“App for That”: The Transformative Potential of Mobile Diagnostic Applications

Today’s mobile applications provide a bevy of useful data for cardiovascular patients and physicians alike. These diagnostic apps show great promise to revolutionize healthcare delivery, especially with real-time heart monitoring and visualization, but they also pose important questions. 

In cardiology, it is hard to overestimate the importance of timely care for a patient’s outcome. During a heart attack or stroke, the clock is ticking, encouraging clinicians and industry to seize new opportunities to speed up healthcare delivery whenever possible. So, when a technology comes along that shows promise to reduce delays from symptom to diagnosis, it is not surprising when many in the specialty take notice. Such has been the case with mobile diagnostic apps for smart devices.

Once a novelty item, smartphones have become nearly ubiquitous, with a 2015 Pew Research Center (PRC) report indicating that 64 percent of Americans own a smartphone of some kind, up nearly twofold from 35 percent in 2011. As of January 2014, 42 percent of Americans owned a tablet computer, the PRC found. 

Having such powerful devices within arm’s reach has opened up a world of opportunities for patient care, and the cardiology community has taken advantage by developing apps that provide real-time heart monitoring and visualization.

“Right now, we see patients based on when they are not doing well, and what we would like to do is move toward a more value-based system where we’re improving patients’ health and not just managing disease,” says Zubin J. Eapen, MD, MHS, medical director of Duke Same-Day Access Heart Failure Clinic, Durham, N.C. “We need continuous streams of data to understand a patient’s state of wellness in the home, and these technologies have the potential to provide that.”

ECG on the go

One of the smartphone technologies that clinicians have begun to implement in practice is a mobile electrocardiograph (ECG; AliveCor). The FDA-cleared device provides real-time ECG recordings that can detect whether a patient is having atrial fibrillation (AF or afib) via its mobile phone-based heart monitor. Results can then be confirmed with a U.S. board-certified cardiologist or personal physician. The device costs $74.99 and the app is free, according to the manufacturer.

Jordan Safirstein, MD, director of radial intervention for the cardiac cath lab at Morristown Medical Center, Morristown, N.J., has already seen the impact of the mobile ECG device on his patients and practice. “I’ve had patients show up in my office and say, ‘I went into afib,’” Safirstein notes. “Normally the way that conversation goes is they say they felt an irregular heartbeat and aren’t sure whether it was afib. So, the usual recommendation would be to have them put on a monitor for seven days. That is a very inefficient and expensive way to assess for afib because it’s not dependent on the patient’s symptoms.”

Although the financial impact of mobile ECG to the healthcare system is unknown, results from the SEARCH-AF (Screening Education And Recognition in Community pHarmacies of Atrial Fibrillation) trial suggest it may be cost effective.

In a population of 1,000 screened pharmacy customers (mean age, 76 ± 7 years; 56 percent women), of whom 1.5 percent had newly identified AF, researchers found that the incremental cost-effectiveness ratio of extending the smartphone ECG screening into the community (based on 55 percent warfarin prescription adherence) was $4,066 per quality-adjusted life year gained and $20,695 for preventing one stroke. The device also demonstrated a 98.5 percent sensitivity for AF detection and 91.4 percent specificity (Thromb Haemost 2014;111:1167-1176).

Kevin Campbell, MD, assistant professor of medicine at the University of North Carolina, Chapel Hill, cautioned that while there are good data showing this technology is safe and effective and detects silent AF, there are not a lot of data available comparing it with different heart rhythm–measuring devices on the market.

Other novel applications

Not only can smart device technology monitor the electrical activity of the heart, but it can provide visualization. By downloading an app and connecting a transducer, a tablet can become a portable ultrasound system, allowing physicians to meet patients at the point of care.

According to a press release, the ultrasound system (Lumify, Philips) is available with a monthly subscription—which includes the transducer, app, access to an online portal, warranty and support—starting at $199.

“The ability to do an echo anywhere at anytime and then share that information immediately has immense power in emergency and trauma medicine,” Safirstein says. “The ease with which we can now perform ultrasound may facilitate these devices being used in an ambulance, en route to a hospital, rather than having to wait.”

Safirstein added that the relatively low cost of these devices may also facilitate the screening of large, previously unreachable populations.

In addition, a remote patient monitoring app (AirStrip ONE, AirStrip Technologies; price not available from manufacturer) allows physicians to track patient data, including vital signs, cardiac waveforms and medications, with their smart device. The FDA-cleared technology pulls information from hundreds of different types of patient monitors and ECG machines, and a variety of other clinical information coming from electronic medical records, the manufacturer stated in a release.

For patients with certain pacemakers, a recently approved app-based remote monitoring system will give them access to their own raw data. The system (MyCareLink Smart, Medtronic), which was FDA approved in November 2015, consists of a physician-prescribed, handheld portable device reader  and a free mobile app. The system lets patients with a pacemaker use their own smartphone or tablet to securely transmit data from their device to their physicians.

This approval represents the first time patients have had access to their raw data, Campbell says. “There has been a big fight because we have had remote monitoring for more than 10 years for all the major companies and patients have not been allowed to access their own device information,” he says. “The initial fear was that we are going to give patients information they are not trained to interpret, and that might affect how they behave. Ultimately, though, it’s the patients' condition—their body, their device—and they have a right to that information.”

However, Campbell noted that not all the data from the device is going to the patient, only select data. “I understand that we must be careful about giving patients direct data that they may not understand how to interpret, but at the same time I don’t think we should be allowed to withhold data from them,” he says.

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Avoiding potential pitfalls

Although these diagnostic apps provide tremendous opportunities to advance patient care, Eapen emphasizes that the technology is in its infancy and few apps have been properly studied to understand their impact.

“The traditional path to market for drugs or devices is they undergo clinical studies to understand their safety and effectiveness; many of these diagnostic apps have not undergone similar evidence generation,” Eapen says. “So, I think that needs to happen before we can understand which ones are helpful. In addition, understanding how to match the right app to the right patient at the right time will be imperative for both clinicians and companies.”

As mobile diagnostic modalities continue to become more accessible, it is going to be critical for patients to understand that these apps are meant to enhance physician care, not replace it, says Campbell. “Patients are really savvy, and may think they no longer need to take 30 minutes out of their work day to visit their doctor," he says. "It’s important that we warn them against this."

Furthermore, with the influx of data provided by real-time patient monitoring, Eapen says clinical decision support will be necessary, so that clinicians are not monitoring flow sheets of streams of data, but rather understanding when a patient is not doing well.

“Physicians will need notifications on meaningful deviations from normal, so that they can act upon patients who are not doing well,” he says. “That kind of clinical decision support is going to be an important layer to build on top of the continuous data … so that [physicians] are not overwhelmed.”

Changing patient behavior & care

Despite these concerns, mobile diagnostic apps represent a significant medical breakthrough, one that Campbell believes will help modify patient behavior in the long run. “We know that if patients stick their heads in the sand … we are not going to make any headway,” Campbell says. “However, when you put the power of information and knowledge in patients’ hands, they become more engaged in their healthcare and disease management. And by engaging patients electronically, we are going to improve outcomes.”