Atrial fibrillation (AF) poses challenges to primary care on a number of fronts.
AF is the most common sustained cardiac arrhythmia and causes higher risk of both developing and dying from cardiovascular disease (CVD).
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Bipin Patel Bipin Patel is CEO & Founder of electronRx, a deep tech team of interdisciplinary scientists and engineers developing novel technologies to sense the physiological environment and inform personalized therapeutic interventions. Dr. Patel is an entrepreneur with over 20 years of biomedical engineering, drug development and commercialization experience. He previously held leadership roles at […]
Not only is it associated with a five-fold increased risk of stroke, with up to 25% of stroke patients presenting with AF, but AF-related strokes are also more severe due to higher mortality and greater disability. One study also found that AF is a direct cause in 5% of congestive heart failure cases, and AF has been established as present in up to 50% of patients with severe heart failure.
As a result, it’s estimated that the total direct medical costs of AF patients are 73% higher than matched control subjects. This is accumulating a substantial economic burden on healthcare systems as a whole. In 2011, the most recent figures, AF is estimated to have been responsible for up to $26 billion in annual U.S. healthcare costs. The primary driver of costs is hospitalizations.
These costs will only continue to climb as the prevalence of AF is set to increase dramatically in line with the growth of the most at-risk patient population; those aged over 50. Between 3-6 million people suffered from AF in the U.S. in 2020. Its prevalence increased by 33% in the past 2 decades alone, and over the next 30 years it is estimated to increase 2.5-fold, becoming one of the largest epidemics and public health challenges we face.
So, where does primary care come into this?
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
A rise in prevalence is driving a rise in hospitalizations and therefore costs due to the nature of disease progression and the resulting low opportunity for diagnosis and intervention within the clinically recognized ‘golden 6-month period’.
This golden 6-month period is the pre-diagnostic and diagnostic stage of the patient journey whereby primary care screening can allow for various forms of prevention;
- primordial (i.e. preventing risk factors through healthy lifestyle interventions),
- primary (i.e. preventing onset through risk factor reduction such as weight loss, hypertension and diabetes control), and
- secondary (i.e. providing an early diagnosis and preventing complications).
Within this first 6-month period, patients will initially enter paroxysmal AF whereby episodes of arrhythmia are self-terminating, last no longer than 7 days and commonly last less than 24 hours. Due to the transient nature of these episodes, and the fact that between 10-40% of episodes are asymptomatic, paroxysmal AF is very difficult to diagnose and hence opportunities for prevention (as outlined above) are limited.
Without effective prevention, the frequency and severity (in terms heart rate increase) of AF episodes will progress as patients become more symptomatic and enter persistent AF, whereby episodes are not self-terminating, last more than 7 days, and require pharmaceutical or electrical cardioversion to terminate. Beyond this, 40% of persistent AF patients will develop permanent AF within one year post-diagnosis, whereby no therapeutic interventions are successful in terminating AF.
The key challenge for primary care is the current lack of means for population-wide screening as this significantly lowers our ability to catch the condition early in patients within this golden window. Anticoagulation can prevent around two-thirds of AF-related strokes, and so overcoming this barrier to diagnosis is vital.
Current means of screening are limited to opportunistic pulse palpations during in-clinic appointments. If AF is suspected during pulse palpation, an electrocardiogram (ECG/EKG) will then be used to confirm diagnosis; either in the form of a 12-lead ECG in a clinical setting or an ambulatory ECG, worn as a holter/event monitor or as a loop recorder implanted under the chest skin, which is more effective in diagnosing paroxysmal AF. More recently, FDA-approved portable ECGs have also become available in the form of AliveCor’s KardiaMobile device.
Regardless, none of these methods of screening are accessible enough to facilitate the population-wide screening required and stem the growth of this epidemic and its pressure on our healthcare services. Primary care services are already overstretched, and bringing every member of the public in for pulse palpation is not an option.
Hence, in an effort to find the missing 1-2% of the US population estimated to be living undiagnosed with AF, innovation is bolstering which can boost capacity for opportunistic AF screening as well as go beyond this to facilitate early diagnoses on a population-wide scale.
Recent advancements in remote monitoring technology have included applying machine learning algorithms to accurately measure vital signs and other physiological parameters, including heart rhythm and AF detection, from smartphone sensor data alone; without the need for additional devices.
Built into patient-friendly smartphone applications that form a real-time communication channel with care providers, such scalable, population-wide screening tools may provide the golden opportunity to limit barriers to diagnosis to a minimum, and in doing so may aid more timely interventions, improve patient outcomes and streamline primary care workflows while also lowering overall costs of care.
Not only would this allow primary care providers to facilitate earlier diagnosis, catching more patients in their ‘golden 6 month window’, but it would also enable a proactive, preventative approach to the diagnosis and management of AF that will stem the epidemic at its source and improve the lives of millions across the globe.
Photo: hudiemm, Getty Images
Bipin Patel is CEO & Founder of electronRx, a deep tech team of interdisciplinary scientists and engineers developing novel technologies to sense the physiological environment and inform personalized therapeutic interventions. Dr. Patel is an entrepreneur with over 20 years of biomedical engineering, drug development and commercialization experience. He previously held leadership roles at big pharma like Merck KGaA, GSK and Pierre Fabre.
