Penn State Health Milton S. Hershey Medical Center has joined two multicenter trials that evaluate a total artificial heart (TAH) and may save the lives of even more patients with irreversible biventricular heart failure (BVHF). The focus of the observational studies is the SynCardia® TAH, which was first approved by the FDA as a bridge to transplant in a 70cc size, based on a study of 81 patients, 79 percent of whom survived to receive a transplant.1
The first study examines the safety of the 70cc device for use as destination therapy in patients with life-threatening BVHF who are ineligible for cardiac transplant. To date, 12 centers, including Milton S. Hershey Medical Center, are set to enroll patients and follow them for six months to confirm the device’s benefits. Researchers define success as survival to six months without permanent deficits from stroke. Patients may also participate in a secondary arm of the trial to determine whether a broader patient population would also benefit from the device.2 Continue reading
Number of eligible patients not taking oral anticoagulation (OAC). Image courtesy of Gerald Naccarelli, M.D.
As the population ages, increasing numbers of patients are presenting with atrial fibrillation, with the number projected to grow to more than 7.5 million in the U.S. by 2050.1 A strong correlation exists between atrial fibrillation and severe acute ischemic stroke.2 Citing large databases such as the PINNACLE-AF registry,3 Gerald Naccarelli M.D., Bernard Trabin Chair in Cardiology and chief, cardiology, Penn State Hershey Heart and Vascular Institute, says, “We have known since the late 1980s that warfarin was able to reduce the risk of stroke by two-thirds in high-risk patients with atrial fibrillation. However, close to half the patients who should be on anticoagulant therapy, according to guidelines, are not receiving it.” He cites multiple co-morbidities, shifting recommendations, and bleeding risk as possible causes, but emphasizes that maintaining brain function must be a key factor in treatment planning for even the most medically complex patients. Continue reading
Bellerophon Therapeutics Bioabsorbable Cardiac Matrix
A new device, bioabsorbable cardiac matrix (BCM), was just investigated in a randomized, double-blind, placebo-controlled trial to determine its safety and efficacy in preventing ventricular remodeling and congestive heart failure (CHF), when administered to subjects who had successful percutaneous coronary intervention (PCI) with stent placement after ST-elevation myocardial infarction (STEMI). Penn State Hershey Medical Center participated in this multi-center trial named PRESERVATION I.
BCM is an aqueous mixture of sodium alginate and calcium gluconate,1 which self-assembles in the body to form a gel-like “scaffold” for the heart in the presence of severely elevated calcium levels that occur as a result of cell death. This scaffold-like structure is designed to replace the damaged extracellular matrix that degraded during infarction, support the damaged myocardial tissue, decrease wall stress and prevent the heart from dilating.1 According to Ian Gilchrist, M.D., Penn State Hershey Heart and Vascular Institute, “It is thought that the heart dilates in the end-stage of congestive heart failure to compensate for areas of the muscle that are no longer viable; however, this causes the heart muscle to stretch and is the beginning of a downward spiral.” Continue reading
HEART AND VASCULAR INSTITUTE CARDIOLOGISTS USE LATEST TOOLS TO EXPAND PATIENT OPTIONS
Since 1976, when surgeons at Penn State Hershey Medical Center implanted the first Pierce-Donachy left ventricular assist device (LVAD) in the country, the technology has helped thousands of patients with severe heart failure survive until a donor heart is available for transplant. Today, however, Penn State Hershey Heart and Vascular Institute uses LVAD therapy not only as a bridge-to-transplant (BTT), but also as long-term destination therapy (DT). In fact, half of the LVAD placements now performed at Penn State Hershey are for DT usage.
Although heart transplantation remains the gold standard for advanced heart failure, LVAD can provide a viable option for many. Patients must have three main qualifications to be considered for LVAD therapy: 1) must be in advanced heart failure, but contraindicated for a heart transplant, or too sick to wait for a transplant, 2) must have reached the limits of medical therapy, and 3) must have a life expectancy of more than two years. Continue reading
- 37-year-old woman with the rare heart condition, giant cell myocarditis
- Presented with cardiogenic shock and was placed on Extracorporeal Membrane Oxygenation (ECMO).Initially received a HeartWare® LVAD and a CentriMag® right ventricular assist device.
- Developed heparin-induced thrombocytopenia, and as a result, clotted the LVAD.
- Additional surgery performed to remove pump and the majority of the heart and replace entire system with original Thoratec pump, T-VAD®, an external pump connected to pipes inside the body.
- Excellent. After close to ten surgeries and the entire spectrum of available pumps, the goal is heart transplantation.
Surgical aortic valve replacement is extremely low-risk for most patients. However, a significant number of patients are at high-risk for surgical valve replacement or are ineligible for surgery because of comorbidities. The less invasive TAVR procedure allows a new valve to be inserted within the native, diseased aortic valve, and can be performed utilizing multiple approaches (e.g., transfemoral, transapical, or transaortic).¹
Penn State Hershey Heart and Vascular Institute is unusual in its balanced case mix, according to chief of cardiac surgery, Walter E. Pae, Jr., M.D., “Our practice is fairly evenly divided among congenital pediatric heart defects, adult coronary disorders, and adult cardiac valve abnormalities. We perform up to 100 aortic valve replacements per year.” Interventional cardiologist Mark Kozak, M.D., concurs, noting that coronary disease is the focus of many institutions, due to its far greater frequency. Continue reading
Lawrence Sinoway, M.D., director, Penn State Hershey Heart and Vascular Institute, has been the lead investigator on “Acute and Chronic Afferent Engagement: Sympathetic and End Organ Responses,” a National Institutes of Health-funded project that started in 2010 and examines four separate aspects of peripheral arterial disease (PAD).
Less than 50 percent of PAD patients report the classic symptom of claudication, making the condition difficult to diagnose and treat. However, PAD is an alarming prognostic sign and correlates with significantly increased risk of cardiovascular mortality.¹ Sinoway describes another common therapeutic conundrum: “On the one hand, we as physicians see a disease caused by an arterial blockage and believe that by removing the blockage, patients will improve. While this may be true acutely, it is crucial to note that PAD, and indeed all forms of atherosclerosis, are chronic conditions that will return if patients don’t make lifestyle changes to reduce their future risk.”
In his primary study, Sinoway demonstrates that when PAD patients perform exercise with the affected leg, their arterial blood pressure becomes elevated as a result of the exercise pressor reflex, a cardiovascular change caused by muscular contractions. (Figure)
This blood pressure increase, which is directly related to the severity of the arterial blockage, can be controlled with high doses of ascorbic acid administered intravenously. Continue reading