de Cardiologia y Medicina Vascular, Escuela de Medicina, Tecnológico de Monterrey, México; Houston Methodist DeBakey Heart & Vascular Center, Houston, TX, USA.
authors: Guillermo
authors: G
authors: Torre-Amione
authors: Kenneth
authors: K
authors: Alo
authors: Jerry D
authors: JD
authors: Estep
authors: Miguel
authors: M
authors: Valderrabano
authors: Nashwa
authors: N
authors: Khalil
authors: Taraneh G
authors: TG
authors: Farazi
authors: Stuart P
authors: SP
authors: Rosenberg
authors: Lanitia
authors: L
authors: Ness
authors: John
authors: J
authors: Gill
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018592:Cross-Over Studies; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D005240:Feasibility Studies; D005260:Female; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D062187:Spinal Cord Stimulation / Q000379:methods*; D013904:Thoracic Vertebrae; D016896:Treatment Outcome
keywords: Heart failure; Neuromodulation; Neuroradiology; Neurostimulation