Predictors of Occlusion after Carotid Stenting.

BACKGROUND: Carotid artery stent (CAS) occlusion is a rare complication not well studied. We used a national dataset to assess real world CAS experience to determine the rate of stent occlusion. The purpose of this study was to 1) Identify risk factors associated with CAS occlusion on long-term follow-up (LTFU) and 2) Determine the adjusted odds of death/transient ischemic attack (TIA)/stroke (cerebrovascular accident (CVA)) in patients with occlusion. METHODS: The national Vascular Quality Initiative CAS dataset (2016-2021) comprised the sample. The primary endpoint was occlusion on LTFU (9-21 months postoperatively as defined by the Vascular Quality Initiative LTFU dataset) with secondary endpoint examining a composite of death/TIA/CVA. Descriptive analyses used chi-square and Wilcoxon tests for categorical and continuous variables respectively. Adjustment variables were selected a priori based on clinical expertise and univariate analyses. Multivariable logistic regression was used to model the odds of occlusion and the odds of death/TIA/CVA. Generalized estimating equations accounted for center level variation. RESULTS: During the study period, 109 occlusions occurred in 12,143 cases (0.9%). On univariate analyses, symptomatic indication, prior stroke, prior neck radiation, lesion calcification (>50%), stenosis (>80%), distal embolic protection device (compared to flow reversal), balloon size, >1 stent and current smoking at time of LTFU were predictive for occlusion. Age ≥ 65, coronary artery disease (CAD), elective status, preoperative statin, preoperative and discharge P2Y12 inhibitor, use of any protection device intraoperatively and protamine were protective. On multivariable analyses, age ≥ 65, CAD, elective status and P2Y12 inhibitor on discharge were protective for occlusion, while patients with prior radiation and those taking P2Y12 inhibitor on LTFU were at increased odds. The adjusted odds of death/TIA/CVA in patients with occlusion on LTFU were 6.05; 95% confidence interval: 3.61-10.11, P < 0.0001. CONCLUSIONS: This study provides an in-depth analysis of predictors for CAS occlusion on LTFU. On univariate analyses, variables related to disease severity (urgency, degree of stenosis, nature of lesion) and intraoperative details (balloon diameter, >1 stent) were predictive for occlusion. These variables were not statistically significant after risk adjustment. On multivariable analyses, prior neck radiation was strongly predictive of occlusion. Elective status, patient age ≥ 65, CAD, and P2Y12 inhibitor upon discharge (but not on LTFU) were protective for occlusion. Additionally, patients who developed occlusion had high odds for death/TIA/CVA. These findings provide important data to guide clinical decision-making for carotid disease management, particularly identifying high-risk features for CAS occlusion. Closer postoperative follow-up and aggressive risk factor modification in these patients may be merited.

Comparative effectiveness of azathioprine and mycophenolate mofetil for myasthenia gravis (PROMISE-MG): a prospective cohort study.

BACKGROUND: Myasthenia gravis is an autoimmune disorder of the neuromuscular junction. Treatment typically includes symptomatic oral cholinesterase inhibitors, immunosuppression, and immunomodulation. In addition to corticosteroids, azathioprine and mycophenolate mofetil are the most frequently used immunosuppressants in North America. We aimed to evaluate the comparative effectiveness of these two drugs, and to assess the effect of the dose and duration of treatment. METHODS: We did a prospective cohort study at 19 academic centres in Canada and the USA. We included patients (aged ≥18 years) with autoimmune myasthenia gravis, who were never treated with immunosuppressants. Treating clinicians determined the choice of medication, dose, follow-up intervals, and drug monitoring. Outcome measures and adverse events were recorded at each visit. We assessed two co-primary outcomes. The first was the patient-reported Myasthenia Gravis-Quality of Life 15-revised (MGQOL-15r) score, measured as the mean change from treatment initiation to the follow-up visit with the lowest score. A clinically meaningful reduction (CMR) in MGQOL-15r was defined as a 5-point decrease. The second was a composite clinical outcome of disease improvement (Myasthenia Gravis Foundation of America Post-Intervention Status Minimal Manifestations or better) and low adverse event burden (defined as grade ≤1 Common Terminology Criteria for Adverse Events). We also compared these outcomes in patients receiving an adequate dose and duration of azathioprine (≥2 mg/kg per day for at least 12 months) or mycophenolate mofetil (≥2 g per day for at least 8 months) and a lower dose or shorter duration of these agents. We used propensity score weighting with generalised linear regression models. This study is registered with ClinicalTrials.gov (NCT03490539). FINDINGS: Between May 1, 2018, and Aug 31, 2020, 167 patients were enrolled; 85 did not receive azathioprine or mycophenolate mofetil and were excluded. Four were excluded from outcome analyses because they had scores of 0 on an outcome measure at treatment initiation. Of the 78 patients included in analyses, 47 received mycophenolate mofetil (median follow-up 25 months [IQR 13·5-31·5]) and 31 received azathioprine (median follow-up 20 months [IQR 13-30]). The mean change in MG-QOL15r was -10·4 (95% CI -18·9 to -1·3) with mycophenolate mofetil and -6·8 (-17·2 to 3·6) with azathioprine (mean difference -3·3, 95% CI -7·7 to 1·2; p=0·15). 38 (81%) of 47 patients receiving mycophenolate mofetil and 18 (57%) of 31 receiving azathioprine had a CMR in MG-QOL15r (risk difference 24·0%; 95% CI -0·2 to 48·0; p=0·052). The clinical composite outcome was achieved in 22 (47·7%) of 47 patients who received mycophenolate mofetil and nine (28·1%) of 31 who received azathioprine (risk difference 19·6%, 95% CI -4·9 to 44·2; p=0·12). Descriptive analysis did not find a difference in the proportion of patients reaching a CMR in MG-QOL15r between the adequate dose and duration group and the lower dose or shorter duration group. Adverse events occurred in 11 (32%) of 34 patients who received azathioprine and nine (19%) of 48 who received mycophenolate mofetil. The most frequent adverse events were hepatotoxicity with azathioprine (five [15%] of 34) and gastrointestinal disturbances (seven [15%] of 48) with mycophenolate mofetil. There were no study-related deaths. INTERPRETATION: More than half of patients treated with azathioprine and mycophenolate mofetil felt their quality of life improved; no difference in clinical outcomes was noted between the two drugs. Adverse events associated with azathioprine were potentially more serious than those with mycophenolate mofetil, although mycophenolate mofetil is teratogenic. Lower than recommended doses of azathioprine might be effective, with reduced dose-dependent adverse events. More comparative effectiveness studies are required to inform treatment choices in myasthenia gravis. FUNDING: Patient-Centered Outcomes Research Institute, Myasthenia Gravis Foundation of America.

Outcomes of the Kawashima: A Society of Thoracic Surgeons Congenital Heart Surgery Database Analysis.

BACKGROUND: We aimed to evaluate the effect of age at operation on postoperative outcomes in children undergoing a Kawashima operation. METHODS: The Society of Thoracic Surgeons Congenital Heart Surgery Database was queried for Kawashima procedures from January 1, 2014, to June 30, 2020. Patients were stratified by age at operation in months: 0 to <4, 4 to <8, 8 to <12, and >12. Subsequently, outcomes for those in whom the Kawashima was not the index operation and for those undergoing hepatic vein incorporation (Fontan completion or hepatic vein-to-azygos vein connection) were evaluated. RESULTS: We identified 253 patients who underwent a Kawashima operation (median age, 8.6 months; median weight, 7.4 kg): 12 (4.7%), 0 to <4 months; 96 (37.9%), 4 to <8 months; 81 (32.0%), 8 to <12 months; and 64 (25.3%), >12 months. Operative mortality was 0.8% (n = 2), with major morbidity or mortality in 17.4% (n = 44), neither different across age groups. Patients <4 months had a longer postoperative length of stay (12.5 vs 9.3 days; P = .03). The Kawashima was not the index operation of the hospital admission in 15 (5.9%); these patients were younger (6.0 vs 8.4 months; P = .05) and had more preoperative risk factors (13/15 [92.9%] vs 126/238 [52.9%]; P < .01). We identified 173 patients undergoing subsequent hepatic vein incorporation (median age, 3.9 years; median weight, 15.0 kg) with operative mortality in 6 (3.5%) and major morbidity or mortality in 30 (17.3%). CONCLUSIONS: The Kawashima is typically performed between 4 and 12 months with low mortality. Morbidity and mortality were not affected by age. Hepatic vein incorporations may be higher risk than in traditional Fontan procedures, and ways to mitigate this should be sought.

Center-level factors associated with shorter length of stay following stage 1 palliation: An analysis of the national pediatric cardiology quality improvement collaborative registry.

BACKGROUND: Stage 1 single ventricle palliation (S1P) has the longest length of stay (LOS) of all benchmark congenital heart operations. Center-level factors contributing to prolonged hospitalization are poorly defined. METHODS: We analyzed data from infants status post S1P included in the National Pediatric Cardiology Quality Improvement Collaborative Phase II registry. Our primary outcome was patient-level LOS with days alive and out of hospital before stage 2 palliation (S2P) used as a balancing measure. We compared patient and center-level characteristics across quartiles for median center LOS, and used multivariable regression to calculate center-level factors associated with LOS after adjusting for case mix. RESULTS: Of 2,510 infants (65 sites), 2037 (47 sites) met study criteria (61% male, 61% white, 72% hypoplastic left heart syndrome). There was wide intercenter variation in LOS (first quartile centers: median 28 days [IQR 19, 46]; fourth quartile: 62 days [35, 95], P < .001). Mortality prior to S2P did not differ across quartiles. Shorter LOS correlated with more pre-S2P days alive and out of hospital, after accounting for readmissions (correlation coefficient -0.48, P < .001). In multivariable analysis, increased use of Norwood with a right ventricle to pulmonary artery conduit (aOR 2.65 [1.1, 6.37]), shorter bypass time (aOR 0.99 per minute [0.98,1.0]), fewer additional cardiac operations (aOR 0.46 [0.22, 0.93]), and increased use of NG tubes rather than G tubes (aOR 7.03 [1.95, 25.42]) were all associated with shorter LOS centers. CONCLUSIONS: Modifiable center-level practices may be targets to standardize practice and reduce overall LOS across centers.

Long-term Outcomes and Anticoagulation in Mitral Valve Surgery-A Report From The Society of Thoracic Surgeons Database.

BACKGROUND: Anticoagulation after bioprosthetic mitral valve (MV) replacement (BMVR) and repair (MVrep) is controversial. We explore outcomes among BMVR and MVrep patients in The Society of Thoracic Surgeons Adult Cardiac Surgery Database based on discharge anticoagulation status. METHODS: BMVR and MVrep patients aged ≥65 years in The Society of Thoracic Surgeons Adult Cardiac Surgery Database were linked to the Centers for Medicare and Medicaid Services claims database. Long-term mortality, ischemic stroke, bleeding, and a composite of the primary end points were compared as a function of anticoagulation. Hazard ratios (HRs) were calculated using multivariable Cox regression. RESULTS: A total of 26,199 BMVR and MVrep patients were linked to the Centers for Medicare and Medicaid Services database; of these, 44%, 4%, and 52% were discharged on warfarin, non-vitamin K-dependent anticoagulant (NOAC), and no anticoagulation (no-AC; reference), respectively. Warfarin was associated with increased bleeding in the overall study cohort (HR, 1.38; 95% CI 1.26-1.52) and in the BMVR (HR, 1.32; 95% CI, 1.13-1.55) and MVrep subcohorts (HR, 1.42; 95% CI, 1.26-1.60). Warfarin was associated with decreased mortality only among BMVR patients (HR, 0.87; 95% CI, 0.79-0.96). Stroke and the composite outcome did not differ across cohorts with warfarin. NOAC use was associated with increased mortality (HR, 1.33; 95% CI 1.11-1.59), bleeding (HR, 1.37; 95% CI, 1.07-1.74), and the composite outcome (HR, 1.26; 95% CI, 1.08-1.47). CONCLUSIONS: Anticoagulation was used in fewer than half of mitral valve operations. In MVrep patients, warfarin was associated with increased bleeding and was not protective against stroke or mortality. In BMVR patients, warfarin was associated with a modest survival benefit, increased bleeding, and equivalent stroke risk. NOAC was associated with increased adverse outcomes.

Contemporary Patterns of Care in Tetralogy of Fallot: Analysis of The Society of Thoracic Surgeons Data.

BACKGROUND: Against the background of earlier studies, recent patterns in surgical management of tetralogy of Fallot (TOF) were assessed. METHODS: A retrospective review of The Society of Thoracic Surgeons (STS) Congenital Database (2010-2020) was performed on patients aged <18 years with TOF or pulmonary stenosis and primary procedure TOF surgical repair or palliation. Procedural frequencies were examined by epoch. Demographics, clinical variables, and outcomes were compared between the initial palliation and primary repair groups. Among those operated on at 0 to 60 days of age, variation in palliation rates across hospitals was assessed. RESULTS: The 12,157 operations included 11,307 repairs (93.0%) and 850 palliations (7.0%); 68.5% of all palliations were modified Blalock-Taussig-Thomas shunts. Of 1105 operations on neonates, 45.4% (502) were palliations. Among neonates, palliations declined from 49.0% (331 of 675) in epoch 1 (2010-2015) to 39.8% (171 of 430) in epoch 2 (2016-2020; P = .0026). Overall, the most prevalent repair technique (5196 of 11,307; 46.0%) was ventriculotomy with transanular patch, which was also used in 520 of 894 (58.2%) of repairs after previous cardiac operations. Patients undergoing initial palliation demonstrated more preoperative STS risk factors (50.1% vs 24.3% respectively; P < .0001) and more major morbidity and mortality than patients undergoing primary repair (21.2% vs 7.46%; P < .0001). In the 0- to 60-day age group, risk factor-adjusted palliation rates across centers varied considerably, with 32 of 99 centers performing significantly more or significantly fewer palliations than predicted on the basis of their case mix. CONCLUSIONS: Surgical palliation rates have decreased across all age groups despite increasing prevalence of risk factors. Ventriculotomy with transanular patch remains the most prevalent repair type. The considerable center-level variation in rates of palliation was not completely explained by case mix.

Development of a Novel Society of Thoracic Surgeons Adult Congenital Mortality Risk Model.

BACKGROUND: Operative mortality risk models for adults with congenital heart disease (ACHD) undergoing cardiac operations are essential, given the growing population of these patients, yet they are currently unavailable. Existing adult Society of Thoracic Surgeons (STS) models exclude congenital procedures, whereas existing congenital models exclude operations for acquired disease. We aimed to develop an STS mortality risk model for ACHD patients undergoing cardiac operations. METHODS: Leveraging a comprehensive list of diagnostic and procedure codes, ACHD patients who underwent cardiac operations were identified from the STS Adult Cardiac Surgery Database (versions: v2.73, v2.81, and v2.9) between 2011 and 2019. The model was developed and validated in the ACHD population using a 60/40 development/validation split. Univariate analyses and clinical expertise informed the addition of ACHD-relevant procedure and diagnosis variables to existing STS adult risk model variables. Model performance was assessed overall and in 38 subgroups based on patient demographics, procedures, and diagnoses. RESULTS: Forty-seven procedure and diagnosis variables relevant to ACHD were added to existing STS adult risk model variables. The derived ACHD model for operative mortality was well calibrated within demographic, procedural, and diagnosis subgroups and the overall ACHD population, and discrimination in the validation cohort was excellent (C statistic, 0.815) compared with the model using only existing STS adult risk model variables (C statistic, 0.79; P < .0001). CONCLUSIONS: A novel, high-performing STS ACHD mortality risk model has been developed on the basis of contemporary patient data. The ACHD risk model represents an important expansion of the STS portfolio. Implementation with an online risk calculator is planned.

Robotic Esophagectomy Trends and Early Surgical Outcomes: The US Experience.

BACKGROUND: Recent esophagectomy trends were evaluated to describe the shift in surgical approach and outcomes using The Society of Thoracic Surgeons General Thoracic Surgery Database. METHODS: All patients who underwent an esophagectomy with gastric conduit from 2015 to 2019 were identified and analyzed according to original intended approach. After performing volume trend analysis of patients, operative outcomes were evaluated. RESULTS: Among 10,607 patients, esophagectomy was open in 5763 (54.3%), minimally invasive (MIE) in 3524 (33.2%), and robotic (RAMIE) in 1320 (12.4%). Within 5 years, MIE and RAMIE combined rose to majority approach (open from 58% to 42% of annual volume). While MIE and RAMIE were associated with higher rates of anastomotic leak, loss of conduit, pulmonary embolus, and reoperation, R0 resection and harvested number of lymph nodes exceeded those in open approaches. Operative mortality did not differ by approach (3.21% open vs 2.72% MIE vs 2.50% RAMIE; P = .2329). On multivariable analysis, RAMIE was independently associated with higher rate of anastomotic leak compared to open (adjusted odds ratio 1.53, 95% CI 1.14-2.04), while both MIE and RAMIE had lower mean length of stay. Propensity matching of 1320 pairs found a higher risk of anastomotic leak requiring surgery for RAMIE compared with MIE (adjusted odds ratio 1.39, 95% CI 1.01-1.92). CONCLUSIONS: In less than a decade, the dominant surgical approach in The Society of Thoracic Surgeons General Thoracic Surgery Database has become minimally invasive (RAMIE and MIE). While anastomotic leak and reoperation, more common in RAMIE, require a technical solution, these complications have not raised operative mortality. Further studies are needed to address long-term results and oncologic outcome.

Optimal circulatory arrest temperature for aortic hemiarch replacement with antegrade brain perfusion.

OBJECTIVE: This study sought to identify the optimal temperature for moderate hypothermic circulatory arrest in patients undergoing elective hemiarch replacement with antegrade brain perfusion. METHODS: The Society of Thoracic Surgeons adult cardiac surgery database was queried for elective hemiarch replacements using antegrade brain perfusion for aneurysmal disease (2014-2019). Generalized estimating equations and restricted cubic splines were used to determine the risk-adjusted relationships between temperature as a continuous variable and outcomes. RESULTS: Elective hemiarch replacement with antegrade brain perfusion occurred in 3898 patients at 374 centers with a median nadir temperature of 24.9°C (first quartile, third quartile = 22.0°C, 27.5°C) and median circulatory arrest time of 19 minutes (first quartile, third quartile = 14.0 minutes, 27.0 minutes). After adjustment for comorbidities, circulatory arrest time, and individual surgeon, patients cooled between 25 and 28°C had an early survival advantage compared with 24°C, whereas those cooled between 21 and 23°C had higher risks of mortality compared with 24°C. A nadir temperature of 27°C was associated with the lowest risk-adjusted odds of mortality (odds ratio, 0.62; 95% confidence interval, 0.42-0.91). A nadir temperature of 21°C had the highest risk of mortality (odds ratio, 1.4; 95% confidence interval, 1.13-1.73). Risk of experiencing a major morbidity was elevated in patients cooled between 21 and 23°C, with the highest risk occurring in patients cooled to 21°C (odds ratio, 1.12; 95% confidence interval, 1.01-1.24). CONCLUSIONS: For patients with aneurysmal disease undergoing elective hemiarch with antegrade brain perfusion, circulatory arrest with a nadir temperature of 27°C confers the greatest early survival benefit and smallest risk of postoperative morbidity.

Mortality and cost of post-cardiotomy extracorporeal support in the United States.

BACKGROUND: Extracorporeal membrane oxygenation (ECMO) has been used increasingly for cardiopulmonary rescue. Despite recent advances however, post-cardiotomy shock (PCS)-ECMO survival remains comparatively poor. We sought to evaluate outcomes and define factors that predict in-hospital mortality. METHODS: We used the Nationwide Inpatient Sample (NIS) to evaluate adult hospitalizations with a primary procedure code for coronary artery bypass grafting (CABG), and/or valve procedures performed between 2013 and 2018, which also required post cardiotomy ECMO support. Patient-related factors and hospital costs were evaluated to identify those associated with in-hospital mortality. RESULTS: There were 1,247,835 admissions for cardiac surgical procedures during the study period. Post-cardiotomy shock-ECMO support was provided in 4475 (0.3%) within the study cohort. A total of 2000 (44.7%) hospitalizations involved isolated valvular procedures, 1700 (38.0%) isolated CABG, and 775 (17.3%) involved a combination of both. Overall, in-hospital mortality was 42.1% (n = 1880). Factors significantly associated with in-hospital mortality included patients with multiple comorbidities (> 7) and those undergoing combination of valve and CABG procedures. Only 26.6% of those who survived to discharge, were discharged home independently. CONCLUSION: Survival to independent home discharge is rare following PCS-ECMO. Its high mortality is associated with multiple comorbidities and combination of CABG and valve surgery.

Comparing Consumer-Directed Hospital Rankings With STS Adult Cardiac Surgery Database Outcomes.

BACKGROUND: 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. METHODS: 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. News & World Report (USNWR) Cardiology & Heart 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. RESULTS: 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). CONCLUSIONS: 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.

Impact of Diabetes on Pathologic Response to Multimodality Therapy for Esophageal Cancer.

BACKGROUND: The incidence of esophageal cancer has increased faster than that of most cancers. Evidence from other malignant neoplasms suggests that diabetic patients have a worse response to multimodality therapy. We hypothesized that diabetic patients with esophageal cancer will have a decreased response to neoadjuvant chemotherapy and radiation therapy compared with nondiabetic patients. METHODS: A retrospective study of The Society of Thoracic Surgeons General Thoracic Surgery Database identified all patients who had an esophagectomy after neoadjuvant therapy for esophageal cancer between 2012 and 2019. Patients were compared on the basis of the presence of diabetes. A pathologic complete response (pCR) was defined as ypT0 N0. The χ2 and Wilcoxon rank sum tests were used to compare patients' demographic and clinical characteristics between those with and those without diabetes. Multivariable logistic regression was used to evaluate the predictors of response to neoadjuvant therapy. RESULTS: Of the 9171 patients who met inclusion criteria, 2011 (22%) patients were diabetic and 7160 (78%) patients were nondiabetic. Patients with diabetes were older, more likely to be male, and more likely to have all comorbidities. Univariate analysis revealed that diabetic patients were less likely to have pCR (16% vs 18%; P = .026). Although multivariable analysis showed a trend toward diabetic patients' having lower odds of achieving pCR, diabetes was not independently associated with pCR (odds ratio, 0.89; 95% CI, 0.78-1.01; P = .075). CONCLUSIONS: Diabetic patients may be less likely than nondiabetic patients to achieve pCR after neoadjuvant treatment of esophageal cancer. This suggests the need for further exploration as diabetic patients with esophageal cancer can potentially benefit from different treatment paradigms compared with their nondiabetic counterparts.

Congenitally Corrected Transposition Cardiac Surgery: Society of Thoracic Surgeons Database Analysis.

BACKGROUND: Congenitally corrected transposition of the great arteries (ccTGA) has many management strategies, with the emergence of anatomic repair increasing the available surgical options. Contemporary surgical practices have not been described in multicenter analyses. This study describes the distribution of heart surgery in patients with ccTGA and defines contemporary outcomes in a large multicenter cohort. METHODS: Index cardiovascular operations in patients with primary or fundamental diagnosis of ccTGA were identified in The Society of Thoracic Surgeons Congenital Heart Surgery Database from 2010 to 2019. Operations of interest were combined into mutually exclusive groups designating overall ccTGA management strategies. Outcomes were defined with standard Society of Thoracic Surgeons Congenital Heart Surgery Database definitions. Pearson χ2 and Kruskal-Wallis tests were used for statistical comparisons. RESULTS: One hundred one centers performed 985 index operations, with anatomic repair the most common approach. Twenty-six centers performed more than 10 operations. Atrial switch plus Rastelli operations had the highest rate of operative mortality (8.4%) and major complications (38.2%). Heart transplant operations had the longest postoperative length of stay among survivors (18 days [interquartile range, 13.5-26]). CONCLUSIONS: Patients with ccTGA remain a challenging cohort, with significant diversity in the operations used and a substantial burden of operative mortality and morbidity.

Population-Based Study of Nonelective Postpartum Readmissions in Women With Stroke, Migraine, Multiple Sclerosis, and Myasthenia Gravis.

OBJECTIVE: To compare maternal obstetric complications and nonelective readmissions in women with common neurologic comorbidities (WWN) vs women without neurologic disorders. METHODS: We performed a retrospective cohort study of index characteristics and acute postpartum, nonelective rehospitalizations from the 2015-2017 National Readmissions Database using ICD-10 codes. Wald χ2 testing compared baseline demographic, hospital, and clinical characteristics and postpartum complications between WWN (including previous stroke, migraine, multiple sclerosis [MS], and myasthenia gravis [MG]) and controls. Multivariable logistic regression models examined odds of postpartum complications and nonelective readmissions within 30 and 90 days for each neurologic comorbidity compared to controls (α = 0.05). RESULTS: A total of 7,612 women with previous stroke, 83,430 women with migraine, 6,760 women with MS, 843 women with MG, and 8,136,335 controls met the criteria for index admission after viable infant delivery. WWN were more likely than controls to have inpatient diagnoses of edema, proteinuria, or hypertensive disorders and to have received maternal care for poor fetal growth. The adjusted odds of a Centers for Disease Control and Prevention severe maternal morbidity indicator were greater for women with previous stroke (adjusted odds ratio [AOR] 8.53, 95% CI 7.24-10.06), migraine (AOR 2.04, 95% CI 1.85-2.26), and MG (AOR 4.45, 95% CI 2.45-8.08) (all p < 0.0001). Readmission rates at 30 and 90 days for WWN were higher than for controls (30 days: previous stroke 2.9%, migraine 1.7%, MS 1.8%, MG 4.3%, controls 1.1%; 90 days: previous stroke 3.7%, migraine 2.5%, MS 5.1%, MG 6.0%, controls 1.6%). Women with MG had the highest adjusted odds of readmission (30 days: AOR 3.96, 95% CI 2.37-6.65, p < 0.0001; 90 days: AOR 3.30, 95% CI 1.88-5.78, p < 0.0001). DISCUSSION: WWN may be at higher risk of severe maternal morbidity at the time of index delivery and postpartum readmission. More real-world evidence is needed to develop research infrastructure and create efficacious interventions to optimize maternal-fetal outcomes in WWN, especially for women with previous stroke or MG.

The Society of Thoracic Surgeons 2021 Adult Cardiac Surgery Risk Models for Multiple Valve Operations.

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.

Evolving Cost-Quality Relationship in Pediatric Heart Surgery.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Sex Differences in Coronary Artery Bypass Grafting Techniques: A Society of Thoracic Surgeons Database Analysis.

BACKGROUND: Female patients with coronary artery disease have inferior outcomes compared with male patients, including higher mortality after coronary artery bypass graft surgery (CABG). We aimed to evaluate the association of female sex with the use of guideline-concordant CABG revascularization techniques. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database was queried for adult patients who underwent first-time isolated CABG in the United States from 2011 to 2019. The association between female sex and the odds of (1) receiving a left internal mammary artery graft for revascularization of the left anterior descending artery, (2) undergoing complete revascularization, and (3) undergoing multiarterial grafting was assessed, adjusting for procedural anatomy. RESULTS: Among 1,212,487 patients meeting inclusion criteria, 75% were male (n = 911,178) and 25% were female (n = 301,309). Female sex was associated with lower unadjusted rates of revascularization with an internal mammary artery graft (93.9% vs 95.9%, P < .001), bilateral internal mammary artery graft (2.9% vs 5.6%, P < .001), or radial artery graft (3.2% vs 5.6%, P < .001). After adjustment, female patients had lower odds than males of receiving a left internal mammary artery graft to the left anterior descending artery (adjusted odds ratio 0.79; 95% confidence interval, 0.75 to 0.83; P < .001), undergoing complete revascularization (adjusted odds ratio 0.86; 95% confidence interval, 0.83 to 0.90; P < .001), and undergoing multiarterial grafting (adjusted odds ratio 0.78; 95% confidence interval, 0.75 to 0.81; P < .001). CONCLUSIONS: Female sex was associated with 14% to 22% lower odds of undergoing guideline-concordant revascularization including left internal mammary artery to left anterior descending artery grafting, multiarterial grafting, and complete revascularization. Further investigation is necessary to determine why revascularization approaches differ by sex and to what degree sex disparities in coronary artery disease outcomes are due to surgical approach.

Utilization and Outcomes of the Nikaidoh, Rastelli, and REV Procedures: An Analysis of The Society of Thoracic Surgeons Congenital Heart Surgery Database.

BACKGROUND: Aortic root translocation (Nikaidoh), Rastelli, and réparation à l'etage ventriculaire (REV) are repair options for transposition of the great arteries (TGA) with ventricular septal defects and left ventricular outflow tract obstruction (VSD-LVOTO) or double outlet right ventricle TGA type (DORV-TGA). METHODS: This retrospective study using The Society of Thoracic Surgeons Congenital Heart Surgery Database evaluates surgical procedure utilization and outcomes of patients undergoing repair of TGA-VSD-LVOTO and DORV-TGA with a Nikaidoh, Rastelli, or REV procedure. RESULTS: A total of 293 patients underwent repair at 82 centers (January 2010 to June 2019). Most patients underwent a Rastelli (n = 165, 56.3%) or a Nikaidoh (n = 119, 40.6%) operation; only 3.1% (n = 9) underwent a REV. High-volume centers performed the majority of the repairs. Fewer Nikaidoh than Rastelli patients had prior cardiac operations (n = 57 [48.7%] vs n = 102 [63.0%]; P = .004). Nikaidohs had longer median cardiopulmonary bypass time (227 [interquartile range (IQR), 167-299] minutes vs 175 [IQR, 133-225] minutes; P < .001) and median aortic cross-clamp times (131 [IQR, 91-175] minutes vs 105 [IQR, 82-141] minutes; P = .0015). Operative mortality was 3.1% (95% confidence interval [CI], 1.0%-7.0%; n = 5) for Rastelli, 4.4% (95% CI, 1.4%-9.9%; n = 5) for Nikaidoh, and 11.1% (95% CI, 0.3%-48.3%, n = 1) for REV. The rates of cardiac arrest, unplanned reoperation, mechanical circulatory support, prolonged ventilation, and permanent pacemaker placement were higher in the Nikaidoh population but with 95% CIs overlapping those of the other procedures. CONCLUSIONS: Rastelli and Nikaidoh procedures are the prevalent repair strategies for patients with DORV-TGA and TGA-VSD-LVOTO. Most are performed at high-volume institutions, and early outcomes are similar.

Association of Volume and Outcomes in 234 556 Patients Undergoing Surgical Aortic Valve Replacement.

BACKGROUND: The relationship between institutional volume and operative mortality after surgical aortic valve replacement (SAVR) remains unclear. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Aortic Prosthetic Valve Endocarditis: Analysis of The Society of Thoracic Surgeons Database.

BACKGROUND: This study sought to characterize the current US experience of aortic prosthetic valve endocarditis (PVE) compared with native valve endocarditis (NVE). METHODS: The Society of Thoracic Surgeons Database was queried for entries of active aortic infective endocarditis (IE). Two analyses were performed: (1) trends of surgical volume and operative mortality (2011-2019); and (2) descriptive and risk-adjusted comparisons between PVE and NVE (2014-2019) using multivariable logistic regression. RESULTS: From 2011 to 2019, there was a yearly increase in the proportion of PVE (20.9% to 25.9%; P < .001) with a concurrent decrease in operative mortality (PVE, 22.5% to 10.4%; P < .001; NVE, 10.9% to 8.5%; P < .001). From 2014 to 2019, active aortic IE was identified in 9768 patients (NVE, 6842; PVE, 2926). Aortic root abscess (50.1% vs 25.2%; P < .001), aortic root replacement (50.1% vs 12.8%; P < .001), homograft implantation (27.2% vs 4.1%; P < .001), and operative mortality (12.2% vs 6.4%; P < .001) were higher in PVE. After risk adjustment, PVE (odds ratio [OR], 1.5; 95% CI,1.16-1.94; P < .01), aortic root replacement (OR, 1.49; 95% CI,1.15-1.92; P < .001), Staphylococcus aureus (OR, 1.5; 95% CI,1.23-1.82; P < .001), and unplanned revascularization (OR, 5.83; 95% CI,4.12-8.23; P < .001) or mitral valve surgery (OR, 2.29; 95% CI,1.5-3.51; P < .001) correlated with a higher operative mortality, whereas prosthesis type (P = .68) was not an independent predictor. CONCLUSIONS: IE in the United States has risen over the past decade. However, operative mortality has decreased for both PVE and NVE. PVE, extension of IE requiring aortic root replacement, and additional unplanned surgical interventions carry an elevated mortality risk. Prosthesis selection did not affect operative mortality.