Man Survives 105 Days with Electromagnetic Heart - IEEE Spectrum

Earlier this year, a man went shopping in Sydney with a new type of artificial heart buried in his chest. He was the first person to use the device outside of a hospital setting.

The company Bivacor announced last week that the Australian clinical-trial patient used its total artificial heart for a record 105 days before receiving a heart transplant in early March. The patient was also able to leave the hospital and stayed out for almost four weeks before being called back for transplantation surgery. None of the five U.S. patients who tried out a Bivacor heart last year had the device for longer than a month, and none left the hospital in that time.

Passing the 100-day milestone and the hospital discharge are meaningful firsts for Bivacor, though not unheard of in total artificial hearts. They are steps on a long journey to regulatory approval as a short-term life saver for patients awaiting transplantation, and perhaps eventually, as a long-term alternative to a donor organ.

“It’s a continuous process,” says Daniel Timms, founder and chief technology officer of Bivacor. “My analogy for that is the space program—we’re not going to Mars straightaway.”

The Bivacor heart uses electromagnets to spin a core in a chamber that propels blood. This sets it apart from alternative devices, which generally have more potential physical failure points in their various valves, seals, and moving parts. Bivacor hopes this durability will prove out, with patients able to use the device for 10 to 20 years. Donor hearts are generally expected to last 10 years.

Bivacor engineers described the technology in greater detail for IEEE Spectrumin 2019. The device uses a single magnetically levitated rotor to pump blood to both the lungs and the body, replacing the function of both heart ventricles. With its one moving part levitating in a magnetic field, there’s no worry that friction and mechanical wear will cause the machine to give out.

Since 2019, says Timms, though no major technical details have changed, the team has been pleasantly surprised at how responsive the heart has been to changes in patient activity. They’ve also been satisfied by how naturalistic the artificial pulse has proven, even detectable by the standard techniques of fingers, pulse oximeter, and wrist cuff.

Some patients in advanced stages of heart failure require mechanical assistance pumping blood to the lungs and throughout the body. If only part of the heart is malfunctioning, they may receive a ventricular assist device, a small implanted pump that gives a boost to blood flow. But for complete heart failure, heart transplantation is currently the preferred long-term treatment. Total artificial hearts, such as the Bivacor device, are being used and investigated to serve as a “bridge to transplantation,” keeping patients alive for the days or months until suitable organs are found and keeping them healthy enough for transplantation.

Bivacor’s artificial heart can replace a failing heart and keep a patient alive until transplant surgery. BiVACOR

Around 5,000 heart transplants are performed every year globally, according to the International Society for Heart and Lung Transplantation, but there are 10 times as many people awaiting a donor organ at any given time.

“I am very optimistic that it will be extremely helpful for patients,” says Francisco Arabía, an artificial heart expert with Banner Health in Phoenix, a U.S. Bivacor trial site. “Now, compared to other [total artificial hearts], time will tell.” Another 15 patients are expected to take part in early feasibility and safety research in the United States, and a larger pivotal study would follow. That whole process could take three to five years, he says.

In the meantime, Timms highlights the bravery of trial participants, when device failure likely means death. “That’s an incredible leap of faith they’re taking,” says Timms.

In the United States, there is just one alternative total artificial heart that’s been approved by regulators, produced by SynCardia; its current device is a descendant of the first-ever artificial heart, the Jarvik 7 device, which was first implanted in a patient in 1982. SynCardia’s device is pneumatically powered, so users carry around a large and somewhat noisy pneumatic driver. Other total artificial hearts are also in development. For example, a Swedish company called Real Heart is seeking a humanitarian device exemption from U.S. regulators that would facilitate use of its total artificial heart, a lighter and quieter device with pumps powered by batteries.

For Timms, an Australian who began designing the Bivacor heart in his Ph.D. research more than 20 years ago, the first Australian patient also marks a significant return of the technology, which has traveled around the world with him in development. He was inspired to create the heart when his father, a plumber and a tinkerer, was diagnosed with heart failure. The two built the first prototype together in the family’s backyard shed.