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Temple University hospital offers new Tandemheart® Trial for heart attack patients
September 18, 2013
The trial – called the TandemHeart® to Reduce Infarct Size (TRIS) – is investigating whether using the TandemHeart® percutaneous left ventricular assist device in patients with acute heart attacks can reduce the area of scarring in the heart, as well as improve the function of the heart and the long-term survival of the patient when compared to patients who undergo current standard treatments.
The local Principal Investigator for the trial is Brian O’Murchu, MD, Associate Director of the Cardiac Catheterization Laboratories at TUH and Associate Professor of Clinical Medicine at Temple University School of Medicine (TUSM). "Bringing this trial to Temple continues our commitment to increasing the clinical options available to our patients," says Dr. O'Murchu.
Howard A. Cohen, MD, Director of Interventional Cardiology and the Cardiac Catheterization Laboratories at TUH, will be one of the Temple doctors implanting the TandemHeart® device into patients taking part in the trial. "Our hope is that the results will allow us to improve the long-term outlook and quality of life of patients who sustain a large heart attack," says Dr. Cohen, who also serves as Director of the Temple Interventional Heart & Vascular Institute and Professor of Medicine at TUSM.
The TandemHeart® device is a pump that temporarily takes the workload off of the patient's heart, and can cycle up to 5 liters of blood per minute. The pump itself remains outside the patient's body. The TandemHeart® is designed to augment the flow of oxygenated blood to the patient's vital organs while simultaneously decompressing, or "unloading," the left ventricle to reduce the workload of the heart.
The TRIS Trial is investigating whether that "unloading" can reduce reperfusion injury, which plays a large role in the amount of scarring that occurs in the heart after a heart attack. Reperfusion injury is what occurs when blood supply returns to the heart tissue after a period of ischemia, or lack of oxygen. The return of blood can cause inflammation and damage, which leads to scarring. Reducing scarring is critical because scarring is directly related to the heart's ability to pump. The larger the scar, the smaller the amount of blood that is pumped out per beat.
Patients enrolled in the trial will receive the TandemHeart® treatment, followed by angioplasty and stenting to restore normal blood flow to the heart. The TandemHeart® remains connected to the patient for 6-12 hours before being removed. Following removal of the device, physicians will perform an MRI to determine the amount of scarring in the heart and to measure the myocardial salvage index, which is the amount of tissue spared from scarring. Patients will be monitored for complications and re-examined and given follow up echocardiograms at 30 days, six months and one year.
The results of patients who receive the TandemHeart® device will be compared to those that receive standard therapy, which is angioplasty and stenting. TUH hopes to begin enrolling patients in the very near future.
"This has the potential to be a landmark trial that will change the whole paradigm of treatment of large heart attacks," added Dr. Cohen.
Editor's Note: This trial is sponsored by Cardiac Assist, Inc., the manufacturers of the TandemHeart® device. Dr. Cohen serves as the Medical Director of Cardiac Assist, Inc. Dr. Cohen is not the Principal Investigator of this trial locally or nationally. He will have no role in enrolling patients for the trial.
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