Jefferson scientists test new device for fixing holes in hearts of young stroke patients

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 (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).


Contact: Nan Myers
Thomas Jefferson University

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