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
For patients in cardiac arrest, every second counts, and targeted temperature management (TTM), or therapeutic hypothermia (TH), can prevent further damage. At Penn State Hershey, TTM protocol begins in the field, as the mobile intensive care unit, Life Lion, is empowered to initiate this neuroprotective therapy to unresponsive patients with vital signs. Upon arrival at the Medical Center, cooling to a targeted temperature of 32 to 36 degrees Celsius is continued via leg and torso wraps that are connected to a core cooling/warming pump device that travels with the patient to the cardiac catheterization lab and to the cardiac critical care unit. This temperature range is new, and recently has changed based on the most current research. TTM has been shown to improve neurological outcomes in patients following sudden cardiac arrest with return of spontaneous circulation (SCA-ROSC).1 A cerebral performance category (CPC) scale is used to measure cognitive recovery. Continue reading
Due to advances in treatment and technology, more patients than ever before who are born with congenital heart disease (CHD) are living into adulthood. For the first time, there are more adult than pediatric CHD patients, with the number of adult cases in the U.S. estimated at 1.3 million.1 The management of these patients is so complex that a new subspecialty of adult congenital heart disease (ACHD) is now available for certification by the American Board of Medical Specialties. Penn State Hershey Heart and Vascular Institute has long recognized the complex needs of this growing population, and started a program for adult congenital heart disease (PACHD) in 1991, which is directed by William Davidson, Jr., M.D.
Color Doppler image of severe pulmonic insufficiency, commonly found in Tetralogy of
Currently, the PACHD has three ACHD providers, all of whom are board certified, having sat for the first-ever ACHD subspecialty boards in October 2015. These specialized clinicians provide 24/7 coverage to all ACHD inpatients, and provide personalized, consistent care to complex patients, most of whom have six to 10 active medical conditions. Problems associated with congenital heart disease include valve disease, heart failure, arrhythmias, aortic and other vascular diseases; pulmonary, renal and liver disease; and a history of multiple surgeries. For example, one of the fastest growing ACHD patient populations have tetralogy of Fallot (ToF).2 This condition requires complex intracardiac “corrective” surgery. A common late consequence is pulmonary valve insufficiency (PI), which can lead to right ventricular dysfunction and sudden death.2 PI is a common lesion in this population that is often missed with conventional testing, according to Dr. Davidson. All ACHD patients require lifelong follow-up and regular visits to an ACHD specialist. Continue reading
MORE PATIENTS NOW CANDIDATES FOR VALVE REPAIR AND REPLACEMENT
Open sternotomy has long been considered the standard of care in cardiac valve surgery, affording the surgeon an unobstructed field in which to operate. Non-sternotomy procedures, however, are gaining in popularity as the advantages become clearer. However, due to the steep learning curve involved in this less invasive approach, a paradigm shift still needs to occur before it becomes as commonplace as open sternotomy is currently. Given the proliferation of hybrid surgical approaches and the increasing usage of non-sternotomy cardiac valve surgeries, Walter Pae, M.D., chief, cardiac surgery, Penn State Hershey Heart and Vascular Institute, hopes that paradigm shift is beginning. “Ultimately, our goal is to eradicate the sternotomy altogether.”
Single-institution experiences, compared to national results in the absence of randomized trials, have demonstrated that both mortality rates and the rate of dysrhythmias, such as supraventricular arrhythmias, are the same with non-sternotomy cardiac procedures and open sternotomy procedures. Length of hospital stay is reduced more than 20 percent, and one study showed 100 percent five-year survival using the non-sternotomy surgery versus 85 percent using the open sternotomy technique.¹ 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
Current guidelines recommend a multidisciplinary approach as optimal for treating patients who qualify for transcatheter aortic valve replacement (TAVR).1 In addition to a care team of cardiac surgeons and interventional cardiologists, echocardiographers are involved in every phase of transcatheter valve replacement: from pre-implantation patient screening and selecting an appropriate valve size, to intraprocedural guidance of wire and valve position and post-implantation assessment.1
At Penn State Hershey Heart and Vascular Institute, patients first receive a transthoracic echocardiogram (TTE) to examine the aortic valve and quantify the degree of stenosis. Based on the combination of those results and other factors, high-risk patients who are not surgical candidates (due to multiple comorbidities) are referred for TAVR. “Further preparation involves several additional studies including a transesophageal echocardiogram (TEE) with three-dimensional (3D) imaging of the aortic root. This allows physicians to measure the aortic annulus and determine the appropriate size for the replacement valve,” says Michael Pfeiffer, M.D., Penn State Hershey Heart and Vascular Institute. TEE with 3D imaging also examines other aspects of the heart that may impact the TAVR procedure, such as the morphology of the left ventricular outflow track and aortic root, co-existing mitral valve disease and coronary artery position. Patients also receive multi-detector computed tomography (MDCT) evaluation as part of their pre-procedure assessment. Both imaging techniques are complementary pieces of the complete pre-implantation assessment. Continue reading
The CardioMEMS™ HF System is the first Food and Drug Administration (FDA)-approved heart failure (HF) monitor proven to significantly reduce HF hospital admissions and improve quality of life in NYHA class III patients.1 This implanted, wireless, battery-free device measures key vital signs, including pulmonary artery pressure in HF patients, and transmits this information remotely to the patient’s doctors for proactive management. The device was evaluated in 550 people in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Patients) trial; Penn State Hershey Medical Center participated as an active enrolling center. During 15 months of follow-up, the treatment group had a 39 percent reduction in heart failure-related hospitalization compared with the control group.1
To participate, patients must have been hospitalized for HF in the 12 months prior. “That defines a relatively unstable population,” says John P. Boehmer, M.D., Penn State Hershey Heart and Vascular Institute. Once implanted, the CardioMEMS device requires patients to lie on a special mat every day. The mat includes an antenna that wirelessly connects and transmits data securely to a monitor that records 18 seconds of a pulmonary pressure tracing.
CardioMEMS Heart Failure Sensor. CardioMEMS and St. Jude Medical are trademarks of St. Jude Medical, Inc. or its related companies. Reprinted with permission of St. Jude Medical, ©2015. All rights reserved.