New Stem Cell Therapy May Transform Heart Failure Treatment

Washington, D.C., April 18, 2018 – Clinical trial planning is underway at MedStar Heart & Vascular Institute to determine whether a novel stem cell therapy will improve heart function for patients with heart failure. MedStar Heart, in partnership with CardioCell, a subsidiary of Stemedica Cell Technologies, pioneered the use of stem cells in regenerative medicine. The trial will use CardioCell’s proprietary mesenchymal stem cells (MSCs), manufactured by Stemedica. The goal is to improve outcomes in patients with heart failure and left ventricular assist devices (LVAD).

MedStar Heart & Vascular Institute has been studying the causes of the progressive deterioration of heart function that patients with heart failure experience over time, as well as the potential therapeutic role of stem cells. “We have developed compelling evidence that one of the major mechanisms leading to progressive myocardial dysfunction in patients with heart failure is the presence of persistent and inappropriate inflammation," said Stephen Epstein, MD, director of Translational and Vascular Biology Research at MedStar Heart & Vascular Institute. "Of great therapeutic relevance is the fact that mesenchymal stem cells have marked anti-inflammatory effects.” Dr. Epstein and his colleagues demonstrated in mouse models of heart attack and of heart failure that intravenously administered MSCs lead to a magnitude of improved heart function that is unprecedented.

“This study, if successful, will lead to pivotal trials that, in turn, will have the potential to alter strategies of treating LVAD patients that could markedly improve their symptoms and outcomes,” added Steven Boyce, MD, surgical director of the Advanced Heart Failure program at MedStar Heart & Vascular Institute.

There are nearly six million Americans with heart failure, and about 650,000 new cases occur each year. Each year 200,000 to 250,000 heart failure patients need heart transplantation, but with the very low supply of donor hearts, LVADs are being used with increasing frequency. An LVAD is a small pump that helps circulate the patient’s blood when their heart becomes too weak to pump effectively on its own. Although highly effective in alleviating symptoms and improving longevity, patients with LVAD support still have a high incidence of serious complications, including a high mortality rate. Persistent inflammation is also a probable major cause of deterioration of LVAD patients.

“If we are successful in showing stem cells improve outcomes in LVAD patients, the results would extend to the general population of heart failure patients and, in the process, fundamentally transform current paradigms for treating heart failure patients,” Dr. Epstein concluded.

 


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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How to manage the rising epidemic of heart disease

Click to listen to Dr. Samer Najjar’s podcast on heart failure.

Heart disease is the leading cause of death for both men and women in the United States.

While heart attacks and strokes get much of the attention when it comes to heart-related conditions, there is another common killer: congestive heart failure.

In fact, recent statistics indicate that more than five million Americans are living with congestive heart failure (CHF), and nearly 550,000 new cases are diagnosed each year.

Unfortunately, many people aren’t even aware that they are living with this very deadly disease.

"The difficult thing about heart failure is that it doesn’t have just one way that it presents itself,” says Samer Najjar, MD, director of the Advanced Heart Failure Program at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center. “With heart attacks and strokes, when you have symptoms, you have to go to the hospital very early because there are things that can be done. The longer you wait, the more injury can happen. Heart failure is different. There is a myriad of different types of symptoms people can have, which makes it harder to distinguish who has heart failure and who does not."

Once a patient has been diagnosed with heart failure, Dr. Najjar explains it’s quite likely he or she will need to continue treatment for a lifetime. “This is not just a condition of something happened and you ended up in the hospital, we treat you and you go home and it’s over with. Not at all. Heart failure is something people live with for the rest of their lives.”

Signs & Symptoms

Common symptoms of CHF include swelling of the legs, shortness of breath, lethargy, loss of appetite and abdominal pain.

Dr. Najjar explains there are two different types of heart failure. In one form, the heart is trying to pump but the muscle is too weak to do so efficiently. “If the muscle is weak, it’s having a hard time pumping the blood forward. Therefore, the blood will back up. It will back up into the lungs which is what causes shortness of breath and then it backs up into the rest of the body and that’s how patients start retaining fluid.”

The other form of heart failure, known as preserved ejection fraction, can be deceiving, because despite the fact that the heart appears to be squeezing normally, it’s having difficulty getting blood to the rest of the body. “That’s something that we in the medical field have struggled with for some time, because it’s not immediately obvious to us,” says Dr. Najjar.

Risk Factors

Anything that can cause injury to the heart puts people at risk for having heart failure. For example, high blood pressure, high cholesterol, high blood sugar, previous heart attack(s), smoking–all of these can contribute.

However, approximately 30 to 40 percent of those with heart failure have no discernible risk factors.

Still, Dr. Najjar is quick to emphasize that while some cases seem to appear out of nowhere, “there are known risk factors, which is why these risk factors have to be addressed during one’s lifetime.”

There are also lifestyle choices that are very important. “Exercise is a huge risk factor modifier and our population needs to do much more physical activity and exercise than what is common.”

Treatment Options

Advancements in medical science have provided a variety of treatment options, including oral medications.

“There are a lot of medications that have been studied, and several have been shown without any doubt that they actually improve survival. People live longer and feel better,” says Dr. Najjar. With these medications, it’s important for patients to keep close contact with their doctors until the correct dosage has been determined.

Other treatment options include devices such as pacemakers and defibrillators.

And, there are steps patients need to take to ensure these treatments remain viable. For example, salt is a huge culprit in terms of fluid retention. Patients also need to monitor how much fluid they take in on a daily basis. Consistent weigh-ins can be helpful to monitor fluid retention and identify a problem prior to the appearance of any other symptoms.

Life-Long Care

Once a patient has heart failure, Dr. Najjar explains it’s quite likely he or she will need to continue treatment for a lifetime.

The crucial thing to remember is that you cannot ignore risk factors. “You don’t want to wait until you have a problem, either a heart attack or heart failure,” says Dr. Najjar. “You have to be able to modify those risk factors in middle age, in young age, as soon as you find out that they happen, because when you’ve already developed the disease, you’ve already lost the opportunity to prevent them.”

Click to listen to Dr. Najjar’s full podcast on heart failure.

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What Does Heart Failure Mean for Intimacy?

What does Heart Failure Mean for Intimacy?

Patients with advanced illnesses face a variety of side effects. But little thought may be given to the concern of compromised physical intimacy.

That’s why our palliative care specialists decided to explore the matter further. Hunter Groninger, MD, director, Palliative Care, and Anne Kelemen, LICSW, Palliative Care social worker, designed a simple tool to assess sexuality and intimacy concerns among patients hospitalized with advanced conditions.

During the pilot study, 57 patients at MedStar Washington Hospital Center and MedStar Harbor Hospital were asked these questions during a palliative care consult:

  1. How much has your illness affected intimacy?
  1. How has your illness affected your relationships?
  1. Has this been discussed before during your hospital stay?
  1. Is this helpful to talk about?

Some 72 percent said that their condition had significantly or moderately impacted intimacy. For those facing the end of life, 83 percent reported the same feelings. Further, they wanted more conversation on the subject with their health care providers.

Defining Intimacy

Intimacy was defined broadly, including physical and emotional closeness, affectionate contact, sexual interactions and the communication of thoughts and feelings.

“Intimacy is bigger than just sexual intercourse. It can include cuddling, holding hands or playing with children or grandchildren,” Kelemen says.

Patients’ concerns included low libido, erectile dysfunction, lack of privacy and fear.  They also cited difficulties in finding and maintaining relationships overall.

“We had talked about the issues around intimacy, and knew they were overlooked,” Dr. Groninger says. “Then a family member brought up the issue, and we realized that it should be part of all routine palliative care consults. Patients do want to talk about intimacy, however they define it for themselves.”

Raising Awareness and Encouraging Open Conversations

Patients may not know how to bring up the subject. Kelemen describes such a case.

“I had a patient who had been hospitalized a very long time, and was nearing the end of his life. His wife wanted to talk to me; she wanted to have some ‘alone time’ with her husband, but didn’t know how to ask his doctors about that.”

Both researchers noted that important biases often exist.  First, clinicians often assume that intimacy only means physical sexuality or sexual health.  Second, clinicians often assume that patients with advanced conditions were too sick to be concerned with intimacy and sexuality.

“But we found that even patients at the end of life wanted to talk about these issues,” Dr. Groninger says.

George Ruiz, MD, MedStar Heart & Vascular Institute’s chief of Cardiology at MedStar Union Memorial Hospital and MedStar Good Samaritan Hospital, who was an advanced heart failure provider at the Hospital Center for 10 years, also believes that intimacy is important to these patients, and should be addressed.

“Heart failure systematically steals people’s humanity, taking away their ability to engage in living a full life,” Dr. Ruiz explains. “This includes walking around the house, climbing stairs and sharing intimacy. As physicians, we are so focused on the day-to-day challenges of caring for very sick patients, that we can overlook important quality-of-life issues these patients face.”

Kelemen stresses that addressing the issue is the whole point. “This is not just about addressing their concerns with VIAGRA®, it’s about having the conversation and encouraging conversations with their partners.”

It can be simple to do. “This is something any clinician can do,” Kelemen adds. “We just need to raise awareness and facilitate conversation.”

Samer Najjar, MD, medical director of Advanced Heart Failure for MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, supports the effort. “We recognize that intimacy is important to patients at every stage of life,” he says.  “This is an important part of patients’ overall health.”

The end result? “We hope to educate providers about how to initiate this conversation,” Dr. Groninger says.

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Gerard Folly’s Second Chance

Gerard Folly’s Second Chance

A Really Bad Cough

Forty-seven-year-old Gerard Folly gradually lost the stamina needed for his job as director of operations for a major Washington, D.C. hotel. A persistent dry cough made him think he had a nagging cold. But swelling in his feet and ankles, a recent diagnosis of high blood pressure, and the feeling of being out of breath even after only minimal exertion all suggested something far more serious. Even when he was sitting still, “It looked like I just finished running a marathon,” he recalls.

Gerard was concerned that he would now require the same procedures as his father, Roger, who received a left ventricular assist device (LVAD) in 2007 and a heart transplant a year later. Gerard turned to MedStar Heart & Vascular Institute at MedStar Washington Hospital Center and the same team of specialists at who had helped his father, including Samer Najjar, M.D, director of  the Hospital Center’s Advanced Heart Program. The team confirmed that Gerard would require extensive treatment to repair his heart condition.

After discussing his options with Dr. Najjar, Gerard decided a transplant offered the best long-term solution for himself and his family. He was placed on the transplant list in July 2015, and once his heart function dropped to a dangerous level, he entered MedStar Washington Hospital Center’s Cardiac Intensive Care Unit (ICU) in September.

A Second Chance

After nearly two months, Dr. Najjar told Gerard that a suitable donor organ was on its way. “He said, ‘Today’s the day for you,’” Gerard recalls. “It took me a moment to realize that he was serious, and that the transplant was really going to happen.”

A little more than 24 hours later, Gerard was in the Cardiac ICU’s recovery area. “I mainly remember my wife and nurses telling me that it was over, and I was OK,” Gerard says. “All I could do was listen to what they said, and be patient.”

Over the next few days and weeks, Gerard worked with MedStar Washington Hospital Center’s medical staff to regain his strength. “Everyone moved with confidence, which made me feel confident about what was going on” Gerard says, adding that his recovery is now proceeding faster than had been expected.

“I feel happy as a lark,” he says. “If I could do a cartwheel, I would.”

 

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