Researchers in the US have developed what is claimed to be the first fully implantable micropacemaker for use in a foetus.
Developed by a team from the Los Angeles Children’s Hospital and the University of Southern California the device has been designed to treat complete foetal heart block, a relatively rare condition that occurs when the electrical signal from the upper chambers of the heart is prevented from reaching the lower chambers.
As reported in the journal Heart Rhythm the team has done preclinical testing and optimisation and the device has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA). The team anticipates the first human use of the device in the near future.
“Up until now, the pacemaker devices that have been used in an attempt to treat this condition in a fetus were designed for adults,” said Yaniv Bar-Cohen, MD, pediatric cardiologist at CHLA and lead author on the paper. “We have lacked an effective treatment option for fetuses.”
With each beat of a healthy heart, an electrical signal moves from the upper to the lower chambers of the heart. As this signal moves, it results in the heart contracting and pumping blood. Congenital heart block is a defect of the heart’s electrical system that originates in the developing foetus, greatly slowing the rate of the heart and impacting its ability to pump blood. Although the condition can be diagnosed in utero, all attempts to treat the condition with a standard pacemaker have failed.
“We now have a pacemaker that can be implanted in utero, potentially without harm to the fetus or the mom,” said Ramen H. Chmait, MD, Director of the CHLA-USC Institute for Maternal-Fetal Health. “This novel device provides a real opportunity to prevent miscarriage and premature birth in babies affected with these abnormalities.”
Each year, approximately 500 pregnancies in the US are affected by foetal heart block and could be candidates for receiving this device