Clinical characteristics and in-hospital outcomes of patients with cardiogenic shock undergoing coronary artery bypass surgery: insights from the Society of Thoracic Surgeons National Cardiac Database.

BACKGROUND: There exist few studies that characterize contemporary clinical features and outcomes or risk factors for operative mortality in cardiogenic shock (CS) patients undergoing coronary artery bypass grafting (CABG). METHODS AND RESULTS: We evaluated data of 708,593 patients with and without CS undergoing CABG enrolled in the Society of Thoracic Surgeons National Cardiac Database (2002-2005). Clinical, angiographic, and operative features and in-hospital outcomes were evaluated in patients with and without CS. Logistic regression was used to identify predictors of operative mortality and to estimate weights for an additive risk score. Patients with preoperative CS constituted 14,956 (2.1%) of patients undergoing CABG yet accounted for 14% of all CABG deaths. Operative mortality in CS patients was high and surgery specific, rising from 20% for isolated CABG to 33% for CABG plus valve surgery and 58% for CABG plus ventricular septal repair. Although mortality for CABG surgery overall declined significantly over time (P for trend <0.0001), mortality for CS patients undergoing CABG did not change significantly during the 4-year study period (P=0.07). Factors associated with higher death risk for CS patients undergoing CABG were identified by multivariable analysis and summarized into a simple bedside risk score (c statistic=0.74) that accurately stratified those with low (<10%) to very high (>60%) mortality risk. CONCLUSIONS: Patients with CS represent a minority of those undergoing CABG yet have persistently high operative risks, accounting for 14% of deaths in CABG patients. Estimation of patient-specific risk of mortality is feasible with the simplified additive risk tool developed in our study with the use of routinely available preprocedural data.

Regulatory and ethical considerations for linking clinical and administrative databases.

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.

Contemporary impact of state certificate-of-need regulations for cardiac surgery: an analysis using the Society of Thoracic Surgeons' National Cardiac Surgery Database.

BACKGROUND: Prior research using administrative data associated certificate-of-need (CON) regulation for open heart surgery with higher hospital coronary artery bypass grafting (CABG) volume and lower CABG operative mortality rates in elderly patients. It is unclear whether these findings apply in a general population and after controlling for detailed clinical characteristics and region. METHODS AND RESULTS: Using the Society of Thoracic Surgeons' (STS) National Cardiac Surgery Database, we examined isolated CABG surgery volume, operative mortality, and the composite end point of operative mortality or major morbidity for the years 2000 to 2003. The presence of CON regulations for open heart surgery was ascertained from the National Directory of the American Health Policy Association and by contacting CON administrators. Results were analyzed nationally, by state, and by region (West, Northeast, Midwest, South) and were adjusted for clinical factors and both population density and region with mixed-effects hierarchical logistic regression models. During 2000 to 2003, there were 314,710 isolated CABG surgeries performed at 294 STS hospitals in CON states (n=27, including Washington, DC) and 280 512 procedures at 343 STS hospitals in non-CON states (n=24). Patient clinical characteristics were similar among CON and non-CON hospitals. States with CON regulations tended to have higher population densities and had significantly higher median hospital annual CABG volumes in each of the years 2000 to 2003 (P<0.005). This difference remained significant after adjustment for region and population density. Operative mortality was 2.52% for CON versus 2.62% for non-CON states (P=0.32). There was a significant association between CON law and operative mortality in the South. After adjustment for patient risk factors and region, there was a marginally significant reduction of mortality risk in states with CON regulation (adjusted OR 0.92, 95% CI 0.86 to 1.00). However, this difference was not statistically significant when a revised model accounted for random state effects. Similar volume and outcomes results were seen when the analysis was repeated with data from the national Medicare database. CONCLUSIONS: CON states have significantly higher hospital CABG surgery volumes but similar mortality compared with non-CON states. CON regulation alone is not a sufficient mechanism to ensure quality of care for CABG surgery.

Bedside tool for predicting the risk of postoperative dialysis in patients undergoing cardiac surgery.

BACKGROUND: Estimation of an individual patient's risk for postoperative dialysis can support informed clinical decision making and patient counseling. METHODS AND RESULTS: To develop a simple bedside risk algorithm for estimating patients' probability for dialysis after cardiac surgery, we evaluated data of 449,524 patients undergoing coronary artery bypass grafting (CABG) and/or valve surgery and enrolled in >600 hospitals participating in the Society of Thoracic Surgeons National Database (2002-2004). Logistic regression was used to identify major predictors of postoperative dialysis. Model coefficients were then converted into an additive risk score and internally validated. The model also was validated in a second sample of 86,009 patients undergoing cardiac surgery from January to June 2005. Postoperative dialysis was needed in 6451 patients after cardiac surgery (1.4%), ranging from 1.1% for isolated CABG procedures to 5.1% for CABG plus mitral valve surgery. Multivariable analysis identified preoperative serum creatinine, age, race, type of surgery (CABG plus valve or valve only versus CABG only), diabetes, shock, New York Heart Association class, lung disease, recent myocardial infarction, and prior cardiovascular surgery to be associated with need for postoperative dialysis (c statistic=0.83). The risk score accurately differentiated patients' need for postoperative dialysis across a broad risk spectrum and performed well in patients undergoing isolated CABG, off-pump CABG, isolated aortic valve surgery, aortic valve surgery plus CABG, isolated mitral valve surgery, and mitral valve surgery plus CABG (c statistic=0.83, 0.85, 0.81, 0.75, 0.80, and 0.75, respectively). CONCLUSIONS: Our study identifies the major patient risk factors for postoperative dialysis after cardiac surgery. These risk factors have been converted into a simple, accurate bedside risk tool. This tool should facilitate improved clinician-patient discussions about risks of postoperative dialysis.

Role of amiodarone in reducing atrial fibrillation after cardiac surgery in adults.

Atrial fibrillation is a common occurrence after cardiac surgery and the source of financial expenditure and complications. A critical literature review was undertaken to examine the use of amiodarone therapy to prevent or manage atrial fibrillation after cardiac surgery. Evidence strongly suggests that perioperative treatment of cardiac patients with amiodarone may reduce the incidence of atrial fibrillation with minimal adverse effects. Further study is warranted to determine the optimal timing and dosing, for the drug's most cost-effective use.

Effect of beta blockers after coronary artery bypass in postinfarct patients: what can we learn from available literature?

Studies have shown that beta adrenergic antagonist therapy benefits patients with coronary disease through reduced mortality rate after acute myocardial infarction and reduced incidence of postoperative atrial fibrillation after coronary artery bypass grafting. The long-term benefit of this therapy in survivors of myocardial infarction who are subsequently revascularized, however, has not been defined or studied rigorously. We reviewed the published data to clarify the role of beta blockade in patients who had surgical revascularization after myocardial infarction. We found that patients who received beta blockers after myocardial infarction had a reduced mortality rate and fewer cardiac events in most clinical situations, a benefit which likely extends to patients who have had subsequent surgical revascularization.

The Society of Thoracic Surgeons practice guideline series: transmyocardial laser revascularization.

BACKGROUND: Patients with chronic severe angina refractory to medical therapy who cannot be completely revascularized with either percutaneous catheter intervention or coronary artery bypass graft surgery present clinical challenges. Transmyocardial laser revascularization, either as sole therapy or as an adjunct to coronary artery bypass graft surgery, may be appropriate for some of these patients. Although transmyocardial revascularization has consistently been demonstrated as an efficacious means of relieving angina, the mechanism of its effects are still debated, and criteria for the selection of patients for this novel therapy have not been adequately defined. METHODS: We reviewed the available evidence to allow us to make recommendations for the appropriate therapeutic applications of transmyocardial revascularization following the format of the American Heart Association and the American College of Cardiology guidelines for diagnostic and therapeutic procedures. Our recommendations were classified as class I, IIA, IIB, or III. For each recommendation we defined the level of supporting evidence as A, B, or C. RESULTS: We identified class I indications for transmyocardial revascularization as sole therapy and class IIA indications for transmyocardial revascularization as an adjunct to coronary artery bypass graft surgery with levels of evidence A and B, respectively. CONCLUSIONS: Transmyocardial laser revascularization may be an acceptable form of therapy for selected patients: as sole therapy for a subset of patients with refractory angina and as an adjunct to coronary artery bypass graft surgery for a subset of patients with angina who cannot be completely revascularized surgically.

The risks of moderate and extreme obesity for coronary artery bypass grafting outcomes: a study from the Society of Thoracic Surgeons' database.

BACKGROUND: Obesity is epidemic in the United States and afflicts 97 million adults. Prior single center studies have been contradictory as to obese patients having higher risks with coronary artery bypass operations. Our objective was to assess the independent effect of both moderate (body mass index [BMI], 35 to 39.9) and extreme (BMI > or = 40) obesity on bypass operation outcomes using the Society of Thoracic Surgeons National Cardiac Database. METHODS: The study population consisted of 559,004 patients from the Society of Thoracic Surgeons database who underwent first-time, isolated coronary artery bypass grafting between January 1997 and December 2000. We compared 42,060 moderately obese patients (BMI, 35 to 39.9) and 18,735 extremely obese patients (BMI > or = 40) with 498,209 normal or mildly obese patients (BMI, 18.5 to 34.9). Multivariable logistic regression was used to determine whether BMI subgroups were independent predictors of operative risk after adjusting for other preoperative factors. RESULTS: Compared with normal or mildly obese patients (BMI, 18.5 to 34.9), moderate and severely obese patients were younger and more likely to be diabetic and hypertensive. After adjusting for these and other known preoperative risk factors, moderate obesity slightly elevated patients' operative risk (adjusted odds ratio, 1.21; confidence interval, 1.13 to 1.29). In contrast, extremely obese patients had marked higher risk for operative mortality (adjusted odds ratio, 1.58; confidence interval, 1.45 to 1.73). Major perioperative complications, particularly deep sternal wound infection, renal failure, and prolonged postoperative hospital stay also increased for extremely obese patients. CONCLUSIONS: Extreme obesity (body mass index > or = 40) is a significant independent predictor for adverse outcomes and prolonged hospitalization after coronary artery bypass operation.

Procedural volume as a marker of quality for CABG surgery.

CONTEXT: There have been recent calls for using hospital procedural volume as a quality indicator for coronary artery bypass graft (CABG) surgery, but further research into analysis and policy implication is needed before hospital procedural volume is accepted as a standard quality metric. OBJECTIVE: To examine the contemporary association between hospital CABG procedure volume and outcome in a large national clinical database. DESIGN, SETTING, AND PARTICIPANTS: Observational analysis of 267 089 isolated CABG procedures performed at 439 US hospitals participating in the Society of Thoracic Surgeons National Cardiac Database between January 1, 2000, and December 31, 2001. MAIN OUTCOME MEASURE: Association between hospital CABG procedural volume and all-cause operative mortality (in-hospital or 30-day, whichever was longer). RESULTS: The median (interquartile range) annual hospital-isolated CABG volume was 253 (165-417) procedures, with 82% of centers performing fewer than 500 procedures per year. The overall operative mortality was 2.66%. After adjusting for patient risk and clustering effects, rates of operative mortality decreased with increasing hospital CABG volume (0.07% for every 100 additional CABG procedures; adjusted odds ratio [OR], 0.98; 95% confidence interval [CI], 0.96-0.99; P =.004). While the association between volume and outcome was statistically significant overall, this association was not observed in patients younger than 65 years or in those at low operative risk and was confounded by surgeon volume. The ability of hospital volume to discriminate those centers with significantly better or worse mortality was limited due to the wide variability in risk-adjusted mortality among hospitals with similar volume. Closure of up to 100 of the lowest-volume centers (ie, those performing < or =150 CABG procedures/year) was estimated to avert fewer than 50 of 7110 (<1% of total) CABG-related deaths. CONCLUSION: In contemporary practice, hospital procedural volume is only modestly associated with CABG outcomes and therefore may not be an adequate quality metric for CABG surgery.

Postcrisis redevelopment of sustainable healthcare systems.

OBJECTIVE: Research and field experience have identified a global gap in postdisaster rebuilding of healthcare systems due to the current primary focus on returning devastated community infrastructures to predisaster conditions. Disasters, natural or man-made, present an opportunity for communities to rebuild, restructure, and redefine their predisaster states, creating more resilient and sustainable healthcare systems. DESIGN: A model for sustainable postdisaster healthcare rebuilding was developed by bridging identified gaps in the literature on the processes of developing healthcare systems postdisaster and utilizing evidence from the literature on postdisaster community reconstruction. RESULTS: The proposed model-the Sustainable Healthcare Redevelopment Model-is designed to guide communities through the process of recovery, and identifies four stages for rebuilding healthcare systems: (1) response, (2) recovery, (3) redevelopment, and (4) sustainable development. Implementing sustainable healthcare redevelopment involves a bottom-up approach, where community stakeholders have the ability to influence policy decisions. Relationships within internal government agencies and with public-private partnerships are necessary for successful recovery. CONCLUSION: The Sustainable Healthcare Redevelopment Model can serve as a guideline for delivery of healthcare services following disaster or conflict and use of crisis as a window of opportunity to improve the healthcare delivery system and incorporate resilience into the healthcare infrastructure.

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.

Graduate medical education leadership development curriculum for program directors.

OBJECTIVE: Program director (PD) orientation to roles and responsibilities takes on many forms and processes. This article describes one institution's innovative arm of faculty development directed specifically toward PDs and associate PDs to provide institutional resources and information for those in graduate medical education leadership roles. METHODS: The designated institutional official created a separate faculty development curriculum for leadership development of PDs and associate PDs, modeled on the Association of American Medical Colleges-GRA (Group on Resident Affairs) graduate medical education leadership development course for designated institutional officials. It consists of monthly 90-minute sessions at the end of a working day, for new and experienced PDs alike, with mentoring provided by experienced PDs. We describe 2 iterations of the curriculum. To provide ongoing support a longitudinal curriculum of special topics has followed in the interval between core curriculum offerings. RESULTS: Communication between PDs across disciplines has improved. The broad, inclusive nature allowed for experienced PDs to take advantage of the learning opportunity while providing exchange and mentorship through sharing of lessons learned. The participants rated the course highly and education process and outcome measures for the programs have been positive, including increased accreditation cycle lengths. CONCLUSION: It is important and valuable to provide PDs and associate PDs with administrative leadership development and resources, separate from general faculty development, to meet their role-specific needs for orientation and development and to better equip them to meet graduate medical education leadership challenges. This endeavor provides a foundational platform for designated institutional official and PD interactions to work on program building and improvement.

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.

Successful linking of the Society of Thoracic Surgeons adult cardiac surgery database to Centers for Medicare and Medicaid Services Medicare data.

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) Medicare database complements The Society of Thoracic Surgeons (STS) database by providing information about long-term outcomes and cost. This study demonstrates the feasibility of linking STS data to CMS data and examines the penetration, completeness, and representativeness of the STS database. METHODS: Using variables common to both STS and CMS databases, STS operations were linked to CMS data for all CMS coronary artery bypass graft surgery (CABG) hospitalizations discharged between 2000 and 2007, 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% to 78%. In 2007, 854 of 1,101 CMS CABG sites (78%) 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% to 84%. In 2007, 94,409 of 111,967 CMS CABG hospitalizations (84%) were 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% to 97%. In 2007, 88,857 of 91,363 CMS CABG hospitalizations at STS sites (97%) were linked to an STS record. CONCLUSIONS: The successful linking of STS and CMS databases demonstrates high and increasing penetration and completeness of the STS database. Linking STS and CMS data will facilitate studying long-term outcomes of cardiothoracic surgery.