Einstein Heart Institute Participates in STICH Trial to Investigate Treatment for Congestive Heart Failure

Philadelphia, PA, February 10, 2003– Einstein Heart Institute is participating in the STICH Trial, a multi-center randomized study sponsored by the National Institutes of Health, to evaluate a treatment for patients with congestive heart failure who have underlying coronary artery disease. STICH (Surgical Treatment for Ischemic Heart Failure) involves Surgical Ventricular Restoration (SVR) –– a procedure which removes damaged scar tissue from the heart muscle and reforms the heart’s enlarged left ventricle to its normal, pre-diseased shape. Einstein Heart Institute, part of Albert Einstein Healthcare Network, is one of 50 medical centers around the world participating in the clinical trial, and is the first hospital in the Philadelphia area to enroll patients. It will take three to four years to complete, and patients will be followed for five years.

The STICH Trial will compare outcomes of traditional medical therapies (drug therapies), traditional coronary artery bypass graft surgery (CABG), and CABG combined with Surgical Ventricular Restoration, to determine which treatment is optimal for improving survival and quality of life.

Heart failure, which affects five million Americans and results in 300,000 deaths each year, can involve the left side of the heart, the right side or both. Typically, the left side is affected first. Left-sided heart failure results from the failure of the left ventricle to pump blood adequately to the rest of the body, often resulting in backup of fluid in the lungs. Our bodies depend on the heart’s pumping action to deliver oxygen- and nutrient-rich blood so it can function normally. People with congestive heart failure do not receive an adequate blood supply, and often feel weak, fatigued or short of breath. The disease is caused by various factors such as a prior heart attack, high blood pressure, diabetes or an abnormal heart valve.

When a severe heart attack occurs, heart muscle is replaced with scar tissue which makes the heart wall thinner and causes the heart chamber to enlarge. This process ultimately causes the left ventricle to develop a bulging, distended appearance, and decreases the heart’s ability to pump normally.

"What’s exciting about the STICH Trial is that it’s the first time Surgical Ventricular Restoration (SVR) is being scientifically studied to determine its effectiveness in the treatment of heart failure," says Robert Quigley, MD, PhD, Chairman, Division of Cardiothoracic Surgery, Einstein Medical Center, and Einstein’s Lead Surgical Investigator for the trial. SVR involves surgically removing dead heart muscle and tissue and re-shaping the left ventricle to its normal shape with the aid of a balloon-like device. During the procedure, the ventricle is reconstructed from within by opening the ventricular chamber, inflating and temporarily inserting a balloon-like device filled with saline to determine the correct size and shape of the chamber. The balloon device is then deflated and removed, a patch is sewn over the hole, and excess dead muscle is folded over the patch and sutured. Based on the patient’s size and weight, the balloon device calculates how much blood is required to fill up the patient’s ventricular chamber if they were in a healthy condition.

"Bypass surgery improves blood flow to the heart, but does not strengthen the weakened heart muscle," says Aman Amanullah, MD, PhD, Principal Investigator of the STICH Trial at Einstein. "If coronary bypass surgery alone is performed, it does not prevent the damaged heart from getting increasingly larger and weaker, so this is why we’re studying the benefits of SVR combined with bypass surgery." Cardiac surgeons from Einstein Heart Institute learned the SVR procedure in Europe where it has been used for several years.

Patients suitable for the study must have scar tissue on the anterior wall of the left ventricle (front of the heart) and have an ejection fraction below 35 percent. Ejection fraction is the portion of the blood in the left ventricle pushed out to the rest of the body with each beat. Normal ejection fraction is 55 percent or greater.

Albert Einstein Healthcare Network, a member of the Jefferson Health System, provides healthcare services through Albert Einstein Medical Center, Germantown Community Health Services, Willow Terrace (a nursing home), MossRehab, Willowcrest (a center for subacute care), Belmont Behavioral Health and a number of outpatient and satellite locations. Einstein also operates a primary care network, Einstein Neighborhood Healthcare. For more information, visit www.einstein.edu.

Publish date: February 10, 2003