The Safety of Outpatient Health Care : Review of Electronic Health Records.

BACKGROUND: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE: To measure AEs in the outpatient setting. DESIGN: Retrospective review of the electronic health record (EHR). SETTING: 11 outpatient sites in Massachusetts in 2018. PATIENTS: 3103 patients who received outpatient care. MEASUREMENTS: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION: Retrospective EHR review may miss AEs. CONCLUSION: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

The Society of Thoracic Surgeons Preoperative Beta Blocker Working Group Interim Report.

BACKGROUND: Atrial fibrillation (AF) occurs commonly following cardiac surgery and is associated with multiple adverse outcomes. Older randomized trials suggested that perioperative beta blockade reduced postoperative AF, and the Society of Thoracic Surgeons (STS) CABG composite measure includes beta blocker administration preoperatively within 24 hours of surgery and at discharge. However, some more recent studies suggest preoperative beta blockade has limited value and question its continuation as an STS quality measure. METHODS: In 2022, an STS Preoperative Beta Blocker Working Group was formed with representatives from the STS and the Society of Cardiovascular Anesthesiologists. Published randomized trials, observational studies, societal guidelines, and the current state of available data from the STS Adult Cardiac Surgery Database (ACSD) were reviewed. RESULTS: Review of existing studies reveals substantial heterogeneity or insufficient detail regarding specific beta blockers used; timing of initiation; management of patients on chronic beta blockade; and whether other pro- or anti-arrhythmic drugs were used concurrently. Further, beta blocker data currently collected in the STS ACSD lack sufficient granularity. CONCLUSIONS: As a new randomized trial seems unlikely, the working group believes that more granular data on real-world practice would facilitate assessment of the value of preoperative beta blockade in the current era, development of best practice recommendations, and evaluation of their continued appropriateness as an STS quality metric. STS ACSD participants have been invited to participate in a voluntary survey whose additional data, when linked to STS ACSD records, will better delineate contemporary beta blocker practice and outcomes.

2024 Update of The Society of Thoracic Surgeons Short-term Esophagectomy Risk Model: More Inclusive and Improved Calibration.

BACKGROUND: The Society of Thoracic Surgeons General Thoracic Surgery Database (STS-GTSD) previously reported short-term risk models for esophagectomy for esophageal cancer. We sought to update existing models using more inclusive contemporary cohorts, with consideration of additional risk factors based on clinical evidence. METHODS: The study population consisted of adult patients in the STS-GTSD who underwent esophagectomy for esophageal cancer between January 2015 and December 2022. Separate esophagectomy risk models were derived for 3 primary end points: operative mortality, major morbidity, and composite morbidity or mortality. Logistic regression with backward selection was used, with predictors retained in models if P < .10. All derived models were validated using 9-fold cross-validation. Model discrimination and calibration were assessed for the overall cohort and specified subgroups. RESULTS: A total of 18,503 patients from 254 centers underwent esophagectomy for esophageal cancer. Operative mortality, morbidity, and composite morbidity or mortality rates were 3.4%, 30.5%, and 30.9%, respectively. Novel predictors of short-term outcomes in the updated models included body surface area and insurance payor type. Overall discrimination was similar or superior to previous STS-GTSD models for operative mortality (C statistic = 0.72) and for composite morbidity or mortality (C statistic = 0.62), Model discrimination was comparable across procedure- and demographic-specific subcohorts. Model calibration was excellent in all patient subgroups. CONCLUSIONS: The newly derived esophagectomy risk models showed similar or superior performance compared with previous models, with broader applicability and clinical face validity. These models provide robust preoperative risk estimation and can be used for shared decision making, assessment of provider performance, and quality improvement.

Association Between Past and Present Operative Mortality in Congenital Heart Surgery: An Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: Mortality after congenital heart surgery is an important metric across benchmarking, quality, and reporting initiatives. All rely on estimates from prior years, and how well these reflect current outcomes is unclear. METHODS: Index operations from The Society of Thoracic Surgeons Congenital Database (2014-2019) were included. Adjusted operative mortality in "past" 4-year and 1-year intervals vs the most recent year ("present") was evaluated using Bayesian hierarchical logistic regression with results presented as odds ratios and 95% credible intervals (CrI). RESULTS: Among 115,699 operations (106 hospitals), overall present observed mortality was 2.5%. Regression to the mean was evident, and individual hospital's present vs past adjusted mortality were only weakly correlated (-0.11 vs past 1-year data, 0.22 vs past 4-year data). A significant relationship was found between past and present mortality only for the group of hospitals in the highest mortality quartile, most prominent for past 4-year data (adjusted odds ratio vs lowest mortality quartile, 2.04; 95% CrI, 1.44-2.80). The proportion of present hospital mortality variation explained by past mortality quartile was 52% (95% CrI, 20%-90%) using past 4-year data and only 27% (95% CrI, 92%-83%) using past 1-year data. Overall 66% of hospitals changed mortality quartiles from past to present (30% by ≥2 quartiles). CONCLUSIONS: Past mortality relates to present primarily for groups of hospitals at the extremes, with past 4-year data more informative than past 1-year data. For individual hospitals, past may differ from present, regression to the mean is common, and many change quartiles. Past mortality should be used thoughtfully and not as the sole factor informing present decision making.

Outcomes of Isolated Tricuspid Valve Surgery: A Society of Thoracic Surgeons Analysis and Risk Model.

BACKGROUND: To provide patients and surgeons with clinically relevant information, The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database was queried to develop a risk model for isolated tricuspid valve (TV) operations. METHODS: All patients in the STS Adult Cardiac Surgery Database who had undergone isolated TV repair or replacement (N = 13,587; age 48.3 ± 18.4 years) were identified (July 2017 to June 2023). Multivariable logistic regression accounting for TV replacement vs repair was used to model 8 operative outcomes: mortality, morbidity or mortality or both, stroke, renal failure, reoperation, prolonged ventilation, short hospital stay, and prolonged hospital stay. Model discrimination (C-statistic) and calibration were assessed using 9-fold cross-validation. RESULTS: The isolated TV study population included 41.1% repairs (N = 5,583; age 52.6 ± 18.1 years) and 58.9% replacements (N = 8,004; age 45.3 ± 18.0 years). The overall predicted risk of operative mortality was 5.6%, and it was similar in TV repairs and replacements (5.5% and 5.7%, respectively), as was the predicted risk of composite morbidity and mortality (28.2% and 26.8%). TV replacements were generally performed in younger patients with a higher endocarditis prevalence than TV repairs (45.7% vs 21.1%). The model yielded a C-statistic of 0.81 for mortality and 0.76 for the composite of morbidity and mortality, with excellent observed-to-expected calibration that was comparable in all subcohorts and predicted risk decile groups. CONCLUSIONS: An STS risk model has been developed for isolated TV surgery. The current mortality of isolated TV operations is lower than previously observed. This risk prediction model and these contemporary outcomes provide a new benchmark for current and future isolated TV interventions.

Hematocrit and Renal Failure in Aortic Arch Surgery: A Society of Thoracic Surgeons Database Study.

BACKGROUND: We examined the association between cardiopulmonary bypass (CPB) hematocrit and postoperative acute renal failure (ARF) in patients undergoing aortic arch surgery with hypothermic circulatory arrest. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was queried from 2011-2019 for patients undergoing aortic arch surgery with hypothermic circulatory arrest. A multivariable logistic regression model estimated the adjusted odds of postoperative ARF based on CPB hematocrit. Effects were stratified by preoperative kidney function and duration of hypothermic circulatory arrest using interaction terms. We also investigated the association between postoperative ARF and major postoperative outcomes using multivariable regression models. RESULTS: On adjusted analysis, higher CPB hematocrit (>20-25%, >25-30%, >30%) was associated with lower odds of ARF as compared to lower CPB hematocrit (≤20%) [>20-25%: aOR=0.78(0.65-0.93), p=0.006, >25-30%: aOR=0.65(0.50-0.84), p=0.0007, >30%: aOR=0.45(0.28-0.72), p=0.0008]. The predicted probability of postoperative ARF by CPB hematocrit was higher in patients with lower preoperative renal function (<60 mL/min/1.73m2) (interaction p=0.03). The association between hematocrit and postoperative ARF was not significantly modified by hypothermic circulatory arrest time (interaction p= 0.74). All postoperative outcomes were significantly worse in patients with postoperative ARF (all p<0.0001). CONCLUSIONS: Among patients undergoing aortic arch surgery, a higher CPB hematocrit level is associated with reduced likelihood of postoperative ARF. Preoperative renal function, but not hypothermic circulatory arrest duration, significantly modified this association. The maintenance of higher CPB hematocrit may reduce the incidence of postoperative ARF, especially for patients with poor preoperative renal function.

Association Between Functional Tricuspid Regurgitation and Mortality Following Cardiac Surgery.

Background: Current guidelines recommend concomitant repair of certain non-severe cases of tricuspid regurgitation (TR) in patients undergoing cardiac surgery, but the prognostic relevance and postsurgical impact of the TR remain uncertain. Objectives: The purpose of this study was to determine the prognostic impact of functional TR in patients undergoing diverse cardiac surgeries and to examine the effect-modifying role of patient characteristics in patients in whom TR confers a greater risk of adverse outcomes. Methods: Patients undergoing coronary artery bypass, aortic, and mitral valve surgery were included. Patients with severe TR, organic tricuspid valve pathology, undergoing tricuspid valve surgery or without a recent preoperative echocardiogram were excluded. Clinical variables were extracted from the Society of Thoracic Surgeons Adult Cardiac Surgery Database. An independent cohort was used for external validation. Results: Of 2,119 patients (mean age 67.4 years; 29% females), TR severity was moderate in 185 (9%), mild in 636 (30%), trivial in 1,126 (53%), and absent in 172 (8%). There were 238 deaths during the median follow-up period of 2.6 years. After adjusting for relevant factors, moderate TR was found to be independently associated with mid-term mortality (HR: 2.58; 95% CI: 1.22-5.47) and with in-hospital mortality or major morbidity (OR: 3.18; 95% CI: 1.37-7.42). The association between TR and mortality was apparent when preoperative pulmonary artery systolic pressure was <40 mm Hg but not ≥40 mm Hg (P for interaction = 0.036). Conclusions: In this diverse cohort of contemporary cardiac surgery patients, moderate functional TR was associated with increased mortality and major morbidity, particularly in the absence of pulmonary hypertension.