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Here’s another re-post from Heartwire :

Midei and unnecessary stents—or lack thereof—make news again

April 25, 2011            |            Shelley Wood

Baltimore, MD and Greensburg, PA – “Unnecessary stents” and the people who place them have been back in the news this past week with a confusing twist of the tale in Pennsylvania, previously reported by heartwire, where two cardiologists stepped down on charges of unnecessary stenting [1], and a published Commentary, by Dr Mark Midei, in the Baltimore Sun [2].

The latest development in the Greenburg, PA case, reported Saturday in the Pittsburgh Tribune-Review, involves an admission by the hospital’s chief medical officer that at least six of 141 Westmoreland Hospital patients sent letters telling them they may have received “unnecessary stents” in fact never got stents in the first place. Instead, the hospital now says, these six patients underwent angioplasty procedures that appeared, on review, to not have been medically warranted, although no stents were placed.

The two cardiologists who treated the 141 patients—Drs Ehab Morcos and George Bousamra—voluntarily resigned after hospital administrators first questioned the medical necessity of the procedures. Those questions stemmed from the conclusions of eight independent cardiologists, as part of a review by the American Medical Foundation in Philadelphia. The hospital alerted patients to the situation via a letter, and 19 patients have since launched lawsuits against the two cardiologists and the parent health organization for the hospital, Excela Health.

The hospital has now sent new letters “of clarification,” the Tribune-Review reports, a move that has been slammed by lawyers handling the lawsuits and by outside observers.

“It is confusing,” Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple) is quoted in the article. “The bottom line is that it was an unnecessary procedure, whether they got a stent or not.”

Midei’s day in the Sun

Meanwhile, Dr Mark Midei, whose predicament in Baltimore is viewed by many as the catalyst for the stepped-up scrutiny of interventionalists around the US, once again lays out his side of the story—this time in the Baltimore Sun, the newspaper that has meticulously covered this saga. In the article, published Friday, Midei notes that he will soon be appearing before the Maryland Board of Physicians to “make the case for retaining my license to practice medicine” but in the meantime wants his voice heard.

Midei repeats an allegation he made when he first spoke out on the case, in an interview with heartwire, saying that St Joseph used him as a “decoy” when the hospital was embroiled in a federal investigation.  He has also, he says, been falsely portrayed as “manipulating” the peer-review process at the hospital, when in fact “any doctor, nurse, technologist, or physician assistant could suggest additional cases for review.” As well, he notes, he was not paid by the hospital based on the number of cases he performed, as press reports have suggested.

As for his relationship with stent manufacturers, he says he never accepted gifts or offers from companies, and any personal honoraria were donated to outside charities or foundations. He does not specifically address the now famous “appreciation pig roast” paid for by Abbott held for St Joseph’s cardiac staff in Midei’s backyard.

But he does, with some humility, acknowledge that may not “have been perfect in my practice of medicine; no doctor can make that claim.”

And he concludes: “I can say unequivocally that my decisions as a doctor have been motivated by one thing only: The well-being of my patients.”

As reported by heartwire, two cardiology organizations recently asked the state of Maryland to legislate cath lab oversight in an effort to avoid the tangles unraveling in Baltimore and Pittsburgh; that plan has since been nixed.

Update: 22 July 2011 – Dr. Midei’s medical license has been revoked. (article re-post – Heartwire.com in another report by Shelley Wood).

Dr Mark Midei’s medical license revoked

July 13, 2011            |            Shelley Wood

Baltimore, MD (updated) – The Maryland Medical Board has concluded its review of Dr Mark Midei, deciding to revoke his license, calling his violations of the Medical Practice Act “repeated and serious.”

The disciplinary actions alert published on the board’s website today notes that the board will not accept any application for reinstatement by Midei for at least two years. At that time, it is up to the board whether it will consider reinstatement of his license.

As previously reported by heartwire, Midei is alleged to have implanted hundreds of unneeded stents when he worked at St Joseph Medical Center in Towson, MD. The imbroglio was ultimately taken up by the US Senate Finance Committee, which issued a damning report back in December 2010.

For years, however, watchers have been waiting to hear what the Maryland Board of Physicians concluded, having charged Midei with violating the Medical Practice Act back in July 2010, focusing specifically on five patients it was alleged may have received stents unnecessarily. A subsequent seven-day hearing before an administrative law judge (ALJ) led to her issuing a 77-page “proposed decision” that Midei have his license revoked for having violated five provisions of the act, specifically those prohibiting:

  • Unprofessional conduct in the practice of medicine.
  • Willfully making a false report or record in the practice of medicine.
  • Gross overutilization of health care services.
  • Violations of the standard of quality care.
  • Failure to keep adequate records.

In its “findings of fact,” the board concluded that Midei implanted six cardiac stents unnecessarily in four out of the five cases reviewed and noted in his charts that the extent of the stenosis was 80%, when in fact it was lower “and in most cases much lower.” In three cases he falsely reported that patients had unstable angina, when in fact they didn’t, and in all five patients he failed to obtain the active coagulation time and instead administered heparin while inserting the catheter. In one of the patients, Midei “also failed to look at or disregarded the hospital’s note that the patient had already been given an anticoagulant and should not be given another.”

In June, Midei filed exceptions with the board in an oral hearing, which was considered in advance of today’s announcement. Those included a request by Midei that the board reverse the judge’s opinion on which expert reviewer to believe. The ALJ had used Dr Matthews Chacko (Johns Hopkins Hospital, Baltimore, MD) as expert reviewer, whereas Midei’s primary expert witness was Dr William O’Neill (University of Miami, FL). The board’s “consideration of exceptions” notes that all of the experts were “qualified” but that the ALJ “made her determination based on the consistency of Dr Chacko’s testimony and his clear presentation and demeanor” as well as her consideration of professional publications. By contrast, the ALJ “noted some inconsistencies or equivocations in the testimony” of O’Neill. Also at issue was the fact that Chacko was paid $1400 for his report and expert testimony—something Midei raised as problematic. The board report notes that O’Neill, Midei’s expert, was “paid more than 20 times that much.”

Asked to comment, O’Neill emailed heartwire to say: “I think it’s a tragedy that a fine doctor’s reputation and livelihood are ruined when there was never a single shred of proof that he harmed any patient. I stand by my [previous] comment that after reviewing all the records and films personally, I would have no problem letting Dr Midei treat me or a family member. I pity any interventional cardiologist practicing in Maryland today; if Dr Midei can lose his license, any of them could.”

The board agreed with the ALJ’s conclusions and, “using its own expertise,” agreed that Chacko’s testimony “represents an accurate statement of the standard of quality care.” The board clearly took exception to Midei’s suggestion that he sometimes wrote “80%” as a form of shorthand for blockages that in fact were less than 50%, calling that “a justification for a blatant falsehood that resulted in patients receiving unneeded stents as well as the creation of false records.”

The board also questioned the believability of Midei’s testimony that his decision to stent certain patients was on the basis of “remembered” symptoms not recorded in patients’ medical records. “The ALJ found it not credible that Dr Midei could remember these unrecorded symptoms in the cases of patients who were among thousands that he saw only once, for very brief period of time (from 20 to 37 minutes) three years previously.”

As reported by heartwire, Midei, who is being sued by hundreds of former patients believing they received unnecessary devices, is himself suing his former hospital, St Joseph, alleging in part that he was a scapegoat in “an epic campaign of corporate deception, trickery, and fraud” relating to past business deals and a federal investigation. In his medical-board hearing, Midei was permitted to present evidence to support this claim; the board, ultimately, agreed with the ALJ that “nothing St Joseph Medical Center did or failed to do is relevant to the issues of this case.”

The final decision and order, signed by board chair Dr Paul T Elder, contains a number of scalding conclusions about Midei’s conduct, stating that he failed to deal honestly with patients and colleagues and that his reports intentionally and nonaccidentally “exaggerated” patient symptoms and degree of stenosis.

“Dr Midei’s violations were repeated and serious. They unnecessarily exposed his patients to the risk of harm,” the decisions states. “They increased the cost of the patients’ medical care. Dr Midei’s willful creation of false percentage numbers for the degree of occlusion of coronary arteries is indefensible and amounts to a deliberate and willful fabrication of medical records.”

Requests for a reaction from Midei’s lawyers have not been returned. Midei has 30 days to ask for a judicial review of the decision.

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Another article highlighting the incidence of major bleeding after CABG in patients receiving clopidogrel (plavix) pre-operatively.

This study looked at patients requiring urgent surgery who had previously received clopidogrel.. (this article barely mentions the emergent cases)

Several important things for my lay readers to note:

First “Major bleeding was defined as a fall in hemoglobin >5g/dL, fatal or intracranial bleeding, or cardiac tamponade.” – this are all indicators of severe, severe bleeding.. Normal hemoglobin is around 12 – 14mg/dl for most adult males. (less for women).

– Timing of clopidogrel dose: “Mean duration from clopidogrel loading to CABG was 3.0 ± 1.5 and 3.0 ± 1.6 days for the 300 and 600 mg loading doses, respectively” – these aren’t even the patients that get loaded with clopidogrel and go straight to the operating room from the cath lab.. These patients received clopidogrel three days before surgery.

– Percent of patients with major bleeding after plavix:
” Major bleeding occurred in 47% of patients receiving 300 mg and 73% of patients receiving ≥600 mg clopidogrel loading”

So what does this mean, and what should we do about it??

– First – we need to question the trend, and recent guidelines suggesting that patients receive clopidogrel (and some patients receive as much as 900mg!) in the Emergency department – or even in the cath suite – before we know the coronary anatomy!

The anatomy determines the treatment – and we need to follow that.. If the anatomy is favorable for stenting AND stenting is performed – give the clopidogrel..

But we shouldn’t blindly give clopidogrel without knowing what we are going to find.. that’s a recipe for the disasters we have been reading about.. Because that strategy harms the very patients with the most critical disease and active symptoms.. (The people who can’t wait five days..)

I looked all over the website and can’t find another free text site for this article – (medscape is free with registration.) It’s a multiple page article so I haven’t re-posted, but if I get enough requests, I will.

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If you’ve been following the cardiology and vascular surgery journals – then you’ve been bombarded with articles about strokes in the last two days.

The first series has blazing headlines linking the increased rate of strokes in young people with diet soda consumption (excess salt consumption, obesity, poor dietary habits).

The second series of articles discuss the very topics we’ve been discussing here at Cartagena Surgery.. Surgery versus Stenting..  But as people have been asking, are the two related??

Probably not.  The proposed causes of the increased incidence of stroke in people aged 15 – 44 is theorized to be related to increased sodium intake – which in turn causes hypertension.  Hypertension itself may increase the ‘chipping’ effect on plaques in the carotid artery (in people with pre-existing carotid disease)

or may cause strokes themselves by causing blood vessels in the brain to rupture from the increased pressure.  In young people, it is usually the latter.. (because it usually takes a long time to accumulate carotid plaques.) Unfortunately, it’s this younger population that often goes undetected/ untreated or fails to realize the significance of the diagnosis.  Hypertension/ high blood pressure is a serious condition, and aggressive treatment is warrented.. It’s never just high blood pressure.. It’s THE number one cause of kidney failure, the number one cause of heart failure, and a major cause of stroke (just to name a few.)  and it’s usually easily treatable.

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As Featured On EzineArticles

Carotid stenting sounds like a wonderful solution to the layperson.  But the truth is always more complicated.  I’ll talk about it more here to give a better understanding of the disease, diagnosis, and treatment options.

The carotid arteries

The carotid arteries (along with the vertebral arteries) bring blood to the brain. Plaque embolization (or flecks of plaque breaking off diseased or blocked arteries) is one of the main causes of embolic (or non-bleeding) strokes.  In people with blockages in this artery, treating or removing the plaque can prevent stroke.

Today we will talk about screening and diagnosis.. Next time: treatment options.

Detecting Carotid Stenosis:

These blockages can be detected with the use of a carotid doppler (or ultrasound) to listen to the speed of the blood (velocities) in the carotid artery and to visualize blockages.  Some blockages can also be heard on physical exam –  as a bruit (bru-ee) but this is not always a reliable indicator, as the most severe stenoses (or narrowing from plaque) usually don’t have a bruit.

Results are reported as a range – and this decides treatment options.  Generally, in people that have NOT had a stroke – surgical treatment is not advised until the blockage is 70 – 80% blocked.  This is because the risk of stroke increases with the amount of blockage, as the speed of the blood increases to pass through the narrowed space.  (Picture a garden hose, now put your thumb over the end, covering most of it and make the water shoot out – that’s what we mean by increased velocity.)

If you have had a stroke or mini stroke from a plaque breaking off and travelling to the small vessels of the brain, the doctors will usually operate with lesser blockages – because you have already demonstrated a tendency to have pieces break off.

Now this is important – strokes usually happen because of high grade (70 or higher stenosis) not occlusions (or 100% blockages).  That’s because there is more than one vessel bringing blood to the brain – (remember the vertebrals we mentioned earlier..)  Doctors do not undo occlusions because that actually increases the risk of stroke at the time of surgery.

If you have an occlusion – count yourself as lucky that you didn’t have a stroke when it was 99%  and worry about keeping the remaining vessels as clean as possible with medicines.

Screening for Carotid Stenosis:

Currently there are no screening guidelines for asymptomatic individuals.  Since symptomatic means the person has had a stroke or TIA (mini-stroke) knowing when to screen is important.

Generally screening should be done in people at high risk for developing accelerated plaque formation – and in people with vasculopathic disease history (people with a history of plaque or blockages other places.)

High risk for accelerated plaques:

1. Diabetes – diabetes accelerates plaque formation, which is why new guidelines suggest ALL people with Diabetes, regardless of blood cholesterol tests should be on a statin drug (simvastatin, rosuvastatin, lovastatin, atorvastatin, pravastatin)*

2. History of smoking – smoking causes similar effects inside blood vessels as diabetes.  As I explain to patients in the office, it makes plaque form faster by irritating blood vessels and making plaque more likely to stick.  This is also important when we talk about ‘medical management’ of plaque diseases.

Note: ‘Medical Management’ is a term that means exactly that – managing conditions (not curing or fixing) by use of medications.  The disease won’t go away but the thought is that medicines will slow the worsening of the conditioning.

People with history of vasculopathic disease:  these people should be screened because they already have a history of artery blockages – but people don’t always realize that carotid arteries and other arteries are essentially the same highway, so to speak.

This includes:

1. People with a history of Coronary artery disease (CAD) such as people with previous heart stents or bypass surgery.  In fact, one-third of people screened for carotid artery while awaiting bypass surgery (also called CABG) have significant carotid disease or stenosis.

2. People with blockages elsewhere: Renal artery stenosis (kidneys), peripheral artery disease (PAD) aka blockages in the legs, mesenteric artery disease (abdomen).

3. People with an abnormal eye exam or Amarosis fugax – this is basically a small stroke or mini-stroke to the eye.  Sometimes people develop symptoms (amarosis fugax – which is described as a sudden loss of vision, like a shade coming down over your eye).  Other times, the ophthalmologist sees a plaque in the artery to the eye on exam.

I’ll talk about more in my next post – and I am happy to answer condition related questions but not offer medical advice.  My legal eagles have a fit otherwise..

*as I have previously mentioned in Hidden Gem – it is vitally important patients know the generic names of their medications, along with dosages and administration information.

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