Alabama has the second-highest rate of death from stroke, and AF patients’ risk is five times higher, according to Jose Osorio, MD of Alabama Cardiovascular Group. The Watchman device, approved by the FDA in April, offers a safe and effective option for reducing that risk.
“Until about five years ago, the only option we had to treat these patients was Coumadin,” Osorio says. “Then the first of a new class of drugs that we call novel oral anticoagulants (NOACs) was released. These new blood thinners - Pradaxa, Xarelto, Eliquis and Savaysa – are easier to take because patients don’t have to have frequent blood work done like they do with Coumadin. Those meds have made it much better for patients, and they decrease the risk of stroke significantly.”
In AF patients, the high risk of stroke comes from the left atrial appendage (LAA), a small pouch in the left atrium of the heart. “When you have AF, blood can pool in the LAA causing clots. A clot can dislodge and go to the brain, causing a stroke, or to another part of the body,” Osorio says. “So with the knowledge that most clots form in the LAA, scientists developed this device which can occlude the appendage.”
The Watchman device looks like a small parachute made of mesh and wires. Once implanted, heart tissue grows over the device, completely occluding the LAA. This growth typically occurs within 45 days during which the patient must continue to take blood thinners. Because of that, patients who can’t tolerate blood thinners are not candidates for this device.
“Once the LAA is completely occluded, after about 45 days, we can stop the blood thinner since clots no longer will form inside the appendage,” Osorio says. “Trials have shown that the device is similar to Coumadin in terms of stroke reduction, yet you have a significantly lower risk of bleeding with the Watchman. That’s the advantage. For patients at a higher risk of bleeding, elderly patients for example, this is an important option.”
St. Vincent’s Birmingham is the first hospital in the state to offer the Watchman device to these heart patients, and Osorio implanted the device in the first Alabama patient in late June. Since then, he has implanted devices in another 18 patients. The first three of those patients underwent their 45-day evaluation in August which revealed that the appendage was completely closed. They all have been taken off Coumadin.
“This is a novel, game-changing device. It’s different from anything else we have used to treat AF,” Osorio says. “During the first device trials done in the U.S., there were some complications, but researchers made some modifications in the way the procedure is performed and now it is much safer. In the hands of experienced physicians, the complication rate is very low.”
As with many new medical devices, patients who received the Watchman device after the initial clinical trials were tracked through Continuous Access Programs (CAP), which are registries that follow patients’ results. The device has been used in Europe for years and in the U.S. there have been two randomized trials (PROTECT AF and PREVAIL) and two registries (CAP Registry and CAP 2 Registry).
“A recent analysis of all patients enrolled in trials in the U.S. and CAP registries showed that this device is equal to Coumadin in stroke reduction, and patients who had the Watchman device died less often, with a 50-percent reduction in mortality,” Osorio says. “We are collecting data that will also be on another registry soon so we can track the patients thoroughly to make sure everything is going well. Since new physicians will be implanting the device, we want to make sure the procedure remains safe.”
Osorio takes referrals from physicians with patients who might benefit from the Watchman device, which he believes will be life-changing for people who don’t want to take blood thinners.
“You have to spend time talking to patients to know how much being on a blood thinner affects their lives. Even for patients who can reach a normal rhythm, being on those medicines causes them to worry about cutting themselves or falling,” he says. “Living with the constant fear from being on a blood thinner impacts people significantly, and my patients are thankful that the Watchman device is now an option for them.”
Read more about the Watchman device at http://www.theafibclinic.com/watchman-device.html