At Penn State Health Milton S. Hershey Medical Center, physician-scientists provide advanced treatments for acute and chronic heart conditions, while furthering the Heart and Vascular Institute’s mission to develop and perfect lifesaving therapies and technologies.
Soraya Samii, MD, PhD, performs a WATCHMAN procedure at Penn State Health Milton S. Hershey Medical Center.
The region’s only academic medical center, Hershey Medical Center incorporates multiple disciplines to treat patients with any type of heart and vascular condition. From ongoing treatment of heart failure to structural and heart valve concerns, to acute care for cardiogenic shock, physicians in the Heart and Vascular Institute play a vital role in the cardiac health of the patients throughout the region.
Advanced Structural Procedures
Mark Kozak, MD
Penn State Heart and Vascular Institute
“Medical science has long understood the disease processes that cause structural heart disease,” says Mark Kozak, MD, interventional cardiologist at Penn State Heart and Vascular Institute. “However, continuous development and refinement of methods to deal with valve and related problems have radically advanced the range and effectiveness of interventions that clinicians at Hershey Medical Center can offer to patients.”
The heart valves act like doors to keep the blood flowing in one direction. Various diseases cause them either to leak and let blood flow backward or to get stuck closed and impede the forward flow of blood. In the past, replacing these valves required major surgery. Today, transcatheter aortic valve replacement (TAVR) can extend life and heighten quality-of-life for many patients with valve disease who cannot tolerate open surgery. This minimally invasive procedure is continually being improved to expand the pool of patients on whom it may be performed.
Pradeep Yadav, MD
Penn State Heart and Vascular Institute
“In the beginning, TAVR was approved for patients who were not surgical candidates,” explains Pradeep Yadav, MD, interventional cardiologist at Penn State Heart and Vascular Institute. “Now, with tremendous success, evolution of the procedure and more data, TAVR is available to relatively less ill patients as an alternative to surgery. In March 2016, a large, multicenter, randomized study presented at the American College of Cardiology conference showed that when performed via transfemoral (groin) access, TAVR has better outcomes and lower mortality compared with surgical valve replacement.”
Performed in a cardiac catheterization lab, TAVR entails a one- to three-day hospital stay. Typically, the procedure is performed via the femoral artery.
“We insert a 6-millimeter catheter through a small incision in the groin,” Dr. Kozak says. “We then thread equipment to the heart and place a new valve, which expands inside the diseased valve to function in its place.”
“The valve delivery system is removed at the end of the procedure, and the artery is repaired with sutures — all through the small incision in the groin,” Dr. Yadav adds.
“Key advances in TAVR include progressively smaller devices. Whereas once only about half of patients had arteries wide enough to accommodate a TAVR system, now about 90 percent do,” Dr. Kozak says. The result is a short procedure performed under local anesthesia, followed by a quick return home.
“In frail, elderly patients, lying in bed just a day or two can reduce mobility so that they cannot return home,” Dr. Kozak adds. “Every hospital day spared is a huge blessing for our patients.”
Heart failure may be accompanied by mitral regurgitation, a condition in which blood flows against the current, from the left ventricle back into the left atrium, through the mitral valve. This occurs when the valve leaflets fail to coapt completely.
“Conventional repair techniques involve the risks of open-chest surgery,” Dr. Kozak notes. However, patients at Hershey Medical Center benefit from the MitraClip® procedure, a minimally invasive approach that avoids those dangers.
“We insert catheters into the femoral vessels of the groin and thread them from the right atrium to the left atrium through a hole in the interatrial septum,” Dr. Kozak explains. “We then steer the clip into place, grabbing the mitral valves and holding them together to prevent excess mobility and leaking.”
“Since there are no incisions and the entire procedure is done through a small hole in the groin, the recovery is fairly quick and patients go home in one to two days,” Dr. Yadav says.
“This procedure can significantly improve symptoms of heart failure, including shortness of breath,” Dr. Kozak says.
About 6 million people in the United States have atrial fibrillation. The condition causes approximately 75,000 strokes per year. To prevent stroke due to atrial fibrillation, the WATCHMAN™ device is the only FDA-approved device for patients who cannot tolerate anticoagulants.
“Most of the clots form in the left atrial appendage, a pouch-like extension off the left upper chamber of the heart,” Dr. Yadav says. “The WATCHMAN device, a self-expanding metal and fabric device that serves as a plug, is placed at the opening to the left atrial appendage, sealing it. Blood can no longer enter the appendage and form clots, thus preventing the risk for a stroke.”
Typically, patients with atrial fibrillation are prescribed anticoagulants to reduce the risk of clots, in order to reduce the risk for stroke. However, dosing may be complicated, and blood thinners — typically warfarin — require close monitoring and expose patients to side effects, such as easy bleeding and bruising.
“Patients who have recurrent bleeding on warfarin have traditionally been forced to make a difficult choice,” Dr. Kozak says. “They accept a fairly high risk of stroke, or they take blood thinners and bleed.”
Hershey Medical Center utilizes the WATCHMAN device to solve this dilemma.
“The WATCHMAN insertion, a minimally invasive procedure, involves a screening echocardiogram or a CT scan to assess the size and shape of the left atrial appendage,” Dr. Yadav explains. “The procedure is performed while the patient is under general anesthesia.”
“We advance a small catheter (tube) through the femoral vein all the way, up to the top right upper chamber, then make a tiny hole in the interatrial septum to cross to the left side to the left atrial appendage. Then, under X-ray and echo guidance, we carefully implant the WATCHMAN device. The delivery catheter is removed, and a small dressing is applied to the hole in the groin.”
“Patients are sitting upright, eating in few hours and able to go home the next day,” Dr. Yadav says.
All three procedures are offered at Hershey Medical Center. TAVR and WATCHMAN are also offered at Penn State Health St. Joseph in Reading.
The Advanced Heart Failure Program
Patients with heart failure who are unable to sustain adequate cardiac function with other medical treatments and procedures can avail themselves of the advanced capabilities of the Heart and Vascular Institute’s advanced heart failure team.
“We provide the entire spectrum of therapies for patients with advanced heart failure, and we participate in all major U.S. trials for heart failure-related devices. Additionally, we enjoy the strong support of the leadership of our organization. Those factors, combined with the expertise of our physicians and allied specialists, position us to provide comprehensive, state-of-the-art care.”
— Behzad Soleimani, MD, surgical director of the heart transplant program at Penn State Heart and Vascular Institute
Behzad Soleimani, MD
heart transplant program
Penn State Heart and Vascular Institute
“Heart transplant remains the gold standard for managing people with end-stage heart failure in the chronic setting,” says Behzad Soleimani, MD, surgical director of the heart transplant program at the Heart and Vascular Institute. “We evaluate every patient who is at-risk of death from heart failure, and not responding to medical therapy.”
“Patients with stage D heart failure should be referred for advanced therapies, which include heart transplant,” explains Omaima Ali, MD, associate medical director of the heart transplant program at the Heart and Vascular Institute. “These patients typically have severe cardiac dysfunction, a significant decline in their functional capacity, and either cannot tolerate their heart failure regimen as they once did or are having frequent hospitalizations despite their therapy.”
To these patients, the Heart and Vascular Institute offers the hope of longer life and enhanced quality-of-life with advanced heart failure therapies with either a ventricular assist device or a heart transplant.
“The history of the Penn State heart transplant program helps explain its success. William Pierce, MD, one of the pioneers of mechanical circulatory support, practiced at Hershey Medical Center and was a co-inventor of the first FDA-approved ‘bridge to transplantation’ pump,” according to Dr. Soleimani.
“Penn State has a storied history of helping patients survive to transplant,” Dr. Soleimani says. “Most who reach transplant surgery get there with a mechanical circulatory device, such as an artificial heart or left ventricular assist device (LVAD). Success rates are high. These are complex patients who require care from an integrated and experienced team.”
Care of these patients is meticulous, and judicious selection fosters a high likelihood that the operation will benefit candidates who are approved for surgery.
Omaima Ali, MD
associate medical director
heart transplant program
Penn State Heart and Vascular Institute
“We meet as a multidisciplinary committee to evaluate patients for advanced heart failure therapies,” Dr. Ali says. “Our surgeons, physicians, pharmacists, social workers, VAD and transplant nurse coordinators and dietitians conduct the evaluations. During the evaluations, we also utilize input from other specialists, including those in pulmonology, gastroenterology, infectious disease, nephrology, and psychology and psychiatry.”
“In addition to making sure patients are eligible, we want to ensure they would benefit the most from these therapies, with the fewest complications possible. “
“Patients awaiting transplant are monitored with frequent follow-up,” Dr. Ali says.
“We assess their kidney and liver function, making sure there is no significant end-stage dysfunction,” she says. “Patients work with our nutritionist and dietitian to ascertain that they aren’t having issues with significant weight gain or weight loss that would preclude them from the transplant list. Also, we regularly monitor their hemodynamics by means of heart catheterization. We ensure they haven’t developed significant pulmonary hypertension, which, if severe, is another contraindication for heart transplant.”
“This rigorous preparation and selection process pays off in the success of the heart transplant procedure. Medical advances have greatly increased the number of patients who live to transplant, and along with that shift, surgeons have adapted to performing heart transplant on patients who have already undergone several cardiac or circulatory procedures,” Dr. Soleimani says. “Along with other academic transplant programs, Hershey Medical Center has adopted new immunosuppressive regimens to prevent rejection.”
“It’s an evolving field,” Dr. Soleimani says. “New drugs are constantly being evaluated. At Hershey Medical Center, we participate in clinical trials to find improved ways of preventing rejection. Of course, rejection is a natural response to a foreign object in the body; when you suppress rejection, you suppress the immune system and put the patient at risk of infection. There is a fine art to suppressing the immune system just enough to prevent rejection without the risk of infection. Part of the practice of transplant is to identify that point, and the research in which we participate helps us do that.”
A Community Concern
For heart failure patients, coordination among cardiac surgeons and primary care providers and cardiologists in the community is of utmost importance.
“There are more than 6 million individuals in the United States with heart failure,” Dr. Soleimani points out. “The vast majority are cared for by their primary care physicians or their primary cardiologists, rather than at institutions that offer the full range of common to complex and advanced heart failure care. It is very important for us to establish lines of communication with providers to let them know when it is time to refer to us.”
“Our primary providers, whether family physicians or referring cardiologists, play key roles in early identification of patients who might need an advanced procedure or heart transplant,” Dr. Ali states. “They also play a crucial role in medical decision-making. They’ve known their patients for years, and patients have a strong rapport with them. Identifying patients and making early referrals allows us to evaluate them before they are too sick to benefit from the advanced therapies we offer, improving their overall survival and quality-of-life.”
“Our research at Hershey Medical Center indicates there’s an optimal time to institute advanced heart failure therapy in relation to how far a patient’s condition has progressed,” Dr. Soleimani says. “There is a point in the disease process at which even transplant and mechanical circulatory support will not change the outcome. Conversely, there is clearly a period when a patient is not yet a candidate for these therapies. The transition can be subtle and sudden. Close collaboration between the individuals who care for these patients in the community is vital for referring patients to us in a timely fashion.”
Keeping the Blood Flowing
While Penn State Heart and Vascular Institute has built a reputation for refining and developing life-extending cardiac procedures and devices, the physicians and staff also have a high level of experience in caring for acute problems as they emerge. Patients suffering from cardiogenic shock due to heart attack, drug overdose or other conditions receive rapid, expert support, first in the emergency department, then in the Heart and Vascular Critical Care Unit.
“The Heart and Vascular Institute has been on the forefront of cardiogenic shock treatment,” Dr. Yadav says. “When traditional IV medications are not sufficient, we use hemodynamic support devices to raise blood pressure and maintain perfusion.”
One such device is the Impella® pump, a catheter-inserted pump that connects the left ventricle to the ascending aorta. Using a small motor controlled via a bedside computer, the Impella draws blood from the ventricle into the aorta, helping the patient’s heart deliver enough oxygenated blood to the body.
Extracorporeal life support — once more commonly called extracorporeal membrane oxygenation (ECMO) — sustains life for patients who are experiencing refractory cardiogenic shock or hypoxemia. These patients may have conditions ranging from trauma to cardiac arrest to failed lung transplant. Extracorporeal life support serves Hershey Medical Center’s wider patient population. Specialists who implant these devices work side-by-side with intensivists, who oversee extracorporeal life support.
Christoph Brehm, MD, is director of the Heart and Vascular Critical Care Unit. He also oversees the Heart and Vascular ECMO program. He explains that while availability of extracorporeal life support has grown in Pennsylvania, it is best overseen at high-volume medical centers that regularly manage these patients.
“Hershey Medical Center has a high rate of survival to discharge in patients who are placed on extracorporeal life support for cardiogenic shock — about 50 percent,” Dr. Brehm notes, “well above the national average.”
“For the past five or six years, smaller hospitals have been starting patients on this technology, but they lack the capacity to manage them for long durations,” he says. “The advantage to ECMO is that patients who previously would have died in the emergency department or ICU can now survive the transfer to a more advanced medical facility for treatment.”
“Extracorporeal life support requires teamwork between physicians and other providers from a host of disciplines — demands an academic medical center is best equipped to meet. Hershey Medical Center trains specialized bedside nurses in extracorporeal life support,” Dr. Brehm says. Nurse practitioners and intensivists also undergo advanced training. Moreover, Hershey Medical Center partners with other health care organizations to expand availability of this lifesaving treatment.
“We were the first program to offer these specialized courses in central Pennsylvania,” Dr. Brehm says. “We train our own teams, and we offer training programs for institutions that are developing ECMO programs.”
“At Hershey Medical Center, extracorporeal life support is most commonly used in the following cases: cardiogenic shock, the inability to be weaned from bypass after open-heart surgery, acute heart failure and respiratory failure, such as from certain types of influenza,” notes Dr. Brehm.
While extracorporeal life support is not a long-term solution, it saves lives in the short term by giving Hershey Medical Center specialists time to decide on the most effective intervention. For instance, a patient in heart failure may be placed on an extracorporeal life support machine while a determination is made whether he or she could benefit from an LVAD or heart transplant. ECMO thus becomes a bridge-to-decision.
In respiratory patients, extracorporeal life support is also a transitional tool.
“We had a significant flu outbreak a few years ago,” Dr. Brehm says. “ECMO gave patients’ lungs a chance to heal, avoiding aggressive ventilation, which can damage the lungs. The more familiarity we develop with this technology, the more ways we will develop to save patients. For example, in cases of significant medication overdose, such as with a beta blocker, we can use ECMO to stabilize patients and wait until the beta blockers are eliminated from their system. The same is true for patients who have overdosed on an unknown substance.”
Dr. Brehm encourages physicians throughout the region to have a transfer plan at the ready for patients who may need to be placed on extracorporeal life support.
“Patients who are not in prolonged cardiogenic shock or prolonged respiratory failure have better outcomes,” he says. “Early transition to ECMO can make all the difference.”
For additional information, visit hmc.PennStateHealth.org/heart-and-vascular-institute or call 1-877-467-7484.