Abstract

HomeCirculationVol. 128, No. 6Circulation Editors’ Picks Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessResearch ArticlePDF/EPUBCirculation Editors’ PicksMost Read Articles in Cardiovascular Interventions, Part II The Editors The Editors Search for more papers by this author Originally published6 Aug 2013https://doi.org/10.1161/CIRCULATIONAHA.113.004843Circulation. 2013;128:e77–e83Introduction of the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Costing Tool: A User-Friendly Spreadsheet Program to Estimate Costs of Providing Patient-Centered InterventionsSummary—Published economic evaluations of disease management programs apply a variety of approaches to cost estimation, making comparisons across studies difficult. High-quality, comprehensive cost estimates are essential for informed decision making about program budgeting, negotiating payments for services, and conducting cost-effectiveness analyses to evaluate the value of patient-centered interventions. We developed the Tools for Economic Analysis of Patient Management Interventions in Heart Failure Costing Tool for use by research groups and health care managers to estimate costs of patient-focused programs. The tool facilitates data collection and cost estimation for personnel, facilities, equipment, supplies, patient incentives, miscellaneous items, and start-up activities. Adoption of the tool and systematic reporting of resulting cost estimates would lead to the availability of standardized cost estimates across different types of patient-focused interventions for heart failure or other conditions.Conclusions—The TEAM-HF Costing Tool could prove to be a valuable resource for researchers and health care managers to generate comprehensive cost estimates of patient-centered interventions in heart failure or other conditions for conducting high-quality economic evaluations and making well-informed health care management decisions.1Bivalirudin for Primary Percutaneous Coronary Interventions: Outcome Assessment in the Ottawa STEMI RegistrySummary—The HORIZONS AMI trial demonstrated a reduction in bleeding and mortality with bivalirudin use compared with a glycoprotein IIb/IIIa inhibitor and heparin in primary percutaneous coronary intervention. Observational data from the Swedish Coronary Angiography and Angioplasty Registry registry suggest that adding unfractionated heparin to bivalirudin may be beneficial. Direct comparisons of bivalirudin to heparin alone in primary percutaneous coronary intervention are lacking. The current study confirms the efficacy and safety of bivalirudin compared with glycoprotein IIb/IIIa inhibitor and heparin in a real-world contemporary cohort. A benefit of bivalirudin compared with heparin alone could not be demonstrated, highlighting the need for randomized studies between these antithrombotic strategies.Conclusions—Bivalirudin use compared with glycoprotein IIb/IIIa inhibitors plus heparin as an antithrombotic strategy in primary percutaneous coronary intervention results in less major bleeding in contemporary practice. A benefit of bivalirudin over heparin could not be established with this registry and requires additional investigations to either confirm or refute.2Repeat Revascularization After Contemporary Percutaneous Coronary Intervention: An Evaluation of Staged, Target Lesion, and Other Unplanned Revascularization Procedures During the First YearSummary—Restenosis and target lesion revascularization (TLR) occur less frequently since the introduction of drug-eluting stents. Nonetheless, repeat revascularization remains common after contemporary percutaneous coronary intervention (PCI). It remains unclear whether these repeat events represent TLR, staging of complex PCI procedures, or progressive atherosclerosis or unrecognized ischemia at previously untreated sites. In a large multicenter registry of contemporary PCI, repeat revascularization occurred in ≈12% of patients within 1 year. One fourth of these repeat procedures were staged or planned, generally occurring within the first 1 to 2 months after PCI, and there was significant variability in multivessel disease management between hospitals. The remaining 9% of repeat procedures were unplanned, with half involving TLR and half involving nontarget revascularization, and predictors of these 2 subgroups of repeat revascularization were remarkably different. The low early hazard for stent thrombosis decreases even further after the first month. These findings suggest that future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.Conclusions—Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.3Left and Codominant Coronary Artery Circulations Are Associated With Higher In-Hospital Mortality Among Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Report From the National Cardiovascular Database Cath Percutaneous Coronary Intervention (CathPCI) RegistrySummary—Two prior studies have suggested that left-dominant circulation may confer excess short- and long-term mortality after acute myocardial infarction. Both left and right coronary artery circulation are associated with excess in-hospital death after percutaneous coronary intervention for acute coronary syndrome in the United States in American College of Cardiology’s National Cardiovascular Data Registry Cath Percutaneous Coronary Intervention Registry. This association between left dominance and codominance and in-hospital death was independent of 23 demographic, clinical, and angiographic characteristics known to be associated with in-hospital death during percutaneous coronary intervention for acute coronary syndrome. The specific location of culprit vessel lesion did not modify the association between left and right dominance and in-hospital death in percutaneous coronary intervention for acute coronary syndrome.Conclusions—Left and codominance are associated with modestly increased postpercutaneous coronary intervention in-hospital mortality in patients with acute coronary syndrome. Confirmation of these findings with angiographic core laboratory verification of coronary dominance and longer term follow-up will be desirable.4Percutaneous Coronary Intervention Versus Optimal Medical Therapy in Stable Coronary Artery Disease: A Systematic Review and Meta-Analysis of Randomized Clinical TrialsSummary—The optimal management of stable coronary artery disease is controversial. With evolving percutaneous coronary intervention strategies and novel medical therapies, the best evidence-based treatment strategy is unknown. In this meta-analysis of 7182 individuals, percutaneous coronary intervention, as compared with optimal medical therapy, did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. Revascularization with percutaneous coronary intervention was associated with greater angina relief, compared with optimal medical therapy alone. It is unknown whether the above results hold true in the contemporary era of third generation drug-eluting stents and contemporary medical management. Larger studies with sufficient power are required to detect contemporary differences in treatment strategies.Conclusions—In this most rigorous and comprehensive analysis in patients with stable coronary artery disease, PCI, as compared with optimal medical therapy (OMT), did not reduce the risk of mortality, cardiovascular death, nonfatal myocardial infarction, or revascularization. PCI, however, provided a greater angina relief compared with OMT alone, larger studies with sufficient power are required to prove this conclusively.5Comparative Effectiveness of Population Interventions to Improve Access to Reperfusion for ST-Segment–Elevation Myocardial Infarction in AustraliaSummary—Many strategies are advocated to improve access to reperfusion therapy for STEMI. The population impacts of these interventions are unknown. We evaluated time access to reperfusion therapy for the Australian population and found that, overall, 93.2% had timely access predominately through fibrinolysis (53.0%) rather than PPCI (42.0%). We found that the population interventions varied widely in their ability to improve timely access to reperfusion. Interhospital transfer and EMS diversion to PPCI facilities increased timely access to reperfusion the most. Our analysis suggests significant potential to improve timely access to reperfusion by systematic deployment of interventions. Geographical Information Systems provides a robust tool to model the population effects of health service interventions.Conclusions—Significant gaps in timely provision of reperfusion remain in Australia. Systematic implementation of changes in service delivery has potential to improve timely access to PPCI for a majority of the population and improve access to fibrinolysis to those living in regional and remote areas.6Appropriateness of Percutaneous Coronary Interventions in Washington StateSummary—Percutaneous Coronary Intervention (PCI) appropriateness is an emerging quality metric that provides an assessment of anticipated procedural benefit relative to the risk of the procedure. Prior work from a large national PCI registry (NCDR CathPCI) suggested 1% of acute PCIs and 12% of nonacute PCIs are performed for clinical indications classified as inappropriate, with substantial hospital level variation of inappropriate PCI for nonacute procedures. In a complete cohort of PCIs performed in Washington state that includes non-NCDR participating facilities, we found 1% of PCIs for acute indications and 17% of PCIs for nonacute indications were classified as inappropriate. We found similar proportions of inappropriate PCI and broad facility-level variation at NCDR and non-NCDR participating hospitals, adding to the weight of evidence suggesting at least 1 in 9 PCIs for nonacute indications are inappropriate and opportunities exist to improve patient selection for PCI. Our application of the Appropriate Use Criteria for Coronary Revascularization in PCI quality improvement efforts was challenged by a high proportion of nonacute PCI performed without documentation of preprocedural stress testing.Conclusions—In a complete cohort of PCIs performed in Washington state, 1% of PCIs for acute indications and 17% of PCIs for nonacute indications were classified as inappropriate. Missing data on noninvasive stress tests present a challenge in the application of the criteria for quality improvement.7High Sensitivity C-Reactive Protein and Outcomes Following Percutaneous Coronary Intervention in Contemporary PracticeSummary—Higher levels of high sensitivity C-reactive protein (hsCRP) before and after percutaneous coronary intervention are independently associated with a higher risk of major adverse cardiac events. Postprocedural elevation of hsCRP has been attributed to the inflammatory response to percutaneous coronary intervention and related complications and may also predict outcomes. Higher preprocedural hsCRP levels relate to baseline patient characteristics and are independently predictive of periprocedural myocardial injury but not long-term outcome. Postprocedural increase in hsCRP also relates to baseline patient characteristics but, in general, is not secondary to periprocedural myocardial injury and does not predict long-term outcome. The prognostic yield of periprocedural hsCRP measurements argues against routine use in patients undergoing percutaneous coronary intervention in contemporary practice.Conclusions—High hsCRP is associated with a greater independent risk of periprocedural myocardial infarction, as defined by the universal definition, but is not an independent determinant of mortality after percutaneous coronary intervention. Our findings suggest that routine measurement of hsCRP in patients undergoing percutaneous coronary intervention in contemporary practice is unlikely to be beneficial.8A Percutaneous Coronary Intervention Laboratory in Every Hospital?Summary—In 2001, 1176 of 4609 US hospitals (25%) had a primary percutaneous coronary intervention (PCI) program. Hospital PCI capability in 2001 was sufficient to provide timely primary PCI to 79% of the population. In 2006, 1695 of 4673 US hospitals (36%) had a primary PCI program. Hospital PCI capability in 2006 was sufficient to provide timely primary PCI to 80% of the population. From 2001 to 2006, hospital capability to perform PCI grew by 44%, whereas timely access to the procedure grew by only 1%. Thus, the expansion in hospital capability did not appreciably increase access to care.Conclusions—Our data indicate a large increase in the number of hospitals capable of performing PCI from 2001 to 2006, but this increase was not associated with an appreciable change in the proportion of the population with access to the procedure. In the future, more attention is needed on changes in PCI capacity over time and on the effects of these changes on outcomes of interest such as service utilization, expenditures, patient outcomes, and population health.9Hospital Percutaneous Coronary Intervention Appropriateness and In-Hospital Procedural Outcomes: Insights From the NCDRSummary—Measuring PCI quality has traditionally focused on processes of care and postprocedural outcomes, such as in-hospital mortality, bleeding and vascular complication rates, and provision of guideline-recommended medications. PCI appropriateness is increasingly being incorporated into registries and quality improvement programs to measure the quality of patient selection for PCI, although the relationship to traditional PCI quality metrics is unknown. In a large national registry of PCI, we found no relationship between a hospital’s proportion of inappropriate PCIs for nonacute indications and traditional performance measures of processes of care and postprocedural outcomes. The observed large hospital-level variation in the proportion of inappropriate PCIs suggests differences in the quality of patient selection that was unrelated to how well the procedure was performed and emphasizes the importance of both appropriateness and postprocedural outcomes to informing PCI quality. Systems to improve a hospital’s selection of patients for PCI may include decision-making tools and interventions prior to patient arrival in the cardiac catheterization laboratory and will differ from systems to minimize procedural complications.Conclusions—In a national cohort of nonacute PCIs, a hospital’s proportion of inappropriate PCIs was not associated with in-hospital mortality, bleeding, or medical therapy at discharge. This suggests PCI appropriateness measures aspects of hospital PCI quality that are independent of how well the procedure is performed. Therefore, PCI appropriateness and postprocedural outcomes are both important metrics to inform PCI quality.10Dimensions of Socioeconomic Status and Clinical Outcome After Primary Percutaneous Coronary InterventionSummary—There is a well-known association between low socioeconomic status (SES) and high incidence of and mortality from coronary heart disease. There also appear to be SES-related differences in care among ST-elevation myocardial infarction patients, but the exact role of SES in relation to post-ST-elevation myocardial infarction outcomes remains poorly understood. Even in a universal, tax-financed, healthcare system, low-SES ST-elevation myocardial infarction patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be primarily explained by differences in baseline patient characteristics, rather than differences in acute treatment or long-term secondary medical prophylaxis. Employment status and income, but not education level, were associated with clinical outcomes.Conclusions—Even in a tax-financed healthcare system, low-SES patients treated with primary percutaneous coronary intervention face a worse prognosis than high-SES patients. The poor outcome seems to be largely explained by differences in baseline patient characteristics. Employment status and income (but not education level) were associated with clinical outcomes.11The Quality and Impact of Risk Factor Control in Patients With Stable Claudication Presenting for Peripheral Vascular InterventionsSummary—Patients with peripheral vascular disease are at high risk for developing coronary and cerebrovascular disease. Risk factor modification with use of statins and aspirin has been shown to reduce major adverse cardiovascular events in patients with peripheral vascular disease. Risk factors are often under treated in patients with peripheral vascular diseases. Patients presenting for elective intervention for stable claudication often arrive on suboptimal medical therapy. Despite contact with a vascular specialist during the peripheral vascular intervention encounter patients are frequently discharged without statin therapy. Patients who present on a statin and aspirin before a peripheral vascular intervention have a lower odds of developing a peripheral vascular event in the six months after the intervention.Conclusions—The fundamental elements of medical therapy in patients with lifestyle-limiting claudication are often underutilized before referral for revascularization. Appropriate medical therapy before percutaneous revascularization is associated with fewer peripheral vascular events at 6 months.12The Index of Microcirculatory Resistance Predicts Myocardial Infarction Related to Percutaneous Coronary InterventionSummary—Periprocedural myocardial infarction occurs in a significant proportion of patients undergoing percutaneous coronary intervention and portends poor outcomes. Currently, no clinically applicable method predicts periprocedural myocardial infarction in the cardiac catheterization laboratory before it occurs. The results of the current study suggest that the status of the coronary microcirculation plays a role in determining susceptibility toward periprocedural myocardial infarction at the time of elective percutaneous coronary intervention. The index of microcirculatory resistance can predict subsequent risk of developing myocardial necrosis and may guide adjunctive prevention strategies.Conclusions—These data suggest that the status of the coronary microcirculation plays a role in determining susceptibility toward periprocedural MI at the time of elective PCI. The index of microcirculatory resistance can predict subsequent risk of developing myocardial necrosis and may guide adjunctive prevention strategies.13Public Reporting on Risk-Adjusted Mortality After Percutaneous Coronary Interventions in New York State: Forecasting Ability and Impact on Market Share and Physicians’ Decisions to Discontinue PracticeSummary—Since the advent of public reporting on risk-adjusted mortality for coronary artery bypass graft surgery, at least 8 states have embarked on similar efforts for percutaneous coronary interventions. To date, little is known about the utility of PCI public reporting programs. Public reporting on nonemergent PCIs in New York State identifies very high and low performers but provides insufficient information to differentiate between most hospitals. The utility of public reporting of risk-adjusted mortality rates may vary for different conditions and procedures.Conclusions—Public reporting on nonemergent percutaneous coronary interventions in New York State identifies very high and low performers but provides insufficient information to differentiate between most hospitals. It appears to have had no effect on market share or physicians’ decisions to leave practice. The utility of public reporting on RAMRs may differ for different conditions and procedures.14Operator Versus Core Laboratory Assessment of Angiographic Reperfusion Markers in Patients Undergoing Primary Percutaneous Coronary Intervention for ST-Segment–Elevation Myocardial InfarctionSummary—Compared with an independent angiographic core laboratory, operators tend to overestimate severity of stenoses before PCI and underestimate them after the procedure. Much less is known regarding the ability of operators to accurately assess markers of reperfusion, such as TIMI flow grade and myocardial blush grade. This is the largest comparison to date of operator and core laboratory assessment of angiographic reperfusion parameters in patients with STEMI undergoing primary PCI. Nearly one quarter of patients had discordant scoring between prognostically different categories of TIMI flow and densitometric myocardial blush grade.Conclusions—Op and ACL assessment of angiographic markers of reperfusion in ST-segment–elevation myocardial infarction demonstrates fair to moderate agreement. Op tended to favorably grade unfavorable ACL results. Nonetheless, both Op and ACL assessment of reperfusion strongly inform prediction of 3-year mortality.15Systematic Review and Cost–Benefit Analysis of Radial Artery Access for Coronary Angiography and InterventionSummary—In the United States, radial artery catheterization is performed in the minority of diagnostic angiograms and percutaneous coronary interventions. Radial artery catheterization can reduce hemostasis time and vascular complications but can take longer to perform and may require conversion to the femoral site. Cost savings from reducing complications appear to outweigh additional direct procedure costs of radial catheterization. On average, the radial approach saved $275 in direct hospital costs per patient as compared with the femoral approach. None of the changes to cost variables brought the net cost savings to a point that would favor femoral catheterization.Conclusions—Radial catheterization was favored over femoral catheterization in our cost–benefit analysis.16Impact of Door-to-Activation Time on Door-to-Balloon Time in Primary Percutaneous Coronary Intervention for ST-Segment Elevation Myocardial Infarctions: A Report From the Activate-SF RegistrySummary—Door-to-balloon time in primary percutaneous coronary intervention for ST-elevation myocardial infarction is strongly related to both short- and long-term mortality. The time from hospital arrival to ST-segment elevation myocardial infarction diagnosis and activation of the catheterization laboratory (door-to-activation time) varies widely at the hospital level and is more strongly correlated with overall door-to-balloon times than other components of the primary percutaneous coronary intervention process. A door-to-activation time <20 minutes may be key to achieving a door-to-balloon time <90 minutes consistently.Conclusions—The interval from hospital arrival to ST-segment elevation myocardial infarction diagnosis and catheterization laboratory activation (door-to-activation time) is a strong driver of overall door-to-balloon times. Achieving a door-to-activation time ≤20 minutes was key to achieving a door-to-balloon time ≤90 minutes. Delays in door-to-activation time are not associated with delays in other aspects of the primary percutaneous coronary intervention process.17Do Differences in Repeat Revascularization Explain the Antianginal Benefits of Bypass Surgery Versus Percutaneous Coronary Intervention?: Implications for Future Treatment ComparisonsSummary—The SYNTAX trial found that patients with left main or multivessel coronary disease treated with initial CABG surgery had lower rates of repeat revascularization and less angina than those treated with initial PCI. Using the SYNTAX population, we evaluated the relationship between initial treatment, repeat revascularization during follow-up, and angina at 1 year. We found that patients who underwent repeat revascularization had worse angina frequency scores than patients who did not in both treatment groups, similar to other studies. Among patients who did not undergo repeat revascularization, patients treated with CABG still had better angina relief at 12 months than patients treated with PCI, with an adjusted between-group difference similar to the treatment effect in the overall population. These findings suggest that some of the antianginal benefits of CABG may result from mechanisms unrelated to relief of myocardial ischemia (eg, denervation, placebo effects). The strength of association between repeat revascularization and angina was greater among patients treated with CABG as compared with those treated with PCI, indicating that the end point of repeat revascularization has a different clinical impact based on the original treatment and thus should play a limited role as an indirect measure of health outcomes between these 2 revascularization strategies.Conclusions—Among patients with multivessel coronary artery disease treated with PCI or CABG, the occurrence of repeat revascularization during follow-up did not fully explain the antianginal benefit of CABG in the overall population. The differential association between repeat revascularization and anginal status, according to the type of initial revascularization procedure, suggests that this end point should play a limited role in any direct comparison of the 2 treatment strategies.18Sources of Hospital Variation in Short-Term Readmission Rates After Percutaneous Coronary InterventionSummary—Readmission within 30 days of discharge after percutaneous coronary intervention (PCI) is common and accounts for a large share of potentially preventable healthcare expenditures. The National Quality Forum has endorsed hospital risk-standardized, 30-day readmission rates after PCI as a publicly reported quality measure, which may be used to determine hospital reimbursement. This study is the first to examine variation in risk-standardized, 30-day readmission rates after PCI among hospitals. Wide variation in these rates was observed among Massachusetts PCI-performing hospitals, very little of which was explained by differences in assessed measures of hospital quality including procedural complications and discharge medications. Modifiable and unmodifiable factors responsible for the wide variation in short-term readmission rates after PCI between hospitals are largely unknown.Conclusions—We observed wide variation in hospital 30-day all-cause RSRRs after PCI, most of which could not be explained by identifiable differences in procedural and postprocedural factors. A better understanding of etiologies of hospital variation is necessary to determine whether this measure is an actionable assessment of hospital quality, and, if so, how hospitals might improve their performance.19Cause and Circumstance of In-Hospital Mortality Among Patients Undergoing Contemporary Percutaneous Coronary Intervention: A Root-Cause AnalysisSummary—Previous studies of in-hospital mortality after percutaneous coronary intervention (PCI) determined that most deaths were attributable to procedural complications. Rates of in-hospital mortality after PCI have declined over time and have remained stable over the past decade. The leading causes of in-hospital death in patients undergoing PCI in the contemporary era are unknown. Procedural complications accounted for only a few current in-hospital deaths after PCI in this study. Most deaths were attributable to left ventricular failure, arrhythmia, and neurological injury. This study suggests that most deaths after contemporary PCI may be unpreventable.Conclusions—Procedural complications are responsible for a small fraction of deaths among patients undergoing contemporary PCI. Measures to further enhance procedural safety are unlikely to translate into meaningful reductions in PCI mortality.20Bivalirudin Versus Heparin Plus a Glycoprotein IIb/IIIa Inhibitor in Patients With Non–ST-Segment Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention After Clopidogrel Pretreatment: Pooled Analysis from the ACUITY and ISAR-REACT 4 TrialsSummary—Patients with non–ST-segment elevation acute coronary syndrome undergoing percutaneous coronary intervention benefit from unfractionated heparin plus abciximab. Bivalirudin, a direct thrombin inhibitor, has improved outcomes of patients with a broad spectrum of acute coronary syndromes as compared with a regimen of heparin plus a glycoprotein IIb/IIIa inhibitor. This pooled analysis of patients in the ACUITY and ISAR-REACT 4 randomized trials, who underwent a percutaneous coronary intervention after clopidogrel treatment, showed a 46% reduction of the bleeding risk with bivalirudin compared with heparin plus a glyocoprotein IIb/IIIa inhibitor. The risk of ischemic complications (a composite of death, myocardial infarction, or urgent target vessel revascularization) was not affected by bivalirudin. The treatment effect of bivalirudin was consistent across various subgroups and not dependent on the type of heparins (unfractionated heparin or enoxaparin) and glycoprotein IIb/IIIa inhibitor (abciximab versus eptifibatide versus tirofiban) assigned in the control group.Conclusions—NACE rates were not significantly different between bivalirudin and heparin plus a GPI in patients with non–ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention after clopidogrel pretreatment. Although no significant difference in efficacy was seen in terms of suppression

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