Doctors at NewYork-Presbyterian Hospital/Columbia University Medical Center are offering their patients to undergo an innovative procedure to implant a new aortic heart valve without open-heart surgery.
The new approach is being tested as part of a multi-centre study called the PARTNER (Placement of AoRTic traNscathetER valves) trial, which is in its third phase.
Principal investigators Dr. Martin Leon and Dr. Craig Smith say that their study is focused on the treatment of patients who are at high risk or not suitable for open-heart valve replacement surgery.
They have revealed that the Edwards SAPIEN transcatheter heart valve, made of bovine pericardial tissue leaflets hand-sewn onto a metal frame, is implanted through 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.
The researchers say that they position it inside the patient's existing valve using a balloon to deploy the frame, which holds the artificial valve in place.
According to them, both procedures are performed on a beating heart, without 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," says Dr. Leon, the study's national co-principal investigator, associate director of the Cardiovascular Interventional Therapy (CIVT) Program at NewYork-Presbyterian Hospital and Columbia University Medical Center, and professor of medicine at Columbia University College of Physicians and Surgeons.
"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," says Dr. Smith, study co-principal investigator, interim surgeon-in-chief and chief of cardiothoracic surgery at NewYork-Presbyterian Hospital/Columbia University Medical Center, and the Calvin F. Barber Professor of Surgery at Columbia University College of Physicians and Surgeons.
It takes about 90 minutes for the transcatheter valve procedures to complete, compared with four to six hours for open-heart surgery.
Another advantage of this procedure is that it requires only a few days for recovery, compared to a two- to three-month recovery period with open-heart surgery.