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Please use this identifier to cite or link to this item: http://hdl.handle.net/11055/581
Title: Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): First-in-man experience
Authors: Tse, Hung-Fat
Turner, Stuart
Sanders, Prashanthan
Okuyama, Yuji
Fujiu, Katsuhito
Cheung, Chi Wai
Russo, Marc
Green, Matthew D
Yiu, Kai-Hang
Siu, David
Anzca Brief Name: Russo, M
Keywords: heart failure
spinal cord stimulation
Issue Date: Mar-2015
Citation: 12(3):588-595
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. CONCLUSION: 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.
URI: http://hdl.handle.net/11055/581
DOI: 10.1016/j.hrthm.2014.12.014
PubMed URL: https://www.ncbi.nlm.nih.gov/pubmed/25500165
Study Name: NCT01362725
Journal Title: Heart Rhythm
Type: Journal Article
Affiliates: University of Hong Kong, Queen Mary Hospital
John Hunter Hospital
Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital
Osaka University Hospital
University of Tokyo Hospital
Hunter Pain Clinic
Pain Medicine of South Australia, Ashford Private Hospital
St. Jude Medical, Inc
Study/Trial: Clinical Trial
Appears in Collections:Scholarly and Clinical

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