U.S. cardiologists say they've developed a transcatheter heart valve replacement procedure for congenital heart disease that eliminates open-chest surgery.
The interventional cardiologists from the Rush University Medical Center in Chicago -- one of three sites participating in the study of minimally invasive pulmonic valve replacement -- said they successfully implanted the first three patients enrolled in the trial last Thursday.
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial," said Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves."
Hijazi, Dr. Clifford Kavinsky and Dr. Zahid Amin used a bovine pericardial heart valve replacement in a procedure accomplished without requiring cardiopulmonary bypass or an open-chest incision.
The study of 30 patients at the three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a U.S. Food and Drug Administration commercial approval application.
The interventional cardiologists from the Rush University Medical Center in Chicago -- one of three sites participating in the study of minimally invasive pulmonic valve replacement -- said they successfully implanted the first three patients enrolled in the trial last Thursday.
"We were able to successfully implant the Edwards SAPIEN transcatheter heart valve percutaneously in the first three patients treated in this trial," said Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease. "Patients with congenital right ventricular outflow tract problems typically face the burden of multiple open-heart surgeries throughout their lives, either to replace their 'native' diseased valves or, as they age, their bioprosthetic replacement valves."
Hijazi, Dr. Clifford Kavinsky and Dr. Zahid Amin used a bovine pericardial heart valve replacement in a procedure accomplished without requiring cardiopulmonary bypass or an open-chest incision.
The study of 30 patients at the three hospitals will enable the collection of safety and effectiveness data, ultimately in support of a U.S. Food and Drug Administration commercial approval application.
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