Washington Regional Participates in Heart Failure Clinical Trial; First in Area to Implant Investigational Device
Washington Regional Medical Center is pleased to announce the region’s first implant of the BAROSTIM NEO® device in a patient with heart failure. BAROSTIM NEO is a new investigational device that is available only by order of a doctor who is participating in the BeAT-HF clinical trial. Dr. Joel Carver of Walker Heart Institute is leading the BeAT-HF™ clinical study site at Washington Regional Medical Center. Dr. Carver is working with other Walker Heart Institute physicians and staff, as well as Dr. Russell Wood of NWA Cardiovascular Surgery, Dr. Paul Farris of Farris Memorial ENT Clinic and numerous Washington Regional Medical Center departments to bring this new treatment to heart failure patients in the region.
CVRx, Inc., which has been developing and improving BAROSTIM THERAPY® products for over 10 years, is sponsoring the BeAT-HF Study. The study will evaluate the safety and effectiveness of the BAROSTIM NEO device for the treatment of heart failure. Up to 90 clinical sites and 480 patients will be involved in the study. Patients who have heart failure that cannot be controlled with medications and lifestyle changes are potential candidates for the study. The BAROSTIM NEO is like a pacemaker, consisting of a lead and a pulse generator that is implanted under the skin below the collarbone.
Heart failure is a condition where the heart cannot pump enough blood to meet the body’s needs. Heart failure is a serious condition that impairs heart function, resulting in shortness of breath, exercise intolerance and fluid retention. In the United States, heart failure is estimated to affect 5.1 million adults.1 Overall, heart failure is associated with a four-fold increased risk of death and a six to nine times increased risk of sudden cardiac death.1
Heart failure is a result of pumping problems. This can be due to a heart attack or other causes. A heart attack damages the heart muscle. The heart muscle stretches out and becomes frail and weak. A weak heart cannot squeeze strongly. This means the heart cannot pump out enough blood to meet the body’s needs. The main symptoms of heart failure are general fatigue or weakness, shortness of breath, and swelling in the legs and ankles.
BeAT-HF study patients will be randomized into two groups to either receive the investigational BAROSTIM NEO and medical management or to receive medical management only. The BeAT-HF Study will determine whether the BAROSTIM NEO System can help patients live longer, reduce the number of hospital stays due to heart failure, reduce heart failure symptoms, and improve quality of life.
BAROSTIM THERAPY has been studied in many patients with cardiovascular disease. In one global analysis of heart failure patients, 76 patients implanted with the BAROSTIM NEO showed improvement in functional status, quality of life, exercise capacity, and reduced heart failure hospitalizations compared with 70 patients without the BAROSTIM NEO. In that same study two people had complications from the BAROSTIM NEO System: One had a hematoma (internal bleeding) in the surgical area where the device was placed. The patient recovered with no lasting adverse effects. The other patient had a hematoma and an infection in the surgical area where the device was placed. The device was removed and the patient recovered with no lasting adverse effects.2
CAUTION: BAROSTIM NEO is an investigational device and is limited by United States law to investigational use.
1. Go A, Heart Disease and Stroke Statistics. American Heart Association - 2013 Update.
Circulation 2013;127:e6-e245
2. Abraham W, et al. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced
Ejection Fraction, JACC: Heart Failure 2015; 3(6):487-496