We carry Star-Trek-style pocket computers, and worry that “screen time” is rotting our children’s brains. We know we’re living in the future. But it’s rare that we get actual hard data on whether a new technology we are inviting into our lives is a good idea.
Such an opportunity will come Saturday, when we’ll learn more about the Apple Watch and its ability to detect serious heart conditions such as atrial fibrillation. Researchers from Stanford will present the results of a study of more than 400,000 patients testing the device’s ability to accurately detect heart rhythm problems, which can lead to strokes and other problems. The Apple-sponsored study will be the first test of whether putting wrist sensors on people to detect heart rhythm changes is a good idea that get them necessary care, or a bad one that is raising false alarms and possibly leading to overtreatment of the worried well. It is also one of the largest heart screening studies ever.
The Apple study will be the kickoff of the annual meeting of the American College of Cardiology in New Orleans. And it is just one example of how cardiology, which demands perhaps the highest medical evidence of any specialty, is becoming a testing ground for new tech.
The boom in cardiac drugs and devices 20 years ago led experts in the field to become accustomed to clinical trials that included tens of thousands of patients and used rigorous standards, often taking extra steps to limit the involvement of pharmaceutical companies in testing their own products. Now, cardiology is becoming a collision point between medicines traditionalists and those infatuated with new technologies, from watches to new ways of using genetics.
In the case of latter approach, one of the closely watched trials has involved the use of a genetics to vet a still experimental drug, bempedoic acid, being developed by Esperion Therapeutics (ESPR). The study, released by the New England Journal of Medicine ahead of the ACC meeting, looked at a database of 650,000 patients to see if changes in the genetic code near the gene for a protein called ATP citrate lyase (ACLY) lowered patients’ risk of heart disease. If genetic mutations in the ACLY gene — the protein targeted by the drug — reduces the risk of heart disease, the logic goes, bempedoic acid should, too.
The data, from a yearlong study of 2,230 patients, showed that the drug reduced low-density lipoprotein, the “bad” form of cholesterol, by 16.5 percent, but also was associated with a quadrupling of the rate of gout. More concerning, there was an increase in the number of deaths, which both Esperion and outside researchers working with it have said was probably due to the play of chance, which is to say, bad luck.
The logic that ACLY affects cholesterol and heart disease probably holds, said Dr. Sekar Kathiresan, director of the Cardiovascular Disease Initiative at the Broad Institute. But he worries that the study was not as rigorous as it could have been because the genetic changes were simply near the ACLY gene, not mutations in it. It leaves questions for him on how useful bempedoic acid will be.
“It’s not a home run, it’s a single, but you know, you get three singles, it’s the same as a home run,” said Dr. Christie Ballantyne, chief of cardiology at Baylor College of Medicine. “It’s just going to be an additional tool for helping patients.”
On Monday, an even bigger study will be presented at the ACC meeting, giving doctors and investors a better look at Esperion’s prospects.
The conference will provide a look at a study of two devices that allow doctors to replace heart valves without cutting open the chest, from Edwards Lifesciences (EW) and Medtronic (MDT), and another of an Abbott device that uses maglev technology in an implanted heart pump. Another Medtronic study will test wrapping an implanted device in an antibiotic pouch to prevent infection.
There will also be the latest chapter in the dramatic story of fish oil. Once used by some cardiologists as an add-on to drugs like statins, it fell out of favor after study after study showed no benefit. Then, late last year, a trial showed that a drug called Vascepa — itself a highly purified component of fish oil, eicosapentaenoic acid, given at a high dose — reduced heart attacks. Doctors have been pressure-testing the results. Expect them to give them another look as researchers working with Vascepa’s maker, Amarin (AMRN), present a deeper dive into the results from that study on Monday.