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Archive for the ‘Overstenting Scandal’ Category

As readers know, I recently gave a CME presentation on The Syntax Trial   and discussed the new Revascularization guidelines that were released last month.  I’ve posted the slides for anyone who wants to use them.  (It would be nice if you mentioned where you got them – but feel free to use them.)

Now – new criticisms of these revised guidelines are already emerging.  But before tackling these new criticisms, we should review the old controversies surrounding the previous guidelines.

In a interesting article (by one of my favorite summarists) Reed Miller over at The Heart.org reviews the issues behind the old (2009) guidelines..  It’s a good article that talks about many of the issues behind the 2012 revisions. I’ve re-posted the article below.

PCI appropriateness criteria draw criticism

(originally posted February 8th, 2012 at the Heart.org)

Kansas City, MO – The interminable controversy about appropriate use and overuse of PCI is being stirred up again [1].

Dr Steven P Marso (St Luke’s Mid-America Heart Institute, Kansas City, MO) and five other cardiologists have published a paper online February 8, 2012 in the Journal of the American College of Cardiology: Cardiovascular Interventions criticizing both the 2009 coronary revascularization appropriate-use criteria (AUC) and how those criteria have been applied to the study of contemporary practice patterns.

As reported by heartwire, the AUC were created by a technical committee representing six professional societies. Last summer, Marso’s colleague in Kansas City, Dr Paul Chan (St Luke’s Mid-America Heart Institute), led a study of PCI cases in the National Cardiovascular Data Registry (NCDR) that showed that only 50.4% of nonacute cases in the registry during the yearlong study period would be classified as appropriate under the AUC and that 11.6% of nonacute cases were classified as inappropriate.

“We are duty bound to evaluate appropriate use of PCI and other medical procedures,” Marso told heartwire. “The problem is that we are no closer to being able to identify overuse based upon these appropriate-use criteria than before they were created. The reason is that there are too many assumptions and too much variability that go into that 11.6% inappropriate rate.”

For example, Marso et al argue that the AUC put too much emphasis on stress testing without precise definitions to guide the interpretation of those tests. “The vast majority of AUC scenarios require knowledge of preprocedural stress-test findings . . . [but] the NCDR does not require interpreting physicians to determine this risk. Therefore, this data-collection burden falls onto the data abstractors, who are required to assign a risk category based on vague guidelines,” they say. “Essentially, they are required to interpret the interpretation.”

Chan told heartwire that the appropriateness criteria were never intended to be perfect, but they are the best effort to sort out which procedures are supported by evidence and which are not. They will evolve over several iterations, including the recent update, which provides more detail on patients with unstable angina. However, Chan does not expect any major changes from the 2009 version to be made soon.

Chan also pointed out that the purpose of the AUCs is to explain the existing evidence base, not pass judgment on each procedure, so nobody should interpret “inappropriate” in the AUCs to mean “fraudulent.”

“Ultimately, my main concern is that we don’t lose sight of the forest for the trees. Our profession of cardiology has taken an amazing leadership role in defining quality and appropriateness of care—in a way that no subspecialty has done to date. In so doing, we have moved the quality yardstick forward,” Chan said. “[But] we need to be humble as physicians to recognize that sometimes we may actually be doing procedures that have little evidence to support their use . . . and that not only are we not providing benefit but perhaps subjecting patients to unnecessary procedure risks and costs.”

Who decides which side is “right” and which side is “wrong?”

Marso et al are especially concerned with the AUC’s treatment of patients with one- or two-vessel disease, no proximal left anterior descending artery involvement or prior coronary artery bypass graft, class I or II symptoms, low-risk noninvasive findings, and on no or minimal medications. The AUC state that PCI in this scenario, labeled scenario 12b, is “inappropriate.” This scenario accounted for nearly 40% of the inappropriate nonacute procedures categorized by Chan et al as inappropriate, making it the most common type of procedure in this category.

Prior to the release of the 2009 AUCs, Chan et al surveyed 85 cardiologists—including 44 interventionalists and 41 noninterventional cardiologists—on the appropriateness of 68 coronary revascularization indications also addressed by the AUCs. That group classified scenario 12b as “uncertain.” Instead of assuming that the cardiologists in the survey need to be educated about the appropriateness of this procedure, Marso et al suggest it’s the technical panel that could learn something from the cardiologists in the survey. “These are 80 clinical cardiologists who answered questions about what they thought was appropriate, driven by medical decision-making, and they concluded that the technical panel just plain got it wrong,” Marso told heartwire.

In response to this specific point, Chan told heartwire, “The decision of the AUC technical panel to make this scenario inappropriate was based on the lack of available clinical evidence to support PCI in patients who have only mild to moderate symptoms with intermediate stress tests without a trial of medical therapy. This is, indeed, consistent with the COURAGE trial, wherein medical therapy was found to be comparable to PCI for patients with even greater symptoms and more severe ischemia.

“Although the COURAGE quality-of-life substudy did find that patients who underwent PCI, compared with medical therapy, had modestly improved angina relief during the first year, this benefit was likely concentrated in those COURAGE patients who had far greater symptoms than [Canadian Cardiovascular Society (CCS)] class I or II—eg, CCS class II or IV,” Chan said. “Dr Marso’s assertion that this indication should be uncertain, however, is not supported by any evidence to date.”

Who decides who gets to decide?

Marso et al also object to the composition of the technical panel, which included only four interventionalists out of 16 total members. The panel was put together according to the so-called Rand method to prevent conflicts of interest. Marso objects to the technical panel’s insinuation that “interventional cardiologists are inherently biased due a financial bias or an intellectual bias, that their ideas are preconceived, and that they are unwilling to evaluate data in an objective manner.” He points out that the FDA, which certainly has a vested interest in rooting out both financial and intellectual bias from its advisory panels, does not limit whole categories of experts from serving on these panels. Instead, it evaluates the background and potential conflicts of interest of each individual.

Dr John Spertus, the director of outcomes research at Saint Luke’s Mid America Heart Institute and senior author of the AUC writing group, does not agree that the AUC technical committee needs more interventionalists. “The benefits of revascularization should be very transparent. Clinicians caring for patients should all be on the same page with the same perspectives of revascularization of patients. That isn’t information that is uniquely known to the interventional community,” he said. “While they have extensive expertise and knowledge around the technical aspects of doing the procedure, whether it should be done or not is something that all clinicians caring for patients with coronary disease should know, appreciate, and be able to communicate to their patients.”

The missing voice: The patient

In an accompanying editorial [2], Dr James Blankenship (Geisinger Medical Center, Danville, PA) argues that the AUC “will never fully define the best treatment decision for a particular patient . . . because occasionally, patients will have exceptional circumstances that dictate treatment different from that recommended by AUC and guidelines; and different patients experience a given level of symptoms differently.

“Determinations of appropriateness by the AUC based on angina class fail to take patients’ perceptions and preferences into account. This is a fundamental flaw, because patients’ perceptions and preferences are a critical component of decision making,” Blankenship argues. However, he acknowledges that “factoring in patient preferences raises a host of new problems. Patients’ preferences are routinely based on incorrect perceptions and nonobjective factors; [they] routinely overestimate the benefits of PCI, underestimate its risks, and underestimate the efficacy of medical therapy [and] tend to discount the sometimes-superior benefits of one treatment (eg, CABG for very complex triple-vessel disease), because those benefits accrue later, and instead prefer the more immediate but lesser benefits of another treatment (eg, PCI) because they accrue sooner (temporal discounting).”

More data on the way

Chan said that a prospective study of 7000 to 8000 patients measuring the change in quality of life from baseline to six months among patients who have undergone PCI will soon be complete. Results of this study, intended to validate the ratings of the AUC, will probably be available this summer, he said.

“We anticipate that we will find that patients with inappropriate AUC ratings will have little to no improvement in quality of life at six months, appropriate AUC ratings will have substantial improvements in quality of life, and uncertain AUC ratings will have modest improvements in quality of life,” Chan said. “Once we have these results, we will be able to say with confidence whether indications such as 12b should be kept as inappropriate or changed to uncertain.”

Spertus said that the AUC will be updated when there are methodological or technical deficiencies in the current approach or if important new evidence on PCI is published. One of the goals of the AUC is to identify gaps in the scientific knowledge that need further study.

Marso reports no personal conflicts of interest during the previous 24 months.
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On the heels of the SYNTAX study which evaluated the effectiveness of using stents to treat multiple blockages, a new journal article outlined the appropriateness of both PCI (stenting and angioplasty) and CABG (bypass surgery) has been published.

For the Full Guidelines – click here..

Here’s an early glimpse of the article’s main points – most of which reinforce guidelines we’ve known since the early 1980’s (but which were questioned during the height of the stent-enthusiasm.)

[As usual, my comments are in italics and brackets.]

Article Re-post:

Title:  ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update Date

Posted:  January 30, 2012

Authors:  Patel MR, Dehmer GJ, Hirshfeld JW, Smith PK, Spertus JA, on behalf of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, Society of Cardiovascular Computed Tomography, American Society of Echocardiography, Heart Rhythm Society. Citation:  J Am Coll Cardiol 2012;Jan 30:[Epub ahead of print].

Comments (6)Related Resources Cardiosource Video News Update on Appropriate PCI

Cardiosource Video News PCI AUC, Hydration and Afib Ablation

Perspective: The following are 10 points to remember about this focused update on appropriate use criteria for coronary revascularization:

1. The writing group and technical panel felt that some quantification of coronary artery disease (CAD) burden, either by description or SYNTAX score, could be helpful to clinicians. Coronary artery bypass grafting (CABG) was rated as appropriate in all of the new clinical scenarios developed, whereas percutaneous coronary intervention (PCI) was rated as appropriate only in patients with two-vessel CAD with involvement of the proximal left anterior descending artery (LAD) and in patients with three-vessel disease with a low CAD burden. [This means that people with a lot of blackages or disease should not receive multiple stents – but should have bypass surgery instead.  The ‘syntax score’ is a rating system used by cardiologists to assign a number to the amount of blockage.  The higher the number, the more blockage.].

2. ST-segment elevation myocardial infarction (STEMI) ≤12 hours from onset of symptoms and revascularization of the culprit artery is rated as appropriate with a score of 9 (on a 1-9 scale). [in the middle of a heart attack, stenting is an appropriate treatment to open the blockage that is causing the heart attack.]

3. Revascularization in patients with one- or two-vessel CAD without involvement of the proximal LAD and no noninvasive testing performed is considered inappropriate.  [This says that You can’t just stent disease that isn’t causing a problem unless the disease is located in critical areas, or just take asymptomatic people to the cath lab.]

4. PCI is considered inappropriate for left main stenosis and additional CAD with intermediate to high CAD burden. [This artery is too important to risk treating with stents.  If this vessel were to have a stent thrombosis – the patient almost always dies.]

5. Revascularization is considered uncertain in unstable angina/NSTEMI and low-risk features (e.g., Thrombolysis in Myocardial Infarction [TIMI] score ≤2) for short-term risk of death or nonfatal MI, but appropriate for those with intermediate-risk features (e.g., TIMI score 3-4) and for those with high-risk features.

6. Appropriateness for PCI is uncertain for three-vessel CAD with intermediate to high CAD burden (i.e., multiple diffuse lesions, presence of chronic total occlusion, or high SYNTAX score), but CABG is appropriate.  [this means that this is still ‘under discussion.’]

7. PCI for isolated left main stenosis is now graded as uncertain. [see number 4.]

8. For patients with acute MI (STEMI or NSTEMI) and evidence of cardiogenic shock, revascularization of one or more coronary arteries is appropriate.

9. It should be noted that uncertain indications require individual physician judgment and understanding of the patient to better determine the usefulness of revascularization for a particular clinical scenario.  [not all treatments fit all patients].

10. The Appropriate Use Criteria writing group and technical panel favor the collaborative interaction of cardiac surgeons and interventional cardiologists heart team approach regarding revascularization decisions in complex patients or coronary anatomy, as recommended in the PCI guidelines. [We should work together to treat the patient, which kind of works against PCI without surgical backup.]

Author(s): Debabrata Mukherjee, M.D., F.A.C.C.

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New allegations of gross medicare fraud from overstenting and unnecessary interventional procedures has been filed against surgeons in Pennsylvania, including the prestigious UPMC medical center.  This story, (based on cases dating back to 2001 and onwards), comes just as the dust in settling from an outbreak of unnecessary stent cases in neighboring Maryland.

What is overstenting?

Article by Michael R’iordan from the Heart.com re-posted below:

Cardiologists accused of defrauding Medicare by performing unnecessary cardiac procedures

Erie, PA – A new whistle-blower lawsuit filed in US District Court in Erie, PA claims that five cardiologists from two medical practices defrauded Medicare by performing unnecessary cardiac and vascular surgeries and interventional procedures between 2001 and 2005.

The suit, filed under the False Claims Act (FCA) and first reported January 22, 2012 in the Erie Times-News [1], states that as a result of the fraud, Medicare overpaid for these procedures, which wasted substantial public money, and patients were placed at significant and unnecessary risk of harm.

According to a copy of the lawsuit obtained by heartwire, the physicians named are Drs Richard Petrella, Robert Ferraro, Charles Furr, Timothy Trageser, and Donald Zone. The two medical practices named in the lawsuit are Medicor Associates Inc—and its affiliate Flagship Cardiac, Vascular, and Thoracic Surgery (CVTS)—and the University of Pittsburgh Medical Center (UPMC) Hamot (formerly known as Hamot Medical Center). The Medicor practice is the full-service cardiology center affiliated with UPMC Hamot.

The lawsuit states that from June 2001 and earlier, the defendants “knowingly, systematically, routinely, and repeatedly submitted false claims to and received reimbursements from Medicare and other federal healthcare programs for medically unnecessary cardiac catheterizations and cardiac and vascular surgical procedures, including but not limited to . . . PCI.”

As result of the false claims, the physicians received money to “which they were not entitled.”

Paid directorships and kickbacks

Dr Tullio Emanuele, who worked at Medicor and Hamot Medical Center from 2001 to 2005, filed the suit and claims that Medicor engaged in illegal “kickbacks” with Hamot Medical Center and referred cardiac patients to the hospital. In the lawsuit, it is alleged that Hamot signed contracts with Medicor and Flagship CVTS, valued at $75 000 per physician and as high as $525 000 per year, and the doctors would refer patients in need of medical procedures to Hamot Medical Center.

“Specifically, Hamot identified physicians who referred a high volume of patients and/or had potential to refer a high volume of patients for special treatment and offered remuneration to them in the guise of sham contracts for medical directorships or other similar personal service arrangements,” according to the lawsuit.

The claim states the physicians and the participating hospitals violated the federal Anti-Kickback Statute and the federal Stark Act, which says that a hospital is not allowed to submit a claim for reimbursement from Medicare if the procedure has been referred by a physician with improper financial ties to the hospital.

The suit also claims that Emanuele began to grow suspicious in 2004 when he noticed higher rates of intervention among certain physicians within the group. Between 2004 and 2005, 4408 catheterizations were performed, and Petrella, Trageser, and Ferraro had a “rate of surgical intervention following catheterization of double the junior members of the group.”

Emanuele, according to the lawsuit, believes that many of the procedures were performed unnecessarily. For example, Trageser is accused of performing a cardiac catheterization in a patient with chest pain, despite the symptomology being inconsistent with angina. Ferraro is accused of implanting a stent in an artery with moderate stenosis, even though Emanuele previously recommended medical therapy. Zone performed a cardiac catheterization and overstated the severity of stenosis, sending the patient on to CABG surgery, where he/she later died.

UPMC Hamot and the named physicians received copies of the lawsuit last week, according to the Erie Times-News, and have 20 days to respond. If they are found guilty, UPMC Hamot and the Medicor physicians would be required to reimburse Medicare at triple the cost of the original procedure. Emanuele, as the whistle-blower in the case, would be entitled to 30% of the reimbursed money.

More on similar stories here at Cartagena Surgery:

The Ethics of the Syntax Trial

Stent Scandal series:

Cardiology takes another hit

Mark Midei – or the man who started it all..

This is just a sample of the articles available here at Cartagena Surgery.. For more on this topic, look under the cardiology tab..

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The is no easy buttonA new headline in Reuters brings home this notion, “Many stent patients get re-hospitalized.”  While this article highlights the high rates of re-hospitalization – (1 in 6! in this study) it fails to mention one of potential culprits.  While the authors discuss increasing patient co-morbidities, they fail to address increasing burdens of coronary artery disease (CAD) in patients receiving stents.  This isn’t a new phenomenon – but the strategy of  multiple stent treatment is. 

In the past, patients with a heavy burden of CAD such as multiple lesions, long length lesions or strategically placed lesions affecting multiple vessels (such as left main disease or trifurcation lesions) were treated more definitively, with open heart surgery (aka ‘bypass surgery’).

However, in the last decade, cardiology has ‘pushed the envelope’ in an effort to treat more diffuse and severe disease with stents and other temporary measures.  Despite multiple research studies showing the shortfalls of this method (as discussed previously here at Cartagena Surgery) this strategy has proved wildly successful with the general public.  Why?

The answer is obvious:  stents are the ‘easy option.’  [compared to surgery].  Too bad one of the other options is death..

multiple stents aka a 'full metal jacket"

Will the latest research (and news headlines) heralding the shortcomings of stents for permanent treatment of serious disease end this trend?

Unlikely.  There is just too much money involved.. and human nature doesn’t change.  Preventable behaviors cause the vast majority of human disease, but our behaviors seldom change.   And people will always seek to press the ‘easy button’.  [note the date on the headline below…]

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In a disturbing story out of Maryland, the Heart.org reports that Dr.  John Chung Yee Wang, one of the doctors investigating claims of improper, and unnecessary stenting in the wake of the Mark Midei overstenting scandals has now been charged with unnecessary stenting.

Is this just a sign of how incredibly pervasive this practice is?  Is this an example of the widespread corruption of a specialty due to a lack of outside oversight or accountability – and the incredible ease of creating huge profits [by performing unneeded procedures?]

Or is it as some cardiologists suggest, a crazed witch hunt?   I don’t know – but angiography doesn’t lie, and there have been too many cases of 20% and even 10% lesions being ‘over-called’ and stented as critical disease.  This is particularly important now – as a recent study [the landmark Syntax trial] shows that stents are not the ‘miracle cure’ they’ve been touted as.  In fact – one in ten patients who receives a stent has to be re-hospitalized within 30 days.

Overstenting, stent fractures, sudden stent thrombosis* and stent deformities – in the wake of all of this – we need to stop and consider our other options; the ones that aren’t quite as easy..

* Please note that both of these sources are heavily biased in favor of interventional cardiologists.

Supervised exercise programs as effective as stents

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As I delve further into the Syntax trial, (in preparation for a presentation at work):

Mark Midei was charged with another 175 counts of unneccessary stenting this week..

The Syntax trial is a great example of the ‘big lie’ of the easy fix – and the publicity spin, as explained on this blog by (what appears to be ) one of the last honest cardiologists..  As I slosh through reams and reams of printed articles, as well as on-line stories, and links to journals on the Syntax trial and the results – it becomes readily apparent – that it is almost impossible to find an honest, and unbiased report of actual syntax results (particularly since cardiologists are doing most of the writing.)  Cardiac surgeons – listen up!!  You know the truth about outcomes with stents versus cabg (surgery) – you see it every single day.. But stop sitting there smugly, and self-assuredly, so certain that the truth will out..

The truth is out, but it’s so muddied as to be unrecognizable.  Start writing your own research papers and defend yourself (and your patients) from this watershed of biased reporting.. Stenting is EASY but it’s NOT effective, and bypass surgery remains the standard of practice and the best treatment for longevity.. No propaganda can change that – but surgeons can’t lie back and rest on their laurels..

Dr.  DeMaio escapes..

and the most infamous cardiologist in America.

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Dr. John McLean, a now notorious Maryland cardiologist was recently sentenced to eight years in prison for placing unnecessary stents in over 100 patients (and defrauding Medicare.)

An army cardiologist, Dr. John Davis was ordered to payback kickbacks he received from Boston Scientific device manufacturer for preferencial use of their products.

The Chief of the Union Memorial Hospital in Baltimore is being sued for unnecessary stents in the aftermath of these high profile cases (including Dr. Midei at St. Joseph’s.)

As for Dr. Midei, himself, who we first mentioned several months ago – after losing his license – he’s fallen from the headlines.

Hopefully, this is the end of the 2011 cardiology bloodbath.

 

 

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