Joshua Larned, MD, Medical Director of Heart Failure Services at Holy Cross Hospital talks about a device to help the heart to relax.
Interview conducted by Ivanhoe Broadcast News in May 2018.
Let’s talk about first of all how many people suffer from congestive heart failure in the US?
Dr. Larned: A lot of people suffer from heart failure, over five million Americans in any given year will be diagnosed with heart failure and that number is expected to rise for a variety of different reasons.
Is it genetic or is it something that can be affected by diet and other factors?
Dr. Larned: A lot of different things can result in the hearts inability to circulate blood ranging from coronary disease, to obesity, to uncontrolled high blood pressure. Some common things but also some uncommon things as well such as your heart valves may start to fail or you develop a heart muscle condition because of genetics. You are correct there are a few things which can cause it.
Like in Joe’s case, in the patient’s case he had suffered a few heart attacks previously.
Dr. Larned: Joe had the most common form of heart disease where he had coronary artery disease where he’s hearts arteries became blocked and impaired. He had, had heart attacks and unfortunately for him he started to progress where the muscle started to become dysfunctional and he developed heart failure.
Once a patient has heart failure, is diagnosed with heart failure what are the treatments? Are there medications they need to be on and do they need to sort of either exercise more, change diet, what are some of the things that you tell them?
Dr. Larned: First of all untreated heart failure carries a worse prognosis than many forms of cancer and people don’t often think about realize this. If you don’t get it treated it can be potentially terminal. However, there are a multitude of treatment options which we know can benefit patients with heart failure including medications. The medications are important because there are certain medicines when used properly have an enormous benefit for the heart muscle, also in Joe’s case. Some cases doing things such as angioplasty and stenting or even bypass surgery for coronary disease can improve heart failure. However, for him unfortunately none of those options helped him feel better and they did not keep him out of heart failure.
Heart failure, what is the definition, what does that mean?
Dr. Larned: So let’s talk about what it means. It actually is a condition where any circumstance or a variety of circumstances can result in the hearts inability to circulate blood.
Like you said some medications you put the patients on and that can help but what happens, and in Joe’s case, did the medication stop working or helping?
Dr. Larned: What can happen as this disease progresses is that when the heart starts to fail various other organs become dysfunctional as a result of not having good blood flow. You can get activation of certain hormones which cause the kidneys to be dysfunctional, your blood pressure can be inappropriately lowered. You can start to retain fluid as a result of the kidneys inability to eliminate fluid. So as certain patients get sicker in this disease process often what we find is that the medications can become less effective or frankly ineffective. So that’s where we were with Joe, is that he really started to fail standard of care medical therapy.
Part of that too do patients feel fatigue, I heard him say he was so tired, shortness of breath, he barely could get from the kitchen to the bedroom without being short of breath.
Dr. Larned: The analogy is when the car can’t drive up the hill as the engine has some damage- it’s the same thing with the heart. Patients can get profoundly fatigued with ordinary activity, even such as walking from their bedroom to the bathroom. They can start to retain fluid,and get very, very short of breath just because the heart simply can’t circulate.
So now this clinical trial that Holy Cross is involved in and then Joe became the first patient in South Florida to do this, talk about how the BEAT-HF and say the proper name of it and what it is.
Dr. Larned: Just to take a step back two hundred and fifty thousand individuals in this country will progress with their heart failure and go on to pass away from it. And those are the patients where you start to think about advanced therapies. The approved advance therapies for severe heart failure include heart transplantation or left ventricular assist devices. And Joe just wasn’t a candidate for either one of those two treatments for a variety of different reasons. Clinical trials are things that we do at our hospital which can certainly offer therapies to patients and may sort of pave the way toward better outcomes and that’s where we decided to go with Joe’s treatment.
Two hundred and fifty thousand that’s a big number what you’re saying it’s when medications to help patients with heart failure stop working that you get to this point of either a heart transplant, he did have a pacemaker put in and so talk about the clinical trial.
Dr. Larned: This clinical trial investigates the use of a device called a Barostim stimulation device which the design of it is to help the heart simply relax. As we mentioned earlier certain things get activated in the body when the heart is working harder called neurohormones. This device in and of itself helps just to block some of those pathways that get activated just to help the heart relax and function better on its own.
How does it work as far as it’s a device that needs to be implanted in the chest?
Dr. Larned: It’s a small procedure that’s placed by a surgeon with a small incision at the level of the neck with the technology sitting right on top of the carotid artery. That artery in and of itself talks to the heart in other parts of the circulation. By placing this device on the artery it actually tells the heart to relax by lowering what’s called sympathetic activity to the heart.
Lowers sympathetic activity to the heart by communicating so it does have to do with the carotid artery?
Dr. Larned: It has to do with the receptor that sits on top of the carotid artery. So it helps the heart relax by turning off the activation that occurs in that receptor when the heart is really working hard. Think of it like this, is that under a period of stress your adrenalin levels get activated. And that’s a normal adaptive response except when you have heart failure to have adrenalin activation all the time can be a bad thing and cause the heart which is already diseased to work that much harder. So this device shuts that whole pathway down so the heart can relax and become more functional.
The device for Joe they were adjusting it, talk about the adjustment, what they were doing and how many times he would have to come in and have that done as part of the study and that kind of thing.
Dr. Larned: These are great technical questions but it’s actually a lot more simplistic because when you actually turn up the device itself it actually down regulates those sympathetic or adrenalin pathways with higher amounts of activation. Each visit when he comes in is part of the trial and it’s a protocol that the device gets adjusted so he can get the maximum benefit of the device without any potential side effects because it is a device which has electrical impulses adjacent to the heart.
So for him because he says he feels better with the higher it goes except he said he had some mild headaches and that tooth ache in the beginning. So he’s got more energy, in other words is it decreasing the effects, the symptoms of heart failure?
Dr. Larned: Exactly. I’s just like turning out all the other noise which can affect the heart by increasing the output of the device itself.
What have been the benefits so far that you’ve seen with him?
Dr. Larned: He could not even walk from the entry to our office to our examination table without being profoundly short of breath. He was pale, he had poor circulation. He was enormously fatigued he was essentially home bound because of this problem. Now Joe is back to doing some of things that he really likes doing. He has an RV he travels around the state and even the country he loves to camp. He’s walking without any shortness of breath what so ever. That is not to say that other patients would have the same benefit that he has but I would say it’s made him a functional person again.
I know he’s one of many patients across the country trying – what’s it called again the Barostim?
Dr. Larned: It’s called the BeAT Heart Failure Clinical Trial.
So you think that the FDA is going to approve this device and would this be a device that a patient could keep forever? Would it be okay if it was implanted, is that the thought?
Dr. Larned: We don’t know what the long term effects of this device are but the initial clinical trial using this technology showed that it was safe, it was well tolerated. Patients felt better and there was a trend towards improvement in heart muscle function. That’s the purpose of this larger trial prior to the FDA approval. We clearly think, and Joe I think is a living example of this, we clearly think that it makes a difference in patient’s heart failure outcomes. But that’s what the trial is designed to prove. Looking at Joe himself he’s a totally different person.
It’s not a cure for heart failure this device but it’s decreasing the symptoms of heart failure so it’s giving patients a better quality of life so far that you’ve seen. And I guess preventing possible heart transplant.
Dr. Larned: So there are many patients who will have severe impairment of their functional abilities because of pump failure due to circulation. Many of those patients will be in a state of limbo on medications and feeling generally well but not feeling normal. Some of those patients will progress to require heart transplant. Some of those patients will never benefit from those types of therapies. This technology is additive to all of the standard of care and it may actually change the game in terms of how we manage certain patients with heart failure. Because certainly we know that it helps people feel better and we certainly hope that in the long term it helps the heart do better in addition to people feeling better.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Christine Walker, Holy Cross Hospital PR
954-958-4893
Christine.Walker@holy-cross.com
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