Emile Daoud, MD, formerly at The Ohio State University, talks about a new way to perform AFib surgery.
Interview conducted by Ivanhoe Broadcast News in 2023.
Tell me what Afib is and how many people it affects.
Daoud: Atrial fibrillation is a rapid and irregular rhythm that comes from the top chamber of the heart, called the atrium. It’s very common, millions of people are affected worldwide. The main problem with atrial fibrillation is that it can cause symptoms, of course, that people can feel the heart beating irregularly, rapidly. It can cause fatigue, shortness of breath, stroke, heart failure, it’s quite involved when you have atrial fibrillation.
So my big question is, it seems like I’m hearing it a lot more – are we just getting better at diagnosing it? Are people living longer? So they are getting it?
Daoud: All of that. So obviously, probably the number one risk factor for having atrial fibrillation is aging. And people are living longer. That’s certainly there too, is there’s a lot more awareness of atrial fibrillation. The explosion of commercial products to detect heart rhythm problems is quite a few. We all see them on the commercials. And without a doubt, I see at least a handful of patients every week who have diagnosed atrial fibrillation through other than routine monitoring technique.
Like a smartwatch?
Daoud: Smartwatch, or they went to local health fair and they were found to be atrial fibrillation, or went to their dentist and they checked their pulse and things like that.
What’s the most common way to treat it?
Daoud: Well, there’s a couple ways of treating atrial fibrillation. The first and most important is to prevent strokes. That’s one treatment that doesn’t actually treat the heart rhythm problem. And then treatment of the heart rhythm problem, in of itself is either a medical therapy, meaning a medication, or what’s called an ablation procedure.
And ablations are pretty normal, but there is a risk to it, right?
Daoud: Sure. Without a doubt, in the electrophysiology world, electrical heart doctors, ablation of atrial fibrillation is a very common procedure done worldwide. And the technique is designed to deliver energy on the back of the heart wall to eliminate the electrical short circuits that are presumed to be causing the atrial fibrillation. But as the energy radiates out beyond the tip of the catheter, the equipment that you’re using, the energy can injure the surrounding organs, including the esophagus. The likelihood of injury to the esophagus is pretty common, but fortunately, most often, that type of injury is fairly minor. The tricky point though is that in some patients, which is a small percentage, you can have injury to the esophagus which then becomes a life-threatening issue.
What would happen to those people?
Daoud: So the really challenging part about this is at the time of the procedure its- you’re not aware of doing that type of injury. The patient will leave the hospital to feel well, then they’ll slowly develop symptoms that may be 10 days, two weeks later. And so by that time the injury, which is a hole, or injury to the esophagus has already developed. So there’s risk of infection, bleeding, stroke, and there’s a very high mortality rate, high risk of dying from this complication. So the challenge for the electrical heart doctor is this, so when you go in there, you want to deliver enough energy to eliminate the electrical short circuits causing the atrial fibrillation. On the other hand, you don’t want to deliver too much energy where then you could run the risk of injuring the esophagus. So if you can avoid the injury to the esophagus, then you have greater freedom and confidence of ablating the atrial fibrillation.
And so you are trying to take that risk or injury out of the picture?
Daoud: Yeah, that’s the goal. So there are a couple of techniques, and we have one that was developed at Ohio State University to move the esophagus away from the energy source so then the physician can deliver the amount of energy they need and at the spots they want, to treat the atrial fibrillation, but then minimize the risk of injury to the esophagus.
How does it work?
Daoud: This is the device it’s called Esolution, meaning esophagus plus solution so Esolution. It’s a fairly common type of design in the sense that it’s circular because its placed in the patient’s esophagus during the procedure. It has two techniques. You have these little holes here and you deliver a vacuum suction, which pulls in all the walls of the esophagus and then once the walls are adhered to this tip, you can then. So once the walls are adhered through the suction force to the tip of the device the physician can then move the device and which then moves the esophagus either to the right or then to the left. And if you’re not ablating near the esophagus, you don’t need to do anything. You just leave it in position. And then obviously when the procedure’s done, this comes out.
I love about that there’s no electricity, there is no anything.
Daoud: If you want the remarkable. I don’t know. The unique feature of this type of way of moving the esophagus is that we use a vacuum suction delivered through these small holes. Which then pulls in all the walls of the esophagus around the lever which then moves the esophagus to the side. The unique advantage is that with the vacuum suction if you just move the esophagus to the right, the right wall would move, but the left wall does not come along. If you use the vacuum suction, then when you move it to the right, the left side of the esophagus also comes along so you’re physically moving the entire segment of the esophagus, giving greater protection from the ablation energy.
Is there any risk of tearing the esophagus wall or anything?
Daoud: Whenever you say the word any, I presume there is, but in all the clinical trials we’ve done, we’ve never had any injury to esophagus with the device. And importantly, every patient that has had this device used, we have a gastroenterologist do an endoscopy. They place the scope into this esophagus and look for any injury related to the device, and there has not been any. It’s a very soft floppy design.
Is this out there now for every hospital?
Daoud: It is not. It’s going through a second review for the FDA. And our hope is that once we get FDA approval, we’ll then be able to educate physicians on how to use it and get it to all the hospitals.
Did you use this with Amanda Mitchem?
Daoud: Yes.
Do you remember that one?
Daoud: I do.
And was she part of a study?
Daoud: Yeah, so we’ve used this internationally. The first and man studies were done in Argentina and then the clinical trial, we randomly assigned some patients to get the device and some people not to and then compared the results. And the patients who got the device had very low injury, and the patients who didn’t get the device, about 35% of them had an injury to this esophagus, showing that the device was very significant reduction in the injury to this esophagus.
How many people were part of that trial?
Daoud: There are 120 patients in the US trial, but by statistical analysis, since the results were so much in favor of the device ethically, we had to stop the study early. It was initially designed to go to about 250 patients, but we already reached such a compelling result that it wasn’t fair to continue to enroll patients and assign them to not using the device.
And I hate using this word, but it’s a game-changer for treating Afib, right?
Daoud: Well, there’s a lot of new technologies that are coming into atrial fibrillation. Hopefully, this is another piece of the puzzle to help when you do an ablation. I’m not sure about a game-changer.
Am I missing anything?
Daoud: I mean, I didn’t get all of this. All the other devices that are out there are not FDA approved. And they’re going to the hospital and say you could use this in the esophagus, but they cannot discuss the clinical results. They have never been studied like this device has been. This is the first device ever to be studied in the rigorous manner that the FDA requires. We are intentionally putting it through that test because we believe in the technology, we believe in the way it can help patients. We just need a higher level of evidence to prove it and that’s why we went through the FDA while other designs are being commercially available, but they don’t have the FDA approval. They don’t have the study design to back it up.
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.
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