‘Watchman’ at UMass Memorial replaces heart fibrillation patients’ need for blood thinners
By Geraldine A. Collier, Correspondent
Posted Apr 3, 2018 at 8:00 PM
Updated Apr 4, 2018 at 1:53 PM
WORCESTER — It took Dr. Kevin Floyd, an electrophysiologist at UMass
Memorial Medical Center, and his team only about 20 minutes one day last
April to negate a major threat to the health and possibly even the life
of 86-year-old Northboro resident Bucky — nobody has called him by his
first name, Grenville, since he was a teenager — Rogers.
That threat came from what Dr. Floyd terms a “nuisance,” a small part of the heart’s anatomy called the left atrial appendage that serves no good purpose anyone knows of, but whose existence can be deadly for people like Mr. Rogers, whose heartbeat can sometimes become disorganized and chaotic.
Those erratic heartbeats — atrial fibrillation — can hardly be noticed by some patients, while others say it’s like having a wild bird trapped in your chest fighting to escape. However, no matter how much those unsteady heartbeats are felt, they make for an inefficient squeezing of blood from the heart’s upper chamber (the left atrium) into the bottom chamber (the left ventricle).
Now that small outpouching in the left atrium referred to as an appendage can be shaped like either a chicken wing, broccoli or a windsock. Silly as those names sound, there’s nothing humorous about that appendage, where, with inefficient pumping, blood can pool. A clot can then form and travel through the heart’s arteries up to the brain, causing a stroke. People with atrial fibrillation are five to seven times more likely to have a stroke than average people, and the majority of those are caused by a blood clot coming from that appendage.
To prevent that clot from forming, atrial fibrillation patients are put on blood thinners. You may recognize the name warfarin or its brand name Coumadin, or newer blood thinners, such as Eliquis, Xarelto or Pradaxa. But blood thinners come with a problem of their own. If the blood thins out too much, bleeding can occur. In some cases, the bleeding and medication — if it’s Coumadin or Pradaxa — can be reversed; in some cases it cannot.
Coumadin, which Mr. Rogers was prescribed, comes with constant monitoring at UMass Memorial’s Anticoagulation Clinic to establish the correct dosage, while other blood thinners do not require monitoring. However, those new alternatives come with their own set of pros and cons
Now Mr. Rogers is a very active man, despite his age. “I still walk two miles every morning, play 18 holes of golf during the week, (am) still driving and I run a real estate business,” he said. At one time he also liked to travel but had to give that up because of the need for monitoring.
“I asked them how long I was going to be on this and they told me, ‘It’s for life,’ ” said Mr. Rogers.
“I figured that whatever life I had left was not going to be very pleasurable,” he added, and traveled twice a week from Northboro to the busy “Coumadin clinic” off Lincoln Square, where a step-by-step screening process can involve lengthy waits. “It took the whole day each time.”
However, even with those frequent visits and manipulation of the Coumadin dosage, there was a problem. Turns out Mr. Rogers is a bleeder. And switching medications would not have been any help, according to Dr. Floyd, because the safety profile or risk of bleeding is the same for all blood thinners.
Internal bleeding can manifest itself in different ways. “The most
devastating bleeding events that we see are neurological bleeding or
bleeding in/around the brain,” said Dr. Floyd. Severe headaches or even
stroke-like symptoms of slurred speech, vision changes and weakness can
occur.
Now in medicine, timing is everything. Fortunately, for Mr. Rogers and other patients with atrial fibrillation for whom blood thinners are a poor option, in 2015 the federal Food and Drug Administration approved a device called the Watchman. Like putting a cork in a bottle of wine, the Watchman serves to plug up that little appendage.
Sounds like a simple concept. However, after initial clinical trials produced a fairly high complication rate of 10 percent, the FDA mandated special training for all physicians who were going to implant the device, such as Dr. Floyd and UMass Memorial’s interventional cardiologist Dr. Nikolaos Kakouros.
The FDA also mandated a somewhat different kind of training for cardiologists who are echocardiographers such as UMass Memorial’s Dr. Bryon Gentile, who guides the implant procedure and reviews pre- and postechocardiograms.
As a result of training, complication rates fell to about 2 percent, but the need for such a highly trained team, which at UMass Memorial includes Nicole Navis, a nurse practitioner who coordinates the cases, has led to only a few sites in New England offering the procedure.
With the patient under general anesthesia, a large intravenous line is inserted in the femoral vein, which is located next to the femoral artery in the leg and groin. Through that line, a catheter — basically a plastic tube containing the compressed, quarter-sized Watchman device — is moved up through the blood stream into the upper right chamber (atrium) of the heart. A small hole is made through the wall between the two upper chambers (the two atria) of the heart so that the catheter can be guided into the left chamber (the left atrium), then into the appendage.
“We then take pictures of it, to make sure it’s not going anywhere and to make sure there is no leakage around the device,” said Dr. Floyd. Once the team is satisfied with the positioning, the device is deployed — much like opening an umbrella — which basically plugs up the appendage so ultimately blood can’t flow into it or out of it.
Usually a patient stays on the blood-thinner medication for about 45
days after having the procedure done. Then, with the use of a special
kind of ultrasound, the cardiologists look for any leak around the
device or a blood clot that could have formed on top of the device. If
nothing is found, the blood-thinner medication is stopped. About 90 to
95 percent of patients across the country who have this procedure done
are able to get off their medication. At UMass Memorial, where 60
procedures have been done so far, the success rate has been 100 percent,
according to Dr. Floyd.
Over time, the heart just forms a lining over the top of it, completely sealing it off from the rest of the heart to the point that if you were going to take a camera and try to find the device, you wouldn’t be able to see it.
Because of a restraint on the medical center’s resources, Dr. Floyd and his team are implanting the Watchman device only two days a month, with a maximum of three patients each day. Consequently, Dr. Floyd anticipates treating about 70 patients annually.
The focus is on patients who have atrial fibrillation who are at risk for a stroke or have “a compelling reason” not to be on blood thinners. That compelling reason could apply to patients who are unsteady on their feet and at risk for a fall. It can also apply to patients who live an active lifestyle and need an alternative to blood thinners.
As for Mr. Rogers, now off his blood thinner, well, there’s an active — and happy — man.
That threat came from what Dr. Floyd terms a “nuisance,” a small part of the heart’s anatomy called the left atrial appendage that serves no good purpose anyone knows of, but whose existence can be deadly for people like Mr. Rogers, whose heartbeat can sometimes become disorganized and chaotic.
Those erratic heartbeats — atrial fibrillation — can hardly be noticed by some patients, while others say it’s like having a wild bird trapped in your chest fighting to escape. However, no matter how much those unsteady heartbeats are felt, they make for an inefficient squeezing of blood from the heart’s upper chamber (the left atrium) into the bottom chamber (the left ventricle).
Now that small outpouching in the left atrium referred to as an appendage can be shaped like either a chicken wing, broccoli or a windsock. Silly as those names sound, there’s nothing humorous about that appendage, where, with inefficient pumping, blood can pool. A clot can then form and travel through the heart’s arteries up to the brain, causing a stroke. People with atrial fibrillation are five to seven times more likely to have a stroke than average people, and the majority of those are caused by a blood clot coming from that appendage.
To prevent that clot from forming, atrial fibrillation patients are put on blood thinners. You may recognize the name warfarin or its brand name Coumadin, or newer blood thinners, such as Eliquis, Xarelto or Pradaxa. But blood thinners come with a problem of their own. If the blood thins out too much, bleeding can occur. In some cases, the bleeding and medication — if it’s Coumadin or Pradaxa — can be reversed; in some cases it cannot.
Coumadin, which Mr. Rogers was prescribed, comes with constant monitoring at UMass Memorial’s Anticoagulation Clinic to establish the correct dosage, while other blood thinners do not require monitoring. However, those new alternatives come with their own set of pros and cons
Now Mr. Rogers is a very active man, despite his age. “I still walk two miles every morning, play 18 holes of golf during the week, (am) still driving and I run a real estate business,” he said. At one time he also liked to travel but had to give that up because of the need for monitoring.
“I asked them how long I was going to be on this and they told me, ‘It’s for life,’ ” said Mr. Rogers.
“I figured that whatever life I had left was not going to be very pleasurable,” he added, and traveled twice a week from Northboro to the busy “Coumadin clinic” off Lincoln Square, where a step-by-step screening process can involve lengthy waits. “It took the whole day each time.”
However, even with those frequent visits and manipulation of the Coumadin dosage, there was a problem. Turns out Mr. Rogers is a bleeder. And switching medications would not have been any help, according to Dr. Floyd, because the safety profile or risk of bleeding is the same for all blood thinners.
Now in medicine, timing is everything. Fortunately, for Mr. Rogers and other patients with atrial fibrillation for whom blood thinners are a poor option, in 2015 the federal Food and Drug Administration approved a device called the Watchman. Like putting a cork in a bottle of wine, the Watchman serves to plug up that little appendage.
Sounds like a simple concept. However, after initial clinical trials produced a fairly high complication rate of 10 percent, the FDA mandated special training for all physicians who were going to implant the device, such as Dr. Floyd and UMass Memorial’s interventional cardiologist Dr. Nikolaos Kakouros.
The FDA also mandated a somewhat different kind of training for cardiologists who are echocardiographers such as UMass Memorial’s Dr. Bryon Gentile, who guides the implant procedure and reviews pre- and postechocardiograms.
As a result of training, complication rates fell to about 2 percent, but the need for such a highly trained team, which at UMass Memorial includes Nicole Navis, a nurse practitioner who coordinates the cases, has led to only a few sites in New England offering the procedure.
With the patient under general anesthesia, a large intravenous line is inserted in the femoral vein, which is located next to the femoral artery in the leg and groin. Through that line, a catheter — basically a plastic tube containing the compressed, quarter-sized Watchman device — is moved up through the blood stream into the upper right chamber (atrium) of the heart. A small hole is made through the wall between the two upper chambers (the two atria) of the heart so that the catheter can be guided into the left chamber (the left atrium), then into the appendage.
“We then take pictures of it, to make sure it’s not going anywhere and to make sure there is no leakage around the device,” said Dr. Floyd. Once the team is satisfied with the positioning, the device is deployed — much like opening an umbrella — which basically plugs up the appendage so ultimately blood can’t flow into it or out of it.
Over time, the heart just forms a lining over the top of it, completely sealing it off from the rest of the heart to the point that if you were going to take a camera and try to find the device, you wouldn’t be able to see it.
Because of a restraint on the medical center’s resources, Dr. Floyd and his team are implanting the Watchman device only two days a month, with a maximum of three patients each day. Consequently, Dr. Floyd anticipates treating about 70 patients annually.
The focus is on patients who have atrial fibrillation who are at risk for a stroke or have “a compelling reason” not to be on blood thinners. That compelling reason could apply to patients who are unsteady on their feet and at risk for a fall. It can also apply to patients who live an active lifestyle and need an alternative to blood thinners.
As for Mr. Rogers, now off his blood thinner, well, there’s an active — and happy — man.
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