January 2005
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Doctors urge heart patients to 'put a sock on it'
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Cardiologists at Baylor College of Medicine in Houston have found an effective way to treat heart failure simply by placing a mesh "sock" on the outside of the organ.
The CorCap Cardiac Support Device, a polyester mesh stocking that wraps around the heart, appears to improve the organ's ability to function, said Douglas Mann, MD, the Mary and Gordon Cain Chair and a professor of medicine and director of the Winters Center at BCM, during a presentation at the recent American Heart Association meeting in New Orleans.
"This device works by relieving the stress on the enlarged heart and allows the heart to regain a more energetically and mechanically favorable elliptical shape," said Mann, also a staff cardiologist at the Michael E. DeBakey Veterans Affairs Medical Center. Mann served as principal investigator of both the nationwide study and local research site at the VA Center.
The three-year trial enrolled 300 patients nationwide with moderate to severe levels of heart disease. Since "one size does not fit all," six different stocking sizes were used, said Mann.
Using external cardiac support proved to be far less invasive than open-heart surgery or implantation of a left ventricular assist device and much more practical at present than cell-based or gene therapies, said Mann. Although the patient's chest must be opened to insert the sleeve, the heart does not need to be stopped or cut open.
Many scientists in the Texas Medical Center and around the world have spent decades trying to understand the signals that occur in the heart cells as the heart begins to dilate in response to tissue injury (as in a heart attack). The hope for these types of studies is that they will lead to the development of new compounds, genes or proteins that might prevent the heart from enlarging and contracting poorly. However, these types of studies have not yet led to meaningful clinical benefits in patients with heart failure.
By relieving tension on the heart and reducing wall stress, the sock allows for the deactivation of some genes that cause the heart to enlarge and contract poorly, and thereby allows the heart to achieve a more normal shape and size.
"It actually works by being incorporated into part of your heart as the stocking is covered in tissue," Mann said. "Basically, it becomes part of you."
On average, patients in the study showed a 75 percent improvement in functional status with a 50 percent decrease in the need for major procedures such as transplants, left ventricular assist devices and implantation of pacemakers.
Study participants' hearts not only became smaller but also changed shape to become more elliptical with the cardiac support sleeve. These changes in the heart size and shape were accompanied by improvements in the quality of life for patients who received the stocking compared those who did not.
"We were concerned about the possibility that there might be cardiac constriction, so we did careful, detailed serial assessment of that over the course of the study," Mann said. "Overall the device was very safe."
Mann believes the procedure works well with existing therapies such as drugs and pacemakers.
The idea of devising a mesh stocking originated from an old surgical procedure in which the patient's skeletal muscle was wrapped around the heart and stimulated to contract by a pacemaker. Researchers conducting these experiments were surprised to learn that heart performance actually improved when the pacemaker was turned off and the skeletal muscle was not contracting.
"The idea behind the cardiac support device was actually so incredibly simplistic that when I first heard about it, I thought it was absolutely crazy," Mann said. "But when I observed that the hearts were actually getting smaller with the cardiac support device, and not just staying the same size, I began to believe the amount of reduction in stress on the heart with the cardiac support device might be clinically significant."
Mann said the company would seek approval of the cardiac support device from the U.S. Food and Drug Administration in 2005.
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