New ‘WATCHMAN’ Device Reduces Stroke Risk, Need for Meds

The innovative new device is called WATCHMAN, and while it does not keep time like the name suggests, it helps patients with irregular heartbeats and a high risk of stroke manage their condition by eliminating the need for blood-thinning medication for the rest of their lives.

That’s an appealing prospect for those who dislike taking such medicine, but even more so for those who can suffer serious side effects from warfarin, an anticoagulant used to prevent heart attacks, strokes, and blood clots.

In late March, Miami Cardiac & Vascular Institute became the fourth hospital in the nation, and the first in the Southeast, to implant the so-called WATCHMAN Left Atrial Appendage Closure (LAAC) Implant (pictured).

Ramon Quesada, M.D., Medical Director of Interventional Cardiology, Cardiac Research and Structural Heart Program at Miami Cardiac & Vascular Institute at Baptist Hospital, was the second interventional cardiologist in the country to perform the procedure — only days after the U.S. Food and Drug Administration’s approval on March 13 of the WATCHMAN implant for patients with non-valvular, atrial fibrillation (AFib or AF). He had participated in the clinical trials leading up to this approval since 2005 and thus had considerable experience in performing the procedure.

AFib-Related Strokes
The WATCHMAN device effectively closes off an area of the heart called the left atrial appendage (LAA) to keep harmful blood clots from entering the blood stream and potentially causing a stroke.  Twenty percent of all strokes occur in patients with AFib., and AFib-related strokes are more frequently fatal and disabling.  The most common treatment to reduce stroke risk in patients with AFib is blood-thinning warfarin medication.

By closing off the heart’s LAA, the risk of stroke may be reduced and, over a short period of time, patients should be able to stop taking warfarin, said Dr. Quesada, whose experience  during the  clinical studies developed his expertise; he now trains other interventional cardiologists across the country on the WATCHMAN procedure.

‘Very Impressive Results’
“We’ve had very impressive results with our trials, with a greater than 95 percent success rate,”  said Dr. Quesada. “Now that the device is approved anyone with AFib who doesn’t want to take warfarin for life, or those prone to serious side effects from such medication, can be evaluated and treated with the WATCHMAN implant.”

Patients at high risk from anticoagulants, or blood thinners, could suffer from excessive bleeding if they accidentally cut themselves. If you’re older than 75, you’re bleeding risk increases. You could also be at higher risk of bleeding if you have high blood pressure, a history of stroke, kidney problems, cancer and liver disease.

Implanting the WATCHMAN device is a one-time procedure that normally takes about an hour. Following the procedure, patients typically need to stay in the hospital for 24 hours. The key follow-up visit comes after 45 days, at which time the patient can stop taking warfarin after a thorough post-implant evaluation is done.

“After 45 days, we perform imaging diagnostics to make sure the patient’s body accepts the foreign device and that there is no trauma to surrounding issue or cell growth around it,” says Dr. Quesada. “This device offers a potentially life-changing option to reduce the risk of stroke, and frees patients from the challenges of long-term warfarin therapy.”