First-in-human implant saves patient with heart failure

The first-in-human implantation of Cardiosolutions’ Mitra-Spacer device has helped save a patient with severe heart failure, according to the BBC

The Mitra-Spacer is a tethered atraumatic inflatable and volume adjustable balloon that is placed between two valve leaflets on a heart.

It is intended to treat or bridge heart failure patients whose operative mortality risk for undergoing conventional open-heart surgery is deemed too high.

Richard Reach had damaged his heart, causing one of the valves to no longer work correctly and creating a backflow of blood that put pressure on Reach’s heart, reported the BBC.

Reach’s condition meant that he was too high of a risk for conventional heart surgery, so he was implanted with the Mitra-Spacer device that had previously only been used in pigs.

The device was implanted by doctors at King’s College Hospital using keyhole surgery and inflated to stop the backflow of blood that was putting pressure on Reach’s heart.

The balloon was then connected to a port just below the patient’s skin – so it could be inflated or deflated over time, depending on the patient’s condition, reported the news site.

The implant procedure was performed by Olaf Wendler, professor of cardiac surgery at King's College Hospital London, he said: "A unique design feature of this promising technology is the ability to modify the fill volume of the Mitra-Spacer System post-procedure.”

After five months with the Mitra-Spacer device, Reach’s heart had recovered enough to allow for conventionally heart surgery to repair the valve.

Reach said to the BBC: “Just as it seemed the medical team had run out of options Wendler suggested the new treatment.

"Now I'm walking around and feeling better each day. What the team has done for me is nothing short of a miracle. I owe my life to them."

Peter Weissberg, medical director at the British Heart Foundation, said to the BBC that the approach was imaginative and relatively simple.

He added: "By using an adjustable balloon to reduce the amount of blood leaking across the valve, this techniques gives the heart a chance to recover sufficiently to withstand conventional valve surgery.

"It allows the surgeon to buy time and should also alleviate some of the patient's symptoms.

"Further research is now needed to establish which patients are most likely to benefit from it."