PERFORMANCE MEASURES ACC/AHA/SCAI/AMA Convened PCPI/NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Intervention A Report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, the Society for Cardiovascular Angiography and Interventions, the American Medical Association Convened Physician Consortium for Performance Improvement, and the National Committee for Quality Assurance Developed in Collaboration With the American Association of Cardiovascular and Pulmonary Rehabilitation and Mended Hearts Endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and Mended Hearts WRITING COMMITTEE MEMBERS Brahmajee K. Nallamothu, MD, MPH, FACC, FAHA, Co-Chair*; CarlL.Tommaso,MD,FACC,FAHA,FSCAI,Co-Chairy;H.VernonAnderson,MD,FACC,FAHA,FSCAI*; Jeffrey L. Anderson, MD, FACC, FAHA, MACP*; Joseph C. Cleveland, JR, MDz; R. Adams Dudley, MD, MBA; Peter Louis Duffy, MD, MMM, FACC, FSCAIy; David P. Faxon, MD, FACC, FAHA*; Hitinder S. Gurm, MD, FACC; Lawrence A. Hamilton, Neil C. Jensen, MHA, MBA; Richard A. Josephson, MD, MS, FACC, FAHA, FAACVPRx; David J. Malenka, MD, FACC, FAHA*; Calin V. Maniu, MD, FACC, FAHA, FSCAIy; Kevin W. McCabe, MD; James D. Mortimer, Manesh R. Patel, MD, FACC*; Stephen D. Persell, MD, MPH; John S. Rumsfeld, MD, PhD, FACC, FAHAjj; Kendrick A. Shunk, MD, PhD, FACC, FAHA, FSCAI*; Sidney C. Smith, JR, MD, FACC, FAHA, FACP{; Stephen J. Stanko, MBA, BA, AA#; Brook Watts, MD, MS *ACC/AHA Representative. ySociety of Cardiovascular Angiography and Interventions Representative. zSociety of Thoracic Surgeons Representative. xAmerican Association of Cardiovascular and Pulmonary Rehabilitation Representative. kACC/AHA Task Force on Performance Measures Liaison. {National Heart Lung and Blood Institute Representative. #Mended Hearts Representative. The measure speci cations were approved by the American College of Cardiology Board of Trustees, American Heart Association Science Advisory and Coordinating Committee, in January 2013 and the American Medical Association Physician Consortium for Performance Improvement in February 2013. This document was approved by the American College of Cardiology Board of Trustees and the American Heart Association Science Advisory and Coordinating Committee in October 2013, and the Society of Cardiovascular Angiography and Interventions in December 2013. The American College of Cardiology requests that this document be cited as follows: Nallamothu BK, Tommaso CL, Anderson HV, Anderson JL, Cleveland JC, Dudley RA, Duffy PL, Faxon DP, Gurm HS, Hamilton LA, Jensen NC, Josephson RA, Malenka DJ, Maniu CV, McCabe KW, Mortimer JD, Patel MR, Persell SD, Rumsfeld JS, Shunk KA, Smith SC, Stanko SJ, Watts B. ACC/AHA/SCAI/AMA Convened PCPI/NCQA 2013 perfor- mance measures for adults undergoing percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures, the Society for Cardiovascular Angiography and Interventions, the American Medical Association Convened Physician Consortium for Performance Improvement, and the National Committee for Quality Assurance. J Am Coll Cardiol 2014;63:722 45. This article has been copublished in Circulation. Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.cardiosource.org) and the American Heart Asso- ciation (http://my.americanheart.org). For copies of this document, please contact Elsevier Inc. Reprint Department, fax (212) 633-3820, e-mail reprints@elsevier.com. Permissions: Multiple copies, modi cation, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology. Requests may be completed online via the Elsevier site (http://www.elsevier.com/authors/obtaining- permission-to-re-use-elsevier-material). This Physician Performance Measurement Set (PPMS) and related data speci cations were developed by the Physician Consortium for Performance Improvement (the Consortium), including the American College of Cardiology (ACC), the American Heart Association (AHA), and the American Medical Association (AMA),to facilitatequality-improvementactivitiesby physicians.Theperformancemeasurescontained inthisPPMS are notclinical guidelines,do not establish a standard of medical care, and have not been tested for all potential applications. Although copyrighted, they can be reproduced and distributed, without modi cation, for noncommercial purposesdfor example, use by health care providers in connection with their practices. Commercial use is de ned as the sale, license, or distribution of the performance measures for commercial gain, or incorporation of the performance measures into a product or service that is sold, licensed, or distributed for commercial gain. Commercial uses of the PPMS require a license agreement between the user and the AMA (on behalf of the Consortium) or the ACC or the AHA. Neither the AMA, ACC, AHA, the Consortium, nor its members shall be responsible for any use of this PPMS. THE MEASURES AND SPECIFICATIONS ARE PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND. Limited proprietary coding is contained in the measures speci cations for convenience. Users of the proprietary code sets should obtain all necessary licenses from the owners of the code sets. The AMA, the ACC, the AHA, the NCQA, and the PCPI and its members disclaim all liability for use or accuracy of any Current Procedural Terminology (CPT ) or other coding contained in the speci cations. CPT contained in the measures speci cations is copyright 2004-2012 American Medical Association. LOINC copyright 2004-2012 Regenstrief Institute, Inc. This material contains SNOMED CLINICAL TERMS (SNOMED CT ) copyright 2004-2012 International Health Terminology Standards Development Organization. All Rights Reserved. Journal of the American College of Cardiology 2014 by the American College of Cardiology Foundation, American Heart Association, Inc., American Medical Association, and National Committee for Quality Assurance Published by Elsevier Inc. ACC/AHA TASK FORCE ON PERFORMANCE MEASURES Eric D. Peterson, MD, MPH, FACC, FAHA, Chair; Paul A. Heidenreich, MD, MS, FACC, FAHA, Chair-Elect; Nancy M. Albert, PhD, CCNS, CCRN, FAHA; Paul S. Chan, MD, MSc, FACC; Lesley H. Curtis, PhD; T. Bruce Ferguson, JR, MD, FACC; Gregg C. Fonarow, MD, FACC, FAHA; Marjorie Funk, RN, PhD, FAHA, FAAN; P. Michael Ho, MD, PhD, FACC, FAHA; Kathy J. Jenkins, MD, MPH, FACC; Sean O Brien, PhD; Paul D. Varosy, MD, FACC; Henry H. Ting, MD, MBA, FACC, FAHA TABLE OF CONTENTS Preamble 723 1. Introduction 724 1.1. Scope of the Problem 724 1.2. Structure and Membership of the Writing Committee 724 1.3. Disclosure of Relationships With Industry and Other Entities 725 2. Methodology 726 2.1. Identifying Clinically Important Outcomes 726 2.2. Dimensions of Care 726 2.3. Literature Review 727 2.4. De nition and Selection of Measures 727 Percutaneous Coronary Intervention Measures . 727 3.1. Target Population and Care Period 727 3.2. Avoiding Overlap and Ensuring Alignment With Existing Measure Sets and Guidelines 727 4. General Discussion 728 4.1. Process Measures 728 4.1.1. Patient Selection Measures 728 4.1.2. Patient Education/Shared Decision-Making Measures 729 4.2. Outcome Measures 729 4.2.1. Level of Attribution/Aggregation 730 4.2.2. Infrequently Occurring Complications 730 4.2.3. Death/Readmission 730 4.2.4. Patient Surveys 730 4.3. Structural Measures 730 5. Measures Included in This Set 731 5.1. Comprehensive Documentation of Indications for PCI 731 5.2. Appropriate Indication for Elective PCI 731 5.3. Assessment of Candidacy for Dual-Antiplatelet Therapy 732 of Saphenous Vein Bypass Graft Disease 732 5.5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedure 732 5.6. Radiation Dose Documentation 733 5.7. Postprocedural Optimal Medical Therapy Composite 733 5.8. Cardiac Rehabilitation Patient Referral 733 5.9. Regional or National PCI Registry Participation 733 5.10. Annual Operator and Hospital PCI Volume 734 6. Potential Measures Considered But Not Included in This Set 734 6.1. Process Measures 734 6.2. Outcome Measures 734 6.3. Structural Measures 735 7. Areas for Further Research 736 7.1. Documentation of Prescription of Drugs Versus Filling of Drug Prescriptions and Optimal Dosing of Drugs 736 7.2. Limitations of Current Data Systems for PCI 736 7.3. Shared Accountability 736 7.4. Patient Surveys 736 Staff 736 References 737 Key Words 738 Appendix A. Relevant Author Relationships With Industry and Other Entities 739 Appendix B. Relevant Reviewer Relationships With Industry and Other Entities 741 Appendix C. ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Percutaneous Coronary Interventions Performance Measures: Summary Analysis Table 744 Preamble American College of Cardiology (ACC)/American Heart Association (AHA) performance measure sets can serve as vehicles to accelerate appropriate translation of scienti c evidence into clinical practice. These documents are intended to provide practitioners and institutions that deliver cardiovascular services with tools to measure the JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA quality of their care and identify opportunities for improvement. The present set of measures breaks important ground for performance measurement. Here, the writing committee was charged with developing measures to benchmark and improve the quality of one of cardiology s most common and important procedures: percutaneous coronary inter- vention (PCI). In this task, the ACC/AHA Task Force on Performance Measures partnered with representatives from several other organizations, including the Society for Cardiovascular Angiography and Interventions (SCAI), the American Medical Association (AMA) Convened Physician Consortium for Performance Improvement (PCPI), and the National Committee for Quality Assur- ance (NCQA). These bodies provided invaluable input in the development and review of these measures. The writing committee was instructed to follow the methodology of performance measure development (1,2) and to assure that the measures developed were aligned with national standards so as to promote harmony across measures. The writing committee was also charged with constructing measures that maximally capture multiple important aspects of quality (timeliness, safety, effec- tiveness, ef ciency, equity, and patient-centeredness) while minimizing the reporting burden imposed on participants. As in other cases, all selected measures pose potential challenges to implementation that could result in unin- tended consequences. The manner in which these issues are addressed is dependent on several factors, including the measure design, data collection method, performance attribution, baseline performance rates, reporting methods, and incentives linked to these reports. These imple- mentation challenges are appropriately discussed in indi- vidual sections dedicated to each of the measures. These new performance measures for PCI are notable for several reasons. First, the writing committee considered the key initial question of whether performing the proce- dure was appropriate, in line with a growing body of evidence in this area. Determining procedural appropri- ateness of PCI is complex and requires comprehensive documentation of the procedure s priority, the presence and severity of angina symptoms, the use of antianginal medical therapies, and the presence and severity of stenosis (as documented by angiography or other metrics of lesion severity, e.g., intravascular ultrasound or fractional ow reserve). The present PCI performance measure set rep- resents the rst time in the cardiology literature that a speci c performance measure has been constructed to address procedural appropriateness. Next, the writing committee listed important tasks to be done by the care team before the procedure, including determining whether the patient can and would be likely to take dual-antiplatelet therapy on an ongoing basis (an important requirement if drug-eluting stents are to be used), as well as documenting the patient s renal function (which can in uence both the patient s candidacy for the procedure and procedural strategiesde.g., amount of iodinated contrast). Many procedural and postprocedural factors that can affect patient outcomes are considered in this measure set, such as the use of embolic protection devices and the documentation of ionized radiation and iodinated contrast dosage. The writing committee also put the procedure in the context of patients longitudinal disease process. Specif- ically, they considered that procedural quality must extend beyond the laboratory and should involve implementation of appropriate secondary prevention cardiac rehabilitation and medications to modify long-term risk. Finally, the writing committee considered other indicators of quality related to the interventionalist and the institution. These measures include such factors as procedural volume and whether the institution routinely tracks and benchmarks their care relative to others in clinical registries. Combined, these PCI metrics break important new ground. As noted by the authors, the eld of quality assessment and performance measurement in PCI is maturing, and many advances are still needed. Neverthe- less, this initial metric set provides a solid foundation for quality improvement in the eld and sets the stage for future advancement. Eric D. Peterson, MD, MPH, FACC, FAHA Chair, ACC/AHA Task Force on Performance Measures The ACC/AHA/SCAI/AMA-PCPI/NCQA Percuta- neous Coronary Interventions Performance Measures Writing Committee (the writing committee) was charged with creating the rst performance measure set in this area. In this measure set, the writing committee presents 11 mea- sures, which are intended for ambulatory and hospital (inpatient) settings. The measure set is summarized in Table 1. 1.1. Scope of the Problem The ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI performance measurement set, which is available on the PCPI Web site at http://www.ama-assn.org/apps/listserv/ x-check/qmeasure.cgi?submit PCPI, discusses in detail the scope of the problem and opportunities for improving the quality of care provided to patients undergoing PCI. 1.2. Structure and Membership of the Writing Committee The members of the writing committee included clinicians specializing in interventional cardiology, general cardiol- ogy, internal medicine, cardiac surgery, and cardiac reha- bilitation, as well as individuals with expertise in guideline development and performance measure development, implementation, and testing. The writing committee also included patient/consumer representatives and a payer Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 representative. The writing committee had representation from the American Association of Cardiovascular and Pulmonary Rehabilitation, Mended Hearts, SCAI, and the Society for Thoracic Surgeons (STS). 1.3. Disclosure of Relationships With Industry and Other Entities The ACC/AHA Task Force on Performance Measures makes every effort to avoid actual, potential, or perceived con icts of interest that could arise as a result of re- lationships with industry or other entities (RWI). Detailed information on the ACC/AHA policy on RWI can be found at http://www.cardiosource.org/Science-And-Quality/ Practice-Guidelines-and-Quality-Standards/Relationships- With-Industry-Policy.aspx. All members of the writing committee, as well as those selected to serve as peer re- viewers of this document, were required to disclose all current relationships and those existing within the 12 months before the initiation of this writing effort. ACC/ AHA policy also requires that the writing committee co- chairs and at least 50% of the writing committee have no relevant RWI. Table 1. 2013 ACC/AHA/SCAI/AMA-PCPI/NCQA Percutaneous Coronary Intervention Measurement Set Measure Description* 1. Comprehensive Documentation of Indications for PCIy Percentage of patients aged 18 years for whom PCI is performed with comprehensive documentation of the procedure. This documentation includes, at a minimum, the following elements: 1. Priority (acute coronary syndrome, elective, urgent, emergency/salvage); 2. Presence and severity of angina symptoms (e.g., Canadian Cardiovascular Society classification system); 3. Use of antianginal medical therapies within 2 weeks before the procedure, if any; 4. Presence, results, and timing of noninvasive stress test, fractional flow reserve, or intravascular ultrasound, if performed; and 5. Significance of angiographic stenosis (may be quantitative or qualitative) on coronary angiography for treated lesion. 2. Appropriate Indication for Elective PCIz Percentage of patients aged 18 years for whom elective PCI is performed in a native coronary artery who have an appropriate indication for the procedure that suggests its overall benefits outweigh its risks. 3. Assessment of Candidacy for Dual-Antiplatelet Therapyy Percentage of patients aged 18 years for whom PCI is performed who have documentation in the medical record that an assessment of candidacy for initiation and duration of dual-antiplatelet therapy was performed prior to the procedure. 4. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Diseasez Percentage of patients aged 18 years for whom saphenous vein graft PCI is performed who received an embolic protection device during the procedure. 5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedurez Percentage of patients aged 18 years for whom PCI is performed who have both preprocedural estimated glomerular filtration rate or an indication that the patient is on dialysis AND the administered contrast dose documented in the catheterization report or procedure notes. 6. Radiation Dose Documentationz Percentage of patients aged 18 years for whom PCI is performed who have the administered radiation dose documented in the catheterization report or procedure notes. 7. Postprocedural Optimal Medical Therapy Compositey Percentage of patients aged 18 years for whom PCI is performed who are prescribed optimal medical therapy at discharge. 8. Cardiac Rehabilitation Patient Referraly Percentage of patients aged 18 years for whom PCI is performed who have been referred to an outpatient cardiac rehabilitation / secondary prevention program. 9. Regional or National PCI Registry Participationy Participation in a national or multisystem geographic regional PCI registry that provides regular performance reports based on benchmarked data. 10. Annual Operator PCI Volumez Average annual volume of PCIs performed by an operator over the previous 2 calendar years. 11. Annual Hospital PCI Volumey Annual volume of PCIs performed by a hospital over the previous calendar year. *For comprehensive information on these measures, including measure exceptions, please refer to the complete ACC/AHA/AMA-PCPI/NCQA/SCAI performance measurement specifications through the PCPI Web site (http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit PCPI). yThese measures have been designated performance measures. Performance measures are process, structure, efficiency, or outcome measures that have been developed with ACCF/AHA methodology, including the process of public comment and peer review, and have been specifically designated as performance measures by the ACC/AHA Task Force on Performance Measures. These measures not only are intended for internal quality improvement but also may be considered for purposes of public reporting or other forms of accountability. zIndicated in shading, these measures have been designated quality metrics. Quality metrics are measures that have been developed to support self-assessment and quality improvement at the provider, hospital, or healthcare system level. These metrics are valuable tools to aid clinicians and hospitals in improving quality of care and enhancing patient outcomes but might not meet all specifications of formal performance measures and are, therefore, not appropriate for any use other than internal quality improvement. ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement;NCQA,NationalCommitteeforQualityAssurance;PCI,percutaneouscoronaryintervention;andSCAI,SocietyforCardiovascularAngiographyandInterventions. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Any writing committee member who develops new RWI during his or her tenure on the writing committee is required to notify staff in writing. These statements are reviewed periodically by the Task Force and by members of the writing committee. Author and peer reviewer RWI relevant to the document are included in the appendices: Please see Appendix A for relevant writing committee RWI and Appendix B for relevant peer reviewer RWI. Additionally, to ensure complete transparency, the writing committee members comprehensive disclosure information, including RWI not relevant to the present document, is available on- line at http://jaccjacc.cardiosource.com/DataSupp/ACCF/ 2013_Comprehensive_RWI_WC.pdf. Disclosure infor- mation for the Task Force is also available online at http:// www.cardiosource.org/ACC/About-ACC/Who-We-Are/ Leadership/Guidelines-and-Documents-Task-Forces.aspx. The work of the writing committee was supported exclusively by the ACC, the AHA, and the AMA, without commercial support. Members of the writing committee volunteered their time for this effort. Meetings of the writing committee were con dential and attended only by committee members and staff from the ACC, AHA, SCAI, AMA-PCPI, and NCQA. The development of performance measurement systems involves identi cation of a set of measures targeting a speci c patient population observed over a particular time period. To achieve this goal, the ACC/AHA Task Force on Performance Measures has outlined a set of mandatory sequential steps (1). The following sections outline how these steps were applied by the present writing committee. 2.1. Identifying Clinically Important Outcomes To guide the selection of measures for inclusion in the measure set, the writing committee sought to identify structures, processes, and outcomes that are most mean- ingful to patients undergoing PCI, as recommended by recent guidelines and appropriate use criteria (AUC). A key aspect was to determine outcomes that are most rele- vant for patients. A complete list of the desirable outcomes identi ed by the writing committee and how they relate to the proposed process measures is included in the measure speci cations that can be found at http://www.ama-assn. org/apps/listserv/x-check/qmeasure.cgi?submit PCPI. 2.2. Dimensions of Care Given the multiple measurable domains of providing care, the writing committee identi ed and explicitly articulated the relevant dimensions of care that should be evaluated. As part of the methodology, each potential performance measure was categorized into its relevant dimension of care (Table 2). Classi cation into dimensions of care facilitated identi cation of areas in which evidence was lacking and prevented duplication of measures within the set. Diagnostics, patient education (including on the topics of prognosis and etiology), treatment, self-management, and Table 2. 2013 ACC/AHA/SCAI/AMA-PCPI/NCQA Percutaneous Coronary Intervention Performance Measure Set: Dimensions of Care Measures Matrix* Measure Name Diagnostics Patient Education Treatment Self-Management Monitoring of Disease Status 1. Comprehensive Documentation of Indications for PCIy U 2. Appropriate Indication for Elective PCIz U U 3. Assessment of Candidacy for Dual-Antiplatelet Therapyy U U U 4. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Diseasez U 5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedurez U U 6. Radiation Dose Documentationz U 7. Postprocedural Optimal Medical Therapy Compositey U 8. Cardiac Rehabilitation Patient Referraly U U U U 9. Regional or National PCI Registry Participationy U 10. Annual Operator PCI Volumez U 11. Annual Hospital PCI Volumey U *For comprehensive information on these measures, including measure exceptions, please refer to the complete ACC/AHA/AMA-PCPI/NCQA/SCAI performance measurement set through the PCPI Web site (http://www.ama-assn.org/apps/listserv/x-check/qmeasure.cgi?submit PCPI). yThese measures are performance measures. zIndicated in shading, these measures have been designated quality metrics and are for use in internal quality-improvement programs only. They are not appropriate for any other use (e.g., pay-for-performance, physician ranking, public reporting programs). ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; NCQA, National Committee for Quality Assurance; PCI Percutaneous Coronary Intervention; and SCAI, Society for Cardiovascular Angiography and Interventions. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 monitoring of disease status were selected as the relevant dimensions of care for PCI performance measures. In addition, to ensure the measure set would be as comprehensive as possible, the writing committee evaluated the potential measures against the Institute of Medicine domains of healthcare quality (safety, effectiveness, patient- centeredness, timeliness, ef ciency, and equity) (3). The writing committee focused primarily on processes of care, but they also considered structural and outcome measures for PCI. Although the writing committee cannot endorse speci c measures developed by others and believes that many measures are needed to quantify the full spectrum of relevant healthcare dimensions of quality, the measures proposed in the present set are intended to complement existing National Quality Forum endorsed PCI measures. 2.3. Literature Review The practice guidelines and other clinical guidance docu- ments that provided the basis for these measures can be seen in Table 3. 2.4. De nition and Selection of Measures The writing committee reviewed both recent guidelines and other clinical guidance documents, such as the ACCF/ Appropriate Use Criteria for Coronary Revascularization (11). The writing committee also examined available information on gaps in care and the clinical epidemiology of PCI. All measures were designed to assess quality of care in pa- tients undergoing PCI across a variety of ambulatory and hos- pital settings to support achievement of the desirable outcomes identi ed. The measures also were designed to allow for the exclusion of patients with contraindications or other valid rea- sons for exclusion from the measure. In de ning the measure exceptions, the writing committee was guided by the AMA- PCPI Recommendations for Speci cation and Categoriza- tion of Measure Exclusions (13), as discussed further below. The writing committee evaluated the potential measures against the ACC/AHA attributes of performance measures (Table 4) to reach consensus on which measures should be advanced for inclusion in the nal measure set; the Summary Analysis Table (Appendix C) captures this evaluation process. After the peer review and public comment period, the writing committee reviewed and discussed the comments received, and further re nements were made in the measure set. 2013 Percutaneous Coronary Intervention Measures 3.1. Target Population and Care Period The target population for the measures consists of all patients undergoing PCI for coronary artery disease. That said, a large focus of the writing committee was on measures aimed at patients coming to the cardiac cath- eterization laboratory for elective proceduresdthat is, those originating as outpatients. Patients arriving from the inpatient setting or emergency department and those with acute coronary syndromes were considered second- arily. The writing committee decided on this approach for 2 reasons. First, in patients with acute coronary syndromes, abundant data indicate that revascularization with PCI is bene cial, and prior measure sets focused on this disease condition have included measures targeting these patients (e.g., door-to-balloon time in ST-elevation myocardial infarction). Second, in selected patients un- dergoing elective procedures, such as those with chronic stable angina, there is greater controversy as to the best therapy that should be used. Patients referred to the cardiac catheterization laboratory in these settings usually have stable angina that is no longer controlled with medications or have high-risk ndings on a noninvasive stress test. The bene t of PCI in these patients is pri- marily symptom reduction, and data on a mortality rate bene t for this group are limited (14 16). 3.2. Avoiding Overlap and Ensuring Alignment With Existing Measure Sets and Guidelines The writing committee made every effort to avoid overlap with existing measure sets and to harmonize these Table 3. Associated Guidelines and Other Clinical Guidance Documents ACCF/AHA/SCAI 2011 Guideline for Percutaneous Coronary Intervention (4) ACCF/AHA 2013 Guideline for the Management of ST-Elevation Myocardial ACC/AHA 2007 Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction (6) ACCF/AHA 2011 Focused Update of the Guidelines for the Management of Patients with Unstable Angina/Non ST-Elevation Myocardial Infarction (updating the 2007 guideline) (7) ACCF/AHA 2012 Focused Update of the Guideline for the Management of Patients with Unstable Angina/Non-ST-Elevation Myocardial Infarction (updating the 2007 guideline and replacing the 2011 focused update) (8) AHA/ACCF 2011 Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and other Atherosclerotic Vascular Disease: 2011 Update (9) ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary ACCF/SCAI/STS/AATS/AHA/ASNC/HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Revascularization Focused Update (11) Appropriate Use Criteria for Diagnostic Catheterization (12) AATS indicates American Association for Thoracic Surgery; ACC, American College of Cardiology; ACCF, American College of Cardiology Foundation; AHA, American Heart Association; ASE, American Society of Echocardiography; ASNC, American Society of Nuclear Cardiology; HFSA, Heart Failure Society of America; HRS, Heart Rhythm Society; PCI, percutaneous coronary intervention; SCAI, Society for Cardiovascular Angiography and Interventions; SCCM, Society of Critical Care Medicine; SCCT, Society of Cardiovascular Computed To- mography; SCMR, Society for Cardiovascular Magnetic Resonance; STEMI, ST- elevation myocardial infarction; and STS, Society of Thoracic Surgeons. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA performance measures with other ACC/AHA/AMA- PCPI performance measure sets when possible. For example, the writing committee did not explore door-to- balloon time as a performance measure, given that this would overlap with performance measures for acute myocardial infarction already constructed and endorsed by numerous organizations. An example of harmonization within the measure set is the postprocedural optimal medical therapy composite measure in the present docu- ment, which is aligned with the similar National Quality Forum endorsed ACCF facility-level measure. 4. General Discussion 4.1. Process Measures Process measures have several advantages. They are more readily under the control of clinicians than are structural or outcome measures and also are actionable targets for quality improvement. Performance measures of processes are most useful when 1) they are directly linked to improved clinical outcomes through robust evidence, and 2) true gaps in care exist. Expending resources to measure processes that are already conducted at uniformly high rates is not justi ed, particularly when burdensome chart abstraction is required. An acknowledged limitation of process measures is that they might not always indicate how well the process was done. For example, measure 4 (use of embolic protection devices in the treatment of saphenous vein bypass graft disease) measures use of the embolic protection device during PCI but does not capture the technical skill with which it was deployed. We considered including measures assessing technical care processes performed in the cardiac catheterization labora- tory but did not include any such measures because of the lack of feasible, nonsubjective measurement criteria. This should be an area of future investigation. Two areas in which the writing committee tried to advance process measures were in patient selection measures and patient education/shared decision-making measures. Given the novelty of these topics, these are discussed in greater detail in the subsequent sections. 4.1.1. Patient Selection Measures As with many procedures, evaluating patient selection and determining appropriateness is a crucial rst step in ensuring high-quality clinical care. Nevertheless, this has not been done previously in performance measures for procedures. Ideally, this evaluation would revolve around both patients undergoing PCI and patients who are de- ferred from the procedure, to ensure that underutilization of potentially bene cial treatments is not occurring (17). Moreover, the indication (or reason) for the revasculariza- tion is attributable to several providers, including the referring physician and interventional cardiologist, as well as their discussions with the consenting patient. To date, the ACCF/SCAI/STS/AATS/AHA/ASNC/ HFSA/SCCT 2012 Appropriate Use Criteria for Coronary Table 4. ACC/AHA Task Force on Performance Measures: Attributes for Performance Measures 1. Evidence Based High-impact area that is useful in improving patient outcomes a) For structural measures, the structure should be closely linked to a meaningful process of care that in turn is linked to a meaningful patient outcome. b) For process measures, the scientific basis for the measure should be well established, and the process should be closely linked to a meaningful patient outcome. c) For outcome measures, the outcome should be clinically meaningful. If appropriate, performance measures based on outcomes should adjust for relevant clinical characteristics through the use of appropriate meth- odology and high-quality data sources. 2. Measure Selection Measure de nition a) The patient group to whom the measure applies (denominator) and the patient group for whom conformance is achieved (numerator) are clearly defined and clinically meaningful. Measure exceptions and exclusions b) Exceptions and exclusions are supported by evidence. Reliability c) The measure is reproducible across organizations and delivery settings. Face validity d) The measure appears to assess what it is intended to. Content validity e) The measure captures most meaningful aspects of care. Construct validity f) The measure correlates well with other measures of the same aspect of care. 3. Measure Feasibility Reasonable effort and cost* a) The data required for the measure can be obtained with reasonable effort and cost. Reasonable time period b) The data required for the measure can be obtained within the period allowed for data collection. Actionable* a) Those held accountable can affect the care process or outcome. Unintended consequences avoided b) The likelihood of negative unintended consequences with the measure is low. ACC indicates American College of Cardiology; AHA, American Heart Association. Adapted from: Normand SL, McNeil BJ, Peterson LE, et al. Eliciting expert opinion using the Delphi technique: identifying performance indicators for cardiovascular disease. Int J Qual Health Care. 1998;10:247 60. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Revascularization (11) and the ACCF/SCAI/AATS/ AHA/ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/ STS 2012 Appropriate Use Criteria for Diagnostic Catheter- ization (12) represent the professional societies attempt at providing a framework for evaluating the appropriateness of procedures in the cardiac catheterization laboratory (18). Prior research demonstrated that the indication for revascularization can be captured and evaluated for appropriateness, although high rates of incomplete data collection were noted (19). These criteria propose that emergency or urgent revascularization for patients with acute coronary syndromes is generally considered appropriate. However, for elective revascularization, several important features should be considered in determining appropriateness of cases, including symptom status, degree of ischemia, anatomy, and current medical therapy. These ele- ments are central to the data that should be captured as the indicationformostrevascularizationprocedures.Therefore,the initial goal of measure 1 (comprehensive documentation of indications for PCI) and measure 2 (appropriate indication for elective PCI) is to ensure that adequate information for assessing the indication for revascularization procedures is captured and reported, so that continued evaluation and feed- back to improve both the AUC ratings and clinical care can occur. 4.1.2. Patient Education/Shared Decision-Making Measures Although the aforementioned factors highlight the dif- culty of determining when PCI is clinically indicated, reaching a high-quality decision goes beyond meeting the AUC. In an area in which decision making is so com- plex, performance measurement ideally also would address how the decision was made. This is necessary because patient preferences can play an important role in many cases, especially with regard to elective PCI. For example, some patients whose medical history and diagnostic testing results suggest PCI is indicated might still want to consider other options. Conversely, there will be patients for whom it is equivocal whether PCI is indicated, but the patient nonetheless expresses a strong preference to undergo PCI. The ideal approach to decision making is to involve the patient to the extent he or she wishes to be involved. Performance measurement should re ect this process as much as possible. Many patients will want to be involved in these crucial decisions, and physicians performance with these patients ideally would be assessed in part by surveying patients about whether their input was solicited and their preferences drove or at least in uenced the decision. Alternatively, some patients will prefer that their physician make their decisions for them, and physicians who do so in such instances should be regarded as giving patient-centered care. In addition, all patients should be educated about their options. This education can be very brief in urgent settings, such as when a patient is having an ST-elevation myocardial infarction with cardiogenic shock. However, if any uncertainty exists about the superiority of PCI versus optimal medical therapy or surgical revascularization (as is usually the case with elective PCI), then the patient should be provided an opportunity to learn about the relative risks and bene ts of therapies under consideration. The writing committee struggled with whether to include process measures that focused on decision making and education through patient surveys. Surveys might be able to address general quality of decisions and ask patients about whether they were involved as much or as little as they desired. Survey results could then be shared at the physician and hospital levels, so both individual clinicians and institutions could understand and improve their decision-making processes. However, there are as yet no validated instruments addressing these domains, nor have other critical details been worked out. These limitations left the writing committee less enthusiastic about sup- porting a measure at the present time, but this should be a priority area for future investigation. 4.2. Outcome Measures If the focus of process measures re ects the journey, outcome measures shed light on the destinationdthe end, rather than the means. Outcome measures offer the potential advantage of providing readouts on entire populations, rather than smaller population subsets, and they focus on the end results of care that are most important to clinicians and patients. The challenges with outcome measures are primarily in the risk-adjustment modeling methods, which, though never perfect, can substantially enhance the ability to compare outcomes across different delivery teams, settings, locations, and systems (20). Krumholz et al. (20) have described 7 preferred attributes of models used for outcomes that are publicly reported (Table 5), which this the writing com- mittee strongly believes should remain at the core of any performance measure that includes outcomes. Table 5. Preferred Attributes of Models Used for Publicly Reported Outcomes 1. Clear and explicit definition of an appropriate patient sample 2. Clinical coherence of model variables 3. Sufficient high-quality and timely data 4. Designation of an appropriate reference time before which covariates are derived and after which outcomes are derived 5. Use of an appropriate outcome and a standardized period of outcome assessment 6. Application of an analytical approach that takes into account the multilevel organization of data 7. Disclosure of the methods used to compare outcomes, including disclosure of performance or risk-adjustment methodology in derivation and validation samples Reprinted with permission from Krumholz et al. (20). JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA 4.2.1. Level of Attribution/Aggregation Contributions of multiple healthcare providers across mul- tiple settings are re ected in outcomes associated with any particular episode of care, and this can be especially true in the case of PCI. In addition, various data sources and data systems are the window into that episode, such that the ability to aggregate data at the level of an individual clinician versus a broader grouping (e.g., practice or hospital) will depend on the types of data available and the outcomes being evaluated. Although data are increasingly available, most sources of information, like administrative claims data, generally lack adequate granularity to be of meaningful use for attribution of outcomes performance at the level of the individual provider, which makes aggregation of PCI out- comes more appropriate for the health system or hospital. 4.2.2. Infrequently Occurring Complications Certain outcomes could be of inarguable importance in PCI but occur rarely. Such outcomes are dif cult to interpret at the individual-provider level simply because of the fact that low-frequency events in a small sample size will produce unreliable estimates of provider performance. For this reason, certain measures are appropriately applied only to larger aggregated provider groupings where sample sizes are larger. These principles have substantial implications for PCI outcomes because the rates of major complications, such as death and the need for emergency coronary artery bypass surgery, have decreased signi cantly in recent years. Death is perhaps the most important and least ambiguous outcome measure. Proper risk adjustment isdand will remainda mandatory cornerstone of mortality monitoring for PCI. However, the writing committee also recognized that even the best risk-adjustment model cannot correct for potentially unmeasured confounders, and most risk- adjustment models perform less well at the extremes of risk. This requires a careful design of outcome measures to avoid the unintended consequence of either penalizing facilities or clinicians who take on more dif cult cases or rewarding those who avoid certain high-risk patients requiring treatment. In this context, the writing committee did not believe it was necessary to reproduce existing National Quality Forum endorsed measures that are already available in the public realm on in-hospital and 30-day mortality rate after PCI. The writing committee also considered a potential measure of 30-day readmission after PCI, given reportedly high rates of readmission and recent interest in this outcome by payers and policymakers. As in the case of mortality rate, risk- adjusted measures of 30-day readmission after PCI have been developed, and we point interested readers toward those measures (21 23). 4.2.4. Patient Surveys Patient survey data have been used to compare the care provided across health systems and providers. For example, the Mended Hearts pilot program conducted surveys of patients 6 months after PCI, asking a range of questions: What type of procedure did you have?, Are you following your medication regimen?, and What can be done to improve knowledge of medications? Medicare Health Outcome Surveys also have been administered, as have a NCQA-HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) and system-level survey. In addition, many individual hospital systems have devel- oped and implemented diagnosis-related group-based postdischarge surveys. Such surveys might be appropriate for measuring certain outcomes, including subjective func- tional status, symptoms, knowledge, and overall satisfaction with the care process. However, critics point out that such measures can be disproportionately weighted by items un- related to care, including availability of channels on the hospital television, food menu choices, and parking con- venience. In addition, standardized tools for symptom measurement and for patient subsets are generally lacking. For example, the response to the question, Did this pro- cedure save your life? could be different for a patient un- dergoing PCI with an acute myocardial infarction and a patient with stable angina. In addition, validated risk- adjustment models for patient survey data do not currently exist. Although the writing committee believes that patient surveys are an important area for future development (see also Section 4.1.2: Patient Education/ Shared Decision Making Measures), these limitations raised concerns about their inclusion in the present document. 4.3. Structural Measures For PCI, measures to evaluate process and outcomes are more clearly substantiated by an evidence base than are structural measures. Still, compared with many clinically important process and outcome measures, it is easier to assess structural measures and, importantly, to track changes longitudinally without need for risk adjustment. Given these considerations, as well as interest in and evi- dence on registries and the role of case volume in out- comes, we elected to include 3 measures of structure: measure 9 (regional or national PCI registry participation), measure 10 (annual operator PCI volume) (quality improvement only), and measure 11 (annual hospital PCI volume). It is the consensus of the writing committee that these structural measures can provide important contribu- tions to the assessment of care equity and safety without imposing undue data collection burden on hospitals or practitioners. For both of the PCI case volume speci c structural measures, existing standards encourage reporting (24). However, although the experience of the operator and the hospital performing PCI has been associated with improved outcomes, it is not clear what speci c threshold volume of PCI cases represents a true clinically important indicator. Thus, the intent of these case-volume measures is to encourage data collection rather than speci c targets. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 In addition, the writing committee recognizes the unique challenges of accurately documenting operator volume because some data systems cannot capture data for opera- tors who work at multiple sites, and self-reporting can have limitations. Given the challenges in capturing the required data, the limitations of the evidence supporting a speci c threshold for operator volume, and the potential for un- intended consequences, the writing committee designated the operator volume metric for use only in internal quality improvement because it does not comply with all the desirable attributes required (see Table 4 and footnotes to Table 1). The writing committee believes it is important to encourage tracking of operator volume, but it would not be appropriate to evaluate operators on the basis of volume of procedures alone, so this measure should not be used in accountability or public reporting programs. 5. Measures Included in This Set 5.1. Comprehensive Documentation of Indications for PCI Comprehensive documentation of the indication for PCI is an absolute requirement for performing the procedure. This should include an appropriate description of the key features of the clinical presentation, along with documentation of noninvasive stress testing and functional assessments (if clinically indicated and performed) and the severity of angiographic stenosis for the treated lesion. PCIs are per- formed to improve symptoms or survival. Documentation of these elements allows for an evaluation of the patient s indication for the procedure and also provides prognostic utility. This ultimately permits an appropriate risk/bene t ratio to be inferred for the procedure. In addition, ful llment of this measure will enable assessment of other important quality indicators derived from the ACC/AHA/SCAI guideline for PCI (4) and the appropriate use criteria for coronary revascularization documents (11,12). The docu- mentation for many PCIs performed in the United States lacks essential data to determine the procedure s appropri- ateness, making this a measure with a possibly important gap in care (19). A potential concern is that several of the features pertaining to the indication for PCI are attributable to both the physician referring the patient for PCI and the physician performing the procedure, which leads to chal- lenges with attribution. Nonetheless, the writing commit- tee s opinion is that compiling all the required elements at the level of the therapeutic intervention is a process of care that is linked to desirable outcomes for patients undergoing PCI. It is therefore the ultimate responsibility of the physician performing the PCI and of the physician s insti- tution to accurately document key features. 5.2. Appropriate Indication for Elective PCI There has been considerable discussion among the writing committee members about this performance measure in the context of the recently published AUC for coronary revascularization (11), which include assessments of both coronary artery bypass surgery and PCI, and the well- documented variation (25) in practice of PCI across the United States (11,12). Furthermore, prior attempts to construct performance measures have not relied heavily on AUC, so this represents one of the more innovative and unexplored aspects of this performance measure set. The writing committee therefore approached the creation of this measure cautiously to maximize its value to users without leading to unintended consequences that could be harmful to patients. Several key aspects of this measure deserve to be high- lighted. To optimize our opportunity to improve care, we focused on elective PCIs that occur in nonacute settings, inasmuch as analyses of PCIs performed in acute settings have shown that the vast majority of these procedures are classi ed as appropriate according to AUC (19). In addi- tion, even though we aimed to harmonize the document with recently published guidelines and AUC, this perfor- mance measure is not completely superimposable on their de nitions for 2 reasons. First, it is acknowledged that the AUC cannot possibly include every conceivable patient presentation of appropriateness. The AUC are created via a modi ed Delphi approach, in which experts reach consensus after being presented with speci c clinical sce- narios that focus on coronary anatomy, symptoms, current medical therapy, and noninvasive studies. Thus, subtle differences between the AUC and guidelines do exist, particularly for PCI. For example, the guidelines for PCI categorize the usefulness of these procedures for survival bene t in asymptomatic patients to be uncertain in pa- tients with 2- or 3-vessel [coronary artery disease] (with or without involvement of the proximal [left anterior descending] artery) or 1-vessel proximal [left anterior descending] disease (Class IIb recommendation), on the basis of insuf cient data. However, the AUC, as rated by experts, vary in their assessments of the usefulness of PCI in this setting from uncertain to appropriate, on the basis of the additional factors described previously (e.g., current medical therapy, noninvasive studies). Second, the criteria for the AUC are becoming a frequent part of daily clinical practice and of quality-improvement efforts, but they are not entirely noncontroversial (26). We therefore created a measure that more broadly captured appropriate use of PCI, using both the guidelines and the AUC as tools. Finally, the writing committee considered that, at the present time, the current measure does not entirely meet the strict criteria for accountability measures as put forth by Chassin et al. (27) and the ACC/AHA Task Force on Performance Measures (28). For example, the measure- ment of appropriateness of PCI is certainly consistent with 2 criteria, in that it is based on a strong foundation of research and captures a process proximate to a desired outcome (i.e., treating the right patient). Without existing data on its use in test populations, however, it is dif cult to JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA know whether the current measure accurately captures appropriateness (as opposed to encouraging gaming) or whether it will lead to unintended consequences by discouraging operators from taking on dif cult or high-risk procedures where, although the risk is high, the bene t could be great (i.e., whether the measure will promote underuse). Concern for this last issue is evident in the evolving processes of the AUC, which have undergone signi cant changes since their early iterations (see below). For these reasons, we designated this measure for internal quality improvement only (see Appendix C for a summary of the writing committee s evaluation). The writing committee also considered addressing the inappropriate indications for elective PCI, as this has been one of the most important features of the AUC. However, the AUC documents speci cally underscore the pivotal role of clinical judgment in determining whether revascu- larization is indicated for an individual patient. The rating of a revascularization as inappropriate by any schematic should not preclude a provider from performing PCI when patient- and condition-speci c data support that decision (11,12). This is re ected in new language; inappropriate has been changed to rarely appropriate. Nevertheless, documentation of the reasons for performing a PCI should still be mandatory. Because the criteria for appropriate indications for elective PCI appear to be, in general, less prone to various interpretations, the writing committee decided to focus on appropriate procedures at the present time. It is certainly possible that measurement of rarely appropriate indications for elective PCI might become part of future performance measures. 5.3. Assessment of Candidacy for Dual-Antiplatelet Therapy Dual-antiplatelet therapy is integral to preventing stent thrombosis in patients treated with stents during PCI. Current guidelines recommend dual-antiplatelet therapy for 4 weeks in patients who are treated with bare metal stents and 1 year in patients who are treated with a drug- eluting stent, though it is recognized that this recom- mendation is in ux (4). In any case, considerable data suggest that premature cessation of dual-antiplatelet ther- apy is associated with an increased risk of stent thrombosis and resultant myocardial infarction or death (29,30). It is therefore important that an assessment of tolerability of and adherence with long-term dual-antiplatelet therapy be made before the procedure and that the importance of dual-antiplatelet therapy be discussed with the patient before and after the procedure. For example, this might include (but not be limited to) questions about scheduled or anticipated surgeries. Ideally, this discussion should be part of the informed consent process, and the intended duration of dual-antiplatelet therapy should be docu- mented clearly before the procedure. It is recognized that ascertainment of candidacy for dual-antiplatelet therapy might not be feasible during emergencies or when a patient is unresponsive, and these patients have been excluded from the measure. 5.4. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Disease It is the opinion of the writing committee that, when technically feasible, embolic protection devices should be used during saphenous vein graft PCIs. This is consistent with current (2011) ACCF/AHA/SCAI guidelines, which made embolic protection device use during saphenous vein graft intervention a Class I recommendation (4). Of course, the writing committee recognizes that it might not be technically feasible to use an embolic protection device in all cases, depending on such factors as vessel tortuosity, lesion location and severity, vessel size, and Thrombolysis in Myocardial Infarction (TIMI) ow. If an embolic pro- tection device is not used during saphenous vein graft PCI, the writing committee believes that documentation of technical reasons, unsuitable anatomy, or patient refusal of the device should be provided. This measure was desig- nated for internal quality improvement only because a potential unintended consequence of this measure could be that it might inappropriately encourage use of embolic protection devices by operators without suf cient experi- ence in their use. 5.5. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedure Assessment of renal function should be a standard part of the preprocedural work-up of patients undergoing coronary angiography and intervention. It is well recognized that serum creatinine concentration by itself is a poor surrogate for renal function and that estimated glomerular ltration rate (GFR) should be calculated for each patient (4). Renal function (as estimated by calculated GFR) is important for dosing medications (including anticoagulants) and contrast media. An excess of bleeding events has been reported in patients who do not receive appropriately adjusted dosing of anticoagulation in the setting of renal dysfunction (31,32). Furthermore, current guidelines recommend use of preprocedural hydration in patients who have a reduced GFR (33,34). Estimated GFR should be calculated as close to the day of the procedure as possible and should be documented in the medical record, ideally as part of the preprocedural checklist. The writing committee also recommends that the total amount of contrast volume administered to a patient should be documented clearly in the procedure report. The risk of contrast-induced renal injury increases with increasing volume of contrast administered, and physicians should follow a principal of as low as reasonably pos- sible, especially in patients who have preexisting renal dysfunction (35). Although recent studies suggested an as- sociation between high total contrast dose (or GFR-based Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 contrast dose) and contrast-induced acute kidney injury, we do not believe that the current evidence is robust enough to support a speci c contrast threshold that should not be exceeded under any circumstance (4,32). In addition, no evidence indicates that simply documenting the dose is linked to improved patient outcomes. For these reasons, the writing committee designated this measure only for internal quality improvement at the present time. Of course, indi- vidual circumstances during a case often will dictate whether the use of additional contrast is worthwhile for the safety of the procedure. Nevertheless, recording the total volume of contrast used for each case, as required by the measure, should serve as the rst step toward understanding and modifying patterns of contrast use in cardiac catheterization laboratories. 5.6. Radiation Dose Documentation Current guidelines recommend that procedural radiation dose should be recorded for all patients and should be limited to as low as reasonably achievable, according to clinical circumstances. Measures of radiation dose include total air kerma at the interventional reference point, air kerma area product, uoroscopy time, and number of cine images (4). Furthermore, it is recommended that every catheterization laboratory de ne thresholds, with corre- sponding follow-up protocols, for patients who receive a high procedural radiation dose. It is most typical to report total uoroscopy time, but the writing committee recog- nized that this is a limited measure of total radiation exposure and dose. All contemporary interventional x-ray systems report the total air kerma area product (in Gray [Gy]) and air kerma area product (in Gycm2 ). When available, one or both of these measures should be docu- mented in the procedure report in addition to uoroscopy time. At the present time, the writing committee desig- nated this measure for internal quality improvement only to avoid potential unintended consequences, such as op- erators feeling a need to limit additional imaging even when it would be clinically useful (see Appendix C for a summary of the analysis). 5.7. Postprocedural Optimal Medical Therapy Composite Medical therapy, including aspirin, P2Y12 inhibitors, and statins, has been proved to reduce all-cause mortality and cardiovascular morbidity in multiple studies. These medi- cations should be prescribed to all patients who are eligible for them after PCI, except for the rare circumstances in which the life expectancy of the patient is limited or the patient has a known allergy or intolerance. Despite the strong endorsement from the guidelines and their robust evidence base, the use of these medications is less than optimal, particularly for statin therapy. Recently, Borden and colleagues (36) evaluated the use of optimal medical therapy in patients undergoing PCI for stable disease who were enrolled in the National Cardiovascular Data Registry CathPCI Registry. Statins were prescribed to 83% of pa- tients who were discharged alive after PCI, after exclusion of patients with a contraindication to or history of intol- erance of statins. Thus, opportunity remains for substantial improvement in the use of these medications in patients undergoing PCI (36). Incorporating these medications into the standard post-PCI order sets and having a detailed discussion of their bene ts can be very effective at ensuring patient adherence, particularly with statin therapy (37). This measure harmonizes closely with the corresponding facility-level postprocedural optimal medical therapy composite measure from the ACC (38). 5.8. Cardiac Rehabilitation Patient Referral Cardiac rehabilitation is a multidisciplinary exercise-based outpatient service that has been proved to provide patient bene t in terms of improved functional status, quality of life, medical resource use, and, ultimately, mortality rate reduction (39 46). Patients with coronary artery disease treated with PCI are at high risk of recurrent events and are particularly suitable for risk reduction via cardiac rehabili- tation. Unfortunately, cardiac rehabilitation is a vastly underutilized service, with available data indicating that less than half of eligible patients ultimately enroll in a program (47). There are numerous barriers to referral, entry, and completion of cardiac rehabilitation by patients. Although some of these barriers are nancial or system related (e.g., lack of a geographically convenient program), physician referral is a modi able barrier. Explicit physician referral of patients to cardiac rehabilitation has been shown to substantially increase the likelihood of patient enroll- ment (47,48). Although it could be argued that referral is the responsibility of a patient s primary physician or other members of the healthcare team, the writing committee believes that cardiac rehabilitation referral should be part of the comprehensive care of a patient undergoing PCI and should be the responsibility of the providers involved with that procedure, in a manner similar to treatment of dysli- pidemia. Referral during the index hospitalization for PCI is therefore optimal. The performance measure takes into account appropriate exclusions, such as medical non- suitability (e.g., history of comorbidities), patient prefer- ence, and lack of availability of a suitable program. This performance measure harmonizes closely with the corre- sponding measure from the ACCF/AHA/PCPI coronary artery disease performance measure set. In the future, broadening this measure to assess levels of participation on the basis of attendance, rather than simply referral, might be examined. 5.9. Regional or National PCI Registry Participation The writing committee believed strongly that every cath- eterization laboratory should participate in a national or regional PCI registry for benchmarking purposes. The bene ts of participating in a registry include the ability to JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA compare the catheterization laboratory s outcomes with those of similar laboratories of comparable volumes, so that the laboratory staff understands their outcomes in relation to national or regional standards. We believe this measure will encourage more cardiac catheterization laboratories to participate in large multicenter databases and collaboratives to improve the evidence base to support quality efforts in PCI. 5.10. Annual Operator and Hospital PCI Volume The writing committee designated the operator procedure volume as appropriate for internal quality improvement only, as indicated in Appendix C. It is well recognized that operator volume, though useful, is a limited surrogate for quality. This is due partly to the dif culty of collecting volume data for individual operators, who can practice across numerous facilities and even states. The volume of the catheterization laboratory in which an operator works seems to be a more trustworthy surrogate for quality than does individual operator volume. Although updated rec- ommendations exist for operator and institutional volumes (24), they are still based on observational studies that looked at a variety of facility volume thresholds. However, the preponderance of evidence suggests that facilities that perform <200 PCIs per year have worse outcomes than facilities that perform more procedures. Given the limita- tions of the evidence base, the writing committee felt strongly that no speci c threshold should be required for these measures, though it did see value in collecting these data for institutional and operator quality assurance. The writing committee also recognized the potential challenges of operators who are recently out of training or who transiently cease performing procedures because of job changes or health reasons (e.g., pregnancy). A potential unintended consequence of this measure that was discussed by the writing committee is that an operator might perform unnecessary procedures to achieve a threshold level. Future iterations of this measure will need to also address whether adjunctive coronary procedures (e.g., fractional ow reserve, intravascular ultrasound) and noncoronary pro- cedures (e.g., transcatheter aortic valve replacement) should be included in these assessments of operator and institu- tional volume, given that these techniques require over- lapping technical skills. 6. Potential Measures Considered But Not Included in This Set 6.1. Process Measures The writing committee considered several additional pro- cess measures for inclusion. A longitudinal measure assessing use of dual-antiplatelet therapy at 30 days and 1 year was considered. Although such a measure has a greater likelihood of improving care, the logistical challenges of collecting longitudinal drug data on an outpatient basis made it dif cult to implement this measure at the present time. 