Michael E. DeBakey VA Medical Center - Houston, Texas

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Houston VA Medical Center In Trial of Cardiac Gene Therapy

September 10, 2002

Houston VA Medical Center In Trial of Cardiac Gene Therapy

Heart doctors in the future will likely rely on a variety of therapies, from conventional, effective oral medications like cholesterol-lowering drugs that reduce the risk of heart attacks and death, to cutting-edge therapies like this, to treat coronary artery disease in individual patients.

Released: 2002/09/10

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As part of an innovative gene therapy designed to grow new blood vessels in the hearts of patients with blocked coronary arteries, Dr. Naji Yazbek, Baylor College of Medicine fellow; Dr. Glenn N. Levine, director of the HVAMC Cardiac Catheterization Laboratory and chief of the HVAMC Cardiac Critical Care Unit; and Dr. Dieter Lubbe, assistant director of the HVAMC Cardiac Catheterization Laboratory inject a gene called FGF-4 into a coronary artery of veteran, Jere Dillon.


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Alvin Blaustein, MD, chief of cardiology at the HVAMC, answers a few, last minute questions from Jere Dillon, one of the first gene therapy patients at the Houston VA Medical Center. Once inside heart cells, the gene is believed to trigger the production of a blood-vessel growth factor. It is this protein that causes the growth of new vessels to feed blood-deficient areas of the heart. "We're hopeful these new vessels will increase the total amount of blood supply going to the heart muscle, and that this will relieve symptoms," said Dr. Blaustein.

Photos by Agenda Burnett, HVAMC Media Section

HOUSTON, TX - An innovative gene therapy designed to grow new blood vessels in the hearts of patients with blocked coronary arteries was tested by physicians at the Houston VA Medical Center (HVAMC) for the first time on July 11 and 12, 2002. The VA doctors are part of an international team of heart specialists testing the new therapy in about 600 patients at more than 50 sites over the coming months.

A VA team led by Dr. Glenn Levine and Dr. Dieter Lubbe, interventional cardiologists, along with their catheterization lab team injected a gene called FGF-4 into the coronary arteries of three patients. It is hoped this gene will increase blood supply to parts of the heart supplied by diseased vessels, decreasing chest pains the patients experience with activity.

"We're hopeful these new vessels will increase the total amount of blood supply going to the heart muscle, and that this will relieve symptoms," said co-investigator Alvin Blaustein, MD, chief of cardiology at the HVAMC.

Blaustein said the new therapy is not intended to replace therapies such as bypass surgery or angioplasty, but may be suitable for patients who cannot receive those treatments. Some patients, for instance, are beyond help with medication, and the blockage of blood flow to their heart is too diffuse to target any particular vein with angioplasty and stenting, or surgery. Others may be too ill or their lesions are too complex to safely undergo other procedures.

The gene therapy, developed by New Jersey- and California-based Berlex Laboratories, the sponsor of the trial, uses a specially engineered gene packaged in a weakened cold virus. The virus is injected directly into a coronary artery, where it attaches to the lining of the vessel and transfers the gene into the heart. Once inside heart cells, the gene is believed to trigger the production of a blood-vessel growth factor. It is this protein that causes the growth of new vessels to feed blood-deficient areas of the heart.

The technology is one of a handful of new gene therapies developed in recent years to treat the growing epidemic of coronary artery disease, which affects some 12 million Americans.

The disease is caused by atherosclerosis, in which arteries supplying blood to the heart are clogged by cholesterol and other substances. More than half these patients experience a heart pain known as angina. When medication and lifestyle changes fail to ease symptoms, doctors often turn to surgery or angioplasty.

Blaustein said heart doctors in the future will likely rely on a variety of therapies, from conventional, effective oral medications like cholesterol-lowering drugs that reduce the risk of heart attacks and death, to cutting-edge therapies like this, to treat coronary artery disease in individual patients.

"For many patients a strategy that combines therapies is appropriate," Blaustein said. "Medications that treat the underlying disease will complement procedures that restore blood supply [through surgery, angioplasty]. Others might also be treated, in a selective way, with gene therapy, when we can't open these vessels because they're too small or the disease is too diffuse."

The gene-therapy patients in the trial will be followed intensively for six months, and overall, for several years. Doctors will check how much additional exercise the patients can do after treatment before developing chest pain and showing changes in their electrocardiogram. Physicians will also monitor how often the patients take nitroglycerin to quiet chest pain.

Individuals interested in participating in this study should call the HVAMC at (713) 794-7658 and leave a message.

The HVAMC boasts a surgical staff that performs over 5,000 surgical procedures each year and represents nine surgical subspecialties. These include general surgery, cardiac surgery, neuro-surgery, orthopedic surgery, plastic surgery, urology surgery, vascular surgery, otolaryngology, and gynecology. The HVAMC recently accepted an award from the National Surgical Quality Improvement Program (NSQIP) for having the second lowest risk adjusted mortality rate among 123 VA Medical Centers nationwide.

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Point of Contact: VHAHOU Public Affairs

04/21/04 08:25