RAH doctors cleared of wrongdoing over ‘unauthorised’ heart procedure on man who died after surgery

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Cardiologists at South Australia’s biggest hospital have been cleared of wrongdoing after they performed an ‘unauthorised’ heart procedure on an elderly patient who died after surgery.

Documents obtained by the ABC show Royal Adelaide Hospital (RAH) doctors performed a heart valve repair procedure called MitraClip on four patients in 2015.

One of those patients, a 77-year-old man with chronic kidney disease, developed severe kidney failure “post procedure” and died a few days later.

It is unknown whether the procedure contributed to the man’s death.

The next month, medical services director Peter Satterthwaite reviewed his death as part of a regular mortality committee convened by the hospital.

“I was surprised to see this procedure being provided at the Royal Adelaide Hospital,” Dr Satterthwaite said in an email to cardiologists.

“The prevailing view is that this is not a procedure we should be providing in public hospitals.”

‘Critical breach of clinical governance’ warning

Documents show there was a plan in 2013 for a limited MitraClip program to occur at the Royal Adelaide Hospital, but doctors required approval from the hospital, including from its ethics committee before they could go ahead with the operation.

Just one month after the 77-year-old’s death in 2015, top officials warned a “critical breach of clinical governance” had occurred.

SA Health’s chief executive at the time, David Swan, was among several senior executives informed about legal advice being sought from the Crown Solicitor’s Office.

Exterior of a modern hospital
Four MitraClip procedures were performed at the Royal Adelaide Hospital.(ABC News: Dean Faulkner)

Two years later, SA Health commissioned an investigation into the use of MitraClip, and found there was “no reasonable basis” for allegations of misconduct against the cardiologists involved.

In that same year, a coronial investigation into the man’s death was closed without proceeding to a public inquest.

Under South Australian law, the ABC is unable to access the coroner’s report or findings.

Ongoing investigation

SA Health blocked the release of dozens of documents about the incident that the ABC sought under Freedom of Information, telling the state’s Ombudsman last year that they would infringe an ongoing investigation.

“[The] information contained within the documents is sensitive of nature and involved extensive in-house investigations not only of the topic matter, but also of staff involved.”

SA Health has refused to answer the ABC’s questions about the nature of the investigation.

Committee rejected device over ‘safety, effectiveness’ months after man’s death

MitraClip is a medical device used to repair mitral heart valves in patients too sick for open heart surgery.

It was first approved for use in Australia by the country’s Therapeutic Goods Administration more than a decade ago.

While the device is used in hospitals across Australia, its manufacturer Abbott Vascular confirmed it is currently not approved for use in South Australia’s public hospitals.

A graphic representation of the MitraClip device repairing a mitral valve.
The MitraClip device is used to repair leaking mitral valves in cardiology patients.(Abbott Vascular)

In a decision published in December 2015, eight months after the elderly patient’s death, the medical committee that considers the use of new medical devices rejected the use of MitraClip in South Australia’s public hospitals.

The decision was made due to concerns about the lack of high-quality evidence about its “effectiveness, safety and cost-effectiveness”.

The document stated it was also unclear what patients would benefit from the procedure.

An Abbott Vascular spokesperson told the ABC that “with more than 100,000 patients treated in over 65 countries, the MitraClip therapy has shown improved clinical outcomes and quality of life through a minimally-invasive option”.

Meeting minutes changed after warning over liability for ‘unauthorised’ procedures

Emails released under Freedom of Information show that on April 13, 2015 — six days before the elderly man died — doctors and bureaucrats from the Central Adelaide Local Health Network attended a regular cardiology meeting at the Royal Adelaide Hospital.

Whether or not the use of MitraClip was discussed at that meeting would be the subject of a volley of internal communication over the following month.

Dr Christopher Zeitz wrote to fellow members of the Cardiology Stream committee on May 29: “You will note from the minutes circulated today that [the cardiologist] is advising that he informed the last meeting of his intent to push ahead with a clinical program with MitraClip.”

Several committee members responded that they did not recall any discussion about MitraClip at the meeting.

In another email the following day, seen by the ABC, Dr Zeitz warned that liability for the unapproved procedures could shift from the doctors to the committee if the written meeting minutes continued to mention MitraClip.

“I know that the clinicians involved have been advised that, because these procedures occurred without authorisation from the organisation, that there is no indemnity from the clinicians,” Dr Zeitz wrote.

“If the minutes as currently recorded stand, the liability will shift from the clinician to the committee.”

The written record was revised to confirm that the procedure was not discussed.

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