Nov. 9 (UPI) — A pacemaker protype the size of an almond designed to make procedures for infants less invasive, less painful and more efficient has been tested on pigs.
Dr. Rohan Kumthekar, a cardiology fellow at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center in Washington, D.C., will show off the device and present his abstract Sunday at the American Heart Association’s Scientific Sessions 2018 in Chicago.
Kumthekar believes the process will lead to shorter surgeries, faster recovery times and reduced medical costs.
“Placing a pacemaker in a small child is different than operating on an adult, due to their small chest cavity and narrow blood vessels,” Kumthekar said in a press release. “By eliminating the need to cut through the sternum or the ribs and fully open the chest to implant a pacemaker, the current model, we can cut down on surgical time and help alleviate pain.”
With the new device, doctors could implant the pacemakers with a tiny incision just below the ribcage.
“The advantage is that the entire surgery is contained within a tiny 1-center incision, which is what we find groundbreaking,” Kumthekar said.
Eight piglets were tested without any complications, the researcher said.
In the procedure, a patented two-channel, self-anchoring access port is used to allow a camera to be inserted into the chest to directly visualize the entire procedure.
Then a narrow tube is inserted through the second channel to access the pericardial sac, which is the plastic-like cover around the heart. The leadlet, which is the short extension of the miniature pacemaker, is affixed onto the surface of the heart under direct visualization.
Finally, the pacemaker is inserted into the incision and the skin closed, leaving a tiny scar instead of two large suture lines.
The entire procedure took less than an hour on average, including a median 21 minutes from incision to implantation. Pediatric open-heart surgery could take up to several hours.
“As cardiologists and pediatric surgeons, our goal is to put a child’s health and comfort first,” Kumthekar said. “Advancements in surgical fields are tending toward procedures that are less and less invasive. … 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.”
He noted many laparoscopic surgeries in adults and children used to be open surgeries, such as appendix and gall bladder removals.
The miniature pacemakers and surgical approach also may be used on adult patients, including those with limited vascular access, such as those born with congenital heart disease, or ones who have had open-heart surgery or previous cardiovascular procedures.
The second phase of testing will involve analyzing how the tailored devices hold up over time before clinical testing and availability for infants.
Kumthekar developed the device in the bioengineering lab of Dr. Charles Berul, who is an electrophysiologist and the chief of cardiology at Children’s National.
“The concept of inserting a pacemaker with a 1-centimeter incision in less than an hour demonstrates the power of working with multidisciplinary research teams to quickly solve complex clinical challenges,” said Berul, a guiding study author.