Kyle Reynolds, MD

MedStar Health was the first in the nation to enroll a patient in this multicenter trial of a new device to treat in-stent thrombosis. In rare cases, a stent placed in a vein can develop a blood clot, which may obstruct the vein that the device was originally meant to treat. Currently, there are few effective treatments available, but new research at MedStar Health could lead to a safe and effective option. Blood clot formation in deep veins can be just the beginning of a complicated health journey. About 20%-50% of the 900,000 people who have deep vein thrombosis in the U.S. each year will develop a chronic, painful condition called post-thrombotic syndrome (PTS). An expandable metal tube called a stent can help keep veins open in many patients with PTS. Yet about 25% of those stents fail within three years, causing the vein to close off. This complication, called in-stent thrombosis (IST), causes challenging symptoms, including fatigue, swelling, and pain.  There hasn’t been a good treatment for venous ITS—until now. MedStar Health was the first research center in the U.S. to enroll a patient in a single-arm, multicenter prospective study to evaluate the safety and effectiveness of The RevCore™ Thrombectomy Catheter, a device designed to meet this unmet need for patients with venous thrombosis.  To explore the safety and effectiveness of the RevCore device, 30 study sites across the country will enroll 100 adults with IST.  All enrolled patients will receive treatment with the device, and we will closely monitor them to study whether the treatment successfully reopens the vein. We’ll follow patients for a year to examine how their quality of life improves and whether they need to return to the hospital.  MedStar Health was the first to implant this device in a patient. We’re proud to be at the forefront of this exciting research because we know these advances make a difference for our patients and communities.   Existing treatments for IST have produced subpar outcomes. Techniques involving suction, using a balloon to reopen the vein, and methods to dissolve clots have had limited success.  These procedures can be helpful when a clot first forms, but they are less effective for chronic clots. This is due in part to the nature of these clots. After about two weeks, clots can become tough and fibrous with scarring and collagen deposits. Chronic clots can’t be suctioned and won’t dissolve. Balloons offer limited results, producing small channels in the vein that close again in time.The device is highly adjustable for stubborn IST clots which has that scar like morphology. Vascular surgeons thread the device through the vein until it reaches the clot. There, they can precisely adjust the diameter of the core and spin (rev) the device, so it removes the entire clot from inside the stent and reopens the vein. ​ Our patients have been very pleased with the outcomes in anecdotal early results. When clots form deep in leg veins, there can be serious consequences for patients’ quality of life. For years, there were no practical solutions to help patients with IST. Now, we can offer them hope. We’re excited to see the RevCore device make a real difference for our patients, and we’re looking forward to helping even more patients get access to this innovative treatment. Here in Washington, DC, treatments like these help underserved patient populations not just live longer but live better with procedures that can decrease the severity of their symptoms, help heal wounds, and improve their quality of life.

September was peripheral artery disease (PAD) awareness month, but it’s never too late to talk about this often silent, but serious condition. Nearly 6.5 million people in the United States forty and older have PAD, which causes reduced blood flow to the arteries in the legs. Because many people who have the disease don’t experience symptoms, it’s important to understand how it develops so you can manage any potential risks and know when to seek treatment. Peripheral artery disease is a chronic condition caused by atherosclerosis, which occurs when a buildup of fatty deposits lead to narrowed or hardened blood vessels. Blood vessels (arteries) carry blood to your organs and limbs, so atherosclerosis can severely limit or block blood flow. Although gradual, this process can result in serious complications, such as stroke, limb loss, or heart attack. When atherosclerosis develops in the legs, it’s typically called peripheral artery disease (PAD) or peripheral vascular disease (PVD). Because many people with the disease don’t have symptoms, it can sometimes go undetected. For others who do experience symptoms, leg pain and chronic wounds can begin to negatively impact an individual’s mobility and quality of life.  Atherosclerosis and peripheral artery disease are caused by smoking and other chronic medical conditions that affect the blood vessels, such as: Elevated cholesterol High blood pressure Diabetes In addition, your risk increases with age. While less than five percent of men and women have the condition at age 50, nearly 20 percent of men and women in their 80s have PAD. Many people with PAD don’t experience symptoms. However, others may experience disabling cramping or pain in the leg muscles when walking or climbing stairs. This pain is called claudication, and it’s reproducible, meaning the pain occurs after walking the same distance and goes away with rest. More advanced cases of PAD may also lead to pain in the feet or toes while resting, especially if the legs are elevated. In addition, an open wound or ulcer on the foot that won’t heal can be a sign of PAD, warranting immediate medical attention.  The most common way we detect signs of peripheral artery disease is through a physical exam conducted in your physician’s office. There are several things that can increase our suspicions for limited blood flow, such as a decreased pulse in the lower extremities, a lack of hair growth on the legs, or cold feet.  Your doctor may also perform additional, non-invasive tests to gather more information. These may include: Ankle brachial index (ABI), which uses a blood pressure cuff to measure and compare the blood pressure in your foot and arm Arterial duplex (ultrasound), an imaging test that uses soundwaves to identify if and where blood flow may be restricted Just because you have poor blood flow doesn’t mean we need to immediately begin medical or surgical interventions. That’s why it’s important to seek care from a specialist who is familiar with the disease process and the specifics of your unique condition. Although there is no cure for PAD, there are several ways we can treat PAD symptoms and slow down its progression. However, it’s not a one-size-fits all approach for everyone. Your treatment should be tailored to manage your personal risk factors and may vary based on your age, disease severity, symptoms, and related health conditions.  Treatments may include one or more of the following: For many people with PAD, healthy lifestyle changes alone can be an effective way to eliminate symptoms and prevent the disease from worsening. This includes prioritizing a healthy diet, supervised exercise therapy (SET), and quitting smoking. In fact, even decreasing the amount of cigarettes you smoke can make a significant difference. All of these habits can contribute to a healthier heart and improved blood flow, thereby improving your symptoms. Our specialists offer a variety of services to help you manage and monitor your progress, so you won’t have to do it alone. Some patients benefit from medications that help to control other chronic conditions, such as blood pressure, elevated cholesterol, and diabetes. For severe cases of PAD where blood vessels are significantly restricted, we may perform a surgical procedure to restore blood flow. Surgical options range from minimally invasive procedures that involve placing a balloon and/or stent to open up the blockage to bypass surgery that requires your surgeon to use your own vein or a prosthetic graft to reroute blood flow.  If you’re at risk of developing PAD, talk to your doctor about how to manage your risk factors and whether or not you may benefit from being screened. And if you have symptoms, seek care right away from a specialist. At MedStar Health, we work with a multidisciplinary team of experts in different fields to personalize care for patients with PAD and other arterial diseases. This ensures we can provide treatment that will most effectively address your symptoms using the most advanced techniques available so you can live a healthier, longer life. 

MedStar Health Research Institute is now enrolling patients with peripheral artery disease in an observational study of two devices used to treat the condition.   Diversity, equity, and inclusion (DEI) initiatives are the subject of focus throughout American society as governments, corporations, individuals, and medical researchers increasingly recognize the importance of including many different perspectives in their work. Research is the creation of new, generalized knowledge to advance health and every investigator wants their research to apply to all members of the community. It’s no different for those studying peripheral artery disease (PAD), the narrowing or blockage of vessels that carry blood from the heart to the legs. A buildup of fatty tissue in the arteries, known as atherosclerosis, generally causes it. There is an age-related increase in Americans living with PAD, with a prevalence of >20% in people older than 80. Given that the life expectancy of women exceeds the life expectancy of men, the overall atherosclerotic burden is likely to be higher in women. Although women make up roughly 50 percent of the U.S. population, they only make up approximately 33% of enrolling patients for medical device trials.       Among people of color, cardiovascular research imbalances are even higher. Black Americans develop peripheral artery disease at rates more than twice that of other ethnicities, yet they make up fewer than 7% of patients involved in research about PAD.  The reasons for such disparity are very complex and beyond the scope of this article. It involves social determinants of health, access to quality healthcare (such as transportation), and implicit bias known to exist in healthcare. Patient perception also plays a role since historical non-consensual medical experimentation has led to a reluctance to enroll in research. At MedStar Health Research Institute, we’re not just talking about DEI; we’re doing something about it to improve the health of all our patients. MedStar Health Research Institute studies are inclusive by design. The latest example of our focus on health equity is our strong participation in The Elegance Trial,  This unique post-market study sets minimum enrollment goals of 40% women and 40% historically minoritized community members as it seeks to study the performance of devices to treat PAD in real-world conditions. About 6.5 million people over 40 in the U.S. have PAD. Symptoms of PAD include pain in the legs with physical activity that goes away after resting, muscle weakness, hair loss, smooth skin that is cool to the touch, cold toes, or sores/wounds in the legs and feet that do not heal. Risk factors for developing PAD include: Age greater than 60 Atherosclerosis (buildup of substances in the arteries) Diabetes High blood pressure High cholesterol Smoking Black men and women are about twice as likely to develop PAD as their white counterparts, yet Black Americans are less likely to be promptly diagnosed and treated. Treatment inequity can have serious consequences, including higher rates of amputation due to delays and more severe cardiovascular outcomes such as coronary artery disease and cerebrovascular disease,  leading to heart attack and stroke. The Elegance Trial is unique and essential because it assesses how treatments for PAD perform in patients in the real world and prioritizes the populations that need these treatments most.  The Elegance Trial is enrolling participants at clinical sites throughout the U.S. to study two devices that are used in clinical practice to help keep arteries open and blood flow in patients with peripheral artery disease: a drug-coated balloon and a drug-eluting stent, both designed to clear artery blockages and prevent them from coming back.  Enrolled patients are observed for five years, during which researchers collect data on their health, economics, and the performance of the PAD-treatment devices. Elegance seeks real-world data, so there are a few exclusion criteria—most interested patients with PAD treated with these devices can participate. This is vital as it allows patients with other conditions to participate in the trial, so researchers can learn how these devices function in the “real world.” In an update delivered in November of 2022, investigators indicated their enrollment goals are finding success. So far, sites like MedStar Health Research Institute have enrolled 579 patients, 40% of whom are women and 41% of whom come from underrepresented backgrounds. More specifically, 20% of enrollees are Black, 9.5% are Asian American, and 8% are Latinx. This early success is heartening, and here at MHRI, we’re seeing tremendous enthusiasm from patients of color and an eagerness to enroll. I attribute that excitement to the opportunity to be fairly represented in this unique trial. It is probably also beneficial that this study is a real-world, post-market analysis of approved devices that many patients would be treated with anyway, not an experimental new treatment being pushed to have increased enrollment in diverse populations. From the perspective of understanding peripheral artery disease, this unique study is one of the first to take a systemic approach,  ensuring that these products work well in all patients that are  likely to receive them instead of most clinical trials that are disproportionately white males. We continue to enroll patients in The Elegance Trial at MedStar Washington Hospital Center and MedStar Montgomery Medical Center. If you’re interested in getting involved, talk with your doctor about a referral.