Karl E. Nelson, MBA, RN |
Karl Nelson is a clinical director for the Utah Artificial Heart Program at LDS Hospital in Salt Lake City. He is a 1996 BSN graduate from the University of Utah, and in 1991, was able to obtain his MBA from Brigham Young University as well as having a degree in finance from the University of Utah with a minor in Japanese. Pretty interesting resume…
In 1993, he started his career as a financial investor and sales manager, and worked as a stockbroker for many, many years and decided to then transition to nursing, where he is now, as I mentioned, the clinical director for the Utah Artificial Heart Program.
He has published quite a few publications, has presented and is also a member of the International Society of Heart and Lung Transplantation, as well as a member of the American Society for Artificial Organs, and his talk this morning will be on an overview of heart failure and mechanical devices.
Let me get started here real quickly. I am an interesting bird in a lot of ways. The one way is, when I, in 1993, decided to become a nurse, I received quite a bit of flack. I come from a family of business majors. My mother especially just couldn’t understand why. I’d have a brother who was a Ph.D. in business. I have another brother who is an actuary. Why I would decide to become a nurse and throw away Wall Street?
Well, after 11 years of working on Wall Street, I decided that I needed a little something more meaningful in life, and so I had to kind of girt up my loins and, with a family of four children, decide to do a major career switch. I want to tell you today in front of you that it was the finest decision I ever made. My job is the best job in the entire world and daily I go to work and tell my wife that I go to work just to play and have fun.
The artificial heart is alive and well. The future of the artificial heart is phenomenal. It is spectacular. The only hope on the horizon in the future for heart failure is artificial heart blood pumps. I will show you some statistics here in just a moment. Now it is not too often you get to meet some pioneers, but people who have blazed the trail for you.
As you look around this room, people in this room will suffer from heart disease. You look at your neighbor next to you. Some of you will be beneficiaries of artificial heart technology. So I am going to introduce you to the people who have blazed the trail for us and your generation -- your posterity.
All these people clearly were swept right out the ICU, right out of the ER, on their death’s bed. When you see the smiles on their faces, you can’t help but have your life changed.
The young African-American boy was a high school student, contracted a virus and at the age of 16 -- a football player had his life swooped out from beneath him, rushed into the ICU, quickly installed temporary support, of which I will show you here in a minute, was taken to the operating room for an emergent implant with multi-organ dysfunction and, within two weeks, was out of the ICU enjoying life.
I could go through that whole list and tell you stories; unbelievable stories, absolutely utterly unbelievable stories, and I can tell you today that modern miracles do exist.
On behalf of Intermountain Health Care and LDS Hospital in Salt Lake City, it is my pleasure today to present to you artificial heart pumps for failing hearts.
Heart failure is a disease that affects all aspects of your life -- socially, financially. Your energy is gone. Your strength is gone. Your life is literally taken away from you with heart failure. Lots of people have it. Two hundred thousand patients per year in the U.S. die from heart failure. Heart failure is very expensive. Seventy billion dollars a year is spent for heart failure.
It is actually, now, in the U.S. the single most expensive disease. People are contracting the disease at a rate of 50,000 a year -- 50,000 new cases every year, of heart failure.
Today in the United States, there are well over 2,000 people in the U.S. waiting on current donor heart lists waiting for hearts. On any given day in the United States, only six, only six hearts come available. There are still 1,994 people every day waiting for that heart, but the problem is that every year 50,000 more people are diagnosed.
So the list will never shrink. It is only getting bigger and bigger and bigger. With the advent of air bags, new safety regulations, most states now requiring seatbelts as a citable citation, the donor pool has decreased. Across the U.S. cardiac transplantation is down.
What are we going to do? It is a dilemma. It is an epidemic in the U.S. today -- such an epidemic that, in November of 1999, [a national magazine] did a major article. Currently, 50,000 Americans need new hearts. Most will never get it. Who lives? Who dies? What an ethical question.
What approaches are currently in the industry today for managing heart failure? Well, you’ve got medical and pharmacological treatment. There are all kinds of new drugs, therapies coming out. Unfortunately, those run their course.
I have likened this to a horse. You can only whip a tired horse so long. You can wind up in an ICU on multiple inotrophes trying to keep this patient alive to make it to transplant, but you can only beat that horse so long and then finally that horse gives out.
Revascularization -- you can take patients down to the operating room and try to correct a mitral valve, revascularize them to see. This is high-risk surgery here. We receive most of the high-risk surgeries in the area. Why? Because we have a top-notch mechanical support program.
We have a way to rescue these people and still perform operations to try to give people back life so we are doing a lot of high-risk valve, high-risk bypass surgery, because we have this artificial heart technology as backup.
In any given year, I work up probably 25-30 patients, who we call LVAD backup -- meaning that these are surgeries we do, but they came to needing the LVAD. They were able to get off pump and go on their merry way with their high-risk surgery.
RVLV patient -- that is the new thing that cardiology is coming out with, pacing the heart, trying to get better function of the heart muscle with RVLV pacing. There is a new clinical trial coming out with this.
LV remodeling -- you have all heard of the Batista Procedure. The Batista Procedure in this county, jury is still way out on that. The results that reported in Brazil weren’t anything like that. We actually performed one of those at our hospital.
Heart transplantation right now is the gold standard. If somebody that is heart transplant eligible and needs a new heart, heart transplantation is the gold standard treatment. Xenografting -- use of animal organs -- a huge amount of research is going into xenografts. Is there some way that we can biogenetically engineer pig hearts? Primarily, that is what they are working on -- to implant these and try to fill this gap of 50,000 hearts. Probably a decade or two away, if you can image trying to clone a heart and/or bioengineer a pig heart to fit a human, it is a ways off.
Then you’ve got circulatory support. In the circulatory support field, there are currently a few things underway. There is cardiomyoplasty. Cardiomyoplasty is actually taking a piece of the deltoid muscle, wrapping it around the myocardium, putting a pacemaker to it, and stimulating the muscle of the deltoid to squeeze your heart. You are kind of putting external compression around your heart. That is one thing that is in research.
Mechanical cardiac assist or replacement -- this is where I come in. The original and most-rudimentary version of subcirculatory support is intra-aortic balloon pump. All of you have seen an intra-aortic balloon pump before -- cardiopulmonary support, ventricular assist devices and total artificial hearts. I will go through these in detail in just a second here.
Let me give you a quick history of the artificial heart world. In 1958, was the first experiment with artificial hearts in the United States. That goes back some 42 years. 1965 -- the first human use of a heart assist pump. 1969 -- the first human use of an artificial heart. One thing I want to bring attention to is 1982, because this happened in my backyard.
Barney Clark a Seattle dentist, of which, I am a personal friend with his widow, came to Salt Lake City, knowing that he was going to be a guinea pig. He was a very smart man. He was a retired dentist, but knew that so much in medical technology had to go forward through experimentation and through investigation, and came to the University of Utah and had the first ever total implanted artificial heart. I will show it to you in a second here.
He was wheeled down to the operating room, and, as you know, was supported for four to six weeks. He ended up dying of multiorgan failure, but he started the trail. Barney Clark’s vision was that, by doing this experiment, his life would not go for naught. He would give back something to society that might spark -- in the minds of the scientists, doctors, researchers, all the people across the spectrum -- to continue to develop technology that could provide artificial circulation to people in need, and that fire is burning and burning brightly.
Artificial hearts and assists pumps, in 1985, began the use of bridge to transplant. Wow. That is 15 years ago, and do you know when these were finally FDA approved? To tell you how slow things move, the original pneumatic LVAD was approved in 1994. The electric LVAD, which I will show you here in a minute, was approved in 1998. So, after essentially 13 years of clinical trial, we finally got the thing FDA approved. So now the LVAD, as we know it, is now FDA approved.
The first permanent use of a heart assist pump in the U.S. in 1998; that is referring to the REMATCH trial. By a show of hands, who knows what the REMATCH trial is? A couple of you? Okay. We are going to talk about the REMATCH trial at length here in just a moment. All of you should know about the REMATCH trial.
Until I came to this conference, I thought that my industry had all kinds of acronyms. But I can’t keep PRN and TPA and URN and PRN and all this stuff straight anymore, so finally I gave up and went back to my acronyms.
But these are different names for artificial heart technologies. You need to understand them because when you get a case, people will throw names around, BiVAD, RVAD, LVAS, …all this stuff, CPS, MCS, RVAS, LVAS, extracorporal, paracorporal, implantable…all these different words come at you. In the next five to ten minutes, I hope to give you just a brief explanation to what this is so when they start throwing jargon on you, you can understand and talk their lingo.
Ventricular assist devices come in left ventricular assist, right ventricular assist, bi-ventricular assist, implantable, extracorporeal, and paracorporeal -- the key here is assist. These pumps assist the native heart. The native heart is left in place. We basically plumb into the heart and a pump assists the function of the native heart. So keep the word assist in mind. You can put them on the left side, and you can put them just on the right side or you can put them in both. Thus, you have a right assist, a left assist or bi-ventricular assist. So that is where those words come in.
Implantable -- some of the pumps stay out of the body, and that’s what paracorporal means. That word right there means paracorporal. It is close to the body. Paracorporal.
Extracorporeal means it is away from the body. I have examples of them here all in a minute, and I’ll show you.
Ventricular assist systems -- ll that is is a play on words. We all call them LVADs, left ventricular assist devices, but once in a while someone will say, “I want to put in an LVAS,” left ventricular assist system. It is the same thing. It’s just they’re monkeying with you.
Cardiopulmonary support -- what is cardiopulmonary support? It’s no different from what you have in the OR. When people don’t make it off bypasses -- like I told you, we do a lot of the high-risk surgeries in the area -- when people don’t make it off of the machine, we have to have something that we can basically transition off the perfusion machine and get them into the ICU.
Yes, they still are on support, but we’ve got them out of the OR and then we can do some planning. We can have time. What are we going to do here with this patient?
Mechanical circulatory support -- these are just names for the industry -- mechanical circulatory support, advanced circulatory support. The word artificial heart program I use loosely, but it would contain all artificial circulatory pumps. When I say I work for the Artificial Heart Program, what I’m telling you is I work for the program that makes artificial circulatory pump…. not makes, installs them and cares for the patient.
Let’s show you some pumps. This is the fun stuff. This is what I really like to do. This contraption here is what you see on the screen. This is a temporary bridging device. This is called a Biomedicus centrifugal VAD.
Inside this cone, is a blood-contacting rotor that spins the blood at high RPMs, 3,000 to 4,000 RPMs, and has the capability of pumping four to five liters-per-minute of blood flow. These two big huge tubes, one of these is arterial and one of these is venous, and when you walk into the ICU and see this running, these tubes are bright red with blood.
One of them is a little darker than the other because it’s venous. Okay. So if you look at these, and you look down at your patient, and he is not doing well and both sides are dark, you have it hooked up wrong. It happens. If someone is having trouble and you happen to go on a site visit, you take a good look at these tubes.
Another problem, you have the opportunity in this. This is a very good device. We can put artificial lungs in here; stick a membrane oxygenated in circuit. So if the lungs are in good shape, we only have to install this. We don’t need to put an oxygenator in, but sometimes, when people come in in fulminant cardiogenic shock, their lungs are full of fluid.
When their lungs are full of fluid, we can’t count on their own lungs oxygenating the blood, so we need to put an artificial lung in this circuit. So we cut in and splice in a membrane oxygenator to oxygenate the blood for the patient. So, not only are we pumping blood through the cone, we are also oxygenating the blood for them, and we can bypass the lungs altogether. Okay.
But these cones come in different sizes and shapes. The interesting thing of note is the cone sits right in this little red area. The cone sits right there, and it spins at high RPM spinning the blood. This device only lasts four to seven days. It is very temporary. But this is how we get our decision-making going.
When people come to the ER after a severe MI, and they are in fulminant cardiogenic shock and they arrest, the first thing we do is go get this. They are still doing CPR on the chest in the ER, and we are getting this out because, no matter what rhythm they are in, we can maintain their body in good shape with this device.
Okay, so if someone comes into the ER in full arrest, I call the perfusion team. I get all the teams together to get this going. Within five minutes, we have this thing going. In that case this is implanted in the great vessels of the groin. One goes in the femoral vein. One goes in the femoral artery.
For the patients that don’t make it off bypass, it is cannulated right directly into the heart. Patients come back to the ICU with an open chest because you have two blood tubes coming out to drive this blood. It’s covered and things, but the chest is left open. Okay. Good device. Let’s pass this around.
Next device, that’s a Biomedicus centrifugal VAD is what that is. Some people call it CPS. Cardiopulmonary support is when we put the membrane oxygenator in circuit. That is CPS, cardio and pulmonary support with the oxygenator. So if someone says “CPS,” that’s what that means, that means artificial heart and artificial lung, essentially.
This shows some of the cannulation. I just explained it to you. As you can see, you can cannulate the heart just like it is shown here, and this is when they have the open chest coming out of the OR or you can say it to the femoral groin great vessels.
This is an Abiomed. How many have heard of an Abiomed? Abiomed is used in quite a few centers in the U.S. We do not use it. This contraption here is the Abiomed. It is also temporary -- four to seven days, at best. What happens after four to seven days, you might ask. Well you have to replace the circuit. The cones don’t last forever. These kind of things don’t last forever, so -- these devices -- you need to replace them about every four to seven days, so when you see patients on a temporary RVAD, LVAD, whatever, these temporaries are, Biomedicus or AbioMed, you know darn well they are going to be changing that out or they should be because these don’t last forever.
I don’t know a whole lot about this one because I’ve never seen it implanted, or I’ve never managed it. I just happened to get my hands on one to show you. But when someone says “AbioMed,” that is AbioMed. That is called BVS 5000.
Unknown female: Karl is there any particular reason why you don’t use that device?
Nelson: The main reason we don’t is our surgeon finds this other one a lot easier to manage so, early on, we’ve never had it in our facility. It was a surgeon preference. The surgeons that are out there using the AbioMed, it is their preference. Okay?
Thoratec -- how many know Thoratec? Thoratec is out of California. This is paracorporal. You can see it very clearly here. Look right here on his body. See that? Those are the pumps. They are outside the body. That is paracorporal. But they are right next to the body, so that’s why you call it paracoporal and not extracorporal, away.
This is a Thoratec driver. It is 400 pounds. So when someone uses the word biventricular support with a Thoratec, guaranteed, they are in the hospital for a long time. There is no way to get this patient out of the hospital. So if you are working with somebody that says I’m putting in a thoratec biventricular, they are hospital bound.
So here is a patient here. As you can see, they do fairly well. We have this technology at our facility. We don’t use it that often. I’ll explain it to you in a minute why not. But we do use it. It has some flexibility that other technologies don’t. You can use it as an RVAD, as a right heart support. Most technologies don’t give you that flexibility so you can use it as a straight right, a straight left, or both. You can cannulate this patient either way with Thoratec, so it gives some flexibility.
From our perspective because we have another device that does biventricular, the only benefit to us is because the pumps are outside the body here, we can install this in small patients. You can’t put all this hardware into tiny people necessarily.
There are pediatric utilizations of Thoratec. As a matter of fact, I am currently working with the primary children’s hospital and starting their artificial heart program up there, and we’ll be using Thoratec there for their pediatric patients. I didn’t bring my 400-pound console with me.
This is the one I want to spend a little time on, because this device will receive FDA approval probably by the end of the year. This is the artificial heart. This is the Barney Clark heart. It is [attached with a hook and loop fastener], so it has a lot of flexibility to shape this to the chest cavity so when I pass this around you are welcome to play with it.
It is no different than any other [hook and loop fastener] you’ve seen. You can actually move this and adjust this right inside the body to fit the patient. The problem with this device is you have to be a certain size to receive it. That’s where Thoratec comes in, where this one can’t provide. But this is fully implantable.
The CardioWest heart is fully implanted. These cusps are actually sewn to the atrium. The surgeon actually takes a pair of scissors and excises the ventricles right out of the chest. Then these cusps, these are two artificial ventricles, are sewn on to the remaining atriums with these cannulating the great vessels.
Now in the industry, this is called CardioWest Total Artificial Heart. Is it investigational? Today, yes it is. Have I ever been denied payment for this? No I haven’t. How many times have I done it? Nine times. Now why is that? The reason why is once again, the management of this is a little bit easier. This is implanted.
How would you like blood pumps and tubes hanging outside of your body? This is all implanted. All the blood surfaces and everything are inside the body. All you have is two external air hoses that exit the body down below. Console, in terms of managing this device, is about the same. But you get the gist here. It’s a 400-pound console right here that drives this pump.
This patient here is one of the one of the patients in the slide show. He was a property developer back in Boise -- as you can see in the hospital, once again hospital bound -- was developing properties up in Boise. Now let me go ahead and pass this one around.
This is the advent of the left ventricular assist pump. Now this is the most widely-used pump in the industry today. This pump is implanted in the left upper quadrant. If someone tells you they’ve implanted it anywhere else, they’ve made a big mistake, but this pump is cannulated right here. This enters the left ventricular apex and downloads the blood from your tired, weak heart, puts it into the pump and returns it through pressure back to the aorta.
There have been about 756 of these put in in the U.S. to date, through May [2000]. Currently, in the United States, Thermocardio Systems, the manufacturer of this reports that there are 76 centers in the United States that can put this in. Okay. There are only a handful of them that have a long track record. I’ll talk about that in just a moment too.
But this pump is a very good pump. We’ve had great success with it. Our success rate at LDS Hospital installing this pump into patients and successfully taking them to transplant approaches 90 percent. It was 86 percent at last calculation, but I have transplanted two since then so I think it’s 88 or 89 -- somewhere in there. This has now been mothballed in most centers.
If you deal with a lot of centers that are still putting in the pneumatic pump, you’ve got a problem. The reason why is there is new technology that will allow patients to go home, and go home is the key -- quality of life for the patient. Is it ethical to keep these patient’s bound in the hospital? At our facility, we say no, and we do everything possible to get them in and get them out.
I pretty-near fast-track them out the door. I will give you my results here in just a moment, but this is old technology. This is technology that went away. We don’t even have this on our shelf anymore, but I bet you of those 76 centers, I’ll bet 20 of them are still doing this only.
This was FDA-approved for bridge to transplant use. And LDS Hospital was involved in all these clinical trials. Here’s a little picture of the pump, but I’ve got it here, physically, for you to see.
It’s a very interesting technology. It’s technology that’s completely counterintuitive. What I mean by that is the surface of the pump is rough. This company Thermocardio Systems has a patent on this surface.
What happens is that you would think that you would need the insides of these pumps, the blood contacting surface as smooth as glass so that nothing would glob up on them, right? Wrong. The reason it is wrong is what happens is inside this pump it’s a rough surface. What you see is all these little tinctured beads here. It is very rough on the inside. It feels like sandpaper.
If I happen to transplant somebody early in their course, I can go back and see different phases of neointima being formed by the body. The body actually formed its own intima layer inside the pump. So the pump actually becomes incorporated into the body and acts like body to the body. So you see this, this is a pump that has been in a long time. When we take it out, it’s gone -- this smooth-as-glass surface, but it’s not something that is plastic or polyurethane.
It’s the body’s intima. It’s as slick as can be. This is the only company that has that feature. Because of that, this company reports a very, very low thrombotic embolus rate -- Thermocardio Systems.
This is the advent of the electric pump. On the right hand side, is called a power-base unit. On the left hand side, is called the system controller. The power-base unit is what every patient has at home. It costs $12,500 or you can rent these things, but leave it at that. Every patient needs to take this home. This is how they charge their batteries.
But the electric pump different than the pneumatic pump. This one runs on an air console. You saw the slide show with the patients with that grocery cart-looking device. That is the pneumatic driver. That is the old pump, but that’s all we had early on in 1993 was the old pump. Okay. We’ve thrown that all away. Now we’ve gone to this.
With this they need batteries. The pump runs on batteries. So they have the battery charger. This little box on the left is what is called the system controller. It is the device that has the brains of the pump. You can actually, well, I tell you what here. This is a patient with a pneumatic driver. You saw one of those just moments ago in the slide show.
This is another picture I had to throw in. This is our patient Number One. This is the true pioneer. This is the guy that came in, Idaho potato farmer, laying in the ER. Dr. Jim Long, the surgeon at LDS Hospital says, “You know, I think I just received something on the dock this morning that might help you.”
“Well, doc, you know I’m dead anyway so I have nothing to lose.”
This is really how the conversation went. Shortly thereafter, we went to OR and put the first ever at LDS Hospital pneumatic device in this man right here. This is implant Number One at LDS Hospital 1993. You can see him trying to do something for fun in the hospital. In those days they all stayed in the hospital. During the clinical trial days, we had to keep them in too, but we had fun with them.
Here’s the electric pump. This patient has the electric device and just to give you a visual, I have the electric device too. Now the electric device, I’ve had this on the whole time. I have people teaching school, college level. Some of those pictures you saw there, you saw people teaching school. I have a professor teaching school on an LVAD. Okay.
These patients go out in the community, and you don’t know it. They go to movies. They go out and play, and they have fun. There are people here that have worked with people on electric VADs who can testify to that. But these patients go out and live normal lives.
The electric LVAD runs on two video camera batteries. The video camera batteries ride in these holsters underneath their shoulders, underneath their armpits. Every patient makes their own creative way for it. Some people cut them off and put them on fanny packs. Some people cut these off and put them on their belt loops, but whatever patients like, they do. Some patients, especially the females, don’t like it hanging on their shoulders, so they do put it on their hips and a belt that they get made for themselves.
But these are the batteries. The batteries then are connected into a clip. This is how somebody would fire this up for themselves. So the batteries are popped into what’s called battery clips, and you will see all these things showing up on your bills. Battery clips, batteries, battery holster. That’s on there.
Now our patients do fly. We are one of the first centers in the United States that has allowed patients to drive and to fly. We have protocols in place. As a matter of fact, next week, we are presenting at the American Society of Artificial Internal Organs Flying Protocols. How these patients get out and fly.
So if you ever see a big guy behind a screen getting frisked by a bunch of security, it’s probably me. Sometimes it takes me 15-20 minutes. I walk up to the security people at different airports with my patients, because sometimes I fly with them, because they are scared or whatever. I say, “My patient has an artificial heart.”
“Yeah, right, get behind the screen.”
They have to show where it comes out and the whole bit.
Everything is internal up to this point. This tube is implanted like so, between the internal and external oblique muscles on your left upper quadrant. The driveline, as we call it, is tunneled through the subcutaneous tissue right about the umbilicus and exits the body right upper quadrant. Early on, patients had these drivelines dangling down here. This was how the technology was, and when the surgeons got together, gosh how do we do this. It was all Star Wars and pioneering. We didn’t know what to do.
So the driveline started hanging out down like this. Well it got caught on stuff, and it interfered with everybody’s pants, and quality of life was a bummer. Everybody had to cut and alter all their pants to accommodate this hose hanging straight down like this. Then it transitioned over to the right lower quadrant hanging out like this, and they thought that was the greatest way. Well, that became like a third appendage on your side. It also would get snagged. If you sat in a chair, it would get banged. That became a problem.
Today, if they are up to speed, this should exit the right upper quadrant in this orientation like this. Our patients wear an abdominal binder, your standard GI abdominal binder, to immobilize this exit site. The Achilles heel of this technology is infection. But with proper management, I can tell you today that my infection rate is almost zero. It’s a weird phenomenon, and the phenomenon is it doesn’t matter how much betadine, hydrogen peroxide, vancomycin, gentamycin, irrigation washes does not matter what solutions they are putting on their would. What matters is the immobilization of this line to that abdominal binder to prevent torsion on that fresh skin, the wound that is around this tube.
You can put all the vanco and betadine and hydrogen peroxide and chlorhexadine you want on this, but all it takes is one wrestling match with the grandkids, which I’ve paid the price for this one, where that thing got pulled, and you’ve lost 12 months of great tissue healing. All it takes it one patient to sleep on their belly when they’ve been told not to, and it tears it down with pressure on that site. So it is important then to keep this immobile, and the abdominal binder is well reported by us because we were the people that came up with that.
Actually the implant of this thing coming up, this orientation, was also one of our findings. This has a velour surface on it, very soft, and the skin will grow into it. The longer these pumps are in the skin, just like the inside of the pump, the skin will assimilate that tube right into the body. The longer its in, I’ve seen the skin grow up as much as an inch on that drive line, but all it takes it one tear, and you’ve lost 14 months, or 19 months, or 15 months of good wound care.
So from day one, it’s got to be banged home on these patients. Any questions?
So this is the VE Heartmate. This is cutting edge. This is what gets people out of the hospital. This is all we put in for left ventricular assist. Some of you may have also heard of novacore. Novacore is another left ventricular assist pump, basically the same thing. Sits over here, cannulated here, takes blood out of the LV, not as widely used as the TCI.
Now people may wonder, will this thing fit into me? There are very few people in this room that it would not fit into. This particular patient --21 years old, 114 pounds, 5 ft. 10 -- we shoehorned that thing in.
But you see, this is what is critical. It’s a learning curve. Some centers wouldn’t even attempt it. They would go right to a Thoratec or something and boom now you’ve got the $500,000 bill. But because of the learning curve, we know what we can do and what we can’t do.
Here is our patient. He’s 21 years old. Here he is as an outpatient, with his family. We put the pump in -- 110 pounds, 5 ft. 10. It’s not cool to be 21 with a pump -- not at all. So he conceals it. He puts another t-shirt over the top to hide all his hardware. He can go out and disco and everything without being seen.
This is another patient of which you’ve seen. This is important. Clinical indications essentially for advanced circulatory support -- temporary treatment of shock. We can put these devices into rescue people.
External ventricular assist -- that was this. Okay. Temporary; we can put these in with patients come to the ER, put this in and support them so we can make a very good decision on what we are going to do.
External cardiopulmonary support -- that is the one with the oxygenator in the circuit.
Bridge to transplantation, currently the only FDA approved indication, right. Bridge to transplant.
All these different devices you can use for it, and I’m not going to go through that.
The artificial heart that I mentioned -- the Thoratec biventricular, and the CardioWest, the one that is being held right there -- both are used as a bridge device. Although it’s investigational, the reason it is going to get FDA approval this year is because the results for that device are as good as any other device.
So managing somebody on the artificial heart has proven to be successful. So we use that as a bridge pump. Actually, one of the reasons why it gets approved is that pump is about $35,000, and Thoratec -- who’s paid for a thoratec? They are pricey. So it doesn’t take too much, if I show my outcomes and then say “I’ve got this device that is half the money.” That is why I am nine out of nine.
LVAD advantage -- this is important stuff right here. This is state-of-the art stuff. Donna Mancini in 1998 from Columbia. The exercise capacity of device patients is better than that of ambulatory heart failure patients awaiting cardiac transplantation. People who are on the cardiac transplant list without an LVAD are in a death spiral. They are going downhill. As a matter of fact, they are doing less activity than more. They are getting weaker, cachectic, loosing weight.
They are poor transplant candidates, if they make it. Patients supported for greater than 30 days with left ventricular assist devices have improved physiologic status secondary to aggressive physical rehab. It’s been proven that patients who transplant off of an LVAD have fewer complications than patients who don’t.
Why? Because they can exercise. They can hike mountains. They can bowl. They can fish. Their mental psyche is there. They are enjoying life. They have their life back instead of having the rug pulled out from underneath them, sitting in a chair with O2, gasping for every last breath hoping that heart comes.
The status of them -- where I want to go here is to the bottom, just now starting permanent use. Let’s talk about the REMATCH trial. Should the REMATCH trial be something we should look at? Absolutely. LDS Hospital is one of 20 centers in the entire U.S. that are participating in the REMATCH trial. To date, there are 90 people enrolled. They are looking for 140. LDS has enrolled nine people in that trial. The REMATCH trial is the randomized evaluation. Forget the acronym.
It’s the permanent use for people who are non-transplant eligible. What do we do for the 50-year-old person who has diabetes and has peripheral vascular disease and blind in one eye and has severe heart failure? Do we turn our back on them? We enrolled them in REMATCH trial. I am going to show you Disneyland here in just a minute.
The objectives of this? It is a trial that is studying the safety and efficacy and cost-effectiveness of using the LVAD as destination therapy for people in heart failure. Permanent use. They will die with this pump. Death is the end-point for people in the trial.
Inclusion criteria - people in Class 4 heart failure, people that have had good medical management, digoxin, vasotec, and lasix, EF less than 12 and exercise capacity less than 12.
Exclusion criteria. We don’t throw anybody in the trial. Anybody that has these problems: renal disease greater than 3.5 creatinine; liver dysfunction; people who are too small, and the only reason that is, is the pump won’t fit by definition; people who have had strokes. So you have to be a purist in heart failure, essentially. Heart failure is your main problem. Then you can enroll in the REMATCH trial.
Here she is Disneyland. On the right hand side, a 56-year-old lady. This patient came to us. She had no hope. She had a month to live. Came in the hospital; couldn’t walk 15 feet. Now she’s got her pump, enjoying her grandchildren at Disneyland -- REMATCH trial.
Clinical considerations -- this is critical stuff -- importance of timing. These cardiologists and different clinicians will hold on these patients until we have to rescue them. Read the bottom line.
“Withdrawal is always an option, but resurrection is not.”
We can, literally, put this in fairly cheaply. We can implant this device. It is not very expensive. Look at it. It’s just plastic. We can put this in through the groin. We don’t even have to go to the operating room, but it will return blood flow, and we bring their livers back, and we can bring their kidneys back.
Now we have a specimen. So we can implant this device and get the patient optimized before we try to go to the OR to put in this other pump. But sometimes, in the country, clinicians are holding onto these guys, and they expect us, literally, to resurrect these patients. Got to get to them early.
Timing is the key, and communication is even more important -- likelihood of success, early communication.
I tried to put together what’s the Clinical Center of Excellence for you. In this field, currently, the national average for survival in somebody who has had the pump implanted and has successfully bridged to transplant is 70 percent. That is the national average. If you are less than that, you are below national average.
Patient volumes are critical. This is a stab in the dark, but you better be doing six to eight of these pumps a year or you’re wasting your time. How do you keep a full team of people staffed, ready to go, trained, OR, anesthesia, perfusion? It’s a big team. I’m going to show you my team here.
What is the benefit of a Clinical Center of Excellence? Improved clinical outcomes, low cost, highly skilled centers, and better quality of life for the patients. Everything we espouse.
Here’s my team. I am most proud of these people. In the back left is Dr. Jim Long, the surgeon. He is the grandfather of our program. He put this team together. There is a smug guy in the back. On the far right is Dr. George Pantalis, a bioengineer. It requires a big team to keep this program going. He’s our troubleshooter. The guy in the back is a masters-prepared engineer. This is an R.N. in the front left. The two in the middle are research people. The one on the right next to Dr. Pantalis is our office coordinator. This is my team. This is what it takes to keep this stuff going.
This is kind of a little team hierarchy, and as you can see we involve home health in our team. We have a dedicated person with home health that we work with. We include our patient account people of which you guys speak to from time to time. Our administrators, we have definite people that we know that write the contracts and all that kind of thing that we go to, etc., etc.
This is kind of an interesting slide. This is some of our highlights at the program. We were involved in pneumatic trials. We were one of the first ones to discharge LVAD patients.
Regional transport -- if there is somebody in this room that can attest to this, but we have a highly skilled team -- a team of nurses, paramedics, etc., that will actually take aircraft and pick up folks. As you saw from the slides, we’ve taken people from Minneapolis for bi-ventricular support -- South Dakota, Oklahoma, Oregon, etc. We send our own team out to bring these people in.
We put in 15 devices last year. That’s basically what that said.
This is an important slide. Cost for LVAD patients at LDS Hospital, bottom line. Look at the bottom. Average cost per patient, $188,000. That includes the price of the pump. Implant-to-discharge, including the price of the pump, $188,000. Note that it is skewed to the left on this curve. Everybody has the outlarge, and we’ve had our share out there. But the majority of the patients lie in this center region here.
This is even more important. Don’t tell me heart failure isn’t already costing you a lot of money. Patient Number One, admission number one $58,000, admission number two, $32,000, admission number three, $3,000.
I consulted on this guy right here for an LVAD. Never got one. Couldn’t pull him away from the physician.
“Oh, let’s put him on home milrinone $700 every other day. Throw in a picc line, two times a week, home health $100 a crack. Oh, another admission. He has an arrhythmia. Let’s throw in an AICD, $177,000 on that one.”
Okay. This is expensive stuff. Patient Number One, what was the cost of the LVAD? We should have put it in here nine months ago. This guy has since been transplanted; had nothing but complications.
Patient Number Two, a little bit simpler, but the bottom line here, two admissions, two biggies, $135,000 through the ICU to rescue him out of cardiogenic shock. Then they held onto him for $180,000 worth of inpatient milrinone, $315,000 two admissions. That doesn’t include transplant.
Let’s go right there. Average discharge time for patients at our hospital from implant to discharge is 26 days. Majority of our patients lie right there, two weeks. Over half the time, I can get the patient out in less than two weeks. That’s basically what that’s telling you.
Factors to success -- a team, world-class program, aggressive protocols -- you see this is learning curve stuff. You have to be able to develop these protocols Day One. The patient is in the OR. That team of mine is training the family back in the waiting room. They have the pump out. They are showing the emergency procedures. They are getting the family all excited and psyched about this pump.
Day Two, I have a training program. Day Three, Day Four they are out of the ICU. About that time is when the patient starts getting hit with training. It is unethical for that patient to be medically ready and everybody throw up their hands and say, well no one knows how to care for the pump. You can’t send this guy home. They sit in the hospital another two weeks while some training takes place. The training has to start on day 1. The training is key.
This is a quick demonstration of what I do in the field. When I discharge a patient, I train the sheriff. I train the paramedics. I train the whole community -- sometimes 200 and 300 people. The whole church comes. I have done this everywhere from Oklahoma to you-know-where. I train the whole entire community.
Here is a 14-year-old sister performing, actually this is not a fake, emergency hand pumping procedures on her brother. I presented this at a conference in New York City last year, and nurses stood up and said, “How do you dare do that? Because in order to do that, you have to turn their pump off.”
So I will turn their pump off, then we install this little hand pump here, and this is how we return blood flow back to that pump. It is nothing more than a hand bellows. I can pump blood through this hand pump. Well if the patient can’t feel comfortable at home knowing that he can do that, how do you rightfully send them home?
So most centers in the U.S. are sending them home, and they have never tested this out. I train nine-year-old kids how to do this. Now, go turn off your Dad’s pump. Now put your hand pump in and get it going. And they do it. Nine-year-old kids know this technology and can sit there and stay with their dad or mom, while their wife or spouse is out during their thing shopping. I can leave this to a nine-year-old kid only because of the training.
Outpatient management is a big deal. Here is a patient on an airplane. This is our patient on her way to Disneyland. This is where all this frisking comes in, but this is a major feat -- giving people back quality of life. This only happens in four or five centers in the U.S.
Last year when I asked how many centers, this is all the TCI Centers in the world come to this, and I say, how many of you let your patients fly About three hands went up. How many of you let them drive? About three or four more. So this is cutting edge stuff. The patients are flying with this technology. The only hope on the horizon for end-stage heart failure is the artificial heart.
The next generation frontier, and this is where I need to take a couple minutes here, the next generations. These are issues for the new pumps. As was mentioned in the back, it is a little noisy. The patients sometimes complain of that. I can’t sleep very well. The person that complains the most, however, is not the patient. It’s the spouse.
Making these things smaller, quieter, and vibration free, eliminate tubes through the skin, fully-implanted, reduce the chance of infection, clots, bleeding, make them more suited for durability, pumps that last a long time -- this pump may only last two to five years. Improving quality of life, reducing costs, make sure the right people are getting these pumps.
Okay. This is the new pump. The new pump is no bigger than a ketchup bottle that you get from the burger shop -- a little cup of ketchup that you dip your fries in. That is all the bigger it is. Look how it sits in the palm of the hand here. That is the pump. All it is is a jet turbine. People from NASA -- NASA technology -- have developed that.
This is what I want to show you. This is Star Wars. This is third generation technology. Second generation is the turbine. Third generation is magnetically-levitated, blood-contacting rotors that sit inside of a vat. There are no bearings. There is nothing to wear out. These pumps will last 10-20 years.
It is actually suspended in a magnetic field and turned by magnets. They run at high RPMs to spin blood, but this is a magnetically levitated pump -- probably five years out. If these last 10-20 years, this could be the way to treat heart failure. The only reason I give you this is to give you a scope of the technology that is being developed.
Look at this. By the year 2010, 35,000 to 70,000 patients per year will need these pumps -- per year -- by the year 2020, maybe 200,000 per year. Did I make this up? No, it came from National Heart and Lung and Blood Institute.
This is my last slide. This is why I am in the business -- picturesque Salt Lake City mountain range behind us, the Wasatch Mountains. We are standing on top of the hospital here on the helicopter pad looking out to the east, and this little group of patients right here represents a very unique set.
Here is a patient with postpartum cardiomyopathy, 29-year-old female. She is on an LVAD right here. We’ve had five cases of postpartum cardiomyopathy. Here is that. LVAD…these are both electric. Both these patients went home and enjoyed life. Her pump was the first one we had to fail, and the only one we had to fail, mind you. But she made it. Why? Because that nine-year-old kid could hand pump.
Just one last important point, and then I’ll sit down. This little thing right here, you’ve got these patients sitting in the hospital for months on end on a pneumatic driver. They are racking up big bills. That little guy right there is a pneumatic driver. That is called a HeartPak.
The HeartPak is in clinical trial, and if you’ve got a center that is camping on three or four of these guys on pneumatics, they need to call TCI and get involved in the heart pack study. The HeartPak Study, although it’s investigational, they all get out of the hospital on the HeartPak. We’ve been involved in the heart pack since the beginning. But that’s what that is right there. That is the HeartPak, and that replaces the grocery cart.
Thanks for your time. Just a couple of quick tidbits of information I want to give you. I’d be a miss if I didn’t tell you to go home and touch somebody’s life. I consider all of you my friends. Some people in the industry, and you might butt heads with some of these guys in the hospital, but not me. I’m your friend. You guys are important to my team. My success up here that you see on the screen, you are just as vitally important to me as anybody else. So if any of you ever have a chance to work with me, I hope I will be able to work with you on a real friendly basis.
Lilly Tomlin once said, “We’re all involved in a rat race, but even if you win the rat race, you’re still a rat.”
Take yourself a little lightly, enjoy yourself, relax, and enjoy life.
Thanks for your time.
Q: Of those nine patients you have in the REMATCH trial, has anybody expired yet?
Nelson: Oh yes.
Q: How many?
Nelson: Of the nine, let’s see, four. I have people in the REMATCH trial that are going 14, 15 months now, on the pump, enjoying life 100 percent. Now I’m just going to give you one quick tidbit. The people that randomized the medicine, it’s not a pretty picture. The people that randomized the device -- remember these are the sickest of the sick -- if they can survive that operation, the mortality curve goes out, and they are enjoying quality life this. But they have a little perioperative mortality, and then it flattens out.
Q: Is there any age exclusion with this device?
Nelson: No, I’ve enrolled people in the REMATCH trial up to the age of 77.