A-fib? Expert warns to watch out for the ‘Watchman’
If you have a-fib, more likely than not, you’ve been told by your doctor to take a blood thinner in order to prevent a stroke.
Now, however, you may be hearing about another way – one that will allow you to ditch the drugs with a device called the Watchman.
But one prominent cardiologist who has taken a good long look at this device and how it’s supposed to work has found that it not only won’t protect you against a stroke… but it could trigger a life-threatening stroke.
And if anyone at the FDA had been paying attention, the agency would know that as well.
And considering that the Watchman is now being heavily promoted – even by hospitals – it’s especially important to know the whole story before deciding whether you literally want to “take it to heart.”
‘It should bother you’
Tens of thousands of Americans now have what Dr. John Mandrola, a specialist in heart rhythm disorders, calls a “foreign body in the heart.”
It’s not because of some freak accident, but rather because they had surgery to have the Watchman device implanted.
It looks like a mini-parachute, and a doctor threads it up a leg vein until it reaches a part of the heart called the left atrial appendage (LAA), where it pops open.
The idea is that heart tissue will grow over the Watchman and, according to the ads, “form a barrier against a blood clot.”
In theory, it may sound like a good idea: Close off the part of the heart where someone with a-fib may develop a blood clot and, voilà! No more need to take a blood thinner!
But after carefully researching the Watchman, Dr. Mandrola found that it won’t protect you from suffering an ischemic stroke (the most common kind) in the first place. And he was able to discover that by looking at the very same industry-conducted trial data that was presented to the FDA when it OK’d the Watchman.
That information has prompted Dr. Mandrola to refer to the whole approval of the device as “weird” and suggest that experts were distracted with “complicated statistics.”
Call me crazy, but aren’t complicated statistics what the FDA is supposed to analyze?
That’s why, in an article written for other cardiologists, Mandrola told them that “it bothers me” and “it should bother you.”
To say the least!
But mere ineffectiveness isn’t the only thing that should bother you about the Watchman, because the device can actually cause the very thing it’s supposed to prevent — a clot or stroke.
Not only did the device fail to do as good a job as warfarin, the old blood-thinning drug it was tested against, but in one of the early trials, the patients inserted with the Watchman were suffering strokes at a 50 percent higher rate!
It turns out that clots can form simply due to the device sitting in your heart. In fact, “stroke” is one of the side effects the maker warns you about!
So, does that mean that if you have a-fib, taking a risky drug to thin your blood is the only option?
Not exactly.
As you’ve read here in eAlert, numerous studies, including a large one from the University of California, San Francisco, discovered that a good number of people – 25 percent of the 11,000 subjects with a-fib that researchers looked at – were at low risk of having a stroke and didn’t need to take a blood thinner at all.
Then there are patients who only have “short bouts” of this abnormal heart rhythm, which other research has found also takes them off the list for needing an anticoagulant.
So, before you allow a doctor to insert a foreign object inside of your body — and especially into your heart — it’s of the utmost importance that you do your own research and know exactly what’s involved and how it works.
“Left atrial appendage closure should stop now” Dr. John Mandrola, Medscape, Medscape.com
