Replacing leaky heart valves in situ

In a first-in-humans trial, Sydney surgeons have successfully replaced leaking valves in two human hearts while they were still beating.

Usually when heart valves are repaired, bypass surgery is performed to stop a patient’s heart, allowing surgeons to repair valves. In this procedure, surgeons implanted artificial valves inside the patients while their hearts continued to beat.

The procedure is much less invasive and better tolerated by patients, especially those who are unwell.

The two patients had mitral valve regurgitation or mitral insufficiency, a common condition where the mitral valve between the left ventricle and left atrium does not close properly and allows blood to flow backward in the heart. When severe, mitral insufficiency can cause heart failure and arrhythmias.

Developed by a US medical devices company, the artificial mitral valve is currently in a first-in-human clinical trial being conducted in Australia.

The early feasibility trial is being conducted here due to the expertise of Australian cardiac surgical teams and our expeditious regulatory system.

The trial commenced at  St Vincent’s Hospital in Sydney with the first patient operated on in late November last year. After six weeks without complications, doctors performed the procedure on another patient in February 2015.

The artificial valve is shaped like a flower. It is made from the heart tissue of a pig, which is sewn into a metal cage and tethered to the apex of the heart with string to hold it in place. It is also easily removed.

The trial will commence at other Australian sites including the Prince Charles Hospital in Brisbane and Flinders Medical Centre in Adelaide.

Australian CRO Mobius Medical is managing the trial and also acts as local sponsor for the US medical devices company.