Differences In Baseline Characteristics Research Articles

Abstract PO2-16-09: Dose-dense versus 3-weekly AC during Neoadjuvant Chemoimmunotherapy for Early-Stage Triple-Negative Breast Cancer (TNBC): a Real-World Safety and Efficacy Data Analysis

Abstract Background: The Keynote-522 (KN-522) study established the use of pembrolizumab in combination with neoadjuvant carboplatin-paclitaxel, followed by 3-weekly (3w) anthracycline-cyclophosphamide (AC), as the standard of treatment for stage II-III TNBC. However, dose-dense chemotherapy (CT) improves survival rates compared to the standard schedule in early-stage breast cancer and several groups have been modifying the KN-522 regimen with dose-dense AC (ddAC). The objective of this study was to compare the safety and effectiveness of ddAC versus the q3w schedule. Methods: We conducted a multicentric real-world analysis of patients (pts) with early-stage TNBC who received neoadjuvant CT plus pembrolizumab at nine cancer centers. Safety endpoints included grade ≥ 3 adverse events (AEs), drug discontinuation, hospitalization due to AEs, and the use of antibiotics during neoadjuvant therapy. Pathologic complete response (pCR) was used as the effectiveness endpoint, and we performed univariate and multivariable logistic regression to evaluate factors associated with pCR. Results: To date, we included 168 pts in this study of which 137 pts have finished the neoadjuvant therapy phase and constituted our safety cohort. Among them, 86 pts (62.8%) received ddAC and 51 pts (37.2%) were treated with the 3w schedule. The two groups exhibited no significant differences in baseline characteristics; the median age was 42 years (range 29 - 75), 70.8% had stage II and 25.5% had stage III TNBC, 46.7% had positive lymph nodes, and 74.4% had a Ki67-index ≥ 50%. Overalls, 30.2% and 27.4% presented grade ≥ 3 AEs with ddAC and 3w AC, respectively, with no significant difference between the two groups (p=0.177). Grade ≥ 3 immune-related AEs (irAEs), occurred in 8.1% with ddAC and 3.9% with 3w AC (0.335). The most common grade ≥ 3 irAEs were pneumonitis (n=4) and hepatitis (n=2). The ddAC group had a higher rate of any drug discontinuation due to toxicities (24.4% vs. 11.8%, p=0.043) and a greater use of antibiotics (27.9% vs. 11.8%, p=0.009) compared to the 3w group. There was a trend toward more rates of hospitalization due to AEs in the ddAC group, although this was not statistically significant (17.4% vs 11.8%, p=0.131). At the time of data analysis cutoff, a total of 119 pts underwent surgery and have pathology report available and were included in the efficacy cohort. In the univariate analysis, the pCR rates were 65.8% with ddAC and 55.8% with 3w AC (OR 1.52, 95% CI 0.70-3.27, p=0.282). The rates of RCB (residual cancer burden) 0-1 were 81.2% and 67.6%, respectively (OR 2.06, 95% CI 0.82 – 5.16, p=0.120). Factors influencing rates of pCR were Ki67 index ≥ 50% and tumor staging, which remained significant in the multivariable analysis (Table). In the 3w AC group, no difference in pCR was observed between pts who used or not granulocyte colony stimulating-factors (61.1% vs 52%, p=0.553). Conclusion: No difference in grade ≥ 3 AEs was observed between ddAC and 3w AC in pts with early-stage TNBC receiving neoadjuvant CT plus pembrolizumab. Nevertheless, the dose-dense regimen was linked to higher rates of drug discontinuation and antibiotic use. Although the pCR rates numerically favored ddAC, the difference was not statistically significant. Thus, the medical community should consider carefully risks and benefits of using ddAC within the KN522 regimen. Larger studies and longer follow-up are warranted to assess the long-term outcomes of the CT schedules. Multivariable regression of factors associated with pCR Citation Format: Renata Colombo Bonadio, Fernanda Madasi, José Bines, Rafael Ferreira, Daniela Rosa, Candice Santos, Zenaide Souza, Daniele Assad-Suzuki, Julio Araujo, Débora Gagliato, Carlos dos Anjos, Bruna Zucchetti, Anezka Ferrari, Mayana Lopes, Renata Cangussu, Maria Marcela Monteiro, Paulo Hoff, Laura Testa, Romualdo Barroso-Sousa. Dose-dense versus 3-weekly AC during Neoadjuvant Chemoimmunotherapy for Early-Stage Triple-Negative Breast Cancer (TNBC): a Real-World Safety and Efficacy Data Analysis [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-16-09.

Enteral Access Outcomes in Patients Hospitalized With Cardiac Disease: A Retrospective Cohort Study

IntroductionPatients admitted with principal cardiac diagnosis (PCD) can encounter difficult inpatient stays that are often marked by malnutrition. In this setting, enteral feeding may improve nutritional status. This study examined the association of PCD with perioperative outcomes after elective enteral access procedures. MethodsAdult patients who underwent enteral access procedures between 2018 and 2020 at a tertiary care institution were reviewed retrospectively. Differences in baseline characteristics between patients with and without PCD were adjusted using entropy balancing. Multivariable logistic and linear regressions were subsequently developed to evaluate the association between PCD and nutritional outcomes, perioperative morbidity and mortality, length of stay, and nonelective readmission after enteral access. Results912 patients with enteral access met inclusion criteria, of whom 84 (9.2%) had a diagnosis code indicating PCD. Compared to non-PCD, patients with PCD more commonly received percutaneous endoscopic gastrostomy by general surgery and had a higher burden of comorbidities as measured by the Charlson comorbidity index. Multivariable risk adjustment generated a strongly balanced distribution of baseline covariates between patient groups (standardized differences ranged from −2.45 × 10−8 to 3.18 × 108). After adjustment, despite no significant association with in-hospital mortality, percentage change prealbumin, length of stay, or readmission, PCD was associated with an approximately 2.25-day reduction in time to meet goal feeds (95% CI -3.76 to −0.74, P = 0.004) as well as decreased odds of reoperation (adjusted odds ratio 0.28, 95% CI 0.09-0.86, P = 0.026) and acute kidney injury (adjusted odds ratio 0.24, 95% CI 0.06-0.91, P = 0.035). ConclusionsDespite having more comorbidities than non-PCD, adult enteral access patients with PCD experienced favorable nutritional and perioperative outcomes.

Lower extremity arterial disease vs. coronary artery disease: mortality differences after revascularization.

Patients undergoing revascularization for lower extremity arterial disease (LEAD) may face a higher risk of mortality than those with coronary artery disease (CAD). This study aimed to characterize the difference in mortality risk between patients undergoing revascularization for LEAD and CAD and identify associated factors. The 1-year database of 10 754 patients undergoing revascularization for CAD (n = 6349) and LEAD (n = 4405) was analysed. Poisson regression models were used to characterize interpopulation differences in mortality, adjusting for baseline clinical features, including age, sex, polyvascular disease, comorbidities, medications, and vulnerabilities. Individuals with LEAD were older, were more likely to have polyvascular disease, had more comorbidities, and received fewer cardioprotective drugs than those with CAD. Vulnerabilities remained more common in the LEAD group even after adjusting for these clinical features. The crude risk ratio of mortality incidence for LEAD vs. CAD was 2.91 (95% confidence interval, 2.54-3.34), attenuated to 2.14 (1.83-2.50) after controlling for age, sex, and polyvascular disease. The percentage attenuation in the excessive mortality associated with LEAD was 29%. The stepwise addition of comorbidities, medications, and vulnerabilities as adjusting factors attenuated the incidence risk ratio to 1.48 (1.26-1.72), 1.33 (1.12-1.58), and 1.17 (0.98-1.39), respectively, and increased the percentage attenuation to 64%, 73%, and 86%, respectively. Mortality risk was almost three-fold higher in patients undergoing revascularization for LEAD than in those with CAD. The excessive mortality was considerably attributable to inter-group differences in baseline characteristics, including potentially clinically or socially modifiable factors.

Mode of mutual-help group attendance: Predictors and outcomes in a US national longitudinal survey of adults with lifetime alcohol use disorder

IntroductionAlthough attending substance use-focused mutual-help meetings online may reduce attendance barriers, associations of attendance mode with group participation and outcomes are unknown. Using longitudinal data from mutual-help group attendees, this study, after identifying differences in baseline characteristics by attendance mode, examined associations of attendance mode with mutual-help participation (number of meetings attended, involvement) and outcomes (alcohol abstinence, heavy drinking, alcohol problems). MethodsThe Peer Alternatives for Addiction Study 2021 Cohort sampled attendees of 12-step groups (e.g., Alcoholics Anonymous), Women for Sobriety, LifeRing Secular Recovery, and/or SMART Recovery in-person and/or online within 30 days before baseline. The baseline sample, recruited in fall 2021, was 531 adults with lifetime alcohol use disorder, followed at 6 (88 %) and 12 months (85 %). Differences in baseline characteristics by attendance mode were tested using Chi-squares and ANOVAs. GEE models examined associations of attendance mode, time, and their interactions with mutual-help group participation and alcohol outcomes. The in-person only mode was compared to the online-only, and to the in-person plus online, modes. ResultsAt baseline, 53.7 % of participants had attended only online meetings in the past 30 days, 33.7 % had attended both in-person and online meetings, and 12.6 % had attended only in-person meetings. Online meeting attendees were less likely to endorse lifetime abstinence as an alcohol recovery goal than in-person-only meeting attendees. In adjusted models (including for recovery goal), those attending online meetings only, or both online and in-person meetings, attended a greater number of meetings compared to those attending only in-person meetings. However, online-only attendance was associated with less involvement than in-person-only attendance. In adjusted models, compared to baseline, involvement increased and outcomes improved at follow-ups. Adjusted models examining alcohol outcomes found that no attendance at mutual-help groups at follow-ups was associated with more heavy drinking compared to in-person-only attendance. ConclusionsFindings inform efforts to ascertain benefits of mutual-help group participation by suggesting that online attendance is associated with attending more meetings, less involvement, and lower endorsement of abstinence as a recovery goal, and is comparable to in-person attendance on alcohol outcomes. In-person attendance may be more beneficial for less heavy drinking than terminating attendance.

Surgical outcomes and survival following esophagectomy for squamous cell carcinoma with or without liver cirrhosis: retrospective cohort study.

Esophageal squamous cell carcinoma (ESCC) shares common risk factors with liver cirrhosis (LC). The influence of LC in patients with ESCC has not been fully investigated. This study aimed to investigate the postoperative and long-term survival outcomes of esophagectomy for ESCC according to LC presence. Among patients who underwent curative-intent surgery for ESCC between 1994 and 2018, 121 patients with Child-Pugh class A LC and 2810 patients without LC were compared. Among the LC patients, 73 (60.3%) were diagnosed with LC before surgery and 48 (39.7%) were diagnosed intraoperatively. There were no significant differences in baseline characteristics between patients with LC and those without LC. However, intraoperative blood loss was higher, and operation time, hospital stay, and ICU stay were longer in patients with LC than in those without LC. Moreover, the reoperation, 30-day morbidity (60.6 vs. 73.6%, P =0.006) and 90-day mortality (2.2 vs. 4.9%, P =0.049) were significantly higher in patients with LC. The 5-year overall survival (OS) rate was significantly higher in patients without LC than in those with LC. After adjusting the confounding variables, LC was an adverse risk factor of OS (hazard ratio 1.402, P =0.004). Among patients with LC, the Model of End-Stage Liver Disease score was related to the development of complications of grade more than III (odds ratio 1.459, P =0.013). ESCC patients with Child-Pugh class A LC have high incidences of postoperative morbidity and mortality, and poor OS. Thus, careful patient selection, meticulous operation, and careful postoperative care are needed.

Sex Differences in Hemodynamic and Autonomic Reactivity during Cold Pressor Test in Chronic Kidney Disease

Introduction: Chronic kidney disease (CKD) is characterized by sympathetic nervous system (SNS) overactivity that contributes to increased cardiovascular risk. Hemodynamic reactivity during the cold pressor test (CPT) has been widely used to evaluate sympathetic neural control in patient populations, and increased neurocardiovascular reactivity to CPT has been shown to predict greater risk of future cardiovascular events. Prior studies have suggested that males with CKD have higher long-term cardiovascular disease risk compared to females with CKD; however, whether sex differences in neurocardiovascular responsivity during CPT exists within CKD remains unknown. Objectives: Our primary objective was to evaluate potential sex differences in hemodynamic and autonomic reactivity during CPT in patients with CKD. Hypothesis: Males with CKD have an augmented pressor and sympathetic response to sympathoexcitation induced by CPT compared with females with CKD. Methods: Patients with CKD (Stage III and IV) with stable renal function were included. Continuous beat to beat blood pressure (BP), heart rate (HR) and muscle sympathetic nerve activity (MSNA) by microneurography were measured at rest for 10 minutes and during CPT that consisted of immersion of the hand to the wrist in ice water (4–5 °C) for one minute, followed by a 5-min recovery period. Results: 25 participants with CKD were included (N= 14 male, N=11 female). There were no differences in baseline characteristics, resting hemodynamics or MSNA between male and female groups. Males with CKD had a steeper rate of increase and higher peak levels of diastolic BP (DBP, 101±3 vs 87±3; p=0.008) and mean arterial BP (MAP, 130±4 vs 112±5 mm Hg, p=0.023) during CPT compared to females with CKD, respectively. Conversely, females with CKD had a steeper rate of increase in HR during CPT compared to males. MSNA increased in both males and females during CPT; however, there was no difference in MSNA reactivity during CPT between groups. Conclusions: Males with CKD had greater BP reactivity during CPT compared to females with CKD, while females with CKD had greater HR reactivity during CPT compared to males. There was no difference in sympathetic reactivity between groups. Augmented BP reactivity during CPT in males with CKD may contribute to sex differences in cardiovascular disease risk in patients with CKD. Supported by NIH Grants R33AT010457 and R01HL135183. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Hepatology consultation is associated with decreased early return to alcohol use after discharge from an inpatient alcohol use disorder treatment program.

Alcohol cessation is the only intervention that both prevents and halts the progressions of alcohol-associated liver disease. The aim of this study was to assess the relationship between a return to alcohol use and consultation with hepatology in treatment-seeking patients with alcohol use disorder (AUD). Two hundred forty-two patients with AUD were enrolled in an inpatient treatment program, with hepatology consultation provided for 143 (59%) patients at the request of the primary team. Patients not seen by hepatology served as controls. The primary outcome was any alcohol use after discharge assessed using AUDIT-C at 26 weeks after discharge. For the primary endpoint, AUDIT at week 26, 61% of the hepatology group and 28% of the controls completed the questionnaire (p=0.07). For the secondary endpoint at week 52, these numbers were 22% and 11% (p = 0.6). At week 26, 39 (45%) patients in the hepatology group versus 31 (70%) controls (p = 0.006) returned to alcohol use. Patients evaluated by hepatology had decreased rates of hazardous alcohol use compared to controls, with 36 (41%) versus 29 (66%) (p = 0.008) of the patients, respectively, reporting hazardous use. There were no significant differences in baseline characteristics between groups and no difference in rates of prescribing AUD therapy. There was no difference in outcomes at 52 weeks. Patients evaluated by hepatology had significantly lower rates of return to alcohol use and lower rates of hazardous drinking at 26 weeks but not at 52 weeks. These findings suggest that hepatology evaluation during inpatient treatment of AUD may lead to decreased rates of early return to alcohol use.

Mindfulness-based Stress Reduction and Endothelial Function in Chronic Kidney Disease

Introduction: Chronic Kidney Disease (CKD) is associated with increased cardiovascular disease risk in part due to endothelial dysfunction. Studies have suggested that mindfulness-based stress reduction (MBSR) may have beneficial physiologic effects on cardiovascular disease risk; however, the potential beneficial effects of MBSR on endothelial function in CKD are unknown. We tested the hypothesis that MBSR improves endothelial function in patients with CKD. Methods: Participants with CKD (Stages III-IV) were enrolled and randomized to 8 weeks of MBSR versus the Health Enhancement Program (HEP), a structurally parallel control intervention to MBSR. Each intervention consisted of daily homework and 2.5hr weekly classes of mindfulness meditation (for MBSR) and health education (for HEP). Each intervention also included a day-long retreat. Endothelial function was quantified as brachial artery reactive hyperemia index (RHI) using peripheral artery tonometry (EndoPAT). RHI and offce blood pressure were obtained at baseline and at the end of the intervention. Intervention groups were also stratified into subgroups based on normal (RHI ≥2.10) and abnormal (RHI <2.10) baseline values for secondary analyses. Results: Data were obtained from 37 participants with CKD who were enrolled and randomized to MBSR (N=21) versus HEP (N=16). There were no differences in baseline characteristics, hemodynamics or RHI between groups. There were no significant differences in baseline versus end of study RHI within (HEP p=0.76; MBSR p=0.57) and between intervention groups (p=0.36). There was no difference in change in RHI after MBSR between the normal and abnormal RHI subgroups. Conclusions: MBSR did not have significant effects on endothelial function measured as RHI among individuals with CKD. Supported by NIH Grants R33AT010457 and R01HL135183. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

A novel stratification scheme combined with internal arteries in CT imaging for guiding postoperative adjuvant transarterial chemoembolization in hepatocellular carcinoma: a retrospective cohort study.

Although postoperative adjuvant transarterial chemoembolization (PA-TACE) improves survival outcomes in a subset of patients with resected hepatocellular carcinoma (HCC), the lack of reliable biomarkers for patient selection remains a significant challenge. The present study aimed to evaluate whether computed tomography imaging can provide more value for predicting benefits from PA-TACE and to establish a new scheme for guiding PA-TACE benefits. In this retrospective study, patients with HCC who had undergone preoperative contrast-enhanced computed tomography and curative hepatectomy were evaluated. Inverse probability of treatment weight was performed to balance the difference of baseline characteristics. Cox models were used to test the interaction among PA-TACE, imaging features, and pathological indicators. An HCC imaging and pathological classification (HIPC) scheme incorporating these imaging and pathological indicators was established. This study included 1488 patients [median age, 52 years (IQR, 45-61 years); 1309 male]. Microvascular invasion (MVI) positive, and diameter >5cm tumors achieved a higher recurrence-free survival (RFS), and overall survival (OS) benefit, respectively, from PA-TACE than MVI negative, and diameter ≤5cm tumors. Patients with internal arteries (IA) positive benefited more than those with IA-negative in terms of RFS ( P =0.016) and OS ( P =0.018). PA-TACE achieved significant RFS and OS improvements in HIPC3 (IA present and diameter >5 cm, or two or three tumors) patients but not in HIPC1 (diameter ≤5cm, MVI negative) and HIPC2 (other single tumor) patients. Our scheme may decrease the number of patients receiving PA-TACE by ~36.5% compared to the previous suggestion. IA can provide more value for predicting the benefit of PA-TACE treatment. The proposed HIPC scheme can be used to stratify patients with and without survival benefits from PA-TACE.

Application of three dimensional printed personalized guide plate assisted arthroscopic ankle arthrodesis in the treatment of ankle arthritis

Objective: To compare the efficacy of conventional open ankle fusion and three dimensional(3D) printed guide plate assisted arthroscopic ankle fusion. Methods: A retrospective cohort study was performed on 256 patients with advanced traumatic ankle arthritis, who were admitted to the Department of Orthopaedics, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from May 2018 to February 2023 and underwent ankle fusion procedures. The study cohort comprised 119 males and 137 females, with an age of (59.6±9.5) years (range: 37 to 83 years). Among them, 175 cases underwent internal fixation with plates and screws (58 cases through the combined medial and lateral approach, and 117 cases through the simple lateral approach), 48 cases underwent internal fixation with screws through the anterior approach (conventional open group), and 33 cases underwent minimally invasive arthroscopic ankle fusion assisted by 3D printed guide plate (3D printed guide plate arthroscopy group). Propensity score matching was employed to achieve a 1∶1 match(caliper value=0.02) between the baseline characteristics of patients in the 3D printed guide plate arthroscopy group and the conventional open group. Perioperative and follow-up data between the two groups were compared using the t-test, Mann-Whitney U test, Wilcoxon signed rank test,χ² test, or Fisher's exact probability method, as appropriate. Results: Matching was successfully achieved with 20 cases in both the 3D printed guide plate arthroscopy group and the conventional open group, and there were no statistically significant differences in baseline characteristics between the two groups (all P>0.05). The operation time in the 3D printed guide plate arthroscopy group was significantly longer than that in the conventional open group ((88.9±5.6) minutes vs. (77.9±11.7) minutes;t=-2.392, P=0.022), while the frequency of intraoperative fluoroscopies ((1.7±0.8) times vs. (5.2±1.2) times; t=10.604, P<0.01) and length of hospitalization ((5.5±0.9) days vs. (6.4±1.5) days;t=2.480, P=0.018) were significantly lower in the 3D printed guide plate arthroscopy group compared to the conventional open group. The fusion rate was 95.0% (19/20) in the 3D printed guide plate arthroscopy group and 85.0% (17/20) in the conventional open group, with no statistically significant difference between the two groups (χ²=1.111,P=0.605). The fusion time was (12.1±2.0) weeks in the conventional open group and (11.1±1.7) weeks in the 3D printed guide plate arthroscopy group, with no statistically significant difference between the two groups (t=1.607, P=0.116). At the final follow-up, the American Orthopedic Foot and Ankle Society ankle hindfoot scale was (72.6±5.5)points in the 3D printed guide plate arthroscopy group and (70.5±5.8)points in the conventional open group, with no statistically significant difference between the two groups (t=-1.003, P=0.322). The VAS score of the 3D printed guide plate arthroscopy group was (M(IQR)) 1.50 (1.00) points, lower than that of the conventional open group by 3.00 (1.00) points, with statistically significant differences (Z=-3.937, P<0.01). The complication rate was significantly higher in the conventional open group (25.0%(5/20) vs. 5.0%(1/20), P=0.182). Conclusion: 3D printed guide plate assisted arthroscopic ankle fusion exhibited several advantages, including reduced frequency of fluoroscopies, alleviation of postoperative pain, and decreased complications and length of hospitalization.

Early Postnatal Administration of Erythropoietin and Its Association with Neurodevelopmental Outcomes and Incidence of Intraventricular Hemorrhage and Hypoxic-Ischemic Encephalopathy: A Four-Week Observational Study.

This study aimed to investigate the impact of early erythropoietin (EPO) administration on the neurodevelopment of newborns, specifically focusing on its effects on hypoxic-ischemic encephalopathy (HIE) and intraventricular hemorrhage (IVH). The primary objective was to determine whether early EPO administration could impact the short-term neurodevelopmental outcomes and provide safety in neonates at risk for neurodevelopmental disorders. Conducted at the "Louis Turcanu" Children's Emergency Clinical Hospital in Timisoara, Romania, this observational study included 121 neonates receiving EPO and 130 No EPO controls. EPO was administered within the first 48 h of life, with doses of 1000 U/kg that escalated to 2000 U/kg if necessary. Besides observing the occurrence of IVH and HIE, this study measured clinical and biochemical markers, including LDH, blood glucose, urea, creatinine, CPK, CRP, PCT, and erythropoietin levels alongside hematology and coagulation profiles. There were no significant differences in baseline characteristics between the groups. The EPO group showed significant reductions in LDH levels from days 1-3 to 7-10 (695.0 U/L to 442.0 U/L) and the APTT value (54.0 s) compared with the No EPO group (38.0 s). Notably, early EPO administration was associated with a significant decrease in HIE severity (beta coefficient: -0.38, p = 0.001). Additionally, lower gestational ages and hemoglobin levels correlated with increased severity of HIE. By week four, there was a significant reduction in moderate and severe HIE cases in the EPO group compared with controls (p = 0.001). Early administration of EPO in neonates significantly reduced the severity of IVH and HIE, suggesting its potential as a neuroprotective agent in neonatal care.

Long-term Outcomes of Hepatic Resection Combined With Intraoperative Ablation Versus Hepatic Resection Alone for Multinodular Hepatocellular Carcinoma: Insights from a Single-center Study.

The efficacy of combining hepatic resection (HR) with ablation therapy in treating multinodular hepatocellular carcinoma (mHCC) remains uncertain. This study aimed to compare the long-term survival outcomes of patients with mHCC undergoing HR combined with intraoperative ablation (HRA) versus those undergoing HR alone. A retrospective analysis was conducted on 296 patients diagnosed with early-stage [Barcelona Clinic Liver Cancer (BCLC)-A] or intermediate-stage (BCLC-B) mHCC who underwent initial HR. Patients were divided into two groups: those who received HRA (HRA group, n=159) and those who underwent HR alone (HR group, n=137). Propensity score (PS), estimated as the likelihood of undergoing HRA, was applied to adjust for between-group differences in baseline characteristics. Overall survival (OS) and relapse-free survival (RFS) were compared using Cox regression and Kaplan-Meier analyses. There were no significant differences in survival between the HRA and HR groups, with 5-year OS and RFS rates of 47.7% versus 51.9% (p=0.837) and 17.0% versus 25.9% (p=0.094), respectively. After adjusting for PS, the differences remained non-significant (p=0.579 for OS and p=0.410 for RFS). Consistent results were also observed in PS-adjusted subgroup analysis stratified by factors such as BCLC stage, "Up-to-7" criteria, and Child-Pugh class. HRA may offer comparable long-term efficacy to HR alone in mHCC, suggesting broader treatment options that challenge the guideline-based monotherapy.

Comparison of the surgical outcomes between paravaginal repair and anterior colporrhaphy: A retrospective case–control study

ABSTRACT Objectives: This study compared the surgical outcomes of anterior vaginal wall repair (A-repair) and paravaginal repair (PVR) for laparoscopic pelvic organ prolapse (POP) surgeries. Materials and Methods: This retrospective case–control study recruited patients who underwent laparoscopic POP surgeries in our hospital from May 1, 2013, to May 31, 2022, using the health insurance surgical code payment system (laparoscopic colpopexy/hysteropexy/cervicopexy: 80025B) in Taiwan. The patients were divided into A-repair (group 1) and PVR (group 2). Patients aged &lt;20 years, without postoperative outcomes, and without baseline characteristics were excluded. Baseline characteristics (age, menopausal status, parity, diabetes mellitus, and hypertension) were collected. The outcome was to compare the changes in Pelvic Organ Prolapse Quantification (POP-Q) scores (Aa, Ba, and total vaginal length) preoperatively and 1–2 months, 3–6 months, and 1 year postoperatively in the two groups. Results: After exclusion, 23 and 10 patients in A-repair and PVR, respectively, were recruited. There was no significant difference in baseline characteristics between the two groups. Patients in both groups showed significant improvement in Aa and Ba of POP-Q 1–2 months and 3–6 months postoperatively, except for those in group 2 1 year postoperatively. However, there was no significant difference in postoperative scores between the two groups at 1–2 months, 3–6 months, and 1 year postoperatively. The estimated blood loss did not exhibit a significant difference between the two groups; however, PVR had a longer duration of operation. Conclusion: The surgical outcomes of A-repair and PVR for the anterior compartment were comparable at 1–2 months, 3–6 months, and 1 year postoperatively.

Magnetic resonance-guided focused ultrasound thalamotomy for essential tremor patients with low skull density ratio: a case-matched analysis.

Skull density ratio (SDR) is the ratio between the mean Hounsfield units of marrow and cortical bone, impacting energy transmission through the skull. Low SDR has been used as an exclusion criterion in major trials of magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy for medication-refractory essential tremor (ET). However, some studies have suggested that patients with low SDR can safely undergo MRgFUS with favorable outcomes. In this case-matched study, we aim to compare the characteristics, sonication parameters, lesion sizes, and clinical outcomes of patients with low SDR vs. patients with high SDR who underwent unilateral MRgFUS thalamotomy for medication-refractory ET. Between March 2016 and April 2023, all patients (n = 270) who underwent unilateral MRgFUS thalamotomy for medication-refractory ET at a single institution were classified as low SDR (<0.40) and high SDR (≥0.40). All clinical and radiological data was prospectively collected and retrospectively analyzed using non-case-matched and 1:1 case-matched methodology. Thirty-one patients had low SDR, and 239 patients had high SDR. Fifty-six patients (28 in each cohort) were included in 1:1 case-matched analysis. There were no significant differences in baseline characteristics between the two groups in both non-case-matched and 1:1 case-matched analyses. In both analyses, compared to patients with high SDR, patients with low SDR required a significantly higher maximum sonication power, energy, and duration, and reached a lower maximum temperature with smaller lesion volumes. In the non-case-matched and case-matched analyses, low SDR patients did not have significantly less tremor control at any postoperative timepoints. However, there was a higher chance of procedure failure in the low SDR group with three patients not obtaining an appropriately sized lesion. In both analyses, imbalance was observed more often in high SDR patients on postoperative day 1 and month 3. ET patients with SDR <0.40 can be safely and effectively treated with MRgFUS, though there may be higher rates of treatment failure and intraoperative discomfort.

Prior acupuncture experience among elderly participants enrolled in a clinical trial of acupuncture for chronic low back pain: Implications for future trials

BackgroundThe effectiveness of acupuncture for chronic low back pain (cLBP) has not been studied specifically in the 65-and-older population. To inform the validity and generalizability of future acupuncture studies among older adults, we characterized elderly participants’ prior experience with and views toward acupuncture and tested for clinical and sociodemographic differences between acupuncture-naïve and non-naïve participants. MethodsData for this study were collected during the baseline telephone interview from the participants enrolled in the Kaiser Permanente Northern California site of an NIH-funded, multicenter clinical trial of acupuncture for cLBP in older adults. ResultsNearly two-thirds (65.6 %) of participants surveyed reported they had previously received acupuncture treatment with the vast majority seeking acupuncture treatment for pain-related issues (84.8 %). The majority of these participants reported relatively modest levels of exposure to acupuncture with most participants (63.1 %) reporting fewer than 10 treatment sessions over their lifetimes. There were no significant differences in age, sex, race, ethnicity, disability scores, income levels, or pain levels between the acupuncture-naïve and non-naïve groups. ConclusionContextual consideration for prior acupuncture utilization rates is warranted and may be higher than expected or previously reported. We found few differences in baseline characteristics between participants who were acupuncture-naïve and those with prior acupuncture experience; thus, future pragmatic clinical trials might relax previous acupuncture-use considerations in their recruitment criteria. For trials focused on acupuncture-naive patients, it may be more feasible to expand the definition of "acupuncture-naive" based on lifetime acupuncture visits or time since last treatment. Trial registrationThe protocol was registered at clinicaltrials.gov (#NCT04982315).

Retrospective analysis on diameters of drug-coated balloons and predilatation balloons in infra-inguinal endovascular treatment (RABBIT study).

This multicenter retrospective study assessed the clinical outcomes of endovascular therapy (EVT) using a drug-coated balloon (DCB) that was larger than the predilatation balloons for femoropopliteal artery lesions. We analyzed 1140 cases with symptomatic peripheral artery disease that underwent EVT with DCB for femoropopliteal lesions between 2017 and 2021. The primary endpoint was procedural failure, defined as a composite of deteriorated dissection and bailout stenting. The secondary endpoints included deteriorated dissection, bailout stenting, restenosis, and target lesion revascularization. We performed propensity score matching to compare the clinical outcomes between EVT with a DCB which was larger than the predilatation balloon (larger DCB) and EVT with a DCB which was not (nonlarger DCB). We assigned 276 cases to the larger DCB group and 864 cases to the nonlarger DCB group. Procedural failure was observed in 75 cases, whereas restenosis occurred in 282 cases during a mean follow-up period of 12.7 ± 9.7months. Propensity score matching extracted 273 pairs with no intergroup difference in baseline characteristics, except the predilatation balloon size. Procedural failure (9.2% versus 6.1%, P = 0.11), deteriorated dissection and bailout stenting proportion (both P > 0.05), and 1-year rates of freedom from restenosis (82.4% versus 84.1%, P = 0.59) and target lesion revascularization (89.7% versus 90.4%, P = 0.83) showed no significant difference between the larger and nonlarger DCB groups. Irrespective of whether the DCB size was larger than the predilatation balloon, no difference was observed in either procedural or clinical outcomes.

Repeat cytoreduction with Hyperthermic Intraperitoneal chemotherapy in patients with peritoneal disease: A 5-year retrospective analysis

BackgroundCytoreductive surgery with Hyperthermic Intraperitoneal Chemotherapy (CR-HIPEC) is a locorregional surgical therapy applied in patients with peritoneal-only metastatic disease of primary abdominal malignancies. Integrated in a multimodal treatment, CR-HIPEC is associated with increased overall survival. In cases of peritoneal-site only relapse, it may be carried out more than once. MethodsPatients who received a CR-HIPEC between January 2016 and December 2020 at Instituto Português de Oncologia do Porto, Portugal were included in a unicentric, retrospective, observational study. Short- and long-term outcomes after surgery were analyzed. ResultsIn this period, 259 CR-HIPEC were performed on 248 patients. Of these, 31 were CR-HIPEC repeats, with 6 being the third HIPEC in the same patient. Of the 31 cases, 15 (48.4 %) had an appendicular origin. Mean PCI in re-HIPEC group was 10.6 (SD ± 7.1). No significant differences in baseline characteristics between the first and re-HIPEC groups were found, except for mean PCI, higher in the 1st HIPEC group (p = 0.047). In re-HIPEC group, major complications rate (CT-CAE 3–4) was 12.9 % (n = 4), without postoperative mortality. The 1st and re-HIPEC group had similar morbidity rates and hospitalization time. With a median follow-up time of 44 months, relapse rate after repeat CR-HIPEC was 45.2 % (n = 14), with a mean overall survival (OS) of 68.7 months and 5-year OS of 78 %. ConclusionsRepeat CR-HIPEC is a safe approach with an acceptable complication rate for its complexity, associated with a survival benefit in selected patients. It should be presented as a valid therapeutic option in recurrent peritoneal disease.

Comparative Effectiveness of Valoctocogene Roxaparvovec and Prophylactic FactorVIII Replacement in Severe HemophiliaA.

A prospective, non-interventional study (270-902) followed 294 adults with severe hemophiliaA (SHA) receiving prophylactic factorVIII (FVIII). From these participants, 112 rolled over into a single-arm, multicenter, phase3 trial (GENEr8-1; NCT03370913) that evaluated efficacy and safety of valoctocogene roxaparvovec, a gene therapy that provides endogenous FVIII in individuals with SHA. Participants from 270-902 who did not roll over provide an opportunity for a contemporaneous external control. Therefore, the comparative effectiveness of valoctocogene roxaparvovec vs FVIII prophylaxis was evaluated using propensity scoring (PS). This posthoc analysis compared 112 participants from GENEr8-1 (treated cohort) to 73 participants in 270-902 who did not enroll in GENEr8-1 (control cohort). The primary analysis used standardized mortality ratio weighting to re-weight baseline characteristics of the control cohort to better match the treated cohort. Mean annualized bleeding rates (ABR) for treated and all bleeds were compared between cohorts along with the proportion of participants with zero bleeds (treated and all bleeds). Sensitivity and scenario analyses were also conducted. PS adjustments reduced differences in baseline characteristics between cohorts. Mean treated (4.40 vs 0.85; P < 0.001) and all (5.01 vs 1.54; P < 0.001) ABR were significantly lower, and the proportions of participants with zero treated bleeds (82.1% vs 32.9%; P < 0.001) and all bleeds (58.0% vs 28.5%; P < 0.001) were significantly higher in GENEr8-1. PS-adjusted analyses were consistent with prior intra-individual comparisons. Compared with participants receiving prophylactic FVIII, the participants receiving valoctocogene roxaparvovec experienced lower ABR, and a higher proportion had zero bleeds. ClinicalTrials.gov identifier, NCT03370913.

Total hip arthroplasty outcomes in Ehlers-Danlos patients: data from the Statewide Planning and Research Cooperative System.

Ehlers-Danlos syndromes (EDS) are genetic connective tissue disorders affecting multiple organ systems that frequently result in connective tissue hyperlaxity and early osteoarthritis. Short- and long-term outcomes after primary total hip arthroplasty (THA) in this patient population remain poorly characterised. The primary purpose of this study is to compare postoperative outcomes and survivorship after primary THA in patients with and without EDS. The New York Statewide Planning and Research Cooperative System (SPARCS) database was queried for all patients undergoing primary elective THA between September 2009 and December 2020. Patients with EDS were identified using ICD9 and ICD10 diagnosis codes. Given the relatively low incidence of EDS in this patient population, the cohort was propensity-matched 1:10 to patients without diagnosis of EDS based on demographics characteristics and medical comorbidities as measured by the Elixhauser Comorbidity Index. A total of 66 THA patients with and 660 without EDS were included in each group after 1:10 propensity-matching. There were no significant differences in baseline characteristics or THA indications. Early postoperative outcomes such as length of hospital stay and discharge disposition were similar. Emergency Room visits and inpatient readmission rates at 3 months postoperatively did not significantly differ between groups. Patients with EDS had a higher overall revision rate compared to those without (15.0% vs. 3.2%, p < 0.001). Revision free survival after primary THA in patients with EDS was significantly lower than those without EDS at 9-year follow-up. Cox proportional hazard regression demonstrated EDS patients had 7-times higher risk of revision (hazard ratio [HR] 7.43; 95% CI, 3.46-16.00; p < 0.001). Lastly, revision due to instability insignificantly trended higher in the EDS cohort (HR 2.29; 95% CI, 0.95-5.49; p = 0.063). EDS patients undergoing primary THA have increased rate of all cause revision and demonstrate decreased revision free survival compared to non-EDS THA patients.

Effects of Administration and Intensity of Statins on Mortality in Patients Undergoing Hemodialysis.

(1) Background: Few studies have investigated the association between the intensity of statins and patient survival rates in patients undergoing hemodialysis (HD) as primary outcomes. This study aimed to evaluate patient survival rates according to the intensity of statins using a large sample of patients undergoing maintenance HD. (2) Methods: Data from a national HD quality assessment program were used in this study (n = 53,345). We divided the patients into four groups based on the administration and intensity of statins: Group 1, patients without a prescription of statins (n = 37,944); Group 2, patients with a prescription of a low intensity of statins (n = 700); Group 3, patients with a prescription of a moderate intensity of statins (n = 14,160); Group 4, patients with a prescription of a high intensity of statins (n = 541). (3) Results: Significant differences in baseline characteristics were observed among the four groups. Group 1 had the best patient survival among the four groups in the univariate Cox regression analyses. However, multivariable Cox regression analyses showed that the patient survival rate was higher for Group 3 than for Group 1. Cox regression analyses using data of a balanced cohort showed that, on univariate analyses, the HRs were 0.93 (95% CI, 0.91-0.95, p < 0.001) in Group 2 and 0.95 (95% CI, 0.93-0.96, p < 0.001) in Group 3 compared to that in Group 1. Group 4 had a higher mortality rate than Groups 2 or 3. The results from the cohort after balancing showed a similar trend to those from the multivariable Cox regression analyses. Young age and less comorbidities in Group 1 were mainly associated with favorable survival in Group 1 in the univariate analysis using cohort before balancing. Among the subgroup analyses based on sex, age, presence of diabetes mellitus, and heart disease, most multivariable analyses showed significantly higher patient survival rates in Group 3 than for Group 1. (4) Conclusions: Our study exhibited significant differences in baseline characteristics between the groups, leading to limitations in establishing a robust association between statin intensity and clinical outcomes. However, we conducted various statistical analyses to mitigate these differences. Some results, including multivariable analyses controlling for baseline characteristics and analyses of a balanced cohort using propensity score weighting, indicated improved patient survival in the moderate-intensity statin group compared to non-users. These findings suggest that moderate statin use may be associated with favorable patient survival.