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Dangerous Heart Rates in Children Treated Remotely with Smartphone Device

The FDA approved over-the-counter sales of the AliveCor Heart Monitor, a device and app that allow users to keep track of their episodes, helping doctors better manage patients’ conditions.

Before Carmen Agniel left the hospital, her newborn baby girl experienced an episode where her heart raced dangerously fast. Agniel was trained to monitor baby Vivian’s heart rate with a stethoscope at home to make sure it didn’t happen again.

“It was very scary because I didn’t know if I was doing it right,” said Agniel, 33, of O’Fallon, Mo. “I wondered, ‘Is it really what I’m hearing? Am I counting it right?’”

When another episode landed Vivian in St. Louis Children’s Hospital at 2 weeks old, Dr. Jennifer Silva asked Agniel if she would like to use a device that attaches to her smartphone and accurately records the heart’s electrical activity. The readings transmit to an app on the phone that would allow Silva to monitor them anytime.

“I was all for it,” Agniel said. The mom of two has since been able to manage all of Vivian’s episodes by using the device and app, even on Easter night. Because babies grow fast, Vivian often just needed a higher dose of medication.

“We’ve not had to go back to the hospital at all,” Agniel said. “Without having this app, we would’ve at least had four more trips to the hospital.”

Agniel is among 30 families who tried the mobile electrocardiogram over the past year as part of a study Silva helped conduct to test its accuracy and ease of use for children suffering from irregular heartbeats, such as tachycardia and atrial fibrillation.

Researchers found the device generated quality tracings, and doctors were able to use the information to make changes to treatments remotely. Patients and families also found it easy and convenient.

“What we’ve been able to do with this device is manage them outside the emergency room,” Silva said. “It’s all transferred to us by email, so it’s very quick. We can instantly see what the rhythm is and what to do next.”

The preliminary study findings were presented at the annual conference of the Heart Rhythm Society earlier this year, and Silva hopes the results will be published in the next few months.

The device is the only FDA-approved mobile ECG recorder outfitted for smartphones. It fits both iPhone and Android models and consists of two electrodes, where users can place their fingers for a recording. The electrodes can also be placed on the chest of an infant. The free app securely stores and transfers the readings wirelessly. Users can access their own data any time and grant access to their doctor.

The FDA approved over-the-counter sales of the AliveCor Heart Monitor in February. It costs $199 and has been largely used and studied in patients over the age of 60 to monitor their arrhythmia, particularly atrial fibrillation, which causes a third of all strokes.

The app also allows users to keep track of their medications and symptoms or activities that may have triggered episodes, helping doctors better manage patients’ conditions.

Silva, director of pediatric electrophysiology at Washington University School of Medicine, asked AliveCor to supply her with the devices to study in children, whom she believed could uniquely benefit.

“We are constantly adapting adult heart monitors for the pediatric population,” Silva said. “What was appealing to us about this was the accessibility. Everyone has a smartphone. This generation of parents, we have our smartphones with us constantly, and our kids are so familiar with these devices.”

Over the course of a year, her patients ranging in age from 2 weeks to 18 years old, sent 144 readings using the monitor. All but three were of high enough quality for a diagnosis, she found. All were able to manage outside the hospital.

Surveys showed that more than 95 percent of users (parents and children) felt the device was easy to use, were comfortable using it to manage their condition and wanted to continue using it.

Cases included one infant who had stopped her medication because she appeared better. She had a recurrence, and doctors were able to remotely diagnose her and resume her regimen. A teen who only takes medicine when having an episode was able to quickly verify questionable readings, take a prescribed dosage and confirm it worked – avoiding multiple hospital visits.

“Conversely, we have patients who are panicked,” Silva said, “and we can tell them everything looks normal and are able to reassure them.”

AliveCor product manager Iman Abuzeid said the San Francisco-based company envisions the device being used for all ages.

“We were very thrilled that Washington University was conducting a trial in the pediatric population ...,” Abuzeid said. “With this population, sometimes they can’t always communicate when something is wrong. The AliveCorps device is a way to capture what is really happening with their heart.”

Agniel said usually the only sign of trouble in babies is that they get very tired. Whenever Vivian, now 7 months old, seemed overly tired, “it would make me so nervous,” she said?. Using the device eased her worry, Agniel said. “It’s definitely provided a lot of piece of mind.”

Silva said parents often seem unsure of results using a stethoscope, and doctors have to err on the side of caution and order a visit to the doctor.

“When your kid is sick or something is going on and the kid is not right, you go into panic mode,” Silva said. “It sort of distorts reality, so what this (device) does is take all that out of the picture. … It takes out all the subjectivity.”

Silva recommends the mobile monitor to her patients, and she is willing to check readings any time, she said. Patients can also subscribe to an analysis service staffed by board-certified cardiologists or U.S.-based cardiac technician.

“I think it’s the way medicine is headed,” with technology playing a vital role in treatments tailored to each individual, Silva said. “This generation of doctors who is coming up is not going to know how they did it before.”

©2014 the St. Louis Post-Dispatch


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