Level 1 Messaging
Barostim is......
What is a novel device therapy that improves the symptoms of heart failure by targeting the neurohormonal pathway that drives disease progression.
The responder rate and BeAT HF was.....
What is 94% of patients responded in at least one of the symptom-based endpoints and 79% were considered super responders in a publication by Dr. Abraham. Generally, response to Barostim is high, like what has been seen with CRT.
I can't offer Barostim because there is no M&M benefit.
What is I understand that living longer is important to many patients. Do you also have patients in your practice tell you that they are more interested in their quality of life during the years they have remaining? We see that when these patients are presented with the improvements seen in BeAT-HF, they are thankful for the opportunity, and many decide to move forward with Barostim.
BeAT-HF stands for
What is Baroreflex Activation Therapy for Heart Failure
Year in the USA that Barostim was first FDA approved
What is 2019
Barostim's FDA indication is....
What is patients who are on guideline directed therapies, with an EF of 35% or less, is a NYHA class III or II with a recent history of class III, and an NTproBNP of less than 1,600.
Patients with low blood pressure, will this make them more hypotensive?
What is during BeAT HF, blood pressures remain stable in both arms, but the control arm had many more episodes of hypotension and syncope than the Barostim arm. In fact, in the Phase II HOPE4HF trial, Barostim significantly increased systolic BP and pulse pressure.
I was hoping you would have done a sham-controlled study.
Year and publication of original BeAT-HF trial
What is 2020 -Journal of American College of Cardiology
A patient needs to be on GDMT before I can prescribe Barostim
What is in a recent consensus statement from the HFSA on the use of devices in systolic HF, the recommendation was to consider additional devices, like Barostim, if the patient remains a NYHA II or greater 3-6 months after initiation of GDMT.
The patient can't feel the stimulation from Barostim.
What is like any implantable electronic device, if the output is programmed too high, the patient may feel the stimulation. We have a protocol we follow to ensure there is enough of a buffer between where the patient feels Barostim and the output the device is programmed to. It is very unlikely the patient will feel, but if it Barostim, but if that does happen, simple programming changes will resolve any felt stimulation.
This seems to be a lot like Vagal Nerve Stimulation. How is it different.
What is the main difference is that despite 3 large trials by different companies, Vagal Nerve Stimulation was not able to demonstrate the safety and efficacy needed for FDA approval in HF. Barostim, on the other hand, received FDA approval as part of the FDA breakthrough designation.
Objectives of original trial
What is The BeAT-HF trial was a multicenter, prospective, randomized controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management or optimal medical management alone.
Year CVRx was founded
What is 2001
Based on your indications, most patients will have an ICD. Is there any interaction between the two devices?
What is about 80% of patients in the BeAT HF trial had an existing ICD and interaction between the devices has not been an issue. It's not contraindicated.
If I already have my HFrEF patients on good neurohormonal blockade, why would I prescribe Barostim? That seems redundant.
What is BeAT-HF showed significant improvements in exercise capacity, QOL, and symptom reduction. There were additional improvements such as a 34% relative risk reduction in all-cause death, or the use of LVAD or heart transplant in the Barostim arm, and more recently a large publication showed an 85% reduction in HF hospitalizations when comparing the year before Barostim with the year after.
We have been using CCM and seeing great results in those patients. We do not need Barostim in our practice.
What is I think it's great that you are using new therapies to treat HF. We believe Barostim offers you and even better and even better option for patients with an EF of 35% or less. Pause. Three reasons: 1) Barostim does not add any hardware into the heart or vasculature. 2) Compliance isn't an issue; there is nothing for the patients to charge. 3) the clinical evidence strongly favors Barostim for patients with ejection fractions 35% and below.
I am glad you are able to help those patients, what about those patients with an EF below 25% who are not indicated for CCM. Would you consider Barostim for those patients?
Conclusions of original BeAT-HF trial
What is BAT was safe and significantly improved exercise capacity, QOL, and NT-proBNP.
Barostim works by....
What is Barostim compliments the neurohormonal blockade by working earlier in the same pathway. May I share with you what I mean? This is an oversimplified view of the neurohormonal pathway. A weakened heart resulting in reduced contractility, the reduced contractility of the heart results in less stretch to the carotid baroreceptors, causing them to decrease their signaling to the brain. The brain interprets the reduced signaling as a crisis, like hemorrhage or dehydration, and responds with: increase sympathetic tone and decreased parasympathetic tone and increased activation of the RAAS. All of this is meant to build and conserve blood volume. In an acute crisis the increase in neurohormones may be lifesaving, but chronic excesses of neurohormones produces adverse hemodynamics and organ toxicity, driving disease progression. Neurohormonal blockade works by blocking the receptors on the organs essentially shielding them from the negative effects of chronic excess neurohormones. Barostim complements neurohormonal blockade, intervening earlier in the pathway by increasing baroreceptor signaling, essentially signaling to the brain that the crisis is over.
We really don't know if there is any benefit to Barostim given that it was not studied against contemporary GDMT that includes SGLT2i.
What is That is a similar situation for any device or drug trial that compares the treatment arm to a control arm of best available current therapies. We know GDMT, including SGLT2i, provides significant improvements in mortality and morbidity. However, in a paper written by Greg Lewis at Mass General which contained a meta-analysis of 29 GDMT trials, including SGLT2i, he showed GDMT provides at best a modest improvement in exercise capacity. Given that, it is not likely the inclusion of SGLT2i in BeAT-HF would have changed the reported results.
Who should I consider for Barostim?
What is Indicated patients who still suffer from symptoms despite max tolerated guideline therapies. These patients often present as: Indicated patients with an ICD who are still symptomatic or significantly limited in activity, patients that have not responded to CRT despite optimization of CRT/Meds, recently hospitalized for HF or patients unable to tolerate GDMT or have difficulty titrating GDMT.
Journal and year of publication for BeAT-HF -Long term outcomes.
What is European Journal of Heart Failure 2024.
Mission statement for CVRx
What is CVRx is dedicated to improving the health and QOL for individuals affected by cardiovascular disease. The company focuses on developing, manufacturing, and marketing innovative medical devices.