Ventracor trial patient dies from pre-existing condition

One of the four patients to have been implanted with Ventracor's artificial heart device to date has died from an unrelated medical condition, the company (ASX: VCR) reported yesterday.

The patient, who was the third patient to be implanted with the VentrAssist device, had made steady progress since the implant in October, but died at Melbourne's Alfred Hospital on the weekend after developing acute infective complications from a pre-existing abdominal condition, according to chief medical investigator Prof Don Esmore.

The heart pump had functioned well since being implanted, he said.

The news caused a six per cent decline in the company's share price, closing on Tuesday at AUD$1.94.

Ventracor CEO Dr Colin Sutton said the risk of patients dying during the trial was something that had to be taken into account. Participants in Ventracor's trial are not eligible for heart transplants due to age or other factors, and are generally not responding well to other medical therapy.

"The patients are so ill... we are dealing with the sickest of the sick," he said. "We try to exclude obvious contraindications, but ultimately the surgeons make the decision of who they want to treat."

Examples of exclusion criteria used by the investigators to evaluate potential participants include patients who are not strong enough to withstand the surgery and patients at risk of right-sided heart failure -- the implant is a left-ventricular assist device.

Deaths due to unrelated causes were generally excluded from reliability statistics for devices such as heart devices, including pacemakers and artificial hearts, according to Sutton.

Sutton said that, by coincidence, a second artificial heart patient in an trial undertaken by one of Ventracor's competitors had also died recently from causes unrelated to the trial, highlighting the grave condition of patients participating in these kind of trials.

However, the three remaining patients in Ventracor's trial are progressing satisfactorily, with two discharged from hospital last year, and the third, who received the implant in December, "doing very well", Sutton said.

Some criticism was levelled at the company for not immediately disclosing the patient's death to the market, but Sutton defended the company's decision to hold the news until further information was available from the hospital about the cause of death.

"We made the announcement as soon as we responsibly could have. If we were to make an announcement on the basis of incomplete information or misinformation, we would be doing a disservice to our shareholders," he said.