PMID- 25500165
OWN - NLM
STAT- MEDLINE
DCOM- 20160119
LR  - 20171104
IS  - 1556-3871 (Electronic)
IS  - 1547-5271 (Linking)
VI  - 12
IP  - 3
DP  - 2015 Mar
TI  - Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment 
      (SCS HEART study): first-in-man experience.
PG  - 588-595
LID - S1547-5271(14)01422-2 [pii]
LID - 10.1016/j.hrthm.2014.12.014 [doi]
AB  - 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 mus). 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.
CI  - Copyright (c) 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights 
      reserved.
FAU - Tse, Hung-Fat
AU  - Tse HF
AD  - University of Hong Kong, Queen Mary Hospital, Hong Kong. Electronic address: 
      hftse@hkucc.hku.hk.
FAU - Turner, Stuart
AU  - Turner S
AD  - John Hunter Hospital, Newcastle, Australia.
FAU - Sanders, Prashanthan
AU  - Sanders P
AD  - Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide 
      Hospital, Adelaide, Australia.
FAU - Okuyama, Yuji
AU  - Okuyama Y
AD  - Osaka University Hospital, Osaka, Japan.
FAU - Fujiu, Katsuhito
AU  - Fujiu K
AD  - University of Tokyo Hospital, Tokyo, Japan.
FAU - Cheung, Chi-Wai
AU  - Cheung CW
AD  - University of Hong Kong, Queen Mary Hospital, Hong Kong.
FAU - Russo, Marc
AU  - Russo M
AD  - Hunter Pain Clinic, Newcastle, NSW, Australia.
FAU - Green, Matthew D S
AU  - Green MDS
AD  - Pain Medicine of South Australia, Ashford Private Hospital, Welland, Australia.
FAU - Yiu, Kai-Hang
AU  - Yiu KH
AD  - University of Hong Kong, Queen Mary Hospital, Hong Kong.
FAU - Chen, Peter
AU  - Chen P
AD  - St. Jude Medical, Inc, Irvine, USA.
FAU - Shuto, Chika
AU  - Shuto C
AD  - St. Jude Medical, Inc, Irvine, USA.
FAU - Lau, Elizabeth O Y
AU  - Lau EOY
AD  - St. Jude Medical, Inc, Irvine, USA.
FAU - Siu, Chung-Wah
AU  - Siu CW
AD  - University of Hong Kong, Queen Mary Hospital, Hong Kong.
LA  - eng
SI  - ClinicalTrials.gov/NCT01362725
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20141212
PL  - United States
TA  - Heart Rhythm
JT  - Heart rhythm
JID - 101200317
RN  - 114471-18-0 (Natriuretic Peptide, Brain)
SB  - IM
CIN - Nat Rev Cardiol. 2015 Feb;12(2):66. PMID: 25560377
MH  - Aged
MH  - Female
MH  - Follow-Up Studies
MH  - Heart Failure, Systolic/blood/physiopathology/*therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Natriuretic Peptide, Brain/blood
MH  - Oxygen Consumption
MH  - Prospective Studies
MH  - *Spinal Cord
MH  - Spinal Cord Stimulation/adverse effects/*methods
MH  - Surveys and Questionnaires
MH  - Thoracic Vertebrae
MH  - Treatment Outcome
MH  - *Ventricular Function, Left
OTO - NOTNLM
OT  - Heart failure
OT  - Spinal cord stimulation
EDAT- 2014/12/17 06:00
MHDA- 2016/01/20 06:00
CRDT- 2014/12/16 06:00
PHST- 2014/10/26 00:00 [received]
PHST- 2014/12/16 06:00 [entrez]
PHST- 2014/12/17 06:00 [pubmed]
PHST- 2016/01/20 06:00 [medline]
AID - S1547-5271(14)01422-2 [pii]
AID - 10.1016/j.hrthm.2014.12.014 [doi]
PST - ppublish
SO  - Heart Rhythm. 2015 Mar;12(3):588-595. doi: 10.1016/j.hrthm.2014.12.014. Epub 2014 
      Dec 12.