A little one a year ago I wrote about the Watchman device. People with atrial fibrillation often develop a blood clot in the part of the left atrium called the left atrial appendage. This Watchman device basically closes off this area to prevent clot formation.
Last time I wrote the device was relatively new (long term data wasn’t yet available), and based on my research it didn’t seem like a great choice. I would refer you to this excellent article on John Mandrola, MD’s blog: Say No to Watchman.
As a person who has already had a ministroke and a verified blood clot in my left atrial appendage, well yes, I am very interested in a device that would prevent me from having a stroke which, at this point, for me, seems pretty much inevitable. Technology improves over time, right?
So what is going on with the Watchman now?
Well, Boston Scientific released its final five year outcome data from the PREVAIL study, along with five year outcome data from the PROTECT-AF trial. I would refer you to an excellent article in Cardiac Rhythm News (link).
At first look I was fairly optimistic:
In the PREVAIL and PROTECT-AF randomized clinical trials, LAAC with the WATCHMAN device was compared to warfarin for stroke prevention in high-risk patients with non-valvular AF. In addition to stroke prevention comparable to warfarin, the analysis concluded the WATCHMAN device also effectively reduced non-procedure related major bleeding, disabling or fatal stroke, and mortality.
Source Cardiac Rhythm News
I had been thinking the best course of action would be to, perhaps, have a Watchman implant and just remain anti coagulated. After researching this, however, that doesn’t seem like a good plan. The Watchman device has been shown to protect from strokes with an outcome similar to warfarin; but it turns out most of the additional benefit of the Watchman is basically related to the fact that those patients didn’t suffer as many warfarin related side effects/deaths from strokes caused by bleeding or from other major bleeds:
The analysis confirmed a 55% reduction in disabling or fatal stroke, largely driven by an 80% statistically significant reduction in hemorrhagic stroke. Further, the combined data demonstrated a 52% decrease in non-procedure related major bleeding and 27% reduction in all-cause mortality when compared to long-term warfarin therapy
Source Cardiac Rhythm News
At best, regrettably, the Watchman device might be equivalent to warfarin as far as stroke prevention is concerned, but not necessarily better. At best, I think, it would be a good choice for people who have had problems (such as bleeding) with warfarin; but it hasn’t been tested on people who are not eligible for anticoagulation (who are generally less healthy patients). And the Watchman hasn’t been tested against the newer anticoagulants (Pradaxa, Eliquis, Xarelto) which may actually be more effective than warfarin.
So I’m just going to keep watching and hoping for a better option than the Watchman device. I’d be interested in your opinions, and especially in the opinions of anybody reading this who has had a Watchman implant. Please comment below.
Thank you so much for the details of the Watchmen device. I have a comment, it’s not actually on this device it’s on the anticoagulant Eliquis, which I am. Have they come out with a reversal agent for Eliquis yet and if not is there one on the horizon? I worry about having to have an emergency surgery and having to sit in the hospital waiting for Eliquis to wear off.
There is a reversal agent for Eliquis and Xarelto, it is a drug called “Andexxa” but so far it has not been FDA approved. The approval process is ongoing and a decision by the FDA is expected by May, 2018.
This would be a good topic for a blog post!
Thanks so much! Please keep us posted. I will be so relieved when I reversal agent is approved.