True to its rich history of innovation, Penn State Heart and Vascular Institute at Penn State Health Milton S. Hershey Medical Center offers advanced therapies available only through clinical trials — treatments in the vanguard of care that can improve quality of life while laying the groundwork to help untold numbers of patients enjoy a brighter future.
As part of a university medical center that is central Pennsylvania’s leading destination for advanced, comprehensive medical care, Penn State Heart and Vascular Institute provides services that span the gamut of cardiovascular medicine, including programs in general cardiology, cardiovascular imaging and diagnostics, adult congenital heart disease, cardiac surgery, cardiovascular and interventional radiology, heart rhythm disorders, interventional cardiology, structural and valvular heart disease, vascular and endovascular surgery, extracorporeal membrane oxygenation, cardiac rehabilitation, heart failure, and mechanical circulatory support and transplantation. The institute is home to the region’s only heart transplant center, which boasts a 100% one-year survival rate — the best in the mid-Atlantic region — according to the most recent data collected by the Scientific Registry of Transplant Recipients.
Innovation is in Penn State Heart and Vascular Institute’s DNA, especially in the field of heart failure and mechanical circulatory support. In the 1970s, William Pierce, MD, and colleagues developed the air-driven Penn State heart-assist pump (also known as the Pierce-Donachy pump), which gained widespread use by the 1980s and became the second implantable, artificial heart to receive FDA approval. The Milton S. Hershey Medical Center’s Division of Artificial Organs grew out of the work of Dr. Pierce and others. Led by biomedical engineer Gerson Rosenberg, PhD, the division developed the Arrow LionHeart — a first-of-its-kind electrical, implantable, left ventricular assist device (LVAD) — two decades ago, and its work on artificial hearts continues.
“Our potential to advance the field of heart failure by conducting research in the labs and then transitioning that work into first-in-human trials is, in my opinion, unparalleled,” says Robert Dowling, MD, PhD (honorary), professor of surgery, director of research in cardiac transplantation and mechanical circulatory support and director of clinical applied biomedical engineering research at Penn State Health. “Our engineers help companies develop their devices. As the Division of Artificial Organs, my team and I can then perform animal trials to ensure safety. Then we enlist the help of our heart failure and intensivist colleagues down the hall to identify suitable patients, start first-in-human trials and help people.”
Keith McCann has his vitals taken by medical assistant, Amanda Kochanowicz. Katie Loffredo, RN, BSN, CCRC, met with Keith at Penn State Heart and Vascular Institute IO Silver Clinic Friday, Dec. 20, 2019. Keith is enrolled in the NanoWear study at Penn State Health.
A Less Invasive Heart-Assist Device
The opportunity to add to a legacy of innovation in heart failure and mechanical circulatory support brought Dr. Dowling to Penn State Heart and Vascular Institute one year ago, after years overseeing the heart transplant program at the University of Louisville. Dr. Dowling also worked in private practice and consulted for heart pump manufacturers. Since his move to Penn State Health, he has not been disappointed.
“When I arrived, I was blown away by the depth and breadth of what’s available at Penn State Heart and Vascular Institute in heart failure, mechanical circulatory support and transplantation,” Dr. Dowling says. “The level of clinical care, devotion to research and desire to advance the field are incredible. Before I finish my career, I want to know I contributed to moving the field forward and developed new pumps that can help more people, and everyone here shares that feeling.”
Dr. Dowling is leading Penn State Heart and Vascular Institute’s participation in a single-arm, nonrandomized feasibility trial of the intravascular ventricular assist system (iVAS) by NuPulseCV, a novel heart pump for individuals with heart failure not severe enough to warrant an LVAD. During a minimally invasive operation, a surgeon makes an approximate four-inch incision below the patient’s collarbone and places a balloon pump in the descending aorta. The surgeon makes two more small incisions in the chest to place subcutaneous electrocardiogram leads, which feed into a skin interface device connected to an external, shoulder-worn drive unit. The operation is less invasive than implanting an LVAD.
“The iVAS doesn’t provide as much support as the sickest patients need, but if an individual is failing medical therapy and we know he or she isn’t going to do well, this system is likely to provide enough support,” Dr. Dowling says.
Dr. Dowling equates the support the heart receives from the iVAS with a weightlifter receiving an assist from a spotter.
“If I were asked to bench press 150 pounds over and over, I would get fatigued, but if someone were to grab the bar and pull up every time, I could do it and even get stronger,” Dr. Dowling states. “As the iVAS pump deflates and inflates with each of the heart’s 100,000 beats per day, the heart gets stronger. Another advantage is that when the heart is not beating, the balloon fills, so the organs get another pulse of blood when the heart rests.”
Penn State Heart and Vascular Institute has implanted one iVAS — the first in Pennsylvania and 71st worldwide — as part of the study, and hopes to do more; investigators would like to implant a total of 100 at the 18 hospitals and health systems taking part in the study. So far, none of the more than 70 patients who received the iVAS have experienced an ischemic stroke, which is a complication of LVADs. Dr. Dowling expects the stroke rate among study participants to remain low, as the pump’s position in the descending aorta would seem to prevent any blood clots that form on the device from making their way upstream to the brain.
The iVAS offers another advantage patients with an LVAD don’t have – the ability to unhook the iVAS for short periods of time. That, Dr. Dowling explains, is a boon for quality of life and mental outlook, as patients are able to disconnect from the device for everyday activities, such as taking a shower or walking a dog. Kevin Gardner, RN, BSN, CCRC, clinical research operations manager at Penn State Heart and Vascular Institute, says the fact that individuals can unhook from the device underscores the importance of careful patient selection.
“Most LVAD patients would develop heart failure symptoms if their device turned off for a few seconds,” Gardner says. “The iVAS is for people who need extra cardiac support, but could tolerate unhooking the device for a certain amount of time.”
That extra support has the potential to benefit a wider range of patients than just those with chronic heart failure, according to Dr. Dowling. He envisions additional applications for the iVAS, such as using it to support individuals for several months after a heart attack to help the heart recover.
“A lot of data indicate that if the heart has an insult, such as a heart attack, supporting it with a balloon pump or another type of pump speeds recovery,” Dr. Dowling states. “The big promise of the iVAS is in heart recovery after a heart attack, high-risk surgery or transplantation. The iVAS could expand the number of transplants we could do if we knew we could leave this device in and help the heart recover after transplantation.”
Keith McCann meets with Katie Loffredo, RN, BSN, CCRC, at Penn State Heart and Vascular Institute IO Silver Clinic Friday, Dec. 20, 2019. Keith is enrolled in the NanoWear study at Penn State Health.
A Wearable Heart Failure Diagnostic
Hospitalization is a common occurrence for people with heart failure, and the costs to quality of life and the health care system are steep. Nearly two heart failure-related hospitalizations occur every minute in the United States, according to the American Heart Association. A 2019 study in the Journal of the American College of Cardiology found that 23% of patients with heart failure were readmitted to the hospital within 30 days after discharge. Heart failure hospitalizations cost the healthcare system an estimated $11 billion in 2014, according to a 2018 study in Circulation: Heart Failure.
“Despite the fact that we admit heart failure patients to the hospital and treat them, they don’t do well and frequently come back,” says John Boehmer, MD, director of the Heart Failure Program at Penn State Heart and Vascular Institute. “Our goal is to figure out who the high-risk patients are and focus resources on managing them and keeping them out of the hospital. Putting an implantable device in every patient admitted for heart failure is impractical. What we want is a wearable device that patients can use while they’re at high risk and then move on to more traditional care.”
Dr. Boehmer is leading a national study of a wearable diagnostic device that may fit the bill. He is the national principal investigator for NanoSENSE, a clinical study of a garment called SimpleSENSE developed by nanotechnology company Nanowear. SimpleSENSE uses nanosensors in the fabric as dry-contact electrodes to gather a variety of physiological data. Researchers will use the data to develop an algorithm to predict worsening heart failure before symptoms occur, thereby allowing clinicians – and, eventually, patients themselves – to manage heart failure more effectively and avoid hospitalizations.
NanoSENSE launched in the summer of 2019 at Hershey Medical Center and at Hackensack Meridian Health Hackensack University Medical Center in New Jersey, and will eventually include up to three more centers. Researchers hope to recruit up to 500 participants. Penn State Heart and Vascular Institute enrolled its first patient in November and hopes to enroll approximately two per week. Candidates are individuals with a primary diagnosis of heart failure who are hospitalized or have been discharged within the past two weeks.
Researchers ask NanoSENSE participants to wear the size-adjustable SimpleSENSE garment for 12 hours per day — approximately two hours before going to bed, eight during sleep and two after waking — for 90 days. The garment gathers a host of measurements that can be useful in predicting heart failure symptoms, including electrical activity in the heart and chest, respiratory rate, posture and activity level. SimpleSENSE also records heart sounds.
“Measuring how frequently and deeply a patient breathes can be helpful in managing heart failure because many patients with this condition have sleep apnea or another form of sleep-disordered breathing, which would show up in the respiratory data,” Dr. Boehmer explains. “Measurements of posture can also be important clues because people with heart failure often get short of breath when they lie flat, so if a patient suddenly props himself up, that can be a signal of symptoms. The same goes for a change in activity, such as a sudden decline. We’ll be able to combine all of these data and more to create a risk scale that will tell us how great the risk that something might happen in a given individual.”
Collecting three months’ worth of data per patient should allow researchers to identify physiological trends. Those reams of data are what most excite Dr. Boehmer.
“NanoSENSE is going to produce many types of data we haven’t had previously for heart failure patients,” he says. “Being able to describe what happens in patients with heart failure when they’re stable and in the lead-up to a heart failure event is going to teach us so much about this condition. Our hope is to generate a risk scale and then move into further clinical trials to demonstrate the efficacy of this tool to manage patients. We want to demonstrate not only that we can predict what will happen but also that we can intervene to prevent adverse outcomes.”
SimpleSENSE features an attached electronic unit and a mobile phone for uploading data to the cloud. Eventually, Dr. Boehmer envisions using the mobile device to allow patients to access and manage their data. He sees the benefits of SimpleSENSE as equal parts patient empowerment and improved heart failure management.
“We have too many patients experiencing recurrent symptoms, too many who don’t know what’s going on until they’re gasping for air and too many coming back to the hospital,” Dr. Boehmer says. “We want to give patients control of their life, not only so they can know what’s happening when they become symptomatic, but also so they can manage heart failure preemptively.”
“Penn State Heart and Vascular Institute is quality driven. Whatever we offer, whether it’s new technology or therapies that are well established, we pride ourselves on assuring patient safety and quality. That is so the physicians who refer to us and the patients who seek care from us will have no doubt that ours is the best possible place to receive cardiac care.”
— Behzad Soleimani, MD, interim chief of cardiac surgery, associate professor of surgery, co-director of heart failure services and surgical director of heart transplant and mechanical circulatory support at Penn State Health
Reducing the Burden of Heart Pump Explant Operations
For a century, cardiologists have understood that ailing hearts need rest to recover, says Behzad Soleimani, MD, interim chief of cardiac surgery, associate professor of surgery, co-director of heart failure services and surgical director of heart transplant and mechanical circulatory support at Penn State Health. Eventually, bed rest as treatment gave away to a more targeted form of rest — allowing a mechanical heart pump to assume the heart’s function while giving the muscle an opportunity to recover.
“With a heart pump in place, a minority of hearts respond by rejuvenating and regenerating to a sort of normal function,” Dr. Soleimani states. “In up to 10% of patients, the heart recovers to a point where, if we turn off the pump while it’s in place, the heart takes over and the patient’s cardiac function is normal.”
In such cases, a cardiac surgeon will explant (remove) the heart pump, an operation that — because of its complexity and potential to reverse the heart’s recovery due to the stress of surgery — surgeons are increasingly performing using a minimally invasive approach. Using this approach, the surgeon removes the pump through a small incision over the apex of the heart rather than a sternotomy. The minimally invasive procedure, however, is not without drawbacks.
“With a minimally invasive explant, our ability to do the maneuvers we could do with an open operation is limited,” Dr. Soleimani explains. “When we remove the pump, the patient is left with a defect at the heart’s apex that is up to two inches in diameter. The conventional way to deal with that is to close it by suturing, but that prolongs the operation and risks bleeding and other complications that could hamper the patient’s recovery and compromise the recovery state of the heart.”
To solve that problem, in carefully selected patients, Dr. Soleimani uses an emerging technology — solid titanium plugs to close the hole in the heart. A non-FDA-approved technology that is not widely used in the United States, titanium plugs increase the speed and efficiency, as well as reduce complications of minimally invasive heart pump explantations.
“Titanium is not a reactive metal, so the metal surface that’s exposed within the heart doesn’t cause inflammation or other reactions,” Dr. Soleimani says. “The plug stays in place for life.”
Penn State Health has used titanium plugs in two cases, both of which received FDA approval on compassionate use grounds. The results have been excellent, and Dr. Soleimani hopes to perform up to five minimally invasive heart pump explantations with titanium plugs per year. Minimally invasive explantation using the plugs is ripe for widespread adoption, he believes, once other centers recognize its benefits.
“A lot of centers are concerned about the fragility of the recovery state and the risks of performing a complex operation to remove these pumps, so they keep patients who are in a recovery state on mechanical circulatory support,” Dr. Soleimani explains. “Heart pumps aren’t perfect. They can cause complications, such as stroke. Leaving patients on pumps when they no longer need them puts them at unnecessary risk. As other centers realize the safety and efficacy of this new technology, more and more patients will benefit from explanting these devices and freeing them of the burden of living with a pump.”
For more information about Penn State Heart and Vascular Institute, visit hmc.pennstatehealth.org/heart-and-vascular-institute or call 877-467-7484.