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  • January 18, 2022

    By MedStar Team

    Structural racism is one of the most pressing issues facing healthcare today.  Unfortunately, academic medicine historically exacerbating the exploitation of vulnerable communities to achieve educational and research goals, especially in Black, Indigenous, and People of Color (BIPOC) communities. For example, many traditional research practices among marginalized communities highlight and, in most cases, magnify inequities in care. These can include:   

    • Community members are under informed about research methods and strategies. 

    • Researchers prioritize extraction of information from communities rather than community ownership of information.

    • Researchers accrue funding, prestige, and publications (in which academics’ voices predominate over the narrative perspective of community members) without similar accrual to participating communities.  

    • Researchers’ understanding of questions to be answered may lack cultural context because of their incomplete comprehension of community conditions.  

    The relationship between research institutions and many BIPOC communities is estranged and needs mending to dismantle racial disparities and inequitable research practices. As the area’s largest healthcare provider, MedStar Health is committed to do the work needed to address these issues in everything we do in order to advance health equity for everyone we serve.

    “Of all the forms of inequality, injustice in health care is the most shocking and inhumane.” – Dr. Martin Luther King, Jr.

    (March 25, 1966 speech to the Medical Committee for Human Rights)

     

    Advancing Health Equity in Early Childhood and Family Mental Health Research

    MedStar Health investigators Arrealia Gavins, Celene E. Domitrovich, Christina Morris, Jessica X. Ouyang, and Matthew G. Biel recently published research emphasizing the need to co-learn and to co-develop research with community members themselves to prioritize benefits for both participants and researchers. “Advancing Antiracism in Community-Based Research Practices in Early Childhood and Family Mental Health” was published in the Journal of the American Academy of Child & Adolescent Psychiatry. This work was done through the Early Childhood Innovation Network (ECIN),  a community-based partnership between two academic medical centers (MedStar Georgetown University Hospital & Children’s National Health System) and several community-based organizations in Washington, DC that strives to provide support to families through caregiver and child mental health services, family peer support, child social and emotional learning, initiatives to address social determinants of physical and mental health for families, and place-based support to families within select communities.  

    In this study, researchers found that to begin to undo the inherent inequities within academic medical research, particularly in studies involving children and caregivers, investigators need to consider how best to build equitable, long-term partnerships with communities through Community-Engaged Research (CEnR) or more specifically, Community-Based Participatory Research (CBPR). CBPR offers an alternative to traditional non-participatory research with a collaborative, strengths-based orientation that equitably involves researchers, community members and other stakeholders in all phases of research while embracing their unique expertise. 

    Recently documented increasing rates of depression, anxiety, and suicide in BIPOC youth, compounded by the disproportionate impact of the COVID-19 pandemic on BIPOC communities, has heightened the urgency for progress in community-based research.

    The research team started to utilize CBPR practices to advance antiracism in their clinical research work in child and family health along with working with BIPOC communities. This approach to integrate CBPR practices into the development, implementation, and evaluation of community-based interventions seeks to support early childhood mental health in primarily Black communities in Washington, DC. 

    Making an Impact: Insights & Lessons Learned from CBPR

    Through this work of the EICN, the research team found five valuable lessons from applying CBRP principles to research collaborations in community settings. 

    Intervention Practices

    Lessons Learned and Applied

    ECIN launched a group-based mindfulness parenting program to explore how to support the emotional health of parents at a Head Start early education center with the intention to reduce caregiver stress and enhance caregiver-child relationships.

     

    Lesson 1: Invest the time to build trusting relationships

    Providers set up several discussion groups with community partners and medical center-based researchers to review proposed assessment tools to be used with children and families receiving psychotherapy services.

    Lesson 2: Involve community partners in the development of the intervention theory of change and measurement strategy

     

    Clinical staff organized peer specialists to provide support to families with young children through 3 evidence-based strategies: enhancing parents’ knowledge about caregiving with young children;optimizingparent use of existing resources; and increasing parents’ access to social supports.

     

    Lesson 3: Create interventions in partnership with community members

    Clinical staff providedearly childhood mental health consultation (ECMHC) in preschool classrooms to enhance educators’capacitiesto support early childhood development and to recognize early signs of mental health concerns

    Lesson 4: Interpret findings in partnership with community members

    ECIN membersparticipatedin formal antiracism training with external experts to incorporate antiracism principles into ECIN’s operations and into the culture of the Network. ECIN formed a Racial Equity Community of Practice (RECOP), that supports 8 intervention teams in developing practices that advance racial equity goals.

    Lesson 5: Embed an antiracism focus in research structures and processes

     

    The research team found this community-based approach to be helpful in conducting research that will have a long-lasting impact on not only the community, but also on members of the research team. During a time where BIPOC families are experiencing the effect of COVID-related deaths and grief, unemployment, housing instability, and police violence; researchers have an opportunity to be engaged in the community and work to eliminate racial inequities within academic medicine and research. 

    Journal of the American Academy of Child & Adolescent Psychiatry, DOI: 10.1016/j.jaac.2021.06.018

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  • May 17, 2019

    By MedStar Health

    "Achoo!” It’s that time of year for seasonal allergies and sometimes the common cold, two of the most common illnesses in the U.S. for both adults and children. In fact, the average American has two to three colds a year and more than 50 million people in the U.S. experience allergies.

    People often confuse allergies and a cold due to symptoms they share, such as coughing and a runny or congested nose. The conditions have different causes, however, and if you can identify which one you or your child has, it will allow for the most successful treatment.

    #Allergies and the #Cold can be hard to differentiate due to symptoms they share, such as a #Cough or #RunnyNose. Identifying which one you have can lead to the most successful treatment, via @MedStarHealth
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    Differentiating A Cold From Allergies

    A cold is a viral infection that affects your nose and throat, or the upper respiratory system. In order to catch a cold, you must be in contact with someone else who has one—often times your kids, spouse, or someone else in your home. Common symptoms of a cold that don’t usually apply to allergies include:

    • Body aches and chills
    • Fever
    • Sore throat

    Allergies, meanwhile, are often associated with the spring and summer, as this is when you are exposed to pollen, grass, and other common allergens (although allergies to cats and dogs are also common and can develop at any age). Common symptoms of allergies that don’t apply to a cold include:

    • Itchy eyes, nose, and throat
    • Watery eyes
    • Post nasal drip, or excess mucus that forms in the back of the nose and throat

    As previously mentioned, you can experience a runny or congested nose with both a cold and allergies as well as a cough due to post nasal drip. Furthermore, a cold can lead you to develop pink eye, an infection or inflammation on the outer membrane of the eye and inner eyelid, which can be confused with the itchy and watery eyes you experience with allergies. In these cases, try to evaluate your other symptoms to help determine whether you have a cold or allergies. Make sure to speak to your doctor if you’re still having trouble differentiating the two.

    Common Treatments

    Treating a cold typically starts with giving your body a few days to fight it off. However, if you’re experiencing a sore throat, body aches, or fever, you can take Tylenol® or other over-the-counter anti-inflammatory medications to help alleviate your symptoms. Numerous over-the-counter medications exist to help you relieve nasal congestion and post nasal drip.

    Antihistamines, such as Claritin®, Allegra®, and Zyrtec®, are effective in treating allergies. These medications help stop your body from releasing histamines when it’s exposed to an allergen, which normally causes a buildup of mucus and inflammation. If you experience a congested or runny nose, over-the-counter nasal sprays are an effective way to relieve your symptoms. If over-the-counter medications don’t relieve symptoms, we typically suggest you visit your doctor to receive allergy shots, which introduce allergens to your body, so you react less strongly the next time you’re exposed to them.

    To help prevent allergy symptoms, take a shower right away after you spend time outside. This will remove all the pollen or other substances you were exposed to. You also should wash your pillows and sheets frequently to remove dust, pollen, and other particles that your body and clothes can leave on your bedding.

    When to See a Doctor

    You should see a doctor if you feel that you have a cold and it isn’t improving after three to four days. Or, you have an underlying medical condition that puts you more at risk of experiencing complications with a cold, such as:

    Furthermore, you should see a doctor if you feel as though you initially were getting better but then experienced worsening symptoms as you could be developing a secondary bacterial infection, pneumonia, or bacterial sinus infection.

    Most allergies are controlled through over-the-counter medication. However, if you find that these medications aren’t effective, visit your doctor to determine exactly what you’re allergic to and learn new strategies to better manage your allergies.

    Determining whether you have a cold or are suffering from allergies can be difficult in some cases. However, if you consider the numerous ways to differentiate the two, you can receive the best possible treatment and get back to feeling like yourself again.

    Want to learn more about MedStar Health Urgent Care and its services? Click below to learn more and find a location near you.

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  • May 16, 2019

    By Rachel Marcus, MD

    The name “kissing bug” conjures up some scary images. And the reality is, the bug should be scary. Triatomine insects are widespread throughout Latin American and the southern half of the United States and they like to bite around the eyes and mouth – hence the name. Not only do they steal a bit of blood when they bite, they may also leave behind a parasite called “Trypanosoma cruzi,” which can lead to Chagas disease, causing serious heart and digestive problems.

    Recent reports confirm new sightings of kissing bugs in Delaware, leading to public concern about the risks and generating many questions. In this blog article, I answer the many questions around Chagas. But most importantly, I want to stress two points. First, there is no current cause for panic. A kissing bug bite that leads to Chagas is rare in this country. Nevertheless, there is growing research suggesting that particularly in Texas, there may be a small but important risk of getting Chagas disease in the U.S.

    Second, there is a group of individuals in the U.S. who are at much higher risk of having Chagas disease: those who emigrated from Latin America, or who spent extended periods of time there, particularly in rural environments. Screening for Chagas is very important, particularly among women of childbearing age, because the disease can pass through the placenta. Let’s get to the details.

    What is the Kissing Bug, and Who Should Be Concerned about It?

    The kissing bug is a large, beetle-like critter that thrives in the mud and corrugated metal housing common in rural Latin America. While the bug has been reported in 28 states in the U.S., mostly in the southern half, it is not common. The warmer temperatures of climate change may increase the bug’s numbers, but they are relatively low at this time.

    However, people in this country who have lived in Latin America should be aware of the long-term impact of a kissing bug bite. The parasite it passes along can cause Chagas disease, which affects 5.7 million people across the globe, according to the World Health Organization.

    The Centers for Disease Control (CDC) estimates there are now 300,000 people living with Chagas in the U.S., with almost all of these cases contracted in other countries.

    What Does the Kissing Bug Look Like, and What Do I Do if I See One?

    These bugs look like beetles, are about ¾ to 1 ¼” in length, and have orange or red stripes around the body. If you see one or think you see one, do not touch it. Rather, the CDC recommends placing a jar over the bug, sliding it into the jar, and filling it with rubbing alcohol. Use bleach to clean any surface the bug touched, and contact your local health department, university or the CDC to show experts the captured bug.

    How Do I Know if I’ve Been Bitten?

    There is no consistent reaction to such a bug bite, and it is very possible to be bitten and not know it.

    Signs and Symptoms of Chagas Disease. Is Early Diagnosis Possible and is It Important?

    There are two stages of Chagas disease – the initial, acute phase and the chronic phase. In the acute phase, which may last a few weeks to a few months, people may experience mild flu-like symptoms such as fever, fatigue, body aches, headache, rash, loss of appetite, diarrhea, and vomiting, according to the CDC. Because these symptoms are similar to many other illnesses, though, most people don’t realize they have been infected with the parasite.

    However, a doctor may be able to identify other signs of infection, including mild enlargement of the liver or spleen, swollen lymph nodes, or swelling at the site of the bug bite. If treated with antiparasitic medication, the Chagas infection can be eradicated. Otherwise, the parasite remains in the body for life.

    That is why screening is so very important if there is a possibility of Chagas, particularly among women of childbearing age. The disease can be passed through the placenta, so a pregnant woman who has lived in or visited Latin America for more than a few months should be tested immediately.

    Two recent developments have improved both the chances for early diagnosis and the treatment of Chagas disease. In 2017, the Food and Drug Administration (FDA) approved the first rapid test for Chagas and has also recently approved the use of the anti-parasitic drug, benznidazole, to treat children between the ages of two and 12. Early treatment in children can cure the disease, and treatment of women of childbearing age is associated with a dramatic reduction in the passage of the infection through the placenta.

    What is the Chronic Phase of Chagas?

    Decades after being infected, about 30 percent of those who have Chagas develop serious health effects, including cardiomyopathy (disease of the heart muscle), heart failure, heart rhythm problems, and strokes. Less common are disorders that affect the digestive system. Research has shown that Chagas patients who develop heart issues tend to have higher rates of arrhythmia (irregular heart rhythms) and higher death rates overall.

    Cardiologists with experience in advanced heart failure and serious arrhythmias can provide treatment, but currently, there is no cure for Chagas in the chronic phase.

    What’s Most Important Now?

    Studies are now underway to try to better understand the link between the parasite and Chagas, and to improve treatment for patients who develop long-term health problems. The key right now is education. Our goal is to reach people from Latin America with information about their risks and to encourage them to talk with their doctors early if they develop symptoms. We are also reaching out to our physician colleagues to encourage screening when appropriate.

    Public education campaigns about Chagas are common in Latin America. With our country’s growing Latin American population, my colleagues and I want to see public education and awareness increase here as well.

    Dr. Marcus discusses the importance of screening for Chagas disease. She's the founder of the Latin American Society of Chagas (LASOCHA), a non-profit organization dedicated to promoting the awareness of Chagas among healthcare providers, public institutions and the public at large.

    Call 202-877-3627 or click below to make an appointment with a doctor.

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  • May 14, 2019

    While skin cancers can develop all around the body, the head and neck regions are extremely common locations for skin cancer to appear, as they regularly are exposed to ultraviolet (UV) radiation from the sun. Specific areas in which we commonly see skin cancer include the:

    • Cheeks
    • Ears
    • Neck
    • Nose
    • Scalp

    People often are nervous about removing skin cancer on visible parts of the body. However, treatment typically involves a plastic surgeon, who can offer ways to rearrange the facial tissue and camouflage the scar.

    In fact, we saw one patient with a small skin cancer on the left side of his face that rapidly increased in size, as he was taking immunosuppressive drugs for a kidney transplant, which prevent the body from fighting cancer. By the time we saw him, almost the entire left side of his face had cancer. To treat him, we removed both skin cancer and lymph nodes in the neck, and we reconstructed the defect with skin and fat from his thigh. This was followed by radiation and chemotherapy. His appearance today is excellent and he remains cancer-free.

    Dr. Giurintano discusses treating skin cancers on the head and neck in the Medical Intel podcast.

    Common Types of Skin Cancer on the Head and Neck

    Some of the most common types of skin cancer that we treat include:

    • Basal cell carcinomas: These are abnormal, uncontrollable growths or lesions found on the outermost layer of the skin and often look like open sores, red patches, and pink growths. This is the most common type of skin cancer.
    • Squamous cell carcinomas: These develop in the skin’s outermost layer and typically look like scaly red patches, open sores, and warts. This is the second most common type of skin cancer.
    • Melanoma: This is a form of skin cancer that arises when pigment-producing cells on the skin mutate and become cancerous. People often experience a new spot or mole that changes in color, shape, or size; a sore that fails to heal; or a spot or sore that becomes painful, itchy, or tender.

    While basal and squamous cell carcinomas generally are easily treatable, melanoma requires more strategic treatment, as it’s more likely to spread to other parts of the body.

    How We Treat Skin Cancer of the Head and Neck

    Basal Cell and Squamous Cell Carcinomas

    For both basal cell and squamous cell carcinomas, Mohs micrographic surgery typically is the best treatment option. Specially trained dermatologists perform this surgery to remove individual layers of cancer tissue, one at a time, and examine them under a microscope until cancer cells are no longer present. This helps to remove all cancer cells while preserving as much normal skin as possible. Once the cancer is completely removed, we can then reconstruct the skin defect in the most cosmetically pleasing way possible.

    Treatment for common types of #skincancer of the head and neck removes individual layers of cancer tissue, one at a time, to ensure all cancer cells are removed while saving uninvolved skin. https://bit.ly/2W2Qkd5 via @MedStarWHC

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    Melanoma

    Unlike basal and squamous skin cancer, Mohs surgery cannot be reliably used for melanoma removal. Instead, we remove one to two additional centimeters of normal-looking skin that surrounds the melanomas to help ensure all cancer cells are removed; this is called a “margin.” Because of this, even if the melanoma is small, the resultant defect is often quite large. In these cases, advanced reconstructive techniques can yield a normal appearance. Make sure to speak to your doctor to learn which plastic surgery options might be best for you.

    Additionally, melanoma can spread to lymph nodes in the neck, increasing the likelihood that it spreads to other parts of the body. Because of this, in certain cases, we perform sentinel lymph node biopsy at the same time as melanoma removal surgery. The sentinel lymph node is hypothetically the first lymph node draining the cancer site. In sentinel lymph node biopsy, we inject the tumor site with a special dye. We can then locate the one or two lymph nodes that most absorb this dye. These lymph nodes are removed and examined by the pathologist to determine if cancer is present. If we determine that lymph nodes are not cancerous, the patient can avoid removal of all the lymph nodes from the neck, which is a much bigger surgery. If the lymph nodes do have melanoma, then we know it is best to go forward with a neck dissection, or removal of the lymph nodes from the neck.

    Recovering from Skin Cancer Surgery

    Patients typically go home the same day of surgery or one to two days after surgery, depending on the severity of the cancer. Following surgery, it is important that patients prepare for skin defects that can exist for three to four weeks while their skin recovers. While the scars often are small, some patients opt to address them via reconstructive surgery by a plastic surgeon.

    Additionally, if we remove the lymph nodes, recovery requires a close follow-up to ensure that patient’s head and neck skin remains cancer-free.

    Skin on the nose, ears, and cheeks often lacks elasticity; this makes defects in these regions more difficult to close by simply suturing the skin edges back together. For these defects, reconstructive surgeons can perform a “local flap”, which moves tissue from nearby areas on the face to reconstruct the defect. We encourage patients to have this surgery within six weeks of their initial surgery for the best results.

    Some people are hesitant to receive treatment for skin cancer on the head and neck due to the scars they might receive. However, with the techniques we use today, patients often have the chance to become cancer-free with hardly any visual reminders.

    Call 202-877-3627 or click below to make an appointment with a head and neck cancer specialist.

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  • May 07, 2019

    By Ali Rahnama, DPM

    A bunion is a bony lump that develops on the base of the big toe with the big toe pushing against the second toe. While Bunions affect mostly women—more than one-third of women have them, it is not uncommon to see them in men as well. Common bunion symptoms include:

    • Pain
    • Restricted movement of the big toe
    • Swelling and redness around the big toe

    Tight shoes and high heels can make symptoms worse, but genetics likely are the root cause of bunions. In fact, we commonly see bunions that are associated with a knee or foot and ankle deformity, such as flat-footedness or tightness in your Achilles tendon.

    With minimally invasive treatment, most patients with bunions return to their everyday activities pain-free and are able to wear the types of shoes they want without discomfort.

    Dr. Rahnama discusses bunions in the Medical Intel podcast.

    Effective Treatment for Bunions

    First-Line Treatment for Pain

    First-line treatments for bunions can’t cure them, but these treatments can help relieve pain. Some of the most common first-line treatments include:

    • Anti-inflammatory medication, such as Motrin, Advil, or topical Voltaren gel
    • Shoe inserts
    • Toe spacers

    If these treatments aren’t enough to relieve pain, or if a patient is experiencing symptoms such as restricted toe movement, a surgeon might recommend minimally invasive surgery to correct the bunion.

    First-line treatments for #bunions, or a bony lump in the big toe, include anti-inflammatory medication and toe spacers. If patients have symptoms other than pain, however, surgery might be necessary. https://bit.ly/2H8UAzI via @MedStarWHC

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    Minimally Invasive Surgery

    Surgery to correct bunions aims to reposition the big toe. For example, the most common procedure we do shaves the bump in the big toe down, makes small cuts in the bone, turns the bone over, and holds it in place with one or two screws.

    In rare cases, patients have either severe bunions and the first surgery isn’t enough or they’re young and we want to ensure they don’t have a recurrence later in life. This entails a surgery in which we fuse a joint that is near the midfoot, an area of the foot that doesn’t appear to show symptoms but is where the root of the bunion is. If we can fuse the joint near the midfoot and straighten out the bone, the chances of recurrence decline.

    Following surgery, many people are immediately able to bear weight on the foot. Individuals who receive surgery for more serious bunions, however, often are unable to put weight on the foot for a few weeks and must wear a boot.

    What If Bunions are Left Untreated?

    When a patient doesn’t seek treatment for a bunion with symptoms, both the pain and the bunion itself can become worse with time, and the big toe joint can develop arthritis. As a result, if someone lets a bunion go untreated for a long time, they may need to have a fusion of the great toe joint, which is a more invasive procedure than those that we discussed.

    Patients should keep in mind, however, that if bunions aren’t symptomatic, there is no reason to operate on them. Correcting bunions shouldn’t ever be seen as a cosmetic surgery. Instead, they should only be thought of as a way to alleviate symptoms.

    It’s important to be able to consult with a specialist who can help patients choose the procedure that’s right for them. We have a highly skilled team of surgeons at MedStar Washington Hospital Center who is well-equipped to deal with patients’ foot and ankle needs.

    Call 202-877-3627 or click below to make an appointment with a foot and ankle surgeon.

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  • May 03, 2019

    By MedStar Health

    Recently published collaborative research investigated patients’ primary care utilization and the association with early-stage cancer diagnosis and survival outcomes for Medicaid enrollees. “Association of Medicaid Enrollee Characteristics and Primary Care Utilization with Cancer Outcomes for the Period Spanning Medicaid Expansion in New Jersey” was published in the journal Cancer. The study sought to examine cancer outcomes that may be affected by primary care and other outpatient care utilization for Medicaid enrollees. 

    The study utilized data from the New Jersey State Cancer Registry (NJSCR) and the New Jersey Medicaid Management Information Systems to conduct a retrospective cohort study for 3,253 patients with incident breast (female only), colorectal, or invasive cervical cancer (aged 21 - 64) diagnosed between 2012 and 2014. The study team examined late-stage diagnoses, treatment delays, and 2-year survival rates.

    They found that Medicaid enrollees diagnosed with cancer just before and in the initial year of Medicaid expansion are significantly more likely to have late-stage disease and lower 2-year survival in comparison with corresponding non-Medicaid cases. Within the Medicaid cohort, primary care utilization prior to a cancer diagnosis is associated with earlier stage detection and less delay in treatment. Newly enrolled Medicaid patients had higher odds of late-stage disease and treatment delays and lower survival than longer-term enrollees in Medicaid managed care plans. The results show that late-stage diagnoses of breast cancer and colorectal cancer were more frequent among newly enrolled Medicaid cases than non-Medicaid cases. 2-year survival rates were low among newly enrolled Medicaid cases in comparison with established Medicaid cases and non-Medicaid cases. 

    The findings emphasize the importance of outpatient utilization and improved access to primary care providers among Medicaid patients. In conclusion, “Targeted strategies to enhance care continuity, including access to PC providers before the diagnosis and a better understanding of pathways to cancer care upon Medicaid enrollment, are needed to improve outcomes in this population.”

    This research was funded by a Rutgers Cancer Institute of New Jersey Cancer Prevention and Control Pilot Award (P30CA072720) from the National Cancer Institute, the American Cancer Society, the National Cancer Institute, and Centers for Disease Control and Prevention.

    The research team included Derek DeLia, PhD, from MedStar Health Research Institute in collaboration with researchers from the Cancer Institute of New Jersey, School of Public Health, Center for State Health Policy, and the Robert Wood Johnson Medical School, all part of Rutgers, the State University of New Jersey. Additional collaborators were from the New Jersey State Cancer Registry.

    Cancer, 2019. DOI: 10.1002/cncr.31824

  • May 03, 2019

    By MedStar Health

    Investigators from MedStar Washington Hospital Center and the Division of Intramural Research at the National Heart, Lung, and Blood Institute at the National Institutes of Health have recently published a study on commonly reported modes of failure and device-related adverse events related to Impella RP. “Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database” was published in Cardiovascular Revascularization Medicine.

    Impella RP is a percutaneous right ventricular assist device (RVAD), approved for providing temporary right ventricular (RV) support for patients with acute right heart failure, or decompensation, following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Research has shown that patients with right ventricular failure (RVF) have a higher risk of mortality and morbidity, with growing associated health-care costs.

    The research team analyzed various event types such as injury, malfunction, death and other modes of failure from the Food and Drug Administration MAUDE database to report on these endpoints. The MAUDE database is updated monthly and is limited to adverse events reported within the last 10 years.

    The study looked at data from 2009 through 2018, with 35 reports being included for the final analysis. Out of those 35 reports, 20 were categorized as injury, 10 as malfunction, and 5 as death. The results showed that the Impella RP was placed most commonly for RVP developing in postcardiotomy patients (20%). Of the 35 Impella RP devices, the most commonly reported complication was bleeding (42.9%) with 80% of these patients requiring a blood transfusion. 8 patients reported significant vascular complications, with 5 patients requiring surgical repairs. 16 of the 35 devices were returned to the manufacturer for further analysis. There were several modes of failure identified and structural damage of the different components (34.2%) was the most commonly reported.

    “The primary endpoint of survival to 30 days was achieved in 73.3% of the patients”, the study stated. The study concludes that “the MAUDE dataset serves as an important platform for both manufacturers and physicians to optimize device performance and clinical outcomes.”

    This research publication was led by Ron Waksman, MD. The research team included Nauman Khalid MD; Hasan Javed MD; Toby Rogers MD, PhD; Hayder Hashim, MD; Evan Shlofmitz DO; Yuefeng Chen MD, PhD; Jaffar M. Khan BM, BCh; Anees Musallam MD; Rebecca Torguson MPH; Nelson L. Bernardo, MD.

    Cardiovascular Revascularization Medicine, 2019. DOI:  10.1016/j.carrev.2019.03.010