Stepwise Cox Proportional Hazards Model Research Articles

Prognostic analysis of percutaneous vertebroplasty (PVP) combined with 125I implantation on lumbosacral vertebral osteoblastic metastases

ObjectiveLumbosacral vertebral osteoblastic metastasis is treated with percutaneous vertebroplasty (PVP) combined with 125I seed implantation and PVP alone. Compared to PVP alone, we evaluated the effects of combination therapy with PVP and 125I seed implantation on pain, physical condition, and survival and evaluated the clinical value of PVP combined with 125I particle implantation.MethodsWe retrospectively analyzed 62 patients with lumbosacral vertebral osseous metastases treated at our hospital between 2016 and 2019. All the patients met the inclusion criteria for 125I implantation, and they were randomly divided into a combined treatment group and a pure PVP surgery group. The visual analog pain scale (VAS), Karnofsky Performance Status (KPS), and survival time were recorded at different time points, including preoperative, postoperative 1 day, 1 month, 3 months, 6 months, 12 months, and 36 months in each group. The variation in clinical indicators and differences between the groups were analyzed using SPSS version 20.0. Correlations between different variables were analyzed using the nonparametric Spearman’s rank test. The Kaplan–Meier method was used to estimate the relationship between survival time and KPS score, VAS score, or primary tumor progression, and survival differences were analyzed using the log-rank test. Multivariate analyses were performed using a stepwise Cox proportional hazards model to identify independent prognostic factors.ResultsCompared to the PVP treatment group, the pain level in the combined treatment group was significantly reduced (P = 0.000), and the patient’s physical condition in the combination treatment group significantly improved. Kaplan–Meier analysis showed that the survival rate of the PVP group was significantly lower than that of the combination group (P = 0.038). We also found that the median survival of patients in both groups significantly increased with an increase in the KPS score (14 months vs. 33 months) (P = 0.020). Patients with more than three transfer sections had significantly lower survival rates than those with one or two segments of the section (P = 0.001). Further, Cox regression analysis showed that age (P = 0.002), the spinal segment for spinal metastasis (P = 0.000), and primary tumor growth rate (P = 0.005) were independent factors that affected the long-term survival of patients with lumbosacral vertebral osseous metastases.ConclusionsPVP combined 125I seeds implantation surgery demonstrated superior effectiveness compared to PVP surgery alone in treating lumbosacral vertebral osseous metastases, which had feasibility in the clinical operation. Preoperative KPS score, spine transfer section, and primary tumor growth rate were closely related to the survival of patients with lumbosacral vertebral osteoblastic metastasis. Age, spinal segment for spinal metastasis, and primary tumor growth can serve as prognostic indicators and guide clinical treatment.

A nomogram model for predicting 5-year risk of prediabetes in Chinese adults

Early identification is crucial to effectively intervene in individuals at high risk of developing pre-diabetes. This study aimed to create a personalized nomogram to determine the 5-year risk of pre-diabetes among Chinese adults. This retrospective cohort study included 184,188 participants without prediabetes at baseline. Training cohorts (92,177) and validation cohorts (92,011) were randomly assigned (92,011). We compared five prediction models on the training cohorts: full cox proportional hazards model, stepwise cox proportional hazards model, multivariable fractional polynomials (MFP), machine learning, and least absolute shrinkage and selection operator (LASSO) models. At the same time, we validated the above five models on the validation set. And we chose the LASSO model as the final risk prediction model for prediabetes. We presented the model with a nomogram. The model's performance was evaluated in terms of its discriminative ability, clinical utility, and calibration using the area under the receiver operating characteristic (ROC) curve, decision curve analysis, and calibration analysis on the training cohorts. Simultaneously, we also evaluated the above nomogram on the validation set. The 5-year incidence of prediabetes was 10.70% and 10.69% in the training and validation cohort, respectively. We developed a simple nomogram that predicted the risk of prediabetes by using the parameters of age, body mass index (BMI), fasting plasma glucose (FBG), triglycerides (TG), systolic blood pressure (SBP), and serum creatinine (Scr). The nomogram's area under the receiver operating characteristic curve (AUC) was 0.7341 (95% CI 0.7290–0.7392) for the training cohort and 0.7336 (95% CI 0.7285–0.7387) for the validation cohort, indicating good discriminative ability. The calibration curve showed a perfect fit between the predicted prediabetes risk and the observed prediabetes risk. An analysis of the decision curve presented the clinical application of the nomogram, with alternative threshold probability spectrums being presented as well. A personalized prediabetes prediction nomogram was developed and validated among Chinese adults, identifying high-risk individuals. Doctors and others can easily and efficiently use our prediabetes prediction model when assessing prediabetes risk.

Abstract 15698: Association of Social Factors on Sex-Specific Management of Atrial Fibrillation

Introduction: Prior studies have reported disparities by sex in managing atrial fibrillation (AF), with many studies having limited analysis of the effects of social risk factors. We examined the effect of social risk factors on sex differences in the management of AF in a large, socially diverse cohort of insured patients. Hypothesis: We hypothesized that women with AF would receive less AF care, including the receipt of AF-related medications, pulmonary vein isolation ablation, and cardiology follow-up, compared to men. Methods: We identified individuals with AF from 2013-2019 captured by Optum’s de-identified Clinformatics® Data Mart Database. Sex was categorized as men and women. Covariates included demographics (age, sex, race, and ethnicity), Elixhauser variables, and social factors such as estimated annual household income and race or ethnicity. We used stepwise multivariable-adjusted Cox proportional hazards models to assess the effect of race, ethnicity, and household annual income on sex-specific differences in the receipt of AF-related medications, pulmonary vein isolation ablation, and cardiology follow-up. Results: We identified 190,760 individuals (age 74.0±11.4 years; 49.9% women) with incident AF. Women with AF were less likely to receive pulmonary vein isolation ablation and cardiology follow-up over a six-year follow-up than men. Prescriptions of antiarrhythmic were identical among both sexes. When stratified by race and ethnicity, women of Black (HR 0.75, 95% CI 0.61,0.92) and White race (HR 0.83, 95% CI 0.78, 0.88) were less likely to receive pulmonary vein isolation ablation than men. Women of Asian (HR 0.90, 95% CI 0.83,0.97) and White race (HR 0.93, 95% CI 0.92,0.94) were less likely to have cardiology follow-up after initial diagnosis of AF than men. Higher household income did not attenuate sex-specific differences in AF care. Across all income categories, women were less likely to have pulmonary vein isolation and cardiology follow-up. Conclusions: We identified sex differences in AF management that were not attenuated when considering race, ethnicity, and annual household income. Our findings suggest continued evidence of sex, racial, ethnic, and socioeconomic inequities in contemporary AF management.

Radiotherapy for Liver Cancer: An International Multi-Centre Pooled Analysis of 925 Cases

Primary and secondary liver cancer incidence is growing and has a poor prognosis. The standard use of radiation has been hampered by studies with a wide range of patients, different management protocols and varied outcomes. To overcome this heterogeneity in the literature, larger and higher-level trials are warranted, but, so far, have been difficult to implement. Therefore, pooled analyses may offer the best way to determine the benefit of radiation, identify treatment parameters needed to optimize treatment techniques, and identify patient factors that allow for better patient selection. Patients with liver cancer treated by radiotherapy at centers in Canada, United States and Australia was pooled. Patient and treatment characteristics were noted, as well as the clinical outcomes of local control within 1 year, recurrence and mortality. Stepwise Cox proportional hazards models were used to identify significant predictors for recurrence and mortality. Patients were stratified by center, and primary versus metastatic disease. A total of 925 patients were included in this study. Mean age was 67 years, and 45% had a primary diagnosis of hepatocellular carcinoma. 1-year local control rate was 80%. Median survival was 1.8 years (1.9 years for primary liver cancer, and 1.4 years for metastatic liver cancer). Higher total dose and BED was associated with better survival. Median time to recurrence was 1.5 years. Higher total dose was associated with lower risk of recurrence CONCLUSION: As one of the largest pooled analyses in hepatic cancer, this international multi-center study provides pragmatic data on clinical outcomes of patients receiving radiotherapy for liver cancer. This database may assist in better selection of patients for future studies and answer questions such as what is the optimal dose and which patients benefit from treatment.

A novel immunogenomic classification for prognosis in non-small cell lung cancer.

To facilitate immunotherapy and prognostic assessment of non-small cell lung cancer (NSCLC), weestablished a novel immunogenomic classification to provide valid identification criteria. The immune enrichment scores were calculated by single sample gene set enrichment analysis (ssGSEA) and clustered into Immunity_L and Immunity_H, and the reliability of this classification was demonstrated. Immune microenvironment score and immune cell infiltration analysis of NSCLC were also performed. Randomly divided into training group and test group, a prognosis-related immune profile was developed using least absolute shrinkage and selection operator (LASSO) and stepwise COX proportional hazards model to construct a prognostic mode. The risk score for this immune profile was identified as an independent prognostic factor and can be usedas a powerful prognostic tool to refine tumor immunotherapy. Our study identified two NSCLC classifications basedon immunomic profiling, Immunity_H and Immunity_L. In conclusion, Immunogenomic classification can distinguish the immune status of different types ofNSCLC patients and contribute to the immunotherapy of NSCLC patients.

Lower extremity symptoms and ankle-brachial index screening as predictors of cardiovascular outcomes in Black adults.

The prevalence of peripheral artery disease (PAD) and leg symptoms are higher in Black than White adults. We studied the effects of self-reported lower extremity symptoms and ankle-brachial indices (ABI) groups on outcomes. Black participants in the Jackson Heart Study with baseline ABI and PAD symptom assessments (exertional leg pain by the San Diego Claudication questionnaire) were included. Abnormal ABI was < 0.90 or > 1.40. Participants were divided into (1) normal ABI, asymptomatic, (2) normal ABI, symptomatic, (3) abnormal ABI, asymptomatic, and (4) abnormal ABI, symptomatic to examine their associations with MACE (stroke, myocardial infarction, fatal coronary heart disease) and all-cause mortality, using Kaplan-Meier survival curves and stepwise Cox proportional hazard models adjusting for Framingham risk factors. Of 4586 participants, mean age was 54.6 ± 12.6 years, with 63% women. Compared with participants with normal ABI who were asymptomatic, participants with abnormal ABI and leg symptoms had highest risk of MACE (adjusted HR 2.28; 95% CI 1.62, 3.22) and mortality (aHR 1.82; 95% CI 1.32, 2.56). Participants with abnormal ABI without leg symptoms had higher risk for MACE (aHR 1.49; 95% CI 1.06, 2.11) and mortality (aHR 1.44; 95% CI 1.12, 1.99). Participants with normal ABI and no leg symptoms did not have higher risks. Among Black adults, the highest risk for adverse outcomes were in symptomatic participants with abnormal ABIs, followed by asymptomatic participants with abnormal ABIs. These findings underscore the need for further studies to screen for PAD and develop preventative approaches in Black adults with asymptomatic disease.

Nomogram model and risk score to predict 5-year risk of progression from prediabetes to diabetes in Chinese adults: Development and validation of a novel model.

To develop a personalized nomogram and risk score to predict the 5-year risk of diabetes among Chinese adults with prediabetes. There were 26 018 participants with prediabetes at baseline in this retrospective cohort study. We randomly stratified participants into two cohorts for training (n=12 947) and validation (n=13 071). The least absolute shrinkage and selection operator (LASSO) model was applied to select the most significant variables among candidate variables. And we further established a stepwise Cox proportional hazards model to screen out the risk factors based on the predictors chosen by the LASSO model. We presented the model with a nomogram. The model's discrimination, clinical use and calibration were assessed using the area under the receiver operating characteristic (ROC) curve, decision curve and calibration analysis. The associated risk factors were also categorized according to clinical cut-points or tertials to create the diabetes risk score model. Based on the total score, we divided it into four risk categories: low, middle, high and extremely high. We also evaluated our diabetes risk score model's performance. We developed a simple nomogram and risk score that predicts the risk of prediabetes by using the variables age, triglyceride, fasting blood glucose, body mass index, alanine aminotransferase, high-density lipoprotein cholesterol and family history of diabetes. The area under the ROC curve of the nomogram was 0.8146 (95% CI 0.8035-0.8258) and 0.8147 (95% CI 0.8035-0.8259) for the training and validation cohort, respectively. The calibration curve showed a perfect fit between predicted and observed diabetes risks at 5 years. Decision curve analysis presented the clinical use of the nomogram, and there was a wide range of alternative threshold probability spectrums. A total risk score of 0 to 2.5, 3 to 4.5, 5 to 7.5 and 8 to 13.5 is associated with low, middle, high and extremely high diabetes risk status, respectively. We developed and validated a personalized prediction nomogram and risk score for 5-year diabetes risk among Chinese adults with prediabetes, identifying individuals at a high risk of developing diabetes. Doctors and other healthcare professionals can easily and quickly use our diabetes score model to assess the diabetes risk status in patients with prediabetes. In addition, the nomogram model and risk score we developed need to be validated in a prospective cohort study.

Outcomes and Prognostic Factors in Acinic Cell Carcinoma of the Parotid Gland: Mature Results From a Single Institution

<h3>Purpose/Objective(s)</h3> Acinic cell carcinoma is a rare subtype of salivary gland cancer, with little published data on management or survival outcomes. We aimed to describe a cohort of patients from a single institution, and to identify factors that impacted oncologic outcomes. <h3>Materials/Methods</h3> We retrospectively identified patients with acinic cell carcinoma who received treatment at our tertiary referral center. Demographic, tumor, and treatment data were collected. Locoregional control (LRC), relapse free survival (RFS), and overall survival (OS) were estimated using the Kaplan Meier method. A multivariate analysis explored the association between demographics, tumor characteristics, and receipt of postoperative radiation therapy (PORT) in non-metastatic patients with oncologic outcomes using a stepwise Cox proportional hazards model. <h3>Results</h3> Between 1/1/1984 and 12/31/2019 65 eligible patients were identified. Patient characteristics are described in Table 1. All patients had disease originating within the parotid gland, and two patients were metastatic at presentation. The majority of patients received upfront surgical resection, with 79% receiving PORT. With a median follow up of 11.7 years, the 5-year OS, LRC, and RFS estimates were 85%, 71%, and 63%, respectively. 15 patients ultimately received palliative systemic therapy. In a multivariate analysis excluding those metastatic at presentation, age at diagnosis and nodal status were associated with OS, LRC, and RFS. PORT was not associated with survival outcomes on multivariate analysis. <h3>Conclusion</h3> Acinic cell patients receiving treatment at a single tertiary referral center demonstrate excellent five-year survival outcomes. With long term follow up, only age at diagnosis and nodal status were associated with survival outcomes. Further work is necessary to assess generalizability of these results.

Ustekinumab does not increase risk of new or recurrent cancer in inflammatory bowel disease patients with prior malignancy.

There is limited data on the rate of new or recurrent cancer in patients with inflammatory bowel disease (IBD) and a history of prior or current malignancy who are initiated on biologic therapies. Furthermore, there is no data on this topic in patients using ustekinumab. The retrospective study included 341 patients with IBD and a history of cancer who were subsequently treated with vedolizumab (VDZ; n=34), ustekinumab (USK; n=27), tumor necrosis factor α antagonists (anti-TNF; n=99), or had no immunosuppressive therapy (control; n=181). Cox proportional hazard models were developed to determine the independent effect of post-cancer immunosuppressive treatment on the occurrence of incident cancer. Over a median of 5.2 person-years of follow up, cancer recurrence occurred in only one patient on anti-TNF, while new cancers developed in one patient on VDZ, three patients on USK, and six patients on anti-TNF, corresponding to cancer rates of 0.4, 1.8, and 0.7 per 100 person-years, respectively. The rate of incident cancer in control patients was 2.4 per 100 person-years and included 18 new and 9 recurrent cancers. Compared with controls, a stepwise Cox proportional hazards model adjusting for significant covariates found no increased risk of incident cancer in patients receiving post-malignancy treatment with USK (hazard ratio [HR] 0.88; 95% confidence interval [CI] 0.25-3.03), VDZ (HR 0.18; 95% CI 0.03-1.35), or anti-TNF (HR 0.47; 95% CI 0.20-1.12). Use of biologic therapy in IBD patients with a previous history of malignancy was not associated with an increased risk of new or recurrent cancer.

Comparative study of the outcomes of the second kidney transplantation from the young deceased donors versus living-unrelated donors

PurposeTo compare the kidney graft function and survival in patients who had second kidney transplantation from living donors versus those who had a second transplant from young deceased donors. MethodsIn this retrospective cohort study, a total of 86 patients who underwent second kidney transplantation in Shariati hospital from 2001 until 2017 were enrolled. Baseline clinical data on the age, sex, type of kidney donor (living unrelated or deceased), duration of pretransplant dialysis, and the length of hospitalization were recorded. As the indicators of the graft function, we used the serum creatinine level and estimated glomerular filtration rate (eGFR) at time intervals during the study. The 1, 5, and 10-year graft survival rates were reported using life tables and the relative hazard ratios of the graft failure were calculated using the forward stepwise Cox proportional hazard model. ResultsForty-six of our patients were men (53.5%), with a mean ± SD age of 44.3 ± 12.3 years at the time of transplantation. The majority of the enrolled patients received the kidney from living unrelated donors (50 vs. 36 patients). In terms of serum creatinine and eGFR, at time intervals, no significant difference was found between the two recipient groups. In the living donor group, the 1, 5, and 10-year graft survival rates of the second transplant were 91% (95%CI: 73–96%), 87% (95%CI: 69–95%), and 82% (95%CI: 59–92%), and for the deceased donor group were 95% (95% CI: 69–99%), 95% (95%CI: 69–99%), and 79% (95%CI: 31–95%), respectively. ConclusionConsidering the long-term outcomes of the second kidney transplantation, in our experience, the graft function and survival, either from the living or deceased donors, were favorable; and the type of organ donation had no significant effect on the risk of graft failure.

Surgical site complications in kidney transplant recipients: incidence, risk factors and outcomes in the modern era.

Background:Surgical site complications (SSCs) are an important source of morbidity after kidney transplantation. We assessed the incidence, risk factors, outcomes and economic impact of SSCs in a large, diverse population of kidney transplant recipients.Methods:We conducted a single-centre, observational cohort study of adult (age ≥ 18 yr) patients who underwent kidney transplantation between Jan. 1, 2005, and Dec. 31, 2015, with a minimum of 1 year of follow-up. Cases of SSC, including infections and wound dehiscence, were determined from patient records. Inpatient and outpatient hospital costs were determined 6 and 12 months after transplantation. We used the Kaplan–Meier product-limit method to determine the cumulative probability of SSCs and other outcomes. We evaluated risk factors and clinical outcomes using Cox proportional hazard ratios. Linear regression models were used to study the effect of SSCs on graft function.Results:The incidence rate of SSCs within 30 days after transplantation was 4.19 per 100 person-months. The cumulative probability of developing an SSC within 30 days after transplantation was 4.13% (95% confidence interval [CI] 3.23%–5.28%). Increased recipient body mass index (BMI) (hazard ratio [HR] 1.07, 95% CI 1.02–1.11), longer cold ischemic time (HR 1.05, 95% CI 1.01–1.09) and transplantation in 2010–2012 versus 2005–2009 (HR 2.20, 95% CI 1.19–4.04) were risk factors for SSC development. In multivariable stepwise Cox proportional hazard models, SSC was a significant risk factor for death-censored graft failure (HR 3.08, 95% CI 1.60–5.90) and total graft failure (HR 2.09, 95% CI 1.32–3.32). Cumulative median hospital costs were $2238.46 greater for patients with an SSC than for those without.Conclusion:Increased BMI, longer cold ischemic time and the 2010–2012 transplantation period predisposed to SSCs. The development of SSCs was associated with a higher risk of graft failure. Strategies to minimize SSCs may improve outcomes after kidney transplantation and reduce costs.

Timing of postoperative radiation therapy and survival in resected salivary gland cancers: Long-term results from a single institution

ObjectivesTimely administration of postoperative radiation therapy (PORT) impacts oncologic outcomes in resected squamous cell carcinomas of the head and neck. Salivary gland cancers (SGCs) are uncommon, and timing of PORT has not been extensively explored. We aimed to determine if the interval between surgery and PORT impacts outcomes in SGCs. Materials and MethodsThis is a retrospective study of patients with SGCs who underwent curative intent surgical resection followed by adjuvant PORT. Locoregional recurrence free survival (LRFS), disease free survival (DFS), and overall survival (OS) were estimated using the Kaplan Meier method. A multivariate analysis explored the association between demographics, tumor characteristics, and PORT timing with oncologic outcomes using a stepwise Cox proportional hazards model. Results180 eligible patients were identified. The median time to PORT start was 61 (range 8–121) days. 169 (93.5%) of patients received neutron radiation. With a median follow up of 8.2 years in surviving patients, the 10-year OS and LRFS estimates were 61% and 53%. In a multivariate analysis, nodal involvement, histologic grade, and age at diagnosis were associated with OS, while nodal involvement, tumor size, and age at diagnosis were associated with LRFS and DFS. Time to PORT start or completion was not statistically associated with survival outcomes. ConclusionSGC patients who underwent surgery in our tertiary institution received PORT within a median of 61 days after surgery. With long term follow up, PORT timing in this retrospective series was not associated with worse oncologic outcomes, and support timely administration of PORT.

Left Atrial Geometry and Phasic Function Determined by Cardiac Magnetic Resonance Are Independent Predictors for Outcome in Non-Ischaemic Dilated Cardiomyopathy.

Left atrial (LA) geometry and phasic functions are frequently impaired in non-ischaemic dilated cardiomyopathy (NIDCM). Cardiac magnetic resonance (CMR) can accurately measure LA function and geometry parameters. We sought to investigate their prognostic role in patients with NIDCM. We prospectively examined 212 patients with NIDCM (49 ± 14.2-year-old; 73.5% males) and 106 healthy controls. LA volumes, phasic functions, geometry, and fibrosis were determined using CMR. A composite outcome (cardiac death, ventricular tachyarrhythmias, heart failure hospitalization) was ascertained over a median of 26 months. LA phasic functions, sphericity index (LASI) and late gadolinium enhancement (LA-LGE) were considerably impaired in the diseased group (p < 0.001) and significantly correlated with impaired LV function parameters (p < 0.0001). After multivariate analysis, LA volumes, LASI, LA total strain (LA-εt) and LA-LGE were associated with increased risk of composite outcome (p < 0.001). Kaplan–Meier analysis showed significantly higher risk of composite endpoint for LA volumes (all p < 0.01), LASI > 0.725 (p < 0.003), and LA-εt < 30% (p < 0.0001). Stepwise Cox proportional-hazards models demonstrated a considerable incremental predictive value which resulted by adding LASI to LA-εt (Chi-square = 10.2, p < 0.001), and afterwards LA-LGE (Chi-Square = 15.8; p < 0.0001). NIDCM patients with defective LA volumes, LASI, LA-LGE and LA-εt had a higher risk for an outcome. LA-εt, LASI and LA-LGE provided independent incremental predictive value for outcome.

Predictors of Skeletal Related Events in Patients Treated With Surgical Stabilization for Bone Metastases With or Without Radiotherapy

<h3>Purpose/Objective(s)</h3> In patients with metastatic disease involving weight-bearing bones, postoperative radiation (PORT) is commonly administered following surgical stabilization of an impending or confirmed pathologic fracture to reduce the risk of a seeded local recurrence. The goal of this analysis was to re-evaluate the beneficial effect of PORT in a modern cohort of patients, and to determine any clinical predictors of skeletal related events (SRE). <h3>Materials/Methods</h3> Consecutive patients undergoing surgical stabilization of metastatic disease to weight-bearing bones of the extremities between 2012-2019 were reviewed. Patient, disease, and treatment factors were abstracted. Freedom from skeletal related event (SRE, defined as pathologic fracture, necessity for (re)irradiation, or surgery of the involved bone) and overall survival (OS) were estimated using the Kaplan-Meier method. Predictors of SRE were evaluated using backwards stepwise Cox proportional hazards models. <h3>Results</h3> A total of 82 patients were identified, 74% of whom had undergone intramedullary nail fixation and 26% internal fixation or replacement. 73% of surgeries were prophylactic and 27% were for pathologic fracture. The femur was the most commonly involved bone (94%) followed by the humerus (5%), and tibia (1%). Disease histology was breast (26%), lung (24%), prostate (10%), or other (40%). A majority (78%) had ECOG performance status of 1-2. Bone-strengthening agents were given to 38% and postoperative RT to 54%. Median PORT dose was 30 Gy in median 10 fractions and median percent coverage of surgical hardware was 100% (range, 25-100). SRE occurred in 10 of 82 patients. Overall, 1-year freedom from SRE was 90.4%, and notably was 89.8% vs 91% for those who did or did not receive PORT, respectively. The only identified predictors of SRE were the use of bone strengthening agents (HR 0.22, 95% CI 0.05-1.06, <i>P</i> = 0.06) and malnutrition (HR 3.69, 95% CI 0.91-14.93, <i>P</i> = 0.07). For patients treated with PORT, biologically effective dose or percent coverage of the surgical hardware was not associated with SRE. Median OS was 11.3 months (95% CI: 8.0-24.6). <h3>Conclusion</h3> In this series, the addition of PORT following surgical stabilization of metastatic disease involving weight-bearing bones does not significantly affect rate of SRE, which remained approximately 10% at 1 year. The use of bone strengthening agents appeared to be protective, and malnourished patients were at particularly high-risk for future SRE.

Double-valve infective endocarditis: clinical features and prognostic impact; a retrospective study in a surgical centre

Abstract Introduction Most cases of infective endocarditis (IE) involve a single valve, and little is known concerning IE that simultaneously affects two valves. The involvement of more than one valve may imply more severe and extensive cardiac lesions. In these patients, surgery may be challenging. Purpose We aimed to determine the clinical characteristics, the therapeutic strategy, and the prognostic impact of double-valve IE (DVIE). Method We retrospectively included in the analysis 380 consecutive patients with definite active IE in a single surgical centre. The univariate and multivariate long-term survival was analysed by the Kaplan-Meier method and by stepwise Cox proportional hazards models, respectively. We repeated the mortality analysis using the propensity score matching technique, to adjust for baseline differences between SVIE and DVIE groups. Results DVIE occurred in 60 of the total enrolled 380 patients (15.8%) and involved mostly the combination of mitral and aortic valves (N=52, 87%). Most patients had double-native IE (N=38, 63%). Staphylococci were significantly less frequent in patients with double-valve than single-valve IE (SVIE). The proportion of patients undergoing valve repair among those treated surgically was higher for patients with DVIE than for SVIE (p&amp;lt;0.001). Valve repair of at least one valve was associated with non-significant better survival than double replacement. DVIE was associated with higher all-cause mortality than SVIE (p&amp;lt;0.001). DVIE was not associated with a higher risk of relapse or non-fatal adverse events. Conclusions DVIE represents a considerable proportion of overall cases of IE, mainly involving aortic and mitral valves, with a jet lesion on the mitral valve; Staphylococcus is significantly less frequent than in SVIE; DVIE is independently associated with higher mortality; finally, mitral valve repair is feasible in a considerable proportion of surgical cases. Funding Acknowledgement Type of funding sources: None. Propensity score matchingKaplan-Meier analysis: survival of DVIE

Progression of aortic stenosis in patients with bicuspid aortic valve.

Bicuspid aortic valve is the most common congenital heart defect and predisposes patients to developing aortic stenosis more frequently and at a younger age than the general population. However, the influence of bicuspid aortic valve on the rate of progression of aortic stenosis remains unclear. In 236 patients (177 tricuspid aortic valve and 59 bicuspid aortic valve) matched by initial severity of mild or moderate aortic stenosis, we retrospectively analyzed baseline echocardiogram at diagnosis with latest available follow-up echocardiogram. Baseline comorbidities, annualized progression rate of hemodynamic parameters, and hazard of aortic valve replacement were compared between valve phenotypes. Median echocardiographic follow-up was 2.6 (interquartile range [IQR] 1.6-4.2) years. Patients with tricuspid aortic stenosis were significantly older with more frequent comorbid hypertension and congestive heart failure. Median annualized progression rate of mean gradient was 2.3 (IQR 0.6-5.0) mmHg/year versus 1.5 (IQR 0.5-4.1) mmHg/year (p = .5), and that of peak velocity was 0.14 (IQR 0-0.31) m/s/year versus 0.10 (IQR 0.04-0.26) m/s/year (p = .7) for tricuspid versus bicuspid aortic valve, respectively. On multivariate analyses, bicuspid aortic valve was not significantly associated with more rapid progression of aortic stenosis. In a stepwise Cox proportional hazards model adjusted for baseline mean gradient, bicuspid aortic valve was associated with increased hazard of aortic valve replacement (hazard ratio: 1.7, 95% confidence interval [1.0-3.0], p = .049). Bicuspid aortic valve may not significantly predispose patients to more rapid progression of mild or moderate aortic stenosis. Guidelines for echocardiographic surveillance of aortic stenosis need not be influenced by valve phenotype.

Long- and short-term survival following laparoscopic and open pancreaticoduodenectomy for patients with periampullary tumors in Vietnam

BackgroundLaparoscopic pancreaticoduodenectomy (LPD) is a less invasive alternative to the traditional open pancreaticoduodenectomy (OPD) approach used to treat periampullary tumors. However, previous studies examining the advantages of this surgery over OPD have produced mixed results. Here, a retrospective observational approach was used to compare the short- and long-term outcomes of patients with periampullary tumors who underwent LPD or OPD at a single institution in Vietnam. Materials and methodsData were obtained from hospital medical records collected over five years from patients that underwent OPD or LPD. Information on demographics, medical status, tumor characteristics, operative variables, complications, and mortality was examined. Survival curves were constructed and the stepwise multivariate Cox proportional hazard model was used to identify the factors associated with the risk of death following surgery. ResultsEighty-four patients aged 26–80 years were included. Twenty-two patients underwent LPD and 62 received OPD. The operative time for the LPD group was significantly longer than that for the OPD group, and the LPD group was less likely to require a blood transfusion during surgery. While the short- and long-term survival rates did not differ for the procedures, the factors associated with the risk of death following surgery were tumors at the N1 stage and an age >65 years. ConclusionBoth LPD and OPD procedures for treating periampullary tumors exhibited comparable safety profiles, with similar short-term outcomes and long-term survival rates observed. Future studies with a larger sample size should be conducted to further examine the treatment outcomes following these surgical approaches.

Timing of postoperative radiation therapy and survival in resected salivary gland cancers: Long-term results from a single institution.

e18052 Background: Timely administration of postoperative radiation therapy (PORT) impacts oncologic outcomes in resected squamous cell carcinomas of the head and neck. Salivary gland cancers (SGCs) are uncommon, and timing of PORT has not been extensively explored. We aimed to determine if the interval between surgery and PORT impacts outcomes in SGCs. Methods: We retrospectively identified patients with SGCs who underwent curative intent surgical resection followed by adjuvant PORT at our tertiary referral center. Demographic, tumor, and treatment data were collected. Patients with non-oncologic resections and/or delay of &gt; 6 months to radiation start were excluded. Locoregional control (LRC), relapse free survival (RFS), and overall survival (OS) were estimated using the Kaplan Meier method. A multivariate analysis explored the association between demographics, tumor characteristics, and PORT timing with oncologic outcomes using a stepwise Cox proportional hazards model. Results: Between 1/1/1997 and 12/31/2017 180 eligible patients were identified. Patient characteristics are described in Table. The median time to PORT start was 61 (range 8-121) days, 169 (93.9%) of patients received neutron beam PORT. With a median follow up of 8.2 years in surviving patients, the 5-year OS and LRC estimates were 73% and 67%, respectively. In a multivariate analysis, only nodal involvement, histologic grade, and age at diagnosis were associated with OS, while nodal involvement, tumor size, and age at time of diagnosis were associated with LCR and RFS. Time to PORT start or completion was not statistically associated with survival outcomes on multivariate analysis. Conclusions: SGC patients who underwent surgery in our tertiary institution received PORT within a median of 61 days after surgery. With long term follow up, PORT timing in this retrospective series was not associated with worse oncologic outcomes, and support timely administration of PORT with 3 months of surgical resection. Further work is necessary to assess generalizability of these results.[Table: see text]

Post-operative heparin reduces early venous thrombotic complications after orthotopic paediatric liver transplantation.

Despite significant improvements in surgical techniques and medical care, thrombotic complications still represent the primary cause of early graft failure and re-transplantation following paediatric liver transplantation. There is still no standardized approach for thrombosis prevention. The study aimed to evaluate the effectiveness of early intravenous unfractionated heparin started 12 hours postoperatively at 10 UI/kg per hour and used a retrospective "before and after" design to compare the incidence of early thrombotic complications prior to (2002-2010) and after (2011-2016) the introduction of heparin in our institute. From 2002 to 2016, 479 paediatric patients received liver transplantation in our institution with an overall survival rate over one year of 0.91 (95% CI: 0.87-0.94). Of 365 eligible patients, 244 did not receive heparin while 121 did receive heparin. We reported a lower incidence of venous thrombosis (VT) in the group treated with heparin: 2.5% (3/121) vs 7.9% (19/244) (p=0.038). All clinical and laboratory variables considered potential risk factors for VT were studied. By multivariate stepwise Cox proportional hazards models, heparin prophylaxis resulted significantly associated to a reduction in VT (HR=0.29 [95% CI: 0.08-0.97], p=0.045), while age <1 year was found to be an independent risk factor for VT (HR=2.62 [95% CI: 1.11-6.21]; p=0.028). Early postoperative heparin could be considered a valid and safe strategy to prevent early VT after paediatric liver transplantation without a concomitant increase in bleeding. A future randomised control trial is mandatory in order to strengthen this conclusion.

Safety and efficacy of drug-eluting bead transarterial chemoembolization with CalliSpheres® microsphere for hepatocellular carcinoma with portal vein tumor thrombus: a preliminary study.

Objective: To prospectively evaluate the safety and therapeutic effectiveness of drug-eluting beads transcatheter arterial chemoembolization (DEB-TACE) with CalliSpheres® microsphere (CSM) for the treatment of hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT), and to analyze the prognostic factors.Method: Between November 2015 and November 2017, consecutive 58 HCC patients with PVTT who received DEB-TACE with CSM treatment were prospectively enrolled in this study. The demographic characteristics, adverse events (AEs) and treatment response were collected. Overall survival (OS) and progression-free survival (PFS) were calculated using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were performed to determine the independent factors correlated with OS.Results: The objective response rate (ORR) was 79.3% in terms of tumors and 44.8% in thrombi. The median PFS and OS of patients were 5.0 months and 9.0 months respectively. The cumulative survival rate at 3-, 6-, 9-, 12-, 18- and 24-month were 94.8%, 72.4%, 53.4%, 41.4%, 22.4% and 19.0%, respectively. In a stepwise multivariate Cox proportional hazards model, the higher Child-Pugh classification (HR=2.279; 95%CI, 1.042-4.985, p = 0.039) and tumor burden (p = 0.008) were the significant predictors of poorer OS after adjustment for known risk factors. The most common clinical AEs were postembolization syndrome (PES) and the most prevalent laboratory toxicity was transient liver function damage.Conclusion: DEB-TACE with CSM is safe and well-tolerated in HCC patients with PVTT, and reveals a favorable preliminary clinical outcome. The higher Child-Pugh classification and liver tumor burden are independent prognostic factors associated with poor survival for HCC patients with PVTT treated by DEB-TACE with CSM.