Watchman Device Update

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.

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Runners with Atrial Fibrillation – Considering the Watchman?

Are you considering the Watchman device?

Watchman_2

Ever since having a TIA/stroke, I certainly have thought a lot about it.

What is it? The Watchman, by Boston Scientific is a little device, sort of like a basket, that can be inserted into the left atrial appendage, theoretically blocking it off and preventing clot formation. As you probably know already, clot formation may lead to Stroke. The device was FDA approved in the US in March, 2015, and has been used in Europe since 2005.

It’s placed in the left atrial appendage via a catheter through an artery in the groin, and if all goes well the patient can discontinue their blood thinner (warfarin, etc.) within six months.

Sounds great, doesn’t it?

I know I’d love to be protected from having another TIA or stroke and not have to take a blood thinner – I’m currently on warfarin + aspirin which makes bicycling, especially mountain biking, quite hazardous. But truthfully, it’s not that I necessarily want to be off the warfarin: I just don’t want to ever have another TIA/stroke. Recall that I had my event while I was already taking Pradaxa (and I never missed a dose). I just want a treatment that is going to work.

trail

But there is some evidence to suggest the Watchman might not be as terrific as it sounds.

A recent study showed that the risk of a major bleed over the course of three years is the same with the Watchman compared to just staying on warfarin. Huh?

This is an excerpt from a Medscape article:

Patients with atrial fibrillation (AF) who received a left atrial appendage closure device (Watchman, Boston Scientific) or stayed on long-term warfarin therapy had similar rates of major bleeding during a mean follow-up of 3.1 years, in pooled analysis of two randomized clinical trials[1]. However, patients who received the device and were able to stop taking warfarin and clopidogrel at 6 months had lower rates of major bleeding from then onward, compared with patients receiving long-term warfarin.

Furthermore, in a very thoughtful, somewhat technical, article CMS Proposal on Watchman Is the Right Decision, Dr John Mandrola, a thought leader in Cardiology and Electrophysiology, agrees with the CMS proposal that “the evidence is sufficient to determine percutaneous left atrial appendage closure therapy using an implanted device is not reasonable and necessary.”

dogwalking

There are two major studies in the US regarding the Watchman. According to Dr Mandrola in the PREVAIL study, “Due to an excess of ischemic strokes, Watchman did not reach noninferiority in this category in the updated analysis presented to the FDA.” In PROTECT-AF study, “ischemic strokes were numerically higher in the Watchman group.” Which, ultimately, “leads one to conclude that the device is not effective.”

As for me, personally, as much as I’d like to believe the Watchman is a solution for me, the evidence, so far, is not convincing. I’m going to wait.

By the way, if any readers have experience with the Watchman PLEASE leave a comment below. We would love to hear from you!

Adverse effects of the Watchman:

“The main adverse events related to this procedure are pericardial effusion, incomplete LAA closure, dislodgement of the device, blood clot formation on the device requiring prolonged oral anticoagulation, and the general risks of catheter-based techniques (such as air embolism). The left atrium anatomy can also preclude use of the device in some patients.”

By the way – I linked a couple of articles from Medscape. I’m not certain but I think you need to be registered for that sight. Sorry.