December 21, 2020 — U.S. Food and Drug Administration (FDA) approved updated labeling December 17 for Abbott's HeartMate 3 left ventricular assist device (LVAD) to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, physicians now have additional options for treating this underserved population awaiting a heart transplant or for those not eligible to receive a transplant as a result of potential complications or risk related to the procedure.
The approval follows similar pediatric cardiology innovations for Abbott in recent years, including the Masters HP, a 15 mm pediatric heart valve the size of a dime, approved in 2018; and the Amplatzer Piccolo Occluder, a pea-sized plug approved in 2019 to help treat a potentially life-threatening opening in the heart of some premature or newborn babies.
Many children and adolescents with congestive heart failure require a heart transplant or mechanical device implant to survive. The HeartMate 3 LVAD heart pump is an implantable device that pumps blood through the body in people whose heart is too weak to do so on its own. The HeartMate 3 pump was initially approved in the United States in 2017 for adults awaiting a heart transplant and received FDA approval for long-term use in adults in 2018. In the largest LVAD trial in the world, the HeartMate 3 pump showed a survival rate of 79 percent at two years, an outcome that the company says is comparable to patients receiving a heart transplant.
"For families with children battling chronic diseases the future is often bleak. As physicians, we see the fear in the eyes of not only the child, but also the mothers and fathers," said Robert L. Kormos, M.D., divisional vice president, global medical affairs, Abbott's heart failure business. "Imagine a child with a heart condition that does not allow them to play with friends, sing or run. Innovations, such as the HeartMate 3, can lessen the crippling effects of heart failure and allow that child to live a more normal life."
New LVAD Indication Supported by ACTION Learning Collaborative
The updated labeling for HeartMate 3 to be used in pediatric patients was supported by clinical data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION Learning Collaborative), a consortium of more than 50 U.S. pediatric hospitals that pooled together data to show advantageous outcomes of the HeartMate 3 in pediatric patients.
"Our mission is to improve the outcomes of children with heart failure. Historically, this has been an underfunded and understudied area in pediatrics," said Angela Lorts, M.D., MBA, and David Rosenthal, M.D., co-founders of ACTION Learning Collaborative. "This technology will benefit our pediatric patients and is a leap forward for improving heart failure outcomes in children. We are honored to collaborate with Abbott on this pediatric initiative."
LVAD Helps 14-year-old With Heart Failure
Katrina Sellens, now 16-years-old, was an active teenager before being diagnosed with cardiomyopathy, which can lead to heart failure. She could not walk 10 feet without feeling exhausted and had to bend over just to breath. In 2019, Katrina received the Abbott HeartMate 3 under a special request to treat her life-threatening disease.
"One of the most depressing aspects of heart failure is seeing your child lose the ability to do what had always come naturally," said Maria Bautista, Katrina's mother. "I didn't believe she would get as strong as she has with the HeartMate 3. We are back to living life on her terms."
Nearly two years later, Katrina is back to camping and taking care of her family's chickens. The high school sophomore recently earned her driver's permit and dreams of becoming an LVAD nurse so she can help others with heart failure. For more on Katrina's story.
About Abbott's HeartMate 3 heart pump
Abbott's HeartMate 3 heart pump is a small, implantable mechanical circulatory support device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE mark and FDA approved) heart pump with Full MagLev technology, which allows the device's rotor to be suspended by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.