Second Sunshine implant removed after infection

The second patient to receive Sunshine Heart's (ASX:SHC) C-Pulse device has had the device removed one month after it was implanted, after he developed a related infection.

The first patient to have the C-Pulse device implanted died of multi-organ failure nearly three months after the operation, from unrelated causes. But the company remains upbeat about the progress of the device in trials.

"The company has learned a great deal from the first two patients," said Crispin Marsh, the company's director of corporate affairs.

"We now know that it is possible to place the device in sick patients in less than two hours and the operation is well tolerated. From the autopsy of the first patient we found that there was no damage to the aorta -- this provides evidence that counterpulsation is not damaging to the patient, at least over a three-month period.

"We know from the second patient that after a month there was substantial improvement in heart function. We also know the device can be turned on and off, which can't be done with other heart devices -- it allows the patient to use the device when they want to, and if it fails, the patient's life is not at risk.

"Finally, we have shown that if it becomes infected in can be removed safely -- which is not the case with most heart assist devices."

The second patient was implanted at Auckland City Hospital at the end of July. Dr Paget Milsom, head of cardiothoracic surgery at the hospital and the chief investigator in the C-Pulse trial, said the patient was already very sick at the time of the implantation.

"He tolerated the operation well and was released from the hospital after nine days," Milsom said. "By one month, improvement in the objective measures of cardiac performance and quality of life were seen, to the extent that his functional classification had reduced from class IV to class III. Plus there was a significant improvement in the distance he was able to walk.

"Unfortunately, while at home, the patient noticed an infective discharge around the C-Pulse driveline. It was in the patient's best interests to remove the device. This was undertaken successfully. The patient is now recovering in the hospital."

Sunshine Heart medical director Dr William Peters said in a statement that infections were a fact of life with medical devices.

"Although it is unfortunate that the patient suffered from this all-too-common event, which occurs in up to 38 per cent of cases, it is pleasing to note that the C-Pulse device was able to be removed safely from the patient. This is in contrast to the experience of many of these patients, with ventricular assist devices, where removal of the device is not possible."

The clinical trial is continuing and potential patients are currently being screened at Auckland City Hospital.

"There is no date as yet for a third implantation in New Zealand," March said "Surgeons are actively looking for patients. They are still confident the device offers appropriate treatment for a group of patients. Patients come along when they come along -- but we are well advanced in obtaining ethics committee approval from two Melbourne centres.

"We expect to undertake our first Australian implantation in the reasonable future."