DURHAM, N.C. (Ivanhoe Newswire) - It's a deadly waiting game. As many as 20 percent of children standing by for a heart transplant die before they get one, but a device for adults is now helping kids.
These days, CJ Moore is happy to be playing basketball, even if it's from the couch.
"Well, there's not much I can do right now," 10-year-old CJ Moore told Ivanhoe.
Several months ago, CJ was in much worse shape. His heart was enlarged, and doctors didn't know why.
"I was scared because I didn't know what an enlarged heart could do to a person," CJ said.
"It was a hard, hard thing to see my child, and I couldn't do anything about it," an emotional Reshella Moore, CJ's mom, told us.
CJ needed a new heart. He got on the transplant list, but to keep him alive until one was available Duke surgeon Andrew Lodge implanted a pump in his chest. It's in clinical trials for adults. CJ was only the fourth child in the U.S. to receive it.
"We had to pursue the company and the FDA to allow us to implant the device," Andrew Lodge, M.D., a cardiac pediatric surgeon at Duke University Hospitals, explained.
The battery-powered device is placed in the left ventricle and pumps blood to the aorta. It's small enough to use insome kids, and it's portable, so patients don't have to stay in the hospital. CJ wore the device for four long months. The holidays were especially hard.
"I said ‘CJ, what do you want for Christmas?' He said, ‘granny, I want me a heart!,'" Joan Howell, CJ's grandmother, said.
Then they finally got the call.
"I just started hollering and screaming, and he said 'mama, what's wrong?' and I said ‘CJ, we got a heart!'" Reshella said.
Since the transplant CJ's getting back to normal. He's on 32 pills a day, but excited about his new heart and his new life. All made possible by a pump.
CJ will be on some of his medications for the rest of his life. Doctor Lodge said he may need one or two more heart transplants because he's so young.
BACKGROUND: The human heart works like a pump, circulating blood to all the body's cells. The right side takes blood from the body and pumps it into the lungs, while the left side takes blood from the lungs and pumps it out to the body. An average heart beats about 100,000 times a day. When the heart starts to fail, it may struggle to pump blood, and muscle function can deteriorate. Patients with a failing heart may need a heart transplant. There are many devices that can support and keep adults healthy until they receive a donor heart transplant. However, that's not the case for kids. As many as 20 percent of children waiting for a transplant die before an organ is available. (SOURCE: http://childrenshospitalblog.org/heart-week-francis-fynn-thompson/)
THE BERLIN HEART: The Berlin Heart is a device that was recently FDA approved for use in children. It takes over the heart's work of pumping blood and can be used while a child is waiting for a heart transplant. Most of the device sits outside the body. Only the tubes are implanted. The tubes emerge from small openings in the skin to enter the pump, which is a small, round chamber. While this device is currently the only pump approved for children, there are some drawbacks, according to Andrew Lodge, M.D., a cardiac pediatric surgeon at Duke University Hospitals. "The problem with that device is it's not an implantable device," Dr. Lodge told Ivanhoe. "It's not as neat. The pump is outside the body. The hardware is a little more cumbersome. It's not designed for hospital discharge. It's designed for shorter-term use." Patients must take a higher dose of a blood thinner medication, which can also lead to complications. (SOURCES: Ivanhoe interview with Dr. Lodge, http://www.childrensmemorial.org/depts/heartcenter/berlin-heart.aspx)
HEARTWARE: Dr. Lodge recently used a pump that is currently in clinical trials for adults on a child with a failing heart. 10-year-old C.J. Moore was just the fourth child in the United States to have the HeartWare ventricular assist device implanted in his chest. The pump is placed in the left ventricle of the heart and takes blood through a tube to the aorta, which moves oxygen-replenished blood throughout the body. A cord extending from the patient's stomach to a battery pack keeps the machine alive. According to Dr. Lodge, the hardware in this pump is more portable because it's implantable. Patients can be discharged to their homes if they wish. "It takes a patient who is basically dying from heart failure, it takes that situation and turns it into a situation where the patient feels better, can be up rehabilitating from a physical standpoint…and it makes them better transplant candidates because they're healthier, basically, when they receive their transplant," Dr. Lodge told Ivanhoe. C.J. wore the HeartWare pump for four months until a donor heart became available. (SOURCES: Ivanhoe interview with Dr. Lodge, Duke press release)
Andrew Lodge, MD, a Pediatric Cardiac Surgeon at Duke University Hospital, talks about a device that saved a young boy's life.
What are left ventricular assist devices?
Andrew Lodge: Left ventricular assist devices are basically blood pumps; they're mechanical pumps that pump blood. They're connected to a chamber or vessel that provides the inflow of blood and then they pump the blood out to some other place. It's typically hooked up to the left ventricle usually at the apex (the tip of the left ventricle) and then has an outflow graft, which attaches to the aorta. It pumps the blood from the left ventricle into the aorta. If the left ventricle is failing people can develop what's referred to as end stage heart failure, where the heart failure has progressed to the extent that they no longer maintain adequate circulation by themselves. Typically those people are waiting for a transplant and the device is used to help them to get to the transplant, which is called a bridge to transplant. Other people who are not candidates for transplant may have the devices implanted for what's called destination therapy or permanent ventricular assist device therapy. Who can receive these devices?
Andrew Lodge: Up until fairly recently, the initial devices were developed for adults, which is typical for all kinds of medical technology actually. Most of the experience has been accumulated in adults and in fact up until very recently the only approved pumps in the United States have been for adults. The market is much smaller for children and so companies aren't as motivated to go through the long and expensive process of developing this technology, but there have been some pediatric pumps that have been developed and some of the adult pumps which have now become smaller and smaller as the field has progressed have been used in some children.
Tell me about the Berlin device.
Andrew Lodge: Ventricular assist devices come in different types. They can be categorized in different ways, but one way to categorize them is implantable pumps and non-implantable pumps. Implantable pumps are basically placed entirely inside the body. They do have an electrical connection that comes out and connects to a computer that controls the device. The non-implantable pumps are pumps that are outside the body and then are connected to the heart by tubing that the blood travels through. The only approved pediatric pump that's used in the U.S. these days with any frequency is referred to as the Berlin Heart EXCOR. It's made by a company called Berlin Heart and they've actually done a lot of work and spent a lot of time and effort introducing this pump and getting it approved. It was just recently approved in December of this past year and now is available in this country and comes in different sizes. It can be used to support patients from infant size all the way up to teenagers, but the problem with the device is that it's not an implantable device and it has a fairly high anti coagulation or blood thinner requirement. It has been used very successfully to support kids while they're awaiting a transplant. However, it's associated with problems such as having to remain in the hospital, sometimes in an ICU setting. There are also issues related to the amount of blood thinner that has to be used for it that can lead to complications, so other pumps are being designed that parallel the same process that's happened in adult patients where initially pumps similar to the Berlin Heart were used and then the field progressed towards using more of these implantable pumps.
Can you tell me about CJ?
Andrew Lodge: CJ was nine years old when he presented to the hospital with severe heart failure that was previously unrecognized, which is actually typical when children present with advanced heart failure. A lot of times the symptoms are attributed to something else until the point where they get really sick because they can tolerate a lot before they really start to go downhill. He was very sick when he came to our hospital and his heart was functioning very poorly. We knew he would need a heart transplant, and thought that the best way to support him while he was waiting would be with a ventricular assist device. Given his age and size, at the time we felt that a relatively new implantable pump made by a company called HeartWare would be the best device for him. The reason for that is that it's a smaller pump, and it can sit almost entirely within the pericardial space, which is the space that contains the heart, and the configuration makes it a little bit more amenable to putting in somebody who's smaller or thinner, which CJ is compared to an adult. We felt that would be the best type of support for him but that device is not approved by the FDA at this point. Clinical trials are ongoing, but only in adult patients. Because of this we had to pursue the company and the FDA to allow us to implant the device. It's implanted under what are called emergency or compassionate use guidelines and in that case you have to obtain the approval of the institution, as well as the company, and the FDA to be able to use it. We went through those steps to get the device for him. Unfortunately during the time that was required to obtain the approval to use the device for him, he became even sicker and required temporary support with a different type of pump called ECMO, and we supported him with that for a number of days and then transitioned from the ECMO pump to this type of implantable device. He was the only 4th child to be implanted with this particular device in the U.S.
Why aren't these studied in children?
Andrew Lodge: They are studied in children, but the requirements for these clinical trials extremely rigorous and in order to get a trial through the FDA, it's a very time consuming and expensive process.
What are the benefits of having this (should specify what "this" is) over the Berlin heart or something else?
Andrew Lodge: There is no standard mechanical circulatory support yet for children. A ventricular assist device is used for a patient that is basically dying of heart failure and in many ways is a poor candidate for transplantation because they're debilitated or they may have other organs that are failing. It takes that situation and turns it into a situation where the patient feels better, can be up and rehabilitating from a physical standpoint and their other organs typically start to work better. It makes them better transplant candidates because they're healthier. That's the benefit of having the ventricular assist device in general. With this particular type of pump (the HeartWare pump) compared to the Berlin heart, there are a couple of potential benefits. Number 1 is that these pumps in adults have had fewer complications with bleeding and with clotting, particularly related to the brain and has generally had a lower incidence of stroke as a complication. Number 2 is, as the device is implantable, the hardware is a little bit more portable. It's easier to get the patients up and mobilized after the surgery and potentially even discharged to home. From an implantation standpoint the device is relatively small. It's attached directly to the heart. The only connection that comes to the outside world is a small electrical connection that comes through the skin whereas with the Berlin heart device, there's two relatively large pieces of tubing to go through the body wall, and whenever you have a breech in the skin, there's potential for problems like infection and things like that.
How common is heart failure like CJ's in kids?
Andrew Lodge: It's pretty uncommon compared to adults. There are a couple hundred thousand patients in the US who are potential candidates for these types of devices or have this degree of heart failure, but in kids it's much more rare.
How rewarding is this line of work for you?
Andrew Lodge: It's very rewarding not just for me but for the whole team. I think everybody is very gratified when you take somebody who basically would have died otherwise and get them to the point where they can go back to school and resume more or less a normal life.
What does the future hold for CJ?
Andrew Lodge: After you have a heart transplant, you are subject to ongoing medical care. What we frequently tell people is a heart transplant is not a cure but it's a treatment. The transplanted heart is at risk for rejection by the body throughout the rest of the patient's life, so they're always on some amount of medication to suppress the immune system. That has some side effects. It can have an impact on other organs like the kidneys, and at the same time it reduces the potential for rejection, it also reduces the body's ability to fight infection. They're at higher risk of infections and at higher risk of some kind of tumors as they grow and become adults, so he'll have relatively frequent doctors' appointments compared to other children and he'll have to come occasionally for biopsies of the heart. Those become less and less frequent as he gets further out from the transplant procedure itself provided that he is doing well. He can have a normal lifestyle, but it does come with the expense of having to take medications and to get regular follow-up with doctors for basically the rest of his life.
How about his lifespan?
Andrew Lodge: It's hard to know. If you look at the averages and the odds it's likely that his life expectancy will be shorter than the average person. There is a life expectancy for the transplanted heart itself such that maybe after 10 years about 50 to 60% of the hearts are still functioning adequately. In children who have heart transplants, they may need to undergo another transplant or even two additional transplants in the future. Overall, the survival of patients that have heart transplants is reduced compared to the general population. That being said, there are people who have had heart transplants that are living happily and healthy 20 years later.
FOR MORE INFORMATION, PLEASE CONTACT: Debbe Geiger Senior Media Relations Officer Duke Medicine Office of News and Communications Debbe.Geiger@duke.edu (919) 660-9461
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