Slowdown in Watchman sales?

[www.startribune.com]

Article is behind a paywall, but indicates recent patient result studies comparing the Watchman to blood thinners have slightly less favorable results on stroke risk. Article is written from an economic/investment standpoint rather than a medical one.

It is not a definitive article. It does not delve into why a person may want a Watchman due to the downsides of life long blood thinners. But it says "patients" are choosing to remain on blood thinners, whereas I believe doctors are steering the decisions. Although if it weren't for this website, I wouldn't have known what a Watchman was about. Dr. Natale's office just indicated he would be inserting one in me without much discussion. However, they could probably tell I was familiar with the device by the way I reacted to their news.

Article mentions that the newest model of Watchman appears to be slightly less successful than a previous version. Now I wonder which version I have, and what the difference is.

The article appears in a Minneapolis paper because Boston Scientific manufactures them in Minnesota.

Quote
nonthumper
Article mentions that the newest model of Watchman appears to be slightly less successful than a previous version. Now I wonder which version I have, and what the difference is.

I didn't see that at all. The only comparison was a study that compared Watchman alone vs. anticoagulants alone, which found that the anticoagulants had a slight edge. But that doesn't take bleed risk into account, which is very much part of the decision for going with a Watchman. What it did business-wise is lower the demand for Watchmans for what they call "soft" reasons, meaning reasons such as just not wanting to be on an anticoagulant for life.

If you got your Watchman after Sept 26 2023, it would be the third generation Watchman FLX Pro. I have the second generation Watchman FLX, which I received as part of the clinical trials for it in 2018 (it was approved in 2020).

[www.acc.org]

There are some clouds hovering over the Watchman data indicating there needs to be more time, possibly a rethink about the way it is installed or something. The cited article warns that there is a measured, but not statistically significant overage of strokes in the Watchman patients.

@Carey: I will have to look at the article again. My wife was reading it to me, as she has the subscription to that news source on her device. That is what I heard her to say, but I will double check.

So here is the paragraph that caught my attention:

"Results from a German clinical trial in March suggested that the latest Watchman version wasn’t quite as effective as blood-thinner medications in preventing strokes and cardiac deaths."

So I interpreted that incorrectly on hearing it. It is not comparing newer Watchman models with previous ones. It is merely stating the latest Watchman model was compared to blood thinners.

Click here to read the article without the paywall.

Another new issue with Watchman are newer studies such as OCEAN and ALONE-AF which are the basis of why EPs in many major cardiac hospitals are allowing patients off of anticoagulation after a successful ablation. In other words, neither Watchman or anticoagulation may be needed by many after "x" months. The problem vs Watchman vs anticoagulation is that Watchman is in forever, but you can stop anticoagulation.

That doesn't mean Watchman doesn't have a place, but for many of us, it may no longer be the best choice based on these newer studies. For example, I'm a 4 and was allowed to stop anticoagulation after six months of my successful ablation. Had I opted for Watchman, I'd be stuck with it.

Jim

Quote
mjamesone
Had I opted for Watchman, I'd be stuck with it.

True, but that begs the question: So what? It has no impact on your life whatsoever. You can't see it, can't feel it, has no side effects, it's MRI safe, doesn't show up on TSA scans -- nothing. For all intents and purposes, it's not there.

I think it's great that someone like you with a CHADS 4 can come off anticoagulants, but personally, I'd be very wary of doing that based on only a couple of recent studies. I would want to see more confirmation. Anticoagulants don't worry me in the least, nor do I have any side effects from them so I'm in no rush to get off them. And above all, I've seen too much of what strokes can do to a person. I'm not a fearful person but stroke scares the crap out of me because it's one of the few things in life that has worse outcomes than death.

And to stress what you said about it still having its place, that's definitely true. Without it, I could not safely stop anticoagulants ever, not even for a single day. That's because my LAA was ablated and afterwards it did not meet the criteria for ever coming off. There are a few people here who are in the same situation and many more out in the world.

What I have learned here about isolating the LAA makes sense to me. That is: if you had an ablation, and the EP could not correct afib until they isolated the LAA, a dilemma has been created. In the short term, while the Afib was corrected, the patient's stroke risk has actually gone up due to the LAA not pulsing with the rest of the heart any more.

At that point, it is either blood thinner for the rest of your life, or the possibility of getting off them with the Watchman. Like Carey, I did not like the chances of me never missing a single dose of Eliquis. So for now I feel better with the Watchman in. I did not really see many problems with Eliquis though. I did not bleed extremely when cut, and have not had any internal problems I am aware of.

I just had my TEE yesterday, and have to wait a week to find out if I can get off Eliquis.

Carey: So what? It has no impact on your life whatsoever. You can't see it, can't feel it, ...

You may not see or feel it, but Watchman has both procedural and ongoing risks, i.e. permanent. Anticoagulation, on the other hand, does not have to be permanent.

As to ACs, yes, strokes can be devastating, but I personally know of two people, one who died, and one who became profoundly impaired, because of AC related bleeds. If it was only the stroke risk to be concerned about, I'd still be on ACs.

Jim