Rapid advances in technology to monitor atrial fibrillation (AF or Afib) are enabling clinicians to access real-time patient data more easily and effectively than ever before. 

The challenges of obtaining data through previous technology like Holter monitors have limited the clinician’s ability to better understand AF burden and its connection to increased stroke risk. As a result, studies have traditionally analyzed the outcomes of AF simply based on whether AF is present or not, according to the American Heart Association (AHA). [1]

With recent advances in wearable cardiac monitoring, however, physicians can better detect and quantify their patient’s AF burden. 

When studies have analyzed the outcomes of AF burden, they typically classify AF type as paroxysmal or nonparoxysmal. However, as the AHA points out,[1] AF burden can be defined quantitatively, “by longest duration, number of AF episodes during a monitoring period, and the proportion of time an individual is in AF during a monitoring period (expressed as a percentage).” 

Much remains unclear about how AF burden is linked to cardiovascular and neurological outcomes. 

The Connection Between AF Burden and Increased Stroke Risk

Research has shown that higher AF burden is associated with a higher risk of stroke, according to the AHA. However, the correlation between AF and stroke risk is higher than previously thought, according to Robert Hauser, M.D., FACC, FHRS, senior consulting cardiologist at the Minneapolis Heart Institute, former president of the Heart Rhythm Society and chair of Cardiac Insight’s scientific advisory board. 

“We used to think that AF was responsible for about 15 percent of strokes,” Hauser said. “It’s clearly much higher than that. I’m seeing numbers of 30 to 40 percent. That’s vital to know because the last thing anyone wants to have is a stroke. There needs to be increased awareness that AF can cause stroke.”

Current guidelines recommend assessing stroke risk based on a patient’s individual risk profile and not on AF burden, pattern or type. Whether increased stroke risk is directly proportional to AF burden or whether risk rises until a certain threshold of AF burden, is unclear, according to the AHA, and such a threshold has not yet been discovered. 

What To Do Once AF Occurs

Longer term continuous ambulatory cardiac monitoring over the typical 48 hours is resulting in a rapid increase in the amount of data that can be used to assess AF burden. 

“What to do with that information remains a looming question for patients who are asymptomatic and have short periods of AF,” said Albert Waldo, M.D., FACC, FHRS, The Walter H. Pritchard Professor of Cardiology, professor of medicine and professor of biomedical engineering at Case Western Reserve University School of Medicine and associate chief of cardiovascular medicine for academic affairs at University Hospitals Cleveland Medical Center.

These are patients whose AF would be first detected by wearable cardiac monitoring. 

“The real issue is what do you do with the data when you have (that information)?” Waldo said. “What is the threshold of AF to prevent stroke?” 

Cardiologists typically begin anticoagulation therapy when a patient at risk for stroke has AF. At present, recommendations for anticoagulation are identical regardless of AF burden or pattern, according to the AHA.[3] In addition to stroke, patient risk for systemic embolism is also of concern.

Some clinical trials have demonstrated that stroke risk is lower for patients with paroxysmal AF than those with persistent AF. However, so far, there is little consensus about what threshold of AF warrants therapy for patients whose AF is asymptomatic and of short duration. 

One trial Waldo took part in originally found that six minutes of AF led to an increased risk of stroke. When the trial was later replicated, he said, the conclusion was that experiencing between six minutes and 24 hours of AF had the same impact as having no AF.

“The bottom line is there are almost no two trials that have come to the same conclusion about how much AF you need to recommend treatment,” Waldo said. “It’s a moving target, and nobody has a good idea.” 

Given the lack of consensus about treating patients with AF burden, Waldo argues that treating every AF episode with anti-coagulation may unnecessarily expose patients to risk. 

“All of us are concerned when we find AF no matter how short-lived it is. All of us want to protect our patients,” Waldo said. “But, if we start treating every little episode of AF with anti-coagulation when there’s no benefit to it, you just exposed the patient to potential risk. That’s the issue.”

Considering Other Rhythms

As longer term continuous ambulatory cardiac monitoring can capture, analyze and report a more complete ECG waveform history, this can help clinicians learn more about the effects of AF burden. Hauser and Waldo emphasize the importance of using such technology to monitor other rhythms as well.  

“It’s all a matter of getting the diagnosis when a patient comes in with symptoms,” Hauser said. “Yes, it may be AF but it may be some other arrhythmia.” 

Gathering information about all rhythms, such as the onset of the arrhythmia, is important for diagnosis and treatment. There are numerous wearable ECG monitors available for long-term cardiac monitoring.  

“If we have all the information, it makes the diagnosis of the rhythms easy and points to the treatment that’s very effective,” Waldo said. “That’s another important part of these new devices.” 

References: 

1. Chen LY, Chung MK, Allen LA, et al. Atrial Fibrillation Burden: Moving Beyond Atrial Fibrillation as a Binary Entity: A Scientific Statement From the American Heart Association.  Circulation, May 15, 2018, e623-e644. 

2. Goff DC, Lloyd-Jones DM, et al. 2013 ACC/AHA Guideline on the Assessment of Cardiovascular Risk. Circulation. 2014;129[suppl 2]:S49-S73. DOI: 10.1161/01.cir.0000437741.48606.98. 

3.  Chen LY, Chung MK, Allen LA, et al. Atrial Fibrillation Burden: Moving Beyond Atrial Fibrillation as a Binary Entity: A Scientific Statement From the American Heart Association. Circulation 2018;Apr 16:[Epub ahead of print].

October 29, 2018 — Blood pressure readings of 130/80 millimeters of mercury (mmHg) or higher taken at home can be used to diagnose hypertension in white, black and Hispanic U.S. adults, according to new research in the American Heart Association’s journal Hypertension.1

“Until now, recommendations for diagnosing high blood pressure with measurements done at home were primarily from Japanese and European studies,” said Wanpen Vongpatanasin, M.D., study author, professor of medicine and hypertension director at UT Southwestern Medical Center in Dallas. “We didn’t know if these recommendations actually applied to U.S. adults.”

Researchers analyzed large multi-ethnic studies that compared home blood pressure to clinic measurements of primarily young and middle-aged adults in Dallas, Texas and Durham, N.C. In 420 participants in the North Carolina clinic, high blood pressure readings (130/80) were confirmed with similar readings at home. In 3,132 participants in the Dallas study, researchers determined risks of stroke, heart attack and death associated with a clinic systolic blood pressure reading of 130 mm Hg. During the 11-year follow up, researchers also determined that people with high blood pressure levels measured at home had the same heart disease risk as people with similar levels measured by medical professionals.

Vongpatanasin added that the findings correlate with the American Heart Association/American College of Cardiology 2017 blood pressure guideline.

“It’s important to measure blood pressure at home because clinic readings might not reflect a person’s true blood pressure. Some people have higher readings in the clinic because of the ‘white coat’ phenomenon, while studies have shown that others — especially blacks — have lower blood pressure readings in the clinic than at home,” she said.

This study included adults aged 30 to 65 years old from two U.S. cities, so the findings might not apply to younger or older people or adults in different geographical areas, she said.

With the definition of high blood pressure set at 130/80 mm Hg, nearly half (46 percent) of U.S. adults have high blood pressure. Researchers have found that at least 30 percent to 45 percent of U.S. adults with hypertension monitor their blood pressure at home.

The American Heart Association recommends consumers follow the proper technique when measuring blood pressure:

• Be still and rest quietly for at least 5 minutes before measurements;
• Avoid caffeine or cigarettes in the half hour before your reading;
• Keep both feet flat on the floor and void talking during the test;
• At least two readings should be taken one minute apart in the morning before taking medications and in the evening before eating; and
• Ideally, blood pressure readings should be taken during one week beginning a few weeks after a change in the treatment regimen and during the week before a doctor’s visit.

For more information: www.ahajournals.org/journal/hyp

Reference

1. Vongpatanasin W., Ayers C., Lodhi H., et al. Diagnostic Thresholds for Blood Pressure Measured at Home in the Context of the 2017 Hypertension Guideline. Hypertension, published online Oct. 29, 2018. doi/10.1161/HYPERTENSIONAHA.118.11657

November 30, 2018 — Healthcare technology company Livongo recently announced the launch of its Applied Health Signals product category, with technologies that combine data science, behavior enablement and clinical impact to help people with chronic conditions stay healthy. The new category includes a voice-enabled, at-home, cellular blood pressure monitoring system, free medication incentives for eligible members, and a number of new data science capabilities and partnerships.

Health signals are created by an individual’s behaviors, health status, lifestyle and preferences. These signals can guide individuals and their care providers to proactively make changes to optimize clinical outcomes. Too often, people living with chronic conditions are presented with too many health data points to take meaningful action, according to Livongo. The company aggregates, interprets, applies and iterates (AI+AI) health signals to make healthy behaviors more accessible.

The new product offerings and partnerships, which harness the power of Applied Health Signals and enable AI+AI, include:

• The first voice-enabled cellular blood pressure monitoring system. This enhancement builds on Livongo’s previously announced cellular blood pressure monitoring system, which allows members to instantly upload readings to the Livongo cloud (Cuff to Cloud). This next-generation system will allow a user to easily interact with Livongo via voice at each check, enabling a whole new way to deliver actionable, personalized and timely health signals that can lead to behavior change and clinical outcomes;
• A behavior-driven incentives program that makes medication free. Eligible Livongo members receive co-pay waivers on medications, making their medications free. This overcomes the critical access barrier of cost and leverages personalized data insights to motivate the healthy behaviors that can lead to clinical outcomes; and
• Data partnerships. Livongo is bringing key partners to research data sets and uncover new outcome-focused health signals that will improve the Livongo Applied Health Signals Engine over time. Livongo initially announced a partnership with Medisafe that will improve medication management for people with chronic conditions and further its data and capabilities in the Applied Health Signals category.

Livongo’s voice-enabled blood pressure system and co-pay incentive programs will be made available to members in 2019.

For more information: www.livongo.com

February 6, 2019 – Omron Healthcare Inc. and physIQ Inc. announced a collaboration to integrate Omron’s HeartGuide wearable blood pressure monitoring device into the pinpointIQ platform to monitor at-risk patients in an outpatient setting. The strategic collaboration aims to generate actionable clinical information for at-risk patients in an outpatient environment by leveraging the complementary technologies of each company.

The U.S. Food and Drug Administration (FDA)-cleared Omron HeartGuide, which recently announced its retail availability at the 2019 Consumer Electronics Show (CES) and awarded the Engadget “Best of CES” award for best wearable, is a wearable blood pressure monitor made in the convenient form of a wristwatch. It uses oscillometric technology to measure medically-accurate blood pressure readings and monitors activity and sleep. PhysIQ’s pinpointIQ solution is an enterprise-ready, device-agnostic platform designed to capture continuous multivariate physiological data from wearable sensors, apply FDA-cleared artificial intelligence-based analytics, and provide actionable clinical information to a patient’s care team. Collectively, the combined solution represents an opportunity to enable a proactive care delivery model to better support at-risk patients at home.

The initial implementation of the combined solution will be with a major Chicago-area integrated health system and focus on supporting post-discharge patients who have been hospitalized for either heart failure or heart attack. Patients will wear HeartGuide, which will transmit data through the physIQ mobile app to the pinpointIQ cloud-based platform. Clinicians will access patient data and analytics through the pinpointIQ user interface such that they can proactively manage their at-risk patients.

For more information: www.omronhealthcare.com, www.physiq.com

February 19, 2019 — Ochsner Health System in Louisiana recently announced a new partnership with device data management and remote monitoring vendor Geneva Health Solutions (GHS) for implantable cardiac devices. This partnership marks the first time the GHS cloud-based technology platform and remote monitoring service for patients with cardiac implants will be utilized in the region, which includes Louisiana, Arkansas, Mississippi, Alabama and Georgia. The GHS system will drive full automated scheduling and reporting in collaboration with Ochsner’s established Epic electronic medical record (EMR).

Todd Mule, vice president, cardiology service line, Ochsner Health System, said, “Ochsner is committed to investing in patient-centric technology and are confident that partnering with Geneva Health Solutions will further enhance what we are able to offer our patient and coordinated care team through our electronic medical records platform, Epic. Ochsner’s investment in and enthusiasm for technology offers our patients enhanced coordination of care, convenience and better results.”

Millions of Americans have implanted cardiac devices. Patients with these devices — such as pacemakers, defibrillators and loop recorders — transmit critical cardiac data from their implanted device from the comfort of their homes to the provider via the cloud. These transmissions allow providers to monitor their patients proactively for both routine device follow-up and alerts regarding device issues or clinical events, like atrial fibrillation and other indicators of heart failure. The GHS patent-pending platform aggregates cardiac device data from all major device manufacturers’ remote monitoring portal, in-office checks and ER visits. The GHS remote monitoring service helps providers manage the incoming data in an outpatient setting.

For more information: www.genevahealthsolutions.com

February 21, 2019 — At the recent Healthcare Information and Management Systems Society (HIMSS) annual conference, AT&T’s healthcare team demonstrated the key role connectivity and the internet of medical things (IoMT) plays throughout the continuum of care. This concept was highlighted by a demonstration of the Bodyport remote monitoring solution.

The device, being developed by the San Francisco-based company Bodyport, can help detect early signs of cardiovascular disease. By stepping on the Bodyport scale, the device’s sensor technology captures electrical and mechanical heart function, data that is typically only available through in-clinic measures such as electrocardiogram (ECG) and echocardiography. The AT&T LTE-M cellular network enables the transmission of multiple biomarkers of cardiovascular function to a remote care team. This allows the clinician to determine in near real-time patient risk and status.

Bodyport is currently performing clinical trials at leading hospitals. They are studying patients with cardiometabolic risk factors like high blood pressure and diabetes. They are also monitoringheart failure patients to help clinicians identify those at highest risk of readmissions.

For more information: www.business.att.com, www.bodyport.com

March 5, 2019 — Connected healthcare solutions provider VivaLNK announced its internet of things (IoT)-enabled medical wearable Sensor Platform, complete with a range of sensors, edge computing technologies and an internet of health things (IoHT) data cloud. This platform captures human vitals and biometrics, and delivers data from the patient to edge computing devices, as well as to the cloud, for application integration and analysis.

Available through the VivaLNK Developer Program, the Sensor Platform enables IoHT solution partners to easily capture streams of patient data such as heart and respiratory rates, temperature, electrocardiogram (ECG) rhythms, activity and more. Partners such as Vitalic Medical, a digital health company focusing on early detection of patient health deterioration and potential falls, is developing a bedside monitoring solution using the platform.

IoHT has the potential to significantly change healthcare for the better, and the key starts with data, according to VivaLNK. Much of the machine learning and intelligence will come from user-generated data that currently does not exist or is not easily accessible. This is where wearable devices collecting medical-grade data that can easily connect to networked applications becomes crucial.

VivaLNK showcased its new platform at the 2019 Healthcare Information and Management Systems Society (HIMSS) conference, Feb. 11-15 in Orlando, Fla.

For more information: www.vivalnk.com

July 31, 2019 — Silicon Valley-based digital health company Eko announced Eko Home, a new service that enables precise remote monitoring of cardiac function using electrocardiogram (ECG) and heart sounds. Eko Home can be used to create drug-data combinations to demonstrate real-world efficacy for pharma trials, while simultaneously allowing clinicians to collect high-quality data while outside of the clinical environment.

The Eko Home application is currently being used in an active Mayo Clinic study. The purpose of the study is to evaluate different strategies of cardiovascular therapy with carvedilol, aiming to reduce the incidence of heart function declines and heart failure in at-risk breast cancer patients while on trastuzumab therapy.

The future of drug trials includes better data and continuous monitoring, according to a recent Harvard Business Review article. Per the authors, digital technologies “can revolutionize the antiquated process of developing new drug therapies and can vastly improve how we collect, measure and assess health data so that we can offer new treatments to patients without wasting valuable time and limited resources.” This is exactly what Eko Home offers to researchers, according to the company, providing precise monitoring for home cardiac patients using ECG and heart sounds, as well as other biometric data.

Eko expects to offer the drug-data combinations with other life science partners by the end of the year, with additional plans to offer its SDK to hospitals and healthcare providers that wish to build the platform directly into their applications.

For more information: www.ekohealth.com

August 15, 2019 — Bardy Diagnostics Inc. announced that HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in the organization's 2019 accelerator program. BardyDx was chosen for its advancements in cardiac monitoring by delivering diagnostic accuracy with the Carnation Ambulatory Monitor (CAM), a P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device.

HealthTech Arkansas is a new and expanded iteration of two previous accelerator programs in the state, Health InnovatAR and HubX-LifeSciences. This year, with more provider partners and increased investment for participating companies, HealthTech Arkansas is focused on bringing the most innovative healthcare technologies to Arkansas. The 2019 cohort selection was announced at the Arkansas Heart Hospital with a welcome from CEO Bruce Murphy, M.D., Ph.D., followed by a message from Arkansas Gov. Asa Hutchinson and presentations from each of the six chosen companies. Both Murphy and Hutchinson focused on the importance of working together to bring innovative technologies to Arkansas.

This year's six companies were selected from hundreds of applicants across 18 different countries. The cohort will participate in a program that provides them the opportunity to partner with and build solutions specifically identified by Arkansas Heart Hospital, Arkansas Children's, Arkansas Urology, Baptist Health, CHI St. Vincent, Conway Regional, Mercy, the University of Arkansas for Medical Sciences (UAMS) and Washington Regional Medical Center as areas of opportunity within their organizations. Each of the cohort companies will receive seed investment as well as complete and total access to clinicians and administrators at each partnering site.

"We're delighted to have the participation of BardyDx as one of six companies in our cohort this year," said Jeff Stinson, Director of HealthTech Arkansas. "Collectively, they're among the most accomplished early-stage healthcare companies in the country. BardyDx was specifically chosen because the leadership teams in our partner hospitals believe the company can significantly increase the quality of care through its innovative devices. We can't wait to begin our work with BardyDx."

For more information: www.bardydx.com

September 12, 2019 — Corvia Medical has sponsored and is actively enrolling patients in a heart failure (HF) device trial that, in addition to measuring traditional heart failure endpoints, includes collecting and analyzing biosensor data with physIQ’s continuous remote monitoring platform. The clinical trial is designed to evaluate the clinical efficacy of Corvia’s InterAtrial Shunt Device (IASD) in patients with heart failure and is enrolling patients at more than 100 sites worldwide. Of note, the pivotal Phase 3 study design mirrors commentary within a recent U.S. Food and Drug Administration (FDA) Public Workshop and FDA Draft Guidance for Industry related to using biosensor data.

In the randomized controlled double blinded study, enrolled patients are provided with a wearable biosensor and mobile data transfer hub. Each patient wears the biosensor prior to study randomization to establish a personalized pre-intervention baseline and then for up to 12 months after the device implant. Data continuously streams from the biosensor to the cloud for retrospective analysis with physIQ’s proprietary artificial intelligence (AI)-based analytics. With these novel real-world data and personalized analytics, the objective is to assist in demonstrating meaningful change in cardiopulmonary function and support novel clinical endpoints – a focus of FDA’s recent public workshop entitled “Endpoints for Drug Development in Heart Failure.”  At the workshop, leading experts discussed the promise of biosensor data in heart failure trials to assess changes in physical function and quality of life.  

Of particular note in the REDUCE LAP HF-II study is the fact that the continuous biosensor data and AI analytics will be generated in conjunction with the periodic evaluation of the six-minute walking distance test (6MWDT) and Kansas City Cardiomyopathy Questionnaire (KCCQ) assessments. By integrating these traditional markers of heart failure, novel continuous multivariate biosensor data and hard clinical outcomes, Corvia believes there is opportunity to transform how heart failure clinical trials are designed, implemented and evaluated.

With this approach, it is possible to continuously collect physiological data and utilize AI to assess therapeutic impact and disease progression in a way that can revolutionize how we think about clinical evidence. 

The study is anticipated to complete enrollment in 2020 and, upon conclusion, will generate more than 2 million hours of continuous, annotated, clinical-level physiological data.

The Interatrial Shunt Device is a transcatheter device approved in the European Union to treat heart failure with preserved (HFpEF) or mid-range ejection fraction (HFmrEF). After creating a small opening in the atrial septum, the IASD implant is deployed, forming a passage between the left and right atria that enables the left atrium to decompress at rest and during physical activity, with the aim of lowering left atrial pressure. By facilitating continuous and dynamic decompression of the left atrium, the IASD aims to improve heart failure symptoms and quality of life, decrease heart failure hospitalization rates, and reduce the overall cost burden of managing heart failure patients. 

For more information: www.corviamedical.com, www.physiq.com

The Centers for Disease Control and Prevention (CDC) highlights physical activity as one of four key behaviors people can take to improve their heart health.[1] This ties in with the explosion of heart rate and fitness trackers on the consumer market in the past few years. Clinicians are trying to figure out how to correlate consumer heath tracking big data into usable data from tracking patients' health. Here are some examples of how data from wearable health tracking devices can be used to examine trends in population health in various regions of the United States.

While obesity and other heart disease risk factors remain a growing national health crisis, big data from these consumer fitness trackers may allow population health insights into geographic variations. An example of this is Fitbit’s online Activity Index, which reveals how each state compares to the national average based on body mass index (BMI), resting heart rate (RHR) and other data, such as daily steps and active minutes per day.

What Hospitals Are Doing With Wearable Data

"There are a lot of people wearing these devices producing data and the manufacturers are collecting data and the question really is this something that can be utilized in healthcare to improve outcomes," said Karl Poterack, M.D., medical director, applied clinical informatics, Mayo Clinic. He presented on how wearable technology can be used at the 2019 Healthcare Information Management and Systems Society at (HIMSS) conference. "Obviously there are technical barriers to putting the infrastructure in place to collecting that data. The bigger question is what is the healthcare system going to do with that data."

Right now, if a patient goes to their doctor and shows them their step and heart rate data, the doctor is going to say they really have no idea what that means, Poterack explained. "The challenge to this is that we need a way to collect this data and tie it to outcomes, and it is going to take a lot of resources to build the infrastructure needed to collect and prices that data. Until we know what that data really means, it is going to be hard for people to make the commitment to build that infrastructure."

Poterack said Fitbit alone has data on more than 3 billion steps, and that is just part of the data that is out there. He said partnerships between wearable vendors collecting this data and healthcare organizations that have outcomes data will be needed to take the next step to making wearable data more clinically useful. 

Steps are being take by some healthcare systems to use wearables for outpatient tracking. The Sheba Medical Center in Israel is using an assortment or wearable devices interfaced by a third-party app to make the data accessible and HIPAA compliant in one location and trends trackable. 

"All this information comes to one place and goes into our system so we have all this data in one patient dashboard," said  Robert Klempfner, M.D., director of the Cardiovascular Prevention Institute, Sheba Medical Center. "We can decide that we want to get glucose levels on a patient, so we give them a glucometer that connects with my system. It is like a Lego system where everything can connect together, so we can add things like blood pressure monitors or SpO2 monitors to measure oxygen saturation. 
 

Examples of Wearable Data and Variables in That Data

While activity and heart rate trackers offer some insights, other population health also may play a role as variables on the data. This includes the demographic of who purchased these devices and using them, diet, access to fresh food rather than processed foods, environment, and the society attitudes toward health, diet and exercise between regions. These variables play a role in the data maps shown below. 

Below are several examples of how big data from wearables can be used to map population variables and their possible links to health trends seen in various regions of the United States. These data heat makes below are from Fitbit's online, interactive activity index. 

As can be seen in these comparisons below and realizing the many variables involved, artificial intelligence (AI) deep learning algorithms are now being used by researches and some health IT vendors to sift through this sort of data. Deep learning software enables the machine to identify complex patterns that can be used for better regional health risk assessments, or identify variables that impact public health. 

Fitbit device population health average daily activity vs. cardiovascular disease rates by state. 

Fitbit population health data for the average daily activity of Fitbit users vs. cardiovascular disease rates by state.

Fitbit big data heat map from Fitbit wearable health tracker users showing a comparison of steps vs. obesity rates by state. 

Fitbit population health data from Fitbit users showing a comparison of steps vs.cardiovascular disease rates by state.

Fitbit population health data from Fitbit users showing a comparison of resting heart rate vs. cardiovascular disease rates by state.

Fitbit Population health data showing a comparison of steps per day vs. diabetes rates. This is an example of how big data from consumer wearables can be used to track regional health trends.

Fitbit population health average daily activity vs. cardiovascular disease rate comparison by state.

Another example of big data can be used to track population health, using data from the siocial media network Twitter. These maps show a correlation between a CDC study on cardiovascular disease rates by country and a study conducted based on hostility in Twitter tweets by users based on their county location. [2]

Related Content on Wearables and Big Data in Healthcare:

Understanding How Big Data Will Change Healthcare

VIDEO: Use of Wearable Medical Devices for Cardiac Rehabilitation— Interview with Robert Klempfner, M.D.

VIDEO: Mobile App Links Wearable Data to Electronic Medical Records

Apple Heart Study Demonstrates Ability of Wearable Technology to Detect Atrial Fibrillation

VIDEO: Use of Wearables to Track Electrophysiology Patients— Interview with Khaldoun Tarakji, M.D.

VIDEO: The Future of Wearables in Healthcare— Karl Poterack, M.D.

8 Cardiovascular Technologies to Watch in 2020

VIDEO: Healthcare Technology Advances at CES 2019

The Cardiovascular Disease Technology Market Will Exceed $40 Billion by 2030

Welcoming Apple to the World of ECG

VIDEO: How Smartphones May Revolutionize Healthcare in the Developing World— Interview with Jacques Kpodonu, M.D.,

VIDEO: Use of Technology to Address Underserved Populations — Interview with Partho Sengupta, M.D.

Reference:

1. Centers for Disease Control and Prevention (CDC) website. Promoting Healthy Behaviors. https://www.cdc.gov/healthyschools/healthybehaviors.htm. Accessed Feb 14,2020.

2. Johannes C. Eichstaedt, Hansen A. Schwartz, Margaret L. Kern, et al. “Psychological Language on Twitter Predicts County-Level Heart Disease Mortality.” Psychological Science. Feb. 2015 26: 159-169, 2015 doi:10.1177/0956797614557867

When the patients of Michael Boler, M.D. need cardiac monitoring, the Holter monitor is no longer his first choice. “The newer ECG devices we have now are so much less cumbersome. It’s like wearing a Band-Aid versus carrying a bulky device,” said the Greenwood, Mississippi internist. “My patients prefer the more comfortable, wire-free form factor, and the quality is as good as, or better, than the Holter,” continued Boler. “Plus, my patient compliance has increased. With the Holter, the leads sometimes come off. The patient may think the device isn’t working, so they take it off and we have to restart the process.” 

Holter ECG technology was created in the 1940s, with the ambulatory version introduced in the mid-1950s. While it gives accurate data, the device is worn around a patient’s chest or waist, with multiple electrodes adhered to the chest. The patient can’t shower or get wet while wearing it. In 2009, the first ECG patch monitor was cleared by the U.S. Food and Drug Administration (FDA). Since then, a number of less-obtrusive ECG monitors for longer wear have been approved, including Cardiac Insight’s Cardea SOLO, ScottCare novi+ Patch Holter, Biotricity Bioflux, Medicalgorithmics PocketECG, and the iRhythm Zio patch. 

Extended ECG monitoring duration is an important reason why physicians are transitioning to  newer ECG wearables and compact body-worn devices. Longer device wear time allows more time to capture cardiac arrhythmia events that may not present during a one- or two-day test period. Today’s ECG wearables can be worn for 7 to 14 days – and some for up to 30 days. Many studies suggest, however, that the peak diagnostic yield for arrhythmia detection occurs by about 8 days of device wear time. Wearing an ECG recording device for at least a week can significantly improve diagnostic yield compared to the traditional Holter, which is typically worn for 24 to 48 hours.

When measuring palpitations, one study documented that 24-hour Holter monitoring resulted in a diagnostic yield of 15% to 39%. In a study where patients wore both a Holter ECG for 24 hours, and a 14-day patch, the Holter recorded 61 arrhythmia events and the patch recorded 96 events. In that study, 90% of physicians felt they had a definitive diagnosis from the patch monitor, compared to 64% who felt the same way after Holter monitor usage. Also, 81% of patients preferred the patch over the Holter. 

Tools in a the Cardiac Monitoring Tool Box

Cardiologist Mohammed Abuzahra, M.D., chief, division head of cardiology, Lifebridge Health, Baltimore, Md., thinks about heart monitoring devices as different tools in a tool box, and prescribes them according to patient need. “I prescribe a lot of single-channel, wearable ECG patches,” said Abuzahra. “However, if a patient has frequent PVCs (premature ventricular contractions) on an ECG, and I’m trying to quantify the number of PVCs, a multi-channel Holter test is the right way to go,” he said. Abuzahra continued that Holter ECG data can be more accurate in analyzing complex ventricular ectopy, since Holter-type devices offer a choice of three, five or seven leads, enabling multiple simultaneous views of cardiac electrical activity. With multiple leads for patients to wear, and more data to analyze, selection of the appropriate ECG monitoring device is paramount. 

“Some ECG wearables use more than a single lead, but they are larger, bulkier, may have external lead wires and require more adhesive than single lead devices such as our lightweight Cardea SOLO ECG Sensor,” said Robert Odell, president and chief operating officer of Cardiac Insight. “Single channel ECG wearables are good at detecting the most commonly-occurring arrhythmias such as atrial fibrillation (AFib), among others, making them an efficient, cost-effective and patient-friendly choice for most conditions that physicians want to diagnose.”

Usage and physician acceptance of the patches is increasing, Abuzahra said. “Patients like them. Doctors like them. They’re simple to use,” he said. “With no wires, the devices are comfortable for patients and produce quality diagnostic yields. They’re especially good for patients needing a longer-term monitor, like those who might have symptoms once or twice per week. With seven days’ worth of ECG recording, that will catch it,” he said. 

Like most ECG wearables, the ECG Sensor used by Abuzahra records continuously throughout the wear period, capturing every heartbeat and any abnormal activity. If the patient feels symptoms, they notate the event by pushing a button on the Sensor. After patient wear-time concludes, the great majority of wearable ECG devices require that they be returned by mail or connected to a remote, third-party ECG service center for review and processing, which can take days, or even up to a few weeks for return of results. Innovating on the status quo, Abuzahra’s practice processes its own wearable ECG device data completely onsite. The Cardiac Insight Cardea SOLO ECG System uploads and automatically analyzes Sensor data on the practice’s own Windows-based PCs, producing a draft report onsite that is ready for physician review in minutes. 

With ECG wearables growing in popularity, physicians now have more choices of ambulatory ECG monitoring solutions for their office-based patients. Assuming appropriate medical indications (subject to the patient’s individual insurance plan and coverage), insurer reimbursement of prescription-based ECG wearables is widely available and should not be a barrier to adoption. 

Apple created a stir when it announced in 2018 that its Apple Watch Series 4 was the first consumer health and fitness product to enable wearers to get an electrocardiogram (ECG) from their wristwatch. The device monitors the user’s heart rate and rhythm, sending notifications if abnormal findings are detected. The Food and Drug Administration (FDA) cleared the product as an “over-the-counter” (OTC) Class II medical device, clearing the way for more brand entrants and follow-on next generation improvements, with greater opportunity for research on their health impact and efficacy. While these platforms continue to evolve, input from manufacturer product labeling, medical professionals and associations agree that current OTC ECG wearables have performance limitations and are not intended for medical diagnostic decision-making.

That doesn’t stop patients from bringing OTC device data to their doctors, though. Cardiologist Mohammed Abuzahra, M.D., said that each month, one or two patients in his Pikesville and Baltimore, Maryland practices raise questions about the heart data seen on their devices. He expects this number to rise as the technology becomes more prevalent and affordable. In addition to watches, Abuzahra has also seen ECG information gleaned from smartphone cases with a single ECG lead, where the data is captured when the patient puts a finger or fingers on the device.

Using wearables for health purposes is gaining popularity in the United States. A 2018 national survey showed that 49% of consumers want devices to monitor their heart health. The survey also showed 63% of respondents owned a wearable device currently or in the past, compared to 42% just two years earlier. Consumer demographics, underlying motivation for OTC health device adoption and long-term wear compliance implications are being more deeply studied.

“Some OTC devices have a fairly good track record of detecting silent but serious treatable cardiac arrhythmias, which are not a rare occurrence,” said Abuzahra. If the patient shows evidence of a suspected clinically actionable arrhythmia, given that most heart arrhythmias are inconsequential and benign, the doctor can use this as a data point to discuss potential further workup.

In the U.S., Atrial Fibrillation (AFib) is the most common serious cardiac arrhythmia that increases in incidence with age, and typically requires treatment and/or monitoring. AFib affects an estimated 2.7 to 6.1 million people, can occur without symptoms and increases a person’s risk of a life-changing stroke, heart failure and death. Detection of silent Afib in particular, could help physicians and their patients get an earlier confirmed diagnosis. With less labeled accuracy compared to prescriptive ECG devices, using an OTC ECG device could increase the potential for false positives and wasteful use of healthcare resources. Conversely, OTC ECG device false negatives could give patients a false sense of security, even if they experience other symptoms of an abnormal heart rhythm.

 “Over the counter ECG technology is a “double-edged sword,” commented Abuzahra. “The devices can be helpful, but too much information can make patients anxious if they don’t understand how to interpret it, or don’t know when the device isn’t working.” A heart rate decrease to 40 beats per minute on the treadmill, for example, may be due to a technical issue, such as the electrode not making good contact with the skin.

“The patient’s full clinical history must be considered, and additional diagnostic testing completed before making a diagnosis and offering treatment, if needed,” concluded Abuzahra.

In spite of these concerns, Abuzahra is a fan of the technology. He’s recommended it for his patients who have experience working in the medical field, with some knowledge of heart arrhythmias. The devices can provide self-directed feedback for someone with an arrhythmia who wants to gauge whether their medication is working. But should all consumers use an ECG smartwatch or phone? Currently, Abuzahra steers patients without a medical background, and those who might get overly anxious about the results, away from wearable heart tracking devices. 

Validating OTC wearable heart monitors

A Stanford University study followed 419,297 self-enrolled participants tracking ECG rhythms on Apple Watch and iPhone. During the nine-month study, almost 2,100 (0.5%) received notification of an irregular pulse – defined as the sensor detecting five out of six repeat episodes in 48 hours. These participants were instructed to call the study physician for a video consultation. Doctors recommended that 658 of those participants wear a heart monitor patch for a week, with 450 (68%) completing the task.

Of this latter group, the ECG readings found that 34% of them experienced atrial fibrillation episodes. In 84% of the cases where the participant wore the patch and watch concurrently, the ECG results matched. While promising, this level of accuracy does not meet the standards of ambulatory ECG devices used and prescribed by healthcare professionals.

Accuracy is rising in the devices, said Dr. Abuzahra, with the software and recording algorithms improving. That said, unlike wearable medical ECG devices designed to meet the stringent performance and testing standards required to be labeled for prescription-use, many OTC ECG devices are constrained by data-processing know-how and other technology limitations.  Battery power, product size, form factor, consumer use design and not the least, consumer cost also come into play.

Prescription ECG Wearables Set the Standard for Medical Diagnosis

Prescription medical devices for heart rate and rhythm monitoring differ in that they rely on one or more “leads” or views of the heart and are typically attached to the chest wall. “This reduces motion artifact and provides more detailed information about cardiac electrical activity needed for medical diagnosis, “ said Robert Odell, President and Chief Operating Officer of Cardiac Insight, a digital health and ECG algorithm technology company based in Bellevue Washington.

As one example of the newer long-term continuous ECG recorders that record and report all cardiac electrical activity from 7 to 14 days, Cardiac Insight has developed and markets the Cardea SOLO system, a wearable ECG sensor and automated in-office cardiac arrhythmia analysis system prescribed by cardiologists, internal medicine, primary care and other medical professionals.

 “OTC ECG devices are already helping detect abnormal heart rhythms in the general population and will continue to improve. They are not intended to replace prescription ECG devices or the care of your physician, however,” said Odell. 

“Surveillance heart monitoring of those at risk is helpful as our population ages and acquires certain chronic conditions,” continued Odell, “but this also requires proof of consumer adoption and wear-time compliance. Someone periodically spot-checking their heart rhythm with an OTC ECG device may find an issue, but given that a significant percent (25-40%) of arrhythmias are silent, the diagnostic yield will be low. Perhaps in 10 or 20 years, with unlimited cloud storage and continuous monitoring, these OTC devices may be more helpful for population health,” said Odell.

One positive outcome from the many new OTC ECG devices is that they have raised awareness of the importance of the ECG as a diagnostic tool, said Odell.

Related Wearable ECG Monitoring Content:

Moving Beyond Holter ECG: The Rise in Next Generation Technology

How Advances in Wearable Cardiac Monitors Improve the Patient and Clinician Experience

Longer Continuous Ambulatory Cardiac Monitoring Enables More Comprehensive Evaluation of Atrial Fibrillation

Cardea Solo Wearable ECG Collects High-altitude Cardiac Data on Denali Expedition

Cardiac Insight Partners With VivoSense for Cardiovascular Research

Wearable Cardiac Monitors Are Effective for Tracking Atrial Fibrillation Following Ablation

As Interpretation Criteria Evolve, False Positive Athlete ECG Screening Rates Can Decrease

March 17, 2020 — The Trump Administration today announced expanded Medicare telehealth coverage that will enable beneficiaries to receive a wider range of healthcare services from their doctors without having to travel to a healthcare facility. This is part of the federal effort to prevent the spread of novel coronavirus (COVID-19), while still allowing patients with minor health issues or chronic conditions to check in with their doctors.

Beginning on March 6, 2020, Medicare, administered by the Centers for Medicare and Medicaid Services (CMS), will temporarily pay clinicians to provide telehealth services for beneficiaries residing across the entire country.

Telehealth has been a major topic of discussion the past couple weeks as COVID-19 continues to spread across the U.S. and health systems are looking for ways limit patients physically come coming into hospitals or offices, while still being able to deliver care. Medical societies, include the American College of Cardiology (ACC), have urged CMS to cover Telehealth services. Many healthcare systems and hospitals have already cancelled thousands of elective procedures and office appointments to help limit the spread of the virus. Telehealth services are the only options for many non-emergency patients. ACC President Richard J. Kovacs, M.D., FACC, and ACP Executive Vice President & CEO Darilyn V. Moyer, M.D., urged "policymakers to consider the important role digital and telehealth services can play to mitigate community spread while allowing clinicians to continue caring for patients."

The measure was also supported by the American Medical Association (AMA).

“The use of telemedicine and remote care services are critical to the management of the COVID-19, while also ensuring uninterrupted care for 100 million Americans with chronic conditions," said AMA President Patrice Harris, M.D., M.A. "The AMA encourages any private payers that are not already covering telehealth services to remove those limitations now. The AMA stands ready to help physicians expand their use of telemedicine and continues to invest in resources that provide physicians with a proven path for integrating telemedicine and digital health technologies into patient care".

“The Trump Administration is taking swift and bold action to give patients greater access to care through telehealth during the COVID-19 outbreak,” said CMS Administrator Seema Verma. “These changes allow seniors to communicate with their doctors without having to travel to a healthcare facility so that they can limit risk of exposure and spread of this virus. Clinicians on the frontlines will now have greater flexibility to safely treat our beneficiaries.”

On March 13, 2020, President Trump announced an emergency declaration under the Stafford Act and the National Emergencies Act. Consistent with President Trump’s emergency declaration, CMS is expanding Medicare’s telehealth benefits under the 1135 waiver authority and the Coronavirus Preparedness and Response Supplemental Appropriations Act. This guidance and other recent actions by CMS provide regulatory flexibility to ensure that all Americans, particularly high-risk individuals, are aware of easy-to-use, accessible benefits that can help keep them healthy while helping to contain the spread of COVID-19.

Prior to this announcement, Medicare was only allowed to pay clinicians for telehealth services such as routine visits in certain circumstances. For example, the beneficiary receiving the services must live in a rural area and travel to a local medical facility to get telehealth services from a doctor in a remote location. In addition, the beneficiary would generally not be allowed to receive telehealth services in their home.

The Trump Administration previously expanded telehealth benefits. Over the last two years, Medicare expanded the ability for clinicians to have brief check-ins with their patients through phone, video chat and online patient portals, referred to as “virtual check-ins”. These services are already available to beneficiaries and their physicians, providing a great deal of flexibility, and an easy way for patients who are concerned about illness to remain in their home avoiding exposure to others.

A range of healthcare providers, such as doctors, nurse practitioners, clinical psychologists, and licensed clinical social workers, will be able to offer telehealth to Medicare beneficiaries. Beneficiaries will be able to receive telehealth services in any healthcare facility including a physician’s office, hospital, nursing home or rural health clinic, as well as from their homes.

Medicare beneficiaries will be able to receive various services through telehealth including common office visits, mental health counseling, and preventive health screenings. This will help ensure Medicare beneficiaries, who are at a higher risk for COVID-19, are able to visit with their doctor from their home, without having to go to a doctor’s office or hospital which puts themselves or others at risk. This change broadens telehealth flexibility without regard to the diagnosis of the beneficiary, because at this critical point it is important to ensure beneficiaries are following guidance from the CDC including practicing social distancing to reduce the risk of COVID-19 transmission. This change will help prevent vulnerable beneficiaries from unnecessarily entering a healthcare facility when their needs can be met remotely.  

President Trump’s announcement comes at a critical time as these flexibilities will help healthcare institutions across the nation offer some medical services to patients remotely, so that healthcare facilities like emergency departments and doctor’s offices are available to deal with the most urgent cases and reduce the risk of additional infections. For example, a Medicare beneficiary can visit with a doctor about their diabetes management or refilling a prescription using telehealth without having to travel to the doctor’s office. As a result, the doctor’s office is available to treat more people who need to be seen in-person and it mitigates the spread of the virus.

As part of this announcement, patients will now be able to access their doctors using a wider range of communication tools including telephones that have audio and video capabilities, making it easier for beneficiaries and doctors to connect.

Clinicians can bill immediately for dates of service starting March 6, 2020. Telehealth services are paid under the Physician Fee Schedule at the same amount as in-person services. Medicare coinsurance and deductible still apply for these services. Additionally, the HHS Office of Inspector General (OIG) is providing flexibility for healthcare providers to reduce or waive cost-sharing for telehealth visits paid by federal healthcare programs.

Medicaid already provides a great deal of flexibility to states that wish to use telehealth services in their programs. States can cover telehealth using various methods of communication such as telephonic, video technology commonly available on smart phones and other devices. No federal approval is needed for state Medicaid programs to reimburse providers for telehealth services in the same manner or at the same rate that states pay for face-to-face services.

This guidance follows on President Trump’s call for all insurance companies to expand and clarify their policies around telehealth.

Read the CMS Fact Sheet on this announcement.

Read the Frequently Asked Questions on this announcement.

This guidance, and earlier CMS actions in response to the COVID-19 virus, are part of the ongoing White House Task Force efforts.

To keep up with what the Task Force is doing in response to COVID-19 at www.coronavirus.gov.

For information specific to CMS, please visit the Current Emergencies Website.
 

April 24, 2020 — AliveCor and Omron Healthcare announced a global, strategic alliance that combines AliveCor's mobile device ECG technology with blood pressure devices from Omron to better serve customers and expand access to remote patient care. This partnership aligns with global trends to deploy noninvasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact during the current pandemic.

"At AliveCor, we are committed to providing life-saving cardiological services to those who need them most. The scope, scale, and strategic importance of this transaction are unprecedented in our corporate history," said AliveCor CEO Priya Abani. "Omron's enormous R&D and distribution resources will bring AliveCor technology to more markets and more end users than ever before."

The COVID-19 pandemic underscores the importance of telemedicine in how we care for ourselves and loved ones. Those with chronic illness, including heart disease, are at higher risk of infection. AliveCor and Omron serve this vulnerable population every day by allowing patients to send personal health data to physicians without leaving their homes. The companies' ability to provide innovative, medical-grade technologies at home offers peace of mind to their users.

"The integration of these complementary technologies allows us to expand the heart health data we provide our customers and physician partners for a more complete picture of a patient's heart health," said Isao Ogino, president and CEO of Omron Healthcare.  "Our mission is 'going for zero' heart attacks and strokes. It is a lofty goal and we have committed to combining forces with like-minded partners to achieve it. Omron has already made important strides with AliveCor to advance our mission and this expansion of that collaboration, including the development of remote patient monitoring services, is a valuable boost to our growing healthcare portfolio."

The first technology collaboration between the two companies is the FDA cleared, award-winning Omron Complete. Introduced in 2019, Complete is the first blood pressure monitor with ECG capability in a single device. The companies expect this product to be the first in a line of integrated ECG and blood pressure devices making home heart care more accessible to consumers than ever before. Omron Complete is available for purchase in the U.S. at OmronHealthcare.com and participating retailers.

The companies also announced today the closing of an equity investment by Omron Corp., Omron Healthcare's parent company, in AliveCor. 

For more information: alivecor.com, OmronHealthcare.com