Debbie A. Rinde-Hoffman, MD, FACC is an Advanced Heart Failure and Transplant Cardiologist and the Vice Chief HVI Business Development and Physician Networks at Tampa General Hospital.
At Tampa General Hospital, she and her team have integrated Barostim into their heart failure offerings to address the unmet needs of patients with advancing heart failure who are not yet candidates for therapies like LVAD or heart transplantation. In our conversation, Dr. Rinde-Hoffman discusses her experience with Barostim and its role in the heart failure care continuum.
Why have you incorporated Barostim into your clinical practice?
Dr. Rinde-Hoffman: In Class III heart failure, certain patients may benefit from other modalities beyond medication to help them feel better. The quality of life for patients with persistent Class III heart failure symptoms can be poor and limited, despite maximally tolerated Guideline Directed Medical Therapy (GDMT) and disease specific procedures. These patients are unable to do everyday activities like walking up a flight of stairs or caring for themselves without having to stop to rest. Barostim is an additional modality to help improve quality of life for these heart failure patients. Barostim helps them live better, so they can do the things that they enjoy with more ease.
How would you describe Barostim’s mechanism of action to a colleague?
Dr. Rinde-Hoffman: We consider congestive heart failure a state of autonomic distress. The sympathetic nervous system is overstimulated, which has its own cascade of negative ramifications. The parasympathetic nervous system is under stimulated, which has its own set of negative ramifications. With better regulation of the autonomic nervous system, using Barostim, we can get a bang on both sides. If we can decrease sympathetic output, that’s a good thing. If we can increase parasympathetic output, that’s a good thing. There is considerable potential to explore how Barostim and medical therapies can work together to achieve more for patients in this area.
How does Barostim work with GDMT?
Dr. Rinde-Hoffman: Barostim and GDMT complement each other to better help the patient. Ultimately, Barostim works on the same neurohormonal pathways as GDMT, but further upstream.
What patients do you consider for Barostim?
Dr. Rinde-Hoffman: When a heart failure patient continues to feel poor when on maximally tolerated medications we then look for other correctable sources. Some of these sources may be coronary artery disease, mitral valve disease, atrial fibrillation, sleep apnea, or other thyroid problems. We consider Barostim for heart failure patients who did not respond to corrective treatments or did not qualify, with the goal of improving their quality of life.
How does Barostim demonstrate a positive impact on quality of life?
Dr. Rinde-Hoffman: Barostim received FDA approval based on quality of life measures, including: MLWHF scores, NYHA class improvement, and increased 6-minute hall walk. The BeAT-HF pivotal trial results, and subsequent data reviews, illustrate that the quality of life of a patient with persistent heart failure symptoms can be positively impacted by receiving Barostim.
Have you seen medication adjustments after implementing Barostim?
Dr. Rinde-Hoffman: Yes. At times, not always, but at times diuretic requirement goes down, which makes sense if the patient is able to physiologically do better. Diuretics or the loop diuretics are not a part of GDMT. They are not disease modifying medications. They are symptom controlling medicines and volume controlling medications.
Do you have a real-world example of how Barostim made an impact on a patient’s quality of life?
Dr. Rinde-Hoffman: One of our very first Barostim patients, a 67-year-old gentleman, had to retire because he could not keep up at work due to his heart failure symptoms. He also had to quit riding his bike because he just couldn’t physically do it anymore. His heart failure had not advanced enough to be a candidate for LVAD or heart transplant, but his persistent symptoms limited his life and left him suffering.
We moved forward with implanting Barostim and not only was he able to return to work, but he rides his bike there! He was just the happiest guy ever. While not all patients will have the same response he did, Barostim can allow people to do the things they like with more ease. It’s a win-win for the patient and the clinician.
Is Barostim considered an advanced heart failure therapy?
Dr. Rinde-Hoffman: No. If a heart failure patient is so far down the road as to need an LVAD, you probably missed the window for Barostim. We really want to consider patients before their condition progresses to being evaluated for advanced heart failure therapies like LVAD and heart transplantation. The indication for Barostim also takes this into consideration with the BNP cut off and heart failure class designation. You really don’t want to take Class IV patients who are so far down the road and then expect the device to help because I just don’t think that is the right patient population. Right patient, right procedure. Right patient, right time.
When making health decisions, do heart failure patients tend to prioritize quality of life?
Dr. Rinde-Hoffman: Yes, however, I think it also depends on their stage of life. Younger patients tend to want to live longer, while feeling better. For patients later in years, it is often more important to live well than to live longer. It is important to recognize that each patient’s situation is individual, and they have their own personal goals. In my experience, for patients in the latter half of their life, quality of life is probably more important than quantity of life. This is especially true, if they do not feel good or are unable to function.
Views expressed are those of the physician and not necessarily of CVRx. Dr. Debbie Rinde-Hoffman is a paid consultant for CVRx.
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Important Safety Information
CAUTION: Federal law restricts this device to sale by or on the order of a physician. See Instructions for Use 900133-001 for a complete instruction for use and a description of indications, contraindications, warnings, precautions and adverse events.
Barostim™ Brief Summary for Physicians
The Barostim System is indicated for patients who are NYHA Class III or Class II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a left ventricular ejection fraction of ≤ 35%, and a NT-proBNP <1600 pg/ml. Barostim delivers Baroreflex Activation Therapy for improvement of patients’ heart failure functional status, six-minute hall walk, and quality of life.
Patients are contraindicated if they have bilateral carotid bifurcations located above the level of the mandible, baroreflex failure or autonomic neuropathy, uncontrolled symptomatic cardiac bradyarrhythmias, carotid artery stenosis greater than 50% caused by atherosclerosis, as determined by ultrasound or angiographic evaluation, ulcerative plaques in the carotid artery as determined by ultrasound or angiographic evaluation, known allergy to silicone or titanium.
Warnings include: only trained physicians may use this system, prescribing physicians should be experienced in the diagnosis and treatment of heart failure and should be familiar with the use of this system, blood pressure and heart rate should be monitored during Carotid Sinus Lead placement and when adjusting stimulation parameters intra-operatively, system programming post-implantation, should avoid the following: heart rate falls below 50 beats per minute (BPM), or systolic pressure falls below 90 mmHg, or diastolic blood pressure falls below 50 mmHg, or problematic adjacent tissue stimulation is noted, or undesirable interaction indicated by monitoring of any other implanted electrical device, or any other potentially hazardous patient responses are observed. For patients who currently have an implanted electrical medical device, physicians must verify compatibility with the implanted device during implantation of the system as well as whenever settings are changed in either implant. Interactions are more likely in devices that contain a sensing function, such as an implantable cardiac defibrillator or pacemaker. If an interaction is observed, the Barostim NEO and NEO2 should be programmed to reduced therapy output settings in order to eliminate the interaction. If necessary, change settings in the other implant only if the changes are not expected to negatively impact its ability to perform its prescribed therapy. During the implant procedure, if device interactions cannot be eliminated the Barostim System should not be implanted. Improper system implantation could result in serious injury or death. Do not use diathermy therapy including shortwave, microwave, or therapeutic ultrasound diathermy on patients implanted with the system. Patients should be counseled to stay at least 15 cm (6 inches) away from devices with strong electrical or magnetic fields such as strong magnets, loudspeaker magnets, Electronic Article Surveillance (EAS) system tag deactivators, arc welders, induction furnaces, and other similar electrical or electromechanical devices. This would include not placing items such as earphones in close proximity to the implanted pulse generator. The system may affect the operation of other implanted devices such as cardiac defibrillators, pacemakers, or neurological stimulation systems.
Precautions include: the system should be implanted and programmed carefully to avoid stimulation of tissues near the electrode or in the area of the IPG pocket. Such extraneous stimulation could involve the following: the regional nerves, causing laryngeal irritation, difficulty swallowing, or dyspnea, the cervical musculature, causing intermittent contraction, skeletal muscles, causing intermittent contraction around the IPG pocket. Proper sterile technique during implantation should be practiced and aggressive pre-operative antibiotics are recommended. Infections related to any implanted device are difficult to treat and may necessitate device explanation.
It is anticipated that subjects will be exposed to operative and post-operative risks similar to related surgical procedures involving the neck and/or a pacemaker implant. These risks and potential risks of chronic device based Barostim may include, but are not limited to: stroke, transient ischemic attack (TIA), systemic embolization, surgical or anesthetic complications, infection, wound complications, arterial damage, pain, transient, temporary or permanent nerve damage/stimulation, hypotension, hypertensive crisis, respiratory, exacerbation of heart failure, cardiac arrhythmias, tissue erosion/IPG migration, injury to baroreceptors, fibrosis, allergic reaction, general injury to user or patient, need for reoperation, secondary operative procedure, and death. Patients implanted with the system may receive Magnetic Resonance Imaging (MRI) only when all MR Conditional safety parameters are met as listed in the instructions for use.
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For a list of all potential benefits and risks go to www.barostim.com/benefit-risk-analysis/
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