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Posts Tagged ‘stents’

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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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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Below is a re-post from Heartwire.com on the use of multi-vessel PCI (stenting) for patients presenting with an acute myocardial infarction (heart attack).  As you can see for the headlines – two research studies suggest “Don’t do it.”  The studies suggest that only the culprit (or vessel causing chest pain/ heart attack) should be treated during the event.  Of course, these studies ignore the other, BIGGER question of whether we should be doing multi-vessel PCI (staged or not) AT ALL.  There is quite a bit of research (presented in other posts) to suggest that the strategy should be stenting the culprit vessel (to treat the immediate ischemia) followed by surgery, not more stents.  But since interventional cardiologists were conducting the study, not surgeons – this isn’t addressed at all.

Of course, I am speaking from my own position as someone who has worked in both cardiology and cardiothoracic surgery – which carries it’s own bias.  But, I do know the long-term data, which clearly favors surgery for multi-vessel disease.

Multivessel PCI during STEMI associated with higher short- and long-

term mortality

August 5, 2011            |            Michael O’Riordan

Groningen, the Netherlands and Tel Aviv, Israel – Two new studies published this week confirm clinical recommendations that a deferred angioplasty strategy of nonculprit lesions should remain the standard interventional approach in patients with ST-segment elevation MI (STEMI) undergoing primary PCI [1,2].

In the first study, an analysis of the Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction (HORIZONS AMI) study, investigators, led by Dr Ron Kornowski (Tel Aviv University, Israel), observed significantly higher one-year mortality and stent-thrombosis rates among patients undergoing multivessel PCI compared with individuals undergoing staged PCI.

In the second study, a meta-analysis that included 18 studies and more than 40 000 patients, the investigators report that multivessel PCI was associated with the highest rates of death in short- and long-term follow-up when compared with culprit-lesion PCI and staged PCI.

Dr Pieter Vlaar (University Medical Center, Groningen, the Netherlands), the lead researcher of the meta-analysis, told heartwire that the results support current guidelines discouraging multivessel primary PCI for STEMI patients. That said, the guidelines are not based on large randomized controlled clinical trials, and this had led to some confusion and variability across different centers. Even at their institution, Vlaar said clinicians differ in their opinions about whether nonculprit lesions should be treated during the initial intervention. However, these new data suggest that when significant nonculprit lesions are suitable for PCI, “they should be treated only during staged interventions.”

Both studies, as well as an accompanying editorial [3], are published in the August 9, 2011 issue of the Journal of the American College of Cardiology.

HORIZONS-AMI and the meta-analysisIn the meta-analysis, Vlaar and colleagues included data from four prospective and 14 retrospective studies involving 40 280 patients with multivessel disease undergoing primary PCI for STEMI. Three treatment strategies were compared:

  • PCI of the culprit vessel only.
  • Multivessel PCI, defined as PCI of the culprit vessel as well as one or more nonculprit vessel lesions.
  • Staged PCI, defined as PCI confined to the culprit vessel only, with one or more nonculprit lesions treated in staged interventions.

Compared with the staged-PCI strategy, PCI of the culprit lesion only and multivessel PCI were associated with a significant three- and fivefold increased risk of in-hospital/30-day mortality, respectively. In addition, 30-day mortality was significantly lower in patients treated with culprit PCI compared with multivessel PCI (odds ratio 0.66; 95% CI 0.48-0.89). Regarding long-term mortality, multivessel PCI was associated with a 60% increased risk of long-term mortality compared with culprit PCI, as well as a significantly greater risk compared with staged PCI.

In the HORIZONS-AMI study, the investigators compared primary PCI of the culprit and nonculprit lesions with patients who underwent PCI of the culprit lesions only and those who underwent staged PCI of the nonculprit lesion at a later date. Of the 3602 patients enrolled in the trial, 668 underwent PCI of the culprit and nonculprit lesions for multivessel disease, of whom 275 underwent a single PCI strategy and 393 underwent staged PCI.

At one year, patients who underwent single PCI had a mortality rate of 9.2% compared with 2.3% in patients who underwent staged PCI. In addition, single PCI was associated with significantly higher rates of cardiac mortality compared with staged PCI (6.2% vs 2.0%, respectively) and higher rates of definite/probable stent thrombosis (5.7% vs 2.3%, respectively).

In their paper, Kornowski and colleagues, including senior investigator Dr Gregg Stone (Columbia University, New York), state that a “deferred angioplasty strategy of nonculprit lesions should remain the standard approach in patients with STEMI undergoing primary PCI, as multivessel PCI may be associated with a greater hazard of mortality and stent thrombosis.”

Some unanswered questionsCommenting on the findings for heartwire, Dr David Kandzari (Piedmont Heart Institute, Atlanta, GA) said, “Both papers provide welcome information to clinicians,” especially since there are few randomized trials to provide sufficient information to guide treatment decisions. Most of the clinical recommendations are based on some clinical evidence, including cohort and retrospective studies, but they are largely the opinion of interventional experts.

In the US, the American College of Cardiology/American Heart Association guidelines state definitively that PCI “should not be performed in a noninfarct artery at the time of primary PCI in patients without hemodynamic compromise.” The class-III (harm)/level-of-evidence B recommendation differs slightly from the European Society of Cardiology/European Association for Cardiothoracic Surgery guidelines, which are slightly more lenient. The European guidelines state that with the exception of cardiogenic shock, PCI for STEMI should be limited to the culprit lesion (class IIa, level of evidence B).

To heartwire, Kandzari explained that treating other lesions in patients with cardiogenic shock remains a “bit of a gray area” in the US. Although the guidelines explicitly state not to perform PCI of the nonculprit lesions, some clinicians will treat other stenoses in cardiogenic-shock patients in an attempt to provide as much flow as possible. That said, there is a discrepancy between the number of clinicians performing multivessel PCI and rates of cardiogenic shock. Dr John Bittl (Ocala Heart Institute, FL), who wrote an editorial accompanying the published studies, observed a similar discrepancy. For example, in HORIZONS-AMI, 18.5% of patients underwent multivessel PCI, but only 1.5% had cardiogenic shock. In the New York State registry, 12.5% of patients were treated with multivessel PCI, but only 4.4% met the definition of hemodynamic compromise.

Kandzari said he would like to know the reasons that the clinicians performed multivessel PCI in these STEMI patients, noting that in some instances it is difficult to determine what the culprit lesion is in acute MI. Some centers might not perform left and right coronary angiography before revascularizing the patient, and without assessment of the entire coronary anatomy, it is possible, although rare, to treat the wrong lesion. Some patients might not show any improvement following culprit PCI and as a result will undergo treatment of other lesions, he said.

In his editorial, Bittl made similar statements, noting that “no single approach is applicable to the myriad presentations of STEMI.” He also noted that multivessel PCI might be necessary in the cases where patients do not show improvement following primary PCI of the culprit lesion. He added that patients with severe multivessel disease might require follow-up angiography and that fractional flow reserve (FFR) can be considered during the acute phase, but the “results should be used whenever possible to support a decision for staged PCI.”

To heartwire, Vlaar said the benefit of staging patients is that angiograms can be discussed with a joint heart team and additional noninvasive ischemia tests and FFR can be performed before deciding to perform additional revascularizations.

Kandzari told heartwire that there still remain some questions regarding staged PCI in STEMI patients. For example, Kandzari said the optimal time for the second PCI is unknown. In the US, revascularization is driven by reimbursement issues, with physicians not compensated for staged PCI performed within 30 days of PCI for acute MI, so most clinicians are reluctant to treat other vessels even when the patient is in the hospital.

“Financial issues aside, we still don’t know if it’s better to treat the nonculprit lesions when the patient is still in the hospital, two weeks after the primary PCI, or four weeks after primary PCI,” said Kandzari.

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Today’s headline is a bit like alphabet soup for readers, but don’t worry, we’ll sort it all out for all of you.

PCI – percutaneous intervention (stenting)

CABG – coronary artery bypass surgery “bypass surgery”

ACS – acute coronary syndrome – acute ischemia, if untreated leads to acute myocardial infarction (AMI) also known as a heart attack.

Now that we have that all sorted out, we will continue our discussion on the latest Medscape article by Megan Brooks – which is re-posted below.

Generally, when a person is found to have significant coronary artery disease (CAD) or blockages, the decision whether to stent, treat with medicines or surgery is made based on several criteria including the amount of blockages, the number of places with blockages and the location of blockages.

For many years, doctors (cardiologists and surgeons) followed a few general guidelines when determining whether a patient should have stents or surgery.  Surgery was generally indicated in the following cases (provided the patient could tolerate surgery):

1. Multi-vessel disease (blockages in more than one artery)

2. Left main disease (because anatomically the left main serves two arteries – making it multiple vessel disease).  Left main disease was also considered a specific entity because of the consequences – patients rarely survive an infarction caused by the left main, which is how it received it’s nickname, ‘the widowmaker’.

(There are some other guidelines, and quite a bit more goes into the decision-making process but we will just talk about these two for now.)

Left main disease is particularly deadly for this reason, because in many people, they are asymptomatic (without chest pain or other physical symptoms) until the left main artery becomes very, very narrowed.  This disease pattern (or pattern of blockages also runs in families, and is sometimes seen in younger people (forties). Due to the importance of this vessel for survival, and due to the known durability of bypass surgery – this patients were usually sent automatically for a surgical referral.  These are also the patients that sometimes skipped right ahead to surgery – particularly if they came into the hospital with chest pain/ and had chest pain in the cath lab. (The ACS portion of the title)

But as stenting grew in popularity, not just with cardiologists but with patients (medicine is market-driven, just like cars or anything else) cardiologists began placing more and more stents in more and more people for disease that had traditionally been treated with surgery.  (Every time you seen an article about decrease in bypass surgery rates – think more stents – people don’t have less disease, they are just having less surgery to treat it.)

People began receiving four, five even six stents at a time, in multiple vessels.. Then cardiologists started stenting the left main..  All of this was done under the guise of “it’s what the patients want” which is a pretty important point to consider.  Now, in the five plus years I’ve been doing this, I’ve never, ever had a patient in the cath lab, or in the office come to me, or the surgeons I’ve worked for and say, “Hey – I’d like to have heart surgery.”  But we managed to stay pretty busy all the same – because it’s not about if the patient wants surgery – that’s using semantics..

But if I were to ask those same patients, “Do you want a proven therapy for your disease with good 20 year outcomes?”  then we get a very different answer, and surgery becomes a necessary evil – to get to that twenty years – to the children’s graduation, fiftieth anniversary and all of those other milestones of life.

Now researchers are looking at the data behind PCI for left main and comparing it to CABG.  That always tends to be fraught with danger because it seems that so many times, these trials are bought and paid for by drug companies – the ones that make the devices, and the drugs used in the cath lab..  So often when looking at the methodology for studies comparing surgery to stents – the researchers are actually comparing apples to oranges.

The other big error that a lot of these studies do – is ignore the long-term data.  They usually stop looking after six months or a year.  We know that stents can usually last a year if patients take their medication (clopidogrel, statins, aspirin, etc.) and we also know that surgery is proven to last twenty years or more.. But, invariably, the researchers stop the trials, and stop looking so we don’t see how all those patients with left main stents, or five stents fared even five years later.  Did they need more stents?  Did they have a heart attack?  Did they die? 

This image from the Texas Heart Institute to illustrate our discussion:

Coronary anatomy

I’ve added my own comments in [brackets and italics].

PCI for left main CAD and ACS linked to more adverse events

By Megan Brooks

NEW YORK (Reuters Health) May 16 – In patients with left main coronary artery disease (CAD) and acute coronary syndrome (ACS), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) carry similar risks of death and re-infarction, new research from Italy shows.

However, PCI carries a significantly higher risk of major adverse cardiac events, driven by more frequent repeat revascularizations, the researchers found. [this means the patient had to come back and get another stent – or ended up having surgery later].

“Similarly to non-ACS presentations, PCI patients experience a higher risk of re-intervention, perhaps inflated by a more liberal use of follow-up angiography compared to CABG,” said co-author Dr. Davide Capodanno from Ferrarotto Hospital in Catania, in e-mail to Reuters Health.

The best way to manage patients with left main CAD and ACS remains uncertain, he and his colleagues said in a May 5 online paper in the American Journal of Cardiology.

Using registry data, the researchers analyzed one-year outcomes of patients with left main CAD and ACS who were treated with PCI and drug-eluting stents (n = 222) or CABG (n = 361), since 2002.  [another one year study].

They found that the rate of major adverse cardiac events was significantly higher in the PCI group than the CABG group (14.4% vs 5.3%; P < 0.001).  [Note that this is almost three times higher – or 1 in 6].

The difference was driven by a higher rate of target lesion revascularization with PCI (8.1% vs 1.7%; P = 0.001). This difference persisted after statistical adjustment for major adverse cardiac events (adjusted hazard ratio 2.7) and target lesion revascularization (adjusted hazard ratio 8.0).

Follow-up angiography was significantly associated with higher odds of major adverse cardiac events and target lesion revascularization at one year (P < 0.001 for both). There were no statistically significant differences in rates of death (6.3% for PCI vs 3.6% for CABG) or myocardial infarction (1.8% vs 0.6%). [not statistically significant but  PCI carries double the rate of CABG patients].

The diagnosis – either ST-segment elevation myocardial infarction (STEMI), or unstable angina/non-STEMI – was not correlated with treatment, a finding the authors say is noteworthy.

It seems from our data that the clinical scenario in which a left main stenosis is detected does not significantly interact with the type of revascularization offered to the patient,” Dr. Capodanno told Reuters Health.

“Decision making might not necessarily rely on whether the patients present with an ACS or not,” he said. “This is consistent with the notion that score algorithms — such as the SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score – have been proven to work well in stable angina patients as well as in those with an ACS,” he noted. [actually multiple studies showed the ‘Syntax score’ was a poorly validated tool, and essentially useless, which is why it was revised multiple times.]

The findings could mean that guidelines for using scores to aid decision-making in left main disease “may also theoretically apply to ACS patients,” he said. “However, the impact of other clinical variables could be not negligible. Therefore, careful patient selection on a case-by-case basis is necessary.”

The observational nature of a registry study is the most important limitation of the current analysis, he and his colleagues note in their report, adding that “only randomization can provide an unbiased estimation of effects of a treatment.”

In addition, because the “presumptive benefit of CABG is likely to increase over time, longer follow-up would add meaningfully to the present report.”

Additional references:

In an unrelated report – on the use of NSAIDS following myocardial infarction. : NSAIDs (acetaminophen, ibuprofen, as well as COX-2 inhibitors) unsafe after heart attack. I don’t usually write posts on pharmacology (with the exception of clopidogrel) because I usually leave that to my co-writer, Dr. Albert Klein (PharmD), a clinical pharmacist.  But in this instance, I think it is an important reminder to readers – that even over-the-counter medications can prove harmful.

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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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Another re-post of a widely published article from the Wall Street Journal.. (featured at WSJ and several other news sites..)

This article questions the validity of some of the cardiology guidelines that have been published (stenting of the unprotected left main, anyone?) due to financial ties many of these cardiologists have with device manufacturers..

Conflicts of Interest Cloud Heart Treatment Guidelines: Study
More than half of guideline authors report ties with drug makers, related companies

MONDAY, March 28 (HealthDay News) — More than half of the nearly 500 writers and reviewers of recent cardiology clinical practice guidelines reported a conflict of interest due to ties with drug makers and other companies, a new study finds.

The findings are troubling because clinical practice guidelines (CPGS) are often adopted as the standard of care and taught in medical training programs, according to background information in the study.

Researchers examined the 17 most recent American College of Cardiology/American Heart Association clinical practice guidelines issued through 2008. Of the 498 people involved in creating those guidelines, 277 (56 percent) reported a conflict of interest (COI).

The most common types of conflict of interest were: being a consultant or member of an advisory board, receiving a research grant, being on a speaker’s bureau and/or receiving honoraria, and owning stock.

Through these types of links, there were 510 commercial companies involved in the 17 guidelines, compared with only 18 noncommerical organizations.

“Our finding that most episodes of guidelines participation involve COIs, and that most individuals involved in producing guidelines report COIs, is a cause for concern. These findings are a particular cause for concern given the fact that many of the newest ACC/AHA guideline recommendations are based more on expert opinion than on clinical trial data,” wrote Dr. Todd B. Mendelson, of the University of Pennsylvania, in Philadelphia, and colleagues.

“However, our findings of the average number of companies [38] and the range of numbers of companies [2(two to 242) reported per guideline are perhaps less salient than the finding that a few companies were most reported in multiple different guidelines, and that one company was most reported in seven of 17 guidelines,” they added.

The study appears in the March 28 issue of the Archives of Internal Medicine.

The findings “raise disturbing questions about the independence and reliability of CPGs in cardiovascular medicine,” Dr. Steven E. Nissen, of the Cleveland Clinic Foundation, wrote in an accompanying commentary.

— Robert Preidt

SOURCE: Archives of Internal Medicine, news release, March 28, 2011

Now, folks – you tell me..

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