Friday, 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.

About Loyola University Health System

Loyola University Health System (LUHS) is a member of Trinity Health. Based in the western suburbs of Chicago, LUHS is a quaternary care system that includes Loyola University Medical Center (LUMC), located on a 61-acre campus in Maywood, Gottlieb Memorial Hospital (GMH), on a 36-acre campus in Melrose Park, and convenient locations offering primary and specialty care services throughout Cook, Will and DuPage counties. At the heart of LUMC is a 547-licensed-bed hospital that houses the Center for Heart & Vascular Medicine, the Cardinal Bernardin Cancer Center, a Level 1 trauma center, a burn center, a children's hospital, Loyola Outpatient Center, and Loyola Oral Health Center. The campus also is home to Loyola University Chicago Stritch School of Medicine, Loyola University Chicago Marcella Niehoff School of Nursing and the Loyola Center for Fitness. The GMH campus includes a 254-licensed-bed community hospital, a Professional Office Building with 150 private practice clinics, an adult day care program, the Gottlieb Center for Fitness, the Loyola Center for Metabolic Surgery and Bariatric Care and the Loyola Cancer Care & Research at the Marjorie G. Weinberg Cancer Center at Melrose Park.

Trinity Health is one of the largest multi-institutional Catholic health care delivery systems in the nation. It serves people and communities in 22 states from coast to coast with 93 hospitals, and 120 continuing care locations — including home care, hospice, PACE and senior living facilities — that provide nearly 2.5 million visits annually.