WATCHMAN FLX™ in Clinical Trial at MedStar Heart & Vascular Institute

Study of Stroke Prevention Device Which May Give Physicians More Flexibility in Optimal Cardiac Positioning

 

Washington, D.C., June 12, 2018 – MedStar Heart & Vascular Institute physicians participating in a clinical trial have become the first in the Mid-Atlantic region to implant the next generation of a potentially life-changing device proven to reduce the risk of stroke in certain patients with atrial fibrillation (AFib).

Watchman Notice

The next-generation device, called the WATCHMAN FLX™, is being studied for its ability to provide doctors with greater flexibility and safety while positioning the device in the left atrial appendage, a sub-chamber of the heart where blood can pool and form clots. Those clots may then escape into the circulatory system and block blood flow to brain tissue.

“Our participation in this clinical trial is an example of how the comprehensive AFib program at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center is providing patients with access to cutting-edge devices and treatments before they are widely available,” said Manish Shah, MD, director of the Clinical Cardiac Electrophysiology Fellowship Training Program at the Hospital Center and principal investigator for the new trial.

MedStar Heart &Vascular Institute is one of approximately 40 sites in the U.S. selected for WATCHMAN FLX implantation, and Dr. Shah is currently the leading implanter of devices nationwide.

AFib is the most common cardiac arrhythmia in adults, affecting more than five million Americans, and is expected to become even more common as the population ages. AFib causes about 20 percent of all strokes, and strokes from AFib are particularly severe and twice as likely to cause death or incapacitation compared to strokes from other causes.

Blood thinners are commonly prescribed to patients with AFib to reduce their risk of stroke, but patients and their physicians often have reservations about these types of drugs because of bleeding risks, especially in those patients with an increased risk of falls, along with the potential for medication interactions. As a result, up to 45 percent of patients with AFib may go untreated and unprotected from stroke.

WATCHMAN FLX is designed to prevent the movement of blood clots formed within the left atrial appendage into the bloodstream, thereby protecting patients from AFib-related strokes.

“Atrial fibrillation and its consequences are a growing epidemic, especially as our population ages,” said Stuart F. Seides, MD, physician executive director, MedStar Heart & Vascular Institute. “The refinement of a tool that may prevent strokes more securely in more patients is welcome.”

The first version of WATCHMAN™ became available internationally in 2009, and since then various generations of the device have been implanted more than 50,000 times.

Patients or physicians interested in learning more about this study and possible participation, please contact clinical study coordinator, Roshila Mohammed, at 202-877-0805.

 


About MedStar Heart & Vascular Institute
MedStar Heart & Vascular Institute is a national leader in the research, diagnosis and treatment of cardiovascular disease. A network of 10 hospitals and 150 cardiovascular physicians throughout Maryland, Northern Virginia and the Greater Washington, D.C., region, MedStar Heart also offers a clinical and research alliance with Cleveland Clinic Heart & Vascular Institute, the nation’s #1 heart program. Together, they have forged a relationship of shared expertise to enhance quality, improve safety and increase access to advanced services. MedStar Heart & Vascular Institute was founded at MedStar Washington Hospital Center, home to the Nancy and Harold Zirkin Heart & Vascular Hospital. Opened in July 2016, the hospital ushered in a new era of coordinated, centralized specialty care for patients with even the most complex heart and vascular diagnoses.

Media Contact

So Young Pak
202-877-2748
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When to go to the emergency department for heart palpitations

Most people barely notice their hearts beating. And that’s natural. But any noticeable change in the heartbeat should be concerning. Heart palpitations can be a sign of a serious condition, but some heart palpitations are totally normal.

I describe the feeling of heart palpitations as the heart-pounding sensation you get after running up a flight of stairs. But for people with heart palpitations, that feeling could just show up while they’re sitting on the couch.

What are heart palpitations?

A heart palpitation is the feeling of the heart racing or pounding. Heart palpitations may feel like the heart is:

  • Beating irregularly
  • Beating too quickly
  • Beating too strongly
  • Skipping beats

We see one or two patients per day who are complaining of these or similar symptoms. Patients sometimes tell me they can see their shirts move because their hearts are beating so hard.

Most heart palpitations aren’t dangerous. But they can be signs of several serious heart conditions. Get help if you feel heart palpitations that don’t go away quickly on their own. We’ll work to find what’s causing palpitations and refer you to additional care from a cardiologist if necessary.

"Get help if you feel heart #palpitations that don’t go away quickly on their own." via @MedStarWHC

What causes heart palpitations?

Older adults are more likely to have medical conditions that can increase their likelihood of having palpitations. But heart palpitations can show up in people of any age.

Some of the heart conditions that can cause heart palpitations include:

  • Cardiac arrhythmia (an irregular heartbeat), including atrial fibrillation (also known as A-fib) and atrial flutter
  • Supraventricular tachycardia (SVT)
  • Premature atrial complexes (PACs)
  • Premature ventricular complexes (PVCs)
  • Tachycardia

Other issues that can cause heart palpitations include: 

  • Being dehydrated
  • Caffeine, nicotine or alcohol
  • Certain medications, including decongestants or inhalers for asthma
  • Hormonal fluctuations in women who are menstruating, pregnant or about to enter menopause
  • Problems with electrolytes, including low potassium levels
  • Strong feelings of anxiety, fear or stress, including panic attacks

Overactive thyroid, also known as hyperthyroidism, can throw off the heart’s normal rhythm, causing palpitations. This type of thyroid disorder is treatable with medications to slow the heart rate and treat the overactive thyroid.

Heart palpitations and anxiety

Heart palpitations sometimes can be caused by extreme anxiety, rather than a heart condition. That might lead to a patient needing treatment for a possible anxiety disorder from a psychiatrist.

But we still have to make sure patients are checked out by a cardiologist for any possible heart problems first. We do have some patients who have been diagnosed before with anxiety and know that’s what’s happening. For the majority of patients, however, we don’t want to label their condition as an anxiety attack before knowing for sure that there isn’t a heart problem we need to address.

When to get help for heart palpitations

Most people’s hearts beat between 60 and 100 times per minute. If you’re sitting down and feeling calm, your heart shouldn’t beat more than about 100 times per minute. A heartbeat that’s faster than this, also called tachycardia, is a reason to come to the emergency department and get checked out. We often see patients whose hearts are beating 160 beats per minute or more. The body can’t sustain that for long periods of time.

You also should get checked out if you feel like your heart’s beating irregularly. The heart should beat steadily, like a metronome. If you feel like it’s pausing or skipping beats, that could be a sign of an abnormal heartbeat, which can increase the risk of a stroke.

"You should get checked out if you feel like your heart’s beating irregularly." via @MedStarWHC

If a patient comes into the emergency department while the palpitations are going on, we may be able to provide medications to slow the heart rate or convert an abnormal heart rhythm to a normal one. In extreme cases where medications aren’t enough, we may need to do a cardioversion. That’s when we shock the heart so it can reset itself to a normal rhythm. Patients are sedated during this procedure so they do not feel the electrical shock.  

Further testing for heart palpitations

In most cases, we see patients in the emergency department whose palpitations have either gone away or aren’t critical by the time they arrive. Like a car problem that clears up when you visit the mechanic, this can be frustrating for patients.  

We reassure them that just because we don’t see an abnormal heart rhythm now doesn’t mean that they didn’t have one before. We check for any signs of damage or injury, and we may monitor patients for a few hours at the emergency department to see if they have another episode of palpitions, but there may not be enough time to capture an abnormal heart rhythm that comes and goes.  

We often refer patients who have had heart palpitations to a cardiologist in the MedStar Heart & Vascular Institute. For example, we might diagnose an abnormal heart rhythm in the emergency department, but it’s not something that needs emergency treatment. Or we might not see evidence of an abnormal heart rhythm, but we think the patient could benefit from additional monitoring to rule out possible heart problems.  

A cardiologist can provide patients with special monitoring equipment to examine the heart’s rhythm. There are two main types of monitoring equipment. A Holter monitor will record the heart’s rhythm continuously for a defined time limit (often 24-48 hours), while an event recorder will only record briefly when a patient has symptoms of palpitations and presses a record button. If this testing shows evidence of a heart condition, our cardiologists work with patients to create an effective treatment plan.  

A normal heartbeat is easy to take for granted. So when we feel heart palpitations, it can be very scary. But with quick medical attention and advanced monitoring, your heart can beat steadily for a long time to come.

New Device Reduces Stroke Risk for Certain A-Fib Patients

Atrial Fibrillation Facts

Atrial fibrillation (A-fib) is the most common arrhythmia—or abnormal heart rhythm—in the United States today, affecting between 2.7 and 6 million adults. Why such a wide ranging estimate? While some patients report debilitating symptoms from A-fib—including strong palpitations that feel like a fish flip-flopping in their chest—others only experience shortness of breath, fatigue or less energy than usual. And some have no symptoms at all. As a result, many people with A-fib have yet to be diagnosed and, by extension, treated.

Unfortunately, A-fib puts people at a five times greater risk of stroke than the general population, especially if they’re also 65 and older with high blood pressure. Put another way, 20 percent of all A-fib patients will eventually have a stroke. Even more alarming, strokes from A-fib are more severe than those arising from other causes and twice as likely to cause death or debilitation.

That’s the most worrisome aspect of A-fib for heart specialists everywhere, and why stopping blood clots from forming through blood thinners is our typical first line of defense. Not everyone can tolerate the powerful medications and their side effects, however, especially those who are at high risk of dangerous internal bleeds. As a result, those patients, who may account for up to 45 percent of all people with A-fib, are left unprotected from stroke.

But a novel, new device called WATCHMAN™ has given such patients a safe and effective alternative.  

Tune in to the full podcast about the WATCHMAN device with Dr. Manish Shah.

How does the WATCHMAN work?

WATCHMAN works by blocking the source of most strokes caused by A-fib: the left atrial appendage (LAA). Basically a pouch extending from the left top chamber of the heart, the LAA acts like a reservoir where blood can pool and cluster into clots which can then migrate into the bloodstream. If a clot reaches the brain and gets stuck, it causes a stroke.

During a WATCHMAN procedure, we thread a catheter—a thin, plastic tube— up through your groin to the heart, and then deposit the self-expanding device at the entrance to the left atrial appendage.WATCHMAN’s mesh-like filter, shaped like a parachute, then traps clots inside the LAA where they can do no harm.  Over time, the body lays down scar tissue over the device, effectively sealing off the LAA forever.  

WATCHMAN received FDA approval in the summer of 2015, following two large, well-constructed national trials that I and my colleagues at MedStar Washington Hospital Center, hub of the MedStar Heart & Vascular Institute, participated in.  Study findings and subsequent experience have shown that WATCHMAN is just as good as blood thinners in preventing strokes, with the additional benefit of protecting against bleeding in the brain, the most serious risk associated with such traditional anticoagulants as Warfarin and Coumadin.

Experienced WATCHMAN site

Our team has performed more than 100 WATCHMAN procedures to date (the largest volume on the mid-Atlantic seaboard) with the same great results. Minimally invasive, the procedure is safe, simple and effective, generally taking less than an hour. It’s also easy on patients, who go home the day after the procedure with no pain or discomfort.     

WATCHMAN is currently only approved for patients who have atrial fibrillation not caused by a valvular problem, so not everyone is eligible.  Furthermore, candidates for the procedure must be able to tolerate a short-term treatment with blood thinners for about 45-days. While that’s a drop in the bucket compared to the life-long blood thinning regimen other A-fib patients face, it’s still enough to rule out individuals with a very high risk of bleeding.

Fortunately, new developments are occurring all the time. Right now, we’re studying an investigational device similar to WATCHMAN but without the 45-day blood-thinner requirement. If approved, the new device, called “Amulet,” could widen the field of patients eligible for these clot-trapping mechanisms.

In the meantime, WATCHMAN’s been a game-changer in how we manage certain high-risk A-fib patients and protect them from stroke. With the aging of the U.S. population and an attendant rise in people with A-fib, WATCHMAN and similar devices will play an ever larger role in the years ahead.

Tune in to the full podcast with Dr. Shah.

 

View the WATCHMAN story featured on WUSA-TV (Channel 9).

 

 

 

 

First in Northeast Region to Implant Investigational Stroke-Reducing Device

Washington, D.C., March 9, 2017 – MedStar Heart & Vascular Institute at MedStar Washington Hospital Center became the first facility in the Northeast region to implant an investigational device designed to prevent stroke in patients with atrial fibrillation (A-fib) or an abnormal heart rhythm.  

The electrophysiology team–Manish Shah, MD and Sarfraz Durrani, MD– implanted the AMPLATZER™ Amulet investigational device, as part of a nationwide clinical trial to evaluate the device’s safety and effectiveness. The Amulet works by sealing off the left atrial appendage (LAA), a small area of the heart, where blood clots form and migrate into the bloodstream, potentially causing a stroke.  

“The Amulet left atrial appendage closure system is a new device that may potentially offer protection to our patients at high risk of stroke who are poor candidates for blood thinning medications,” said Dr. Shah, who is the principal investigator of the Amulet trial and director of the Clinical Cardiac Electrophysiology Fellowship Training Program at MedStar Washington Hospital Center.  

In some patients with A-fib, the LAA does not contract effectively and it can become a source of blood clots. These clots can then be released into the heart and enter the bloodstream, where they can travel to the brain and cause a stroke. Currently, patients with A-fib are often prescribed blood-thinning medication, but this treatment option comes with a lifetime of medical management and the risk of major bleeding. By closing the LAA with the Amulet, physicians can block off the LAA and potentially reduce the risk of stroke.    

Patients enrolled in the clinical trial are randomly assigned to receive either the AMPLATZER™ Amulet or the WATCHMAN™, the only FDA-approved LAA closure device in the control arm of the study. The main difference between the two devices is that Amulet does not require patients to take blood thinners for 45 days after implantation.  

In the meantime, WATCHMAN has been a game-changer to protect A-fib patients from stroke. After WATCHMAN gained its FDA approval, MedStar Washington Hospital Center became the first facility in the Washington region to implant the device. To date, more than 100 patients have been outfitted with the WATCHMAN devices. That’s more implants than any other institution on the Mid-Atlantic seaboard. 

How the WATCHMAN™ Device Reduced Stroke Risk for A-fib Patient Connie Wiley

It’s been just over a year since the specialists at MedStar Washington Hospital Center implanted the WATCHMAN device in Connie Wiley, a grandmother of six from Woodbridge, Virginia, and she is feeling better than ever. Connie was one of the first patients in the world to receive this treatment, used to reduce the risk of stroke in patients with atrial fibrillation (A-fib), and since her procedure, we have performed more than 50 WATCHMAN procedures —the most in the Mid-Atlantic region.

If you're like Connie, you have had the shadow of atrial fibrillation and its associated complications looming over you. Atrial fibrillation (A-fib) is an arrhythmia of the upper two chambers of the heart. Because the blood flow from the atria to the ventricles in the heart is compromised due to an irregular heartbeat, blood pools (and consequently can clot) in the atria. In the past, the most common treatment for A-fib was a blood thinner, such as warfarin. However, the main problem with long-term blood thinner use is the risk of internal bleeding.

With atrial fibrillation, the risk of heart attack and stroke increases exponentially. Even blood thinners used to combat the clotting can have their own set of difficulties. However, the WATCHMAN gives hope to those who want complete freedom from some of the potential problems and complications of both A-fib and the medications used to treat it.

Connie's Story

As an avid gardener and grandmother of six, Connie hardly fits the image of a massive coronary and three-time stroke survivor. Looks, however, can be deceiving. A-fib was dragging Connie down, sapping her energy and leaving her feeling tired and unable to function at an optimal level.

“I am an active person, and I wanted to do things,” Connie reflected. “But my body wouldn’t let me do them.”

Not only was she feeling fatigued, her condition was also leading to strokes that could have eventually been fatal. But with a great team of cardiologists and other specialists on her side, Connie was able to reclaim her active lifestyle without the worry of another stroke on the horizon.

“If it wasn’t for them, I wouldn’t even be here,” she said.

The WATCHMAN Device

The doctors at the MedStar Heart & Vascular Institute, located at MedStar Washington Hospital Center in Washington, D.C., gave Connie a new lease on life after her third stroke, caused by a blood clot that formed due to her atrial fibrillation. It was determined that Connie would be an excellent candidate for receiving an innovative device called the WATCHMAN. For the region, this procedure was the first of its kind. For Connie, she was one of the first WATCHMAN patients in the world.

Using minimally invasive techniques, surgeons introduced the WATCHMAN into her heart, closing off the left atrial appendage (LAA), the area in which most major clots in atrial fibrillation patients develop.

Life, Renewed

After she received the WATCHMAN, Connie almost instantly noticed an increase in her energy level -- she was able to start doing all of the things she'd thought she wouldn't ever be able to enjoy again. One of her biggest victories — and perhaps the moment she knew things were looking up — was when she was able to water her garden the evening of her return home following the implantation of her WATCHMAN device.

One Year Later

Just over a year after her procedure, Connie is feeling better than she has in a long time. Her energy continued to increase following her procedure, allowing her to resume all of her beloved activities. “Not only do I have energy now, I have peace of mind, knowing that I’m not going to stroke,” Connie shared.

At times, Connie's life can become complicated and stressful. Many of these instances would have spelled disaster before the WATCHMAN, precipitating the possibility of another stroke event. The WATCHMAN has allowed her to sail through each challenge without the worry of clots leaving the LAA and traveling to her brain again.

Another advantage Connie is quick to point out is that she has also been able to discontinue her blood thinners, making the possibility of a bleeding event almost nonexistent. Although they can be the difference between life and death for many patients, blood thinners can heighten the risk of bleed-out from even the slightest bumps and bruises — many of which Connie experiences chasing after her six wonderful grandchildren.

If you suffer from atrial fibrillation and are at an increased risk for stroke, you may want to consider the option of the WATCHMAN. By taking control of your A-fib and its associated risks, you, just like Connie, can take your life back and live it on your terms.

Have questions?

We are here to help! If you have any questions about MedStar Washington Hospital Center, call us at 855-546-1974.

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29 Things You Should Do for a Healthy Heart

You’re heard it many times before -- follow a healthy lifestyle for a healthy heart. Sounds simple, right?  But it’s not always so easy to pull off. A heart healthy lifestyle can reduce the risk for heart disease by as much as 80%!  But what is a “heart healthy lifestyle”?  It’s a commitment to many habits in our daily lives centered on our activity, diets, mindset and awareness.  There is no one “magic” thing. When lifestyle isn’t enough, talk with your doctor to set goals you can realistically achieve, such as losing weight or lowering your cholesterol or blood pressure levels. Sometimes, it takes medications that can be very helpful to optimizing your heart risk.

So, commit to making the many small lifestyle changes that make a healthy heart a snap! The key to success is to make small changes in many areas. No matter what you do, remember to take it day by day, and work to sustain your gains.

With that in mind, we’ve compiled 29 heart health tips. Knowledge is power!  Read on to find out what you can do to keep your heart healthy. Only you can love your heart. So start today!

1. Make time for exercise: Exercising 30 to 60 minutes on most days will cut your heart risk in half.

2. Know your heart disease risk: Calculate your risk by plugging your numbers into an online calculator.

3. Never ignore your chest pain:  Pain can be felt anywhere in the chest area, arms, your back and neck.

4. Check your blood pressure: Let the healthy blood pressure number be below 140/90. Both numbers matter!

5. No smoking: Don’t smoke, and ask your loved ones to quit.

6. Aspirin: Should you take aspirin? If you have heart disease, yes! If you don’t have heart disease, then maybe not! Ask your doctor.

7. Moderate exercise: How do you know whether you are exercising moderately? You should able to carry on a light conversation

8. Stress: Is it bad for your heart? Yes, sustained stress is, no matter the source. Learn to control your stress to prevent heart disease.

9. Second hand smoke is dangerous! Public smoking bans in the community have reduced heart attack risk by 20%.

10. Sex: Is your heart healthy enough for sex? Sex has a “heart workload” like climbing two flights of stairs.

11. Dark chocolate: Give your loved ones chocolate as a gift on Valentine’s day! Regular chocolate eaters have less heart and stroke risk!

12. Order wine with your dinner! Moderate intake is associated with lower heart risk. (Consume wisely!)

13. Red or white wine? Is one better for your heart? Wine, beer or spirits all show a similar relationship to lower heart risk.

14. The “Mediterranean diet” is the most heart healthy way to eat. Studies show this diet reduces heart attack risk up to 30%.

15. Mediterranean diet = veggies, fruits, nuts, seeds, grains, herbs, spices, fish, seafood, olive oil, poultry, eggs, cheese, yogurt and wine.

16. Take your heart meds fully and faithfully! It’s the only way to get the full benefit of the treatments!

17. Stairs burn twice as many calories as walking. Regular stair climbing reduces your risk of premature death by 15%!

18. The quantified self. Keep moving! Steps per day: Very active >10,000, active >7500, sedentary <5000.

19. Fish eaters have less heart disease! Think about fish as a first choice when eating out- let somebody else do the cooking!

20. Did you know that people who are optimistic have less heart disease? See the bright side- it is truly good for your heart!

21. If you snore, tell your doctor. Snoring can be treated, and could signal risks for your blood pressure and heart rhythm.

22. Want to really know your risk of heart attack? Get a calcium scan of your heart. Accurate, safe, and costs less than dinner for 2!

23. Do you know CPR? Simple! Learn it here and double somebody’s chance of surviving cardiac arrest. http://www.cpr.heart.org

24. Ditch the soda and energy drinks. Please.

25. Coffee lover? For your heart’s sake, it is OK! (But, skip the donut!)

26. Like music? So does your heart! Music listening lowers your heart rate, and blood pressure!

27. Are statin cholesterol drugs safe? For most patients, yes! Unfortunately, over the counter supplements aren’t very helpful.

28. Heart attack or stroke symptoms? Don’t delay! Call 911 immediately. Minutes matter to save lives!

29. Taking vitamins or other supplements for heart disease risk? Be careful- few have little, if any, proven benefit.

Have any questions?

We are here to help! Contact us for more information about heart health or to schedule an appointment. Call us at 855-546-1974.

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