NEW YORK (Reuters Health) – In a proof-of-concept study, researchers demonstrate the feasibility of biodegradable, wireless bioelectronic device that can temporarily monitor the heart and permit minimally invasive cardiac control after cardiac surgery.
“Temporary postoperative cardiac pacing requires devices with percutaneous leads and external wired power and control systems. This hardware introduces risks for infection, limitations on patient mobility, and requirements for surgical extraction procedures,” Dr. Igor Efimov of Northwestern University in Evanston and colleagues explain in Science. While bioresorbable pacemakers address some of these disadvantages, they still must be paired with external wired systems and other mechanisms, unlike the new system.
“This paper is a result of about a decade of work of our laboratories,” Dr. Efimov told Reuters Health by email. “We had to solve many surprises, one at a time.”
“For example,” he said, “an early version of our pacemaker was damaging heart muscle due to its stiffness (being incompatible) with soft tissue; this was solved by organ-conformal electronics. Another issue was difficulty with attaching the pacemaker to the beating heart using surgical sutures; this was solved with development of a bioresorbable bioadhesive. How to provide power to the implantable pacemaker in humans was solved by employing a wearable cardiac module.”
“Here, we demonstrated safe and effective function of the temporary cardiac pacemaker, which was designed to work for up to one week and safely dissolve after that, without the need to surgically remove or pull wires,” he said.
“Safety is the main question,” he acknowledged. “We have demonstrated safety in rodents, and will work on a safety study in a large animal model. But human biology is different; thus, surprises are possible.”
The pacemaker combines a time-synchronized, wireless network of skin-integrated devices with a bioresorbable pacemaker to control cardiac rhythms, track cardiopulmonary status, provide multihaptic feedback, and enable temporary operation with minimal patient burden.
The device wirelessly receives power through the skin for epicardial pacing. The skin surface-interfaced sensors collect and transmit data to an external control module via Bluetooth technology.
After completion of therapy, the internal module dissolves in the body and the skin-interfaced modules are removed by peeling them off the skin, obviating the need for surgical removal.
For the proof-of-concept study, the team used the device to monitor and control heart pacing in experiments in rats, canines, and in ex-vivo human heart studies.
Dr. Wolfram-Hubertus Zimmermann of University Medical Center Gottingen, author of a related editorial, commented in an email to Reuters Health, “Fully resorbable implantable devices will be game changing in how patients are monitored in- and outside the hospital. The presented data open the door for a broad application in monitoring and controlling bodily functions, beyond post-surgical bradycardia control.”
“The challenge for the healthcare system will be to keep up with the enormous pace of new developments,” he said. “Clinical implementation will depend on the data handling capacities of healthcare providers.”
SOURCE: https://bit.ly/3xdqUKw and https://bit.ly/3tgtPB2 Science, online May 26, 2022.