TAVR Clinical Trial Provides ‘Strong Signal’ Procedure is Safe for Patients with Low Surgical Mortality Risk

Washington, D.C., September 5, 2018 – Results of a clinical trial using transcatheter aortic valve replacement provided a “strong signal” that it is safe for patients with low surgical risk, potentially helping to open the way for broader use of the minimally invasive procedure, also known as TAVR.

The Low-Risk TAVR trial results, presented at the European Society of Cardiology Congress in late August, showed no deaths or disabling strokes within 30 days of undergoing the procedure for 200 patients with low surgical risk who participated in the study, led by MedStar Heart & Vascular Institute at MedStar Washington Hospital Center.

The results of the trial–the firs-of-its-kind approved by the Food and Drug Administration–were published online in the Journal of the American College of Cardiology.

TAVR is currently approved by the FDA for patients with symptomatic severe aortic stenosis– an abnormal narrowing of the aortic valve in the heart–who are at extreme, high and intermediate risk for death from surgery. Surgical aortic valve replacement, or SAVR is the standard of care for the low-risk population, but the trial results indicate that TAVR in low-risk patients is a safe alternative, with lower complication rates from the procedure.

SAVR involves open heart surgery to replace the valve, while with TAVR, instead of opening the chest, physicians insert a new valve using a catheter threaded into the heart through a small incision in the groin or chest wall.

“The results of the Low-Risk TAVR trial are a strong signal that it is just a matter of time until TAVR is approved for general use with low-risk patients,” said Ron Waksman, MD, director, Cardiovascular Research and Advanced Education, MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, and the study’s principal investigator.

The trial, conducted at 11 medical centers, compared results for the 200 TAVR patients with a control group of 719 patients who underwent SAVR at the same institutions. There were no deaths in the TAVR group at 30 days versus a 1.7 percent mortality rate in the SAVR group. Also, there were no in-hospital strokes in the TAVR group versus a 0.6% stroke rate in the SAVR group.

Dr. Waksman emphasized that the trial was sponsored by the participating investigators, heart teams and centers. The trial was managed by the academic clinical research organization at MedStar Heart & Vascular Institute.

“We are grateful to the FDA for trusting us to be the first to conduct a low-risk TAVR study in the U.S.,” Dr. Waksman said. “We are grateful to all the investigators across the U.S. who were willing to conduct the study at their own expense. They showed exceptional dedication and commitment.”


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

Media Contact

So Young Pak
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Dr. William O. Suddath Named Chairman of Cardiology at MedStar Southern Maryland Hospital Center

 

Washington, D.C., June 4, 2018 – MedStar Heart & Vascular Institute is pleased to announce that William O. Suddath, MD, is the new chairman of Cardiology and medical director of the cardiac catheterization laboratory at MedStar Southern Maryland Hospital Center.

Dr. Suddath is a highly experienced interventional cardiologist, having spent the last 22 years as an integral member of the renowned interventional cardiology team at MedStar Washington Hospital Center. He is the program director for the interventional cardiology fellowship program, which trains physicians in advanced cardiac catheterization skills. Dr. Suddath was instrumental in the start-up and growth of CodeHeart, MedStar Heart & Vascular Institute’s regional program, which expedites the transport and treatment of patients with heart attacks. Dr. Suddath is a Maryland native, and has worked closely with physicians and EMS providers in the southern Maryland area for more than two decades. 

“Bill Suddath will be able to build on the outstanding work already underway by our MedStar Southern Maryland Hospital Center physicians, leadership and staff,” said Stuart F. Seides, MD, physician executive director, MedStar Heart & Vascular Institute. “His proven leadership skills and clinical expertise will be invaluable in his role as the new team leader for our cardiovascular colleagues practicing in this region.”    

Late last year, MedStar Southern Maryland Hospital Center was invited to join the MedStar Heart & Vascular Institute-Cleveland Clinic alliance, after meeting the high quality standards required of all members. This alliance between two nationally-recognized cardiac programs has accelerated improvements in heart care and research, and resulted in even better outcomes for the patients served by the participating healthcare organizations.

“We are very pleased that Dr. Suddath is taking the leadership role in cardiology at our hospital,” said Chile Ahaghotu, MD, vice president of Medical Affairs, MedStar Southern Maryland Hospital Center. “He has an impeccable track record as a top notch clinician and teacher. His leadership will complement our unrelenting commitment to provide best-in-class cardiovascular services for the Southern Maryland community.”

Southern Maryland residents have local access to physicians who specialize in cardiology, interventional cardiology, cardiac electrophysiology (heart rhythm experts), vascular surgery and vascular access surgery at MedStar Southern Maryland Hospital Center located in Clinton, Maryland and at MedStar clinical offices throughout the Southern Maryland peninsula.


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.

About MedStar Southern Maryland Hospital Center:
MedStar Southern Maryland Hospital Center, located in Clinton, Maryland, is a 182-bed acute care hospital serving the Washington, D.C., metro and Southern Maryland area. The hospital is focused on caring for patients and their loved ones utilizing advanced technology under the guidance of expert clinicians. Quality, Safety, Wellness, and Patient Satisfaction are achieved through a spirit of patient-centered services that connect MedStar Southern Maryland to the community it serves.

 

So Young Pak
202-877-2748
[email protected]

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.

 

So Young Pak
202-877-2748
[email protected]

Heart Surgery Program Earns Top Quality Rating

 

Washington, D.C., February 12, 2018 – MedStar Heart & Vascular Institute’s cardiac surgery program has earned the highest quality rating of three stars from the prestigious Society of Thoracic Surgeons (STS), placing it once again among the top surgical heart programs in the nation.

MedStar Heart & Vascular Institute, headquartered at MedStar Washington Hospital Center, received the highest, three-star rating in all three ranked categories: coronary artery bypass grafting (CABG), aortic valve replacement (AVR) and combined AVR + CABG. It’s an achievement shared by an elite group of less than five percent of cardiac surgery centers in the U.S. and Canada. Physicians widely regard the STS rating as the gold standard by which to evaluate cardiac surgery programs, and this rating also allows patients to make informed decisions about where to receive heart care.

“This is a great honor and reflects hard work by the entire team of cardiovascular surgeons, intensivists, anesthesiologists, surgical assistants and mid-level practitioners,” said Paul Corso, MD, senior cardiac surgeon at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center. “We have always strived to be better tomorrow than today, and have instituted uniform best practices verified by an extensive quality data system.”

MedStar Washington Hospital Center has earned the top-tier, three-star rating in coronary artery bypass grafting since 2006 when STS developed a sophisticated star rating system that evaluates the quality of cardiac surgical procedures performed at hospitals nationwide. The three-star rating is based on a composite score using a combination of 11 quality measures grouped into four categories: patient survival, the absence of surgical complications, recommended medications, and optimal surgical technique.

The STS releases quality awards semiannually. The three-star designation for coronary artery bypass grafting (CABG) is for the data period July 2016 to June 2017. For aortic valve replacement (AVR) and the combined AVR + CABG, the data covers a three-year period from July 2014 to June 2017.

To learn more about the cardiac surgery program at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, click here.


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

Media Contact

So Young Pak
202-877-2748
[email protected]

Dr. Seth Worley Joins MedStar Heart & Vascular Institute’s Cardiac Electrophysiology Program

Washington, D.C., August 17, 2017 – MedStar Heart & Vascular Institute is pleased to announce that Seth Worley, MD, has joined the Section of Cardiac Electrophysiology as a senior consultant. An internationally recognized expert in cardiac resynchronization therapy (CRT), Dr. Worley brings with him extensive expertise in device and lead implantation for those patients who present with challenging vascular anatomy. He has personally developed unique tools and techniques to facilitate and optimize the success of transvenous left ventricular (LV) lead implantation. The approach he pioneered is referred to as ‘Interventional CRT” and patients from centers around the country who have had an unsuccessful attempt at lead implantation are regularly referred to Dr. Worley for treatment.

Dr. Worley joins MedStar Heart & Vascular Institute from Lancaster General Hospital in Lancaster, Pa., where he was the director of Interventional Implant Program at the Lancaster Heart and Vascular Institute. He is the founder and past president of the Lancaster Heart & Stroke Foundation, a non-profit organization dedicated to improving cardiovascular health through clinical research and community programs.

“The addition of Dr. Worley to our Electrophysiology team will substantially broaden the types of therapies MedStar Heart & Vascular Institute can offer patients,” says Zayd Eldadah, MD, PhD, director, Cardiac Electrophysiology at MedStar Washington Hospital Center. “By joining MHVI, Dr. Worley gains a destination medical center from which to deliver care, as well as conduct and expand his internationally acclaimed teaching program for caregivers from all over the world.”

Dr. Worley is a graduate of the Temple University School of Medicine and completed his internship and residency in internal medicine at Strong Memorial Hospital in Rochester, NY. After completing a fellowship in cardiology and electrophysiology at Duke University Medical Center, he became the co-director of the Coronary Care Unit and Assistant Professor of Medicine. From Duke, he was recruited to the Mayo Clinic where he was Assistant Professor of Medicine in the Division of Cardiology prior to relocating to Lancaster. He is board certified in clinical cardiac electrophysiology, and a fellow of the Heart Rhythm Society.

Dr. Worley is an active participant in academic, research and teaching activities. He has been the principal, co-principal or sub-investigator of 87 clinical trials, published numerous scientific papers, case reports, book chapters and abstracts and holds four U.S. patents for medical devices. He is a frequent speaker at national and international medical meetings.

 


About MedStar Heart & Vascular Institute

MedStar Heart & Vascular Institute is a national leader in the research, diagnosis and treatment of cardiovascular disease, and has been recognized by U.S. News & World Report and The Society of Thoracic Surgeons as one of the top cardiovascular programs in the nation. 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.

So Young Pak
202-877-2748
[email protected]

Shared decision-making: It’s no longer ‘doctor knows best’

Does this sound familiar? You go to the doctor. They diagnose you and tell you what the treatment will be. The end.

This one-sided approach to decision-making involves the doctor dictating care without much, if any, input from the patient. But this is now beginning to change. We’re moving away from that sort of “doctor knows best” model of medical decision-making and toward a newer approach known as shared decision-making.

We’ve moved away from a “doctor knows best” model of decision-making and moved toward shared decision-making. via @MedStarWHC

Here’s the big idea:  I have expertise in medicine. You have expertise in you. Shared decision-making recognizes the expertise of patients and empowers them to engage in the medical process. This is illustrated in the principle “Nothing about me without me.”  

Shared decision-making provides numerous benefits to patients. One review of 105 studies compared patients who received usual care with those who used decision aids, which are tools designed to facilitate shared decision-making. These tools can include written materials, videos or interactive web-based programs. The review found that patients who used decision aids felt more knowledgeable and confident in decisions, better understood the benefits and risks of treatment options and had a greater likelihood of receiving care aligned with their values.  

As patients increasingly play a more active role in their health care, learn how shared decision-making works and how you can take an active role in it. But first, let’s look at a hypothetical situation to see how shared decision-making can influence your treatment.  

What shared decision-making looks like in practice

You come to the hospital after having a small heart attack. You’re stable but have blocked arteries. We discuss your condition and treatment options, which include medication and bypass surgery.  

Often, I’d recommend surgery for a patient with blocked arteries. But if you’re unable to be off work for the eight weeks it will take to get back to full function after bypass surgery or you serve as the primary caregiver for an elderly parent, we may be able to delay surgery and discuss alternatives.

There’s no confrontation or hard feelings. Rather, it’s a negotiation about the interaction between a medical recommendation and your personal situation. Instead, we may tailor your medications to your situation, discuss warning signs of which to be aware, and send you home with the understanding that we may discuss surgery again in the future.  

This situation illustrates how shared decision-making is meant to work. The doctor and patient have an open, honest conversation and a decision is reached based on the perspective of both parties.  

How shared decision-making works

Shared decision-making may sound like common sense. And it is. Unfortunately, medicine got away from this type of doctor-patient collaboration as quality measures focused on enforcing care guidelines.  

In the past, if you came in with high cholesterol, quality care was defined as you leaving with a prescription for a statin – whether you wanted one or not. It didn’t matter if you didn’t understand why, didn’t agree, or threw the prescription in the garbage the second you left the doctor’s office. By gosh, the guidelines said to give you a statin, so the doctor gave you a statin.  

No one wants to have decisions made for them, or to have their thoughts and opinions not taken into consideration. We now consider quality treatment to be achieved if three steps have been followed:

  • The doctor explains the treatment options
  • The doctor and patient have a thoughtful discussion about each one
  • A decision is reached that is right for the patient

In this meeting between the doctor and the patient:

  • The doctor contributes knowledge about the condition and treatment options
  • The patient contributes their past experiences, preferences, goals and values, along with information they have from research about their condition and treatment options  

In a perfect world, the doctor’s recommendation and patient’s wishes align. But sometimes they don’t, and in those cases, we come up with another plan. Or maybe we decide it’s not right today, but we keep the topic open and talk about it later.  

I find that patients usually have valid reasons for why they don’t want to follow certain treatments. “I tried it in the past and it didn’t work.” “A friend did it and it didn’t turn out well.” “My family doesn’t think I should do it.” “My primary care doctor disagrees.”  

At the end of the day, I want my patients to feel comfortable with their care decisions. To do that, doctors need to sit down at the table and talk with you eye to eye – not stand up and dictate what you should do. We need to encourage patients to open up by asking questions and listening to the answers:

  • Do you understand your condition?
  • What do you think about the treatment recommendation?
  • Is it right for you, and if not, how can we make it right for you?
  • What are your concerns?  

Your role and responsibility in shared decision-making

Shared decision-making is a two-way street. The doctor must be willing to involve you and respect your expertise and preferences, but you also must take an active role in the process.

  • Learn about your condition and treatment options: Listen to your doctor and read the information they give you. You also can do your own research before or after appointments.
  • Speak up: Ask questions when you don’t understand something. Share your concerns, goals and preferences.  
  • Recruit family or friends to help: Needing medical care can feel overwhelming. Sometimes it helps to have a loved one with you as a second set of eyes and ears. They can take notes to help you remember details later and ask questions you may think of later.  

The first step toward making a medical decision is to fully understand your options. While each condition is different, here are a few questions to ask to get started:

  • What are my treatment options?
  • What are the risks and benefits of each?
  • What is the goal of each option? Is it to treat the condition or improve the symptoms?
  • How will each treatment make me feel?
  • What are the side effects and how will they affect my quality of life?  

When you and your doctor actively collaborate on care, you’re more likely to feel confident and satisfied in your decisions. Find a doctor who engages in shared decision-making, and play your role in it as well.  

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Dr. Vinod Thourani Named Chairman of Cardiac Surgery for MedStar Heart & Vascular Institute

Washington, D.C., July 31, 2017 – MedStar Heart & Vascular Institute is pleased to announce that Vinod Thourani, MD, will join its leadership team as the chairman of Cardiac Surgery, effective August 14. A nationally recognized cardiothoracic surgeon and researcher, Dr. Thourani brings with him extensive expertise in structural heart disease and valve surgery, specifically TAVR (Transcatheter Aortic Valve Replacement) and minimally invasive aortic and mitral valvular surgery.

Dr. Thourani joins MedStar Heart & Vascular Institute from Emory Healthcare in Atlanta, Ga., where he is a professor of surgery and medicine, and was co-director of the Structural Heart and Valve Center, and chief of Cardiothoracic Surgery at Emory University Hospital Midtown. In his new role at MedStar Heart, Dr. Thourani will be responsible for all cardiac surgical services at MedStar Washington Hospital Center and MedStar Union Memorial Hospital in Baltimore.

“Dr. Thourani is the rising star in his generation of cardiovascular surgeons,” said Stuart F. Seides, MD, physician executive director, MedStar Heart & Vascular Institute. “With his strong and well-established background in academic surgery, education and research, Dr. Thourani will continue to enhance our already highly distinguished cardiac surgery program, and will help us secure our position as one of the nation’s premier heart and vascular institutes.”

Dr. Thourani will be building on the legacy established by Dr. Paul Corso who has led the cardiac surgery program for more than 20 years. Under Dr. Corso’s direction, MedStar Heart & Vascular Institute has continually pioneered innovations in surgical techniques and secured the highest three-star rating from the Society of Thoracic Surgeons for 10 consecutive years. Dr. Corso will be remaining with MedStar Heart in order to focus on one of his passions–ensuring the highest quality outcomes for cardiac surgery patients–and to help ensure a smooth leadership transition.

During his tenure at Emory, Dr. Thourani focused on developing and refining innovative strategies and devices to treat structural heart disease, particularly in those patients who previously had no treatment alternatives. He played a pivotal role in directing a number of large studies that have helped to significantly expand the understanding of the use of TAVR in ever larger populations, having served as national principal investigator and having received NIH funding for his work in the structural heart arena. His skills are a strong fit with the high level of expertise and innovation in the treatment of structural heart disease that is already well-established at MedStar Washington Hospital Center and MedStar Union Memorial Hospital.

Dr. Thourani also brings with him a commitment to education and leadership development. He served as the director of the Advanced Transcatheter Valve Surgery fellowship at Emory, and he was a fellow of Emory’s Woodruff Leadership Academy. He currently holds significant leadership positions in the major cardiology and cardiothoracic surgical associations, including serving on the Board of Directors of the Society of Thoracic Surgeons.

 


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.

So Young Pak
202-877-2748
[email protected]

Why I think it’s time to make statins available over-the-counter

Heart disease and stroke are the leading cause and fifth-leading cause of death of adults in the United States, respectively. Studies show that statins – cholesterol-lowering drugs – can reduce the risk of heart attack, stroke and death from heart disease by 25 to 30 percent.

Yet of the more than 78 million adults who are eligible to take statins, 45 percent don’t. There are plenty of reasons for this: some don’t realize they’re at risk for these conditions; others don’t want to take medication or have been scared off by misinformation about statins.

But people who could benefit from a statin also face an additional barrier: it requires a prescription.

A May 2016 study estimated that giving statins over-the-counter (OTC) status would result in more than 250,000 fewer major coronary events such as heart attack, more than 41,000 fewer strokes, and reduce heart disease- and stroke-related deaths by nearly 69,000 over 10 years.

We’ve been using statins for 30 years, and they’ve proven to be some of the safest and most effective drugs for heart disease prevention. I think it’s time we remove the prescription barrier and allow people to buy them over-the-counter.

Statins as OTC medication: Why now?

Selling statins over-the-counter isn’t a new concept. It’s been discussed for years. In fact, one pharmaceutical company even began the process for developing an OTC statin before abandoning it due to sky-high requirements. But evidence found in a 2016 study really drove home for me that this is a valid idea.

“The Heart Outcomes Prevention Evaluation” (HOPE-3) study, published in May 2016 in The New England Journal of Medicine, followed more than 12,000 participants age 55-65 with at least one heart disease risk factor, such as high blood pressure or tobacco use. Half of the participants were given 10 mg of rosuvastatin, more commonly known as Crestor, and half were given a placebo. After five years, those who took a statin had a 24 percent lower risk for cardiovascular events. And, importantly, there were few if any important differences in side effects between the statin and placebo.

One interesting aspect of this study is that cholesterol levels were not used to select patients or to guide the treatment. The requirement was simply age and one heart disease risk factor. And to me, that’s the formula for an OTC medication: you don’t need a lot of fancy measurements to figure out if you could benefit from a statin. The HOPE-3 study showed statins were safe and effective in a broad population of people who didn’t already have heart disease, which I think is justification for conversion to OTC status.

A few years ago, Pfizer sought Food and Drug Administration (FDA) approval to convert its statin Lipitor to an OTC medication. The FDA set a pretty high bar for Pfizer’s study, requiring patients to measure their own cholesterol and take appropriate action based on the test results – actions no other OTC drug requires. Basically, the FDA wanted patients to act as a doctor, and it proved too complicated for most study participants. Pfizer ended the trial early.

The HOPE-3 study showed people don’t need to measure the effect of a statin on cholesterol for it to work. And by working, I mean it saves lives. So how do we narrow the gap between people who could benefit most from statins and those who take them?

Options for how to make statins available over-the-counter

There’s no question that giving a drug OTC status increases its use. One study showed an average 27 percent increase in utilization in several therapeutic drug classes, such as antihistamines and analgesics (a form of painkiller) after becoming available over-the-counter.

There are a few ways to go about expanding the availability of statins.

1. No longer require people to renew prescriptions

This is sort of a step up to true OTC status. Currently, if you have a prescription for a statin, you need to return to your doctor every year to renew the prescription. What if instead, that initial prescription was a lifetime prescription? It would be noted in your electronic medical records and you could walk up to any pharmacy window and refill it on an ongoing basis, without visiting the doctor to get a new prescription.

2.  Make statins available without a prescription

There are some people who just don’t want to see a doctor, but realize they’re at risk for heart disease or stroke. They’d take a statin if it was available like an antacid for heartburn or Tylenol for headache.

This would make statins available to anyone who stands to benefit from taking one: middle-aged individuals with one additional heart risk factor like in the HOPE-3 study. Given the poor job we do right now in getting statins to everyone who can benefit from them, it is time we begin to “think differently.”

Suggesting these options doesn’t mean I never want you to see a doctor, but it does remove a barrier to taking a potentially life-saving drug. Plus, instead of needing to discuss your statin during every visit, we can take a little extra time to focus on other topics, such as lifestyle modifications or answering questions.

How to keep people safe with OTC statins

Every medication has potential side effects. Statins are no different, although I think some concerns have been exaggerated on the internet. The most common side effect of statins is muscle pain, although it’s usually mild. Other side effects include a slightly increased risk to develop diabetes, seen as an earlier time to the diagnosis among patients likely to develop diabetes.

Have you ever bought aspirin or ibuprofen over the counter? Sure you have. In my view, statins are, in fact, safer than these drugs, and provide more benefit. Nonsteroidal anti-inflammatory drugs such as these are incredibly effective when needed, but they do have potentially serious side effects, including increased risk of bleeding in the brain and gastrointestinal bleeding. However, like statins, the benefits of these drugs greatly outweigh the potential harm.

Labels for OTC statins should carry warnings and recommended uses just like any other drug. And not every variation of statins should be available over-the-counter. For example, if you needed a dose higher than 10 mg, your doctor should have to write a prescription, just as you would for high doses of other OTC drugs.

There are still questions to be answered before statins become available over-the-counter, such as who will pay for them. Most OTC drugs aren’t covered by insurance. But statins prevent health events that insurance companies ultimately would have to pay for, so I think they should be a reimbursable expense. How that happens needs to be worked out.

Statins have a solid 30-year track record of preventing heart attacks, stroke and death from heart disease. They’re ready for prime-time. We’re entering a new era of empowering people to take charge of their health. It is time to give the public more control of their cardiovascular destiny by making statins available over-the-counter.

 

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When to go to the emergency department for heart palpitations

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

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

What are heart palpitations?

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

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

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

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

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

What causes heart palpitations?

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

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

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

Other issues that can cause heart palpitations include: 

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

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

Heart palpitations and anxiety

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

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

When to get help for heart palpitations

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

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

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

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

Further testing for heart palpitations

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

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

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

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

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

Safer, Faster, More Comfortable Cardiac Catheterization Gaining Ground

Since the 1970s, heart specialists have diagnosed and even treated certain conditions through cardiac catheterization—the process of threading a thin tube through an artery to reach the heart and its vessels. The technique gives cardiologists a close look at what’s going on inside, and even more importantly, the ability to intervene on the spot in cases of blocked, narrowed or weakened arteries.

In fact, cardiac catheterization is so common today that more than 1 million people in the United States undergo the procedure each year. And in nearly every case, cardiologists use the femoral artery, a large vessel deep in the groin, as the point of entry.

But not always.

Listen to the full podcast with Dr. Robert Lager.

The Current Landscape

“There’s been a push over the last five years or so to approach cardiac catheterization through the wrist, using the much smaller radial artery,” says Robert Lager, MD, an interventional cardiologist at MedStar Heart & Vascular Institute at MedStar Washington Hospital Center, and president of MedStar Cardiology Associates. “It poses less of a risk of bleeding—the major complication of traditional cardiac catheterization techniques—and it’s more comfortable for patients.”

That’s because recovery from the femoral approach requires patients to remain motionless on their back for four to eight hours to prevent significant post-procedure bleeding and other potential complications. For many, that inconvenience is a small price to pay for a potentially life-saving procedure. But for those with congestive heart failure, back or breathing problems, the protracted time lying flat can be miserable.

By contrast, recovery from the transradial approach is fast and easy.

“In theory, a patient could literally walk off the table after transradial catheterization,” says Dr. Lager, who uses the approach for approximately 80 percent of his cases. “In reality, we keep people in bed for an hour or so post-procedure to monitor for any problems from sedation. But they’re free to sit up, and even get a drink or eat soon afterward.” In addition, the time to discharge is shortened for those going home, and avoiding the groin allows patients to resume more strenuous activities like climbing stairs and aerobic activity earlier in their recovery, adds Dr. Lager.

Transradial cardiac catheterization has been the norm in many parts of Asia and Europe for decades. In the U.S., it currently only accounts for about 30 percent of procedures, in part because of the steep learning curve. However, that ratio is quickly changing.

“As more cardiology fellowship programs train new doctors to use the wrist instead of the groin for cardiac catheterization, we are getting closer to a tipping point of transradial becoming the default approach,” says Dr. Lager. “It’s already the preferred choice among younger cardiologists.”

Who Should Get Transradial Cardiac Catherization?

Not everyone is a good candidate for the transradial catheterization, however. Patients on dialysis may not be eligible, for example. And patients who have had bypass surgery can also pose more technical challenges, although Dr. Lager still uses the wrist for the vast majority of his bypass patients. In fact, national statistics report a 90 percent success rate for the transradial approach overall.

For those who are eligible, however, the advantages in comfort and convenience are compelling.

“Patients are already seeking out physicians who will do the transradial procedure,” concludes Dr. Lager. “As more people learn about its benefits, the demand is only going to increase.”

Catch the full podcast featuring Dr. Lager here.