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Ahead of Regulatory Approval, iPhone ECG Is Saving Lives—Human and Animal


Posted by Brian Buntz on April 4, 2012

The AliveCor iPhone ECG has already been used to diagnose several cardiac conditions and it isn’t even on the market yet—although FDA and CE Mark approvals of the device are pending. A recent study designed to investigate the potential use cases of the technology led to the diagnosis of serious cardiac problems such as silent ischemia, tachycardia, and Wolff-Parkinson-White syndrome in a study involving 54 patients. “None of these people were selected because they were supposed to be patients. We were just looking at the quality of the data,” says David Albert, MD, inventor of the device and chief medical officer of AliveCor.  After the study at the University of Southern California (USC) was completed, 16% of the participants believed they had discovered a health condition that they previously did not know about. After taking part in the study, 24% of the participants contacted their private physicians for a consultation.

In a separate event, Eric Topol, MD, chief academic officer at Scripps Health, used the iPhone ECG on a flight from Dulles to San Diego to diagnose a heart attack, forcing the plane to land so that the patient could be rushed to a hospital. The patient survived the ordeal. 

AliveCor iPhone ECG

The aforementioned study at USC was initially organized to learn more about the potential use cases for the iPhone ECG—which are far ranging. The iPhone ECG can be used for everything from consumer use, clinical diagnostics, to veterinary applications. When asked about the latter, Albert says “I can absolutely tell you that our product from the top of the veterinary cardiology, they find it extremely useful on dogs, cats, and even horses. The iPhone ECG is going to be used by veterninarians, by electrophysiologists, cardiologists, internists, family medicine doctors, ER doctors, EMTs, paramaedics, home health nurses, medics, and then by patients themselves,” Albert adds. “Our device is just as appropriate in the hands of an electrophysiologist like Leslie Saxon, MD or cardiologists like Eric Topol, MD as it is in the hands of Brian Buntz—or his dad. And it is just as appropriate in the hands of a veterinarian.” 

David Albert, MD demonstrates the AliveCor Vet ECG on an equine patient at Oklahoma State University.

“It is a device that sort of expands your imagination,” says Leslie Saxon, MD, who designed and oversaw the study. “I never leave home without my iPhone. And as a cardiologist and a heart rhythm doctor, I can obviously use the iPhone ECG on myself, I can use it in the clinic on my patients or in the hospital, and I can even use it at home to get my golden retriever’s ECG.”

Saxon, who is a professor of clinical medicine at the USC Keck School of Medicine, recruited 54 patients from the iPhone-owning demographic in attendance at the annual Body Computing Conference at USC. Participants in the study were not given instructions on how to use the device. People from various background were enrolled: engineers, entertainment, media, bloggers, as well as doctors.

In the study, the participants were provided with a case and an app to use with their iPhone. Without receiving instructions on how to use the product, the participants were told to go and to record their ECG at least once per day.

Over the course of eight weeks, about 1500 ECGs were recorded and transmitted—about 90% of which were clinically useful, Albert says. The participants used the device consistently throughout the duration of the study. Saxon and Albert read the ECGs generated from the study.

Saxon recounts that one of the patients enrolled in the study had received negative cursory screenings for arrhythmia. In the course of the study, however, it became apparent that he had a serious arrhythmia. “It was a very, very good thing that he had [the iPhone ECG] around because he could have been a sudden cardiac death patient.”

 

I want to reach patients globally, wirelessly all of the time. I want every cardiologist to have that kind of reach.”

In another case, a businessman participating in the study had transmitted an abnormal ECG, which could indicate that the patient’s heart wasn’t getting enough blood. Saxon called the man in the study, who was then in Mumbai on business, and expressed her concern about the ECG reading. The patient informed her that the ECG came from a Nigerian acquaintance he had met at a reception. “And I said, well, go and find him,” Saxon says.

“For me, the gratifying thing was, here I am, I have had 25 years of experience as a heart rhythm doctor, and who can access me? Only patients with an appointment in L.A., right?” In this example, wireless technology enabled her to reach reach a Nigerian, who may have a serious heart condition. “How cool is that? That is really what we talk about in terms of global health and leveraging our experts across the world over mobile. For me that was just a paradigm shift and I thought, gosh, I want to do that for everybody in our division. I want to reach patients globally, wirelessly all of the time. I want every cardiologist to have that kind of reach. And God knows, people need it.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

For more on the iPhone ECG, check out the “Ahead of His Time” series of MD+DI articles:

 


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