Follow-up compliance in patients undergoing abdominal aortic aneurysm repair at Veterans Affairs hospitals.

OBJECTIVE: The Society for Vascular Surgery guidelines recommend annual imaging surveillance following endovascular aneurysm repair (EVAR) and every 5 years following open surgical repairs (OSR) of abdominal aortic aneurysms (AAAs). Adherence to these guidelines is low outside of clinical trials, and compliance at Veterans Affairs (VA) hospitals is not yet well-established. We examined imaging follow-up compliance and mortality rates after AAA repair at VA hospitals. METHODS: We queried the VA Surgical Quality Improvement Program database for elective infrarenal AAA repairs, EVAR and OSR, then merged in follow-up imaging and mortality information. Mortality rate over time was derived using Kaplan-Meier estimation. Generalized estimating equation with a logit link and a sandwich standard error estimate was performed to compare the probability of having annual follow-up imaging over time between procedure types and to identify variables associated with follow-up imaging for EVAR patients. RESULTS: Our analysis included 11,668 patients who underwent EVAR and 4507 patients who underwent OSR at VA hospitals between the years 2000 and 2019. The 30-day mortality rate for EVAR and OSR was 0.37% and 0.82%, respectively. OSR was associated with lower long-term mortality after adjusting age, sex, American Society of Anesthesiologists classification and preoperative renal failure with an adjusted hazard ratio of 0.88 (95% confidence interval, 0.84-0.92; P < .01). Of surviving patients, the follow-up imaging rate was 69.1% by 1 year post-EVAR. The follow-up rate after 5 years was 45.6% post-EVAR compared with 63.6% post-OSR of surviving patients. A history of smoking or drinking, baseline hypertension, and known cardiac disease were independently associated with poor follow-up after EVAR. CONCLUSIONS: Patients undergoing elective open AAA repair in the VA hospital system had lower long-term mortality compared with patients who underwent endovascular repair. Compliance with post-EVAR imaging is low. Patient factors associated with poor post-EVAR imaging surveillance were smoking within the last year, excess alcohol consumption, and cardiac risk factors including hypertension, prior myocardial infarction, and congestive heart failure.

Neighborhood social vulnerability and disparities in time to kidney cancer surgical treatment and survival in Arizona.

BACKGROUND: Hispanics and American Indians (AI) have high kidney cancer incidence and mortality rates in Arizona. This study assessed: (1) whether racial and ethnic minority patients and patients from neighborhoods with high social vulnerability index (SVI) experience a longer time to surgery after clinical diagnosis, and (2) whether time to surgery, race and ethnicity, and SVI are associated with upstaging to pT3/pT4, disease-free survival (DFS), and overall survival (OS). METHODS: Arizona Cancer Registry (2009-2018) kidney and renal pelvis cases (n = 4592) were analyzed using logistic regression models to assess longer time to surgery and upstaging. Cox-regression hazard models were used to test DFS and OS. RESULTS: Hispanic and AI patients with T1 tumors had a longer time to surgery than non-Hispanic White patients (median time of 56, 55, and 45 days, respectively). Living in neighborhoods with high (≥75) overall SVI increased odds of a longer time to surgery for cT1a (OR 1.54, 95% CI: 1.02-2.31) and cT2 (OR 2.32, 95% CI: 1.13-4.73). Race and ethnicity were not associated with time to surgery. Among cT1a patients, a longer time to surgery increased odds of upstaging to pT3/pT4 (OR 1.95, 95% CI: 0.99-3.84). A longer time to surgery was associated with PFS (HR 1.52, 95% CI: 1.17-1.99) and OS (HR 1.63, 95% CI: 1.26-2.11). Among patients with cT2 tumor, living in high SVI neighborhoods was associated with worse OS (HR 1.66, 95% CI: 1.07-2.57). CONCLUSIONS: High social vulnerability was associated with increased time to surgery and poor survival after surgery.

The impact of gender, race, and ethnicity on bariatric surgery outcomes.

BACKGROUND: The rates of postoperative complications can vary among specific patient populations. OBJECTIVES: The aim of this study is to examine how gender, race, and ethnicity can affect short-term postoperative complications in bariatric surgery patients. SETTING: United States. METHODS: Patients who underwent bariatric surgery between the years 2016 and 2021 were included and stratified based on gender, race/ethnicity, and procedure type. The 30-day outcomes were assessed using Clavien-Dindo (CD) classification of III-V. Wilcoxon rank-sum test was performed to compare continuous variables among groups and Chi-squared test for categorical variables. Logistic regression was performed to examine the effects of gender, race/ethnicity on CD classification ≥ III complications by the procedure type. RESULTS: A total of 975,642 bariatric surgery patients were included. Descriptive univariate analysis showed that CD ≥ III complications were higher among non-Hispanic blacks (NHB) and lowest in Hispanic patients, regardless of their gender, except in the duodenal switch DS group, where non-Hispanic whites (NHW) had the lowest complication rate. There was no difference between male and female patients with regards to postoperative complications, except in the sleeve gastrectomy (SG) group, where NHW males had more complications than NHW females. Sleeve gastrectomy showed the lowest complication rates followed by gastric bypass and DS in all groups. In multivariate logistic regression model, for both females and males NHBs had higher odds of postoperative complications compared to NHWs in sleeve gastrectomy (Female aOR:1.31, 95% CI: [1.23-1.40]; Male aOR:1.24, 95% CI: [1.08-1.43], P < .001) and gastric bypass (Female aOR:1.24, 95% CI: [1.16-1.33]; Male aOR:1.25, 95% CI: [1.06-1.48], P < .01). CONCLUSIONS: Non-Hispanic Black patients are at a higher rate of developing CD ≥ III complications compared to non-Hispanic Whites after bariatric surgery. The male gender was not a significant risk factor for serious postoperative complications. Among the different types of bariatric procedures, sleeve gastrectomy has the lowest rates of severe complications, followed by gastric bypass and duodenal switch. These results highlight the significance of considering gender, race, ethnicity, and procedure type during preoperative evaluation, surgical planning, and postoperative care.

Carotid Revascularization is Associated with Improved Mood in Patients with Advanced Carotid Disease.

OBJECTIVE: To investigate the impact of carotid interventions on patients' mental condition in patients with carotid stenosis. SUMMARY BACKGROUND DATA: Ongoing research highlights the impact of carotid interventions on neurocognitive function in patients with advanced carotid atherosclerosis. However, data regarding the impact of carotid revascularization on mood is scarce. METHODS: A total of 157 patients undergoing carotid revascularization were prospectively recruited. The primary outcome was depression, evaluated pre-operatively, and at 1-,6- and 12-month post-intervention using the long form of the geriatric depression scale (GDS-30) questionnaire. Other tests were also used to assess cognition at the respective timepoints. Statistical analyses were performed to assess the postoperative outcomes compared to baseline. RESULTS: Baseline depression (GDS>9) was observed in 49(31%) subjects, whereas 108(69%) patients were not depressed (GDS≤9). The average pre-operative GDS score was 15.42 ± 4.40(14.2-16.7) and 4.28 ±2.9(3.7-4.8) in the depressed and non-depressed groups, respectively. We observed a significant improvement in GDS scores within the depressed group at 1-month (P=0.002), 6-months (P=0.027), and 1-year (P<0.001) post-intervention compared to preop, whereas the non-depressed group had similar post-op GDS scores at all time points compared to baseline. Significant improvement in measures of executive function was seen in non-depressed patients at all three timepoints whereas depressed patients showed an improvement at 1-year follow-up. CONCLUSIONS: Our study highlights improvement in mood among patients with advanced carotid disease who screened positive for depression at baseline. Further studies with larger sample sizes are warranted to investigate the association between depression, carotid disease, and carotid intervention.

Early versus delayed coronary angiography in patients with out-of-hospital cardiac arrest and no ST-segment elevation: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Recent randomized controlled trials did not show benefit of early/immediate coronary angiography (CAG) over a delayed/selective strategy in patients with out-of-hospital cardiac arrest (OHCA) and no ST-segment elevation. However, whether selected subgroups, specifically those with a high pretest probability of coronary artery disease may benefit from early CAG remains unclear. METHODS: We included all randomized controlled trials that compared a strategy of early/immediate versus delayed/selective CAG in OHCA patients and no ST elevation and had a follow-up of at least 30 days. The primary outcome of interest was all-cause death. Odds ratios (OR) were calculated and pooled across trials. Interaction testing was used to assess for heterogeneity of treatment effects. RESULTS: In total, 1512 patients (67 years, 26% female, 23% prior myocardial infarction) were included from 5 randomized controlled trials. Early/immediate versus delayed/selective CAG was not associated with a statistically significant difference in odds of death (OR 1.12, 95%-CI 0.91-1.38), with similar findings for the composite outcome of all-cause death or neurological deficit (OR 1.10, 95%-CI 0.89-1.36). There was no effect modification for death by age, presence of a shockable initial cardiac rhythm, history of coronary artery disease, presence of an ischemic event as the presumed cause of arrest, or time to return of spontaneous circulation (all P-interaction > 0.10). However, early/immediate CAG tended to be associated with higher odds of death in women (OR 1.52, 95%-CI 1.00-2.31, P = 0.050) than in men (OR 1.04, 95%-CI 0.82-1.33, P = 0.74; P-interaction 0.097). CONCLUSION: In OHCA patients without ST-segment elevation, a strategy of early/immediate versus delayed/selective CAG did not reduce all-cause mortality across major subgroups. However, women tended to have higher odds of death with early CAG.

First Assistant In Bariatric Surgery: A Comparison Between Laparoscopic And Robotic Approaches: A 4-Year Analysis of the MBSAQIP Database (2016-2019).

PURPOSE: The first assistant (FA) plays an important role in the operating room for bariatric surgery. The aim of this study was to examine the relationship between the type of FA and operative time (OT) and postoperative outcomes comparing robotic and laparoscopic approaches in bariatric surgery. METHODS AND MATERIALS: The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) data for 2016-2019 was queried. Log-normal regression was performed to evaluate the association of FAs and OT variations within and between groups. We used logistic regression to examine the relationship between the type of FA and 30-day outcomes across all procedures and approaches. RESULTS: A total of 691,789 patients who underwent robotic (R), and laparoscopic (L) sleeve gastrectomy (SG), Roux-en-Y gastric-bypass (RYGB), and duodenal switch (DS) were included. The percentage variation of OT was higher in the laparoscopic group (L-SG: 8.18%, L-RYGB: 9.88%, and L-DS: 15.00%) compared to the robotic group (R-SG: 2.43%, R-RYGB: 5.76%, and R-DS: 0.80%). There was not a significant difference in 30-day outcomes between laparoscopic and robotic approaches for the same procedures. CONCLUSIONS: The FA was associated with a decreased variability in OT in the robotic cohort compared to the laparoscopic group with no significant difference in complication rates. These results suggest that the robotic approach may decrease the need for skilled FAs in bariatric procedures.

The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.

STUDY OBJECTIVES: Children with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA). Current OSA treatments have limited effectiveness in this population. We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome. METHODS: Children ages 6-7 years old with Down syndrome and OSA participated in a double-blind crossover clinical trial evaluating two dose regimens of ato-oxy. Participants received low-dose ato-oxy (0.5 mg/kg atomoxetine and 5 mg oxybutynin) and high-dose ato-oxy (1.2 mg/kg atomoxetine and 5 mg oxybutynin) for 1 month in random order. The primary study outcome was change in obstructive apnea-hypopnea index. Health-related quality of life as measured by the OSA-18 as well as changes in sleep architecture were secondary outcomes. RESULTS: Fifteen participants qualified for randomization and 11 participants had complete data at all points. Baseline obstructive apnea-hypopnea index was 7.4 ± 3.7 (mean ± standard deviation), obstructive apnea-hypopnea index with low-dose ato-oxy was 3.6 ± 3.3 (P = .001 vs baseline), and obstructive apnea-hypopnea index with high-dose ato-oxy was 3.9 ± 2.8 (P = .003 vs baseline). No significant sleep architecture differences were present with ato-oxy. No significant difference in OSA-18 score was present. OSA-18 total score was 51 ± 19 at baseline, 45 ± 17 (P = .09) at the end of 4 weeks of low-dose ato-oxy, and 45 ± 16 (P = .37) at the end of high-dose ato-oxy therapy. The most common adverse effects were irritability and fatigue, and these were generally mild. CONCLUSIONS: Ato-oxy is a promising treatment for OSA in children with Down syndrome. CLINICAL TRIAL REGISTRATION: Registry: Clinicaltrials.gov; Name: Medications for Obstructive Sleep Apnea In Children With Down Syndrome (MOSAIC); URL: https://clinicaltrials.gov/ct2/show/NCT04115878; Identifier: NCT04115878. CITATION: Combs D, Edgin J, Hsu C-H, et al. The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome. J Clin Sleep Med. 2023;19(12):2065-2073.

Cognitive effects of carotid revascularization in octogenarians.

BACKGROUND: Cognitive impairment is the epitome of cerebrovascular diseases, causing a significant economic burden on our health care system. Growing evidence has indicated the benefits of carotid interventions in patients with severe carotid atherosclerosis. However, the neurocognitive outcome of carotid revascularization in octogenarians is not clearly understood. We aim to evaluate postintervention cognitive changes in seniors older than 80 years. METHODS: We prospectively recruited 170 patients undergoing carotid interventions. Neurocognitive testing was performed preoperatively and at 1, 6, and 12 months postoperatively. Episodic memory was assessed with Rey's Auditory Verbal Learning Test. Other executive functions and language measures were also evaluated at individual time points. Raw test scores were converted to z-scores or scaled scores adjusted for age and education. The sample was divided into 2 groups based on age: octogenarian (≥80 years) and nonoctogenarian (<80 years old). Postoperative cognitive scores were compared to baseline within each subcohort. RESULTS: A total of 23 subjects (13%) were octogenarians, and 147 (87%) were younger than 80 years. Younger patients demonstrated significant cognitive improvements up to 12 months postop compared to the baseline. However, octogenarians exhibited a lack of improvement in verbal memory, measures of executive function, and language at all 3 postintervention time points. CONCLUSION: Carotid interventions improve cognitive functions in younger patients with carotid occlusive atherosclerosis. However, no cognitive benefits were seen in male seniors older than 80 years. Further investigations are warranted to better understand the postinterventional cognitive changes in octogenarians.

Examining health care access disparities in Hispanic populations with peripheral artery disease and diabetes.

INTRODUCTION: This study investigated disparities in health care access for Hispanic adults with diabetes and peripheral artery disease (PAD) who are at risk of lower-extremity amputation and other cardiovascular morbidities and mortalities. METHODS: We utilized the health care access survey data from the All of Us research program to examine adults (⩾ 18 years) with either diabetes and/or PAD. The primary associations evaluated were: could not afford medical care and delayed getting medical care in the past 12 months. Multivariable logistic regression models were used to assess the association of Hispanic ethnicity and survey responses, adjusting for age, sex, income, health insurance, and employment status. RESULTS: Among 24,104 participants, the mean age was 54.9 years and 67% were women. Of these, 8.2% were Hispanic adults. In multivariable analysis, Hispanic adults were more likely to be unable to afford seeing a health care provider, and receiving emergency care, follow-up care, and prescription medications (p < 0.05) than non-Hispanic adults. Furthermore, Hispanic adults were more likely to report being unable to afford medical care due to cost (odds ratios [OR] 1.72, 95% CI 1.50-1.99), more likely to purchase prescription drugs from another country (OR 2.20, 95% CI 1.69-2.86), and more likely to delay getting medical care due to work (OR 1.46, 95% CI 1.22-1.74) and child care (OR 1.80, 95% CI 1.35-2.39) issues than non-Hispanic White adults. CONCLUSION: The Hispanic population with diabetes and PAD faces substantial barriers in health care access, including a higher likelihood of delaying medical care and being unable to afford it.

Gemcitabine as first-line therapy for high-grade non-muscle invasive bladder cancer: results from a tertiary center in the contemporary BCG-shortage era.

Background: To evaluate the safety profile and efficacy of intravesical gemcitabine as first-line adjuvant therapy for non-muscle invasive bladder cancer (NMIBC) in the setting of ongoing Bacillus Calmette-Guérin (BCG) shortage. Methods: We performed an institutional, retrospective review of patients treated with intravesical gemcitabine induction and maintenance therapy from March 2019 to October 2021. Patients with intermediate or high-risk NMIBC who were BCG-naïve or experienced a high-grade (HG) recurrence after 12 months since the last dose of BCG were included in the analysis. The primary endpoint was complete response (CR) rate at the 3-month visit. Secondary endpoints were recurrence-free survival (RFS) and assessment of adverse events. Results: A total of 33 patients were included. All had HG disease and 28 (84.8%) were BCG-naive. The median follow-up was 21.4 months (range, 4.1-39.4). Tumor stages were cTa in 39.4%, cT1 in 54.5%, and cTis in 6.1% of patients. Most patients (90.9%) were in the AUA high-risk category. The 3-month CR was 84.8%. Among patients who achieved CR with adequate follow-up, 86.9% (20/23) remained disease-free at 6 months. The 6-month and 12-month RFS were 87.2% and 76.5%, respectively. The estimated median RFS was not reached. Approximately 78.8% of patients were able to complete full induction. Common adverse events (incidence ≥10%) included dysuria and fatigue/myalgia. Conclusions: Intravesical gemcitabine for intermediate and high-risk NMIBC in areas where BCG supply is limited was safe and feasible at short-term follow-up. Larger prospective studies are needed to better ascertain the oncologic efficacy of gemcitabine.

Feasibility of 5-fluorouracil and imiquimod for the topical treatment of cervical intraepithelial neoplasias (CIN) 2/3.

OBJECTIVES: To determine the feasibility (as measured by tolerability and safety) and efficacy of topical 5-fluorouracil (5-FU) and imiquimod for the treatment of cervical intraepithelial neoplasia (CIN) 2/3. METHODS: This pilot prospective study was conducted in women aged 18-45 years with p16+ CIN 2/3. Participants underwent an 8-week alternating regimen of self-applied 5% 5-FU on weeks 1, 3, 5, and 7 and physician-applied imiquimod on weeks 2, 4, 6, and 8. Adverse events (AEs) were collected by symptom diary and clinical exam. Feasibility was measured by tolerability and safety (AEs) of the study intervention. Tolerability was assessed as the number of participants able to apply 50% or more of the treatment doses. The safety outcome was calculated as the number of participants who experienced "specified AEs" defined as possibly, probably, or definitely related grade 2 or worse AE or grade 1 genital AEs (blisters, ulcerations, or pustules) lasting more than 5 days. The efficacy of the intervention was determined by histology and high-risk human papillomavirus (hrHPV) testing was done after treatment. RESULTS: The median age of the 13 participants was 27 ± 2.9 years. Eleven (84.61%) participants applied 50% or more of the treatment. All participants reported grade 1 AEs; 6 (46.15%) reported grade 2 AEs; and 0 reported grade 3/4 AEs. Three (23.08%) participants had specified AEs. Histologic regression to normal or CIN 1 among those completing 50% or more of the treatment doses was observed in 10 (90.91%) participants, and 7 (63.63%) tested negative for hr-HPV at the end of the study. CONCLUSIONS: Topical treatment for CIN 2/3 with 5-FU/imiquimod is feasible, with preliminary evidence of efficacy. Topical therapies need further investigation as adjuncts or alternatives to surgical therapy for CIN 2/3.

Robotic Bariatric Surgery in Older Adults, Is It Safer Than the Laparoscopic Approach? A 7-Year Analysis of Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Database.

BACKGROUND: Utilization of the robotic platform in bariatric surgery has increased over the past several years. The population of older adults who benefit from bariatric surgery is also growing. This study evaluated the safety of robotic-assisted bariatric surgery in older adults using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) Database. METHODS: Adults who underwent gastric bypass or sleeve gastrectomy and were ≥ 65 years old between the years 2015 and 2021 were included. The 30-day outcomes were assessed and stratified based on Clavien-Dindo (CD) classification of III-V. Univariable and multivariable logistic regressions were performed to identify predictors of CD ≥ III complications. RESULTS: A total of 62,973 bariatric surgery patients were included. Most of the patients (90%) underwent laparoscopic surgery, and the remainder (10%) underwent robotic surgery. Robotic sleeve gastrectomy (R-SG) was associated with lower odds of developing CD ≥ III complications compared to three other procedures (adjusted odds ratio (aOR), 0.741; confidence interval (CI), 0.584-0.941; p 0.014). CONCLUSIONS: Bariatric surgery using a robotic approach is considered safe for older patients. Robotic sleeve gastrectomy (R-SG) has the lowest morbidity and mortality rates compared to laparoscopic sleeve gastrectomy (L-SG), laparoscopic Roux-en-Y gastric bypass (L-RYGB), and robotic Roux-en-Y gastric bypass (R-RYGB). The findings of this study can help surgeons and their elderly patients to make informed decisions regarding the safety of different bariatric surgical approaches.

HPV16/18 Antibody Responses After a Single Dose of Nonavalent HPV Vaccine.

OBJECTIVES: A single dose of human papillomavirus (HPV) vaccine would simplify logistics and reduce costs of vaccination programs worldwide. We conducted a phase IIa trial to determine the stability of HPV type-specific antibody responses after a single dose of the nonavalent HPV vaccine, Gardasil9. METHODS: Two hundred-and-one healthy 9 to 11-year-old girls and boys were enrolled at 2 centers in the United States to receive a prime dose of the nonavalent vaccine at baseline, a delayed dose at month 24, and an optional third dose at month 30. Blood samples were collected to measure HPV type-specific antibodies at baseline and at 6, 12, 18, 24, and 30 months after the prime dose. The primary outcomes were serum HPV16 and HPV18 antibody responses. RESULTS: In both girls and boys, geometric mean concentrations of HPV16 and HPV18 antibodies increased at 6 months, declined between months 6 to 12, and then remained stable and high (at 20- and 10-times those at baseline for HPV16 and HPV18, respectively) throughout months 12, 18, and 24 (prebooster) visits. Both HPV16 and HPV18 antibody responses demonstrated anamnestic boosting effect at 30-months after the delayed (24-month) booster dose. CONCLUSIONS: A single dose of the nonavalent HPV vaccine induced persistent and stable HPV16 and HPV18 antibody responses up to 24 months. This study contributes important immunogenicity data to inform feasibility of the single dose HPV vaccination paradigm. Further research is needed to assess the long-term antibody stability and individual clinical and public health benefit of the single dose schedule.

Testing the Efficacy of a Scalable Telephone-Delivered Guided Imagery Tobacco Cessation Treatment: Protocol for a Randomized Clinical Trial.

BACKGROUND: Tobacco use continues to be a leading preventable cause of death and disease in the United States, accounting for >480,000 deaths each year. Although treatments for tobacco use are effective for many, there is substantial variability in outcomes, and these approaches are not effective for all individuals seeking to quit smoking cigarettes. New, effective therapeutic approaches are needed to meet the preferences of people who want to stop smoking. Guided imagery (GI) is a mind-body technique that involves the guided visualization of specific mental images, which is enhanced with other sensory modalities and emotions. Preliminary evidence provides initial support for the use of GI as a treatment for cigarette smoking. Meta-analyses have shown that standard treatment for cigarette smoking delivered over the telephone via quitlines is effective. A telephone-based intervention that uses GI might provide another effective treatment option and increase the reach and effectiveness of quitlines. OBJECTIVE: This study aims to test the efficacy of Be Smoke Free, a telephone-delivered GI treatment for smoking cessation. METHODS: This multisite randomized clinical trial (RCT) will compare a novel telephone-delivered GI tobacco cessation treatment with a standard evidence-based behavioral treatment. The study will be conducted over 5 years. In phase 1, we refined protocols and procedures for the New York State and West Virginia sites for use in the RCT. During phase 2, we will conduct an RCT with 1200 participants: 600 (50%) recruited via quitlines and 600 (50%) recruited via population-based methods. Participants will be randomly assigned to either the GI condition or the behavioral condition; both treatments will be delivered by trained study coaches located at the University of Arizona. Assessments will be conducted at baseline and 3 and 6 months after enrollment by University of Arizona research staff. The primary outcome will be self-reported 30-day point prevalence abstinence 6 months after enrollment. Secondary outcomes include biochemically verified 7-day point prevalence abstinence 6 months after enrollment. RESULTS: Recruitment in West Virginia and New York began in October 2022. As of March 31, 2023, a total of 242 participants had been enrolled. Follow-up assessments began in November 2022. As of March 31, 2023, of the 118 eligible participants, 97 (82.2%) had completed the 3-month assessment, and 93% (26/28) of eligible participants had completed the 6-month assessment. Biochemical verification and qualitative interviews began in April 2023. Recruitment will continue through 2025 and follow-up assessments through 2026. Primary results are expected to be published in 2027. CONCLUSIONS: The Be Smoke Free study is a first-of-its-kind RCT that incorporates GI into telephone-based tobacco cessation treatment. If successful, Be Smoke Free will have substantial benefits for the long-term health of people who use tobacco across the United States. TRIAL REGISTRATION: ClinicalTrials.gov NCT05277831; https://clinicaltrials.gov/ct2/show/NCT05277831. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/48898.

Gastric Cancer Surgery in the US: a Contemporary Trend Analysis of Lymphadenectomy and the Impact of Minimally Invasive Approaches.

BACKGROUND: The National Comprehensive Cancer Network guidelines recommend harvesting 16 or more lymph nodes for the adequate staging of gastric adenocarcinoma. This study examines the rate of adequate lymphadenectomy over recent years, its predictors, and its impact on overall survival(OS). STUDY DESIGN: The National Cancer Database was utilized to identify patients who underwent surgical treatment for gastric adenocarcinoma between 2006-2019. Trend analysis was performed for lymphadenectomy rates during the study period. Logistic regression, Kaplan-Meier survival plots, and Cox proportional hazard regression were utilized. RESULTS: A total of 57,039 patients who underwent surgical treatment for gastric adenocarcinoma were identified. Only 50.5% of the patients underwent a lymphadenectomy of ≥ 16 nodes. Trend analysis showed that this rate significantly improved over the years, from 35.1% in 2006 to 63.3% in 2019 (p < .0001). The main independent predictors of adequate lymphadenectomy included high-volume facility with ≥ 31 gastrectomies/year (OR: 2.71; 95%CI:2.46-2.99), surgery between 2015-2019 (OR: 1.68; 95%CI: 1.60-1.75), and preoperative chemotherapy (OR:1.49; 95%CI:1.41-1.58). Patients with adequate lymphadenectomy had better OS than patients who did not: median survival: 59 versus 43 months (Log-Rank: p < .0001). Adequate lymphadenectomy was independently associated with improved OS (HR:0.79; 95%CI:0.77-0.81). Laparoscopic and robotic gastrectomies were independently associated with adequate lymphadenectomy compared to open, OR: 1.11, 95%CI:1.05-1.18 and OR: 1.24, 95%CI:1.13-1.35, respectively. CONCLUSION: Although the rate of adequate lymphadenectomy improved over the study period, a large number of patients still lacked adequate lymph node dissection, negatively impacting their OS despite multimodality therapy. Laparoscopic and robotic surgeries were associated with a significantly higher rate of lymphadenectomy ≥ 16 nodes.

The Impact of Metabolic Syndrome on the Prognosis of High-Risk Alcoholic Hepatitis Patients: Redefining Alcoholic Hepatitis.

Background: Alcoholic hepatitis (AH) is characterized by acute symptomatic hepatitis associated with heavy alcohol use. This study was designed to assess the impact of metabolic syndrome on high-risk patients with AH with discriminant function (DF) score ≥ 32 and its effect on mortality. Methods: We searched the hospital database for ICD-9 diagnosis codes of acute AH, alcoholic liver cirrhosis, and alcoholic liver damage. The entire cohort was categorized into two groups: AH and AH with metabolic syndrome. The effect of metabolic syndrome on mortality was evaluated. Also, an exploratory analysis was used to create a novel risk measure score to assess mortality. Results: A large proportion (75.5%) of the patients identified in the database who had been treated as AH had other etiologies and did not meet the American College of Gastroenterology (ACG)-defined diagnosis of acute AH, thus had been misdiagnosed as AH. Such patients were excluded from analysis. The mean body mass index (BMI), hemoglobin (Hb), hematocrit (HCT), and alcoholic liver disease/non-alcoholic fatty liver disease index (ANI) were significantly different between two groups (P < 0.05). The results of a univariate Cox regression model showed that age, BMI, white blood cells (WBCs), creatinine (Cr), international normalized ratio (INR), prothrombin time (PT), albumin levels, albumin < 3.5, total bilirubin, Na, Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), MELD ≥ 21, MELD ≥ 18, DF score, and DF ≥ 32 had a significant effect on mortality. Patients with a MELD greater than 21 had a hazard ratio (HR) (95% confidence interval (CI) of 5.81 (2.74 - 12.30) (P < 0.001). The adjusted Cox regression model results showed that age, Hb, Cr, INR, Na, MELD score, DF score, and metabolic syndrome were independently associated with high patient mortality. However, the increase in BMI and mean corpuscular volume (MCV) and sodium significantly reduced the risk of death. We found that a model including age, MELD ≥ 21, and albumin < 3.5 was the best model in identifying patient mortality. Our study showed that patients admitted with a diagnosis of alcoholic liver disease with metabolic syndrome had an increased mortality risk compared to patients without metabolic syndrome, in high-risk patients with DF ≥ 32 and MELD ≥ 21. A bivariate correlation analysis revealed that patients with AH with metabolic syndrome were more likely to have infection (43%) compared to AH (26%) with correlation coefficient of 0.176 (P = 0.03, CI: 0.018 - 1.0). Conclusion: In clinical practice, the diagnosis of AH is inaccurately applied. Metabolic syndrome significantly increases the mortality risk in high-risk AH. It signifies that the presence of features of metabolic syndrome modifies the behavior of AH in acute settings, warranting different therapeutic strategies. We propose that in defining AH, patients overlapping with metabolic syndrome may need to be excluded as their outcome is different with regard to risk of renal dysfunctions, infections and death.

A multiple imputation-based sensitivity analysis approach for regression analysis with a missing not at random covariate.

Missing covariate problems are common in biomedical and electrical medical record data studies while evaluating the relationship between a biomarker and certain clinical outcome, when biomarker data are not collected for all subjects. However, missingness mechanism is unverifiable based on observed data. If there is a suspicion of missing not at random (MNAR), researchers often perform sensitivity analysis to evaluate the impact of various missingness mechanisms. Under the selection modeling framework, we propose a sensitivity analysis approach with a standardized sensitivity parameter using a nonparametric multiple imputation strategy. The proposed approach requires fitting two working models to derive two predictive scores: one for predicting missing covariate values and the other for predicting missingness probabilities. For each missing covariate observation, the two predictive scores along with the pre-specified sensitivity parameter are used to define an imputing set. The proposed approach is expected to be robust against mis-specifications of the selection model and the sensitivity parameter since the selection model and the sensitivity parameter are not directly used to impute missing covariate values. A simulation study is conducted to study the performance of the proposed approach when MNAR is induced by Heckman's selection model. Simulation results show the proposed approach can produce plausible regression coefficient estimates. The proposed sensitivity analysis approach is also applied to evaluate the impact of MNAR on the relationship between post-operative outcomes and incomplete pre-operative Hemoglobin A1c level for patients who underwent carotid intervetion for advanced atherosclerotic disease.

Post Treatment Mastalgia is a Common Complaint but not an Indication of Recurrence or Second Primary Breast Cancer.

BACKGROUND: Post-treatment mastalgia is a common complaint in up to 68% of patients after treatment. This symptom is worrisome to patients as many believe it is a sign of recurrence. The current study was performed to evaluate if post-treatment mastalgia is associated with a second breast cancer diagnosis. MATERIALS AND METHODS: Patients included were seen from January 1, 2000 to December 31, 2020. All patients who were treated for breast cancer and then presented with breast pain during follow up were considered to have post-treatment mastalgia. All patients who were diagnosed with a second breast cancer but did not experience post-treatment mastalagia were also evaluated. RESULTS: 1799 patients had a mean age 52.9 years. 36% of patients experienced post-treatment mastalgia. Of patients who complained of post-treatment mastalgia, 19 were diagnosed with a chest wall recurrence (CW), ipsilateral breast tumor recurrence (IBTR), or contralateral breast cancer (CBC). 17 of the 19 patients had breast pain after the second diagnosis and treatment were completed. The average duration between their second diagnosis and initial complaint of breast pain was 6.2 years. The two patients who complained of breast pain prior to their second diagnosis did not have mastalgia at the time of their second diagnosis. Local recurrence or contralateral breast cancer were more common in patients without post treatment mastalgia (10.1% vs 0.3%, p < 0.0001) during follow up. CONCLUSION: Post treatment mastalgia is not associated with recurrence. Interval or repeat imaging does not appear necessary and instead patient education and reassurance are important in its management.

A Phase 2, Double-blind, Randomized Controlled Trial of PROSTVAC in Prostate Cancer Patients on Active Surveillance.

BACKGROUND: There is an unmet clinical need for interventions to prevent disease progression in patients with localized prostate cancer on active surveillance (AS). OBJECTIVE: To determine the immunologic response to the PROSTVAC vaccine and the clinical indicators of disease progression in patients with localized prostate cancer on AS. DESIGN, SETTING, AND PARTICIPANTS: This was a phase 2, double-blind, randomized controlled trial in 154 men with low- or intermediate-risk prostate cancer on AS. INTERVENTION: Participants were randomized (2:1) to receive seven doses of subcutaneous PROSTVAC, a vaccinia/fowlpox viral vector-based immunotherapy containing a prostate-specific antigen (PSA) transgene and three T-cell co-stimulatory molecules, or an empty fowlpox vector (EV) over 140 d. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary outcome was the change from baseline in CD4 and CD8 T-cell infiltration in biopsy tumor tissue. Key secondary outcomes were safety and changes in prostate biopsy tumor pathology, peripheral antigen-specific T cells, and serum PSA. Continuous variables were compared using nonparametric tests. Categorical variables were compared using Fisher's exact test. RESULTS AND LIMITATIONS: The PROSTVAC/EV vaccination was well tolerated. All except one participant completed the vaccination series. Changes in CD4 or CD8 density in biopsy tumor tissue did not differ between the PROSTVAC and EV arms. The proportions of patients with Gleason upgrading to grade group 3 after treatment was similar between the arms. There were no differences in postvaccination peripheral T-cell responses or the PSA change from baseline to 6-mo post-treatment follow-up between the groups. CONCLUSIONS: In this first-of-kind trial of immunotherapy in patients on AS for prostate cancer, PROSTVAC did not elicit more favorable prostate tissue or peripheral T-cell responses than the EV. There was no difference between the arms in clinicopathologic effects. Despite the null findings, this is the first study reporting the feasibility and acceptability of an immunotherapy intervention in the AS setting. PATIENT SUMMARY: We looked at responses after an experimental prostate cancer vaccine in patients with prostate cancer on active surveillance (AS). Participants who received the vaccine did not show more favorable outcomes than those receiving the control. Despite these findings, this is the first report showing the feasibility and acceptability of immunotherapy for prostate cancer in patients on AS.

Cellular Cytosolic Energy Replenishment Increases Vascularized Composite Tissue Tolerance to Extended Cold Ischemia Time.

BACKGROUND: Vascularized composite allotransplantation (VCA) is a restorative surgical procedure to treat whole or partially disfiguring craniofacial or limb injuries. The routine clinical use of this VCA surgery is limited using compromised allografts from deceased donors and by the failure of the current hypothermic preservation protocols to extend the allograft's cold ischemia time beyond 4 h. We hypothesized that the active replenishment of the cellular cytosolic adenosine-5`-triphosphate (ATP) stores by means of energy delivery vehicles (ATPv) encapsulating high-energy ATP is a better strategy to improve allograft's tolerance to extended cold ischemia times. MATERIALS AND METHODS: We utilized established rat model of isolated bilateral in-situ non-cycled perfusions of both hind limbs. Ipsilateral and contralateral limbs in the anesthetized animal were randomized for simultaneous perfusions with either the University of Wisconsin (UW) solution, with/without O2 supplementation (control), or with the UW solution supplemented with the ATPv, with/without O2 supplementation (experimental). Following perfusion, the hind limbs were surgically removed and stored at 4°C for 12, 16, or 24 hours as extended cold ischemia times. At the end of each respective storage time, samples of skin, and soleus, extensor digitalis longus, and tibialis anterior muscles were recovered for assessment using tissue histology and tissue lysate studies. RESULTS: Control muscle sections showed remarkable microvascular and muscle damage associated with loss of myocyte transverse striation and marked decrease in myocyte nucleus density. A total of 1,496 nuclei were counted in 179 sections of UW-perfused control muscles in contrast to 1,783 counted in 130 sections of paired experimental muscles perfused with the ATPv-enhanced perfusate. This yielded 8 and 13 nuclei/field for the control and experimental muscles, respectively (P < .004). Oxygenation of the perfusion solutions before use did not improve the nucleus density of either the control or experimental muscles (n = 7 animals, P > .05). Total protein isolated from the muscle lysates was similar in magnitude regardless of muscle type, perfusion protocol, or duration of cold ischemia time. Prolonged static cold preservation of the hind limbs completely degraded the composite tissue's Ribonucleic acid (RNA). This supplementary result confirms the notion that that reverse transcription-Polymerase Chain Reaction, enzyme-linked immunosorbent assay, or the respiratory complex II enzyme activity techniques should not be used as indices of graft quality after prolonged static cold storage. CONCLUSIONS: In conclusion, this study demonstrates that active cellular cytosolic ATP replenishment increases hind limb composite tissue tolerance to extended cold ischemia times. Quality indicators and clinically relevant biomarkers that define composite tissue viability and function during static cold storage are warranted.