For many of the 550,000 patients who show up in doctors’ offices with heart failure each year the choice of treatment is clear, but for others the decision between medication versus medication plus surgery to manage the disease is not so simple."There is a large group of patients, that if we can show earlier surgery would save lives, they could benefit from the more aggressive treatment," said Dr. Robert Jones, a heart surgeon and professor of surgery at Duke University Medical Center in Durham North Carolina. He is the principle investigator of the STICH Trial, which stands for Surgical Treatments of Ischemic Heart Failure.
The STICH Trial will enroll patients with ischemic heart failure into 1 of 3 treatment groups—medical therapy, medical therapy with coronary artery bypass surgery, or medical therapy with coronary artery bypass surgery plus surgical ventricular restoration. The trial is supported by the National Institutes of Health.
Surgical ventricular restoration is a relatively new procedure that repairs valve abnormalities, decreases the size of the left ventricle, and restores the shape of the left ventricle—or the main pumping chamber—to improve the heart’s ability to pump blood to the body. Surgeons use a soft and flexible patch and a shaping device to reshape the ventricle. The procedure is done to restore the diseased heart rather than just treating the symptoms of heart failure.
Heart failure develops when the heart struggles to pump enough blood to the body. Over time, the overexertion causes the left ventricle to enlarge and the heart muscle becomes weakened. The visual results are shortness of breath, especially with increased activity or when lying in bed. Patients also experience swelling in the feet, ankles, and legs, as a result they may experiences weight gain, despite a change in appetite.
Patients with heart failure are put on a strict low sodium diet and are prescribed a drug regimen of about 7 different medications to reduce the symptoms. Ace inhibitors decrease the strain on the heart. Aspirin makes the blood less sticky to prevent arteries from blocking. Beta-blockers reduce strain on the heart by slowing the heart rate, which lowers blood pressure. Digoxin/Lanoxin increases the strength of the heart’s pumping action. Diuretics remove excess fluid from the body. Lipid-lowering drugs, like statins, lower bad cholesterol levels. And vasodilators expand blood vessels to create less resistance against the heart as it pumps blood to the body.
Heart failure is usually caused by damage to the heart muscle brought on by a heart attack or by disease or injury to a valve in the heart. High blood pressure and diabetes are also common causes of heart failure.
Dr. Jones said that the existing data supports a more laid-back management style of heart failure, which involves diet and lifestyle changes and medication. Those who’ve had a heart attack often are those get bypass surgery or angioplasty, which counts for about two-thirds of heart failure patients.
"But if we could identify those who would live longer healthier lives by more aggressive intervention…then we would go ahead with the appropriate surgery," said Dr. Jones.
The STICH Trial is expected to be partially complete by the end of 2005, and all results should be in by the end of 2006. Investigators are hoping it will provide strong clinical evidence that surgery, medication, or both is the best option for patients with ischemic heart failure.
Anyone interested in participating in the STICH Trial should ask his or her doctor for more information. Patients are being enrolled at 90 centers around the world—including several US locations. For more information on the trial, go to www.stichtrial.org.
