Purdue students see room for improvement in pacemaker safety

WEST LAFAYETTE, Ind. (WLFI) — A device created by a team of Purdue students could one day play a part in thousands of pacemaker surgeries. The device, called Safepace, could allow surgeons to ensure they properly implant the wires that tell the heart how and when it should beat.

It’s not yet approved for use in humans, or even animals, but Safepace designers are confident it will share a place in a standard pacemaker surgery kit.

“It’s low-cost, it’s simple, very effective — and that’s what the huge benefits of Safepace are,” said Elizabeth Mercer, a 23-year-old graduate student who worked on the device.

The Safepace is made up of two parts: a cylinder that secures one end of the pacemaker wire, which is called a lead; and a base for the cylinder to fit into. Both parts fit in the palm of a hand, and are made with inexpensive materials.

Pacemakers are often used for people whose heartbeat is too slow. Once implanted, a pacemaker sends electrical signals through the leads to different chambers of the heart, allowing it to beat normally.

Safepace wouldn’t change the way a surgeon implants a pacemaker, but rather give him or her an added safeguard to assure the other end of the lead, which is attached to the heart wall, is secured. This prevents the lead from coming undone, which is called a dislodgement.

About 600,000 Americans receive a pacemaker every year according to the American Heart Association, but dislodgements are rare.

“I would say once maybe every couple of years I will have to go back in and reinsert it,” said Dr. Igor Tubin, an IU Health Arnett cardiologist who performs 50-70 pacemaker surgeries per year.

Dr. Tubin admits that dislodgements do occur, particularly when attaching the lead to the right-upper chamber of the heart, but there are many ways to prevent one from happening. He says X-ray technology is effective at spotting dislodgements, among other procedures.

Johnny Zhang, another member of the Purdue team, says that about one to five percent of all pacemaker surgeries end in dislodgement, which means it still affects hundreds of people every year.

Once the surgeon thinks the lead is properly attached to the heart wall, he attaches the other end — which will be attached to the pacemaker — to the Safepace.

“The surgeon then does a gentle tug and if the pacemaker lead is well-implanted the Safepace device disengages,” said Mercer.

By disengaging, the cylinder part of the Safepace leaves its base, because the force of the lead attached to the heart wall is greater than the force holding the Safepace in its base.

The Safepace is patent pending, and still years away from any potential use in humans, but the device’s inventors remain hopeful. Cardiologists like Dr. Tubin will have to wait and see if regulators see the Safepace as a viable addition to pacemaker kits around the country.

“Obviously, any new technology which will make lead positioning more secure and safer will be welcome,” said Dr. Tubin.

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