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FDA approves novel study of neurostimulation as treatment for heart disease
Study marks first new approach in five years aimed at treating debilitating heart failure

Houston, TX - 2/1/2010

The FDA recently approved the first study of neurostimulation as a treatment for heart failure, a chronic disease that affects nearly six million Americans and is the leading cause of hospitalization in America.

Despite our best efforts to treat heart failure with current drugs, patients with advanced heart failure continue to deteriorate," said Dr. Guillermo Torre-Amione, heart failure specialist at the Methodist DeBakey Heart & Vascular Center and principal investigator for the study. "There is an urgent need to improve treatment for these patients."

Heart failure is a condition in which the heart muscle can’t pump effectively enough to meet the body’s need for blood and oxygen. Neurostimulation, which is currently used to treat certain forms of pain, activates nerves in the spine to create changes in blood flow, potentially improving the heart’s ability to pump effectively. This stimulation may improve blood pressure and reduce the number of fatal cardiac arrhythmias.

Historical data shows connections between the brain, the nervous system and the heart, but no one has attempted to harness this relationship for therapeutic results, said Torre, who is developing the idea of using neurostimulation to treat heart failure. Torre said he hopes to open up a whole new way to treat this devastating disease beyond what’s available today.

Heart failure is usually caused by damage to the heart after a heart attack or viral infection. After the heart is damaged, nerves in the spine activate the release of hormones that are designed to protect the heart. Sometimes, these hormones overreact, causing further damage and progression of the disease. Patients showing symptoms of heart failure can have a mortality risk as high as 75 percent within 12 months. The causes of death are linked to deterioration of the heart’s ability to function and the development of fatal arrhythmias that are in part caused by the over-activation of hormones that are triggered by nerves in the spine.

Torre and his team will study whether they can control this process and improve patients’ symptoms and outcomes by stimulating the nerves that activate the release of hormones.

Additionally, heart failure tends to activate patients’ immune systems in a way that damages the heart, causing its main pumping chamber to thicken and pump blood ineffectively. This study will evaluate neurostimulation as a technique to improve blood flow.

Neurostimulation involves an implantable electrical system similar to a cardiac pacemaker. It is designed to deliver low-intensity electrical impulses to nerves in the spinal cord. The system includes a neurostimulator, a small device that generates electrical impulses, and a lead, a wire that connects the device to the spine and transmits the impulses. The system is implanted via small puncture holes in the back. The procedure is done in a catheterization lab.

About the study

The study will be a randomized double blind crossover feasibility study of 10 patients who will be treated with neurostimulation. Patients enrolled in the study will be patients with non-ischemic or ischemic cardiomyopathy with a length of illness of at least 6 months.

Similar to a cardiac pacemaker, the system consists of an implantable pulse generator (IPG) and an implanted lead. Electrical impulses travel from the IPG through the leads to electrodes near selected nerve fibers in order to provide therapeutic stimulation. The activation of selected nerve groups are intended to create responses characterized by changes in blood flow, deactivation of cathecolamines and a reduction of inflammation.  Neurostimulation has been shown to be effective in alleviating the symptoms of chronic angina and pain secondary to peripheral vascular disease, both conditions characterized by inflammation and decreased blood flow, but no studies have been previously conducted in patients with heart failure.

For more information about the Methodist DeBakey Heart & Vascular Center, see www.debakeyheartcenter.com.  Follow us on Twitter at http://twitter.com/MethodistHosp and Facebook at http://www.facebook.com/methodisthospital.