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Prakash Chandran: Heart failure affects nearly 6 billion people in the United States and is escalating rapidly with about 670,000 newly diagnosed cases annually. Luckily, there is a technology called the CardioMEMS system that can help cardiologists monitor and treat heart failure in ways that could never be done before.

We're going to talk about it today with Dr. Ali Al-Mudamgha, a cardiac electrophysiologist at St. Joseph's Health.

St. Joseph's Health presents another edition of its podcast, St. Joseph's Health MedCast.

Prakash Chandran: This is St. Joseph's Health MedCast from St. Joseph's Health. My name is Prakash Chandran. So first of all, Dr. Ali Al-Mudamgha, it's great to have you here today. Why don't you start by telling us a little bit more about this new technology called CardioMEMS?

Dr. Ali Al-Mudamgha: Thanks, Prakash. So the CardioMEMS system is a small device that is implanted within a blood vessel of the lung field that allows us as cardiologists to monitor certain parameters in the heart. Which can give us an idea on the patient's heart failure status, and hopefully allow us to get ahead of the curve with these heart failure patients to prevent exacerbations of their heart failure symptoms and, more importantly, recurrent hospitalizations that occur.

Prakash Chandran: That sounds amazing. Can you talk to us a little bit about the dynamics of how it works?

Dr. Ali Al-Mudamgha: Sure. So this is a little monitor that is placed into the patient's body typically by a cardiologist. It is placed through a vein of the groin directly into the heart. As we go into the heart, we take certain blood pressure measurements, if you will, from certain chambers of the heart. The device is then placed into a branch of what we call the pulmonary artery, which is a blood vessel that comes off of the lung circulation and is positioned in such a way that it is sitting in one of the arteries that are in the back of the body. And this is essentially a monitor. It monitors what we call pulmonary artery pressure, which is a very sensitive way of determining the patient's heart failure status.

Depending on the patient and the followup that's needed, there is a little transmitter that goes essentially on a pillow. The patient lies down on it. And that monitor then downloads the real-time measurements that the monitor has recorded. That gets transmitted then remotely to the patient's cardiologist who can then look at these numbers and then adjust therapy as needed. Sort of similar in a way that you get blood pressure measurements in the doctor's office and, depending on what those blood pressure measurements are, the physician might increase or decrease certain medications for you.

Prakash Chandran: Yeah, that really sounds fascinating. I had no idea that a little device like this exists. Tell me who exactly is this for. Is this for a patient that's already had a cardiac incident? Talk to us a little bit about who makes a good candidate.

Dr. Ali Al-Mudamgha: Sure. So we use the term congestive heart failure to imply an abnormality of the heart that results in inadequate blood being pushed out of the heart. In some cases, patients have a weak heart muscle that may be due to a previous heart attack or it may be due to a viral illness or some other illness that caused weakening of the heart muscle. In other patients, their heart muscle themselves may be actually normal and strength, but other parameters prevent blood from being ejected as it should be and the blood then backs up into the lung circulation.

So if you have a clinical diagnosis of congestive heart failure, and you have what we call symptoms with moderate activity, sort of day to day activity, where you get more short of breath and you've been admitted to the hospital at least once within 12 months for a diagnosis of heart failure, you are then a candidate for the CardioMEMS system.

Prakash Chandran: How about for patients who have potentially already had, like let's just call it a stent in and they're experiencing some of the symptoms that you're talking about, is this system also for them?

Dr. Ali Al-Mudamgha: Sure. So if the patient, let's say, had a stent put in two weeks ago and they develop heart failure symptoms and then get admitted and have to be treated for their heart failure symptoms, after they get discharged, they could potentially be a candidate for the CardioMEMS.

Prakash Chandran: Okay. So this is the first time I'm hearing about the CardioMEMS system. Talk to us a little bit about how long it's been around and maybe some of the success stories that has come as a result of using it.

Dr. Ali Al-Mudamgha: So the CardioMEMS system initially was approved, FDA approval, back in 2014. And then as part of the approval process, the FDA required what we call a post-market study, which included approximately 1200 patients and that occurred from 2014 until October of 2017. That study was ultimately published back in the summer of 2020. And that sort of corroborated the initial studies in terms of the benefit of the CardioMEMS system.

So if you look at heart failure patients with a CardioMEMS device, there is a risk reduction in terms of heart failure admissions or hospitalizations of approximately 57%. And then, you know, our heart failure patients tend to be pretty sick. And so they also get admitted for other things that are probably related to the fact that they have congestive heart failure, but not necessarily a direct heart failure admission. When you look at the CardioMEMS post-market approval study, there was a 27% risk reduction in terms of all-cause hospitalization.

Prakash Chandran: Wow. Those definitely seem like very promising results. As people evaluate getting the CardioMEMS, are there any side effects or downsides that people should be aware of?

Dr. Ali Al-Mudamgha: Sure. So, you know, obviously this is a procedure where, you know, we are placing a catheter into a blood vessel and then through the heart. But when we look at, you know, real-time data or real life data, I should say, the post-market study was 104 hospitals throughout the United States. And it was a mix of academic medical centers as well as community-based medical centers. And there was a 99.6% freedom from complication. There were five device complications within the study, so 0.4%. And there was one patient, who what we call the pressure sensor of the device failed. So it is a very low complication procedure compared to other procedures that we do in cardiology. And obviously, we always tell patients every procedure carries potential risk. But in this case, the benefit clearly outweighs the risk when you look at the risk reduction and a 99.6% freedom from complications.

Prakash Chandran: Absolutely. Talk to us a little bit about how long the CardioMEMS system stays in your body. So let's say you put it in there, does it stay in indefinitely or do you take it out after a while?

Dr. Ali Al-Mudamgha: It stays in indefinitely,

Prakash Chandran: Okay. And is it something that is uncomfortable? Will the patient notice anything when it's in there?

Dr. Ali Al-Mudamgha: Not at all. So the body's blood vessels, whether it's an artery or vein doesn't feel things going in and out of it. So if you think for example of a pacemaker that has wires that go into a major vein below the collarbone and those wires go directly to the heart, through the veins of the body, the patient never feels those wires in their body. And this is very similar from that respect. Or stent, for example, a patient that gets a stent procedure doesn't feel the stent in their body. And so patients won't feel the CardioMEMS unit either.

Prakash Chandran: Okay. Thanks for that clarity. And I imagine that over time collecting all of this data from these patients and collecting that pressure data over a large cohort is just going to help medicine advance by way of understanding what causes heart failure and how to prevent it ahead of time. Isn't that correct?

Dr. Ali Al-Mudamgha: Yeah. So, you know, our major challenge with our heart failure patients is keeping them out of the hospital and improving their quality of life. So there are traditional ways that we do this. You know, we ask patients to check their weight, report back, tell us if their legs are swollen. But when you really look at hard medical data, when you look at the use of weight and vital signs and clinical symptoms in a study fashion, there doesn't seem to be any incremental value to doing that. And so we're kind of spinning our wheels, right? We're asking our patients to weigh themselves and call us with any symptoms. The problem is once there is an appreciable change in either the weight or the vital signs or the symptoms, it's probably already too late and we really didn't do them any favors, if you will.

With CardioMEMS, the idea is these changes that occur before the patient develops clinical signs and symptoms. And so we can act much earlier in terms of adjusting medicines and, you know, look, nobody wants to be admitted to the hospital and nobody wants to stay in the hospital. Certainly nobody wants to have episodes where all of a sudden they get short of breath and they can't do their day to day activity. So from that perspective, this is very helpful.

Prakash Chandran: Absolutely. So Dr. Al-Mudamgha, tell us a little bit about what this tool means for central New York.

Dr. Ali Al-Mudamgha: Well, I think what this tool means for central New York is the same thing it means throughout the United States, in that we have really good medical therapy for our patients with congestive heart failure. We have other devices that we use to treat our patients with congestive heart failure. Now, we have one more tool to help our patients feel better, potentially live longer and, more importantly, stay out of the hospital. So it has tremendous clinical value for us.

Prakash Chandran: Yeah, there's no question about it. Having a tool now to allow doctors to monitor their patients in real time and prevent things before they happen is truly a technological breakthrough. So, Dr. Al-Mudamgha, is there anything else that you would like to share with our patients around this device or heart failure in general before we sign off?

Dr. Ali Al-Mudamgha: Yeah. Treatment of heart failure, although we know there are certain medications that patients need to be on, it really is individualized for the patients. I can't stress enough, but the CardioMEMS does not take the place of taking your medications, does not take the place of talking to your medical provider about how you're feeling. It's just one more tool. And so it is important that patients understand that even with this type of monitoring, it is very important that they still see their medical provider as scheduled, they take their medications as prescribed and follow the instructions that the medical provider has given them regarding, you know, diet, exercise, and salt intake.

Prakash Chandran: Yes, that is understood. Just another tool in the toolbox and not meant to replace any of the recommendations or medications being provided by your doctor. So I think that's a perfect place to end Dr. Al-Mudamgha. I truly appreciate your time today.

Dr. Ali Al-Mudamgha: Thank you. I appreciate it.

Prakash Chandran: That's Dr. Ali Al-Mudamgha, a cardiac electrophysiologist at St. Joseph's Health.

For more information, please visit cvi.sjhsy.org. If you found this podcast helpful, please share it on your social channels and be sure to check out the entire podcast library for topics of interest to you. This is St Joseph's Health MedCast from St. Joseph's Health. My name is Prakash Chandran. Thanks again for listening.