Key Study Results
Rheos® Pivotal Hypertension Trial
The effectiveness and safety of the Rheos System was evaluated in the Rheos Pivotal Trial. A total of 322 resistant hypertension patients participated in the trial. A subset of 60 patients from this trial had images of their heart taken prior to having the Rheos implant and after 12 months of therapy.
- 13% reduction of left ventricular mass
Pressure Volume Study
In a pressure volume study by Wachter R. et al, PV loop images were taken of a 78 year old male patient who had received 12 months of Barostim Therapy™ to evaluate the therapy’s impact on heart structure and function. The below PV loops demonstrate that Barostim Therapy significantly improves cardiac function by increasing the stroke volume and reducing the arterial resistance.
Barostim neo™ Heart Failure Study
11 patients with HFrEF enrolled in an open-label study of Barostim neo. Therapeutic effect was measured by chronic changes in NYHA functional class, Minnesota living with HF questionnaire, 6-minute walk distance, and estimated glomerular filtration rate (eGFR).
- Reduction in the pathologic elevation of sympathetic nerve activity present in HFrEF
- Improved 6-minute hall walk
- Improved NYHA class
Barostim neo® Randomized Controlled Trial for Heart Failure
A 146-patient, prospective, randomized, controlled clinical study to determine efficacy and safety for patients with heart failure has been completed.
Participating centers were from Europe and North America. Key patient characteristics were NYHA Class III and LVEF ≤ 35%. Patients were randomized to Barostim Therapy® plus medical management or to medical management. Results were presented at the 2015 American College of Cardiology at a Featured Clinical Research Session and simultaneously published in JACC-HF: “Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction”¹. A subgroup analysis of patients with and without Cardiac Resynchronization Therapy (CRT) was presented at the European Society of Heart Failure’s Heart Failure 2015 meeting and simultaneously published in the European Journal of Heart Failure: “Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction: Safety and Efficacy in Patients with and without Cardiac Resynchronization Therapy”².
- Barostim Therapy is safe in heart failure with reduced ejection fraction (HFrEF) patients
- Improved 6-minute hall walk
- Improved patients’ quality of life (Minnesota Living with Heart Failure Questionnaire)
- Improved LV ejection fraction
- Improved patients’ NYHA classification
- Reduced NTproBNP levels
- Reduced heart failure hospitalizations
¹Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE, Senni M, Swarup V, Wachter R, Little WC, Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction, JACC: Heart Failure (2015), doi: 10.1016/j.jchf.2015.02.006.
²Zile M, Abraham W, Weaver F, Butter C, Ducharme A, Halbach M, Klug D, Lovett E, Mueller-Ehmsen J, Schafer J, Senni M, Swarup V, Wachter R, Little W. Baroreflex Activation Therapy for the Treatment of Heart Failure with a Reduced Ejection Fraction: Safety and Efficacy in Patients with and without Cardiac Resynchronization Therapy. European Journal of Heart Failure (2015), doi: 10.1002/ejhf.299/abstract.
Disclaimer for Canadian Healthcare Professionals: Exclusively for clinical investigations