It’s fair to say James Thompson, MD, is an expert in patent foramen ovale (PFO) device implantation, having performed device closure procedures more than 1,000 times spanning nearly two decades. A pediatric cardiologist and medical director with Child Cardiology Associates, an affiliate of MEDNAX, in Fairfax, Virginia, Thompson has worked with the devices since their early years, practiced through the evolution of the procedure, successfully completed the device implantation an impressive number of times and — most importantly — has encountered and understands the rare complications.
One in five people have a PFO.
Everyone is born with a small hole between the upper chambers of the hearts. The hole typically closes a few weeks after birth. However, for 20 percent of the population, the hole remains open. This condition is called a PFO.
A PFO is not life threatening on its own. Most people living with a PFO are unaware of it, and may never realize they have it. The risk arises if a blood clot forms. Blood should circulate through the lungs, which acts as a filter for small clots. But a PFO — an open passage between the chambers — is an opportunity for a clot to skip the lungs and escape through the PFO into the body. This could lead to a stroke.
While a PFO repair is relatively simple and complications are rare, the diagnosis is more difficult. A PFO is usually only discovered after an otherwise healthy adult suffers a stroke. “Most people who come to me have already had a stroke and they are scared,” said Thompson. A PFO device repair “leads to roughly a 75 percent reduced risk for reoccurring stroke,” he said.
Dr. Thompson has implanted PFO devices in a handful of pediatric patients, but “the procedure is almost exclusively done on adults,” he said. There is no set age, however, most patients are in their 30s to early 50s. In his experience, the most sensitive and thorough test to diagnose or rule out a PFO is a Transcranial Doppler (TDC) ultrasound.
“A PFO is easy to miss,” said Thompson. “You need a physician who will aggressively search for the cause of a stroke, and someone who knows what to look for.” With more than 18 years of experience with this technique, Thompson says, “I don’t stop looking until I’m sure.”
PFO device implantation is an outpatient procedure.
Before the late 1990s, a PFO repair involved open-heart surgery to stitch the hole closed. With a PFO repair device, “a patient is under moderation sedation,” said Dr. Thompson, “and the procedure takes less than an hour.”
Dr. Thompson inserts a catheter through a large vein in the patient’s groin, which is carefully threaded up to the heart. The PFO repair device is attached to the catheter. With the assistance of echo imaging, he is able to slip the catheter through the hole in the heart and release the first stage of the device. It opens similar to a small umbrella, said Thompson. Then the catheter is pulled back through the hole and the second stage of the device — another small umbrella — is also opened. The hole is caught between the two elements of the device. The catheter is released and removed through the vein, while the device is left inside the heart. “Over time, new heart tissue grows over the device and repairs the hole,” said Thompson.
“We typically keep a patient overnight,” he said. “And I usually recommend the patient relaxes for a day or so after; no heavy lifting for a week.” But in general, the process is minimally invasive. “Once I’ve finished and removed my mask, the patient’s response is usually: ‘That’s it?’”
While follow-up appointments occur after a week, a month, six months and a year, “a patient can resume life as before,” he said. Former NFL player Tedy Bruschi returned to professional football after having a PFO device repair, remarked Thompson.
PFO device closure began as an “off label” procedure.
Dr. Thompson first encountered PFO repair procedures during his pediatric cardiology fellowship in the late 1990s. At the time, devices were being studied to treat an atrial septal defect (ASD). An ASD is an unintended hole in the heart that forms in the womb. It is present at birth and not destined to close itself, meaning an ASD is a congenital condition and is treated by a pediatric cardiologist. “But we eventually had cardiologists in our hospital coming to our team with adult patients who had suffered strokes due to PFOs,” said Thompson. A theory began to develop that perhaps ASD devices used in pediatric cardiology to repair congenital holes could help stroke patients with PFOs.
The Food and Drug Administration (FDA) was consulted about clinical trials to test the “off label” use of ASD devices for PFO closure. The FDA initially considered the pool of PFO patients too small, said Thompson. “But the Humanitarian Device Exemption (HDE) protocol allowed us limited use permission of ASD devices to treat PFO patients.” The following circumstances were required:
- The patient had suffered a stroke
- The patient was diagnosed with a PFO
- The patient was treated with Coumadin
- The patient experienced a second stroke despite drug intervention
“The results of ASD devices used for PFOs were positive,” said Thompson. “Over the years, the technology has continued to improve.”
The FDA has since approved device closure of PFOs for first-time stroke patients, making these device procedures a viable option for those patients to prevent future stokes caused by their PFOs.
About Dr. Thompson
James Thompson, MD, earned his undergraduate and medical degrees at the University of North Carolina at Chapel Hill. He completed his pediatric residency at Children’s National Medical Center in D.C., and his pediatric cardiology fellowship at the University of California, San Francisco. He is board certified in pediatric cardiology.
About the practice
Child Cardiology Associates specializes in the diagnosis and treatment of congenital and acquired heart disease for pediatric and adult patients. The team provides care in the region of Fairfax, Virginia; Rockville, Maryland; and the greater Washington D.C. metropolitan area.
Reviewed by: Dr. James Thompson