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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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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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The newest study (meta-analysis) on the use of clopidogrel for ACS (acute coronary syndrome) gives dramatically different results that previously published studies, and years of clinical experience.  This study, (abstract lifted from cardiosource and re-posted below) attributes adverse events and increased mortality in the patients receiving clopidogrel to underlying cardiac status.  In this patient population – that could certainly be true.

However, when a meta-analysis comes up with results that our dramatically different from the previous studies it’s using for its composite – then it’s time to take a closer look at the data they used to compile their conclusions..

Without further access to the rest of the study (abstract published ahead of article publication), we will just have to wait..

But in the meantime, I’d still recommend judicious/ cautious clopidogrel use prior to the operating room.  Ten years of clinical reports and multiple studies showing increased bleeding/ bleeding complications/ MACE can’t be undone by one statistical analysis.. (At least until methodology is examined.)

Also the phrasing of the study is pretty precarious – I’ve italicized some of the results – where the authors skirt around the results to try and prove the hypothesis that they want.. Re-operation is increased in patients receiving clopidogrel BUT.. it’s increased in all patients receiving clopidogrel, not just ACS patients..  [That’s kind of a thready conclusion, in my humble opinion..]

Readers, what do you think?

Abstract:  Safety of Clopidogrel Being Continued Until the Time of Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome: A Meta-Analysis of 34 Studies

        Authors:   Nijjer SS, Watson G, Athanasiou T, Malik IS

        Citation:

        Safety of Clopidogrel Being Continued Until the Time of Coronary Artery Bypass Grafting in Patients With Acute Coronary Syndrome: A Meta-Analysis of 34 Studies
        June 2, 2011
        Nijjer SS, Watson G, Athanasiou T, Malik IS.
Eur Heart J 2011;May 24:[Epub ahead of print].
 
Study Question:
      What is the risk of mortality, reoperation, perioperative myocardial infarction (MI), and stroke in the acute coronary syndrome (ACS) population undergoing coronary artery bypass grafting (CABG) while on clopidogrel?

        Methods:

Thirty-four studies with 22,584 patients undergoing CABG were assessed. Patients with recent clopidogrel exposure (CL) were compared with those without recent clopidogrel (NC). Uni- and multivariate meta-regression was performed for the main outcomes of mortality, reoperation, postoperative MI, and stroke using the logarithm of the odds ratio (OR) as the dependent variable. Interaction analysis was performed creating interaction terms between the variable ACS status and the following variables: year of study, the use of on-pump surgery, patient urgency status, and use of concomitant antiplatelet agents, including aspirin and glycoprotein IIb/IIIa antagonists.

        Results:

Although mortality is increased in CL versus NC (OR, 1.6; 95% confidence interval [CI], 1.30-1.96; p < 0.00001), it is influenced by the ACS status and case urgency in these mainly nonrandomized studies. In ACS patients, there is no significant difference in mortality (OR, 1.44; 95% CI, 0.97-2.1; p = 0.07) or in postoperative MI (OR, 0.57; 95% CI, 0.31-1.07; p = 0.08) and stroke rates (OR, 1.23; 95% CI, 0.66-2.29; p = 0.52). Combined major adverse cardiovascular events (MACE) (stroke, MI, and death) were not different in the two groups (OR, 1.10; 95% CI, 0.87-1.41; p = 0.43). Reoperation rates are elevated on clopidogrelbut have reduced over time, and were specifically not different in ACS patients (OR, 1.5; 95% CI, 0.88-2.54; p = 0.13).

        Conclusions:

The authors concluded that ACS patients requiring urgent CABG proceed with surgery without delay for a clopidogrel-free period.

        Perspective:

This meta-analysis suggests that continuing dual antiplatelet therapy until the day of CABG reduces the risk of recurrent ischemic events in ACS patients and reduces MI postoperatively. While mortality and reoperation rates are increased after recent clopidogrel exposure, event rates were still low and overall MACE rates did not appear to be significantly increased in the clopidogrel group. These data demonstrate the need for a randomized clinical trial assessing different discontinuation times prior to CABG to definitively answer the question. Meanwhile, the evidence appears to suggest that many ACS patients can undergo CABG safely with recent clopidogrel exposure in expert hands.

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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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Intra – Operative Myocardial Infarction 

One of the most feared, yet preventable complications is intra-operative / post operative myocardial infarction (heart attack).  Alarmingly, a new paper published on Medscape by Reed Miller suggests that too often we aren’t doing enough to prevent this devastating complication and miss the diagnosis of this condition when it does occur*.

In many cases, patients are asymptomatic, which is no cause for relief – since the thirty day mortality after post-operative infarction is frightening high.  Part of my job in my practice as an acute care nurse practitioner in cardiovascular and thoracic surgery is to perform pre-operative risk stratification and risk reduction for this, and other potentially preventable complications.

There are several important, but easy things we can do to reduce the risk of our patients having a heart attack during or immediately after surgery:

Pre-operative Evaluation:

1. First, screen your patient for the presence of anginal symptoms and associated risk factors – before scheduling an operation.  Surprisingly, many patients are experiencing atypical angina, dyspnea on exertion and other symptoms in their daily lives, yet ascribe these symptoms to “being out-of-shape” or “getting old”.

If there is one thing, I’ve learned after greeting people in the cardiac cath lab to tell them they need heart surgery – it’s that the majority of people tend to ignore or overlook subtle signs until acute chest pain, or an infarction brings them to the hospital.  So, ask you patients about these symptoms, so you aren’t surprised in the operating room.

Ask yourself, What other risk factors do they have?

–     Diabetes, (of any duration) should prompt consideration for pre-operative cardiology workup and a possible exercise stress test.

–     Claudication (peripheral vascular disease), carotid stenosis (or hx of TIAs) or any other history suggestive of arterial disease

–     Elevated cholesterol or unknown cholesterol status, history of cholescystetomy or gallbladder disease or visible xanthomas (particularly on the face)

–    Advanced age – anyone over the age of 65

–    Hypertension, particularly if poorly controlled

–    Anemia, of any origin

–    Poor overall health, poor exercise tolerance (again this may be related to undiagnosed angina)

2. Secondly, Pre-operative Maximization!! This is important for  all major surgeries, but often isn’t implemented for orthopedic, general surgery and other large surgeries.  The other thing to realize is, this isn’t the anesthesia team’s job; it’s the attending surgeon and the primary care physician (jointly).  This means controlled, or correcting all of the items listed  in the previous section (as much as possible):

– cardiac evaluation for patients at medium / high risk for cardiac disease – and having an index of suspicion for people with vague  symptoms.

– treating underlying disease conditions – for example, if your patient has a hemoglobin A1c of 9.0 – delay elective cases until glucose is better managed.  Remember to monitor and manage glucose in the operating room too – unfortunately, this is often only done in cardiac surgery, but it’s important during all surgeries.  Intraoperative Hyperglycemia is an independent risk factor for myocardial infarction/ and is considered a ‘marker’ for infarction.

And check everyone, not just diagnosed diabetics – since hyperglycemia occurs in some normal individuals under physiological stress, and diabetes is grossly underdiagnosed.

Don’t discontinue statins pre-operatively – not only does evidence suggest that statins are protective against intraoperative strokes and sepsis, but the evidence to support discontinuing these medications preoperatively is slim.  Too often, we
discontinue patients needed medications as part of a routine, not an individualized treatment plan.  (Now clopidogrel (Plavix) and warfarin are a little different, but sometimes we continue these medications too – in very
select cases..)

Pre-operative beta blockade – the evidence is overwhelming
in favor of pre-operative beta blockade, yet some people are still neglecting
this (or even stopping these medications in people already on them.)  Continue metoprolol, carvedilol, propanolol, and make sure to ask why patients are taking them in the first place.  “Heart medicine” is an answer that should prompt further investigation.

– Consider and re-consider before discontinuing Aspirin.  In our thoracic (and cardiac ) surgery patients – we always continue aspirin, safely, and have had no increase in bleeding complications.  Often, surgeons can very safely operate on patients taking aspirin – but discontinuing it in these patients may contribute to the risk of intraoperative/ postoperative infarction.

Intraoperatively:

–  Control that heart rate!  We KNOW through decades of research that
slower is better.  Keep the heart rate at sixty or below to reduce cardiac demand.

–   Prevent hypotension – keep the MAP at 70 or above (and be particularly intolerant of hypotension in anyone with a cardiac history –you don’t want to collapse those grafts.
Remember that patients with vasculopathic disease don’t tolerate low
blood pressure as well as you or I – and don’t allow it (low blood pressure) to happen.

–    Monitor for changes in telemetry during the case.

–    Monitor and control hyperglycemia (as mentioned above.)

Article Re-Post from Medscape (Reed Miller):

MIs After Noncardiac Surgery are Often Overlooked

April 20, 2011 (Hamilton, Ontario) — A new study from the Perioperative Ischemic Evaluation (POISE) trial suggests that monitoring non–cardiac-surgery patients for asymptomatic MIs in the first few days after surgery could dramatically reduce their short-term mortality risk [1].

The study shows that “consistently, all over the world, people are at substantial risk of suffering a heart attack after surgery, and if they do, they’re at substantial risk to die or suffer a major event in the coming days, and we need to do a better job to detect them and manage them,” primary author Dr PJ Devereaux (McMaster University, Hamilton, ON) told heartwire. “We want to make the broader cardiology world aware that this is a huge emerging epidemic that’s going to confront cardiology, because there are 200 million adults having surgery every year in the world. . . . We need to get a lot more aggressive about monitoring for these events and recognizing that the majority of people won’t have symptoms when they have these events.”

Devereaux and colleagues followed 8351 patients at 190 centers in 23 countries with four cardiac biomarker assays for three days postsurgery. All of the patients were part of the original POISE trial, reported by heartwire, which showed that beta blockers reduce the risk of MI but increase the risk of severe stroke and overall death in patients undergoing non–cardiac surgery (including orthopedic, cancer, and noncardiac vascular surgeries). Results of the new study by Devereaux et al are published in the April 19, 2011 issue of the Annals of Internal Medicine.

“Surgery is sort of the ultimate stress test. It does everything that is relevant to causing acute coronary syndrome. It’s very proinflammatory, and it activates the sympathetic system, coagulation, and platelets. That’s why we have this problem of people having myocardial infarction after surgery, [and yet until now] there’s not that much research on the outcomes of heart attacks after surgery,” Devereaux told heartwire. Patients and physicians are often unaware of an MI during this early postoperative period because most of the patients are on high doses of narcotics that “blunt the discomfort of the surgery but may mask ischemic symptoms,” Devereaux said.

Within 30 days of randomization, 415 patients in the study (5.0%) showed evidence of a perioperative MI, defined as either autopsy findings of acute MI or an elevated level of a cardiac biomarker or enzyme assay plus ischemic symptoms, development of pathologic Q waves, ischemic changes on electrocardiography, coronary artery intervention, or cardiac imaging evidence of MI. Nearly three-quarters of the MIs happened within 48 hours of the surgery, but almost two-thirds of the MI patients did not did not experience ischemic symptoms. In fact, patients with a periprocedural MI without ischemic symptoms had a higher mortality rate (12.5%) than those who had symptoms (9.7%).

The short-term prognosis for patients who suffer periprocedural MIs is very poor, with 11.6% mortality at 30 days postprocedure compared with 2.2% for patients who did not suffer a periprocedural MI (p<0.001). Furthermore, Devereaux noted that a recent meta-analysis by his group found that people who suffer a periprocedural MI continue to be at higher risk for death than those who do not for at least a year after the surgery.

Nobody thinks twice about being incredibly assertive about managing an MI in the emergency room . . . [and yet] those MIs have a much better prognosis than these MIs, and we’re ignoring these MIs for the most part.

Regression analysis of the data showed that relatively simple therapies could have prevented many of these deaths. In the study, patients on aspirin had about half the 30-day mortality risk as those not on aspirin, while statins reduced the 30-day mortality rate by about three-quarters. Only 64.8% of patients who suffered an MI in the trial were on aspirin, only 17.8% were receiving clopidogrel or ticlopidine, 52.0% were receiving a statin, and 55.4% were receiving an ACE inhibitor or angiotensin-receptor blocker.

“Patients expect us to look for things that are modifiable and change their risks of very serious events quickly, and perioperative MI is definitely in that category,” Devereaux said. “Nobody thinks twice about being incredibly assertive about managing an MI in the emergency room, which is completely appropriate, but those MIs have a much better prognosis than these MIs, and we’re ignoring these MIs for the most part.”

Commenting on the study by Devereaux et al, Dr Adrian Banning (John Radcliffe Hospital, Oxford, UK) told heartwire, “We are not optimizing medical therapy before surgery. There are existing guidelines and risk scores that are probably underused. Preoperative testing for ischemia and revascularization is probably overused in a minority of patients, leaving an occult majority without simple medical measures that are likely to be beneficial–including aspirin, statins, and good perioperative blood-pressure control.”

More Research Needed to Clarify Who Is at Risk and How to Treat Them

Devereux’s group is currently enrolling patients into the 40 000-patient prospective cohort VISION study, which is intended to define the optimal approach for predicting major perioperative vascular events, the extent to which troponin measurement after surgery can identify asymptomatic MIs, and these patients’ risk of vascular-related death within one year.

The first 20 000 patients in the study have been monitored with “fourth-generation” troponin assays, and the next 20 000 will be monitored with higher-sensitivity troponin assays. Commenting on the research, Dr Stephen Ellis (Cleveland Clinic, OH) pointed out that with the advent of highly sensitive troponin tests, more research will be needed to define what degree of troponin change is clinically important. “I’m sure there’s some level of troponin where you see a bump that doesn’t mean anything.” For example, Banning and colleagues recently completed a study that suggests the current standard troponin cutoff used to detect an MI has been arbitrarily set too low and leads to an overestimate of the number of MIs.

Dr John French (University of New South Wales, Australia) added that future research should also try to risk-stratify these patients by collecting both pre- and postprocedural troponin levels. Elevated preprocedural troponin may also be a risk marker, he told heartwire.

Devereaux hopes there will also soon be a large national trial to evaluate the best way to manage non–cardiac-surgery patients in the vulnerable perioperative period. Ellis agreed that “we don’t really understand the benefits of some of the medical treatments that we have in our armamentarium in this patient population. . . . There may be some other treatments that are less utilized at present that could cut down on the incidence of perioperative infarction.”

Banning agreed that further research is needed to understand how to prevent these perioperative MIs, not merely detect them. “Troponin measurement postoperatively can help define a risk group with adverse outcome, [but] it is uncertain that we can influence that adverse outcome once the event has happened in those patients already on optimal medical therapy,” he said. “There will be a group identified by routine troponin testing where this event is the first declaration of occult coronary disease, and perhaps this group potentially has the most to gain.”

Although the best approach to managing these patients has yet to be clearly defined, Devereaux emphasized that “in the short term, there’s a lot of intuitive things that we can do better that will likely improve the outcomes, and there’s lots of reasons to be optimistic that, even if we just start monitoring them, we can improve the outcomes.” Devereaux recommends that physicians caring for a surgery patient order a troponin test sometime between six and 12 hours after the surgery and then repeat tests for the first three days after surgery.

His institution has made perioperative MI prevention a priority for its cardiologists. “We’ve changed cardiology from regular cardiology to cardiology and perioperative vascular medicine,” he said. All surgery patients’ cardiac biomarkers are monitored, and the patients are triaged to the coronary care unit or less-intensive care based on their MI risk. He expects his group will be able to present data on the impact of this approach within the next year.

This study was supported by the Canadian Institutes of Health Research, the Commonwealth Government of Australia’s National Health and Medical Research Council, the Instituto de Salud Carlos III in Spain, the British Heart Foundation, and AstraZeneca.

part of patient education series – Ask your doctor about your risk for peri-operative MI, and what he’s doing to reduce your risk.

* Diagnosing MI after surgery is another article.

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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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In honor of the Latin-American Bariatric Surgery Congress, currently in progress in Cartagena – (since I couldn’t make time in my research to go) I am posting a brand new article about bariatric surgery and the severely obese. It seems American medicine is finally starting to catch up, and take notice..

It’s hard concept out there – and I still have trouble with it myself, sometimes.. In our society, it seems we are too busy blaming ourselves, and others for being overweight and attaching labels; ‘lazy’, to really see how fundamentally things need to change to improve our health as a nation.

From my perspective, down here in Bogota – it’s interesting, because I am seeing Colombians just beginning to start to struggle with obesity – as more and more imported snack foods, and fast foods replace traditional diets. Obese people are still very rare here – and after several months, I can still say I’ve not seen a single super-obese person here, but the ‘chubbies’ are starting to grow in number..

At the same time, by being in such a walkable city, and having access to (cheap!), delicious, ripe fruit every day, I’ve managed to lose over ten pounds with almost no effort.. I’ve been tracking my walking, and I walk about 6 to 10 miles a day with my various errands. But these are things that aren’t readily available – in the urban sprawl of American life.. A week’s worth of fruit for several meals for ten dollars? Not hardly, unless you gorged yourself on bananas every single day..

Surgery as a solution seems drastic to American healthcare providers, myself including.. Removing/ destroying a perfectly functioning organ.. But then – when you look at the drastic effects, and the desperate states our patients are in – Bariatric surgery really is as lifesaving as cardiac surgery for many people.. Until we change society as a whole (which may never happen), we need to help these individuals regain their health,and their lives..

Bariatric Surgery for the Severely Obese

In the meantime, everyone, stay away from soft drinks (all soft drinks, including ‘diet drinks’, juices and fruit drinks, sweet tea) and stick to water, plain tea. Coffee too – if you remember not to load it up with too many calories.. Try it for a month, and I wager you will be unable to go back to the supersurgery drinks you formerly enjoyed out cringing..

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