title: Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience.
abstract: BACKGROUND
  Preclinical studies suggest that neuromodulation with thoracic spinal cord stimulation (SCS) improves left ventricular (LV) function and remodeling in systolic heart failure (HF).
  
  
  OBJECTIVE
  The purpose of this study was to evaluate the safety and efficacy of a SCS system for the treatment of systolic HF.
  
  
  METHODS
  We performed a prospective, multicenter pilot trial in patients with New York Heart Association (NYHA) class III HF, left ventricular ejection fraction (LVEF) 20%-35%, and implanted defibrillator device who were prescribed stable optimal medical therapy. Dual thoracic SCS leads were used at the T1-T3 level. The device was programmed to provide SCS for 24 hours per day (50 Hz at pulse width 200 μs).
  
  
  RESULTS
  We enrolled 22 patients from 5 centers:17 patients underwent implantation of a SCS device and 4 patients who did not fulfill the study criteria served as nontreated controls. No deaths or device-device interactions were noted during the 6-month period in the 17 SCS-treated patients. Fifteen of 17 completed the efficacy endpoint assessments: composite score improved by 4.2 ± 1.3, and 11 patients (73%) showed improvement in ≥4 of 6 efficacy parameters. There was significant improvement in NYHA class (3.0 vs 2.1, P = .002; 13/17 improved); Minnesota Living with Heart Failure Questionnaire (42 ± 26 vs 27 ± 22, P = .026; 12/17 improved); peak maximum oxygen consumption (14.6 ± 3.3 vs 16.5 ± 3.9 mL/kg/min, P = .013; 10/15 improved); LVEF (25% ± 6% vs 37% ± 8%, P<.001; 14/16 improved); and LV end-systolic volume (174 ± 57 vs 137 ± 37 mL, P = .002; 11/16 improved) but not in N-terminal prohormone brain natriuretic peptide. No such improvements were observed in the 4 nontreated patients.
  
  
  CONCLUSIONS
  The results of this first-in-human trial suggest that high thoracic SCS is safe and feasible and potentially can improve symptoms, functional status, and LV function and remodeling in patients with severe, symptomatic systolic HF.
authors.affiliation: University of Hong Kong, Queen Mary Hospital, Hong Kong. Electronic address: hftse@hkucc.hku.hk.
authors.forename: Hung-Fat
authors.initials: HF
authors.lastname: Tse
authors.affiliation: John Hunter Hospital, Newcastle, Australia.
authors.forename: Stuart
authors.initials: S
authors.lastname: Turner
authors.affiliation: Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, Australia.
authors.forename: Prashanthan
authors.initials: P
authors.lastname: Sanders
authors.affiliation: Osaka University Hospital, Osaka, Japan.
authors.forename: Yuji
authors.initials: Y
authors.lastname: Okuyama
authors.affiliation: University of Tokyo Hospital, Tokyo, Japan.
authors.forename: Katsuhito
authors.initials: K
authors.lastname: Fujiu
authors.affiliation: University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: Chi-Wai
authors.initials: CW
authors.lastname: Cheung
authors.affiliation: Hunter Pain Clinic, Newcastle, NSW, Australia.
authors.forename: Marc
authors.initials: M
authors.lastname: Russo
authors.affiliation: Pain Medicine of South Australia, Ashford Private Hospital, Welland, Australia.
authors.forename: Matthew D S
authors.initials: MDS
authors.lastname: Green
authors.affiliation: University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: Kai-Hang
authors.initials: KH
authors.lastname: Yiu
authors.affiliation: St. Jude Medical, Inc, Irvine, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: Chen
authors.affiliation: St. Jude Medical, Inc, Irvine, USA.
authors.forename: Chika
authors.initials: C
authors.lastname: Shuto
authors.affiliation: St. Jude Medical, Inc, Irvine, USA.
authors.forename: Elizabeth O Y
authors.initials: EOY
authors.lastname: Lau
authors.affiliation: University of Hong Kong, Queen Mary Hospital, Hong Kong.
authors.forename: Chung-Wah
authors.initials: CW
authors.lastname: Siu
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D054143:Heart Failure, Systolic / Q000097:blood / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020097:Natriuretic Peptide, Brain / Q000097:blood; D010101:Oxygen Consumption; D011446:Prospective Studies; D013116:Spinal Cord; D062187:Spinal Cord Stimulation / Q000009:adverse effects / Q000379:methods*; D011795:Surveys and Questionnaires; D013904:Thoracic Vertebrae; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D020097:Natriuretic Peptide, Brain
keywords: Heart failure; Spinal cord stimulation