UP TO one-third of coronary stents inserted in patients with stable coronary artery disease (CAD) in Australia each year ― about 3500 stents —  may be unnecessary, potentially harmful and costing the nation millions of dollars, according to a leading cardiologist.

Professor Richard Harper, emeritus director of cardiology at MonashHeart, Monash Medical Centre in Melbourne, said any experienced interventional cardiologist would admit that many coronary lesions with 50‒70% stenosis were being stented in Australia without certain knowledge that the particular lesion was causing ischaemia.

Medicare statistics show that, last year, there were 22 383 operations for insertion of a stent or stents in Australia (20 780 in 2008 and 21 204 in 2007), for which Medicare paid $6.78 million ($6.24 million in 2008 and $6.2 million in 2007).

These payments do not include the cost of a coronary angiography, radiological services and preparation, or aftercare.

The average cost of coronary angiography with stent insertion, including hospital stay, is $18 300 of which Medicare pays $1647.

Professor Harper said about 50% or more of stents were inserted in stable CAD patients and the remainder were in patients with acute heart attack, for which stenting was almost always warranted.

A rapid online publication of a detailed paper written by Professor Harper on the use of stents in CAD patients has been published by the MJA.

He was commenting after the issue of unnecessary stenting hit the headlines in the United States, with the revelation that Baltimore cardiologist Dr Mark Midei may have implanted 585 stents that were medically unnecessary from 2007 to 2009.

An article in theheart.org, the website for cardiovascular health professionals, said a US Senate Finance Committee report called the Midei imbroglio “a clear example of potential fraud, waste, and abuse”.(1)

The Finance Committee reportedly found that Abbott Laboratories, which manufactures stents, had long been in the practice of rewarding Dr Midei financially for being a high-volume user of its stents.

However, many US cardiologists believe Dr Midei is being treated unfairly.

The Cardiac Society of Australia and New Zealand (CSANZ)’s Interventional Council chair, Associate Professor Andrew MacIsaac, said any fraud or criminal behaviour by a cardiologist, as was being alleged in the US, was appalling and would be totally unacceptable.

However, he had never heard of it occurring in Australia and it was different from doctors having a diversity of opinion over the appropriate indications for coronary stenting.

“Stenting in stable angina is open to debate in some circumstances as to whether it reduces mortality but every study done shows it is effective in relieving symptoms,” he said.

Professor Harper said the problem with what he considers to be unnecessary stents in Australia “lies in our system of reimbursement for coronary procedures”.

He said patients often had more than one coronary lesion and the only sure way to tell which one was the cause of the myocardial ischaemia was by measuring fractional flow reserve (FFR) — or the effect of the narrowing on blood flow — during coronary angiography.

However, FFR was not commonly undertaken in Australia because the flow wire was costly and not adequately reimbursed in either the public or private system.

The procedure was also fiddly, took time and resulted in fewer stent insertions — a procedure which attracted a much higher fee.

“Faced with a 50-70% coronary stenosis, it is easier and more remunerative for an interventional cardiologist to stent the lesion rather than measure FFR — particularly when there is a two-thirds likelihood that the result will show no need for the stent,” Professor Harper said.

Medicare statistics show that, last year, only 385 procedures for FFR were carried out in Australia (234 in 2008 and 131 in 2007).

Professor Harper said the health system should be restructured to make it more financially viable to measure FFR.

He said a pivotal randomised study in the New England Journal of Medicine last year, of 1000 patients with multi-vessel coronary artery disease, showed that routine measurement of FFR in patients undergoing percutaneous coronary intervention with drug-eluting stents significantly reduced the rate of death, non-fatal myocardial infarction and repeat revascularisation compared with patients who had stents inserted on the basis of angiography alone.(2)

The patients who underwent FFR had fewer stents implanted at a lower cost.

The results were replicated in a follow-up study at two years, which was reported in the Journal of the American College of Cardiology.(3)

Professor MacIsaac said CSANZ had been lobbying for more than 10 years for the establishment of a national registry of coronary interventions to audit outcomes and quality assurance.

However, it was still waiting for federal and state funding.

“A database has essentially been prepared but there is no funding mechanism to implement the collection or analysis of the data,” he said.

“If we really want to be assured that everything is fine, that would be the way to go.”

A Medicare spokeswoman said the unnecessary insertion of cardiac stents had not been identified as a specific compliance issue.

“However, health professionals should be aware that when Medicare Australia has a concern that items are being claimed without meeting the item requirements, an audit may be conducted,” she said.

Medicare Australia treated all allegations of non-compliance seriously and encouraged anyone who suspected potential fraud or non-compliance under the Medicare program to call the Australian Government Services Fraud Tip-off Line on 131 524.

1. theheart.org
2. N Engl J Med 2009; 360: 213-224
3. J Am Coll Cardiol, 2010; 56:177-184

Posted 13 December 2010

14 thoughts on “Unnecessary stents costing millions

  1. Periop Anaesthetist says:

    Would the result of a perfusion scan (eg Sestamibi) have similar utility to a FFR assessment, in understanding whether a lesion should or should not be stented? Can anyone comment?

  2. Burt Cohen says:

    I completely agree with Professor Harper. And for those interventionalists who are concerned about reduced volume, Nico Pijls (who was PI for the FAME study that showed FFR to be superior to angio-guided PCI) told us that FFR would allow multivessel patients who might be sent to CABG to be done via PCI, if it turned out only 1 (or 2) lesions were significant — also some lesions that “look” mild on angio may actually be ischemia-producing. So while FFR probably reduces total stenting, it does make stenting more successful. You can read interviews about FFR with Dr. Pijls, Fearon and Pichard at Angioplasty.Org

  3. Justin Williamson says:

    Hi Periop Anaesthetist,
    You are quite right. Have a look at Circulation, 2002;105:1060. Validation of Collateral Fractional Flow Reserve by Myocardial Perfusion Imaging
    Hitoshi Matsuo, MD; Most of the information from FFR is available readily and safely from MPI perfusion type studies. This has the massive pecuniary advantage that angiography does not need to be carried out unless needed. There are several high quality studies where the concept of MPI as gatekeeper for intervention was trialed. A good outcome was obtained. This type of strategy would be expected to have better and better results as medical therapy (as opposed to revascularisation) improves, which it has considerably.

  4. Anonymous says:

    MIBI will assess myocardial uptake and give regional wall motion assessment. We use it often after cardiac CT.
    Cardiac CT allows assessment of the wall – not just the lumen shown on angiography. Like FFI it would likely show the best place to stent – but we need the evidence

  5. Sue says:

    There is also another interesting dynamic operating here. In the days when the cardiologists did “medical therapy” and the Cardiothoracic surgeons did bypass procedures, the cardiologists were the gatekeepers to the surgical therapy, referring on those who had failed medical therapy. The dynamics have now changed with interventional cardiology – there is no gatekeeper to interventional therapy – cardiologists self-refer for intervention – procedures from which they derive considerable profit. It would be difficult to argue that this has had no influence on the stent rate.

  6. Rick says:

    Very interesting and informative article with some good comments – need more like this.
    – Highlights a long-standing major problem with Medicare failing to keep up with technology, but would interventionalists change their habits if Medicare changed? In the public sector the Medicare rebate usually doesn’t matter; in private they’ll charge (and should charge) what they feel is the appropriate fee. What is needed is proper peer review and clinical governance in both sectors.
    – Probably highlights the need for better funding of cognitive work compared to intervention.
    – As far as MIBI scans go, not all labs are equal. If I can, I get mine done in hospital labs with regular through-put where they regularly correlate results with angiography.
    – Predictable response from the Medicare bureaucrat, but not understanding the issue at all (nothing to do with fraud, and everything to do with delivering a better outcome more cheaply).

  7. Stewart mair says:

    Myocardial perfusion studies are well reimbursed and are an arm’s length procedure. It is also rumoured that stress echo, not an arm’s length procedure, works.

  8. Stenter says:

    The emperor has no clothes!
    As an interventionist, I unfortunately know of at least one cardiologist who stents clearly non-significant disease a la Dr Midei. He doesn’t “believe” in FFR or MIBI scans! It is very hard to prove though.

  9. Brett Forge says:

    The article makes some very important and quite radical points about diagnosis and assessment of chest pain and atherosclerosis.
    But they then assert that in patients with ischaemia, revascularisation improves outcomes, and that patients with significant ischaemia should have invasive angiography.
    This is unproven. All the randomised trials of stable angina show that revascularisation may reduce short term angina but does not reduce mortality or myocardial infarction rates.
    If they want to reduce the cost and wastage in modern cardiology just restrict PCI to those patients in whom angina is limiting or in whom an adequate trial of medical therapy has failed to control symptoms.
    This will reduce the numbers of interventions by far more than 30%.
    If and when FFR measurements are shown to reduce mortality or AMI then the conclusions of this article will be evidence based. At the moment they are not.
    Whilst many procedures are beneficial to patients, vast numbers of procedures are performed on patients in whom no proven long-term benefit has been demonstrated.
    Has there been a greater racket in the history of medicine?

  10. Anonymous says:

    Hasn’t MIBI scanning been providing this info for the past 20 years already?
    It’s arms length and much more reliable than stress echoes.

  11. Rick says:

    The MJA article also states that stenting non-ischaemic lesions (ie with normal FFR) worsens the prognosis. This is of concern.
    The article also suggests abolishing the item number for MIBIs and using CT coronary angios to diagnose CAD – not sure that this is a viable option for patients with significant renal failure or even in areas where CT coronary angio is relatively new; seems like an exclusively teaching hospital perspective.

  12. Surgeon says:

    And this overuse does not cover the large number of patients having multiple stents and ending up with a definitive operation some time and multiple infarcts later

  13. prof Montage says:

    I was late to look at this dialogue.
    Brett Forge has it spot-on.
    He usually does!

  14. john langdon says:

    John.
    This is happening in australia now. Have 3 drug eluting stents fitted with no tests prior,same niggles of exertional pain continued at start of exersise then dissapeared for duration of 1.5 hours bike ride after stents.niggles of chest pain lasted approx 4 months after stenting. Never breathless/overweight/or smoked,very athletic. Father 100 years old no cardiac history. Have had conformation of my angiogram confirmed that there were no restrictions by leading USA medical institution, that needed intervention. Qld cardiologist also falsified his files, where do I go now?.

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