The Massachusetts General Hospital Heart Center has joined a clinical trial evaluating the effectiveness of a novel therapy to replace heart valves using a minimally invasive, catheter-based approach. The first of its kind tissue valve is designed to treat patients with severe aortic heart valve stenosis (a narrowing of the valve that restricts blood flow) who are considered high-risk or not candidates for traditional open heart surgery.
The Mass General Hospital Heart Center is the only center in New England offering this life-saving technology. The PARTNER (Placement of Aortic Transcatheter Valves) clinical trial is evaluating the transcatheter heart valve developed by Edwards Lifesciences. This valve is implanted without open heart surgery, using minimally invasive techniques. The valve is mounted and crimped onto a balloon delivery system and then threaded through the patient’s circulatory system from the leg. Once in place, the balloon expands and the new valve is placed to open the patient’s own diseased heart valve. The procedure is performed on a beating heart, without the need for cardiopulmonary bypass and its associated risks.
“This technology advancement holds promise for a large number of high-risk patients suffering from aortic stenosis but who were not eligible for open-heart surgery,” says Igor Palacios, MD, director of the Heart Center’s Interventional Cardiology Program.
Annually, an estimated 200,000 people in the United States need a new heart valve, but nearly half do not receive the new valve for a variety of reasons, including the risk of undergoing the traditional open heart surgery.
Mass General Hospital is one of 25 sites nationwide and five sites internationally offering this innovative treatment. It is the only hospital in New England doing this procedure. The PARTNER Trial is a prospective randomized study with two separate treatment arms. The surgical arm will focus on high-risk patients who are candidates for conventional open-heart surgery. Those patients will be randomized to receive either a traditional surgical valve or the new transcatheter valve. The results will determine whether the transcatheter heart valve is as effective as surgical valve replacement.
Patients at very high risk for heart surgery, or those thought to be inoperable, will be able to participate in this randomized study. For high risk patients (those with an open surgical risk of >10%), half will receive the valve and the other half open surgery. For the inoperable patients, half will get the valve and the other half standard medical therapy. These studies aim to demonstrate the effectiveness of this new valve and procedure as compared to transitional surgery and medical management.
“We are excited to be participating in this groundbreaking trial. The ability to treat narrowing of the aortic valve by valve replacement has been one of the major advances in cardiac medicine, and we believe that this technology is a great advance in valve therapy,” said Arvind Agnihotri, MD, a cardiac surgeon at the Mass General Hospital Heart Center. “We hope that transcatheter valve therapy will reduce risk of intervention in some high risk patients, and may allow us to treat some that were previously felt to be at too sick or weak for surgery.”
The Mass Genearl Hospital Heart Center’s heart valve program cares for patients with all forms of valvular heart disease, including congenital, rheumatic, degenerative, ischemic, and those related to valve endocarditis. Patients are treated by a team of specialists in non-invasive cardiology, interventional cardiology, cardiac surgery, and cardiovascular radiology to provide optimal evaluation, treatment, and longitudinal care of patients with heart valve problems.