Miniature pacemakers aim to make cardiac interventions in infants less invasive and more effective

Children's National Introduces a Proof of Principle Concept for Miniature Pacemakers at the 2018 Scientific Sessions of the American Heart Association

At 2:15 pm CT on Sunday, November 11, Rohan Kumthekar, MD, a cardiology researcher working in Dr. Charles Berul's bioengineering laboratory at the Sheikh Zayed Institute for Pediatric Surgical Innovation, belonging to the health system National Children's, presents a prototype for a miniature pacemaker at the American Scientific Sessions of the 2018 Heart Association. The prototype, about 1 cm 3, the size of an almond, is designed to make cardiac pacing procedures for infants less invasive, less painful and more effective, measured by shorter interventions, shorter recovery times and reduced medical costs.

Kumthekar, recipient of the Young Travel Award in the field of cardiovascular disease, will present his oral summary, titled "Minimally Invasive Percutaneous Epicardial Placement of a Personalized Thumbnail Pacemaker with Direct Visualization", in S101A as part of the best abstracts on translational science in pediatric cardiology session.

"As pediatric cardiologists and surgeons, our goal is to make the health and comfort of the child a priority," Kumthekar said. "Advances in the surgical field tend to lead to less and less invasive procedures.Many laparoscopic surgeries in adults and children were open-air surgeries, such as appendix and gallbladder specimens. However, placing a pacemaker on infants' hearts has always tried to put these advances in our area of ​​pediatric cardiology to the benefit of our patients. "

Instead of using open-chest surgery, the current standard for implanting cardiac pacemakers in children, doctors could implant tiny pacemakers by making a relatively small incision of 1 cm just below them. ribcage.

"The advantage is that all the surgery is contained in a small 1 cm incision, which we find revolutionary," Kumthekar said.

Using a patented two-channel self-anchoring access port developed by the Berul research group, the operator can insert a camera into the chest to visualize directly the entire procedure. They can then insert a sheath (narrow tube) into the second cbad to access the pericardial sac, the plastic cover that surrounds the heart. The probe, the short extension of the miniature pacemaker, can be affixed to 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 small scar instead of two large suture lines.

The median time between incision and implantation in this thoracoscopic surgery study was 21 minutes and the full procedure took less than an hour on average. In contrast, pediatric open heart surgery can last for several hours, depending on the medical complexities of the child.

"Placing a pacemaker in a small child is different from the operation in the adult, because of the small thoracic cavity and narrow blood vessels," Kumthekar explains. "By eliminating the need to cut the sternum or ribs and fully open the chest to implant a pacemaker, the current model we can reduce the time for surgery and help relieve pain."

Miniature pacemakers and the surgical approach can also work well in adult patients with limited vascular access, such as those born with conbad heart disease, or in patients who have had open heart surgery or multiple prior cardiovascular procedures.

The miniature simulators have pbaded a proof of concept simulation and the experimental model is ready for a second test phase, which will badyze the behavior of the customized devices over time, before the clinical tests and the availability for the infants.

"The concept of inserting a pacemaker with a 1 cm incision in less than an hour demonstrates the strength of working with multidisciplinary research teams to quickly solve complex clinical problems," says Charles Berul, MD, author of the study, Electrophysiologist and Chief of Cardiology at Children's National.

The Berul de Children's National team collaborated with Medtronic PLC, the developers of the first implantable pacemakers, to develop the prototype and provide resources and technical support to test minimally invasive surgery.

The National Institutes of Health awarded a grant to the Berul research team to develop PeriPath, the all-in-one 1 cm access port, to reduce the number of incisions in allowing the insertion of the camera, needle, lead and pacemaker. in a port, through a small incision.