1-year Outcomes Research Articles

Prognostic significance of adjuvant therapy and specific radiation dosages in Taiwanese patients with oral cavity cancer and extra-nodal extension: a nationwide cohort study

BackgroundThe evidence for adjuvant chemoradiotherapy (CRT) of oral cavity squamous cell carcinoma (OCSCC) with extra-nodal extension (ENE) in National Comprehensive Cancer Network (NCCN) guidelines is derived from patients with head and neck cancer. The guidelines further suggest a radiation dose ranging from 6000 to 6600 cGy. In this nationwide study, we sought to evaluate the prognostic significance of adjuvant therapy and the specific radiation dosage in Taiwanese patients with pure OCSCC and ENE.MethodsA retrospective analysis of 1577 OCSCC patients with ENE who underwent resection and received adjuvant CRT or radiotherapy (RT) between January 2011 and December 2020 was conducted.ResultsMultivariable analysis revealed that adjuvant RT, more than four pathologically positive nodes, and radiation dosage below 6000 cGy were independent risk factors for unfavorable 5-year disease-specific survival (DSS) and overall survival (OS). Comparing patients who received CRT (n = 1453) to those treated with RT (n = 124) before and after propensity score (PS) matching, the 5-year outcomes were as follows: before PS matching, DSS (54% versus 30%, p < 0.0001), OS (42% versus 18%, p < 0.0001); after PS matching (n = 111 in each group), DSS (52% versus 30%, p = 0.0016), OS (38% versus 21%, p = 0.0019). For patients who underwent CRT, the 5-year outcomes for different radiation dose groups (6600 − 7000 cGy, n = 1155 versus 6000 − 6500 cGy, n = 199) were as follows: before PS matching, DSS (52% versus 54%, p = 0.1904), OS (43% versus 46%, p = 0.1610); after PS matching (n = 199 in each group), DSS (55% versus 54%, p = 0.8374), OS (46.5% versus 46.3%, p = 0.7578).ConclusionsFor OCSCC patients with ENE, our study shows CRT improved survivals than RT alone, underscoring the clinical significance of chemotherapy. Patients undergoing CRT with irradiation doses ranging from 6000 to 6500 cGy exhibited comparable survival outcomes to those receiving doses of 6600–7000 cGy. This observation suggests that irradiation doses exceeding the 6600 cGy may not confer the survival advantage in these patients. Further research is needed to confirm our results and explore the optimal irradiation dose for managing these patients.

Minimally Invasive Transforaminal Versus Lateral Lumbar Interbody Fusion for Degenerative Spinal Pathology: Clinical Outcome Comparison in Patients With Predominant Back Pain.

Retrospective review. To compare perioperative and postoperative clinical outcomes between minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and lateral lumbar interbody fusion (LLIF) in patients presenting with predominant back pain. Two popular techniques utilized for lumbar arthrodesis are MIS-TLIF and LLIF. Both techniques have reported high fusion rates and suitable postoperative clinical outcomes. Scarce literature exists, however, comparing these 2 common fusion techniques in a subset population of patients presenting with predominant back pain preoperatively. A retrospective review of lumbar procedures performed between November 2005 and December 2021 was conducted using a prospectively maintained single-surgeon database. Inclusion criteria were set as primary, elective, single, or multilevel MIS-TLIF or LLIF procedures for degenerative spinal pathology in patients with predominant preoperative back pain [visual analog scale (VAS) back pain preoperative score > VAS leg preoperative score]. Patients undergoing a revision procedure, single-level procedure at L5-S1, or surgery indicated for infectious, malignant, or traumatic etiologies were excluded. In addition, patients with VAS leg preoperative scores ≥ to VAS back preoperative scores were excluded. Patient demographics, perioperative characteristics, postoperative complications, and patient-reported outcome measures (PROMs) were collected. PROMs included VAS for back and leg pain, Oswestry Disability Index (ODI), and Short Form-12 (SF-12) Item Survey Mental (MCS) and Physical (PCS) Composite Scores with all values collected at the preoperative, 6-week, 12-week, 6-month, 1-year, and 2-year follow-up time point. Patients were grouped into 2 cohorts, depending on whether a patient underwent a MIS-TLIF or LLIF. Demographic and perioperative characteristics were compared between groups using χ2 and Student t test for categorical and continuous variables, respectively. Mean PROM scores were compared between cohorts at each time point utilizing an unpaired Student t test. Postoperative improvement from preoperative baseline within each cohort was assessed with paired samples t test. Achievement of minimum clinical important difference (MCID) was determined by comparing ΔPROM scores to previously established threshold values. MCID achievement rates were compared between groups with χ2 analysis. Statistical significance was noted as a P value <0.05. Eligible study cohort included 153 patients, split into 106 patients in the MIS-TLIF cohort and 47 patients in the LLIF cohort. The mean age was 55.9 years, the majority (57.5%) of patients were males, the mean body mass index was 30.8kg/m2, and the majority of the included cohort were nondiabetic and nonhypertensive. No significant demographic differences were noted between cohorts. The MIS-TLIF cohort had a significantly greater proportion of patients with preoperative spinal pathology of recurrent herniated nucleus pulposus, whereas a significantly greater proportion of patients in the LLIF cohort demonstrated isthmic spondylolisthesis (P < 0.046, all). No significant differences were noted between cohorts for operative duration, estimated blood loss, 1-year rate of arthrodesis, postoperative length of stay, postoperative VAS pain scores on postoperative day 0 or 1, and postoperative narcotic consumption on postoperative day 0 or 1. Patients in the LLIF cohort showed greater rates of postoperative ileus (4.3% vs 0.0%). No other significant differences were noted between cohorts for postoperative complications. Between cohorts, preoperative PROM scores did not significantly differ. The following significant postoperative mean PROM scores were demonstrated: VAS back at 12 weeks and ODI at 12 weeks with both mean scores favoring the LLIF cohort. The MIS-TLIF cohort reported significant improvement from preoperative baseline to the 2-year time point for all PROMs collected at all individual postoperative time points except SF-12 MCS at 6 weeks (P < 0.0, all). LLIF cohort reported significant improvement from preoperative baseline to the 1-year time point for all PROMs collected at all individual postoperative time points except for ODI at 6 weeks, 1 year, and 2 years, SF-12 MCS at 6 weeks and 2 years, and SF-12 PCS at 2 years(P < 0.042, all). The majority of patients in both cohorts achieved overall MCID for VAS back, VAS leg, ODI, and SF-12 PCS. A significantly greater proportion of patients in the LLIF cohort achieved MCID for SF-12 PCS at 12 weeks (94.4% vs 61.1%; P < 0.008). Patients with predominant back pain undergoing MIS-TLIF or LLIF for degenerative spinal pathology demonstrated similar 2-year mean clinical outcomes for physical function, disability, leg pain, and back pain. At the 12-week time point, mean outcome scores for back pain and disability favored the lateral approach with concurrent higher rates of MCID achievement for physical function at that time point.

Short-term outcomes of 47 selective laparoscopic lymph node dissection for rectal cancer: A retrospective study.

This study aims to analyze the safety, feasibility, and short-term oncology outcomes of selective laparoscope lateral lymph node dissection (LLND) with total mesorectal excision surgery. Between December 2019 and May 2023, LLND with total mesorectal excision surgery was performed in 47 selected patients with advanced rectal cancer. Surgical complications and 2-year oncology survival outcomes were analyzed in the study. All 47 procedures were technically successful without converting conversion to open surgery. The mean operation time was 200.6 minutes (135-321 minutes), and the mean estimated blood loss was 92.9 mL (range 10-2000 mL). The most common postoperative complications were anastomotic (8.5%, n = 4), ileus (6.4%, n = 3), and chyle leakage (4.3%, n = 2). Lateral pelvic lymph node metastases were found in 19 (40.4%) patients. When divided into lateral pelvic lymph node positive and negative groups, there was no significant impact on overall survival (94.4% vs 100%, Log-rank P = .596) and local recurrence-free survival (LFRS) (76.7% vs 89.6%, Log-rank P = .210), except disease-free survival (DFS) (58.3% vs 90.2%, Log-rank P = .005). Subgroup analysis showed similar short-term survival outcomes between the pN+ group and the internal iliac metastasis group (Log-rank P of overall survival, LFRS, and DFS were all ˃.05). LRFS and DFS in the obturator or external iliac metastasis group were worse than those in the internal iliac metastasis group when the follow-up time was extended (Log-rank P of LFRS and DFS were .05 and .063). Selective laparoscopy LLND for rectal cancer is safety and feasibility, and its complications are manageable. Oncology survival outcomes for lateral pelvic lymph node metastases limited to the internal iliac are similar to the pN+ stage; therefore, it should be treated positively.

Clinical features, outcomes, and anticoagulant strategies in lung cancer-associated isolated distal deep vein thrombosis

IntroductionThe clinical presentation, outcomes, and anticoagulation strategies in patients with lung cancer-associated isolated distal deep vein thrombosis (LC-iDDVT) are not well-defined. Materials and methodsThe study included 593 patients with LC-iDDVT and 260 patients with lung cancer-associated proximal DVT (LC-Proximal DVT). LC-iDDVT was further classified into axial venous thrombosis (AVT; 112 patients) and muscular venous thrombosis (MVT; 481 patients). Cox proportional risk regression models with Fine-Gray tests and competing risk models were employed to evaluate short-term (90-day) and long-term (1-year) outcomes (hazard ratio [HR]; 95 % confidence interval [CI]). ResultsAt the 90-day follow-up, patients with MVT had lower adjusted risks of pulmonary embolism (PE; HR = 0.20 [0.07–0.55], p = 0.002) and venous thromboembolism (VTE) recurrence (HR = 0.54 [0.34–0.88], p = 0.013) than those with LC-Proximal DVT. Similar results were observed at the 1-year follow-up. However, adjusted risks for PE (HR = 0.74 [0.29–1.92], p = 0.540; HR = 0.87 [0.42–1.78], p = 0.700) and VTE recurrence (HR = 0.96 (0.54–1.71), p = 0.890; HR = 0.99 [0.63–1.56], p = 0.970) at 90-day and 1-year were not significantly different between patients with AVT and those with LC-Proximal DVT. Among patients with LC-iDDVT, those receiving anticoagulation had reduced risks of VTE recurrence (HR = 0.57 [0.35–0.95], p = 0.030) and DVT deterioration (HR = 0.28 [0.13–0.60], p = 0.001) compared to those without anticoagulation. Moreover, AVT patients on >3 months of anticoagulation had a lower VTE recurrence risk (HR = 0.23 [0.03–0.92], p = 0.038) than those on ≤3 months of anticoagulation. ConclusionIn the context of lung cancer, patients with AVT may have a higher tendency for recurrent thrombosis compared to those with MVT, especially if anticoagulation is refused or given briefly.

Decreased volume of rectus femoris and iliocapsularis in patients with femoroacetabular impingement syndrome after primary hip arthroscopy

Purpose(1) to investigate the consecutive changes in hip muscle volume in patients with femoroacetabular impingement syndrome (FAIS) during the initial postoperative period, and (2) to determine the potential effect of the early changes in hip muscle volume on clinical outcomes.MethodsData between March 2021 and March 2022 was reviewed. Patients diagnosed with FAIS based on clinical symptoms and radiographic findings, and undergoing hip arthroscopic treatment were included. Exclusion criteria were incomplete MRI data, prior history of hip surgery, and concomitant hip conditions including hip osteoarthritis with a Tönnis grade > 1, avascular necrosis, Legg-Calvé-Perthes disease, osteoid osteoma, synovial chondromatosis, pigmented villonodular synovitis, and developmental dysplasia of the hip (DDH). MRI was performed preoperatively and 3, 6, 12-month postoperatively. Cross-sectional area (CSA) of hip muscles including rectus femoris (RF), iliocapsularis (IC), iliopsoas (IP), gluteus medius/minimus complex (G-med/min), and gluteus maximus (G-max) were collected on MRI. The CSA was corrected by body surface area (BSA). Preoperative and a minimum of 2-year postoperative patient-reported outcome (PRO) scores including Visual Analog pain Scale (VAS), modified Harris Hip Score (mHHS), and international Hip Outcome Tool, 12-component form (iHOT-12) were collected. A multivariate linear regression model was built to determine the influence of the potential factors on postoperative PROs.ResultsA total of 76 patients were included in the study. Compared to the preoperative level, decreased volume of RF and G-max, and increased IC/RF ratio were observed at postoperative 3 months (all with P < .05). Both G-med/min and G-max presented decreased volume at postoperative 6 months (all with P < .05). G-med/min presented decreased volume (P = .001) at postoperative 12 months. Changes in RF at postoperative 3 months and 12 months were positively related to improvement of iHOT-12 (Beta = 0.371, P = .012 and Beta = 0.330, P = .026, respectively). Changes in IC at postoperative 6-month was positively related to improvement of mHHS (Beta = 0.367, P = .027) and iHOT-12 (Beta = 0.315, P = .044).ConclusionDuring the initial first year following arthroscopic treatment for FAIS, decreased volume of the RF and gluteal muscles was observed. Early changes in volume of RF and IC were positively correlated to the improvement of minimum 2-year PROs.Level of evidenceLevel IV; case series.

Outcomes of primary transobturator mid-urethral sling surgery in women of different ages

IntroductionOlder age is associated with greater likelihood of urinary incontinence and unmet care needs. It was hypothesized that age might influence clinical and ultrasound outcomes of transobturator mid-urethral sling (TOS) surgery. The aim of this study was to compare 1-year postoperative clinical and ultrasonographic outcomes of TOS surgery among women of different ages. MethodsA retrospective analysis of a cohort of women who underwent primary and isolated TOS surgery for uncomplicated urodynamic stress incontinence was undertaken. All women underwent pre-operative and 1-year postoperative evaluations including clinical interview, pelvic examination, urodynamic studies and introital four-dimensional ultrasound. To be eligible for surgery, women needed to be independent in their daily life, and to have an acceptable level of surgical risk on pre-operative assessment. The primary outcome was the rate of stress urinary incontinence (SUI) after surgery. The secondary outcomes comprised postoperative adverse events and ultrasound findings. ResultsIn total, 162, 213, 60 and 29 women aged <51, 51–64, 65–74 and ≥75 years, respectively, were included in this study. At 1-year postoperative assessment, older women were more likely to report SUI and bothersome SUI, while the severity of SUI and postoperative adverse events were similar in older women compared with other age groups. Ultrasound revealed that the sling tended to be looser and higher in older women. ConclusionTOS surgery is effective and safe for women of all ages who are independent in their daily life and who have an acceptable level of surgical risk. The sling tended to be looser and higher in older women.

IVUS-Guided vs Angiography-Guided PCIin Patients With Diabetes With AcuteCoronary Syndromes: The IVUS-ACS Trial.

Intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) reduces the risk for clinical events in patients with acute coronary syndromes (ACS), compared with angiographic guidance. However, the benefits of IVUS guidance in high-risk patients with diabetes with ACS is uncertain. The aim of this prespecified stratified subgroup analysis from the IVUS-ACS randomized trial was to determine the effectiveness of IVUS-guided PCI vs angiography-guided PCI in patients with diabetes with ACS. From August 20, 2019, to October 27, 2022, 1,105 patients with diabetes with ACS were randomized, including 554 patients in the IVUS-guided group and 551 in the angiography-guided group. The primary endpoint was the rate of target vessel failure (TVF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization. At 1-year follow-up, TVF occurred in 20 patients in the IVUS guidance group and in 46 patients in the angiographic guidance group (Kaplan-Meier rates 3.6% vs 8.3%; HR: 0.46; 95%CI: 0.27-0.81; P=0.007), driven by a reduction in clinically driven target vessel revascularization (0.9% vs 3.8%; P=0.003). IVUS-guided PCI also reduced the risk for TVF without procedural myocardial infarction (2.0% vs 6.7%; HR: 0.29; 95%CI: 0.15-0.57; P< 0.001) and all-cause mortality (HR: 0.30; 95%CI: 0.10-0.93; P=0.037). There were no significant differences in the rates of stent thrombosis or major bleeding between the groups. In the large-scale IVUS-ACS trial, IVUS-guided PCI improved 1-year clinical outcomes in high-risk patients with diabetes with ACS. (1-Month vs 12-Month DAPT for ACS Patients Who Underwent PCI Stratified by IVUS: IVUS-ACS and ULTIMATE-DAPT Trials; NCT03971500).

Mid-Term Results of Popliteal-Pedal Inframalleolar Vein Bypasses in Chronic Limb-Threatening Ischemia Patients After Previous Failed Tibial Endovascular Recanalization

Inframalleolar bypass still preserves its role in the modern endovascular era. Aim of this study was to evaluate the mid-term outcomes of "short" inframalleolar vein bypasses in patients with chronic limb-threatening ischemia (CLTI) after previous failed tibial endovascular recanalization. Between January 2015 and December 2021 107 CLTI patients in 3 Italian Departments of Vascular Surgery underwent "short" inframalleolar vein bypass after failed tibial endovascular recanalization. Early (30-day) and 3-year outcomes were evaluated in terms of survival, primary patency, primary assisted patency, secondary patency, and amputation-free survival. Univariate analysis of the perioperative factors affecting outcomes were performed by means of log-rank test. Associations of procedure variables were sought based on a multivariate Cox regression analysis. Distal anastomosis (inframalleolar) was mostly performed on dorsal pedis (64, 59.8%). At 30 days bypass occlusion was recorded in 5 cases (4.6%). Mean follow-up period was 20.5 ± 17.9 months. Estimated 3-year overall survival was 66.7%. Three-year estimates of primary patency, primary assisted patency, secondary patency, and amputation-free survival were 68.5%, 70.1%, 70.2%, and 76.7%, respectively. Multivariate analysis showed a negative association of insulin treatment with primary patency (HR 4.3, p = .04), primary assisted patency (HR 5.1, p = .02), and secondary patency (HR 5.1, p = .02). Negative association of long-term corticosteroid use was also found with primary patency (HR 7.8, p = .005), primary assisted patency (HR 8.7, p = .003), secondary patency (HR 8.7, p = .003), and amputation-free survival (HR 3.9, p = .05). "Short" vein bypasses to the foot arteries in CLTI patients yielded good mid-term overall patency, and limb salvage rates after a failed tibial endovascular recanalization. Insulin dependent diabetes mellitus, and long-term corticosteroid use seemed to affect the outcomes.

Intraoperative central venous pressures related to early graft function in deceased donor kidney transplant recipients with low immunological risks

This study aims to analyze data from patients who received kidney transplantation from deceased donors to investigate the anesthetic factors influencing early and late graft outcomes, including the incidence of slow graft function (SGF), delayed graft function (DGF), and 3-year graft outcomes. We retrospectively analyzed 202 recipients who underwent deceased donor kidney transplantation from March 2010 to December 2020. Anesthetic monitoring data during the intraoperative period was analyzed at 5-minute intervals, and basic clinical parameters were evaluated. The mean recipient age was 46.6 ± 10.3 years, and the mean donor age was 41.7 ± 12.7 years. Anesthetic time averaged 285.8 ± 70.2 min, and operation time averaged 223.1 ± 44.0 min. The incidence of SGF was 11.8%, and the incidence of DGF was 3.9%. Mean central venous pressures (CVPs) were higher in recipients with SGF or DGF (11.7 mmHg) compared to those with immediate graft function (9.7 mmHg). Higher CVP was identified as an independent risk factor for SGF or DGF (odds ratio 1.219, p = 0.006). This study suggests that intraoperative monitoring of CVP is crucial for predicting short-term graft function in deceased donor kidney transplantation and should be managed to prevent excessive fluid intake.

Ischemic Stroke in Young Adults in India: Predictors of Recurrence and Functional Outcome.

Ischemic stroke (IS) in young is increasingly recognized as an important health problem in low- and middle-income countries (LMICs). Limited data is available from LMICs about the predictors of outcome and recurrence of IS in young. The study aims to assess the predictors of short-term and long-term functional outcome and the recurrence of the first-ever IS and transient ischemic attack in young. The clinical, radiological data, functional outcome, and recurrence of 569 IS patients aged 18-50 years were recorded. The etiological classification was done. The functional outcome was assessed using the modified Rankin scale (mRS), with a good outcome being mRS 0-2. Logistic regression was used to analyze the predictors of recurrence and outcome. The most common risk factors were hypertension (40.3%) and diabetes mellitus (34.3%). Stroke of undetermined etiology (33.6%) was the most common etiological subtype. Among the cardioembolic subtypes, rheumatic heart disease constituted 47.4%. A good functional outcome at 1 year was seen in 76.3%. While baseline stroke severity predicted both the 3-month and 1-year functional outcome, age ≥40 years and male gender predicted poor outcome at 1 year. The risk of recurrent strokes at 1 year was 2.5%. On multiple logistic regression analysis, diabetes mellitus independently predicted recurrent vascular events at 1 year (odds ratio = 2.43, 95% confidence interval 1.07-5.50). We found a good functional outcome with a relatively low recurrence at 1 year among young IS patients. Baseline stroke severity, age, and male gender predicted a poor 1-year functional outcome.

Establishing prognostic models for intrahepatic cholangiocarcinoma based on immune cells.

Intrahepatic cholangiocarcinoma (ICC) is a malignant liver tumor that is challenging to treat and manage and current prognostic models for the disease are inefficient or ineffective. Tumor-associated immune cells are critical for tumor development and progression. The main goal of this study was to establish models based on tumor-associated immune cells for predicting the overall survival of patients undergoing surgery for ICC. To establish 1-year and 3-year prognostic models for ICC after surgical resection. Immunohistochemical staining was performed for CD4, CD8, CD20, pan-cytokeratin (CK), and CD68 in tumors and paired adjacent tissues from 141 patients with ICC who underwent curative surgery. Selection of variables was based on regression diagnostic procedures and goodness-of-fit tests (PH assumption). Clinical parameters and pathological diagnoses, combined with the distribution of immune cells in tumors and paired adjacent tissues, were utilized to establish 1- and 3-year prognostic models. This is an important application of immune cells in the tumor microenvironment. CD4, CD8, CD20, and CK were included in the establishment of our prognostic model by stepwise selection, whereas CD68 was not significantly associated with the prognosis of ICC. By integrating clinical data associated with ICC, distinct prognostic models were derived for 1- and 3-year survival outcomes using variable selection. The 1-year prediction model yielded a C-index of 0.76 95% confidence interval (95%CI): 0.65-0.87 and the 3-year prediction model produced a C-index of 0.69 (95%CI: 0.65-0.73). Internal validation yielded a C-index of 0.761 (95%CI: 0.669-0.853) for the 1-year model and 0.693 (95%CI: 0.642-0.744) for the 3-year model. We developed Cox regression models for 1-year and 3-year survival predictions of patients with ICC who underwent resection, which has positive implications for establishing a more comprehensive prognostic model for ICC based on tumor immune microenvironment and immune cell changes in the future.

Anterior circulation location-specific results for stent-assisted coiling – carotid versus distal aneurysms: 1-year outcomes from the Neuroform Atlas Stent Pivotal Trial

BackgroundThe Neuroform Atlas Stent System is an established treatment modality for unruptured anterior and posterior circulation intracranial aneurysms. Location-specific results are needed to guide treatment decision-making. However, it is unclear...

VI-RADS followed by Photodynamic Transurethral Resection of Non-Muscle-Invasive Bladder Cancer vs White-Light Conventional and Second-resection: the 'CUT-less' Randomised Trial Protocol.

A second transurethral resection of bladder tumour (Re-TURBT) is recommended by European Association of Urology (EAU) Guidelines on non-muscle-invasive bladder cancers (NMIBCs) due to the risk of understaging and/or persistent disease following the primary resection. However, in many cases this may be unnecessary, potentially harmful, and significantly expensive constituting overtreatment. The CUT-less trial aims to combine the preoperative staging accuracy of Vesical Imaging-Reporting and Data System (VI-RADS) and the intraoperative enhanced ability of photodynamic diagnosis (PDD) to overcome the primary TURBT pitfalls thus potentially re-defining criteria for Re-TURBT indications. Single-centre, non-inferiority, phase IV, open-label, randomised controlled trial with 1:1 ratio. The primary endpoint is short-term BC recurrence between the study arms to assess whether patients preoperatively categorised as VI-RADS Score 1 and/or Score 2 (i.e., very-low and low likelihood of MIBC) could safely avoid Re-TURBT by undergoing primary PDD-TURBT. Secondary endpoints include mid- and long-term BC recurrences and progression (i-ii). Also, health-related quality of life (HRQoL) outcomes (iii) and health-economic cost-benefit analysis (iv) will be performed. All patients will undergo preoperative Multiparametric Magnetic Resonance Imaging of the bladder with VI-RADS score determination. A total of 327 patients with intermediate-/high-risk NMIBCs, candidate for Re-TURBT according to EAU Guidelines, will be enrolled over a 3-year period. Participants will be randomised (1:1 ratio) to either standard of care (SoC), comprising primary white-light (WL) TURBT followed by second WL Re-TURBT; or the Experimental arm, comprising primary PDD-TURBT and omitting Re-TURBT. Both groups will receive adjuvant intravesical therapy and surveillance according to risk-adjusted schedules. Measure of the primary outcome will be the relative proportion of BC recurrences between the SoC and Experimental arms within 4.5 months (i.e., any 'early' recurrence detected at first follow-up cystoscopy). Secondary outcomes measures will be the relative proportion of late BC recurrences and/or BC progression detected after 4.5 months follow-up. Additionally, we will compute the HRQoL variation from NMIBC questionnaires modelled over a patient lifetime horizon and the health-economic analyses including a short-term cost-benefit assessment of incremental costs per Re-TURBT avoided and a longer-term cost-utility per quality-adjusted life year gained using 2-year clinical outcomes to drive a lifetime model across the two arms of treatment. ClinicalTrial.gov identifier (ID): NCT05962541; European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) ID: 2023-507307-64-00.

One-year follow-up of neurobehavioral therapy in functional seizures or epilepsy with traumatic brain injury: A nonrandomized controlled trial.

Patients with traumatic brain injury (TBI) often present with seizures (functional and/or epileptic), but treatments for patients with TBI and seizures are limited. We examined treatment phase and 1-year post-enrollment outcomes following neurobehavioral therapy (NBT) for patients with TBI + functional seizures (FS) and TBI + epilepsy. In this multicenter, prospective, three-group, nonrandomized, controlled trial, with 1-year post-enrollment follow-up, three cohorts of adults were recruited: TBI + video-electroencephalography (EEG)-confirmed FS (n = 89), TBI + EEG-confirmed epilepsy (n = 29), and chart/history-confirmed TBI without seizures (n = 75). Exclusion criteria were recent psychotic or self-injurious behavior, current suicidal ideation, pending litigation or long-term disability, active substance use disorder, and inability to participate in study procedures. TBI + FS and TBI + epilepsy groups completed NBT for seizures, an evidence-based, 12-session, multimodal psychotherapy, whereas TBI without seizures participants received standard medical care. The primary outcome was change in seizure frequency; secondary outcomes were changes in mental health, TBI-related symptoms, disability, and quality of life. Reductions in average monthly seizures occurred during treatment in TBI + FS participants (p = .002) and were significant from baseline (mean = 16.75; 95% confidence interval [CI] = 11.44-24.53) to 12 months post-enrollment (mean = 7.28, 95% CI = 4.37-12.13, p = .002, d = .38). Monthly seizures decreased during treatment in TBI + epilepsy participants (p = .002); reductions were not statistically significant from baseline (mean = 2.38, 95% CI = 1.12-5.04) to 12-month postenrollment (mean = .98, 95% CI = .40-2.42, p = .07, d = .22). Regarding treatment-phase changes in secondary outcome measures, TBI + FS participants improved significantly on 10 of 19 variables (52.6%), TBI + epilepsy participants improved on five of 19 (26.3%), and TBI-onlycomparisons improved on only one of 19 (5.3%). NBT benefited patients with TBI + FS and TBI + epilepsy. Improvements were demonstrated at 1 year post-enrollment in those with TBI + FS. NBT may be a clinically useful treatment for patients with seizures.

1- and 2-year outcomes and predictors of weight loss after gastric sleeve to Roux-en-Y gastric bypass conversion: a retrospective cohort study.

Sleeve gastrectomy to Roux-en-Y bypass conversion is a commonly performed procedure, yet data are limited on outcomes and their predictors. The purpose of this study is to characterize the long-term outcomes of patients after sleeve-to-bypass conversion and identify predictors of post-conversion outcomes. We performed a retrospective cohort study of patients who underwent sleeve-to-bypass conversion for obesity across four hospitals from 06/2017 to 04/2023. Predictors of the below-average percent excess weight loss (%EWL; relative to pre-conversion weight) at 1 and 2years following conversion were identified using multivariate logistic regression models adjusting for comorbidities, demographics, and neighborhood socioeconomic status. 150 Patients undergoing sleeve-to-bypass conversion were identified. 99 had 1-year data and 63 had 2-year data. Mean %EWL at 1- and 2-years following conversion were 40.2% and 37.4%, respectively. EWL > 40% after sleeve gastrectomy was an independent predictor of the below-average %EWL 1-year post-conversion (OR 10.0, 95% CI 2.2-63.0, p < 0.01), and BMI > 40kg/m2 at the time of conversion was an independent predictor of both 1- and 2-year below-average %EWL post-conversion (p = 0.01 and 0.05, respectively). Insignificant predictors of the below-average %EWL after conversion included: weight regain after sleeve, time between sleeve and conversion, alimentary limb length, and any bariatric surgery prior to sleeve gastrectomy. Patients should be counseled that the typical expected %EWL for sleeve-to-bypass conversion is less than the 50% EWL benchmark of success for index bariatric operations. The main predictors of a suboptimal conversion outcome are > 40% EWL after sleeve or > 40 BMI kg/m2 at the time of conversion. Most variables in our analysis were not predictors of post-conversion %EWL, including weight regain between sleeve and conversion, alimentary limb length, and time interval between procedures, which suggests that these factors should not play a large role when considering sleeve-to-bypass conversion.

Long-Term Clinical Efficacy of Radiotherapy for Patients with Stage I-II Gastric Extranodal Marginal Zone B-Cell Lymphoma of Mucosa-Associated Lymphoid Tissue: A Retrospective Multi-Institutional Study.

To evaluate long-term treatment outcomes in patients with localized gastric mucosa-associated lymphoid tissue (MALT) lymphoma treated with radiation therapy (RT). A total of 229 patients who received RT in ten tertiary hospitals between 2010 and 2019 were included in this multi-center analysis. Response after RT was based on esophagogastroduodenoscopy after RT. Locoregional relapse-free survival (LRFS) and disease-free survival (DFS) were evaluated. After a median follow-up time of 93.2 months, 5-year LRFS, DFS, and OS rates were 92.8%, 90.4%, and 96.1%, respectively. LRFS, DFS, and OS rates at 10 years were 90.3%, 87.7%, and 92.8%, respectively. Of 229 patients, 228 (99.6%) patients achieved complete remission after RT. Five-year LRFS was significantly lower in patients with stage IIE than in those with stage IE (77.4% vs. 94.2%, p=0.047). Patients with age ≥ 60 had significantly lower LRFS than patients with age < 60 (89.3% vs. 95.1%, p=0.003). In the multivariate analysis, old age (≥ 60 years) was a prognostic factor for LRFS [hazard ratio (HR) of 3.72 and confidence interval (CI), 1.38-10.03; p=0.009). Grade 2 or higher gastritis was reported in 69 (30.1%) patients. Secondary malignancies including gastric adenocarcinoma, malignant lymphoma, lung cancer, breast cancer, and prostate cancer were observed in 11 (4.8%) patients after RT. Patients treated with RT for localized gastric MALT lymphoma showed favorable 10-year outcomes. Radiation therapy is an effective treatment without an increased risk of secondary cancer. The toxicity for radiotherapy to the stomach is not high.

Prevalence and Clinical Impact of Coronal Malalignment Following Circumferential Minimally Invasive Surgery (CMIS) for Adult Spinal Deformity Correction.

Retrospective study. To determine prevalence and clinical importance of patients who had postoperative CM after CMIS for ASD correction. We reviewed patients who underwent CMIS technique. Inclusion criteria were patients who were diagnosed with ASD, which is defined as having at least one of the following: coronal Cobb angle >20, SVA >50mm, PI-LL >10, PT >20. They underwent >4 spinal levels fusion with CMIS technique and had at least 1-year follow-up. Preoperative and 1-year postoperative radiographs and clinical outcome measures (VAS, ODI, and SRS-22 scores) were used to make the comparisons. 120 patients were included. Radiographic outcomes, including CVA, coronal Cobb angle, LSF curve, SVA, LL, and PI-LL, and clinical outcomes, were significantly improved postoperatively in each of the 3 preoperative subgroups (Bao type A, B, and C). At 1-year post-operation, 10 patients (12.4 %) of type A turned out to be CM, 4 patients (21.1%) of type B, and 8 patients (40%) of type C remained CM. Comparing coronally aligned (CA) to coronally mal-aligned patients at 1-year follow-up in each coronal subtype revealed that clinical and radiographic outcomes were comparable. CMIS technique significantly improves radiographic and clinical outcomes for ASD patients. Incidence rates of postoperative CM were similar to open surgery. Type C patients were at risk of postoperative CM than types A and B. However, most 1-year outcomes were not significantly different between postoperative CA and CM patients regardless of the preoperative coronal alignment characteristics except ODI scores in type A.

Jetstream Atherectomy with Paclitaxel-Coated Balloons: 3-Year Outcomes of the Prospective Randomized JET-RANGER Study

AbstractThe JET-RANGER study (NCT03206762) was a multicenter (11 U.S. centers), randomized trial, core-lab adjudicated and designed to demonstrate the superiority of Jetstream + paclitaxel-coated balloon (JET + PCB) versus percutaneous transluminal angioplasty (PTA) + PCB in treating femoropopliteal arterial disease. The 1- and 2-year outcomes have been recently published. The 3-year outcome data are presented in this report. The JET-RANGER trial initially had 47 patients with 48 lesions. Thirty-one in the JET-PCB arm and 16 in the PTA + PCB arm (2:1 randomization). At 3-year follow-ups, there were 20 patients in the JET-PCB arm and 14 patients in the PTA + PCB arm. Kaplan–Meier survival analysis was performed to estimate the freedom from target lesion revascularization (TLR) at 3 years. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value &lt; 0.05. Freedom from TLR was statistically similar between the two groups at 3 years between JET + PCB and PTA + PCB (freedom from TLR was 88.0 vs. 67.8%, respectively, p = 0.1380). There was also no significant difference in the change of ankle-brachial index (ABI) between the PTA + PCB and JET + PCB from baseline at 6 months (p = 0.7890), 1 year (p = 0.4070), 2 years (p = 0.7410), and 3 years (p = 0.8010). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more categories from baseline to 3 years (p = 0.8949). There were no minor or major amputations for either arm throughout the 3-year follow-up. Five JET + PCB patients died before the 3-year specified window and none in the PTA + PCB arm (p = 0.137). Two of the deaths were due to cancer and three due to cardiac causes. None were deemed related to the device or procedure. JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 3-year follow-up with no difference in amputation or mortality between the 2 arms. A trend toward less TLR was seen in the JET + PCB arm.

Multimodal Outcomes of Early Open Extended Midline Strip Craniectomy With Bilateral Microbarrel Staving for Correction of Isolated Nonsyndromic Sagittal Synostosis.

Sagittal synostosis is the most common craniosynostosis. The aim of surgery is to preserve cognitive function and to correct the morphologic changes. In our unit, the authors offer strip craniectomy and microbarrel staving (SMB) performed at 16 to 22 weeks. This study aims to ascertain the 7-year outcome of scaphocephaly correction by SMB. The authors investigate whether the improvement in cranial index (CI) is sustained over time, and report speech and language and neurodevelopmental outcomes. All nonsyndromic patients with sagittal synostosis who underwent SMB between 2009 and 2012 were identified from a prospectively created database that recorded anthropometric measurements, quality metrics, and neurodevelopmental outcomes. A total of 27 patients were analyzed. The mean CI preoperatively was 67.5% (±3.5), and at 7 years 78% (±4.8). Regarding neurodevelopmental outcomes at 7 years, SDQ responses did not highlight any concerns for social, emotional, or behavioral outcomes. The vast majority of those who completed a WASI-II assessment performed within the average ranges in terms of cognitive ability. In terms of speech and language 70% of subjects demonstrated receptive language within normal level (WNL). Seventy-seven percent of subjects demonstrated expressive language WNL. In conclusion, after 7 years of follow-up, early open extended SMB is a safe and effective method for correction of isolated nonsyndromic isolated sagittal synostosis. Across the neurodevelopmental measures and assessments, the children in the current study appeared to perform within expected ranges. Speech and language problems are more prevalent than in the general population.

Comparison of Open and Endovascular Repair of Complex Abdominal Aortic Aneurysms

To compare perioperative and 5-year outcomes following endovascular (FEVAR) and open repair (OAR) of complex abdominal aortic aneurysms (cAAA) in males and females separately, given the known sex related differences in perioperative outcomes. We studied all elective cAAA repairs between 2014-2019 in the Vascular Implant Surveillance and Interventional Outcomes Network (VISION) registry. We stratified patients based on sex. We calculated propensity scores for assignment to either OAR or FEVAR. Covariates including age, race, diameter, baseline comorbidities, proximal extent of repair, annual center volumes, and annual surgeon volumes were introduced into the model for estimating propensity scores. Within matched cohorts, perioperative outcomes and 5-year outcomes (mortality, reinterventions, and ruptures) were evaluated using multivariable logistic and Cox regression models. We identified 2,825 patients of whom 29% were female. Within both the sexes, OAR was more commonly performed (OAR vs FEVAR: males: 53% vs 47%; females: 63% vs 37%). After matching, among males (n=1326), FEVAR was associated with lower perioperative mortality (FEVAR vs OAR: 2.3% vs 5.1%; p<.001). However, FEVAR was associated with comparable 5-year mortality (38% vs 28%; hazard ratio (HR) 1.2 [0.92-1.4]; p=.22) and a higher hazard of 5-year reintervention (19% vs 3.7%; aHR: 4.5 [2.6-7.6], p<.001). Among females (n=456), FEVAR and OAR showed similar perioperative mortality (8.3% vs 7.0%; p=.73). At 5 years, FEVAR was associated with higher hazards of mortality (43% vs 32%; aHR: 1.5 [1.03-2.2], p=.034) and reintervention (20% vs 3.0%; aHR: 4.8 [2.1-11], p<.001) compared with OAR. Among males, FEVAR was associated with favorable perioperative outcomes compared with OAR, though these advantages attenuate over time. However, among females, FEVAR was associated with similar perioperative outcomes, eventually leading to higher reinterventions and possibly higher mortality within 5 years. Future efforts should focus on determining the factors associated with these sex disparities to improve outcomes following FEVAR in females. Based on current evidence, females undergoing elective cAAA repair should be selected with due caution, especially for endovascular repair.