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.


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.


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.


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.


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.


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.


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).


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.


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).


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.


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).


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.


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.


, 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. We are hopeful that advances in information tech- nology, 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 angiogram) and multivessel PCI. These measures focused on examining the core question of whether the PCI was appropriate in the context of additional therapeutic op- tions, like medical therapy and coronary artery bypass surgery. This was an area of great interest and much dis- cussion for the writing committee. However, in the end the group felt limited in our ability to construct feasible mea- sures 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 de nitive data on the risks and bene ts of ad hoc PCI and multivessel PCI and their role in shared decision making by patients and providers (49,50).


Our greatest barriers were the lack of de nitive data on the risks and bene ts of ad hoc PCI and multivessel PCI and their role in shared decision making by patients and providers (49,50). The writing committee, therefore, decided that this topic might be considered in future updates of these measures or might be better handled by a writing com- mittee focused entirely on developing performance mea- sures for coronary revascularization (rather than just PCI). 6.2. Outcome Measures As noted previously, outcome measures are highly desirable but often dif cult to incorporate into performance measure sets because of vulnerability to in uences outside the pro- vider 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 kidney 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.


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 procedure. Emergency coronary artery bypass surgery after Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 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 considered. However, stan- dardized collection of cardiac biomarkers after PCI is still a variable practice, and this strongly in uences rates of peri- procedural infarction. Given these concerns and that stan- dardized 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 assess- ment of angina. Given that one of the primary reasons for performing 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 ap- peal. However, the writing committee noted several chal- lenges. 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 recognized that rigorous, standardized anginal class assessment (e.g.


Second, it was recognized that rigorous, standardized anginal class assessment (e.g., 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 Classi - cation 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 reasons, the writing committee decided not to include an assessment 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 identi ed as the time point (as opposed to 1 year) at which outcomes would be most closely related to the index procedure. For the reasons discussed in Section 4.2, death as an outcome measure has obvious appeal. It is overall an unambiguous 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 pri- marily to risk-adjustment issues, and 2 main sentiments prevailed: 1) There was a strong desire to avoid penalizing operators for taking dif cult cases. This arose from recog- nition that risk adjustment is less robust at the extremes of risk, as well as from acknowledgment of some of the un- intended negative consequences that could result from focus on this outcome, at the individual-operator level, in terms of avoidance of dif cult cases altogether or an undesirable displacement of them to nearby regions and operators subject to lesser scrutiny.


This arose from recog- nition that risk adjustment is less robust at the extremes of risk, as well as from acknowledgment of some of the un- intended negative consequences that could result from focus on this outcome, at the individual-operator level, in terms of avoidance of dif cult 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 restenosis or stent thrombosis, was also considered as an outcome measure. The writing committee generally agreed that restenosis and stent thrombosis are negative outcomes but was not in agreement that all of the factors that contribute to these outcomes are understood, or at least there was some lack of consensus about the extent to which these outcomes are related to factors within the operator s direct control. More importantly, 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 ascertaining 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 standardized protocols were carefully considered by the writing committee. However, these structural measures were determined to be inappropriate for inclusion in the measure set at the present time.


However, these structural measures were determined to be inappropriate for inclusion in the measure set at the present 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 mor- tality 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 speci c agents; however, there is a wide range of variability even in the guidelines to account for important clinical considerations, including adjustments for renal impair- ment, 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 implementa- tion 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. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Second, the writing committee considered use of a protocol for managing contrast-related nephropathy before and during 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 committee did elect to include documentation of preprocedural estimated GFR and contrast dose as in- ternal quality-improvement measures in this set.


However, as discussed in Section 5.1, the writing committee did elect to include documentation of preprocedural estimated GFR and contrast dose as in- ternal quality-improvement measures in this set. There is a tight linkage between GFR and contrast dose and devel- opment of contrast-related nephropathy. The writing committee felt that these measures should capture, with suf cient granularity, important data to guide local improvement efforts. As the evidence base to guide the management of contrast-related nephropathy continues to evolve, consideration for inclusion might be appropriate in future iterations of this measure set. 7. Areas for Further Research The writing committee identi ed 4 areas of interest for further investigation. Although the areas are relevant to performance measures in general, the writing committee felt they would have particularly important implications for measurement 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 lling of drug prescriptions and the optimal dosing of drugs. Unfortu- nately, using existing data collection systems to measure these is currently too dif cult, expensive, and prone to error to serve as a useful quality 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.


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 differences exist in PCI utilization, leading to concerns that PCI is overutilized (25). A thorough un- derstanding of the reasons for regional variation in these procedures and their value for outcomes, such as im- provements 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 contact with more than one physician before receiving their procedure from an interventional cardiologist. These can include a primary care physician, emergency physician, hospitalist, intensivist, noninvasive cardiologist, and clin- ical cardiologist. Accountability for quality needs to occur throughout the process and should be shared by all the providers who care for the patient. Although accountability and subsequent outcomes lie primarily with the interven- tionist, 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 edu- cation, and perception of outcomes of their procedures. This is an exciting and important method of ascertaining and ensuring patient education with regard to their perceived outcomes of PCI.


This is an exciting and important method of ascertaining and ensuring patient education with regard to their perceived outcomes of PCI. The writing committee did not support including this as a measure because the out- comes of PCI vary according to presenting symptoms; for example, patients with an acute myocardial infarction could have an improved risk of mortality 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 Of cer 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 Donna Arnett, PhD, MSPH, FAHA, President Nancy Brown, Chief Executive Of cer Rose Marie Robertson, MD, FACC, FAHA, FESC, Chief Science Of cer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Of ce of Science Operations Melanie B. Turner, MPH, Science and Medicine Advisor, Of ce of Science Operations Nallamothu et al. JACC Vol. 63, No.


Staff American College of Cardiology John Gordon Harold, MD, MACC, FAHA, President Shalom Jacobovitz, Chief Executive Of cer 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 Donna Arnett, PhD, MSPH, FAHA, President Nancy Brown, Chief Executive Of cer Rose Marie Robertson, MD, FACC, FAHA, FESC, Chief Science Of cer Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Of ce of Science Operations Melanie B. Turner, MPH, Science and Medicine Advisor, Of ce of Science Operations Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Jody Hundley, Production Manager, Scienti c Publishing, Of ce of Science Operations American Medical AssociationdPhysician Consortium for Performance Improvement Mark Antman, DDS, MBA, Director, Measure Development Operations Kendra Hanley, MS, Project Manager II, Measure Speci cations, Standards, and Informatics Karen Kmetik, PhD, Vice President, Performance Improvement Marjorie Rallins, DPM, Director, Measure Speci cations, 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. American College of Cardiology and American Heart Association methodology for the selection and creation of performance measures for quantifying the quality of cardiovascular care. J Am Coll Cardiol 2005;45:1147 56. 2. Spertus JA, Bonow RO, Chan P, et al.


J Am Coll Cardiol 2005;45:1147 56. 2. Spertus JA, Bonow RO, Chan P, et al. ACCF/AHA new insights into the methodology of performance measurement: a report of the American College of Cardiology Foundation/American Heart As- sociation Task Force on Performance Measures. J Am Coll Cardiol 2010;56:1767 82. 3. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. 4. Levine GN, Bates ER, Blankenship JC, et al. 2011 ACCF/AHA/ SCAI guideline for percutaneous coronary intervention: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 2011;58:e44 122. 5. O Gara PT, Kushner FG, Ascheim DD, et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/Amer- ican Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013;61:e78 140. 6. Anderson JL, Adams CD, Antman EM, et al. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction). J Am Coll Cardiol 2007;50:e1 157. 7. Wright RS, Anderson JL, Adams CD, et al. 2011 ACCF/AHA focused update of the guidelines for the management of patients with unstable angina/non-ST-elevation myocardial infarction (updating the 2007 guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2011;57:1920 59. 8. Jneid H, Anderson JL, Wright RS, et al.


J Am Coll Cardiol 2011;57:1920 59. 8. Jneid H, Anderson JL, Wright RS, et al. 2012 ACCF/AHA 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): a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2012;60:645 81. 9. Smith SC Jr., Benjamin EJ, Bonow RO, et al. AHA/ACCF sec- ondary prevention and risk reduction therapy for patients with cor- onary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American Col- lege of Cardiology Foundation. Circulation 2011;124:2458 73. 10. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/ AATS/AHA/ASNC 2009 appropriateness criteria for coronary revascularization: a report by the American College of Cardiology Foundation Appropriateness Criteria Task Force, Society for Car- diovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, and the American Society of Nuclear Cardiology. J Am Coll Cardiol 2009;53:530 53. 11. Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/STS/ AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology, and the Society of Cardiovascular Computed Tomog- raphy. J Am Coll Cardiol 2012;59:857 81. 12. Patel MR, Bailey SR, Bonow RO, et al.


J Am Coll Cardiol 2012;59:857 81. 12. Patel MR, Bailey SR, Bonow RO, et al. ACCF/SCAI/AATS/AHA/ ASE/ASNC/HFSA/HRS/SCCM/SCCT/SCMR/STS 2012 appro- priate use criteria for diagnostic catheterization: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and In- terventions, American Association for Thoracic Surgery, American Heart Association, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Failure Society of America, Heart Rhythm Society, Society of Critical Care Medicine, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, and Society of Thoracic Surgeons. J Am Coll Cardiol 2012;59:1995 2027. 13. Physician Consortium for Performance Improvement. Speci cation and Categorization of Measure Exclusions: Recommendations to PCPI Work Groups. American Medical Association; 2008Available at: http://www. ama-assn.org/resources/doc/cqi/exclusions053008.pdf. Accessed May 7, 2013. 14. Boden WE, O Rourke RA, Teo KK, et al. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med 2007; 356:1503 16. 15. Trikalinos TA, Alsheikh-Ali AA, Tatsioni A, et al. Percutaneous coronary interventions for non-acute coronary artery disease: a quantitative 20-year synopsis and a network meta-analysis. Lancet 2009;373:911 8. 16. Wijeysundera HC, Nallamothu BK, Krumholz HM, et al. Meta- analysis: effects of percutaneous coronary intervention versus medical therapy on angina relief. Ann Intern Med 2010;152:370 9. 17. Ko DT, Guo H, Wijeysundera HC, et al. Assessing the association of appropriateness of coronary revascularization and clinical outcomes for patients with stable coronary artery disease. J Am Coll Cardiol 2012;60:1876 84. 18. Patel MR, Wolk MJ, Allen JM, et al. The privilege of self-regulation: the role of appropriate use criteria. J Am Coll Cardiol 2011;57:1557 9. 19. Chan PS, Patel MR, Klein LW, et al. Appropriateness of percuta- neous coronary intervention. JAMA 2011;306:53 61. 20. Krumholz HM, Brindis RG, Brush JE, et al.


JAMA 2011;306:53 61. 20. Krumholz HM, Brindis RG, Brush JE, et al. Standards for statistical models used for public reporting of health outcomes: an American Heart Association scienti c statement from the Quality of Care and Outcomes Research Interdisciplinary Writing Group. Circulation 2006;113:456 62. 21. Curtis JP, Schreiner G, Wang Y, et al. All-cause readmission and repeat revascularization after percutaneous coronary intervention in a cohort of Medicare patients. J Am Coll Cardiol 2009;54:903 7. 22. Hannan EL, Zhong Y, Krumholz H, et al. 30-Day readmission for patients undergoing percutaneous coronary interventions in New York State. J Am Coll Cardiol Intv 2011;4:1335 42. 23. Khawaja FJ, Shah ND, Lennon RJ, et al. Factors associated with 30- day readmission rates after percutaneous coronary intervention. Arch Intern Med 2012;172:112 7. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA 24. Harold JG, Bass TA, Bashore TM, et al. ACCF/AHA/SCAI 2013 update of the clinical competence statement on coronary artery inter- ventional procedures: a report of the American College of Cardiology Foundation/American Heart Association/American College of Physi- cians Task Force on Clinical Competence and Training (Writing Committee to Revise the 2007 Clinical Competence Statement on Cardiac Interventional Procedures). J Am Coll Cardiol 2013;62:357 96. 25. Brownlee S, Wennberg JE, Barry MJ, et al., for the Dartmouth Institute for Health Policy and Clinical Practice. Improving Patient Decision-Making in Health Care: A 2011 Dartmouth Atlas Report Highlighting Minnesota. Hanover, NH: Dartmouth Institute for Health Policy and Clinical Practice; 2011. Available at: http://www. dartmouthatlas.org/downloads/reports/Decision_making_report_022411. pdf. Accessed October 11, 2013. 26. Marso SP, Teirstein PS, Kereiakes DJ, et al. Percutaneous coronary intervention use in the United States: de ning measures of appro- priateness. J Am Coll Cardiol Intv 2012;5:229 35. 27. Chassin MR, Loeb JM, Schmaltz SP, et al.


J Am Coll Cardiol Intv 2012;5:229 35. 27. Chassin MR, Loeb JM, Schmaltz SP, et al. Accountability measures using measurement to promote quality improvement. N Engl J Med 2010;363:683 8. 28. Bonow RO, Masoudi FA, Rumsfeld JS, et al. ACC/AHA classi - cation of care metrics: performance measures and quality metrics: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures. J Am Coll Car- diol 2008;52:2113 7. 29. Grines CL, Bonow RO, Casey DE Jr., et al. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angi- ography and Interventions, American College of Surgeons, and American Dental Association, with representation from the Amer- ican College of Physicians. J Am Coll Cardiol 2007;49:734 9. 30. Iakovou I, Schmidt T, Bonizzoni E, et al. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126 30. 31. Melloni C, Peterson ED, Chen AY, et al. Cockcroft-Gault versus modi cation of diet in renal disease: importance of glomerular ltration rate formula for classi cation of chronic kidney disease in patients with non-ST-segment elevation acute coronary syndromes. J Am Coll Cardiol 2008;51:991 6. 32. Gurm HS, Dixon SR, Smith DE, et al. Renal function-based contrast dosing to de ne safe limits of radiographic contrast media in patients undergoing percutaneous coronary interventions. J Am Coll Cardiol 2011;58:907 14. 33. Schweiger MJ, Chambers CE, Davidson CJ, et al. Prevention of contrast induced nephropathy: recommendations for the high risk patient undergoing cardiovascular procedures. Catheter Cardiovasc Interv 2007;69:135 40. 34. Stacul F, van der Molen AJ, Reimer P, et al. Contrast induced ne- phropathy: updated ESUR Contrast Media Safety Committee guidelines. Eur Radiol 2011;21:2527 41. 35.


Contrast induced ne- phropathy: updated ESUR Contrast Media Safety Committee guidelines. Eur Radiol 2011;21:2527 41. 35. Mehran R, Aymong ED, Nikolsky E, et al. A simple risk score for prediction of contrast-induced nephropathy after percutaneous cor- onary intervention: development and initial validation. J Am Coll Cardiol 2004;44:1393 9. 36. Borden WB, Redberg RF, Mushlin AI, et al. Patterns and intensity of medical therapy in patients undergoing percutaneous coronary intervention. JAMA 2011;305:1882 9. 37. Fonarow GC, Gawlinski A, Moughrabi S, et al. Improved treatment of coronary heart disease by implementation of a Cardiac Hospitali- zation Atherosclerosis Management Program (CHAMP). Am J Cardiol 2001;87:819 22. 38. National Cardiovascular Data Registry. Measures and Metrics. Available at: https://www.ncdr.com/WebNCDR/home/metrics-and- measures. Accessed May 10, 2013. 39. Goel K, Lennon RJ, Tilbury RT, et al. Impact of cardiac reha- bilitation on mortality and cardiovascular events after percutaneous coronary intervention in the community. Circulation 2011;123: 2344 52. 40. Taylor RS, Brown A, Ebrahim S, et al. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med 2004;116: 682 92. 41. Giannuzzi P, Temporelli PL, Marchioli R, et al. Global secondary prevention strategies to limit event recurrence after myocardial infarction: results of the GOSPEL study, a multicenter, randomized controlled trial from the Italian Cardiac Rehabilitation Network. Arch Intern Med 2008;168:2194 204. 42. Witt BJ, Jacobsen SJ, Weston SA, et al. Cardiac rehabilitation after myocardial infarction in the community. J Am Coll Cardiol 2004;44: 988 96. 43. Thompson PD. Exercise and physical activity in the prevention and treatment of atherosclerotic cardiovascular disease. Arterioscler Thromb Vasc Biol 2003;23:1319 21. 44. Clark AM, Hartling L, Vandermeer B, et al. Meta-analysis: sec- ondary prevention programs for patients with coronary artery disease. Ann Intern Med 2005;143:659 72. 45.


Meta-analysis: sec- ondary prevention programs for patients with coronary artery disease. Ann Intern Med 2005;143:659 72. 45. Thomas RJ, King M, Lui K, et al. AACVPR/ACC/AHA 2007 performance measures on cardiac rehabilitation for referral to and delivery of cardiac rehabilitation/secondary prevention services. J Am Coll Cardiol 2007;50:1400 33. 46. Walther C, M bius-Winkler S, Linke A, et al. Regular exercise training compared with percutaneous intervention leads to a reduction of in- ammatory markers and cardiovascular events in patients with coronary artery disease. Eur J Cardiovasc Prev Rehabil 2008;15:107 12. 47. Balady GJ, Ades PA, Bittner VA, et al. Referral, enrollment, and delivery of cardiac rehabilitation/secondary prevention programs at clinical centers and beyond: a presidential advisory from the American Heart Association. Circulation 2011;124:2951 60. 48. Barber K, Stommel M, Kroll J, et al. Cardiac rehabilitation for community-based patients with myocardial infarction: factors pre- dicting discharge recommendation and participation. J Clin Epi- demiol 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 percu- taneous coronary intervention: a consensus statement from the So- ciety for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv 2013;81:748 58. Key Words: ACC/AHA/SCAI/AMA-PCPI/NCQA Performance Measures - health policy and outcome research - quality indicators - ambulatory-level quality - hospital quality - percutaneous coronary intervention. Nallamothu et al. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Appendix A.


63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Appendix A. Author Listing of Relationships With Industry and Other Entities (Relevant)d 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 Bene t Expert Witness Brahmajee K. Nallamothu, Co-Chair Ann Arbor VAMC Center for Clinical Management Research University of Michigand Associate Professor  Prescription Solutions* None None  BCBS Foundation of Michigan*  Abbott Vasculary None Carl L. Tommaso, Co-Chair NorthShore University HealthSystemd Associate Professor, Rush Medical College Physician None None None None None None H. Vernon Anderson University of Texas Health Science Center Houstond Professor, Department of Medicine None  Bristol-Myers Squibb  Sano -Aventis None  MedPace (DSMB)  DCRIz  Novartis  Eli Lilly None None Jeffrey L. Andersonx Intermountain Medical CenterdAssociate Chief of Cardiology  AstraZeneca  Sano -Aventis None None  Atherotech  GlaxoSmithKline None None Joseph C. Cleveland, Jr. University of Colorado at Denverd Professor of Surgery and Surgical Director, Cardiac Transplant and MCS  Baxter Biosurgery None None None None None R. Adams Dudley Institute for Health Policy Studiesd Professor of Medicine and Health Policy None None None None None None Peter Louis Duffy FirstHealth of the Carolinasd Medical Director, Cardiovascular Service Line at Reid Heart Center, Interventional Cardiology None  Volcano None  Volcano None None David P. Faxon Brigham and Women s HospitaldVice Chair of Medicine, Cardiology  Johnson & Johnson None  Reva Medical  Biotronik (DSMB)z  Medtronic (DSMB)z  Direct Flow (DSMB)  Boston Scienti c (DSMB) None None Hitinder S. Gurm University of Michigan Cardiovascular CenterdAssociate Professor None None None  BCBS of Michigank* None None Lawrence A. Hamilton Kaiser Permanente, Northern Californiad Regional Director, Cardiac and Renal Services None None None None None None Neil C. Jensen United Healthcared Director, Cardiology Network None None None None None None Richard A. Josephson University Hospitals of Cleveland Medical GroupdProfessor of Medicine, Case Western Reserve University School of Medicine None None None None None None David J. Malenka Dartmouth-Hitchcock Medical Centerd Professor of Medicine, Division of Cardiology  Wellpoint* None None  Abbott Vascular None None Continued on the next page JACC Vol.


63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Appendix A. Continued Committee Member Employment Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Calin V. Maniu Bon Secours Health System, Suffolk, VirginiadPhysician None None None None None None Kevin W. McCabe S.C. Johnson & Son, Inc.dDirector of Occupational and Preventive Medicine None None None None None None James D. Mortimer Jim Mortimer Consultingd Consultant None None None None None None Manesh R. Patel Duke University Medical Centerd Assistant Professor of Medicine None None None  Genzyme None None Stephen D. Persell Feinberg School of Medicine, Northwestern Universityd Assistant Professor of Medicine None None None None None None John S. Rumsfeld{ U.S. Veterans Health Administrationd National Director of Cardiology; Chief Science Of cer, National Cardio- vascular Data Registry  United Healthcare* None None None None None Kendrick A. Shunk San Francisco VA Medical Centerd Director of Interventional Cardiology  Revascular Therapeutics None  Revascular Therapeutics  Siemens Medical Systemsk  Abbott Vasculark  IntraRedxk  Gilead None None Sidney C. Smith, Jr. University of North Carolina at Chapel HilldProfessor of Medicine None None None None None None Stephen J. Stanko The Mended Hearts, Inc.dNational Cath Patient Outreach Chair None None None None None None Brook Watts Louis Stokes Cleveland VAMedicalCenterd 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.


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 $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. 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. yDr. 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. zNo financial relationship. xRecused from voting on measure 7. kSignificant (greater than $10,000) relationship. {Recused from voting on measures 9 and 11.


xRecused from voting on measure 7. kSignificant (greater than $10,000) 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. JACC Vol. 63, No.


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. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Appendix B. Reviewer Relationships With Industry and Other Entities (Relevant)d 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 Bene t Expert Witness Nancy Albert Content Reviewerd ACC/AHA Task Force on Performance Measures  Merck*  BG Medicine  Medtronic None None None None None Joseph M. Allen Content Reviewerd ACC Appropriate Use Criteria Task Force None None None None None None Steven R. Bailey Content Reviewerd ACC Appropriate Use Criteria Task Force None None  Biostar  Palmaz Scienti c  Boston Scienti c (DSMB) None None Justin M. Bachmann Of cial Reviewerd ACC Board of Governors None None None None None None Biykem Bozkurt Content Reviewerd ACC/AHA Task Force on Data Standards None None None  Forest PharmaceuticalsdPIy  NIHdPIy  NIHd Co-Investigatory None Nakela L. Cook Organizational Reviewerd NHLBI None None None None None None Pamela S. Douglas Content Reviewerd 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 Reviewerd ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee Content ReviewerdAHA None None None None None None Robert C. Hendel Content Reviewerd ACC Appropriate Use Criteria Task Force  Bayer  Adenosine Therapeutics None None None None None Kalon K.L.


7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Appendix B. Reviewer Relationships With Industry and Other Entities (Relevant)d 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 Bene t Expert Witness Nancy Albert Content Reviewerd ACC/AHA Task Force on Performance Measures  Merck*  BG Medicine  Medtronic None None None None None Joseph M. Allen Content Reviewerd ACC Appropriate Use Criteria Task Force None None None None None None Steven R. Bailey Content Reviewerd ACC Appropriate Use Criteria Task Force None None  Biostar  Palmaz Scienti c  Boston Scienti c (DSMB) None None Justin M. Bachmann Of cial Reviewerd ACC Board of Governors None None None None None None Biykem Bozkurt Content Reviewerd ACC/AHA Task Force on Data Standards None None None  Forest PharmaceuticalsdPIy  NIHdPIy  NIHd Co-Investigatory None Nakela L. Cook Organizational Reviewerd NHLBI None None None None None None Pamela S. Douglas Content Reviewerd 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 Reviewerd ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee Content ReviewerdAHA None None None None None None Robert C. Hendel Content Reviewerd ACC Appropriate Use Criteria Task Force  Bayer  Adenosine Therapeutics None None None None None Kalon K.L. Ho Of cial ReviewerdSCAI Content Reviewerd ACC NCDR Science and Quality Oversight Committee None None None None  Boston Scienti c* None Hani Jneid Content ReviewerdAHA None None None None None None Christopher M. Kramer Content Reviewerd ACC Appropriate Use Criteria Task Force  Synarc None None  Novartisy  Siemens None None Carl J. Lavie Jr.


Ho Of cial ReviewerdSCAI Content Reviewerd ACC NCDR Science and Quality Oversight Committee None None None None  Boston Scienti c* None Hani Jneid Content ReviewerdAHA None None None None None None Christopher M. Kramer Content Reviewerd ACC Appropriate Use Criteria Task Force  Synarc None None  Novartisy  Siemens None None Carl J. Lavie Jr. Organizational Reviewerd AACVPR  Abbott  Boehringer Ingelheim  GlaxoSmithKliney  P zery  Upsher Smith  Amarin*  AstraZeneca None None None None None Alice M. Mascette Organizational ReviewerdNHLBI None None None None None None Continued on the next page JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Appendix B.


7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Frederick A. Masoudi Content Reviewerd ACC NCDR Science and Quality Oversight Committee Content ReviewerdAHA None None None None None None Laura Mauri Of cial ReviewerdAHA  Abbott  Cordis  Johnson & Johnson  Medtronic None None  Abbotty  Abiomedy  Boston Scienti cy  Bristol-Myers Squibby  Cordisy  Daiichi Sankyoy  Eli Lillyy  Johnson & Johnsony  Medtronicy  Sano -Aventisy  Harvard Clinical Research Institutey None None James K. Min Content Reviewerd ACC Appropriate Use Criteria Task Force None  GE Healthcare  TC3*  Phillips Healthcare*  Arineta* None None Manesh R. Patel Content Reviewerd ACC Appropriate Use Criteria Task Force None None None None None None Eric D. Peterson Of cial Reviewerd ACC/AHA Task Force on Performance Measures  Boehringer Ingelheim  Genentech  Janssen Pharmaceuticals  Johnson & Johnson  Merck None None  Eli Lillyy  Johnson & Johnsony  Janssen Pharmaceuticalsy  DCRIz None Sunil V. Rao Of cial ReviewerdSCAI  AstraZeneca  Bristol-Myers Squibb  Cordis  Daiichi Sankyo  Terumo Medical  The Medicines Company None None  Sano -Aventis  Abbott Vascular* None None Matthew T. Roe Content Reviewerd ACC NCDR Science and Quality Oversight Committee  KAI Pharmaceuticalsy  Daiichi Sankyoy  GlaxoSmithKline  Janssen Pharmaceuticalsy  Eli Lilly  Bristol-Myers Squibby  Sano -Aventisy None  AstraZenecay  Bristol-Myers Squibby  Eli Lillyy  Mercky  Roche Pharmaceuticalsy  Sano -Aventisy  AstraZeneca*  AstraZenecadlectures performed within DCRI None Frank Rybicki Content Reviewerd ACC/AHA/ACR/AMA- PCPI/NCQA Cardiac Imaging Writing Committee None None None  Bracco Diagnosticsy  Toshiba Medical Systemsy None None Leslee Shaw Content Reviewerd ACC Appropriate Use Criteria Task Force None None None  Bracco Diagnostics None None Marc Shelton Content Reviewerd ACC Board of Governors None None None None None None John Spertus Content Reviewerd ACC Appropriate Use Criteria Coronary Revascularization  Genentech  United Healthcare Sci- enti c Advisory Board  Amgen None None  Eli Lillyy  CV Outcomes* None Raymond F. Stainback Content Reviewerd ACC Appropriate Use Criteria Task Force None None None None None None Continued on the next page Nallamothu et al.


JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Appendix B. Continued Peer Reviewer Representation Consultant Speaker s Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Bene t Expert Witness Eric Stecker Content Reviewerd ACC Clinical Quality Committee None None None  Biotroniky  Medtronicy  Boston Scienti cy None None James E. Tcheng Content Reviewerd ACC/AHA Task Force on Data Standards None None None  Philips Medical Systemsy None None Randal J. Thomas Organizational Reviewerd AACVPR None None None None None None Thomas T. Tsai Content Reviewerd ACC NCDR Science and Quality Oversight Committee None None None None None None Thad Waites Of cial Reviewerd ACC Board of Trustees None None None None None None Tracy Y. Wang Content Reviewerd ACC/AHA Task Force on Data Standards  AstraZeneca  Medco Health Solutions None None  Bristol-Myers Squibb  Canyon Pharmaceuticals  Daiichi Sankyo  Eli Lilly  Heartscape  Merck  Sano -Aventis  The Medicines Company  Gilead None None Michael J. Wolk Content Reviewerd 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 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. ySignificant (greater than $10,000) relationship. zDCRI has numerous grants and contracts sponsored by industry.


ySignificant (greater than $10,000) relationship. zDCRI has numerous grants and contracts sponsored by industry. These include the following: Aastrom Biosciencesy; Abbotty; Abiomedy; Acom Cardiovasculary; Adolor Corp.y; Advanced Cardiovascular Systemsy; Advanced Stent Technologiesy; Adynnx; Aijnomotoy; Allergany; Amgeny; Alnylam Pharmay; Alpharmay; Amylin Pharmaceuticalsy; Anadysy; Anesivay; Angel Medical Systemsy; ANGES MGy; Angiomedtrixy; APT Nidus Centery; ASCA Biopharmay; Astellas Pharmay; Asklepiosy; AstraZenecay; Atritechy; Attention Therapeuticsy; Aventisy; Baxtery; Bayery; Berlexy; BG Mediciney; Biogeny; Biolex Therapeuticsy; Biomarker Factoryy; Biositey; Boehringer Ingelheim Biogeny; Boston Scientificy; Bristol-Myers Squibby; BMS Pfizery; Carbomedy; CardioDxy; CardioKinetixy; Cardiovascular Systemsy; Cardiovaxy; Celsion Corp.y; Centocory; Cerexay; Chase Medicaly; Conatus Pharmaceuticalsy; Conor Medsystemsy; Cortexy; Corgentechy; CSL Behringy; CV Therapeuticsy; Daiichi Pharmaceuticalsy; Daiichi Sankyoy; Daiichi Sankyo Lillyy; Datascope; Dendreony; Dainippony; Dr. Reddy s Laboratories; Eclipse Surgical Technologiesy; Edwards Lifesciencesy; Eisaiy; Endicory; EnteroMedicsy; Enzon Pharmaceuticalsy; Eli Lillyy; Ethicony; Ev3y; Evalvey; F2Gy; Flow Cardiay; Fox Hollow Pharmaceuticalsy; Fujisaway; Genetechy; General Electricy; General Electric Co.y; General Electric Healthcarey; General Electric Medical Systemsy; Genzyme Corp.y; Genome Canaday; Gilead Sciencesy; GlaxoSmithKliney; Guidant Corp.y; Heartscape Technologiesy; Hoffman-LaRochey; Hospiray; Idera Pharmaceuticalsy; Ikariay; Imcor Pharmaceuticalsy; Immunexy; INFORMDy; Inimexy; Inspire Pharmaceuticalsy; Ischemixy; Jansseny; Johnson and Johnsony; Jomedy; Juventus Therapeuticsy; KAI Pharmaceuticalsy; King Pharmaceuticalsy; Kyowa Pharmay; Luitpoldy; Mardily; MedImmuney; Medscapey; Medtronic Diabetesy; Medtronicy; Medtronic Vasculary; Merck Groupy; MicroMed Technologyy; Millennium Pharmaceuticalsy; Mitsubishi Tanabey; Momentay; Nabrivay; Neuron Pharmaceuticalsy; NitroMed; NovaCardia Incy; Novartis AG Groupy; Novartis Pharmaceuticalsy; Oncuray; Orexigeny; Ortho-McNeil-Jansseny; OSI Eyetechy; OSI Pharmaceuticalsy; Pfizery; Pharmacyclicsy; Pharmassety; Pharmosy; Phyxius Pharmaceuticals; Pharsighty; Pluristen Therapeuticsy; Portola Pharmaceuticalsy; Proventysy; Radianty; Regado Biosciencesy; Rengeneron Pharmaceuticalsy; Roche Molecular Systemsy; Roche Groupy; Roche Diagnosticy; Salix Pharmaceuticalsy; Sanofi-Pasteur, Inc; Sanofi-aventisy; Santaris Pharmaceuticalsy; Schering-Ploughy; Sciosy; Siemensy; Southwest Oncology Groupy; Spectraneticsy; Summity; Sunovion Pharmaceuticalsy; TAP Pharmaceutical Productsy; Tengiony; The Medicines Companyy; Theravancey; TherOxy; Tethys Biosciencey; Theregeny; Three Rivers Pharmaceuticalsy; The EMMES Corporationy; UCBy; Valentisy; Valleylaby; Vertexy; Viacory; and Wyethy.


These include the following: Aastrom Biosciencesy; Abbotty; Abiomedy; Acom Cardiovasculary; Adolor Corp.y; Advanced Cardiovascular Systemsy; Advanced Stent Technologiesy; Adynnx; Aijnomotoy; Allergany; Amgeny; Alnylam Pharmay; Alpharmay; Amylin Pharmaceuticalsy; Anadysy; Anesivay; Angel Medical Systemsy; ANGES MGy; Angiomedtrixy; APT Nidus Centery; ASCA Biopharmay; Astellas Pharmay; Asklepiosy; AstraZenecay; Atritechy; Attention Therapeuticsy; Aventisy; Baxtery; Bayery; Berlexy; BG Mediciney; Biogeny; Biolex Therapeuticsy; Biomarker Factoryy; Biositey; Boehringer Ingelheim Biogeny; Boston Scientificy; Bristol-Myers Squibby; BMS Pfizery; Carbomedy; CardioDxy; CardioKinetixy; Cardiovascular Systemsy; Cardiovaxy; Celsion Corp.y; Centocory; Cerexay; Chase Medicaly; Conatus Pharmaceuticalsy; Conor Medsystemsy; Cortexy; Corgentechy; CSL Behringy; CV Therapeuticsy; Daiichi Pharmaceuticalsy; Daiichi Sankyoy; Daiichi Sankyo Lillyy; Datascope; Dendreony; Dainippony; Dr. Reddy s Laboratories; Eclipse Surgical Technologiesy; Edwards Lifesciencesy; Eisaiy; Endicory; EnteroMedicsy; Enzon Pharmaceuticalsy; Eli Lillyy; Ethicony; Ev3y; Evalvey; F2Gy; Flow Cardiay; Fox Hollow Pharmaceuticalsy; Fujisaway; Genetechy; General Electricy; General Electric Co.y; General Electric Healthcarey; General Electric Medical Systemsy; Genzyme Corp.y; Genome Canaday; Gilead Sciencesy; GlaxoSmithKliney; Guidant Corp.y; Heartscape Technologiesy; Hoffman-LaRochey; Hospiray; Idera Pharmaceuticalsy; Ikariay; Imcor Pharmaceuticalsy; Immunexy; INFORMDy; Inimexy; Inspire Pharmaceuticalsy; Ischemixy; Jansseny; Johnson and Johnsony; Jomedy; Juventus Therapeuticsy; KAI Pharmaceuticalsy; King Pharmaceuticalsy; Kyowa Pharmay; Luitpoldy; Mardily; MedImmuney; Medscapey; Medtronic Diabetesy; Medtronicy; Medtronic Vasculary; Merck Groupy; MicroMed Technologyy; Millennium Pharmaceuticalsy; Mitsubishi Tanabey; Momentay; Nabrivay; Neuron Pharmaceuticalsy; NitroMed; NovaCardia Incy; Novartis AG Groupy; Novartis Pharmaceuticalsy; Oncuray; Orexigeny; Ortho-McNeil-Jansseny; OSI Eyetechy; OSI Pharmaceuticalsy; Pfizery; Pharmacyclicsy; Pharmassety; Pharmosy; Phyxius Pharmaceuticals; Pharsighty; Pluristen Therapeuticsy; Portola Pharmaceuticalsy; Proventysy; Radianty; Regado Biosciencesy; Rengeneron Pharmaceuticalsy; Roche Molecular Systemsy; Roche Groupy; Roche Diagnosticy; Salix Pharmaceuticalsy; Sanofi-Pasteur, Inc; Sanofi-aventisy; Santaris Pharmaceuticalsy; Schering-Ploughy; Sciosy; Siemensy; Southwest Oncology Groupy; Spectraneticsy; Summity; Sunovion Pharmaceuticalsy; TAP Pharmaceutical Productsy; Tengiony; The Medicines Companyy; Theravancey; TherOxy; Tethys Biosciencey; Theregeny; Three Rivers Pharmaceuticalsy; The EMMES Corporationy; UCBy; Valentisy; Valleylaby; Vertexy; Viacory; and Wyethy. 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.


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. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA Appendix C. ACC/AHA/SCAI/AMA-PCPI/NCQA 2013 Percutaneous Coronary Interventions Performance Measures: Summary Analysis Table Completely Ful lls Attribute* Partially Ful lls or Does Not Ful ll Attribute* Summary Commentsx Measures included in the performance measure set Comprehensive Documentation of PCIy 1,2,3,4 Appropriate Indication for Elective PCIz 1,2,3b,4 3a Lack of existing data on use in test populations makes it dif cult 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 Therapyy 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 Diseasez 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 Procedurez 2,3,4 1 There are few potential unintended consequences, given that there are no thresholds speci ed 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.


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 Documentedz 2,3,4 1 There are few potential unintended consequences given that there are no thresholds speci ed 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 Compositey 1,2,3,4 Registry data are currently limited, making it unfeasible to capture speci c medical, patient, or system exceptions. Cardiac Rehabilitation Patient Referraly 1,2,3,4 Regional or National PCI Registry Participationy 2,3,4 1 The guideline Class of Recommendation is 1, but Level of Evidence is only C. Annual Operator PCI Volumez 2,3b 1,3a,4  There are potential unintended consequences because opera- tors 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 Volumey 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 bene ts 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.


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. yThese measures are performance measures. zIndicated 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 (e.g., pay-for-performance, physician ranking, or public reporting programs). xWhere 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. JACC Vol. 63, No. 7, 2014 ACC/AHA/SCAI/AMA-PCPI/NCQA February 25, 2014:722 45 Attributes and subcriteria key: 1. Evidence based: 1a. 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. 1b. For process measures, the scienti c basis for the measure is well established, and the process should be closely linked to a meaningful patient outcome. 1c. For outcome measures, the outcome should be clinically meaningful.


1c. For outcome measures, the outcome should be clinically meaningful. If appropriate, perfor- mance measures based on outcomes should adjust for relevant clinical characteristics through the use of appropriate methodology and high-quality data sources. 2. Measure selection: 2a. The patient group to whom the measure applies (denominator) and the patient group for whom conformance is achieved (numerator) are clearly de ned and clinically meaningful. 2b. Exceptions and exclusions are supported by evidence. 2c. The measure is reproducible across organiza- tions and delivery settings. 2d. Face validitydThe measure appears to assess what it is intended to. 2e. Content validitydThe measure captures most meaningful aspects of care. 2f. Construct validitydThe measure correlates well with other measures of the same aspect of care. 3. Measure feasibility: 3a. The data required for the measure can be ob- tained with reasonable effort and cost. 3b. The data required for the measure can be ob- tained within the period allowed for data collection. 4a. ActionabledThose held accountable can affect the care process or outcome. 4b. The likelihood of negative unintended conse- quences with the measure is low. JACC Vol. 63, No. 7, 2014 Nallamothu et al. February 25, 2014:722 45 ACC/AHA/SCAI/AMA-PCPI/NCQA


CLINICAL STATEMENTS AND GUIDELINES T he comorbidities of hypertension, diabetes mellitus, obesity, hyperlipidemia, and metabolic syndrome are common in patients with heart failure (HF) and affect clinical outcomes.1 3 Interestingly, although these comorbidities are associated with the development of incident HF in the general population, in pa- tients with established HF, their contributory roles to clinical outcomes are not pre- dictable, and their management is quite challenging. Recent American College of Cardiology Foundation (ACCF)/American Heart Association (AHA) guidelines have addressed the role of lifestyle modification,4 treatment of blood cholesterol,5 and management of overweight and obesity6 in the general population and in patients with increased cardiovascular risk, and a recent report from the Eighth Joint Na- tional Committee addressed the management of hypertension.7 However, these guidelines did not specifically address the management of such comorbidities in patients with HF. Similarly, the most recent ACCF/AHA HF practice guidelines8 in 2013 addressed the overall management of comorbidities in patients with HF in broad terms, but again, specific and detailed recommendations on how to man- age hypertension, obesity, diabetes mellitus, hyperlipidemia, and metabolic syn- drome are lacking. The intent of this AHA scientific statement is to summarize data relevant to contributory risk and to provide guidance on the management of hypertension, obesity, diabetes mellitus, hyperlipidemia, and metabolic syndrome in the development and prognosis of HF to provide recommendations (Table 1) and to foster communication between physicians and other healthcare professionals and patients on the management of these comorbidities. Recommendations in this document are based on published studies and the multidisciplinary expertise of the writing group and harmonized with published practice guidelines from the and other organizations.7,13 15 Hypertension and HF Hypertension is a worldwide epidemic; in many countries, 50% of the population >60 years of age has hypertension.


Recommendations in this document are based on published studies and the multidisciplinary expertise of the writing group and harmonized with published practice guidelines from the and other organizations.7,13 15 Hypertension and HF Hypertension is a worldwide epidemic; in many countries, 50% of the population >60 years of age has hypertension. Hypertension is defined as a repeatedly elevated blood pressure (BP) exceeding 140/90 mmHg. The prevalence of hypertension is steadily increasing, even with the expanded use of antihypertensive medications.16 It is widely recognized that hypertension is associated with increased cardiovascular and all-cause mortality independently of other risk factors.14,17 Specific HF mortality attributable to hypertension is probably underreported because of the competing adjudication for stroke or myocardial infarction (MI) at the end of the spectrum of hypertensive cardiovascular death.


The prevalence of hypertension is steadily increasing, even with the expanded use of antihypertensive medications.16 It is widely recognized that hypertension is associated with increased cardiovascular and all-cause mortality independently of other risk factors.14,17 Specific HF mortality attributable to hypertension is probably underreported because of the competing adjudication for stroke or myocardial infarction (MI) at the end of the spectrum of hypertensive cardiovascular death. Biykem Bozkurt, MD, PhD, FAHA, Chair David Aguilar, MD, FAHA Anita Deswal, MD, MPH, FAHA Sandra B. Dunbar, RN, PhD, FAHA Gary S. Francis, MD, FAHA Tamara Horwich, MD, MS, FAHA Mariell Jessup, MD, FAHA Mikhail Kosiborod, MD, FAHA Allison M. Pritchett, MD Kumudha Ramasubbu, MD Clive Rosendorff, MD, PhD, DScMed, FAHA Clyde Yancy, MD, MSc, FAHA On behalf of the American Heart Association Heart Failure and Transplan- tation Committee of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; Council on Hypertension; and Council on Quality and Outcomes Research Contributory Risk and Management of Comorbidities of Hypertension, Obesity, Diabetes Mellitus, Hyperlipidemia, and Metabolic Syndrome in Chronic Heart Failure A Scientific Statement From the American Heart Association 2016 American Heart Association, Inc. Key Words: AHA Scientific Statements cardiovascular diseases comorbidity diabetes mellitus heart failure hyperlipidemia hypertension obesity risk factors AHA Scientific Statement Bozkurt et al Hypertension Plays a Significant Role in the Development of HF Elevated levels of diastolic BP and especially systolic BP (SBP) are major risk factors for the development of One of the most impactful observations from the Framingham cohort was that the cumulative incidence of HF was significantly higher in patients with hyperten- (Figure 1) Among 5143 patients, 91% of the patients with HF had hypertension antedating the devel- opment of HF, underlining that in the majority of patients with HF, hypertension was a contributing cause.


Biykem Bozkurt, MD, PhD, FAHA, Chair David Aguilar, MD, FAHA Anita Deswal, MD, MPH, FAHA Sandra B. Dunbar, RN, PhD, FAHA Gary S. Francis, MD, FAHA Tamara Horwich, MD, MS, FAHA Mariell Jessup, MD, FAHA Mikhail Kosiborod, MD, FAHA Allison M. Pritchett, MD Kumudha Ramasubbu, MD Clive Rosendorff, MD, PhD, DScMed, FAHA Clyde Yancy, MD, MSc, FAHA On behalf of the American Heart Association Heart Failure and Transplan- tation Committee of the Council on Clinical Cardiology; Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular and Stroke Nursing; Council on Hypertension; and Council on Quality and Outcomes Research Contributory Risk and Management of Comorbidities of Hypertension, Obesity, Diabetes Mellitus, Hyperlipidemia, and Metabolic Syndrome in Chronic Heart Failure A Scientific Statement From the American Heart Association 2016 American Heart Association, Inc. Key Words: AHA Scientific Statements cardiovascular diseases comorbidity diabetes mellitus heart failure hyperlipidemia hypertension obesity risk factors AHA Scientific Statement Bozkurt et al Hypertension Plays a Significant Role in the Development of HF Elevated levels of diastolic BP and especially systolic BP (SBP) are major risk factors for the development of One of the most impactful observations from the Framingham cohort was that the cumulative incidence of HF was significantly higher in patients with hyperten- (Figure 1) Among 5143 patients, 91% of the patients with HF had hypertension antedating the devel- opment of HF, underlining that in the majority of patients with HF, hypertension was a contributing cause. The haz- ard ratios (HRs) for developing HF in hypertensives com- pared with normotensives were 2-fold higher in men and It should be noted that the risk associated with hypertension may be accentuated through its confounding effect on ischemic heart disease and other cardiovascular outcomes such as stroke.


The haz- ard ratios (HRs) for developing HF in hypertensives com- pared with normotensives were 2-fold higher in men and It should be noted that the risk associated with hypertension may be accentuated through its confounding effect on ischemic heart disease and other cardiovascular outcomes such as stroke. Fur- thermore, these studies predate current HF management strategies and guidelines and may no longer reflect the risk in the current population treated for hypertension. However, they underscore the importance of hyperten- sion as a cause of HF when left untreated. The residual lifetime risk for hypertension for middle-aged and elderly Table 1. Applying Classification of Recommendations and Level of Evidence A recommendation with Level of Evidence B or C does not imply that the recommendation is weak. Many important clinical questions addressed in the guidelines do not lend themselves to clinical trials. Although randomized trials are unavailable, there may be a very clear clinical consensus that a particular test or therapy is useful or effective. *Data available from clinical trials or registries about the usefulness/efficacy in different subpopulations, such as sex, age, history of diabetes, history of prior myocardial infarction, history of heart failure, and prior aspirin use. For comparative effectiveness recommendations (Class I and IIa; Level of Evidence A and B only), studies that support the use of comparator verbs should involve direct comparisons of the treatments or strategies being evaluated. Management of Comorbidities in Chronic Heart Failure CLINICAL STATEMENTS AND GUIDELINES individuals in the United States is 90%, indicating a huge public health burden20 and defining the importance of strategies to control hypertension to prevent HF.


Management of Comorbidities in Chronic Heart Failure CLINICAL STATEMENTS AND GUIDELINES individuals in the United States is 90%, indicating a huge public health burden20 and defining the importance of strategies to control hypertension to prevent HF. Treatment of Hypertension Prevents the Development of HF Long-term treatment of both systolic and diastolic hyper- tension has been shown to reduce the risk of HF.21,22 With treatment of hypertension, the risk of developing HF is reduced by 30% in younger populations,23 by 50% in the and by almost 80% among the elderly with history of MI.22 A meta-analysis of long-term hyperten- sion treatment trials25 and a number of large, controlled have uniformly demonstrated that optimal BP control decreases the risk of new HF by 50%. In pla- cebo-controlled trials, although the relative risks of total major cardiovascular events were reduced by regimens based on angiotensin-converting enzyme (ACE) inhibitors (22%) or calcium antagonists (18%), the risk for develop- ing HF was reduced significantly by ACE inhibitors but not calcium antagonists.27 Greater risk reductions were produced by treatment regimens that targeted lower BP goals than those targeting relatively higher BP goals.28 Treatment Treatment of Hypertension in Patients at Risk for Developing HF Goals of Treatment of Hypertension to Prevent HF Patients with hypertension are at high risk for develop- ing HF (stage A), and their BP should be controlled in accordance with contemporary guidelines to lower the risk of HF (Level of Evidence A8 ; Table 2).