Impact of dose volume parameters and clinical characteristics on radiation-induced acute oral mucositis for head and neck cancer patients treated with carbon-ion radiotherapy dose volume outcome analysis.

OBJECTIVES: To assess the predictive value of different dosimetric parameters for acute radiation oral mucositis (ROM) in head and neck cancer (HNCs) patients treated with carbon-ion radiotherapy (CIRT). METHODS: 44 patients with HNCs treated with CIRT were evaluated for acute ROM which was defined as severe when the score ≥3 (acute ROM was scored prospectively using the Radiation Therapy Oncology Group (RTOG) score system). Predictive dosimetric factors were identified by using univariate and multivariate analysis. RESULTS: Male gender, weight loss >5%, and total dose/fractions were related factors to severe ROM. In multivariate analysis, grade ≥3 ROM was significantly related to the Dmax, D10, D15, and D20 (P < 0.05, respectively). As the receiver operating characteristics (ROC) curve shows, the area under the curve (AUC) for D10 was 0.77 (p = 0.003), and the cutoff value was 51.06 Gy (RBE); The AUC for D15 was 0.75 (p = 0.006), and the cutoff value was 42.82 Gy (RBE); The AUC for D20 was 0.74 (p = 0.009), and the cutoff value was 30.45 Gy (RBE); The AUC for Dmax was 0.81 (p < 0.001), and the cutoff value was 69.33 Gy (RBE). CONCLUSION: Male gender, weight loss, and total dose/fractions were significantly association with ROM. Dmax, D10, D15 and D20 were identified as the most valuable predictor and we suggest a Dmax limit of 69.33 Gy (RBE), D10 limit of 51.06 Gy (RBE), D15 limit of 42.82 Gy (RBE), and D20 limit of 30.45 Gy (RBE) and for oral mucosa.

Peri-Operative Mortality and Survival After Repair of Abdominal Aortic Aneurysm in Advanced Age Patients: A National Study from the Norwegian Registry for Vascular Surgery Focused on Nonagenarians.

OBJECTIVE: Treatment of abdominal aortic aneurysm (AAA) in nonagenarians has become more frequent. This national observational cohort study aimed to investigate peri-operative mortality and survival after AAA surgery in nonagenarians in Norway. METHODS: All AAA repairs registered in the Norwegian Registry for Vascular Surgery from 2015 to 2021 were identified and stratified into nonagenarians > 90 years old (n = 77), octogenarians 80 - 89 years old (n = 1 362), and patients < 80 years old (n = 4 590). The patient characteristics and comorbidities were recorded, and the 30 and 90 day mortality rates were calculated. Kaplan-Meier analysis was performed to obtain the estimated median survival and survival curves. RESULTS: In the nonagenarians, the 30 day mortality rates were 2.5% in asymptomatic patients, 33.3% in symptomatic patients, and 59.1% in the patients with a ruptured AAA (rAAA). The estimated median survival (years) were 3.3 (95% confidence interval [CI] 1.95 - 4.59) for asymptomatic AAA, 2.9 (interquartile range [IQR] 2.82, 5.80) for symptomatic AAA, and 0.1 for rAAA (IQR 0.01, 3.04). For nonagenarians surviving the first 90 days, the estimated median survival (years) were 4.2 (95% CI 2.56 - 5.88) for asymptomatic AAA, 3.4 (IQR 2.86, 5.80) for symptomatic AAA, and 3.8 (IQR 1.49, 4.85) for rAAA. The 90 day mortality rates were 100.0%, 80.0%, and 62.5% for asymptomatic, symptomatic, and rAAA, respectively, after open surgical repair (OSR), and 5.1%, 10.0%, and 50.0%, respectively, after endovascular aortic repair (EVAR). CONCLUSION: Peri-operative mortality and survival results after AAA surgery in nonagenarians support treatment of selected asymptomatic patients. The 90 day survivors had an expected survival of more than three years, enabling balanced decision making regarding surgical vs. conservative treatment options in this challenging cohort. EVAR is the treatment method of choice for AAA in nonagenarians because most of them would probably live longer untreated than if treated by OSR.

Comparative study on anterior pelvic plating and pubic ramus screw fixation for straddle fracture: a matched-pair outcome analysis.

PURPOSE: Straddle fractures involving both the superior and inferior rami often require surgical fixation due to instability. This study compared the clinical and radiological outcomes of pubic ramus screw fixation (PRSF) and anterior pelvic plating (APP) for the treatment of these fractures to identify the superior method. METHODS: A retrospective analysis was conducted on 70 patients (37 males, 33 females; average age 47.6 years) treated surgically for straddle fractures at two Level 1 trauma centres between May 2017 and August 2022. The patients were divided into two groups, where 26 underwent PRSF and 44 underwent APP. The groups were matched based on preoperative characteristics such as age, sex, body mass index, injury mechanism, and severity. The key variables analysed included operation time, blood transfusion volume, early weight-bearing capability, and complication and reoperation rates. RESULTS: After matching, PRSF was associated with a shorter operative time (71.0 min vs. 118.3 min for APP, p < 0.0009) and lower blood transfusion requirements (0 units vs. 1 unit, p < 0.0001). Postoperatively, 61.5% of PRSF patients tolerated early weight-bearing, compared to none in the APP group. However, in two cases, PRSF could not be performed due to severe comminution or anatomical limitations, necessitating conversion to APP. Complication rates were similar between the groups (30.8% for PRSF vs. 27.3% for APP, p = 0.93). CONCLUSION: PRSF demonstrated advantages, such as shorter operative time, reduced blood transfusions, and earlier weight-bearing. However, APP remains valuable for complex fracture patterns. Treatment should be individualized based on fracture complexity and patient-specific factors to optimize outcomes.

Long-term clinical and radiological outcome of a cementless titanium-coated total knee arthroplasty system.

INTRODUCTION: To ensure a high-quality standard, it is important to frequently evaluate different prostheses models to avoid prostheses with high failure rates. Thus, the aim of the study was to evaluate the long-term outcome of the uncemented titanium-coated total knee arthroplasty (TKA) system (Advanced Coated System (ACS) III, Implantcast, GERMANY). We hypothesized that the ACS III would have a similar performance as other cemented TKA systems. MATERIALS AND METHODS: A total of 540 ACS III mobile-bearing knee joint prostheses were implanted in 495 patients. The visual analogue scale (VAS) score, Tegner activity score (TAS), knee society score (KSS), Western Ontario and McMaster (WOMAC) score, and the Short Form 12 (SF-12) score for the evaluation of quality of life (QoL) were taken after at least 9 years of follow-up. In addition, we measured range of motion (ROM) and assessed potential sex differences. In addition, the survival analysis was calculated at a median follow-up of 16.7 years. RESULTS: At the final follow-up, 142 patients had died, and 38 had been lost to follow-up. The rate of revision-free implant survival at 16.7 years was 90.0% (95% CI 87.1-92.2%) and the rate of infection-free survival was 97.0% (IQR 95.2-98.2%). The reasons for revision surgery were aseptic loosening (32.9%), followed by infection (27.1%), inlay exchange (15.9%), and periprosthetic fractures (5.7%). At the clinical follow-up visit, the mean VAS score was 1.9 ± 1.9, the median TAS was 3 (IQR 2-4), and the mean KSS for pain and function were 83.5 ± 15.3 and 67.5 ± 25.2, respectively. The mean WOMAC score was 81.1 ± 14.9, and the median SF-12 scores for physical and mental health were 36.9 (IQR 29.8-45.1) and 55.8 (IQR 46.2-61.0), respectively. The mean knee flexion was 102.0° ± 15.4°. Male patients had better clinical outcome scores than female patients [SF-12 mental health score, p = 0.037; SF-12 physical health score, p = 0.032; KSS pain score (p < 0.001), and KSS functional score (p < 0.001)]. CONCLUSION: The ACS III TKA system is a suitable option for the treatment of end-stage osteoarthritis of the knee joint because of its adequate long-term survival. Our findings are in line with published data on similar TKA systems that have shown favourable clinical scores in males. LEVEL OF EVIDENCE: Level III-Retrospective cohort study.

[18F]FDG PET-MRI provides survival biomarkers in primary central nervous system lymphoma in the elderly: an ancillary study from the BLOCAGE trial of the LOC network.

PURPOSE: Primary central nervous system lymphoma (PCNSL) incidence is rising among elderly patients, presenting challenges due to poor prognosis and treatment-related toxicity risks. This study explores the potential of combining [18F]fluorodeoxyglucose ([18F]FDG) PET scans and multimodal MRI for improving management in elderly patients with de novo PCNSL. METHODS: Immunocompetent patients over 60 years with de novo PCNSL were prospectively enrolled in a multicentric study between January 2016 and April 2021. Patients underwent brain [18F]FDG PET-MRI before receiving high-dose methotrexate-based chemotherapy. Relationships between extracted PET (metabolic tumor volume (MTV), sum of MTV for up to five lesions (sumMTV), metabolic imaging lymphoma aggressiveness score (MILAS)) and MRI parameters (tumor contrast-enhancement size, cerebral blood volume (CBV), cerebral blood flow (CBF), apparent diffusion coefficient (ADC)) and treatment response and outcomes were analyzed. RESULTS: Of 54 newly diagnosed diffuse large B-cell PCNSL patients, 52 had positive PET and MRI with highly [18F]FDG-avid and contrast-enhanced disease (SUVmax: 27.7 [22.8-36]). High [18F]FDG uptake and metabolic volume were significantly associated with low ADCmean values and high CBF at baseline. Among patients, 69% achieved an objective response at the end of induction therapy, while 17 were progressive. Higher cerebellar SUVmean and lower sumMTV at diagnosis were significant predictors of complete response: 6.4 [5.7-7.7] vs 5.4 [4.5-6.6] (p = 0.04) and 5.5 [2.1-13.3] vs 15.9 [4.2-19.5] (p = 0.01), respectively. Two-year overall survival (OS) was 71%, with a median progression-free survival (PFS) of 29.6 months and a median follow-up of 37 months. Larger tumor volumes on PET or enhanced T1-weighted MRI were significant predictors of poorer OS, while a high MILAS score at diagnosis was associated with early death (< 1 year). CONCLUSION: Baseline cerebellar metabolism and sumMTV may predict response to end of chemotherapy in PCNSL. Tumor volume and MILAS at baseline are strong prognostic factors.

Childhood anxious/withdrawn behaviour and later anxiety disorder: a network outcome analysis of a population cohort.

BACKGROUND: Several previous studies have identified a continuity between childhood anxiety/withdrawal and anxiety disorder (AD) in later life. However, not all children with anxiety/withdrawal problems will experience an AD in later life. Previous studies have shown that the severity of childhood anxiety/withdrawal accounts for some of the variability in AD outcomes. However, no studies to date have investigated how variation in features of anxiety/withdrawal may relate to continuity prognoses. The present research addresses this gap. METHODS: Data were gathered as part of the Christchurch Health and Development Study, a 40-year population birth cohort of 1265 children born in Christchurch, New Zealand. Fifteen childhood anxiety/withdrawal items were measured at 7-9 years and AD outcomes were measured at various interviews from 15 to 40 years. Six network models were estimated. Two models estimated the network structure of childhood anxiety/withdrawal items independently for males and females. Four models estimated childhood anxiety/withdrawal items predicting adolescent AD (14-21 years) and adult AD (21-40 years) in both males and females. RESULTS: Approximately 40% of participants met the diagnostic criteria for an AD during both the adolescent (14-21 years) and adult (21-40 years) outcome periods. Outcome networks showed that items measuring social and emotional anxious/withdrawn behaviours most frequently predicted AD outcomes. Items measuring situation-based fears and authority figure-specific anxious/withdrawn behaviour did not consistently predict AD outcomes. This applied across both the male and female subsamples. CONCLUSIONS: Social and emotional anxious/withdrawn behaviours in middle childhood appear to carry increased risk for AD outcomes in both adolescence and adulthood.

Design and analysis of two-phase studies with multivariate longitudinal data.

Two-phase studies are crucial when outcome and covariate data are available in a first-phase sample (e.g., a cohort study), but costs associated with retrospective ascertainment of a novel exposure limit the size of the second-phase sample, in whom the exposure is collected. For longitudinal outcomes, one class of two-phase studies stratifies subjects based on an outcome vector summary (e.g., an average or a slope over time) and oversamples subjects in the extreme value strata while undersampling subjects in the medium-value stratum. Based on the choice of the summary, two-phase studies for longitudinal data can increase efficiency of time-varying and/or time-fixed exposure parameter estimates. In this manuscript, we extend efficient, two-phase study designs to multivariate longitudinal continuous outcomes, and we detail two analysis approaches. The first approach is a multiple imputation analysis that combines complete data from subjects selected for phase two with the incomplete data from those not selected. The second approach is a conditional maximum likelihood analysis that is intended for applications where only data from subjects selected for phase two are available. Importantly, we show that both approaches can be applied to secondary analyses of previously conducted two-phase studies. We examine finite sample operating characteristics of the two approaches and use the Lung Health Study (Connett et al. (1993), Controlled Clinical Trials, 14, 3S-19S) to examine genetic associations with lung function decline over time.

Morphological and Clinical Predictors of Early/Follow-up Failure of the Endovascular Infrarenal Abdominal Aneurysm Repair With Currently Available Endografts.

PURPOSE: To report outcomes of endovascular repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs) with currently-available endografts and identify predictors of technical/clinical failure. MATERIALS AND METHODS: Patients undergoing EVAR between 2012 and 2020 were prospectively collected and retrospectively analyzed. Technical success (TS: no type I-III endoleaks, renal/hypogastric arteries loss, iliac leg occlusion, conversion to open repair and mortality within 24 postoperative hour), proximal neck-related TS (nr-TS: no proximal type I endoleaks, unplanned renal arteries coverage), and 30-day mortality were assessed as early outcomes. Proximal type I endoleak (ELIa), survival and freedom from reinterventions (FFRs) were assessed during follow-up. Uni/multivariate analysis and Cox-regression were used to identified factors associated with early and follow-up outcomes; FFR and survival were assessed by Kaplan-Meier analysis. RESULTS: A total of 710 were included. Technical success and nr-TS were 692 (98%) and 700 (99%), respectively. The presence of ≥2 hostile anatomical infrarenal neck characteristics was associated with technical failure (odds ratio [OR]: 2.4; 95% confidence interval [CI]: 1.3-4.1; p: 0.007). Infrarenal neck angle >90° (OR: 2.88; 95% CI: 9.6-50.3; p: 0.004), barrel shape (OR: 2.33; 95% CI: 11.1-100.3; p: 0.02) or presence of ≥2 hostile anatomical infrarenal neck characteristics (OR: 2.16; 95% CI: 2.5-5.3; p: 0.03) were independent risk factors for neck-related technical failures. Six (0.8%) patients died within 30 postoperative days. Chronic obstructive pulmonary disease (OR: 16; 95% CI: 1.1-218.3; p: 0.04) and urgent repair (OR: 15; 95% CI: 1.8-119.6; p: 0.01) were independent risk factors for 30-day mortality. The mean follow-up was 53±13 months. There were 12 (1.7%) ELIa during follow-up. Infrarenal neck length <15 mm (hazard ratio [HR]: 2.8; 95% CI: 1.9-9.6; p: 0.005), diameter >28 mm (HR: 2.7; 95% CI: 1.6-9.5; p: 0.006), angle ≥90° (HR: 2.7; 95% CI: 8.3-50.1; p: 0.007), and persistent type II endoleak (HR: 2.9; 95% CI: 1.6-10.1; p: 0.004) were independent risk factors for ELIa. Freedom from reintervention was 91% at 5 years. The ELIa was an independent risk factor for reinterventions during follow-up (HR: 29.5; 95% CI: 1.4-1.6; p<0.001). Survival was 74% at 5 years with 2 cases (0.3%) of late aortic-related mortality. Peripheral arterial occlusive disease (HR: 1.9; 95% CI: 1.4-3.65; p: 0.03), aneurysm diameter ≥65 mm (HR: 2.2; 95% CI: 1.4-3.26; p<0.001), and infrarenal neck length <15 mm (HR: 1.7; 95% CI: 1.2-2.35; p: 0.04) were independent risk factors for mortality during follow-up. CONCLUSION: Endovascular repair with currently-available endografts has high TS and low 30-day mortality. Survival and FFRs were satisfactory at mid-term. Pre/postoperative risk factors for technical and clinical failure were identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome. CLINICAL IMPACT: Pre and postoperative risk factors for technical and clinical EVAR failure can be identified and they should be considered in EVAR indication and postoperative management to reduce complications and improve mid-term outcome.

Retrospective comparison of percutaneous balloon compression and radiofrequency-thermocoagulation in the management of trigeminal neuralgia.

PURPOSE: To compare percutaneous balloon compression (PBC) and radiofrequency thermocoagulation (RFTC) for the treatment of trigeminal neuralgia. METHODS: This was a retrospective single-center analysis of data from 230 patients with trigeminal neuralgia who underwent 202 PBC (46%) and 234 RFTC (54%) from 2002 to 2019. Comparison of demographic data and trigeminal neuralgia characteristics between procedures as well as assessment of 1) initial pain relief by an improved Barrow Neurological Institute (BNI) pain intensity scale of I-III; 2) recurrence-free survival of patients with a follow-up of at least 6 months by Kaplan-Meier analysis; 3) risk factors for failed initial pain relief and recurrence-free survival by regression analysis; and 4) complications and adverse events. RESULTS: Initial pain relief was achieved in 353 (84.2%) procedures and showed no significant difference between PBC (83.7%) and RFTC (84.9%). Patients who suffered from multiple sclerosis (odds ratio 5.34) or had a higher preoperative BNI (odds ratio 2.01) showed a higher risk of not becoming pain free. Recurrence-free survival in 283 procedures was longer for PBC (44%) with 481 days compared to RFTC (56%) with 421 days (p=0.036) but without statistical significance. The only factors that showed a significant influence on longer recurrence-free survival rates were a postoperative BNI ≤ II (P=<0.0001) and a BNI facial numbness score ≥ 3 (p = 0.009). The complication rate of 22.2% as well as zero mortality showed no difference between the two procedures (p=0.162). CONCLUSION: Both percutaneous interventions led to a comparable initial pain relief and recurrence-free survival with a low and comparable probability of complications. An individualized approach, considering the advantages and disadvantages of each intervention, should guide the decision-making process. Prospective comparative trials are urgently needed.

Does intraoperative patellar eversion affect clinical and functional outcomes in patients undergoing primary total knee arthroplasty? An evidence-based meta-analysis.

PURPOSE: This meta-analysis aims to compare the early postoperative recovery, complications encountered, length of hospital stay, and initial functional scores between patellar eversion and non-eversion manoeuvres in patients undergoing during primary total knee arthroplasty (TKA) based on clinical studies available in the literature. METHODS: A systematic literature search was conducted using PubMed, Embase, Web of Science, and the Cochrane Library databases between January 1, 2000 and August 12, 2022. Prospective trials comparing clinical, radiological, and functional outcomes in patients undergoing TKA with and without patellar eversion manoeuvre were included. The meta-analysis was performed using Rev-Man version 5.41 (Cochrane Collaboration). Pooled-odds ratios (for categorical data) and mean differences with 95% confidence intervals (for continuous data) were calculated (p < 0.05 was regarded as statistically significant). RESULTS: Ten (out of the 298 publications identified in this subject) were included for the meta-analysis. The patellar eversion group (PEG) had a significantly shorter tourniquet time [mean difference (MD) - 8.91 min; p = 0.002], although the overall intraoperative blood loss was higher (IOBL; MD 93.02 ml; p = 0.0003). The patellar retraction group (PRG), on the other hand, revealed statistically better early clinical outcomes in terms of shorter time necessary to perform active straight leg raising (MD 0.66, p = 0.0001), shorter time to achieve 90° knee-flexion (MD 0.29, p = 0.03), higher degree of knee flexion achieved at 90 days (MD - 1.90, p = 0.03), and reduced length of hospital stay (MD 0.65, p = 0.03). There was no statistically significant difference in the early complication rates, 36-item short-form health survey (1 year), visual analogue scores (1 year), and Insall-Salvati index at follow-up between the groups. CONCLUSION: The implications from the evaluated studies suggest that in comparison with patellar eversion, patellar retraction manoeuvre during surgery provides significantly faster recovery of quadriceps function, earlier attainment of functional knee range of motion (ROM), and shorter length of hospital stay in patients undergoing TKA.

How does sickle cell disease affect the peri-operative outcome in patients undergoing total knee arthroplasty? A large-scale, National Inpatient Sample-based study.

INTRODUCTION: In view of the vaso-occlusive pathophysiology affecting osseous micro-circulation, sickle cell disease (SCD) is well known to present with diverse skeletal and arthritic manifestations. With prolonged life-expectancy over the past decades, there has been a progressive increase in the proportion of SCD patients requiring joint reconstructions. Owing to the paucity of evidence in the literature, the post-operative complication rates and outcome in these patients following total knee arthroplasty (TKA) are still largely unknown. METHODS: Based on the National Inpatient Sample (NIS) database (using ICD-10 CMP code), patients who underwent TKA between 2016 and 2019 were identified. The cohort were classified into two groups: A-those with SCD; and B-those without. The data on patients' demographics, co-morbidities, details regarding hospital stay including expenditure incurred, and complications were analyzed and compared. RESULTS: Overall, 558,361 patients underwent unilateral, primary TKA; among whom, 493 (0.1%) were known cases of SCD (group A). Group A included a significantly greater proportion of younger (60.14 ± 10.87 vs 66.72 ± 9.50 years; p < 0.001), male (77.3 vs 61.5%; p < 0.001); and African-American (88.2 vs 8.3%B; p < 0.001) patients, in comparison with group B. Group A patients were also at a significantly higher risk for longer duration of peri-operative hospital stay (p < 0.001), greater health-care costs incurred (p < 0.001), and greater need for alternative step-down health-care facilities (p < 0.001) following discharge. Among the SCD patients, 24.7%, 20.9% and 24.9% developed acute chest syndrome, pain crisis and splenic sequestration crisis, respectively during the peri-operative period. Group A patients had a statistically greater incidence of acute renal failure (ARF; p = 0.014), need for blood transfusion (p < 0.001) and deep vein thrombosis (DVT; p = 0.03) during the early admission period. CONCLUSION: The presence of SCD substantially lengthens the duration of hospital stay and enhances health care-associated expenditure in patients undergoing TKA. SCD patients are at significantly higher risk for systemic complications including acute chest syndrome, pain crisis, splenic sequestration crisis, acute renal failure, higher need for blood transfusions and deep venous thrombosis during the initial peri-operative period following TKA.

Predictors of outcome in diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia.

OBJECTIVE: The incidence of chronic limb-threatening ischemia in diabetic patients is increasing. The factors influencing outcome after infrapopliteal revascularization in these patients are largely unknown. Therefore, this study aims to identify the impact of perioperative glucose control on the long-term outcomes in this patient cohort, and furthermore to identify other factors independently associated with outcome. METHODS: Consecutive diabetic patients undergoing infrapopliteal endovascular revascularization for chronic limb-threatening ischemia were identified. Patients' demographics, procedural details, daily capillary blood glucose, and hemoglobin A1C levels were collected and analyzed against the study end points using Kaplan-Meier and Cox regression analysis. RESULTS: A total of 437 infrapopliteal target vessels were successfully crossed in 203 patients. Amputation-free survival by Kaplan-Meier (estimate (standard error)%) was 74 (3.3)% and 63 (3.7)%, primary patency was 61 (4.2)% and 50 (4.9)%, assisted primary patency was 69 (5.2)% and 55 (6.1)%, and secondary patency was 71 (3.8)% and 59 (4.1)% at 1 year and 2 years, respectively. Cox regression analysis showed high perioperative capillary blood glucose levels to be an independent predictor of binary restenosis (hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.31-1.1.78; P = .015). Postprocedural dual-antiplatelet therapy was found to be an independent predictor of amputation-free survival (HR, 1.69; 95% CI, 1.04-2.75; P = .033), and freedom from major adverse limb events (HR: 1.96; 95% CI, 1.16-3.27; P = .023) and baseline estimated glomerular filtration rate was significantly associated with better amputation-free survival (HR, 0.52; 95% CI, 0.31-0.87; P = .014). CONCLUSIONS: Poor perioperative glycemic control is associated with a higher incidence of restenosis after infrapopliteal revascularization in diabetic patients. Dual antiplatelet therapy is associated with better outcomes in this group.

Fenestrated Aortic Aneurysm Repair in Patients Treated Inside Versus Outside of Instructions for Use.

OBJECTIVES: The aim of this study was to compare outcomes of patients treated with the Cook Zenith Fenestrated (ZFEN) device for juxtarenal aortic aneurysms inside versus outside the IFU. METHODS: We retrospectively reviewed our institutional ZFEN database for cases performed between 2012 and 2018, with analysis performed in 2020 in order to report midterm outcomes. The cohort was stratified based on treatment inside (IFU group) and outside (non-IFU group) the IFU for criteria involving the proximal neck: neck length 4 to 14 mm, neck diameter 19 to 31 mm, and neck angulation ≤45°. Patients with thoracoabdominal aneurysms or concurrent chimney grafting were excluded. The primary outcomes in question were mortality, type 1a endoleak, and reintervention. Univariate and multivariate analyses were performed to determine associations between adherence to IFU criteria and outcomes. RESULTS: We identified 100 consecutive patients (19% female, mean age 73.6 years) for inclusion in this analysis. Mean follow-up was 21.6 months. Fifty-four patients (54%) were treated outside the IFU because of inadequate neck length (n=48), enlarged neck diameter (n=10), and/or excessive angulation (n=16). Eighteen patients were outside IFU for two criteria, and one patient was outside IFU for all three. Non-IFU patients were exposed to higher radiation doses (3652 vs 5445 mGy, p=0.008) and contrast volume (76 vs 95 mL, p=0.004). No difference was noted between IFU and non-IFU groups for 30-day mortality (0% vs 3.7%, p=0.18), or type 1a endoleak (0% vs 1.9%, p=0.41). Reintervention was also similar between cohorts (13% vs 27.8%, p=0.13). Being outside IFU for neck diameter or length was each borderline significant for higher reintervention on univariate analysis (p=0.05), but this was not significant on multivariate Cox proportional hazard modeling (HR 1.82 [0.53-6.25]; 2.03 [0.68-7.89]), respectively. No individual IFU deviations were associated with the primary outcomes on multivariate analysis, nor being outside IFU for multiple criteria. CONCLUSIONS: Patients with juxtarenal aortic aneurysms may be treated with the ZFEN device with moderate deviations from the IFU. While no differences were seen in mortality or proximal endoleak, larger studies are needed to examine the potential association between IFU nonadherence and reinterventions and close follow-up is warranted for all patients undergoing such repair.

Multidisciplinary tumor boards and their analyses: the yin and yang of outcome measures.

BACKGROUND: The standard to ensure utmost cancer treatment is a prerequisite in national cancer plans for comprehensive cancer centers (CCCs) and ensured through multidisciplinary tumor boards (MTBs). Despite these being compulsory for CCCs, various analyses on MTBs have been performed, since MTBs are resource-intensive. Outcome measures in these prior analyses had been survival (OS), MTB-adherence and -satisfaction, inclusion of patients into clinical trials and better cancer care. MAIN BODY: A publication from Freytag et al. performed an analysis in multiple tumor entities and assessed the effect of number of MTBs. By matched-pair analysis, they compared response and OS of patients, whose cases were discussed in MTBs vs. those that were not. The analysis included 454 patients and 66 different tumor types. Only patients with > 3 MTBs showed a significantly better OS than patients with no MTB meeting. Response to treatment, relapse free survival and time to progression were not found to be better, nor was there any difference for a specific tumor entity with vs. without MTB discussions. An in-depth discussion of these results, with respect to the literature (PubMed search: "MTBs AND cancer") and within the author group, including statisticians specialized in data analysis of cancer patients and questions addressed in MTBs, was performed to interpret these findings. We conclude that the results by Freytag et al. are deceiving due to an "immortal time bias" that requires more careful data interpretation. CONCLUSIONS: The result of Freytag et al. of a seemingly positive impact of higher number of MTBs needs to be interpreted cautiously: their presumed better OS in patients with > 3 MTB discussions is misleading, due to an immortal time bias. Here patients need to survive long enough to be discussed more often. Therefore, these results should not lead to the conclusion that more MTBs will "automatically" increase cancer patients' OS, rather than that the insightful discussion, at best in MTBs and with statisticians, will generate meaningful advice, that is important for cancer patients.

Modelling hospital outcome: problems with endogeneity.

BACKGROUND: Mortality modelling in the critical care paradigm traditionally uses logistic regression, despite the availability of estimators commonly used in alternate disciplines. Little attention has been paid to covariate endogeneity and the status of non-randomized treatment assignment. Using a large registry database, various binary outcome modelling strategies and methods to account for covariate endogeneity were explored. METHODS: Patient mortality data was sourced from the Australian & New Zealand Intensive Society Adult Patient Database for 2016. Hospital mortality was modelled using logistic, probit and linear probability (LPM) models with intensive care (ICU) providers as fixed (FE) and random (RE) effects. Model comparison entailed indices of discrimination and calibration, information criteria (AIC and BIC) and binned residual analysis. Suspect covariate and ventilation treatment assignment endogeneity was identified by correlation between predictor variable and hospital mortality error terms, using the Stata™ "eprobit" estimator. Marginal effects were used to demonstrate effect estimate differences between probit and "eprobit" models. RESULTS: The cohort comprised 92,693 patients from 124 intensive care units (ICU) in calendar year 2016. Patients mean age was 61.8 (SD 17.5) years, 41.6% were female and APACHE III severity of illness score 54.5(25.6); 43.7% were ventilated. Of the models considered in predicting hospital mortality, logistic regression (with or without ICU FE) and RE logistic regression dominated, more so the latter using information criteria indices. The LPM suffered from many predictions outside the unit [0,1] interval and both poor discrimination and calibration. Error terms of hospital length of stay, an independent risk of death score and ventilation status were correlated with the mortality error term. Marked differences in the ventilation mortality marginal effect was demonstrated between the probit and the "eprobit" models which were scenario dependent. Endogeneity was not demonstrated for the APACHE III score. CONCLUSIONS: Logistic regression accounting for provider effects was the preferred estimator for hospital mortality modelling. Endogeneity of covariates and treatment variables may be identified using appropriate modelling, but failure to do so yields problematic effect estimates.

Ordinal outcome analysis improves the detection of between-hospital differences in outcome.

BACKGROUND: There is a growing interest in assessment of the quality of hospital care, based on outcome measures. Many quality of care comparisons rely on binary outcomes, for example mortality rates. Due to low numbers, the observed differences in outcome are partly subject to chance. We aimed to quantify the gain in efficiency by ordinal instead of binary outcome analyses for hospital comparisons. We analyzed patients with traumatic brain injury (TBI) and stroke as examples. METHODS: We sampled patients from two trials. We simulated ordinal and dichotomous outcomes based on the modified Rankin Scale (stroke) and Glasgow Outcome Scale (TBI) in scenarios with and without true differences between hospitals in outcome. The potential efficiency gain of ordinal outcomes, analyzed with ordinal logistic regression, compared to dichotomous outcomes, analyzed with binary logistic regression was expressed as the possible reduction in sample size while keeping the same statistical power to detect outliers. RESULTS: In the IMPACT study (9578 patients in 265 hospitals, mean number of patients per hospital = 36), the analysis of the ordinal scale rather than the dichotomized scale ('unfavorable outcome'), allowed for up to 32% less patients in the analysis without a loss of power. In the PRACTISE trial (1657 patients in 12 hospitals, mean number of patients per hospital = 138), ordinal analysis allowed for 13% less patients. Compared to mortality, ordinal outcome analyses allowed for up to 37 to 63% less patients. CONCLUSIONS: Ordinal analyses provide the statistical power of substantially larger studies which have been analyzed with dichotomization of endpoints. We advise to exploit ordinal outcome measures for hospital comparisons, in order to increase efficiency in quality of care measurements. TRIAL REGISTRATION: We do not report the results of a health care intervention.

Microvascular decompression in trigeminal neuralgia: predictors of pain relief, complication avoidance, and lessons learned.

OBJECTIVE: To analyze characteristics associated with long-term pain relief after microvascular decompression (MVD) for trigeminal neuralgia (TGN). Description of associated morbidity and complication avoidance. METHODS: One hundred sixty-five patients with TGN underwent 171 MVD surgeries at the authors' institution. Patient characteristics and magnetic resonance imaging (MRI) datasets were obtained through the hospital's archiving system. Patients provided information about pre- and post-operative pain characteristics and neurologic outcome. Favorable outcome was defined as a Barrow Neurological Institute (BNI) pain intensity score of I to III with post-operative improvement of I grade. RESULTS: Type of TGN pain with purely paroxysmal pain (p = 0.0202*) and TGN classification with classical TGN (p = 0.0372*) were the only significant predictors for long-term pain relief. Immediate pain relief occurred in 90.6% of patients with a recurrence rate of 39.4% after 3.5 ± 4.6 years. MRI reporting of a neurovascular conflict had a low negative predictive value of 39.6%. Mortality was 0% with major complications observed in 8.2% of patients. Older age was associated with lower complication rates (p = 0.0009***). Re-MVD surgeries showed improved long-term pain relief in four out of five cases. CONCLUSIONS: MVD is a safe and effective procedure even in the elderly. It has the unique potential to cure TGN if performed on a regular basis, and if key surgical steps are respected. Early MVD should be offered in case of medical treatment failure and paroxysmal pain symptoms. The presence of a neurovascular conflict on MRI is not mandatory. In case of recurrence, re-MVD is a good treatment option that should be discussed with patients. HIGHLIGHTS: • Long-term analysis of pain relief after MVD. • Positive predictors for outcome: classical TGN and purely paroxysmal pain. • Presence of neurovascular conflict in MRI is not mandatory for MVD surgery. • Analysis of complications and surgical nuances for avoidance. • MVD is a safe procedure also in the elderly.

Preliminary Results of the Outpatient Endovascular and Interventional Society National Registry.

PURPOSE: To present a new outcomes-based registry to collect data on outpatient endovascular interventions, a relatively new site of service without adequate historical data to assess best clinical practices. Quality data collection with subsequent outcomes analysis, benchmarking, and direct feedback is necessary to achieve optimal care. MATERIALS AND METHODS: The Outpatient Endovascular and Interventional Society (OEIS) established the OEIS National Registry in 2017 to collect data on safety, efficacy, and quality of care for outpatient endovascular interventions. Since then, it has grown to include a peripheral artery disease (PAD) module with plans to expand to include cardiac, venous, dialysis access, and other procedures in future modules. As a Qualified Clinical Data Registry approved by the Centers for Medicare and Medicaid Services, this application also supports new quality measure development under the Quality Payment Program. All physicians operating in an office-based laboratory or ambulatory surgery center can use the Registry to analyze de-identified data and benchmark performance against national averages. Major adverse events were defined as death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery. RESULTS: Since Registry inception in 2017, 251 participating physicians from 64 centers located in 18 states have participated. The current database includes 18,134 peripheral endovascular interventions performed in 12,403 PAD patients (mean age 72.3±10.2 years; 60.1% men) between January 2017 and January 2020. Cases were performed primarily in an office-based laboratory (85.1%) or ambulatory surgery center setting (10.4%). Most frequently observed procedure indications from 16,086 preprocedure form submissions included claudication (59%), minor tissue loss (16%), rest pain (9%), acute limb ischemia (5%), and maintenance of patency (3%). Planned diagnostic procedures made up 12.2% of cases entered, with the remainder indicated as interventional procedures (87.6%). The hospital transfer rate was 0.62%, with 88 urgent/emergent transfers and 24 elective transfers. The overall complication rate for the Registry was 1.87% (n=338), and the rate of major adverse events was 0.51% (n=92). Thirty-day mortality was 0.03% (n=6). CONCLUSION: This report describes the current structure, methodology, and preliminary results of OEIS National Registry, an outcomes-based registry designed to collect quality performance data with subsequent outcome analysis, benchmarking, and direct feedback to aid clinicians in providing optimal care.

Outcome analysis for prediction of intraaortic balloon pump support failure and long-term survival in high-risk patients undergoing mitral valve surgery.

The outcome predictors of intra-aortic balloon pump (IABP) in patients who undergo mitral valve surgery remain unknown. This study aimed to retrospectively review valvular surgery in patients who received an IABP to identify the predictors of failure of IABP support and anticipate the necessary therapy. This retrospective observational study recruited a total of 157 consecutive patients who underwent open-heart mitral valve surgery with IABP implantation intraoperatively or postoperatively. Univariate and multivariate logistic regression analyses were performed to identify the risk factors attributed to 30-day mortality. Follow-up data of survivors were collected to investigate the effect of IABP support to evaluate long-term outcomes. The overall 30-day mortality was 35.7% (56 patients). The following factors that contributed to 30-day mortality included sepsis (P < .001, OR: 5.627, 95%CI: 2.422-11.683); IABP implantation postoperatively rather than intraoperatively (P = .001, OR: 6.395, 95%CI: 2.085-19.511); right heart failure (P = .042, OR: 3.419, 95%CI: 1.225-12.257); and lack of subvalvular apparatus preservation (P = .033, OR: 3.710, 95%CI: 1.094-13.167). Furthermore, follow-up data of these patients showed an estimation of 5-year and 10-year survival rates of 58.9% and 35.7%, respectively. Patients with intraoperative IABP demonstrated better long-term survival outcomes when compared to those with postoperative IABP (χ2  = 4.291, P = .038). In summary, this study distinguished the preoperative predictors of 30-day mortality of IABP-support in mitral valve surgery patients. These results indicated that early intervention with IABP should be taken into consideration in case of hemodynamic instability in critically ill patients undergoing mitral valve surgery.

Analysis of clinical outcome and postoperative organ function effects in a propensity-matched comparison between conventional and minimally invasive mitral valve surgery.

BACKGROUND: Minimally invasive mitral valve (MV) surgery (MIVT) is increasingly performed with excellent clinical outcome, despite longer procedural times. This study analyzes clinical outcomes and effects on secondary organ functions in a propensity-matched comparison with conventional MV surgery. METHODS AND RESULTS: Out of 439 patients undergoing MV surgery from January 2005 to May 2017, 233 patients were included after propensity-matching: 90 sternotomy patients and 143 MIVT patients. Endpoints focused on survival, quality of MV repair, and organ function effects through analysis of biomarkers and functional parameters. Regardless of longer cardiopulmonary bypass (sternotomy: 101(IQR33) min-MIVT:143(IQR45) min, p < .001) and cardioplegic arrest times(sternotomy: 64(IQR25) min-MIVT:90(IQR34) min, p < .001), no differences in survival nor complication rate were found. Effect on renal function(creatinine, p = .751 - ureum, p = .538 - glomerular filtration, p = .848), myocardial damage by troponine I level (sternotomy:1.8 ± 3.9 ng/ml - MIVT:1.2 ± 1.3 ng/ml, p = .438) and prolonged ventilatory support >24 h (sternotomy:5.5% - MIVT:8.4%, p = .417) were comparable. The systemic inflammatory reaction by postoperative C-reactive protein count was markedly lower for MIVT(p < .001). Increased rhadomyolysis was found after MIVT surgery, based on a significant elevation of creatinine-kinase levels(sternotomy: 431 ± 237 U/L - MIVT: 701 ± 595 U/L, p < .001). CONCLUSION: Despite an inherent learning curve, minimally invasive MV surgery guarantees a clinical outcome and MV repair quality, at least non-inferior to those of MV surgery via sternotomy. Notwithstanding longer cardiopulmonary bypass and cardiac arrest times, the impact on secondary organ function is negligible, except for a lower systemic inflammatory response. The postoperative increase of CK-enzymes suggestive for enhanced rhabdomyolysis needs to be accounted for when procedural times tend to exceed the critical time threshold for severe limb ischemia.