2019 guidelines for management of patients with atrial fibrillation

UMN Medical School expert is part of the writing committee that drafted the 2019 guidelines for the management of patients with atrial fibrillation (AFib)

Nearly 3 million Americans are living with atrial fibrillation (AFib), which is described as quivering or irregular heartbeat (arrhythmia). With increasing lifespan and increasing prevalence of risk factors such as obesity, experts believe the number of people living with AFib will increase at an exponential rate in the next decade. This has important public implications since AFib is associated with a higher risk of stroke, heart failure, cognitive decline and dementia, and death.

Lin Yee Chen, MD, MS, Associate Professor with Tenure, Cardiovascular Division, in the Department of Medicine with the University of Minnesota Medical School was part of a Writing Committee tasked with updating the 2014 guidelines for patients with AFib. The 2019 American College of Cardiology/American Heart Association/Heart Rhythm Society Guidelines for the Management of Patients with Atrial Fibrillation were just published in Circulation, the Journal of the American College of Cardiology, and Heart Rhythm as the standard for the management of Afib in the U.S.

“These guidelines are written for all physicians in all specialties,” said Chen. “It doesn’t matter whether the clinician is an orthopedic surgeon, gynecologist, oncologist or brain surgeon, everyone is bound to encounter AFib in their patients because it is so prevalent.”

One section of the new guidelines speaks to guiding practitioners across the whole spectrum of medicine, focusing on the use of new blood thinners or anticoagulants in people with AFib. The new guidelines help determine how and when to use these new agents, including in a situation that involves surgery.

Another portion of the document addresses the management of AFib in different scenarios, such as patients who have developed heart attacks.

“AFib patients are put on blood thinners to prevent stroke. When we need to perform procedures like a coronary angioplasty to open up any blockage in the heart arteries during a heart attack in AFib patients, we will also have to prescribe other agents called antiplatelets which when used in combination with blood thinners can elevate significantly the risk of bleeding, which is a real dilemma.” said Chen. “Current research is now in favor of double therapy- one antiplatelet agent and one anticoagulant, as opposed to two antiplatelets and an anticoagulant.”

A final section addresses the importance of weight-loss and weight management in improving the outcomes in people with AFib. In recent years, there is increasing evidence to suggest that lifestyle modification such as weight loss and physical activity can reduce the frequency and the burden of AFib. This has been incorporated into the new guidelines.

“The University of Minnesota could potentially make some significant contributions in the field of lifestyle modification and AFib,” explained Chen. “Currently, I am the Principal Investigator of an Academic Health Center Faculty Research and Development grant which funds a randomized controlled trial aimed at evaluating different exercise protocols in reducing the burden of AFib.

“Being represented on the Writing Committee is a great honor for the University of Minnesota Medical School, because ultimately, the point of our research is to influence and impact the way we practice medicine,” said Chen. “I think this is testimony to the outstanding research we perform for AFib at the University of Minnesota which is recognized by the American Heart Association and the American College of Cardiology.”




UMN researchers show how to improve prediction of stroke in patients with AFib

Atrial fibrillation (AFib) is associated with a 5-fold increased risk of stroke. Nearly 3 million Americans are living with AFib. For years, researchers have been looking for ways to reduce the risk of stroke for this patient population. In a recent article published in Circulation, Lin Yee Chen, MD, MS, Associate Professor with tenure, Cardiovascular Division, in the Department of Medicine with the University of Minnesota Medical School demonstrates how to improve the prediction of stroke in patients with AFib.

The CHA2DS2-VASc score is a prediction tool that is commonly used to stratify the risk of stroke in patients with AFib. In this article, Dr. Chen and colleagues reported that in people with AFib, abnormal P-wave indices during sinus rhythm are associated with stroke independent of CHA2DS2- VASc variables. They did this by investigating groups of P-wave indices and tested their association with the risk of stroke in two population-based cohort studies known as ARIC and MESA. They also came up with a scoring system known as P2-CHA2DS2-VASc score.

“We now possibly have a better scoring system that we can use to more accurately classify which patients with AFib are at higher risk of stroke, and who may require treatment to prevent stroke,” explained Dr. Chen.

This discovery was a culmination of years of work, which grant funding (R01HL126637 and R01HL141288 from the National Heart, Lung and Blood Institute) allowed Chen to take to the next level.

“We hope to transform care for patients with AFib, but there is still additional research to be done,” said Chen. “For example, we need more studies to confirm the reproducibility of P wave axis. In other words, if I did an ECG today and I repeat the ECG one week later, will it report the same number for the P wave axis?”

This discovery by Chen and colleagues is an important step and one which could have a big impact on the management of AFib because the P2-CHA2DS2-VASc score is easy to use and can be applied to a very wide community.

Source:

https://www.med.umn.edu/news-events/university-minnesota-medical-school-researchers-refine-ability-predict-atrial-fibrillation-related-stroke




Understanding AFib: Tips for a healthy life with atrial fibrillation

While living with a serious and complex health condition such as atrial fibrillation, there are many approaches and health behaviors that can increase your quality of life.

My colleague Paul Wang, MD, director of Stanford’s Cardiac Arrhythmia Service, describes three steps AFib patients can take to improve their health: increase physical activity, eat a healthy diet, and care for your mental well-being.

“All three work together to improve your overall health,” Wang said.

Let’s break down these key healthy behaviors, plus a few more: 

  • Eat a heart-healthy diet. A healthy diet emphasizes fresh fruits and vegetables, fiber-rich foods, and plant-derived fats like olive oil. Such a diet can slow down underlying problems that may have led to AFib.
  • Be physically active. Regular physical activity, such as brisk walking at least 30 minutes each day, will keep your heart as healthy as possible.
  • Take care of your own mental well-being. It is important to take time to do things that bring you joy and improve how you feel. If you have ongoing trouble with depression, anxiety or other mental health issues, seek out the advice of a physician or therapist.
  • Don’t smoke. Cigarettes and other smoking devices (e.g., vaping, marijuana, etc.) can damage the blood vessels of the heart.
  • Carefully manage other medical issues. Many other conditions — such as high blood pressure and high thyroid hormone levels — if not well controlled, can worsen AFib.
  • Limit alcohol and caffeine. These two compounds stimulate the heart and can make episodes of AFib more likely. Limit alcohol to one drink per day for women and two drinks a day for men. Keep caffeine intake down to the equivalent of one strong cup of coffee (250 mg) per day.
  • Manage your stress levels. Stress can contribute to AFib episodes and can impair your ability to cope with the added tasks needed to deal with AFib. Yoga, tai chi, and meditation are effective ways to manage stress.
  • Get adequate sleep. Most people require at least seven hours of sleep each night to feel their best. Sleep deprivation has unfavorable effects on the body.
  • Take prescribed medications consistently and as directed. Drugs prescribed for atrial fibrillation will only work if taken consistently and as prescribed. Warfarin and other blood thinners are less effective when you miss even a single dose.

These strategies, particularly when combined with standard medical approaches to AFib, are effective and life-changing.

George H., our 71-year-old retired engineer with AFib, has taken his doctor’s advice seriously. He has reduced his alcohol intake, gets more sleep, started to improve his diet, and every day either rides his bicycle or walks. His AFib has led to many complex issues that require doctors’ decisions and he has often felt left out of the conversation. For George, there is something satisfying and encouraging about doing his own part to improve his health. Overall, his quality of life has improved.

In addition to health habits that will keep your heart as healthy as possible, we recommend learning the details about AFib that can help you better manage your own health.

Three key AFib learning goals include:

  • Learn how to assess your heart beat so that you can tell when your heart is in AFib. Being able to feel the difference between AFib and a normal heart rhythm can allow you to seek help when you really need it. Similarly, assessing how fast your heart is beating can help you make better decisions about seeking help.
  • Learn your risk of having a stroke in the next year. Knowing your stroke risk score will help inform you and your doctor of whether blood thinners are recommended.
  • Know your medications. Gain knowledge about the medications used to treat AFib. Learning a little bit about blood thinners, heart rate-lowering medications and anti-arrhythmic drugs will go a long way towards making your visits with your doctor as effective as possible.

Finally, AFib patients and their doctors should strive to make shared decisions together that consider the advantages and disadvantages of drugs and other strategies. Only by proactively pursuing health and taking part in AFib treatment decisions will patients be able to maximize their outcomes and live their lives as fully as possible.

This is the final post in the Understanding AFib series to help patients with atrial fibrillation live healthier lives. George H. is an actual patient with some details altered to protect his confidentiality.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Illustration by Vinita Bharat/Fuzzy Synapse




Understanding AFib: Drugs and procedures to help restore a normal rhythm

As we have learned in earlier posts in the Understanding AFib series, atrial fibrillation is a serious heart condition where the heart beats rapidly without a regular beat, like dancing without rhythm.

A typical approach is to slow down the heart rate with medications, such as beta blockers. If the heart is weak to begin with, however, slowing down the heart may not be an adequate solution. If this is the case, special drugs, pacemakers, and procedures may help keep the heart in a normal rhythm, rather than in AFib.

Medications

Several drugs, called anti-arrhythmic drugs, may be useful in keeping the heart from going into AFib. In many instances, they have proven successful in maintaining the normal rhythm of the heart.

My colleague Paul Wang, MD, who specializes in arrhythmias like atrial fibrillation, explained:

Anti-arrhythmic medications are often used if a patient continues to have symptoms from AFib (like dizziness or fatigue) even after starting medications to lower their heart rate. These drugs can increase the time spent in a normal rhythm, which improves quality of life… The problem with anti-arrhythmic drugs is that they often have side-effects that make them difficult to take long-term.

National data show that the most commonly used anti-arrhythmic drugs are amiodarone (used by 5 percent of AFib patients), sotalol (4 percent), and flecainide (3 percent).

Pacemakers

In addition to medications, some patients with AFib may also need to have a pacemaker. A pacemaker is a small device placed under the skin of the chest that delivers an electrical signal to the heart that forces the heart to beat.

Some of the drugs that keep patients in a normal rhythm also slow down the heart to the point where it would beat too slowly. A pacemaker provides a back-up system so that the pacemaker fires when the heart slows down too much. Many modern pacemakers are also small computers that can perform multiple functions, including recording recent heart activity.

Procedures

Several procedures can be performed on the heart that force it to remain in a normal rhythm. Many of these procedures are done through a catheter, a thin tube that is threaded through a blood vessel up to the heart.

Once in the heart, small areas of the heart can be burned or frozen so that the chaotic electrical impulses in the heart’s upper chambers are interrupted and no longer continue firing. By destroying some of the tissue in the atria, these ablation procedures disrupt the heart’s faulty electrical impulses.

It is also possible to destroy the electrical connection between the heart’s upper (atria) and lower chambers (ventricles), known as the atrioventricular (AV) node. By destroying the AV node, no electrical signals can make it into the ventricles. A pacemaker is then required to keep the heart beating.

Other options, such as a Cox Maze procedure, may require open-heart surgery. Like ablation, they disrupt the electrical circuits in the heart’s upper chambers by creating a pattern (like a maze) of scar tissue using a scalpel or other device. These procedures are generally not recommended early in AFib because they carry their own risks and potential complications. It’s also possible the surgery may not work, especially long-term.

For some patients, however, these types of procedures offer a chance for a cure for Afib, allowing for greater health and well-being.

This is the sixth post in the Understanding AFib series to help patients with atrial fibrillation live healthier lives. George H. is an actual patient with some details altered to protect his confidentiality. Estimates of drugs used for rhythm control in AFib come from IQVIA’s National Disease and Therapeutic Index.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Photo by ulleo




Understanding AFib: How to measure your own heart rate and rhythm

George, the patient we have been following through the Understanding AFib series, found it easy to recognize when his heart was in atrial fibrillation (AFib) and beating very quickly (at 150 beats per minute). Like a heart dancing without rhythm, the rapid, irregular heart rate made him unable to exert himself.

Once George started the beta blocker, metoprolol, to slow down his heart, he felt better. But it became more difficult for him to tell whether his heart was in a normal pattern of beating or in AFib.

His doctor ordered a three-day, continuous electrocardiogram (ECG) monitor that confirmed he was in AFib several times for an hour at a time. He would have benefited from knowing when he was in AFib earlier, without having to wait for the test results.

In previous posts, we discussed blood thinning medications that reduce the chances of stroke and medications used to slow down the heart. But as you might guess, drugs are only part of the strategy to remain healthy with AFib.

Several other important, heart-healthy strategies, include:

  • Avoid stimulants, including excessive caffeine, that can speed up the heart.
  • Take your heart-rate control medications consistently. Heart rates can speed up very quickly when beta blockers are stopped abruptly.
  • Limit alcohol consumption. It is generally safe for women to have one drink per day and for men to have two.

It is also very useful to recognize when you are in AFib. While some people immediately know when their heart is in AFib because of palpitations, chest fluttering, shortness of breath, or other symptoms. Others may not have obvious indicators.

You can tell you are in AFib by paying close attention to whether your heartbeat is regular or irregular:

  • Begin by placing your right hand on the left side of your chest while seated and leaning forward.
  • Position your hand so that you feel your heartbeat most strongly with your fingertips.
  • A normal heart rhythm should feel like a regular drum beat cadence; you can usually anticipate when each beat will come after the last beat.
  • Because heart rate and the strength of the heartbeat can vary with breathing, sometimes holding your breath for a few seconds is helpful. With an irregular rhythm, it will be hard to predict when the next beat will come.
  • In addition, some irregular beats will be softer (less strong) than other beats, so the strength as well as the timing may not be consistent.

An ECG or continuous ECG monitor is the only foolproof way to tell if AFib is present, but learning to recognize symptoms and gain greater awareness of when it is occurring can be a crucial part of managing your health.

A second self-care skill is the ability to measure your heart rate. A very rapid heart rate can tell you when you need to seek medical care. Remember, an optimal heart rate is between 50 and 100 beats per minute when you are at rest.

To measure your heart rate:

  • Place your right hand over your heart so that you feel your heart beating under your fingertips.
  • Use a watch or timer and count the number of beats for 15 seconds.
  • Be sure to count all heartbeats; including beats that are not as strong or that come quickly following one another.
  • Take the number of beats you’ve counted and multiply it by four. For example, if you count 30 beats in 15 seconds, then you would calculate 4 x 30 = 120 beats per minute.
  • Repeat this process three times right away, writing down each heart rate to later share with your doctor.

It is also possible to use an automatic blood pressure cuff that measures heart rate.

In the next blog post, I’ll review the drugs and procedures that may help the heart return to a normal, regular rhythm.

This is the fifth post in the Understanding AFib series to help patients with atrial fibrillation live healthier lives. George H. is an actual patient with some details altered to protect his confidentiality.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Illustration by Vinita Bharat/Fuzzy Synapse




Understanding AFib: Slowing down the dancing heart

In atrial fibrillation (AFib), half of the heart’s four chambers aren’t beating properly, but are dancing around randomly without rhythm.

This sounds scary and, in some ways, it’s astonishing that people with AFib can function well at all. But remember that the heart’s upper chambers (the atria), which are malfunctioning in AFib, don’t pump blood to the body or through the lungs. They simply pass blood on to the muscular lower chambers of the heart (the ventricles) that do the hard work.

People with AFib tend to do fine when they’re not exerting themselves. Without treatment for AFib’s fast heart rate, however, the ability to be physically active is greatly reduced and the heart muscle can be damaged over time. As with all of us, AFib patients benefit from consistent, moderate exercise. Thus, slowing down the heart in AFib is a key goal.

Sometimes finding the right solution for AFib patients is like a puzzle.

When George H., our 71-year-old patient with AFib, was first diagnosed, his heart rate was 150 beats per minute (normal at rest is 60-100). With his heart rate this high, he felt that he could not do anything requiring even mild exertion.

During his first visit to the ER, he was given metoprolol, a beta blocker drug, to slow down his heart. When this dose did not consistently lower his heart rate below 100 beats per minute, his doctor doubled his dose.

George, however, often has a normal electrical pattern of regular heartbeat and only goes into AFib on occasion. When his heart is not in AFib and he took the doubled dose of metoprolol, his blood pressure fell to 105/55, his heart rate went down to 48, and he became “fuzzy-headed.” For George, finally switching to a dose halfway in between the low and high doses solved this problem.

For some people, AFib is an occasional problem, termed “paroxysmal AFib.”  When their hearts go into AFib they often go back to a normal rhythm on their own or can be given drugs or a mild electrical shock to return them to a normal heart rhythm. For others, AFib is permanent, meaning once their heart is in AFib, it stays in AFib.

For both groups, it is critical to keep the heart rate in a normal range. This makes people in AFib feel much better and allows them to be more active. It also protects the heart muscle from damage. Three types of inexpensive drugs are used to the lower heart rate in AFib:

  • Beta blockers, also used to lower blood pressure, are prescribed to 21 percent of AFib patients to reduce heart rate. They reduce the number of chaotic electrical signals from the heart’s upper chambers (the atria) that can travel into the lower ventricles where the signals trigger contraction of the muscular part of the heart. When using beta blockers, heart rate often goes down dramatically, for example, from 140 to 90 beats per minute. Commonly used beta blockers include metoprolol (brand name Toprol) and carvedilol (Coreg). Potential side effects include weight gain, cold hands or feet, and fatigue.
  • The calcium channel blockers verapamil and diltiazem are also used to lower heart rate in AFib. They work in a similar way to beta blockers. These drugs are taken by 10 percent of AFib patients and have side effects that include headache, constipation, and ankle swelling.
  • Digoxin, often used in the past to slow down the heart rate in AFib, is less effective and requires more monitoring than other drugs. Today only 3 percent of AFib patients use this drug.

The relatively low rate of use of these drugs implies that they may be underused. Some AFib patients not taking these heart-rate-lowering medications might benefit from their effectiveness in reducing AFib symptoms and improving quality of life.

A logical first step in the AFib journey is to understand the risk of stroke as well as the benefits and dangers of blood thinners. Knowing the drugs commonly used to slow down the heart in AFib is also important as you become more aware of AFib and how it is treated.

This is the fourth in a series of blog posts called Understanding AFib to help patients with atrial fibrillation live healthier lives. Next week, the blog post will discuss how patients can tell whether they are in AFib and how to measure their heart rate. George H. is an actual patient with some details altered to protect his confidentiality. Estimates related to drugs used for heart rate control come from IQVIA’s National Disease and Therapeutic Index.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Photo by Max Pixel




Understanding AFib: Blood thinners simplified

For those patients with atrial fibrillation (AFib) at high risk of having a stroke, drugs that reduce the blood’s ability to clot are quite effective. In most cases, these blood thinners effectively eliminate the risk of having a type of stroke that frequently occurs with this heart condition. At the same time, excessive bleeding is a serious side effect of these medications and requires that they be used carefully.

In earlier posts, we met George H., a 71-year old retired engineer.

After years of experiencing episodes of a rapid heart rate, George was diagnosed with AFib during a doctor’s visit. Sent to the emergency room for further evaluation, he was at first reassured that he wasn’t having a heart attack.

After a review of his stroke risk, the ER physician prescribed Eliquis (generic name: apixaban), a strong blood thinner.

A week later, however, George was startled to find blood in his stool and naturally worried that his bleeding was serious. Luckily, he quickly went to urgent care where blood tests for anemia were stable.

A few days later, a colonoscopy revealed bleeding from his hemorrhoids, a startling, but more mild problem rather than something more ominous. He was annoyed, however, that no one had told him that abnormal bleeding was a frequent side effect of blood thinners: the price to pay for protection from a stroke.

The blood’s ability to clot is miraculous. It is critical to human survival; without this well-tuned system of blood clotting, we would die from minor injuries.

In AFib, however, drugs are given to intentionally impair the blood’s ability to clot. The upper chambers of the heart (the atria) do not beat properly in AFib, which allows small blood clots to form on the inner walls of the heart. These blood clots can then fall off and travel to the brain where they block off an artery supplying oxygen and nutrients to the brain, resulting in a stroke.

Strokes can be mild or temporary, or so severe that major disability or death occurs. Without blood thinners, the risk of someone with AFib having a stroke averages about 2.3 percent per year or 20 percent over 10 years. As we talked about previously, the trade-off of preventing these strokes is major bleeding, which occurs in 2 percent of patients annually taking blood thinners.

What type of blood thinner is best?

There are four groups of drugs that block blood clotting. While all these drugs can be used to prevent strokes in people with AFib, each has its advantages and disadvantages.

  • Warfarin (brand name Coumadin) was until 2012 the standard oral blood thinner for AFib. Stronger than aspirin, it knocks out special proteins in the blood needed for clots to form. Warfarin is inexpensive, but can be a hassle because it requires precise dosing and careful monitoring with frequent lab tests. Excessive doses can be dangerous. Currently, 20 percent of patients with AFib are prescribed warfarin.
  • Direct oral anticoagulants work in a way that is similar to warfarin, but don’t need monitoring or special dosage adjustments. Their big advantage is simplicity, although they are expensive ($400 per month). They also wear off very quickly if a dose is missed. These drugs include apixaban (brand name Eliquis, 26 percent of patients with AFib use this drug), rivaroxaban (Xarelto, 15 percent ), and dabigatran (Pradaxa, 5 percent).
  • Aspirin interferes with small blood cells known as platelets to reduce blood clotting. Taken by 3 percent of AFib patients, aspirin and drugs similar to aspirin are weaker in protecting against strokes.
  • Heparins, injected drugs used by 1 percent of AFib patients, are useful for urgent blood thinning.

Research suggests that about 10 percent of AFib patients don’t need blood thinners because their risk of having a stroke is so low. National data also suggests that an additional 20 percent of AFib patients are not taking a blood thinner when they should be. Remember, without protection from a blood thinner, these patients are at risk for preventable strokes.

If you or someone you know has AFib, it is critical to have a discussion with a doctor about the potential benefits of taking a blood thinner.

This is the third in a series of blog posts called Understanding AFib to help patients with atrial fibrillation live healthier lives. Next, I’ll discuss drugs that slow down the heart so that patients with AFib can function better. George H. is an actual patient with some details altered to protect his confidentiality. Estimates of blood thinner use come from IQVIA’s National Disease and Therapeutic Index.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Illustration by National Institutes of Health




Study finds suboptimal antithrombotic care in AFib patients with cancer history

Atrial fibrillation (AFib) patients with a history of cancer are less likely to see a cardiologist or fill anticoagulant prescriptions compared with AFib patients who never had cancer, according to a study in the Journal of the American College of Cardiology. By not filling and taking prescribed medication, these patients are potentially putting themselves at increased risk of stroke.

Cancer detection and treatment methods have improved significantly over time, leading to a greater number of older people who are surviving and living longer after a cancer diagnosis, and as a result, developing other health conditions. AFib specifically is an important comorbid condition in cancer patients. Both have several common predisposing factors, including advanced age and inflammation, plus certain chemotherapeutic agents have been linked to the development of AFib.

How to best care for the increasing number of cancer survivors who are reaching older ages is a challenge for clinicians since comorbid conditions usually span multiple specialties. This study looked at the relationship between early cardiology involvement after an AFib diagnosis in patients with a history of cancer and how that affected outcomes.

“Overall, our data suggest that suboptimal antithrombotic care exists in AFib patients who have a history of cancer,” said Wesley T. O’Neal, MD, MPH, lead author of the study and a cardiology fellow at Emory University School of Medicine. “The decision to initiate antithrombotic therapy or refer to a cardiology provider should be individualized to the patient, but our data suggest that cardiology providers positively influence outcomes among these patients.”

Researchers looked at over 380,000 AFib patients in the MarketScan database and found 17 percent had a history of cancer. Prostate and breast cancers were the most common types of cancer, and patients with a history of cancer were also older and more likely to have other cardiovascular conditions. The data showed that patients with a history of cancer were less likely to see a cardiologist after AFib diagnosis and less likely to fill prescriptions for oral anticoagulants, which are essential to reducing the future risk of stroke. Differences were similar when looking at active cancers versus remote history of cancer.

The researchers confirmed that a beneficial association existed between early cardiology involvement at the time of AFib diagnosis among patients with a history of cancer. After 1.1 years of follow up, cancer patients who did see a cardiologist were more likely to fill their prescriptions, showed a reduced risk of stroke and did not show an increased risk of bleeding. These patients were more likely to be hospitalized, which may be due to more aggressive treatments.

According to a related editorial, the number of cancer survivors in the United States is expected to increase from over 15 million to over 20 million by 2026, which will lead to an increased focus on addressing their long-term medical and psychosocial needs.

“The management of cancer patients must extend beyond their primary malignancy and will require an interdisciplinary approach from oncologists, primary care providers and other subspecialists,” said Sean T. Chen, MD, an author of the editorial from Duke University Medical Center. “The increase in survivorship is a testament to the dramatic improvements in cancer therapy, but continued emphasis on a patient’s diagnosis of cancer can shift significant attention away from other essential aspects of care.”




Diagnosing Atrial Fibrillation in 30 Seconds

An interview with Glyn Barnes, Marketing Director for AliveCor, about Kardia Mobile and the Kardia Band, the FDA approved devices which can provide a diagnostic quality ECG reading in 30 seconds.

By AvectorImage Credit: Avector / Shutterstock

Why is it important to monitor your heartbeat regularly if you think you may have Atrial Fibrillation (AFib)?

If a doctor or nurse suspects that you may be suffering from atrial fibrillation or AFib, you will typically undergo two tests. Firstly, a simple pulse check which looks for an irregular heartbeat. If this is found to be positive, a patient may undergo a 12 lead ECG and then be given a 24 hour ECG monitor to wear at home.

A healthy ECG has a particular shape, denoted by the letters PQRST. The P wave is a small bump at the start of the trace. Typically, in a patient with AFib, this wave is missing.

A missing P wave, combined with an irregular heartbeat, is a strong indication that AFib is present. Doctors also use a scoring system to test how likely you are to have the condition.

Irregular electrical pulses in the upper chambers of the heart (atria) are characteristic of AFib and they prevent the heart from contracting properly. This can cause blood to pool in these chambers, which in turn increases the risk of clot formation.

If these clots break away from the heart, they pass quickly into the connecting large blood vessels. From there, they can travel upwards and lodge in the narrower vessels of the brain. This causes ischemia (a lack of oxygen to the tissue) and thus a stroke.

Strokes of this magnitude can be debilitating for patients, who often fail to make a full recovery assuming they survive the initial event.

Hence, monitoring your heartbeat regularly is highly important if you have (or are at risk of) AFib.

What is Kardia Mobile, and how does it work?

Kardia Mobile is a miniature clinical-grade ECG device that can be used to monitor the electrical activity of the heart and it works with most smartphones and tablets. Typically, an ECG involves attaching wires and electrodes to your body in a clinical setting.

The Kardia Mobile has only two of these electrodes, which are encompassed within a slimline device that’s smaller than a credit card.

When you feel your heart behaving unusually such as beating faster than normal or exhibiting palpitations, all you need do is activate the app on your phone and place fingers from each hand of the electrodes. The app then counts down 30 seconds after which, the device will have completed an ECG recording.

The results of your ECG are automatically analyzed, and if AFib is present, you will be notified by the app immediately.

You can then instantly email the results to your doctor or nurse. As the recording is of diagnostic quality, they can confirm the diagnosis of AFib upon receipt. You may then be given medication such as an anticoagulant, which will dramatically reduce your risk of stroke and could save your life.

One of the challenges with atrial fibrillation is that can be what’s known as paroxysmal, or intermittent. You may only have an event once a fortnight for example, which makes it incredibly difficult for doctors and nurses to make a diagnosis.

It is not very often that a patient has an episode of AFib whilst in the hospital at an appointment, so a diagnosis of AFib can take months or even years to make. During this time, you are five times more likely to have a stroke than a person of a similar age who doesn’t have AFib.

AFib is a huge health concern. It’s the most commonly diagnosed arrhythmia and places a heavy financial burden on health services. In England alone, the AFib costs the NHS £2.2bn per year, once you add in the after-care costs for patients who’ve had a stroke.

We’re not by any means replacing the ECG machines used in hospitals, as they provide a much greater amount of information than Kardia does. However, the Kardia Mobile is a fantastic low-cost device that enables patients to carry out an ECG anytime and anywhere.

You might be on the London underground, or in a supermarket, and you can take a real-time measurement of your heart’s activity, capturing events as they happen.

What is the Kardia Band, and how does it differ from Kardia Mobile?

The Kardia Band is a watch strap for the Apple Watch that allows you to take an ECG measurement. This displays on the screen of the watch as you use it. There’s a small, square sensor in the middle of the strap that’s double-sided.

When you need to take an ECG measurement, you place your right thumb on the top sensor and ensure that the bottom of the sensor is touching the skin on your left arm, as it should be when you are wearing the watch. From here, you will see a diagnostic quality ECG reading scrolling across the watch screen.

Like Kardia Mobile, a measurement using Kardia Band takes just 30 seconds and can be sent straight to your GP or cardiologist.

The added benefit of the Kardia Band is that it can be used to monitor your heart rate all day, and from this it makes predictions using AI about what your heart rate should be, relative to your current activity.

For example, if I’m busy and running between meetings in London, my heart rate should be higher than normal. However, if I’m sat at home having a cup of coffee and suddenly my heart rate spikes, the app will detect that, and prompt me to do an ECG there and then.

How is the technology useful for patients with conditions such as heart palpitations?

When Kardia Mobile and the Kardia Band were first launched, we focused on patients with AFib. However, it very quickly became apparent that the product could be used to monitor several other arrhythmias.

For example, when it comes to heart palpitations, we know that the vast majority of patients (80-85%) have nothing wrong with them. They are just experiencing normal palpitations that can be brought on by stress or too much coffee.

For these patients, being able to purchase a low-cost device such as the Kardia Mobile can give them piece of mind, while reducing the burden on the healthcare service.

They can then take the recordings to their GP, who, once confirmed ‘normal’ can reassure the patient and tell them that there is nothing to worry about. This can help to free up time for cardiologists and help to reduce waiting times for appointments.

By catshilaImage Credit: catshila / Shutterstock

It is clear that Kardia Mobile and the Kardia Band will help patients identify when their heartbeat is irregular, but how will it help clinicians?

More and more doctors are becoming interested in employing the Kardia Mobile in their clinics, and they’re also finding new uses for the devices. Some clinics are using the device to screen patients at routine appointments, whereas others are loaning it to patients so that they can capture the data they need to make a diagnosis.

The devices can also be used to monitor patients after surgery. For example, patients with AFib will sometimes undergo a procedure called ablation, where a wire is passed into the atria of the heart and, using heat or freezing, creates more direct channels of electrical activity. This helps the atria to contract properly and therefore blood to flow freely.

The procedure isn’t always successful, and it’s important to be able to detect this early. Even after a successful procedure, the symptoms of AFib may return with time. Some doctors now monitor their patients’ post ablation using KardaiMobileto check their progress.

A different and creative example of a hospital clinician using the device was an anesthetist. Sometimes, patients arriving in theatre are discovered to have an arrhythmia when hooked up to the monitor.

The case may then be canceled, causing unnecessary stress on the patient and wasting valuable operating time. So, this doctor now uses the Kardia Mobile to carry out ECG’s on every patient before they go down to theatre, saving time and resources.

Where can readers find more information?

https://www.alivecor.com/

About Glyn Barnes

Glyn Barnes - intervieweeGlyn has spent over twenty-five years working in the medical device industry holding senior roles in companies such as GE Healthcare and Spacelabs. With a passion for healthcare technology, he believes significant changes are underway with the provision of care in this country.

‘The NHS understands that we have to look at new technologies, empowering patients to be involved with their own care, and ultimately achieving efficiencies in the process. I joined AliveCor as I could see the company had developed exciting new devices to match this need and current product developments will further enhance our offering to the market.’




Understanding AFib: Why do I have this? Should I take blood thinners?

In my clinical practice, I’ve found that patients with the irregular heart rhythm atrial fibrillation (AFib) do the best when they contribute to their own care by:

  • Learning the difference between AFib and a normal heart rhythm.
  • Eating a heart-healthy diet that slows down underlying problems linked to AFib.
  • Gaining knowledge about AFib medications and taking them consistently.

Oftentimes, patients wonder why them — why is their heart not working as it should?

About 9 percent of people over 65 have atrial fibrillation. Although diseased arteries in the heart often lead to AFib, other causes include high blood pressure, obesity, and excessive alcohol use. It is also more common in those of European descent.

AFib comes in several forms; often it is permanent with no possibility of a return to a normal rhythm. Other times, it can come and go (a condition called paroxysmal AFib, the type that George H., who we met in our last blog post, has).

As I mentioned  there, preventing a stroke in AFib patients is a major consideration.

Unfortunately, people with this heart condition are 4 to 5 times more likely to have a stroke. AFib’s irregular heartbeat may lead to small blood clots that form within the heart. When these blood clots travel to the brain, they can produce major damage by blocking essential blood flow and causing a stroke. While AFib is a serious health condition, the good news is that the use of blood thinners drastically reduces the chance of having a stroke.

All medications have risks. While reducing the blood’s ability to clot makes blood thinners incredibly useful drugs, they also have significant risks. They must be taken carefully and only with a doctor’s advice. The most common side effect of blood-thinning medications is unwanted minor bleeding or bruising. Serious bleeding, while less common, is most likely to occur in the digestive tract, particularly in the lining of the stomach.

Since there are inherent risks in taking blood thinners, deciding who is a good candidate to use them is always a balancing act.

It is critical to carefully weigh the prevention of a future stroke against the potential for increased bleeding. Doctors frequently use a stroke risk scoring system called CHADS2-VASc to help with the decision about who should take blood thinners. The guidelines for the scoring system follow a couple basic rules:  Blood thinners are recommended if any ONE of these risk factors is present:

  • Age 75 years or older,
  • A past stroke or mini-stroke, or
  • A past blood clot.

Blood thinners are also favored if any TWO of these risk factors are present:

  • Female
  • Age 65-74 years,
  • Heart failure,
  • High blood pressure,
  • Diabetes, or
  • Vascular disease (e.g., chest pain, carotid artery disease, heart attack).

The more risk factors you have, the greater the chance of having a stroke and the more reason to use blood thinners to protect against a stroke. For those with none of these risk factors, the possibility of harm from these drugs is greater than the possible benefits. In general, the risk of having a stroke is the same whether AFib is permanent or only occurs occasionally.

We introduced George H. in our last blog post. He is a 71-year-old retired engineer with episodes of AFib. Based on the risk factors for stroke reviewed above, should George take blood thinners?

Let’s check out his risk factors: He is 71 years-old and taking medications for high blood pressure, although he has none of the other listed stroke risk factors. Based on his age (1 point) and having high blood pressure (1 point), George’s risk of a stroke is 2 percent per year. Following the guidelines, the doctor started him on a blood thinner. But as we’ll see, George came to have some second thoughts about this, his blood thinners were more than he bargained for.

Knowing your stroke risk score is a critical piece of information for every patient with AFib. Several online tools are available to help calculate stroke risk scores. You can use this easy-to-use, online risk scoring calculator to help assess your situation and then work with your doctor to review your personal calculations.

This is the second in a series of blog posts called Understanding AFib to help patients with atrial fibrillation live healthier lives. The first blog post explained AFib, while the next blog post will review blood thinning drugs. George H. is an actual patient with some details altered to protect his confidentiality.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Photo by rawpixel




Understanding AFib: A heart dancing without rhythm

The irregular heartbeat of atrial fibrillation (or AFib) is like dancing without rhythm, moving fast without a beat and stepping on your partner’s toes. If not treated, AFib is serious. It can reduce quality of life and, most ominously, can lead to a stroke. A stroke can kill off many millions of brain cells, paralyze parts of the body, interfere with speaking, or even cause death.

However, the nearly 6 million people in the U.S. who have AFib can take steps to reduce their risk of stroke. This blog series presents information, skills and health habits needed to lead a vigorous, fulfilling life with AFib.

First, let’s meet George H., a 71-year-old retired engineer with high blood pressure. George frequently experienced episodes of a rapid, irregular heartbeat lasting up to an hour. Initially occurring monthly, over time the rapid fluttering in his chest became more frequent. Often, these episodes occurred in combination with lack of sleep, increased stress, or after drinking a few beers.

During one particularly frightening episode, George phoned his doctor who instructed him to come immediately to her office. An electrocardiogram (ECG) showed AFib with an irregular heartbeat of 150 times per minute, a potentially serious situation. His doctor sent George to the emergency room for further evaluation. He left with two new prescriptions, but was disappointed by the lack of information he received.

To better understand AFib, let’s review the mechanics of how the heart works.

An internal electrical impulse travels within the heart, which triggers the muscle cells, and the muscles to contract. Normally, the electrical signal first runs through the heart’s upper chambers (the atria) and then, moments later, through the larger, more muscular lower chambers (the ventricles). The squeezing power of the lower chambers pushes blood out of the heart.

A pulsation of blood travels like a wave through the arteries to reach everywhere in the body. This creates the usual rhythmic sound we associate with a heartbeat: lub-dub, lub-dub, lub-dub.

In AFib, abnormal, random electrical impulses in the upper chambers cause the atria to quiver (or fibrillate) rather than squeeze in a normal, coordinated way. Only some electrical signals in the upper chambers are allowed to trigger the muscles of the ventricles, thanks to the heart’s own safety system. As a result, the ventricles squeeze irregularly, usually 2-3 times a second in untreated atrial fibrillation (120-180 heartbeats per minute). In contrast, normal is 60-100 beats per minute.

What results is a dancing, irregular rhythm that is more like the fast gallop of a lame horse: dub-lu-dub-lu-lu-dub-lu-dub-lu-lu-lu-dub-lu-dub-lu-dub. With this rapid, syncopated rhythm, the heart can’t pump blood as strongly as it should. It can’t fill fully with blood and has too little time to rest between beats. As a result, people with atrial fibrillation often cannot exert themselves. Enjoyable physical activity is limited, a real problem given the health benefits of exercise.

A stroke can result when the quivering in the upper chambers allows small blood clots to form on the inside walls of the heart. These tiny clots can ultimately lodge in the brain, killing the part of the brain robbed of oxygen and nutrients.

Treatment of AFib can prolong life and promote greater well-being. Overall treatment goals include:

1) preventing blood clots and strokes through the use of blood thinners (anticoagulants)
2) slowing down the irregular beating of the heart to allow better heart function
3) and, for some patients, resetting the heart’s rhythm to a normal flow of electrical signals.

AFib, along with its underlying causes and recommended treatments, can be overwhelming. Learning to live with AFib, however, is worth the effort.

This is the first in a series of blog posts called Understanding AFib to help patients with atrial fibrillation live healthier lives. The next blog post will discuss which patients with AFib should consider taking blood thinners. George H. is an actual patient with some details altered to protect his confidentiality.

Randall Stafford, MD, PhD, is a professor of medicine at Stanford and practices primary care internal medicine. Stafford and Stanford cardiologist Paul Wang, MD, lead an American Heart Association effort to improve stroke prevention decision-making in atrial fibrillation.

Illustration by Vinita Bharat/Fuzzy Synapse




Family history in blacks, Latinos associated with higher risk of AFib

Despite being the most common heart arrhythmia disorder in the U.S., there is not much research on the causes of atrial fibrillation in minority populations. And while researchers know that black and Latino individuals are less likely than whites to develop the condition, which is also known as AFib, they cannot yet fully explain why these groups are paradoxically more likely to experience higher rates of complications and even death as a result of AFib.

Thanks to the development of a large, diverse registry of patients, researchers at the University of Illinois at Chicago who have been studying AFib in minority populations think they have unlocked one small part of the mystery.

“Our analysis shows that there is a genetic predisposition to early-onset AFib in blacks and Latinos that is greater than what we see in whites,” said Dr. Dawood Darbar, professor of medicine and head of cardiology at the UIC College of Medicine.

The findings from the study, which looked at data from 664 patients with AFib, are published in JAMA Network Open.

Darbar says that the study offers the first research-based evidence in support of increased monitoring, even including genetic testing, of individuals and their families who have first-degree relatives diagnosed with AFib prior to age 60 as a preventive measure against complications that can develop as a result of the condition, including stroke.

“Many people with AFib do not know they have the condition until they present to the emergency room with a stroke,” Darbar said. “Identifying people at risk for AFib and preventing these complications is the most effective way to improve AFib outcomes in black and Latino communities.”

While Darbar says more studies on AFib are needed, this one is unique because most prior studies on family history and AFib relied on data from mostly white populations, leaving doctors with little research to guide personalized treatment in minority communities. Of the 664 patients enrolled in UIC’s AFib registry at the time of the study, 40 percent were white, 39 percent were black and 21 percent were Latino.

The researchers found that there was a family history of AFib in 49 percent of patients who were diagnosed with early-onset AFib — which is defined as occurring in patients younger than 60 years of age — compared with only 22 percent of patients diagnosed with AFib later in life. When broken down by race, the chances of a patient with early-onset AFib having a first-degree relative with the condition was more than two-and-a-half times more likely for blacks and almost 10 times more likely for Latinos, compared with only two-and-a-half times more likely for whites.

“I was surprised to see that even though blacks and Latinos have a lower risk of developing AFib than whites, they had similar or higher risk if there was a family history of the condition,” Darbar said. “This is telling information for practicing health care providers who, while working with patients, need to determine risk and develop preventive strategies — not just for patients, but for their families, as well.”




Awareness of arrhythmia symptoms to prevent stroke and heart failure

Butterflies in a patient’s stomach are one thing, but palpitations in their chest can mean serious heart problems.

“Having atrial fibrillation (AFib) can increase your risk for stroke and heart failure. It’s vital to know your risk and get help before it strikes,” said cardiologist Dr. Mark Link, Professor of Internal Medicine and Director of Cardiac Electrophysiology at UT Southwestern Medical Center.​

September is AFib awareness month, and UT Southwestern cardiologists can help patients determine when to seek treatment. According to the American Heart Association, AFib is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure, and other heart-related complications. At least 2.7 million Americans are living with AFib.

Many people get occasional palpitations that may raise concerns about a possible heart rhythm disorder. Such palpitations may be caused by too much caffeine (including caffeine found in chocolate), alcohol, nicotine, stress, exercise, dehydration, or an abnormal heart rhythm. Even when palpitations are caused by a heart rhythm disorder, most aren’t dangerous.

There are exceptions, however. “If a patient has palpitations accompanied by chest pain, lightheadedness or dizziness, shortness of breath, sweating, or fainting, he or she should seek immediate medical attention,” said Dr. Link, who also holds the Laurence and Susan Hirsch/Centex Distinguished Chair in Heart Disease at UT Southwestern.

Symptoms of AFib

  • A feeling that the heart is skipping a beat
  • A heartbeat that is too fast or “racing”
  • A heartbeat that is too slow
  • An irregular heartbeat
  • Pauses between heartbeats

According to Dr. Link, tests that may be performed to diagnose arrhythmia include:

  • Electrocardiogram (ECG): Measures heart rate, heart rhythm, and strength of electrical signals in the heart
  • Event monitoring: Records and transmits heart patterns using a small, pager-size device that records ECG patterns when activated by the patient
  • Holter monitor: An external device worn by the patient that records a continuous ECG of the heart’s electrical activity
  • Echocardiogram: Produces a moving picture of the heart, using a device called a transducer that is placed on the chest
  • Electrophysiology study: Insertion of a specially outfitted catheter into the heart to measure electrical signals, pinpoint injured and abnormal heart muscle, and administer electric impulses to evaluate arrhythmias
  • Cardiac stress testing: Evaluates how the heart performs during exertion, such as walking on a treadmill or riding a stationary bike

“All of these tests are important measures of cardiac health,” Dr. Link said. “It’s important to work with your physician to determine the right test for you.”​​

Source:

https://www.utsouthwestern.edu/newsroom/articles/year-2018/afib.html




Patients who develop AFib following TAVR have greater risk for complications

Better care management strategies are needed to help reduce risks

Patients developing AFib after TAVR are at higher risk of death, stroke and heart attack compared to patients who already had AFib prior to the procedure, according to a study today in JACC: Cardiovascular Interventions. The paper is the first nationwide examination of patients who developed AFib for the first time following TAVR.

Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure to replace aortic valves by inserting a catheter into an artery in the leg to reach the patient’s heart. Heart rhythm disorders, particularly atrial fibrillation (AFib), frequently complicate TAVR. Prior research has shown that if a patient has AFib before TAVR, they are much more likely to have worse outcomes after the procedure in comparison to patients who do not have pre-existing AFib. When it comes to patients who did not have AFib before TAVR, but developed it after the procedure, data has been limited until now.

“We found that about 8 percent of patients undergoing TAVR that did not have pre-existing AFib developed new-onset AFib after their procedure,” said lead study author Amit N. Vora, MD, MPH, an interventional cardiologist and researcher from Duke University Medical Center and the Duke Clinical Research Institute. “When you combine patients that had AFib prior to the TAVR procedure and those that develop it after, more than one-half of all patients undergoing TAVR have to also deal with co-existing AFib.”

The study looked at data from the STS/ACC TVT Registry, a collaboration of the Society of Thoracic Surgeons and the American College of Cardiology, linked with outcomes data from the Centers for Medicare and Medicaid Services. Researchers analyzed 13,356 patients undergoing TAVR at 381 sites across the U.S. From this group, 1,138 patients developed AFib for the first time after the procedure. The study focused on how often new AFib was occurring, how it was managed if it did happen, and what the outcomes were for patients who developed AFib after TAVR.

The analysis found that patients who developed new-onset AFib following TAVR were more likely to be female, older and have severe chronic obstructive pulmonary disease. TAVR that was not performed via transfemoral access was also shown to be associated with the development of new-onset Afib.

The study also examined short- and long-term outcomes among patients who developed new-onset AFib. Rates of in-hospital death, stroke and heart attack were all higher among new-onset AFib patients. Additionally, these patients were at a 37 percent higher risk of death one year after the TAVR procedure as well.

“Current guidelines are murky regarding the optimal treatment strategy for these patients, who often tend to be at high risk for stroke but also high risk for bleeding,” Vora said. “Although there are a number of trials that are examining various strategies for this population, we need to continue to look very closely at this and determine the best care management for these high-risk patients.”




Mobile health devices diagnose hidden heart condition in at-risk populations

Study authors and coordinators included (front row, left to right) Reina Estrada, Lauren Ariniello, Jill Waalen, Elisa Felicone, (back row) Eric Topol, Gail Ebner, Steven Steinhubl and Melissa Peters. Credit: Scripps Research

Wearable mobile health devices improved the rate of diagnosis of a dangerous and often hidden heart condition called atrial fibrillation (AFib), according to a first of its kind, home-based clinical study conducted in part by researchers at the Scripps Translational Science Institute (STSI).

By catching AFib, which can increase the risk of stroke fivefold, in people who are at risk but might have gone undiagnosed, the mobile health (mHealth) devices resulted in more people receiving critical preventive therapies, the study found.

“Our study shows an almost threefold improvement in the rate of diagnosis of AFib in the those actively monitored compared to usual care,” says Steven Steinhubl, MD, director of digital medicine at STSI and an associate professor at The Scripps Research Institute (TSRI). “Timely diagnosis of AFib more effectively can enable the initiation of effective therapies and help reduce strokes and death.”

Findings from the mHealth Screening To Prevent Strokes (mSToPS) study were published today in the Journal of the American Medical Association.

A need for better screening

As many as six million Americans live with AFib, an irregular heartbeat (arrhythmia) that beyond its associated stroke risk also doubles the risk of death. Fortunately, effective therapies can help substantially reduce the risk of stroke in individuals diagnosed with AFib. However, approximately a third of individuals with the disorder are asymptomatic, and the lack of effective screening prevents or delays diagnosis and treatment.

Recent advances in digital medicine technologies present opportunities for both innovative screening strategies, as well as more inclusive and participant-centric approaches to clinical research. Novel mobile health (mHealth) devices can provide a means of monitoring AFib more effectively and continuously without interfering with routine activities.

The mSToPS study sought to compare outcomes of intermittent screening for AFib during regular visits to a primary care physician with continuous, single-lead electrocardiogram (ECG) monitoring using a patch sensor. The primary objective was to determine whether monitoring with wearable sensor technology can identify people with asymptomatic AFib more efficiently than routine care.

Re-imagining clinical research

STSI researchers teamed with Aetna’s Healthagen Outcomes unit and Janssen Pharmaceuticals, Inc., to conduct the study using the FDA approved wireless iRhythm Zio®XT patch for ECG screening. Aetna’s data and analytics made the innovative study design possible.

The study population consisted of members of the Aetna fully insured Commercial and Medicare health plans. Using Aetna’s data sets, eligible members were identified based on clinical characteristics associated with a possible increased incidence of AFib. They were invited to participate in the study through a nationwide email outreach campaign that then enabled interested participants to enroll through a web-based digital consent process.

The digital outreach and enrollment, and the home-based approach meant that anyone who met the inclusion criteria could participate in the study, regardless of their geographical location.

All of the study data was participant-generated, with individuals self-applying the wearable sensor they received in the mail and returning it to iRhythm for analysis once they had worn the patch for up to two weeks. The generated data was also returned to the monitored participants and, with their approval, to their physicians.

A total of 5,214 individuals were included in the one-year analysis, with a third being assigned to the monitored cohort and the rest being observational controls. AFib was newly diagnosed in 6.3 percent of the monitored participants and in 2.4 percent of the controls.

According to Steinhubl, this is the first study to describe the early term clinical consequences of active ECG screening. By reviewing claims data, the researchers observed that active monitoring was associated with increased initiation of anticoagulant and antiarrhythmic therapies.

“This study demonstrates the utility of a digital approach not only to diagnosing asymptomatic AFib, but to the clinical research field as a whole,” says Steinhubl. “We hope that it will set a precedent for future real-world, participant-centric clinical trials that leverage the power of digital medicine technologies.”

STSI’s founder and director Eric Topol, MD, also a TSRI professor, deems the use of digital sensors as vital to the future of medicine and clinical research. “For clinical research to change practice it needs to be more participant focused and reflect the real world of those participants, by taking advantage of digital tools and infrastructure that is possible as never before,” says Topol.


Explore further:
Study launched by STSI uses wearable sensors to detect AFib

More information:
Journal of the American Medical Association (2018). jamanetwork.com/journals/jama/ … .1001/jama.2018.8102