During an overnight stay at a truck stop in New Jersey, Parkes’ right hand started flopping uncontrollably, with no sensation. He was light-headed and dizzy, his entire right arm felt heavy as lead, and a door eerily seemed to move away from him.

Confused and concerned, Parkes called his wife, Carmen. She listened closely, noticed that his words seemed slurred, and urged him to call an ambulance.

Parkes soon found himself hospitalized at the Robert Wood Johnson University Hospital in Hamilton, New Jersey, where tests determined he probably had experienced a mild stroke.

In evaluating the likely factors for that stroke, doctors determined that Parkes had a patent foramen ovale (PFO),a small opening in the dividing wall between the heart’s upper two chambers. This opening sometimes increases a person’s risk of stroke or transient ischemic attack (see related sidebar).

The New Jersey physicians recommended that Parkes seek a second opinion from Harold Adams, M.D., a nationally known stroke expert at University of Iowa Hospitals and Clinics. Adams is principal investigator of the Iowa portion of a national stroke study called Closure I.

 “Until recently, the only alternative to medication for preventing TIA or stroke in persons with PFO was open heart surgery,” Adams explains. “Today, these people may benefit from a non-surgical method using a device called a PFO closure device.”

The FDA-approved Closure I clinical trial seeks to evaluate which of two treatments is most effective in preventing future strokes in people with PFOs--medication (aspirin, warfarin, or both) or a promising new PFO closure device called STARFlex®. The STARFlex device opens like an umbrella to permanently close the hole in the heart.

After considering his options, Parkes volunteered to enroll in the Closure I study. Enrollment meant he would receive either medication or the device and that other patients would likely benefit from the study’s outcome in the future.

Parkes was pleased to learn that he had randomly been assigned to receive the new device implant.

The procedure was performed in April 2004 by Thomas Fagan, M.D., a pediatric cardiologist with University of Iowa Children's Hospital, located at UI Hospitals and Clinics (the Iowa study involves pediatric cardiologists because holes within the heart are more commonly identified in children than adults, so pediatric cardiologists usually have the most experience with actual treatment of patients with these types of holes).

Parkes says the procedure--in which the implant is placed by a catheter inserted through the groin--was painless. In fact, he was awake for the entire procedure and was able to watch it on a monitor.

Six months later, Parkes has had no recurrence of stroke and feels great. He will continued to be monitored in the coming months as part of the study protocol.

For more information about Closure I, patients and families may call UI Health Access and ask for Jeri Sieren, study coordinator. Sieren can be called directly at 319-356-8744 or e-mailed at jeri-sieren@uiowa.edu. Physicians should call UI Consult.

All babies have PFOs

We all have patent foramen ovales (PFO) before birth. These are small, flap-like openings in the dividing wall (septum) between the heart’s upper two chambers. The flap-like opening usually fuses after birth. In a surprising number of us--15 to 20 percent--the foramen remains open or “patent”. Problems rarely occur (most people with PFOs don’t know they have one). In some people, however, this opening might allow a clot to enter the arteries that supply the brain and cause a stroke or transient ischemic attack.

About stroke

• Affects 700,000 Americans each year
• Third leading cause of death (after heart disease and cancer)
• Leading cause of long-term disability
• One-third of stroke patients are under age 60

Disoriented and dizzy from the symptoms of stroke, Barth Parkes called his wife Carmen, from a truck stop in New Jersey. Her advice was on target and crucial: get help immediately.

Neurologist Harold Adams, M.D. (foreground) and pediatric cardiologists Thomas Fagan, M.D., jointly participate in a UI study evaluating which of two treatments is most effective in reducing the risk of stroke in people with a certain type of heart defect.