New Medical Device Getting National Attention
TUPELO, Miss.-When 75-year-old Patrick Clemens of Amory signed on for a clinical research trial in 2012, he hoped for the best but certainly never expected the national attention he recently received.
Clemens is one of more than 30 patients at North Mississippi Medical Center to receive an investigational device called “Watchman” to prevent strokes in people with irregular heartbeats. In December he accompanied cardiac electrophysiologist Jim Stone, M.D., and Cardiology Associates of North Mississippi research nurse Marsha Jones, RN, to Gaithersburg, Md., to convince advisers to the Food and Drug Administration of Watchman’s benefits. Following all the testimony, the advisory panel voted 13-1 that the benefits outweigh risks associated with surgery to implant the device. Full FDA approval could come by mid-summer.
Clemens’ heart problems date back to 2004, when he underwent quadruple bypass surgery for blocked arteries. Two years later he received a pacemaker to correct irregular heartbeats. He was then diagnosed with atrial fibrillation, a heart condition in which the upper chambers of the heart beat too fast. Because the heart’s upper chambers quiver instead of beating effectively, blood can stagnate and form clots in an area of the heart called the left atrial appendage.
“Everyone has a left atrial appendage on the left side of your heart,” explained Jones. “It’s a small pouch, about the size of your thumb. If a clot forms there and you get an effective heartbeat, it can send that clot to your brain and cause a stroke.”
In 2012, Clemens’ physician prescribed blood thinning medication to help prevent blood clots that could cause a stroke. Like many other patients on blood thinners, the retired shipbuilder struggled with an undesirable side effect-bleeding from everyday pricks and bumps. “I tried two different blood thinners,” Clemens’ said, “but because I’m active, I was just having too much bleeding.”
Dr. Stone and Jones told Clemens about the Watchman device, which seals the left atrial appendage to keep larger blood clots from entering the bloodstream. During the procedure, Dr. Stone guides the Watchman device into the heart through a catheter, or flexible tube inserted through a vein in the groin. Once the catheter is in place, Dr. Stone determines what size Watchman device to use (five sizes are currently available) for a snug fit inside the left atrial appendage. After placing the device, he releases it from the catheter to leave it permanently implanted in the heart. The procedure takes less than an hour in NMMC’s Electrophysiology Laboratory, and the patient leaves with only a bandage on the groin.
Clemens stayed overnight at NMMC and recovered quickly. “The procedure was pretty easy,” he said. “There was no discomfort.”
“The vast majority of blood clots that cause strokes in patients with atrial fibrillation come from the left atrial appendage,” Jones said. “This device removes that risk.”
Dr. Stone, who served as principal investigator for two related research studies at NMMC, is encouraged by results and believes the Watchman’s implications are significant. “This is probably the single biggest advance for preventing stroke caused by atrial fibrillation since the advent of blood thinners about 50 years ago,” he said. “I think it’s a paradigm shift in how we will treat atrial fibrillation in the future.”
While the Watchman does not cure atrial fibrillation, it does reassure patients like Clemons. “When you know you have the possibility of suffering a stroke, there’s a fear that scares you,” Clemons said. “Now, 95 percent of that fear is gone.”
Because NMMC has been a major player in the clinical research trials, Dr. Stone said the local hospital is being considered as a training site if the Watchman gains full FDA approval. “We sincerely thank the patients who have volunteered for the clinical trials,” he said. “They have put a lot of faith in us.”