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The Society of Thoracic Surgeons (STS) Congenital Heart Surgery Database was queried to document variation of patient characteristics, procedure types, and programmatic case-mix.All index cardiac operations in patients less than 18 years of age in the STS Congenital Heart Surgery Database (July 2016 to June 2020) were eligible for inclusion except patients weighing ≤2.5 kg undergoing isolated patent ductus arteriosus closure. At the hospital level, we describe variations in patient and procedural characteristics known from previous analyses to be associated with outcomes. We also report variations across hospitals of programmatic case-mix.Data were analyzed from 117 sites (90 322 total operations, 87 296 total index cardiac operations eligible for STAT [STS-European Association for Cardio-Thoracic Surgery] 2020 Mortality Score). The median annual total index cardiac operations eligible for STAT 2020 Mortality Score per hospital was 157 (interquartile range [IQR], 94-276). Wide variability was documented in total annual index cardiac operations eligible for STAT 2020 Mortality Score per hospital (ratio 90th/10th percentile = 9.01), operations in neonates weighing2.5 kg (ratio 90th/10th percentile = 4.09), operations in patients with noncardiac anatomic abnormalities (ratio 90th/10th percentile = 3.46), and operations in patients with preoperative mechanical ventilation (ratio 90th/10th percentile = 3.97). At the hospital level, the median percentage of all index cardiac operations in STAT 2020 Mortality Category 5 was 3.7% (IQR, 1.7%-4.9%), the median percentage of all index cardiac operations in STAT 2020 Mortality Category 4 or 5 was 24.4% (IQR, 19.0%-28.4%), the median hospital-specific mean STAT Mortality Category was 2.39 (IQR, 2.20-2.47), and the median hospital-specific mean STAT Mortality Score was 0.86 (IQR, 0.73-0.91).Substantial variation of patient characteristics, procedure types, and case-mix exists across pediatric and congenital cardiac surgical programs. Knowledge about programmatic case-mix augments data about indirectly standardized programmatic observed-to-expected (O/E) mortality. Indirectly standardized O/E ratios do not provide a complete description of a given pediatric and congenital cardiac surgical program. The indirectly standardized programmatic O/E ratios associated with a given program apply only to its specific case-mix of patients and may represent a quite different case-mix than that of another program.

For the more than 40,000 children in the United States undergoing congenital heart surgery annually, the relationship between hospital quality and costs remains unclear. Prior studies report conflicting results and clinical outcomes have continued to improve over time. We examined a large contemporary cohort, aiming to better inform ongoing initiatives seeking to optimize health care value in this population.Clinical information (The Society of Thoracic Surgeons Congenital Database) was merged with standardized cost data (Pediatric Health Information Systems) for children undergoing heart surgery from 2010 to 2015. In-hospital cost variability was analyzed using Bayesian hierarchical models adjusted for case-mix. Quality metrics examined included in-hospital mortality, postoperative complications, postoperative length of stay (PLOS), and a composite.Overall, 32 hospitals (n = 45,315 patients) were included. Median adjusted cost per case varied across hospitals from $67,700 to $51,200 in the high vs low cost tertile (ratio 1.32; 95% credible interval, 1.29 to 1.35), and all quality metrics also varied across hospitals. Across cost tertiles, there were no significant differences in the quality metrics examined, with the exception of PLOS. The PLOS findings were driven by high-risk The Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery categories 4 and 5 cases (adjusted median length of stay 16.8 vs 14.9 days in high vs low cost tertile [ratio 1.13, 1.05 to 1.24]), and intensive care unit PLOS.Contemporary congenital heart surgery costs vary across hospitals but were not associated with most quality metrics examined, highlighting that performance in one area does not necessarily convey to others. Cost variability was associated with PLOS, particularly related to intensive care unit PLOS and high-risk cases. Care processes influencing PLOS may provide targets for value-based initiatives in this population.

Background The Society of Thoracic Surgeons (STS) Quality Measurement Task Force has developed risk models and composite performance measures for isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR), isolated mitral valve replacement or repair (MVRR), AVR+CABG, and MVRR+CABG. To further enhance its portfolio of risk-adjusted performance metrics, STS has developed new risk models for multiple valve operations ± CABG procedures. Methods Using July 2011 to June 2019 STS Adult Cardiac Surgery Database data, risk models for AVR+MVRR (n = 31,968) and AVR+MVRR+CABG (n = 12,650) were developed with the following endpoints: Operative Mortality, major morbidity (any 1 or more of the following: cardiac reoperation, deep sternal wound infection/mediastinitis, stroke, prolonged ventilation, and renal failure), and combined mortality and/or major morbidity. Data were divided into development (July 2011 to June 2017; n = 35,109) and validation (July 2017 to June 2019; n = 9509) samples. Predictors were selected by assessing model performance and clinical face validity of full and progressively more parsimonious models. Performance of the resulting models was evaluated by assessing discrimination and calibration. Results C-statistics for the overall population of multiple valve ± CABG procedures were 0.7086, 0.6734, and 0.6840 for mortality, morbidity, and combined mortality and/or morbidity in the development sample, and 0.6953, 0.6561, and 0.6634 for the same outcomes, respectively, in the validation sample. Conclusions New STS Adult Cardiac Surgery Database risk models have been developed for multiple valve ± CABG operations, and these models will be used in subsequent STS performance metrics.

Machine learning algorithms are increasingly used in the clinical literature, claiming advantages over logistic regression. However, they are generally designed to maximize the area under the receiver operating characteristic curve. While area under the receiver operating characteristic curve and other measures of accuracy are commonly reported for evaluating binary prediction problems, these metrics can be misleading. We aim to give clinical and machine learning researchers a realistic medical example of the dangers of relying on a single measure of discriminatory performance to evaluate binary prediction questions. Prediction of medical complications after surgery is a frequent but challenging task because many post-surgery outcomes are rare. We predicted post-surgery mortality among patients in a clinical registry who received at least one aortic valve replacement. Estimation incorporated multiple evaluation metrics and algorithms typically regarded as performing well with rare outcomes, as well as an ensemble and a new extension of the lasso for multiple unordered treatments. Results demonstrated high accuracy for all algorithms with moderate measures of cross-validated area under the receiver operating characteristic curve. False positive rates were [Formula: see text]1%, however, true positive rates were [Formula: see text]7%, even when paired with a 100% positive predictive value, and graphical representations of calibration were poor. Similar results were seen in simulations, with the addition of high area under the receiver operating characteristic curve ([Formula: see text]90%) accompanying low true positive rates. Clinical studies should not primarily report only area under the receiver operating characteristic curve or accuracy.

ImportanceProfessional societies and the Centers for Medicare & Medicaid Services suggest volume thresholds to ensure quality in transcatheter aortic valve implantation (TAVI).ObjectiveTo model the association of volume thresholds vs spoke-and-hub implementation of outcome thresholds with TAVI outcomes and geographic access.Design, Setting, and ParticipantsThis cohort study included patients who enrolled in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy registry. Site volume and outcomes were determined from a baseline cohort of adults undergoing TAVI between July 1, 2017, and June 30, 2020.ExposuresWithin each hospital referral region, TAVI sites were categorized by volume (Main Outcomes and MeasuresThe primary outcome was the absolute difference in events between the adjusted observed and modeled 30-day composite of death, stroke, major bleeding, stage III acute kidney injury, and paravalvular leak. Data are presented as the number of events reduced under the above scenarios with 95% bayesian credible intervals (CrIs) and median (IQR) driving distance.ResultsThe overall cohort included 166 248 patients with a mean (SD) age of 79.5 (8.6) years; 74 699 (47.3%) were female and 6657 (4.2%) were Black; 158 025 (95%) were treated in higher-volume sites (≥50 TAVIs) and 75 088 (45%) were treated in best-outcome sites. Modeling a volume threshold, there was no significant reduction in estimated adverse events (−34; 95% CrI, −75 to 8), while the median (IQR) driving time from the existing site to the alternate site was 22 (15-66) minutes. Transitioning care to the best outcome site in a hospital referral region resulted in an estimated 1261 fewer adverse outcomes (95% CrI, 1013-1500), while the median (IQR) driving time from the original site to the best site was 23 (15-41) minutes. Directionally similar findings were observed for Black individuals, Hispanic individuals, and individuals from rural areas.Conclusions and RelevanceIn this study, compared with the current system of care, a modeled outcome-based spoke-and-hub paradigm of TAVI care improved national outcomes to a greater extent than a simulated volume threshold, at the cost of increased driving time. To improve quality while maintaining geographic access, efforts should focus on reducing site variation in outcomes.

Patient tracers and leadership WalkRounds proactively identify quality and safety issues. However, these programs have been inconsistent in application, results, and sustainability. The goal was to identify a more consistent and efficient approach to survey health care facilities. The authors developed a Peer-to-Peer Interdisciplinary Patient Tracer program to assess compliance with National Patient Safety Goals and to proactively identify areas of inpatient, ambulatory, and procedural risk. The program has been operational for more than 5 years, with continued expansion annually. In all, 96% of frontline leadership reported satisfaction; 100% reported that they would recommend the program to others (Kirkpatrick level 1 results). Mean absolute change in performance scores from 2014 to 2018 was 15%. All survey findings triggered the development of an improvement project. This novel integrated program advanced institutional improvement by strengthening internal peer-to-peer surveillance, engaging leadership, and creating an accountability structure for internal improvement efforts.

We assessed volume-outcome relationships of resternotomy coronary artery bypass grafting (CABG).We studied 1,362,218 first-time CABG and 93,985 resternotomy CABG patients reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2010 and 2019. Primary outcomes were in-hospital mortality and mortality and morbidity (MM) rates calculated per hospital and per surgeon. Outcomes were compared across 6 total cardiac surgery volume categories. Multivariable generalized linear mixed-effects models were used considering continuous case volume as the main exposure, adjusting for patient characteristics and within-surgeon and hospital variation.We observed a decline in resternotomy CABG unadjusted mortality and MM from the lowest to the highest case-volume categories (hospital-level mortality, 3.9% ± 0.6% to 3.3% ± 0.1%; MM, 18.5% ± 1.1% to 15.7% ± 0.4%, P .001; surgeon-level mortality, 4.1% ± 0.3% to 4.1% ± 1.3%; MM, 18.5% ± 0.6% to 14.5% ± 2.2%, P.001). Looking at outcomes vs continuous volume showed that beyond a minimum annual volume (hospital 200-300 cases; surgeon 100-150 cases, approximately), mortality and MM rates did not further improve. Using individual-level data and adjusting for patient characteristics and clustering within surgeon and hospital, we found higher procedural volume was associated with improved surgeon-level outcomes (mortality adjusted odds ratio, 0.39/100 procedures; 95% CI, 0.24-0.61; MM adjusted odds ratio, 0.37/100 procedures; 95% CI, 0.28-0.48; P.001 for both). Hospital-level adjusted volume-outcomes associations were not statistically significant.We observed an inverse relationship between total cardiac case volume and resternotomy CABG outcomes at the surgeon level only, indicating that individual surgeon's experience, rather than institutional volume, is the key determinant.

Background: Optimal strategies to improve national congenital heart surgery outcomes and reduce variability across hospitals remain unclear. Many policy and quality improvement efforts have focused primarily on higher-risk patients and mortality alone. Improving our understanding of both morbidity and mortality and current variation across the spectrum of complexity would better inform future efforts. Methods: Hospitals participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2014–2017) were included. Case mix–adjusted operative mortality, major complications, and postoperative length of stay were evaluated using Bayesian models. Hospital variation was quantified by the interdecile ratio (IDR, upper versus lower 10%) and 95% credible intervals (CrIs). Stratified analyses were performed by risk group (Society of Thoracic Surgeons–European Association for Cardiothoracic Surgery [STAT] category) and simulations evaluated the potential impact of reductions in variation. Results: A total of 102 hospitals (n=84 407) were included, representing ≈85% of US congenital heart programs. STAT category 1 to 3 (lower risk) operations comprised 74% of cases. All outcomes varied significantly across hospitals: adjusted mortality by 3-fold (upper versus lower decile 5.0% versus 1.6%, IDR 3.1 [95% CrI 2.5–3.7]), mean length of stay by 1.8-fold (19.2 versus 10.5 days, IDR 1.8 [95% CrI 1.8–1.9]), and major complications by >3-fold (23.5% versus 7.0%, IDR 3.4 [95% CrI 3.0–3.8]). The degree of variation was similar or greater for low- versus high-risk cases across outcomes, eg, ≈3-fold mortality variation across hospitals for STAT 1 to 3 (IDR 3.0 [95% CrI 2.1–4.2]) and STAT 4 or 5 (IDR 3.1 [95% CrI 2.4–3.9]) cases. High-volume hospitals had less variability across outcomes and risk categories. Simulations suggested potential reductions in deaths (n=282), major complications (n=1539), and length of stay (101 183 days) over the 4-year study period if all hospitals were to perform at the current median or better, with 37% to 60% of the improvement related to the STAT 1 to 3 (lower risk) group across outcomes. Conclusions: We demonstrate significant hospital variation in morbidity and mortality after congenital heart surgery. Contrary to traditional thinking, a substantial portion of potential improvements that could be realized on a national scale were related to variability among lower-risk cases. These findings suggest modifications to our current approaches to optimize care and outcomes in this population are needed.

Supplemental digital content is available in the text., Background Twenty-five years after the seminal work of the Harvard Medical Practice Study, the numbers and specific types of health care measures of harm have evolved and expanded. Using the World Café method to derive expert consensus, we sought to generate a contemporary list of triggers and adverse event measures that could be used for chart review to determine the current incidence of inpatient and outpatient adverse events. Methods We held a modified World Café event in March 2018, during which content experts were divided into 10 tables by clinical domain. After a focused discussion of a prepopulated list of literature-based triggers and measures relevant to that domain, they were asked to rate each measure on clinical importance and suitability for chart review and electronic extraction (very low, low, medium, high, very high). Results Seventy-one experts from 9 diverse institutions attended (primary acceptance rate, 72%). Of 525 total triggers and measures, 67% of 391 measures and 46% of 134 triggers were deemed to have high or very high clinical importance. For those triggers and measures with high or very high clinical importance, 218 overall were deemed to be highly amenable to chart review and 198 overall were deemed to be suitable for electronic surveillance. Conclusions The World Café method effectively prioritized measures/triggers of high clinical importance including those that can be used in chart review, which is considered the gold standard. A future goal is to validate these measures using electronic surveillance mechanisms to decrease the need for chart review.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is the most mature and comprehensive database in cardiac surgery and one of the most respected clinical data registries in health care. It is widely acknowledged for accurately benchmarking risk-adjusted outcomes and serving as the foundation for quality measurement and improvement activities in cardiac surgery. In addition, the database is a valuable resource for novel research. The advent of the database's fourth decade in operation is being heralded with major revisions to its functionality, ease of use, and value to multiple stakeholders. This report is the fifth in a series of annual reports that provides updated national outcomes, volume trends, and database-related developments, as well as a summary of research performed in the past year using data from this valuable repository on quality and performance improvement.

Biykem Bozkurt, MD, FACC, FAHA, Chair Hani Jneid, MD, FACC, FAHA, Chair-Elect Srinath Adusumalli, MD, MSc, FACC Sana Al-Khatib, MD, MHS, FACC, FAHA[‖][1] H. Vernon Anderson, MD, FACC, FAHA[‖][1] Deepak L. Bhatt, MD, MPH, FACC, FAHA Bruce E. Bray, MD, FACC Grant Nigel Graham, MD, FACC

Background The Society of Thoracic Surgeons (STS) General Thoracic Surgery Database (GTSD) has developed composite quality measures for lobectomy and esophagectomy. This study sought to develop a composite measure including all resections for lung cancer. Methods The STS lung cancer composite score is based on 2 outcomes: risk-adjusted mortality and morbidity. GTSD data were included from January 2015 to December 2017. "Star ratings" were created for centers with 30 or more cases by using 95% Bayesian credible intervals. The Bayesian model was performed with and without inclusion of the minimally invasive approach to assess the impact of approach on the composite measure. Results The study population included 38,461 patients from 256 centers. Overall operative mortality was 1.3% (495 of 38,461). The major complication rate was 7.9% (3045 of 38,461). The median number of nodes examined was 10 (interquartile range, 5 to 16); the median number of nodal stations sampled was 4 (interquartile range, 3 to 5). Positive resection margins were identified in 3.7% (1420 of 38,461). A total of 214 centers with 30 or more cases were assigned star ratings. There were 7 1-star, 194 2-star, and 13 3-star programs; 70.6% of resections were performed through a minimally invasive approach. Inclusion of minimally invasive approach, which was adjusted for in previous models, altered the star ratings for 3% (6 of 214) of the programs. Conclusions Participants in the STS GTSD perform lung cancer resection with low morbidity and mortality. Lymph node data suggest that participants are meeting contemporary staging standards. There is wide variability among participants in application of minimally invasive approaches. The study found that risk adjustment for approach altered ratings in 3% of participants.

In this issue of BMJ Quality & Safety , Yamamoto and colleagues1 describe an innovative national quality improvement intervention to identify and remediate low-performing Japanese cardiac surgery programmes. This is the most recent of numerous quality initiatives by Japanese cardiothoracic surgical leaders,2–11 and they deserve recognition for their ambitious and ongoing efforts. In 2000, emulating the Society of Thoracic Surgeons Database,12 they developed the Japan Cardiovascular Surgery Database (JCVSD), the foundation for all their subsequent quality activities. Because their board certification requires JCVSD participation,4 this assures that every board-certified cardiac surgeon, and presumably every CT programme, has access to rigorous, nationally benchmarked results. With their newest quality programme, these results are used to target low-performing centres. What can we learn from their experience, and where might there be additional improvement opportunities? Selection criteria for the Japanese site visit initiative are based on JCVSD outcomes data and include high-mortality outlier status for isolated coronary artery bypass grafting (CABG), heart valve or thoracic aortic surgical procedures, as well as hospital volumes and the number of procedures for which a hospital is an outlier. During the study period, 10 hospitals (about 1.7% of all Japanese programmes) were visited. We were not provided with the number of initial candidate hospitals that were high-mortality outliers for at least one procedure but were not visited. It is also not clear if selected hospitals were required to participate in the site visit intervention or whether this was voluntary. Previsit observed mortality rates for site visit hospitals were quite high compared with non-visited hospitals (9.0% vs 2.7% for CABG, 10.7% vs 4.0% for heart valve procedures and 20.7% vs 7.5% for thoracic aortic procedures). They also had, for each of the three procedures, about double the rate of postoperative kidney injury requiring dialysis, which …

OBJECTIVE: To assess the quantity and impact of research publications among US acute care hospitals; to identify hospital characteristics associated with publication volumes; and to estimate the independent association of bibliometric indicators with Hospital Compare quality measures. DATA SOURCES: Hospital Compare; American Hospital Association Survey; Magnet Recognition Program; Science Citation Index Expanded. STUDY DESIGN: In cross‐sectional studies using a 40% random sample of US Medicare‐participating hospitals, we estimated associations of hospital characteristics with publication volumes and associations of hospital‐linked bibliometric indicators with 19 Hospital Compare quality metrics. DATA COLLECTION/EXTRACTION METHODS: Using standardized search strategies, we identified all publications attributed to authors from these institutions from January 1, 2015 to December 31, 2016 and their subsequent citations through July 2020. PRINCIPAL FINDINGS: Only 647 of 1604 study hospitals (40.3%) had ≥1 publication. Council of Teaching Hospitals and Health Systems (COTH) hospitals had significantly more publications (average 599 vs. 11 for non‐COTH teaching and 0.6 for nonteaching hospitals), and their publications were cited more frequently (average 22.6/publication) than those from non‐COTH teaching (18.2 citations) or nonteaching hospitals (12.8 citations). In multivariable regression, teaching intensity, hospital beds, New England or Pacific region, and not‐for‐profit or government ownership were significant predictors of higher publication volumes; the percentage of Medicaid admissions was inversely associated. In multivariable linear regression, hospital publications were associated with significantly lower risk‐adjusted mortality rates for acute myocardial infarction (coefficient −0.52, p = 0.01), heart failure (coefficient −0.74, p = 0.004), pneumonia (coefficient −1.02, p = 0.001), chronic obstructive pulmonary disease (coefficient −0.48, p = 0.005), and coronary artery bypass surgery (coefficient −0.73, p

Public interest in stratifying hospital performance has led to the proliferation of commercial, consumer-oriented hospital rankings. In cardiac surgery, little is known about how these rankings correlate with clinical registry quality ratings.The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried for isolated coronary artery bypass grafting or coronary artery bypass grafting/valve patients at hospitals among the top 100 U.S. NewsWorld Report (USNWR) CardiologyHeart Surgery rankings from 2016 to 2020. Hospitals were grouped into deciles by risk-adjusted observed/expected (O/E) ratios for morbidity and mortality using the STS 2018 risk models. Agreement between STS Adult Cardiac Surgery Database and USNWR ranked deciles was calculated by Bowker symmetry test. The association between each center's annual change in STS O/E ratio and change in USNWR ranking was modeled in repeated measures regression analysis.Inclusion criteria were met by 524 393 patients from 149 hospitals that ranked in USNWR top 100 at least once during the study period. There was no agreement between USNWR ranking and STS major morbidity and mortality O/E ratio (P.50 for all years). Analysis of patients undergoing surgery at the 65 hospitals that were consistently ranked in the top 100 during the study period demonstrated no association between annual change in hospital ranking and change in O/E ratio (P all.3).There was no agreement between annual USNWR hospital ranking and corresponding risk-adjusted STS morbidity or mortality. Furthermore, annual changes in USNWR rankings could not be accounted for using clinical outcomes. These findings suggest that factors unrelated to key surgical outcomes may be driving consumer-directed rankings.

Background This study evaluated the role of supplementing Society of Thoracic Surgeons (STS) risk models for surgical aortic valve replacement with machine learning (ML). Methods and Results Adults undergoing isolated surgical aortic valve replacement in the STS National Database between 2007 and 2017 were included. ML models for operative mortality and major morbidity were previously developed using extreme gradient boosting. Concordance and discordance in predicted risk between ML and STS models were defined using equal‐size tertile‐based thresholds of risk. Calibration metrics and discriminatory capability were compared between concordant and discordant patients. A total of 243 142 patients were included. Nearly all calibration metrics were improved in cases of concordance. Similarly, concordance indices improved substantially in cases of concordance for all models with the exception of deep sternal wound infection. The greatest improvements in concordant versus discordant cases were in renal failure: ML model (concordance index, 0.660 [95% CI, 0.632–0.687] discordant versus 0.808 [95% CI, 0.794–0.822] concordant) and STS model (concordance index, 0.573 [95% CI, 0.549–0.576] discordant versus 0.797 [95% CI, 0.782–0.811] concordant) (each P Conclusions Supplementing ML models with existing STS models for surgical aortic valve replacement may have an important role in risk prediction and should be explored further. In particular, for the roughly 25% to 50% of patients demonstrating discordance in estimated risk between ML and STS, there appears to be a substantial decline in predictive performance suggesting vulnerability of the existing models in these patient subsets.

The National Cardiovascular Data Registry is a group of registries maintained by the American College of Cardiology Foundation. These registries are used by a diverse constituency to improve the quality and outcomes of cardiovascular care, to assess the safety and effectiveness of new therapies, and for research. To achieve these goals, registry data must be complete and reliable. In this article, we review the process of National Cardiovascular Data Registry data collection, assess data completeness and integrity, and report on the current state of the data. Registry data are complete. Accuracy is very good but variable, and there is room for improvement. Knowledge of the quality of data is essential to ensuring its appropriate use.

We sought to quantify the risk trend of resternotomy coronary artery bypass grafting (CABG) over the past 2 decades.We compared the outcomes of 194 804 consecutive resternotomy CABG patients and 1 445 894 randomly selected first-time CABG patients (50% of total) reported to The Society of Thoracic Surgeons Adult Cardiac Surgery Database between 1999 and 2018. Primary outcomes were in-hospital mortality and overall morbidity. Using multiple logistic regression for each outcome for each year, we computed the annual trends of risk-adjusted odds ratios for the primary outcomes in the entire cohort and in 194 776 propensity-matched pairs.The annual resternotomy CABG case volume from participating centers declined by 68%, from a median of 25 (range, 14-44) to a median of 8 (range, 4-15). Compared with first-time CABG, resternotomy CABG patients were consistently older, with higher proportions of comorbidities. After propensity matching, primary outcomes of resternotomy and first-time CABG were similar (mortality: 3.5% vs 2.3%, standardized difference [SDiff], 7.5%; morbidity: 40.7% vs 40.3%, SDiff, 0.9%). Mortality of resternotomy CABG performed after prior CABG was higher than that after prior non-CABG (4.3% vs 2.4%; SDiff, 10.8). Morbidity was similar between these subgroups (41.0% vs 39.1%; SDiff, 2.9). The adjusted odds ratio for mortality after resternotomy CABG declined from 1.93 (95% CI, 1.73-2.16) to 1.22 (95% CI, 0.92-1.62), and that of morbidity declined from 1.13 (95% CI, 1.08-1.18) to 0.91 (95% CI, 0.87-0.95), P.001 for both.The risk of resternotomy CABG has decreased substantially over time. Resternotomy CABG performed after a prior CABG is higher risk compared with that performed after a non-CABG operation.

The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) provides observed-to-expected (O/E) operative mortality ratios to more than 100 congenital heart centers in North America. We compared the current approach for estimating O/E ratios to approaches incorporating information on diagnosis as moderators of procedures, other unused risk factors, and additional variation in confidence interval construction to characterize center performance.Bayesian additive regression trees (BART) and lasso models linked operative mortality to diagnosis-procedure categories, procedure-specific risk factors, and syndromes/abnormalities. Bootstrapping accounted for variation in the STS-CHSD (STS bootstrap) and lasso CIs. We compared O/E estimates, interquartile range of CI widths, and concordance of center performance categorizations (worse-than-, as-, or better-than-expected mortality) of the new approaches to the STS-CHSD.In 110 surgical centers including 98,822 surgical operative encounters, there were 2818 (2.85%) operative mortalities (center range, 0.37%-10%). Compared with the STS-CHSD, BART- and lasso-estimated O/E ratios varied more and had narrower confidence intervals (interquartile range of confidence interval: STS-CHSD = 1.11, STS bootstrap = 0.98; lasso = 0.80; BART = 0.96). Concordance of performance categorization with the STS-CHSD ranged from 84% (lasso) to 91% (STS Bootstrap); more than 70% of discordant centers improved categories. Discordant centers had smaller volumes, fewer operative mortalities, and treated more patients with congenital lung abnormalities.Relative to the STS-CHSD, up to 16% of hospitals changed performance categories, most improving performance. Given the significance of quality reports for congenital heart centers, inclusion of additional risk factors and unaddressed variation should be considered.

Background The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model adjusts not only for procedure and age group pairings but also for additional patient factors, including the binary presence or absence of a chromosomal abnormality (CA), syndrome (S), and/or a noncardiac congenital anatomic abnormality (NCAA). This analysis refines case-mix adjustment by adding more granular adjustment for individual conditions (CA, S, and NCAA), consistent with a hypothesis that associated risk of mortality differs between individual conditions. Methods CA/S corresponding to the same condition were merged to a single condition code. Odds ratios were estimated for all CA/S. For CA/S associated with at least 10 deaths in neonates and infants and at least 10 deaths in children and adults, odds ratios were estimated for the effect of the CA/S separately in neonates/infants and in children/adults. In addition to these condition/age interactions, condition/age/procedure interactions were explored (eg, effect of Down syndrome was estimated based on age and procedure subgroups, including atrioventricular canal repair and single-ventricle palliation). Bayesian modeling was used to create 5 maximally homogeneous groups of CA/S from 81 candidate CA/S variables. A standard logistic regression model then incorporated indicator variables for the 5 categories of CAs/Ss, 7 unique NCAAs, and all other covariates in the previously published Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Model. Results Analysis included 107,062 operations in 100 centers (2010 to 2015). Operative Mortality was 3,629 (3.4%). In the development sample, the C statistics of the original nonaugmented model and the augmented model were 0.872 and 0.875, respectively. Conclusions The Society of Thoracic Surgeons Congenital Heart Surgery Database Mortality Risk Model has been augmented by addition of covariates representing individual CAs, Ss, and NCAAs.

This statement was commissioned as a Multisociety Expert Consensus Systems of Care Document by the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Society for Cardiovascular Angiography and Interventions (SCAI), and

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.

This multisocietal Expert Consensus Systems of Care document was commissioned by the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS). Expert

Background We describe the statistical methods and results related to development of the first congenital heart surgery composite quality measure. Methods The composite measure was developed using The Society of Thoracic Surgeons Congenital Heart Surgery Database (2012 to 2015), Bayesian hierarchical modeling, and the current Society of Thoracic Surgeons risk model for case-mix adjustment. It consists of a mortality domain (operative mortality) and morbidity domain (major complications and postoperative length of stay). We evaluated several potential weighting schemes and properties of the final composite measure, including reliability (signal-to-noise ratio) and hospital classification in various performance categories. Results Overall, 100 hospitals (78,425 operations) were included. Each adjusted metric included in the composite varied across hospitals: operative mortality (median, 3.1%; 10th to 90th percentile, 2.1% to 4.4%) major complications (median 11.7%, 10th to 90th percentile, 6.4% to 17.4%), and length of stay (median, 7.0 days; 10th to 90th percentile, 5.9 to 8.2 days). In the final composite weighting scheme selected, mortality had the greatest influence, followed by major complications and length of stay (correlation with overall composite score of 0.87, 0.69, and 0.47, respectively). Reliability of the composite measure was 0.73 compared with 0.59 for mortality alone. The distribution of hospitals across composite measure performance categories (defined by whether the 95% credible interval overlapped The Society of Thoracic Surgeons average) was 75% (same as expected), 9% (worse than expected), and 16% (better than expected). Conclusions This congenital heart surgery composite measure incorporates aspects of both morbidity and mortality, has clinical face validity, and greater ability to discriminate hospital performance compared with mortality alone. Ongoing efforts will support the use of the composite measure in benchmarking and quality improvement activities.

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is one of the most mature, comprehensive, and respected clinical data registries in health care. Through nearly three decades of growth and refinement, it is widely recognized for accurately benchmarking risk-adjusted outcomes in cardiac surgery and serves as the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This is the fourth in a series of annual reports that provides updated national outcomes, volume trends, and database-related developments in quality measurement and performance improvement.

The Society of Thoracic Surgeons (STS) National Database was established in 1989 as an initiative for quality improvement and patient safety among cardiothoracic surgeons. As of January 1, 2018, the STS National Database has four components, each focusing on a different area of cardiothoracic surgery-adult cardiac surgery, general thoracic surgery, and congenital heart surgery, as well as mechanical circulatory support through the STS Intermacs Database. In December 2015, The Annals of Thoracic Surgery began publishing a monthly series of scholarly articles on outcomes analysis, quality improvement, and patient safety. As part of that series, this article provides an annual summary of the status of the STS National Database as of October 2018 and provides a synopsis of related articles that appeared in The Annals of Thoracic Surgery 2018 series entitled: "Outcomes Analysis, Quality Improvement, and Patient Safety".

Background: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. Methods: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. Results: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. Conclusions: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.

The Society of Thoracic Surgeons (STS) original coronary artery bypass graft surgery (CABG) composite measure uses a 1-year analytic cohort and 98% credible intervals (CrI) to classify better than expected (3-star) performance or worse than expected (1-star) performance. As CABG volumes per STS participant (eg, hospital or practice group) have decreased, it has become more challenging to classify performance categories using this approach, especially for lower volume programs, and alternative approaches have been explored.Among 990 STS Adult Cardiac Surgery Database participants, performance classifications for the CABG composite were studied using various analytic cohorts: 1 year (current approach, 2017); 3 years (2015 to 2017); last 450 cases within 3 years; and most recent year (2017) plus additional cases to 450 total. We also compared 98% CrI with 95% CrI (used in other STS composite measures).Using 3 years of data and 95% CrIs, 113 of 990 participants (11.4%) were classified 1-star and 198 (20%) 3-star. Compared with 1-year analytic cohorts and 98% CrI, the absolute and relative increases in the proportion of 3-star participants were 14 percentage points and 233% (n = 198 [20%] vs n = 59 [6%]). Corresponding changes for 1-star participants were 6.5 percentage points and 133% (n = 113 [11.4%] vs n = 48 [4.9%]). These changes were particularly notable among lower volume (fewer than 199 CABG per year) participants. Measure reliability with the 3-year, 95% CrI modification is 0.78.Compared with current STS CABG composite methodology, a 3-year analytic cohort and 95% CrI increases the number and proportion of better or worse than expected outliers, especially among lower-volume Adult Cardiac Surgery Database participants. This revised methodology is also now consistent with other STS procedure composites.

In this issue of BMJ Quality and Safety , Jorro-Baron and colleagues1 report the findings of a stepped-wedge cluster randomised trial (SW-CRT) to evaluate the implementation of the I-PASS handover system among six paediatric intensive care units (PICUs) at five Argentinian hospitals between July 2018 and May 2019. According to the authors, prior to the intervention there were complaints that handovers were ‘…lengthy, disorganized, …participants experienced problems with interruptions, distractions, and … senior professionals had problems accepting dissent’. Adverse events were assessed by two independent reviewers using the Global Assessment of Pediatric Patient Safety instrument. Study results demonstrated significantly improved handover compliance in the intervention group, validating Kirkpatrick Level 3 (behavioural change)2 effectiveness of the training initiative. Notably, however, on the primary outcome there were no differences between control and intervention groups regarding preventable adverse events per 1000 days of hospitalisation (control 60.4 (37.5–97.4) vs intervention 60.4 (33.2–109.9), p=0.998, risk ratio: 1.0 (0.74–1.34)). Regarding balancing measures, there was no observed difference in the ‘full-shift’ handover duration (control 35.7 min (29.6–41.8); intervention 34.7 min (26.5–42.1), p=0.490), although more time was spent on individual patient handovers in the intervention period (7.29 min (5.77–8.81); control 5.96 min (4.69–7.23); p=0.001). From the provider perspective, preintervention and postintervention Agency for Healthcare Research and Quality (AHRQ) safety culture surveys did not show significant differences in their responses to communication-focused questions before and after the intervention. Thus, consistent with all previous studies, I-PASS was implemented successfully and handover quality improved. However, is the lack of association of I-PASS implementation with clinical outcomes and adverse events in this study a concern? To answer this question, it is necessary to review the origins of I-PASS more than a decade ago and its continually expanding evidence base. Handovers are among the most vulnerable reoccurring processes in healthcare. In …

The Society of Thoracic Surgeons Adult Cardiac Surgery Database is the most mature and comprehensive cardiac surgery database. It has been the foundation for quality measurement and improvement activities in cardiac surgery, facilitated the generation of accurate risk adjusted performance benchmarks and serves as a platform for novel research. Recent enhancements have added to the database's functionality, ease of use, and value to multiple stakeholders. This report is the sixth in a series of annual reports that provide updated volumes, outcomes, database-related developments, quality improvement initiatives, and research summaries using the Adult Cardiac Surgery Database in the past year.

The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear.From January 2013 to June 2018, 234 556 patients underwent isolated SAVR (n = 144 177) or SAVR with coronary artery bypass grafting (CABG) (n = 90 379) within the Society of Thoracic Surgeons Adult Cardiac Surgery Database. The association between annualized SAVR volume (group 1 [1-25 SAVRs], group 2 [26-50 SAVRs], group 3 [51-100 SAVRs], and group 4 [100 SAVRs]) and operative mortality and composite major morbidity or mortality was assessed. Random effects models were used to evaluate whether historical (2013-2015) SAVR volume or risk-adjusted outcomes explained future (2016-2018) risk-adjusted outcomes.The annualized median number of SAVRs per site was 35 (interquartile range, 22-59; isolated aortic valve replacement [AVR], 20; AVR with CABG, 13). Among isolated SAVR cases, the mean operative mortality and composite morbidity or mortality were 1.5% and 9.7%, respectively, at the highest-volume sites (group 4), with significantly higher rates among progressively lower-volume groups (P trend.001). After adjustment, lower-volume centers had increased odds of operative mortality (group 1 vs group 4 [reference]: adjusted odds ratio [AOR] for SAVR, 2.24 [95% CI, 1.91-2.64]; AOR for SAVR with CABG, 1.96 [95% CI, 1.67-2.30]) and major morbidity or mortality (AOR for SAVR, 1.53 [95% CI, 1.39-1.69]; AOR for SAVR with CABG, 1.46 [95% CI, 1.32-1.61]) compared with the highest-volume institutions. Substantial variation in outcomes was observed across hospitals within each volume category, and prior outcomes explained a greater proportion of hospital operative outcomes than did prior volume.Operative outcomes after SAVR with or without CABG is inversely associated with institutional procedure volumes; however, prior outcomes are more predictive of future outcomes than is prior volume. Given the excellent outcomes observed at many lower-volume hospitals, procedural outcomes may be preferable to procedural volumes as a quality metric.