Tiny pacemakers aim to make infant heart surgeries less invasive, while cutting operating costs and time

November 09, 2018

At 2:15 p.m. C.T. on Sunday, Nov. 11, Rohan Kumthekar, M.D., a cardiology fellow working in Dr. Charles Berul's bioengineering lab at the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of Children's National Health System, presents a prototype for a miniature pacemaker at the American Heart Association's Scientific Sessions 2018. The prototype, approximately 1 cc, the size of an almond, is designed to make pacemaker procedures for infants less invasive, less painful and more efficient, measured by shorter surgeries, faster recovery times and reduced medical costs.

Kumthekar, a Cardiovascular Disease in the Young Travel Award recipient, will deliver his oral abstract, entitled "Minimally Invasive Percutaneous Epicardial Placement of a Custom Miniature Pacemaker with Leadlet under Direct Visualization," in S101A as part of the Top Translational Science Abstracts in Pediatric Cardiology session.

"As cardiologists and pediatric surgeons, our goal is to put a child's health and comfort first," says Kumthekar. "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."

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

"The advantage is that the entire surgery is contained within a tiny 1-cm incision, which is what we find groundbreaking," says Kumthekar.

With the help of a patented two-channel, self-anchoring access port previously developed by 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.

"Placing a pacemaker in a small child is different than operating on an adult, due to their small chest cavity and narrow blood vessels," says Kumthekar. "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."

The miniature pacemakers and surgical approach may also work well for adult patients with limited vascular access, such as those born with congenital heart disease, or for patients who have had open-heart surgery or multiple previous cardiovascular procedures.

The miniature pacemakers passed a proof-of-concept simulation and the experimental model is now ready for a second phase of testing, which will analyze how the tailored devices hold up over time, prior to clinical testing and availability for infants.

"The concept of inserting a pacemaker with a 1-cm incision in less than an hour demonstrates the power of working with multidisciplinary research teams to quickly solve complex clinical challenges," says Charles Berul, M.D., a guiding study author, electrophysiologist and the chief of cardiology at Children's National.
-end-
Berul's team from Children's National collaborated with Medtronic PLC, developers of the first implantable pacemakers, to develop the prototype and provide resources and technical support to test the minimally-invasive surgery.

The National Institutes of Health provided a grant to Berul's research team to develop the PeriPath, the all-in-one 1-cm access port, which cut down on the number of incisions by enabling the camera, needle, leadlet and pacemaker to be inserted into one port, through one tiny incision.

Other study authors listed on the abstract presented at Scientific Sessions 2018 include Justin Opfermann, M.S., Paige Mass, B.S., Jeffrey P. Moak, M.D., and Elizabeth Sherwin, M.D., from Children's National, and Mark Marshall, M.S., and Teri Whitman, Ph.D., from Medtronic PLC.

Media contact: Jessica Frost - jsfrost@childrensnational.org | 301-828-7521| 202-476-4500

About Children's National Health System

Children's National Health System, based in Washington, D.C., has served the nation's children since 1870. Children's National is one of the nation's Top 5 pediatric hospitals and, for a second straight year, is ranked No. 1 in new born care, as well as ranked in all specialties evaluated by U.S. News & World Report. It has been designated two times as a Magnet® hospital, a designation given to hospitals that demonstrate the highest standards of nursing and patient care delivery. This pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers in the D.C. Metropolitan area, including the Maryland suburbs and Northern Virginia. Home to the Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is the seventh-highest NIH-funded pediatric institution in the nation. Children's National is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels.

Children's National Health System

Related Pacemaker Articles from Brightsurf:

No need to steer clear of electric cars if you have a pacemaker
A study published in Technology and Health Care shows that four leading brands of e-cars do not trigger electromagnetic interference (EMI) with cardiac implantable electronic devices (CIED).

Developing next-generation biologic pacemakers
University of Houston associate professor of pharmacology Bradley McConnell is helping usher in a new age of cardiac pacemakers by using stem cells found in fat, converting them to heart cells, and reprogramming those to act as biologic pacemaker cells.

U of T Mississauga study identifies 'master pacemaker' for biological clocks
What makes a biological clock tick? According to a new study from U of T Mississauga, the surprising answer lies with a gene typically associated with stem and cancer cells.

Powering a pacemaker with a patient's heartbeat
Implantable pacemakers have without doubt altered modern medicine, saving countless lives by regulating heart rhythm.

Wireless 'pacemaker for the brain' could offer new treatment for neurological disorders
A new neurostimulator developed by engineers at the University of California, Berkeley, can listen to and stimulate electric current in the brain at the same time, potentially delivering fine-tuned treatments to patients with diseases like epilepsy and Parkinson's.

Cleveland clinic- led study shows leadless pacemaker patients experience less complications
Patients receiving leadless pacemakers experience overall fewer short-term and mid-term complications than those receiving traditional transvenous pacemakers, a Cleveland Clinic-led research study found.

What is impact of permanent pacemaker implantation after transcatheter aortic valve replacement?
The need for a patient to have a permanent pacemaker implanted while hospitalized after undergoing a transcatheter aortic valve replacement is a complication associated with worse survival and increased risk of more time spent in the hospital then and in the future.

Ohio State study of brain pacemaker shows promise in slowing decline of Alzheimer's
Researchers at The Ohio State University Wexner Medical Center studied how using an implant -- likened to a pacemaker for the brain -- could help Alzheimer's patients to retain cognitive, behavioral and functional abilities longer while also improving quality of life.

Bacteria as pacemaker for the intestine
For the first time, a research team from the Cell and Developmental Biology (Bosch AG) working group at the Zoological Institute at Kiel University (CAU) has been able to prove that the bacterial colonisation of the intestine plays an important role in controlling peristaltic functions.

Mexican doctors safely reuse donated pacemakers after sterilisation
Mexican doctors have safely reused donated pacemakers after sterilisation, shows a study presented at the 30th Mexican Congress of Cardiology.

Read More: Pacemaker News and Pacemaker Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.