Zayd Eldadah, MD, Executive Director of Cardiac Electrophysiology at MedStar Health and Cyrus Hadadi, MD, Associate Director of Cardiac Arrythmia Research at MedStar Washington Hospital Center talk about a wireless pacemaker.
Interview conducted by Ivanhoe Broadcast News in 2024.
You’re the only ones in the area that actually offered at this point. How did you get into that position?
Eldadah: That’s right. MedStar Health has the unique privilege, but more importantly responsibility of being able to offer this technology to the region, and the region is actually a very large one because we’re the only hospital between New York and Florida, basically for the time being to be able to offer this on the East Coast. So that’s a responsibility we take seriously and it’s very part and parcel of our mission of being able to provide latest generation high technology, highly effective therapies for communities that might not otherwise have access to them. We’re very privileged and honored to be able to do this, and we’re happy as well because there’s nothing like seeing patients who need something get that something, especially when it’s so terrific as this technology is. And it represents really a sea change in our ability to take care of slow heart rhythms.
Technically, what does this do, technologically? What does it do to the patient?
Eldadah: So most fundamentally, a cardiac pacemaker really does one thing, and that is maintain heart rhythm at a rate above a preset minimum. It’s specifically designed to help patients who might otherwise have very slow heart rhythms or unacceptably slow heart rhythms, and the reason that a slow heart rhythm is a problem is you can think of an engine. If an engine isn’t cycling at an adequate rate, the car won’t move well, so that means for a person not being able to do activities that they may otherwise wish to do being slow, tired, fatigued, out of energy, not tolerant of exercise, not able to really manage their day to day life and quality of life. That’s what a pacemaker does. Pacemakers have been around for decades, but historically what has been available to us is a traditional device that involves a fairly bulky metal unit that contains the battery and circuitry required to run the pacemaker and two wires that are typically threaded underneath the collar bone into a vein there. Two wires, sometimes three wires, sometimes just one wire, depending on the circumstance but always a wire that actually is threaded through a vein and implanted in the heart. The wire in the heart acts as eyes and ears inside the heart, identifies when the pacemaker needs to exert its action, which is deliver a pulse of electricity to keep the heart beating, and that information gets relayed to the pacemaker and the pacemaker issues the energy to the heart that way. This technology is revolutionary because what it does is eliminates the wires. It eliminates that device and puts everything into two small capsules, which are actually threaded through a vein in the thigh and implanted directly in the heart leaving no trace of any wire or anything other than the capsule within the heart. The capsules will work for years on end. When they exhaust their battery life, they can be removed and replaced very easily. It’s really a big deal because it’s a miniaturization, it’s an increase in capability, and it frees patients from some of the problems, the obstacles that they would have to face with a traditional system.
Let’s get into the numbers. How many of these procedures have you done here at MedStar?
Eldadah: I would be talking off the top of my head. We’ve put in over 100 of the single capsule devices and the dual devices we’ve put in, if I’m correct, fewer than 20.
Did you participate or you directe the clinical trials on this?
Eldadah: So the technology was developed by industry a few years ago and the key thing to mention is that there has been a leadless pacemaker placed in one chamber of the heart, the bottom chamber. That has been around commercially available for a while. The advance that this represents is a dual chamber system, so a capsule in the bottom chamber of the heart, as well as a capsule in the top chamber of the heart, with the ability of both of those capsules to communicate with one another. There are some real technologic hurdles that had to be overcome to achieve that and the true pacemaker system that gives maximal support really does require two units. This is the first truly leadless complete pacemaker system because it’s a dual chamber system, upper chamber as well as lower chamber. That technology was developed a few years ago. It was put under clinical investigation in the United States over about a year and our institution was among a handful of centers around the country that tested this technology in human patients. The trial was completed, the results were submitted to the Food and Drug Administration, which subsequently gave approval for this technology this past summer and we implanted our first commercial devices over the past few weeks, as you know.
Do you see this really taking off in the future and how readily available does Abbott make the devices to MedStar?
Eldadah: So we believe that this technology is fundamentally going to change the landscape of cardiac pacing because it represents such a leap forward in technology, it confers great comfort. It does potentially avoid risks to patients and it’s inherently more attractive as a concept than a traditional bulky device, which often appears under the skin with wires that go under veins with the potential problems those wires may pose down the road, especially. So we believe it’s a technological leap forward. It’s going to be very well received. At the moment, we’re limited by the actual numbers of devices we have available to us because we actually have a quite substantial waiting list that continues to grow as we work through the patients who need this device.
How would you distinguish between who would be more suited to this wireless dual lead and somebody that could take the traditional? Or do you leave the choice to them?
Eldadah: Essentially, anybody who would benefit from a traditional two-lead system would derive the same benefit from a leadless system. We try to ultimately be able to offer that technology to everybody, at least presented to everybody. There are some circumstances in which if there is not immediate availability of the new technology, because again, it is new that a patient may be better suited to the traditional technology for urgency reasons but we always want to have transparent conversations with our patients. Let them know that both technologies exist, go over the risks and benefits of either approach, and then make that decision in a collaborative way with our patients.
You were at the juncture of human machine, right?
Hadadi: I’ve always loved this very complex interaction between advanced devices and the human body, and the human body, I tell my patients the analogy I use, your heart is like a super charged Italian sports car. It has its engine and that’s Doctor Hof, Meyer’s purview. You’re going to chat with him a little bit later about cardiomyopathy or weakness of the engine, but you also have a very delicate electrical system. If you step into your car and the alternator doesn’t turn, regardless of how many horsepower, you’re not going to go anywhere and the same way with the human heart. If your heart is beating too slow, you’re going to feel awful. You’re going to feel short of breath, tired all the time and so our hope is that for the millions of Americans who have pacemakers, for the 200,000 Americans every year who need a pacemaker. This option, this leadless dual chamber device created by Abbott in partnership with us as implanters let’s patients feel better, and let’s patients have the ultimate experience. You come in, you wake up, your issue is resolved, you don’t have any scar on your chest. You know that there are not these long wires running through your bloodstream that in the short term give you limitations, but in the long term give you complications. I was a cardiac extractor and what I mean by that is I’m one of the members of our group who takes care of problematic devices. So if your leads fracture or if your leads get infected, you really ought to take those leads out of your body. Something that’s been in your body for five, six, seven,10 years develops scar tissue, develops adhesions. So the light bulb moment for me was when I said, why would I just want to keep doing this over and over again? Put in traditional devices, remove traditional devices when we have a solution that instantly resolves all problems with what we call the pocket, the incision in the skin and all the problems with these long wires running through your bloodstream.
Most people, when they think of heart rhythm, they think it’s speeding too fast. In this case, too slow. And I love your story about the race car. That’s very aproppriate. Well, like Jonathan said, his was down in the 40s and certainly not a marathon runner. What is it that triggers that initially?
Hadadi: I think what’s frustrating for patients and for physicians is that it’s not anything you did. It’s not your fault, it’s not diet, it’s not exercise. We’re just blessed to live into our 70s, 80s, 90s. And just like you get changes on the outside of your body, we get gray hair or wrinkles or if you’re very high testosterone, you lose your hair. You get changes on the inside of the body when the natural pacemaker of the heart loses some of the ability to keep itself regularized, you can have fast and irregular heart beats. You could have slow heart beats and many people actually are lucky or unlucky enough to have both, what we call Techacardia, Bradycardia Syndrome. So the heart can go too fast, but when you try to give medications, then it goes too slow as a paradoxical response and pacemakers are perfect for these patients because now you can regularize the heartbeat. You can gently stimulate it to beat in what we think is a healthy zone but also treat the too fast heartbeats.
What’s happening with the rhythm of the heart that it suddenly is just going too slow?
Hadadi: So the natural pacemaker of a heart is in the top right chamber and from the moment that we’re born, it’s designed to automatically send out 60-80 electrical signals a minute. We’ve probably had billions of heart beats between the people in this room, and hopefully billions more to come and so what happens is the natural pacemaker sends out a signal, and the top pumping chamber receives it and squeezes In response. You have this very beautiful, intimate electrical mechanical coupling inside your heart and then the signal goes down the thick electrical cables in the middle of the heart to the bottom chambers, which then also squeeze in response. So you have this beautiful rhythm of the heart, top, bottom, top, bottom. Now unfortunately, sometimes with time, that natural pacemaker again loses some of its ability to keep itself in sync so It slows down. Instead of 60 or 80 beats a minute, it sends out 35 or 40, so just too slow. Or sometimes the problem is more in the middle of the heart. The top is sending out those 60-80 electrical signals, but at that critical juncture in the middle of the heart, we call the AV groove Atria for top chamber, V, for ventricle bottom chamber, the AV node, you have a delay of transmission. So instead of 1-1, you sometimes will only get one heartbeat in the bottom chamber for every two signals coming from the top. So the heart is wanting to go 80 beats a minute. It’s sending out 80 electrical signals, but the bottom chamber is only squeezing 40 times a minute. Pacemaker will fix that too, especially the new dual chamber, because you’ll have one component at the top, one component in the bottom, and they’re synchronized. They communicate with one another in a very ingenious way, very low energy, using the body’s own bloodstream as a communication means.
But how do people find this? How long can they live with say, 140/minute?
Hadadi: Well, these are excellent questions and the answer is, it’s often very subtle. Because our temptation is to say, well, I’m getting older. But the truth is, you should feel great at any age you really should and you should be able to do the things that you’ve always been able to do. If you walk a mile a day, you should continue to do that. There should not be a sudden decrease in your ability to do your daily living activities. Go up and down the stairs, cook for yourself, exercise at the Y. What we often see in our patients is as the heart rate goes down, people become more and more sedentary. Sometimes I talk to patients and they say, well, I feel great even though my heart rate is 40. But when I really ask them, are you still going to the Y? Are you still chasing your grandkids around? Are you swimming? The answer is, well, I stopped doing these things. And we want to give people back that ability to live their lives. In general, signs of a slow heartbeat are fatigue, inability to do exercise that you previously could, inability to live your life. So any of those things could potentially be due to a slow heartbeat and warrant a discussion with your doctor.
That sounds counter-intuitive. You can take metoprolol to slow it down. Is there a medication to speed it up?
Hadadi: Well, it’s an excellent question. The truth is, there aren’t really any good medications to speed your heart rate up. Metoprolol is a wonderful medicine because it’s been shown to help weakened hearts heal and regain their strength. That helps the engine of your heart say strong, but it slows the rate down. There really is no equivalent medicine to speed the heart up, but with these new pacemakers, nobody will even know you have one. There’s no cut, there’s no scar, there’s no limitation. I think people feel great. Do great. Many of our patients say I was back on the golf course the next day. Or I was back to chasing my grand babies around with really zero downtime. And that’s critical for us.
But nowadays, people have got all these combo things going on in the heart and kidney.
Hadadi: Absolutely.
How do people tell the difference? How do they get on alert?
Hadadi: I’m actually going to answer your question in two parts, if that’s okay. To address what you said about the interplay between our bodies, the truth is our bodies are one, homogeneous, integrated whole. We artificially divide ourselves into heart doctors and kidney doctors and lung doctors just because no one physician can know it all in the year 2023. Even in these specialties, well, we have the heart electricity doctors and the heart pump doctors and the heart plumbing doctors. But often if you don’t feel well, it is what we call multifactorial. It’s your heart interacting with your kidneys, interacting with your lungs. What we know is that when the heart rate is too slow, and the pump is not putting out the blood flow that your body needs, it affects all the downstream organ. And just think about how remarkable our circulatory system really is. You’ve got the heart pump right here and it sends oxygenated blood straight to the brain. And then you make this tremendous loop, lungs and kidneys, and down to your toes and then all the way back up through the veins. So every organ system interacts with every organ system. As a cardiologist, I’m going to tell you that the heart is the most important organ and that the heart affects all the other organs but if you ask a nephrologist, they’ll tell you the same thing about the kidneys. If you ask a neurologist, they’ll tell you the same thing about the brain. What we often see is that multifactorial malaise has at least certain roots that we can address and if one of the roots is that your heart rate is too slow for your body, now we can fix that very, easily but to go back to what you said about it skewing older. Well, yes and no. I have a number of patients who, for example, have congenital heart block. They were born with their hearts out of rhythm and a little bit slow and actually in some ways they’re the worst patients to get traditional pacemakers, because think about how long those leads are going to be running through their bloodstream down into the heart. It’s not uncommon, unfortunately, for us sometimes to be asked to see people who are in their 40s and have leads that are 20 years old. Managing those leads, or if we have to, removing them from the body safely, can be very, tricky. So when I talk about leadless pacemakers and when I talk about being a cardiac extractor, I really am looking forward to putting myself out of business because I want to see a day where everybody who needs a pacemaker gets a leadless pacemaker. We don’t have to worry about problems with decades old leads running through your veins and into your heart.
For people who see this in Los Angeles, Peoria, whatever, are these available all over the country or are they restricted regionally?
Hadadi: Well, the answer is they are available all across the country. But the Abbott Corporation, partnering with health centers has made a decision that they really want every patient to receive the best experience possible. So for the time being they’re looking at centers like here at MedStar where we have a good track record of safety, a good track record of great patient experiences. Dr. El Dada touched on this earlier. MedStar is the only center between New York and Florida on the East Coast to offer this technology. I think it’s because as a group, our doctors, our nurses, our office staff, our cardiovascular technicians have really committed to building a wonderful program. We’ve done well over 100 and close to 150 of the single chamber devices. And we’ve done 15 and hopefully many, more of the dual chamber devices. Six in our original trial that Dr. El Dada spearheaded nine so far in our commercial experience, we are implanting about two a week in order to do them safely, not have to rush, give our patients great outcomes. I’m so thrilled. There are some moments in your life where you say, this is going to change everything going forward and I turned to my fellow physician, one of the younger physicians in almost an apprenticeship to learn more.
END OF INTERVIEW
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