May 9 2005
A 56-year-old New Zealand man, a heart failure patient, is recovering in hospital after world-first surgery to implant an Australian-designed device which helps the heart pump blood.
The man, who has had heart failure for almost a decade had been considered unsuitable for a transplant and he received the device during a two and a half hour operation at Auckland City Hospital this week.
William Peters, the hospital's clinical research fellow in cardiothoracic surgery says the patient is up and moving about, and the device, which is like a little turbo booster on top of the heart which is definitely being well assisted by it.
Peters, who designed the C-pulse heart device with surgeon Paget Milsom, said before the operation, the patient had a very poor quality of life and a reduced life expectancy and he was already on optimum medication.
The man had frequently been in and out of hospital, had not worked for a number of years and had no other option other than to suffer as he had been doing.
Dr Peters says the key component of the device was a balloon cuff, similar to a blood pressure cuff, which was wrapped around the patient's aorta.
A sensing wire picks up the heart's electrical signals, allowing the device to time the inflation and deflation of the balloon to the heart beat. The balloon helps the aorta pump blood to the body, reducing the heart's workload. A wearable unit driving the device works on rechargeable batteries and a home unit is also available which can be plugged into an electricity outlet.
Dr Peters said the device was designed to be turned off occasionally without affecting the patient.
If it fails, the balloon will just collapse and deflate and as the heart and the blood vessels are all in their natural state they will just carry on as they would normally. Unlike other heart pumps, the C-pulse avoided blood contact, reducing the risk of blood clots.
The device was developed by Australian company Sunshine Heart Incorporated, and Dr Peters first came up with the idea while working at Melbourne's Alfred Hospital, later co-founding Sunshine Heart Inc with Sydney businessman Crispin Marsh.
The company, which received an Australian Government startup grant, is listed on the Australian stock exchange.
Dr Peters said a non-randomised pilot study of 10 people implanted with the device was planned, using patients in Australia and New Zealand.
He said patients with moderate heart failure, aged 18 to 80, would be eligible for the implant but it was important to follow the patients over the long term to ensure there were no significant risks.
Peters says a larger randomised study will eventually be carried out, possibly in the United States, to facilitate full market approval.
An estimated 325,000 Australians have some degree of heart failure and about half of those were due to heart attacks, while another 50 per cent were either caused by a virus or an unknown reason.
The Auckland man who agreed to be the device's first recipient suffers cardiomyopathy, a disease affecting the function of the heart.
He is expected to be released from hospital in five days.