Trends in Monitoring and Treating Atrial Fibrillation

Atrial fibrillation, or Afib, is a leading cause of stroke. It is estimated that 35 percent of atrial fibrillation patients will experience a stroke at some point in their lives.¹ Patients older than the age of 40 have a 25 percent chance of developing Afib in their lifetime. This makes the treatment of Afib a significant challenge to global healthcare systems. If left untreated, Afib increases the risk of cardiovascular death, stroke, congestive heart failure and impaired quality of life.^2,3 Due to the aging population, Afib prevalence in the United States is forecast to grow to 15.9 million by 2050. More than 50 percent of these patients will be 80 years or older in 2050, leading to a significant healthcare and economic burden.⁴ The U.S. cost of Afib care that is not heart valve-related was estimated in 2005 at $6.7 billion per year. Almost 350,000 U.S. hospitalizations per year are attributed to Afib and approximately 75 percent of this cost has been attributed to inpatient care.⁵

Why It’s Important 
The World Health Organization has quantified the burden that Afib imposes on society by using metrics called disability-adjusted life-years, often called DALYs. This burden has increased by nearly 19 percent for male and female patients between 1990 and 2010 (Chart 1).^6,7 Physicians warn that the longer the patient has Afib, the higher the probability they will convert from intermittent to frequent Afib, a condition more difficult to stop or cure.⁸

The Challenge: How to Detect and Diagnose Afib to Prevent Stroke?
Strokes that occur without a defined cause are labeled as cryptogenic, and of the estimated 750,000 strokes in the United States, 40 percent are diagnosed as cryptogenic. The other stroke category is defined as ischemic and is segmented as lacunar stroke, cardiac embolism, large-artery atherosclerosis and other known causes.⁹

Arrhythmia Monitoring
Diagnoses of arrhythmia are tricky and elusive, as they can be sporadic, irregular and may not result in perceptible symptoms. The patient population with Afib symptoms may only be symptomatic 10 percent of the time; many patients are diagnosed at the emergency room at the onset of their first stroke.¹⁰

In response, medical device manufacturers are racing toward the Holy Grail—development of new cardiac monitor technologies that meet the unmet needs of the patient population with Afib and clinicians who treat them. The ideal cardiac monitor will be small, smart, wireless, easy-to-use, sensitive, accurate, cost-effective, efficient, and can monitor for longer periods than traditional non-implantable monitors. The next generation of cardiac monitors will help detect Afib, assist in patient management, diagnose the success of treatment outcomes, and measure the true impact of Afib in stroke and heart disease.

According to a report from Medtech Insight, the Holter monitor, a device that records heart rhythms for 24-48 hours, is still the most commonly used cardiac monitor for the detection of Afib. However, continuous monitoring solutions are in development for the large and growing market for ambulatory cardiac monitoring devices, valued at $1.5 billion.^11,12 According to the report, the market is segmented into four sets of patient indications for continuous cardiac monitoring (see Chart 3).¹³
Conclusion and Recommendations

Hospitals continuously assess medical technology to improve clinical outcomes and sustain their own financial health. The technological landscape of cardiac monitoring for Afib is changing dramatically. If you serve the medical specialty of cardiology, explore product design changes in the race to market in cardiac monitoring for inspiration. These same design innovations may be adaptable to your technology, which may strengthen your medtech economic value proposition. 

References:

1. www.heart.org/HEARTORG/Conditions/Arrhythmia/AboutArrhythmia/What-is-Atrial-Fibrillation-AFib-or-AF_UCM_423748_Article.jsp
2. Ibid
3. Ibid
4. Ibid
5. www.physiciansweekly.com/atrial-fibrillation-awareness-month/
6. Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum P. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value health. 2006;9:348-356.
7. www.physiciansweekly.com/increasing-burden-af/#sthash.U5f6xVwS.dpuf
8. Chugh S, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a global burden of disease 2010 study. Circulation. 2014;129:837-847. Available at http://circ.ahajournals.org/content/early/2013/12/16/CIRCULATIONAHA.113.005119.abstract. See more at: www.physiciansweekly.com/increasing-burden-af/#sthash.U5f6xVwS.dpuf
9. www.physiciansweekly.com/atrial-fibrillation-awareness-month/#sthash.61sToJdF.dpuf
10. www.uptodate.com/contents/cryptogenic-stroke/abstract/6?utdPopup=true
11. Medtech Insight, May 2014 Arrhythmia Monitoring: the Challenges of Detecting AF in Cryptogenic Stroke
12. Ibid
13. Ibid, Medtronic Inc.

Readers are invited to submit market data and trend questions to Maria Shepherd. Periodically, selected questions will be presented in this column, with answers from Maria. Send your questions to [email protected].

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Maria Shepherd has 20 years of leadership experience in medical device/life-science marketing in small startups and top-tier companies. After her industry career, including her role as vice president of marketing for Oridion Medical, where she boosted the company valuation prior to its acquisition by Covidien plc, director of marketing for Philips Medical and senior management roles at Boston Scientific Inc., she founded Data Decision Group. Data Decision Group provides white-space research and critical data to support medical device decision making. The firm quantitatively and qualitatively sizes opportunities, evaluates new technologies, provides marketing services and assesses prospective acquisitions. Shepherd has taught marketing and product development courses, and is on the board of the MSBiV Medtech Investment Committee. She can be reached at (617) 548-9892 or at [email protected]