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Despite the established benefits of antiplatelet agents in coronary artery disease (CAD), many appropriate patients are not receiving them. We investigated the prevalence of and factors associated with aspirin use and nonuse within a large referral population with CAD. The goal was to identify an approach to increase the use of antiplatelet agents by such patients. We surveyed a subset (n = 2,694) of a large CAD referral population (n = 16,174) to determine the use of aspirin and factors associated with its use or nonuse. The subset was made up of all of the CAD referral population who were considered nonusers of aspirin and a 5% sample of those considered aspirin users. We then extrapolated survey data to the overall population to estimate how many eligible patients were not taking antiplatelet agents. In all, 1,626 (63%) of the surviving patients responded to the survey. Of these, 948 (58%) reported taking aspirin, and 678 (42%) reported no aspirin use. The extrapolated rate of aspirin use in the overall population was 85%. Of 2,367 nonusers, 998 (42%, or 6% of the overall cohort) were eligible for antiplatelet agents but were not taking such therapy. Although the rate of aspirin use in this population was higher than previously reported, an estimated 6% of eligible patients were not receiving antiplatelet therapy. [ABSTRACT FROM AUTHOR]

Although coronary stenting has been shown to be effective, retrospective studies have suggested that stents do not provide better results than angioplasty in small coronary arteries. We sought to examine procedural, in-hospital, and long-term outcomes of patients undergoing small-vessel stenting with Palmaz-Schatz stents hand-crimped on a balloon catheter <3 mm in diameter. We retrospectively analyzed the outcomes of 117 patients who underwent this type of coronary stent implantation at Duke University Medical Center between January 1, 1997 and May 30, 1998. The clinical indications for percutaneous revascularization included unstable angina in 67.5% of patients, acute myocardial infarction in 4.3%, postinfarct angina in 3.4%, silent ischemia in 3.4%, and stable angina in 1% of patients. Quantitative angiographic analysis was performed immediately before angioplasty and after stent implantation. Stents were used for elective indications in 24%, for suboptimal angiographic result in 61.5%, and for abrupt and/or threatened closure in 14.5% of patients. Reference vessel diameter was similar before and after the procedure. Minimum luminal diameter increased from 0.63 to 2.35 mm, an acute gain of 1.72+/-0.43 mm. Percent stenosis decreased from 74.2% to 4.7%. The clinical composite of death (n = 1, 1%), nonfatal myocardial infarction (n = 6, 5.1%), and revascularization (n = 1, 1%) occurred in-hospital in only 8 patients (6.8%), resulting in clinical procedure success in 109 patients (93%). Our data suggest that stents designed for vessels >3.0 mm can be deployed in small vessels, with a low in-hospital event rate. However, target lesion revascularization in small vessels remains high. Development of antiproliferative strategies could improve long-term outcomes for small-vessel interventions. [ABSTRACT FROM AUTHOR]

Background: Single Institutional Review Boards (sIRB) are not achieving the benefits envisioned by the National Institutes of Health. The recently published Health Level Seven (HL7®) Fast Healthcare Interoperability Resources (FHIR®) data exchange standard seeks to improve sIRB operational efficiency., Methods and Results: We conducted a study to determine whether the use of this standard would be economically attractive for sIRB workflows collectively and for Reviewing and Relying institutions. We examined four sIRB-associated workflows at a single institution: (1) Initial Study Protocol Application, (2) Site Addition for an Approved sIRB study, (3) Continuing Review, and (4) Medical and Non-Medical Event Reporting. Task-level information identified personnel roles and their associated hour requirements for completion. Tasks that would be eliminated by the data exchange standard were identified. Personnel costs were estimated using annual salaries by role. No tasks would be eliminated in the Initial Study Protocol Application or Medical and Non-Medical Event Reporting workflows through use of the proposed data exchange standard. Site Addition workflow hours would be reduced by 2.50 h per site (from 15.50 to 13.00 h) and Continuing Review hours would be reduced by 9.00 h per site per study year (from 36.50 to 27.50 h). Associated costs savings were $251 for the Site Addition workflow (from $1609 to $1358) and $1033 for the Continuing Review workflow (from $4110 to $3076)., Conclusion: Use of the proposed HL7 FHIR® data exchange standard would be economically attractive for sIRB workflows collectively and for each entity participating in the new workflows., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 Elsevier Inc. All rights reserved.)

The Project Baseline Health Study (PBHS) was launched to map human health through a comprehensive understanding of both the health of an individual and how it relates to the broader population. The study will contribute to the creation of a biomedical information system that accounts for the highly complex interplay of biological, behavioral, environmental, and social systems. The PBHS is a prospective, multicenter, longitudinal cohort study that aims to enroll thousands of participants with diverse backgrounds who are representative of the entire health spectrum. Enrolled participants will be evaluated serially using clinical, molecular, imaging, sensor, self-reported, behavioral, psychological, environmental, and other health-related measurements. An initial deeply phenotyped cohort will inform the development of a large, expanded virtual cohort. The PBHS will contribute to precision health and medicine by integrating state of the art testing, longitudinal monitoring and participant engagement, and by contributing to the development of an improved platform for data sharing and analysis., Competing Interests: Competing interestsK.A. received research funding from Verily Inc. for work at Duke Clinical and Translational Science Institute. R.C. and J.H. are employed or have a leadership role at at Google Health. R.C. is also a Board member, Cytokinetics. M.D. receives research funding from Celgene, Abbvie, United Therapeutics, Varian, Genzyme, Novartis, Verily Inc., and consults or receives honoraria from Astra Zeneca, Bristol Myer Squibb. A.H. receives research funding from American Regent, AstraZeneca, Merck, Novartis, Verily Inc., and consults for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Merck, Novartis, and Sanofi. C.L. has the following engagements Shareholder and Advisory Board, whiterabbit.ai; Shareholder, Nines.ai; Advisory Board, Nines.ai; Shareholder, GalileoCDS, Inc.; Advisory Board, GalileoCDS, Inc; Shareholder and Board of Directors Bunker Hill, Inc.; Research Grant, GE Healthcare; Departmental Research Grant, Koninklijke Philips NV; Departmental Research Grant, Siemens AG; School of Medicine Research Grant, Google, Inc.; Travel Grant, Canon Medical Systems Corp; Travel Grant, Siemens Healthineers. S.S.G. is a consultant or receives funding from several companies that work in the healthcare space although none of these companies are directly involved in the current work. K.W.M.’s financial disclosure can be viewed at http://med.stanford.edu/profiles/kenneth-mahaffey. W.J.M., J.M., D.M., and S.S. are employed, have a leadership role, or receive equity from Verily Inc. J.M. is also a Board Member, Danaher. L.K.N. received research grant support from Verily Inc., (© The Author(s) 2020.)

Background: Although the relationship between psychoactive substance use and injury is known, evidence remains conflicting on the impact of substance use on clinical outcomes after injury. We hypothesized that preinjury substance use would negatively impact clinical outcomes., Methods: National Trauma Registry American College of Surgeons identified patients (n = 9793) presenting to Duke Hospital from 2006 to 2010. Logistic regression models assessed potential predictors of receiving substance screening, mortality, length of stay, ventilator requirement, intensive care admission, or emergency department disposition., Results: Forty-seven percent (4607/9793) of patients received blood alcohol screen (BAS) and 31% (3017/9793) received urine drug screen (UDS). Men were more likely to receive both BASs (P < 0.001) and UDSs (P = 0.001) than women after controlling for potential confounders. There was no significant difference between men and women over the legal limit for alcohol (OLLA; 27.2%, 95% confidence interval [CI]: 25.7%-28.8% versus 24.8%, 95% CI: 22.3%-27.5%). Similarly, younger patients more likely received both BASs (P < 0.001) and UDSs (P < 0.001) compared with older patients. The proportion of patients aged ≤45 y OLLA (26.5 %, 95% CI: 24.9%-28.2%) was similar to those aged >45 y OLLA (26.8%, 95% CI: 24.5%-29.3%). After controlling for potential confounders neither alcohol, nor tetrahydrocannabinol, nor cocaine was predictive of mortality, ventilator requirement, length of stay, or emergency department disposition, but a higher alcohol level (P = 0.0174) predicted intensive care admission., Conclusions: Females and those aged >45 y are less likely to receive BASs and UDSs. Differential screening that is biased may place patients at risk for receiving inadequate care., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Major postoperative infections (MPIs) are poorly understood complications of cardiac surgery. We examined the epidemiology, microbiology, and outcome of MPIs occurring after cardiac surgery., Methods: The study cohort was drawn from the Society of Thoracic Surgeon National Cardiac Database and comprised adults who underwent cardiac surgery at 5 tertiary hospitals between 2000 and 2004. We studied the incidence, microbiology, and risk factors of MPI (bloodstream or chest wound infections within 30 days after surgery), as well as 30-day mortality. We used multivariate regression analyses to evaluate the risk of MPI and mortality., Results: MPI was identified in 341 of 10,522 patients (3.2%). Staphylococci were found in 52.5% of these patients, gram-negative bacilli (GNB) in 24.3%, and other pathogens in 23.2%. High body mass index, previous coronary bypass surgery, emergency surgery, renal impairment, immunosuppression, cardiac failure, and peripheral/cerebrovascular disease were associated with the development of MPI. Median postoperative duration of hospitalization (15 days vs 6 days) and mortality (8.5% vs 2.2%) were higher in patients with MPIs. Compared with uninfected individuals, odds of mortality were higher in patients with S aureus MPIs (adjusted odds ratio, 3.7) and GNB MPIs (adjusted odds ratio, 3.0)., Conclusions: Staphylococci accounted for the majority of MPIs after cardiac surgery. Mortality was higher in patients with Staphylococcus aureus- and GNB-related MPIs than in patients with MPIs caused by other pathogens and uninfected patients. Preventive strategies should target likely pathogens and high-risk patients undergoing cardiac surgery., (Copyright © 2012 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Mosby, Inc. All rights reserved.)

Background: Hypertension control is an important and modifiable risk factor for cardiovascular disease. The overall rate of hypertension control among patients followed in cardiology clinics, as well as clinician variability in control rates, is unknown., Methods and Results: We conducted a retrospective cohort study of patients with hypertension (n=5979) routinely followed in a cardiology clinic (n=47 physicians). Overall, 30.3% of patients with hypertension had suboptimal control (blood pressure [BP] ≥ 140/90 mm Hg) at the end of a 13-month follow-up period. Patient-level factors associated with control were younger age, male sex, white ethnicity, having a primary care provider at Duke, private insurance, Medicare/Medicaid, and comorbid diagnoses of heart failure or coronary artery disease. Unadjusted rates of suboptimal BP control among clinicians' clinic patient panels ranged from 16% to 44%. Even after adjusting for patient factors, patients' odds of BP control varied 6-fold, depending on their treating clinician. Using a patient's average BP rather than their most recent BP did not result in significant changes in provider performance. In chart reviews (n=300), clinicians failed to document a plan to address hypertension in 38% of patients with elevated BP in the clinic., Conclusions: Up to one-third of patients followed routinely by cardiologists in clinic have suboptimally controlled BP, with wide variability in performance across individual clinicians. This variability, alongside evidence that elevated BP is often not acted on during clinic visits, demonstrates a potential opportunity for quality improvement.

Objective: Pulmonary dysfunction/multiorgan failure syndrome is an important cause of mortality and morbidity after cardiac operations. In this series, results of immune augmentation were assessed in patients experiencing pulmonary dysfunction/multiorgan failure syndrome after cardiac surgery., Methods: Since 2002, 44 consecutive patients with primary antibiotic-refractory pulmonary dysfunction/multiorgan failure syndrome were treated with intravenous immunoglobulin (0.3 g/kg × 5 days; 1.5 g/kg total dose). Thirty patients had undergone complex valve or aortic surgery, and 14 patients had coronary bypass. Median age was 66 years, and risk profiles were especially high preoperatively. Clinical variables were assessed for 3 days prior (-3) to beginning intravenous immunoglobulin (on day 0) and for 5 days afterward (+5). A postoperative morbidity index was generated as a weighted sum of all relevant clinical variables. By using each patient as his or her own control, the therapeutic effect of intravenous immunoglobulin was assessed with linear regression of postoperative morbidity index over time with a spline and a knot at day 0, coincident with beginning intravenous immunoglobulin., Results: At day 0, all patients were deteriorating clinically and refractory to major antibiotics. Overall morbidity was high, and immunoglobulin-G levels, obtained in the last 14 patients, were consistently low. By using linear regression of postoperative morbidity index over time, intravenous immunoglobulin administration was associated with significant improvement in clinical status (P < .0001). A total of 42 of 44 patients (95%) recovered uneventfully to hospital discharge. No significant complications of intravenous immunoglobulin therapy occurred., Conclusions: This experience suggests that management of immune dysfunction with intravenous immunoglobulin is safe and effective for treatment of primary pulmonary dysfunction/multiorgan failure syndrome after cardiac surgery. Expanded application seems indicated., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: The previous Pexelizumab for Reduction of Infarction and Mortality in Coronary Artery Bypass Graft Surgery I (PRIMO-CABG I) trial (n = 3099) indicated that C5 complement inhibition with pexelizumab might reduce myocardial infarction (MI) and postoperative mortality. PRIMO-CABG II was designed to investigate the safety and efficacy of terminal complement inhibition in reducing perioperative MI and mortality in patients undergoing CABG surgery who have 2 or more predefined preoperative risk factors., Methods: PRIMO-CABG II, a randomized, double-blind, placebo-controlled trial, enrolled 4254 patients undergoing CABG with or without valve surgery at 249 hospitals in North America and Western Europe from June 2004 to July 2005. The patients were randomly assigned to receive intravenous pexelizumab or placebo. The primary composite endpoint was the incidence of death or MI within 30 days of randomization., Results: The PRIMO-CABG II trial did not meet its prespecified primary endpoint of death or MI at 30 days, the secondary endpoints of death at 30 days, or the development of new or worsening congestive heart failure (relative risk 0.91, 0.82, and 1.01, respectively; P > .05). However, in a combined analysis of both pivotal trials, PRIMO-CABG I and II (n = 7353), death at 30 days was significantly reduced for the greatest risk subset (n = 2156, pexelizumab 5.7% vs placebo 8.1%, P = .024). Furthermore, this mortality reduction persisted throughout the 180-day follow-up period (pexelizumab 11.1% vs placebo 14.4%, P = .036)., Conclusions: Pexelizumab was associated with a nonsignificant 6.7% reduction in the primary composite endpoint of death or MI at postoperative day 30 in CABG patients enrolled in the PRIMO-CABG II trial, despite the suggestion of a more favorable treatment effect in the previous PRIMO-CABG I trial. However, an exploratory analysis of the combined PRIMO I and II data set using an established predictive risk model showed a mortality benefit for high-risk surgical patients., (Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Although the informed consent process is supposed to help potential research participants make informed and voluntary decisions about participating in research, little is known about how participants react to language in the informed consent document and whether their reactions are related to their willingness to enroll in clinical trials. We examined the relationship between patients' reactions to standard informed consent language and their willingness to participate in a hypothetical clinical trial., Methods and Results: We simulated the consent process for a hypothetical cardiology clinical trial with 470 patients in an outpatient cardiovascular medicine clinic at a large academic medical center. We analyzed the spontaneous comments and questions that participants made during the interviews about each section of the informed consent document. Few participants made positive comments. Participants made the most negative comments about the sections on risks, study purpose or protocol, and payment for injury. Having a negative reaction to any section was associated with a lower likelihood of participating in the clinical trial. Using a multivariable model, we found that negative reactions in the patient rights, financial disclosure, and confidentiality sections predicted willingness to participate (P<0.001)., Conclusions: Recognizing elements of informed consent that elicit questions and concerns from potential research participants may help investigators design clinical research trials and model language in a way that reduces concerns or increases participant understanding, thereby enhancing informed consent for research.

Clinical data registries are valuable tools that support evidence development, performance assessment, comparative effectiveness studies, and the adoption of new treatments into routine clinical practice. Although these registries do not have important information on long-term therapies or clinical events, administrative claims databases offer a potentially valuable complement. This article focuses on the regulatory and ethical considerations that arise from the use of registry data for research, including linkage of clinical and administrative data sets. (1) Are such activities primarily designed for quality assessment and improvement, research, or both, as this determines the appropriate ethical and regulatory standards? (2) Does the submission of data to a central registry, which may subsequently be linked to other data sources, require review by the institutional review board (IRB) of each participating organization? (3) What levels and mechanisms of IRB oversight are appropriate for the existence of a linked central data repository and the specific studies that may subsequently be developed using it? (4) Under what circumstances are waivers of informed consent and Health Insurance Portability and Accountability Act authorization required? (5) What are the requirements for a limited data set that would qualify a research activity as not involving human subjects and thus not subject to further IRB review? The approaches outlined in this article represent a local interpretation of the regulations in the context of several clinical data registry projects and focuses on a specific case study of the Society of Thoracic Surgeons National Database.

Objective: Staphylococcus aureus infections after cardiac surgery result in significant morbidity and mortality. Identifying patients at elevated risk for these infections preoperatively could facilitate efforts to reduce infection rates. The objectives of this study were to estimate the incidence of postoperative S. aureus infections in cardiac surgery patients, to identify preoperative risk factors for these infections, and to establish a patient risk profile by means of data available to clinicians prior to surgery., Design: Cohort study., Setting: Eight medical centers that participate in the Society of Thoracic Surgeons National Cardiac Database., Patients: Patients who were undergoing elective cardiac surgery during the period January 1, 2000 through December 31, 2004., Methods: Clinical and microbiological data from 16,386 patients were combined. Multivariable stepwise logistic regression analysis was performed to predict S. aureus infection, which was defined by culture results., Results: Of the 16,386 patients, 205 (1.3%) developed S. aureus bloodstream or chest wound infection within 90 days after surgery. On multivariable analysis, bootstrap-validated preoperative risk factors for S. aureus bloodstream or chest wound infection included a body mass index greater than 40 (adjusted odds ratio [aOR], 1.9 [95% confidence interval {CI}, 1.1-3.2]), chronic renal failure (aOR, 1.8 [95% CI, 1.1-2.9]), and chronic lung disease (aOR, 1.4 [95% CI, 1.0-2.0]). Only 8 patients had all 3 risk factors., Conclusions: Although preoperative risk factors can be easily identified, the majority of patients who developed S. aureus infections after cardiac surgery did not have any risk factors. Preventive measures should not be restricted to a select group of cardiac surgery patients and should rather address the entire patient population.

Background: Residence in a lower-income area has been associated with higher mortality among patients receiving dialysis. We sought to determine whether these differences persist and whether the effect of income-area on mortality is different for African Americans versus patients of other races., Methods: We evaluated relationships between lower- and higher-income versus middle-income area residence and mortality to 5 years after adjusting for differences in baseline clinical, dialysis facility, and socioeconomic characteristics in 186,424 adult patients with end-stage renal disease initiating hemodialysis at stand-alone facilities between 1996 and 1999. We also compared mortality differences between race and income level groups using non-African Americans residing in middle-income areas as the reference group., Results: Patients with end-stage renal disease who reside in lower-income areas were younger and more frequently African American. After adjustment, there were no mortality differences among income level groups. However, African Americans in all income level groups had lower adjusted mortality compared with the reference group (lower-income hazard ratio [HR]=0.771, 95% confidence interval [CI], 0.736-0.808; middle-income HR=0.755, 95% CI, 0.730-0.781; higher-income HR=0.809, 95% CI, 0.764-0.857), whereas adjusted mortality was similar among non-African-American income level groups (lower-income HR=1.019, 95% CI, 0.976-1.064; higher-income HR=1.003, 95% CI, 0.968-1.039)., Conclusion: Adjusted survival for patients receiving hemodialysis in all income areas was similar. However, this result masks the paradoxically higher survival for African American versus patients of other race and demonstrates the need to adjust for differences in demographic, clinical, provider, and socioeconomic status characteristics.

Objectives: We sought to determine whether dialysis patient mortality rates are associated with differences in dialysis facility size, and whether this relationship differs among higher risk diabetic and lower-risk non-diabetic patients., Methods: Using 186,554 adult end-stage renal disease patients initiating hemodialysis at standalone facilities in the United States between 1996 and 1999, we evaluated relationships between dialysis facility size and survival to 5 years. We performed separate analyses for patients with and without diabetes as their primary cause of end-stage renal disease. Facility size was defined according to the number of hemodialysis patients at year's end (smallor=120)., Results: Increasing facility size was associated with a reduced risk of mortality at 4 years for both diabetic (HR=0.983 per 10 unit increase, 95% CI=0.967, 0.999) and non-diabetic patients (HR 0.977 per 10 unit increase, 95% CI=0.963, 0.992) dialyzing in small facilities, and for diabetic patients (HR 0.989 per 10 unit increase, 95% CI=0.980, 0.998) dialyzing in medium size facilities., Conclusions: Smaller facility size is associated with increasing long-term mortality for in-center hemodialysis patients. This relationship appears to be more pronounced among higher-risk diabetic vs. lower-risk non-diabetic patients.

Justifiable concerns about the use of personal data in many aspects of daily life have led to the recent introduction in many countries of laws intended to regulate data use. Although participation in randomized clinical trials is generally with informed consent, recruitment procedures, complete follow-up, and the efficient conduct of trials may be substantially affected by such national or local privacy legislation. The relevant laws often have exceptions that allow the use of patient information in the public interest - including the use of data collected to improve or monitor public health or as part of medical research. However, regulatory bodies often give conflicting interpretations of the law, and this affects the conduct of large-scale trials. In particular, unnecessarily restrictive interpretation of the law may be a serious impediment to identification of potential participants for a trial, access to records to confirm events, continued follow-up of patients after the trial has been concluded, and secondary use of the trial data for purposes not directly related to the original purpose of the study. These obstacles could be overcome by better informing patients of the uses of records for medical research purposes, by using informed consent procedures that explain the nature of the research and the uses of the data, and by the use of identifiers, such as social security numbers that allow central follow-up. The clinical trial research community needs to ensure that the substantial benefits of large-scale randomized trials are explained both to the public and to those responsible for introducing legislation. The negative impact of privacy legislation on the use of personal health information and on conducting large studies needs to be understood and minimized.

VNP40101M, or 1,2-bis(methylsulfonyl)-1-(2-choloroethyl)-2-(methylamino)carbonylhydrazine (Cloretazine), is a bifunctional prodrug that belongs to a class of DNA-modifying agents-the sulfonylhydrazines-that has been synthesized and been shown to have activity against a wide spectrum of xenografts. The current study was designed to assess the activity of VNP40101M administered at a dose of 18 mg/kg daily for five days against a panel of human adult and pediatric CNS tumors growing subcutaneously or intracranially in athymic nude mice. The results demonstrated statistically significant (p < 0.05) growth delays of 15.0, 8.3, 51.0, 60+, 60+, and 60+ days in subcutaneous xenografts derived from childhood glioblastoma multiforme (D-456 MG), childhood ependymoma (D-528 EP and D-612 EP), childhood medulloblastoma (D-425 MED), and adult malignant glioma (D-245 MG and D-54 MG), respectively, with corresponding tumor regressions in 10 of 10, 4 of 10, 8 of 10, 9 of 10, 9 of 10, and 10 of 10 treated mice, respectively. Delayed toxicity was seen more than 60 days after treatment, with 23 deaths in 100 treated animals, despite a median weight loss of only 0.06%. In mice bearing intracranial D-245 MG xenografts, treatment with VNP40101M at a dose of 18 mg/kg daily for five days produced a 50% increase in median survival compared with controls. Additional experiments conducted against subcutaneous D-245 MG xenografts by using reduced doses of 13.5 or 9.0 mg/kg daily for five days demonstrated tumor growth delays of 82.2 and 53.5 days, with corresponding tumor regressions in 8 of 9 and 9 of 10 treated mice, respectively (all values, p < 0.001), with one toxic death. These findings suggest that VNP40101M is active in the treatment of a wide range of human central nervous system tumors and warrants translation to the clinic.

Background: Postoperative stays after coronary artery bypass graft surgery (CABG) decreased substantially in the 1990s. Although shorter stays offer clinical benefits, premature discharge could increase adverse events and offset initial savings. This study examined the effect of early discharge after CABG on readmission/death and cost within 60 days of discharge home. Variability in hospitals' tendencies for early discharge and adverse outcomes was also explored., Methods: Analyses were based on clinical and claims data for 55,889 New York CABG patients discharged home 1995 to 1998. Early discharge was defined as a postoperative stay below the 15th percentile for patients with similar risk. The likelihood of early discharge and its effect on readmission/death were examined using hierarchical logistic regression, accounting for patient risk and within-hospital correlation. The correlation between early discharge and adverse outcomes at the hospital level was assessed. The effect of early discharge on subsequent inpatient, outpatient, skilled nursing, and home health costs was examined in the Medicare subset., Results: Overall, 17% of patients were discharged early, with increasing prevalence over time. The tendency to discharge early varied widely among hospitals (2% to 42% of patients). We found no association between hospitals' tendencies for early discharge and adverse outcomes. Lower postdischarge costs among patients discharged early (mean = 3,491 dollars versus 5,246 dollars for typical stays) resulted in average cumulative savings of 6,309 dollars., Conclusions: Patients selected for earlier discharge after CABG did not have increased adverse event rates or higher costs. Variation among hospitals in early discharge suggests that more efficient patient management could be achieved at some hospitals.

Background: Although single-site studies have reported reductions in coronary artery bypass graft (CABG) surgery length of stay (LOS) over the last 15 years, less information is available regarding overall temporal trends and interhospital variability. This study examined trends in postoperative LOS, associated rates of transfer at discharge and variation among hospitals in LOS at CABG hospitals in New York State., Methods: Trends in postoperative LOS and transfers at discharge for 105,842 CABG patients treated in 30 hospitals in New York between 1992 and 1998 were first described graphically. Mixed models were then used to assess temporal trends and interhospital variability in LOS, accounting for differences in patient risk and within-hospital correlation in outcomes. Clinical and LOS data were obtained from the Cardiac Surgery Reporting System. Additional information was extracted from the New York Statewide Planning and Research Cooperative System., Results: Postoperative LOS decreased 30% between 1992 and 1998 after adjusting for patient risk. A concurrent increase in the probability of nonacute patient transfers occurred over time, with the most pronounced increase in patients with stays exceeding 5 days. Underlying the downward trend in LOS was substantial interhospital variability that peaked in 1994 and remained significant in 1998. Stays were longer at hospitals located in New York City., Conclusions: The downward shift in LOS observed in the 1990s was achieved in part by an increase in nonacute care transfers, reflecting a shift in care setting. After decreasing trends in postoperative stays tapered off, significant variability among hospitals remained.

Hypothesis: Decreased preoperative levels of antiendotoxin core antibody (EndoCAb) in patients undergoing cardiac surgery with cardiopulmonary bypass are associated with increased long-term mortality., Design: Observational study., Setting: Academic medical center., Patients: A total of 474 patients undergoing coronary artery bypass graft surgery with cardiopulmonary bypass., Interventions: Preoperative serum IgM EndoCAb levels were determined, and established preoperative risk factors were assessed. Patients were assigned a risk score using a validated method., Main Outcome Measures: The primary end point was mortality. Statistical analysis used the Cox proportional hazards regression model with log EndoCAb as the predictor of interest and Parsonnet additive risk score as a covariate. Kaplan-Meier survival curves were generated to visually compare groups with high vs low EndoCAb levels., Results: Forty-six deaths occurred in 5 years. Annual follow-up rates during the 5 years were 100%, 94%, 93%, 98%, and 98% for the 1-, 2-, 3-, 4-, and 5-year periods, respectively. Parsonnet additive risk score (hazard ratio, 1.07; 95% confidence interval [CI], 1.04-1.11; P < .001) and log EndoCAb (hazard ratio, 0.73; 95% CI, 0.53-0.99; P = .04) were independent predictors of long-term mortality in the final model. Kaplan-Meier analysis revealed that the preoperative EndoCAb level was significantly associated with mortality up to 5 years (P = .01 by log-rank test)., Conclusion: Lower preoperative serum EndoCAb level is a significant predictor of long-term mortality independent of other known risk factors.

Background: Despite a survival benefit and guideline recommendation for beta-blockers in left ventricular systolic dysfunction, beta-blockers are underused in clinical practice., Methods: Medical practices with > or = 15 patients with heart failure (HF) in the Duke Databank for Cardiovascular Disease (DDCD) were identified for a prospective, randomized study using a multifaceted intervention to improve beta-blocker use. Intervention practices received provider education, patient education materials, feedback on beta-blocker use of their patients with HF, and access to telephone consultation with an HF expert. The primary outcome was a comparison between intervention and control practices of the proportion of patients with HF self-reporting beta-blocker use on their first routine DDCD follow-up in the postintervention year. A random effects model was used for the analysis., Results: Post intervention, 2631 patients (1701 in 23 intervention practices and 930 in 22 control practices) completed DDCD follow-up. No significant difference in the proportion of patients with HF reporting beta-blocker use was found in the intervention versus control groups (OR 1.16, 95% CI 0.94-1.43, P = .2), although more patients in the intervention group started a beta-blocker than stopped a beta-blocker during the study period (P = .02)., Conclusions: This multifaceted intervention did not significantly increase the mean proportion of patients taking beta-blockers within practices exposed to the intervention, although favorable trends were observed. Further studies are needed to identify and evaluate strategies for translating evidence into clinical practice to reduce the global health burden associated with HF.

Background and Aim of the Study: Pulmonary dysfunction/multiorgan failure (PD/MF), usually due to refractory pulmonary infection, is an important cause of mortality and morbidity after cardiac operations. Moreover, the incidence of PD/MF may be increasing due to the emergence of antibiotic-resistant pathogens., Methods: Fifteen consecutive patients (median age 69 years) who were developing antibiotic-refractory PD/MF were administered 24 g per day intravenous immunoglobulin (IV-IgG; Carimune) for five days. Ten patients had undergone complex valve surgery, and five coronary bypass. Preoperatively, 93% of patients had significant comorbidity, 73% presented acutely, 53% were hypoalbuminemic and 47% had antecedent acute pulmonary derangement. Clinical variables were assessed by retrospective chart review for three days prior to (-3) the start of IV-IgG (day 0) and for five days afterwards (+5). A postoperative morbidity index (PMI) was generated as a weighted sum of: worsening lung infiltrates (I); leukocytosis (L); pulmonary dysfunction (P); ventilator requirement (V); septic shock (S); renal (R), gastrointestinal (G), or hepatic (H) dysfunction; thrombocytopenia (T); and delirium (D)., Results: At day 0, all patients were refractory to major antibiotics, with morbidities of: 1-100%, L-93%, P-93%, V-60%, S-27%, R-67%, G-40%, H-13%, T-27%, and D-20%. Using regression analysis, IV-IgG administration was associated with a statistically significant fall in white blood count and improvement in PMI (p <0.006). Fourteen patients (93%) recovered uneventfully, and one patient (7%) died from progressive sepsis. No complications of IV-IgG therapy occurred., Conclusion: Given the high predicted mortality of PD/MF patients, these data suggest that IV-IgG is a safe and efficacious adjunct to antibiotics in this setting. Further studies, including a randomized trial and investigation of immunomodulatory mechanisms, seem indicated.

Background: Evidence suggests that laparoscopic appendectomy (LA) has advantages over open appendectomy (OA) in the treatment of appendicitis. It remains, however, unclear whether LA is indicated in the elderly patient population., Methods: Patients with primary International Classification of Diseases, revision 9, procedure codes for LA (n=32406 patients) and OA (n=112884 patients) were selected from the 1998, 1999, and 2000 Nationwide Inpatient Samples. The end points that were under investigation were the length of hospital stay, the rate of routine discharge, and in-hospital morbidity and mortality rates. Multiple linear and logistic regression analyses were performed to assess the risk-adjusted association between the surgery type and the patient outcomes. Stratified analyses were performed according to age (65 years and older; less than 65 years old) and to the presence of appendiceal perforation or abscess., Results: After risk adjustment, patients who underwent LA had a significantly shorter mean length of stay (LA, 2.45 days; OA, 3.71 days; P <. 0001), higher rate of routine discharge (odds ratio, 2.80; P <.0001), lower overall complication rate (odds ratio, 0.92; P=.03), and mortality rate (odds ratio, 0.23; P=.001) compared with OA patients. Similar benefits of LA were found in the strata of patients who were less than 65 years old, in elderly patients, and in patients with appendiceal perforation or abscess., Conclusion: LA has statistically significant advantages over OA with respect to the length of hospital stay, the rate of routine discharge, and postoperative morbidity and mortality rates for patients who are less than 65 years old, in elderly patients, and in patients with appendiceal abscess or perforation.

Background: The full kallikrein-inhibiting dose of aprotinin has been shown to reduce blood loss, transfusion requirements, and the systemic inflammatory response associated with cardiopulmonary bypass graft surgery (CABG). A half-dose regimen, although having a reduced delivery cost, inhibits plasmin and fibrinolysis without substantially effecting kallikrein-mediated inflammation associated with bypass surgery. The differing pharmacologic effects of the two regimens impact the decision-making process. The current study assessed the medical cost offset of full-dose and half-dose aprotinin from short- and long-term perspectives to provide a rational decision-making framework for clinicians., Methods: To estimate CABG admission costs, resource utilization and clinical data from aprotinin clinical trials were combined with unit costs estimated from a Duke University-based cost model. Lifetime medical costs of stroke and acute myocardial infarction were based on previous research., Results: Relative to placebo, the differences in total perioperative cost for primary CABG patients receiving full-dose or half-dose aprotinin were not significant. When lifetime medical costs of complications were considered, total costs in full-dose and half-dose aprotinin-treated patients were not different relative to that of placebo. Total perioperative cost was significantly lower for repeat CABG patients treated with aprotinin, with savings of $2,058 for full-dose and $2,122 for half-dose patients when compared with placebo. Taking lifetime costs of stroke and acute myocardial infarction into consideration, the cost savings estimates were $6,044 for full-dose patients and $4,483 for half-dose patients, due to substantially higher lifetime stroke costs incurred by the placebo patients., Conclusions: Using this cost model, use of full-dose and half-dose aprotinin in primary CABG patients was cost neutral during hospital admission, whereas both dosing regimens were significantly cost saving in reoperative CABG patients. Additional lifetime cost savings were realized relative to placebo due to reduced complication costs, particularly with the full-dose regimen. As the full kallikrein-inhibiting dose of aprotinin has been shown to be safe and effective, the current results support its use in both primary and repeat CABG surgery. No demonstrable economic advantage was observed with the half-dose aprotinin regimen.

Objective: To compare length of hospital stay, in-hospital complications, in-hospital mortality, and rate of routine discharge between laparoscopic and open appendectomy based on a representative, nationwide database., Summary Background Data: Numerous single-institutional randomized clinical trials have assessed the efficacy of laparoscopic and open appendectomy. The results, however, are conflicting, and a consensus concerning the relative advantages of each procedure has not yet been reached., Methods: Patients with primary ICD-9 procedure codes for laparoscopic and open appendectomy were selected from the 1997 Nationwide Inpatient Sample, a database that approximates 20% of all US community hospital discharges. Multiple linear and logistic regression analyses were used to assess the risk-adjusted endpoints., Results: Discharge abstracts of 43757 patients were used for our analyses. 7618 patients (17.4%) underwent laparoscopic and 36139 patients (82.6%) open appendectomy. Patients had an average age of 30.7 years and were predominantly white (58.1%) and male (58.6%). After adjusting for other covariates, laparoscopic appendectomy was associated with shorter median hospital stay (laparoscopic appendectomy: 2.06 days, open appendectomy: 2.88 days, P < 0.0001), lower rate of infections (odds ratio [OR] = 0.5 [0.38, 0.66], P < 0.0001), decreased gastrointestinal complications (OR = 0.8 [0.68, 0.96], P = 0.02), lower overall complications (OR = 0.84 [0.75, 0.94], P = 0.002), and higher rate of routine discharge (OR = 3.22 [2.47, 4.46], P < 0.0001)., Conclusions: Laparoscopic appendectomy has significant advantages over open appendectomy with respect to length of hospital stay, rate of routine discharge, and postoperative in-hospital morbidity.

Despite the established benefits of antiplatelet agents in coronary artery disease (CAD), many appropriate patients are not receiving them. We investigated the prevalence of and factors associated with aspirin use and nonuse within a large referral population with CAD. The goal was to identify an approach to increase the use of antiplatelet agents by such patients. We surveyed a subset (n = 2,694) of a large CAD referral population (n = 16,174) to determine the use of aspirin and factors associated with its use or nonuse. The subset was made up of all of the CAD referral population who were considered nonusers of aspirin and a 5% sample of those considered aspirin users. We then extrapolated survey data to the overall population to estimate how many eligible patients were not taking antiplatelet agents. In all, 1,626 (63%) of the surviving patients responded to the survey. Of these, 948 (58%) reported taking aspirin, and 678 (42%) reported no aspirin use. The extrapolated rate of aspirin use in the overall population was 85%. Of 2,367 nonusers, 998 (42%, or 6% of the overall cohort) were eligible for antiplatelet agents but were not taking such therapy. Although the rate of aspirin use in this population was higher than previously reported, an estimated 6% of eligible patients were not receiving antiplatelet therapy.

Despite substantial evidence that antiplatelet therapy saves lives and reduces adverse events in patients with coronary artery disease (CAD), use of the most widely available and lowest cost antiplatelet agent, aspirin, continues to be disappointingly low. In a large database of patients with known CAD, we (1) explored trends in the use of aspirin over time, (2) characterized patients most likely to take aspirin regularly, and (3) estimated the effectiveness of aspirin use by examining long-term outcomes. Using patients entered in the Duke Databank for Cardiovascular Diseases, we explored the use of aspirin from 1969 to 1999. More than 25,000 patients were sent a questionnaire that included several questions about medication use, including 1 question specifically about aspirin. Patients who failed to respond to the questionnaire received a follow-up telephone call. Aspirin use increased substantially over the most recent 4 years in the study, from 59% in 1995 to 81% in 1999. Predictors of aspirin use included younger age, male sex, being a nonsmoker, and having had a myocardial infarction or revascularization procedure. Patients who never took aspirin had a risk ratio for death of 1.85 compared with patients who regularly took aspirin. Despite the well-known beneficial effects of aspirin, too many patients without contraindications to aspirin fail to take it regularly. The health care system currently lacks effective methods to ensure that patients who have CAD have adequate follow-up concerning aspirin use.

Objectives: The objective of this study was to identify preprocedure patient factors associated with percutaneous intervention costs and to examine the impact of these patient factors on economic profiles of interventional cardiologists., Background: There is increasing demand for information about comparative resource use patterns of interventional cardiologists. Economic provider profiles, however, often fail to account for patient characteristics., Methods: Data were obtained from Duke Medical Center cost and clinical information systems for 1,949 procedures performed by 13 providers between July 1, 1997, and December 31, 1998. Patient factors that influenced cost were identified using multiple regression analysis. After assessing interprovider variation in unadjusted cost, mixed linear models were used to examine how much cost variability was associated with the provider when patient characteristics were taken into account., Results: Total hospital costs averaged $15,643 (median, $13,809), $6,515 of which represented catheterization laboratory costs. Disease severity, acuity, comorbid illness and lesion type influenced total costs (R(2) = 38%), whereas catheterization costs were affected by lesion type and acuity (R(2) = 32%). Patient characteristics varied significantly among providers. Unadjusted total costs were weakly associated with provider, and this association disappeared after accounting for patient factors. The provider influence on catheterization costs persisted after adjusting for patient characteristics. Furthermore, the pattern of variation changed: the adjusted analysis identified three new outliers, and two providers lost their outlier status. Only one provider was consistently identified as an outlier in the unadjusted and adjusted analyses., Conclusions: Economic profiles of interventional cardiologists may be misleading if they do not adequately adjust for patient characteristics before procedure.

Background: Depressive symptoms are an independent risk factor for outcome in patients with cardiac disease, but their effect on outcome among patients undergoing coronary artery bypass grafting is not well understood., Objectives: To determine whether or not clinical variables including length of stay, readmission rates, and mortality are related to patients' level of depressive symptoms before and after coronary artery bypass grafting., Methods: An observational, longitudinal design was used. The Medical Outcomes Study 36-item short-form health survey was used to collect data on depressive symptoms in 416 patients undergoing coronary artery bypass grafting. The distribution of depressive symptoms was correlated with length of stay after the procedure, readmission, and mortality., Results: The level of depressive symptoms before coronary artery bypass grafting correlated with the level of depressive symptoms at 6 weeks follow-up, both for the individual items "feeling down in the dumps" (r = 0.24, P = .009) and "feeling downhearted" (r = 0.36, P < .001) and for the overall score on the Mental Health scale (r = 0.40, P < .001). Feeling down in the dumps (P = .007) and overall scores on the Mental Health scale (P = .02) were significantly related to readmission within 6 months., Conclusions: Higher levels of depressive symptoms before coronary artery bypass grafting are related to higher hospital readmission rates 6 months after the procedure. Nurses can play a pivotal role in determining which patients require evaluation, educating patients, and initiating effective treatment, which may prevent readmission related to depressive symptoms.

Objectives: We sought to evaluate the predictive accuracy of four bypass surgery mortality clinical risk models and to examine the extent to which hospitals' risk-adjusted surgical outcomes vary depending on which risk-adjustment method is applied., Background: Cardiovascular "report cards" often compare risk-adjusted surgical outcomes; however, it is unclear to what extent the risk-adjustment process itself may affect these metrics., Methods: As part of the Cooperative Cardiovascular Project's Pilot Revascularization Study, we compared the predictive accuracy of four bypass clinical risk models among 3,654 Medicare patients undergoing surgery at 28 hospitals in Alabama and Iowa. We also compared the agreement in hospital-level risk-adjusted bypass outcome performance ratings depending on which of the four risk models was applied., Results: Although the four risk models had similar discriminatory abilities (C-index, 0.71 to 0.74), certain models tended to overpredict mortality in higher-risk patients. There was high correlation between a hospital's risk-adjusted mortality rates regardless of which of the four models was used (correlation between risk-adjusted rating, 0.93 to 0.97). In contrast, there was limited agreement in which hospitals were identified as "performance outliers" depending on which risk-adjustment model was used and how outlier status was defined., Conclusions: A hospital's risk-adjusted bypass surgery mortality rating, relative to its peers, was consistent regardless of the risk-adjustment model applied, supporting their use as a means of provider performance feedback. Designation of performance outliers, however, can vary significantly depending on the benchmark and methods used for this determination.

Objectives: We sought to define the risks facing octogenarians undergoing contemporary percutaneous coronary interventions (PCIs)., Background: The procedural risks of PCI for octogenarians have not been well established., Methods: We compared the clinical characteristics and in-hospital outcomes of 7,472 octogenarians (mean age 83 years) with those of 102,236 younger patients (mean age 62 years) who underwent PCI at 22 National Cardiovascular Network (NCN) hospitals from 1994 through 1997., Results: Octogenarians had more comorbidities, more extensive coronary disease and a two- to fourfold increased risk of complications, including death (3.8% vs. 1.1%), Qwave myocardial infarction (1.9% vs. 1.3%), stroke (0.58% vs. 0.23%), renal failure (3.2% vs. 1.0%) and vascular complications (6.7% vs. 3.3%) (p < 0.001 for all comparisons). Independent predictors of procedural mortality in octogenarians included shock (odds ratio [OR] 5.4, 95% confidence interval [CI] 3.3 to 8.8), acute myocardial infarction (OR 3.2, 95% CI 2.3 to 4.4), left ventricular ejection fraction (LVEF) <35% (OR 2.9, 95% CI 2.1 to 3.9), renal insufficiency (OR 2.8, 95% CI 2.0 to 3.8), first PCI (OR 2.3, 95% CI 1.7 to 3.3), age >85 years (OR 2.1, 95% CI 1.5 to 2.7) and diabetes mellitus (OR 1.5, 95% CI 1.1 to 2.0). For elective procedures, octogenarian mortality varied nearly 10-fold, and was strongly influenced by comorbidities (0.79% mortality with no risk factors vs. 7.2% with renal insufficiency or LVEF <35%). Despite similar case-mix, PCI outcomes in octogenarians improved significantly over the four years of observation (OR of 0.61 for death/myocardial infarction/stroke in 1997 vs. 1994; 95% CI 0.45 to 0.85)., Conclusions: Risks to octogenarians undergoing PCI are two- to fourfold higher than those of younger patients, strongly influenced by comorbidities, and have decreased in the stent era.

Objectives: The purpose of this study was to evaluate characteristics and outcomes of patients age > or =80 undergoing cardiac surgery., Background: Prior single-institution series have found high mortality rates in octogenarians after cardiac surgery. However, the major preoperative risk factors in this age group have not been identified. In addition, the additive risks in the elderly of valve replacement surgery at the time of bypass are unknown., Methods: We report in-hospital morbidity and mortality in 67,764 patients (4,743 octogenarians) undergoing cardiac surgery at 22 centers in the National Cardiovascular Network. We examine the predictors of in-hospital mortality in octogenarians compared with those predictors in younger patients., Results: Octogenarians undergoing cardiac surgery had fewer comorbid illnesses but higher disease severity and surgical urgency than younger patients. Octogenarians had significantly higher in-hospital mortality after cardiac surgery than younger patients: coronary artery bypass grafting (CABG) only (8.1% vs. 3.0%), CABG/aortic valve (10.1% vs. 7.9%), CABG/mitral valve (19.6% vs. 12.2%). In addition, they had twice the incidence of postoperative stroke and renal failure. The preoperative clinical factors predicting CABG mortality in the very elderly were quite similar to those for younger patients with age, emergency surgery and prior CABG being the powerful predictors of outcome in both age categories. Of note, elderly patients without significant comorbidity had in-hospital mortality rates of 4.2% after CABG, 7% after CABG with aortic valve replacement (CABG/AVR), and 18.2% after CABG with mitral valve replacement (CABG/MVR)., Conclusions: Risks for octogenarians undergoing cardiac surgery are less than previously reported, especially for CABG only or CABG/AVR. In selected octogenarians without significant comorbidity, mortality approaches that seen in younger patients.

Background: Although multiple new coronary interventional devices have been approved for marketing in the United States, use of these technologies in general clinical practice and their associated outcomes have not been reported., Methods and Results: Using the National Cardiovascular Network's Coronary Interventional Database, we examined temporal trends in the use and outcomes of coronary stents, lasers, directional atherectomy, and rotational atherectomy devices at 12 US hospitals between January 1994 and December 1997 (n = 76,904). Over this period, the percentage of cases involving coronary stents rose more than 12-fold (from 5.4% in 1994 to 69.0% in 1997). In contrast, use of atherectomy-type devices declined significantly. Device selection was strongly influenced by the patient's coronary anatomy and procedural indication, but less by age, sex, or race. Device use also varied significantly among individual centers (4-fold variation among sites in stent use and 6-fold variation in atherectomy use) even after adjusting for patient characteristics. Although overall mortality rates were unchanged during this 4-year period, procedural success rates have improved and complication rates have declined significantly. Lengths of postprocedure hospital stay also fell significantly for all patients undergoing coronary intervention in this time period., Conclusions: Percutaneous interventional strategies are rapidly changing with the explosive growth of coronary stent use and the decline in use of atherectomy devices. Patient outcomes, including complication rates and postprocedure lengths of stay, have also improved as the new interventional strategies have been refined in clinical practice.

Background: Rising health care costs have prompted careful review of comparative hospital resource use. Length of stay after bypass surgery has received particular attention. However, many providers assert that these variations are caused by differences in the clinical mix of patients treated. Our goals were to identify the major clinical predictors of postoperative length of stay (PLOS) after coronary artery bypass graft surgery (CABG), document variations in PLOS among 28 hospitals, and assess the degree to which patient characteristics account for hospital variations in PLOS., Methods: Detailed clinical data on 3605 Medicare patients undergoing CABG in 28 Alabama and Iowa hospitals were analyzed by stepwise linear regression to identify significant clinical predictors of PLOS. Analysis of variance was used to compare hospitals' PLOS while controlling for significant patient risk factors., Results: The mean age was 72.1 years, 34.7% were female, and the in-hospital mortality rate was 5.6%. The median and mean PLOS were 8 and 11.1 days, respectively. Significant predictors of longer PLOS included increasing age, female sex, history of chronic obstructive pulmonary disease, cerebrovascular disease, or mitral valve disease, elevated admission blood urea nitrogen, and preoperative placement of an intraaortic balloon pump. Hospitals varied significantly (P =.0001) in their unadjusted PLOS. These hospital-level variations persisted despite adjustment for both preoperative patient characteristics (P =.0001) and postoperative complications and death (P =.0001)., Conclusions: This study found significant between-hospital variations in PLOS that were not explained by patient factors. This finding suggests the potential for increased efficiency in the care of patients undergoing CABG at many institutions. Further research is needed to determine the practice patterns contributing to variations in length of stay after bypass surgery.

Background: Epsilon-aminocaproic acid is routinely used to reduce bleeding during cardiac surgery. Anecdotal reports of thrombotic complications have led to speculation regarding this drug's safety. We investigated the association between epsilon-aminocaproic acid administration and postoperative stroke., Methods: Six thousand two hundred ninety-eight patients undergoing isolated coronary artery bypass graft surgery between 1989 and 1995 were studied. Data was obtained from the Duke Cardiovascular Database as well as from an automated intraoperative anesthesia record keeper. Patients identified as having postoperative stroke were reviewed and confirmed by a board certified neurologist blinded to epsilon-aminocaproic acid administration., Results: Postoperative stroke occurred in 97 patients (1.5%). Three thousand one hundred thirty-five (49.8%) patients received epsilon-aminocaproic acid. Increased age was associated with a higher incidence of postoperative stroke (p = 0.0001). In contrast, there was no significant difference (p = 0.7370) in the incidence of stroke between use of epsilon-aminocaproic acid (1.3%) and nonuse (1.7%). Multivariable logistic regression found no significant effect of epsilon-aminocaproic acid use on stroke after accounting for age, date of surgery, and history of diabetes., Conclusions: This series suggests that epsilon-aminocaproic acid administration does not increase the risk of postoperative stroke.

Background: Pectoralis flaps are frequently used to treat poststernotomy mediastinitis. We compared the outcomes of omental transfer, an alternative treatment for mediastinitis, with those of pectoralis flaps., Methods: Patients treated for poststernotomy mediastinitis with isolated omental flaps (n = 21) were compared with a group of consecutive patients treated with pectoralis flaps (n = 38). Baseline characteristics were equivalent for the two groups, and both early and late outcomes were compared., Results: Length of procedure and length of postoperative hospitalization were reduced significantly and there were significantly fewer early complications in the group treated with omental flaps. Furthermore, there were no early or late flap failures or abscesses in the omental flap group., Conclusions: This study found that omental flaps had improved early outcomes and are a more effective therapy relative to pectoralis flaps for poststernotomy mediastinitis. Technical considerations for omental transfer that could optimize results are given.

Background: Exercise testing is useful in the assessment of symptomatic patients for diagnosis of significant or extensive coronary disease and to predict their future risk of cardiac events. The Duke treadmill score (DTS) is a composite index that was designed to provide survival estimates based on results from the exercise test, including ST-segment depression, chest pain, and exercise duration. However, its usefulness for providing diagnostic estimates has yet to be determined., Methods and Results: A logistic regression model was used to predict significant (>/=75% stenosis) and severe (3-vessel or left main) coronary artery disease, and a Cox regression analysis was used to predict cardiac survival. After adjustment for baseline clinical risk, the DTS was effectively diagnostic for significant (P<0.0001) and severe (P<0.0001) coronary artery disease. For low-risk patients (score >/=+5), 60% had no coronary stenosis >/=75% and 16% had single-vessel >/=75% stenosis. By comparison, 74% of high-risk patients (score <-11) had 3-vessel or left main coronary disease. Five-year mortality was 3%, 10%, and 35% for low-, moderate-, and high-risk DTS groups (P<0.0001)., Conclusions: The composite DTS provides accurate diagnostic and prognostic information for the evaluation of symptomatic patients evaluated for clinically suspected ischemic heart disease.

Objective: The aim of this study was to examine the effects of provider profiling on bypass surgery access and outcomes in elderly patients in New York., Background: Since 1989, New York (NY) has compiled provider-specific bypass surgery mortality reports. While some have proposed that "provider profiling" has led to lower surgical mortality rates, critics have suggested that such programs lower in-state procedural access (increasing out-of-state transfers) without improving patient outcomes., Methods: Using national Medicare data, we examined trends in the percentages of NY residents aged 65 years or older receiving out-of-state bypass surgery between 1987 and 1992 (before and after program initiation). We also examined in-state procedure use among elderly myocardial infarction patients during this period. Finally, we compared trends in surgical outcomes in NY Medicare patients with those for the rest of the nation., Results: Between 1987 and 1992, the percentage of NY residents receiving bypass out-of-state actually declined (from 12.5% to 11.3%, p < 0.01 for trend). An elderly patient's likelihood for bypass following myocardial infarction in NY increased significantly since the program's initiation. Between 1987 and 1992, unadjusted 30-day mortality rates following bypass declined by 33% in NY Medicare patients compared with a 19% decline nationwide (p < 0.001). As a result of this improvement, NY had the lowest risk-adjusted bypass mortality rate of any state in 1992., Conclusions: We found no evidence that NY's provider profiling limited procedure access in NY's elderly or increased out-of-state transfers. Despite an increasing preoperative risk profile, procedural outcomes in NY improved significantly faster than the national average.

Background: We sought to describe the resuscitation preferences of patients hospitalized with an exacerbation of severe congestive heart failure, perceptions of those preferences by their physicians, and the stability of the preferences., Methods and Results: Of 936 patients in this study, 215 (23%) explicitly stated that they did not want to be resuscitated. Significant correlates of not wanting to be resuscitated included older age, perception of a worse prognosis, poorer functional status, and higher income. The physician's perception of the patient's preference disagreed with the patient's actual preference in 24% of the cases overall. Only 25% of the patients reported discussing resuscitation preferences with their physician, but discussion of preferences was not significantly associated with higher agreement between the patient and physician. Of the 600 patients who responded to the resuscitation question again 2 months later, 19% had changed their preferences, including 14% of those who initially wanted resuscitation (69 of 480) and 40% of those who initially did not (48 of 120). The physician's perception of the patient's hospital resuscitation preference was correct for 84% of patients who had a stable preference and 68% of those who did not., Conclusions: Almost one quarter of patients hospitalized with severe heart failure expressed a preference not to be resuscitated. The physician's perception of the patient's preference was not accurate in about one quarter of the cases. but communication was not associated with greater agreement between the patient and the physician. A substantial proportion of patients who did not want to be resuscitated changed their minds within 2 months of discharge.

Risk-adjustment and provider profiling have become common terms as the medical profession attempts to measure quality and assess value in health care. One of the areas of care most thoroughly developed in this regard is quality assessment for coronary artery bypass grafting (CABG). Because in-hospital mortality following CABG has been studied extensively, risk-adjustment mechanisms are already being used in this area for provider profiling. This study compares eight different risk-adjustment methods as applied to a CABG surgery population of 28 providers. Five of the methods use an external risk-adjustment algorithm developed in an independent population, while the other three rely on an internally developed logistic model. The purposes of this study are to: (i) create a common metric by which to display the results of these various risk-adjustment methodologies with regard to dichotomous outcomes such as in-hospital mortality, and (ii) to compare how these risk-adjustment methods quantify the 'outlier' standing of providers. Section 2 describes the data, the external and internal risk-adjustment algorithms, and eight approaches to provider profiling. Section 3 then demonstrates the results of applying these methods on a data set specifically collected for quality improvement.

Background: Recent emphasis on cost-containment in the health-care environment has focused attention on the cost of medical procedures. Selection of the appropriate treatment for coronary artery disease is of increasing concern. Coronary artery bypass grafting is common and very expensive, and this procedure will continue to be examined closely by reimbursement systems, particularly with regard to the lower initial cost of coronary angioplasty as a competing therapy., Methods: Duke University Medical Center has a sophisticated accounting system that enables individual cost components to be identified, facilitates prospective analysis of cost/benefit, and aids allocation of limited hospital resources. In 1996, 1,114 coronary artery bypass procedures were performed at Duke. Preoperative patient characteristics were also analyzed in an attempt to predict risk factors for increased cost., Results: The median cost for these procedures was $20,682, excluding professional fees. Sixty percent of the costs were directly associated with patient care, and the other 40% were accounted for by indirect costs to support patient care. The most significant preoperative predictor of increased postoperative cost was the mortality estimate. If this variable was excluded from the analysis, other variables (for example, ejection fraction, age, identity of the surgeon, and congestive heart failure) were all related to increased costs., Conclusions: Predicting costs based on preoperative variables offers the potential to reduce total costs through case-management strategies and aids in negotiating a risk-shared contract. However, cost reduction in routine care will have more financial impact than cost reduction by patient selection.

Objectives: This study examined the impact of early hospital discharge on short-term clinical outcomes of elderly patients treated with coronary artery bypass graft surgery (CABG) in the United States in 1992., Background: Protocols that encourage earlier discharge of patients who have had CABG have been implemented across the country. Although delivery of efficient care benefits both patients and providers, premature discharge can adversely affect clinical outcomes, resulting in increased hospital readmissions and higher long-term costs., Methods: We examined the prevalence of early discharge (postoperative length of stay < or = 5 days) among 83,347 non-health maintenance organization (HMO) Medicare patients who underwent CABG in the United States in 1992. Using logistic regression models, we identified patient characteristics associated with early discharge and obtained risk-adjusted rates of death and readmission or death for postoperative lengths of stay between 4 and 14 days., Results: In 1992, 6% of Medicare patients undergoing CABG were discharged within 5 days of the operation. The prevalence of early discharge varied considerably among states, ranging from 1% to 21%. Patients discharged early tended to be younger and male and have fewer comorbid illnesses. Risk-adjusted rates of death and death or cardiovascular readmission were lowest among patients discharged early., Conclusions: As of 1992, early discharge of elderly patients treated with CABG in non-HMO settings was not associated with higher 60-day rates of death or readmission. This suggests that physicians were able to identify low risk candidates for early discharge. Variation across the nation in early discharge rates, along with the percentage of patients without major risk factors for adverse outcomes, suggests that higher rates of early discharge might be safely achieved.

Background: With the expectation that physicians who perform larger numbers of coronary angioplasty procedures will have better outcomes, the American College of Cardiology/ American Heart Association guidelines recommend minimum physician volumes of 75 procedures per year. However, there is little empirical data to support this recommendation., Methods and Results: We examined in-hospital bypass surgery and death after angioplasty according to 1992 physician and hospital Medicare procedure volume. In 1992, 6115 physicians performed angioplasty on 97,478 Medicare patients at 984 hospitals. The median numbers of procedures performed per physician and per hospital were 13 (interquartile range, 5 to 25) and 98 (interquartile range, 40 to 181), respectively. With the assumption that Medicare patients composed one half to one third of all patients undergoing angioplasty, these median values are consistent with an overall physician volume of 26 to 39 cases per year and an overall hospital volume of 196 to 294 cases per year. After adjusting for age, sex, race, acute myocardial infarction, and comorbidity, low-volume physicians were associated with higher rates of bypass surgery (P < .001) and low-volume hospitals were associated with higher rates of bypass surgery and death (P < .001). Improving outcomes were seen up to threshold values of 75 Medicare cases per physician and 200 Medicare cases per hospital., Conclusions: More than 50% of physicians and 25% of hospitals performing coronary angioplasty in 1992 were unlikely to have met the minimum volume guidelines first published in 1988, and these patients had worse outcomes. While more recent data are required to determine whether the same relationships persist after the introduction of newer technologies, this study suggests that adherence to minimum volume standards by physicians and hospitals will lead to better outcomes for elderly patients undergoing coronary angioplasty.

Objectives: The purpose of this study was to examine the national variability in patient-level cost and length of stay for coronary artery bypass grafting (CABG) in Medicare patients., Methods: Retrospective multivariate regression analysis was done using Medicare administrative files and American Hospital Association files. Patients in the study had an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure code for CABG, with accompanying 1990 procedure data, in the Medicare Provider Analysis and Review File (n = 92,449)., Results: Outcome measures used were inpatient cost (exclusive of professional fees) and inpatient length of stay associated with bypass admission. The national average cost of bypass surgery was $22,847 (median $18,783), with an accompanying average length of stay of 16 days (median 13 days). Multivariate regression analysis revealed that patient-level cost and length of stay were related to clinical, demographic, hospital, and regional characteristics (R2 = 25% and 16%, respectively). After accounting for these characteristics at the patient level, considerable variation among states persisted in both cost and length of stay. In addition, states with similar adjusted lengths of stay varied widely with respect to adjusted cost. No relation was found at the state level between level of resource use and either procedural mortality or 60-day mortality/readmission rates., Conclusions: Considerable variability exists among states in patient-level cost and length of stay for CABG surgery, after adjusting to the extent possible for clinical, demographic, hospital, and regional characteristics. The lack of association at the state level between resource use and rates of mortality and hospital readmission suggests that costs could be reduced in many areas of the United States without compromising quality of care.