Lankenau Medical Center, part of Main Line Health’s Lankenau Heart Institute has been chosen to participate in PARTNER 3, a nationwide clinical trial that could transform the treatment of severe aortic stenosis. The focus of Edwards Lifesciences’ PARTNER 3 is TAVR, a non-surgical catheter-based therapy that has proven to be a safe and effective alternative to surgical aortic valve replacement in patients at moderate or higher risk for undergoing heart surgery. PARTNER 3 is the first large randomized clinical trial in the U.S. to assess whether these benefits also translate to patients at low risk for surgery.
Aortic stenosis is a narrowing of the valve that opens to let blood flow from the heart to the rest of the body. People with aortic stenosis usually have no symptoms until the disease has progressed and become life threatening, at which point valve replacement is usually recommended. Patients at low risk for surgery typically have low rates of complication from the valve replacement operation.
“The outcome of this trial could profoundly change treatment for many people suffering from aortic stenosis,” says interventional cardiologist Paul Coady, MD, Lankenau Heart Institute’s principal investigator for PARTNER 3. As he explains, “TAVR can significantly improve the quality of life for patients who suffer from the debilitating symptoms of aortic stenosis and the minimally invasive approach will allow these patients to recover more quickly than is possible with traditional treatment options.”
The aim of PARTNER 3 is to determine the safety and effectiveness of TAVR therapy using the SAPIEN 3 transcatheter heart valve in patients requiring aortic valve replacement and at low operative risk for surgical aortic valve replacement. The study will compare all forms of complications and rehospitalization rates with TAVR versus surgical aortic valve replacement at one year post-procedure.
Lankenau Heart Institute’s TAVR program is one of only a select the few programs in the nation chosen to participate in PARTNER 3 and is one of only two centers in the Philadelphia region.
“We’re gratified by the opportunity to contribute to this important research,” Dr. Coady says, speaking on behalf of Lankenau Heart Institute’s specialized team for structural heart disease. He says the team has worked hard to build a robust TAVR program, which has grown substantially since its launch in 2012 and is among the highest volume centers in the nation. “We just completed our 500th TAVR procedure, and we’re proud of the excellent patient outcomes we’ve achieved.”
Aortic stenosis usually develops later in life. Once symptoms start, the risk of death increases quickly—up to 50 percent of untreated patients die within two years of symptom onset. Although valve replacement is recommended for most patients with severe or symptomatic aortic stenosis, many who would benefit from the treatment do not undergo aortic valve replacement.
“One reason PARTNER 3 is important is because if it shows TAVR is safe and effective in low-risk patients, it could help break down barriers to non-surgical treatment,” says cardiac surgeon Scott Goldman, MD, surgical leader of Lankenau Heart Institute’s Structural Heart Program and a key member of the TAVR team.
In PARTNER 3, more than 1200 qualified low-risk patients will be enrolled and randomly assigned to treatment with TAVR or surgical aortic valve replacement. Study patients will be seen for follow-up at 30 days, six months, and one year post-procedure and then annually in years two through 10. Enrollment by Lankenau Heart Institute’s TAVR team began September 2016 and is occurring at Lankenau Medical Center. If evaluated as clinically appropriate, trial participants randomized to surgical aortic valve replacement will be offered a minimally invasive option.
To qualify for PARTNER 3, patients must have severe, calcific aortic stenosis and meet all study criteria. View the complete study criteria.