This is the 2018 paper, correct?

Yeah, that's right.

And we actually presented it in 2017 at a meeting.

It got a lot of press.

I was on like CNET and, you know, and Gizmodo and all these things.

And the idea was that we know that atrial fibrillation can be asymptomatic.

So it can be very symptomatic.

Okay.

[laughs]

They're like, "Oh, okay, yeah.

Now I know what your name is." Um, so as you mentioned, there's, there's this in- intuition that because caffeine tends to ramp up our sympathetic nervous system, that being the side of our nervous system that has to do with adrenaline, that that may be harmful and especially, uh, m- might increase the risk for abnormal heart rhythm disorders.

And so it has long been conventional wisdom that caffeine, caffeinated coffee, if anything, only increase, uh, uh, increase the risk for various forms of heart disease.

But it turns out that when you look at actual evidence, uh, studies that have been done, it's not that simple.

Uh, I wouldn't go so far as to say that, well, it's a panacea, it's definitely good for you, it's always healthy, and, and hopefully we can, uh, dig into this.

Uh, I think some of the challenges arise because there are many forms of heart disease, and it may be that the same substance, in this case caffeine, has some benefits for some of those outcomes, but maybe can be harmful in other cases.

Okay.

But, uh, as people get older and perhaps they've had some heart damage, uh, we still haven't, uh, turned a corner on congestive heart failure, and so let's talk about that.

Yes, indeed.

So I think that the, um...

So cardiovascular disease is the number one killer in the world, in the US.

Even among women, you know, I think there's this, uh, idea that it's breast cancer, but even in women, heart disease is the number one killer.

It used to be that that was all due to heart attack, the blockages of the blood vessels supplying blood to the heart.

As you mentioned, we, we, it's, that has been a success story, where the risks of heart attack are much, much lower than they used to be.

Hmm

Right, so about the new American Heart Association publication and statement, which you just referred to, can you explain what exactly is this publication? Is it a single research study or something much bigger than that that you did?

Yeah, so this was a very careful review of the medical literature that was generated by a lot of work over more than a year among selected experts in the field.

And there were multiple levels of peer review.

So number one, this had to be identified as a topic of interest of something of priority.

The outline and the author panel needed to be approved by multiple levels of, again, other experts who also weighed in and provided their input.

Similarly, we had multiple meetings, multiple discussions among the experts who then did their literature review, and generally they were assigned areas where within the caffeine arena.

For example, myself as a heart rhythm specialist, having done a lot of research in the field specifically related to our rhythms, I wrote that section.

Now, if you had to summarize the biggest takeaway for the general public in one or two minutes, what would it be from all this work that you did over the year?

Well, in reality, Greg found-

On days where people were randomly assigned to consume coffee, that evening, they on average slept 30 minutes less.

Wow, that's a lot.

It is a lot.

And in fact, there's other evidence that that magnitude of a difference may be meaningful in the long run in enhancing longevity.

So Greg, given your, uh, perspective from writing the editorial, if you can give us a high-level overview of the trial design of CHAMPION AF and what were the key findings.

Sure.

So it might be useful just for a little bit of background to remember that prior to this study, all the data on left atrial appendage occlusion was either in the setting of a comparison to warfarin, so not really representative of modern-day practice with NOACs or DOACs, or in patients with-- who clearly had some bleeding issue.

And other important context, uh, is the recent publication of the CLOSURE AF study that, uh, failed to show that the left atrial appendage, uh, occlusion approach, uh, with a variety of devices was inf- uh, non-inferior to NOACs.

So CHAMPION, uh, enrolled quite broadly those patients with atrial fibrillation at a heightened risk for stroke, but not necessarily with any known problems with taking anticoagulation, uh, to either undergo, uh, left atrial appendage occlusion with a Watchman device or a NOAC.

Uh, there was no specified requirement regarding the type of NOAC that was used.

Uh, really the inclusion was just CHA2DS2-VASc score of at least two or greater than two in, in men, greater than three in women.

Are we seduced here by saying that we close up the appendage with a device and it's as good as anticoagulation? And were there any, any downsides that this trial, or if you were to redesign it, would be-