Heart Valves Replaced Without Surgery
Interventional cardiologists (Drs. Hijazi, Kavinsky and Amin) at Rush University Medical Center ( Chicago,Il ) are performing minimally invasive nonsurgical valve replacement procedure for patients with congenital heart disease that doesn’t involve open heart surgery.
Rush is one of 3 sites participating in an investigational study of minimally-invasive pulmonary valves and successfully implanted the first three patients enrolled in the trial on Thursday, April 17.
The Edwards SAPIEN transcatheter heart valve was inserted through a small puncture in a blood vessel in 3 patients who were treated in a recent trial. Patients with congenital heart disease that have abnormal blood flow in the right side of their heart traditionally have had to have repeated cardiac surgeries to fix their abnormal heart valves. The new type of valves were placed in patients that had a narrowed pulmonary valve associated with their congenital heart disease. The new artificial heart valve can be compressed onto a balloon to the approximate diameter of a pencil was passed into the heart from a leg blood vessel and then expanded with a balloon to position it in the position previously occupied by the diseased pulmonary valve.
The U.S. Food and Drug Administration (FDA) conditionally approved the investigational device exemption (IDE) clinical trial in late 2007. The study of thirty patients at three hospitals is in progress to collect safety and effectiveness data, to gain FDA approval.
Edwards Lifesciences Corporation of Irvine, Calif., makes the Edwards SAPIEN transcatheter valve that was implanted. The company also mskes similar valves for the mitral and aotic valves.
source: www.rush.edu
