Expanding Kane's argument-based validity framework: What can validation practices in language assessment offer health professions education?

CONTEXT: One central consideration in health professions education (HPE) is to ensure we are making sound and justifiable decisions based on the assessment instruments we use on health professionals. To achieve this goal, HPE assessment researchers have drawn on Kane's argument-based framework to ascertain the validity of their assessment tools. However, the original four-inference model proposed by Kane - frequently used in HPE validation research - has its limitations in terms of what each inference entails and what claims and sources of backing are housed in each inference. The under-specification in the four-inference model has led to inconsistent practices in HPE validation research, posing challenges for (i) researchers who want to evaluate the validity of different HPE assessment tools and/or (ii) researchers who are new to test validation and need to establish a coherent understanding of argument-based validation. METHODS: To address these identified concerns, this article introduces the expanded seven-inference argument-based validation framework that is established practice in the field of language testing and assessment (LTA). We explicate (i) why LTA researchers experienced the need to further specify the original four Kanean inferences; (ii) how LTA validation research defines each of their seven inferences and (iii) what claims, assumptions and sources of backing are associated with each inference. Sampling six representative validation studies in HPE, we demonstrate why an expanded model and a shared disciplinary validation framework can facilitate the examination of the validity evidence in diverse HPE validation contexts. CONCLUSIONS: We invite HPE validation researchers to experiment with the seven-inference argument-based framework from LTA to evaluate its usefulness to HPE. We also call for greater interdisciplinary dialogue between HPE and LTA since both disciplines share many fundamental concerns about language use, communication skills, assessment practices and validity in assessment instruments.

Assessment of Natural Language Processing Methods for Ascertaining the Expanded Disability Status Scale Score From the Electronic Health Records of Patients With Multiple Sclerosis: Algorithm Development and Validation Study.

BACKGROUND: The Expanded Disability Status Scale (EDSS) score is a widely used measure to monitor disability progression in people with multiple sclerosis (MS). However, extracting and deriving the EDSS score from unstructured electronic health records can be time-consuming. OBJECTIVE: We aimed to compare rule-based and deep learning natural language processing algorithms for detecting and predicting the total EDSS score and EDSS functional system subscores from the electronic health records of patients with MS. METHODS: We studied 17,452 electronic health records of 4906 MS patients followed at one of Canada's largest MS clinics between June 2015 and July 2019. We randomly divided the records into training (80%) and test (20%) data sets, and compared the performance characteristics of 3 natural language processing models. First, we applied a rule-based approach, extracting the EDSS score from sentences containing the keyword "EDSS." Next, we trained a convolutional neural network (CNN) model to predict the 19 half-step increments of the EDSS score. Finally, we used a combined rule-based-CNN model. For each approach, we determined the accuracy, precision, recall, and F-score compared with the reference standard, which was manually labeled EDSS scores in the clinic database. RESULTS: Overall, the combined keyword-CNN model demonstrated the best performance, with accuracy, precision, recall, and an F-score of 0.90, 0.83, 0.83, and 0.83 respectively. Respective figures for the rule-based and CNN models individually were 0.57, 0.91, 0.65, and 0.70, and 0.86, 0.70, 0.70, and 0.70. Because of missing data, the model performance for EDSS subscores was lower than that for the total EDSS score. Performance improved when considering notes with known values of the EDSS subscores. CONCLUSIONS: A combined keyword-CNN natural language processing model can extract and accurately predict EDSS scores from patient records. This approach can be automated for efficient information extraction in clinical and research settings.

Variation in Antithrombotic Therapy and Clinical Outcomes in Patients With Preexisting Atrial Fibrillation Undergoing Transcatheter Aortic Valve Replacement: Insights From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: Optimal antithrombotic management of patients with preexisting atrial fibrillation undergoing transcatheter aortic valve replacement is challenging given the need to balance the risk of bleeding and thromboembolism. We aimed to examine variation in care and association of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality in patients undergoing transcatheter aortic valve replacement with concomitant atrial fibrillation in the United States. METHODS: Patients who underwent transcatheter aortic valve replacement with preexisting atrial fibrillation from November 2011 through September 2015 in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry linked to the Medicare database were examined according to receipt of oral anticoagulants (OACs) or antiplatelet therapies (APTs) or a combination of these (OAC+APT) at discharge. To assess the associations of antithrombotic therapies with 1-year outcomes of stroke, bleeding, and mortality, we utilized inverse probability weighting for antithrombotic therapies and multivariable regression modeling to adjust for patient- and hospital-level variables. RESULTS: In the 11 382 patients included in our study, 5833 (51.2%) were discharged on OAC+APT, 4786 (42.0%) on APT alone, and 763 (6.7%) on OAC alone. There was significant variability in discharge medication patterns, including 42% of patients discharged without OAC therapy. In adjusted analyses, the risk for all-cause mortality and stroke was not significantly different when comparing the 3 different antithrombotic strategies. Risk of bleeding was higher with OAC+APT compared with APT alone (hazard ratio, 1.16 [95% CI, 1.05­1.27]) and similar compared with OAC alone (hazard ratio, 1.17 [95% CI, 0.93­1.47]). CONCLUSIONS: There was significant variability in discharge medication patterns across US sites in patients with atrial fibrillation undergoing transcatheter aortic valve replacement, including significant underuse of OAC in this high-risk cohort. The use of OAC+APT (versus OAC alone or APT alone) was not associated with a lower risk of stroke or mortality but was associated with increased risk of bleeding complications at 1 year compared with APT alone.

Differential Longitudinal Outcomes Following Percutaneous Coronary Intervention to the Left Internal Mammary Artery and Other Bypass Grafts of the LAD: Findings From the NCDR.

OBJECTIVES: Limited studies of percutaneous coronary intervention (PCI) of the left internal mammary artery (LIMA) graft exist. We compared outcomes of different bypass grafts to the left anterior descending (LAD) coronary artery. METHODS: Participants ≥65 years old in the CathPCI Registry who underwent PCI of a bypass graft to the LAD between 2009 and 2014 were included. Individuals were divided by graft type: LIMA; saphenous vein graft (SVG); or other. Clinical characteristics and outcomes using Medicare claims data for mortality, rehospitalization for myocardial infarction (MI), stroke, or unplanned repeat revascularization at 1 year were examined. RESULTS: There were 10,051 PCIs performed on grafts to the LAD: 6797 SVGs (67.6%), 3011 LIMA grafts (30.0%); and 243 other (2.4%). Procedural success rates (SVG 92.9%, LIMA 91.1%, other 93.4%; P=.65) and in-patient mortality rates (SVG 3.0%, LIMA 2.7%, other 2.1%; P=.61) were similar. However, dissection rates were higher in LIMA interventions (SVG 0.7%, LIMA 2.8%, other 2.5%; P<.001). At 1 year, mortality, MI, and repeat revascularization were lower in arterial grafts (mortality: SVG 16.6%, LIMA 14.8%, other 11.8% [P<.001]; MI: SVG 9.9%, LIMA, 6.6%, other 8.1% [P<.001]; revascularization: SVG 14.4%, LIMA 9.5%, other 10.4% [P<.001]). After multivariable adjustment, LIMA patients had lower rates of MI (hazard ratio, 0.71; 95% confidence interval, 0.60-0.84) and repeat revascularization (hazard ratio, 0.68; 95% confidence interval, 0.59-0.79) compared with the SVG group. Mortality was not significantly different. CONCLUSIONS: Despite similar procedural success rates compared with SVG and other graft types, LIMA interventions were independently associated with lower rates of recurrent MI and repeat revascularization at 1 year.

Procedural Volume and Outcomes for Transcatheter Aortic-Valve Replacement.

BACKGROUND: During the introduction of transcatheter aortic-valve replacement (TAVR) in the United States, requirements regarding procedural volume were mandated by the Centers for Medicare and Medicaid Services as a condition of reimbursement. A better understanding of the relationship between hospital volume of TAVR procedures and patient outcomes could inform policy decisions. METHODS: We analyzed data from the Transcatheter Valve Therapy Registry regarding procedural volumes and outcomes from 2015 through 2017. The primary analyses examined the association between hospital procedural volume as a continuous variable and risk-adjusted mortality at 30 days after transfemoral TAVR. Secondary analysis included risk-adjusted mortality according to quartile of hospital procedural volume. A sensitivity analysis was performed after exclusion of the first 12 months of transfemoral TAVR procedures at each hospital. RESULTS: Of 113,662 TAVR procedures performed at 555 hospitals by 2960 operators, 96,256 (84.7%) involved a transfemoral approach. There was a significant inverse association between annualized volume of transfemoral TAVR procedures and mortality. Adjusted 30-day mortality was higher and more variable at hospitals in the lowest-volume quartile (3.19%; 95% confidence interval [CI], 2.78 to 3.67) than at hospitals in the highest-volume quartile (2.66%; 95% CI, 2.48 to 2.85) (odds ratio, 1.21; P = 0.02). The difference in adjusted mortality between a mean annualized volume of 27 procedures in the lowest-volume quartile and 143 procedures in the highest-volume quartile was a relative reduction of 19.45% (95% CI, 8.63 to 30.26). After the exclusion of the first 12 months of TAVR procedures at each hospital, 30-day mortality remained higher in the lowest-volume quartile than in the highest-volume quartile (3.10% vs. 2.61%; odds ratio, 1.19; 95% CI, 1.01 to 1.40). CONCLUSIONS: An inverse volume-mortality association was observed for transfemoral TAVR procedures from 2015 through 2017. Mortality at 30 days was higher and more variable at hospitals with a low procedural volume than at hospitals with a high procedural volume. (Funded by the American College of Cardiology Foundation National Cardiovascular Data Registry and the Society of Thoracic Surgeons.).

Total Breastfeeding Duration and Household Food Insecurity in Healthy Urban Children.

OBJECTIVE: Health care policy positions breastfeeding as an important part of the solution to household food insecurity; however, there are critical gaps in our knowledge of the relationship between breastfeeding duration (exposure variable) and household food insecurity (outcome variable). Our objective was to examine this relationship. METHODS: A cross-sectional study was conducted from 2008 to 2016 of healthy urban children (N = 3838) who were 0 to 3 years old and recruited from The Applied Research Group for Kids (TARGet Kids!), a practice-based research network in Toronto, Canada. Total breastfeeding duration was collected from parent-reported questionnaires. Household food insecurity was measured using 1-item and 2-item food insecurity screens. Multivariable regression analysis was performed adjusting for prespecified covariates. RESULTS: The median total breastfeeding duration was 10.5 months (interquartile range, 6.0-14.0), and 14.7% of households were food insecure. After adjusting for child characteristics (age, sex), maternal characteristics (age, ethnicity, education, employment), and family characteristics (number of children, single parent family, neighborhood equity score), there was no significant association between total breastfeeding duration and household food insecurity (odds ratio, 0.99; 95% confidence interval, 0.98-1.01). Although low-income families had an increased odds of being household food insecure (P ≤ .001), we found no significant association between total breastfeeding duration and household food insecurity at varying income levels. CONCLUSIONS: We found no association between breastfeeding duration and household food insecurity, regardless of family income. Although breastfeeding is associated with improved child health outcomes and considered to be part of the solution to household food insecurity, interventions focused on social determinants may provide more promising targets for the prevention of household food insecurity.

Hospital Resource Utilization Before and After Transcatheter Aortic Valve Replacement: The STS/ACC TVT Registry.

BACKGROUND: Patients with severe aortic stenosis (AS) have repeat hospitalizations for multiple conditions. OBJECTIVES: The purpose of this study was to assess the effect of transcatheter aortic valve replacement (TAVR) on hospitalizations in severe AS. METHODS: Using data from the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) registry with linkage to Medicare claims, the authors examined rates of all-cause, cardiovascular, and noncardiovascular hospitalizations and hospital days, as well as inpatient costs in the year pre-TAVR and post-TAVR. Multivariable modeling was used to determine rate ratios of post-TAVR versus pre-TAVR hospitalizations and costs. RESULTS: Among 15,324 patients at 328 sites with Medicare linkage undergoing TAVR, the median age was 84 years, the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 7.0, and 61.1% patients underwent TAVR via transfemoral access. Post-TAVR, heart failure hospitalization rates and hospitalized days were reduced compared with pre-TAVR (rate ratio: 0.87 and 0.95 respectively; p < 0.01 for all). However, all-cause, noncardiovascular, and bleeding hospitalization rates and hospitalized days were increased (p < 0.01 for all). Post-TAVR hospitalizations were reduced the most among those with left ventricular ejection fraction <30%. Mean post-TAVR costs were reduced among all TAVR patients and among 1-year survivors (rate ratio: 0.95, p < 0.01; and 0.90; p < 0.01, respectively). CONCLUSIONS: Patients had lower costs and fewer heart failure hospitalizations but more all-cause, noncardiovascular, and bleeding hospitalizations post-TAVR. Reduction in hospitalizations varied by specific patient subgroups, and thus, payors and providers seeking to reduce resource use may consider strategies designed to improve processes of care among patients with increased resource utilization post-TAVR as compared with pre-TAVR.

Variation in Hospital Risk-Adjusted Mortality Rates Following Transcatheter Aortic Valve Replacement in the United States: A Report From the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

BACKGROUND: The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers. METHODS AND RESULTS: We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014). A Bayesian hierarchical model was developed to estimate hospital-specific risk-adjusted mortality rates adjusting for 40 patient baseline factors. A total of 1130 in-hospital deaths (5.1%) were observed. Reliability-adjusted risk-adjusted mortality rate estimates ranged from 3.4% to 7.7% with an interquartile range of 4.8% to 5.4%. A patient's predicted odds of dying was 80% higher if treated by a hospital 1 standard deviation above the mean compared with a hospital 1 standard deviation below the mean (odds ratio =1.8; 95% credible interval, 1.4%-2.2%). CONCLUSIONS: Risk modeling of TAVR in-hospital mortality revealed variation in risk-adjusted mortality rates during the US early commercial experience. Transcatheter Valve Therapy Registry analyses using this model will support research, feedback reporting, and the identification of factors associated with quality.

Trends in Bare-Metal Stent Use in the United States in Patients Aged ≥65 Years (from the CathPCI Registry).

In 2006, the United States (US) Food and Drug Administration published advisory highlighting concerns for late drug-eluting stent thrombosis; its impact on US bare-metal stent (BMS) utilization is unknown. We examined rates of BMS use among Medicare patients at 946 US hospitals in the CathPCI Registry who underwent percutaneous coronary intervention (PCI) during 3 periods: (1) 2004 to 2006 preadvisory (n = 166,458); (2) 2007 to 2008 postadvisory (n = 216,318); and (3) 2012 to 2014 contemporary (n = 827,948). We examined predicted risks of target vessel revascularization and bleeding among BMS recipients by period. We compared 1-year repeat revascularization and death/myocardial infarction risks among BMS recipients immediately preadvisory and postadvisory. BMS were used in 15.8% of preadvisory, 40.9% of postadvisory, and 20.0% of contemporary PCI procedures. Although 19.5% of preadvisory BMS patients had a predicted target vessel revascularization risk ≥15%/year, this decreased to 16.7% postadvisory (p <0.001), and increased back to 18.7% among contemporary BMS recipients (p <0.001). In contrast, 12.3% of preadvisory BMS recipients had a predicted bleeding risk ≥5%/year, compared with 14.6% postadvisory (p <0.001), and 18.2% in contemporary BMS recipients (p <0.001). Postadvisory BMS recipients had a lower risk of repeat revascularization (12.8% vs 14.6%, adjusted hazard ratio 0.87, 95% CI 0.84 to 0.90) but no difference in the composite risk of death/myocardial infarction (15.9% vs 15.9%, adjusted hazard ratio 0.97, 95% CI 0.93 to 1.00). In conclusion, a surge in BMS use after the advisory was not associated with an increased risk of repeat revascularization or adverse outcomes in BMS-treated patients. One in 5 contemporary PCI procedures still involve BMS implantation.

Safety and clinical effectiveness of drug-eluting stents for saphenous vein graft intervention in older individuals: Results from the medicare-linked National Cardiovascular Data Registry(®) CathPCI Registry(®) (2005-2009).

OBJECTIVES: To evaluate the safety of drug-eluting stents (DES) when treating patients with failing saphenous vein grafts (SVG). BACKGROUND: DES reduce target vessel revascularization in patients with failing SVGs; however, compared with bare metal stents (BMS), DES have been variably associated with increased mortality. METHODS: Clinical records from National Cardiovascular Data Registry(®) CathPCI Registry(®) (49,325 older individuals [≥65 years] who underwent SVG stenting 2005-2009) were linked to Medicare claims to create a longitudinal record. Death, myocardial infarction (MI), and urgent revascularization with DES versus BMS were evaluated to 3 years using propensity matching (PM). Results were stratified by clinical presentation (acute coronary syndrome [ACS], non-ACS), previous lesion treatment (in-stent, de novo), and graft segment (aortic, body, distal anastomosis). RESULTS: In this older cohort (median age, 75 years), acute presentations were prevalent (ACS, 69%; TIMI flow <3, 45%), and adverse clinical outcomes were common by 3 years (death, 24.5%; MI, 14.6%; urgent revascularization, 29.5%). Among DES patients (n = 31,403), 3-year mortality was lower (vs. BMS) (22.7% vs. 28.0%, P < 0.001; PM hazard ratio [HR] 0.87, 95% confidence interval 0.83-0.91), and no difference was observed in the adjusted risk for MI (PM HR 0.97, 0.91 to 1.03) or urgent revascularization (PM HR 1.04, 0.99-1.08). These findings were independent of clinical presentation, previous lesion treatment, and graft segment (P interaction, ns). CONCLUSIONS: In this large SVG PCI cohort, all-cause mortality was lower among those receiving DES, and no difference in MI or urgent revascularization was observed to 3 years. © 2015 Wiley Periodicals, Inc.

Quality of Care and Ischemic Stroke Risk After Hospitalization for Transient Ischemic Attack: Findings From Get With The Guidelines-Stroke.

BACKGROUND: Patients with transient ischemic attack (TIA) are at increased risk for ischemic stroke. We derived a prediction rule for 1-year ischemic stroke risk post-TIA, examining estimated risk, receipt of inpatient quality of care measures for TIA, and the presence or absence of stroke at 1 year post discharge. METHODS AND RESULTS: We linked 67 892 TIA Get With The Guidelines-Stroke patients >65 years (2003-2008) to Medicare inpatient claims to obtain longitudinal outcomes. Using Cox proportional hazards modeling in a split sample, we identified baseline demographics and clinical characteristics associated with ischemic stroke admission during the year post-TIA, and developed a Get With The Guidelines Ischemic Stroke after TIA Risk Score; performance was examined in the validation sample. Quality of care was estimated by a global defect-free care measure, and individual performance measures within estimated risk score quintiles. The overall hospital admission rate for ischemic stroke during the year post-TIA was 5.7%. Patients with ischemic stroke were more likely to be older, black, and have higher rates of smoking, previous stroke, diabetes mellitus, previous myocardial infarction, heart failure, and atrial fibrillation. The Risk Score showed moderate discriminative performance (c-statistic=0.606); highest quintile patients were less likely to receive statins, smoking cessation counseling, and defect-free care. Although not associated with 1-year ischemic stroke, DCF was associated with a significantly lower risk of all-cause mortality. CONCLUSIONS: TIA patients with high estimated ischemic stroke risk are less likely to receive defect-free care than low-risk patients. Standardized risk assessment and delivery of optimal inpatient care are needed to reduce this risk-treatment mismatch.

Three-year outcomes associated with embolic protection in saphenous vein graft intervention: results in 49 325 senior patients in the Medicare-linked National Cardiovascular Data Registry CathPCI Registry.

BACKGROUND: Information is limited on contemporary use and outcomes of embolic protection devices (EPDs) in saphenous vein graft interventions. METHODS AND RESULTS: We formed a longitudinal cohort (2005-2009; n=49 325) by linking National Cardiovascular Data Registry CathPCI Registry to Medicare claims to examine the association between EPD use and both procedural and long-term outcomes among seniors (65+ years), adjusting for clinical factors using propensity and instrumental variable methodologies. Prespecified high-risk subgroups included acute coronary syndrome and de novo or graft body lesions. EPDs were used in 21.2% of saphenous vein grafts (median age, 75; 23% women) and were more common in acute coronary syndrome (versus non-acute coronary syndrome; 22% versus 19%), de novo (versus restenotic; 22% versus 14%), and graft body lesions (versus aortic and distal anastomosis; 24% versus 20% versus 8%, respectively). EPDs were associated with a slightly higher incidence of procedural complications, including no reflow (3.9% versus 2.8%; P<0.001), vessel dissection (1.3% versus 1.1%; P=0.05), perforation (0.7% versus 0.4%; P=0.001), and periprocedural myocardial infarction (2.8% versus 1.8%; P<0.001). By 3 years, death, myocardial infarction, and repeat revascularization occurred in 25%, 15%, and 30% of cases, respectively. EPD use was associated with a similar adjusted risk of death (propensity score-matched hazard ratio, 0.96; 95% confidence interval, 0.91-1.02), myocardial infarction (propensity score-matched hazard ratio, 1.00; 95% confidence interval, 0.93-1.09), and repeat revascularization (propensity score-matched hazard ratio, 1.02; 95% confidence interval, 0.96-1.08) in the overall cohort and high-risk subgroups. CONCLUSIONS: In this contemporary cohort, EPDs were used more commonly among patients with high-risk clinical indications, yet there was no evidence of improved acute- or long-term outcomes. Further prospective studies are needed to support routine EPD use.

Comparative effectiveness of drug-eluting stents on long-term outcomes in elderly patients treated for in-stent restenosis: a report from the National Cardiovascular Data Registry.

OBJECTIVE: We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND: Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS: We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS: Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS: There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

Effect of race and ethnicity on outcomes with drug-eluting and bare metal stents: results in 423 965 patients in the linked National Cardiovascular Data Registry and centers for Medicare & Medicaid services payer databases.

BACKGROUND: Black, Hispanic, and Asian patients have been underrepresented in percutaneous coronary intervention clinical trials; therefore, there are limited data available on outcomes for these race/ethnicity groups. METHODS AND RESULTS: We examined outcomes in 423 965 patients in the National Cardiovascular Data Registry CathPCI Registry database linked to Medicare claims for follow-up. Within each race/ethnicity group, we examined trends in drug-eluting stent (DES) use, 30-month outcomes, and relative outcomes of DES versus bare metal stents. Overall, 390 351 white, 20 191 black, 9342 Hispanic, and 4171 Asian patients > 65 years of age underwent stent implantation from 2004 through 2008 at 940 National Cardiovascular Data Registry participating sites. Trends in adoption of DES were similar across all groups. Relative to whites, black and Hispanic patients undergoing percutaneous coronary intervention had higher long-term risks of death and myocardial infarction (blacks: hazard ratio, 1.28; 95% confidence interval, 1.24-1.32; Hispanics: hazard ratio, 1.15; 95% confidence interval, 1.10-1.21). Long-term outcomes were similar in Asians and whites (hazard ratio, 0.99; 95% confidence interval, 0.92-1.08). Use of DES was associated with better 30-month survival and lower myocardial infarction rates compared with the use of bare metal stents among all race/ethnicity groups except Hispanics, who had similar outcomes with DES or bare metal stents. CONCLUSIONS: Black and Hispanic patients undergoing percutaneous coronary intervention had worse long-term outcomes relative to white and Asian patients. Compared with bare metal stent use, DES use was generally associated with superior long-term outcomes in all racial and ethnic groups, although these differences were not statistically significant in Hispanic patients.

High mortality risks after major lower extremity amputation in Medicare patients with peripheral artery disease.

BACKGROUND: Little is known regarding the contemporary outcomes of older patients with peripheral artery disease (PAD) undergoing major lower extremity (LE) amputation in the United States. We sought to characterize clinical outcomes and factors associated with outcomes after LE amputation in patients with PAD. METHODS: Using data from the Centers for Medicare and Medicaid Services from January 1, 2000, to December 31, 2008, we examined the national patterns of mortality after major LE amputation among patients 65 years or older with PAD. Cox proportional hazards models were used to investigate the association between clinical variables, comorbid conditions, year of index amputation, geographic variation, and major LE amputation. RESULTS: Among 186,338 older patients with identified PAD who underwent major LE amputation, the mortality rate was 13.5% at 30 days, 48.3% at 1 year, and 70.9% at 3 years. Age per 5-year increase (hazard ratio [HR] 1.29, 95% CI 1.29-1.29), history of heart failure (HR 1.71, 95% CI 1.71-1.72), renal disease (HR 1.84. 95% CI 1.83-1.85), cancer (HR 1.71, 95% CI 1.70-1.72), and chronic obstructive pulmonary disease (HR 1.33, 95% CI, 1.32-1.33) were all independently associated with death after major LE amputation. Subjects who underwent above knee amputation had a statistically higher hazard of death when compared with subjects who underwent LE amputation at more distal locations (HR with above the knee amputation 1.31, 95% CI 1.25-1.36). CONCLUSIONS: Older patients with PAD undergoing major LE amputation still face a slightly high mortality risk, with almost half of all patients with PAD dying within a year of major LE amputation.

Temporal trends and geographic variation of lower-extremity amputation in patients with peripheral artery disease: results from U.S. Medicare 2000-2008.

OBJECTIVES: This study sought to characterize temporal trends, patient-specific factors, and geographic variation associated with amputation in patients with lower-extremity peripheral artery disease (LE PAD) during the study period. BACKGROUND: Amputation represents the end-stage failure for those with LE PAD, and little is known about the rates and geographic variation in the use of LE amputation. METHODS: By using data from the Centers for Medicare & Medicaid Services (CMS) from January 1, 2000, to December 31, 2008, we examined national patterns of LE amputation among patients age 65 years or more with PAD. Multivariable logistic regression was used to adjust regional results for other patient demographic and clinical factors. RESULTS: Among 2,730,742 older patients with identified PAD, the overall rate of LE amputation decreased from 7,258 per 100,000 patients with PAD to 5,790 per 100,000 (p < 0.001 for trend). Male sex, black race, diabetes mellitus, and renal disease were all independent predictors of LE amputation. The adjusted odds ratio of LE amputation per year between 2000 and 2008 was 0.95 (95% CI: 0.95-0.95, p < 0.001). CONCLUSIONS: From 2000 to 2008, LE amputation rates decreased significantly among patients with PAD. However, there remains significant patient and geographic variation in amputation rates across the United States.

Short- and long-term outcomes of coronary stenting in women versus men: results from the National Cardiovascular Data Registry Centers for Medicare & Medicaid services cohort.

BACKGROUND: Conflicting evidence exists on sex-based outcomes after coronary stenting. METHODS AND RESULTS: Data on 426 996 patients ≥65 years old (42.3% women) from the National Cardiovascular Data Registry CathPCI Registry (2004-2008) were linked to Medicare inpatient claims to compare in-hospital outcomes by sex and long-term outcomes by sex and stent type. In-hospital complications were more frequent in women than in men: death (3869 [2.2%] versus 3737 [1.6%]; adjusted odds ratio, 1.41; 95% confidence interval [CI], 1.33-1.49), myocardial infarction (2365 [1.3%] versus 2858 [1.2%]; odds ratio, 1.19; 95% CI, 1.11-1.27), bleeding (7860 [4.4%] versus 5627 [2.3%]; odds ratio, 1.86; 95% CI, 1.79-1.93), and vascular complications (2381 [1.3%] versus 1648 [0.7%]; odds ratio, 1.85; 95% CI, 1.73-1.99). At 20.4 months, women had a lower adjusted risk of death (hazard ratio [HR], 0.92; 95% CI, 0.90-0.94) but similar rates of myocardial infarction, revascularization, and bleeding. Relative to bare metal stent use, drug-eluting stent use was associated with similar improved long-term outcomes in both sexes: death (women: adjusted HR, 0.78; 95% CI, 0.76-0.81; men: HR, 0.77; 95% CI, 0.74-0.79), myocardial infarction (women: HR, 0.79; 95% CI, 0.74-0.84; men: HR, 0.81; 95% CI, 0.77-0.85), and revascularization (women: HR, 0.93; 95% CI, 0.90-0.97; men: HR, 0.91; 95% CI, 0.88-0.94). There was no interaction between sex and stent type for long-term outcomes. CONCLUSIONS: In contemporary coronary stenting, women have a slightly higher procedural risk than men but have better long-term survival. In both sexes, use of a drug-eluting stent is associated with lower long-term likelihood for death, myocardial infarction, and revascularization.

Safety and efficacy of drug-eluting stents in older patients with chronic kidney disease: a report from the linked CathPCI Registry-CMS claims database.

OBJECTIVES: The purpose of this study was to determine the safety and efficacy of drug-eluting stents (DES) compared with bare-metal stents (BMS) in older patients with chronic kidney disease (CKD). BACKGROUND: DES may be associated with late death and myocardial infarction (MI) secondary to stent thrombosis. However, data on outcomes in older patients with CKD are limited. METHODS: We estimated the glomerular filtration rate (GFR) of 283,593 patients 65 years of age and older who underwent stent implantation between 2004 and 2007. In propensity-matched cohorts grouped by GFR, the association between DES and BMS and the risk of death, MI, revascularization, and major bleeding was examined. RESULTS: A total of 121,446 patients (42.8%) had CKD (GFR <60 ml/min/1.73 m(2)). The 30-month mortality rate for patients on long-term dialysis was 52.0%. In propensity-matched pairs, placement of a DES compared with a BMS in patients with normal renal function was associated with significant reductions in 30-month revascularization (hazard ratio [HR]: 0.91; 95% confidence interval [CI]: 0.86 to 0.95), MI (HR: 0.77; 95% CI: 0.71 to 0.83), and death (HR: 0.73; 95% CI: 0.69 to 0.77), but no difference in bleeding (HR: 0.89; 95% CI: 0.79 to 1.00). Lower MI and mortality rates were also observed after DES compared with BMS implantation in all CKD subgroups with the exception of MI in the long-term dialysis group. Decreased rates of revascularization did not extend to any subgroup of patients with CKD. CONCLUSIONS: The safety of DES compared with BMS is observed in all patients regardless of renal function and is associated with reduced rates of MI and death in some subsets of patients with CKD.

Discharge to a skilled nursing facility and subsequent clinical outcomes among older patients hospitalized for heart failure.

BACKGROUND: Heart failure (HF) is the leading cause of hospitalization among older Americans. Subsequent discharge to skilled nursing facilities (SNF) is not well described. METHODS AND RESULTS: We performed an observational analysis of Medicare beneficiaries ≥65 years of age, discharged alive to SNF or home after ≥3-day hospitalization for HF in 2005 and 2006 within the Get With The Guidelines-HF Program. Among 15 459 patients from 149 hospitals, 24.1% were discharged to an SNF, 22.3% to home with home health service, and 53.6% to home with self-care. SNF use varied significantly among hospitals (median, 10.2% versus 33.9% in low versus high tertiles), with rates highest in the Northeast. Patient factors associated with discharge to SNF included longer length of stay, advanced age, female sex, hypotension, higher ejection fraction, absence of ischemic heart disease, and a variety of comorbidities. Performance measures were modestly lower for patients discharged to SNF. Unadjusted absolute event rates were higher at 30 days (death, 14.4% versus 4.1%; rehospitalization, 27.0% versus 23.5%) and 1 year (death, 53.5% versus 29.1%; rehospitalization, 76.1% versus 72.2%) after discharge to SNF versus home, respectively (P<0.0001 for all). After adjustment for measured patient characteristics, discharge to SNF remained associated with increased death (hazard ratio, 1.76; 95% confidence interval, 1.66 to 1.87) and rehospitalization (hazard ratio, 1.08; 95% confidence interval, 1.03 to 1.14). CONCLUSIONS: Discharge to SNF is common among Medicare patients hospitalized for HF, and these patients face substantial risk for adverse events, with more than half dead within 1 year. These findings highlight the need to better characterize this unique patient population and understand the SNF care they receive.

Association of insurance status with inpatient treatment for coronary artery disease: findings from the Get With the Guidelines program.

BACKGROUND: Prior studies have documented that patients' health insurance status can impact use of guideline-based care as well as acute outcomes for coronary artery disease. Whether insurance status remains a contemporary influence among centers participating in a national quality improvement initiative is unknown. METHODS: We analyzed data from 237,779 admissions with coronary artery disease from 527 hospitals participating in the Get With The Guidelines-Coronary Artery Disease Program from 2000 to 2008. Insurance status was Medicare (48.8%), Private/Health Maintenance Organization (HMO) (34.9%), Medicaid (8.2%), and No Insurance Documented (NID) (8.2%). Quality of care was measured using standard quality indicators covering acute treatment and discharge measures, utilization of invasive procedures, length of stay, and mortality. Relationship between different insurance types was examined using generalized estimating equation logistic regression and propensity-score matching adjusting for demographics, comorbidities and hospital characteristics. RESULTS: After propensity matching, full compliance with all eligible measures (deficit-free care) relative to Private/HMO was lower for Medicare (P < .0001) and Medicaid (P < .0001) and higher for the NID group (P = .0312). The acute reperfusion times were comparable among the groups. Compared with the Private/HMO group, all three groups had higher generalized estimating equation-adjusted mortality (OR, 1.15; 95% CI, 1.08-1.21; P < .001; OR, 1.18; 95% CI, 1.09-1.29; P < .001 and OR, 1.13; 95% CI, 1.01-1.25; P = .026), for Medicare, Medicaid, and NID, respectively. After propensity matching, mortality for Medicare was similar (P = .1197) and higher for NID (P = .0015) and Medicaid (P = .0015) groups. CONCLUSIONS: These findings suggest that among centers participating in a national quality improvement initiative patient insurance status may be associated with differences in cardiovascular care and outcomes.