WHAT ARE MY TREATMENT OPTIONS?
Treatment can help to relieve the symptoms of heart failure and may help you live longer. There are several ways that heart failure can be treated.
Certain lifestyle changes such as increasing physical activity, decreasing emotional stress, weight loss, stopping smoking and eating less salt/fat may reduce heart failure symptoms
Doctors usually treat heart failure with a combination
of medications. Depending on your symptoms, you might take one or more medications including beta-blockers, ACE inhibitors, angiotensin receptor blockers (ARBs), blood thinners and diuretics.
In some cases, doctors recommend interventions such as bypass or valve replacement surgery, implantation of a cardioverter-defibrillator or cardiac resynchronization device, or a heart transplantation.
A NEW APPROACH
A new type of therapy is available for patients with heart failure. It is called Autonomic Regulation Therapy (ART) delivered through Vagus Nerve Stimulation (VNS). ART is being studied in a clinical trial called ANTHEM-HFrEF. This trial is currently enrolling patients who are eligible to participate to determine the long-term benefits of ART on patients suffering from heart failure. All patients who participate in the trial are receiving one of two equally valid and important treatments until the results of the trial are known.
THE ‘HEAD-HEART’ CONNECTION IN NORMAL HEALTH
The autonomic nervous system plays a large role in heart failure. The brain controls the function of the heart through two branches of the autonomic nervous system.
The first is the sympathetic branch, which acts as the body’s ‘accelerator’ and is responsible for the ‘fight or flight’ response during stress.
The second is the parasympathetic branch, which acts as the body’s ‘brake’ and allows the body to rest and digest. The parasympathetic branch acts through a special nerve in your body called the vagus nerve. In normal health, the two branches are said to be ‘in balance.’
BALANCED AUTONOMIC NERVOUS SYSTEM
Rest and digest
Fight or flight
AN AUTONOMIC IMBALANCE
IN HEART FAILURE
In heart failure there is an imbalance in the autonomic nervous system. The sympathetic branch is overactive while parasympathetic activity is under-active. In other words, the body is continually in a state of ‘fight or flight’ therefore not allowing the body to ‘rest and digest.’ While some heart failure medications may help to treat sympathetic overactivity, there are currently no proven treatments to effectively treat the underlying cause.
IMBALANCED AUTONOMIC NERVOUS SYSTEM
RESTORING THE BALANCE WITH ART
How it works:
Autonomic Regulation Therapy (ART) applies mild electrical impulses to the vagus nerve to activate the parasympathetic branch and restore balance. LivaNova uses a unique approach that tailors therapy to individual patient needs.
A new therapy, but a proven approach:
While vagal nerve stimulation is new for heart failure, the approach has been successfully used for over 20 years in the treatment of epilepsy with over 150,000 implants worldwide.
RE-BALANCING THE AUTONOMIC NERVOUS SYSTEM
THE ART SYSTEM AND PROCEDURE
ART IS DELIVERED THROUGH VNS BY THE VITARIA™ SYSTEM FROM LIVANOVA, WHICH CONSISTS OF:
Lead: a flexible insulated wire that transmits tiny electrical signals from the generator to the nerve.
Pulse Generator: a device similar to a pacemaker that is implanted just under the skin and sends the energy to the vagus nerve through the lead.
The VITARIA System is placed during a minimally invasive outpatient procedure lasting about an hour.
LivaNova USA, Inc.
100 Cyberonics Boulevard
Houston, TX 77058
IMPORTANT SAFETY INFORMATION
INDICATIONS FOR USE (EUROPE)
Autonomic regulation therapy (ART) is indicated for patients who have moderate to severe heart failure (NYHA Class II/III) with left ventricular dysfunction (EF ≤ 40%), and who remain symptomatic despite stable, optimal heart failure drug therapy.
CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS
The VITARIA® System cannot be used on patients with a bilateral vagotomy.
The VITARIA System cannot be used on patients with a history of AV block.
Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy on patients implanted with a VITARIA System. Diagnostic ultrasound is not included in this contraindication.
Magnetic Resonance Imaging (MRI) - The VITARIA System is an MR Conditional device that has been
shown to pose no known hazards in a specific MR environment with specified conditions for use. For specific conditions, refer to the VITARIA Physician's Manual. Patients with existing ulcers (gastric, duodenal or other) may have their condition aggravated by ART. Patients with ulcers should be evaluated prior to implantation and monitored following initiation of stimulation. Potential surgery-related adverse events include hematoma, infection, pain and voice alteration (hoarseness). Potential stimulation-related adverse events include dyspepsia (indigestion), dysphagia (difficulty swallowing), dyspnea (difficulty breathing, shortness of breath), increased coughing, laryngismus (throat, larynx spasms), pain, paresthesia (prickling of the skin), pharyngitis (inflammation of the pharynx, throat), satiety (reduced appetite), sensation of stimulation, and voice alteration (hoarseness).