Big Data continue to make inroads into health care and, as we've covered repeatedly in this column, cardiology continues to emerge as an early adopter. This is largely because cardiology is one of the more quantitative fields of medicine, described by innumerable acronyms (RR, QT, EDV, EF, etc.) that we rely on to treat our patients. We recently had the opportunity to speak with Kevin King, CEO of a relatively young company called iRhythm that aims to replace Holter monitoring through enhanced data collection via their flagship product, the Zio® Patch System. Investors have certainly bought into the idea: to date, iRhythm has received more than $63 million in funding and, most recently, a $16 million Series D investment this past April.

Shiv Gaglani: What problem did iRhythm set out to solve?

Kevin King: As our understanding of the impact of untreated arrhythmias deepens, the need for an actionable diagnosis as quickly as possible becomes increasingly important. There are limitations with the historic approach to diagnosing arrhythmias, most notably the common requirement of multiple patient visits and tests prior to diagnosis, consequently driving up cost while delaying their treatment. The Zio Patch System is a simple, intuitive, breakthrough approach to cardiac monitoring innovated around the goal of an efficient and cost-effective diagnosis.

How large is the market for your products, including the Zio, both in terms of number of patients and financial size?

Arrhythmias affect millions of people throughout the world each year, and left untreated may lead to serious consequences including stroke and sudden cardiac death. The American Heart Association estimates that by 2030, 40.5% of the US population is projected to have some form of CVD, which includes cardiac dysrhythmias. The cost of caring for these patients is estimated to triple from $273 billion in 2010 to $818 billion in 2030. In a study published in the Value Health Journal in 2006, researchers estimated the total direct cost for treatment of AF patients greater than 65 years of age is $6.7 billion, with hospitalizations accounting for the largest share. It's estimated that Medicare alone pays approximately $16 billion annually to treat newly diagnosed with AF mostly due to complications including stroke, heart failure, acute MI, and tachycardia.

What are the sensitivity and specificity of the Zio compared to the "gold standard" of Holter monitoring?

Recent peer review data have demonstrated that the Zio® Patch system has the potential to impact clinical decision making for patients with arrhythmias as compared to traditional Holter monitoring. In a study on AF patients conducted by Beth Israel and published in the March 2013 edition of PACE, patients were asked to wear both a Holter monitor and Zio Patch. During the first 24 hours the Zio Patch had the same sensitivity as the Holter monitor. However, beyond the initial 24 hours, longer-term monitoring with the Zio Patch resulted in AF detection in an additional 24% of patients with a median time to detection of 3.7 days. The combination of improved patient compliance and longer-term monitoring of the Zio Patch System lead to a medical management change in 28% of study patients.

Are there any surprising findings you've discovered from the large data set of 20 million hours of patient data? Have you already anonymized, or are there plans to anonymize, these data and open it to researchers?

The combination of recording every beat for the duration of the patient's wear the period and the unobtrusive design of the Zio Patch, allowing patients to live their lives without interruption, confirms the longstanding industry assumption that longer-term continuous monitoring is beneficial to capturing an underlying arrhythmia. Based upon our aggregation of data, we understand that there is a 70% diagnostic yield by day 10 with nominal increases past this point, thus the Zio Patch is prescribed for up to 14 days of wear. What has been particularly surprising about this is the number of asymptomatic but clinically significant arrhythmias that occur later in the patient's wear period. We are in the early stages of assessing the value our aggregate data may provide to health practitioners, health plans, the medical device industry, and the pharmaceutical industry.

What do you think of the proliferation of smartphone-based event monitors?

Smartphone-based event monitors address cardiac monitoring from a technology-driven approach. This is different than iRhythm's problem-driven approach, which aims to identify clinical needs and innovate to address them. The smartphone is an incredibly useful piece of technology and it will be interesting to see how they are able to develop it to be clinically relevant.

Can you describe how you personally became involved in this field?

I've been working in the health care industry for close to 30 years and have led businesses and organizations at leading technology based companies such as HP, GE, Thomson, and Affymetrix. A common thread to these positions has been the use of complex data and information to lower costs and improve quality in healthcare. iRhythm's approach to the arrhythmia detection is a compelling story with tangible benefits for patients, payers and providers. We have a very talented and dedicated team of individuals that has made tremendous progress in the few years we have been on the market.

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Shiv Gaglani is an MD/MBA candidate at the Johns Hopkins School of Medicine and Harvard Business School. He writes about trends in medicine and technology and has had his work published in Medgadget, The Atlantic, and Emergency Physicians Monthly.

Keywords: Health Care Sector, Decision Making, Investments, Peer Review, Medicare, Patient Compliance

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