Raymond Onders, MD, Chief of General Surgery at University Hospitals Cleveland Medical Center talks about a way to help COVID patients breathe better.
So what is a diaphragm pacing system?
ONDERS: Well, diaphragm pacing is a system we’ve been working on here at University Hospital’s Cleveland Medical Center for over 20 years. It’s been my research for this entire time. It initially became famous because Superman was my second patient I ever implanted – Christopher Reeve for spinal cord injury. And we’ve known that we can help get patients off the ventilators for many years. And it’s something we’ve been looking at for anybody on a ventilator. Obviously, almost a little over a year ago, I was actually in Europe in February working at research sites I work in in Milan, Italy, and in Madrid, Spain. Shortly we knew that was some of the hot spots in Europe. With the knowledge I had of a lot of our information, we realized that we might be able to help anybody on a ventilator, especially with the COVID pandemic kind of rearing its ugly, ugly head over a year ago – that we might help patients on a ventilator with this same technology.
And what does it do?
ONDERS: What we know is, when you’re on a ventilator, your diaphragm muscle will atrophy faster than any other muscles. Within 24 hours, you lose 50% of your diaphragm muscle mass. So many times we put patients on a ventilator to help them oxygenate and we also help them ventilate and moving carbon dioxide out. So when somebody has an acute problem, such as a trauma, such as an open heart operation or some other problem where they’re going to be on a ventilator for a certain period of time, we’re maintaining that ventilator until they get better and then we have to do physical therapy for the diaphragm. We’ve shown in spinal cord injured patients such as Christopher Reeve that we can help get anybody off the ventilator by working on their diaphragm with these electrodes that we placed laparoscopically in the diaphragm to maintain the muscle mass. It’s kind of like aggressive physical therapy for that diaphragm so that, once your acute injury is over, we can now get you off the ventilator faster.
And then how long does it take for this to, like, kind of rehab your diaphragm?
ONDERS: So we know when somebody is acutely injured and they’re on the ventilator and they’re going to be sick for a while and we really need that breathing tube to really oxygenate them and get them by that acute illness, then we’ve shown that we can decrease what’s called the weaning time – restrengthening their diaphragm – by 60% percent of the time that they’re on that – at that point in time when they’re ready to come off the ventilator, and that’s significant. And so when we started looking at this last February and March, knowing what would occur – because when we started talking with the FDA in a very mutual conversation – they knew the problem was developing, we knew. And we were able to, by April of last year, get a emergency use authorization from the FDA for the device that we’ve been using for 20 years to help anybody on a ventilator to try to decrease patients that are on a ventilator because we knew our intensive care units would be filling up with patients.
And you’ve seen this work for COVID patients?
ONDERS: We’ve seen it in many patients over the last year. So it’s not just for COVID patients. What we like to say – and as we’re well aware, there’s still traumas that go on. So our ICU still have patients that may have had a traumatic spinal cord injury, may have had other injuries where they need to be on the ventilator, or we’re still doing emergency open heart operations, emergency lung transplants, heart transplants, and those patients are also on ventilators. So we’ve identified that and talking with the FDA and groups – that we can help free up beds for patients that need an ICU from COVID and the other patients are in our ICUs. So it’s working for both groups of patients that are in our intensive care units, trying to help them get off the ventilator faster.
Can you show me how it works?
ONDERS: So this is just the external device. So this is something we had gotten approval in Europe. And, obviously, with this need for ventilators, we realized that this is something we’re going to have to utilize here more rapidly in the United States. So it’s off of our old system, which we have 20 years of data on. And using this temporary electrodes – we just changed the design so we could put them in easier and then remove the electrodes. So it’s just a temporary device, and this is just the external control box. So we’re just pacing that diaphragm, doing aggressive physical therapy to help their own bodies work with the ventilator. So if we’re using our diaphragm muscle, we’re not going to get that atrophy, we’re not going to get the weakness of that muscle. So when it’s time to be extubated, the patient will be ready – their diaphragms will be ready. Now, we’ve shown a lot of other benefits in our ICU by using devices like this to help prevent pneumonias. So what we know in patients that have had a bad injury or even COVID, it’s not the initial viral problem, it’s the secondary pneumonia that they get that leads to the problems. And that’s what leads to the long COVID patients in our ICU or really for everybody that’s in the ICU. So we’re utilizing this technology not just for our COVID patients, but for other patients in our intensive care unit.
And what do the electrodes do? Where are they placed and how does it work?
ONDERS: So what we know is that we place these electrodes – and we’ve shown, laparoscopically, which is a TV camera surgery, just going through your belly button – or we can place it during other operations. We place them right in your diaphragm muscle. And it’s almost like aggressive physical therapy. Many people are used to using what we call TENS units to help your muscle maintain that muscle mass. And we’re just doing this for the diaphragm, which you can’t reach any other way besides putting these electrodes in surgically. And so therefore, we’re just stimulating that muscle to contract. If your diaphragm contracts, it maintains its muscle mass and it helps preserve the good type of muscle. Our diaphragm is made to work every minute of the day. And there’s what we call slow twitch and fast twitch muscles – the marathon muscles and the sprinter muscles. Our diaphragm is a marathon muscle. When you’re on a ventilator, it converts to the sprinter muscle where it gets weak very rapidly when you start trying to use it. We maintain that type one muscle fiber type with the electrical stimulation. So when you’re over your acute injury, your diaphragms will be ready and maintain their muscle mass to help you get off that ventilator. We know, in a spinal cord injured patient – and this is an article that was just published with myself and a group out of Florida – if you’re a high quadriplegic patient – which, unfortunately, we’re still having car accidents and other traumas that are occurring, and that – we’ve shown that we’ve decreased by 20 to 30 days your – the time that you’re on a ventilator if we utilize this early for a spinal cord injured patient. Again, this is a patient who has no control of their muscle. It’s a very catastrophic injury. So we know, in another patient who otherwise was healthy and then developed this overwhelming pneumonia, we can decrease their time. We’ve been able to present at the Society of Thoracic Surgery some of our research on showing in cardiac patients that were a high risk for being on a ventilator we can shorten that to six hours as opposed to maybe 72 hours that they’re on the ventilator. And again, that opens up patients in your ICU. And nobody likes to be on a ventilator. Nobody likes to have that breathing tube in. So it really decreases the risk from that breathing tube. We like to say the breathing tubes are important to keep you alive, but the breathing tubes have complications, especially when you start looking at having a tracheostomy for a chronic area. There’s a risk with that. So utilizing this data that we’re growing in this group of patients on the ventilators will be able to help more patients in the future. This is kind of a jumpstart in this area of technology of getting people off the ventilator.
Are there any risks to this?
ONDERS: Well, the biggest risk is being on the ventilator. And so it’s a laparoscopic operation – and it’s very similar to what we’ve been using for 20 years for spinal cord injured patients. We know it’s safe to put in. We know it can be done fairly routinely laparoscopically. The difference that we’re utilizing in these newer electrodes is that we’ve shown that we can remove them – that they’re just temporary. So in many patients that undergo an open heart operation, they might have temporary cardiac pacing electrodes because you’re working on the heart. What we’re finding is we can put in these temporary just in case the electrodes at the time of another operation, such as a lung transplant or a heart transplant, to help get you off the ventilator faster. Fortunately, there’s not much risks in a laparoscopic procedure, but the biggest risk is the time you’re on a ventilator. The more days that you’re on a ventilator, the greater the risk for death is from another pneumonia or another problem. And our goal – you know, even before the pandemic, in the United States over 105,000 tracheostomies are done for failure to wean off the ventilator. So this is a big problem before the pandemic. In the pandemic, when you heard everybody saying, you know, we’re out of ventilators – we were almost out of ventilators before the pandemic. And so we – really, when you have an increased need, especially in Europe and other countries – is that we didn’t have enough ventilators. If we can shorten the time for some people on a ventilators, that opens up other ventilators for patients, not just during this pandemic, but into the future.
And is it FDA approved now?
ONDERS: It’s emergency use authorization, like the vaccines and everything else. So it’s – FDA saw all of our data – and we worked very closely with the FDA. It was actually – this is really when we thought that first wave, back in April, May, was going to be the terrible wave. As we all know, the worst wave was – you know, we just ended the worst wave. But we – I remember that my – people I work with at the FDA, calling me on a Friday night at 10:00. We’re working on data, they’re calling us. And it was actually a very collaborative experience with the group that I worked with at the FDA in trying to get this technology to patients in need really when we didn’t know what the future was going to hold at that point in time. Fortunately, as you know, we’ve had certain therapies for COVID patients. We’ve realized how to ventilate them better. That we’re helping more patients without COVID than with COVID right now with this same technology, which we’re all realizing is – a lot more people are cognizant and understanding of how bad being on a ventilator is and how tough it is for patients. Because we’ve all known somebody who’s had COVID and some patients have died from covid, and they know what it’s like to be on that ventilator.
Interview conducted by Ivanhoe Broadcast News.
END OF INTERVIEW
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