The HeartMate 3 left ventricular assist device (LVAD) was approved for pediatric patients with advanced heart failure, Abbott .
The approval covers both bridge to transplant and destination therapy for children not eligible to receive a transplant due to potential complications or risk related to the procedure. While the announcement did not include a lower limit on the approved age for use, there are practical limitations. The HeartMate 3 device .
The only VAD approved for use in children previously was the Berlin Heart EXCOR device, a largely external device that can accommodate even babies and which gained that indication in 2011. HeartMate 3 and other internal heart pumps have been used off-label in children who were large enough to take an adult-sized device.
Initial approval for the HeartMate 3 came in 2017 for adults awaiting a heart transplant; long-term use as destination therapy gained the FDA OK for adults in 2018.
Pediatric approval was based on findings from nine centers in the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) consortium of U.S. pediatric centers. Among their 35 patients implanted with a median age of 16 years -- most with dilated cardiomyopathy alone (63%) or in the setting of neuromuscular disease (20%) -- the survival rate was 97% out to the median 78 days of follow-up.
In that study, the device was successful in children as small as 19 kg (41 lb), "indicating that this device may be ," according to the researchers reporting in the Journal of Heart and Lung Transplantation.
No stroke or pump thrombosis was seen, similar to the findings with the HeartMate 3 device in the MOMENTUM 3 trial in adults at shorter follow-up, although the rate was still only 1.4% in the final analysis.
"This announcement is a once-in-a-decade achievement" that should improve accessibility of this device, according to a by the ACTION consortium, which advocated for the approval in collaboration with Abbott.
"Historically, this has been an underfunded and understudied area in pediatrics," said Angela Lorts, MD, MBA, and David Rosenthal, MD, co-founders of ACTION, in the press release. "This device approval is a leap forward for improving heart failure outcomes in children."