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On the heels of the SYNTAX study which evaluated the effectiveness of using stents to treat multiple blockages, a new journal article outlined the appropriateness of both PCI (stenting and angioplasty) and CABG (bypass surgery) has been published.

For the Full Guidelines – click here..

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

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

Article Re-post:

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

Posted:  January 30, 2012

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

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

Cardiosource Video News PCI AUC, Hydration and Afib Ablation

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

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

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

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

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

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

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

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

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

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

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

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

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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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It’s becoming a cardiologist’s worst nightmare: after years of minimal outside oversight, with multiple physicians operating on the fringes of medical legitimacy (stenting the left main, three vessel stenting, overstenting vulnerable populations like diabetics*) new legal and medical scrutiny is being placed on cardiologists and cath labs in the wake of widespread reports of overstenting. (Overstenting is the use of medical devices called stents when surgery, medications or other modalities are called for.)

Overstenting is a combination of two different problems:

1. the placing of a stent in an artery without a severe blockage (aka unnecessary stenting) – this places the patient at risk for cardiac cath lab, and stent complications unnecessarily in patients who DON’T NEED IT. One of the reasons this practice is so prevalent is that patients don’t understand that this is a dangerous practice – this isn’t a preventative measure like a seatbelt or a vaccine.. Not all disease progresses at the same rate, and just because someone has a fifty percent narrowing – it MAY NEVER WORSEN.. But fifty percent sounds scary, doesn’t it? So patients never realize that they’ve been had..

Maybe doctors get away with it much of the time, but what about the patients with acute stent thrombosis – where a blood clot lodges in the stent (the stent is a piece of metal, a foreign body that irritates the walls of the artery, causing increased risk of clot formation.)

Now this patient with the clot – is going to have a heart attack, and potentially even die from this.. Because of a treatment they didn’t even need..

2. Now the second class of patients – these patients are the sick patients.. These people go to the cath lab – and they have lots of blockages and severe blockages (75%, 90%, 100% blocked) in more than one place. These people should have bypass surgery – AND WE KNOW THIS. We know this from thousands and thousands of patients followed over time, in multiple studies.. Survival expectancy in patients with multi-vessel coronary artery disease (CAD) is a MEAN of 17 years.. There isn’t a stent on the planet that has lasted or will last seventeen years. So placing a stent (or lots of stents) in these patients is VERY dangerous – these people will clog up their stents – maybe have heart attacks (damaging their heart muscle); causing congestive heart failure or even death.

ALSO, all those stents make later heart surgery more difficult – imagine the surgeon trying to work around all these little metal coils to find a place to attach a bypass graft. Not pretty.

* Diabetes are considered a vulnerable population because we know that stents don’t last in these patients.

So, now that I’ve had my say – I’m re-posting this article from The Heart.org which is a subscription, paid site, so the rest of you can read it for yourselves.. Just a note to readers: PCI means angioplasty stent placement (PerCutaneous Intervention)

Cardio groups ask Maryland legislature to consider upping cath-lab oversight in wake of over-stenting debacle
March 2, 2011 | Reed Miller
Annapolis, MD – Two major cardiovascular professional societies are taking the unusual step of asking a state government for more oversight of their practice to restore what they perceive to be sinking public confidence in cardiovascular interventionists.

Speaking on behalf of the Society for Cardiovascular Angiography and Interventions (SCAI), Dr Mark Turco (Washington Adventist Hospital, Takoma Park, MD) told heartwire that after the allegations surfaced against interventionalist Dr Mark Midei (St Joseph Medical Center, Towson, MD) and Dr John R McClean (Peninsula Regional Medical Center, Salisbury, MD) many patients began telling their physicians that they did not have confidence in stents.

“Interventional cardiology is a big user of health care dollars and we’re concerned that the public has a perception that we are often moved to treat patients on the basis of relationships with [drug and device] vendors,” Turco said. Turco is also president-elect of the American College of Cardiology’s Maryland Chapter.

Current ACC Maryland Chapter President Dr Sam Goldberg (Bethesda, MD) told heartwire “when the news broke about the inappropriate use of stenting at St Joe’s hospital in 2009 and 2010, I felt that we needed to be proactive in dealing with this issue, so we started reviewing what our own physicians do and what kind of oversight we have and . . . I felt we needed some greater oversight.”

Today, Goldberg and Turco testified before committees of the Maryland General Assembly to pass the Maryland Cardiovascular Patient Safety Act (Senate Bill 742, House Bill 690). They met with the House of Delegates Health and Government Operations Committee a few hours after addressing the Senate Finance Health Subcommittee.

“Rarely do [doctors] develop our own legislation,” Turco testified before both committees. “And rarely do we advocate for more oversight! The fact that we have done both shows how strongly we feel about the need for this legislation.”

Rarely do [doctors] develop our own legislation. And rarely do we advocate for more oversight! The bills, if passed into a law, would launch three new initiatives. It would mandate that the Maryland Health Services Cost Review Commission use data in the Maryland Health Care Commission’s CATH-PCI and ACTION registries, along with administrative data, in order to get the most accurate picture of cath lab practices.

The bills also call for the creation of a system of independent peer review and external oversight that would audit a cath lab’s practices to ensure that they are consistent with the current professional guidelines and in patients’ best interest. “Looking into the [current] in-hospital peer review process, which is a legally protective process, that is done within the hospital . . . I saw that there were very few guidelines about how it’s done and it’s an inherently biased process because you have cardiologists who all know each other reviewing each other, and some are business partners and colleagues, and it’s very difficult for them to be very critical of some things and I felt we needed some greater oversight,” Goldberg said.

The bills also calls for all cath labs in the state of Maryland to be accredited by a nationally recognized accreditation body such as the fledgling Accreditation for Cardiovascular Excellence (ACE) set up by SCAI. Mary Heisler, Executive Director of ACE, also testified before both legislative committees. She said that her group could accredit a Maryland hospital to run a cath lab for under $25 000 a year. “While we recognize this is a difficult economic time, this will avoid the problems that just cost [St Joseph hospital] $22 million,” she said. “This fee is the equivalent to the reimbursement a hospital receives for approximately two stent procedures.”

Denise Matricciani, the Maryland Hospital Association’s (MHA) Vice President for Government Relations, testified that her organization broadly supports the aims of the bills, but that the MHA does not support mandating accreditation at this time. She pointed out that ACE has not yet performed the kinds of surveys of appropriateness envisioned by the bills’ supporters and that there are no data yet to support the effectiveness of its process. Also, MHA is not convinced that an accreditation process would do much to stop inappropriate procedures.

“Accreditation may have merit in the future, we just don’t believe that mandatory accreditation is appropriate at this juncture,” she told the house committee. She also refuted the insinuation of the ACC representatives that MHA’s opposition is based only on cost concerns.

Matricciani outlined some of the efforts her group is undertaking to root out waste and abuse and improve public confidence in cath labs. For example, MHA recently created a Necessary Care Work Group, with medical directors and quality leaders, to study and make recommendations to the Department of Health and Mental Hygiene (DHMH) and the legislature on issues related to inappropriate percutaneous coronary interventions and other medical procedures.

The group also created Guidelines to Ensure the Appropriateness of PCI Procedures. “As this body has witnessed over the years, we can do a lot with our members in terms of doing what’s right,” Matricciani told the house committee. “These guidelines strive to ensure patients, the public, and practitioners that stent placements are appropriate and necessary and right for the patient.”

In his testimony before both committees, Turco argued that internal efforts by the hospitals to oversee the cath labs will not be sufficient to prevent problems like those at Peninsula and St Joseph.

“To those who would advocate for the same old system with ‘suggested regulation’ rather than legislation to fix problems, I would ask—can you explain why and how that regulation would be enforced? And I would ask, if it was so easy to just regulate, why has it not been done in the past, and how have we found ourselves in this situation today?”

He continued: “Accreditation will provide needed oversight for hospitals, while removing much of the variability in care from one center to another.” He added that although accreditation of cath labs would be a new requirement and possible burden on hospitals, the hospitals are already accustomed to handle a variety of accreditation processes for other procedures and departments, so preparing for cath lab accreditation would not be overly burdensome.

Turco also told heartwire that he believes that regulation of cath labs and medicine in general is probably only going to increase in the future regardless, so it behooves the hospitals and the physicians to be proactive in proposing an oversight system to legislators instead of waiting for outsiders to impose one on them.

Update: 17 march 2011

Saw this little gem in my cardiology newsletter – which conveniently, I might add, neglects to mention LONG – TERM outcomes, which as my readers know have been definitively proven to be better with cardiac surgery.. (Come on people, play fair.. it’s hard enough for patients out there without all this deceit..)

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