Cardiac device used by UPMC allows some an alternative to blood thinners
Ralph Bish spent the past 22 years of his life taking blood thinners to stave off increased odds of a stroke.
His stroke risk originates from a heart rhythm disorder known as atrial fibrillation, or AFib, that affects 2.7 million people in the United States.
As a new solution, UPMC doctors introduced Bish to the Watchman, a cardiac surgical device that helped him wean off blood thinners. Some patients like Bish, who take blood thinners as a traditional therapy for atrial fibrillation, suffer severe bleeding as a side effect.
The Watchman, approved by the Food and Drug Administration about a year ago, is lauded by doctors as a viable alternative to blood thinners, such as warfarin, for patients with atrial fibrillation.
UPMC is the first hospital system in Western Pennsylvania to implant the device in a surgery that lasts about an hour. Allegheny Health Network expects to offer it soon.
People with atrial fibrillation are at an increased risk for clots and strokes because the heart's upper chambers beat too fast, which often results in blood pooling and forming clots in a portion of the heart called the left-atrial appendage. If the clots escape into the bloodstream, they can lead to stroke. Because the heart's left atrial appendage doesn't have any useful function, the Watchman, made of mesh and wire, is designed to close it off from blood flow. The quarter-sized, parachute-shaped device is collapsed into a sheath and implanted through a vein in the leg using imaging technology. Once it reaches the heart, the parachute opens, and it closes off the left atrial appendage, where clots often form.
“Essentially, what you are doing is creating a new wall by implanting the device,” said Dr. David Schwartzman, a cardiologist at UPMC's Heart and Vascular Institute. “It's really designed as a scaffold to allow the body to build a wall over it and wall the appendage off from circulation.”
Before receiving the Watchman device, Bish, 83, of Allegheny Township was in poor health: His blood count got so low from internal bleeding that he needed three blood transfusions in 2015 and had to be hospitalized eight times. Doctors never discovered exactly where the bleeding came from but theorized that the blood thinners contributed to the problem.
On Nov. 11, Schwartzman's colleague Dr. Raveen Bazaz implanted the Watchman in Bish at UPMC Presbyterian. He went home the following day. On Dec. 28, he was taken off blood thinners. He's hoping his blood count increases with the new apparatus.
“I'm so glad I found out about this,” said Bish, who for 40 years co-owned a medical electronic equipment company called Capintec. “I did a lot of research on it beforehand, and it was definitely the right thing for me to do.”
So far, 100 medical centers in the United States are using the Watchman, according to Dr. Kenneth Stein, chief medical officer of rhythm management for manufacturer Boston Scientific. In February, the Centers for Medicaid and Medicare Services approved Medicare coverage for the device.
Medicare initially proposed that it would offer coverage only to patients unable to take blood thinners. However, Stein said, patients currently must take blood thinners for 45 days after implantation to avoid any short-term stroke risk.
“It's really exciting for us to offer an alternative beyond lifelong blood thinners for patients with atrial fibrillation who face the risk of stroke,” Stein said. “The Medicare decision was a huge hurdle for us in developing clarity around payment.”
Boston Scientific's goal is to expand clinical trials to the point at which patients no longer need the extra 45 days of blood thinners.
Dr. Jonathan Hsu, a cardiologist and assistant professor of medicine at the University of California, San Diego, is keeping a watchful eye on the Watchman.
Hsu published a study in the March 16 online edition of JAMA Cardiology that shows less than half of atrial fibrillation patients received the recommended amount of blood thinners. Hsu and a team tracked 400,000 people over four years.
While the study did not focus on the Watchman, Hsu said it could welcome technology as a way to reduce stroke in the atrial fibrillation population.
“Overall, I would say the device is a welcome advance as a therapeutics option,” he said. “I don't see the entire field going to the Watchman — there will always be a place for blood thinners — but it certainly looks to be an effective alternative.”
Ben Schmitt is a Tribune-Review staff writer.