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Background: Statistical risk models for durable left ventricular assist device (LVAD) implantation inform candidate selection, quality improvement, and evaluation of provider performance. This study developed a 90-day mortality risk model using The Society of Thoracic Surgeons National Intermacs Database (STS Intermacs)., Methods: STS Intermacs was queried for primary durable LVAD implants from January 2019 to September 2023. Multivariable logistic regression was used to derive a model based on preimplant risk factors by using derivation (2019-2021 implants) and validation (2022-2023 implants) cohorts. Model performance (derivation and validation cohorts) was assessed using C-statistics, Brier scores, and calibration plots. A refined model (all patients) was generated to calculate observed-to-expected (O/E; 95% CI) ratios for each center., Results: The study population consisted of 11,342 patients from 2019 to 2023 who were sequentially divided in time into derivation (n = 6775) and validation (n = 4567) cohorts. Ninety-day mortality was 8.0% (9.2% in the derivation cohort vs 7.4% in the validation cohort; P = .001). Logistic regression applied to derivation and validation cohorts produced similar discrimination (area under the curve [AUC], 0.714 [95% CI, 0.69-0.74]; and AUC, 0.707; [95% CI, 0.67-0.72], respectively) and calibration (Brier score, .08 vs .07), with overestimation of risk among patients with a predicted risk >0.4. The O/E analysis identified 22 (12.5%) centers with worse than expected mortality with a 95% CI >1.0 and 14 centers (8.0%) with better than expected mortality with a 95% CI <1.0 (all P < .05)., Conclusions: The STS Intermacs risk model demonstrated satisfactory discrimination and calibration. This tool may be used to inform candidate selection, facilitate quality improvement, and assess provider performance., Competing Interests: Disclosures Francis D. Pagani has served as a noncompensated ad hoc scientific advisor for Abbott, BrioHealth Solutions, Berlin Heals, FineHeart, and Medtronic; has served as a noncompensated medical monitor for Abiomed; has served as a member of the Data Safety Monitoring Board for Carmat; and has received travel support from BrioHealth Solutions. Aditi Nayak has served on the clinical advisory board of Pumpinheart; and has reported consulting for Alira Health. Jeffrey Teuteberg has reported consulting for Abbott, Broadview Ventures, and Medtronic; has served on the advisory board for Abiomed, Care Dx, Medtronic, and Takeda; and has served as a speaker for CareDx, Medtronic, and Paragonix. Palak Shah has reported consulting for Procyrion, Merck, Natera, Ortho Clinical Diagnostics, Tosoh Biosciences, and JVP Labs. J. David Vega has reported membership on the Clinical Events Committee for BrioHealth INNOVATE IDE clinical trial. Josef Stehlik has reported consulting for Medtronic, Natera, and TransMedics. All other authors declare that they have no conflicts of interest., (Copyright © 2025 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

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 < 1%, however, true positive rates were < 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 ( > 90%) accompanying low true positive rates. Clinical studies should not primarily report only area under the receiver operating characteristic curve or accuracy.

Objectives: STAT Mortality Categories (developed 2009) stratify congenital heart surgery procedures into groups of increasing mortality risk to characterize case mix of congenital heart surgery providers. This update of the STAT Mortality Score and Categories is empirically based for all procedures and reflects contemporary outcomes., Methods: Cardiovascular surgical operations in the Society of Thoracic Surgeons Congenital Heart Surgery Database (January 1, 2010 - June 30, 2017) were analyzed. In this STAT 2020 Update of the STAT Mortality Score and Categories, the risk associated with a specific combination of procedures was estimated under the assumption that risk is determined by the highest risk individual component procedure. Operations composed of multiple component procedures were eligible for unique STAT Scores when the statistically estimated mortality risk differed from that of the highest risk component procedure. Bayesian modeling accounted for small denominators. Risk estimates were rescaled to STAT 2020 Scores between 0.1 and 5.0. STAT 2020 Category assignment was designed to minimize within-category variation and maximize between-category variation., Results: Among 161,351 operations at 110 centers (19,090 distinct procedure combinations), 235 types of single or multiple component operations received unique STAT 2020 Scores. Assignment to Categories resulted in the following distribution: STAT 2020 Category 1 includes 59 procedure codes with model-based estimated mortality 0.2% to 1.3%; Category 2 includes 73 procedure codes with mortality estimates 1.4% to 2.9%; Category 3 includes 46 procedure codes with mortality estimates 3.0% to 6.8%; Category 4 includes 37 procedure codes with mortality estimates 6.9% to 13.0%; and Category 5 includes 17 procedure codes with mortality estimates 13.5% to 38.7%. The number of procedure codes with empirically derived Scores has grown by 58% (235 in STAT 2020 vs 148 in STAT 2009). Of the 148 procedure codes with empirically derived Scores in 2009, approximately one-half have changed STAT Category relative to 2009 metrics. The New STAT 2020 Scores and Categories demonstrated good discrimination for predicting mortality in an independent validation sample (July 1, 2017-June 30, 2019; sample size 46,933 operations at 108 centers) with C-statistic = 0.791 for STAT 2020 Score and 0.779 for STAT 2020 Category., Conclusions: The updated STAT metrics reflect contemporary practice and outcomes. New empirically based STAT 2020 Scores and Category designations are assigned to a larger set of procedure codes, while accounting for risk associated with multiple component operations. Updating STAT metrics based on contemporary outcomes facilitates accurate assessment of case mix.

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., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Objective: The timing of operative revascularization for patients with concomitant carotid artery stenosis and coronary artery disease remains controversial. We examined the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database to evaluate the association of combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG) with postoperative outcomes., Methods: All patients undergoing CABG with known carotid stenosis of >80% were identified from 2011 to 2016. Individuals were stratified by use of cardiopulmonary bypass and whether a concomitant CEA was performed at the time of CABG. Multivariate logistic regression was used to model the probability of combined CABG and CEA. The resulting propensity scores were used to match individuals on the basis of clinical and operative characteristics to evaluate primary (30-day mortality and in-hospital transient ischemic attack and stroke) and secondary (STS morbidity composite events and length of stay) end points, with P < .05 required to declare statistical significance., Results: After propensity score matching, 994 off-pump CABG patients (497 CABG only and 497 CABG-CEA) and 5952 on-pump CABG patients (2976 CABG only and 2976 CABG-CEA) were identified. For patients who received on-pump operations, those undergoing CABG-CEA had no observed difference in rate of in-hospital stroke (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.72-1.21; P = .6), higher incidence of STS morbidity composite events (OR, 1.15, 95% CI, 1.01-1.31; P = .03), longer length of stay (7.0 [interquartile range, 5.0-9.0] days vs 6.0 [interquartile range, 5.0-9.0] days; P < .005), and no observed difference in 30-day mortality (OR, 1.28; 95% CI, 0.97-1.69; P = .08) compared with those undergoing CABG only. For off-pump procedures, CABG-CEA patients had no observed difference in rate of in-hospital stroke (OR, 0.80; 95% CI, 0.37-1.69; P = .56) compared with those undergoing CABG only., Conclusions: Whereas the differences are relatively small, these data suggest that a combined CABG-CEA approach is unlikely to provide significant stroke reduction benefit compared with CABG only. However, comparison with staged approaches merits further investigation., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)

Objectives: Multi-arterial bypass grafting with bilateral internal thoracic (BITA-MABG) or radial (RA-MABG) arteries improves long-term survival, but its increased complexity raises perioperative safety concerns. We compared perioperative outcomes of RA-MABG and BITA-MABG using the Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS-ACSD)., Methods: We analysed the 2004-2015 BITA-MABG and RA-MABG experience in STS-ACSD. Primary end points were operative mortality (OM) and deep sternal wound infections (DSWI). Risk-adjusted odds ratios [AOR (95% confidence interval)] were derived via multivariable logistic regression. Sensitivity analyses were done in patient sub-cohorts and based on institutional BITA-utilization rates (<5%, 5-10%, 10-20%, 20-40% and >40%)., Results: Eighty-five thousand nine hundred five RA-MABG (82.5% men; 61 years) and 61 336 BITA-MABG (85.1% men; 59 years) patients were analysed; 41.6% of BITA-MABG and 27.3% of RA-MABG cases came from institutions with low MABG utilization rates (<10%). Unadjusted OM was equivalent for both techniques (BITA-MABG versus RA-MABG: 1.3% vs 1.2%, P = 0.79), while DSWI was lower for RA-MABG (1.0% vs 0.6%, P < 0.001). RA-MABG was associated with lower adjusted OM [AOR = 0.80 (0.69-0.96)] and DSWI [AOR = 0.39 (0.32-0.46)]. Sensitivity analyses confirmed robustness of these findings. Equivalent outcomes were observed at high BITA-use institutions where BITA cases comprised >20% of all cases for OM and ≥40% for DSWI., Conclusions: This analysis of the STS-ACSD showed that RA-MABG is a generally safer form of multi-arterial coronary artery bypass grafting surgery. However, this advantage is mitigated at institutions with substantial BITA experience., (© The Author(s) 2019. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Background: 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., Objectives: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD., Methods: 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., Results: 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)., Conclusions: 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., (Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged., Objectives: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort., Methods: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.S. patients who underwent commercial TAVR or SAVR were examined. Death, stroke, and days alive and out of the hospital to 1 year were compared, as well as discharge home, with subgroup analyses by surgical risk, demographics, and comorbidities., Results: In a propensity-matched cohort (median age 82 years, 48% women, median Society of Thoracic Surgeons Predicted Risk of Mortality score 5.6%), TAVR and SAVR patients experienced no difference in 1-year rates of death (17.3% vs. 17.9%; hazard ratio: 0.93; 95% confidence interval [CI]: 0.83 to 1.04) and stroke (4.2% vs. 3.3%; hazard ratio: 1.18; 95% CI: 0.95 to 1.47), and no difference was observed in the proportion of days alive and out of the hospital to 1 year (rate ratio: 1.00; 95% CI: 0.98 to 1.02). However, TAVR patients were more likely to be discharged home after treatment (69.9% vs. 41.2%; odds ratio: 3.19; 95% CI: 2.84 to 3.58). Results were consistent across most subgroups, including among intermediate- and high-risk patients., Conclusions: Among unselected intermediate- and high-risk patients, TAVR and SAVR resulted in similar rates of death, stroke, and DAOH to 1 year, but TAVR patients were more likely to be discharged home., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Surgical risk scores do not include frailty assessments (eg, gait speed), which are of particular importance for patients with severe aortic stenosis considering transcatheter aortic valve replacement., Methods and Results: We assessed the association of 5-m gait speed with outcomes in a cohort of 8039 patients who underwent transcatheter aortic valve replacement (November 2011-June 2014) and were included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for Society of Thoracic Surgeons-predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The overall median gait speed was 0.63 m/s (25th-75th percentile, 0.47-0.79 m/s), with the slowest walkers (<0.5 m/s) constituting 28%, slow walkers (0.5-0.83 m/s) making up 48%, and normal walkers (>0.83 m/s) constituting 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for the slowest, slow, and normal walkers, respectively (P<0.001). Each 0.2-m/s decrease in gait speed corresponded to an 11% increase in 30-day mortality (adjusted odds ratio, 1.11; 95% confidence interval, 1.01-1.22). The slowest walkers had 35% higher 30-day mortality than normal walkers (adjusted odds ratio, 1.35; 95% confidence interval, 1.01-1.80), significantly longer hospital stays, and a lower probability of being discharged to home., Conclusions: Gait speed is independently associated with 30-day mortality after transcatheter aortic valve replacement. Identification of frail patients with the slowest gait speeds facilitates preprocedural evaluation and anticipation of a higher level of postprocedural care., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528., (© 2016 American Heart Association, Inc.)

Background: 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., Methods: 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., Results: 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, p < 0.001). 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)., Conclusions: 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., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Coronary artery disease (CAD) outcomes consistently improve when they are routinely measured and provided back to physicians and hospitals. However, few centers around the world systematically track outcomes, and no global standards exist. Furthermore, patient-centered outcomes and longitudinal outcomes are under-represented in current assessments., Methods and Results: The nonprofit International Consortium for Health Outcomes Measurement (ICHOM) convened an international Working Group to define a consensus standard set of outcome measures and risk factors for tracking, comparing, and improving the outcomes of CAD care. Members were drawn from 4 continents and 6 countries. Using a modified Delphi method, the ICHOM Working Group defined who should be tracked, what should be measured, and when such measurements should be performed. The ICHOM CAD consensus measures were designed to be relevant for all patients diagnosed with CAD, including those with acute myocardial infarction, angina, and asymptomatic CAD. Thirteen specific outcomes were chosen, including acute complications occurring within 30 days of acute myocardial infarction, coronary artery bypass grafting surgery, or percutaneous coronary intervention; and longitudinal outcomes for up to 5 years for patient-reported health status (Seattle Angina Questionnaire [SAQ-7], elements of Rose Dyspnea Score, and Patient Health Questionnaire [PHQ-2]), cardiovascular hospital admissions, cardiovascular procedures, renal failure, and mortality. Baseline demographic, cardiovascular disease, and comorbidity information is included to improve the interpretability of comparisons., Conclusions: ICHOM recommends that this set of outcomes and other patient information be measured for all patients with CAD., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Importance: Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials., Objective: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States., Design, Setting, and Participants: Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid 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., Exposure: Transcatheter aortic valve replacement., Main Outcomes and Measures: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling., Results: 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 vs <75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs <75 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)., Conclusions and Relevance: 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.