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 recog- nized that this recommendation is in flux.4 In any case, consid- erable data suggest that premature cessation of dual-antiplatelet therapy 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 discus- sion 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 ascer- tainment 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 fac- tors as vessel tortuosity, lesion location and severity, vessel size, and Thrombolysis in Myocardial Infarction (TIMI) flow. If an embolic protection device is not used during saphenous vein graft PCI, the writing committee believes that documenta- tion of technical reasons, unsuitable anatomy, or patient refusal of the device should be provided. This measure was designated 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 sufficient experience 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 angi- ography and intervention. It is well recognized that serum creatinine concentration by itself is a poor surrogate for renal function and that estimated glomerular filtration rate (GFR) should be calculated for each patient.4 Renal function (as estimated by calculated GFR) is important for dosing medi- cations (including anticoagulants) and contrast media. An excess of bleeding events has been reported in patients who do not receive appropriately adjusted dosing of anticoagula- tion in the setting of renal dysfunction.31,32 Furthermore, cur- rent 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 con- trast-induced renal injury increases with increasing volume of contrast administered, and physicians should follow a princi- pal of as low as reasonably possible, especially in patients who have preexisting renal dysfunction.35 Although recent studies suggested an association between high total contrast dose (or GFR-based contrast dose) and contrast-induced acute kidney injury, we do not believe that the current evidence is robust enough to support a specific contrast threshold that should not be exceeded under any circumstance.4,32 In addi- tion, 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, individual circumstances during a case often will dictate whether the use of additional contrast is worthwhile for the safety of the pro- cedure. Nevertheless, recording the total volume of contrast used for each case, as required by the measure, should serve as the first 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 circum- stances. Measures of radiation dose include total air kerma at the interventional reference point, air kerma area product, fluoroscopy time, and number of cine images.4 Furthermore, it is recommended that every catheterization laboratory define thresholds, with corresponding follow-up protocols, for patients who receive a high procedural radiation dose. It is most typical to report total fluoroscopy time, but the writing committee recognized 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 documented in the procedure report in addition to fluoroscopy time. At the pres- ent time, the writing committee designated this measure for internal quality improvement only to avoid potential unin- tended consequences, such as operators 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 car- diovascular morbidity in multiple studies. These medications 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 colleagues36 evaluated the use of opti- mal medical therapy in patients undergoing PCI for stable dis- ease who were enrolled in the National Cardiovascular Data Registry CathPCI Registry. Statins were prescribed to 83% of patients who were discharged alive after PCI, after exclusion of patients with a contraindication to or history of intolerance of statins. Thus, opportunity remains for substantial improve- ment in the use of these medications in patients undergoing Incorporating these medications into the standard post- PCI order sets and having a detailed discussion of their benefits 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 out- patient service that has been proved to provide patient benefit in terms of improved functional status, quality of life, medi- cal 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 rehabilitation. Unfortunately, cardiac rehabilitation is a vastly underutilized service, with available Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 937 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 financial or system related (eg, lack of a geographically convenient program), physician referral is a modifiable barrier. Explicit physician referral of patients to cardiac rehabilitation has been shown to substan- tially increase the likelihood of patient enrollment.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 under- going PCI and should be the responsibility of the providers involved with that procedure, in a manner similar to treatment of dyslipidemia. Referral during the index hospitalization for PCI is therefore optimal. The performance measure takes into account appropriate exclusions, such as medical nonsuitability (eg, history of comorbidities), patient preference, and lack of availability of a suitable program. This performance measure harmonizes closely with the corresponding measure from the ACCF/AHA/PCPI coronary artery disease performance mea- sure 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 catheter- ization laboratory should participate in a national or regional PCI registry for benchmarking purposes. The benefits of participating in a registry include the ability to 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 inAppendix C. It is well recognized that operator volume, though useful, is a limited surrogate for quality. This is due partly to the difficulty of collecting volume data for individual operators, who can practice across numerous facilities and even states. The vol- ume 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 recommendations exist for operator and institutional volumes,24 they are still based on observational studies that looked at a variety of facility vol- ume thresholds. However, the preponderance of evidence sug- gests that facilities that perform <200 PCIs per year have worse outcomes than facilities that perform more procedures. Given the limitations of the evidence base, the writing committee felt strongly that no specific threshold should be required for these measures, though it did see value in collecting these data for institutional and operator quality assurance. The writing com- mittee 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 (eg, preg- nancy). 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 (eg, fractional flow reserve, intravascular ultrasound) and noncoronary procedures (eg, transcatheter aortic valve replacement) should be included in these assessments of operator and institutional volume, given that these techniques require overlapping technical skills. 6. Potential Measures Considered But Not Included in This Set 6.1. Process Measures The writing committee considered several additional process 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 difficult to implement this measure at the present time. We are hopeful that advances in information technology, electronic health records, and outpatient registries will make reliably collecting these data possible in the future. We also examined additional measures related to ad hoc PCI (PCI performed during the same session as diagnostic angio- gram) and multivessel PCI. These measures focused on exam- ining the core question of whether the PCI was appropriate in the context of additional therapeutic options, like medical therapy and coronary artery bypass surgery. This was an area of great interest and much discussion for the writing committee. However, in the end the group felt limited in our ability to con- struct feasible measures that could be applied reliably in clinical practice. We decided that these topics were ultimately beyond the charge of a writing committee focused on PCI. Our greatest barriers were the lack of definitive data on the risks and ben- efits of ad hoc PCI and multivessel PCI and their role in shared decision making by patients and providers.49,50 The writing com- mittee, therefore, decided that this topic might be considered in future updates of these measures or might be better handled by a writing committee focused entirely on developing performance measures for coronary revascularization (rather than just PCI). 6.2. Outcome Measures As noted previously, outcome measures are highly desirable but often difficult to incorporate into performance measure sets because of vulnerability to influences outside the provider s control. Thus, outcome measures, particularly those intended for use in accountability, should be supported by strong data and should address risk-adjustment concerns. For example, the writing committee considered a measure of the incidence of dialysis after PCI. However, this was ultimately not included because the need for unexpected dialysis after PCI is extremely rare, and when dialysis does occur after PCI, it is often in patients with marginal renal function before the PCI for whom the possibility of dialysis was discussed previously. Creating a measure in this area might dissuade these patients, who are often at high risk for coronary artery disease, from undergoing PCI. Several members of the writing committee supported the inclusion of a related measure of acute kidney injury after PCI that would depend on laboratory assessments of renal function. However, controversy exists about the diagnosis of acute kid- ney injury in this setting, and in many patients, it would require multiple blood tests that are otherwise not indicated. Similarly, the writing committee considered a measure assessing rates of blood transfusion after PCI. This was not included as a measure because the writing committee felt that it is currently challenging to adequately account for all the factors related to the decision to transfuse patients after PCI, some of which might be related only indirectly to the proce- dure. Emergency coronary artery bypass surgery after PCI was also considered as a measure, but in an era of widespread use of stents, the incidence is extremely small, which would make it an unreliable measure. Finally, a measure of periprocedural infarction based on cardiac biomarkers after PCI was consid- ered. However, standardized collection of cardiac biomarkers after PCI is still a variable practice, and this strongly influ- ences rates of periprocedural infarction. Given these concerns and that standardized collection of cardiac biomarkers after PCI is not a Class I recommendation in recent PCI guidelines, this measure was not included. Three outcome measures, in particular, were considered strongly by the writing committee, and these are reviewed in detail in the following sections. The writing committee considered a measure of assessment of angina. Given that one of the primary reasons for perform- ing PCI is to reduce angina, the concept of assessing anginal class in a structured way before PCI, and reassessing it in the same way after PCI, has intuitive appeal. However, the writing committee noted several challenges. First, it was recognized that angina/ischemia can present in different ways, and there was little agreement on how to account for unusual symptoms presenting as an anginal equivalent. Second, it was recog- nized that rigorous, standardized anginal class assessment (eg, the Seattle Angina Questionnaire), though standard in clinical trials, is not typically performed in the clinical setting, and that more common systems, like the Canadian Classification System, have poor reliability and are too subjective. These issues created a tension between the feasibility of a measure related to angina assessment and its usefulness. For these rea- sons, the writing committee decided not to include an assess- ment of angina in the present set, but it believes this should be an area of future development. 6.2.2. Thirty-Day Mortality Rate The writing committee considered a mortality measure, and the 30-day endpoint was discussed in particular, because this was identified as the time point (as opposed to 1 year) at which outcomes would be most closely related to the index proce- dure. For the reasons discussed in Section 4.2, death as an outcome measure has obvious appeal. It is overall an unam- biguous and unarguable endpoint and, along with stroke, is generally considered one of the worst possible outcomes of a PCI procedure. The challenges to using 30-day mortality rate as a performance measure relate primarily to risk-adjustment issues, and 2 main sentiments prevailed: 1) There was a strong desire to avoid penalizing operators for taking difficult cases. This arose from recognition that risk adjustment is less robust at the extremes of risk, as well as from acknowledgment of some of the unintended negative consequences that could result from focus on this outcome, at the individual-operator level, in terms of avoidance of difficult cases altogether or an undesirable displacement of them to nearby regions and operators subject to lesser scrutiny. 2) It was recognized that mortality rate has been a component of numerous prior efforts, and there was a desire to avoid duplicative efforts. For these reasons, the writing committee opted not to include a measure related to 30-day mortality rate. The occurrence of a negative outcome after PCI, such as reste- nosis or stent thrombosis, was also considered as an outcome measure. The writing committee generally agreed that reste- nosis and stent thrombosis are negative outcomes but was not in agreement that all of the factors that contribute to these out- comes are understood, or at least there was some lack of con- sensus about the extent to which these outcomes are related to factors within the operator s direct control. More impor- tantly, restenosis and stent thrombosis are both now relatively low-frequency events for any individual operator. In addition, presentation with either restenosis or thrombosis is not always to the same medical center where the index procedure was performed, which creates a challenge to accurately ascertain- ing the incidence of these outcomes at the individual-operator or center level. For these reasons, the writing committee did not include any outcome measures related to restenosis or thrombosis. 6.3. Structural Measures Two additional structural measures related to use of standard- ized protocols were carefully considered by the writing com- mittee. However, these structural measures were determined to be inappropriate for inclusion in the measure set at the pres- ent time. In both cases, use of protocols has been advocated as a way to potentially mitigate risk for patients in developing complications from PCI. First, given the high potential for morbidity and mortality associated with use of antiplatelet and anticoagulation therapy, the writing committee considered a measure to assess use of a standardized protocol for these agents. However, despite their extensive use of these protocols, there is scant evidence to link their use of a protocol to improved patient outcomes. Dosing guidelines exist for specific agents; however, there is a wide range of variability even in the guidelines to account for important clinical considerations, including adjustments for renal impairment, concomitant warfarin anticoagulation, and other clinical factors. Thus, the writing committee decided that the proposed measure offered little added value to quality care assessment at the present time, given the complexity required for its effective implementation. The writing committee does encourage development and implementation of protocols for antiplatelet and anticoagulant therapy as appropriate on a local basis, and reconsideration of this measure might occur in future iterations of this measure set as the evidence base evolves. Second, the writing committee considered use of a protocol for managing contrast-related nephropathy before and during Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 939 PCI but decided that the evidence base is not substantive enough to support inclusion of such a measure at the present time. However, as discussed in Section 5.1, the writing com- mittee did elect to include documentation of preprocedural estimated GFR and contrast dose as internal quality-improve- ment measures in this set. There is a tight linkage between GFR and contrast dose and development of contrast-related nephropathy. The writing committee felt that these measures should capture, with sufficient granularity, important data to guide local improvement efforts. As the evidence base to guide the management of contrast-related nephropathy con- tinues to evolve, consideration for inclusion might be appro- priate in future iterations of this measure set. 7. Areas for Further Research The writing committee identified 4 areas of interest for fur- ther investigation. Although the areas are relevant to perfor- mance measures in general, the writing committee felt they would have particularly important implications for measure- ment with regard to PCI. Some of these have been discussed throughout the present document in relevant sections but are highlighted here for additional emphasis. 7.1. Documentation of Prescription of Drugs Versus Filling of Drug Prescriptions and Optimal Dosing of Drugs The writing committee felt that it will be important in future work to examine moving beyond documentation of only the prescription of drugs to the actual filling of drug prescriptions and the optimal dosing of drugs. Unfortunately, using existing data collection systems to measure these is currently too dif- ficult, expensive, and prone to error to serve as a useful qual- ity measure. Additionally, a patient could be seen by several practitioners who have different standards for optimal dosing. 7.2. Limitations of Current Data Systems for PCI Administrative claims data are used for a large number of analyses focused on PCI utilization. Although valuable for capturing use and costs, these data are inadequate as a source for quality measures. For example, the Dartmouth Atlas has suggested for several years that substantial regional differ- ences exist in PCI utilization, leading to concerns that PCI A thorough understanding of the reasons for regional variation in these procedures and their value for out- comes, such as improvements in angina and quality of life, however, is still lacking. In addition, hospital-based systems for collecting data on PCI are increasingly incomplete because most elective procedures are now done with an outpatient or observational status rather than an inpatient status. 7.3. Shared Accountability Most patients who have undergone a PCI have come into con- tact with more than one physician before receiving their pro- cedure from an interventional cardiologist. These can include a primary care physician, emergency physician, hospitalist, intensivist, noninvasive cardiologist, and clinical cardiologist. Accountability for quality needs to occur throughout the pro- cess and should be shared by all the providers who care for the patient. Although accountability and subsequent outcomes lie primarily with the interventionist, many steps in the process that occurred before the PCI can contribute to optimizing patient care. This is equally true for care that happens after the PCI. 7.4. Patient Surveys The writing committee suggests that hospitals survey their PCI patients about their level of knowledge, level of educa- tion, and perception of outcomes of their procedures. This is an exciting and important method of ascertaining and ensur- ing patient education with regard to their perceived outcomes of PCI. The writing committee did not support including this as a measure because the outcomes of PCI vary according to presenting symptoms; for example, patients with an acute myocardial infarction could have an improved risk of mortal- ity as a result of their PCI, but patients undergoing elective PCI for chronic stable angina probably have no improvement in their outcome other than symptom relief. Staff American College of Cardiology John Gordon Harold, MD, MACC, FAHA, President Shalom Jacobovitz, Chief Executive Officer William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, and Quality Charlene L. May, Senior Director, Science and Clinical Policy Melanie Shahriary, RN, BSN, Director, Performance Measures and Data Standards American College of Cardiology/American Heart Association Naira Tahir, MPH, Specialist, Clinical Performance Measures American Heart Association Mariell Jessup, MD, FACC, FAHA, President Nancy Brown, Chief Executive Officer Rose Marie Robertson, MD, FACC, FAHA, FESC, Chief Science Officer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations Melanie B. Turner, MPH, Science and Medicine Advisor, Office of Science Operations Jody Hundley, Production Manager, Scientific Publishing, Office of Science Operations American Medical Association Physician Consortium for Performance Improvement Mark Antman, DDS, MBA, Director, Measure Development Operations Kendra Hanley, MS, Project Manager II, Measure Specifications, Standards, and Informatics Karen Kmetik, PhD,Vice President, Performance Improvement Marjorie Rallins, DPM, Director, Measure Specifications, Standards, and Informatics Samantha Tierney, MPH, Project Manager II, Measure Development Operations Gregory Wozniak, PhD, Director, Measure Analytics and Economic Evaluation Society for Cardiovascular Angiography and Interventions Wayne Powell, Senior Director for Advocacy & Guidelines Joel Harder, MBA, Director of Quality Initiatives and Clinical Documents References 1. Spertus JA, Eagle KA, Krumholz HM, et al. 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Barber K, Stommel M, Kroll J, et al. Cardiac rehabilitation for community- based patients with myocardial infarction: factors predicting discharge recommendation and participation. J Clin Epidemiol. 2001;54:1025 30. 49. Nallamothu BK, Krumholz HM. Putting ad hoc PCI on pause. JAMA. 2010;304:2059 60. 50. Blankenship JC, Gigliotti OS, Feldman DN, et al. Ad hoc percutane- ous coronary intervention: a consensus statement from the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2013;81:748 58. Key Words: AHA Scientific Statements health policy and outcome research quality indicators ambulatory-level quality hospital quality percutaneous coronary intervention Appendix A. Author Listing of Relationships With Industry and Other Entities (Relevant) ACC/AHA/SCAI/AMA-Convened PCPI/ NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Intervention Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Brahmajee K. Nallamothu, Co-Chair Ann Arbor VAMC Center for Clinical Management Research University of Michigan Associate Professor Prescription Solutions* None None BCBS Foundation of Michigan* Abbott Vascular None Carl L. Tommaso, Co-Chair NorthShore University HealthSystem Associate Professor, Rush Medical College Physician None None None None None None H. Vernon Anderson University of Texas Health Science Center Houston Professor, Department of Medicine None Bristol-Myers Squibb Sanofi-Aventis None MedPace (DSMB) DCRI Novartis Eli Lilly None None Jeffrey L. Anderson Intermountain Medical Center Associate Chief of Cardiology AstraZeneca Sanofi-Aventis None None Atherotech GlaxoSmithKline None None Joseph C. Cleveland, Jr. University of Colorado at Denver Professor of Surgery and Surgical Director, Cardiac Transplant and MCS Baxter Biosurgery None None None None None R. Adams Dudley Institute for Health Policy Studies Professor of Medicine and Health Policy None None None None None None Peter Louis Duffy FirstHealth of the Carolinas Medical Director, Cardiovascular Service Line at Reid Heart Center, Interventional Cardiology None Volcano None Volcano None None David P. Faxon Brigham and Women s Hospital Vice Chair of Medicine, Cardiology Johnson & Johnson None Reva Medical Biotronik (DSMB) Medtronic (DSMB) Direct Flow (DSMB) Boston Scientific (DSMB) None None Hitinder S. Gurm University of Michigan Cardiovascular Center Associate Professor None None None BCBS of Michigan * None None (Continued) Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 943 Appendix A. Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Lawrence A. Hamilton Kaiser Permanente, Northern California Regional Director, Cardiac and Renal Services None None None None None None Neil C. Jensen United Healthcare Director, Cardiology Network None None None None None None Richard A. Josephson University Hospitals of Cleveland Medical Group Professor of Medicine, Case Western Reserve University School of Medicine None None None None None None David J. Malenka Dartmouth- Hitchcock Medical Center Professor of Medicine, Division of Cardiology Wellpoint* None None Abbott Vascular None None Calin V. Maniu Bon Secours Health System, Suffolk, Virginia Physician None None None None None None Kevin W. McCabe S.C. Johnson & Son, Inc. Director of Occupational and Preventive Medicine None None None None None None James D. Mortimer Jim Mortimer Consulting Consultant None None None None None None Manesh R. Patel Duke University Medical Center Assistant Professor of Medicine None None None Genzyme None None Stephen D. Persell Feinberg School of Medicine, Northwestern University Assistant Professor of Medicine None None None None None None John S. Rumsfeld U.S. Veterans Health Administration National Director of Cardiology; Chief Science Officer, National Cardiovascular Data Registry United Healthcare* None None None None None (Continued) Appendix A. Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Kendrick A. Shunk San Francisco VA Medical Center Director of Interventional Cardiology Revascular Therapeutics None Revascular Therapeutics Siemens Medical Systems Abbott Vascular IntraRedx Gilead None None Sidney C. Smith, Jr. University of North Carolina at Chapel Hill Professor of Medicine None None None None None None Stephen J. Stanko The Mended Hearts, Inc. National Cath Patient Outreach Chair None None None None None None Brook Watts Louis Stokes Cleveland VA Medical Center Associate Professor of Medicine, Case Western Reserve University None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *At the time that this committee was convened, third-party payers were not deemed relevant. Dr. Nallamothu's relationship with Abbott Vascular (attended training for MitraClip) was added shortly before finalization of the performance measures, so it was not relevant during the development of the measures. No financial relationship. Recused from voting on measure 7. Significant (greater than $10000) relationship. Recused from voting on measures 9 and 11. ACC indicates American College of Cardiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; BCBS, Blue Shield Blue Cross; DCRI, Duke Clinical Research Institute; DSMB, Data Safety Monitoring Board; NCQA, National Committee for Quality Assurance; SCAI, Society for Cardiovascular Angiography and Interventions; VA, Veterans Affairs. Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 945 Appendix B. Reviewer Relationships With Industry and Other Entities (Relevant) ACC/AHA/SCAI/AMA-Convened PCPI/NCQA 2013 Performance Measures for Adults Undergoing Percutaneous Coronary Interventions Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Nancy Albert Content Reviewer ACC/AHA Task Force on Performance Measures Merck* BG Medicine Medtronic None None None None None Joseph M. Allen Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Steven R. Bailey Content Reviewer ACC Appropriate Use Criteria Task Force None None Biostar Palmaz Scientific Boston Scientific (DSMB) None None Justin M. Bachmann Official Reviewer ACC Board of Governors None None None None None None Biykem Bozkurt Content Reviewer ACC/AHA Task Force on Data Standards None None None Forest Pharmaceuticals PI NIH PI NIH Co-Investigator None Nakela L. Cook Organizational Reviewer NHLBI None None None None None None Pamela S. Douglas Content Reviewer ACC Appropriate Use Criteria Task Force Pappas Ventures None None Roche* Bristol-Myers Squib* Abiomed* Novartis* Miracor* Edwards Lifesciences* Atritech* None None Thomas C. Gerber Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee Content Reviewer AHA None None None None None None Robert C. Hendel Content Reviewer ACC Appropriate Use Criteria Task Force Bayer Adenosine Therapeutics None None None None None Kalon K.L. Ho Official Reviewer SCAI Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None Boston Scientific* None Hani Jneid Content Reviewer AHA None None None None None None Christopher M. Kramer Content Reviewer ACC Appropriate Use Criteria Task Force Synarc None None Novartis Siemens None None Carl J. Lavie Jr. Organizational Reviewer AACVPR Abbott Boehringer Ingelheim GlaxoSmithKline Pfizer Upsher Smith Amarin* AstraZeneca None None None None None Alice M. Mascette Organizational Reviewer NHLBI None None None None None None (Continued) Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Frederick A. Masoudi Content Reviewer ACC NCDR Science and Quality Oversight Committee Content Reviewer AHA None None None None None None Laura Mauri Official Reviewer AHA Abbott Cordis Johnson & Johnson Medtronic None None Abbott Abiomed Boston Scientific Bristol-Myers Squibb Cordis Daiichi Sankyo Eli Lilly Johnson & Johnson Medtronic Sanofi-Aventis Harvard Clinical Research Institute None None James K. Min Content Reviewer ACC Appropriate Use Criteria Task Force None GE Healthcare TC3* Phillips Healthcare* Arineta* None None Manesh R. Patel Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric D. Peterson Official Reviewer ACC/AHA Task Force on Performance Measures Boehringer Ingelheim Genentech Janssen Pharmaceuticals Johnson & Johnson Merck None None Eli Lilly Johnson & Johnson Janssen Pharmaceuticals DCRI None Sunil V. Rao Official Reviewer SCAI AstraZeneca Bristol-Myers Squibb Cordis Daiichi Sankyo Terumo Medical The Medicines Company None None Sanofi-Aventis Abbott Vascular* None None Matthew T. Roe Content Reviewer ACC NCDR Science and Quality Oversight Committee KAI Pharmaceuticals Daiichi Sankyo GlaxoSmithKline Janssen Pharmaceuticals Eli Lilly Bristol-Myers Squibb Sanofi-Aventis None AstraZeneca Bristol-Myers Squibb Eli Lilly Merck Roche Pharmaceuticals Sanofi-Aventis AstraZeneca* AstraZeneca lectures performed within DCRI None Frank Rybicki Content Reviewer ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee None None None Bracco Diagnostics Toshiba Medical Systems None None Leslee Shaw Content Reviewer ACC Appropriate Use Criteria Task Force None None None Bracco Diagnostics None None Marc Shelton Content Reviewer ACC Board of Governors None None None None None None John Spertus Content Reviewer ACC Appropriate Use Criteria Coronary Revascularization Genentech United Healthcare Scientific Advisory Board Amgen None None Eli Lilly CV Outcomes* None (Continued) Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 947 Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Raymond F. Stainback Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None Eric Stecker Content Reviewer ACC Clinical Quality Committee None None None Biotronik Medtronic Boston Scientific None None James E. Tcheng Content Reviewer ACC/AHA Task Force on Data Standards None None None Philips Medical Systems None None Randal J. Thomas Organizational Reviewer AACVPR None None None None None None Thomas T. Tsai Content Reviewer ACC NCDR Science and Quality Oversight Committee None None None None None None Thad Waites Official Reviewer ACC Board of Trustees None None None None None None Tracy Y. Wang Content Reviewer ACC/AHA Task Force on Data Standards AstraZeneca Medco Health Solutions None None Bristol-Myers Squibb Canyon Pharmaceuticals Daiichi Sankyo Eli Lilly Heartscape Merck Sanofi-Aventis The Medicines Company Gilead None None Michael J. Wolk Content Reviewer ACC Appropriate Use Criteria Task Force None None None None None None This table represents the relationships of reviewers with industry and other entities that were disclosed at the time of peer review and determined to be relevant. It does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $10 000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. A relationship is considered to be modest if it is less than significant under the preceding definition. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACCF/AHA, a person has a relevant relationship IF: a) The relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) The company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) The person or a member of the person's household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *No financial relationship. Significant (greater than $10000) relationship. DCRI has numerous grants and contracts sponsored by industry. These include the following: Aastrom Biosciences ; Abbott ; Abiomed ; Acom Cardiovascular ; Adolor Corp. ; Advanced Cardiovascular Systems ; Advanced Stent Technologies ; Adynnx; Aijnomoto ; Allergan ; Amgen ; Alnylam Pharma ; Alpharma ; Amylin Pharmaceuticals ; Anadys ; Anesiva ; Angel Medical Systems ; ANGES MG ; Angiomedtrix ; APT Nidus Center ; ASCA Biopharma ; Astellas Pharma ; Asklepios ; AstraZeneca ; Atritech ; Attention Therapeutics ; Aventis ; Baxter ; Bayer ; Berlex ; BG Medicine ; Biogen ; Biolex Therapeutics ; Biomarker Factory ; Biosite ; Boehringer Ingelheim Biogen ; Boston Scientific ; Bristol-Myers Squibb ; BMS Pfizer ; Carbomed ; CardioDx ; CardioKinetix ; Cardiovascular Systems ; Cardiovax ; Celsion Corp. ; Centocor ; Cerexa ; Chase Medical ; Conatus Pharmaceuticals ; Conor Medsystems ; Cortex ; Corgentech ; CSL Behring ; CV Therapeutics ; Daiichi Pharmaceuticals ; Daiichi Sankyo ; Daiichi Sankyo Lilly ; Datascope; Dendreon ; Dainippon ; Dr. Reddy s Laboratories; Eclipse Surgical Technologies ; Edwards Lifesciences ; Eisai ; Endicor ; EnteroMedics ; Enzon Pharmaceuticals ; Eli Lilly ; Ethicon ; Ev3 ; Evalve ; F2G ; Flow Cardia ; Fox Hollow Pharmaceuticals ; Fujisawa ; Genetech ; General Electric ; General Electric Co. ; General Electric Healthcare ; General Electric Medical Systems ; Genzyme Corp. ; Genome Canada ; Gilead Sciences ; GlaxoSmithKline ; Guidant Corp. ; Heartscape Technologies ; Hoffman-LaRoche ; Hospira ; Idera Pharmaceuticals ; Ikaria ; Imcor Pharmaceuticals ; Immunex ; INFORMD ; Inimex ; Inspire Pharmaceuticals ; Ischemix ; Janssen ; Johnson and Johnson ; Jomed ; Juventus Therapeutics ; KAI Pharmaceuticals ; King Pharmaceuticals ; Kyowa Pharma ; Luitpold ; Mardil ; MedImmune ; Medscape ; Medtronic Diabetes ; Medtronic ; Medtronic Vascular ; Merck Group ; MicroMed Technology ; Millennium Pharmaceuticals ; Mitsubishi Tanabe ; Momenta ; Nabriva ; Neuron Pharmaceuticals ; NitroMed; NovaCardia Inc ; Novartis AG Group ; Novartis Pharmaceuticals ; Oncura ; Orexigen ; Ortho-McNeil-Janssen ; OSI Eyetech ; OSI Pharmaceuticals ; Pfizer ; Pharmacyclics ; Pharmasset ; Pharmos ; Phyxius Pharmaceuticals; Pharsight ; Pluristen Therapeutics ; Portola Pharmaceuticals ; Proventys ; Radiant ; Regado Biosciences ; Rengeneron Pharmaceuticals ; Roche Molecular Systems ; Roche Group ; Roche Diagnostic ; Salix Pharmaceuticals ; Sanofi-Pasteur, Inc; Sanofi-aventis ; Santaris Pharmaceuticals ; Schering-Plough ; Scios ; Siemens ; Southwest Oncology Group ; Spectranetics ; Summit ; Sunovion Pharmaceuticals ; TAP Pharmaceutical Products ; Tengion ; The Medicines Company ; Theravance ; TherOx ; Tethys Bioscience ; Theregen ; Three Rivers Pharmaceuticals ; The EMMES Corporation ; UCB ; Valentis ; Valleylab ; Vertex ; Viacor ; and Wyeth . AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; ACC, American College of Cardiology; ACR, American College of Radiology; AHA, American Heart Association; AMA-PCPI, American Medical Association Physician Consortium for Performance Improvement; CV, Cardiovascular; DCRI, Duke Clinical Research Institute; DSMB, Data Safety Monitoring Board; NCDR, National Cardiovascular Data Registry; NCQA, National Committee for Quality Assurance; NHLBI, National Heart, Lung, and Blood Institute; SCAI, Society for Cardiovascular Angiography and Interventions. Appendix C. ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Percutaneous Coronary Interventions Performance Measures: Summary Analysis Table Completely Fulfills Attribute* Partially Fulfills or Does Not Fulfill Attribute* Summary Comments Measures included in the performance measure set Comprehensive Documentation of PCI 1,2,3,4 Appropriate Indication for Elective PCI 1,2,3b,4 3a Lack of existing data on use in test populations makes it difficult to know whether the current measure accurately captures appropriateness (as opposed to encouraging gaming) or whether it will lead to unintended consequences by punishing providers. Assessment of Candidacy for Dual- Antiplatelet Therapy 1,2,4 3 ACCF National Cardiovascular Data Registry CathPCI Registry is unable to measure this. It will require additional chart documentation and abstraction. Use of Embolic Protection Devices in the Treatment of Saphenous Vein Bypass Graft Disease 2,3b,4 1b, 3a The guideline Class of Recommendation is 1, and Level of Evidence is only B. Documentation of Preprocedural Glomerular Filtration Rate and Contrast Dose Used During the Procedure 2,3,4 1 There are few potential unintended consequences, given that there are no thresholds specified in this measure. However, evidence indicates that doses are inconsistently documented. Therefore, although this measure is expected to have limited impact because it requires only documentation, it is an intermediate step to a more meaningful performance measure. Radiation Dose Documented 2,3,4 1 There are few potential unintended consequences given that there are no thresholds specified in this measure. However, evidence indicates that doses are inconsistently documented. Therefore, although this measure is expected to have limited impact because it requires only documentation, it is an intermediate step to a more meaningful performance measure. Postprocedural Optimal Medical Therapy Composite 1,2,3,4 Registry data are currently limited, making it unfeasible to capture specific medical, patient, or system exceptions. Cardiac Rehabilitation Patient Referral 1,2,3,4 Regional or National PCI Registry Participation 2,3,4 1 The guideline Class of Recommendation is 1, but Level of Evidence is only C. Annual Operator PCI Volume 2,3b 1,3a,4 There are potential unintended consequences because operators might be more inclined to intervene when the procedure is not indicated. This measure could pose a feasibility challenge if a person works at multiple sites. Annual Hospital PCI Volume 2,3 1,4 Smaller hospitals might be more inclined to intervene when the procedure is not indicated, to achieve higher volumes. Measures considered but not included in the performance measure set Assessment of patient knowledge of benefits and risks of PCI 1,4b 2,3,4a Limited availability of validated surveys. Limited existing literature on patient education or actionable methods to improve it. Postprocedural dialysis 1 2,3,4 Dialysis might not be related to PCI. Long measurement period is needed to capture data, given it is a rare event. Postprocedural blood transfusion 1 3,4 Bleeding might occur outside interventionalists locus of control. Measurement of cardiac biomarkers N/A 1,2,3,4 Evidence is still controversial. Periprocedural angina assessment 1,2 3,4 This is a potentially high-impact area with validated instruments, yet little data exist on how to best incorporate validated instruments into routine practice without excessive effort or costs. Aspirin/thienopyridine at discharge 3,4 1,2 There is little room for major impact or improvement, given existing evidence of already high compliance rates. *Corresponding numbers and letters are linked to the ACC/AHA Task Force on Performance Measures Attributes for Performance Measures. Numbers indicate the entire attribute, and letters indicate specific attribute subcriteria. These measures are performance measures. Indicated in shading, these measures have been designated quality metrics. Quality metric are designated for use in internal quality-improvement programs only. These measures are not appropriate for any other purpose (eg, pay-for-performance, physician ranking, or public reporting programs). Where applicable, the writing committee provided summary comments about why certain measures were included or not included in the final measure set. For all attributes noted as partially or does not fulfill attribute, the writing committee provided summary comments. ACCF indicates American College of Cardiology Foundation; AHA, American Heart Association; GFR, glomerular filtration rate; and PCI, percutaneous coronary intervention. Nallamothu et al ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 PCI Performance Measure 949 Attributes and subcriteria key: 1. Evidence based: 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. For process measures, the scientific basis for the measure is well established, and the process should be closely linked to a meaningful patient outcome. For outcome measures, the outcome should be clini- cally meaningful. If appropriate, performance mea- sures based on outcomes should adjust for relevant clinical characteristics through the use of appropri- ate methodology and high-quality data sources. 2. Measure selection: The patient group to whom the measure applies (denominator) and the patient group for whom con- formance is achieved (numerator) are clearly defined and clinically meaningful. Exceptions and exclusions are supported by evidence. The measure is reproducible across organizations and delivery settings. Face validity The measure appears to assess what it is intended to. 2e. Content validity The measure captures most mean- ingful aspects of care. Construct validity The measure correlates well with other measures of the same aspect of care. 3. Measure feasibility: The data required for the measure can be obtained with reasonable effort and cost. The data required for the measure can be obtained within the period allowed for data collection. Actionable Those held accountable can affect the care process or outcome. The likelihood of negative unintended consequences with the measure is low.