Kingwood Medical Center is first in Northeast Houston to implant only FDA-approved device designed to prevent blood clots from entering brain by sealing hole in heart
Kingwood Medical Center (KMC) is offering a recently approved implant device to help reduce the risk of recurrent ischemic strokes in patients diagnosed with a patent foramen ovale (PFO) – a small opening between the upper chambers of the heart. The Amplatzer PFO Occluder is the first and only FDA-approved device designed to close the PFO and lower the risk of stroke caused by dangerous clots passing between the heart chambers and migrating to the brain. KMC was the first hospital in northeast Houston to implant the device since the product’s approval.
Several months ago, Eagle Springs resident and father of four, Nestor Betancourt, felt dizzy and suddenly lost his speech and movement on the left side. His wife Carolina called 911. By the time they arrived at KMC, both his speech and movement were restored. After further diagnosis, it was determined that Betancourt suffered a stroke caused by a PFO. He was referred to Dr. Khaled Khalaf, a structural and interventional cardiologist, who successfully performed the PFO closure, a minimally invasive procedure performed while the patient is sedated but still conscious, at KMC. Betancourt was awake throughout the procedure and said, “Dr. Khalaf is the best. I was a little nervous, but once I was there – it was so fast. Everyone was so nice and explained everything.”
Normally in a developing fetus, the foramen ovale allows oxygenated blood from the placenta to bypass the lungs. This small, flap-like opening typically closes shortly after birth. When this flap remains open, or “patent,” it is referred to as a PFO. A PFO can potentially allow dangerous clots to pass from the right side of the heart to the left and travel up to the brain and cause a stroke. The Amplatzer PFO Occluder seals the dangerous hole and reduces this risk.
“The Amplatzer PFO Occluder provides a nonsurgical method for doctors to close a PFO,” said Khalaf. “But as the device labeling clearly states, patients need to be evaluated carefully by a neurologist and cardiologist to rule out other known causes of stroke, and ensure that the device will reduce the risk of a recurrent stroke.” Implanting the Amplatzer PFO Occluder device is a one-time procedure that usually lasts about 30 minutes. Following the procedure, patients typically need to stay in the hospital for 24 hours.
Twenty-five percent of adults are potentially affected with a PFO, which is not detected until they have a cryptogenic stroke (a stroke from an unknown cause). Newly released, long-term data from Respect, a landmark clinical trial, showed that patients who received the PFO closure had a reduced risk of recurrent stroke by 45 percent over medical therapy alone.
Khalaf said, “The procedure itself takes only about 30 minutes. Best of all, patients who have been bedridden with strokes have seen outstanding results with this procedure and they get a second chance by getting their lives back. The 30 minutes in the cardiac cath lab becomes a lifetime worth of healing.”
“Blood clots form in our veins all the time,” said Khalaf. “These are tiny blood clots that travel from all over the body into the heart and are pumped into the lungs. These tiny blood clots (venous thrombus) get filtered by the tiny capillaries in the lungs, after which the freshly oxygenated blood is pumped out into the miles of blood vessels that feed oxygen and nutrients to every cell in our bodies. Our lungs normally filter out these tiny clots, but a 2 mm thrombus in the brain can cause significant complications. PFOs don’t actually cause the stroke, but they provide a portal through which a thrombus might pass from the right to the left side of the circulation,” said Khalaf.
The Amplatzer PFO Occluder, from global medical device manufacturer St. Jude Medical, was approved by the U.S. Food and Drug Administration (FDA) in November 2016 for commercial use in the U.S. For more information, visit KingwoodMedical.com.