Australia’s first statewide registry for cardiac devices is to be rolled out in Victoria – hailed as a positive step amid national
controversy over the surveillance of medical devices
The registry, currently operating as a smaller, Melbourne-only version, has secured three years of funding to expand to all the state’s hospitals – public and private alike.
It will initially capture data on stenting, amid soaring numbers of angioplasties, before later including other procedures and devices such as pacemakers.
It is hoped a comprehensive national version will follow, if the Victorian project is successful and further funding can be secured.
The current expansion will be funded with $1.2 million over three years from Medibank Private, and a further $200,000 from the Victorian Government’s Department of Human Services.
Dr Stephen Duffy, head of cardiology general services at the Alfred Hospital and a founding member of the existing Melbourne registry, said the new, expanded version aimed to start by the second quarter of this year.
He said there was “great enthusiasm” for the project, which would help improve outcomes, standardise quality of care, and allow faulty devices to be removed more quickly from the market.
“A lot of randomised trials are done in very selective populations with a lot of exclusions, whereas we’re treating real-world patients who have all sorts of comorbidities,” he said.
“Now as new technologies emerge, such as biodegradable stents, within a year or so [the registry will] be able to provide safety data in a real-world setting.”
The shortage of high-quality Australian registries has recently come under scrutiny in the wake of the Poly Implant Prothese breast implant saga.
With the existing breast implant registry having captured just 5% of PIP implants in Australia, the Therapeutic Goods Administration has resorted to contacting individual surgeons in a bid to establish the implants’ true rupture rate.
The National Joint Replacement Registry, by contrast, captures virtually every hip and knee replacement performed in Australia, and was instrumental in the 2009 withdrawal of the faulty DePuy Orthopaedics ASR hip implant.
Dr Duffy expected that participation in the new Victorian Cardiac Outcomes Registry would be made mandatory, to ensure the data were comprehensive.
He said there were no plans as yet to formally report to the Therapeutic Goods Administration, but that data could be provided on request.
“The idea is that it’s not just data that sits there and collects dust – it’s to be used for a number of purposes, be it quality assurance, research or providing information to governments.”
Australian cardiologists have long
called for the establishment of a national registry to better understand the safety, efficacy and cost of percutaneous coronary intervention, particularly in the wake of concerns over the safety of drug-eluting stents.
A pilot national registry had been trialled two years ago, funded by the Australian Commission on Safety and Quality in Health Care.
However funding had run out, Dr Duffy said, leaving hospitals such as the Alfred to continue collecting data using funding from their own budgets.