Is it a stop gap until a heart transplant is organised?

No. This is a potential permanent alternative to heart transplantation. In the developed world there are about 3,500 heart transplants every year for a patient population of about 800,000. We believe the VentrAssist™ will provide a long-term supplement to these failing hearts and help restore people to a better quality of life.

 
Where does the pump fit? Does it have wires protruding?

Patients undergo a three to four hour operation performed by a cardiothoracic surgeon. Surgery is performed under general anaesthetic and a heart-lung machine is used to maintain blood flow and oxygen levels in the patient’s body while the pump is being implanted. A incision is made in their chest through their breast bone (sternum), extending to the upper abdomen. Two cannulae (tubes) are attached to the circulatory system. One is attached to the base of the heart to enable blood to pass from the left ventricle to the VentrAssist™ blood pump. The other is attached to the ascending aorta, the major artery leaving the heart. This allows blood to be pumped back into the circulatory system. The VentrAssist™ pump is positioned just below the diaphragm on the left-side of the body. A thin lead protrudes from the right-side of the body and connects the implanted pump to the controller and batteries which are worn in a backpack. Once the operation is completed, the patient is moved to an Intensive Care Unit to recover.

 
What is the pump made of?

The implanted parts of the VentrAssist™ system use materials which are fully biocompatible including titanium alloys. Its components are light, strong, non-toxic and highly resistant to degradation within the body.

 
How does someone get to take part in your Clinical Trials?

Clinical trials of new drugs and medical devices have strict guidelines about who can participate which ensure that the benefits of that patient’s participation outweigh any potential risk to them. Factors such as type and stage of disease, treatment history and other existing medical conditions will determine whether a patient qualifies for the trial. Patients taking part in the Pilot Trial to evaluate the safety of the VentrAssist™ do so voluntarily. For the Pilot Trial in Melbourne, the timing of the implant and patient selection is entirely in the hands of the medical investigators at The Alfred hospital. In general, patients who qualify will be suffering end-stage heart failure and no longer be responding to optimal medical therapy. The patients taking part in the Pilot Trial would already be very ill and would not be eligible for a heart transplant.

 
It must be very expensive?

In the USA, insurance authorities are currently reimbursing systems similar to VentrAssist™. The system and cost of the operation are potentially much less than the comparative cost of keeping a heart failure patient in intensive care for several weeks or months. The cost of a implanting a ventricular assist system may be less than the total cost of a heart transplant over a patient’s lifetime due to the greatly reduced need for drug therapy (particularly the lack of immune system suppression drugs).

 
Why is it better than other systems designed for the same purpose?

The VentrAssist system was specifically designed as an alternative to heart transplant as opposed to current devices that are only used for short periods before they wear out. The system has no wear prone components is designed to be extremely compatible with the body.

 
What about rejection?

At present, each rechargeable battery set will last about eight hours. The system can also be powered by mains power. The life of the implanted system is almost unlimited as it has only one moving part which does not come into contact with any other part of the system.

 
What is the life of the battery and the life of the system?

At present, each rechargeable battery set will last about eight hours. The system can also be powered by mains power. The life of the implanted system is almost unlimited as it has only one moving part which does not come into contact with any other part of the system.

 
Does the VentrAssist™ make a noise when it works, do you have a heart beat?

The VentrAssist™ is very quiet, requiring a stethoscope to hear it. Patients hearts will continue to beat normally but their pulse may be hard to detect as the pump provides continuous blood flow

 
And the cord and controller could be implanted as well one day?

Yes. It is possible that the system will be fully implanted in the future.

 
How many patients will be implanted during the Pilot Trial?

Approval has been given to implant 10 patients at The Alfred hospital in Melbourne.

 
Who invented it?

The VentrAssist system was invented by a group of Sydney engineers, two of whom work for Ventracor Limited and one who is employed by a major Sydney university.

 
It’s an artificial heart system, do you mean it’s an add-on to the heart?

The VentrAssist™ blood pump weighs just 298 grams (10oz) and measures 60mm (2.5 inches) in diameter. This allows it to be used in both children and adults. It is attached to the left ventricle of the heart and takes over about eighty per cent of the heart’s pumping function. It does not replace the heart. Its primary application for use is in congestive heart failure patients, of which there are about eight million worldwide. Ventracor has been working on this system for the past five years. The company recently obtained approval to commence a pilot clinical trial at The Alfred hospital in Melbourne.

 

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