Apple-palooza

The Apple Watch had people buzzing. MARCIO JOSE SANCHEZ/AP

The Apple Watch Study, which aimed to test how well an algorithm that uses the watch’s optical sensor to detect atrial fibrillation, was released today. 

The study enrolled an impressive 419,297 people in just eight months. Of those, 0.5 percent — or 2,161 people — were notified that they might have atrial fibrillation, a relatively common arrhythmia that can lead to feelings of weakness and increases the risk of stroke and other conditions. “At least it is not an epidemic of false alarms,” said Dr. Eric Topol, director and founder of the Scripps Research Translational Institute.

But when you get to the part of the study that compared the watch to an electrocardiogram, or EKG, the number of people being studied dwindled to 450; the watch matched the EKG 17 times out of 20. “The technology has arrived. I am not one of those cardiologists that are blaming Apple for giving us too much information,” Dr. Rajat Deo, an associate professor of medicine at the University of Pennsylvania, told me. But he also cautioned other physicians not to make any decisions based on Apple Watch data alone.

Read my story for a deeper look.

Non-invasive heart valves shine

The other big news of the meeting is scheduled to come tomorrow — but you’re getting it early because Reuters accidentally released a story ahead of the presentation, leading to a lifting of a news embargo.

It’s about trans-catheter aortic valve replacement, or TAVR, a breakthrough technology that allows interventional cardiologists to replace the aortic heart valve using a catheter instead of opening a patient’s chest up and sewing in a new valve. Cardiologists already knew that these valves, made by market leader Edwards Lifesciences and device giant Medtronic, were better for patients at higher risk of complications during surgery. But what about low-risk patients?

They’re better there, too, two studies being published in the New England Journal of Medicine and presented here tomorrow say. A 9,000-patient study of Edwards’ Sapien 3 valve showed that at the end of a year, patients were 46 percent less like to have died, had a stroke, or been rehospitalized than those who had a surgical valve replacement. A 1,403-patient study showed that Medtronic’s Evolut Pro stent was superior to surgery at 30 days, and generally equivalent.

Interventional cardiologists say that the two studies are likely to be viewed as roughly equivalent by doctors and that tens of thousands of patients are likely to receive the new valves. The results are very much an example of how slowly and deliberately medical device makers must move: Edwards’ first Sapien valve was first approved in 2011. Last year, Edwards booked profits of $722 million on annual sales of $3.7 billion, and the stock market values the company at $37 billion.

Johnson & Johnson and Apple team up

Apple will also be sponsoring a new study that may answer some of the questions doctors hoped would be answered by the one that was released this morning — and it is doing it with Johnson & Johnson. “In the whole connection of better diagnosis, better treatment, better compliance of the tools and medicines we make, that’s where digital has to become part of our entire world,” said Paul Stoffels, the chief scientific officer at J&J.

The 180,000-patient study, called Heartline, will be a randomized controlled trial that will look at heart attacks, strokes, and deaths. But, like the Apple Heart Study, it will be conducted “pragmatically,” that is, using digital approaches instead of infrastructure. “It’s certainly a vast and gross departure form the bricks and mortar model,” said Michael Gibson, president and CEO of the Baim Institute for Clinical Research and a Harvard professor. “This is one of the most exciting things, the idea that you’re going to find participants through the media, the news, potentially through insurers, and even health care providers.”

As with the alliances that Roche’s Flatiron Health unit has been making in oncology, this is an important sign of how drug companies are looking to learn to collect data in ways that are cheaper and better reflect the experiences of patients in the real world. It’s exciting, but it will also be difficult.

Read my story.

Eggs-asperated

A study that didn’t come out at the ACC meeting but has cardiologists talking: one published in the Journal of the American Medical Association saying that eating eggs is linked to higher blood cholesterol and higher risk of heart attacks and strokes.

The result came from pooling six different observational studies with 29,615 patients. “What we’re suggesting is to consume [eggs] in moderation, to use egg whites as opposed to including the egg yolks, as part of a healthy diet high in fruits and vegetables and whole grains,” said Norrina Allen, an associate professor of preventive medicine at Northwestern University and the study’s senior author.

“I think they can be part of a healthy diet since they are a good protein source, especially for people who don't eat meat or poultry,” said Dr. James Stein, the Robert Turell Professor in Cardiovascular Research University of Wisconsin School of Medicine and Public Health. Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic, pointed out that only 15 percent of blood cholesterol comes from eating cholesterol; the rest is made by the liver. He worries that telling people to stop eating fat or cholesterol leads them to eat sugar, and favors a Mediterranean diet.

“I honestly can’t believe we are spending valuable molecules of brain ATP to have this conversation again,” writes Dr. Ethan Weiss, a cardiologist at the University of California, San Francisco, who's a co-founder of a startup related to a high-fat diet. “If someone wants to do it, then do it right. Otherwise, let’s stop talking about these observational nutritional epi studies once and for all.”

Weiss points to a JAMA paper on the limitations of nutritional observational studies by John P. A. Ioannidis, the Stanford skeptic. Ioannidis noted that if one believes estimates from these studies, eating 12 hazelnuts daily would prolong life by 12 years, as would drinking three cups of coffee daily. Eating a single mandarin orange daily would lead to five additional years of life. Conversely, consuming one egg daily would reduce life expectancy six years, and adding two slices of bacon would shorten life for a decade. “Could these results possibly be true?” Ioannidis wrote.

So maybe it’s OK to eat the eggs, if you add a hazelnut coffee?