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Cardiac monitoring tech: tackling the heart of the matter

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Type in “cardiovascular disease” into a refined search and you’ll be confronted with some grave figures. Every year, nearly 17.9 million people succumb to CVD across the globe. The stats are ominous—it has remained a leading cause of death in the US since 1921, and the economic burden of CVD is estimated to double by 2035, which inevitably underscores the need for solutions that can curb medical costs while improving health outcomes. 
The Covid-19 pandemic added to the CVD challenges because it limited access to care and exacerbated conditions; however, it also shined the light on the crucial role that cardiac monitoring devices played and their practicalities, particularly in at-home health management and remote patient monitoring (RPM). 
In this article, we take a closer look at how cardiac monitoring works, technologies available in the market today, how they address the burden of CVD, as well as the recent developments in the cardiac monitoring space.  

What is cardiac monitoring?

Cardiac monitoring involves collecting and analyzing heart health-related data to support clinical decisions including the early detection of a critical physiological event, disease diagnosis, development of treatment plans, and chronic care management. The system alerts healthcare providers of changes in a patient’s vitals that could indicate deteriorating health conditions and enables timely interventions. 
The monitoring system contains three main components: 1) a medical device collecting the data on physiological parameters (smart scale or cardiac patch), 2) a network and communications interface that enables data transfer to a remote monitoring station or a smartphone, and 3) a cloud analytics platform.
Cardiac monitoring system
Source: SPEEDA Edge

What are the cardiac monitoring technologies currently in use? 

There are several technologies in the market today that were developed to collect and interpret a patient’s heart rhythm for cardiac monitoring, each with different features and methods of data collection. 

Key types of software available in the market

Most device manufacturers and health tech developers focus on electrocardiogram (ECG) recordings, as ECG testing is a simple but important means of evaluating heart health. Unlike standard ECGs that record electrical activity for only 10 seconds, ECG monitoring devices are used for prolonged periods, increasing the probability of capturing cardiac arrhythmias that typically occur infrequently.

Popular types of hardware available in the market today include:

What’s driving the development?

1. Rising prevalence of CVD

Heart disease continues to be a leading cause of death among adults in the US with annual deaths totaling 655,000 (23% of total deaths in the US in 2019). Given the rising prevalence of CVD, companies are looking to develop innovative solutions for continuous and remote patient monitoring that can be adopted widely.
Different types of heart diseases are on the rise: 
  1. CVD: nearly 61% of the US adult population had some form of CVD in 2018, rising at a CAGR of 6% since 2011. 
  2. Atrial fibrillation: estimated to reach nearly 12–16 million in 2030 in the US, representing 5% of the adult population from 2% in 2010, growing at a CAGR of 4%–6% during the period. 
  3. Heart failure: an estimated 8 million Americans will be living with congestive heart failure in 2030 from 6 million in 2016.

CVD prevalence in the US grew at a CAGR of 6% from 2011 to 2018

Underlying health factors and behaviors have contributed to the increase in CVD prevalence

2. The need for cost-effective solutions

The growing incidence of CVD and rising associated costs are a substantial burden to reactive care in the US. Rising spending and a high prevalence (nearly 50%) of CVD are expected to push total costs (medical and indirect costs) to more than USD 1.1 trillion by 2035, doubling from USD 556 million in 2016.
Cardiac monitoring will therefore become an important tool and play a larger role in helping patients and their healthcare providers manage their heart health. Given the potential to reduce healthcare costs significantly, interest in effective remote and ambulatory cardiac monitoring is expected to continue, enabled by new technologies that are more affordable. 

The total economic burden of CVD is estimated to reach USD 1 trillion in 2035

Medical costs are expected to rise at a CAGR of 5% to reach USD 750 billion in 2035

Case study 1: Zio cardiac patch cost savings from implementation at hospital

Case study 2: CardioMEMS heart failure system reducing hospitalization

The implantable wireless pulmonary artery pressure remote monitor has been shown to be effective in reducing hospitalizations among New York Heart Association (NYHA) class III heart failure patients. 
The study below compares outcomes over five years for implanted vs standard of care patients: 
  • At the end of a 60-month period, survival rates stood at 49.6% for CardioMEMS patients and 23.8% for the standard of care patients. 
  • The difference in quality-adjusted life years (QALY) was 0.58, favoring the CardioMEMS patients with an estimated incremental cost-effectiveness ratio of USD 44,832 per QALY gained.

3. Improving patient access and treatment outcomes compared to standard ECG monitoring

Given the need to avoid greater downstream costs and improve patient outcomes, patient access to cardiac monitoring is a key focus. Recent technological developments in cardiac monitoring have proven to improve clinician diagnostic capabilities, while remote monitoring solutions have supported wider reach, particularly in rural areas.

Zio cardiac patch monitor: adoption leads to 5x higher diagnosis of patients

Positive outcomes from incorporating Zio cardiac patch to a hospital’s cardiovascular program

4. Favorable reimbursement policies for remote patient monitoring (RPM): 

Until 2019, coverage decisions in the US for remote patient monitoring (RPM) were ad hoc and relatively limited. However, the US Center for Medicare and Medicaid Services (CMS) released three new reimbursement codes for patients with chronic illnesses including cardiac conditions, facilitating reimbursements for the 1) initial setup of RPM devices, 2) associated patient education, 3) collection and interpretation of physiological data, and 4) treatment management services for RPM. 
These policies now allow US healthcare providers to bill for up to 40 minutes of RPM services per Medicare patient monthly. The Covid-19 pandemic fast-tracked the adoption and public acceptance of RPM, leading to wider coverage across the states. Currently, 29 states have some form of reimbursement policy in their Medicaid and Medicare programs. However, stronger policies for RPM are critical to support greater adoption among clinicians. (See challenges below.)

5. Introduction of data integration and interoperability to support positive outcomes

Interoperability is an important component of cardiac monitoring, as it allows healthcare providers to bridge the gap between clinical decision-making and population health outcomes.  A lack of mandatory interoperability standards, however, led each electronic health record (HER) vendor to create and maintain their own data silo that was only accessible to the hospital they had partnered with or to department-specific providers enrolled in that program. 
The Fast Healthcare Interoperability Resources (FHIR) standards encourage interoperability between legacy hospitals and health systems. In 2020, the HHS Office of the National Coordinator for Health Information Technology and the CMS announced their final rules for implementation of the 21st Century Cures Act interoperability provisions that require the use of the FHIR standard Release 4. Additionally, several EHR vendors also provide developer programs with FHIR and open application programming interfaces to allow third parties to write software. Interoperability rules being broadly adopted will allow patients to have more access to information regarding their health, enabling them to be more proactive and improve health outcomes, while equipping providers to make more informed decisions with greater insights.

What is the estimated market potential for cardiac monitoring tech? 

We looked at market size estimates from several sources to gauge the potential of this space. In summary, the global cardiac monitoring and cardiac rhythm management market is estimated to be USD 20–30 billion in 2020. It is expected to reach USD 30–50 billion by 2027. 
The cardiac monitoring markets are defined as follows:
  • ​​Cardiac monitoring devices for market size include ECG devices, event monitors, implantable loop recorders, cardiac output monitoring devices, mobile cardiac telemetry devices, and smart ECG monitors.
  • Cardiac rhythm management devices included pacemakers, defibrillators, cardiac resynchronization devices, fitness trackers, and smartwatches, which can enhance atrial fibrillation detection and screening.

Global cardiac monitoring market size across sources

What are the challenges in this space?

1. Patient data leakage and cyber security concerns 

Medical devices that cannot be reprogrammed are more vulnerable to cybersecurity attacks and a key area of concern for patients and providers. The following examples are indicative of the potential vulnerabilities: 
  • 500,000 implantable devices were recalled in 2017 by the FDA due to the vulnerabilities to hacking, causing a setback in growth. 
  • In 2019, the Homeland Security Department identified a grave cybersecurity vulnerability in 750,000 heart devices manufactured by Medtronic, where an attacker could harm a patient by changing the programming of an implanted defibrillator.

2. Regulatory challenges resulting from changes to health insurance coverage and CMS reimbursement rates

The revenue prospects and the business model of startups in the industry are highly dependent on reimbursement policies from third-party commercial insurance plans and the CMS. Healthcare providers may be reluctant to prescribe remote cardiac monitoring due to the uncertainty surrounding the reimbursement rates. Additionally, clinicians are concerned about whether they can obtain adequate compensation for the administrative burden of introducing remote patient monitoring services and the effort required to onboard patients. 
Although CMS has introduced codes for telehealth solutions such as RPM, reimbursement levels are still considered to be low and limited. Additional coverage and payments for a wider area of medicine will be required, however, to maximize patient access and incentivize healthcare providers. 

3. Intensifying competition from consumer electronics companies 

Consumer electronics companies such as Apple, Fitbit, and Amazon have entered the market with their consumer-centric monitoring devices and services with a focus on heart health, intensifying the competition in an already fragmented market that has several local and global players.

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