JACC: CARDIOVASCULAR INTERVENTIONS

VOL. 7, NO. 9, 2014

ª 2014 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION

ISSN 1936-8798/$36.00

PUBLISHED BY ELSEVIER INC.

http://dx.doi.org/10.1016/j.jcin.2014.06.005

EDITORIAL COMMENT

Appropriate Use Criteria Lessons From Japan* Olivia Y. Hung, MD, PHD,y Habib Samady, MD,y H. Vernon Anderson, MDz

P

rofessional societies, including the American

methodically compiled a set of clinical scenarios and

College of Cardiology, have for many years

then assigned scores (1 to 9) of relative “appropriate-

developed and periodically updated formal

ness” for PCI to each scenario. This was an initial

guidelines that attempt to provide a comprehensive

attempt to encapsulate a complex clinical decision-

review of available evidence for management of

making process that assimilates the patient’s symp-

certain clinical conditions. These guidelines are

tom status, medical therapy, noninvasive stress test

distinctly structured documents and include recom-

results, and angiographic data. By pre-specified

mendations both for and against various practices.

design, the graded scenarios were grouped into

For some treatments, including percutaneous coro-

3 general categories, with scores 7 to 9 called

nary intervention (PCI), it was observed that there

“Appropriate,” scores 4 to 6 called “Uncertain,” and

are

many

scores 1 to 3 called “Inappropriate.” However, the

geographic regions. It was further recognized that

choice and strength of the clinical scoring factors have

there are gaps in a guidelines approach to under-

raised many questions. How refractory to medical

standing how PCI and other therapies could vary so

therapy should angina symptoms be before one can

widely. In order to address these gaps and investigate

offer a patient symptom relief with PCI? As thorny as

whether there might be overuse or underuse of

that question might be, the issue of noninvasive im-

wide

variations

in

practice

across

various procedures that carry both potential benefit

aging as the ultimate determinant of significant

as well as risk, the American College of Cardiology

ischemia and, by extension, general clinical risk has

established

working

sparked even greater disagreement among thoughtful

group. This group’s first task was to develop a meth-

clinicians. Although there is little debate that at a

an

appropriateness

criteria

odology for evaluating appropriateness of cardiovas-

population level identification of ischemia on stress

cular imaging procedures (1). Other efforts quickly

tests confers an adverse prognosis, the problem for

followed, and in 2009, the initial appropriate use

individual patients is that interpretation of these tests

criteria (AUC) for PCI were published (2). A revised

for each person is highly variable and has substantial

update of these came out in 2012 (3).

false positive and false negative rates (4–7).

The AUC were developed as a schematic way

The AUC are beset by numerous additional diffi-

to provide guidance to clinicians on appropriately

culties. To list just a few: 1) the evidence base is not

selecting

patients

for

PCI.

The

workgroup

strong, with most of the criteria based upon “expert opinion” derived from surveys of the clinical literature rather than from hard comparative science using

*Editorials published in JACC: Cardiovascular Interventions reflect the

the specific written scenarios themselves; 2) the

views of the authors and do not necessarily represent the views of JACC:

scenarios are descriptive, but nonspecific, with only

Cardiovascular Interventions or the American College of Cardiology. From the yAndreas Gruentzig Cardiovascular Center, Division of Cardiology, Department of Medicine, Emory University School of Medicine, Atlanta, Georgia; and the zDivision of Cardiology, Department

about one-half of cases examined able to be classified using them; 3) many or even most individual cases are classified as Uncertain, which further underscores

of Medicine, University of Texas Health Science Center at Houston,

the lack of clear guidance the AUC might otherwise

Houston, Texas. Dr. Hung is supported by grant 5T32HL007745 from the

provide; and 4) the AUC are not validated (neither the

National Heart, Lung and Blood Institute. Dr. Samady has received

scored scenarios nor the group categories), and there

research grant support from Volcano Corp. and St. Jude Medical. Dr. Anderson has reported that he has no relationships relevant to the

currently are no metrics nor method by which to

contents of this paper to disclose.

validate them.

Hung et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1010–3

Appropriate Use Criteria: Lessons From Japan

When these AUC were applied retrospectively to

PCI. So the major finding in this report is that a sub-

clinical practice in the United States using >600,000

stantial and increasing number of nonacute PCI cases

cases from the National Cardiovascular Data Registry

in Japan are classified as Inappropriate using these

(NCDR), several important discoveries were made (8).

U.S. criteria. The reason appears to be that common

Acute PCI procedures were the majority of cases

methods to assess the significance of coronary disease

analyzed (71%), with only a miniscule 1,770 cases

in contemporary Japanese practice are coronary

of >350,000 in the sample that could not be classi-

computed tomographic angiography (CCTA) and/or

fied. Essentially all acute PCI procedures (99%) were

measurement of fractional flow reserve (FFR) during

classified as Appropriate. For nonacute PCI cases the

invasive diagnostic angiography, both of which are

situation was different. Fully 41% (>100,000) of cases

being used increasingly often. The AUC are predi-

in the sample could not be classified at all, and

cated on performing stress tests for determining

therefore, nonacute PCI formed a minority (29%) of

functionally significant ischemia and not on these

cases analyzed. For nonacute PCI cases, 50% were

alternative technologies. This situation

classified as Appropriate, 38% were Uncertain, and

comment.

requires

12% were Inappropriate. The variation between hos-

The first issue is the evolving role of FFR. FFR

pitals was quite broad, with the Inappropriate cate-

is based upon pressure wire measurements in a

gory ranging from 0% of cases to 55%. Another

coronary artery during a diagnostic catheterization

analysis of hospital-level data from NCDR using

procedure. Originally, these measurements were

>426,000 nonacute PCI procedures from 1,199 hos-

validated against myocardial perfusion imaging as a

pitals confirmed these findings (9). Here, 51% of the

correlative assessment for ischemia in the distribu-

procedures could not be classified, and the overall

tion of the tested coronary artery. However, FFR

rates for those that could were Appropriate in 50%,

has now gone beyond correlations with perfusion

Uncertain in 36%, and Inappropriate in 12%. The

imaging–assessed ischemia and arguably is the gold

variation between hospitals for the Inappropriate

standard for identifying lesion-specific ischemia (13).

classification was again extremely broad (0% to 59%).

It has now been validated in its own right as predic-

Other analyses using smaller datasets of nonacute PCI

tive of future clinical events, and elective PCI

in Washington State and New York State are consis-

performed on lesions found significant by FFR are

tent with the findings from NCDR (10,11). Also noted

recognized as fully warranted procedures (13–15). Yet,

in all these datasets is that lack of stress test results

the current collection of guidelines for evaluating

and not matching any written clinical scenarios were

patients for coronary disease specify that FFR mea-

the main reasons for inability to classify nonacute PCI

surements are only justified in patients who are un-

cases.

dergoing Appropriate diagnostic catheterization (i.e., SEE PAGE 1000

only after pre-catheterization stress tests have been found abnormal), and then only on intermediate

Now comes a new study, in this issue of JACC:

lesions in arteries that correlate with the stress test–

Cardiovascular Interventions, that examines applica-

derived ischemic territory (3,16,17). Japanese cardi-

tion of the AUC to a large registry of 10,050 PCI pa-

ologists, like many of their U.S. counterparts, would

tients treated in Japan over a 5-year period between

appear to disagree with this approach. Patients with

2008 and 2013 (12). Two interesting features of this

suspicion of CAD or with known stable ischemic heart

Japanese work are: 1) classification of cases by both

disease may get a diagnostic angiogram without pre-

2009 and 2012 AUC criteria; and 2) examination of the

procedure stress testing, with FFR performed on

trend in classifications over the 5-year interval. These

significant or borderline lesions, and then subsequent

investigators found that 96% of PCI procedures per-

PCI for FFR-positive lesions. Interestingly, when

formed in acute settings were rated as Appropriate

these investigators (12) reclassified their CCTA-based

using the 2009 AUC criteria, but this fell to 78% using

PCI cases from Inappropriate to Appropriate, they

the 2012 criteria. Changes in clinical scenario ratings

found that the proportion of Inappropriate PCI still

accounted for this decrease. Nevertheless, the high

increased over time. Because FFR use also increased

rates of Appropriate for the acute PCI procedures in

over the interval, it is likely that FFR-based cases

Japan are consistent with U.S. reports. For nonacute

account for this finding. All of this suggests that

PCI in Japan, the Inappropriate classification was

Japanese practice may be shifting as both technology

given to 15% according to AUC 2009, and this

and the evidence base evolve (18).

doubled to 31% according to AUC 2012. The analysis

The second issue of importance is the introduc-

by the 8 time subintervals from 2008 to 2013 shows

tion and evolution of CCTA. This is now recognized

steady increases in the percentage of Inappropriate

as

a

powerful

anatomic

tool

with

excellent

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Hung et al.

JACC: CARDIOVASCULAR INTERVENTIONS VOL. 7, NO. 9, 2014 SEPTEMBER 2014:1010–3

Appropriate Use Criteria: Lessons From Japan

specificity for identifying coronary disease. Although

Alternative technologies also have essential roles to

not strictly a functional measure, even this concept

play. Indeed, the concept of combining anatomy with

may be changing inasmuch as sophisticated fluid

lesion-specific physiology is very appealing, whether

dynamics calculations can be made from the ana-

using angiography plus FFR, positron emission to-

tomic data. This has led to efforts to derive a func-

mography plus CCTA, or more recently, CTFFR

tional CCTA-based FFR estimate (CTFFR), which has

(19,20). A recent economic analysis suggests that

been correlated to standard invasive FFR (19,20).

CTFFR may be superior to invasive angiography plus

This may become appealing because it combines

FFR from a cost standpoint (24).

anatomy with estimates of physiology, and a pro-

Although the AUC process is vitally necessary and

spective clinical trial is now underway comparing

must continue to develop as an important method for

CTFFR to noninvasive imaging for risk-stratifying

giving guidance to clinicians and for assessing clinical

patients with coronary disease (21). In addition, the

practice, at the present, we must acknowledge these

relevance of CCTA may expand as the concept of

criteria for what they are: an experimental research

“anatomic burden of disease” re-emerges as clini-

tool for clinical studies. These “criteria” are not now

cally compelling. In a large registry of patients, the

and never have been ready for widespread applica-

extent and severity of coronary disease burden

tion as definitive clinical practice, and they certainly

determined by CCTA was successful in stratifying

should not be used for any punitive or quasi-punitive

mortality risk over 3 years of follow-up (22). The

purposes to which they may be put (25,26). Until a

COURAGE (Clinical Outcomes Utilizing Revasculari-

larger share of nonacute PCI cases can be classified,

zation and Aggressive Drug Evaluation) trial in-

and classified as something other than Uncertain or

vestigators themselves have shown that anatomic

the equally vague “May Be Appropriate,” the ability

burden of coronary disease (assessed from standard

of the AUC to inform clinicians (or anyone else) will

angiography) along with left ventricular function

remain markedly limited. The current AUC should be

were consistent predictors of future adverse clinical

set aside from regular clinical practice, carefully

events, whereas functional ischemic burden was not

investigated as a research tool, and then vetted in the

(23). Unfortunately, in several guidelines, CCTA is

clinical arena, which, to be complete and modern

recommended only after prior stress testing has

as these investigators in Japan suggest (12), will

been found abnormal (16,17).

include all the available technologies in multiple

This welcome report from Japan gives us pause

combinations.

and reminds us that a wider view on the assessment of coronary disease significance is needed. Al-

REPRINT REQUESTS AND CORRESPONDENCE: Dr.

though valuable information is obtained from exer-

H. Vernon Anderson, Division of Cardiology, Department

cise stress testing, reliance on pre-procedure stress

of Medicine, University of Texas Health Science Center

tests for ischemia may not be the single most impor-

at Houston, 6431 Fannin Street, MSB1.246, Houston,

tant factor for justifying the appropriateness of PCI.

Texas 77030. E-mail: [email protected].

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KEY WORDS appropriate use criteria, percutaneous coronary intervention, quality measures

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