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.

Advertisements

Runners with Atrial Fibrillation – Thinking About Having a Cardioversion? “Look Before You Shock”

sunsetbackyard

This is, so far, the most discouraging article about atrial fibrillation I have ever read:

Left Atrial Appendage Thrombus When Least Expected: Look Before You Shock, Evaluate Before You Ablate | EP Lab Digest

As a distance runner with atrial fibrillation, who never missed a single dose of my anti-coagulant, and who has already had a blood clot in my left atrial appendage, and has already had a “mini-stroke” – this one leaves me feeling a bit hopeless.

Feel free to read the article; but I will go over a few key points here. One of the dreaded consequences of atrial fibrillation is having a stroke. Because the top chambers of the heart, the atria (plural of atrium) are beating so fast that they are basically just sitting there vibrating, the blood pools and becomes sluggish, and is prone to forming blood clots. Combine this with an enlarged left atrium and the likelihood is even higher. The blood clot forms in a little corner of the heart called the “left atrial appendage” (LAA).

appendage

That’s where I formed a clot. If the blood clot, or a piece of the clot, breaks off it can quickly travel to the brain, get caught and cut off the circulation to part of the brain. This is a type of stroke, and is a huge problem for people with atrial fibrillation.

There are people who like to refer to a stroke as a “brain attack” because that’s what it is – like a heart attack in the brain. And like heart attacks there are big ones and small ones. I had a small one (TIA – tangent ischemia episode) that fortunately only lasted a minute or so. A big stroke, of course, can be fatal.

Important point: if a person is in atrial fibrillation and has blood clot in the LAA, it might be very stable. It might be just sitting there, hanging out, because the atria isn’t doing any beating. Everything is pretty tranquil in there. But then the person has a cardioversion (shock to reset the beating heart) or an ablation and the atrium begins to beat again, the blood starts moving through more quickly – well – now there’s a problem. Now the clot can break loose and BLAM!! – you’ve had a stroke!

The problem: it’s difficult to tell whether or not a patient has a clot prior to having a procedure. A regular echocardiogram doesn’t even show a small clot; there’s not enough detail. The best way to determine if a clot is present is to do a transesophageal echocardiogram (TEE).

teeTransesophageal Echocardiogram

I’ve had three TEEs – it’s not fun – sort of like swallowing a telephone. Thankfully the last two that I had involved an anesthesiologist who put me to sleep for the procedure.

As far as I know it is fairly common to have a TEE prior to having an ablation procedure; but less common before a cardioversion (the shock!), especially for people who presumably have a low risk of a LAA blot clot – like people who are appropriately anti-coagulated, or people who have had atrial fibrillation for less that 48 hours.

In this article five interesting cases are reviewed.

Case #1 – a patient who was effectively anti-coagulated but turned out to have a LAA clot anyway (sounds familiar).

Case #2 – a patient who was actually more anti-coagulated than thought necessary, and was in atrial flutter for less than 48 hours, but turned out to have a LAA clot anyway.

Case #3 – an appropriately anti-coagulated person with a low risk of clot (CHADS2 score=1), but turned out to have a LAA clot anyway.

Cases #4 and #5 were high risk patients who would be expected to have a high risk of a clot. Case #5 actually had three clots in her heart – yikes!

How does all this apply to athletes with atrial fibrillation? Well, apparently healthy, athletic patients, who are appropriately anti-coagulated, and either undergoing a planned or emergency cardioversion, still have a certain risk of having a LAA clot and subsequent stroke.

Should everybody have a TEE before having a cardioversion? Probably not. TEE is expensive, unpleasant, and if anesthesia is involved it basically takes up an entire day out of your schedule. It might be a good idea to talk it over with your cardiologist, however.

mooreparkrun
Happy Trails