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.

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When stroke strikes, clinical trial decisions need to be made quickly

What comes to mind when you think of clinical trials? If you’re like most people, you think of cancer or other longer-term diseases in which people have time to weigh the benefits and risks before signing the forms to participate.  

This isn’t how it works when it comes to clinical trials for stroke – at least when initially treating a stroke.  

Strokes typically strike out of the blue. Because time is of the essence, we have to give patients and families a crash course in stroke treatment. We’re sensitive to the fact that our patients and their loved ones must absorb a lot of important information very quickly. But we also know that at times a clinical trial may be a patient’s best chance for recovery – and there’s limited time to decide whether to participate.  

Hopefully, you’ll never need to put this information to use, but if you or a loved one is at risk for stroke, take time to learn what questions to ask about clinical trials in the short time you have to make a decision.  

Questions to ask when considering a clinical trial

We participate in observational trials as well as trials in early and later phases through our National Institutes of Health (NIH)-funded stroke clinical research programs: NIH/NINDS Intramural Stroke Program and NIH StrokeNet: Stroke National Capital Area Network for Research (SCANR).

We conduct trials at every stage of stroke:

  • Acute, or immediately after it happens
  • Rehabilitation
  • Preventing another stroke  

Read more about our current and completed stroke trials and studies or find additional stroke-related clinical trials.  

In trials for acute stroke, the decision to participate needs to be made quickly. When it comes to rehabilitation and preventing another stroke, you may have some time to research and think through your options. We know you’re getting a lot of information thrown at you in a short time, but there are a few things you should ask and understand before you decide – whether for yourself or a loved one. 

What’s the standard treatment?

There are two main types of stroke:  

  • Ischemic, in which a clot blocks blood from reaching the brain
  • Hemorrhagic, in which a blood vessel bursts and leaks blood into the brain  

Treatment for either type of stroke may include a clot-busting drug, such as tissue plasminogen activator (tPA), which is the gold standard for treating ischemic strokes. We also may be able to physically remove the clot or repair the vessel to prevent further bleeding.  

Why would a clinical trial be better than the standard treatment?

Some people may not be good candidates for standard stroke treatment. For example, tPA must be given within four-and-a-half hours of the onset of the stroke, and clot retrieval for a subset within six hours of the onset of the stroke, as the bleeding risk and other potential complications may outweigh the potential benefit after that time for most patients. In these cases, a clinical trial may be your best or only option.  

In some situations, a clinical trial may offer a better chance of recovery than the standard treatment, and your doctor should explain why this may be.

 What are the risks and benefits to participating?

Every treatment has potential side effects. Ask what these may be in the short-term and the long-term. Also, learn how the possible risks and benefits compare to those of the standard treatments.  

The benefits can range from the potential for a better recovery or, in the case of an observational study in which you’ll get standard treatment, contributing to and advancing our knowledge of stroke care.  

Advocate for yourself and loved ones

Unfortunately, if you’re told that you or a loved one is not a candidate for standard stroke treatment, there’s no time to go home and Google “clinical trials.” However, that doesn’t mean there’s nothing you can do. You’re your best advocate.  

First, research your local hospitals to learn what stroke resources they offer in the way of specialists, treatments and clinical trials. Ask which facilities they turn to for additional guidance.

If you’re taken to a hospital that doesn’t offer clinical trials, ask the doctor if there is one available in the greater area that you may be eligible for. Our StrokeNet clinical trials network includes multiple hospitals in the mid-Atlantic region, so depending on the trial, you may be closer to a participating hospital than you think.  

We want to help as many stroke patients as possible, but we can’t help if we don’t know who they are. We rely on emergency medicine doctors to notify us about potential candidates – and quickly. We are developing a process through our telestroke program to expand clinical trial access to stroke patients at other hospitals. But for now, asking about potential trials in the area may prompt the doctor to give us or another facility a call.  

While you likely will never be fully prepared for the shock of having a stroke, having some knowledge of clinical trials in the back of your mind may make an emergency situation a little less stressful.  

Request an appointment to learn more about our stroke clinical trials and to discuss whether you or a loved may be a candidate for one. 


(In the photo: Stroke team evaluates a patient. (L to R) Adey Haile-Mariam, RN, nurse responder team, Carlos Portillo, MRI technologist and Dr. Amie Hsia)

Stroke: A young person’s disease?

If you think you’re too young to have a stroke, think again. A study published in April 2017 showed that the rate of stroke among young people has risen dramatically in the past 15 years. The data didn’t surprise me at all. I’ve witnessed this trend firsthand in Washington, D.C.

Most people think of stroke as something that strikes older adults, but the study showed that between 2003 and 2012, stroke rates increased nearly 42 percent among men ages 35 to 44, and 30 percent for women in that age group.

A recent study shows that #stroke rates are increasing in younger adults – up to 42% in men ages 35-44 since 2003.

I’d say the average age of our patients is 40 to 60. When you compare this with our National Institutes of Health extramural stroke program partner Suburban Hospital in nearby Bethesda, Md., you can see where demographics and overall health comes into play. The average age of their stroke patients is 70 to 90.

The Bethesda community is primarily made up of white residents who have fewer health complications. D.C. has a larger population of African-Americans, who are at greater stroke risk overall, and more people with stroke risks such as obesity and high blood pressure.

Let’s take a closer look at why younger adults are at greater risk for stroke than ever before, and what you, health professionals and the community at large can do to turn this trend around.

Why stroke risk has increased in younger people

Stroke risks fall mainly into two levels: non-modifiable risks, which you have no control over, and modifiable risks, which are within your control to manage and treat.

Non-modifiable risk factors include:

  • Age: Your risk of stroke nearly doubles every 10 years after the age of 55.
  • Gender: Men have a higher stroke risk than women.
  • Race and ethnicity: The risk for stroke is two times higher for African-Americans and 1.5 times higher for Hispanics than for whites.
  • Family history: If a grandparent, parent or sibling has had a stroke, particularly before the age of 65, you may be more at risk.

Modifiable risk factors include:

It’s these modifiable risks that are the primary reason stroke rates for younger adults are rising. The 2017 study found that the number of men and women between age 18 and 64 with these conditions increased across the board, as did the prevalence of having three or more of these risk factors. 

The danger of overlooking stroke symptoms

While not a true risk factor, younger adults often face another danger: their feeling of invincibility. Young adults tend to overlook the signs of a stroke. They think they’re too young and what’s happening couldn’t possibly be a stroke. This can lead to a delay in treatment, and in a condition where seconds matter, this can be devastating to survival and recovery.

The gold standard for treating ischemic strokes is tissue plasminogen activator (tPA), a clot-busting drug. However, tPA must be given within four and a half hours of the onset of stroke to work effectively. Younger people, if treated in a timely manner, often have a better chance of recovery because their brains have greater plasticity. The surviving cells take over for those that are killed off by the stroke. We lose some of that regeneration as we age.

Rehabilitation also can be impeded by the presence of health problems such as diabetes, high blood pressure or cholesterol.

Stroke is the fifth leading cause of death in the United States, and the leading cause of disability. It costs the country $33 billion a year in healthcare services, medicines and missed days of work. When someone has a stroke during their most productive years, it can cost even more – not just in money but in quality of life as they may require more years of care and missed work.

Know the signs of stroke and never think you’re too young to have one. Use the acronym FAST to quickly identify common stroke symptoms:

  • Face: Can you smile? An inability to smile or a one-sided expression can indicate a stroke.
  • Arms: Can you raise both arms? One-sided muscle weakness or paralysis can indicate a stroke.
  • Speech: Can you say a simple sentence? Slurred speech or difficulty speaking are signs of a stroke.
  • Time: Call 911 immediately if you notice these symptoms.

Other signs to be aware of include:

  • Sudden vision trouble in one or both eyes
  • Sudden severe headache with no known cause
  • Sudden confusion or trouble understanding
  • Sudden trouble walking, dizziness or loss of balance or coordination

How young adults can reduce risk factors for stroke

As with any health condition, prevention is the best medicine, and stroke is no different. Fortunately, many stroke risks can be prevented, managed or treated if they appear.

A good start to reduce your risk of stroke is to develop a healthy lifestyle:

  • Eat a healthy diet.
  • Stay physically active.
  • Don’t smoke. Ask for help to stop smoking.

One in three adults in the U.S. have high blood pressure, but only about half have it under control. And many younger adults don’t even know they have it. See your doctor for an annual exam, and if it’s discovered that your blood pressure is high, follow recommendations to lower it.

If you’ve been diagnosed with diabetes, monitor your blood sugar and use medicine, diet and exercise to keep it within the recommended range. One in three people have prediabetes, a condition in which blood glucose levels are higher than normal. Talk with your doctor about how to prevent or delay the onset of diabetes.

There are also steps we can take as a community to lower stroke risk. One is to continue and expand nutritional programs, especially in our schools. We want our children to learn healthy eating habits early in life. It should be a given that any meal served in our schools is a healthy one.

We also must work together to address food deserts, those neighborhoods in which there is a lack of fresh fruit and vegetables and other healthy foods. These areas lack grocery stores and farmers’ markets, so people can’t buy healthy foods to make at home. Vending machines in our public spaces and workplaces often offer few healthy choices, so we can work to improve the available options.

Exercise does wonders for our health. It lowers weight, stress, blood pressure, blood sugar and cholesterol. We must create opportunities to promote physical activity and access to suitable spaces – indoors and out.

This trend of younger people having strokes is alarming, but it’s reversible. With hard work from younger adults, health professionals and the community, we can better manage those modifiable risk factors and reduce our risk of stroke.

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).





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 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 202-877-3627.

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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.

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 202-877-3627.

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