Longitudinal Follow-up of Medicare Patients after Esophageal Cancer Resection in the STS Database.

BACKGROUND: Understanding characteristics associated with survival following esophagectomy for cancer is critical to preoperative risk stratification. This study sought to define predictors for long-term survival following esophagectomy for cancer in Medicare patients. METHODS: The STS GTSD was queried for patients age>65 who underwent esophagectomy for cancer between 2012-2020 and linked to CMS data using a deterministic matching algorithm. Patient, hospital, and treatment variables were assessed using a multivariable Cox proportional hazards model to evaluate characteristics associated with long-term mortality and readmission. Kaplan-Meier and cumulative incidence curves were generated and differences evaluated using the Log-rank test and Gray's test respectively. RESULTS: After CMS linkage, 4,798 patients were included. 30-day and 90-day mortality in the study group was 3.84% and 7.45%, respectively. In the multivariable model, ASA>3, BMI>35, and diabetes were associated with increased mortality <90 days post-surgery, while pN/pT upstaging was associated with increased mortality >90 days post-surgery. Patients upstaged to pN(+) had a 147% increased mortality risk (aHR 2.47;95%CI2.02-3.02) and those that remained pN(+) a 75% increased mortality risk (aHR 1.75;95%CI1.57-1.95) compared to down-staged patients. Patients who were pT upstaged had a 109% (aHR 2.09;95%CI1.73-2.53) increased mortality risk compared to pT downstaged patients. Risk for readmission was independent of procedure type or approach and was higher in cStage>2, ASA>4, and pN+. CONCLUSIONS: Medicare patients undergoing esophagectomy for cancer have identifiable patient-specific predictors for short-term mortality and tumor-specific predictors for long-term mortality and readmission. In the absence of pathologic T and N downstaging, risk for long-term mortality and readmission are increased.

Anesthetic Choice for Percutaneous Transcatheter Closure of the Left Atrial Appendage: A National Anesthesia Clinical Outcomes Registry Analysis.

CONTEXT: Left atrial appendage closure (LAAC) was developed as a novel stroke prevention alternative for patients with atrial fibrillation, particularly for those not suitable for long-term oral anticoagulant therapy. Traditionally, general anesthesia (GA) has been more commonly used primarily due to the necessity of transesophageal echocardiography. AIMS: Compare trends of monitored anesthesia care (MAC) versus GA for percutaneous transcatheter LAAC with endocardial implant and assess for independent variables associated with primary anesthetic choice. SETTINGS AND DESIGN: Multi-institutional data collected from across the United States using the National Anesthesia Clinical Outcomes Registry. MATERIAL AND METHODS: Retrospective data analysis from 2017-2021. STATISTICAL ANALYSIS USED: Independent-sample t tests or Mann-Whitney U tests were used for continuous variables and Chi-square tests or Fisher's exact test for categorical variables. Multivariate logistic regression was used to assess patient and hospital characteristics. RESULTS: A total of 19,395 patients underwent the procedure, and 352 patients (1.8%) received MAC. MAC usage trended upward from 2017-2021 (P < 0.0001). MAC patients were more likely to have an American Society of Anesthesiologists (ASA) physical status of≥ 4 (33.6% vs 22.89%) and to have been treated at centers in the South (67.7% vs 44.2%), in rural locations (71% vs 39.5%), and with lower median annual percutaneous transcatheter LAAC volume (102 vs 153 procedures) (all P < 0.0001). In multivariate analysis, patients treated in the West had 85% lower odds of receiving MAC compared to those in the Northeast (AOR: 0.15; 95% CI 0.03-0.80, P = 0.0261). CONCLUSIONS: While GA is the most common anesthetic technique for percutaneous transcatheter closure of the left atrial appendage, a small, statistically significant increase in MAC occurred from 2017-2021. Anesthetic management for LAAC varies with geographic location.

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.

Anesthetic Management for Ventricular Tachycardia Ablation: A National Anesthesia Clinical Outcomes Registry Analysis.

OBJECTIVES: The authors analyzed anesthetic management trends during ventricular tachycardia (VT) ablation, hypothesizing that (1) monitored anesthesia care (MAC) is more commonly used than general anesthesia (GA); (2) MAC uses significantly increased after release of the 2019 Expert Consensus Statement on Catheter Ablation of Ventricular Arrhythmias; and (3) anesthetic approach varies based on patient and hospital characteristics. DESIGN: Retrospective study. SETTING: National Anesthesia Clinical Outcomes Registry data. PARTICIPANTS: Patients 18 years or older who underwent elective VT ablation between 2013 and 2021. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Covariates were selected a priori within multivariate models, and interrupted time-series analysis was performed. Of the 15,505 patients who underwent VT ablation between 2013 and 2021, 9,790 (63.1%) received GA. After the 2019 Expert Consensus Statement on Catheter Ablation of Ventricular Arrhythmias supported avoidance of GA in idiopathic VT, no statistically significant increase in MAC was evident (immediate change in intercept post-consensus statement release adjusted odds ratio 1.41, p = 0.1629; change in slope post-consensus statement release adjusted odds ratio 1.06 per quarter, p = 0.1591). Multivariate analysis demonstrated that sex, American Society of Anesthesiologists physical status, age, and geographic location were statistically significantly associated with the anesthetic approach. CONCLUSIONS: GA has remained the primary anesthetic type for VT ablation despite the 2019 Expert Consensus Statement on Catheter Ablation of Ventricular Arrhythmias suggested its avoidance in idiopathic VT. Achieving widespread clinical practice change is an ongoing challenge in medicine, emphasizing the importance of developing effective implementation strategies to facilitate awareness of guideline release and subsequent adherence to and adoption of recommendations.