This article is more than 5 years old. Information may no longer be current.
SCS HEART: Thoracic spinal cord stimulation may benefit patients with HF
Click Here to Manage Email Alerts
SAN FRANCISCO — Dual-targeted thoracic spinal cord stimulation was safe and effective in patients with severe symptomatic systolic HF, according to pilot study data presented at the Heart Rhythm Society Annual Scientific Sessions.
Researchers evaluated the safety and efficacy of a spinal cord stimulation (SCS) system implant (St. Jude Medical) for treatment of HF. The implant has dual thoracic SCS leads targeted along the midline and the left side at T1-3 levels, said Hung-Fat Tse, MD, PhD, of Queen Mary Hospital and the University of Hong Kong.
For the SCS HEART study, the device was implanted in 17 men (mean age, 63 years) with NYHA class III HF and a mean left ventricular ejection fraction between 20% and 35%. The devices were programmed to provide SCS for 24 hours a day, 50 Hz at pulse width 200 microns, Tse said.
Implantation was successful in all 17 patients, with no acute complications observed, although in one patient, the second lead could not be implanted, according to Tse.
At 6 months, he said, there were no deaths, a 12% rate of hospitalization for HF, no device-device interactions, one device battery replaced due to failure, and ventricular tachycardia/ventricular fibrillation (VT/VF) in 12% of patients. Three patients required device reprogramming or repositioning because of back or neck discomfort.
At a mean of 18 months follow-up, two patients (12%) died, two (12%) were hospitalized for HF and there continued to be no device-device interactions. Four patients (24%) had VT/VF requiring implantable cardioverter defibrillator intervention, but all four had VT/VF before receiving the SCS system, according to results reported.
Patients improved in the following parameters: NYHA class (baseline, 3; follow-up, 2.1; P=.002), Minnesota Living with HF Questionnaire (baseline, 42; follow-up, 27; P=.026), peak maximum oxygen consumption (baseline, 14.6 mL/min/kg; follow-up, 16.5 mL/min/kg; P=.013), LVEF (baseline, 25%; follow-up, 37%; P<.001) and LV end-systolic volume (baseline, 174 mL; follow-up, 140 mL; P=.002), Tse said. There was no change in NT-proBNP levels (baseline, 2,363 pg/mL; follow-up, 2,816 pg/mL; P=.52).
“This first-in-man trial shows that dual-targeted high thoracic SCS was safe and improved symptoms, functional status and LV function and remodeling in patients with severe, symptomatic systolic HF,” Tse said. “These initial promising results should be confirmed with future randomized controlled trials in large patient cohorts.” – by Erik Swain
For more information:
Tse H-F. Abstract LB01-06. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 7-10, 2014; San Francisco.
Disclosure: Tse reports financial ties with Biosense Webster, Biotronik, Boston Scientific, Medtronic and St. Jude Medical.
Perspective
Back to Top
Jagmeet Singh, MD, PhD
The autonomic nervous system is intricately intertwined with cardiac function and plays an important role in the progression of HF. Limited advances on the pharmacotherapy front have led to the development of innovative forms of device therapy that can favorably alter the cardiac autonomic tone. Preclinical work has suggested that SCS may be beneficial in HF, with its cardioprotective effect largely being mediated through a vagus-dependent mechanism. The SCS Heart Study is the first-in-man experience of SCS showing that targeted thoracic SCS was safe and improved symptoms, functional status and LV function and remodeling in patients with severe, symptomatic systolic HF. Although SCS is an FDA-approved therapeutic modality for chronic pain syndromes and refractory angina, its role in HF so far has been unclear. Of note, this therapy involves the placement of a stimulation electrode in the epidural space tunneled to a pulse generator in the para-spinal lumbar region.
The present study, while demonstrating safety and evidence of clinical benefit, needs to be interpreted in light of the fact that this was an open-label pilot study, conducted in a small cohort of 17 patients. Interestingly, despite an improvement in functional status and favorable structural remodeling, there was no change in the cardiac biomarker (NT-proBNP) profile. The era of device therapy to modulate the autonomic tone (via vagal nerve stimulation, SCS, carotid baroreceptor stimulation, etc) has dawned upon us. Whether SCS and other therapeutic modalities live up to their promise will depend on their success in larger randomized controlled clinical trials in the HF population. A good first step, though.
Click Here to Manage Email Alerts