The thin, flexible, lightweight device could be used for patients who need pacing only for a short period of time after heart surgery or while waiting for a permanent pacemaker, according to the report published in Nature Biotechnology.
"This is an example of a new type of technology, an electronic medicine," said study coauthor John Rogers, a professor of biomedical engineering at the Center for Bio-Integrated Electronics at Northwestern University in Evanston, Illinois.
"It's an unusual kind of device," Rogers said. "It's an electronic device, but it's constructed out of materials that are water soluble and bio compatible. We developed it in collaboration with cardiologists at our medical school who expressed a need for this type of platform."
When permanent pacemakers are used in situations where they are only needed for a short time, there can be complications removing them, Rogers said. "They can become encapsulated in scar tissue and removal can lead to tearing of not only the scar tissue but the heart tissue as well," he added.
The key challenge, Rogers said, was to design a device that "would be stable and reliable over the relevant period, but would ultimately disappear completely by natural processes. That requires three classes of materials."
First, insulation could be constructed with already existing biopolymers that are known to be biocompatible and resorbable. Second, the researchers needed current-conducting elements. "There we use metals already present in the body, that in fact are essential for normal life processes, such as iron and magnesium," Rogers said. "The third class of materials, which is maybe the most important, are the semiconductors. We found a few years back that silicon, which is the foundation of all consumer electronic devices, is water soluble and biocompatible."
The device was designed to wirelessly harvest energy from an external, remote antenna using near-field communication protocols - the same technology that is used in smartphones for electronic payments. This eliminated the need for bulky batteries and rigid hardware, including wires, which can lead to infections and scar tissue.
Rogers and his colleagues tested the device in hearts of various sizes, including those of a mouse, a rat, a rabbit, and a dog. They also tested it in human cardiac slices.
Human trials of the device would not happen for at least two years, Rogers said.
"This is a very exciting concept that has significant clinical implications," said Dr. Marc Miller, an associate professor of medicine at the Icahn School of Medicine at Mount Sinai and a electrophysiologist at The Mount Sinai Hospital in New York City. "But we will need clinical trials to test its safety and efficacy."
While the permanent devices are pretty reliable, they can have complications when they are only going to be used short-term because they need to be removed when they are no longer needed for pacing, said Dr. Miller, who was not involved in the new research. "It's been publicly reported that Neil Armstrong died of complications when they pulled the temporary pacing wires prior to discharge," he noted. "That led to bleeding around the heart."
There is a potentially large number of patients who could benefit from the technology, Dr. Miller said. All patients undergoing open heart surgery need temporary pacing as part of postoperative care, he said, adding that 30% to 40% of those patients will require pacing for no more than four to six weeks.
SOURCE: https://bit.ly/3w6ukvK Nature Biotechnology, online June 28, 2021.
By Linda Carroll
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