Determinants of Variation in Pneumonia Rates After Coronary Artery Bypass Grafting.

BACKGROUND: Although conventional wisdom suggests that differences in patient risk profiles drive variability in postoperative pneumonia rates after coronary artery bypass grafting (CABG), this teaching has yet to be empirically tested. We determined to what extent patient risk factors account for hospital variation in pneumonia rates. METHODS: We studied 324,085 patients undergoing CABG between July 1, 2011, and December 31, 2013, across 998 hospitals using The Society of Thoracic Surgeons Adult Cardiac Database. We developed 5 models to estimate our incremental ability to explain hospital variation in pneumonia rates. Model 1 contained patient demographic characteristics and admission status, while Model 2 added patient risk factors. Model 3 added measures of pulmonary function, Model 4 added measures of cardiac anatomy and function and medications, and Model 5 further added measures of intraoperative and postoperative care. RESULTS: Although 9,175 patients (2.83%) experienced pneumonia, the median estimated distribution of pneumonia rates across hospitals was 2.5% (25th to 75th percentile: 1.5% to 4.0%). Wide variability in pneumonia rates was evident, with some hospitals having rates more than 6 times higher than others (10th to 90th percentile: 1.0% to 6.1%). Among all five models, Model 2 accounted for the most variability at 4.24%. In total, 2.05% of hospital variation in pneumonia rates was explained collectively by traditional patient factors, leaving 97.95% of variation unexplained. CONCLUSIONS: Our findings suggest that patient risk profiles only account for a fraction of hospital variation in pneumonia rates; enhanced understanding of other contributory factors (eg, processes of care) is required to lessen the likelihood of such nosocomial infections.

The Society of Thoracic Surgeons National Database 2016 Annual Report.

The art and science of outcomes analysis, quality improvement, and patient safety continue to evolve, and cardiothoracic surgery leads many of these advances. The Society of Thoracic Surgeons (STS) National Database is one of the principal reasons for this leadership role, as it provides a platform for the generation of knowledge in all of these domains. Understanding these topics is a professional responsibility of all cardiothoracic surgeons. Therefore, beginning in January 2016, The Annals of Thoracic Surgery began publishing a monthly series of scholarly articles on outcomes analysis, quality improvement, and patient safety. This article provides a summary of the status of the STS National Database as of October 2016 and summarizes the articles about the STS National Database that appeared in The Annals of Thoracic Surgery 2016 series, "Outcomes Analysis, Quality Improvement, and Patient Safety."

The Society of Thoracic Surgeons Congenital Heart Surgery Database: 2016 Update on Outcomes and Quality.

The Society of Thoracic Surgeons Congenital Heart Surgery Database is the largest congenital and pediatric cardiac surgical clinical data registry in the world. It is the platform for all activities of The Society of Thoracic Surgeons related to the analysis of outcomes and the improvement of quality in this subspecialty. This article summarizes current aggregate national outcomes in congenital and pediatric cardiac surgery and reviews related activities in the areas of quality measurement, performance improvement, and transparency. The reported data about aggregate national outcomes are exemplified by an analysis of 10 benchmark operations performed from January 2011 to December 2014 and documenting overall discharge mortality (interquartile range among programs with more than 9 cases): off-bypass coarctation, 1.0% (0.0% to 0.9%); ventricular septal defect repair, 0.7% (0.0% to 1.1%); tetralogy of Fallot repair, 1.0% (0.0% to 1.7%); complete atrioventricular canal repair, 3.2% (0.0% to 6.5%); arterial switch operation, 2.7% (0.0% to 5.6%); arterial switch operation plus ventricular septal defect, 5.3% (0.0% to 6.7%); Glenn/hemiFontan, 2.1% (0.0% to 3.8%); Fontan operation, 1.4% (0.0% to 2.4%); truncus arteriosus repair, 9.6% (0.0 % to 11.8%); and Norwood procedure, 15.6% (10.0% to 21.4%).

Penetration, Completeness, and Representativeness of The Society of Thoracic Surgeons Adult Cardiac Surgery Database.

BACKGROUND: The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (ACSD) has been successfully linked to the Centers for Medicare and Medicaid (CMS) Medicare database, thereby facilitating comparative effectiveness research and providing information about long-term follow-up and cost. The present study uses this link to determine contemporary completeness, penetration, and representativeness of the STS ACSD. METHODS: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft (CABG) surgery hospitalizations discharged between 2000 and 2012, inclusive. For each CMS CABG hospitalization, it was determined whether a matching STS record existed. RESULTS: Center-level penetration (number of CMS sites with at least one matched STS participant divided by the total number of CMS CABG sites) increased from 45% in 2000 to 90% in 2012. In 2012, 973 of 1,081 CMS CABG sites (90%) were linked to an STS site. Patient-level penetration (number of CMS CABG hospitalizations done at STS sites divided by the total number of CMS CABG hospitalizations) increased from 51% in 2000 to 94% in 2012. In 2012, 71,634 of 76,072 CMS CABG hospitalizations (94%) occurred at an STS site. Completeness of case inclusion at STS sites (number of CMS CABG cases at STS sites linked to STS records divided by the total number of CMS CABG cases at STS sites) increased from 88% in 2000 to 98% in 2012. In 2012, 69,213 of 70,932 CMS CABG hospitalizations at STS sites (98%) were linked to an STS record. CONCLUSIONS: Linkage of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data facilitates studying long-term outcomes and costs of cardiothoracic surgery.

Introduction to the STS National Database Series: Outcomes Analysis, Quality Improvement, and Patient Safety.

The Society of Thoracic Surgeons (STS) National Database is the foundation for most of the Society's quality, research, and patient safety activities. Beginning in January 2016 and repeating each year, The Annals of Thoracic Surgery will publish a monthly Database series of scholarly articles on outcomes analysis, quality improvement, and patient safety. Six articles will be directly derived from the STS National Database and will be published every other month: three articles on outcomes and quality (one each from the STS Adult Cardiac Surgery Database, the STS Congenital Heart Surgery Database, and the STS General Thoracic Surgery Database), and three articles on research (one from each of these three specialty databases). These six articles will alternate with five additional articles on topics related to patient safety. The final article, to be published in December, will provide a summary of the prior 11 manuscripts. This series will allow STS and its Workforces on National Databases, Research Development, and Patient Safety to convey timely information aimed at improving the quality and safety of cardiothoracic surgery.

Sources of Variation in Hospital-Level Infection Rates After Coronary Artery Bypass Grafting: An Analysis of The Society of Thoracic Surgeons Adult Heart Surgery Database.

BACKGROUND: Patients undergoing coronary artery bypass grafting (CABG) are at risk for a variety of infections. Investigators have focused on predictors of these adverse sequelae, but less attention has been focused on characterizing hospital-level variability in these outcomes. METHODS: Between July 2011 and December 2013, The Society of Thoracic Surgeons Adult Cardiac Surgery Database shows 365,686 patients underwent isolated CABG in 1,084 hospitals. Hospital-acquired infections (HAIs) were defined as pneumonia, sepsis/septicemia, deep sternal wound infection/mediastinitis, vein harvest/cannulation site infection, or thoracotomy infection. Hospitals were ranked by their HAI rate as low (≤ 10th percentile), medium (10th to 90th percentile), and high (>90th percentile). Differences in perioperative factors and composite morbidity and mortality end points across these groups were determined using the Wilcoxon rank sum and χ(2) tests. RESULTS: HAIs occurred among 3.97% of patients overall, but rates varied across hospital groups (low: <0.84%, medium: 0.84% to 8.41%, high: >8.41%). Pneumonia (2.98%) was the most common HAI, followed by sepsis/septicemia (0.84%). Patients at high-rate hospitals more often smoked, had diabetes, chronic lung disease, New York Heart Association Functional Classification III to IV, and received blood products (p < 0.001); however, they less often were prescribed the appropriate antibiotics (p < 0.001). Major morbidity and mortality occurred among 12.3% of patients, although this varied by hospital group (low: 8.6%, medium: 12.3%, high: 17.9%; p < 0.001). CONCLUSIONS: Substantial hospital-level variation exists in postoperative HAIs among patients undergoing CABG, driven predominantly by pneumonia. Given the relatively small absolute differences in comorbidities across hospital groups, our findings suggest factors other than case mix may explain the observed variation in HAI rates.

Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons' Society: part 1--rationale and methodology.

PURPOSE: The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) is the largest Registry in the world of patients who have undergone congenital and pediatric cardiac surgical operations. The Congenital Heart Surgeons' Society Database (CHSS-D) is an Academic Database designed for specialized detailed analyses of specific congenital cardiac malformations and related treatment strategies. The goal of this project was to create a link between the STS-CHSD and the CHSS-D in order to facilitate studies not possible using either individual database alone and to help identify patients who are potentially eligible for enrollment in CHSS studies. METHODS: Centers were classified on the basis of participation in the STS-CHSD, the CHSS-D, or both. Five matrices, based on CHSS inclusionary criteria and STS-CHSD codes, were created to facilitate the automated identification of patients in the STS-CHSD who meet eligibility criteria for the five active CHSS studies. The matrices were evaluated with a manual adjudication process and were iteratively refined. The sensitivity and specificity of the original matrices and the refined matrices were assessed. RESULTS: In January 2012, a total of 100 centers participated in the STS-CHSD and 74 centers participated in the CHSS. A total of 70 centers participate in both and 40 of these 70 agreed to participate in this linkage project. The manual adjudication process and the refinement of the matrices resulted in an increase in the sensitivity of the matrices from 93% to 100% and an increase in the specificity of the matrices from 94% to 98%. CONCLUSION: Matrices were created to facilitate the automated identification of patients potentially eligible for the five active CHSS studies using the STS-CHSD. These matrices have a sensitivity of 100% and a specificity of 98%. In addition to facilitating identification of patients potentially eligible for enrollment in CHSS studies, these matrices will allow (1) estimation of the denominator of patients potentially eligible for CHSS studies and (2) comparison of eligible and enrolled patients to potentially eligible and not enrolled patients to assess the generalizability of CHSS studies.

Linking the congenital heart surgery databases of the Society of Thoracic Surgeons and the Congenital Heart Surgeons' Society: part 2--lessons learned and implications.

PURPOSE: A link has been created between the Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) and the Congenital Heart Surgeons' Society Database (CHSS-D). Five matrices have been created that facilitate the automated identification of patients who are potentially eligible for the five active CHSS studies using the STS-CHSD. These matrices are now used to (1) estimate the denominator of patients eligible for CHSS studies and (2) compare "eligible and enrolled patients" to "potentially eligible and not enrolled patients" to assess the generalizability of CHSS studies. METHODS: The matrices were applied to 40 consenting institutions that participate in both the STS-CHSD and the CHSS to (1) estimate the denominator of patients that are potentially eligible for CHSS studies, (2) estimate the completeness of enrollment of patients eligible for CHSS studies among all CHSS sites, (3) estimate the completeness of enrollment of patients eligible for CHSS studies among those CHSS institutions participating in each CHSS cohort study, and (4) compare "eligible and enrolled patients" to "potentially eligible and not enrolled patients" to assess the generalizability of CHSS studies. The matrices were applied to all participants in the STS-CHSD to identify patients who underwent frequently performed operations and compare "eligible and enrolled patients" to "potentially eligible and not enrolled patients" in following five domains: (1) age at surgery, (2) gender, (3) race, (4) discharge mortality, and (5) postoperative length of stay. Completeness of enrollment was defined as the number of actually enrolled patients divided by the number of patients identified as being potentially eligible for enrollment. RESULTS: For the CHSS Critical Left Ventricular Outflow Tract Study (LVOTO) study, for the Norwood procedure, completeness of enrollment at centers actively participating in the LVOTO study was 34%. For the Norwood operation, discharge mortality was 15% among 227 enrolled patients and 16% among 1768 nonenrolled potentially eligible patients from the 40 consenting institutions. Median postoperative length of stay was 31 days and 26 days for these enrolled and nonenrolled patients. For the CHSS anomalous aortic origin of a coronary artery (AAOCA) study, for AAOCA repair, completeness of enrollment at centers actively participating in the AAOCA study was 40%. CONCLUSION: Determination of the denominator of patients eligible for CHSS studies and comparison of "eligible and enrolled patients" to "potentially eligible and not enrolled patients" provides an estimate of the extent to which patients in CHSS studies are representative of the overall population of eligible patients; however, opportunities exist to improve enrollment.

Report from the Society of Thoracic Surgeons National Database Workforce: clarifying the definition of operative mortality.

Several distinct definitions of postoperative death have been used in various quality reporting programs. Some have defined postoperative mortality as the occurrence of death after a surgical procedure when the patient dies while still in the hospital, while others have considered all deaths occurring within a predetermined, standardized time interval after surgery to be postoperative mortality. While mortality data are still collected and reported using both these individual definitions, the Society of Thoracic Surgeons (STS) believes that either approach alone may be inadequate. Accordingly, the STS prefers a more encompassing metric, Operative Mortality. Operative Mortality is defined in all STS databases as (1) all deaths, regardless of cause, occurring during the hospitalization in which the operation was performed, even if after 30 days (including patients transferred to other acute care facilities); and (2) all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day. This article provides clarification for some uncommon but important scenarios in which the correct application of this definition may be challenging.

Successful linking of the Society of Thoracic Surgeons Database to Social Security data to examine the accuracy of Society of Thoracic Surgeons mortality data.

OBJECTIVES: The Society of Thoracic Surgeons Adult Cardiac Surgery Database has been linked to the Social Security Death Master File to verify "life status" and evaluate long-term surgical outcomes. The objective of this study is explore practical applications of the linkage of the Society of Thoracic Surgeons Adult Cardiac Surgery Database to Social Securtiy Death Master File, including the use of the Social Securtiy Death Master File to examine the accuracy of the Society of Thoracic Surgeons 30-day mortality data. METHODS: On January 1, 2008, the Society of Thoracic Surgeons Adult Cardiac Surgery Database began collecting Social Security numbers in its new version 2.61. This study includes all Society of Thoracic Surgeons Adult Cardiac Surgery Database records for operations with nonmissing Social Security numbers between January 1, 2008, and December 31, 2010, inclusive. To match records between the Society of Thoracic Surgeons Adult Cardiac Surgery Database and the Social Security Death Master File, we used a combined probabilistic and deterministic matching rule with reported high sensitivity and nearly perfect specificity. RESULTS: Between January 1, 2008, and December 31, 2010, the Society of Thoracic Surgeons Adult Cardiac Surgery Database collected data for 870,406 operations. Social Security numbers were available for 541,953 operations and unavailable for 328,453 operations. According to the Society of Thoracic Surgeons Adult Cardiac Surgery Database, the 30-day mortality rate was 17,757/541,953 = 3.3%. Linkage to the Social Security Death Master File identified 16,565 cases of suspected 30-day deaths (3.1%). Of these, 14,983 were recorded as 30-day deaths in the Society of Thoracic Surgeons database (relative sensitivity = 90.4%). Relative sensitivity was 98.8% (12,863/13,014) for suspected 30-day deaths occurring before discharge and 59.7% (2120/3551) for suspected 30-day deaths occurring after discharge. CONCLUSIONS: Linkage to the Social Security Death Master File confirms the accuracy of data describing "mortality within 30 days of surgery" in the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The Society of Thoracic Surgeons and Social Security Death Master File link reveals that capture of 30-day deaths occurring before discharge is highly accurate, and that these in-hospital deaths represent the majority (79% [13,014/16,565]) of all 30-day deaths. Capture of the remaining 30-day deaths occurring after discharge is less complete and needs improvement. Efforts continue to encourage Society of Thoracic Surgeons Database participants to submit Social Security numbers to the Database, thereby enhancing accurate determination of 30-day life status. The Society of Thoracic Surgeons and Social Security Death Master File linkage can facilitate ongoing refinement of mortality reporting.

Long-term safety and effectiveness of mechanical versus biologic aortic valve prostheses in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database.

BACKGROUND: There is a paucity of long-term data comparing biological versus mechanical aortic valve prostheses in older individuals. METHODS AND RESULTS: We performed follow-up of patients aged 65 to 80 years undergoing aortic valve replacement with a biological (n=24 410) or mechanical (n=14 789) prosthesis from 1991 to 1999 at 605 centers within the Society of Thoracic Surgeons Adult Cardiac Surgery Database using Medicare inpatient claims (mean, 12.6 years; maximum, 17 years; minimum, 8 years), and outcomes were compared by propensity methods. Among Medicare-linked patients undergoing aortic valve replacement (mean age, 73 years), both reoperation (4.0%) and endocarditis (1.9%) were uncommon to 12 years; however, the risk for other adverse outcomes was high, including death (66.5%), stroke (14.1%), and bleeding (17.9%). Compared with those receiving a mechanical valve, patients given a bioprosthesis had a similar adjusted risk for death (hazard ratio, 1.04; 95% confidence interval, 1.01-1.07), higher risks for reoperation (hazard ratio, 2.55; 95% confidence interval, 2.14-3.03) and endocarditis (hazard ratio, 1.60; 95% confidence interval, 1.31-1.94), and lower risks for stroke (hazard ratio, 0.87; 95% confidence interval, 0.82-0.93) and bleeding (hazard ratio, 0.66; 95% confidence interval, 0.62-0.70). Although these results were generally consistent among patient subgroups, bioprosthesis patients aged 65 to 69 years had a substantially elevated 12-year absolute risk of reoperation (10.5%). CONCLUSIONS: Among patients undergoing aortic valve replacement, long-term mortality rates were similar for those who received bioprosthetic versus mechanical valves. Bioprostheses were associated with a higher long-term risk of reoperation and endocarditis but a lower risk of stroke and hemorrhage. These risks varied as a function of a patient's age and comorbidities.

The society of thoracic surgeons national database.

AIMS: The Society of Thoracic Surgeons (STS) National Database collects detailed clinical information on patients undergoing adult cardiac, paediatric and congenital cardiac, and general thoracic surgical operations. These data are used to support risk-adjusted, nationally benchmarked performance assessment and feedback; voluntary public reporting; quality improvement initiatives; guideline development; appropriateness determination; shared decision making; research using cross-sectional and longitudinal registry linkages; comparative effectiveness studies; government collaborations including postmarket surveillance; regulatory compliance and reimbursement strategies. INTERVENTIONS: All database participants receive feedback reports which they may voluntarily share with their hospitals or payers, or publicly report. STS analyses are regularly used as the basis for local, regional and national quality improvement efforts. POPULATION: More than 90% of adult cardiac programmes in the USA participate, as do the majority of paediatric cardiac programmes, and general thoracic participation continues to increase. Since the inception of the Database in 1989, more than 5 million patient records have been submitted. BASELINE DATA: Each of the three subspecialty databases includes several hundred variables that characterise patient demographics, diagnosis, medical history, clinical risk factors and urgency of presentation, operative details and postoperative course including adverse outcomes. DATA CAPTURE: Data are entered by trained data abstractors and by the care team, using detailed data specifications for each element. DATA QUALITY: Quality and consistency checks assure accurate and complete data, missing data are rare, and audits are performed annually of selected participant sites. ENDPOINTS: All major outcomes are reported including complications, status at discharge and mortality. DATA ACCESS: Applications for STS Database participants to use aggregate national data for research are available at http://www.sts.org/quality-research-patient-safety/research/publications-and-research/access-data-sts-national-database.

Longitudinal outcome of isolated mitral repair in older patients: results from 14,604 procedures performed from 1991 to 2007.

BACKGROUND: Mitral valve (MV) repair is performed with less frequency than MV replacement in older persons, with referral often delayed until symptoms are severe. Surgical practice in this population remains inconsistent in the absence of national MV repair outcomes. The goal of this study was to assess durability and longitudinal outcomes after isolated primary MV repair in patients aged 65 years or more. METHODS: We linked clinical data from The Society of Thoracic Surgeons adult cardiac surgery database (STS) to longitudinal claims data from the Centers for Medicare and Medicaid Services (CMS). Between January 1991 and December 2007, we identified 14,604 isolated nonemergent primary MV repair operations in STS-CMS data. These were longitudinally examined for mortality, mitral reoperation, and readmissions for heart failure, bleeding, and stroke. Predictors of 5-year death after MV repair were identified using Cox proportional hazard modeling. RESULTS: The study cohort had a mean age of 73.3±5.5 years, ejection fraction 54.0%±12.9%; 55.8% (8,148 of 14,604) were female; and 8.4% (1,233 of 14,604) were non-Caucasian. Operative mortality was 2.59% (378 of 14,604). Mean follow-up was 5.9±3.9 years (range, 1.0 to 18.0). Survival during follow-up was 74.9% (10,934 of 14,604). The number of observed events for mitral reoperation, heart failure, bleeding, and stroke were 552 of 14,604 (3.7%), 2,681 of 14,604 (18.4%), 1,051 of 14,604 (7.2%), and 1,131 of 14,604 (7.7%), respectively. The 10-year Kaplan-Meier event rates for mitral reoperation, heart failure, bleeding, and stroke were 6.2%, 30.1%, 15.3%, and 16.4%, respectively. The 10-year actuarial survival of 57.4% was equivalent to the matched US population. CONCLUSIONS: Utilizing linked STS and CMS databases, we demonstrate that MV repair is a safe and durable long-term option for older patients. Survival restored to the normal population suggests repair may suppress the longitudinal impact of mitral regurgitation in the elderly and that the practice of delayed referral should be reevaluated. These data provide a contemporary longitudinal benchmark of MV repair outcomes.

Association between endoscopic vs open vein-graft harvesting and mortality, wound complications, and cardiovascular events in patients undergoing CABG surgery.

CONTEXT: The safety and durability of endoscopic vein graft harvest in coronary artery bypass graft (CABG) surgery has recently been called into question. OBJECTIVE: To compare the long-term outcomes of endoscopic vs open vein-graft harvesting for Medicare patients undergoing CABG surgery in the United States. DESIGN, SETTING, AND PATIENTS: An observational study of 235,394 Medicare patients undergoing isolated CABG surgery between 2003 and 2008 at 934 surgical centers participating in the Society of Thoracic Surgeons (STS) national database. The STS records were linked to Medicare files to allow longitudinal assessment (median 3-year follow-up) through December 31, 2008. MAIN OUTCOME MEASURES: All-cause mortality. Secondary outcome measures included wound complications and the composite of death, myocardial infarction, and revascularization. RESULTS: Based on Medicare Part B coding, 52% of patients received endoscopic vein-graft harvesting during CABG surgery. After propensity score adjustment for clinical characteristics, there were no significant differences between long-term mortality rates (13.2% [12,429 events] vs 13.4% [13,096 events]) and the composite of death, myocardial infarction, and revascularization (19.5% [18,419 events] vs 19.7% [19,232 events]). Time-to-event analysis for those patients receiving endoscopic vs open vein-graft harvesting revealed adjusted hazard ratios [HRs] of 1.00 (95% CI, 0.97-1.04) for mortality and 1.00 (95% CI, 0.98-1.05) for the composite outcome. Endoscopic vein-graft harvesting was associated with lower harvest site wound complications relative to open vein-graft harvesting (3.0% [3654/122,899 events] vs 3.6% [4047/112,495 events]; adjusted HR, 0.83; 95% CI, 0.77-0.89; P < .001). CONCLUSION: Among patients undergoing CABG surgery, the use of endoscopic vein-graft harvesting compared with open vein-graft harvesting was not associated with increased mortality.

Early anticoagulation of bioprosthetic aortic valves in older patients: results from the Society of Thoracic Surgeons Adult Cardiac Surgery National Database.

OBJECTIVES: The aim of this study was to evaluate the risks and benefits of short-term anticoagulation in patients receiving aortic valve bioprostheses. BACKGROUND: Patients receiving aortic valve bioprostheses have an elevated early risk of thromboembolic events; however, the risks and benefits of short-term anticoagulation have been debated with limited evidence. METHODS: Our cohort consisted of 25,656 patients ≥65 years of age receiving aortic valve bioprostheses at 797 hospitals within the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2004 to 2006). The associated 3-month incidences of death or readmission for embolic (cerebrovascular accident, transient ischemic attack, and noncerebral arterial thromboembolism) or bleeding events were compared across discharge anticoagulation strategies with propensity methods. RESULTS: In this cohort (median age, 77 years), the 3 most common discharge anticoagulation strategies included: aspirin-only (49%), warfarin-only (12%), and warfarin plus aspirin (23%). Among those receiving aspirin-only, 3-month adverse events were low (death, 3.0%; embolic events, 1.0%; bleeding events, 1.0%). Relative to aspirin-only, those treated with warfarin plus aspirin had a lower adjusted risk of death (relative risk [RR]: 0.80, 95% confidence interval [CI]: 0.66 to 0.96) and embolic event (RR: 0.52, 95% CI: 0.35 to 0.76) but a higher risk of bleeding (RR: 2.80, 95% CI: 2.18 to 3.60). Relative to aspirin-only, warfarin-only patients had a similar risk of death (RR: 1.01, 95% CI: 0.80 to 1.27), embolic events (RR: 0.95, 95% CI: 0.61 to 1.47), and bleeding (RR: 1.23, 95% CI: 0.85 to 1.79). These results were generally consistent across patient subgroups. CONCLUSIONS: Death and embolic events were relatively rare in the first 3 months after bioprosthetic aortic valve replacement. Compared with aspirin-only, aspirin plus warfarin was associated with a reduced risk of death and embolic events, but at the cost of an increased bleeding risk.

Patterns of anticoagulation following bioprosthetic valve implantation: observations from ANSWER.

BACKGROUND AND AIM OF THE STUDY: The American College of Cardiology/American Heart Association (ACC/AHA) guidelines recommend a three-month administration of warfarin following bioprosthetic valve replacement (BVR). However, strong evidence supporting this recommendation is lacking, making process variation likely. METHODS: In the ANSWER Registry, a total of 386 patients who had received either Epic or Biocor BVRs between May 2007 and August 2008 at 40 centers was enrolled. Patterns of discharge anticoagulation and outpatient International Normalized Ratio (INR) values were collected. Mortality, embolic, and bleeding events were assessed up to six months after BVR. RESULTS: The median patient age was 74 years (interquartile range (IQR): 67-80 years), 39% of patients were female, and 65% were classified as a high thromboembolic risk. Warfarin was prescribed in 38% of all BVR patients, and in 49% of those at high risk of thromboembolism. The median time to therapeutic INR was nine days (IQR: 1 to 18 days), and 20% of patients failed to reach therapeutic levels. Among those patients achieving a therapeutic INR, 78% and 57% respectively had at least one subtherapeutic or supratherapeutic INR during the subsequent follow up to three months. During the follow up, patients treated with warfarin had similar rates of embolic events (2.8% versus 3.1%, p = 0.884), but a substantially higher incidence of bleeding than those not treated with warfarin (12% versus 3%, p = 0.0012). Among patients who were anticoagulated, those with supratherapeutic INR-values had a seven-fold higher risk for overt bleeding events (26% versus 3%). CONCLUSION: Anticoagulation strategies after BVR are highly variable. In this population, challenges in achieving and maintaining therapeutic warfarin anticoagulation are common, and are associated with an increased risk of bleeding. Further studies are required to clarify the optimal post-BVR anticoagulation strategy.

Linking the National Cardiovascular Data Registry CathPCI Registry with Medicare claims data: validation of a longitudinal cohort of elderly patients undergoing cardiac catheterization.

BACKGROUND: The National Cardiovascular Data Registry CathPCI Registry was recently linked with longitudinal Centers for Medicare & Medicaid (CMS) claims data. The degree to which this linked cohort is representative of the overall CathPCI Registry and CMS PCI populations is unknown. METHODS AND RESULTS: CathPCI Registry records were linked to CMS inpatient claims using indirect identifiers. We examined the degree to which hospitals and patients in the linked cohort are representative of the elderly (≥65 years) CathPCI Registry and CMS populations. From 2004 to 2006, 1492 hospitals filed CMS PCI claims and 663 contributed CathPCI Registry data. Of these hospitals, 643 (97%) were linked across data sources. Compared with all CMS PCI hospitals, the linked data set contained fewer governmental, northeastern, southern, and low-volume (<200 beds) sites. Among CMS beneficiaries, 993,351 PCI procedures were performed, including 398,508 (40.1%) at centers in the linked database. Of these, 341,916 (86%) were linked to CathPCI Registry records. Linked and unlinked CMS patients had similar demographic and clinical features. In the CathPCI Registry database, 477,456 elderly patients underwent PCI, with 359,077 (75%) linked to CMS claims. Linked and unlinked National Cardiovascular Data Registry patients were similar, except for less commercial or health maintenance organization insurance in the linked cohort. CONCLUSIONS: By using deterministic matching strategies, a large and representative cohort with detailed clinical data from the CathPCI Registry and longitudinal follow-up from CMS claims has been created.

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.

Postoperative inotrope and vasopressor use following CABG: outcome data from the CAPS-care study.

BACKGROUND/AIM: Limited clinical data exist to guide practice patterns and evidence-based use of inotropes and vasopressors following coronary artery bypass grafting (CABG). METHODS: Contemporary Analysis of Perioperative Cardiovascular Surgical Care (CAPS-Care) collected detailed perioperative data from 2390 CABG patients between 2004 and 2005 at 55 U.S. hospitals. High-risk elective or urgent CABG patients were eligible for inclusion. We stratified participating hospitals into high, medium, and low tertiles of inotrope use. Hospital-level outcomes were compared before and after risk adjustment for baseline characteristics. RESULTS: Hospital-level risk-adjusted rates of any inotrope/vasopressor use varied from 100% to 35%. Hospitals in the highest tertile of use had more patients with mitral regurgitation compared to medium- or low-use hospitals (p < 0.001), more previous cardiovascular interventions (p = 0.002), longer cardiopulmonary bypass (p < 0.001), longer cross-clamp times (p < 0.001), and required more transfusions (p = 0.001). Despite these differences, unadjusted outcomes were similar between high-, medium-, and low-use hospitals for operative mortality (4.5% vs. 5.3% vs. 5.2%; p = 0.702), 30-day mortality (4.1% vs. 4.6% vs. 5.0%; p = 0.690), postoperative renal failure (7.2% vs. 9.2% vs. 6.6%; p = 0.142), atrial fibrillation (23.0% vs. 27.2% vs. 25.6%; p = 0.106), and acute limb ischemia (0.6% vs. 0.5% vs. 0.5%; p = 0.945). These similar outcomes persisted after risk adjustment: adjusted OR = 0.97 (95% CI [0.94, 1.00], p = 0.086) for operative mortality and adjusted OR = 1.00 (95% CI [0.96, 1.04], p = 0.974) for postoperative renal failure. CONCLUSION: While considerable variability is present among hospitals in inotrope use following CABG, observational comparison of outcomes did not distinguish a superior pattern; thus, randomized prospective data are needed to better guide clinical practice.

Successful linking of the Society of Thoracic Surgeons database to social security data to examine survival after cardiac operations.

BACKGROUND: Long-term evaluation of cardiothoracic surgical outcomes is a major goal of The Society of Thoracic Surgeons (STS). Linking the STS Database to the Social Security Death Master File (SSDMF) allows for the verification of "life status." This study demonstrates the feasibility of linking the STS Database to the SSDMF and examines longitudinal survival after cardiac operations. METHODS: For all operations in the STS Adult Cardiac Surgery Database performed in 2008 in patients with an available Social Security Number, the SSDMF was searched for a matching Social Security Number. Survival probabilities at 30 days and 1 year were estimated for nine common operations. RESULTS: A Social Security Number was available for 101,188 patients undergoing isolated coronary artery bypass grafting, 12,336 patients undergoing isolated aortic valve replacement, and 6,085 patients undergoing isolated mitral valve operations. One-year survival for isolated coronary artery bypass grafting was 88.9% (6,529 of 7,344) with all vein grafts, 95.2% (84,696 of 88,966) with a single mammary artery graft, 97.4% (4,422 of 4,540) with bilateral mammary artery grafts, and 95.6% (7,543 of 7,890) with all arterial grafts. One-year survival was 92.4% (11,398 of 12,336) for isolated aortic valve replacement (95.6% [2,109 of 2,206] with mechanical prosthesis and 91.7% [9,289 of 10,130] with biologic prosthesis), 86.5% (2,312 of 2,674) for isolated mitral valve replacement (91.7% [923 of 1,006] with mechanical prosthesis and 83.3% [1,389 of 1,668] with biologic prosthesis), and 96.0% (3,275 of 3,411) for isolated mitral valve repair. CONCLUSIONS: Successful linkage to the SSDMF has substantially increased the power of the STS Database. These longitudinal survival data from this large multi-institutional study provide reassurance about the durability and long-term benefits of cardiac operations and constitute a contemporary benchmark for survival after cardiac operations.