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| Apple Watch flags multiple types of irregular heartbeats, study shows Posted: 30 Sep 2021 07:29 AM PDT  People who get irregular pulse notifications on an Apple Watch but don't have atrial fibrillation — the condition the feature focuses on detecting — could still have another type of problem with their heartbeat, according to a new study. The findings show that even if someone with a concerning alert from their Apple Watch doesn't get an atrial fibrillation diagnosis, they may not be in the clear, says study author Marco Perez, the director of the Inherited Arrhythmia Clinic at Stanford University Medical Center. "Even if you didn't find atrial fibrillation, we were finding a lot of people who had something else that probably needed some clinical attention," he says. The analysis, published in the journal Circulation, was done using data from the Apple Heart Study, which was designed to test the Apple Watch's ability to detect irregular heart rhythms. It launched in 2017 and included over 400,000 participants. In the study, anyone who got an irregular pulse notification from the watch was sent a clinical ECG patch, which could monitor their heart rhythm over a longer period of time. About 2,000 participants got an irregular pulse notification, and an earlier analysis showed that around a third of those people who then wore an ECG patch had atrial fibrillation show up during that monitoring period. This new study looked at the ECG patch data from the remaining participants that didn't have atrial fibrillation detected. "If we didn't find atrial fibrillation — what did we find?" Perez says. Around 40 percent of those people had some other type of irregular pulse, including premature atrial contractions (extra heartbeats coming from the top of the heart) and premature ventricular contractions (extra heartbeats from the bottom of the heart). "They had a lot of these extra heartbeats," he says. "Those are things that we pay attention to." Cardiologists still don't have a good grasp on how dangerous those types of frequent extra heartbeats can be, and often don't agree on how or if they should be treated, Perez says. They've been linked to the development of atrial fibrillation and heart failure, but there isn't a clear understanding of the best way to manage them. The study also showed that almost a third of study participants who did not have atrial fibrillation detected on the ECG patch said that they eventually went on to get the condition diagnosed outside of the study. So even if someone doesn't get a diagnosis on an initial evaluation, it may make sense to keep an eye on them going forward. "We probably have to start thinking about the best strategy for following those patients over time," Perez says. Right now, there's a wide range of responses to these types of alerts. If someone tells a cardiologist that they had an irregular pulse notification, the doctor might do a quick, 10-second check on an ECG in the office. Other doctors might send them home with a patch for a week. Still others, if there are other factors that make them suspicious, might want to do longer-term monitoring. The technology is still new and the approach is still evolving, Perez says. Additional research will help refine the approach. But for now, this study implies that people who get irregular pulse warnings should keep an eye on their heart health, Perez says. "There might very well be something that is going on that could cause you to have an irregular pulse, and could be a sign of something wrong with your heart."  |
| A grueling day in Elizabeth Holmes’ trial ended with evidence that Theranos’ tests sucked Posted: 29 Sep 2021 07:04 PM PDT  A preview of arguments to come After a tedious day of bickering, Victoria Sung appeared like manna from heaven — to tell us that Theranos' tests sucked. Sung worked at Celgene when it contracted with Theranos. Her testimony was brief and to the point: Celgene had not "comprehensively validated" Theranos technology, she said. That would have taken more work than what she did with Theranos' tests. The work she showed the court from 2012 demonstrated Theranos performed dismally compared to standard testing — often returning results that were "out of range." We'll get to the bickering in a minute, I promise, but Sung is a teaser for a big part of US v. Elizabeth Holmes we haven't explored much: Theranos's relationship with pharmaceutical companies. One allegation prosecutor Robert Leach made in his opening statement was that Holmes had deceived Walgreens about its relationship with drug companies. During former employee Surekha Gangakhedkar's testimony a little over a week ago, she said that she didn't think pharma company GlaxoSmithKline's report on Theranos tech "comprehensively validated" it. This phrase felt familiar, and today I realized from where: Bad Blood, John Carreyrou's book about Theranos. In the book, Carreyrou wrote that documents Theranos gave Walgreens "stated that the Theranos system had been 'comprehensively validated over the last seven years by 10 of the largest 15 pharma companies.'" GSK and Celgene's acquirer, Bristol-Myers Squibb, certainly rank among the largest pharma companies. They did have contracts with Theranos; in fact, Celgene was Theranos' largest pharma customer. But neither of the studies those two companies did count as comprehensive validation, according to Sung and Gangakhedkar. I imagine we will work through Theranos' other pharma partners later in the trial; Sung's testimony was brief. She was only on the stand because former lab director Adam Rosendorff had a childcare commitment at 2PM and couldn't continue his cross-examination, which took most of the day. Rosendorff had previously testified that Theranos' tests were bad, even saying he didn't understand the clinical value of one test. Lance Wade, Holmes' attorney, set out to undermine this testimony, and that was the source of a great deal of bickering. Rosendorff could be persnickety about details; for instance, Wade kept mixing up "proficiency tests" with "precision tests," and Rosendorff kept correcting him. At one point, the two got into a fight about whether Rosendorff had forwarded an email or replied to it. At least, I think that's what they were arguing about. We revisited the lab inspection by the California Department of Public Health, where Theranos employees got instructions not to go in or out of the "Normandy" lab, where the Edison machines were kept. In a previous inspection in New York, bulletin boards had been covered with paper so the inspector couldn't see what was on them. Wade asked if that was to protect trade secrets. Rosendorff asked who would pin trade secrets to bulletin boards. But we did find out the results of the audit: some minor deficiencies, which upset Holmes and Balwani, Rosendorff testified. Later, Wade quipped that supervising quality control tests and making sure laws were followed was "why you get the big bucks, right?" "Not as big bucks as you get paid," Rosendorff replied. While he was among the highest-paid employees at Theranos, making $240,000 a year, The Wall Street Journal noted that partners at Wade's firm made an average of about $1.5 million a year. Given the problems at Theranos, as well as lawyers' fees that stemmed from his time there, he should have been paid more, Rosendorff said. That bit of testimony was struck from the record. Bickering aside, Wade did make some progress. He put some of the emails Rosendorff had been asked about on direct examination in chronological order with documents Rosendorff had signed, showing that whatever reservations Rosendorff had didn't stop him from approving tests. Crucially, Wade got Rosendorff to revise his testimony about proficiency testing, which is required by law. Though proficiency testing wasn't run on the Edison devices, Rosendorff said, it had been run on the FDA-approved machines in the lab. Wade produced documents from the American Proficiency Institute that graded Theranos "acceptable." This is a significant narrowing of Rosendorff's testimony from the direct examination. Unlike Wade's attempted "gotcha" moment yesterday, this did make me reconsider how I felt about Rosendorff's direct testimony on proficiency testing. It is far less damning to say that proficiency testing had been done everywhere except the Edison, which was used for only seven tests. Rosendorff was testifying to plans for proficiency testing on the Edison machines when he had to leave for the day. (This was when the email dispute occurred.) Remarks made by counsel after the jury left suggested we have at least one more day of listening to Rosendorff and Wade squabble, which I am not especially looking forward to. But Sung's testimony did give me something to get excited about: What is the rest of Big Pharma going to say about Theranos?  |
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