Closing hole in the heart is no better than drugs in preventing strokes

Loyola University Medical Center is one of the major enrollers in a landmark clinical trial that found that plugging a hole in the heart works no better than drugs in preventing strokes.
Loyola enrolled 24 patients, one of the highest patient enrollments in the multi-centre trial and more than any other Chicago-area hospital. Principal investigators at the Loyola site were stroke specialist Dr. Michael Schneck and interventional cardiologist Dr. Fred Leya.
About 1 in 4 adults has a small hole in the wall that separates the top two chambers of the heart. It’s called a patent foramen ovale (PFO). For most people, a PFO poses no problems. But in some cases, a clot can pass through the hole, migrate to the brain and trigger a stroke.
The standard treatment is medication to prevent blood clots, typically aspirin or Coumadin. A newer treatment is to plug the hole with a device delivered by a catheter. The catheter is inserted into a blood vessel at the top of the leg and guided up to the heart. When the catheter reaches the PFO, the device is deployed, opening like an umbrella to plug the hole.
The clinical trial included 909 patients who had PFOs and had previously suffered strokes or mini strokes called transient ischemic attacks (TIAs). They were randomly assigned to receive a PFO closure device plus blood thinners or drug therapy alone.
The closure device worked no better than drugs alone in preventing recurrent strokes or TIAs. Moreover, major vascular complications occurred in 3.2 percent of the closure group.
Loyola University Health System