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Allegheny Health Network Cardiovascular Institute First in Pittsburgh to Implant Breakthrough Neuromodulation Device as Alternative Therapy for Heart Failure Patients

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“Today’s announcement is an exciting milestone for our heart failure patients…it provides another innovative approach proven to minimize the harmful effects of heart failure and restore the quality of overall life of a patient”, – Dr. Satish Muluk, Director of the AHN Division of Vascular Surgery.

Allegheny General Hospital (AGH) Vascular Surgeons Cardiovascular InstituteThe Allegheny Health Network’s (AHN) flagship academic medical center, today announced the first successful implantation of a new neuromodulation device used as an alternative therapy for patients with progressive heart failure (HF) who are not receiving can -not be adequate relief from medical therapies.

The device, titled Barostim™ Baroreflex Activation Therapy, is from Minneapolis-based medical technology company CVRx and is the world’s first FDA-approved HF device to use manipulation of the nervous system to invigorate the heart and improve its function.

The implantation procedure took place in early September under the clinical direction of Satish Muluk, MDvascular surgeon and director of the AHN Division of Vascular Surgery and Srinivas Murali, MDheart failure specialist and system chair of the AHN Department of Cardiovascular Medicine.

“Heart failure is a disease that slowly weakens and enlarges the muscle in the heart wall, preventing the heart from pumping enough oxygenated blood throughout the body,” Dr. Muluk explained. “Symptoms of heart failure are often progressive and the disease can worsen with medical treatment alone. Today’s announcement is an exciting milestone for our heart failure patients across western Pennsylvania, as it provides another innovative approach that has been proven to minimize the adverse effects of heart failure and restore a patient’s overall quality of life.

According to the American Heart Association, heart failure is one of the most common reasons people over the age of 65 are admitted to hospital. It is a chronic condition with symptoms ranging from shortness of breath and extreme fatigue to dizziness and water retention, among others.

About six million Americans are currently living with heart failure and research indicates the number of people living with cardiovascular disease is likely to reach 12.9 million by 2060. From a local perspective, the leading cause of death in Allegheny County is heart disease, ahead of cancer, injuries accidents and cerebrovascular diseases. Additionally, heart disease in Greater Pittsburgh’s population is significantly higher than the state average, according to the PA Department of Health.

To date, the prescribed management course involves a multidisciplinary approach involving medical therapies, lifestyle enhancements and surgical interventions ranging from minimally invasive implantations of pacemakers and defibrillators to more aggressive management routes of surgery to open heart for implanting a left ventricular assist device (LVAD) or heart transplant.

Unlike other HF treatment options, Barostim requires no hardware implantation in the heart, but uses an electrode that is placed over the patient’s carotid artery in the neck in a minimally invasive outpatient procedure. The electrode provides continuous electrical stimulation to the body’s carotid baroreceptors, the body’s natural mechanism that regulates cardiovascular function.

Barostim stimulation triggers both the sympathetic (“fight or flight”) and parasympathetic (“rest and digest response”) nervous systems of the body to create a unique balance which in turn better regulates the function of the heart system, renal and vascular of the patient.

“Unlike a pacemaker, Barostim stimulates the nervous system to treat a neuro-hormonal imbalance that is causing heart failure. In many cases, the baroreceptors in heart failure patients have lost their vigor and this device kicks the nervous system into high gear by restoring neuro-hormonal balance which, in turn, improves cardiovascular performance,” explained Dr. Murali. “Patients can go home the same day as the procedure, and our team is gradually adjusting the output of the device over the next few weeks to specifically tailor the electrical stimulation to achieve optimal improvement in the patient’s symptoms.”

The Journal of the American College of Cardiology published a study (https://doi.org/10.1016/j.jacc.2020.05.015) from cardiovascular researchers demonstrating the overall efficacy of Barostim in a controlled patient population living with heart failure and reduced ejection fraction. Four patient cohorts were created from 408 randomized patients with selected groups receiving baroreflex activation therapy and medical management or only optimal medical management. The results showed that Barostim patients were able to walk approximately 65 meters further in six minutes and had a three times greater improvement in quality of life scores compared to patients on medication alone.

“Providing innovative treatment options to heart failure patients is an important undertaking and we congratulate Drs. Muluk and Murali and Allegheny General Hospital on a successful implementation of Barostim,” said Nadim Yared, President and CEO. of CVRx.”We look forward to continuing to support Allegheny General Hospital to help more patients live fuller lives.”

For more information or to schedule an appointment with AHN Cardiovascular Institute, visit ahn.org.

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About Allegheny Health Network:

Allegheny Health Network (AHN.org) is an integrated health care delivery system serving the greater western Pennsylvania region. The network is made up of 14 hospitals, ambulatory surgery centers, Health + Wellness pavilions, multiple organizations of employed physicians, home and community health services, a research institute and a group of ‘purchases. The network provides patients with access to a full range of advanced medical services, including nationally recognized programs for primary and emergency care, trauma care, cardiovascular disease, organ transplantation, cancer care, orthopedic surgery, neurology and neurosurgery, women’s health, diabetes, autoimmune disease and more. AHN employs approximately 21,000 people, has more than 2,600 physicians on its medical staff, and serves as the clinical campus for Drexel University College of Medicine and Lake Erie College of Osteopathic Medicine.

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