Mayo Clinic and Eko Health have developed AI Stethoscope That Can Detect Heart Failure. (Now have FDA Clearance)

Mayo Clinic and Eko Health trained the AI program to developed Stethoscope that can detect heart failure.

Now healthcare providers will be able to detect Low EF, a key heart failure indicator, in 15 seconds using an Eko stethoscope during a routine physical examination.

Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam
Developed with Mayo Clinic, Eko Health’s Low Ejection Fraction (Low EF) AI gives healthcare professionals a powerful tool to more accurately assess possible heart failure in at-risk patients during a standard physical exam


In the U.S., more than 6 million people battle heart failure, with half of them experiencing heart failure with reduced ejection fraction (HFrEF)—a condition marked by the heart’s inability to pump blood effectively.1 Traditional heart failure detection tools, such as echocardiography, are often unavailable in primary care settings as they are costly, require specialized training, and add significant time. As a result, many heart failure cases go undiagnosed until symptoms force a specialist or emergency hospital visit, leading to worse patient outcomes and exacerbated healthcare costs.2 Eko’s Low EF AI disrupts this status quo by embedding rapid and accessible low ejection fraction detection into a stethoscope exam on the front lines of care.

“The ability to identify a hidden, potentially life-threatening heart condition using a tool that primary care and subspecialist clinicians are familiar with – the stethoscope – can help us prevent hospitalizations and adverse events,” said Dr. Paul Friedman, Chair of the Department of Cardiovascular Medicine at Mayo Clinic in Rochester. “Importantly, since a stethoscope is small and portable, this technology can be used in urban and remote locations, and hopefully help address care in underserved areas.”

The Low EF AI will be added to Eko’s SENSORA Cardiac Early Detection Platform, the latest advancement to the platform which already features FDA-cleared algorithms to identify AFib and structural heart murmurs, often an indicator of valvular heart disease. When Low EF is detected in a primary care exam with SENSORA, access to life-extending treatment can be expedited with a referral to the cardiology department for thorough diagnostic testing and treatment evaluation.

“The stethoscope, the most recognizable symbol of healthcare, touches the lives of an estimated one billion people around the globe every year,” said Connor Landgraf, co-founder & CEO of Eko Health. “With Eko’s Low EF AI, we’ve transformed the icon of medicine into an AI-powered heart failure early detection tool that can help improve access to care for millions of patients, at a fraction of the time and cost of echocardiography. It’s been a privilege to work alongside Mayo Clinic in this groundbreaking endeavor.”

Clinical Development & Validation Highlights:

Robust AI Training & Validation: Eko’s Low EF AI was trained on a proprietary dataset of over 100,000 ECGs and echocardiogram pairs from unique patients, and was clinically validated in a multi-site, prospective clinical study of 3,456 patients, achieving an AUROC of 0.835 for detection of LVEF <40%, 74.7% sensitivity and 77.5% specificity, demonstrating a strong ability to differentiate between low and normal EF.3

Imperial College London Independent Validation: An independent validation of the Low EF AI by the Imperial College London, published in Lancet Digital Health, reported an AUROC of 0.85 for detection of LVEF below 40%, 84.8% sensitivity, and 69.5% specificity when deployed on over 1,050 patients across multiple real-world settings. This validation prompted the UK NHS and Imperial College London to extend Eko’s deployment to over 100 clinics in London and Wales.4

Demonstrated Impact in Pregnant Women: A clinical study led by Mayo Clinic involving nearly 1,200 pregnant women in Nigeria highlighted the AI’s effectiveness, identifying twice as many cases of pregnancy-related cardiomyopathy than standard care, with an impressive AUROC of 0.98, 100.0% sensitivity, and 79.4% specificity, underscoring its significant potential to assist in the detection and appropriate management of cardiomyopathy in pregnant women, reducing associated disease burden and risk of death.

Eko Digital Stethoscopes, AI Disease Detection, & Telehealth (ekohealth.com)

Heart Failure

Diagnosis
To diagnose heart failure, your health care provider examines you and asks questions about your symptoms and medical history. Your provider checks to see if you have risk factors for heart failure, such as high blood pressure, coronary artery disease or diabetes.

Your care provider listens to your lungs and heart with a device called a stethoscope. A whooshing sound called a murmur may be heard when listening to your heart. Your provider may look at the veins in your neck and check for swelling in your legs and belly.

Tests
Tests that may be done to diagnose heart failure may include:

Blood tests. Blood tests can help diagnose diseases that can affect the heart. Blood tests also can look for a specific protein made by the heart and blood vessels. In heart failure, the level of this protein goes up.
Chest X-ray. X-ray images can show the condition of the lungs and heart.


Electrocardiogram (ECG or EKG). This quick and painless test records the electrical signals in the heart. It can show how fast or how slowly the heart is beating.


Echocardiogram. Sound waves create images of the beating heart. This test shows the size and structure of the heart and heart valves and blood flow through the heart.


Ejection fraction. Ejection fraction is a measurement of the percentage of blood leaving your heart each time it squeezes. This measurement is taken during an echocardiogram. The result helps classify heart failure and guides treatment. An ejection fraction of 50% or higher is considered ideal. But you can still have heart failure even if the number is considered ideal.


Exercise tests or stress tests. These tests often involve walking on a treadmill or riding a stationary bike while the heart is monitored. Exercise tests can show how the heart responds to physical activity. If you can’t exercise, you might be given medicines.


CT scan of the heart. Also called a cardiac CT scan, this test uses X-rays to create cross-sectional images of the heart.


Heart MRI scan, also called a cardiac MRI. This test uses magnetic fields and radio waves to create detailed images of the heart.


Coronary angiogram. This test helps spot blockages in the heart arteries. The health care provider inserts a long, thin flexible tube called a catheter into a blood vessel, usually in the groin or wrist. It’s then guided to the heart. Dye flows through the catheter to arteries in the heart. The dye helps the arteries show up more clearly on X-ray images and video.


Myocardial biopsy. In this test, a health care provider removes very small pieces of the heart muscle for examination. This test may be done to diagnose certain types of heart muscle diseases that cause heart failure.


During or after testing for heart failure, your health care provider may tell you the stage of disease. Staging helps determine the most appropriate treatment. There are two main ways to determine the stage of heart failure:

New York Heart Association (NYHA) classification
This system groups heart failure into four categories by number. You may see Roman numerals used for these category names.

Class 1 heart failure. There are no heart failure symptoms.
Class 2 heart failure. Everyday activities can be done without difficulty. But exertion causes shortness of breath or fatigue.
Class 3 heart failure. It’s difficult to complete everyday activities.
Class 4 heart failure. Shortness of breath occurs even at rest. This category includes the most severe heart failure.
American College of Cardiology/American Heart Association classification
This stage-based classification system uses letters A to D. It includes a category for people who are at risk of developing heart failure.

Stage A. There are several risk factors for heart failure but no signs or symptoms.
Stage B. There is heart disease but no signs or symptoms of heart failure.
Stage C. There is heart disease and signs or symptoms of heart failure.
Stage D. Advanced heart failure requires specialized treatments.
Health care providers often use the classification systems together to help decide the most appropriate treatment options. Your provider can help you interpret your stage.

Treatment
Treatment of heart failure may depend on the cause. Treatment often includes lifestyle changes and medicines. If another health condition is causing the heart to fail, treating it may reverse heart failure.

Some people with heart failure need surgery to open blocked arteries or to place a device to help the heart work better.

With treatment, symptoms of heart failure may improve.

Medications
A combination of medicines may be used to treat heart failure. The specific medicines used depend on the cause of heart failure and the symptoms. Medicines to treat heart failure include:

Angiotensin-converting enzyme (ACE) inhibitors. These drugs relax blood vessels to lower blood pressure, improve blood flow and decrease the strain on the heart. Examples include enalapril (Vasotec, Epaned), lisinopril (Zestril, Qbrelis) and captopril.
Angiotensin II receptor blockers (ARBs). These drugs have many of the same benefits as ACE inhibitors. They may be an option for people who can’t tolerate ACE inhibitors. They include losartan (Cozaar), valsartan (Diovan) and candesartan (Atacand).
Angiotensin receptor plus neprilysin inhibitors (ARNIs). This medicine uses two blood pressure drugs to treat heart failure. The combination medicine is sacubitril-valsartan (Entresto). It’s used to treat some people with heart failure with reduced ejection fraction. It may help prevent the need for a hospital stay in those people.
Beta blockers. These medicines slow the heart rate and lower blood pressure. They reduce the symptoms of heart failure and help the heart work better. If you have heart failure, beta blockers may help you live longer. Examples include carvedilol (Coreg), metoprolol (Lopressor, Toprol-XL, Kapspargo Sprinkle) and bisoprolol.
Diuretics. Often called water pills, these medicines make you urinate more frequently. This helps prevent fluid buildup in your body. Diuretics, such as furosemide (Lasix, Furoscix), also decrease fluid in the lungs, so it’s easier to breathe.

Some diuretics make the body lose potassium and magnesium. Your health care provider may recommend supplements to treat this. If you’re taking a diuretic, you may have regular blood tests to check your potassium and magnesium levels.

Potassium-sparing diuretics. Also called aldosterone antagonists, these drugs include spironolactone (Aldactone, Carospir) and eplerenone (Inspra). They may help people with severe heart failure with reduced ejection fraction (HFrEF) live longer.

Unlike some other diuretics, these medicines can raise the level of potassium in the blood to dangerous levels. Talk to your health care provider about your diet and potassium intake.

Sodium-glucose cotransporter-2 (SGLT2) inhibitors. These medicines help lower blood sugar. They are often prescribed with diet and exercise to treat type 2 diabetes. But they’re also one of the first treatments for heart failure. That’s because several studies showed that the medicine lowered the risk of hospital stays and death in people with certain types of heart failure — even if they didn’t have diabetes. These medicines include canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance).
Digoxin (Lanoxin). This drug, also called digitalis, helps the heart squeeze better to pump blood. It also tends to slow the heartbeat. Digoxin reduces heart failure symptoms in people with HFrEF. It may be more likely to be given to someone with a heart rhythm problem, such as atrial fibrillation.


Hydralazine and isosorbide dinitrate (BiDil). This drug combination helps relax blood vessels. It may be added to your treatment plan if you have severe heart failure symptoms and ACE inhibitors or beta blockers haven’t helped.


Vericiguat (Verquvo). This medicine for chronic heart failure is taken once a day by mouth. It’s a type of drug called an oral soluble guanylate cyclase (sGC) stimulator. In studies, people with high-risk heart failure who took this medicine had fewer hospital stays for heart failure and heart disease-related deaths compared with those who got a dummy pill.


Positive inotropes. These medicines may be given by IV to people with certain types of severe heart failure who are in the hospital. Positive inotropes can help the heart pump blood better and maintain blood pressure. Long-term use of these medicines has been linked to an increased risk of death in some people. Talk to your health care provider about the benefits and risks of these drugs.


Other medicines. Your health care provider may prescribe other medicines to treat specific symptoms. For example, some people may receive nitrates for chest pain, statins to lower cholesterol or blood thinners to help prevent blood clots.


Your health care provider may need to change your medicine doses frequently. This is more common when you’ve just started a new medicine or when your condition is getting worse.

You may be admitted to the hospital if you have a flare-up of heart failure symptoms. While in the hospital, you may receive:

Medicines to relieve your symptoms.
More medicines to help your heart pump better.
Oxygen through a mask or small tubes placed in your nose.
If you have severe heart failure, you may need to use supplemental oxygen for a long time.

Surgery or other procedures
Surgery or other treatment to place a heart device may be recommended to treat the problem that led to heart failure.

Surgery or other procedures for heart failure may include:

Coronary bypass surgery. You may need this surgery if severely blocked arteries are causing your heart failure. The surgery involves taking a healthy blood vessel from the leg, arm or chest and connecting it below and above the blocked arteries in the heart. The new pathway improves blood flow to the heart muscle.


Heart valve repair or replacement. If a damaged heart valve causes heart failure, your provider may recommend repairing or replacing the valve. There are many different types of heart valve repair. The type needed depends on the cause of the heart valve problem.

Heart valve repair or replacement may be done as open-heart or minimally invasive surgery.

Implantable cardioverter-defibrillator (ICD). An ICD is used to prevent complications of heart failure. It isn’t a treatment for heart failure itself. An ICD is a device similar to a pacemaker. It’s implanted under the skin in the chest with wires leading through the veins and into the heart.

The ICD monitors the heartbeat. If the heart starts beating at a dangerous rhythm, the ICD tries to correct the beat. If the heart stops, the device shocks it back into regular rhythm. An ICD can also work as a pacemaker and speed up a slow heartbeat.

Cardiac resynchronization therapy (CRT). Also called biventricular pacing, CRT is a treatment for heart failure in people whose lower heart chambers aren’t pumping in sync with each other. A device sends electrical signals to the lower heart chambers. The signals tell the chambers to squeeze in a more coordinated way. This improves the pumping of blood out of the heart. CRT may be used with an ICD.
Ventricular assist device (VAD). A VAD helps pump blood from the lower chambers of the heart to the rest of the body. It’s also called a mechanical circulatory support device. Although a VAD can be placed in one or both lower chambers of the heart, it’s usually placed in the lower left one.

Your health care provider may recommend a VAD if you’re waiting for a heart transplant. Sometimes, a VAD is used as a permanent treatment for people who have heart failure but who aren’t good candidates for a heart transplant.

Heart transplant. Some people have such severe heart failure that surgery or medicines don’t help. These people may need to have their hearts replaced with a healthy donor heart.

A heart transplant isn’t the right treatment for everyone. A team of health care providers at a transplant center helps determine whether the procedure may be safe and beneficial for you.

Symptom care and end-of-life care
Your health care provider may recommend special medical care to reduce symptoms and improve quality of life. This is called palliative care. Anyone who has a serious or life-threatening illness can benefit from this type of care. It can be used to treat symptoms of the disease or to ease the side effects of treatment.

In some people with heart failure, medicines no longer work and a heart transplant or device isn’t an option. If this occurs, special end-of-life care may be recommended. This is called hospice care.

Hospice care allows family and friends — with the aid of nurses, social workers and trained volunteers — to care for and comfort a loved one. Hospice care is available in your home or in nursing homes and assisted living centers.

Hospice care provides the following for those who are sick and their loved ones:

Emotional support.
Psychological support.
Spiritual support.

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