At right: D. Lynn Morris, MD, Chairman of Cardiology and Director of the Einstein Institute for Heart and Vascular Health, and Sumeet Mainigi, MD, Director of Electrophysiology, with the Watchman™ Implant (Photos by Wes Hilton)
It resembles a tiny wire mesh jellyfish, roughly the size of a quarter. Looking at it, you would never guess what it really is. But if you are one of the 2.7 to 6.1 million Americans who suffer from atrial fibrillation, this diminutive device has the potential to change your life. And Einstein has it.
Atrial fibrillation—also known as “Afib”—is the most common heart arrhythmia. Afib causes the upper chambers of the heart to beat erratically. Because of this irregular heartbeat, blood clots are more likely to form in the heart and move through the bloodstream, increasing the risk of stroke.
For years, the treatment of choice for Afib has been blood-thinning drugs like warfarin (Coumadin). These drugs, also known as anticoagulants, are effective, but often difficult to regulate and patients are often scared to take them, says Sumeet Mainigi, MD, Director of Electrophysiology at Einstein Medical Center. “Patients need to take blood thinners for the rest of their lives to reduce the risk of stroke. The problem is, only about 60 percent of patients will end up taking and staying with blood thinners at the right level,” he says.
|A closeup view of the Watchman Implant|
All sorts of external factors can influence warfarin levels—causing them to rise, exposing the patient to an increased risk of bleeding; or fall, leaving them at risk for the development of highly dangerous blood clots.
Certain medications, for example, like nonsteroidal anti-inflammatory drugs (NSAIDs), can increase warfarin’s effect, raising the risk of bleeding. Antibiotics can have a similar effect. On the other hand, many vegetables high in vitamin K, such as kale or spinach, can decrease warfarin’s effect if eaten in large amounts. Some herbal remedies, such as St. John’s Wort or ginseng, might do the same thing.
“Coumadin is hard to control,” adds D. Lynn Morris, MD, Chairman of Cardiology and Director of the Einstein Institute for Heart and Vascular Health. There are newer drugs that are more reliable, like dabigatran (Pradaxa), he says, “but their effects are harder to quickly reverse.”
With any of these drugs, Morris says, “you have to consider benefit and safety—and you’re balancing those.”
Enter that wire-mesh jellyfish—known by its trade name, the Watchman™ Implant—a deceptively complex device that may eliminate the need for blood-thinning drugs altogether. Until last March the device was regarded as experimental. Since then, following FDA approval, it has begun to find its way into surgical suites, including those at Einstein.
“This is the most studied medical device on the American market. It reduces the risk of stroke with Afib as much as Coumadin but without the need for long-term blood thinners,” says Dr. Mainigi. “It’s a totally new therapy that’s unlike anything we have.”
Here’s how the Watchman Implant works.
There's a small, pouch-like area of the heart called the left atrial appendage (LAA). This is the area of the heart where clots are most likely to form. Making a small incision in the patient's leg, surgeons thread a thin hollow tube, or catheter, into a vein and up into the left side of the heart. The Watchman is guided through the tube, where it unfurls like an umbrella into the LAA, sealing it off. Heart tissue eventually covers the device.
The procedure takes less than an hour to complete under general anesthesia. The average hospital stay is just one day.
For the first 45 days after surgery, the patient remains on a blood thinner. After that, an echocardiogram is performed, and if the device is firmly seated in the LAA, the patient is prescribed aspirin and clopidogrel (another blood thinner) for the next three to six months. Once the LAA is completely closed, most patients can cut back to aspirin only—and remain protected for the rest of their lives.
Einstein is one of the few centers in the United States currently implanting the Watchman device. “We tend to have very early access to the latest cutting edge devices and technologies. It has a lot to do with the philosophy of our department and hospital, our departmental and physician reputations, and the multidisciplinary way we approach cardiac problems,” says Mainigi.
And there’s another first, says Mainigi. Einstein surgeons are starting to use 3D printing to precisely replicate the anatomy of the patient’s heart before implanting the device. “This will allow us to streamline the implant process,” he says. “The more we know about a patient’s heart before we start the procedure, the safer and more effective the procedure will be.”
Over time, Dr. Morris says, the long-term advantages of the implant over blood thinners—both in in cost savings from stroke prevention and enhanced quality of life for patients—will become clear, and the surgery far more commonplace. Says Dr. Morris: “It’s a game changer.”