Thomas Jefferson University Hospital - Results of Multicenter Study: Jefists Test New Device for Fixing Holes in Hearts

of Young Stroke Patients

3/19/12 8:52 AM

NEWS RELEASE
Results of Multicenter Study: Jefferson Scientists Test New Device for Fixing Holes
in Hearts of Young Stroke Patients
As many as one in four adults is walking around with a
hole between the upper chambers of the heart. Most of
them will never know it.
The person who learns about the hole in his or her heart
does so when he or she suffers symptoms of a mini-stroke
(TIA) or a more-debilitating stroke. And it is usually only
then that the person learns the term Patent Foramen
Ovale (PFO), a persistent opening in the upper wall of the
heart which did not close completely after birth.
We are all born with a PFO, says Michael Savage, M.D.
director, Cardiac Catheterization Laboratory at Thomas
Jefferson University Hospital, Philadelphia. For most of
us, the opening closes within months after birth.

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The symptoms occuroften in young adultsbecause the
opening can cause the blood in the heart to be rerouted
from the right to left side. As a result, if a clot forms in
this rerouted blood and passes through the PFO to the
brain, a person may experience a stroke or mini-stroke (TIA).
Interventional cardiologists have been using transcatheter devices designed to close PFO
successfully for many years. Now in a multicenter study to be presented at the American
College of Cardiologys 55 th Scientific Session ( Monday, March 13 at 10 a.m.),
researchers from Thomas Jefferson University Hospital assess the initial U.S. experience with
the Cardia PFO closure device for the prevention of recurrent stroke in patients with PFO. The
Jefferson scientists will report that the Cardia PFO closure device is effective in sealing PFO
and appears highly effective in preventing recurrent stroke.
The device, delivered through a catheter, is a tiny self-expanding double umbrella design
consisting of polyvinyl alcohol sails and nitinol arms. It is positioned on both sides of the PFO
and closes like a clamshell around the hole.
After several months, cells grow over and cover the device and it becomes part of the
patients body. The patient is unaware that this is happening, says David Fischman, M.D.,
assistant director, Cardiac Catheterization Laboratory at Thomas Jefferson University
Hospital.
Thomas Jefferson University Hospital was the lead center for the 22-site study. The goal was
to determine implantation success for the device, procedural complications and recurrent
stroke or embolization.
Ninety patients who had experienced a stroke, 40 men and 50 women with an average age
of 47 years, were treated and received the Cardia closure device. PFO closure was successful
in 89 patients. Each was then prescribed daily doses of 325 mg. aspirin and 75 mg.
clopidogrel (Plavix) for six months after the procedure.
Followup with these patients was favorable in comparison with our prior experiences using
blood thinners alone, said Dr. Savage, who is also associate professor of Medicine, Jefferson
Medical College of Thomas Jefferson University . Of the group, one patient had a stroke, two
died from non-device related causes and two patients experienced transient ischemic attacks
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Thomas Jefferson University Hospital - Results of Multicenter Study: Jefists Test New Device for Fixing Holes in Hearts of Young Stroke Patients

3/19/12 8:52 AM

died from non-device related causes and two patients experienced transient ischemic attacks
(TIA).
In conclusion, the study authors found:
The Cardia PFO closure device is effective in sealing PFO, with a high success rate
observed even during this initial multicenter learning curve experience.
The device appears highly effective in preventing recurrent stroke.
These promising results underscore the importance of the pivotal randomized trial of
this device in patients with strokes of unknown origin (cryptogenic).
For information about treatment for cardiac disease or to make an appointment with a
Jefferson cardiologist, call 1-800-JEFF-NOW.
Media Only Contact:
Nan Myers
Thomas Jefferson University Hospital
Phone: 215-955-6300
Published: 3-10-2006
2004 Thomas Jefferson University Hospital
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