 Good morning. First, before I begin my talk, I just want to take a moment to thank the Planning Committee for putting this conference together. So thank you, Deb, Kathy, and Anne. And if I've forgotten somebody, I apologize. So the evolution of ventricular assist devices at Texas Children's Hospital. Let me just say it is short of miraculous the changes that I have personally witnessed over the last 25 years. Going from having nothing to offer children and infants to what is available today. And I would like to share that with you. These are my disclosures. I thought this picture taken 25 years ago would be an appropriate way to start my presentation. Me standing between Dr. Bud Frazier and Dr. Robert Jarvik. What great bookends. Dr. Frazier is who first placed an assist device in one of our patients back in 1989. And now our newest VAD that we are currently trialing was designed and created by Dr. Jarvik, the Jarvik 2015. Here are all the assist devices that we have either inserted or implanted over the last few decades. There are a total of 14 devices. You know, what I discovered while preparing this presentation was that Texas Children's has been recognized as the most active pediatric VAD program in the world. I mean, I knew we were busy, but I had no idea that we held that recognition. I will address each one of these devices in chronological order along with their positives, negatives, and outcomes. So let's start at the beginning. The Hemopump. The Hemopump was the very first intravascular continuous flow device developed. And there is an interesting story behind the pump. And it has to do with its inventor, Dr. Richard Wampler. So during his medical training, he went on a mission trip to Egypt. And while he was walking along the Nile River, he saw a water pump using the Archimedes screw principle. And he stated that about 10 years later, he had this Eureka moment to miniaturize the pump using the same principle. But the motor back then had to be on the outside of the body. So it was strapped to the leg. Texas Heart Institute actually began FDA trials in 1988. And then in 1989, Dr. Frazier inserted a Hemopump into an eight-year-old patient who was suffering from acute rejection. And she was supported until she recovered. There's a picture down at the bottom of the screen. And that is a picture of Dr. Wampler, Dr. Frazier, and one of the Hemopump patients at Texas Heart Institute. And interestingly, this pump is the precursor to the current impella. And next on the list is the Medtronic Biomedicus BP50 and BP80, which all of you out there who are listening today are probably quite familiar with this pump. It's a short-term centrifugal device. It can be used as an L-VAD, R-VAD, or Bi-VAD. It primes easily and is very quick to place on a patient. Now, at Texas Children's, we never shied away from placing a patient on a VAD versus ECMO as long as their lungs were in good order. So this particular patient on this slide was born with critical AS and required postcardiotomy support within his first 24 hours of life. We supported him for three weeks, and he successfully weaned off. The negative of the Biomedicus is the intense heat generated on the backside of the pump. And it required us cutting out the pump about every three days and replacing it with a new pump. The Biomedicus was used from 1989 to 2008. We inserted a total of 28 as VADs, 17 weaned, three bridge to transplant, and five bridge to another device. Next on the list is the ThorTech P-VAD and I-VAD. It is a long-term pulsatile device. It also can be used as an L-VAD, R-VAD, or Bi-VAD. And the positive actually is the console. Even though it's big and plunky and weighs over 500 pounds, it actually, the rate is variable on it, according to the pump fill. So if you're hypovolemic, your patient is hypovolemic, the pump would actually slow down. And if the patient became hypervolemic, the pump would speed up automatically. So this, I thought, was fairly sophisticated for such an older style console. The negative is that the P-VAD is opaque and impossible to visualize the blood chamber. So all we had to go on was what was called a flash test. And you do this, this picture right here doesn't really show it very well, but we use a flashlight and put it up next to the pump. And if you see a flash, that would indicate that the chamber was fully emptying. We implanted a total of nine P-VADs, one I-VAD, and we inherited one I-Bi-VAD from Hurricane Katrina, who was airlifted to us. And we had a total of 11 patients, seven who were transplanted, and we used this from 1999 to 2007. Then came the Micromed debakie child assist device. And we were all very excited about this because this was the first implantable continuous flow device designed just for children. And oddly enough, its range was in age rather than in weight. So it was six years old to 16 years old. And what we found is that we really struggled with this pump for two reasons. First, it had a physical flow probe attached to the conduit and in smaller sized patients it just was very bulky. And then secondly, the platelets tended to stick to the blades and we had a lot of power surges. And one patient actually had to be placed on platelets to get through to transplantation. We used this from 2004 to 2005 on three patients and two were transplanted. Next came the Berlin heart assist device, which is a small version of the Thorotek P-VAD. It's a pulsatile and it also can be used as an L-VAD, R-VAD, and by VAD. It was the first long-term device for infants and toddlers. And although unlike the Thorotek, the rate was not variable. It was set. But with this device we could visualize the blood chamber. And if we saw a beginning of thrombin, we would change it out and do change it out quite frequently. But it's very quick, easy to prime, and we do it right at the bedside. It only takes a couple of minutes to change out. When we began using this device back in 2005, it wasn't used in the United States. When FDA approved. So we were required to petition to the FDA for compassionate use on each and every patient and then order the equipment from Germany. Then in 2007, we did enter into FDA trials. Texas Children's actually acted as the PI for this trial. And then in 2011, it did receive FDA approval. And this little fella right here sitting with Dr. Frazier was our very first Berlin heart recipient. He at the time weighed 3.3 kilos when he was implanted. And then this precious little girl up here became our poster child. And you could see her picture throughout Houston on many Texas Children's billboards. Up to this date, we have implanted a total of 57 Berlin hearts. 49 have transplanted, one ex-planted, and we have one active patient. The next on the horizon was the heart mate too. Finally, we had an implantable, continuous flow design that was small enough to put into teenage males and females. And actually, it was also the first device that our patients could be discharged home. And actually, Texas Children's was the first pediatric hospital to discharge a patient home that had an assist device. The positive was that it rarely had any kind of thrombus formation inside the pump. And the only negative that we saw was that it was still too big for small teams. We began implanting this pump in 2008 through 2014 and planning a total of 17 patients, 13 were transplanted, and one was ex-planted. The next pump that we introduced into use was the McKay rotoflow centrifugal pump. This also is a short-term device, and it replaced the Medtronic Baumeticus. It actually has a much improved design with very little heat generated on the backside of the pump. So even today, we rarely have to change out one of these pumps while they're in use. Also, the console includes a lot of safety features, such as a bubble detector and a low-pressure servo regulation. The negative, like all short-term vads, is that there is a chance of possible air entrainment, and the patient does have to stay immobile. We started using the rotoflow in 2009, have inserted a total of 39 patients as vads, 15 have weaned, one transplanted, and 16 bridged to another device. The next pump that came down the chute was the tandem heart. This is a short-term centrifugal pump that can be inserted in the cath lab, and you insert it through the femoral vein up into the right atrium, through the septal wall, and then into the left atrium. We only used it on three patients, and that was because, as the nurses were repositioning these patients, all three patients' catheters flipped out of the LA and into the RA. So, after these three experiences, our surgeons were pretty much done with that device. We used it from 2009 to 2010. Two patients weaned quickly, I must say, and one patient was bridged to another device. Then we were introduced to the Sincardia Total Artificial Heart. It is basically two thoratex, literally velcroed together, and it replaces a heart that is in complete failure. It's now available in two pump sizes, the 50cc pump and the 70cc pump, but it still requires quite large chest space area. With our first patient, up at the top picture, all we had available was our big blue console, weighing in at over 500 pounds. And then by the time we implanted our second patient, we did have the companion two driver, so that was a really big improvement. And then for discharge home, the freedom driver is available, and this particular patient right here is, he has his freedom driver on inside his backpack. So we began using the Sincardia in 2011, and both of our patients were successfully transplanted. Then a new, small, innovative, implantable, centrifugal assist device came along, the heart ware. This theory was conceived actually right here at Texas Heart Institute by Dr. Bud Frazier, then engineered by Dr. Richard Wampler. The heart ware is small enough that we can actually implanted in toddler-sized patients, but actually it can go on to be able to be placed inside large adults. And because of its centrifugal design, we rarely see any kind of thrombus formation inside the pump. To date, our smallest patient that we have implanted is a three-year-old, 13.2 kilo toddler, and he is doing quite well. This particular patient over here, right there, actually was our very first heart ware recipient, and she was actually in middle school nine years ago and was implanted as destination therapy. And since then, she's traveled to London for her make-a-wish, and in this picture, she is actually headed to her senior prom, and right now she is completing her freshman year in college, all with her original heart ware pump. So only downside of this device that we can find is there is a weakness in the patient driveline. Or maybe our patients are just hard on the drivelines. We're not really sure. We began putting the heartwares in patients in 2011. We, up to this date, we have implanted 65 patients, 40 of which have been transplanted, five have ex-planted, and 15 are currently active. The impella, again, it is a redesign of the hemopump, and is the only FDA-approved intracardiac continuous flow pump that's on the market. There's two flow sizes available, 2.5 and 5.0 liters per minute, and both can be easily inserted in the cath lab. And there is an impella that's designed for the right side of the heart, but we haven't had a chance yet to use that. What we have found, though, is that it's very beneficial to use the impella in tandem with our ECMO patients, and it helps decompress the left side of the heart. We began using this pump in 2014 and have inserted a total of 31 with 28-weened, one bridge to transplant, and two bridge to another device. Now, this past year, Texas Children entered clinical trials on a new device, the Jarvik 2015. It is an implantable, continuous flow device that can be placed in infant-sized patients. We have found that the study criteria is rather strict, and because of that, of the four patients that we have implanted, only one has officially entered into the trial, and the other patients were implanted as compassionate use. We did find that there was homolysis with all of these patients, but it was manageable, and one patient did have several power surges to the point that we went ahead and changed out the controller. Three of the patients did go on to bridge to transplant, and one was ex-planted, and all are currently doing very well. And you'll notice at the bottom of this slide, there are two publications noted. They are both written by Dr. Ikki Adachi, and they're describing his experience with the Jarvik 2015, if you're interested. And then earlier this year, 2020, we implanted our very first HeartMate 3, and it's much like the hardware in design. It's just a little bigger and a little heavier, and so we're going to reserve this particular pump for our adult-sized teens. There's a unique feature of the HeartMate 3, and that is that there's this artificial pulse every two seconds, and it's to better flush out the pump and reduce production of the thrombus. So so far, we've placed three of these pumps, and all three patients are now waiting for transplant. And then what is out there for the future? Well, the bivocor is a total artificial heart using centrifugal design, and it currently is an animal study testing, and it does show a great deal of promise, so we might see it on the market before too long. Also, wireless vads are coming closer to reality for implantable pumps. So if this does come to pass, there won't be a driveline to deal with. There'll be fewer infections, bad patients can go swimming, bathe, shower without any worries. And before I end my talk, I would like to give a huge shout out to both Barb Elias, our VAD coordinator, and Dr. Iki Adachi, our VAD medical director. I cannot begin to give enough kudos for each of them and their dedicated work that they give every single day. And again, it has been an honor to participate in this conference because Texas Heart Institute has and will always be my home. Thank you for your attention today.