New York: In a first, researchers have designed a fully implantable micropacemaker for use in a foetus with complete heart block.
Reported in the journal Heart Rhythm, the micropacemaker has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA).
The team of researchers from the Children's Hospital Los Angeles (CHLA) and the University of Southern California (USC) has already done pre-clinical testing and optimization and they anticipate the first human use of the device in the near future, the study noted.
This device could help prevent miscarriage and premature birth in babies affected with congenital complete heart block.
“Building on our experience of using microfabrication techniques to create biomedical devices, we have developed a micropacemaker small enough to reside entirely within the fetus,” said Gerald Loeb, professor at the Viterbi School of Engineering at USC.
“Up until now, the pacemaker devices that have been used in an attempt to treat this condition in a foetus were designed for adults,” said study lead author Yaniv Bar-Cohen, pediatric cardiologist at the CHLA.
“We have lacked an effective treatment option for fetuses,” Bar-Cohen pointed out.
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,” Ramen Chmait, director of the CHLA-USC Institute for Maternal-Fetal Health noted.