For the first time in 27 years, Jerry Flowers is looking at life without using blood thinners, thanks to a small device that was implanted in his heart in a clinical trial at Vanderbilt Heart and Vascular Institute (VHVI).
“I feel great about that,” said Flowers, of Hohenwald, Tennessee, who received a stroke protection device for his atrial fibrillation (also known as AF or AFib).
It is a heart condition in which the upper chambers of the heart beat too fast and with irregular rhythm, which puts Flowers at a higher risk for blood clots that cause strokes. AFib, the most common cardiac arrhythmia, affects more than 5 million Americans.
Flowers is among 41 patients at VHVI who have received the Watchman FLX, the latest left atrial appendage (LAA) closure device designed to treat patients with AFib. VHVI is the only site in Tennessee that is participating in the trial.
The standard treatment for AFib is prescribing blood thinners such as Eliquis or Xarelto, but they have several downsides, said Christopher Ellis, MD, associate professor of Medicine. The drugs are expensive and patients may be inconsistent in using them, which increases the risk of a stroke. Patients also bruise easily and carry a significant risk for bleeding complications long term.
In Flowers’ case, he had severe bleeding from ulcers in his stomach and didn’t realize it until it was almost too late. He was rushed to the hospital and stabilized, but had to discontinue the blood thinner while he healed, greatly increasing his risk of stroke from his atrial fibrillation.
Ellis said the Watchman FLX protects from the risk of stroke by eliminating blood flow into the left atrial appendage, with results comparable to blood thinners. The surgery is performed under general anesthesia, typically takes less than 45 minutes and requires a 24-hour hospital stay.
Once implanted, it typically seals off the appendage after six weeks. The device remains effective permanently, with no maintenance, Ellis said. The patients will remain on a regime of Plavix, a less intensive blood thinner, as well as aspirin for six months. If all looks well, they will be able to take aspirin only long term.
“We can close more anatomies more safely with the FLX device, which will allow us to reach more patients in need,” Ellis said. “There are a lot of patients who are not on an anticoagulant and probably about half of patients with AFib can’t maintain compliance with their chronic anticoagulation regimen for various reasons. That’s a million and a half patients or so in the U.S. and growing, because AFib is a burdensome disease and it’s getting more prevalent.”
The Watchman FLX is currently in a clinical trial and has not been approved by the FDA, and no further patients are being taken for the trial. It is designed to be an improvement over the original Watchman device, offering more flexibility to conform with more patients’ anatomies.
The earlier Watchman device, approved by the FDA in 2015, continues to be implanted at Vanderbilt.
Flowers was deemed not to be a candidate for the original Watchman due to his anatomy, but the newer-generation device fit perfectly.
“I have great hopes,” he said.
Pat Kington of Knoxville, another AF patient who received the FLX implant, said she lived in fear of getting a stroke, even on the blood thinners. She is eager to discontinue them.
“I’m thrilled to death, because I can get back on my arthritis medicine,” she said, which she couldn’t take with the blood thinner.
“This hospital is wonderful,” she said. “I can’t say enough good things about that.”
