Cardiac surgeons say they will be forced to boycott a publicly funded transcatheter aortic valve implantation (TAVI) program if the federal government fails to approve a funding model that mandates a surgeon as one of the primary operators conducting the procedure.
“We would not physically support a TAVI program if we felt it would lead to problems,” warned President of the Australian and New Zealand Society of Cardiothoracic Surgeons (ANZSCTS), Professor Paul Bannon in an interview with the limbic.
Professor Bannon says the model currently recommended by the department of health’s medical advisory committee (MSAC), which would see either an interventional cardiologist or a cardio-thoracic surgeon funded as the principle operator, is unsafe and could ultimately lead to problems for patients.
He insists that the society would only support a dual operator model where one of the operators would have to be a cardiac surgeon.
“The consensus between the cardiac society and ANZCTS [in its joint position paper] is that the surgeon along with others, such as a geriatrician, has to be part of the multi disciplinary health team (MDHT) that determines the suitability of the patient going to TAVI.
“If the surgeon feels that TAVI program is unsafe – as all of our members have unanimously declared it is in it current form – then they are morally and ethically bound not to sign off on that patient going ahead with the procedure.”
But in a statement to the limbic a spokeswoman for the federal department of health said that the proposed funding model is in line with other MBS funded procedures that require two operators.
“We accept that the procedure usually requires two medically trained operators, like many other procedures such as open heart surgery. What we have not done is specified a split primary item number, rather we have followed the usual process of having the principal operator claim the main item with the provision for an assistant to claim the assistant fee.
This is the common practice across all Medicare funded procedures and we fully expect two operators to be involved in TAVI as per the joint guidelines,” the department said.
According to the Department, the Medicare proposal requires surgeons to be present and paid to be part of the MDHT, the group of specialists that initially assesses the patient’s suitability for TAVI. The Department maintains that it is this point the surgeon’s presence is most important critical..
“We are confident that surgeons would not wish to compromise the assessment of patients and will continue their involvement in assessment, as they have done so for many years in the public hospital provision of this service in Australia.”
Every second is vital
But Professor Bannon argues that, for best patient outcomes, surgeons need to be scrubbed and in the room during the procedure. Pointing to anecdotal evidence he says there have been cases of ‘terrible injuries’ that support his concerns.
“There are cases where there’s been damage to the peripheral access vessels, the femoral artery, wire lacerations to the ventricle or lost valves and ruptured aortic route”.
According to Professor Bannon, surgeons have only four or five minutes to salvage a patient if something goes wrong.
“That’s every second you need – you actually need to be at the [operating] table and the anecdotal stories where surgeons were on hand but not in the theatre, where they had to come across from their rooms [to assist] – those are the cases where the fatalities occurred.”
Professor Bannon says numbers based on Royal Prince Alfred hospital data, which has the largest unit in NSW to carry out the procedure and where Professor Bannon heads the cardiothoracic unit, indicates that around 4-5% of patients survive the procedure directly because a surgeon had been present in the theatre.
“Four to five per cent doesn’t sound like much except that in the first 100 patients who undergo the procedure that’s four or five people that are alive,” he points out adding that every single case at RPA has been carried out with a surgeon and a cardiologist as equal operators.
Is TAVI a surgical procedure?
Interventional cardiologist Darren Walters from The Prince Charles hospital in Brisbane has carried out close to 700 TAVI procedures since the technology became available in Australia in 2008. He’s also been working with MSAC to develop the MBS funded model for the minimally invasive surgery representing the cardiac society.
Speaking to the limbic Professor Walters said the position held by ANZSCTS is out dated and not one that is widely supported by the research.
“When we first started doing coronary stenting we would have the surgeon standing in the corner of the room with his tools ready to go. In those days the complication rates were higher and the surgeon would be there just in case we needed to operate on a patient straight away … but we’ve come a long way since then and TAVI has come a long way over the last 10 years.
“The issues raised by the surgeons, they’re just not borne out by the published evidence. We have to accept that this is a safe technology – it’s been done in Australia for a long time, its safe in the hands of the operators that we have and we’ve set out very careful guidelines about who does the procedure and where it gets performed.
I think it might be a bridge too far to say that you have to have a surgeon in the room, they have to be scrubbed and they have to be paid that’s a probably a little bit far beyond where evidence and opinion stands at the moment.”
According to Professor Walters, under the current MBS proposal, there is nothing to stop a cardiac surgeon from being involved in the procedure – one proceduralist would be reimbursed as the primary operator while the other would claim an assistant fee, which is typically less than the primary operator fee.
What’s more, he says the recommended TAVI model is in line with other MBS funded programs that involve two operators.
“A vast majority of these procedures performed in Australia currently and in many parts of the world are performed by two interventional cardiologists – the primary operator and usually a second interventional cardiologist assists them and that’s been occurring for nine years in Australia.
Having said that, there’s nothing to stop a cardiac surgeon with an interest and who understands the procedure to be involved.
But the fact is you don’t have to have a surgeon there because there are qualified people who are trained to do the procedure who are not surgeons … because it’s not really a surgical procedure.”
International experience paints a different picture
That’s an argument Professor Bannon says is not backed by the international experience, which he says saw both the US and Germany back track on their single operator models to one that mandates the presence of a surgeon following analysis of German and US TAVI registry data.
He’s written to chief medical officer, Professor Brendan Murphy, requesting an urgent meeting and has asked him to consider a new operator model.
“You could do what the US and Germany did and start with a single operator model in an uncontrolled fashion, make the mistakes, review the data, admit that’s wrong and then come back to a model that mandates a surgeon is present [for the procedure] or you can start with what that model, collect the data in the registry that’s been proposed and then review it in two years time when you’ve got enough data and go to a cardiology operator model if indeed you think its safe enough to do so.”
While MBS listing for the procedure is tabled for later this year, Professor Walters says he’s concerned that the opposition from ANZSCTS could defer a decision meaning the procedure will remain restricted to the few teaching hospitals who have been able to run the program.
“We’re getting so overwhelmed with patients, more centres have to do it – we’re at a point now where the technology is ready for prime time. We’re the last place in the western world to get it imbedded in clinical practice across the board.
I think it’s ready to go. We need to let it be a treatment that’s more widely available to people in Australia.”