Patients at New York-Presbyterian Hospital/Columbia University Medical Center in New York City can now obtain a new aortic heart valve without open-heart surgery, as part of the PARTNER trial.
The Phase 3 PARTNER (Placement of AoRTic traNscathetER valves) multicenter study is being led by co-principal investigators Martin Leon, MD, and Craig Smith, MD, and is focused on the treatment of patients who are at high risk or not suitable for open-heart valve replacement surgery, using the Edwards Sapien transcatheter heart valve.
The Sapien valve, made of bovine pericardial tissue leaflets hand-sewn onto a metal frame, is implanted via one of two catheter-based methods—either navigated to the heart from the femoral artery in the patient's leg, or through a small incision between the ribs and into the left ventricle. It is then positioned inside the patient's existing valve, using a balloon to deploy the frame, which holds the artificial valve in place. Both procedures are performed on a beating heart, eliminating the need for cardiopulmonary bypass and its associated risks.
“This breakthrough technology could save the lives of thousands of patients with heart valve disease who have no other therapeutic options,” said Leon, associate director of the Cardiovascular Interventional Therapy program at New York-Presbyterian Hospital and Columbia University Medical Center, and professor of medicine at Columbia University College of Physicians and Surgeons in New York City.
“This study may show that transcatheter valve replacement is a safe and effective alternative to open surgery, which remains the 'gold standard' for most patients," said Smith, interim surgeon-in-chief and chief of cardiothoracic surgery at New York-Presbyterian Hospital/Columbia University Medical Center, and the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons.
The transcatheter valve procedures take about 90 minutes, compared with four to six hours for open-heart surgery. Open-heart surgery can require a two- to three-month recovery period, compared to only a few days for the transcatheter approach.
The PARTNER trial is a prospective randomized study with two separate treatment arms. In the surgical arm, patients are randomized to receive either the Edwards Sapien transcatheter heart valve or an Edwards surgical valve via open-heart surgery. In the non-surgical, medical management arm, patients considered to be non-operative are randomized to receive either the Edwards Sapien transcatheter heart valve or appropriate medical therapy.