July 30, 2010 – The first prospective, randomized study evaluating the clinical feasibility of spinal cord stimulation (SCS), or neurostimulation, to improve clinical signs and symptoms of heart failure, began this week.
Medtronic Inc. said it began the global launch of the Defeat?HF (Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure) clinical trial. The Defeat?HF study will evaluate whether SCS can restore the natural balance between the sympathetic and parasympathetic nervous systems to improve blood flow, reduce inflammation and restore the heart’s dimensions and function.
“The unique collaboration of cardiologists and neurosurgeons on this novel feasibility trial has the potential to identify new technologies to treat more heart failure patients and specifically slow the deterioration of patients with advanced heart failure,” said Cecilia Linde, M.D., Ph.D., Defeat?HF investigator and cardiologist at the Karolinska University Hospital in Stockholm, Sweden, who enrolled the first patient. The implantation was performed by neurosurgeons Bengt Linderoth, M.D., and Goran Lind, M.D.
Neurostimulation uses an implantable pulse generator (IPG), or neurostimulator, similar to a cardiac pacemaker, with a lead, or thin wire, connecting the device to the spinal cord to deliver low?intensity electrical pulses. The procedure includes percutaneous placement of the leads in the spinal column and the stop?watch?sized neurostimulator is typically implanted in the abdomen.
This clinical trial will explore the potential for neurostimulation to help physicians provide additional device therapy options for the growing population of heart failure patients. As the pioneer in neuromodulation, Medtronic technologies already have gained significant medical acceptance, including SCS for chronic back and leg pain, deep brain stimulation for movement disorders and sacral nerve stimulation for the debilitating symptoms of overactive bladder. There are also neurostimulation therapies approved under humanitarian device exemptions (HDEs) for severe obsessive?compulsive disorder and the nausea and vomiting associated with severe gastroparesis. There are more than 20 years of literature supporting SCS for cardiovascular applications.
The prospective, randomized, feasibility trial is expected to enroll New York Heart Association (NYHA) Class III systolic heart failure patients at up to 15 centers worldwide. All patients are implanted with a Medtronic PrimeAdvanced neurostimulator and followed for 12 months. In this trial, the device delivers stimulation for 12 hours a day.
The trial will measure improvement in heart failure metrics such as heart size and muscle wall thickness, the heart’s efficiency in carrying oxygen, and HF symptoms like fatigue, shortness of breath, and quality of life. Metrics will be measured throughout the trial.
The Medtronic PrimeAdvanced neurostimulator is approved for severe chronic pain from conditions including back and leg pain, complex regional pain syndrome and painful neuropathy. It is limited to investigational use in heart failure patients.
For more information: www.medtronic.com