The appropriate use criteria: Improvements for its integration into real world clinical practice.

The purpose of this position statement is to suggest ways in which future appropriate use criteria (AUC) for coronary revascularization might be restructured to: (1) incorporate improvement in quality of life and angina relief as primary goals of therapy, (2) integrate the findings of recent trials into quality appraisal, (3) employ the combined information of the coronary angiogram and invasive physiologic measurements together with the results of stress test imaging to assess risk, and (4) recognize the essential role that patient preference plays in making individualized therapeutic decisions. The AUC is a valuable tool within the quality assurance process; it is vital that interventionists ensure that percutaneous coronary intervention case selection is both evidence-based and patient oriented. Appropriate patient selection is an important quality indicator and adherence to evidence-based practice should be one metric in a portfolio of process and outcome indicators that measure quality.

Views of Appropriate Use Criteria for catheterization and percutaneous coronary revascularization by practicing interventional cardiologists: Results of a survey of American College of Cardiology Interventional Section members.

OBJECTIVES: The American College of Cardiology (ACC) Interventional Section Council leadership sought to examine the views of interventional cardiologists regarding the practical implementation and the value of the Appropriate Use Criteria (AUC) in their clinical practice. BACKGROUND: The ACC AUC for revascularization were originally intended to assess trends in revascularization patterns by hospitals and physicians to ensure that both under- and over-utilization were minimized. As a quality assurance tool, the AUC were designed to allow physicians to obtain insight into their practice patterns and improve their practice. Recent trends toward tying payment to performance have raised concerns that these criteria will be incorrectly applied to individual patient reimbursement, which is not what they were designed to do. Consequently, the AUC have become controversial, not for their value in quality assessment, but for the manner in which agencies have used the AUC as a tool to potentially deny payment for certain patients. METHODS: Utilizing an online survey, members of the ACC Interventional Section were queried regarding the use of AUC, how they use them, and how they feel utilization impacts the care of patients. RESULTS: We found substantial variability in how the AUC were utilized and concern regarding the value of AUC. Among our findings was that respondents were split (51% vs 49%) regarding the value of AUC to patients and/or their laboratory. CONCLUSIONS: In this article, we discuss the implications of these findings and consider options on how AUC might be made a better-accepted and more impactful tool for clinicians and patients.

Occupational health hazards in the interventional laboratory: Time for a safer environment.

Over the past 30 years, the advent of fluoroscopically guided interventional procedures has resulted in dramatic increments in both X-ray exposure and physical demands that predispose interventionists to distinct occupational health hazards. The hazards of accumulated radiation exposure have been known for years, but until recently the other potential risks have been ill-defined and under-appreciated. The physical stresses inherent in this career choice appear to be associated with a predilection to orthopedic injuries, attributable in great part to the cumulative adverse effects of bearing the weight and design of personal protective apparel worn to reduce radiation risk and to the poor ergonomic design of interventional suites. These occupational health concerns pertain to cardiologists, radiologists and surgeons working with fluoroscopy, pain management specialists performing nonvascular fluoroscopic procedures, and the many support personnel working in these environments. This position paper is the work of representatives of the major societies of physicians who work in the interventional laboratory environment, and has been formally endorsed by all. In this paper, the available data delineating the prevalence of these occupational health risks is reviewed and ongoing epidemiological studies designed to further elucidate these risks are summarized. The main purpose is to publicly state speaking with a single voice that the interventional laboratory poses workplace hazards that must be acknowledged, better understood and mitigated to the greatest extent possible, and to advocate vigorously on behalf of efforts to reduce these hazards. Interventional physicians and their professional societies, working together with industry, should strive toward the ultimate zero radiation exposure work environment that would eliminate the need for personal protective apparel and prevent its orthopedic and ergonomic consequences. © 2008 Wiley-Liss, Inc.

Comparative effectiveness of revascularization strategies.

BACKGROUND: Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS: We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS: Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS: In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.).

Occupational health hazards of interventional cardiologists in the current decade: Results of the 2014 SCAI membership survey.

BACKGROUND: Interventional cardiologists and staff are subject to unique physical demands that predispose them to distinct occupational health hazards not seen in other medical disciplines. METHODS: To characterize the prevalence of these occupational health problems, The Society for Cardiovascular Angiography and Interventions (SCAI) surveyed its members by email. Inquiries included age, years of invasive practice, and diagnostic and interventional cases per year. Questions focused on orthopedic (spine, hips, knees, and ankles) and radiation-associated problems (cataracts and cancers). RESULTS: There were 314 responses. Responders were on average busy and experienced, performing a mean of 380±249 diagnostic and 200±129 interventional cases annually. Of the responders, 6.9% of operators have had to limit their caseload because of radiation exposure and 9.3% have had a health-related period of absence. Furthermore, 153 (49.4%) operators reported at least one orthopedic injury: 24.7% cervical spine disease, 34.4% lumbar spine problems, and 19.6% hip, knee or ankle joint problems. Age was most significantly correlated with orthopedic illnesses: cervical injuries (χ2=150.7, P<0.0001); hip/knee or ankle injuries (χ2=80.9, P<0.0001); lumbar injuries (χ2=147.0, P<0.0001); and any orthopedic illness (χ2= 241.2, P<0.0001). Annual total caseload was also associated: the estimated change in the odds of orthopedic illness for each additional total caseload quintile is 1.0013 (1.0001, 1.0026). There is a small but substantial incidence of cancer. CONCLUSIONS: These findings are consistent with, and extend the findings, of a prior 2004 SCAI survey, in documenting a substantial prevalence of orthopedic complications among active interventional cardiologists, which persists despite increased awareness.

Long-term outcomes following fractional flow reserve-guided treatment of angiographically ambiguous left main coronary artery disease: A meta-analysis of prospective cohort studies.

OBJECTIVE: To define the long term outcomes of Fractional Flow Reserve (FFR) guided revascularization of ambiguous left main coronary artery (LMCA) lesions by performing a pooled meta-analysis of all available studies. BACKGROUND: Prospective studies evaluating the use of fractional flow reserve (FFR) for clinical decision-making in ambiguous unprotected left main coronary artery (LMCA) stenosis suggest the relative safety of that approach, but any final conclusions are limited by small sample size. We performed a pooled meta-analysis of studies to define the long-term outcomes in these patients. METHODS: Six prospective cohort studies involving 525 patients met the inclusion criteria. Patients underwent revascularization (revascularization group) or medical therapy (deferred group) based on FFR. The primary outcome was defined as rate of major cardiovascular events (a composite of death from all causes, nonfatal myocardial infarctions and subsequent revascularizations). The secondary outcomes included individual components of the primary end point. Pooled effect sizes were calculated using a fixed effects model. RESULTS: Based on the FFR results, 217 patients (41%) underwent revascularization. There was no statistically significant difference between the groups in the rates of primary end point (P = 0.15), all-cause mortality (P = 0.06) or nonfatal myocardial infarctions (P = 0.76). However, there was a significant increase in the rate of subsequent revascularizations in the deferred patients (P = 0.002). CONCLUSION: The long term clinical outcomes in patients with ambiguous LMCA stenosis for whom revascularization is deferred based on FFR are favorable and similar to the revascularized group in terms of overall mortality and subsequent myocardial infarctions.

Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI).

Numerous definitions have been proposed for the diagnosis of myocardial infarction (MI) after coronary revascularization. The universal definition for MI designates post procedural biomarker thresholds for defining percutaneous coronary intervention (PCI)-related MI (type 4a) and coronary artery bypass grafting (CABG)-related MI (type 5) which are of uncertain prognostic importance. In addition, for both MI types cTn is recommended as the biomarker of choice, the prognostic significance of which is less well validated than CK-MB. Widespread adoption of a MI definition not clearly linked to subsequent adverse events such as mortality or heart failure may have serious consequences for the appropriate assessment of devices and therapies, may affect clinical care pathways, and may result in misinterpretation of physician competence. Rather than employing an MI definition sensitive for small degrees of myonecrosis (the occurrence of which, based on contemporary large-scale studies, are unlikely to have important clinical consequences), it is instead recommended that a threshold level of biomarker elevation which has been strongly linked to subsequent adverse events in clinical studies be used to define a "clinically relevant MI." The present document introduces a new definition for "clinically relevant MI" after coronary revascularization (PCI or CABG) which is applicable for use in clinical trials, patient care, and quality outcomes assessment.

Conversations in cardiology: bridging antiplatelet therapy before surgery.

Bridging for antiplatelet therapy remains a subject of debate with data favoring GP blockers but at a risk of bleeding. This Conversation in Cardiology addresses a key and often asked question about use of alternatives to P2Y12 agents in patients requiring surgery within 6 months after drug eluting stent implantation.

Clinical effects of physiologic lesion testing in influencing treatment strategy for multi-vessel coronary artery disease.

Background: The application of fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) in multivessel coronary artery disease (CAD) patients has not been definitively explored. We herein assessed how treatment strategies were decided based on FFR/iFR values in vessels selected clinically. Specifically, we sought to determine whether treatment selection was based on whether the vessel tested was the clinical target stenosis. Methods: 270 consecutive patients with angiographically determined multivessel disease who underwent FFR/iFR testing were included. Patients were classified initially based on their angiographic findings, then re-evaluated from FFR/iFR results (normal or abnormal). Tested lesions were classified into target or non-target lesions based on clinical and non-invasive evaluations. Results: Abnormal FFR/iFR values were demonstrated in 51.9 % of patients, in whom 51.4 % received coronary stenting (PCI) and 44.3 % had bypass surgery (CABG). With two-vessel CAD patients, medical therapy was preferred when the target lesion was normal (72.6 %), while PCI was preferred when it was abnormal (78.4 %). In non-target lesions, PCI was preferred regardless of FFR/iFR results (78.0 %). With three-vessel CAD patients, CABG was preferred when the target lesion was abnormal (68.5 %), and there was no difference in the selected modality when it was normal. Furthermore, the incidence of tested lesions was higher in the left anterior descending (LAD) compared to other coronary arteries, and two-vessel CAD patients with LAD stenoses were more frequently treated by PCI. Conclusion: The use of invasive physiologic testing in multivessel CAD patients may alter the preferred treatment strategy, leading to an overall increase in PCI selection.

Prediction of long-term mortality after percutaneous coronary intervention in older adults: results from the National Cardiovascular Data Registry.

BACKGROUND: The purpose of this study was to develop a long-term model to predict mortality after percutaneous coronary intervention in both patients with ST-segment elevation myocardial infarction and those with more stable coronary disease. METHODS AND RESULTS: The American College of Cardiology Foundation CathPCI Registry data were linked to the Centers for Medicare and Medicaid Services 100% denominator file by probabilistic matching. Preprocedure demographic and clinical variables from the CathPCI Registry were used to predict the probability of death over 3 years as recorded in the Centers for Medicare and Medicaid Services database. Between 2004 and 2007, 343 466 patients (66%) of 518 195 patients aged ≥65 years undergoing first percutaneous coronary intervention in the CathPCI Registry were successfully linked to Centers for Medicare and Medicaid Services data. This study population was randomly divided into 60% derivation and 40% validation cohorts. Median follow-up was 15 months, with mortality of 3.0% at 30 days and 8.7%, 13.4%, and 18.7% at 1, 2, and 3 years, respectively. Twenty-four characteristics related to demographics, clinical comorbidity, prior history of disease, and indices of disease severity and acuity were identified as being associated with mortality. The C indices in the validation cohorts for patients with and without ST-segment elevation myocardial infarction were 0.79 and 0.78. The model calibrated well across a wide range of predicted probabilities. CONCLUSIONS: On the basis of the large and nationally representative CathPCI Registry, we have developed a model that has excellent discrimination, calibration, and validation to predict survival up to 3 years after percutaneous coronary intervention.

Predictors of long-term survival after coronary artery bypass grafting surgery: results from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (the ASCERT study).

BACKGROUND: Most survival prediction models for coronary artery bypass grafting surgery are limited to in-hospital or 30-day end points. We estimate a long-term survival model using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database and Centers for Medicare and Medicaid Services. METHODS AND RESULTS: The final study cohort included 348 341 isolated coronary artery bypass grafting patients aged ≥65 years, discharged between January 1, 2002, and December 31, 2007, from 917 Society of Thoracic Surgeons-participating hospitals, randomly divided into training (n=174 506) and validation (n=173 835) samples. Through linkage with Centers for Medicare and Medicaid Services claims data, we ascertained vital status from date of surgery through December 31, 2008 (1- to 6-year follow-up). Because the proportional hazards assumption was violated, we fit 4 Cox regression models conditional on being alive at the beginning of the following intervals: 0 to 30 days, 31 to 180 days, 181 days to 2 years, and >2 years. Kaplan-Meier-estimated mortality was 3.2% at 30 days, 6.4% at 180 days, 8.1% at 1 year, and 23.3% at 3 years of follow-up. Harrell's C statistic for predicting overall survival time was 0.732. Some risk factors (eg, emergency status, shock, reoperation) were strong predictors of short-term outcome but, for early survivors, became nonsignificant within 2 years. The adverse impact of some other risk factors (eg, dialysis-dependent renal failure, insulin-dependent diabetes mellitus) continued to increase. CONCLUSIONS: Using clinical registry data and longitudinal claims data, we developed a long-term survival prediction model for isolated coronary artery bypass grafting. This provides valuable information for shared decision making, comparative effectiveness research, quality improvement, and provider profiling.

Current operator volumes of invasive coronary procedures in Medicare patients: implications for future manpower needs in the catheterization laboratory.

OBJECTIVES: We seek to assess the per-operator volume of diagnostic catheterizations and percutaneous coronary interventions (PCI) among US cardiologists, and its implication for future manpower needs in the catheterization laboratory. BACKGROUND: The number of annual Medicare PCIs peaked in 2004 and has trended downward since, however the total number of catheterization laboratories nationwide has increased. It is unknown whether these trends have resulted in a dilution of per-operator volumes, and whether the current supply of interventional cardiologists is appropriate to meet future needs. METHODS: We analyzed the Centers for Medicare and Medicaid Services 2008 Medicare 5% sample file, and extracted the total number of Medicare fee-for-service (Medicare FFS) diagnostic catheterizations and PCIs performed in 2008. We then determined per-physician procedure volumes using National Provider Identifier numbers. RESULTS: There were 1,198,610 Medicare FFS diagnostic catheterizations performed by 11,029 diagnostic cardiologists, and there were 378,372 Medicare FFS PCIs performed by 6,443 interventional cardiologists in 2008. The data reveal a marked difference in the 2008 distribution of diagnostic catheterizations and PCIs among operators. Just over 10% of diagnostic catheterizations were performed by operators performing 40 or fewer Medicare FFS diagnostic catheterizations, contrasted with almost 30% of PCIs performed by operators with 40 of fewer Medicare FFS PCIs. A significant majority of interventional cardiologists (61%) performed 40 or fewer Medicare FFS PCIs in 2008. CONCLUSIONS: There is a high percentage of low-volume operators performing PCI, raising questions regarding annual volume recommendations for procedural skill maintenance, and the future manpower requirements in the catheterization laboratory.