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Archive for the ‘Overstenting Scandal’ Category

By popular request from several readers – I have re-posted an article summarizing the 2010 Syntax trial results (3 year data in this on-going trial).  This article was originally published at www.theheart.com.  I have also posted the link to a blog discussing these results in context.. Please note the heavily biased language (in favor of stenting) in both of these re-posts. Hard to dismiss the results showing CAGB to be SO much better for patients and longevity, but it seems like several of the cardiologists quoted attempt to do exactly that.

Three-year SYNTAX results extend CABG advantage to intermediate-risk patients

Sep 13, 2010     Shelley Wood

Geneva, Switzerland – Three-year results for the landmark SYNTAX trial are bringing some clarity to a finding just hinted at—then strenuously debated—at the two-year mark: “intermediate-risk” patients with complex coronary disease by SYNTAX score are probably better off getting open-heart surgery than PCI with a Taxus paclitaxel-eluting stent, investigators say. Cumulative event rates also point to ongoing separation of event curves for both MI and even all-cause death, although the latter by no means was statistically significant at three years.

Dr A Pieter Kappetein (Erasmus Medical Center, Rotterdam, the Netherlands), who presented the three-year results at the European Association of Cardiothoracic Surgery 2010 Annual Meeting, called the findings in the intermediate-risk subgroup the “most remarkable” difference to emerge between the two- and three-year mark, although not necessarily surprising. Indeed, Dr Manuel J Antunes (University Hospital, Coimbra, Portugal), who discussed the two-year results after their presentation last year, predicted that between-group differences that were statistically different at year one would remain so and that differences that trended in favor of one group would reach statistical significance in due time.

Dr David Cohen (Saint Luke’s Mid America Heart Institute, Kansas City, MO), commenting on the results for heartwire, said he was not “particularly concerned” by the three-year results, which, he noted, were only marginally different from the two-year results and continue to be driven by a higher revascularization rate in the Taxus/PCI-treated patients. He did single out as “interesting” the “continued gradual separation of the curves for both MI and all-cause mortality” to year three.

“These findings may relate to a variety of factors, including very late stent thrombosis, progression of disease at unstented segments, or the more complete revascularization afforded by initial CABG in these highly complex patients.  Although I suspect that some of these late events might have been avoided with the current generation of drug-eluting stents [DES], which are safer than the paclitaxel-eluting stents used in SYNTAX, bypass surgery continues to set a very high standard for our patients.”

The SYNTAX trial
As previously reported by heartwire, SYNTAX was an 1800-patient trial randomizing patients with left main coronary disease and/or three-vessel disease to either CABG or PCI using the Taxus DES. At one year, PCI failed to meet the prespecified margin of noninferiority against CABG, after the primary end point (major adverse cardiac and cerebral events [MACCE]) occurred significantly more often among PCI-treated patients than among CABG-treated patients, driven by repeat procedures in the PCI group. For the “harder” end point of death/stroke/MI, rates were almost identical between the two groups; the stroke rate was higher in the CABG-treated patients. Two-year results, presented at last year’s European Society of Cardiologymeeting, showed MACCE rates continuing to diverge, still driven by higher repeat-revascularization rates and a signal of increased MI among PCI-treated patients.-SW

At three years, 95% of the original cohort of 1800 patients was available for follow-up. Rates of the primary end point, MACCE, remained statistically lower in the CABG-treated patients, driven by the lower rates of repeat-revascularization procedures—just under 11% in the CABG-treated patients vs nearly 20% in the PCI/DES group. For the hard composite end point of all-cause death, stroke, and MI out to three years, there were no differences between groups.

Stroke, which at one year had significantly favored the DES-treated patients, was no different between the two groups by three years and nearly identical between years one and two and between two and three. MI rates, which had numerically favored the CABG-treated patients at one year and had reached statistical significance by the two-year mark, continued to be significantly lower in CABG group from year two to three and cumulatively were significantly lower in the CABG-treated patients over three years, with an absolute difference of 3.5%.

Cumulative event rates to three years

Cumulative event rate CABG (%) Taxus (%) p
MACCE 20.2 28.0 < 0.001
Death, stroke, MI 12.0 14.1 0.21
All-cause death 6.7 8.6 0.13
Stroke 3.4 2.0 0.07*
MI 3.6 7.1 0.002
Repeat revascularization 10.7 19.7 < 0.001
*Stroke rate between one and two years 0.6% vs 0.7% and between two and three years 0.5% vs 0.6%

For the analysis of outcomes according to baseline SYNTAX score—developed to characterize complex coronary vasculature in patients with high-risk left main and/or three-vessel disease—Kappetein reminded heartwire that at both one and two years, the lowest-risk patients by SYNTAX score (score of 0-22) had MACCE rates that were very similar for both CABG- and DES-treated patients. By contrast, in patients with the highest SYNTAX scores (>33), reflecting the most complex disease, the SYNTAX trial clearly showed that CABG was the best option. As such, surgeons and interventionalists have largely been in agreement that PCI is a reasonable option for the lowest-risk group, while surgery is the clear winner for the highest-risk patients.

In intermediate-risk patients (23-32), the two-year results showed a trend toward improved outcomes with CABG, but no statistically significant differences, leading some to argue that PCI could still be considered for patients with an intermediate SYNTAX score—particularly if they had left main disease, but not triple-vessel disease. The three-year MACCE results in these intermediate-risk patients, however, show that the event curves have continued to separate, reaching 27.4% for DES-treated patients and 18.9% for the CABG-treated patients, a difference that now reaches statistical significance (p=0.02).

What’s clear from these three-year results, Kappetein told heartwire, is that it is only the lowest-risk patients by SYNTAX score in whom both PCI and CABG can be considered to be reasonable options.

What MI type?

According to Kappetein, the increased MACCE rate in the intermediate-risk group was driven by repeat-revascularization procedures, but also by the uptick in MIs among PCI-treated patients. But he acknowledged that it is not yet clear what kinds of MIs are driving this difference. Of note, rates of stent thrombosis (4.5%) among PCI-treated patients at three years were not statistically different from the rates of symptomatic graft occlusion (3.5%), hinting that the MIs being counted were not being caused solely by late stent thrombosis.

Asked if the bulk of these MIs were periprocedural “enzyme leaks,” Kappetein said: “We don’t know that yet, but we need to look deeper into that.”

Cohen, for his part, stressed that the “enduring lesson” from SYNTAX is that revascularization for chronic, complex coronary disease needs to be individualized to coronary anatomy, comorbidities, and patient preferences.

“The real value of SYNTAX continues to be in helping to provide high-quality, objective information to inform these complex decisions,” he commented. “I do think that is an important yet often-unappreciated aspect of SYNTAX. We often focus too much on ‘winners’ and ‘losers.’ The real winner here is the patient.”

Cohen has received grants for clinical research from Abbott Vascular, Boston Scientific, Edwards Lifesciences, Eli Lilly, Daiichi Sankyo, and Medtronic; has served as an advisor or consultant for Eli Lilly, Medtronic, Cordis, Schering-Plough, and Merck; and served as a speaker or a member of a speakers’ bureau for Eli Lilly and the Medicines Company. Kappetein disclosed having no conflicts of interest.

 

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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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A federal jury found Dr. John McLean, the cardiology interventionalist in the center of the latest unnecessary stent scandal guilty.  This comes just weeks after Dr, Midei – (as previously discussed here at Cartagena Surgery), lost his medical license for after placing unnecessary stents in multiple patients.   This  verdict comes in the wake of multiple scandals involving multiple physicians, which has shocked and horrified both medical community and the general public.

As a healthcare provider, the actions of these physicians disgusts and sickens me.  In addition to the unnecessary risks and possible harm done to the patients, it is the betrayal of the patient’s trust, and the erosion of the public’s confidence in their care which is equally  inexcusable.  I, for one, hope that these verdicts serve to show the public that we will not stand for such abuses.  We will not turn a blind eye to the wrong doings of others, simply because we are in health care – and we will not tolerate such practices.

Fraud conviction for McLean in latest unnecessary-stenting case

July 27, 2011            |            Shelley Wood

Baltimore, MD – Maryland, the epicenter du jour for high-profile “unnecessary-stenting” cases in the US, is in the spotlight again this week following a guilty verdict in the case of retired interventional cardiologist Dr John R Mclean.

A federal jury convicted McLean, 59, on six charges of healthcare fraud relating to insurance claims he’d filed for stents deemed to have been placed unnecessarily, as well as for ordering unnecessary tests and making false entries in patient medical records.

“The evidence shows that Dr McLean egregiously violated the trust of his patients and made false entries in their medical records to justify implanting unneeded cardiac stents and billing for the surgery and follow-up care,” US Attorney Rod J Rosenstein said in a statement released by the Office of the Inspector General (OIG) Tuesday [1].

McLean faces a maximum sentence of 10 years in prison for healthcare fraud and five years in prison on each of five counts of making false statements, the OIG statement notes. McLean’s sentencing is scheduled for November 10, 2011.

The jury conviction of McLean comes within weeks of the Maryland Medical Board’s decision to revoke the medical license of Dr Mark Midei, citing “repeated and serious” violations of the Medical Practice Act surrounding the implantation of unnecessary stents.

As previously reported by heartwire, McLean resigned his hospital privileges at Peninsula Regional Medical Center in Salisbury, MD in 2007, citing visual impairment as the reason for his resignation. Hospital administrators, however, acting on an anonymous tip, had conducted internal and external reviews leading them to conclude that McLean had implanted as many as 25 stents in patients who did not meet the clinical criteria for PCI.

During the two-week trial that ended in yesterday’s conviction, evidence brought forward suggested that McLean had performed cardiac catheterizations and implanted unnecessary cardiac stents in more than 100 patients. “He then falsely recorded in the patients’ medical records the existence or extent of coronary artery blockage, known as lesions, observed during the procedures in order to justify the stent and the submission of claims to healthcare benefit programs, including Medicare and Medicaid,” the OIG statement reads.

The US government is also seeking to recoup what it estimates to have been the proceeds of McLean’s scheme—a forfeiture of $711 583. The precise amount will be determined at the time of sentencing.

At least one other cardiologist has been sentenced in criminal charges for unnecessary stenting. As previously reported by heartwire, Dr Mehmood Patel, formerly of Our Lady of Lourdes Hospital and Lafayette General Hospital in Louisiana, was convicted on 51 counts of billing private and government health insurers for unnecessary medical procedures and received a 10-year sentence.

Article re-post from Heartwire.com

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Update: 12 July 2011 :  Another kind of inappropriate stenting makes this news.  In the stories below, interventionalists are placing stents in patients after a heart attack (but days to weeks after – when the artery has already closed – tissue has died).  In these cases, stents are not advised because it’s too late to salvage any heart muscle, making stents in the culprit artery useless.  (However, some interventionalists may still be placing stents inappropriately in these cases not due to fraud but because they have failed to keep up with the most recent guidelines and recommendations for treatment, which is only mildly comforting.)

Guidelines don’t curb unnecessary treatment

Doctors overusing stents  – article quote

“Hochman’s findings apply to about 100,000 Americans a year, suggesting that
about 50,000 people are having the $20,000 procedure done unnecessarily every
year.”  [if you remember from a previous post – a prominent interventional cardiologist considered 50,000 “a rare event”.]  It’s also a billion dollars worth of unnecessary procedures..

From 13 June 2011

More cases of overstenting make the news – again.. This time it’s a cardiologist and a radiologist in Tennessee.  Both are accused of ordering unnecessary tests, including angiography (cardiac caths) and performing unnecessary stenting in a scheme to defraud insurance.. The radiologist received kick backs for his patient referrals..

Article by Reed Miller  (June 10, 2011) over at Heartwire.com re-posted here.

Unnecessary stenting cases grabs government attention in Tennessee

Jackson, TN – The US Department of Justice is looking into charges of fraudulent billing leveled by a Tennessee cardiologist against another cardiologist and two hospitals.

Dr Wood Deming (Regional Cardiology Consultants, Jackson, TN) is accusing Dr Elie Hage Korban (Heart and Vascular Center of West Tennessee, Jackson) of “blatant overutilization of cardiac medical services, including, but not limited to, cardiac sonography, scintigraphic stress imaging, angiography, angioplasty, and stenting” in order to defraud government insurance programs, according to documents filed with the US District Court for Western Tennessee. Deming also alleges that the executives of Jackson-Madison County General Hospital and the Regional Hospital of Jackson and radiologist Dr Joel Perchik (Advanced Radiology, Jackson, TN) condoned or assisted in Korban’s fraud in addition to engaging in a bilateral kickback and self-referral scheme [1].

Deming is seeking to collect a portion of whatever fines the government collects from the defendants in this case, as provided for by the “whistleblower” provisions in federal antikickback and false-claims laws.

According to Deming’s complaint, from 2003 onward the hospitals’ executives allowed Korban to routinely order numerous unnecessary diagnostic studies at the hospitals, including transthoracic echocardiography, scintigraphic stress imaging, and transesophageal echocardiography, and then ordering that the patients be transported by ambulance to one of the hospitals for unnecessary catheterization, coronary angiography, and other coronary and peripheral intervention procedures. The complaint alleges that many of these patients underwent coronary angiography after a negative stress test on the premise that they were still having chest pain, but the records were fraudulently dictated to reflect symptoms that were not present. In many cases, Korban subsequently performed unnecessary interventional procedures including stenting, and patients were then admitted to one of the hospitals for recuperation, Deming alleges.

Deming also alleges that Perchik and the hospitals’ leadership “engaged in a pattern of bad-faith peer review of any physician who chose to oppose the hospitals’ drive for excess and inappropriately collected remuneration, such that such physicians were eliminated from the medical staff if they chose to speak out as whistleblowers concerning any aspect of the scheme,” according to the documents. He also accuses Jackson-Madison County General Hospital of paying for referrals from Medical Specialty Clinic, a group practice led at the time by the hospital’s chief of the medical staff, Dr Charles Hertz. Deming alleges that these illegal payments for referrals were concealed in a series of real-estate transactions.

A statement issued to heartwire from Jackson-Madison County General said that the hospital “is fully cooperating with government investigators and because this is an ongoing investigation we have no further comment.” In a prepared statement, the Regional Hospital of Jackson said it is “pleased that the United States chose not to intervene in the portion of the relator’s lawsuit that named the hospital and a former administrator.”

Likewise, staff at Korban’s office responded saying, “At this time, we have no comment,” and the lawyer for Deming did not return calls.

Deming filed his complaint in 2007, but it remained under seal until Assistant US Attorney William Siler notified the court in May that his office intends to pursue a case against Korban [2]. The US attorneys have agreed to investigate only Deming’s allegations against Korban for false and fraudulent billing for unnecessary cardiac stent procedures that caused the submission of false claims by the hospital. The US attorney’s office in Memphis will file its own complaint against Korban within the next two months.

However, the Department of Justice will not intervene on any of the other charges against any of the other defendants, including the hospitals, but charges against the other defendants cannot be dismissed without approval of the Department of Justice, which also reserves the right to intervene in those actions later.

As first reported in the Jackson Sun [3], last week, US District Judge Dernice Bouie Donald acknowledged the US Attorney’s plan to intervene and ordered that Deming’s complaint be unsealed and served on the defendants with 120 days [4].”

I still think this is only the tip of the iceberg.  If cardiology researchers themselves estimate that over 11% of stents were not ‘appropriate’ with another 38% being ‘undetermined’ (statistics from a previous post) – well, that’s a heck of a lot of folks that got stents that didn’t really need them.

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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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Over at theheart.org they’ve published a whole series of video lectures, articles, and discussions on the phenomena of overstenting and inappropriate PCI.. Of course, you have to be a member to read any of it – which leaves a lot of my readers out in the cold. As longtime blog readers know, we’ve discussed this topic at length in previous posts:

What is overstenting?

The problems with stenting (USAToday report)

I have another re-post from Reed Miller on the topic – which I’ve pasted below.. It’s quite wordy, but I want you to remember while you are reading this – that they are discussing the percentage of inappropriate procedures according to cardiology guidelines – now that’s a particularly important point, because, if you recall – about a month ago: there was an article calling into question the validity and appropriateness of these very guidelines, since the majority of cardiologists that helped draft them were paid large sums of money by stent manufacturers and drug companies.

Also I have placed certain areas in italics.. Areas where I feel the commentary in the article is questionable, or open to debate – such as stenting the left main or three vessel stenting – just because interventional cardiologists have decided that they should perform this procedure doesn’t mean that it benefits the patient – or that the procedure isn’t still somewhat controversal.
So what does this mean to you – it means that we need to continue to focus a critical eye on cardiology, and the current use and indications for stent placement.

So, what should you do if you find yourself in this situation? you or a loved one has just had a cardiac catheterization, and you find yourself wondering about the best/ most appropriate treatment.. Ask to have a cardiac surgeon review your history and films.. A lot of good facilites already do this – to get a second opinion.. A cardiac surgeon is going to be looking at your films with a different perspective – we only want to do surgery once – when it benefits the patient the most, since surgery is nothing to be taken lightly.

NCDR shows 11.6% of nonacute PCIs and 1.1% of acute PCIs are “inappropriate” based on AUC
April 5, 2011 | Reed Miller

“New Orleans – A review of over 500 000 cases presented at the American College of Cardiology (ACC) 2011 Scientific Sessions shows that overuse of PCI is uncommon but that there is still plenty of room for improvement in the number of inappropriate elective PCI procedures.” Really? More than 1 out of ten – and they say it’s uncommon? Pretty darn frequent, you ask me (cartagenasurgery).

This morning, Dr Paul Chan (St Luke’s Mid-America Heart Institute, Kansas City, MO) presented results of a study of over 500 000 cases in the National Cardiovascular Data Registry (NCDR) from July 2009 to June 2010 that categorized each PCI as appropriate, inappropriate, or of uncertain value based on the 2009 coronary revascularization appropriate use criteria (AUC). The AUC writing committee included representatives of the ACC, Society for Cardiovascular Angiography and Interventions (SCAI), and several other cardiology organizations, including two surgical specialty groups.

Chan reported that overall, 84.6% of the procedures in the study that could be categorized were appropriate based on the AUC, while 4.1% were inappropriate and 11.2% were in categories that the AUC deems uncertain.
Former SCAI president and member of the AUC writing committee, Dr Gregory J Dehmer (Texas A&M University College of Medicine, Temple), told heartwire that the study by Chan and colleagues “really gives us our first biopsy of what is the level of appropriateness of PCI care in all of these NCDR hospitals, which include over 900 facilities.”

Dehmer proclaimed that the results are “great news, especially in today’s environment,” referring to the recent cases of interventionalists charged with routinely performing inappropriate PCIs. “It’s very comforting news for both patients and regulators,” he said.

Most of the problems in nonacute procedures

Of the cases that could be categorized by the AUC, 71% were acute patients, and 98.6% of these were deemed appropriate procedures while only 1.1% were inappropriate. Chan also pointed out that there was very little variation among hospitals in their rates of appropriate and inappropriate procedures for acute patients. The acute cases included were ST-elevated MIs (21.3%), non-STEMIs with documented troponin rises (20.5%), and patients with high-risk unstable angina (29%).

However, among the 29% of the categorizable elective PCIs for nonacute patients in the study, 50.4% were categorized as appropriate, 38% were of uncertain value, and 11.6% were inappropriate based on the AUC. About 71% of the inappropriate nonacute patients were low-risk according to their ischemia study results, and two-thirds were asymptomatic to very mildly symptomatic. More detail on the study will be provided when the results are published in a peer-reviewed journal. The paper is currently under review, Chan said.

The study showed wide variation from center to center in the rate of inappropriate intervention in nonacute patients, ranging from below 10% to over 30%, and the median was 10.7%, with an interquartile range of 6% to 16.7%. Some of these cases were appropriate due to special circumstances, Chan said. “However, it is unlikely that exceptions would explain this marked variation across sites” in the rate of inappropriate procedures in nonacute patients.

Mostly good news, but plenty of room to do better

Chan agreed that the study results show that “on the whole, the US angioplasty community is doing a decent job in ensuring that most procedures are appropriate when you look at the acute and nonacute procedures all together, but we do have some work to do in the nonacute setting.” He added that “no other subspecialty has taken the lead on self-regulation and self-reflection like cardiology has, and it’s a tribute to organizations like the ACC that are moving this field.”

Really? Didn’t several cardiologists have to be charged with malpractice for ‘the subspecialty to take the lead’?? Didn’t state legislature (maryland) have to become involved for an investigation to take place?? (cartagenasurgery)

Chan and Dehmer both emphasized that while there is plenty of room for reduction of unnecessary procedures, no center should expect to have a rate of 0% inappropriate procedures. There will be cases where patient characteristics not considered in the AUC make an otherwise inappropriate procedure appropriate for a particular patient. The AUC categorizes 198 clinical scenarios based on acuity of presentation, extent of coronary disease, the extent and magnitude of ischemia, the intensity of medical therapy, and the severity of symptoms, but the AUC do not consider potentially critical factors such as age, Dehmer pointed out. “For example, what you’d do for a 45-year-old guy who can’t hold down a job because of his coronary disease might be different from what you do for an 85-year-old grandmother who just sits and knits all day.”

Sounds like the 45 year old might need CABG or TMR versus 27 stents that will close in a year or two. (cartagenasurgery)

“But when you have some hospitals exceeding 17%, in the upper quartile, and others at 6%, we need to learn what the hospitals with lower rates are doing differently,” Chan said.

Chan also pointed that about 19% of the PCI cases that the investigators originally looked at for inclusion in the study could not be categorized by the AUC because the case record is missing some relevant information. For example, the study had to exclude patients who had stress tests but whose ischemia risk was not recorded by the referring physician. “That’s something that we can improve” by emphasizing to the NCDR sites and referring physicians the importance of collecting all of the information needed to show that a procedure is appropriate.

He also noted that the AUC will soon be updated to reflect more recent clinical trials on left main and three-vessel disease, although most of those procedures are already categorized as appropriate.

this wisdom of doing PCI on the above mentioned patients is still hotly under debate, but as we’ve discussed before- long term data favors CABG (in these patients with SEVERE disease.) The studies they mention only look at six month outcomes. (cartagenasurgery)

Interventionalists must use the data wisely

In the future, centers participating in the NCDR will receive quarterly reports detailing the rates of appropriate, uncertain, and inappropriate PCI procedures performed at their facility, with benchmark data on how other centers are performing. The centers will also receive a line-item list of all the cases that were classified as inappropriate for that quarter so that they can subsequently develop internal quality improvements to better understand why those procedures were performed. “Maybe there are all sorts of reasons to explain it, but we need to find out why. It causes the questions to be asked and then, hopefully, if there is a reason, those reasons can be rectified,” Dehmer said.

Dehmer also pointed out that the continued collection of these data will identify “gaps in our knowledge” and which types of procedures need more study. It may also help to stimulate more discussion among interventionalists about appropriateness. A recent survey by Chan et al found widespread variability of opinion among cardiologists on the appropriateness of some PCI indications.

“Hospitals should look at their rates in relationship to other hospitals and how far above or below the median they are and then look at the list of the inappropriate cases and go back and better understand if there were extenuating circumstances that made them [actually appropriate],” Chan said. “But if there is a pattern such that the majority of those inappropriate cases didn’t have exceptions, then it provides a red flag, and the interventional cardiologists should discuss how this should inform their future practice. Even hospitals with low rates of inappropriate cases can use that information to see if there is further improvement they can make.

“It will be interesting to see how hospitals and physicians work together to develop the quality-improvement effort to look at these questions,” he said. “The use of the reports will dictate how useful the information we’re providing to physicians will be. If the reports are just put on a shelf, they won’t provide hospitals any benefit.”

Also, it appears if you document poorly, when the cardiologists review the data – they will note any discrepancies as ‘uncertain’ instead of ‘inappropriate’ which saves them from admitting what the real incidence of inappropriate PCI is. In 1 out of 5 cases, the cardiologist couldn’t bother to chart completely, but I bet they were more diligent in the billing department…

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