• Cottage Health Uses Watchman Implants to Help Prevent Strokes

Published on August 02, 2016

Cottage Health Uses Watchman Implants to Help Prevent Strokes

Alternative to Blood Thinners

When Jerry Swanitz cut himself, it would take a while for the bleeding to stop. He bruised easily. The 73-year-old Los Olivos resident, who has a heart condition called atrial fibrillation (AFib), was on warfarin, a blood thinner. The medication is intended to stop clots from forming in his left atrial appendage, part of the heart, and migrating to his brain and causing a stroke. But the medication put him at increased risk of bleeding.

Mr. Swanitz doesn't have to worry about that anymore, thanks to a device that looks like a little parachute and is now in his left atrial appendage. You can hold it in the palm of your hand.

The Watchman Left Atrial Appendage Closure Implant eliminates the need for anticoagulants, a more aggressive kind of blood thinners than aspirin, in patients with AFib. The device plugs up the left atrial appendage so clots can't enter the brain and cause a stroke.

Mr. Swanitz is among 35 patients in Santa Barbara County implanted with the device since January at Santa Barbara Cottage Hospital. They range from their 70s to 90s; bleeding risk goes up with age.

"They're doing great. Everybody has been able to come off their anticoagulants," Dr. Joe Aragon, Santa Barbara Cottage Hospital's director of interventional cardiology and structural heart disease, told the News-Press.

Mr. Swanitz, a retired Santa Ynez Valley High School principal and vice principal, said he's doing fine and is now less worried.

"In general, in whatever activity I'm involved in, I feel more confident I have a much lower risk of hemorrhagic bleeding from an injury," he told the News-Press just before working out on a treadmill at the Santa Ynez Valley YMCA in Santa Ynez.

The FDA approved the Watchman last year for patients with non-valvular atrial fibrillation, a condition in which the upper chambers of the heart beat too fast and with irregular rhythm. It's the most common form of cardiac arrhythmia and affects more than 5 million Americans.

The agency previously approved the device in 2007, then wanted further research to verify the device is effective in all kinds of stroke, Dr. Aragon, 45, said.

He explained Santa Barbara Cottage Hospital is the only facility between Los Angeles and San Francisco that implants the Watchman. He said Boston Scientific, the inventor of the device, approved the hospital for the procedure because of its expertise in interventional cardiology and cardiac electrophysiology, which focuses on the heart's electrical activity and arrhythmia.

Dr. Aragon, a Santa Barbara Cottage Hospital and Sansum Clinic cardiologist, and Dr. Brett Gidney, a cardiac electrophysiologist with the hospital, and others in their fields have implanted the device, and Dr. Aragon explained the difference between his and Dr. Gidney's disciplines. "I'm the plumber. He's the electrician."

Drs. Aragon and Gidney as well as Dr. Gregory Cogert, a Santa Barbara Cottage Hospital and Sansum Clinic cardiologist, will discuss advanced treatments for AFib during the free presentation "Meet the Doctors: Heart & Vascular Center" from 6 to 7:30 p.m. Thursday at the hospital, 400 W. Pueblo St.

At his nearby private practice, Dr. Gidney, 41, praised the Watchman. "There's good evidence that this device can be better than a drug. You don't have to remember to take your medication to prevent a stroke. You don't have to worry about stopping it for surgery."

"It's awesome. It's phenomenal for patients," Dr. Gidney said.

Dr. Aragon said private insurance and Medicare cover the device, which he estimated costs somewhere around $10,000 to $15,000. He said that's less than taking Coumadin (warfarin), a common blood thinner, for five years or Pradaxa (dabigatran), another blood thinner, for one year.

"This isn't for everyone. You have to be at high risk of bleeding and high risk of stroke from AFib," he said. "It's a very thoughtful decision process. Patients typically need to have extended conversations with their cardiologists and primary (care) physician. It's an invasive procedure, and it's not without risks."

He said there have been no complications in Cottage's procedures and that internationally, problems were only experienced in 3 to 4 percent of the implants.

He cited staggering statistics for the benefits.

"Research shows that 99 percent of all patients can stop their anticoagulants (blood thinners) within six months and 95 to 96 percent can stop anticoagulants within 45 days," Dr. Aragon said.

He explained patients take aspirin, an antiplatelet blood thinner, indefinitely, but their need for anticoagulants, which are more aggressive blood thinners, ends.

"The bleeding risk goes way, way down, and the patients do very well," he said, calling the device a lifesaver.

"In Europe, it's been approved for three to five years," Dr. Aragon said. "The European data shows patients who get this device and are able to stop their blood thinners and transition to aspirin actually have a mortality benefit. They live longer than patients taking Coumadin. ... We are getting a device that offers the same stroke protection, but has lower bleeding in the long-term. They (patients) have a lower chance of dying."

Dr. Aragon compared the Watchman to a cork and said it plugs up the left atrial appendage, so any clots that form there can't go elsewhere, including the brain. "We know from research that 91 percent of stroke risk from AFib is attributable to clots in the left atrial appendage."

The small device has a polyester membrane — again, it looks like a parachute — and a frame of nitinol, a metal used for years in medical devices, Dr. Aragon said.

He implants the Watchman by attaching it to a cable and pushing the cable through a catheter into a vein in the groin area and to the appendage. He releases the device after seeing it's secure in ultrasounds and X-rays. He studied the procedure with Dr. Saibal Kar, director of cardiac research at Cedars-Sinai Medical Center in Los Angeles.

Dr. Aragon completed his cardiology studies there from 2001 to 2004 and his interventional cardiology studies there from 2004 to 2005 before coming to Sansum Clinic and Cottage Hospital.

Plugging the appendage — effectively removing it from circulation — has no harmful effect, and patients have not reported any side effects from living with the one-time implant, Dr. Aragon said.

He sees the device as part of the groundbreaking improvements in medicine.

"I don't think we're quite at the point, like in 'Star Trek,' when you can take a tricorder and find out you have a blocked artery, and they give you a pill to make it go away. But we're at the point of treating diseases with devices in such a way that medications are not necessary in some cases."

By Dave Mason, News-Press Staff Writer

Posted with permission from the Santa Barbara News-Press

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