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Advances in Bridging Children to Heart Transplant

March 2017

For many years, infants and small children who were waiting for a heart transplant faced the highest risk of death in transplantation medicine.1 The lack of reliable small ventricular assist devices (VADs) was a factor driving this risk. With only adult-sized VADs available in the United States, the options left to American pediatric clinicians were extracorporeal membrane oxygenation and the use of adult VADS, both of which delivered suboptimal results.

In late 2011, the FDA approved the EXCOR® Pediatric Ventricular Assist Device (VAD) (Berlin Heart AG, Berlin, Germany), giving clinicians a much more effective tool for successfully bridging infants and small children to heart transplant or recovery. Also known as the Berlin Heart, the EXCOR® Pediatric VAD is currently the only VAD approved in the United States for use in infants and small children.

The EXCOR® Pediatric VAD was first implanted in a University of Minnesota Masonic Children’s Hospital patient in a 2008 clinical trial. Today the hospital is currently the only one in the Twin Cities metro area approved to implant the VAD into infants and small children. Rebecca Ameduri, MD, Medical Director of Pediatric Heart Failure and Transplant, and the hospital’s Director of the Pediatric Device Innovation Consortium Gwenyth Fischer, MD, served as the site’s principal investigators in the clinical trial.

March-2017-Peds-Heart-Care-Feature-Article-Main-Image-Pump Range Ped2
— The EXCOR Pediatric ventricular assist device features blood pumps ranging from 10 ml to 60 ml in blood pump volumes. Image with permission ©Berlin Heart GmbH

In the trial, 204 children were enrolled across 47 study sites. At 12 months after implantation, 75% of participants remained alive. Of these, 64% survived to transplantation, 6% recovered (the device was explanted and the patient survived 30 days), and 5% were alive with the device in place. The mortality rate in the 12-month trial period was 25%. Strokes occurred in 29% of these patients, and stroke was the leading cause of death.2 To date, University of Minnesota Masonic Children’s Hospital has implanted 26 of the VADs in small children as well as 2 HeartWare VADs and 2 HeartMate II left ventricular assist systems in adolescents. Outcomes for the 26 patients bridged by the EXCOR Pediatric VAD are similar to those in the clinical trial, Ameduri says. Of these patients, 65% have successfully bridged to transplantation, and 10% were weaned from the device. The mortality rate among these patients is 20%. “We also have much lower stroke rates than those reported in national studies,” Ameduri says. “We feel this is because our hematology team keeps tight management over the anticoagulation medications.”

The recent survival rate among patients in the pediatric heart transplant program is 100%, reports Pediatric Heart Center Co-Director and Chief of Pediatric Cardiac Surgery Anthony Azakie, MD. “All of our patients are doing well today,” he says. The national survival rate for these patients age 1-5 years is 92.2% at 1 year after transplant, 87% 3 years after, and 81.4% at 5 years after transplant.3

In addition to heart transplantation, the Heart Center’s services include complete repair of heart defects in newborns, correction of complex lesions, minimally invasive approaches, and implantation of devices such as VADs. University of Minnesota Masonic Children’s Hospital will also be one of the study sites for a clinical trial comparing the Jarvik 15mm LVAD System (Jarvik Heart, New York, NY) to the EXCOR Pediatric VAD. The study is expected to start in 2017.

References

  1. Mah D, Singh TP, Thiagarajan RR, et al. Incidence and risk factors for mortality in infants awaiting heart transplantation in the USA. J Heart Lung Transplant. 2009;28:1292–1298.
  2. Almond CS, Morales DL, Blackstone EH, et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. 2013; 127:1702-1711.
  3. U.S Department of Health and Human Services. Organ Procurement and Transplantation Network. https://optn.transplant.hrsa.gov/data/view-datareports/national-data/#

When to refer

University of Minnesota Health surgeons perform 20 to 30 heart transplants annually in children and adults, making our program among the top 15% in the United States. Our surgeons have been pioneers in heart transplant surgeries. We performed the world’s first heart transplant in an infant, the first heart transplant in Minnesota, and the first stage 1 hybrid Norwood procedure in the Upper Midwest. Our program is also one of the longest running in the world. We have performed more than 800 heart transplants, including 117 in children, the youngest of whom was 1 month old.

We provide a multidisciplinary team to work with pediatric heart transplant patients, their family, and care providers. This team includes a coordinator, cardiologist, surgeon, neuropsychologist, social worker, pharmacist, financial counselor, and dietitian. We offer access to pediatric ventricular assist devices that can be used in infants, children, and adolescents, allowing us to be able to support children while they await transplant. Our goal is to allow the child to be at home while awaiting transplant. However, if this cannot happen, we offer services for the patient and family, including housing, transportation, and emotional support. Most of our patients leave the hospital within 2 weeks of receiving a transplant. After transplant surgery, we can support patients with long-term follow-up care.

Our physicians are on the forefront of research and involved in clinical trials testing heart failure treatments and ventricular assist devices. Through participation in a clinical trial, your child will have access to the latest therapies in development.

To contact our heart transplant specialists, call 888-KIDS-UMN (888-543-7866).

To learn more about transplant-patient care management, contact Rebecca Ameduri, MD, Medical Director of the Pediatric Heart Failure and Transplant Program at amedu001@umn.edu.

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