Valluvan Jeevanandam, MD, Professor and Chief of Cardiac Thoracic Surgery at University of Chicago Medicine, talks about the NuPulse iVAS for patients who suffer from heart failure.
Interview conducted in November 2017.
I wanted to ask you about the NuPulse, could you describe to me what it is and what it’s intended to do?
Dr. Jeevanandam: Sure. When the heart is weak it doesn’t have enough energy to circulate blood in the body and so we have to add energy to the circulation. And one of the ways to add energy is to either take the blood directly and spin it and energize it; which is what LVAD’s do, or what this device does is it is a balloon that rests in the descending aorta and it inflates when the heart relaxes and it deflates when the heart pumps. So the period of time when the heart is relaxing, this pump is actually working and it adds a second pulse to the patient. And so it improves the energetics and improves circulation during that period of time.
How is the NuPulse different than the LVAD and in what ways is it different?
Dr. Jeevanandam: The LVAD’s have to be implanted with a bigger operation because you actually need access to the heart. So whether you do a sternotomy, which is opening up this way or you do an incision to the side you actually have to operate on the heart. And many of these patients have had previous operations on the heart or they are too sick to be able to undergo a huge surgery like that. Plus, you have to go on the heart/lung machine, there’s a lot more bleeding, there’s a lot more recovery time. The advantage of the NuPulse device is because all we do is need access to the descending aorta, it’s done through a one and a half inch incision near the shoulder and then there’s another three inch incision a little bit lower. But we don’t have to open up any bone; we don’t have to get access to the heart. It’s basically an operation just on the skin; it’s very similar to putting in a pacemaker for instance. The patients are extubated on the table, they have zero need for rehabilitation, they’re able to walk the next day, and they’re able to go home much earlier.
This is designed just as a bridge to transplantation and how long can a patient use it?
Dr. Jeevanandam: So right now it was tested as a bridge to transplant, it was designed to be used for anybody who is in heart failure. The real intended patient population is somebody who has failed medical therapy but they don’t want to undergo the huge operation of a conventional LVAD. There’s that space in the middle where patients basically just go home and deteriorate enough to end up getting an LVAD. So instead of deteriorating the idea is to put the NuPulse device in and see if we can actually make them better over a period of time to the point where they may never need and LVAD or a transplant. And so this for the intended patient populations, for the wide group of patients just in heart failure that are quite not sick enough to undergo an LVAD operation. There are patients who can’t walk for long distances because they are short of breath, they can’t go out and exercise, they can’t go up stairs, they retain fluid both in their legs and in their chest, and they have slow deterioration. And so the idea here is to rest the heart because the pump is doing a lot of the work of the heart. So you rest the heart, you give the patient some time to see if by resting the heart the heart can actually recover and then maybe not continue to deteriorate to need a LVAD. But perhaps even get better to the point where they don’t need to be pumped all the time. The other big advantage of the NuPulse device is that as opposed to an LVAD where if it stops it’s a catastrophic event, this pump is designed to be able to be stopped by the patient. So it doesn’t always need to pump and that gives the patient a tremendous amount of control and peace of mind.
So does the patient have a control or access to a control?
Dr. Jeevanandam: The patient has a driver and they can turn it off just by pressing a button and you can turn it off.
Under what circumstances would a patient want to turn it off?
Dr. Jeevanandam: Sometimes if the patient is recovered enough that they don’t need the support every minute they could conceivably just pump at night and then not use it during the daytime or they could when they’re watching TV or they’re sitting down or going to bathroom, taking a shower they may not need to be pumped. But then when they go out and they want to go for a brisk walk with their dog or a brisk walk in the mall they can turn it on.
Is this FDA approved and is it in clinical trial or has it been?
Dr. Jeevanandam: It’s in clinical trials. We were at the current time the first and only institution in the world that has the device because it was developed in conjunction with the University of Chicago and the company. The first trials and the first human trials were all done here. We’ve done twenty five patients so far and within the next couple of weeks it will go out to other sites as well. So there was a large learning period on how to implant the device and how to manage the device and that was on for about a year and a half and now it will go on to other sites. It is not FDA approved in that everybody can use it but the study that we are doing, the clinical trial, is an FDA sponsored trial.
And how long is that trial?
Dr. Jeevanandam: The first implant was in April of 2016 and this trial will go on till we enroll anywhere from fifty to seventy five patients in the trial. And then it will go on to what we call a pivotal trial which is the trial that will get it commercialization.
Can you speak a little bit to Terry’s case?
Dr. Jeevanandam: Sure. Terry is a patient who got a heart transplant several years ago and unfortunately one of the problems with heart transplant is that in certain patients, their transplant causes affects to their immune system which affects their arteries and their arteries start closing. So Terry’s arteries started closing and he really was short of breath, couldn’t do a lot from his transplanted heart and the only way to really help him was to either get a new heart or to put in some kind of device which can improve circulation in his heart. So we put this device in thinking that we may be able to transplant him. He had some other conditions that prevented him from being transplanted, but the device is capable of supporting his heart and by giving it extra blood flow. And so he has done very well with the device. He’s actually a great example of somebody who was doing great with the device and then he had a problem with the device where his drive line kinked. He called us he said, okay I’m going to turn it off I’ll come in the morning and we’ll take care of it. So he came in and we did a very small incision and took care of the problem. But if he was on an LVAD it would be catastrophic and he might have a stroke etc. But with this it was very easy to manage him.
How does he look to you?
Dr. Jeevanandam: I think he looks great; he’s put on a good amount of muscle mass, he looks happier. And we’ve seen him at home; he cuts his grass so he’s gone back to a pretty good lifestyle with the device. So the idea with him particularly is if can be transplanted great, if he cannot be transplanted then you know the device forces blood into the heart during that time that the heart relaxes. And there’s some data that suggests that can actually grow new blood vessels so that’s what we’re hoping for in Terry to see if by doing that we can increase the circulation in his own heart; that way we can start slowly decreasing the amount that he’s actually using the pump.
There’s a chance that Terry might not even need the transplant if he’s on this long enough?
Dr. Jeevanandam: That’s correct. Our idea behind this pump is that it will never be a pump that we call destination therapy. Because destination therapy means that once you get that there’s no other thing to go to. This will always be a bridge. It may be a bridge to a transplant, it may be a bridge to another LVAD, it may be a bridge to a recovery, or it may be kind of a bridge to prolongation of the medical therapy that they’re on. So let’s say with the medical therapy they’re deteriorating slowly and once you put this device in that deterioration stabilizes and they get a little bit better maybe they go on for a very, very long period of time with the device. Our longest implant so far has been six months, so although by FDA clinical trials our end point is thirty days we already have patients out six months.
Is there anything I didn’t ask you that you would want people to know?
Dr. Jeevanandam: I think this device is going to really change the way we normally manage heart failure. And when I say that what I mean is right now we wait for people to deteriorate enough to be able to access an LVAD and I think if we can take those patients and give them a device that’s minimally invasive; where they’re in and out of the hospital within a couple of days, and that can support them for a period of time to either stabilize them or make them better and recover and not ever needing an LVAD I think that would have a dramatic impact on people’s lives.
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:
John Easton
Valluvan Jeevanandam
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