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Drawing on 2 years’ worth of new data, an expert task force has published updated appropriate use criteria for revascularization.

The new guidelines, which were released online January 30, 2012, ahead of print in the Journal of the American College of Cardiology, were co-developed by multiple professional societies including the American College of Cardiology Foundation, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions.

The revision “provides a reassessment of clinical scenarios the writing group believed to be affected by significant changes in the medical literature or gaps from prior criteria,” said lead author Manesh R. Patel, MD, of Duke University Medical Center (Durham, NC), in a prepared statement.

For the earlier, 2009 version, about 180 clinical scenarios reflecting the variety of everyday patient presentations were considered. Task force members scored the scenarios on a scale of 1 to 9, classifying them as:

• Appropriate (7 to 9)
• Uncertain (4 to 6)
• Inappropriate (1 to 3)

New PCI Ratings

The great majority of newer classifications reiterate or confirm earlier judgments. However, the task force identified a number of scenarios for which re-evaluation or expansion was deemed necessary. For example, the 2009 guidelines focused on only 1 clinical scenario for unstable angina/NSTEMI, grading revascularization as appropriate in the case of patients with high-risk features. The update, however, addresses 2 further elaborations of ACS in which revascularization is:

• Appropriate for patients with intermediate-risk features for short-term risk of death or nonfatal MI (eg, TIMI score 3-4)
• Uncertain for those with low-risk features (eg, TIMI score ≤ 2).

On the other hand, revascularization for asymptomatic patients without prior CABG, 1- or 2-vessel CAD without involvement of the proximal LAD is considered inappropriate according to the new guidelines.

New data also led to notable changes in recommendations for multivessel and left main disease. In these scenarios, revascularization was assumed to be appropriate, but the appropriateness of PCI and CABG were rated separately (table 1).

Table 1. New/Updated Guidelines by Revascularization Method^a 

^a Includes multivessel CAD, Canadian Cardiovascular Society angina ≥ class III, and/or evidence of intermediate- to  high-risk findings on noninvasive testing.

Focus on these scenarios was largely spurred by results of the SYNTAX trial, observed Gregg W. Stone, MD, of Columbia University Medical Center (New York, NY) in a telephone interview with TCTMD. “The recommendations for PCI don’t exactly follow the SYNTAX data presented thus far and don’t take into account the data from the MAIN-COMPARE and PRECOMBAT trials,” he noted, “but it’s still a step in the right direction.”

Overall, Dr. Stone stressed that the report’s classifications are meant only to help guide physicians and patients in decision making. He strongly endorsed the authors’ caveat that the criteria “cannot act as substitutes for sound clinical judgment and practice experience.” Moreover, the developers say, the criteria should be individualized according to patient-specific factors such as symptom status, presence or absence of ischemia or noninvasive imaging, CAD burden, and degree of anti-anginal therapy.

Potential for Abuse

Unfortunately, Dr. Stone added, when various indications are classified as ‘uncertain’ or ‘inappropriate,’ “committees and payers that are reviewing these types of [procedures] tend not to understand the nuances and to interpret them as hard facts. I could look at many of these [classifications] and question their validity in individual patients.

“There is a concern about guidelines and appropriate use criteria being abused,” he continued. “Whether they are more beneficial than they are potentially harmful remains to be seen.” Like the authors, he said that an ‘uncertain’ or even ‘inappropriate’ tag does not justify denying reimbursement for a given procedure. “You have to look at everything on a case-by-case basis, taking all the patient’s individual characteristics into account,” he insisted.

One reasonable application of appropriate use criteria might be to investigate practice patterns, either across subspecialties or from one hospital system to another, Dr. Stone suggested. But even in this situation there is potential for abuse, he cautioned, because a higher percentage of ‘uncertain’ and/or ‘inappropriate’ procedures may not correlate with worse outcomes—it may be due to performing more high-risk cases, for example.

In particular, Dr. Stone questioned the use of ‘uncertain’ to describe indications. “I think it’s a very poor term,” he said, noting that it “kind of equates with class 2 in evidence-based medicine guidelines, although most of these scenarios have never been tested by dedicated randomized trials, so there’s a lot of level C evidence, or expert opinion.”

The authors point out that ‘uncertain’ indications, especially if they are common in clinical practice, should be viewed as requiring further research. Future revisions of the appropriateness criteria are to be expected as new data from ongoing trials are published and information from the implementation of the criteria is accumulated, they add.  

Source:

Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update. J Am Coll Cardiol. 2012;Epub ahead of print.

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