Monash University and Monash Health researchers/clinicians have led a collaboration of Australian organisations to solve a global medical problem that will save lives around the world.
The device has been designed, engineered, and tested in Australia. The clinical trials of the device was made possible by a generous grant from the Victorian Government.
The device is used to connect patients to a heart-lung machine through a large artery at the top of the leg. Clinical trials of the device at The Alfred Hospital, led by Associate Professor Silvana Marasco, have yielded very favourable results.
The new device has shown tremendous promise in reducing the risk of leg ischaemia (lack of oxygen supply), a potentially serious complication that can occur during heart surgery and in patients requiring artificial cardiac support in Intensive Care Units.
Current devices used for this purpose direct flow towards the upper body. This compromises blood flow down the leg. The lack of blood flow to the leg can lead to nerve damage, muscle damage, and in severe cases, amputation.
This can result in severe leg ischaemia and is a major issue globally, particularly for patients who have required longer periods of cannulation in Intensive Care Units.
In severe cases of lower-limb ischaemia, surgeons may need to amputate the limb if muscles have deteriorated beyond repair.
Research shows that nearly one-quarter of patients who require prolonged femoral cannulation will develop limb ischaemia, and 2 per cent of these patients will require amputation.
With around 100,000 patients globally, this translates to thousands of patients losing limbs every year. Limb ischaemia also significantly decreases survival rates.
“This has been a major issue for Intensive Care Units around the world,” said Mr Randall Moshinsky, Monash University researcher and Cardiothoracic Surgeon at Monash Health.
“Cannulation of the lower-limb is essential for many cardiac surgery procedures and artificial heart support in Intensive Care Units, however does carry the risk of limb complications.”
The novel device allows the patient to be connected to a heart lung machine without compromising flow to the leg.
Mr Moshinsky worked alongside co-inventors Cardiac Anaesthetist Dr Elli Tutungi and Head of Perfusion Mr Jim McMillan to develop the novel cannula that solves this problem. The device is currently being manufactured for market by global device manufacturer, LivaNova, and is expected to be available in 2018.
“The medical device we have developed allows blood to flow back towards the lower limb while the femoral artery is cannulated,” Mr Moshinsky said.
“It is bidirectional, meaning it allows blood to flow in both directions. We are tremendously thankful to A/Prof Marasco and our colleagues at Alfred Health who trialled the device, which has demonstrated favourable outcomes and device safety.”
“Surgeons and Intensivists around the world are incredibly excited by this development,” Mr Moshinsky said.
“We’ve presented this invention at Surgical and Intensivist Conference around the world, and everyone we’ve spoken to about the bidirectional cannula has asked the same question: ‘How soon will it be available?’”