WATCHMAN device: We lead the clinical trial

Expanding options

Clinical trial could mean end of blood thinners for AFib patients

When competitive water skier John Howell developed chronic atrial fibrillation in his 70s, he started a blood thinner regimen to treat and prevent blood clots and reduce the risk of stroke. But participating in sports can be dangerous for someone taking anticoagulants, which can cause excessive bleeding. One spill from his skis and Howell could bleed uncontrollably.

“You want a nice, efficient heart when you’re exercising,” he said. “Unfortunately, when you ski, you can take some dramatic crashes that can be life-threatening.”

After four or five years on the drug Eliquis, Howell, 80, wanted his AFib cured. Twice he tried cardioversion, a procedure that can restore normal heart rhythm by applying a controlled electric shock to the heart to break the pattern of abnormal electrical signals. After each time, however, his AFib returned.

Out of options, Howell’s cardiologist in Fredericksburg, Virginia, referred him to VCU Health Department of Cardiology chair Dr. Kenneth Ellenbogen, whom they were confident could help the retired dentist. Pauley Heart Center’s Atrial Fibrillation Program offers a full spectrum of innovative therapies and treatments and is focused on meeting the individual needs of each patient. Because Howell had a high risk of stroke, Ellenbogen recommended he receive a WATCHMAN implant, which he’d been successfully using for years. The parachute-shaped device is designed to keep harmful blood clots that form in the left atrial appendage from entering the blood stream and potentially causing a stroke.

The WATCHMAN is permanently placed at the opening of the left atrial appendage. The procedure requires an overnight stay in the hospital, and recovery takes about 24 hours.

“I was all for having it done,” Howell said. “I have the highest regard for Dr. Ellenbogen and felt like I was in really good hands.”

He had the procedure done without incident. “Then, I went about my life playing tennis and water skiing,” said Howell, a multi-time Eastern regional timed slalom champion.

“This is probably one of the most important studies being done in the next five years in clinical cardiology.”

Positive outcomes like Howell’s interested Ellenbogen in studying whether the newest version of the WATCHMAN device may one day be the preferred therapy for patients with non-vascular AFib who are at high risk of stroke. Ellenbogen is a co-chair of CHAMPION-AF, a global, head-to-head clinical trial of the WATCHMAN FLX device versus non-vitamin K antagonist oral anticoagulants (NOACs).

“This is a groundbreaking study that looks at a device that the doctors here have been implanting for a number of years successfully and looks at it as first-line therapy for preventing stroke in patients with atrial fibrillation,” Ellenbogen said. “That’s huge.”

What is AFib?

If your heart beats too rapidly and irregularly, you may require treatment for atrial fibrillation, the most common abnormal heart rhythm. When the upper part of your heart (the atria) beats irregularly and too fast, this can cause your heart to quiver (“fibrillate”). As a result, your most important organ can’t efficiently pump blood to the rest of the body, so the brain and other organs may not receive enough blood to operate their best.

Atrial fibrillation may occur from time to time (paroxysmal) or be constant (chronic). Though AFib is rarely painful, you may feel symptoms such as lightheadedness, shortness of breath, fatigue – or nothing at all. It also increases the risk of stroke five to seven times compared to a person
without AFib. In addition, AFib may cause congestive heart failure. If treated appropriately, atrial fibrillation or flutter seldom cause serious or life-threatening problems. Without treatment, AFib can lead to serious complications and irreversible damage.

Treatment for AFib may include medical management (blood thinners), cardiac assist devices, catheter ablation procedures using advanced mapping technology and a variety of minimally invasive or surgical approaches.

Anticoagulants keep blood clots from forming in an artery, a vein or the heart, and may prevent existing clots from getting larger. They are prescribed for AFib patients because their irregular heartbeats can cause blood to collect in the heart and form a clot that can travel to the brain, cutting off the oxygen and blood supply causing a stroke. About one in five people who have a stroke have AFib. The more conventional anticoagulants are warfarin (Coumadin) and heparin. However, direct oral anticoagulants like Eliquis are a class of newer medications that have fewer drug interactions and do not require regular blood monitoring.

While for many people there is no apparent cause for AFib, it can be related to underlying conditions or risk factors, including previous heart attack, congestive heart failure, leaky valves, coronary artery disease or inflammation near the heart, high blood pressure or diabetes.

WATCHMAN vs. NOAC

The CHAMPION-AF clinical trial compares NOACs like Eliquis with the WATCHMAN FLX, putting the best available drugs up against the best available left atrial appendage closure device.

Dr. Kenneth Ellenbogen prepares for the CHAMPION-AF clinical trial.

“We’re studying different strategies for preventing stroke in patients with atrial fibrillation. And of course, the strategy most commonly used has been drug strategy,” Ellenbogen explains. “Blood thinners are great, but they make it harder for you to stop bleeding when you start bleeding. So, in patients who have atrial fibrillation, most of their strokes come from what we call the left atrial appendage, which some surgeons call the appendix of the heart. Somebody came up with the idea of if we could close off the left atrial appendage, we might be able to prevent strokes for patients with atrial fibrillation. And they wouldn’t have to take blood thinners.”

In a number of pivotal studies, Ellenbogen said, it was found that patients who can’t take blood thinners but who received the WATCHMAN did well with an aspirin a day, or nothing.

The WATCHMAN device has now gone through several iterations, and the implantation procedure has been improved. “Maybe this type of device might be better than drugs for most people,” Ellenbogen said. “That’s the question our study is attempting to answer.”

About the device

The CHAMPION-AF trial will use the next-generation, FDA-approved WATCHMAN FLX device. Manufactured by Boston Scientific, WATCHMAN FLX is built on the WATCHMAN, the most studied and most implanted left atrial appendage closure device. More than 100,000 have been implanted worldwide, Ellenbogen said.

The trial includes about 150 sites globally and will enroll approximately 3,000 patients. Dr. Marty Leon, director of the Center for Interventional Vascular Therapy at New York Presbyterian/Columbia University Irving Medical Center, is a co-chair. Principal co-investigators are Dr. Shephal Doshi, cardiac electrophysiologist at Pacific Heart Institute, and Dr. Saibal Kar, interventional cardiologist at Los Robles Health System.

To be enrolled in the study, patients have to have at least a moderate risk of stroke from AFib.

“We have a lot of patients who come to see us who don’t want to take blood thinners because they’re active, or they’ve had some bleeding,” Ellenbogen said. “This study gives them the opportunity to get a device implanted without having to have had a bleeding episode to get the device implanted. So, if you’re 70 years old and you have high blood pressure, you’re going to be on blood thinners the next 20 years of your life. But if you participate in this study, you have a 50% chance of having a device implanted. So, we can see which is better, the medicine or the drugs.”

After receiving the device, patients will be evaluated in three years. “We’ll be looking to see if this device is safe and effective compared to the drug,” Ellenbogen said.

The big picture

“This is probably one of the most important studies being done in the next five years in clinical cardiology,” he added. “And Pauley is going be involved. I’m going to be involved as one of the two people who is going to steer the study to its conclusion. Whether it’s positive or negative, it’s going to possibly change the way we practice, possibly just reinforce the way we practice.”

That change could mean that any patient with AFib gets a WATCHMAN device implanted to prevent a stroke. The implant would be in place of drug therapy.

Perfect for active people like Howell, who have years of full lives ahead of them — trips to take, grandkids to raise and slalom course races yet to win.


Learn more about our Atrial Fibrillation Program:

https://www.vcuhealth.org/pauley-heart-center/our-expertise/atrial-fibrillation-program


The $2 million man

Research into extra heartbeats resonates with grant-making agencies

Early in his career, Dr. Jose Huizar became increasingly intrigued by extra heartbeats in his cardiac patients.

It was the mid-2000s, and Huizar was providing clinical care to veterans at Hunter Holmes McGuire VA Medical Center, where he is co-affiliated with Pauley Heart Center. At the time, the medical literature was divided on the phenomenon of extra heartbeats, which present as a fluttering or flip-flop feeling in the chest. Some researchers suggested that these extra beats, called premature ventricular contractions, or PVCs, weaken the heart. Others argued that, no, a weak heart causes the extra beats.

The common treatments to eradicate PVCs were medication or ablation — treatments that Huizar and his colleagues routinely provided. But Huizar, who’d become keenly interested in electrophysiological unknowns since completing his post-residency fellowship, was compelled to ask: Were these actions medically necessary? Did the PVCs, in fact, weaken the heart?

The pursuit of answers set Huizar’s career on its current trajectory — and to date has resulted in more than $2 million in research grants.

Huizar, associate professor in the VCU Department of Internal of Medicine, Division of Cardiology, and director of the Arrhythmia and Device Clinic at McGuire, has devoted more than a decade to expanding his understanding and knowledge of the chronic effects of PVCs. He has done so while concurrently caring for patients in his field of cardiac electrophysiology. “I believe this gives me the advantage to better understand and try to answer critical clinical questions,” he explained.

Huizar’s highly successful record of attracting both public and private funding comes as no surprise to Pauley Heart Center Director Dr. Greg Hundley.

Last July, Huizar received a VA Merit Grant from the Department of Veterans Affairs to continue his work exploring the mechanisms behind a type of cardiomyopathy, or disease of the heart muscle, caused by PVCs. The grant builds on a three-year National Institutes of Health R01 grant he received that runs until April 2021. He is also principal investigator for a three-year R34 study, funded by the NIH, that runs until June 2020.

Huizar’s highly successful record of attracting both public and private funding comes as no surprise to Pauley Heart Center Director Dr. Greg Hundley. “[PVC-related cardiomyopathy] is a significant health problem,” he said. “Dr. Huizar brings innovation and a great plan to help solve the problem. He is a rapidly emerging, important investigator in the field.”

Understanding PVCs

Premature ventricular contractions are extra, abnormal heartbeats that begin in one of the heart’s two lower pumping chambers, called ventricles. They occur when ventricle contractions beat sooner than the next expected regular heartbeat, often interrupting the normal order of pumping. The extra beat is followed by a stronger heartbeat, which creates the feeling of a skipped beat or a flutter. These extra beats are usually less effective in pumping blood throughout the body.

PVCs can be triggered by heart disease or injury, which can interfere with the normal electrical impulses. Occasional extra beats are common, and usually no cause can be found. Often, they go away on their own. PVCs are diagnosed with an electrocardiogram test or by analyzing data from a Holter monitor, a portable device that captures heart rhythms over a period of time. Frequently, extra beats coexist in patients with cardiomyopathy, a condition characterized by heart failure and weak heart function. Cardiomyopathy impacts not only quality of life, but also the patient’s health and life expectancy.

“As a junior faculty, I realized the lack of understanding of the chronic effects of PVCs, and of how to identify patients at risk to develop PVC-induced cardiomyopathy,” Huizar said. “At that time, there were skeptics that believed that PVCs were the result of the cardiomyopathy. I took this as a challenge.”

Devising a way to reproduce PVCs for a preclinical study required original thinking and ingenuity. Huizar brought both to the task. He conceived the idea to reprogram a pacemaker to reproduce PVCs. Dr. Kenneth Ellenbogen, chair of VCU’s Division of Cardiology and director of clinical cardiac electrophysiology and pacing, supported the plan and connected him with a pacemaker company. “I thought it was a great idea and a very important line of research,” Ellenbogen said. “I encouraged him to pursue this method to create a clinically relevant model.”

Huizar developed a novel premature pacing algorithm that delivered extra beats on command, allowing him to reproduce chronic states of PVCs and study their lasting effects. “This will not only allow us to understand the mechanism associated with left-ventricular dysfunction and increased sudden cardiac death in patients with frequent PVCs, but, most importantly, will help us find targets to prevent and treat the effects of frequent PVCs,” he said.

From the three years of preclinical research that followed, Huizar proved that a normal heart exposed to “a lot” of extra beats induces a weak heart. In 2012 he was awarded a five-year American Heart Association Scientist Development Grant to study in detail how many extra beats were needed to debilitate the heart and cause heart failure.

In 2016, the American Heart Association published a scientific statement recognizing PVC-induced cardiomyopathy (PVC-CM) as a unique clinical entity — citing Huizar’s published research as establishing proof of concept. “It validated my work,” he said.

R34 and R01 studies

Huizar’s research into PVCs represents a major advance in the field of cardiac electrophysiology as we understand the mechanisms of disease progression and regression, Ellenbogen said.

Dr. Jose Huizar crossing arms in hospital

Huizar, with his unique expertise and interest, has helped make Pauley one of the select centers in the U.S. for PVCs research.

Two NIH grants — an R34 and an R01 — are enabling Huizar to further distinguish himself in the field and advance his understanding of PVCs on heart function. The studies made possible by these grants support the National Heart, Lung and Blood Institute’s mission of advancing translational research and are Huizar’s current research focus.

The R34 clinical pilot study is testing the hypothesis that the prevalence of PVC-CM is underestimated and that conducting a large, randomized clinical trial to test treatments is possible. Twenty thousand ambulatory ECG Holter monitors collected from health care centers around the country are being screened to identify patients with probable diagnosis of PVC-CM. Thirty-six patients with frequent PVCs and cardiomyopathy are being enrolled into the pilot study and randomized to receive either ablation or medication.

Generally, patients identified with PVC-CM are offered radiofrequency ablation, antiarrhythmic drugs or no treatment. “There is clear need for a large clinical trial comparing these strategies,” said Huizar, the study director working alongside co-investigators Ellenbogen, Dr. Adam Sima at VCU Medical Center, and Dr. Alex Tan and Dr. Karoly Kazsala at McGuire VA. “Yet, we need to better understand the prevalence of PVC-CM, and the feasibility and limitations of such a trial.”

VCU Medical Center and McGuire VA are two of the nine patient recruitment sites. All participants are receiving baseline cardiac imaging and are being observed for a three-month period before receiving treatment.

If successful, the R34 study will pave the way for a large, full-scale randomized trial to identify the best treatment strategy for patients with PVC-CM. “The pilot study is to get a sense of how many patients we can recruit and what are going to be the restrictions of recruiting,” Huizar explained.

Concurrent with the pilot study, Huizar and co-investigators Dr. Montserrat Samso, associate professor, and Drs. Jose Eltit and Rafael Ramirez, assistant professors in the Department of Physiology and Biophysics, are conducting an NIH R01 translational study to understand what changes PVCs cause on a molecular level that trigger weakening of the heart. The mechanism responsible for PVCs is unclear.

Some patients have a lot of PVCs but a normal heart, while other patients have a weak heart whose function improves when PVCs are eliminated. “It seems to me that there is some patient susceptibility that we don’t understand yet,” Huizar said. describing the study’s impetus.

He continued, “If you look at the patients that have PVCs versus those who don’t, they tend to have more heart failure in the long term. In general, sudden cardiac death is not that increased. But, if you look at the patients who have had sudden cardiac death versus no sudden cardiac death, those who have had sudden cardiac death have had more PVCs than the ones that haven’t. It indicates some risk.

“We think that there is some susceptibility, maybe genetic or in phenotype,” he added. “So, we’re trying not only to understand the weakening of the heart, but also mechanistically what PVCs have to do with the risk for arrhythmias and sudden death. Obviously, it gets very complicated when you go into a cellular level, and that’s why you need collaboration at a lot of different levels.”

A place for research

Under the direction of Ellenbogen, Pauley Heart Center has gained international recognition in the management of heart disease related to harmful heart rhythms. At Pauley’s electrophysiology clinic, patients with arrhythmias, including PVCs, are evaluated and treated by one of the most highly respected cardiac electrophysiology teams in the country. The team’s experience and expertise place the clinic among the top referral centers for evaluation and treatment of complex arrhythmias.

Huizar, with his unique expertise and interest, has helped make Pauley one of the select centers in the U.S. for PVCs research.

Pauley cardiologists are also leaders in research and part of an active cardiovascular disease research program that furthers knowledge of heart disease, its treatments and its cures. Huizar, with his unique expertise and interest, has helped make Pauley one of the select centers in the U.S. for PVCs research.

“Dr. Huizar is an important member of our cardiac electrophysiology team and an important contributing member to Pauley Heart Center,” Ellenbogen said. “He is focused, thoughtful, creative and persistent. That is what it takes to be successful at research and innovation. Equally important, he is surrounded by a team of collaborators that all work together.” Collaborators like cardiac electrophysiologists Tan and Kaszala, frequent co-investigators who add another layer of research to the knowledge and understanding of PVCs through their own work on the subject.

“VCU really nurtures people that want to do research. They support you here,” Huizar said. He cites colleagues Ellenbogen, Hundley, Dr. Clive Baumgarten and the late Dr. Mark Wood as mentors. “One of the reasons I’m at VCU is for research. I knew that there was no better place for me. There’s never a ‘no’ for an answer.”

Saying yes to research opens the door for bench-to-bedside innovations that benefit patients.

“We’re about the discovery of new ways to reduce heart disease,” Hundley reminded. “Dr. Huizar is researching a frequently encountered problem of palpitations, which his research shows reduce heart performance. Solving this will improve our patients’ well-being.”


A New Chapter Begins

Learn how cardiovascular care is evolving at Pauley with a new director and mission.

Our world-class team takes your heart health personally.

Building on our history of innovation in patient care, scientific discovery, diversity and collaboration, we improve cardiovascular care for all, while continuously training the next generation of doctors.   

These words articulate a new mission, recently unveiled by Pauley. “The new mission reflects the changing terrain of cardiovascular care,” said Director Dr. Greg Hundley.

This changing terrain takes many forms. For instance, while Pauley was once limited to downtown, its reach now extends to communities such as South Hill, Colonial Heights and Williamsburg through outreach clinics and hospitals.

“The expansion of our footprint is critical to bringing Pauley’s exceptional cardiovascular care to all who need it in our state,” said Hundley.

The mission also speaks to the terrains of patient care, scientific discovery and training the next generation of doctors—and the direction Pauley must turn to continue its long history of innovation in these areas.

“In recent years, there has been enormous growth within cardiovascular medicine and cardiovascular surgery,” he said. “At the same time, exciting opportunities have arisen through new partnerships with partners in Oncology, Pharmacy, Pharmacology and Physiology, Behavioral Science, Kinesiology and Exercise, Biomedical Engineering, Population Health and issues related to societal demographics.”

To encompass both the growth within the traditional fields and expand beyond, he said, the heart center needed to come together to develop a new mission to carry it forward for the next 20 years.

“Collaboration will be one of the keys to attaining our mission, and it’s already taking place every day at Pauley,” he said.

It’s 7:30 a.m., and physiologist Dr. Justin Canada is overseeing an innovative MRI procedure in the Cardiovascular Imaging Suite in the North Hospital. The room is full of monitors, which Canada and the other members of his team continually check. One screen shows the black and white image of a patient’s beating heart.

“Please breathe in, breathe out. Now, hold your breath.”

On the other side of a glass wall from them, the patient, lying inside an open-sided magnetic resonance imaging (MRI), follows the directions. There’s a long beeep as her chest scan begins. She is the first patient in this pilot study. During the scan, she pedals a supine exercise bike attached to her table. The harder she pedals, the more her heart rate and VO2 levels—the volume of oxygen that her body uses for metabolic work—spike up.

This is a new diagnostic tool. VCU Medical Center is one of only a handful of centers in the world where this is possible: real-time MRI imaging during an exercise stress test.

“The expansion of our footprint is critical to bringing Pauley’s exceptional cardiovascular care to all who need it in our state,” said Hundley.

“It’s very exciting—I’m stoked,” said Canada, principal investigator for the study.

He is measuring the cardiorespiratory fitness of cancer patients who are undergoing evaluation for bone marrow transplantations, then comparing the results to that of age- and gender-matched healthy individuals, like this morning’s patient. Through the study, he hopes to establish a protocol for determining the specific causes of exercise intolerance in those with cancer, which may have future applications in the assessment of cardiotoxicity in cancer survivors.

“Cancer-related fatigue is the most predominant quality-of-life disabling symptom of the cancer patient,” he said. “With this technique, we’ll be able to look at how much a person’s exercise capacity is related to the heart’s capacity to pump blood and/or the muscles’ ability to extract oxygen. The advantage is, this can be done noninvasively, without the need for measures such as cardiac catheterization or exposure to radiation.”

Co-Investigator Dr. Jennifer Jordan, a biomedical engineer who directs the lab, watches the screens to see if any adjustments are needed for the scans. She’s there to determine “the best way to acquire those images and optimize the protocol—both to get good, crisp pictures and also to reduce patient burden,” she said. “We don’t want someone in the scanner exercising for 60 minutes when we can get them in and out in 15 minutes.”

MRI sessions can involve a series of 1,000 photographs that in many facilities can take 45 minutes to an hour to complete. Pauley’s Siemens Magnetom Vida 3T MRI system can complete similar sessions in 15 minutes. In addition to speed, the system offers extraordinary resolution.

Jordan took part in a similar study at another facility, where the team had to move patients back and forth between a treadmill and a scanner. “Each time, there was a 20-second delay. During that time, the heart rate was already starting to recover. But with the scanner we have here, and the supine bike, Dr. Canada is going to be able to answer that question of: What does that peak heart function really look like?”

The mission control atmosphere in the room, and the makeup of the medical team, also reflects a new approach to cardiology.

“We’ve got an engineer, a cardiologist, an exercise physiologist and an MRI technician. This is a team from across multiple disciplines, across both VCU campuses,” said Hundley, who is observing the study. “We are assembling to address our challenges. And that’s needed because the disease processes that we are managing today are complicated.”

In the clinical setting, multidisciplinary teams are playing a key role in tackling tough situations. For instance, Pauley’s Coronary Intensive Care Unit (CICU) is taking part in a joint program with the Obstetrics and Labor and Delivery Departments that involves early identification of high-risk maternity patients with cardiovascular disease. Patients with existing cardiovascular conditions are especially vulnerable during pregnancy, which can place a significant burden on the heart.

“By the third trimester, you can increase your cardiac output almost 50% during pregnancy and your blood volume expands 30-40% higher than normal. That increase in fluid can also put stress on the heart,” said Jennifer Powers, one of the CICU nursing leaders of the Complex Maternal Cardiac Care Group along with Kerry Patterson and Charlotte Roberts.

The pilot program started five years ago and focused on maternity patients who have advanced heart failure, coronary heart disease with prior heart attacks and congenital heart disease—all of which have been on the uptick in recent years in this population. One troubling condition is hypertrophic cardiomyopathy, which causes an abnormal thickening of the heart muscle that can affect the heart’s ability to pump blood and can cause life-threatening arrhythmias.

The goal is to identify the patients who might qualify for the program early in the process, so that they don’t arrive in the emergency room and CICU unexpectedly as they have in the past, said Powers. “We have a team that meets monthly and reviews the list of high-risk patients. We talk about what their risks are, what their anticipated needs are for labor, delivery and postpartum.”

Depending upon the needs, the team might include representatives from the CICU, Obstetrics (including a specialized pharmacist), Labor & Delivery, Cardiology, Advanced Heart Failure, Electrophysiology, Cardiac Anesthesia and Cardiac Surgery departments. “Everyone knows about the patient before they arrive. The patients are also seeing our cardiologists along with their regular OB visits,” Powers said.

“Collaboration will be one of the keys to attaining our mission, and it’s already taking place every day at Pauley,” he said.

The team creates a plan for each patient that is placed in their file, said Patterson. “We talk about special needs during their stay, maybe certain lines, medicines, or devices they will need—such as an intra-aortic balloon pump, pulmonary artery catheter or a Vigileo monitor.” She added, “Myopathies affect the muscle, which makes it weak. Some patients require LifeVest, an external defibrillator, that they wear during and after their pregnancy.” The patients check into the CICU the night before their scheduled C-section or induction and undergo any necessary testing or precautions.

Patterson recalls one patient in the high-risk program with a cardiomyopathy, who was also on a CPAP for 18 hours a day, who was at risk of having an emergency early delivery. She was admitted to the CICU very early in her pregnancy for a short stay to help optimize her situation. The team worked closely with the patient to prepare her for what to expect and sent her home with a LifeVest.

The high-risk patient was able to carry to full term and delivered a healthy baby. “She did fine and was discharged four days later,” recalled Powers with a smile. “She’s much more educated…and is engaged in follow-up care with specialists in Advanced Heart Failure.”

Multidisciplinary care is a key part of Hundley’s vision. Named Pauley’s first director in 2018, Hundley is a renowned leader in the field of cardiac MRI as Principal/Co-Investigator and Imaging Core Lab Director with a lifetime achievement of significant contributions on NIH-sponsored multicenter trials such as the WFSM Claude D. Pepper Older Americans Independence Center, Multi-Ethnic Study of Atherosclerosis (MESA), Preventing Anthracycline Cardiovascular Toxicity with Statins (PREVENT) and Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT) to assess meaningful cardiovascular preventative, diagnostic and therapeutic end points in multiethnic, cardio-oncology and geriatric populations. His multidisciplinary approach and research expertise make him especially qualified to lead Pauley into its next chapter.

Since his appointment, he has led the first-ever research conference between the MCV and Monroe Park campuses. New faculty include those dually appointed between Pauley and other departments. In addition to taking part in research, they move between the two campuses, teaching a new generation of cardiac care providers.

Some of the dual appointees are Drs. Canada and Jordan, along with biomedical engineer Dr. John Wilson, whose research focuses on the biomechanics of aortic aneurysms and cancer-related cardiovascular toxicity; behavior and health policy scientist Dr. Alex Lucas, whose focus includes exercise interventions for cancer patients and survivors; and Dr. Salvatore Carbone, a nutritionist whose studies include an exploration of the effects of a Mediterranean-style diet on patients with obesity and a specific form of heart failure, called heart failure preserved ejection fraction (HFpEF).

Multidisciplinary teams, such as the cardiac sarcoidosis team that includes Jordan as well as Dr. Jordana Kron, Dr. Greg Hundley and Dr. Antonio Abbate, are zeroing in on important treatments for rare conditions (read online: Dr. Jordana Kron is searching for answers to a mystery disease).

Another team, Dr. Antonio Abbate and his colleague from Pharmacy, Dr. Benjamin Van Tassell, have worked together for 10 years developing and exploring the anti-inflammatory drug anakinra, an Interleukin-1 (IL-1) blocker, to treat heart failure. They began with preclinical studies, then small clinical trials. Their work has come to fruition: They are now busy enrolling patients in REDHART2, a phase II clinical trial to test anakinra on 102 patients, funded with a $2.7 million grant from the National Heart, Lung, and Blood Institute.

Both teams received their first funding in the form of pilot studies funded by Pauley donors, said Hundley. Donors also made the new Cardiovascular Imaging Lab and Hundley’s recruitment possible with $9 million in gifts.

“Our philanthropic supporters are providing the seed funding for innovative research, recruitment and improved facilities. They are helping us achieve our mission to be a premier site for the delivery of cardiovascular care, encompassing excellence in clinical care, education and research,” said Hundley.

Building on the new advances in technology in recent years, multidisciplinary teams that bring together people of different backgrounds and talents are helping to define Pauley’s newest chapter and fulfill its mission.

“I think Pauley will be a beacon to others for how to deliver cardiovascular care in the future.”

Above: Dr. Richard Lower (left) and Dr. Richard Cleveland, with its predecessor: the Pemco Heart Pump. Right: Dr. Daniel Tang; Ali Panahi, computer sciences graduate student; and Dayanjan “Shanaka” Wijesinghe, Ph.D., have worked together to develop AR technology for medical use.


Clinical Trials Provide Hope to Patients

A high school student collapses after football practice and dies. A co-worker who has always been the picture of health goes into sudden cardiac arrest.

These kinds of stories are shocking and, fortunately, uncommon, but they are well-known to cardiologists who treat patients with cardiomyopathies. Cardiomyopathy is a form of heart failure caused by the unusual thickening of the muscles lining the walls of the heart. The rare disease can cause life-threatening arrhythmias and often shows up without any warning. Cardiomyopathies are one of many challenging diseases currently being tackled through Pauley’s specialty clinics and trials. 

“Did you ever have any heart issues growing up? Did any of your siblings ever pass out in basketball practice or anything like that? Are your parents both still living?”

These are some of the questions that cardiologist Dr. Krishnasree Rao and genetic counselor Allison Goodwin ask a patient who is attending a once a month genetic testing clinic for cardiomyopathies. While most heart failure patients are elderly, hereditary cardiomyopathies–especially hypertrophic and arrhythmogenic right ventricular cardiomyopathies—tend to present in young people. A parent with a mutated gene causing the condition “has a 50/50 chance of passing it on,” said Rao. 

Rao reviews the patient’s cardiac history and explains that he has hypertrophic cardiomyopathy and should consider testing to see if there is a genetic link. For the younger patients who may not yet have symptoms, “we’re trying to pre-emptively catch the disease,” said Rao. “We’re working to prevent sudden cardiac death in all these young people.”

Goodwin does a little background digging with the patient, asking him questions about his family’s medical history going back three or four generations. “We pay careful attention to anyone with heart disease, sudden death or heart attacks, and the ages and circumstances of these events,” she said.

While these therapies do not treat the underlying disease, a new drug, Mavacamten, may prove to be “one of the first medications to modify the disease,” said Dr. Keyur Shah.

Goodwin discusses the importance of genetic testing. If testing positively identifies a gene mutation, then everyone in the family can be tested for that specific gene mutation—a process known as “cascade screening.” Echocardiograms and electrocardiograms can help confirm the extent of thickening in the walls of the heart. For those in who the disease has not presented, appropriate surveillance and management protocols will follow. Patients who have developed the disease can receive pacemakers and ablations to prevent arrhythmias. For some, a surgery known as a septal myectomy, which involves excising some of the thick tissue, is appropriate.

While these therapies do not treat the underlying disease, a new drug, Mavacamten, may prove to be “one of the first medications to modify the disease,” said Dr. Keyur Shah, section chief of heart failure.  

Shah and Rao are primary investigators for Explorer and Maverick, two large, multicenter trials involving Mavacamten. Both are open to patients with hypertrophic cardiomyopathy with or without obstructions to blood flow. 

Shah explained how the drug works: “Sometimes with hypertrophic cardiomyopathy, the cells are vigorously contracting and they stay hypercontracted—which is the driver for the thickening. What this drug does is help those muscle cells relax,” he said.

He’s seen momentum for the treatment of heart failure in general. “In the last four to five years, there has been a slew of new therapies introduced that are improving survival and symptoms and delaying advanced treatments,” he said. 

In the cardiac catheterization lab at VCU Medical Center, Dr. Zachary Gertz, director of structural heart disease, is a primary investigator for the CardiAmp clinical trial that involves stem cell injection via catheter to repair heart failure.  

“The therapy involves recovering your heart with your own heart cells, your own tissue,” he said. The exploration is considered a pivotal trial—what used to be known as phase III. “If this works, it could be the first trial that gets the stem cell therapy approved for treatment.”

Gertz was also involved in the COAPT trial, a transaortic valve replacement trial widely reported in The New York Times and other publications. The trial involved using a MitraClip, a small device that is inserted via catheter and clipped to a patient’s mitral valve leaflets to bring them closer together and reduce mitral regurgitation (MR)—the leaking of blood back into the chambers of the heart.

“Your mitral valve is like two sailboat sails,” he said, holding his hands in front of him, fingertips touching. He mimics the motion of a gate opening and closing. “When your heart squeezes, they don’t let the blood go backwards. If one of the sails breaks, you’ll have a tunnel leak. That’s called degenerative—the valve itself is diseased. Now, if you have heart failure, your valve might get stretched. It’s so pulled apart that there’s a leak. That’s called functional.”

Patients with degenerative MR at low to moderate risk of surgical complications or death can undergo surgery, while those at high risk are also eligible for MitraClips; however, there are currently no options for those with functional MR. “The COAPT trial was for people with functional mitral regurgitation, and it showed a 40 percent functional improvement,” said Gertz. “It was also the first treatment that’s ever been shown to improve mortality in patients with functional mitral regurgitation. In our world, that’s a big deal.”

For more than 10 years, Dr. Antonio Abbate, vice chair of the Division of Cardiology, and Dr. Benjamin Van Tassell, vice chair for clinical research in VCU School of Pharmacy’s Department of Pharmacotherapy and Outcomes Science, have together studied anakinra, a drug that blocks a specific mediator of inflammation, Interleukin-1 (IL-1)—“a small protein in the blood that promotes heart failure following a heart attack,” said Abbate.

In June, the pair received a $2.7 million National Heart, Lung, and Blood Institute grant to continue their research through a phase II clinical trial, known as REDHART2, with patient enrollment to initiate by early 2019. 

While the team is not yet screening for REDHART2, a white board on Abbate’s wall lists the names of patients that his team is seeing today for other studies. His patients include those taking new drug therapies for the treatment of pericarditis. This condition involves the inflammation of the pericardium—the sac around the heart. 

“There are some cases that are very difficult to treat that are called recurrent pericarditis. There’s really no treatment right now,” said Abbate. “We are running two studies. One is a multicenter study led by the Cleveland Clinic, and the other is our own study with new drugs that are IL-1 blockers. They’re similar to the drugs that we use for heart failure but in a different population.”

Van Tassell is excited about the studies. “We’ve only had a handful of patients in them, but the benefits have been dramatic so far. Pericarditis is typically defined by pain. It’s very uncomfortable; you have chest pain that can feel every bit as intense as a heart attack. But it doesn’t have the same triggers as the heart attack; it’s the inflammation that’s causing the pain.” With the patients treated with the anakinra, “we’ve seen impressive reductions in pain—which is great.”

Dr. Greg Hundley has received more than $24 million in National Institutes of Health funding over the years for his clinical explorations in cardiovascular imaging. As Pauley’s top administrator, he hopes to increase the amount of research and clinical trials taking place.

Pauley’s new director comes from a strong research-focused background. Dr. Greg Hundley has received more than $24 million in National Institutes of Health funding over the years for his clinical explorations in cardiovascular imaging. As Pauley’s top administrator, he hopes to increase the amount of research and clinical trials taking place.

“We’re looking to grow and expand that. That’s a major focus: how to streamline our processes to enhance entry into trials, facilitate the enrollment of patients and work on the regulatory aspects,” he said. “We’re working to improve efficiency and effectiveness in that area.”

Additionally, “we’ve hired a bunch of people to develop more human subjects research, we’re making a big push into that area. We’re working to develop the infrastructure to be competitive for funding.”

Dr. Vigneshwar Kasirajan, chair of the Department of Surgery, sees research and clinical trials directly related to patient care. “I think the ability to provide excellent care comes from innovation and research to constantly improve what we do and that is the strength of Pauley,” he said. “Then, using that knowledge, we also train another generation of physicians and health care providers. It’s a three-legged mission: good clinical care, supplemented by innovation and research, and training are what make us unique in the region.” 

To see a listing of current clinical trials, please visit studyfinder.cctr.vcu.edu

Above: MARTIN J. MANGINO, PH.D., ASSOCIATE CHAIR FOR BASIC RESEARCH, IN THE LAB THAT DR. RICHARD LOWER USED TO PRACTICE IN.

 


Coming Home

Pauley Welcomes Dr. Greg Hundley as First Director

It’s April, and Dr. Greg Hundley, VCU Health Pauley Heart Center’s first-ever director, has started to move into his new office in West Hospital. Around the room are stacks of boxes filled with books. A dry-erase board, not yet hung, leans against a wall.

He wears a dark suit and a stylish tie. He is 56 years old but looks years younger. 

His glasses give him the appearance of a scholar—which, indeed, he is. Among his achievements, he has more than 200 peer-reviewed articles and $24 million in NIH grants, and 19 years of continuous NIH funding to his name. Despite this, Hundley is approachable. Sitting across from a visitor at a round table near his desk, he is friendly and eager to talk about his new role with Pauley.

“There’s an enormous opportunity here with the talent at VCU Health. We have expertise in heart failure, cancer treatment, electrophysiology, image acquisition and analysis, bioinformatics, biomedical engineering and coronary heart disease,” he said. “We have renowned physicians like Dr. Kenneth Ellenbogen; a phenomenal CEO of the hospital, Deborah Davis; and an exciting new dean with a great vision, Dr. Peter Buckley.”

“I was very impressed with Dr. Hundley when I first met with him due to several factors, among which are his very humble and pleasant personality, his excellent reputation as a physician-scientist, as well as his vision for the heart center,” said Dr. Fadi Salloum.

While winding down his practice at Wake Forest Baptist Medical Center, where he served as program director for the cardiovascular imaging program, he helped the MCV Foundation secure funds to build a new $4 million Cardiovascular Imaging Suite at VCU Medical Center with the magnetic resonance imaging (MRI) technology necessary to do his high-caliber work. The foundation raised an additional $5 million for Hundley’s recruitment and research.

“It was an amazingly generous gift of Stan and Dorothy Pauley and their family, in their tradition of commitment to excellence in health care delivery, that made this all possible,” said Hundley.

The Pauleys’ gift enabled the foundation to receive an additional $5 million in matching funds from the Glasgow Endowment.

The suite will support his groundbreaking work in preventing and treating heart failure in cancer patients and mark a new era of collaboration between Pauley and VCU’s Massey Cancer Center.

“Massey has been one of the research sites with which we have collaborated in the past for my trials,” he said. “Now, with the new lab, I’m going to work side by side with these same physicians as well as VCU engineering and VCU Health exercise physiologists, behavioral scientists and cardiovascular medicine specialists.  We are going to be using the very latest MRI and cardiopulmonary exercise test technologies, which are going to open up all kinds of possibilities. I’m looking forward to seeing what these collaborations will bring.”

“We are all very excited to have him join and lead Pauley,” said Dr. Antonio Abbate, associate chair of research. “Hundley is an internationally renowned expert in cardiac imaging. He is not only a skilled clinician but also a talented researcher. He also brings an extensive experience in mentoring trainees and junior faculty.”

Dr. Greg Hundley running by the river.“I was very impressed with Dr. Hundley when I first met with him due to several factors, among which are his very humble and pleasant personality, his excellent reputation as a physician-scientist, as well as his vision for the heart center,” said Dr. Fadi Salloum, Natalie N. and John R. Congdon Sr. Endowed Chair.

When asked about the impact of hiring Pauley’s first director, Ellenbogen said, “It is highly significant and very exciting. It will be like taking us from the major leagues to the World Series.” He added, “Dr. Hundley is going to provide us with the depth in research and cutting-edge clinical research that will attract physicians from all over the world to study, train and do research with us.”

Hundley grew up in Richmond, then attended the College of William and Mary, where he met his wife, Kim, a native of Ashland. After graduating in 1984, he attended medical school at VCU School of Medicine.

“I was here when the transition occurred to move the main clinical operation from West Hospital to Main Hospital,” he said. During his long hours as a medical student, he remembers taking a tunnel to the capitol to eat at Chicken’s. Skull and Bones was another favorite.

“My class was large, with a lot of diversity and talent and phenomenal clinical and my desired research training,” he said. “Research-wise, I had the distinct opportunity to work with Dr. Hermes Kontos as well as Drs. Joseph Levasseur, Enoch Wei and Joe Patterson.”

Hundley felt drawn to cardiovascular medicine after working in the cardiovascular ICU. “The patients were relatively sick, and there was a lot of satisfaction in the care that could be delivered in that environment to make them well.”

From 1988 to 1996, he completed his internship and residency in internal medicine, as well as his fellowship in cardiovascular disease at Parkland Memorial Hospital and the University of Texas Southwestern (UTSW) Medical Center in Dallas. There, while originally training to be an interventional cardiologist, he grew fascinated by cardiac imaging.

His world changed the first time he saw an MRI. Parkland Hospital was one of few facilities in the country to own the advanced imaging system in 1993. “One morning I went over to pick up a patient from the magnetic resonance imaging scanners who was scheduled to undergo a heart catheterization. On the screen of the MRI scanning console was an image of a beating heart as if it was being displayed on a high-definition TV,” he said. “Thirty years ago, that was an amazing accomplishment.”

Today, as during the 1990s, the cardiac catheterization lab used invasive procedures incorporating angiograms—x-ray photos obtained by using contrast dye injected through catheters placed in the arteries of one’s arms or legs—to detect blockages in the coronary arteries. At Parkland and UTSW, investigators were working on noninvasive MRI methods that did not require an interventional heart catheterization procedure to visualize and measure blood flow in these same coronary arteries. However, the process of viewing the heart and these arteries took a long time.  “It took probably an hour and a half to take 10 pictures of the heart, and then you stayed up all night typing binary commands so you could see them the next day,” he recalled. “Literally all night, until 4 to 6 a.m.”

Today, instead of all-night sessions, “with MRI you can acquire and visualize a complete 3D image data set of the whole heart in 15 seconds,” he said with a laugh, still amazed.

His world changed the first time he saw an MRI. Parkland Hospital was one of few facilities in the country to own the advanced imaging system in 1993.

Inspired, he became involved in research with mentors Drs. David Hillis, Richard Lange, Geoff Clarke and Ron Peshock to corroborate MRI findings by comparing them to coronary angiograms. The research, published by the American Heart Association, gained significant international attention. He also devised protocols for the use of MRIs in creating images of coronary arteries that supplied the heart muscle.

During this time, his innovative work caught the attention of Dr. George Vetrovec, the former chair of cardiology who retired in 2015. “We sat next to each other at a dinner of the Society for Cardiac Angiography and Intervention. He had just won a prize from the organization for imaging studies,” recalled Vetrovec, who later tried to recruit Hundley—twice—but the timing wasn’t right.

Vetrovec recalled his first impressions. “I thought he was very, very intelligent and well-spoken and thoughtful. He had this innovative new technology and was at the forefront of its development.”

While Hundley liked Dallas, he and his wife longed to get back to the East Coast, closer to family. When Dr. William Little at Wake Forest Baptist Medical Center offered him a place on the faculty in 1996, he accepted.

“They recruited me there because they had a lot of patients experiencing heart attacks and they wanted to use this new MRI technology clinically,” he said.

Hundley and Little further developed clinical MRI protocols to image coronary arteries and measure blood flow within them in patients presenting with chest pain suspected of experiencing a heart attack. At the time, patients with blocked arteries were treated with intravenous thrombolytic therapy, which involved using clot-busting drugs. With this therapy, “we could never tell whether the infarct artery was open or closed, and this MRI technique could do this.” 

Dr. Greg Hundley resting after runAfter he’d been there less than three months, a superior new technology emerged that replaced thrombolytic therapy: balloon angioplasty. This meant MRI was not needed to view the coronary arteries because patients went straight to the heart catheterization lab to not only view the arteries but directly open them. 

“So, I was stuck. Because I’d moved there to introduce this new technique, and Little came in said, `Well, we’re not going to do that anymore.’ I said, `What am I going to do?’ And he said, `Well, you’ll think of something.’”

He soon discovered that being a physician deep in the heart of tobacco and barbecue country presented special challenges. “A lot of people had coronary artery disease, but they were not very good candidates, because of their smoking and obesity, to have pictures made of their heart noninvasively to determine if they needed a heart catheterization.” Noninvasive echocardiography and radioisotope techniques were often inadequate in these patients.

Hundley, along with Drs. Craig Hamilton and Kerry Link, began using an MRI to image their hearts, “and that really took off, because it provided an answer for a population that didn’t have one.” A story about their noninvasive MRI ran on NBC Nightly News.

Next, he began to grow interested in heart failure while doing stress tests. While these tests are usually done on just the heart, he and Little began testing all the blood vessels in the body. “Heart failure is a complex disease where not just the heart has problems contracting or relaxing, but also the blood vessels that carry the blood have problems,” he said. “With MRI, one could image the heart, blood vessels, kidneys and other structures simultaneously. In so doing, one could determine why tissues weren’t receiving the blood supply they needed.”

Hundley, in collaboration with Drs. David Herrington and Dalane Kitzman at Wake Forest, studied the etiologies of heart failure when the heart ejection fraction is preserved, or shows up as normal, on echocardiograms.  This latter syndrome, common in older individuals, often causes heart failure to go unidentified until it is significantly progressed.

His interests took a turn one day, while working with program manager Kim Lane and acquiring a MRI of a patient who’d had heart failure after being treated for cancer. “The type of imaging we were doing always produced a picture that was black or white,” he said. “But this time we got gray.”

The physicians first blamed it on a glitch in the new software program. However, they later realized that the gray areas indicated early heart damage from the cancer treatments. Often this damage could be detected before permanent injury occurred.

“The chemotherapies and the radiation therapies were actually damaging the heart and blood vessels in addition to treating the cancer,” he said. “The heart has a high metabolism, so it makes sense that it would be susceptible.”

Working with his associates, Hundley received more than $20 million in NIH funding for a research trial to use MRIs to identify patients who were developing heart injury from their cancer treatment. Additionally, he has had the opportunity to work with a number of emerging younger clinicians and scientists in studying mechanisms and methods to prevent heart attacks, strokes, heart failure and exercise intolerance in those treated for cancer—later putting them into clinical practice.

“Oncologists are so effective in treating cancer that now, for many cancers, heart problems are the primary cause of the death for these patients,” he said.

With all these discoveries, Hundley was highly recruited by other facilities. The opportunity to work at his alma mater as the first-ever director, with a state-of-the-art imaging suite, proved irresistible.

Hundley will be able to continue and expand his work in the new Cardiovascular Imaging Suite. The new 7,200-square-foot imaging suite includes capabilities to assess tissue anatomy, perfusion, function and metabolism with high temporal resolution at rest and during exercise. VCU Medical Center will be one of the few sites in the world capable of these tests.

Although his work focuses on cancer patients, “the techniques are applicable for all patients with cardiovascular disease,” he said. Because of cancer’s rapid metabolism rate, the disease provides a special window to understanding heart disease.

“High blood pressure causes heart or vessel damage, but it takes 60 years for you to see that, so that’s not great for conducting a study. But in a cancer patient, because of how quickly the disease metabolizes, that 60 years is shrunk into weeks,” he said.

“The developments we’re finding in the cancer patient population will help us better understand heart and vascular disease and high blood pressure, diabetes, patients with high cholesterol and all the other causes of heart failure,” he said.

“It’s enormously exciting for us to be able to do this in central Virginia.”

To get a preview of the new Cardiovascular Imaging Suite, please see “New Cardiovascular Imaging Suite Debuts” on page 14.

 

About Dr. Hundley

“Dr. Hundley is a nationally and internationally recognized leader in his area of research on the cardiac complications of cancer therapy. His ability to collaborate with faculty at VCU Massey Cancer Center is already demonstrated through our participation in his cardiac toxicity prevention trials, which bodes well for productive future collaborations between our two centers. We are excited about him joining us at VCU Health.”
— Dr. Gordon Ginder
Director, VCU Massey Cancer Center

“Dr. Hundley is a proud alumnus of VCU School of Medicine, and we are equally proud of him. With his outstanding reputation as a physician-scientist and mentor, Hundley is a perfect fit as medical director. His research in the exciting program of cardio-oncology will build on our strengths. This is central to our strategy to attain comprehensive cancer center designation for Massey. Additionally, Dr. Hundley will elevate Pauley’s national prominence and federal research portfolio.” — Dr. Peter Buckley
Dean, VCU School of Medicine

Did you know…

• Since 1999, Dr. Hundley has been involved with more than $71 million in awarded research funded grants.

• He currently serves as associate editor for Circulation and Cardiology Today and serves on the editorial board of five other peer-reviewed journals.

• He is married to his loving wife of 30 years, Kim Hundley, a speech pathologist, “who has encouraged and tirelessly supported my career,” he said. The Hundleys have three children: Anna, 22; Jennifer, 18; and Will, 17.

From top to bottom: Dr. Greg Hundley points out the superior imaging of the Siemens Magnetom Vida 3T MRI system. Dr. Greg Hundley runs along the James River. He is a longtime advocate for the importance of adopting a healthy lifestyle.

 


Celebrating 50 Years of Heart Transplantation

On the afternoon of May 25, 1968, something mysterious was taking place on the 11th floor of MCV’s West Hospital.

An elevator operator was prohibited from taking visitors to the floor, which was secured by guards. From a landing on the stairwell outside the 11th floor, reporters caught glimpses of doctors and nurses in blue surgical scrubs moving rapidly down the corridors when the guards would briefly open the stairwell doors to let in interns and other hospital personnel. Later, they would learn that pioneering surgeon Dr. Richard Lower, had performed the first cardiac transplant in Virginia—just the 16th in the world.

Fifty years later, Lower’s legacy continues in the innovative work at Pauley, where 581 cardiac transplants have since taken place. While today the procedure is more commonplace—no reporters hunkering down in the stairwells—the event of human cardiac transplantation remains no less extraordinary.

Dr. Richard Lower and Dr. Richard ClevelandDr. Vigneshwar Kasirajan, chair of the Department of Surgery, maintains his office on the 16th floor of the storied West Hospital. A cardiothoracic surgeon, he holds great respect for the physicians who developed MCV into one of the first and foremost centers for organ transplantation—Lower, as well as Drs. David Hume, H.M. Lee, and others.

“They were giants in the field,” he said, sitting at a conference table in an alcove off his office. At the same time, he is excited about recent developments. “I want to talk about what’s been going on at VCU Health over the past few years and what’s ahead in the future for heart transplantation.”

We are experiencing a time of significant growth. In 2016, the hospital’s surgical teams performed 30 heart transplants and were anticipated to complete between 25 and 30 of the operations in 2017. The numbers include heart-kidney and heart-liver transplants.

“If you look at the trajectory, transplants are up
50% in just three to four years. Threefold from eight years ago. It’s a growing program with excellent outcomes.” — Dr. Keyur Shah

According to Kasirajan, “about 60-70% of our patients are still alive and fully functional after 10 years.”

At the same time, the transplant program is limited in its growth by the inadequate supply of donor hearts. On any given day, about 4,000 people in the U.S. are on the wait list for a human heart, but only 2,300 donor hearts are available each year. The wait time can range from six months to one year. Despite the greater public awareness of the need for organ donors, the shortage has remained constant for some time. But Kasirajan, Shah and others are not satisfied with the status quo—instead they keep pushing for new solutions to improve and extend the lives of patients in need of cardiac transplantation.

……….

“The biggest thing that has happened with transplantation at Pauley over the last few years is the development of a comprehensive advanced heart failure and mechanical assist device program under the leadership of Drs. Keyur Shah, Richard Cooke and Daniel Tang.” — Dr. Vigneshwar Kasirajan.

Mechanical assist devices such as heart pumps and total artificial hearts are “bridge-to-transplants” that can buy time for patients with advanced heart failure until a donor heart becomes available.

The 1990s saw the boom of the left ventricular assist device. In 1994, Heart Mate I became the first such device approved by the FDA; VCU Medical Center implanted one that same year.

“Older LVADs were large, noisy and were only available to larger-sized people with large thoracic cavities,” said Shah. Today, LVADs can fit in the palm of the hand and can be implanted in those of a slighter stature. “They’re smaller, quieter and they’ve become more durable and longer lasting.”

Another game changer was the total artificial heart. In 2006, a surgical team led by Kasirajan implanted the first total artificial heart on the East Coast at VCU Medical Center. Today, the program is the third largest in the country.

About 50 LVADs and total artificial hearts are implanted in patients at VCU Medical Center each year. “The introduction of contemporary LVADs and the total artificial heart has been nothing short of revolutionary,” said Shah. “Prior to their development, patients would often die while waiting for the heart transplant list. Now, these patients who are critically ill can live for a long period of time, with a good quality of life, on these mechanical devices.”

Six clinical researchers take part in the busy heart failure program that prides itself on remaining at the cutting edge of device and pharmaceutical research.

“We have participated in clinical trials to implant devices through smaller incisions and are looking forward to participating in a study, hopefully this year, that will evaluate the smallest LVAD we’ve ever implanted in a person,” said Shah. “It’s been studied in Europe, but this would be the first U.S. trial.”

Another study soon to come is that of the Carmat heart, which was designed by noted French cardiologist and valve designer Dr. Alain Carpentier, in conjunction with EADS, the company behind aerospace leader Aerobus. Dubbed the world’s first self-regulating total artificial heart, the device uses embedded sensors and microprocessors to attune the rate of blood flow to patient needs—beating faster during exercise, for instance. It’s also designed to be more biocompatible, with bovine pericardium tissue on all surface areas that contact blood. This pump is electrically powered and has a quiet operation.

According to cardiothoracic surgeon Dr. Daniel Tang, “this would be the first U.S. trial for the device. They’ve done seven patients so far but none in the U.S. Our successful trials with SynCardia [another TAH manufacturer] is why Carmat reached out to us.”

……….

Is it possible to stop or even reverse heart failure before it progresses? That’s a question that will be explored via a new trial that will soon begin in the cardiac catheterization lab. Dr. Zachary Gertz, director of the structural heart disease program, is investigating a therapy that may repair tissue damaged by heart attacks.

“We are about to be involved in the first real pivotal trial of interventional stem cell therapy,” said Gertz. Now in its third phase, the trial involves the injection of stem cells, a class of undifferentiated cells that can morph into other cell types and renew indefinitely.

“When you have a heart attack, a piece of heart muscle dies and it scars. There’s also this rim around it called the peri-infarction zone, which is also not getting good blood supply or working that well,” he explained. “The idea is that by injecting stem cells directly into this peri-infarct area, you might encourage that heart muscle to work better and improve the patient’s outcomes.”

Known as CardiAmp Therapy, the process begins by taking bone marrow out of a patient’s hip and placing it in a spinning device called a centrifuge. “This will give us back just the best cells, the ones we want to use,” he said. Those healthy cells will be transported to the heart by way of a catheter placed in the upper thigh. “There’s a second catheter that screws into 10 spots in that region encircling the area where the heart attack occurred. You can then inject the cells into each of those spots.”

The trial covers some potentially groundbreaking territory. “We’re going to encourage the reinvigoration of nearly dead heart muscle. No one’s been able to ever really do that before,” he said. “If it works, it will be pretty amazing.”

……….

“Dr. Lower’s research and clinical efforts, before the first transplant, during the early days, and for decades afterward, shaped the field of heart transplantation. It affected things from surgical techniques to early immunosuppression, and he defined how to detect rejection and address complications after transplant. Dr. Szabolcs Szentpetery and he were involved in the first long-distance procurement of the heart—and the list goes on and on,” said Dr. Shah.

Sadly, since Lower’s time, little progress has been made in heart preservation, said Kasirajan. A heart can still only be stored for three to four hours. “There are 30 hearts that are discarded every year in Puerto Rico because they’re never used for transplantation. I can’t transfer a heart from Hawaii to the U.S., even if it’s the best match for a patient,” he said.

VCU Health’s new Christine B. and David E. Cottrell Surgical Innovation Laboratory will be created with the intent of not only improving heart preservation but also expanding the available donor pool. A $1 million donation by the Cottrells provided the lead gift as the Department of Surgery aspires to raise $4 million for the modernization and expansion of the ninth floor of Sanger Hall, to include sophisticated labs and operating rooms for training, as well as space ideal for testing and implementation of new devices developed by private industry. An additional $4 million is being raised for an endowment to fund such research in perpetuity.

“The Cottrells’ gift is allowing us to continue to develop our space as a center for excellence for innovation in surgery and help our physicians really bring from the research arena into the clinical practice exciting new innovations in preservation and heart transplantations,” said Kasirajan.

The new lab will support the work of researchers like cardiothoracic surgeon Dr. Mohammed Quader, who is focusing on Donation after Circulatory Death—or “DCD”—hearts. “These are the hearts donated by individuals whose life support has been withdrawn due to futile outcome; they sustain cardiac arrest during this process,” said Quader. Currently, these hearts are not used for transplantation, “other than in maybe two or three centers in the world, that too on a very small scale.”

Brain death donors, who are the current standard heart donors for transplantation, continue to have blood flow to the heart even after pronouncement of brain death. They are the current standard heart donors for transplantation. When blood flow ceases to the heart and cardiac arrest ensues, as it does in the DCD process, the heart sustains cellular damage.

Researchers at VCU Health hope to halt that process. Quader is the principal investigator of three different research grants and leading teams focused on mitigating the ill effects of DCD heart injury. In collaboration with Dr. Stephano Toldo, he has successfully developed an animal DCD heart model and gathered fundamental data to further the study of DCD outside of the body. Through a Pauley Pilot Grant, he is comparing three different preservation solutions to determine which one will best protect the DCD heart. Finally, with Dr. Edward Lesnefsky, he received a four-year Merit Review Grant through the Hunter Holmes McGuire Veteran Affairs Medical Center to study a drug that temporarily paralyzes the mitochondria of DCD cells in an animal model to prevent cellular damage.

His passion for finding alternative sources of heart donors is driven by the patients he sees every day, especially those who are awaiting donor hearts. “I take care of these patients. Not being able to use a DCD donor heart, which I feel has the potential to be used successfully, bothers me,” said Quader. “If I can make these hearts available for transplantation, the future will be better for our patients.”

Above: Dr. Daniel Tang (left) and Dr. Keyur Shah, with a modern heart-lung bypass machine; Above right: Dr. Richard Lower (left) and Dr. Richard Cleveland, with its predecessor: the Pemco Heart Pump.


Partners in Life

ARCTIC Medical Director Dr. Mary Ann Peberdy and her husband, Dr. Joseph Ornato, have created one of the world’s most renowned cardiac resuscitation programs.

The pair have been at the forefront of clinical care and research in cardiac arrest for decades.

With the recent arrival of the Weil Institute, VCU is poised to also become a basic and translational research powerhouse in this field.

“That day is a total blank in my memory. What I’ve been told is that I had been on an elliptical machine, and I left that and went to a stationary bicycle. At that point, I blacked out and fell off the bicycle,” recalled Bob Hershberger, 70, a U.S. Air Force veteran and retired executive vice-president of the Williamsburg Chamber and Tourism Alliance.

“The work Dr. Peberdy and Dr. Ornato did with the ARCTIC Program was pioneering. They did this at a time when no one was really thinking about cardiac arrest and post-sequalae to the brain. Much of the work was done quietly and without much fanfare. Now, this is the cutting edge of cardiovascular medicine.”
— Vigneshwar Kasirajan, M.D.

Hershberger has pieced together some of the details from April 7 when he suffered a cardiac arrest—an often-fatal condition when the heart suddenly stops beating effectively—while working out at a local health club. Attendants at the club rushed to his aid and called a rescue squad. Paramedics shocked his heart with a defibrillator and brought him to Sentara Williamsburg Regional Medical Center, where he was stabilized and then loaded onto a critical care helicopter for transport.

At VCU Medical Center, he was placed under the care of Mary Ann Peberdy, M.D., a cardiologist and the medical director of the Advanced Resuscitation, Cooling Therapeutics, and Intensive Care (ARCTIC) program for post- cardiac arrest care. Peberdy and her husband, Joseph Ornato, M.D., chairman of the VCU Emergency Department, began cooling of patients at VCU in 2004, shortly after “new data became available that demonstrated that if you lower the body temperature you can improve survival and neurological outcomes in patients that have had cardiac arrest,” 
said Peberdy.

Following successful heart resuscitation after cardiac arrest, the patient often remains in a coma from lack of blood flow to the brain during the cardiac arrest. The body undergoes a rapidly escalating inflammatory response that can further jeopardize survival and neurological outcomes. To prevent and reverse this damage, ARCTIC patients like Hershberger undergo therapeutic temperature management with an intravascular cooling device, which chills their body temperature to 92 degrees for 24 hours, then gradually returns the body temperature to normal.

For Hershberger’s wife, Margaret, and other family members who gathered at VCU to wait and worry, it was a lot to process: The death of a loved one, resuscitation, then a coma. But Peberdy helped them through it.

“They were impressed by her. She was very calm, which helped to keep everybody else in somewhat of a calm manner, despite the precariousness of the situation,” said Hershberger.

Peberdy, the C. Kenneth Wright Professor of Cardiology, created the ARCTIC program, one of the first of its kind in the country, in 2004. The program is multi-tiered, with components including a continuum of clinical care, research, community training in CPR, and coordination with a highly trained network of EMS’s and partner hospitals.

“She is a master physician and truly devoted to advancing the science for the care of our patients,” said Vigneshwar Kasirajan, M.D., cardiothoracic surgeon and chair of the department of surgery.

In 1974, on the first day of his cardiology fellowship at New York Hospital—Cornell Medical Center, Ornato was assigned to oversee and hone the training of the paramedics. “At that time, it was the only 24/7 paramedic program in all of New York City,” he recalled.

Although he knew little about the work, he began joining the paramedics on calls during slow times in cardiology. “Within a couple of months, we actually had our first survival from cardiac arrest…which in 1974 was virtually unheard of. If your heart stopped out of hospital, you were going to die,” he recalled. A few days after she awakened in the coronary care unit, his elderly patient—who was looking forward to the birth of her first grandchild—expressed her gratitude to Ornato with a kiss on his cheek. “I remember thinking, `I’ve been kissed by a dead person’. That moment changed my career.”

Today, through his work as a cardiologist and Emergency Medicine specialist, Ornato still works closely with early responders, who play a key part in the “chain of survival” necessary for cardiac arrest patients to survive. In addition to his work at VCU, he is the medical director of the Richmond Ambulance Authority, Richmond Fire & EMS, and Henrico County Division of Fire. He ensures all are kept up-to-date on VCU’s ARCTIC program and cutting-edge science in resuscitation.

Peberdy, the C. Kenneth Wright Professor of Cardiology, created the ARCTIC program, one of the first of its kind in the country, in 2004.

He and Peberdy also oversee the training of ARCTIC attending physicians, a component of the program that separates it from others in the small club of top-tier cooling programs.

“We have five attending physicians who are on call, 24/7, to help with the decision-making for the therapy,” he said. “We really tried to have a small enough number so that we could ensure that every one of us is absolutely up-to-date on what the latest science is showing as to the proper use and selection of patients for this kind of cooling therapy.”
The volunteer group includes Ornato and Peberdy; Antonio Abbate, M.D., Ph.D., James Roberts Professor of Cardiology and vice-chair of the Division of Cardiology; Stephen Miller, D.O., assistant professor of Emergency Medicine; and Harinder Dhindsa, M.D., chair of the Division of EMS.

“Dr. Ornato is one of the leading international experts in cardiac resuscitation. He is not satisfied with the current state of the art, and he and his research and clinical partner, Dr. Mimi Peberdy, are developing new tools for treating and preventing cardiac arrest,” said Kenneth Ellenbogen, M.D., chair of the Division of Cardiology.

One of Ornato’s most important contributions was serving as principal investigator of the Public-Access Defibrillation study, which was funded by the NIH, the AHA, and industry. Peberdy served as the PI for VCU/Richmond. The 18-month study trained 19,000 people and placed 1,500 AEDs in 24 U.S. and Canadian cities in how to perform CPR and how to recognize a cardiac arrest and call 911. In half of the study sites, lay volunteers were also trained and equipped to use an AED on the victims before EMS arrival.

The study’s findings were published in the New England Journal of Medicine in 2004. “We were able to show that lay persons performing CPR and using an AED doubled the chances of survival from cardiac arrest out of hospital compared to having the lay person just perform CPR. And based on the study—which got a lot of national and international press—the AHA got Congress to pass the Cardiac Arrest Survival Act of 2006,” said Ornato.

Soon after the study was published and the Act was passed, all federal buildings in the country were required by law to have AEDs in public places, and all airlines and airports now have AEDs and personnel trained to use them.
The ARCTIC program underwent several big changes in 2008. The first was that VCU began serving as a regional hub to other hospitals for its advanced post-arrest therapies. The second was that the program’s attending physicians shifted their focus from cooling patients from the “outside in”—using cooling blankets, ice bags and gel pads—to the “inside out.” The latter involves endovascular cooling, which involves the use of a closed-circuit catheter that controls body temperature internally.

The newer process allows for “targeted temperature management,” which includes an induction phase, in which the body is cooled; a maintenance phase, in which the lowered temperature is maintained for about 24 hours; and a rewarming phase, in which the body is returned gradually to its normal temperature.

The process of caring for ARCTIC patients in the Coronary ICU is dynamic. “Care is minute-to-minute and hour-to-hour. It’s constant evaluation and re-evaluation,” said Michelle Gossip, BSN, ARCTIC care coordinator.

Nurses play a key role, she said. “It is the nurse who sees subtle changes in our patient population and, working with our physician staff, provides ongoing emotional support for patients and families.”

Unlike many other programs, continuous brain wave monitoring is performed and there is a strong focus on ventilation, hemodynamic, and metabolic parameters to improve outcomes. The ARCTIC program was also the first in the country to perform detailed neuro-cognitive testing in survivors to identify more subtle, persistent areas of brain injury and begin early rehabilitation treatment in these patients. Treatment plans require multidisciplinary teams, made up of heart doctors as well as nurses, neurologists, pulmonologists, technicians, social workers, nutritionists, rehabilitation experts, and physical, occupational, and speech therapists.

Hershberger, who exercised regularly and had no history of heart disease, was found to have blockages in the arteries supplying blood to his heart, which led to his arrhythmia and ultimately cardiac arrest. Once he completed the comprehensive post-arrest care and awoke from his coma, he underwent a successful double bypass surgery at VCU. Upon discharge, he started a 12-week, medically supervised cardiac rehabilitation program near his home.

“We want to arm our patients with all the tools they need to be successful when they’re discharged,” said Gossip, who coordinates the care for this complex patient population and runs a support group for cardiac arrest survivors. She also teaches Hands Only CPR and, with Peberdy, provides training to partner hospitals.

“Michelle is the glue [that holds this program together],” said Ornato. “I just can’t say enough good things about her.”

Despite the great success of the ARCTIC program, “the one thing we were lacking was the ability to go back and forth between the bench and the bedside to further increase our knowledge and improve outcomes,” said Peberdy.

That all changed in 2016, when, after a year-long search, the Weil Institute of Critical Care Medicine chose to move its world-renowned, basic science laboratory from Rancho Mirage, California, to VCU Medical Center. The institute, founded in 1961, was named after the late Max Harry Weil, M.D., Ph.D.—a mentor and friend of Peberdy’s and Ornato’s for over 25 years—who is considered the father of critical care medicine. Most of the institute’s work involves cardiac arrest and emergency care.

“Weil’s board of directors made the decision to come to VCU because they wanted the ability to have their basic science work translate into clinical work and they chose us, in part, because of the ARCTIC program,” she said. “We are working very closely with them so that the projects they do can be easily translated to the bedside if there are promising outcomes found in the laboratory.”

Wanchun Tang, M.D., who was trained by Weil and ran the Institute after Weil passed away in 2011, joined VCU as professor of Emergency Medicine and continues as the Institute’s director. Peberdy and Ornato were named co-deputy directors of the Weil Institute of Emergency and Critical Care Research at VCU, which held its grand opening in October 2016.

“We are learning more and more about how to better care for these patients,” said Peberdy. “And it’s our hope that we can further our research and continue to get better at what we do.”

……….

About the Doctors:
Mary Ann Peberdy, M.D., and Joseph Ornato, M.D., have devoted a significant part of their careers to cardiac arrest patients. Triple board-certified in Cardiology, Internal Medicine, and Emergency Medicine, Ornato has published over 400 papers in the field and recently was awarded the prestigious American Heart Association National Clinical Research Award for his work. Peberdy is also triple boarded in Internal Medicine, Cardiology, and Advanced Heart Failure and Transplant and has published over 200 articles.

Both physicians have served on the AHA national committees for resuscitation science and have been authors in the AHA Guidelines for resuscitation continuously since the 1980s. They are also founding physicians of the AHA Get with the Guidelines-Resuscitation Program, which is the world’s largest repository of performance improvement and research data for in-hospital cardiac arrest.

Learn more…
View the VCU ARCTIC Program on a PBS NOVA program that aired on January 26, 2011. To view it, visit PBS.org/wgbh/nova/body/can-we-live-forever.html (the segment starts around the 47-minute mark).

For updates on the Weil Institute research, presentations and awards go to: www.weil.vcu.edu

Save the Date:
Pauley Heart Center Consortium Event on Thursday, May 17, 2018 at Rhythm Hall on the first floor of Dorothy Pauley Square in the Dominion Arts Center.

……….

According to the American Heart Association, more than 350,000 out-of-hospital cardiac arrests occur in the U.S. each year, and overall survival is 10%. Chances of survival can double or triple with timely CPR and early defibrillation with an AED.


A Spectacular Run

Meet John Duval, Dr. Jerry Strauss and Dr. John Ward—the VCU administrative dream team that has helped shape Pauley into a leading heart center.

For over a decade, the Pauley Heart Center has benefited from the teamwork and devotion of the senior leaders of the VCU Health System and VCU Medical Center.

CEO John Duval, MBA, FACHE, Medical School Dean Jerome F. “Jerry” Strauss III, M.D., Ph.D., and President of MCV Physicians John Ward, M.D., MSHA, have worked closely together and with heart center leaders to provide Pauley with the support and vision necessary to become a top-tier heart program.

With Duval’s retirement last September, and Strauss and Ward returning to research and medicine full-time this year, they will leave behind a legacy of excellence.

……….

When John Duval began as CEO of VCU Hospitals and Clinics and vice president for Clinical Affairs in June 2004, he was impressed with the institution’s innovative cardiology and cardiac surgery programs. But one of his first goals was to rebuild the renowned heart transplant program that began at MCV in the 1960s.

JOHN DUVAL TOURS THE ED WITH WILL WADE.

JOHN DUVAL TOURS THE ED WITH WILL WADE.

“Dr. Richard Lower developed the techniques for human heart transplantation right here on this campus,” says Duval, from his Marshall Street office, where he is working as a consultant until March. “We were one of the most active heart transplant centers nationally and internationally then, but we lost our focus in the ‘80s and ‘90s, and the program was impacted.”

Duval partnered with cardiothoracic surgeon Vigneshwar Kasirajan, M.D., to help rejuvenate the program. Kasirajan helped recruit others, and “we’ve grown from the five transplants that we did back in 2002 to 30 in 2016,” says Duval.

Additionally, the pair, along with Michael Hess, M.D., and George Vetrovec, M.D., were instrumental in bringing the total artificial heart program to VCU in 2006. “We’ve done 100 now, and are now among the largest programs in the world for the total artificial heart,” says Duval. When combined with the explosive growth of the heart failure and mechanical assist device programs, he says, “it’s just been a spectacular run.”

“John always had this notion that what sets this place apart, and what made this place great in terms of cardiovascular science, was the development of heart transplantation here by Dr. Richard Lower decades ago,” said Chair of Cardiology and Kontos Professor Kenneth Ellenbogen, M.D. “John helped us put together what is once again a world class program in heart transplantation, as well as heart failure and mechanical assist devices.”

“We’ve done 100 now, and are now among the largest programs in the world for the total artificial heart,” says Duval.

Duval also pushed for the creation of the $184 million Critical Care Tower, which opened in 2008. The 15-story, 232-bed facility includes intensive care units for surgical trauma, neonatal, burn center, cardiac, neuroscience, medical respiratory and oncology patients and was designed from the ground up to meet the complex needs of critically ill patients, with larger rooms for multidisciplinary care and safety features such as single occupancy and negative pressure ventilation systems that prevent cross-contamination of airborne particles.

“Some were skeptical, at the time, of the tower. But today, I can’t imagine us not having it,” said Chair of Surgery Vigneshwar Kasirajan, M.D. “John always saw things beyond the horizon.”

Under Duval’s leadership, a hospital safety program began in 2008 that has resulted in over 16,000 team members receiving training in safe behaviors and error prevention. VCU has since experienced a 50% reduction in serious safety events, and in 2014 was awarded the American Hospital Association McKesson Quest for Quality Prize, the organization’s top honor for leadership in safety and quality improvement.

One of the highlights of his career at VCU has been “the dedication of the teams to becoming the safest health system in America,” he says. “The fact that patients are leaving our building today not knowing that they benefited from the infection they didn’t get, from the mishap they didn’t have, from the complication that didn’t occur. That excites me. And I think that’s what this journey is all about: We are reducing harm in the delivery system.”

“I could not be more proud of the accomplishments of my teammates.”

……….

Jerry Strauss III, M.D., Ph.D., an internationally recognized researcher in obstetrics and gynecology, began his tenure as dean of the VCU School of Medicine and executive vice president for medical affairs for the VCU Health System in September 2005.

When Strauss arrived to VCU, “the major goal that was handed to me was to increase the quality and the quantity of the research at the institution,” he says, from his office on the 4th floor of the James W. and Frances T. McGlothlin Medical Education Center. “I certainly saw a lot of opportunities for the medical center to become a prominent leader in some core areas, and cardiovascular medicine, because of the rich history of the institution in that research and clinical care domain, really stood out as one of my top priorities.”

Strauss worked with Shelden Retchin, M.D., the former senior vice president for VCU Health Sciences, and then-Chair of Cardiology George Vetrovec, M.D., to begin a philanthropic campaign to build the resources to support the cardiovascular programs. “That’s how the Pauley Heart Center was created initially, with a $5 million gift from Stan and Dorothy Pauley.”

“I think the three of them working together has made a lot of things happen. The CEO of the hospital, the dean of the School of Medicine, and the head of the practice plan all being aligned has really allowed us to move clinical programs, quality, education and research forward.”
— Vigneshwar Kasirajan, M.D.

The 2006 gift led to other significant donations from the philanthropic community to invest in program development “and endow positions that have allowed us to recruit a team of truly exceptional clinicians and researchers,” he says. The donors played a critical role. “We could not have done all this without them.”

Over the past decade, the research of the faculty—including both clinicians and basic scientists—has helped the institution grow in national and international prominence. Strauss points out many examples, including the work in cardiac resuscitation of emergency physician Joe Ornato, M.D., and cardiologist Mary Ann Peberdy, M.D., which recently helped attract the Weil Institute to VCU.

“Jerry had a vision of what he wanted the heart center to become, and he has worked tirelessly towards making it one of the top clinical and scientific centers in cardiovascular disease. He has been steadfast in his determination and devotion,” said Kenneth Ellenbogen, M.D.

VCU PAULEY HEART CENTER STANDS AS A LEADER AMONG ITS PEERS—A REPUTATION MADE POSSIBLE BY THE EXTRAORDINARY TEAMWORK OF IT PHYSICIANS, NURSES AND OTHER STAFF. / JOHN WARD, M.D., AND JERRY STRAUSS, M.D.

VCU PAULEY HEART CENTER STANDS AS A LEADER AMONG ITS PEERS—A REPUTATION MADE POSSIBLE BY THE EXTRAORDINARY TEAMWORK OF ITS PHYSICIANS, NURSES AND OTHER STAFF. / JOHN WARD, M.D., AND JERRY STRAUSS, M.D.

“From a Department of Surgery standpoint, he’s put a lot of effort into helping us to grow innovative programs and research. Over the last few years, he has given us academic funds for research, which we have used as seed money for new faculty to start some new projects,” said Vigneshwar Kasirajan, M.D.

In 2013, Strauss introduced a new medical school curriculum, which departed from the traditional path of two years of basic sciences followed by two years of clinical education. While still a four-year program, “we compressed the preclinical component into one year to get the students into the clinical arena as soon as possible, so that the basic science had meaning with respect to patient care,” he says. 

Boosting the success of the new curriculum—and something that was not anticipated when Strauss began his position-—was the opening in 2013 of the 12-story medical education center, a stunning, modern building designed by I.M. Pei’s firm. The building was initiated with a $25 million gift from the McGlothlin family, and ultimately made possible with over $190 million in gifts and pledges. With two floors dedicated to simulation and learning clinical skills, “the James W. and Frances T. McGlothlin Medical Education Center is the embodiment of the new curriculum in a physical space,” he says.

All the investments are paying off. “Applications to medical school have more than doubled. When I came, there were about 4,200; now we’re close to 9,000,” says Strauss. “What’s happened over the past few years has been remarkable.”

……….

Neurosurgeon and President of MCV Physicians John Ward, M.D., M.S.H.A., is having a busy morning, but makes time for an interview. He’s already made morning rounds and attended senior leadership and MCV Physicians committee meetings. More sessions will follow in the afternoon.

“We have about 700-720 physicians, and as president of the practice plan I represent those physicians, work closely with the chairs in terms of the faculty, and am responsible for the strategic direction of the practice plan,” he says. “It’s a real partnership between myself and the 19 department chairs.”

Since taking the reins in 2009, Ward, working with Strauss and Duval, has been involved with chair and physician recruiting efforts for the downtown campus, including the recruitment of six heart failure cardiologists. He also heads up recruiting for the affiliated specialty clinics. For the VCU Community Memorial Hospital in South Hill, for instance, he helped bring in 14 new physicians, including cardiologists.

“John Ward is the glue that holds the doctors together and makes sure the doctors in the medical center work together. He has also done an outstanding job of putting together a core of cardiovascular doctors throughout the state of Virginia, and taking our footprint outside of downtown Richmond,” said Kenneth Ellenbogen, M.D.

“He has been very important in helping us recruit faculty, making sure that we recruit the right faculty, and that we have the correct resources behind them. For the heart center, that’s been critical,” said Vigneshwar Kasirajan, M.D.

Pauley Heart Center has outreach clinics in Williamsburg, Fredericksburg, South Hill, Ridgefield and Colonial Heights and offers outpatient pediatric cardiology through the Children’s Hospital of Richmond at VCU, which joined as an affiliate in 2010.

The outreach clinics provide greater access to care for patients, especially those who live in suburban and rural areas. “The secret when you’re doing outreach is to, as best you can, complement rather than compete with other local services,” says Ward.

Over the years, Ward observes that patient care—especially for the sickest patients—has grown increasingly multidisciplinary. Some examples include the cardio-oncology program at Massey Cancer Center, and cardiac surgeons and interventional cardiologists working together on hybrid procedures, such as trans-aortic valve replacements.

“Disease is too complex now; no one can really treat in a vacuum any more. And with the explosion of information in terms of genetic markers, new treatments, and the emphasis on more minimally invasive work, we’ve seen more of the various departments working together,” he says.

It’s no surprise that “we’ve seen a gradual coming together of the chairs. They’re much more working like a unit now, which I am happy to see.”

Indeed, when visiting physicians come to VCU, they notice “the way that we work so well together. You don’t always see that in a lot of academic centers.” The collaborative environment, “allows us to focus on the patient and their problems, and not worry about other things,” he says. “So, we can spend most of our energy trying to get patients well.”

The physicians, nurses, administrators and staff of the Divisions of Cardiology and Cardiothoracic Surgery are grateful to John Duval, Dr. Jerry Strauss, and Dr. John Ward for their many years of hard work and tremendous commitment to the Pauley Heart Center, the VCU Health System, and the VCU School of Medicine. Thank you for sharing your extraordinary talents.

 


Taking It to Heart

Celebrating the more than 250 nurses who brighten our patients’ lives.

The tin man from Oz. Inspirational words on a scroll. A big cat with a colorful, swirling mane entitled “Spirit of the Lion Heart.”

When visitors walk down the hallways of the Cardiothoracic Surgery Progressive Unit, they are surprised by the colorful pictures on the ceiling; all were created by patients or their families.

“The ceiling tiles are stories that patients tell, that we encourage them to express. Each of those tiles has a story—in some cases, it’s a message of encouragement for other patients,” says Clinical Nurse Specialist/Nurse Clinician Kim Nelson, DNP, RN-BC, ACNS-BC, who leads the nursing unit along with Nurse Manager Kelly Carter, MS, RN, NE-BC.

While some of their patients may stay just one night, perhaps following a procedure, “some patients waiting for transplants may be here weeks or months; a few may be here a year or more,” she says. “So you have to look at patients’ needs—not only their physical needs but their emotional and spiritual needs as well.”

In addition to the colorful tiles, the unit—composed of Main 10 West and 10 Central—is distinctive for its technology, including “Big Blues,” the 400+-pound compressors that keep things pumping for artificial heart patients not yet ready to return home with a backpack Freedom driver. Nurses on the unit have special training in caring for patients on mechanical circulatory support and ongoing education to stay current with the latest technology. They are also supported and encouraged to obtain nursing board certification in Progressive Care, Heart Failure, or Cardiovascular Nursing.

“We’re geeks for heart failure,” says Nelson, with a laugh. Her interest in the complex condition began in nursing school, when she cared for her grandmother.

The nurses work with interdisciplinary teams to provide holistic care. The transplant/device team, for instance, includes nurses as well as surgeons, cardiologists, heart failure specialists, social workers, physical and occupational therapists, chaplains, psychologists, a dietician, and care coordinators. Art and music therapists also offer support. In January 2011, the Hopeful Hearts Support Group was formed for patients and families who are in the hospital with a mechanical circulatory support device or heart transplant. Activities vary from creating tie-dye shirts to family-style meals. Sharing experiences that are life changing with each other along with the struggles that go along with them provides a special bond in the group.

Sometimes, it’s the things that remind patients of home that matter most. Nurse Practitioner Morgan Childress, MSN, NP, brings in her boxer/hound mix as a volunteer for the “Dogs on Call” program. Often, details are worked out for patients to bring in their own pets for a visit.

KIM NELSON AND DAVID PALUMBO

KIM NELSON AND DAVID PALUMBO

“I cannot say enough great things about our nurses in the Pauley Heart Center,” says Anthony Cassano, MD, interim chair, Division of Cardiothoracic Surgery. “They are very compassionate and always have the patients’ best interest at heart.”

She adds, “We can fix your heart, but if we can’t keep your head and mind in the game, it won’t matter what we do. That’s what these nurses do and they’re brilliant at it.”

The 10 Central and 10 West teams were recognized with a DAISY Team award for arranging a candlelight dinner for a gravely ill artificial heart patient and her husband on Valentine’s Day. “One of the nurses, Lucy Alburger, RN, even brought in her grandmother’s china for them to have that special dinner,” recalls Nelson. (See sidebar for more information on these awards.)

“Sometimes I can’t believe what nurses accommodate here. It’s really the kindness that I’m very proud of,” says Director of Nursing Kathryn Perkinson, MSN, RN, CEN. “We have weddings up here, birthday parties. People get ready for prom here.”

She adds, “We can fix your heart, but if we can’t keep your head and mind in the game, it won’t matter what we do. That’s what these nurses do and they’re brilliant at it.”

—————

It’s only 1 p.m., but Coronary Intensive Care Unit Nurse Practitioner Charlotte “Cha” Roberts, RN, MSN, has just returned from the emergency room, where she assessed her second cardiac arrest patient of the day.

Additionally, she’s participated in rounds, reviewed patient data, and managed transfers from other hospitals.

“A lot of what I do is process-oriented: making sure that we do the right things at the right time, expediently, and making certain that there are not any obstacles to care. Also making sure that our care is consistent and reflects adherence to guidelines,” she says.

SARAH PACIULLI, MS, RN, NP-C

SARAH PACIULLI, MS, RN, NP-C

Roberts, who’s been in the nursing profession for 35 years, made a decision in 1995 to return to graduate school and become a nurse practitioner. “I am lucky to work with an amazing team of nurses and providers, especially in the Pauley Heart Center and the Emergency
Department,” she says.

Roberts is one of 20 Advanced Practice Providers—known as APPs—in the Division of Cardiology who provide bedside care to patients while also offering expertise in operations.

“The APPs come from all different types of backgrounds but share a very high level of sophisticated training in cardiology,” says Kenneth Ellenbogen, MD, the division’s chair.

Roberts’ patients in the 14-bed CICU include heart attack and cardiac arrest survivors, patients in cardiogenic shock or suffering complex ventricular arrhythmias, and those awaiting advanced heart failure therapies.

“Cha epitomizes what we strive for in the Pauley Heart Center, as she provides outstanding and compassionate care to patients as well as giving support to the families of patients who are frequently critically ill,” says CICU Director Michael Kontos, MD.

With today’s lifesaving technologies, “the patient population has certainly become more complex,” says Roberts. Additionally, “we have so much more data to review. You can’t make a plan this morning and expect it to be durable throughout the day. You’ve got to be looking at the patient constantly and reassessing their response to the therapies that you may have changed. It’s very dynamic.”

—————

“Let me take a look at your pills,” says Cardiology Nurse Practitioner Sarah Paciulli, MS, RN, NP-C, to a patient during an office visit.

The middle-aged man, recently discharged from the Pauley Heart Center, dumps out the contents of a black plastic shopping bag. About 12 medicine bottles tumble onto her desk. As he sits nearby, she goes through the bottles one by one with him, entering the data into her laptop. Some of the bottles are empty; others are old, having been replaced by newer prescriptions.

The patient seems confused, admitting that it’s difficult to keep up with the prescriptions when they’re filled at different times of the month.

“I wonder if we could get you on a schedule with them all synched up at the same time,” says Paciulli. She makes arrangements to do just that with a pharmacy, which will also deliver the medications to the patient’s home.

Making care easier for patients is one of the goals of the Cardiology Navigator Team, whose members offer a four-week program aimed at educating heart failure and heart attack patients following their discharge from the hospital.

“Our clinic is a bridge from the hospital to the long term,” says Paciulli, who helped start the program—one of the first of its kind in the country—in February 2015. The team also includes nurse navigators Corey Reed and Amy Patton, pharmacist Patricia Uber, social worker Megan Maltby, and dietician Nicholas Fischetti.

“Patients and their families attend weekly classes on heart failure diet, medications, exercise, and self-care. During class, I pull the patients aside for a quick clinic visit,” says Paciulli. “This has been a great way to make sure that patients are staying clinically stable while also equipping them with the knowledge and skills to take more ownership of their disease.”

Patients present a variety of challenges. For instance, she’s had to color-code medicine bottles for illiterate patients to help make their self-care easier.

“The purpose of this program is to help identify high-risk patients and others who might need extra help to ensure that they have a safe discharge, with the goal of ultimately reducing readmission and improving patient survival,” says Keyur Shah, MD, medical director of the Mechanical Circulatory Support Program. “This team has exhibited extraordinary commitment to the welfare and outcomes for this very complex patient population.”

Nurse navigators Reed and Patton follow up with patients by phone within 72 hours of discharge to ensure that they are seen in clinic within seven days of discharge and ultimately connect with a cardiologist and medical home.

“Heart failure and myocardial infarction patients are very vulnerable in the immediate post-discharge period. Our team works to make this transition more seamless for patients.  We identify the patients while they are still in the hospital and start the education process,” says Paciulli.

The Navigator Cardiology Team is just one example of the outstanding nursing care provided to patients, says Perkinson.

“While we are very high tech with everything we do, I think it’s our nurses who keep it personal, patient-centered, and support the families through their journey, wherever they are,” she says. “That’s the art of what our nurses do at the Pauley Heart Center.”

L to R: SHERRY LOCKHART, NURSE MANAGER; SHELLEY KNOWLSON, NURSE CLINICIAN; MICHELLE GOSSIP, ARCTIC PROGRAM COORDINATOR; VIRGINIA MCGHEE, NURSE MANAGER; LINDA CURRIE, NURSE CLINICIAN; SARAH PACIULLI, NURSE PRACTITIONER; KATHRYN PERKINSON, NURSING DIRECTOR; KELLY CARTER, NURSE MANAGER; LAURA FRANKLIN, NURSE CLINICIAN; ROBYN DIEHL, NURSE MANAGER; AND RUTH WILLIAMS, NURSE MANAGER

 


Dr. Vetrovec Retires After 39 Years in Cardiology

“Dr. Vetrovec has a long history of innovation and being a pioneer in the field of interventional cardiology. He has trained many people all over the world who have gone on to illustrious careers.

He has really been a thinker and been involved in many of the key clinical breakthroughs over the last 25 or 30 years, and his success, along with his colleagues here, has made VCU Health one of the leading institutions in interventional cardiology.”
— Kenneth Ellenbogen, M.D., Chairman of Cardiology and Chief of Surgery

George Vetrovec, M.D., a professor and the recently retired director of the Adult Cardiac Catheterization Laboratory, is in the middle of packing up 39 years’ worth of memories in the West Hospital. As a result, instead of his office, the interview takes place at Einstein’s Bagels in VCU Medical Center’s Main Hospital. A trim man, with wavy gray hair and a neat moustache, Vetrovec smiles and exchanges a few friendly words with the colleagues who call to him as he passes by on his way to the cafe. He picks up the tab for his guest’s coffee and settles into a booth.   

“I was born in Ohio, but as I sometimes tell it, I was conceived in Petersburg,” says the frequent lecturer. “It gets a laugh.”

Vetrovec’s mom was seven month’s pregnant when the family moved from Virginia to Ohio. The family then moved to Chicago—where his paternal grandparents had immigrated (“that’s the Czech background,” he says)—before finally settling in Sandston, Virginia.

An only child, his mother was a stay-at-home mom; his father, an architectural draftsman. “He was a handy guy. As a draftsman, he was very meticulous,” he says. Vetrovec developed an interest in tools, like his father, and was a ham radio operator. “I remember building, when I was in sixth grade, an early transistor radio. I brought it to school. I think the kids thought I was weird,” he says with a laugh.

In ninth grade, his curiosity paid off; he was among the students selected to go to MCV for a student heart day, a program sponsored by the medical center and the American Heart Association. “I remember getting to see an early bypass pump and all that sort of stuff. I found that very exciting.”

A top student at Highland Springs High School, Vetrovec went on to receive a scholarship to University of Virginia, which he attended for both his undergraduate and medical degrees—becoming the first doctor in his family.

He worked at MCV during the summers when he was in college, conducting cardiology research for the physicians that he would later call his mentors, Dave Richardson, M.D., and Hermes Kontos, M.D. He’d written to Richardson after reading an article about his research. “He hired me sight unseen,” he recalls.

Following medical school, Vetrovec returned to MCV for his internship and residency in internal medicine and his fellowship in cardiology. Then, he was hired as an assistant professor at MCV in 1976, initially working in cardiac rehabilitation and running stress tests.        

What drew him? “I really wanted to be on the faculty of a teaching hospital. I love clinical medicine, but I also wanted to be a part of the evolution of new things and the development of new things. And I thought this was where you could do it.”

“As a young doctor, he was very smart and very careful. He was a leader, and he and Dr. [Michael] Cowley were among the first in America to do a balloon dilation of the coronary arteries.  I was the chairman of the Division of Cardiology then, and it was very exciting.” — David W. Richardson, M.D., emeritus professor of medicine

Vetrovec recalls the twist of fate that brought him to the cardiac catheterization lab, which began in the mid-1960s and was one of the first in the state.  In 1976, after the lab’s founder had left, “they brought in a fellow from Boston to head the lab, and ironically, he got terrible asthma in Richmond. And his goal had always been to run the Boston Marathon, so after a year, he quit and went back to Boston. And that’s how ultimately I became head of the cath lab in 1977,” he says.

He describes his early West Hospital days. “Back then, we used 35 millimeter film. The images were X-ray images recorded on movie film. You took the pictures, and the films were developed right there in the cath lab. Now it’s all digital,” he says, noting the superiority of today’s imaging. Catheter lines were inserted through a “cutdown,” which involved making a small incision in the brachial artery in the arm, instead of the groin.

“Dr. Vetrovec is a giant in the field of interventional cardiology. He was an important mentor in my career at VCU. He worked very closely with me to develop a close relationship between cardiology and cardiac surgery, leading to the emergence of VCU Health Pauley Heart Center as a leader in cardiac care.” — Vigneshwar Kasirajan, M.D., chief of Surgery

In September 1977, Andreas Gruentzig, M.D., performed the world’s first balloon angioplasty. Vetrovec traveled with Michael Cowley, M.D., another young VCU doctor, to Geneva to study the technique with Gruentzig. Vetrovec and Cowley became the first physicians in central Virginia—and likely the state—to perform a balloon angioplasty in July 1979.

“It was new, it was different, and it potentially was going to change the cath lab from a diagnostic lab to a treatment lab,” he says. Today, VCU Health Pauley Heart Center physicians undertake the lifesaving procedure, which now includes the placement of a stent, on about 1,000 patients each year.

Over the years, he’s been at the forefront of testing new devices and techniques. He reflects on some of the latest interventions, including robotic-assisted angioplasties and trans-aortic valve replacements, that are taking place in new hybrid labs.

“This is a lab that’s been known for high-quality patient care and outcomes, but it’s also been known for innovations, doing treatments during the investigative stage, and being a lab that was at the cutting edge. I don’t think that’s changed at all,” he says.

“I first met Dr. Vetrovec when I was interviewing for medical school. He took me in under his wing and helped guide and develop my career as a physician scientist, encouraging my efforts in cardiovascular research and fostered a love for bringing scientific discoveries to patient care. He has an impeccable reputation in the interventional cardiology community as an amazing educator and interventionalist.” — Michael J. Lipinski, M.D., Ph.D., interventional cardiologist and scientific lead of Pre-Clinical Research, Medstar Heart and Vascular Institute.

“Dr. Vetrovec is the main reason why I came to VCU from Italy. He always inspired me to give my best, always aim at doing better, and always care deeply about the patients and the coworkers.” — Antonio Abbate, M.D., Ph.D., James C. Roberts, Esq., Professor of Cardiology, VCU Health Pauley Heart Center

Vetrovec has long been a rallying figure for the VCU Health Pauley Heart Center. He served as chairman of the Division of Cardiology from 1991 to 2009 and led two major fundraising campaigns that secured over $14 million in donations for the heart center. In recognition of his efforts, he received the first W. Robert Irby Philanthropic Leadership Award by the MCV Foundation and was also awarded the 2010 Distinguished Service Award.  In 2013, through the support of a grateful patient, the George W. Vetrovec, M.D. Endowed Cardiology Chairmanship was established in his honor.

In his retirement, he’s planning to spend more time with his family, which includes his wife Mary, two children (John, a stockbroker, and Beth, a cardiology nurse) and their spouses, and four grandchildren. He’s looking forward to traveling and photography. Vetrovec stays busy lecturing and is a consultant to Abiomed, which manufactures a cardiac pump used principally during high-risk angioplasties.

He also plans to continue teaching—one of his favorite roles at VCU through the years. He often tells his medical students, “You ought to spend five more minutes talking to your patients because they’re really interesting people.”

“Working with people, that’s the real joy of medicine,” he says with a smile. “There are a lot of long hours and challenges in this profession. But at the end of the day, the patients are so appreciative.”

The faculty, staff and administration of VCU Health Pauley Heart Center and his friends from the MCV Foundation thank Dr. Vetrovec for 39 wonderful years!

Dr. Vetrovec has:

• Performed an estimated 18,000 procedures in the cath lab.

• Trained students who are now cardiologists in more than 25 states and seven countries.

• Authored or co-authored more than 200 papers.

• Received the American Heart Association’s National Award of Merit in 1991.

• Been named “Clinician of the Year” by his colleagues in 1997. 

• Been named a Master of Cardiology by the American College of Cardiology in 2014.

• Received the VCU Presidential Medallion in 2014.

cover-story-collage_lgOn October 11, 2015 members of the Pauley Heart Center Consortium Group gathered together to celebrate the nearly four decade career of Dr. George Vetrovec. Dr. Vetrovec announced his retirement late in the summer, however his passion for medical education will keep him close, he will spend 1-2 days a month working with and mentoring residents and fellows of the Division of Cardiology. The event, hosted by the MCV Foundation Board of Trustees, included over 120 friends, patients, alumni and donors. The evening concluded with a program highlighting Dr. Vetrovec’s accomplishments as a caregiver, educator, fundraiser, academic leader and mentor. Former trainee, Dr. Jeff Marshall, announced that the Division had created the George W. Vetrovec, MD Symposium to honor Dr. Vetrovec’s longstanding and continuing commitment to cardiovascular education. Dr. Marshall urged those who shared Dr. Vetrovec’s passion to join him in supporting the symposium. If you are interested in learning more, please contact Lauren Moore at 804.828.3632 or lauren.moore@vcuhealth.org.