
February 21, 2024
NORTHEAST WISCONSIN — “Together, we inspire your best life by relentlessly caring, learning and innovating.”
Bellin Health’s mission statement, Dr. Rudy Evonich said, is exactly why the healthcare system’s cardiac team was the first to implant the newest WATCHMANô device — the WATCHMAN FLX Pro.
“We’ve been doing (the) WATCHMAN implant for years — (it) is a big game changer for patients,” the cardiac electrophysiologist said. “(The WATCHMAN FLX Pro) expands it, so people with even larger appendages can have it.”
The WATCHMAN device, Evonich said, is a minimally invasive, implantable device that’s used to block or plug up a specific area in the heart where 90% of strokes originate from patients who have atrial fibrillation.
He said it’s a better and safer alternative to being on blood thinners long-term.
Since becoming commercially available in 2009, Evonich said the WATCHMAN has seen several updated versions, the FLX Pro coming with even more benefits than its previous counterpart, the WATCHMAN FLX.
More about the WATCHMAN FLX Pro
With previous versions of the WATCHMAN device, Evonich said patients would need to take several different medications for many months after their procedure.
The regiment he said, included:
For the first 45 days after the procedure, patients had to take Coumadin — an oral anticoagulant (blood thinner) — as well as a low dose of aspirin.After 45 days, the patient would have an ultrasound. If everything looked good, they would be taken off Coumadin and then take aspirin and Plavix, an antiplatelet drug that prevents blood clots, for the next six months.Once the six months were over, patients would take aspirin by itself.
“This is where you start seeing the benefit from the procedure, with less bleeding risk and equal stroke rate compared to continuing the anticoagulant,” Evonich said.
As of a year ago, he said most patients skipped Coumadin and went straight to taking aspirin and Plavix after the insertion, thanks to the newer models of the device.
Now, with the WATCHMAN FLX Pro, Evonich said he is hopeful that the only medication all patients will have to take after the procedure is aspirin.
“There is a special coating that makes it less likely for clots to form and enhances healing,” he said. “Now, the thought is, folks can probably take a baby aspirin from the time of implant, or take Plavix or take half a dose of blood thinning medicine — so that should translate into even lower bleeding risk.”
When Plavix — though not technically a blood-thinning medicine — is combined with aspirin, Evonich said the risk of bleeding goes up significantly, “and is comparable to the risk of being on blood thinners.”
At the moment, Evonich said the dozen patients who have received the WATCHMAN FLX Pro implant at Bellin Health did not leave on solely aspirin, as the new device is “not FDA labeled that way yet.”
“But, we know with the preclinical studies that have been done, that likely that would be okay,” he said. “So, if they go home from the hospital and start having bleeding, we’re confident in saying, ‘you can skip the Plavix, which is causing your issues, and just take the baby aspirin’ (once it’s FDA labeled).”
Dr. Rudy Evonich
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Another benefit of the newest version of the WATCHMAN device, Evonich said, is the addition of a sixth size option, which will allow Bellin Health to treat even more patients.
“Previously, (the WATCHMAN) was covering about 97% of patients, and now it’ll take it up to probably 99% of patients that are compatible with it,” he said.
The safety of the device and insertion itself, Evonich said, is noteworthy.
“With the WATCHMAN 2.5 — which was the first commercially available version — procedural risks were not high, but there was a 5-6% chance of some procedural complication,” he said. “With the WATCHMAN FLX and the FLX Pro, the safety has enhanced with each stage, and so now the chance of some complication with the procedure is less than 3%. It’s very safe.”
Meeting community need
Some patients at Bellin, Evonich said, “have been waiting for a long time” for the WATCHMAN FLX Pro to come out — which is why the cardiac team began to use it as soon as they could.
“(Those patients are) at particularly high risk for bleeding, and there are folks who don’t feel it would be served by needing to be on aspirin and Plavix that full six months after device insertion,” he said. “And so they’ve had multiple bleeding events, they’re not protected against stroke — they were waiting for this technology to become available.”
And, where typically patients may have been able to drive to a larger, metropolitan area to receive care, they wouldn’t have had access to get the WATCHMAN FLX Pro sooner, as it wasn’t released — and Bellin was the first to implant it.
“It doesn’t prevent atrial fibrillation from occurring- it only protects against stroke,” he said. “But that is so satisfying for patients and their peace of mind, so it’s a game changer.”
The WATCHMAN, Evonich said, lowers a lot of risks for stroke, such as:
80% fewer brain bleeding events59% fewer fatal or disabling strokes52% fewer major bleeding events
To learn more about Bellin Health’s heart & vascular care offerings, visit bellin.org.