Tiny New Pacemaker Small Enough for Infants

Researchers at Children’s National Health System, working with engineers from Medtronic, have created a pacemaker appropriately tiny enough to implant into infants. Measuring only one cubic centimeter, about the size of a large pill, it allows the device to be implanted inside the child in a minimally invasive fashion.

Currently, because of their size, pacemakers implanted into very small children either remain outside the body or require open surgery with large incision. The new pacemaker is so small that a one centimeter incision is all that’s necessary to place it under the ribcage.

The incision is used not only for the pacemaker, but through which the electronic lead is delivered through and attached to the pericardium. The procedure is much faster, less invasive, and results in less pain and quicker recovery for the children. Of course, the overall costs of the procedure and follow up treatment should be reduced as well.

“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first,” said Rohan Kumthekar, M.D., one of the docs at Children’s National that worked on the new device and ways to implant it. “Advancements in surgical fields are tending toward procedures that are less and less invasive. There are many laparoscopic surgeries in adults and children that used to be open surgeries, such as appendix and gall bladder removals. However, placing pacemaker leads on infants’ hearts has always been an open surgery. We are trying to bring those surgical advances into our field of pediatric cardiology to benefit our patients.”

The research, so far, has been performed on infant models, but work is moving toward clinical trials that may end up revolutionizing how infant cardiac arrhythmias are treated.

Here are some more details according to Children’s National:

With the help of a patented two-channel, self-anchoring access port previously developed by [Dr. Charles Berul’s] research group, the operator can insert a camera into the chest to directly visualize the entire procedure. They can then insert a sheath (narrow tube) through the second channel to access the pericardial sac, the plastic-like cover around the heart. The leadlet, the short extension of the miniature pacemaker, can be affixed onto the surface of the heart under direct visualization. The final step is to insert the pacemaker into the incision and close the skin, leaving a tiny scar instead of two large suture lines.

The median time from incision to implantation in this thoracoscopic surgery study was 21 minutes, and the entire procedure took less than an hour on average. In contrast, pediatric open-heart surgery could take up to several hours, depending on the child’s medical complexities.