Frequently Asked Questions
Learn more by reading the FAQs below:
Learning About Barostim
- Barostim is an implantable device to improve heart failure symptoms, such as shortness of breath and fatigue.
- There are specialized pressure sensors located on the carotid artery, known as baroreceptors, in your neck that continuously signal information about blood volume and blood pressure to the brain. In heart failure patients, the signals from these sensors to the brain are reduced. The brain interprets this as a problem and responds by increasing the stress response – fight or flight – in the body, which worsens heart failure symptoms. Barostim delivers electrical stimulation to the baroreceptors to increase the signaling to the brain. The brain interprets this to mean that things have returned to normal and, thus, reduces the stress response. This has been shown in clinical trials to significantly improve the symptoms of heart failure, such as the distances patients could walk, their quality of life, and reduced shortness of breath and fatigue.
- Barostim and pacemakers are both cardiovascular therapies but are used for different reasons. A pacemaker treats a slow heart rate. The Barostim System is used for the improvement of heart failure symptoms, including shortness of breath or fatigue, in patients who are already on guideline-directed therapies.
- An ICD is part of guideline-directed therapy for heart failure and is used to prevent sudden cardiac death. Barostim is used to improve the symptoms of heart failure, like shortness of breath and fatigue, in patients who are already on guideline-directed therapies.
- Yes, the majority of patients who receive a Barostim system already have an existing pacemaker, ICD, or CRT device.
- Physicians will work with you to determine if you qualify for Barostim. Generally, patients who qualify for Barostim have been diagnosed with heart failure and have an ejection fraction 35% or less. Physicians will also look at your heart failure symptom classification, EKG and a blood test called NT-proBNP to determine if Barostim is right for you.
Preparing for my Appointment
- It is important for you to speak with your physician about how your heart failure impacts your daily life. Be prepared to talk about the symptoms you experience, like shortness of breath and fatigue. Be prepared to explain what heart failure prevents you from enjoying, like not being able to play with children or grandchildren, not being able to take care of yourself or your home, or not being able to do the things in your daily life that bring you happiness like traveling, gardening, or activities with friends.
Getting Barostim
- First, a physician will review your medical records to determine whether you might qualify for Barostim. If the physician determines Barostim might be an option for you, some diagnostic tests will be performed, including an echocardiogram, EKG, and blood tests, to determine if you are a candidate for Barostim. If you are determined to be a candidate for Barostim, an ultrasound of your carotid arteries will be done, and you will meet with a surgeon to discuss the implant procedure.
- The Barostim system includes a device that is implanted just below the collar bone, similar to an ICD or pacemaker, and an electrode that is sutured to the outside of an artery in the neck without any hardware in the heart or vasculature. Barostim is usually implanted in an outpatient surgical procedure and patients typically go home the same day.
Life With Barostim
- Patients typically experience the full benefits of Barostim between 3 and 6 months as the therapy is optimized.
- Barostim was approved as a therapy to work with heart failure medications. Your physician is the only one who can determine if any medication changes should be made.
- Most patients are able to return to routine, non-strenuous, activities within 72 hours. CVRx recommends following the specific post operative instructions provided by your physician the day of implant.
- As with any surgical procedure, the visibility of the scars will depend on your skin tone and individual healing process.
- Barostim has MRI Conditional approval, which means it is safe to be used during an MRI scan for some body areas and under specific scan settings.
- Your physician can contact Barostim Product Technical Services to determine MRI eligibility at [email protected] or 763-416-2343.
- Yes. However, the Barostim system may cause artifacts in ECG tracings; your provider can temporarily stop Barostim to perform medical diagnostics like an ECG.
- If your provider has technical questions regarding your device, have them contact Barostim Product Technical Services at [email protected] or call 763-416-2343.
Other FAQs
- Typically, patients have 3 to 5 appointments with a physician in the first 3 months following implant to adjust the settings of Barostim. Following this adjustment phase, most patients will have their Barostim device evaluated twice a year during their regular visits with their physician. The number and frequency of adjustments to Barostim are directed by a physician, so the schedule may vary from patient to patient.
- Barostim batteries typically last 5 to 6 years.
- Most insurance plans require a prior authorization is obtained before Barostim surgery to ensure that a patient meets the medical necessity criteria of the plan.
