Evidence from high-quality controlled research trials shows that Optimizer (Impulse Dynamics,Inc.) and Barostim Neo (CVRx, Inc.) are more effective than Optimal Medical Therapy (OMT) for improving both Quality of Life (QOL) and functional status in patients with moderate to severe chronic Heart Failure (HF). Additional studies indicate that Optimizer implantation reduces HF symptoms and hospitalization risk, with benefits reported through five-year follow-up.
This post highlights two specific breakthrough treatments offered to patients with heart failure: the Optimizer Smart System and Barostim Neo System. Optimizer sends electrical impulses to the heart to enable it to pump more oxygen-rich blood to the body. Barostim uses electrical impulses to trigger the autonomic nervous system to regulate the heart, kidney, and vascular function.
Both treatments are implantable, minimally invasive, incorporate cutting-edge technology, and over time boost the heart’s natural contracting mechanisms – making them the best next-generation options when compared to traditional medications- . The Optimizer Smart System is the pioneer in delivering “Cardiac Contractility Modulation” and the Barostim Neo System is the only treatment available that reduces sympathetic nervous system activity while restoring parasympathetic activity, both of which can lead to improvements in heart failure symptoms.
From a bird’s eye view, it seems that the Barostim Neo System offers a more convenient and effective long-term treatment option since it aims to reduce overall heart failure symptoms with zero charging time. However, its battery life is significantly lower than that of the Optimizer Smart System. The Optimizer Smart System, on the other hand, has an outstanding battery life and a lower cost.
Given the severity of the condition, it is important to discuss with your cardiologist to understand your own eligibility for both treatments and if it’s better than having to rely on Medical Therapy alone.
Let’s take a quick look into both the devices:
| Optimizer Smart System | Barostim Neo System | |
|---|---|---|
| Manufacturer | Impulse Dynamics | CVRx |
| Inpatient/Outpatient Procedure? | Outpatient | Outpatient |
| Invasiveness | Minimal | Minimal |
| Sedation | Light | Light |
| FDA Approval | Yes | Yes |
| Eligibility | Patients that do not qualify for pacemakers, have physical limitations, and/or don’t benefit from medication. | Patients above 21 that do not qualify for pacemakers, have Heart Failure with Reduced Ejection Fraction (HFrEF), don’t benefit from medication, and have a regular heart rhythm. |
| Type of Technology | Cardiac Contractility Modulation (CCM) Therapy | Autonomic Nervous System Stimulation |
| Longevity | Up to 15 Years | Up to 6 Years |
| Potential Complications | Device wound, Pain, Infection, Bleeding, Arterial/Nerve damage, Irregular heart rhythm, and Lung damage. | Device wound, Pain, Infection, Bleeding, Arterial/Nerve damage, and Lung damage. |
| Charging Time | 1 Hr Per Week | None Required |
The term ‘heart failure’ sounds worse than it actually is. No, it doesn’t mean that the heart has completely stopped working or there’s no treatment for it. It actually just means that the heart isn’t pumping as well as it should.
It’s true that despite medical therapy, heart failure is challenging to manage. However, if given timely and accurate medical attention, it can be carefully monitored and managed.
We’re in the 21st century – if there’s anything that’s guaranteed, it’s the immense evolution of technology. Thanks to the advancements in health tech, we now have implantable medical devices that use innovative technologies to treat congestive heart failure and are proving to be superior to traditional drugs and treatments.
Some patients with heart failure are treated with traditional pacemakers. For many others, pacemakers will not provide any benefit. This is where Optimizer and Barostim come in. Multiple clinical trials have shown that they’re safe, effective, and convenient (and a godsend for patients that can’t get pacemakers). In fact, these devices go one step further by improving the heart’s natural contracting mechanism over time, according to recent studies.
So, we’ll be talking about two medical devices that demonstrate better outcomes than medical therapy for patients with moderate to severe heart failure. Both devices have their own systemic procedures, pros, and cons; we’ll dive into the details for you to be able to make an informed decision when choosing which one to opt for.
1. Optimizer Smart System
The Optimizer Smart System consists of a minimally invasive device implanted under a patient’s upper left or right chest skin area. It’s connected to 2 standard pacemaker leads that go through the veins into the right ventricle of your heart.
The Optimizer Smart System device is recommended for patients who:
- Do not qualify for traditional cardiac resynchronization therapy (CRT), which is commonly known as implantable pacemakers.
- Remain symptomatic, despite guideline-directed medical treatments.
- Have a marked limitation of physical activity.
The Optimizer Smart System is the first of its kind, offering Cardiac Contractility Modulation (CCM) technology. It delivers timed electrical pulses to the heart to make it work better essentially.
The device enhances the patient’s quality of life and improves exercise tolerance. It is specifically targeted towards moderate to severe chronic heart failure and works towards strengthening the heart to contract more forcibly, delivering a greater supply of blood and oxygen to the body. Moreover, it is known to last for at least 15 years before requiring replacement and is known to have long-term benefits.
As of now, evidence has yielded favorable results, which show that CCM provides statistically significant benefits, including reduced hospitalization and improved quality of life for heart failure patients. Patients have also experienced the ability to walk farther without experiencing shortness of breath.
Below are excerpts from some of the research studies conducted on CCM used by the Optimizer system to demonstrates its favorable outcomes:
- Giallauria et al. 20201 “This comprehensive meta-analysis of individual patient data from all known randomized trials has shown that CCM provides statistically significant and clinically meaningful benefits in measures of functional capacity and HF-related quality of life.”
- Liu et al. 2016 “CCM resulted in significant improvement in long-term survival, in particular in those with EF (ejection fraction) ≥ 25-40%. A reduction in [HF] hospitalizations was also seen in this group of patients with less severely reduced EF.”
- Anker et al. 2019 “In the real-world experience, CCM produces results similar to those of previous studies in subjects with 25% ≤ LVEF ≤ 45% and QRS < 130 ms; cardiovascular and HF hospitalizations are reduced and MLHFQ and NYHA class are improved. Overall mortality was comparable to the predicted by the SHFM but was lower than predicted in patients with 35% ≤ LVEF ≤ 45%.”
The Optimizer Smart System is safe and FDA-approved to deliver CCM therapy, as of March 2019.
Potential complications associated with the device include bleeding, or problems with the device itself, such as fractures of the leads implanted in the heart.
2. Barostim Neo System
Like the Optimizer Smart System, the Barostim Neo System is also an implantable device. However, it involves nerve simulation that is intended to treat hypertension or heart failure. It is targeted towards patients that:
- Are above 21 years of age.
- Have Heart Failure with reduced ejection fraction (HFrEF), which means that the heart muscle is not contracting effectively, reducing the supply of oxygen-rich blood to the body.
- Have repeated heart failure symptoms, despite medication.
- Do not qualify for traditional cardiac resynchronization therapy (pacemaker).
- Have a regular heart rhythm.
How the Barostim Neo device works is different than how the Optimizer Smart device works. It works by stimulating the carotid baroreceptor in the neck with electrical impulses. Consequently, the baroreceptors sense how blood is flowing through the carotid arteries and relay the information to the brain.
Upon receiving this, the brain sends signals to the heart that relax the blood vessels and curb the production of stress-related hormones that can cause heart failure symptoms. Essentially, this treatment, termed baroreflex activation therapy (BAT), focuses on working with the body’s natural mechanism to regulate cardiovascular function.
As with the Optimizer Smart System, the Barostim Neo System has also been supported by favorable research. It is considered to be safe and effective in what it aims to deliver. It has also shown results that show an improvement in overall quality of life, exercise capacity, and a reduction in the number of days patients have been hospitalized due to heart failure.
Here’s what selected clinical researchers have concluded regarding the efficacy of the device and the treatment it uses:
- FDA SSED Document 2019 BeAT-HF Trial Interim analyses performed on Intended Use Population13. “… the BAT + MM (Medical Management) arm consistently showed significant improvement from baseline to six months, while the Medical Management arm showed virtually no change. This data demonstrated that the BAT+MM treated subjects’ QOL(Quality of Life) improved during the course of the trial and was both clinically and statistically significant from baseline and when compared to the MM control arm. In conclusion, given the available information above, the data support that for the BAROSTIM NEO System used in the Intended Use Population for the improvement of symptoms in patients who suffer with heart failure, the data support that for the indication for use of the device, the probable benefits outweigh the probable risks.”
- Abraham et al. 201514 HOPE4HF trial United States, Canada, Europe “BAT is safe and significantly improves functional status, QOL, [and] exercise capacity in well-treated patients with NYHA functional class III HF. The data also support the possibility that BAT reduces the rate of hospitalization and the number of days hospitalized for HF.”
It is also the only treatment to reduce sympathetic activity while restoring parasympathetic activity. In simpler terms, this helps improve cardiac structure and function, which in the long run, can mean an overall improvement in heart failure symptoms.
Barostim Neo was awarded FDA- approval in August 2019.
Ongoing Clinical Trials
While both Optimizer and Barostim have been approved by the FDA and have been successfully implanted in thousands of patients already, clinical trials are ongoing to continue development and refinement of these technologies. Patient participation in a clinical study contributes to medical knowledge. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions. If you are interested in participating in a clinical trial invloving either the Optimizer Smart System, or the Barostim Neo System, visit the links below:
https://clinicaltrials.gov/ct2/results?cond=&term=Optimizer+Smart+System&cntry=&state=&city=&dist=
https://clinicaltrials.gov/ct2/results?cond=&term=Barostim+Neo&cntry=&state=&city=&dist=
Frequently Asked Questions
What are implantable devices for heart failure?
An implantable cardiac defibrillator (ICD) is a medical device that is implanted within the body. An ICD constantly monitors your cardiac rhythm and delivers a tiny shock to the heart muscle if it becomes abnormal (arrhythmia). If a shock is required, it can be very unpleasant, but it is over soon.
What is optimal medical therapy for heart failure?
The Optimal Medical Therapy in Heart Failure Certificate Programme (OMT-HF) teaches healthcare providers who do not specialise in heart failure about therapies, dose, and prescription optimisation in order to better manage their heart failure patients. Setting the standard for heart failure treatment.
What are three types of implantable devices?
Artificial joints, breast implants, cochlear implants, intraocular lenses, pacemakers, other cardiac implants, and intrauterine contraceptive devices are some of the most prevalent implantable medical devices.
What are implantable medical devices for?
Medical implants are devices or tissues that are implanted within or on the body’s surface. Many implants are prosthesis that are designed to replace missing bodily parts. Other implants help organs and tissues by delivering medication, monitoring biological functioning, or providing assistance.
What is the newest treatment for heart failure?
Farxiga (dapagliflozin) oral tablets were approved by the US Food and Drug Administration to lower the risk of cardiovascular death and hospitalization for heart failure in individuals with reduced ejection fraction.
To Conclude
Both the Barostim Neo System and the Optimizer Smart System are revolutionary therapies that use different mechanisms to treat chronic heart failure, offering superior, long-term results that dramatically improve the patient’s quality of life.
We believe that in long-term conditions such as heart failure, enhancing the quality of life for patients is of utmost importance. Living with a condition that keeps you at risk nearly constantly is mentally, physically, and socially exhausting. Therefore, it’s crucial that doctors offer solutions that allow patients to live better, happier lives. And next-gen health tech options like these are a step in the right direction.
While both the devices seem to do well in their specific area of focus, what holds true for each is that in certain specific cases, both are clinically superior methods of preventing and treating heart failure than Optimal Medical Therapy, which refers to a group of medications given for the heart, blood pressure, and cholesterol, all in an attempt to manage heart failure.
Each of these therapies has its own advantages and disadvantages. A patient should fully discuss these alternatives with their physician to select the method that best meets expectations and lifestyle.
Selected References
- Giallauria, F, Cuomo, G, Parlato, A, Raval, NY, Kuschyk, J, and Stewart Coats, AJ. A comprehensive individual patient data meta-analysis of the effects of cardiac contractility modulation on functional capacity and heart failure-related quality of life. ESC Heart Fail. 2020;7(5):2922-2932.
- Liu, M, Fang, F, Luo, XX, Shlomo, BH, Burkhoff, D, Chan, JY, Chan, CP, Cheung, L, et al. Improvement of long-term survival by cardiac contractility modulation in heart failure patients: A case-control study. Int J Cardiol. 2016;206:122-126.
- Anker, SD, Borggrefe, M, Neuser, H, Ohlow, MA, Roger, S, Goette, A, Remppis, BA, Kuck, KH, et al. Cardiac contractility modulation improves long-term survival and hospitalizations in heart failure with reduced ejection fraction. Eur J Heart Fail. 2019.
- Zile, MR, Abraham, WT, Weaver, FA, Butter, C, Ducharme, A, Halbach, M, Klug, D, Lovett, EG, 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;17(10):1066-1074.
- Colucci WS, et al. Clinical manifestations and diagnosis of advanced heart failure. [updated 2017 Jun 14].
- National Institute for Health and Care Excellence (NICE). The Optimizer smart system for managing heart failure. [Medtech Innovation Briefing]. 2019 Jun 27.
- Sobowale CO, Hori Y, Ajijola OA. Neuromodulation therapy in heart failure: Combined use of drugs and devices. J Innov Card Rhythm Manag. 2020;11(7):4151-4159. Published 2020 Jul 15. doi:10.19102/icrm.2020.110705
- Halbach, M, Abraham, WT, Butter, C, Ducharme, A, Klug, D, Little, WC, Reuter, H, Schafer, JE, et al. Baroreflex activation therapy for the treatment of heart failure with reduced ejection fraction in patients with and without coronary artery disease. Int J Cardiol. 2018;266:187-192.
- Bhatt DL et al. Baroreflex activation therapy for resistant hypertension and heart failure. US Card Revs. 2019;13(2).
- Mann JA, Abraham WT. Cardiac contractility modulation and baroreflex activation therapy in heart failure patients. Current Heart Failure Reports. 2019;16(1):38-46.
- Gronda E et al. Baroreflex activation therapy: a new approach to the management of advanced heart failure with reduced ejection fraction. J Cardiovasc Med (Hagerstown). 2017 Sep;18(9):641–649.
- Hanna P et al. Calming the nervous heart: Autonomic therapies in heart failure. Card Fail Rev. 2018 Aug;4(2):92–98.
- FDA SSED Document 2019 BeAT-HF Trial Interim analyses performed on Intended Use Population https://www.accessdata.fda.gov/cdrh_docs/pdf18/P180050b.pdf
- Abraham, WT, Zile, MR, Weaver, FA, Butter, C, Ducharme, A, Halbach, M, Klug, D, Lovett, EG, et al. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction. JACC Heart Fail. 2015;3(6):487-496.
- Abi-Samra F, Gutterman D. Cardiac contractility modulation: a novel approach for the treatment of heart failure. Heart Fail Rev. 2016;21(6):645-660. doi:10.1007/s10741-016-9571-6
- Courtney M Campbell, Rami Kahwash & William T Abraham:Optimizer Smart in the treatment of moderate-to-severe chronic heart failure
- Van Bilsen M. The autonomic nervous system as a therapeutic target in heart failure: a scientific position statement from the Translational Research Committee of the Heart Failure Association of the European Society of Cardiology. Eur J Heart Fail. 2017 Nov;19(11):1361-1378.
