As a national leader in cardiovascular care, Stanford Health Care ranks among the top 1% of stateside hospitals for the category of cardiology and heart and vascular surgery. In March 2024, a team of heart failure (HF) specialists and vascular surgeons completed Stanford Health Care’s first successful implantation of a device to treat patients with drug-resistant HF. The therapy effectively addresses HF symptoms and offers patients a new lease on life.

“This therapy provides immediate and lasting benefits to patients with advanced HF for whom other interventions have shown adverse side effects or proven inadequate,” says Jeffrey Teuteberg, MD, section chief of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support. “Our ability to rapidly improve the lives of these patients is a testament to both the device and the teamwork enabling the therapy it delivers.”

Addressing the symptoms of a progressive disease
In HF and reduced ejection fraction, patients can experience progressive symptoms, including:

• Fluid collecting in the lungs and lower extremities
• Shortness of breath during exercise or daily activity
• Generalized fatigue

Symptoms can be categorized according to four New York Heart Association (NYHA) functional classes. Patients with mild to severe HF (NYHA Class II or III) demonstrate increasing limitations on their physical activity, which are directly associated with decreased quality of life (QoL).

Guideline-directed medical therapy (GDMT) offers drug-based approaches to symptom treatment in these patients. Yet GDMT can have potential drawbacks in which patients demonstrate:

• Unresponsiveness or acquired resistance to the drug regimens
• Intolerance of drug dosages or combinations required for therapeutic response

Although device-based approaches, such as pacemakers and cardiac resynchronization therapy, may represent additional treatment options, not all patients are suitable candidates. Even for those receiving combined GDMT and device-based interventions, symptoms often persist or progress. This results in recurrent hospitalizations, further diminished QoL, and financial burdens on both the patient and health system.

“We’re excited to have another tool in the toolbox for our heart failure patients and especially one with demonstrated success in improving symptoms,” says Daniel Katz, MD, an advanced heart failure and transplant cardiologist. “The patient receiving our first implantation had a smooth recovery and is already experiencing increases in exercise capacity.”

Strengthening the heart–brain connection
To fill the gap in available treatment options for advanced HF, a small electrical device called Barostim™ was developed. This device helps manage nerve signals (neuromodulation) from baroreceptors, nerve endings in the aorta and carotid arteries.

Baroreceptors are responsible for regulating blood pressure and heart rate by sensing fluctuations in blood pressure based on artery wall constriction or dilation. Baroreceptors then signal the brain to activate either the sympathetic or parasympathetic nervous system to increase or decrease cardiac output, respectively (the baroreceptor reflex).

This coordinated response modulates the supply of blood pumped by the heart in response to the body’s needs. The ultimate purpose of baroreceptors is to return periods of high or low blood pressure to homeostasis. However, with HF, the sympathetic nervous system remains constantly active to compensate for the failing heart. The resulting imbalance drives further damage to the heart and symptom deterioration.

The device generates electrical impulses capable of addressing this imbalance. Following implantation under the skin near the collarbone, these signals travel along a small wire sutured to the right carotid artery. The impulses modulate the baroreceptor reflex, balancing activation of both sympathetic and parasympathetic signaling to maintain stable blood pressure and heart function.

The minimally invasive procedure for device implantation requires only two incisions and can be completed in an outpatient setting within one hour. Clinical studies show that therapies combining the device with medication resulted in significant improvements in exercise capacity and patient-reported QoL relative to treatments involving medication alone.

Importantly, studies also report improvements in HF symptoms by at least one NYHA class and a less than 3% incidence of major adverse neurological and cardiovascular events associated with the procedure.

“This device offers a safe, minimally invasive, and highly effective intervention for treating advanced HF,” says Jason Lee, MD, chief of vascular surgery. “Its proven efficacy in patients resistant or nonresponsive to standard therapies qualifies it as a life-changing breakthrough. I am proud of our vascular surgery faculty member Karthikeshwar Kasirajan (Kasi), MD for leading the first operation at Stanford Health Care Tri-Valley.”