Heart Failure Management

The mechanism of action

The human body has its own physiologic mechanisms for sensing changes in blood pressure and other blood flow changes. This natural system is largely located in the brain, as well as in the walls of the carotid arteries, which are the vessels in the neck that supply blood to the brain. Pressure sensors, called baroreceptors, are found on the carotid artery and in the carotid sinus. These sensors measure and report blood flow to the brain, which compares it to the body's needs.  

BAROSTIM THERAPY™ is a neuromodulation therapy that activates the baroreceptors. By doing this, BAROSTIM THERAPY™ triggers the body's main cardiovascular reflex, thereby addressing the underlying causes of the progression of heart failure. ¹

By activating the baroreceptors in the wall of the carotid artery, BAROSTIM NEO™ is able to stimulate the afferent and efferent pathways of the autonomic nervous system. The brain responds to BAROSTIM THERAPY™ by modulating efferent pathways, which relaxes the blood vessels, slows the heart rate and reduces fluid in the body by improved kidney function. BAROSTIM THERAPY™ also works to reduce the load on the heart by decreasing arterial resistance, thereby improving the heart's ability to pump blood to the tissues. The increase in parasympathetic tone and decrease in sympathetic drive results in the restoration of autonomic balance, which improves cardiac structure and function.

BAROSTIM THERAPY™ is the only treatment proven to reduce sympathetic activity while restoring parasympathetic activity. ^2,3,4

References: 
1. Gronda E et al. Baroreflex Activation Therapy: A New Approach to the Management of Advanced Heart Failure with Reduced Ejection Fraction" 2016 (In submission). 2. Abraham WT et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-96. 3. Zile MR et al. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction: safety and efficacy in patients with and without cardiacresynchronization therapy. Eur J Heart Fail. 2015 Oct;17(10):1066-74. 4. BAROSTIM NEO™ system reference guide. Available here – Last accessed March 2016

Demonstrated mechanism of action

BAROSTIM THERAPY™ elicits effect on muscle sympathetic nerve activity and heart rate. ² Muscle sympathetic nerve activity (MSNA) falls as BAROSTIM THERAPY™ is titrated.³

Demonstration of Peripheral Improvement:

Normalisation of cardiac autonomic tone is reflected in improved heart rate variability, as shown after 3 months of BAROSTIM THERAPY™:⁴

The disease

Heart failure is a condition where the heart cannot pump enough blood to meet the body's needs. The main symptoms of heart failure are:

• General fatigue or weakness
• Shortness of breath
• Swelling in the legs and ankles

A person's life is significantly changed when living with heart failure. Symptoms, medications and hospital stays can make living difficult, and heart failure patients' physical, mental and social functioning is worse than other severe conditions. ^1,2 In fact, heart failure patients report more severe impairment of quality of life than people with a history of:^1,2

• Chronic lung disease
• Arthritis
• Angina

And they report a similarly reduced quality of life as patients with: ³

• Parkinson's
• Multiple Sclerosis
• Renal failure      
• Chronic bronchitis
• Emphysema
• Cancer

Heart failure can get worse with time, and without effective treatment, there is a risk of death within five years of being diagnosed. ⁴

Autonomic imbalance plays a major role in the disease progression of patients with heart failure and a reduced ejection fraction. ^5,6 Increased sympathetic tone and decreased parasympathetic activity exerts adverse cardiac, vascular, and renal effects resulting in pathological myocardial remodeling, peripheral vasoconstriction, and salt and water retention.⁶

References:
1. Hobbs FDR et al. Impact of heart failure and left ventricular systolic dysfunction on quality of life. European Heart Journal (2002) 23, 1867–1876. 2. Litwin MS. Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study. J Urol. 1997;May;157(5):1608-12. 3. Cleland JG, Swedberg K, Follath F et al. (2003) The EuroHeart Failure survey programme – a survey on the quality of care among patients with heart failure in Europe. Part 1: patient characteristics and diagnosis. European heart journal 24:442–63. 4. Ho KK et al. Survival after the onset of congestive heart failure in Framingham Heart Study subjects. Circulation. 1993 Jul;88(1):107-15.  5. Abraham WT et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-96. 6. Zile MR et al. 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. Eur J Heart Fail. 2015 Oct;17(10):1066-74.

The need for better therapies

Despite advances in medications and treatments, millions of people with systolic heart failure continue to have symptoms.  In fact, despite current available therapies, 25%- 35% of patients with heart failure and an LVEF ≤ 35% remain categorised as NYHA III.  These patient types are not considered sick enough for end-stage heart failure therapies, such as mechanical circulatory support devices or heart transplantation. ¹

In addition, many patients are not candidates for the only currently approved device therapy also known as cardiac resynchronization therapy. Studies have shown that about 2 out of 3 people with systolic heart failure do not qualify or do not benefit from cardiac resynchronization therapy. ²

References:
1. Abraham WT et al. Baroreflex Activation Therapy for the Treatment of Heart Failure With a Reduced Ejection Fraction. JACC Heart Fail. 2015 Jun;3(6):487-96. 2. Hawkins n et al. Am J cardiol 2015; 116 (2); 318-324.

The key benefits

BAROSTIM THERAPY™ offers a safe and therapeutic benefit for NYHA Class III heart failure patients with LVEF ≤35%, especially for those who are not eligible for CRT. ¹

BAROSTIM THERAPY™ offers heart failure patients improved quality of life, symptoms and functional capacity through its unique mode of action. It is a neuromodulation therapy that triggers the body's main cardiovascular reflex to address the underlying causes of the progression of heart failure.

BAROSTIM THERAPY™ has demonstrated a reduction in HF related hospitalisations along with a substantial improvement in heart failure parameters. 

Beyond guideline-based therapy, BAROSTIM THERAPY™ is considered as an optimal heart failure therapy available for non-eligible CRT patients.

Significant LVEF improvement at Month 6 of BAROSTIM THERAPYTM1

Clinically meaningful, significant NT-proBNP improvement1

References:
1. Zile MR et al. 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. Eur J Heart Fail. 2015 Oct;17(10):1066-74.

An expert's perspective

Hear first-hand how Prof. Gronda uses BAROSTIM THERAPY™ in his cardiology department:

In summary

* average of procedure time of 108 +/- 5 minutes

Improve quality of life, symptoms, and functional capacity of heart failure patients with BAROSTIM THERAPY™

BAROSTIM THERAPY™ is indicated for: NYHA class III heart failure patients with LVEF ≤35%, offering an effective therapeutic benefit especially to those who are not eligible for CRT. ^1,2

Some examples of these patients are:

Patients with QRS <130 ms:

Patient may present with:  3   Moderate to severe HF symptoms In sinus rhythm or not in sinus rhythm Male or female On optimal therapy such as ACEIs, ARBs, beta blockers, and still require increased dose of daily diuretics BAROSTIM THERAPY™ benefits: Safe and effective treatment for heart failure patients with narrow QRS duration2 Substantial improvement in LVEF of 4.4 percentage points in non-CRT patients at 6 months of active treatment2

Patients with non-LBBB and QRS 130-149ms:

Patient may present with: 4-7   Older age of >50 years Male gender Repeated heart failure-related hospitalisations Ischemic or non-ischemic cardiomyopathy BAROSTIM THERAPY™ benefits: Clinically meaningful, significant NT-proBNP improvement2 84% reduction in heart failure hospitalization days2

Patients with cardiorenal syndrome:

References : 
1. Abraham 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), 3(6):487-496. 2. Zile 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. 3. Kogawa R et al. Dramatic Response to Cardiac Resynchronization Therapy With AV Delay Optimization in Narrow QRS Heart Failure. Int Heart J 2015; 56: 671-675. 4. Summary card for general practice. European Society of Cardiology^®; available here last accessed March 2016. 5. CVRx Data on file: Halbach et al. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. 2016. Abstract submitted to ESC. 6. Eriksson P et al. Bundle-Branch Block in a General Male Population: The Study of Men Born 1913. Circulation. 1998;98:2494-2500. 7. Bilchick KC, Kamath S, DiMarco JP, Stukenborg GJ. Bundle-branch block morphology and other predictors of outcome after cardiac resynchronization therapy in Medicare patients. Circulation 2010;122: 2022–30. 8. Tang, WH and W. Mullens W. Cardiorenal syndrome in decompensated heart failure". 2010 Heart 96 (4): 255–260.

Over 1,000 patients have been treated with BAROSTIM THERAPY™

Hear first-hand how BAROSTIM THERAPY™ has impacted these patients' lives: 

The BAROSTIM NEO™ Global Registry 

The BAROSTIM NEO™ Global Registry monitors the effect of BAROSTIM THERAPY™ in patients in a commercial setting.  If you would like more information about the BAROSTIM NEO™ Global Registry, please click here.
 

The Baroreflex Activation Therapy for Heart Failure Pivotal Clinical Trial (BeAT-HF)

Clinical trial sites are currently enrolling up to 480 patients in a Phase III Pivotal Trial, evaluating BAROSTIM THERAPY™ for the treatment of heart failure.  

Please visit the  BeAT-HF website or the ClinicalTrials.gov website for more information.