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March 16, 2012
Closing Hole in the Heart is No Better than Drugs in Preventing Strokes, Study Finds
MAYWOOD, Ill. -- 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.
The study is published in the New England Journal of Medicine. Loyola enrolled 24 patients, one of the highest patient enrollments in the multicenter 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.
"Medical therapy is just as good as the device," Schneck said. "The larger lesson is that we have an impetus in the United States for doing procedures without first standing back and asking all the right questions."
Leya noted the clinical trial used an older version of a closure device. "I would like to see more research to determine if better devices will have better results," he said.
Schneck is medical director of the Neurosciences Intensive Care Unit and a professor in the Departments of Neurology and Neurological Surgery of Loyola University Chicago Stritch School of Medicine.
Leya is medical director of Cardiac Catheterization Laboratories and Interventional Cardiology and a professor in the Department of Medicine, Division of Cardiology of Loyola University Chicago Stritch School of Medicine.
Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system with a 61-acre main medical center campus, the 36-acre Gottlieb Memorial Hospital campus and more than 30 primary and specialty care facilities in Cook, Will and DuPage counties. The medical center campus is conveniently located in Maywood, 13 miles west of the Chicago Loop and 8 miles east of Oak Brook, Ill. The heart of the medical center campus is a 559-licensed-bed hospital that houses a Level 1 Trauma Center, a Burn Center and the Ronald McDonald® Children's Hospital of Loyola University Medical Center. Also on campus are the Cardinal Bernardin Cancer Center, Loyola Outpatient Center, Center for Heart & Vascular Medicine and Loyola Oral Health Center as well as the LUC Stritch School of Medicine, the LUC Marcella Niehoff School of Nursing and the Loyola Center for Fitness. Loyola's Gottlieb campus in Melrose Park includes the 255-licensed-bed community hospital, the Professional Office Building housing 150 private practice clinics, the Adult Day Care, the Gottlieb Center for Fitness, Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.