Washington, November 19 : Scientists at Rush University Medical Center are using a soft-patch device made of a Gore-tex-type material, often used to make durable outerwear, to close a common hole found in the heart called a patent foramen ovale (PFO).
The researchers hope that the new approach may prevent recurrent strokes and transient ischemic attacks (TIAs) in adults.
Rush is one of only 50 sites across the world where such trials are being conducted.
The objective of the multinational research is to see whether repairing a PFO with the aid of the device called the GORE HELEX Septal Occluder is more effective in preventing strokes than medical management alone.
"This PFO-closure device uses a biocompatible material that allows progressive tissue growth to help seal the defect. It shows promise because of its soft, flexible design that has the ability to conform to a patient's anatomy," Dr. Ziyad Hijazi, director of the Rush Center for Congenital and Structural Heart Disease and co-investigator of the clinical trial at Rush.
The tiny umbrella-like device is fed through a catheter that is placed in the vein of the patient's leg using just one small puncture, and it is led through the vein up to the heart where the device is placed to seal the flap.
"Everyone is born with a PFO, which normally closes after birth. But in one in five Americans, the closure process is incomplete allowing blood returning from the body to bypass the filtering system of the lungs and enabling blood clots to travel from one area of the body through the heart and up to the brain causing a stroke," said Hijazi.
Patients often don't show any signs or symptoms, and a PFO can go undetected through adulthood. A PFO defect is often diagnosed only after a patient experiences a stroke, which mostly occurs in people under the age of 50.
The purpose of the study is to help such patients.
"This study may provide useful information that will help us determine a new possible standard of care for stroke patients. We have medications options that work well in reducing a stroke patient's risk of recurrence, but now we can see if PFO closure is an additional option that may also be beneficial to stroke patients," said Dr. Vivien Lee, stroke neurologist and study co-investigator at Rush.