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Clinical Outcome Assessments Inform Indications for Use in Breakthrough Heart Failure Symptoms Device

Clinical Context

Heart failure occurs when the heart’s ability to pump blood does not meet the body’s needs. Patients with heart failure may experience fatigue, shortness of breath, cough, and leg swelling. Heart failure is a chronic disease needing lifelong management and many treatments exist to improve symptoms and extend life. Current treatments include lifestyle changes, medications, cardiac resynchronization therapy, and surgery.

Device Description

The BAROSTIM NEO System (Premarket Approval P180050) is a Class III carotid sinus stimulator, an implantable medical device that delivers electrical signals to the body’s pressure sensors to improve symptoms of advanced heart failure. It was approved in August 2019.

Indications for Use

The BAROSTIM NEO System is indicated for the improvement of symptoms of heart failure – quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction ≤35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines; see Summary of Safety and Effectiveness Data (PDF).

Context of Clinical Outcome Assessment (COA) Use

The Breakthrough Devices Program facilitated development of the prospective, randomized, two-arm, parallel-group trial to evaluate the safety and effectiveness of the BAROSTIM NEO System. The device sponsor, study executive steering committee, and the FDA collaborated to construct the innovative two-phased study design. This PMA is based on results from the first phase.

Inclusion and exclusion criteria were carefully selected and included measures of patient heart failure progression through the New York Heart Association functional class assessment by a clinician (clinician-reported outcome, or ClinRO) and patient performance in a 6-minute walk test (performance outcome, or PerfO).

The investigation was designed to assess patient quality of life, functional capacity, and a heart failure biomarker. Two of these three primary effectiveness endpoints were COAs. Patient quality of life was measured using the Minnesota Living with Heart Failure Questionnaire (patient-reported outcome, or PRO). The 6-minute walk test (PerfO) was employed to track patient functional capacity.

Lessons Learned

Impaired heart function coincides with a reduction in a patient’s quality of life and daily function. In chronic conditions like heart failure, PROs and PerfOs can play an important role in quantifying the impact of a treatment on the patient’s health status, complementing traditional clinical endpoints like ejection fraction and mortality.

The innovative clinical investigation design to assess the safety and effectiveness of the BAROSTIM NEO System relied heavily upon COAs to inform the device’s Indications for Use. The ability of COAs to capture a treatment’s impact on patient function and quality of life makes them critical components to include in device review, especially for devices intending to treat symptoms of heart failure like the BAROSTIM NEO System.


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