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462 11 — Optimization of Clinical Outcomes and Quality
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However, only through active, nonpartisan, nonpunitive physician participation can this process be beneficial to the operator, staff, hospital
administration, and ultimately the patient by continually improving
processes, efficiencies, and outcomes.
Elements of Continuous Quality Improvement
Five elements outlined by SCAI for a CQI program include: (1) identification of quality indicators, (2) systematic data collection using
standard definitions, (3) analysis of the data with benchmarking to
determine areas that require improvement, (4) development of an
implementation plan to correct deficiencies, and (5) repetition of data
collection to determine the effect of corrective action. PR for both
index case and random cases should be a part of this process.
Quality Committee
The quality improvement process starts with a committee of physicians, staff, and hospital administrators. An independent committee
should be established for the cardiac catheterization laboratory to
address issues specific to the laboratory. Although it is essential that
this committee interact with other committees within the hospital, the
cardiac catheterization laboratory catheterization laboratory director
should chair this committee, with specific quality assurance (QA) staff
from the catheterization laboratory. Physician and staff “champions”
are required for this process to be effective.
The composition of a PCI CQI committee may include noninvasive cardiologists, primary care physicians, catheterization laboratory
nurses, and hospital administrators. Rotation of members and lead
should be done in conjunction with department chairs or the hospital
medical director. In small PCI programs, all active staff interventionists
may be included. In larger laboratories, a formal and fair process for
selecting and replacing members must be devised. An expert in interventional cardiology with established credibility, often the laboratory
director, should chair this committee with a dedicated staff lead identified. Interaction with hospital-based risk management to assure confidentiality is appropriate. However, this is an independent group
whose goal is quality in the laboratory. Interaction with all subspecialties should be established to assure that all aspects of patient care
within the laboratory are covered.
The CQI committee’s responsibilities are outlined in Box 11-1.
Protecting patient safety is the central purpose of the CQI process. The
quality program should include monitors to measure such elements
as patient satisfaction, internal customer satisfaction, clinical outcomes, complication rates, and compliance with external regulatory
and/or accrediting bodies as well as internal policies and procedures.
The committee must be nonpunitive and behave equitably and transparently to ensure fairness to the operator, quality for the patient, and
credibility for the committee. The CQI committee should meet at
regular intervals and be available as situations dictate. External reviews
should be requested when deemed to be appropriate.
Quality Indicators and Measures
The key to assessing quality is to address the proper issues. The challenge is to appropriately identify and “measure,” both quantitatively
and qualitatively, indicators directly and indirectly involved in the
delivery of patient care. Three indicators are discussed here for organizational purposes: structural, process, and outcomes.
Structural indicators are often objective, easy to collect, and
may often be established beyond the confines of the catheterization
laboratory. Structural indicators are those often considered by hospital
privileging or staff credentialing/recredentialing and include medical training, licensure, board certification, procedure volume, and
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11 — Optimization of Clinical Outcomes and Quality
463
Box 11-1 Responsibilities of a Catheterization Laboratory
Quality Committee
1. Hold regular meetings (monthly).
2. Identify metrics of care to be monitored (from National Cardiovascular
Data Registry [NCDR] repor ts).
3. Review all serious adverse events (e.g., death, emergency coronary
artery bypass graf t [CABG]).
4. Perform random film audits (e.g., one c ase per MD for appropriateness,
adequate imaging, and outcome).
5. Review data on process and outcome metrics.
6. Identify quality issues (e.g., any complication with frequency >90th
percentile of peer hospitals; any physician with outlier incidence of
complications).
7. D evelop remediation plans, oversee implementation, and check results
(i.e., establish plan/do/check/act cycle).
8. Refer larger issues for appropriate intervention (e.g., disruptive
physician behavior referred to depar tment director).
From Bashore TM, Balter S, B arac A, et al: 2012 A merican College of Cardiology
Foundation/Society for Cardiovascular A ngiography and Interventions exper t
consensus document on c ardiac catheterization laboratory standards update: A
repor t of the American College of Cardiolog y Fo undation Task Force on E xper t
Consensus documents developed in collaboration with t he So ciety of T horacic
Surgeo ns and Society for Vascular Medicine. J Am Coll Cardiol 59 (24):2221–2305,
2012.
participation in conferences/continuing medical education (CME).
Establishing a minimum standard for a given facility limits confrontation when physicians are either inadequately trained or fail to maintain
required qualifications. Operator procedural volume is a weak and
inconsistent measure of quality and should not be used as a quality
indicator in isolation. Institutional volume is a better programmatic
predictor of outcomes but does not supersede actual outcomes.
The method for credentialing and the ongoing assessment of
proficiency must be developed in accord with both local governance
policies and professionally developed standards. The granting of privileges by health care systems is within the legal and ethical purview of
these institutions.
Process indicators reflect how the patient was managed and include evaluation, appropriateness of the procedure, and treatment,
with adherence to guidelines. Because of the potential qualitative
component regarding these measures, they are more challenging to
assess but should include access site management, establishing decreased risk for acute renal injury from contrast, and radiation dose
management.
The key to the QA program is to assess the process for how the
outcomes arise and not merely react to a number. Because these are
less objective and potentially more amenable to observer bias than
objective clinical outcomes, they are more difficult to measure.
However, these indicators are helpful in working through the entire
process from protocols to staffing, turnover of the room, and patient
length of stay. Assessing these indicators allows a more complete
analysis of outcomes in the QA process.
Outcomes as a measure or indicator identify what happened to
the patient as a reflection of how the patient was managed. Such
outcomes include procedure death, cerebrovascular accident (CVA),
and periprocedural myocardial infarction (MI). Because “outcomes”
as an indicator comprise publicly available results for patient care,
they are the most recognizable. Specific adverse events are traditionally tracked by QA programs, with challenges arising in the assessment of both the low-volume and high-volume operator, because
events are often proportional to case number. Risk adjustment is the
essential component to outcomes reporting and therefore dictates the
need for databases. The variables inherent in comparing high-volume
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and low-volume institutions and/or operators require careful identification of many attributes. Both individual physician and hospital
scorecards provide information on performance, but the information
can be insufficient when used alone. Outcome data should not be
used to punish the practitioner but rather to search for causes that can
be remedied and processes that can be improved.
Data Collection, Analysis, and Peer Review
With data as a pivotal component to this process, accurate collection
and entry is essential. Effective data collection requires a data repository and dedicated personnel for data acquisition. Adequate knowledgeable staff is required, necessitating hospital administration to
be actively involved in providing the required full-time equivalents
(FTEs). Random audits are required to assure data authenticity. System
“cross talk” among hospital, catheterization laboratory, and database
entry systems is essential for assessing correct demographic data and
preferable for use in procedural findings. Decreasing repeated samedataset entry decreases staff time as well as potential for error. Information technology systems for the cardiac catheterization laboratory
and hospital should be integrated to allow for information transfer
regarding patient demographics, catheterization data, and hospital
laboratory data. Data access must be restricted for both patient privacy
and potential medical-legal concerns. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) established rules for patient
anonymity that must be followed.
Data analysis requires a review of both specific adverse events
and risk-adjusted event rates for the facility/operator. Specific adverse
events should be identified and individual case reviews performed. A
sample case report form is provided in Table 11-1. Results should be
Table 11-1
Data Quality Event Review Form
Patient Data
Patient Name:__________________ Age:____________ ID#:___________________
Procedure:______________ Physician:________________ Date:________________
Reason for Review:
Potential for Patient Safety:_______________; Sentinel Event:_______________
Mortality: In Lab____________; In Hospital_____________ 30 Day____________
Morbidity: Neuro:___________; Vascular:___________; Coronar y:____________;
Arrhy thmia:_____________; Renal:_______________; Radiation:_______________
Other:_________________________________________________________________
Case Summary:
_______________________________________________________________________
Risk Group Average/Low High Salvage
Clinical __________ __________ __________
Cath __________ __________ __________
Process Review:
Appropriate Uncertain Inappropriate
Indication:______________________________________________________________
Technique:______________________________________________________________
Management:___________________________________________________________
Related to: Disease:__________; Provider:____________; System:____________;
Preventable:__________; Not Preventable:__________; Comments:___________
Recommendation by Reviewer: _________________________________________
____ ___________________________________________________________________
________________________________________________ Reviewer:______________
Recommendation by Committee: _______________________________________
____ ____________________________________________________________________
Patient Safety/Risk Management Review: Y N; Hospital/Depar tment Review : Y N;
Corrective Action: Y N; Education ________; Proctor_________; Other:_________
Date:______________ Signature:____________________________
Modified from Heupler FA, Chambers CE, Dear WE, et al: Guidelines for peer review
in the car diac catheterizatio n laborator y. Cathet Cardiovasc Diagn 40:21–32, 1997.
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reviewed and discussed at CQI meetings. In the case of possible litigation, the cardiac catheterization laboratory CQI process should work
with hospital risk management but not be driven by it.
The PR component for case review applies both to index cases
identified on the basis of adverse outcomes as well as randomly
selected cases. Random cases should include approximately 10% of
the laboratory volume, and external review should be considered if
internal review is not possible due to potential conflicts or overall
workforce issues. Finally, an approach must be developed for quality
improvement that involves not only a process for change but also a
measure for feedback on the effectiveness of the solutions as well as
educational opportunities for all involved.
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Benchmarks and Database
Participation in regional and/or national databases is required for risk
adjustment. Although volume is often considered to be a surrogate for
quality, this may not always be the case. In assessing quality, adverse
outcomes are often equated to (lack of) quality and are, in turn,
related to performance. However, it is well established that adverse
events do occur, even in the best hands and at the best centers. The
frequency of these events is, in large part, related to the condition of
the patient and experience of the operator and center. Volume alone
may not be the best correlate to quality.
Benchmarking against national standards is a valuable means to
understand high variances in low-incidence adverse events. Such
analyses and collection of many of these variables are captured in the
American College of Cardiology’s (ACC’s) National Cardiology Data
Registry (NCDR) CathPCI Registry as well as in other recognized
regional registries. Not only have registr y data been shown to be effective in predicting outcomes, but they also provide quarterly reports
with benchmarking and risk-adjusted outcomes. The registries use
standardized definitions to collect patient demographics, clinical variables, and outcomes for each procedure. These evidence-based data
elements are combined with process and performance measures that
are linked to current ACCF/AHA/SCAI clinical practice guidelines. Collaboration with the Centers for Medicare and Medicaid Services (CMS)
is ongoing in a variety of projects to measure and assess quality. There
are limitations in the registries due to lack of long-term follow-up, selfreporting without mandated periodic auditing, and voluntary participation. Therefore, processes for external validation of these data are
essential.
“Closing the Loop”: Interventions Available for
the Outlier
Interventions to improve performance should be the goal of the CQI/
PR. The CQI process should focus on improving the performance and
not elimination of the low-end physician. Once performance variance
has been identified, the CQI committee must investigate the cause and
devise a solution. Illustrative examples may include an excessively
high rate of access site complications, contrast-induced nephropathy,
radiation dose, and so on.
Nonpunitive programs should be established to correct these variances and address specific issues to improve total laboratory performance. Neutral, nonpartisan reviews are essential and should be
made after removing all potential “conflicts of interest” among individuals and/or competing groups. Quality improvement for better
patient care is the goal.
When the CQI process identifies a systemic problem that requires
remediation, the tools available for this process are many. Establishing
practice protocols and order sets standardizes practice and should
limit variation in individual performance. Scorecards benchmark
performance and can provide feedback that may allow outliers to
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pinpoint potential areas of improvement. Identifying the need for intervention is a clear component of this process. Counseling may be
required, with confidential but swift correction of unprofessionalism.
Education, either with in-lab proctoring or outside CME, can allow for
any potential knowledge gap to be narrowed. Laboratory surveys
provide feedback for both individual as well as overall laboratory
performance. Positive reinforcement created by working with hospital
administration to consider incentives to improve performance and
enhance educational opportunities may prove to be beneficial.
Penalities or sanctions, for example, suspension of privileges,
should be considered only after other methods of correction have
failed. The seriousness of the sanction should fairly mirror the seriousness of the problem and the responsiveness of the operator. If it is
concluded that the operator has a deficiency in knowledge or skill, the
CQI committee or outside reviewer can recommend an appropriate
educational approach or mentorship and consider limiting privileges
until defined expectations have been met. When all other appropriate
measures to improve performance are unsuccessful, the committee
may recommend revocation of an operator’s privileges. All institutions
have a policy for this situation that should be used, including reporting
to required state regulatory bodies.
Application of Continuous Quality Improvement
There are numerous challenges in applying PCI CQI processes in a
constructive and impartial manner. In 2011, SCAI created the QIT to
help catheterization labs with the process. Additionally, SCAI founded
and then partnered with the ACC to form ACE, the only catheterization
laboratory accrediting organization. Both SCAI QIT and ACE are available for laboratories to assist and assure that quality measures are in
place.
Challenges arise with CQI and must be addressed. Use of this data
for nonquality purposes, for example, developing marketing strategies
or improving operating margin, should be strongly discouraged. Conflicts of interest are common among competing physicians who may
perceive a financial advantage to adjudicate adversely another physician’s care. Operator outcomes must be presented so that absolute
confidentiality is maintained. Physicians whose activities are being
investigated for issues related to quality of care also should be protected. Use of confidential information to target an individual physician should be considered a breach of the process. Sanctions for such
behavior should be formalized in the Medical Staff Bylaws and applied
to violators.
Educational Activities
Educational activities, such as cardiac catheterization conferences and
morbidity and mortality conferences, should be held routinely and an
attendance threshold for maintenance of privileges enforced. Presentation of clinical and technically challenging cases, including those
with complications and unexpected developments during the conduct
of a PCI, is rewarding to review and discuss at these conferences.
Separation of PR from such teaching activities is essential to their
success, in view of legal issues involved, in particular, the possibility
of potential discovery in nonprotected conferences. Federal and state
regulations shield participants from litigation in PR activities. Proceedings of PR activities are protected against subpoena and are not
discoverable in most situations. Admixing PR proceedings in other
settings should not occur.
The CQI process may be best implemented by incorporating clinical practice guidelines and appropriateness criteria. Specific quality
measures to constructively improve patient selection for PCI, operator
performance, team proficiency, and overall care systems should be
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selected carefully by the CQI committee. With proper implementation
of the CQI process, physician and laboratory performance will improve
and quality patient care provided.
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467
Documentation
Documentation in the cardiac catheterization laboratory includes
preprocedure documentation of the patient history/physical as well
as informed consent, in-laboratory documentation of events, and
postprocedure report generation with findings and recommendations. In an era of increased litigation, increased scrutiny of procedure appropriateness, and expanding electronic medical records/
informatics, the importance of appropriate documentation cannot be
understated.
The CMS, state regulations governing hospitals and other health
care facilities, professional organizations, and results of lawsuits and
local policy all influence standards for medical record documentation.
Each organization must develop internal policies that govern medical
record documentation and retention of documents. The process for
corrections, revisions, and/or addendums in the medical record is
governed by the organizational policy outlined in the following
sections.
Preprocedure: History/Physical and
Informed Consent
Preprocedure documentation of pertinent information relevant to
cardiac catheterization is required. Standard history should also
include relevant prior cardiac procedures (catheterization/PCI/CABG)
and specifics such as allergies (contrast reaction) and cardiac medications (anticoagulants/antiplatelet agents). The physical exam should
include access to specific findings with documentation of pulses,
bruits, asymmetric blood pressures, ankle-brachial index (ABI), and
so on. Finally, laboratory work appropriate to an invasive procedure
with contrast administration should be recorded.
Informed Consent
Patients have the right to self-determine their care, including making
decisions regarding whether to undergo a cardiac catheterization or
other procedures including PCI or pacemakers. The cardiologist has
a nondelegable duty to provide the patient or responsible party with
adequate information about the planned procedure(s), including the
reasons for recommendations, benefits of the procedure, potential
risks of procedures and refusing the recommended procedure, and
alternatives to the procedures (for example, refusing the procedure).
The patient must be given the opportunity to have his or her questions
answered, and the operator must ensure that those answers are understood. The consent discussion must be documented in the medical
record by the cardiologist who discussed the proposed procedure
with the patient or responsible party. In academic settings, this is often
the resident or cardiology fellow physician.
Each state regulates who can consent to proposed procedures in
the event that a patient is unable to provide consent. Each state also
regulates the way in which a physician deems a patient’s condition as
an emergency and can, therefore, proceed with care and treatment to
include a cardiac catheterization and/or other PCI if judged to be life
sustaining. Generally, each facility will have organizational policies
governing consents for treatment. Failure to properly obtain informed
consent is considered assault and battery. The patient or representative must have the capacity to understand the explanation and be
able to give consent. Consent obtained after the patient has received
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sedation is invalid given the effects of these medications on recall and
judgment.
The consent form is an administrative tool that, when signed
by the patient or responsible party, informs the facility that the cardiologist has provided sufficient information about the proposed
procedure(s). Someone other than the cardiologist and/or family must
witness the patient or responsible party signing and dating the consent
form and then document the signature with his or her own signature
and date. If the patient or responsible party does not fully understand
the proposed procedure, the cardiologist must be notified so that
further discussion can occur.
Procedure Documentation
Intraprocedure documentation begins with the “time out,” mandated
for all invasive procedures. Performed with all staff and operators
present, this verifies that the correct patient is undergoing the correct
procedure, with knowledge of the patient’s essential information
(allergies, medications, and so on) shared by all. For documentation
during procedures, a chronologic procedure log is the standard used
for this essential information. Containing documentation of the time
out, procedure times, medications, equipment used, vital signs, in-lab
complications, radiation, contrast, and so on, this log is generated by
the nurses/staff and is retained as a permanent record in the patient’s
medical record.
The Cardiac Catheterization Report
In 2014, ACC/AHA/SCAI published a Health Policy Statement (HPS) on
structured reporting in the cardiac catheterization laboratory. This
HPS recognizes that the final report is an essential component of every
cardiovascular test and procedure that involves imaging. This vital
document records key data used to assess indications and appropriateness of care, details technical aspects of the procedure, describes
findings and observations, lists results and calculations, provides an
interpretation of the study, and conveys patient care recommendations when appropriate. In addition to providing essential information
to the entire team of care providers, the final report should be used in
billing and inventory management, process and performance improvement, outcomes analysis, teaching and education, and participation
in data registries. The final report is a legal medical record document
and should be of the highest quality so as to optimize both patient
outcomes and institutional operational efficiencies.
The final report should be clear, concise, organized, consistent,
reproducible, understandable, and in a format that is flexible to accommodate evolutionary procedural changes and documentation requirements, with prose limited to allow database interactions. The HPS
statement presents a prototype report for reference and is divided into
three sections. The first section, the front page, should be a single page
that contains highest value clinical information. The second section is
dedicated to the graphical representations of the findings and possibly
images imported into the report. The third section contains all of the
remaining data presented ideally as a series of structured, formatted
tables. Contained within this HPS are procedure-specific content outlined for diagnostic cardiac catheterization, PCI, peripheral vascular
and cerebral vascular procedures, valvular heart disease including
transcatheter aortic valve replacement (TAVR), structural/congenital
heart disease, and combination procedures.
The cardiologist is ultimately responsible for reporting the medical
procedure. When immediate report generation is not possible, a brief
procedure note at the end of the procedure is provided, and the full
report should ideally be available within 24 hours. The final report
should contain all relevant information about the indication for the
procedure, access site(s) used, catheter and sheath sizes used, and
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469
specific procedures performed (e.g., right-heart/left-heart catheterization, left ventriculography, and selective coronary arteriography).
Hemodynamic data should not be accepted as valid until personal
review of the tracings. The final report should also detail any and all
complications that may have occurred during the procedure. Some
physicians conclude reports with therapeutic recommendations.
When provided, care must be taken to recognize legitimate differences
in clinical management strategies so as to avoid potential confusion
among multiple care providers.
Issues in Medical Malpractice
Medical malpractice actions are often initiated as a result of unresolved anger and frustration on the part of the patient. Time and time
again, statements such as “no one would answer my questions,” “no
one took time to explain anything,” and “no one returned my calls”
are made. At a plaintiff’s deposition, the defense counsel awaits the
disclosure that indicates the underlying motivation that provoked
the patient to become a plaintiff. The plaintiff, after the initiation of the
lawsuit, sits confident in the expectation that “they’ll answer my questions now,” “they’ll explain it all to me now,” or “they’ll return this call.”
The best approach to avoiding litigation is to always keep the lines
of communication open between provider (physician, nurse, and
technologist) and patient. The provider must take the time to let the
patient know that he or she is important to the provider.
An Institute of Medicine report quoted rates estimating that
medical errors kill 44,000 to 98,000 people/year in U.S. hospitals. At
44,000 deaths per year, medical errors would be the eighth leading
cause of death in the United States. This loss of lives is staggering. The
response from the health care industry has been to improve the
quality of health care and patient safety by changing procedural
systems. Changing procedures, rather than focusing on human error,
helps to ensure that the processes practitioners follow prevent medical
errors from continuing to occur. Maintaining the legibility of entries
into patient records and the uniformity of medical care within an
institution has proved to prevent errors. The legibility of a health care
provider’s entry into a patient’s record is of paramount importance,
which explains the increasing use of electronic medical records, personal data assistants, and medical software that immediately identifies drug interactions. Many medication errors result because a
medical record entry is unclear and misinterpreted. Box 11-2 lists
Box 11-2 Techniques for Preventing Medication Errors
To prevent medication errors, the following techniques are recommended:
1. Calculate dosages on paper in written form.
2. Give what is poured and pour what is given.
3. Be aler t to drug name similarities (e.g., quinine and quinidine, Maalox
and Marax, Dilantin and Dilaudid, meperidine and Methergine).
4. Know the dosage ranges of the drugs administered.
5. When giving telephone orders, confirm drug names by spelling them
back.
6. Do not become distracted when preparing medications.
7. Listen to the patients; if they question the route, time, or medication
that they are taking, double check the physician’s order.
8. Know the most recent package inser t data for drugs.
9. Always check medication expiration dates.
10. Do not stock “look-alike” medications on the same shelf (i.e.,
potassium chloride, sodium chloride).
11. Use needles that are the appropriate size for the drug to be
administered and the patient.
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techniques for preventing medication errors. The use of these tools
not only affords the patient a better quality of care but also provides
health care professionals with safeguards against professional liability
lawsuits.
Although written communication in the medical record is important, it is equally important to ensure open communication among
health care provider, patient, and patient’s family. Again, letting the
patient know that he or she is important to the health care provider is
an integral part of good health care.
Patient Safety/Risk Management
Patient Safety
Patient safety is defined as the patient being free from accidental harm
as a result of a health care encounter. Cardiac catheterization laboratory leadership must create and nurture a culture of personal safety
in which each individual team member is free to address concerns
without fear of criticism. The Joint Commission requires accredited
organizations to have a patient safety program that is intended to
prevent errors from reaching the patient and a response program in
the event that harm does occur. There are 15 published goals that
organizations must meet, with six applicable to the cardiac catheterization laboratory: (1) Improve accuracy of patient identification by
using two unique identifiers and prevent transfusion errors related to
misidentification; (2) improve communication effectiveness among
the health care team; (3) improve safety of medication use, which
includes labeling all medications, medication containers, and solutions off and on the sterile field in perioperative and other invasive
settings and reduce the likelihood of patient harm from anticoagulant
therapy; (4) reduce the risk of health care–associated infections; (5)
accurately and completely reconcile medication across the continuum; and (6) use universal protocols for preventing wrong site, procedure, or patient by conducting preprocedure verification processes
and preprocedure time out.
Risk Management
Adverse or unexpected outcomes occur in the cardiac catheterization
laboratory. Patients, families, and responsible parties should be
informed as soon as possible of an adverse or unexpected outcome.
Communication should include only the available information and
avoid speculation. Communication is not limited only to the initial
conversation but continues with ongoing patient and family conversations to understand the outcome and its implication for the patient’s
health. Medical malpractice is often reduced with personal interactions. Documentation of events and interaction is essential to this
process.
The type of adverse or unexpected outcome may dictate that
a root cause analysis be conducted by the cardiac catheterization
laboratory. Risk management, quality management, or patient safety
departments within the organization usually facilitate this process.
The purpose of conducting a root cause analysis is to identify systems
and processes that may have contributed to the adverse or unexpected
outcome. Not all adverse outcomes are the result of an error and not
all health care errors cause adverse outcomes.
Changing procedures, rather than focusing on human error, helps
to ensure that the processes practitioners follow prevent medical
errors from continuing to occur. The use of these tools not only affords
the patient a better quality of care but also provides health care professionals safeguards against professional liability lawsuits. Box 11-2 lists
techniques for preventing medication errors.
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471
Appropriate Use Criteria
Appropriate use criteria (AUC) for coronary revascularization were
originally published in 2009 and revised in 2012. Because of coronary
disease prevalence, technical advances in both surger y and PCI,
improved medical therapy for ischemic heart disease, and rising costs
of care, clinicians, payers, and patients are interested in the specific
benefits of revascularization. Inappropriate revascularization may be
harmful to patients and generate unwarranted costs to the health
care system, whereas appropriate revascularization procedures can
improve patients’ clinical outcomes.
The original AUC classification scheme uses ratings of appropriate, uncertain, and inappropriate, which can cause confusion and
imply several, often negative, connotations. The rating of “uncertain”
is used when pertinent literature is unavailable or when true discrepancies exist. It should be recognized that medical practice uncertainties are common and require the clinician to use best judgment on an
individual basis for best decisions about patient management. A rating
of “uncertain” may be assigned unless new clinical information might
shift the scenario into either the appropriate or inappropriate category.
In addition, a rating of “uncertain” means that the decision to perform
revascularization is either appropriate or inappropriate. Uncertain
indications are not inappropriate but rather reflect clinical scenarios
that are reasonable for PCI.
All AUC publications attempt to critically and systematically
create, review, and categorize the appropriateness of certain cardiovascular diagnostic tests, whereas the AUC for coronary revascularization remains the only document addressing treatment. It is worthwhile
to consider the definitions used by the AUC:
Maximal antiischemic medical therapy: This definition refers to
patients who are assumed to be receiving risk factor modification
according to guideline-based recommendations for clinical scenarios
presented. Maximal antianginal medical therapy is defined as the use
of at least two classes of therapies to reduce anginal symptoms.
Risk assessment from stress testing
are those associated with a cardiac mortality of <1% per year,
intermediate-risk findings 1% to 3% per year, and high-risk findings >3%
per year.
Canadian Cardiovascular Society Classification System for Gradings of Angina Pectoris:
Class I: Ordinary physical activity, such as walking and climbing stairs,
does not cause angina. Angina occurs with strenuous, rapid, or
prolonged exertion at work or recreation.
Class II: There is slight limitation of ordinary activity. Angina occurs
on walking more than two blocks on the level and climbing more
than one flight of ordinary stairs at a normal pace and in normal
condition.
Class III: Patient has marked limitations of ordinary physical activity.
Angina occurs on walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at a normal pace.
Class IV: Patient unable to carry on any physical activity without dis-
comfort; anginal symptoms may be present at rest.
The complete AUC document lists complete descriptions of clinical scenarios and ratings (appropriate, uncertain, and inappropriate).
New nomenclature has been used to describe these ratings as
appropriate, may be appropriate, and rarely appropriate. Nonetheless,
review of the complete document is worthwhile.
: Low-risk stress test findings
Applications of Appropriate Use Criteria
There are many potential applications for the AUC. Clinicians can
use the ratings for decision support or as an educational tool in
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