A recent trial has shown that a small, implantable cardiac pump has performed well in the first stage of human testing. The pump is a new type of ventricular assist device (VAD) that is surgically attached to the heart to augment its blood-pumping action in individuals with heart failure. This could allow children to await heart transplants at home instead of in the hospital, and could potentially close an important gap in heart transplant care.or children.
In a preliminary test involving seven children who were given the new pump to help their failing hearts, six eventually underwent heart transplants and one child’s heart recovered, eliminating the need for a transplant. The findings will be released on May 7 in the Journal of Heart and Lung Transplantation. The research was conducted by the Stanford School of Medicine and involved various medical centers in the United States.
If the initial results are confirmed in a larger trial of the device, waiting for a heart transplant could become less difficult for young children and their families. The new pump, known as the Jarvik 2015 ventricular pump, has the potential to be a game-changer for pediatric heart transplant patients.The new heart assist device, which is just a little larger than an AA battery, can be surgically implanted in children weighing as little as 18 pounds. This means that kids can still engage in normal activities while waiting for a heart transplant. In contrast, the only available ventricular assist device for small children, the Berlin Heart, is not implantable and is as big as a large suitcase. It weighs between 60 and 200 pounds, depending on the model, and is connected to the child with two cannulas that are almost as large as garden hoses. The Berlin Heart also carries a relatively high risk of stroke and requires Hospitalization for children waiting for a heart transplant can often last for months, putting a significant burden on them. This is in contrast to adults who receive heart pumps and are typically discharged from the hospital with similar diagnoses. The lead author of the study, Dr. Christopher Almond, noted that while the Berlin Heart is a life-saving device, pediatric ventricular assist devices have not seen the same level of improvement as those for adults, with the technology still being from the 1960s.rd Medicine.
Implantable ventricular assist devices have been accessible to adults for over 40 years, Almond mentioned. These devices not only fit inside patients’ chests but are also generally safer and easier to use compared to external devices such as the Berlin Heart. Patients can maintain their normal lives by living at home, going to work or school, and engaging in physical activities like walking and cycling.
Almond pointed out that the delay in pediatric technology is a concern for other devices intended to aid children with heart conditions, as well as for pediatric medicine in general. He emphasized the significant disparity in medical technology available to kids and adults, highlighting its importance.The issue of developing medical devices for heart failure in children has been a problem for the healthcare industry. Dr. William Mahle, the chief of cardiology at Children’s Healthcare of Atlanta, stated that this is due to the rarity of heart failure in children. Because the number of children needing heart transplants is much lower than adults, there is not much motivation for medical device companies to create smaller pumps for children. This lack of miniaturized ventricular assist devices for children puts a strain on the medical system, leading to high medical bills and extended hospital stays for children using the Berlin Heart.
Recently, there has been a shortage of pediatric ventricular assist devices (VADs). This has led to longer wait times for children in need of these devices, which in turn reduces the availability of these beds for other patients.
Encouraging initial results
A trial involving the Jarvik 2015 VAD included seven children with systolic heart failure. This condition affects the heart’s largest pumping chamber, the left ventricle, which is responsible for pumping blood throughout the body. Six of the children had systolic heart failure due to dilated cardiomyopathy, a disease that causes the heart muscle to become enlarged and weakened, leading to improper pumping. One child’s heart failure was due to complete heart block (electrical failure of the heart).The children in the trial had heart problems caused by lupus, an autoimmune disease. All of them were waiting for a heart transplant. Each child had a Jarvik 2015 device implanted in the left ventricle of their heart, which is the heart’s largest pumping chamber. They also started taking medication to prevent blood clots and lower the risk of stroke. The children who received the pumps were between 8 months and 7 years old and weighed between 18 and 46 pounds. The pump can also be used for children weighing up to 66 pounds. If the new pump is approved by medical regulators, it is estimated that about 200 to 400 children worldwide could benefit from it.dwide would be candidates for its use each year.
The study aimed to determine if the pump could provide support to patients for at least 30 days without any malfunctions or causing serious stroke. Additionally, the researchers gathered initial safety and performance data which would help in designing a larger pivotal trial for potential approval from the Food and Drug Administration.
While the pump is intended to allow children to wait for heart transplants at home, the participants in the clinical trial were required to stay in the hospital for monitoring until they received a heart transplant or recovered. The researchers closely monitored the participants’ blood.The researchers monitored hemoglobin levels to see if the pumps were breaking red blood cells and also checked for other possible complications such as blood clot and stroke risk. The average duration the children used the pump was 149 days. Six children underwent heart transplants and one child’s heart fully recovered.
Some children encountered issues with the new pump. One child who had a recovered heart suffered an ischemic stroke (caused by a blood clot) when the heart became strong enough to compete with the pump. The pump was removed and the child continued to recover, remaining alive a year later. Another patient experienced failure of the pump.The patient’s heart failure led to being placed on a Berlin Heart pump while awaiting transplant. In most cases, complications were manageable and similar to what doctors anticipate when using a Berlin Heart on a child. Quality of life questionnaires indicated that most children were not troubled by the device, did not experience pain, and could participate in various activities. One family noted that their toddler had better mobility with the pump compared to their older child who had previously been supported by the Berlin Heart. A larger trial is being planned for the future.The National Institutes of Health has provided funding for an expanded trial to allow researchers to further test the new pump and collect data for FDA approval. The next phase of the research is beginning now, with the goal of enrolling the first patient by the end of 2024. The team plans to recruit 22 participants from 14 medical centers in the United States and two sites in Europe.
“We are thrilled to start the next phase of the research,” stated Almond. “We have overcome numerous challenges to reach this point, and it is very exciting to see potential better options on the horizon for children.”The study involved patients with advanced heart failure who need a pump to serve as a bridge to transplant.
The researchers involved in the study came from various institutions including the University of Texas Southwestern, Texas Children’s Hospital in Houston, Columbia University, Children’s Healthcare of Atlanta, Nemours Children’s Hospital in Florida, Vanderbilt University Medical Center, the National Heart, Lung, and Blood Institute, Carelon Research, Stollery Children’s Hospital, the Hospital for Sick Children in Toronto, Boston Children’s Hospital, Cincinnati Children’s Hospital, and the University of Oklahoma in Tulsa.
Funding for the study was provided through a contract from the National Institutes of Health.This article was funded by the National Heart, Lung, and Blood Institute (grant number HHS N268201200001I).
