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Article: Thoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience

TitleThoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience
Authors
Issue Date2015
PublisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/heartrhythmjournal
Citation
Heart Rhythm, 2015, v. 12 n. 3, p. 588-595 How to Cite?
AbstractBACKGROUND: 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:7 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/min/kg, 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.
Persistent Identifierhttp://hdl.handle.net/10722/214368
ISSN
2015 Impact Factor: 4.391
2015 SCImago Journal Rankings: 2.756
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorTse, HF-
dc.contributor.authorTurner, S-
dc.contributor.authorSanders, P-
dc.contributor.authorOkuyama, Y-
dc.contributor.authorFujiu, K-
dc.contributor.authorCheng, CW-
dc.contributor.authorRusso, M-
dc.contributor.authorGreen, MD-
dc.contributor.authorYiu, KH-
dc.contributor.authorChen, P-
dc.contributor.authorShunto, C-
dc.contributor.authorLau, EO-
dc.contributor.authorSiu, DCW-
dc.date.accessioned2015-08-21T11:20:05Z-
dc.date.available2015-08-21T11:20:05Z-
dc.date.issued2015-
dc.identifier.citationHeart Rhythm, 2015, v. 12 n. 3, p. 588-595-
dc.identifier.issn1547-5271-
dc.identifier.urihttp://hdl.handle.net/10722/214368-
dc.description.abstractBACKGROUND: 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:7 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/min/kg, 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.-
dc.languageeng-
dc.publisherElsevier Inc. The Journal's web site is located at http://www.elsevier.com/locate/heartrhythmjournal-
dc.relation.ispartofHeart Rhythm-
dc.titleThoracic Spinal Cord Stimulation for Heart Failure as a Restorative Treatment (SCS HEART study): first-in-man experience-
dc.typeArticle-
dc.identifier.emailTse, HF: hftse@hkucc.hku.hk-
dc.identifier.emailCheng, CW: timwai@hku.hk-
dc.identifier.emailYiu, KH: khkyiu@hku.hk-
dc.identifier.emailSiu, DCW: cwdsiu@hkucc.hku.hk-
dc.identifier.authorityTse, HF=rp00428-
dc.identifier.authorityYiu, KH=rp01490-
dc.identifier.authoritySiu, DCW=rp00534-
dc.identifier.doi10.1016/j.hrthm.2014.12.014-
dc.identifier.pmid25500165-
dc.identifier.scopuseid_2-s2.0-84924033921-
dc.identifier.hkuros248759-
dc.identifier.volume12-
dc.identifier.issue3-
dc.identifier.spage588-
dc.identifier.epage595-
dc.identifier.isiWOS:000349966100022-
dc.publisher.placeUnited States-

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