Biomedical subjects
Publications and source records attributed to Ralph G Brindis.
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An American College of Cardiology (ACC)/American Heart Association (AHA) task force on practice guidelines in 2001 published evidence-based recommendations for performing percutaneous coronary interventions (PCIs). These guidelines grouped the indications for PCI into 4 classes (I, IIa, IIb, and III) based on analyses of risks and benefits. In a previous study, we found that clinical success and in-hospital adverse events varied by indications class. However, no adjustment for risk was used in those comparisons. The ACC/National Cardiovascular Data Registry (ACC-NCDR) previously developed a risk-adjustment model for the adverse event of in-hospital PCI mortality. We investigated how the 14 individual risk factors in the ACC-NCDR PCI mortality model might differ across the 4 indications classes and whether estimated mortality for each class approximated the observed mortality for that class. We analyzed the ACC-NCDR PCI database for January 1, 2001 to December 31, 2004. We excluded procedures performed for treatment of acute ST-segment elevation myocardial infarction; all others were included, yielding 559,273 procedures for analysis. An algorithm derived from the 2001 guidelines was used to assign procedures to an indications class. Increasing frequencies of risk components were observed across classes I, IIa, IIb, and III. Expected mortalities for each class calculated by the risk-adjustment model were close to observed values (expected 0.52%, 0.59%, 1.72%, and 1.96%, respectively; observed 0.49%, 0.63%, 1.88%, and 1.60%, respectively). In conclusion, the ACC-NCDR risk-adjusted mortality model can be linked to the ACC/AHA PCI guidelines, and together these produce mortality risk estimates by indications classes that are close to actual observed values. With further refinement, these methods should be able to be used as powerful analytic tools for quality assurance and appropriateness purposes.
BACKGROUND: The extent to which national health quality improvement initiatives have altered reported treatment gaps among patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) is unknown. We sought to determine recent trends in adherence to guideline-based therapies for NSTE ACS. METHODS: We evaluated the treatment of patients with high-risk (positive cardiac markers and/or ischemic ST-segment changes) NSTE ACS enrolled in the Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA (American College of Cardiology/American Heart Association) Guidelines (CRUSADE) Quality Improvement Initiative from 2002 through 2004 (a total of 113 595 patients over 11 calendar quarters). We analyzed adherence to guideline-recommended therapies, including medications used in the acute care period (<24 hours after presentation), invasive procedures, in-hospital outcomes, and discharge therapies and interventions. RESULTS: The use of each class I guideline recommendation, as well as overall adherence to the guidelines, improved significantly (P<.001) during the study period. In the acute care setting, the use of antiplatelet agents increased by 5% and beta-blockers by 12%; at hospital discharge, the use of antiplatelet agents increased by 3% and beta-blockers by 8%. Heparin use in the acute care period increased by 6%, largely owing to a 9% increase in the use of low-molecular-weight heparin. Use of glycoprotein IIb/IIIa inhibitors in the acute care period also increased by more than 13%. At discharge, clopidogrel use increased by 22%, lipid-lowering agents by 11%, and angiotensin-converting enzyme inhibitors by 5%. While adherence improved, many patients still failed to receive 100% indicated treatments at the end of the study period. CONCLUSIONS: During the 4 years since the initial release of the ACC/AHA guidelines for NSTE ACS, adherence to class I recommendations has significantly improved among hospitals participating in CRUSADE. Still, further improvements are needed for optimal implementation of the these guidelines.
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CONTEXT: Selected care processes are increasingly being used to measure hospital quality; however, data regarding the association between hospital process performance and outcomes are limited. OBJECTIVES: To evaluate contemporary care practices consistent with the American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations, to examine how hospital performance varied among centers, to identify characteristics predictive of higher guideline adherence, and to assess whether hospitals' overall composite guideline adherence was associated with observed and risk-adjusted in-hospital mortality rates. DESIGN, SETTING, AND PARTICIPANTS: An observational analysis of hospital care in 350 academic and nonacademic US centers of 64,775 patients enrolled in the CRUSADE (Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes With Early Implementation of the ACC/AHA Guidelines) National Quality Improvement Initiative between January 1, 2001, and September 30, 2003, presenting with chest pain and positive electrocardiographic changes or cardiac biomarkers consistent with non-ST-segment elevation acute coronary syndrome (ACS). MAIN OUTCOME MEASURES: Use of 9 ACC/AHA class I guideline-recommended treatments and the correlation among hospitals' use of individual care processes as well as overall composite adherence rates. RESULTS: Overall, the 9 ACC/AHA guideline-recommended treatments were adhered to in 74% of eligible instances. There was modest correlation in hospital performance among the individual ACS process metrics. However, composite adherence performance varied widely (median [interquartile range] composite adherence scores from lowest to highest hospital quartiles, 63% [59%-66%] vs 82% [80%-84%]). Composite guideline adherence rate was significantly associated with in-hospital mortality, with observed mortality rates decreasing from 6.31% for the lowest adherence quartile to 4.15% for the highest adherence quartile (P<.001). After risk adjustment, every 10% increase in composite adherence at a hospital was associated with an analogous 10% decrease in its patients' likelihood of in-hospital mortality (adjusted odds ratio, 0.90; 95% confidence interval, 0.84-0.97; P<.001). CONCLUSION: A significant association between care process and outcomes was found, supporting the use of broad, guideline-based performance metrics as a means of assessing and helping improve hospital quality.
Limited data are available on the off-label use of drug-eluting stents (DESs) in clinical practice. We used data from the American College of Cardiology National Cardiovascular Data Registry to describe the rates and outcomes of DES use in 4 common off-label situations: ST-elevation myocardial infarction, in-stent restenosis, coronary artery bypass grafts, and chronic total occlusions. The rates of in-hospital adverse events for each off-label situation were determined and compared with the expected rates calculated from a validated model. From approval of DESs to the end of 2004, a total of 408,033 procedures involved placement of a DES. The use of DESs increased from 19.7% at the start of the study to 78.2% by the end of fourth quarter of 2004. Off-label use of DESs occurred in 24.1% of procedures. The rates of in-hospital adverse events with DES use in ST-elevation myocardial infarction, in-stent restenosis, coronary artery bypass grafting, and chronic total occlusions were lower than expected from the validated model. In conclusion, off-label use of DESs is common and is associated with a low rate of short-term adverse events. Randomized clinical trials are needed to confirm the efficacy of DESs in these clinical and angiographic settings. These data also highlight the importance of multicenter registries in tracking new technologies.
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BACKGROUND: Practice guidelines for patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) recommend targeting evidence-based therapies for the highest-risk patients. We characterized guideline adherence for NSTE ACS by risk status. METHODS: We analyzed inhospital treatments and outcomes for 77760 patients with NSTE ACS (ischemic ST-segment changes and/or positive cardiac markers) included in the CRUSADE initiative from January 2001 to September 2003 at 457 US hospitals. Compliance with the American College of Cardiology/American Heart Association Class guideline recommendations for NSTE ACS was evaluated in subgroups of eligible patients without listed contraindications at increased risk for mortality and among risk categories designated by an adapted version of the PURSUIT risk model designed to predict inhospital mortality. RESULTS: Inhospital mortality was increased in patients with diabetes mellitus (5.8% vs 4.3%), renal insufficiency (10.0% vs 3.9%), signs of congestive heart failure on presentation (10.6% vs 3.1%), and age > or = 75 years (8.6% vs 2.7%), compared with patients without these features. Use of guideline-recommended acute medications, invasive cardiac procedures, and discharge medications and interventions was significantly lower in patients with these high-risk features. Patients designated as high-risk for inhospital mortality were less likely to be treated with guideline-recommended therapies compared with low-risk and moderate-risk patients. CONCLUSIONS: Patients with NSTE ACS with the highest risk of mortality are less likely to receive guideline-recommended therapies and interventions. These findings highlight the need to clarify guideline recommendations for high-risk patients and to develop novel quality improvement approaches that target undertreated subgroups of patients with NSTE ACS.
BACKGROUND: Unlike ST-segment elevation myocardial infarction, the degree of stenosis and physiology of ischemia varies in patients with non-ST-segment elevation myocardial infarction (NSTEMI). The prevalence, predictors, and outcomes of patients with NSTEMI who lack significant epicardial coronary artery disease (CAD) in routine clinical practice remain poorly characterized. We sought to determine the prevalence, predictors, and outcomes of patients with NSTEMI and insignificant CAD. METHODS: We analyzed 38301 patients with NSTEMI in the CRUSADE quality improvement initiative who underwent cardiac catheterization to determine the prevalence and factors associated with insignificant CAD (all coronary stenoses <50%) and inhospital outcomes for patients with and without CAD. A multivariable model was used to determine the factors associated with insignificant CAD. RESULTS: A total of 3306 (8.6%) of 38301 patients had insignificant CAD. The strongest multivariable predictors of insignificant CAD were female sex (odds ratio 2.8, 95% CI 2.6-3.1), younger age (odds ratio per 10-year decrease 1.5, 95% CI 1.5-1.6), and lack of current/recent smoking (odds ratio 1.9, 95% CI 1.7-2.0). Inhospital rates of death were 0.65% for patients with insignificant CAD compared with 2.36% for patients with CAD (P < .0001). CONCLUSION: Insignificant CAD is present in 9% of patients with NSTEMI and is associated with a low incidence of adverse outcomes. The strongest predictors of insignificant CAD are female sex and younger age. These findings underscore the need for research to understand the pathophysiology of myocardial infarction in this population.
OBJECTIVE: To determine patterns and outcomes of drug-eluting stents (DES) use in clinical practice. BACKGROUND: DES are technology associated with superior outcomes. The initial limited availability and high cost of DES had the potential to influence their use. METHODS: Data from the American College of Cardiology-National Cardiovascular Data Registry were examined to describe the patterns of DES use in 408,033 percutaneous coronary intervention (PCI) procedures at 383 sites. Predictors of DES use were determined, and inhospital outcomes were examined. RESULTS: From April 2003 through December 2004, the proportion of procedures using DES increased from 19.7% to 78.2%. DES use increased across all patient groups and hospital types, but adoption was slower among older patients and those without health insurance. DES use varied among hospitals such that use was lower at rural and low-volume hospitals. Multivariable regression demonstrated a progressive decrease in the odds of DES use as age increased. White race, female sex, presence of insurance, diabetes mellitus, PCI of de novo lesion, PCI at a high volume center, and PCI at a suburban hospital were significant predictors of DES use. The availability of a second DES product did not influence the adoption patterns. Inhospital outcomes with DES were excellent. CONCLUSIONS: Access to DES was influenced by demographic, socioeconomic, and hospital characteristics. Further study is needed to determine if the availability of another DES platform or increased overall availability of DES impacts favorably on PCI practice patterns.
PURPOSE: An analysis of reginal variation across the United States in the treatment and outcomes of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) has not been previously performed. SUBJECTS AND METHODS: We assessed contemporary practice and outcomes in 56,466 high-risk patients with NSTE ACS (positive cardiac markers and/or ischemic ST-segment changes) admitted to 310 hospitals across four defined regions in the United States from January 1, 2001, to September 30, 2003. Patient clinical characteristics, acute (<24 hours) and discharge medications, in-hospital procedures, and in-hospital case-fatality rates were evaluated. RESULTS: Statistically significant but clinically small differences in baseline characteristics including age, gender, rates of diabetes, hypertension, and smoking, as well as medical treatment, including a greater than 5% variation in acute use of beta-blockers, clopidogrel, and statins use, were noted across regions. Adjusted rates of revascularization were similar across regions. Overall in-hospital case-fatality rate was 4.1%, with the highest rates in the Midwest (4.6%) and the lowest in the Northeast (3.5%). Adjusted odds ratios (OR) (95% confidence interval [CI] for death were significantly higher in the Midwest (OR 1.42, CI 1.19-1.70), West (OR 1.40 CI 1.05-1.87), and South (OR 1.33, CI 1.08-1.62), compared with the Northeast. CONCLUSIONS: Management of high-risk patients with NSTE ACS is relatively uniform across the United States. However, in-hospital case-fatality rates vary significantly by region, and the differences are not explained by adjustment for standard clinical variables.
Academic medicine, often entrenched in biomedical and clinical research, has largely ignored the development and application of quality metrics to ensure the delivery of high-quality health care. Nevertheless, academic medicine has substantial opportunities to lead the charge in building a quality infrastructure with the goal of delivering high-quality and cost-efficient health care to all Americans. The American College of Cardiology (ACC) and American Heart Association (AHA) have worked jointly to measure and improve the quality of cardiovascular care. This effort has led to the development of clinical practice guidelines, performance measures, data standards, national registries, and appropriateness criteria for cardiovascular care. Academic medicine should actively embrace and promote the type of quality metrics and criteria developed by ACC and AHA and apply this model across the entire academic medicine community. Academic medicine, with its many resources, could lead the way in the expanding field of quality science by supporting fundamental research in quality improvement, supporting academicians to improve quality at their own institutions, developing educational models for quality assessment and improvement, creating and implementing data registries, and serving as a conduit for developing the emerging science of quality assessment. In this and many other ways, academic medicine must offer the health care community leadership for improving our nation's health care quality with the same fervor presently exhibited for the advancement of basic science, the development of specialized and experimental therapy, and as centers for tertiary and quaternary patient care.
With the proliferation of efforts to report publicly the outcomes of healthcare providers and institutions, there is a growing need to define standards for the methods that are being employed. An interdisciplinary writing group identified 7 preferred attributes of statistical models used for publicly reported outcomes. These attributes include (1) clear and explicit definition of an appropriate patient sample, (2) clinical coherence of model variables, (3) sufficiently high-quality and timely data, (4) designation of an appropriate reference time before which covariates are derived and after which outcomes are measured, (5) use of an appropriate outcome and a standardized period of outcome assessment, (6) application of an analytical approach that takes into account the multilevel organization of data, and (7) disclosure of the methods used to compare outcomes, including disclosure of performance of risk-adjustment methodology in derivation and validation samples.
BACKGROUND: An American College of Cardiology/American Heart Association (ACC/AHA) Task Force periodically revises and publishes guidelines with evidence-based recommendations for appropriate use of percutaneous coronary intervention (PCI). Some studies have suggested that closer adherence to guidelines can reduce variations in care, can improve quality, and may ultimately result in better outcomes, but this finding is incompletely understood. Guidelines themselves must change to be responsive to continuously evolving clinical practice. Our goal here was to investigate whether any relationship existed between the most recent ACC/AHA recommended indications for PCI and short term in-hospital outcomes. METHODS AND RESULTS: We analyzed the ACC National Cardiovascular Data Registry for the period of January 1, 2001, through March 31, 2004. We excluded PCI procedures performed for acute myocardial infarction (ST-segment elevation myocardial infarction); all others were grouped by their indications according to the standard ACC/AHA scheme: Class I, evidence and/or agreement that PCI is useful and effective; Class IIa, conflicting evidence and/or divergent opinions, weight is in favor; Class IIb, usefulness/efficacy is less well established; and Class III, evidence and/or agreement that PCI is not useful or effective and may be harmful. Clinical success was defined as angiographic success (<20% residual stenosis) at all lesions attempted without the adverse events of myocardial infarction, same-admission bypass surgery, or death. There were 412 617 PCI procedures included in the analysis. Frequency of indications was as follows: Class I, 64%; Class IIa, 21%; Class IIb, 7%; and Class III, 8%. Clinical success declined across the indications classes (92.8%, 91.7%, 89%, and 85.5%, respectively; P<0.001), whereas adverse events increased. CONCLUSIONS: In this large survey of contemporary PCI practice, most procedures were performed for Class I indications. A significant relationship between evidence-based indications recommended by the ACC/AHA Task Force and in-hospital outcomes was noted.
Under the auspices of the American College of Cardiology Foundation (ACCF) and the American Society of Nuclear Cardiology (ASNC), an appropriateness review was conducted for radionuclide cardiovascular imaging (RNI), specifically gated single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI). The review assessed the risks and benefits of the imaging test for several indications or clinical scenarios and scored them based on a scale of 1 to 9, where the upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The mid range (4 to 6) implies that the test may be generally acceptable and may be a reasonable approach for the indication. The indications for this review were primarily drawn from existing clinical practice guidelines and modified based on discussion by the ACCF Appropriateness Criteria Working Group and the Technical Panel members who rated the indications. The method for this review was based on the RAND/UCLA approach for evaluating appropriateness, which blends scientific evidence and practice experience. A modified Delphi technique was used to obtain first- and second-round ratings of 52 clinical indications. The ratings were done by a Technical Panel with diverse membership, including nuclear cardiologists, referring physicians (including an echocardiographer), health services researchers, and a payer (chief medical officer). These results are expected to have a significant impact on physician decision making and performance, reimbursement policy, and future research directions. Periodic assessment and updating of criteria will be undertaken as needed.
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OBJECTIVES: In a large contemporary population of patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS), we sought to describe blood transfusion rates (overall and in patients who did not undergo coronary artery bypass grafting [CABG]), patient characteristics and practices associated with transfusion, variation among hospitals, and in-hospital outcomes in patients receiving transfusions. BACKGROUND: The use of antithrombotic agents and invasive procedures reduces ischemic complications but increases risks for bleeding and need for blood transfusion in patients with NSTE ACS. METHODS: We evaluated patient characteristics and transfusion rates in the overall population (n = 85,111) and determined outcomes and factors associated with need for transfusion in a subpopulation of patients who did not undergo CABG (n = 74,271) from 478 U.S. hospitals between January 1, 2001, and March 31, 2004. RESULTS: A total of 14.9% of the overall and 10.3% of the non-CABG population underwent transfusion during their hospitalization. Renal insufficiency and advanced age were strongly associated with the likelihood of transfusion. Interhospital transfusion rates varied significantly. Non-CABG patients who received transfusions had a greater risk of death (11.5% vs. 3.8%) and death or reinfarction (13.4% vs. 5.8%) than patients who did not undergo transfusion. CONCLUSIONS: Transfusion is common in the setting of NSTE ACS, and patients who undergo transfusion are sicker at baseline and experience a higher risk of adverse outcomes than their nontransfused counterparts. Given the wide variation in transfusion practice, further efforts to understand patient and process factors that result in bleeding and need for transfusion in NSTE ACS are needed.