David Fleming, 68, of Franklin, is one of 2.7 million Americans diagnosed with atrial fibrillation (AFib). People with AFib are at a high risk for stroke because their heart rhythm is abnormal. Chaotic electrical impulses can cause blood to pool in the heart, which can lead to blood clots. An AFib diagnosis can often mean a lifetime of blood thinner medications, but in David’s case, the WATCHMAN™ was a better option.
What Is a WATCHMAN?
The WATCHMAN is a device designed for people with AFib to close off the part of the heart where blood clots that can lead to strokes are most likely to develop. This area is a small pouch in the left atrium called the left atrial appendage (LAA). Its purpose is not well understood because it does not serve a cardiovascular or other physiological function. However, blood cells tend to stick together inside the LAA and can form clots. When a WATCHMAN device is implanted in the LAA, it expands and closes the LAA off to the rest of the heart, preventing blood from pooling and a potential clot from escaping, thus eliminating the need for blood thinners.
“Studies have shown that the WATCHMAN is effective in preventing strokes related to AFib without being on blood thinners,” said James Oujiri, MD, electrophysiologist with the Froedtert & MCW health network. “For patients who cannot tolerate blood thinners or who have a high bleeding risk, this device may be a great alternative.”
WATCHMAN for Atrial Fibrillation
David was diagnosed with AFib and atrial flutter in 2018. His primary care doctor referred him to Dr. Oujiri after an episode of AFib sent David to the hospital. Dr. Oujiri performed an ablation procedure at Froedtert Hospital to relieve David’s AFib symptoms and prescribed blood thinners to reduce David’s risk of stroke.
Around the same time as the ablation, David was being treated for an enlarged prostate. When he noticed blood in his urine, he brought his concerns to his urology and cardiology teams at Froedtert Hospital. With this new increased bleeding risk, they agreed that closing off David’s LAA with a WATCHMAN would be the best way to protect him from a potential stroke.
After the procedure, people are required to take blood thinners for 45 days, while the lining of the heart grows over the device to prevent clots. But a national clinical trial that was enrolling patients at Froedtert Hospital was designed to evaluate the WATCHMAN without blood thinners after the procedure, only anti-platelet therapy and aspirin. David was approved for the device through the ASAP-TOO clinical trial.
“My doctors had extensive knowledge about the latest treatments,” David said. “I truly appreciated that because it meant this clinical trial was available to me.”
The WATCHMAN Procedure
David’s WATCHMAN procedure was in August 2020 at Froedtert Hospital. The implantation took about an hour and was done under general anesthesia. The first step was a transesophageal echocardiogram so that Dr. Oujiri could visualize the LAA. LAA anatomy can vary in size and shape for each individual, and the echocardiogram ensures the device will be a good fit. The imaging is also important to guide the placement of the device.
The procedure does not require any incisions in the chest. Instead, through a small incision in the femoral vein, near the groin, a catheter is used to guide the device into position inside the LAA, where it will expand and seal off the opening.
The team at Froedtert Hospital has been implanting the WATCHMAN since 2015 when the device was approved for use by the FDA and is a leading implanter of the device in the state of Wisconsin. Froedtert & MCW patients benefit from the combined expertise of an interventional cardiologist and electrophysiologist during the procedure.
“My team was top notch,” David said. “I felt very well taken care of every step of the way.”
David spent one night recovering in the hospital after his procedure. After a few days at home, he went back to work as an attorney. A month later, he returned to Froedtert Hospital for another echocardiogram to check the positioning of the device and to ensure the medication regimen set by the clinical trial, without blood thinners, was working well.
Long-term results from two randomized clinical trials found that people with a WATCHMAN reduced their risk of a disabling or fatal stroke by 55% compared with people who are being treated with blood thinners. David said he has also been able to stay more active than he was on the blood thinners, which helps him be a caregiver to his elderly mother. He feels an overwhelming sense of relief.
“Having peace of mind and knowing that I’m not going to have a stroke takes away so much anxiety,” David said. “Having this device gives me a great sense of comfort.”
Learn more about the WATCHMAN device and left atrial appendage management options.
Main photo courtesy of Boston Scientific Corporation.