A simple device that reduces strokes associated with atrial fibrillation is “the talk of the town,” reports a cardiovascular surgeon at Mercy Health.
The conversation in northwest Ohio is being echoed throughout the country and the world, according to Dr. Daniel DiBardino.
As awareness of atrial fibrillation has continued to grow, the 2020 FDA approval of the latest evolution of the Watchman device is garnering unprecedented attention. Manufacturer Boston Scientific Corp. reports the implant has been upgraded with a polymer coating to further promote growth of tissue over the device once it is in the heart, and an additional size.
“With the recognition of how common atrial fibrillation has become, the Watchman has created quite a stir because it is rather a unique device for what it does,” Dr. DiBardino, cardiothoracic medical director, Mercy Health, said.
The device is implanted in the opening of the left atrial appendage, where 90 percent of stroke-causing clots are formed in the heart. It blocks the flow of blood that tends to pool in that unneeded appendage, and then coagulate, allowing clots to travel to other parts of the body.
A physician makes a small incision in the groin area and inserts a catheter into a blood vessel. Computer imaging helps direct the catheter and the device through the vein to the heart.
Once implanted, it offers 90 percent protection from stroke, according to Dr. Stephanie Younes, an interventional cardiologist with ProMedica. Patients are mildly sedated for the procedure and most recover quickly enough to go home the same day.
“Blood can't go in and can't go out,” said Dr. Younes of the left atrial appendage. “Whatever blood is there clots.”
And it remains in place. There are no blood clots rambling around the body looking to create mayhem.
“It is a very powerful, newish tool in our arsenal,” Dr. DiBardino said.
Other than acting as a blockade, the Watchman doesn't really do anything but rest in place. But it results in a significant reduction in the ischemic stroke rate — compared to the expected rate with no device. It is a replacement for blood thinners.
“It does not make the patient feel any different,” said Dr. Oussama Wazni, section head of Cardiac Electrophysiology and Pacing at the Cleveland Clinic, where about 300 of these procedures are done each year. “Complications are rare.”
The polymer coating provides an 86 percent reduction in inflammation three days following the procedure, a 70 percent reduction in blood clots in 14 days and a 50 percent increase in tissue coverage of the device after 45 days, according to Boston Scientific.
Atrial fibrillation is the most common type of heart arrhythmia, when the heart beats too slowly, too fast or in an irregular fashion. The average person with AFib is five times more likely to suffer a stroke than someone with a regular heartbeat. Since the condition lends itself to a greater risk for stroke, patients are often prescribed blood thinners.
“We are recognizing it for the terrible disease it is. The more we look for it the more we find,” said Dr. DiBardino, who foresees increasing use of the device.
Without a Watchman device, AFib patients are put on blood thinners, such as Xarelto or Warfarin. Yet, 83 percent of patients taking a blood thinner say they would be willing to try a different treatment.
“Anticoagulation is not good for patients. It is intrusive on lifestyle,” said Dr. DiBardino, who emphasizes the device does not fix AFib, but it goes a long way in reducing the risk for stroke in people who do have it.
One of the side effects of taking anticoagulants is an increased risk for serious bleeding. Many simple tasks offer increased chances for bleeding. For instance, soft bristled toothbrushes are recommended. Use of an electric razor is preferred to avoid nicks and cuts. Contact sports may need to be avoided. A bruise can result in significant internal bleeding.
“It is important to understand that blood thinners don't make you bleed, but it will definitely increase the amount of bleeding that will happen,” Dr. Younes said.
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