On Tuesday, August 11, 2009, an 82-year old New Orleans resident with severe aortic stenosis successfully had a heart valve replaced at Ochsner Medical Center using the same technique as angioplasty, a far cry from the traditional open heart procedure. Patients who are considered high-risk or non-operable for conventional open heart valve surgery now have a potential new research option available regionally only through The John Ochsner Heart & Vascular Institute.
Ochsner Medical Center is the only hospital in the Gulf South selected to participate as an FDA investigative site in the PARTNER (Placement of AoRTic traNscathetER valves) clinical trial, evaluating the Edwards SAPIEN transcatheter aortic heart valve in patients who are at high risk for open heart surgery and surgical valve repair.
Annually, some 200,000 people in the U.S. need a new heart valve. "This dramatic new procedure offers a new lease on life for patients with severe aortic stenosis, severe narrowing of the heart valve, and highlights Ochsner's continuing efforts to place patient care first by offering a minimally invasive alternative to open heart surgery which may reduce morbidity and recovery time," explains Dr. Stephen Ramee, Ochsner Cardiologist, and clinical investigator.
The purpose of the PARTNER study is to determine the safety and effectiveness of the Edwards SAPIEN Transcatheter Heart Valve device and delivery systems (leg: transfemoral and chest: transapical). Amazingly, the percutaneous arm of this study makes no cuts in the chest at all. A catheter carrying a tissue valve built into a metal stent a half an inch in diameter is threaded up the artery from the leg to the aortic valve, where it positions the new valve within the damaged one. This procedure is performed in a state-of-the-art cath lab on a "beating heart," without the need for bypass machine, which can pose additional risks. As with any research trial, no guarantees can be made about outcomes. Study benefits and risks along with alternatives are reviewed in detail before a person enrolls.