Paper Sparks Renewed Discussion on Appropriate Use of PCI

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On the heels of recently revised appropriate use criteria that seek to codify how physicians employ coronary revascularization, a new paper published online February 8, 2012, ahead of print in JACC: Cardiovascular Interventions criticizes how such standards have been interpreted thus far.

Steven P. Marso, MD, of Saint Luke’s Mid America Heart Institute (Kansas City, MO), and 5 colleagues delve into the 2009 version of the criteria, which were codeveloped by the American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American Heart Association, Society of Thoracic Surgeons, American Association for Thoracic Surgery, and the American Society of Nuclear Cardiology.

While the original intent of the appropriate use criteria was “noble,” Jeffrey W. Moses, MD, a coauthor of the recent paper from Columbia University Medical Center/Weill Cornell Medical Center (New York, NY), told TCTMD in a telephone interview that the document is “being misapplied by regulators and the lay media.”

The paper by Dr. Marso et al aims to spur discussions on what does—and does not—constitute appropriate PCI use. “The interventional cardiology community must engage in this national discussion to better formulate a strategy of minimizing overuse and eradicating the systemic underuse of effective therapies in the United States,” the authors urge. “Our failure to adequately do so has left a large void in this debate.”

Such criteria “have far-reaching implications for the delivery of cardiovascular care,” Dr. Marso and colleagues write, and “will be used as the basis for indications, referral patterns, treatment options, physician education, and shared decision making for years to come.”

A Bone to Pick

This issue reared its head in 2011, when the Journal of the American Medical Association published a “misleading” presentation of PCI use, they argue.

Rather than giving the overall rate of appropriate PCI, the JAMA paper separated the data into acute and nonacute indications. “We believe that the editors . . . and the investigators should have presented the data in a more objective, less ‘sensational’ manner,” the physicians note, pointing out that the practice made it difficult for readers to understand the true prevalence of misuse.

Moreover, Dr. Marso and colleagues question whether it is possible to expect a zero tolerance for inappropriate PCI rates on a national basis, or whether there is an “acceptable threshold.”

“Given the current imprecise methods used to develop the [appropriate use criteria], a zero frequency is neither expected nor realistic,” they comment. “There remains too much uncertainty around the mapping of complex clinical scenarios when assigning [appropriate, uncertain, and inappropriate rankings].”

Limitations to be Considered

The authors also take issue with the make-up of the writing committee that developed the 2009 criteria and released the 2011 update. Of 17 members, only 4 were content experts concerning PCI indications.

“The motivation for excluding interventional cardiologists was to prevent financial and/or intellectual bias from unduly influencing the process. Assessing bias at the individual level, whether financial or intellectual, is challenging,” they write, noting that assigning bias for every individual within a medical subspecialty “seems overly judgmental.”

Dr. Moses said that the lack of PCI experts on the committee likely had an influence on the definitions of appropriateness. He added that the problem stems from “the perception that there’s an intrinsic conflict of interest because [interventional cardiologists] do PCI. But there are other intellectual conflicts of interest as well. People have different perceptions about what pathophysiology of disease is and what’s important in patient treatment, but for some reason it’s only attributed to financial gain.”

According to Dr. Marso and colleagues, another important limitation stems from the fact that most of the scenarios for determining appropriate use are based on preprocedural stress test findings. “However, there are a number of problems regarding the validity and reliability of assigning a low, intermediate, or high risk” based on this test, they note. Such decisions are often made by data abstractors rather than physicians, they say, and the existing risk categories are vague.

“This lack of clarity and specificity in assigning high risk will lead to considerable hospital variation when documenting stress test risk in the [National Cardiovascular Disease Registry (NCDR)] data case report forms,” the authors comment, adding that future criteria should place greater emphasis on functional testing and measures of ischemia.

Another problem is that the original criteria only included 1 complex lesion subset, chronic total occlusion (CTO). “The rationale for this is unclear,” they write. “There are a number of complex lesions that require specific technical approaches to successfully complete the procedure. . . . We think incorporating these lesion subsets including CTO-PCI is beyond the scope of AUC and creates inconsistencies.”

The final issue regards whether the data collected by the NCDR are even valid, Dr. Marso and colleagues note. Because these data are “entirely self-reported” with “minimal monitoring,” the authors say this “undoubtedly led to substantial misclassification” in the 2011 JAMA paper. They propose that interventional cardiologists be more rigorously engaged in the process of collecting and entering data and “to develop complementary methods to assess appropriateness.”

‘Doomed to Imperfection’

In an accompanying editorial, James C. Blankenship, MD, of Geisinger Medical Center (Danville, PA), said that the appropriateness criteria “represent the best efforts of intelligent, well-meaning professionals to identify what we know, but as with all such efforts, these are doomed to imperfection.”

He listed reasons for why the criteria will never “fully define the best treatment decision for a particular patient,” including exceptional circumstances and the fact that patients experience a given level of symptoms differently. Dr. Blankenship expanded on the role of patient preference as a “critical component of decision making,” and noted that this aspect is not included in the current appropriateness criteria.

Dr. Moses agreed with the importance of individualized treatment. For example, “[p]atients with moderate angina without critical disease in the LAD are considered inappropriate for angioplasty. Honestly, that recommendation is inappropriate,” he said, adding that many active people would rather undergo PCI than continue to suffer from angina.

In light of such cases, it is worth remembering that ‘inappropriate’ does not always mean ‘wrong,’ Dr. Moses stressed.

Furthermore, he noted, under treatment can be an issue. Those developing revascularization criteria “are only looking at the appropriateness of the PCI. They are not looking at the appropriateness of [overall] care,” Dr. Moses said. “So my question is, why aren’t the appropriate use criteria being applied across the board to the general cardiologists who are withholding revascularization? We know from studies that withholding treatment to appropriate patients actually puts them at risk. And no one is talking about that.”

Always Room for Conversation

Writing committee chair Manesh R. Patel, MD, of Duke University Medical Center (Durham, NC), emphasized to TCTMD in a telephone interview that the criteria “are not meant to tell you how to practice medicine.”

Because physicians and non-physicians alike are utilizing these guidelines and analyzing the different types of care and costs surrounding cardiovascular issues, he said, there need to be standards in place. Even so, patient preferences and extenuating circumstances may require treatment to deviate from what the criteria suggest.

“The appropriate use criteria clearly need to improve and I think they are improving,” Dr. Patel noted, adding that physicians should be cognizant of accurately capturing and inputting data into the NCDR going forward. “I think this conversation is moving us forward. What we hold most dearly is the privilege to self-regulate ourselves as physicians, and I would argue that all of us want to continue to do that.”

 

 


Sources:
1. Marso SP, Teirstein PS, Kereiakes DJ, et al. Percutaneous coronary intervention use in the United States: Defining measures of appropriateness. J Am Coll Cardiol Intv. 2012;Epub ahead of print.

2. Blankenship JC. Progress toward doing the right thing. J Am Coll Cardiol Intv. 2012;Epub ahead of print.

 

 

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Disclosures
  • Dr. Moses reports serving as a consultant for Abbott and Boston Scientific.
  • Drs. Blankenship and Patel report no relevant conflicts of interest.

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