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In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes.The purpose of this study was to determine the outcomes of TAVR in patients with ESRD.Among the first 72,631 patients with severe aortic stenosis (AS) treated with TAVR enrolled in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT (Transcatheter Valve Therapies) registry, 3,053 (4.2%) patients had ESRD and were compared with patients who were not on dialysis for demographics, risk factors, and outcomes.Compared with the nondialysis patients, ESRD patients were younger (76 years vs. 83 years; p 0.01) and had higher rates of comorbidities leading to a higher STS predicted risk of mortality (median 13.5% vs. 6.2%; p 0.01). ESRD patients had a higher in-hospital mortality (5.1% vs. 3.4%; p 0.01), although the observed to expected ratio was lower (0.32 vs. 0.44; p 0.01). ESRD patients also had a similar rate of major vascular complications (4.5% vs. 4.6%; p = 0.86), but a higher rate of major bleeding (1.4% vs. 1.0%; p = 0.03). The 1-year mortality was significantly higher in dialysis patients (36.8% vs. 18.7%; p 0.01).Patients undergoing TAVR with ESRD are at higher risk and had higher in-hospital mortality and bleeding, but similar vascular complications, when compared with those who are not dialysis dependent. The 1-year survival raises concerns regarding diminished benefit in this population. TAVR should be used judiciously after full discussion of the risk-benefit ratio in patients on dialysis.

Background Stroke is a serious complication after transcatheter aortic valve replacement (TAVR), yet predictive models are not available. A new risk model for in-hospital stroke after TAVR was developed and used to estimate site-specific performance. Methods We included 97,600 TAVR procedures from 521 sites in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from July 2014 to June 2017. Association between baseline covariates and in-hospital stroke was estimated by logistic regression. Discrimination was evaluated by C-statistic. Calibration was tested internally via cross-validation. Hierarchical modeling was used to estimate risk-adjusted site-specific performance. Results Median age was 82 years, 44,926 (46.0%) were women, and 1,839 (1.9%) had in-hospital stroke. Covariates associated with stroke (odds ratio) included transapical access (1.44), access excluding transapical and transfemoral (1.77), prior stroke (1.57), prior transient ischemic attack (1.50), preprocedural shock, inotropes or mechanical assist device (1.48), smoking (1.28), porcelain aorta (1.23), peripheral arterial disease (1.21), age per 5 years (1.11), glomerular filtration rate per 5 mL/min (0.97), body surface area per m2 (0.55 male; 0.43 female), and prior aortic valve (0.78) and nonaortic valvular (0.42) procedures. The C-statistic was 0.622. Calibration curves demonstrated agreement between observed and expected stroke rates. Hierarchical modeling showed 10 (1.9%) centers with significantly higher odds ratios for in-hospital stroke than their peers. Conclusions A risk model for in-hospital stroke after TAVR was developed from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and used to estimate site-specific stroke performance. This model can serve as a valuable resource for quality improvement, clinical decision making, and patient counseling.

Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis. Methods: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid). Results were stratified by older and current (Sapien 3 and Evolut R) generation valve prostheses. Medicare administrative claims were used to evaluate mortality and stroke to 1 year among eligible individuals (≥65 years). Results: After exclusions, there were 170 959 eligible procedures at 593 sites during the specified interval. Of these, 5412 TAVR procedures (3.2%) were performed in patients with bicuspid AV, including 3705 with current-generation devices. In comparison with patients with tricuspid valves, patients with bicuspid AV were younger and had a lower Society of Thoracic Surgeons Predicted Risk of Operative Mortality score. When current-generation devices were used to treat patients with bicuspid AV, device success increased (93.5 versus 96.3; P =0.001) and the incidence of 2+ aortic insufficiency declined (14.0% versus 2.7%; P P =0.07), with a slightly higher incidence of residual moderate or severe aortic insufficiency among patients with bicuspid AV (2.7% versus 2.1%; P Conclusions: Using current-generation devices, procedural, postprocedural, and 1-year outcomes were comparable following TAVR for bicuspid AV versus tricuspid AV disease. With newer-generation devices, TAVR is a viable treatment option for patients with bicuspid AV disease.

Background The Society of Thoracic Surgeons (STS) uses statistical models to create risk-adjusted performance metrics for Adult Cardiac Surgery Database (ACSD) participants. Because of temporal changes in patient characteristics and outcomes, evolution of surgical practice, and additional risk factors available in recent ACSD versions, completely new risk models have been developed. Methods Using July 2011 to June 2014 ACSD data, risk models were developed for operative mortality, stroke, renal failure, prolonged ventilation, mediastinitis/deep sternal wound infection, reoperation, major morbidity or mortality composite, prolonged postoperative length of stay, and short postoperative length of stay among patients who underwent isolated coronary artery bypass grafting surgery (n = 439,092), aortic or mitral valve surgery (n = 150,150), or combined valve plus coronary artery bypass grafting surgery (n = 81,588). Separate models were developed for each procedure and endpoint except mediastinitis/deep sternal wound infection, which was analyzed in a combined model because of its infrequency. A surgeon panel selected predictors by assessing model performance and clinical face validity of full and progressively more parsimonious models. The ACSD data (July 2014 to December 2016) were used to assess model calibration and to compare discrimination with previous STS risk models. Results Calibration in the validation sample was excellent for all models except mediastinitis/deep sternal wound infection, which slightly underestimated risk and will be recalibrated in feedback reports. The c-indices of new models exceeded those of the last published STS models for all populations and endpoints except stroke in valve patients. Conclusions New STS ACSD risk models have generally excellent calibration and discrimination and are well suited for risk adjustment of STS performance metrics.

The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. It contains data pertaining to more than 435,000 total operations. The most recent biannual feedback report to participants (Spring 2017, Report of the Twenty-Sixth Harvest) included analysis of data submitted from 127 hospitals in North America. That represents nearly all centers performing pediatric and congenital heart operations in the United States and Canada. As an unparalleled platform for assessment of outcomes and for quality improvement activities in the subspecialty of surgery for pediatric and congenital heart disease, the STS CHSD continues to be a primary data source for clinical investigations and for research and innovations related to quality measurement. In 2016, several major original publications reported analyses of data in the CHSD pertaining to various processes of care, including assessment of variation across centers and associations between specific practices, patient characteristics, and outcomes. Additional publications reported the most recent development, evaluation, and application of metrics for quality measurement and reporting of pediatric and congenital heart operation outcomes and center level performance. Use of the STS CHSD for outcomes research and for quality measurement continues to expand as database participation has grown to include nearly all centers in North America, and the available wealth of data in the database continues to grow. This article reviews outcomes research and quality improvement articles published in 2016 that are based on STS CHSD data.

Established in 1989, The Society of Thoracic Surgeons Adult Cardiac Surgery Database is one of the most comprehensive clinical data registries in health care. It is widely regarded as the gold standard for benchmarking risk-adjusted outcomes in cardiac surgery and is the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This is the second in a series of annual reports that summarizes current aggregate national outcomes in cardiac surgery and reviews database-related activities in the areas of quality measurement and performance improvement during the past year.

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 General Thoracic Surgery Database has grown to more than 500,000 case records. Clinical research supported by the database is increasingly used to advance patient outcomes. This research review from the General Thoracic Surgery Database in 2014 and 2015 discusses 6 recent publications and an ongoing study on longitudinal outcomes in lung cancer surgery from The Society of Thoracic Surgeons Task Force for Linked Registries and Longitudinal Follow-up. A lack of database variables specific for certain uncommon procedures limits the ability to study these operations; inclusion of clinical descriptors for selected infrequent but clinically important thoracic disorders is suggested.

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.

The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. With more than 400,000 total operations from nearly all centers performing pediatric and congenital heart operations in North America, the STS CHSD is an unparalleled platform for clinical investigation, outcomes research, and quality improvement activities in this subspecialty. In 2015, several major original publications reported analyses of data in the CHSD pertaining to specific diagnostic and procedural groups, age-defined cohorts, or the entire population of patients in the database. Additional publications reported the most recent development, evaluation, and application of metrics for quality measurement and reporting of pediatric and congenital heart operation outcomes. This use of the STS CHSD for outcomes research and for quality measurement continues to expand as database participation and the available wealth of data in it continue to grow. This article reviews outcomes research and quality improvement articles published in 2015 based on STS CHSD data.

Background Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG). Methods The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014. FTR was defined as death after four complications: stroke, renal failure, reoperation, and prolonged ventilation. FTR was determined for each complication and a composite of the four complications. A statistical model to predict FTR was developed. Results FTR rates were 22.3% for renal failure, 16.4% for stroke, 12.4% for reoperation, 12.1% for prolonged ventilation, and 10.5% for the composite. Mortality increased with multiple complications and with specific combinations of complications. The multivariate risk model for prediction of FTR demonstrated a C index of 0.792 and was well calibrated, with a 1.0% average difference between observed/expected (O/E) FTR rates. With centers grouped into mortality terciles, complication rates increased modestly (11.4% to 15.7%), but FTR rates more than doubled (6.8% to 13.9%) from the lowest to highest terciles. Centers in the lowest complication rate tercile had an FTR O/E of 1.14, whereas centers in the highest complication rate tercile had an FTR O/E of 0.91. Conclusions CABG mortality rates vary directly with FTR, but complication rates have little relation to death. FTR rates derived from The Society of Thoracic Surgeons data can serve as national benchmarks. Predicted FTR rates may facilitate patient counseling, and FTR O/E ratios have promise as valuable quality metrics.

Background In older adults undergoing cardiac surgery, prediction of downstream risk is critical. Our objective was to determine the association of 5‐m gait speed with 1‐year mortality and repeat hospitalization following cardiac surgery. Methods and Results In this prospective cohort of patients undergoing cardiac surgery at centers participating in the Society of Thoracic Surgeons Database with gait speed recorded, we examined all‐cause mortality using a landmark analysis at 0 to 30, 30 to 365, and >365 days, as well as repeat hospitalization. The cohort consisted of 8287 patients (median age, 74 years; 32% females). At 1 year, survival was 90% in the slow (1.00 m/s) gait speed tertiles, and risk of hospitalization was 45%, 33%, and 27%, respectively (both P Conclusions Gait speed is a simple tool to screen for frailty and identify older adults at risk for adverse events in the early and midterm postoperative periods.

Patients undergoing post infarction ventricular septal defect repair are at high risk for early morbidity and mortality, but little is known about subsequent clinical events. This study uses short-term clinical data from The Society of Thoracic Surgeons National Database linked with Medicare data to examine longer term outcomes in these patients.This was a retrospective review of The Society of Thoracic Surgeons National Database to link with Medicare data all adults (≥65 years) who underwent ventricular septal defect repair after a myocardial infarction between 2008 and 2012. The primary outcome was 1-year mortality. Risk factors for 1-year survival were modeled using a multivariable Cox regression.Five hundred thirty-seven patients were identified using The Society of Thoracic Surgeons database and Medicare linkage. Median age was 74 years, and 277 patients (52%) were men. One hundred ninety-two patients (36%) were supported preoperatively with an intraaortic balloon pump. Surgical status was emergent or salvage in 138 (26%), and 158 patients (29%) died within 30 days and 207 (39%) within 1 year. Among patients who survived to hospital discharge, 44% were discharged to a facility and 172 (32%) experienced at least 1 all-cause readmission within 1 year. Unadjusted 1-year mortality rates were 13% for elective patients and 69% for emergency status (P.01). On multivariable analysis emergency/salvage status, older age, and concomitant coronary artery bypass grafting were independently associated with worse 1-year survival.These data suggest the greatest mortality risk in this patient population occurs in the first 30 days. Emergency or salvage status strongly predicts 1-year mortality. Optimizing physiologic derangements before operative repair may be considered when possible in this subgroup of patients.

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.

The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty.Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients.Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test).Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups.A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers.

Background— Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear. Methods and Results— We evaluated procedural outcomes in 11 697 blacks and 136 362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients’ clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use). Relative to whites, blacks undergoing coronary artery bypass surgery were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of internal mammary artery was marginally lower in blacks than in whites (93.3% versus 92.2%, P P P Conclusions— The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors, as well, as suggested by the reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.

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.

PURPOSE OF REVIEW Cost-effectiveness has become an increasingly important tool in assessing the value of healthcare. The principles of cost-effectiveness and the need to standardize the methodology are discussed. Documented variation could be used to adjust reimbursement. RECENT FINDINGS The US healthcare system continues to be under financial pressure. Although national health expenditures have slowed, growth rates continue to outpace gross domestic product. Spending in the coming years is expected to grow 7% annually. Treatment of cardiac disease, and in particular ischemic heart disease, is a significant portion of healthcare spending. A strategy to improve clinical and financial outcomes for revascularization procedures is essential. Recently, the SYNTAX trial and ASCERT have addressed cost-effectiveness as an outcome measure in revascularization for coronary artery disease. SUMMARY Cost-effectiveness is becoming an important part of healthcare provider performance and patient outcomes. Difficulties in obtaining cost, resource use, and quality of life data are not insurmountable as recently documented in randomized and observational trials. Reimbursement has already been linked to costs and resource use in current regulation. As the payment systems move toward disease management, cost-effectiveness will be the measure of choice. The prevalence of cardiac disease in the US population will mandate its use in adjusting payments to these providers.

To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program.This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures.The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014).Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range:0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period.STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.

Background Risk-adjusted mortality (RAM) models are increasingly used to evaluate hospital performance, but the validity of the RAM method has been questioned. Providers are concerned that these methods might not adequately account for the highest levels of risk and that treating high-risk cases will have a negative impact on RAM rankings. Methods Using cases of isolated coronary artery bypass grafting (CABG) performed at 1002 sites in the United States participating in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database from 2008 to 2010 (N = 494,955), the STS CABG RAM model performance in high-risk patients was assessed. The ratios of observed to expected (O/E) perioperative mortality were compared among groups of hospitals with varying expected risks. Finally, RAM rates during the overall study period for each site were compared with its performance in a simulated "nightmare year" in which the site's highest risk cases over a 3-year period were concentrated into a 1-year period of exceptional risk. Results The average predicted mortality for center risk groups ranged from 1.46% for the lowest risk quintile to 2.87% for the highest. The O/E ratios for center risk quintiles 1 to 5 during the overall period were 1.01 (95% confidence interval, 0.96% to 1.06%), 1.00 (0.95% to 1.04%), 0.98 (0.94% to 1.03%), 0.97 (0.93% to 1.01%), and 0.80 (0.77% to 0.84%), respectively. The sites' risk-adjusted mortality rates were not increased when the centers' highest risk cases were concentrated into a single "nightmare year." Conclusions Our results show that the current risk-adjusted models accurately estimate CABG mortality and that hospitals accepting more high-risk CABG patients have equal or better outcomes than do those with predominately lower-risk patients.

The current system for postmarket surveillance of medical devices in the United States is limited. To help change this paradigm for transcatheter valve therapies (TVTs), starting with transcatheter aortic valve replacement, the Society of Thoracic Surgeons and the American College of Cardiology partnered to form the TVT Registry program in close collaboration with the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services. The goal of the TVT Registry is to measure and improve quality of care and patient outcomes in clinical practice and to have a pivotal role in the scientific evidence and surveillance for medical devices. Challenges were faced in the early experience of the registry included developing multistakeholder partnerships, data collection requirements, and the use of the registry for pre- and post-market device evaluations. In addressing these challenges, the TVT Registry demonstrates that it is feasible for professional societies to assume a pivotal role in pre- and/or post-market studies, leveraging a clinical registry infrastructure. Sharing the TVT Registry experience may help other professional societies and stakeholders better anticipate and plan for these challenges.

Containing more than 6 million cumulative operative records and accounting for 90% to 95% of adult cardiac surgery performed in the United States, The Society of Thoracic Surgeons Adult Cardiac Surgery Database is an invaluable resource for performance assessment, quality improvement, and clinical research. This article reviews the seven major research efforts published in 2016 that utilized the Adult Cardiac Surgery Database. Two studies evaluated national trends in clinical practice, three assessed the effect of several risk factors on postoperative morbidity and mortality, and two developed new models to evaluate quality of care. The findings of these studies have enhanced clinical practice and delineated areas for future quality improvement research.

Background— Reducing readmissions is a major healthcare reform goal, and reimbursement penalties are imposed for higher-than-expected readmission rates. Most readmission risk models and performance measures are based on administrative rather than clinical data. Methods and Results— We examined rates and predictors of 30-day all-cause readmission following coronary artery bypass grafting surgery by using nationally representative clinical data (2008–2010) from the Society of Thoracic Surgeons National Database linked to Medicare claims records. Among 265 434 eligible Medicare records, 226 960 (86%) were successfully linked to Society of Thoracic Surgeons records; 162 572 (61%) isolated coronary artery bypass grafting admissions constituted the study cohort. Logistic regression was used to identify readmission risk factors; hierarchical regression models were then estimated. Risk-standardized readmission rates ranged from 12.6% to 23.6% (median, 16.8%) among 846 US hospitals with ≥30 eligible cases and ≥90% of eligible Centers for Medicare and Medicaid Services records linked to the Society of Thoracic Surgeons database. Readmission predictors (odds ratios [95% confidence interval]) included dialysis (2.02 [1.87–2.19]), severe chronic lung disease (1.58 [1.49–1.68]), creatinine (2.5 versus 1.0 or lower:1.49 [1.41–1.57]; 2.0 versus 1.0 or lower: 1.37 [1.32–1.43]), insulin-dependent diabetes mellitus (1.45 [1.39–1.51]), obesity in women (body surface area 2.2 versus 1.8: 1.44 [1.35–1.53]), female sex (1.38 [1.33–1.43]), immunosuppression (1.38 [1.28–1.49]), preoperative atrial fibrillation (1.36 [1.30–1.42]), age per 10-year increase (1.36 [1.33–1.39]), recent myocardial infarction (1.24 [1.08–1.42]), and low body surface area in men (1.22 [1.14–1.30]). C-statistic was 0.648. Fifty-two hospitals (6.1%) had readmission rates statistically better or worse than expected. Conclusions— A coronary artery bypass grafting surgery readmission measure suitable for public reporting was developed by using the national Society of Thoracic Surgeons clinical data linked to Medicare readmission claims.

he initial stimulus for developing The Society of TThoracic Surgeons (STS) National Database came in 1986 when the Health Care Financing Administration (HCFA) publicly reported hospital mortality using minimally adjusted, non-clinical data. Because of the lack of adequate risk adjustment and questions regarding the accuracy of diagnoses and procedures, cardiothoracic surgeons became very concerned that such data could be misleading. The STS Standards and Ethics Committee released a “Statement of Concern” in 1986, followed by the Society appointing an Ad Hoc Committee on Risk Factors for Coronary Bypass Surgery, which issued a report in 1988 stating

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.

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.

The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for MedicaidMedicare Services.This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%.The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for MedicaidMedicare Services.This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.The 54,782 patients with transcatheter aortic valve replacement demonstrated decreases in expected risk of 30-day operative mortality (STS Predicted Risk of Mortality [PROM]) of 7% to 6% and transcatheter aortic valve replacement PROM (TVT PROM) of 4% to 3% (both p 0.0001) from 2012 to 2015. Observed in-hospital mortality decreased from 5.7% to 2.9%, and 1-year mortality decreased from 25.8% to 21.6%. However, 30-day post-procedure pacemaker insertion increased from 8.8% in 2013 to 12.0% in 2015. The 2,556 patients who underwent transcatheter mitral leaflet clip in 2015 were similar to patients from 2013 to 2014, with hospital mortality of 2% and with mitral regurgitation reduced to grade ≤2 in 87% of patients (p 0.0001). The 349 patients who underwent mitral valve-in-valve and mitral valve-in-ring procedures were high risk, with an STS PROM for mitral valve replacement of 11%. The observed hospital mortality was 7.2%, and 30-day post-procedure mortality was 8.5%.The TVT Registry is an innovative registry that that monitors quality, patient safety and trends for these rapidly evolving new technologies.

Importance Patient selection for transcatheter aortic valve replacement (TAVR) should include assessment of the risks of TAVR compared with surgical aortic valve replacement (SAVR). Existing SAVR risk models accurately predict the risks for the population undergoing SAVR, but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR. Objective To use a national population of patients undergoing TAVR to develop a statistical model that will predict in-hospital mortality after TAVR. Design, Setting, and Participants Patient data were obtained from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy (STS/ACC TVT) Registry. The model was developed from 13 718 consecutive US patients undergoing TAVR in centers participating in the STS/ACC TVT Registry from November 1, 2011, to February 28, 2014. Validation was conducted using 6868 records of consecutive patients undergoing TAVR from March 1 to October 8, 2014. Covariates were selected through a process of expert opinion and statistical analysis. The association between in-hospital mortality and baseline covariates was estimated using logistic regression. The final set of predictors was selected via stepwise variable selection. Data were collected and analyzed from November 1, 2011, to February 28, 2014. Main Outcomes and Measures In-hospital TAVR mortality. Results The development sample included 13 718 patient records from 265 participant sites (of 13 672 with data available, 6680 men [48.9%]; 6992 women [51.1%]; mean [SD] age, 82.1 [8.3] years). The final validation cohort included 6868 patients from 314 participating centers (3554 men [51.7%]; 3314 women [48.3%]; mean [SD] age, 81.6 [8.8] years). In-hospital mortality occurred in 730 patients (5.3%). The C statistic for discrimination was 0.67 (95% CI, 0.65-0.69) in the development group and 0.66 (95% CI, 0.62-0.69) in the validation group. The final model covariates (reported as odds ratios; 95% CIs) were age (1.13; 1.06-1.20), glomerular filtration rate per 5-U increments (0.93; 0.91-0.95), hemodialysis (3.25; 2.42-4.37), New York Heart Association functional class IV (1.25; 1.03-1.52), severe chronic lung disease (1.67; 1.35-2.05), nonfemoral access site (1.96; 1.65- 2.33), and procedural acuity categories 2 (1.57; 1.20-2.05), 3 (2.70; 2.05-3.55), and 4 (3.34; 1.59-7.02). Calibration analysis demonstrated no significant difference between the model (predicted vs observed) calibration line (−0.18 and 0.97 for intercept and slope, respectively) compared with the ideal calibration line. Conclusions and Relevance Data from the STS/ACC TVT Registry have been used to develop a predictive model of in-hospital mortality for patients undergoing TAVR. Validation based on a population of patient records not used in model development demonstrates discrimination and calibration indices that are more favorable than other models used in populations with TAVR. This model should be a valuable adjunct for patient counseling, local quality improvement, and national monitoring for appropriateness of selection of patients for TAVR.

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.

Although results in valvular heart surgery may be improving, too few cases are available in most centers to quantify changes, especially for uncommon procedural categories. This study examined comprehensively national trends in valve surgery outcomes over the past 15 years.From 1993 through 2007, 623,039 valve procedures were grouped into single aortic (A), mitral (M), and tricuspid (T) operations, along with AM, MT, AT, and AMT multiple valves ± coronary artery bypass graft surgery. Pulmonary valve surgery was excluded. Trends in baseline characteristics were documented, and logistic regression adjusted for differences in patient profiles. Outcomes were expressed as unadjusted operative mortality, adjusted odds ratios for mortality, and a composite of mortality and major complications.Single valves comprised 89% of valve surgery and multiple valves, 11%. Preoperative patient risk profiles worsened over time. Mortality rates were higher for multiple valves, but all mortality rates fell significantly over the 15 years (p0.001). The composite of mortality and major morbidity did not improve, however, largely because of increasing pulmonary/infectious complications. Overall, cardiac etiology accounted for 54% of deaths, and pulmonary/infectious etiologies for 16%. Cardiac etiology of death fell by 16% over time, but pulmonary death and complications increased by 78% and 39%, respectively.Preoperative patient profiles for cardiac valve procedures have worsened over time. Risk-adjusted mortalities have fallen for all valve surgery, but remain higher for multiple valves. The finding of increasing pulmonary deaths and complications suggests that prevention and improved management of pulmonary and infectious complications could be an important focus for quality improvement.

Objective Analysis of congenital heart surgery results requires a reliable method of estimating the risk of adverse outcomes. Two major systems in current use are based on projections of risk or complexity that were predominantly subjectively derived. Our goal was to create an objective, empirically based index that can be used to identify the statistically estimated risk of in-hospital mortality by procedure and to group procedures into risk categories. Methods Mortality risk was estimated for 148 types of operative procedures using data from 77,294 operations entered into the European Association for Cardiothoracic Surgery (EACTS) Congenital Heart Surgery Database (33,360 operations) and the Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database (43,934 patients) between 2002 and 2007. Procedure-specific mortality rate estimates were calculated using a Bayesian model that adjusted for small denominators. Each procedure was assigned a numeric score (the STS–EACTS Congenital Heart Surgery Mortality Score [2009]) ranging from 0.1 to 5.0 based on the estimated mortality rate. Procedures were also sorted by increasing risk and grouped into 5 categories (the STS–EACTS Congenital Heart Surgery Mortality Categories [2009]) that were chosen to be optimal with respect to minimizing within-category variation and maximizing between-category variation. Model performance was subsequently assessed in an independent validation sample (n = 27,700) and compared with 2 existing methods: Risk Adjustment for Congenital Heart Surgery (RACHS-1) categories and Aristotle Basis Complexity scores. Results Estimated mortality rates ranged across procedure types from 0.3% (atrial septal defect repair with patch) to 29.8% (truncus plus interrupted aortic arch repair). The proposed STS–EACTS score and STS–EACTS categories demonstrated good discrimination for predicting mortality in the validation sample (C-index = 0.784 and 0.773, respectively). For procedures with more than 40 occurrences, the Pearson correlation coefficient between a procedure's STS–EACTS score and its actual mortality rate in the validation sample was 0.80. In the subset of procedures for which RACHS-1 and Aristotle Basic Complexity scores are defined, discrimination was highest for the STS–EACTS score (C-index = 0.787), followed by STS–EACTS categories (C-index = 0.778), RACHS-1 categories (C-index = 0.745), and Aristotle Basic Complexity scores (C-index = 0.687). When patient covariates were added to each model, the C-index improved: STS–EACTS score (C-index = 0.816), STS–EACTS categories (C-index = 0.812), RACHS-1 categories (C-index = 0.802), and Aristotle Basic Complexity scores (C-index = 0.795). Conclusion The proposed risk scores and categories have a high degree of discrimination for predicting mortality and represent an improvement over existing consensus-based methods. Risk models incorporating these measures may be used to compare mortality outcomes across institutions with differing case mixes.

When designed in 2000, the Aristotle Complexity Score was entirely based on subjective probability. This approach, based on the opinion of experts, was considered a good solution due to the limited amount of data available. In 2008, the next generation of the complexity score will be based on observed data available from over 100,000 congenital cardiac operations currently gathered in the congenital cardiac surgery databases of the Society of Thoracic Surgeons and the European Association for Cardio-Thoracic Surgery.A mortality score is created based on 70,000 surgeries harvested in the congenital databases of The Society of Thoracic Surgeons and The European Association for Cardio-Thoracic Surgery. It is derived from 118 congenital cardiovascular operations, representing 91% of the operations and including 97% of the patients. This Mortality Index of the new Aristotle Complexity Score could further be stratified into 5 levels with minimal within-group variation and maximal between-group variation, and may contribute to the planned unification of the Aristotle Complexity Score with the Risk Adjustment for Congenital Heart Surgery system.Similarly, a score quantifying morbidity risk is created. Due to the progress of congenital cardiac surgery, the mortality is today reduced to an average of 4%. No instrument currently exists to measure the quality of care delivered to the survivors representing 96% of the patients. An objective assessment of morbidity was needed. The Morbidity Index, based on 50,000 operations gathered in the congenital databases of The Society of Thoracic Surgeons and The European Association for Cardio-Thoracic Surgery, is derived from 117 congenital cardiovascular operations representing 90% of the operations and including 95% of the patients. This morbidity indicator is calculated on an algorithm based on length of stay in the hospital and time on the ventilator.The mortality and morbidity indicators will be part of the next generation of the complexity score, which will be named the Aristotle Average Complexity Score. It will be based on the sum of mortality, morbidity, and subjective technical difficulty. The introduction of objective data in assessment of mortality and morbidity in congenital cardiac surgery is a significant step forward, which should allow a better evaluation of the complexity of the operations performed by a given centre or surgeon.

The latest phase of the Accreditation Council for Graduate Medical Education (ACGME) Outcome Project challenges graduate medical education (GME) programs to select meaningful clinical quality indicators by which to measure trainee performance and progress, as well as to assess and improve educational effectiveness of programs. The authors describe efforts to measure educational quality, incorporating measurable patient-care outcomes to guide improvement. University of Florida College of Medicine-Jacksonville education leaders developed a tiered framework for selecting clinical indicators whose outcomes would illustrate integration of the ACGME competencies and their assessment with learning and clinical care. In order of preference, indicators selected should align with a specialty's (1) national benchmarked consensus standards, (2) national specialty society standards, (3) standards of local, institutional, or regional quality initiatives, or (4) top-priority diagnostic and/or therapeutic categories for the specialty, based on areas of high frequency, impact, or cost. All programs successfully applied the tiered process to clinical indicator selection and then identified data sources to track clinical outcomes. Using clinical outcomes in resident evaluation assesses the resident's performance as reflective of his or her participation in the health care delivery team. Programmatic improvements are driven by clinical outcomes that are shown to be below benchmark across the residents. Selecting appropriate clinical indicators-representative of quality of care and of graduate medical education-is the first step toward tracking educational outcomes using clinical data as the basis for evaluation and improvement. This effort is an important aspect of orienting trainees to using data for monitoring and improving care processes and outcomes throughout their careers.

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.

The Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry has been a joint initiative of the STS and the ACC in concert with multiple stakeholders. The TVT Registry has important information regarding patient selection, delivery of care, science, education, and research in the field of structural valvular heart disease.This report provides an overview on current U.S. TVT practice and trends. The emphasis is on demographics, in-hospital procedural characteristics, and outcomes of patients having transcatheter aortic valve replacement (TAVR) performed at 348 U.S. centers.The TVT Registry captured 26,414 TAVR procedures as of December 31, 2014. Temporal trends between 2012 and 2013 versus 2014 were compared.Comparison of the 2 time periods reveals that TAVR patients remain elderly (mean age 82 years), with multiple comorbidities, reflected by a high mean STS predicted risk of mortality (STS PROM) for surgical valve replacement (8.34%), were highly symptomatic (New York Heart Association functional class III/IV in 82.5%), frail (slow 5-m walk test in 81.6%), and have poor self-reported health status (median baseline Kansas City Cardiomyopathy Questionnaire score of 39.1). Procedure performance is changing, with an increased use of moderate sedation (from 1.6% to 5.1%) and increase in femoral access using percutaneous techniques (66.8% in 2014). Vascular complication rates are decreasing (from 5.6% to 4.2%), whereas site-reported stroke rates remain stable at 2.2%.The TVT Registry provides important information on characteristics and outcomes of TAVR in contemporary U.S. clinical practice. It can be used to identify trends in practice and opportunities for quality improvement.

Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials.To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States.Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for MedicareMedicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014.Transcatheter aortic valve replacement.One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling.The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71).Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.

Heart valve diseases are increasingly prevalent, especially in people older than age seventy. Many of these elderly people have other comorbid conditions, making them poor candidates for surgical treatment of heart valve diseases. Since 2011 such patients have been eligible to receive new nonsurgical heart valve treatments approved by the Food and Drug Administration (FDA) and covered by Medicare. This article examines the Transcatheter Valve Therapy Registry, which captures clinical information on all US patients undergoing new nonsurgical heart valve treatments. The registry has patient-level data from more than 27,000 patients treated with the novel devices. Patient- and procedure-related data are gathered from hospitals, patient-reported outcomes are assessed pre- and postprocedure, and longer-term data on mortality and repeat hospitalization are provided by linking the registry's data to Medicare patient data. The registry is a model of collaboration among professional societies, the FDA, the Centers for Medicare and Medicaid Services, hospitals, patients, and the medical device industry. It has been used to support Medicare coverage decisions, expand device indications, provide comprehensive device surveillance, and establish national quality benchmarks. Beyond having it serve as a collaborative model, future goals for the registry include shortening the FDA-approval timeline for devices, providing data for decision-making tools for patients, and public reporting of hospital performance.

ObjectiveIn some respects, outcome reporting in valvular surgery has been hampered by focusing on specific populations, reluctance to publish high-risk subgroups, and possibly skewed or inadequate samples. The goal of this study was to evaluate risk factors for operative mortality comprehensively across the entire spectrum of cardiac valvular procedures over the past decade.MethodsAll 409,904 valve procedures in the Society of Thoracic Surgeons database performed between 1994 and 2003 were assessed, and Society of Thoracic Surgeons preoperative and operative variables were related to operative mortality by using a multivariable logistic regression model. Data were greater than 95% complete, and the relative importance of relevant risk factors was determined by ranking odds ratios. The analysis had a high predictive power, with a C statistic of 0.735.ResultsIn the model, 19 variables independently influenced operative mortality (all P < .01). The most significant was nonelective (acute) presentation (odds ratios, 2.11), followed by advanced age (odds ratios, 1.88), reoperation (odds ratios, 1.61), endocarditis (odds ratios, 1.59), and coronary disease (odds ratios, 1.58). Generally, valve replacement was associated with higher mortality than repair (odds ratios, 1.52). Overall, female gender was very important (odds ratios, 1.37), and earlier year of operation increased risk (odds ratios, 1.34), implying improving outcomes over time. Although any single comorbidity, on average, was only moderately contributory (odds ratios, 1.19), specific comorbidities, such as renal failure, or multiple comorbidities in a given patient could be very significant. Aortic root reconstruction carried the highest risk (odds ratios, 2.78), followed by tricuspid valve surgery (odds ratios, 2.26), multiple valve procedures (odds ratios, 2.06), and then isolated mitral (odds ratios, 1.47), pulmonic (odds ratios, 1.29), and aortic (reference procedure) operations. Reduced ejection fraction and severity of valve lesion were relatively less important (odds ratios, 1.34 and 0.83, respectively).ConclusionsThese data illustrate the significance of acute presentation in determining operative risk, and earlier surgical intervention under elective conditions might be emphasized for all types of significant valve lesions. Because aortic root reconstruction doubles mortality compared with simple aortic valve procedures, root replacement should be reserved for specific root pathology. Finally, issues related to reoperation, endocarditis, valve repair, gender, and the various procedures deserve more detailed examination.

Division of Cardiothoracic Surgery, University of Florida, Jacksonville, Florida; Division of Cardiac Surgery Research, Baystate Medical Center, Springfield, Massachussetts; School of Public Health and Community Medicine, Department of Epidemiology, University of Washington, Seattle Washington; Department of Surgery, Caritas St. Elizabeth’s Medical Center, Boston, Massachussetts; Department of Surgery, University of Pennsylvania Health System, Philadelphia, Pennsylvania

For sole therapy transmyocardial laser revascularization (TMR), unstable angina has been demonstrated to be a significant independent predictor of operative mortality. The objective of this study was to investigate the preoperative risk profile of patients undergoing TMR plus coronary artery bypass graft surgery (CABG) and to determine the impact of unstable angina on outcomes.Using The Society of Thoracic Surgeons National Cardiac Database from 1998 to 2003, 5,618 patients underwent TMR plus CABG. These patients were compared with 932,715 patients who underwent CABG only operations.The TMR plus CABG patients had a significantly higher incidence of diabetes (50% versus 34%), renal failure (7% versus 5%), peripheral vascular disease (20% versus 16%), reoperative surgery (26% versus 9%), three-vessel coronary artery disease (80% versus 71%), hyperlipidemia (73% versus 62%; p0.001 for all comparisons). The incidence of preoperative unstable angina was similar (46% versus 47%). The unadjusted perioperative mortality was 3.8% for TMR plus CABG patients. When unstable angina patients were removed, the observed mortality for TMR plus CABG was decreased to 2.7%.It is likely that patients who undergo TMR plus CABG have a higher prevalence of diffuse coronary disease based on their preoperative demographics. Despite the increased risk associated with such anatomy, the mortality rate was not significantly increased when TMR was added to CABG in an effort to provide a more complete revascularization. As was noted from the outcomes of sole therapy TMR, in unstable angina patients, TMR plus CABG carries a higher risk, but this risk is not significantly different from that of such patients treated with CABG alone.

niversity of Kentucky Chandler Medical Center, Lexington, Kentucky; Loyola University Medical Center, Maywood, Illinois; niversity of Florida, Jacksonville, Florida; Harefield Hospital, London, United Kingdom; Lahey Clinic, Burlington, Massachusetts; Duke niversity Medical Center, Raleigh, North Carolina; University of Pennsylvania Health System, Philadelphia, Pennsylvania; and ashington University Medical Center, St. Louis, Missouri

American College of C Surgeons Representa tative; xThe Society f tative; kSociety of {Society for Cardiov Society of America R Surgery Representati tative; zzAmerican He Advocate, Patient R Representative. Author Recusals: Writi from voting on sectio entities may apply; se This document was app (ACCF) Board of Tru Council, Society for C of Directors, Society 2012 and endorsed b (AHA) Science Adv Echocardiography (A (EACTS), Heart Fail Cardiovascular Anest phy (SCCT), and the January 2012. For the the ACCF Board of T ument, is available at: Officers-and-Trustees industry to the docum vote on approval. David R. Holmes, Jr, MD, FACC, Chair,* Michael J. Mack, MD, FACC, Vice Chair,y Sanjay Kaul, MBBS, FACC, Vice Chair,* Arvind Agnihotri, MD,z Karen P. Alexander, MD, FACC,* Steven R. Bailey,MD, FACC, FSCAI,x John H. Calhoon,MD,z Blase A. Carabello, MD, FACC,* Milind Y. Desai, MBBS, FACC,k,{ Fred H. Edwards, MD, FACC,y Gary S. Francis, MD, FACC, Timothy J. Gardner, MD, FACC,y A. Pieter Kappetein, MD, PhD,** Jane A. Linderbaum, MS, CNP, AACC,* Chirojit Mukherjee, MD,yyDebabrataMukherjee, MD, FACC,* CatherineM. Otto, MD, FACC,* Carlos E. Ruiz, MD, PhD, FACC, FSCAI,x Ralph L. Sacco, MD, MS, FAHA,zz Donnette Smith,xx and James D. Thomas, MD, FACCkk

Background American College of Cardiology/American Heart Association (ACC/AHA) Guidelines state that patients with an ejection fraction (EF) of 30% or less should not undergo mitral valve replacement for mitral regurgitation (MR). We sought to establish, using a national cardiac surgery database, whether patients with left ventricular dysfunction may safely undergo mitral valve surgery for MR, and if so, which ones. Methods We queried the Society of Thoracic Surgeons (STS) National Database to identify patients who had isolated mitral valve replacement or repair for MR between 1998 and 2001. Mortality and morbidity outcomes were compared by EF category (≤ 30% vs > 30%), and observed mortality compared by EF group, stratified by predicted risk for mortality. A classification and regression tree (CART) model was then used to determine which patient characteristics contributed most to designate the high-risk patient. Results Of the 14,582 patients who had mitral valve surgery, 727 had an EF of 30% or less and 13,855 had an EF of more than 30%. Observed mortality rates were higher for patients with an EF of 30% or less (5.4% vs 3.1%). However, for low-risk to medium-risk patients, mortality rates remained fairly constant across levels of EF. Mortality is notably increased in the high-risk patients (predicted risk > 10%). A classification tree identifies three key characteristics for high risk: age more than 75 years, renal failure, and emergent or salvage procedure. Conclusions When the predicted mortality risk is less than 10%, EF has minimal impact on operative mortality for mitral regurgitation. In contrast to the ACC/AHA Guidelines, our data show that operative risk for mitral valve surgery is not prohibitive for most patients with ventricular dysfunction.

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.

Background. Although 30day risk-adjusted operative mortality (ROM) has been used for quality assessment, it is not sufficient to describe the outcomes after coronary artery bypass grafting (CABG) surgery. Risk-adjusted major morbidity may differentially impact quality of care (as complications occur more frequently than death) and enhance a surgical team’s ability to assess their quality. This study identified the preoperative risk factors associated with several complications and a composite outcome (the presence of any major morbidity or 30-day operative mortality or both). Methods. For CABG procedures, the 1997 to 1999 Society of Thoracic Surgeons (STS) National Adult Cardiac Surgery Database was used to develop ROM and riskadjusted morbidity (ROMB) models. Risk factors were selected using standard STS univariate screening and multivariate logistic regression approaches. Risk model performance was assessed. Across STS participating sites, the association of observed-to-expected (O/E) ratios for ROM and ROMB was evaluated. Results. The 30-day operative death and major complication rates for STS CABG procedures were 3.05% and 13.40%, respectively (503,478 CABG procedures), including stroke (1.63%), renal failure (3.53%), reoperation (5.17%), prolonged ventilation (5.96%), and sternal infection (0.63%). Risk models were developed (c-indexes for stroke [0.72], renal failure [0.76], reoperation [0.64], prolonged ventilation [0.75], sternal infection [0.66], and the composite endpoint [0.71]). Only a slight correlation was found, however, between ROMB and ROM indicators. Conclusions. Used in combination, ROMB and ROM may provide the surgical team with additional information to evaluate the quality of their care as well as valuable insights to allow them to focus on areas for improvement.

When transcatheter aortic valve replacement (TAVR) cannot be carried out through transfemoral access, alternative access TAVR is indicated. The purpose of this study was to explore inhospital and 1-year outcomes of patients undergoing alternative access TAVR through the transapical (TA) or transaortic (TAo) techniques in the United States.Clinical records of 4,953 patients undergoing TA (n = 4,085) or TAo (n = 868) TAVR from 2011 to 2014 in The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy Registry were linked to Centers for Medicare and Medicaid Services hospital claims. Inhospital and 1-year clinical outcomes were stratified by operative risk; and the risk-adjusted association between access route and mortality, stroke, and heart failure repeat hospitalization was explored.Mean age for all patients was 82.8 ± 6.8 years. The median STS predicted risk of mortality was significantly higher among patients undergoing TAo (8.8 versus 7.4, p0.001). When compared with TA, TAo was associated with an increased risk of unadjusted 30-day mortality (10.3% versus 8.8%) and 1-year mortality (30.3% versus 25.6%, p = 0.006). There were no significant differences between TAo and TA for inhospital stroke rate (2.2%), major vascular complications (0.3%), and 1-year heart failure rehospitalizations (15.7%). Examination of high-risk and inoperable subgroups showed that 1-year mortality was significantly higher for TAo patients classified as inoperable (p = 0.012).Patients undergoing TAo TAVR are older, more likely female, and have significantly higher STS predicted risk of mortality scores than patients operated on by TA access. There were no risk-adjusted differences between TA and TAo access in mortality, stroke, or readmission rates as long as 1 year after TAVR.

Although increasing age has been associated with greater risk of mortality for patients undergoing mitral valve replacement, it is less clear whether this elevated risk is related to age-related differences in comorbidity or other clinical characteristics.A population of 31,688 patients from The Society of Thoracic Surgeons National Cardiac Database undergoing mitral valve replacement either alone or in combination with coronary artery bypass grafting or tricuspid surgical procedures from 1997 to 2000 was examined to assess age-related variation in clinical features, morbidity, and mortality. Multivariable logistic regression was used to determine the effect of age after adjusting for other known risk factors. A classification tree was used to identify low-risk elderly (or = 75 years) patients.Operative mortality increased four-fold from 4.1% in patients aged less than 50 years up to 17.0% in patients aged 80 years or more. Similarly, major operative complications (stroke, prolonged ventilation, reoperation for bleeding, renal failure, and sternal infection) also increased with age, rising from 13.5% (age50 years) to 35.5% (ageor = 80 years). Multivariable adjustment attenuated the odds of operative mortality, but age remained a significant risk factor. After adjusting for other patient risk factors, age accounted for 13% and 10% of the explainable risk for mortality and morbidity, respectively. Among the elderly, four variables (hemodynamic instability, New York Heart Association class IV, renal failure, and concomitant coronary artery bypass grafting) were identified to distinguish levels of risk, from operative mortality rates exceeding 31% to those with 7.7% mortality.Operative mortality and morbidity rise with increasing age of patients undergoing mitral valve replacement. Although this excess risk is partially a result of increased comorbid burden and other operative factors, age remains an independent powerful risk factor for operative risk for mitral valve replacement. Understanding the relationship of age with other risk factors for mitral valve replacement can help stratify risk, enabling physicians to identify lower risk patients.

Background . There is growing interest in comparing resource, as well as patient outcome metrics among coronary artery bypass graft surgery (CABG) providers, yet few tools exist for adjusting these provider comparisons for patient case-mix. In this study, we aimed to define the magnitude of hospital variability in postoperative length of stay (PLOS) in contemporary practice and to determine the degree to which this variability was accounted for by differences in patient case-mix. We also sought to determine the relationship between hospitals' risk-adjusted PLOS and mortality outcomes. Methods . We analyzed 496,797 isolated CABG procedures performed between January 1997 to January 2001 at 587 US hospitals participating in the Society of Thoracic Surgeon's National Cardiac Database. Logistic and linear regression were used to identify independent preoperative factors affecting a patient's likelihood for early discharge (PLOS ≤5 day), prolonged stay (>14 days), and overall PLOS. Hierarchical models were used to determine the degree to which hospital factors influenced PLOS beyond patient factors. Results . Overall, 53% of CABG patients were discharged within 5 days of CABG, whereas 5% required prolonged (>14 days) stays. More than 25 preoperative patient factors were independently associated with a patients' likelihood for early discharge and prolonged stay (model C index 0.70 and 0.75, respectively). After adjusting for patient factors, however, there remained wide unexplained variability among hospitals in PLOS and limited correlation between these PLOS metrics and hospitals' risk-adjusted mortality results (Spearman correlation coefficient −0.15 and 0.35). Conclusions . Our study provides a method for institutions to receive meaningful risk-adjusted bypass PLOS information. Given the marked variability among hospitals in CABG PLOS, institutions should consider benchmarking metrics of efficiency, as well as patient outcomes.

Background The empirically derived 2014 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model incorporates adjustment for procedure type and patient-specific factors. The purpose of this report is to describe this model and its application in the assessment of variation in outcomes across centers. Methods All index cardiac operations in The Society of Thoracic Surgeons Congenital Heart Surgery Database (January 1, 2010, to December 31, 2013) were eligible for inclusion. Isolated patent ductus arteriosus closures in patients weighing less than or equal to 2.5 kg were excluded, as were centers with more than 10% missing data and patients with missing data for key variables. The model includes the following covariates: primary procedure, age, any prior cardiovascular operation, any noncardiac abnormality, any chromosomal abnormality or syndrome, important preoperative factors (mechanical circulatory support, shock persisting at time of operation, mechanical ventilation, renal failure requiring dialysis or renal dysfunction (or both), and neurological deficit), any other preoperative factor, prematurity (neonates and infants), and weight (neonates and infants). Variation across centers was assessed. Centers for which the 95% confidence interval for the observed-to-expected mortality ratio does not include unity are identified as lower-performing or higher-performing programs with respect to operative mortality. Results Included were 52,224 operations from 86 centers. Overall discharge mortality was 3.7% (1,931 of 52,224). Discharge mortality by age category was neonates, 10.1% (1,129 of 11,144); infants, 3.0% (564 of 18,554), children, 0.9% (167 of 18,407), and adults, 1.7% (71 of 4,119). For all patients, 12 of 86 centers (14%) were lower-performing programs, 67 (78%) were not outliers, and 7 (8%) were higher-performing programs. Conclusions The 2014 Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model facilitates description of outcomes (mortality) adjusted for procedural and for patient-level factors. Identification of low-performing and high-performing programs may be useful in facilitating quality improvement efforts.