Multiparametric MRI-based VI-RADS: can it predict 1- to 5-year recurrence of bladder cancer?

OBJECTIVES: To evaluate whether Vesical Imaging-Reporting And Data System (VI-RADS) scores based on multiparametric MRI (mp-MRI) can predict bladder cancer (BCa) recurrence. METHODS: In this retrospective study, 284 patients with pathologically confirmed bladder neoplasms from November 2011 to October 2020 were included. Two radiologists blindly and independently scored mp-MRI scans according to VI-RADS. Scoring inconsistency was resolved in consensus. The latest follow-up was completed in December 2022. Pearson's correlation analyses, independent-sample t-tests, and receiver operating characteristic analyses were performed to assess the efficacy of VI-RADS score for the 1- to 5-year recurrence prognostication. RESULTS: Based on the latest follow-up, 37 (of 284, 13.0%), 69 (of 284, 24.3%), 70 (of 234, 29.9%), 72 (of 190, 37.9%), and 63 (of 135, 46.7%) patients had cancer recurrence at 1- to 5-year follow-up, respectively. VI-RADS scores showed significantly intergroup differences between recurrent and nonrecurrent cases during 1- to 4-year surveillance (p < 0.05). The recurrence-free survival was significantly higher in patients with VI-RADS scores of 1 or 2, compared to those with scores of 3, 4, or 5 (p < 0.05). Areas under the receiver operating characteristic curves for 1- to 5-year recurrence prediction were 0.744, 0.686, 0.656, 0.595, and 0.536, respectively. VI-RADS score of 3 or more was the threshold for 1-year recurrence assessment, and VI-RADS more than 3 was the cutoff for 2-year recurrence prediction. CONCLUSION: VI-RADS score has potential in preoperative prognostication of BCa recurrence, but its predictive power decreases over time. CLINICAL RELEVANCE STATEMENT: VI-RADS has potential in bladder cancer recurrence assessment, but its prognostic value decreases over time. Patients with VI-RADS ≥ 3 may be more likely to recur in 1 or 2 years postoperatively, thus should be performed with intensive surveillances. KEY POINTS: • VI-RADS scores had significant differences in 1- to 4-year recurrent and nonrecurrent patient groups. • Patients with VI-RADS scores of ≤ 2 showed more favorable recurrence-free survival outcomes. • The prognostic value of VI-RADS score decreased over time for bladder cancer recurrence prediction.

Optimal cutoff values of primary tumour size to better predict long-term outcomes in patients with papillary thyroid carcinoma undergoing total thyroidectomy: A preliminary study using restricted cubic spline analysis.

OBJECTIVE: Primary tumour size (PTS) is known to be a significant prognostic factor in patients with papillary thyroid carcinoma (PTC) undergoing thyroidectomy. Although cutoff values of 2 and 4 cm are widely used in surgical extent decision and long-term outcomes predictions, the effectiveness of arbitrary cutoff values in stratifying patients for target outcomes is questionable. This study aimed to determine new optimal cutoffs of PTS. DESIGN, PATIENT AND MEASUREMENTS: Patients (n = 529) with PTC who underwent total thyroidectomy were retrospectively reviewed. After risk factor analysis for structural recurrence, the optimal cutoffs of PTS were automatically calculated using restricted cubic spline analysis and X-tile software. Subgroups were classified based on the newly determined cutoff values. Both the recurrence-free survival (RFS) and the proportion of patients in each response-to-therapy category, using the dynamic risk stratification system (DRS), were compared between the subgroups. RESULTS: PTS was confirmed as an independent risk factor for structural recurrence. The optimal cutoff values were calculated as 1.4 and 3.0 cm. The subgroups stratified using these newly determined cutoffs showed significantly different RFS and DRS based on the response to initial therapy, but the subgroups classified using the cutoffs of 2 and 4 cm did not. CONCLUSIONS: The newly determined cutoff values of PTS may be useful in better stratifying patients with PTC undergoing thyroidectomy for target outcomes and can be considered as a new definition in staging and risk stratification systems.

Report of 13-year survival of patients with colon and rectal cancers; lessons from Shiraz colorectal cancer surgery registry system of a level three medical center.

BACKGROUND: Colorectal cancer (CRC) is the second most common cancer in women and the third most common cancer in men worldwide, with an increasing trend in its incidence in Asian countries. In the present study, we aimed to describe the 13-year results of patients with CRC based on the Shiraz Colorectal Cancer Surgery (SCORCS) registry system in patients with a pathologically confirmed diagnosis of colon cancer (CC) and rectal cancer (RC) undergoing surgery. METHODS: Between 2007 and 2020, 811 patients, including 280 patients with CC and 531 patients with RC, registered in SCORCS, were included in the present study. The information collected for this study included demographic characteristics of the patients, primary clinical presentations, laboratory findings before surgery, radiologic and colonoscopy results, and surgical procedures. Death was confirmed by the physician as "CRC-related". The data were analyzed by SPSS software version 21; life table and Kaplan-Meier curve were used for evaluating the overall survival, recurrence, and metastasis rates and Log-Rank test or Breslow test to check significant differences between the subgroups. The Cox proportional regression model was fitted to evaluate the prognostic factors of survival recurrence and metastasis. RESULTS: Laparoscopy was performed in 60% of patients (66% in RC and 51% in CC), laparotomy in 32% (27% in RC and 41% in CC), and 7% required conversion. The median time of follow-up was 29 months in all patients; 28 months in patients with RC, and 33 months in patients with CC; 1, 3, and 5 years' survival rate was 90, 70, and 63% for all the patients, 89%, 67%, and 58% for RC and 90%, 74%, and 71% for CC, respectively (P = 0.009). The Cox regression analysis revealed tumor stages II, (P = 0.003, HR:2.45, 95% CI;1.34-4.49), III, (P ≤ 0.001, HR:3.46, 95% CI;1.88-6.36) and IV, (P ≤ 0.001, HR:6.28, 95% CI;2.73-14.42) in RC and stage IV, (P = 0.03, HR:9.33, 95% CI;1.1-76.37) in CC were the significant survival prognostic factors. The metastasis and recurrence of the tumors occurred earlier in patients with RC than CC (P = 0.001 and 0.03, respectively). CONCLUSIONS: Long-term follow-up of patients with CRC in an Iranian population indicated the significance of screening for diagnosis of early stages and improved survival of the patients.

Association between Birth Region and Time to Tuberculosis Diagnosis among Non-US-Born Persons in the United States.

Approximately 90% of tuberculosis (TB) cases among non-US-born persons in the United States are attributable to progression of latent TB infection to TB disease. Using survival analysis, we investigated whether birthplace is associated with time to disease progression among non-US-born persons in whom TB disease developed. We derived a Cox regression model comparing differences in time to TB diagnosis after US entry among 19 birth regions, adjusting for sex, birth year, and age at entry. After adjusting for age at entry and birth year, the median time to TB diagnosis was lowest among persons from Middle Africa, 128 months (95% CI 116-146 months) for male persons and 121 months (95% CI 108-136 months) for female persons. We found time to TB diagnosis among non-US-born persons varied by birth region, which represents a prognostic indicator for progression of latent TB infection to TB disease.

Reliable prediction of survival in advanced-stage hepatocellular carcinoma treated with sorafenib: comparing 1D and 3D quantitative tumor response criteria on MRI.

OBJECTIVES: To compare 1D and 3D quantitative tumor response criteria applied to DCE-MRI in patients with advanced-stage HCC undergoing sorafenib therapy to predict overall survival (OS) early during treatment. METHODS: This retrospective analysis included 29 patients with advanced-stage HCC who received sorafenib for at least 60 days. All patients underwent baseline and follow-up DCE-MRI at 81.5 ± 29.3 days (range 35-140 days). Response to sorafenib was assessed in 46 target lesions using 1D criteria RECIST1.1 and mRECIST. In addition, a segmentation-based 3D quantification of absolute enhancing lesion volume (vqEASL) was performed on the arterial phase MRI, and the enhancement fraction of total tumor volume (%qEASL) was calculated. Accordingly, patients were stratified into groups of disease control (DC) and disease progression (DP). OS was evaluated using Kaplan-Meier curves with log-rank test and Cox proportional hazards regression model. RESULTS: The Kaplan-Meier analysis revealed that stratification of patients in DC vs. DP according to mRECIST (p = 0.0371) and vqEASL (p = 0.0118) successfully captured response and stratified OS, while stratification according to RECIST and %qEASL did not correlate with OS (p = 0.6273 and p = 0.7474, respectively). Multivariable Cox regression identified tumor progression according to mRECIST and qEASL as independent risk factors of decreased OS (p = 0.039 and p = 0.006, respectively). CONCLUSIONS: The study identified enhancement-based vqEASL and mRECIST as reliable predictors of patient survival early after initiation of treatment with sorafenib. This data provides evidence for potential advantages 3D quantitative, enhancement-based tumor response analysis over conventional techniques regarding early identification of treatment success or failure. KEY POINTS: • Tumor response criteria on MRI can be used to predict survival benefit of sorafenib therapy in patients with advanced HCC. • Stratification into DC and DP using mRECIST and vqEASL significantly correlates with OS (p = 0.0371 and p = 0.0118, respectively) early after initiation of sorafenib, while stratification according to RECIST and %qEASL did not correlate with OS (p = 0.6273 and p = 0.7474, respectively). • mRECIST (HR = 0.325, p = 0.039. 95%CI 0.112-0.946) and qEASL (HR = 0.183, p = 0.006, 95%CI 0.055-0.613) are independent prognostic factors of survival in HCC patients undergoing sorafenib therapy.

Metformin usage and the risk of colorectal cancer: a national cohort study.

PURPOSE: This study aimed to investigate the association between metformin usage and the risk of colorectal cancer (CRC) using data from the Korean National Health Insurance Service-National Health Screening Cohort database. METHODS: Data from the NHIS-HEALS cohort between 2002 and 2015 were longitudinally analyzed. Subjects were divided into three groups: metformin non-users with diabetes mellitus (DM), metformin users with DM, and no DM group. CRC was defined using the ICD-10 code (C18.0-C20.0) at the time of admission. Cox proportional hazard regression models were adopted after stepwise adjustment for confounders to investigate the association between metformin usage and colorectal cancer risk. RESULTS: During the follow-up period, of the total 323,430 participants, 2341 (1.33%) of the 175,495 males and 1204 (0.81%) of the 147,935 females were newly diagnosed with CRC. The estimated cumulative incidence of CRC was significantly different among the three groups based on Kaplan-Meier's survival curve (p values < 0.05 in both sexes). Compared with metformin non-users, hazard ratios (95% CIs) of metformin users and the no DM group were 0.66 (0.51-0.85) and 0.72 (0.61-0.85) in males and 0.59 (0.37-0.92) and 0.93 (0.66-1.29) in females, respectively, after being fully adjusted. CONCLUSIONS: Metformin users with diabetes appear to have a significantly lower risk of CRC compared with metformin non-users.

Real-world time on treatment with immuno-oncology therapy in recurrent/metastatic head and neck squamous cell carcinoma.

Aim: We report real-world time on treatment (rwToT) with immuno-oncology (I-O) and other systemic therapies in second-line recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) previously treated with platinum therapies. Materials & methods: Adult patients receiving first-line platinum therapy for R/M HNSCC between January 2017 and December 2018 and a second-line therapy were selected from a US electronic medical record database. Results: In our study sample of 619 R/M HNSCC patients, second-line treatments primarily included I-O therapies (71%) and resulted in median rwToT of 2.8 months and 12-month on-treatment rate of 19.3%. For other second-line therapies, median rwToT and 12-month on-treatment rate was 1.9 months and 1.3%, respectively. Conclusion: Use of second-line I-O therapies was common and resulted in rwToT consistent with R/M HNSCC clinical trials.

Lay abstract Head and neck cancer include tumors that develops in the mouth, throat, nose, salivary glands, oral cancers or other areas of the head and neck. When this cancer returns or spreads to another part of the body, systemic chemotherapies are often used with the goal of prolonging survival. Immunotherapy has emerged as a new approach to treat head and neck cancer by using the body's own immune system to kill cancer cells. The purpose of this study was to better understand the use of immunotherapies in patients with head and neck cancer after the cancer has returned or spread to another part of the body. The study showed that immunotherapies were commonly used and resulted in fewer treatment discontinuations in comparison to other systemic chemotherapies. These results support the use of immunotherapies in this patient population.

Tooth survival following root canal treatment by general dental practitioners in a Swedish county - a 10-year follow-up study of a historical cohort.

AIM: To evaluate the 10-year survival rate of root filled teeth treated by general dental practitioners (GDPs), and to identify possible prognostic factors. METHODOLOGY: In 2006, 3676 individuals had at least one tooth root filled by a GDP within the Norrbotten Public Dental Service, Sweden. Over the next 10 years, 331 individuals died and were excluded. A random sample of 302 of the remaining individuals was included in the study, of whom 280 (n = 280 teeth) were included in the analysis. Dental records were reviewed retrospectively by a calibrated researcher to collect predetermined data regarding individual, pre-operative, intra-operative and post-operative factors. The outcome measure was tooth extraction over time, and cases with no events were censored, regardless of apical status or symptoms, until last known date of tooth survival. In case of missing data, individuals were recalled for a control visit. Kaplan-Meier survival tables and Cox regression models were used for analysis. P < 0.05 was considered statistically significant. RESULTS: The cumulative 10-year survival was 81.7% (standard error: 2.6%), and the mean incidence of tooth extraction during the 10 years was 1.8% per year. The univariate analysis identified three possible prognostic factors (P < 0.05) that were associated with extraction: molars, two or more emergency inter-appointment visits during the treatment, and root canal treatments consisting of five or more separate sessions. A multivariate regression analysis revealed no significant relationships for the variables gender, tooth type, number of contacts, any emergency visits during endodontic treatment, number of sessions to complete endodontic treatment, pulp diagnosis, or type of permanent restoration and extraction. CONCLUSIONS: The mean incidence of tooth loss over the first 10 years after completion of root canal treatment performed by a GDP was approximately 2% per year. No prognostic factors could be identified.

Four-Year Interim Results of the Safety of Augmentation Mammaplasty Using the Motiva Ergonomix™ Round SilkSurface: A Multicenter, Retrospective Study.

BACKGROUND: The Motiva Ergonomix™ Round SilkSurface (Establishment Labs Holdings Inc., Alajuela, Costa Rica) is the fifth generation of a silicone gel-filled breast implant that is commercially available in Korea. OBJECTIVES: In this study, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women. METHODS: In the current multicenter, retrospective study, we performed a retrospective review of medical records of a total of 1314 patients who received augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface at our hospitals between September 1, 2016, and August 31, 2020. For safety assessment, we analyzed incidences of postoperative complications and Kaplan-Meier complication-free survival of the patients. RESULTS: We included a total of 873 patients (1746 breasts, mean age = 32.18 ± 6.88 years) in the current study. There were a total of 111 cases (12.70%) of postoperative complications; these include 24 cases (2.70%) of early seroma, 18 cases (2.10%) of hematoma, 18 cases (2.10%) of capsular contracture, 17 cases (1.95%) of dissatisfaction with shape, 16 cases (1.83%) of dissatisfaction with size, 9 cases (1.03%) of asymmetry, 6 cases (0.70%) of infection and 3 cases (0.34%) of rippling. Moreover, time-to-events were estimated at 918.34 ± 36.22 days (95% CI 845.44-988.52). CONCLUSIONS: Here, we describe 4-year interim results of the safety of augmentation mammaplasty using the Motiva Ergonomix™ Round SilkSurface in Korean women in a non-manufacturer-sponsored study. But further large-scale, prospective, multicenter studies with a long period of follow-up are warranted to establish our results. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Survival of silver diamine fluoride among patients treated in community dental clinics: a naturalistic study.

BACKGROUND: Silver diamine fluoride (SDF) is a minimally-invasive preventive service used in the U.S. to avert and arrest caries since 2014. No studies document survival outcomes based in real world delivery. We analyzed 12-month survival outcomes of SDF applied independently or concurrently with other restorative procedures among a population receiving community dental care. METHODS: We analyzed data on SDF applications from de-identified dental claims on Oregon Health Plan patients served by Advantage Dental in 2016, who had been seen in 2015 (patient n = 2269; teeth n = 7787). We compared survival rates of SDF alone, SDF applied with a sedative filling, and SDF with a same-day restoration. Failure was defined as a restoration or extraction of the tooth 7 to 365 days after initial application. Survival was defined as a patient returning 180 or more days after application whose tooth did not have a restoration or extraction. Differences were assessed through Wilcoxon equality of survivor function tests and log-rank equality of survivor tests to compare failure rates, Cox Proportional Hazards models to assess factors associated with survival of SDF, and Kaplan-Meier survival estimate to calculate the probability of survival over time. RESULTS: SDF alone had an overall survival rate of 76%. SDF placed with sedative filling and with a same-day restoration had survival rates of 50% and 84% respectively, likely reflecting treatment intent. SDF alone survived exceptionally well on primary cuspids, permanent molars, and permanent bicuspids and among patients aged 10 to 20 years, with modest variation across caries risk assessment categories. A single annual application of SDF was successful in 75% of cases. Among SDF failures on permanent dentition, more than two-thirds of teeth received a minor restoration. CONCLUSION: SDF is a minimally invasive non-aerosolizing option that prevented non-cavitated lesions and arrested early decay among community dentistry patients when applied independently or concurrently with restorative procedures. Professional organizations, policy makers, providers, and payors should broaden optional SDF use by informing clinical guidelines, reimbursement policies, and treatment decisions. Future research should address clinical, social, service delivery, workforce, and economic outcomes using diverse population-based samples, and the mechanisms underlying single application success and caries prevention potential.

A Preliminary Retrospective Study to Assess the Short-Term Safety of Traditional Smooth or Microtextured Silicone Gel-Filled Breast Implants in Korea.

Background and objectives: We conducted this preliminary retrospective study to assess the short-term safety of silicone gel-filled breast implants (SGBIs) that are commercially available in Korean women. Materials and methods :The current retrospective, observational study was conducted in a total of 2612 patients (n = 2612) who underwent augmentation mammaplasty using breast implants at our hospitals between 1 January 2017 and 31 August 2021. Results: Overall, there were a total of 248 cases (9.49%) of postoperative complications; these include 112 cases of early seroma, 52 cases of shape deformation, 32 cases of CC, 12 cases of early hematoma, 12 cases of rupture, 12 cases of infection, 12 cases of stretch deformities with skin excess and 4 cases of rippling. Overall complication-free survival of the breast implant was estimated at 1564.32 ± 75.52 days (95% CI 1416.39-1712.32). Then, the Motiva Ergonomix™ SilkSurface showed the longest survival (1528.00 ± 157.92 days [95% CI 1218.48-1837.56]), followed by the BellaGel® SmoothFine (1458.4 ± 65.76 days [95% CI 1329.56-1587.28]), the Sebbin® Sublimity (1322.00 ± 51.20 days [95% CI 1221.64-1422.32]), the BellaGel® Smooth (1138.72 ± 161.28 days [95% CI 822.6-1454.84), the Mentor® MemoryGel™ Xtra (698.4 ± 52.64 days [95% CI 595.28-801.52]) and the Natrelle® INSPIRA™ (380.00 ± 170.88 days [95% CI 45.04-714.96]) in the decreasing order. On subgroup analysis, both the Motiva ErgonomixTM and Mentor® MemoryGel™ Xtra showed no postoperative complications. However, the BellaGel® SmoothFine, Sebbin® Sublimity and BellaGel® Smooth showed incidences of 8.87%, 4.84% and 1.61%, respectively. A subgroup analysis also showed differences in incidences of postoperative complications between microtextured and smooth breast implants (15.18% vs. 16.67%). Conclusions: In conclusion, our results indicate that diverse types of an SGBI are commercially available and their safety profile varies according to the manufacturer. Plastic surgeons should consider the safety profile of each device in selecting the optimal types of the device for Korean women who are in need of an implant-based augmentation mammaplasty. However, this warrants a single-surgeon, single-center study with long periods of follow-up.

Comparing Kaplan-Meier curves with the probability of agreement.

The probability of agreement has been used as an effective strategy for quantifying the similarity between the reliability of two populations. By contrast to hypothesis testing approaches based on P-values, the probability of agreement provides a more realistic assessment of similarity by emphasizing practically important differences. In this article, we propose the use of the probability of agreement to evaluate the similarity of two Kaplan-Meier curves, which estimate the survival functions in two populations. This article extends the probability of agreement paradigm to right censored data and explores three different methods of quantifying uncertainty in the probability of agreement estimate. The first approach provides a convenient assessment based on large-sample normal-theory (LSNT), while the other two approaches are nonparametric alternatives based on ordinary and fractional random-weight bootstrap (FRWB) techniques. All methods are illustrated with examples for which comparing the survival curves of related populations is of interest and the efficacy of the methods are also evaluated through simulation studies. Based on these simulations we recommend point estimation using the proposed LSNT calculation and confidence interval estimation via the FRWB approach. We also provide a Shiny app that facilitates an automated implementation of the methodology.

Increased warm ischemia time during vessel harvest decreases the primary patency of cryopreserved conduits in patients undergoing lower extremity bypass.

OBJECTIVE: Autologous vein is the preferred conduit for lower extremity bypass. However, it is often unavailable because of prior harvest or inadequate for bypass owing to insufficient caliber. Cryopreserved cadaveric vessels can be used as conduits for lower extremity revascularization when autogenous vein is not available and the use of prosthetic grafts is not appropriate. Many studies have shown that donor characteristics influence clinical outcomes in solid organ transplantation, but little is known regarding their impact in vascular surgery. The purpose of this study was to examine the effects donor variables have on patients undergoing lower extremity bypass with cryopreserved vessels. METHODS: The tissue processing organization was queried for donor blood type, warm ischemia times (WITs), and serial numbers of cryopreserved vessels implanted at a single center from 2010 to 2016. The serial numbers were then matched with their respective patients using the institutional Clinical Data Repository and patient data were obtained from the Clinical Data Repository and chart review. Primary outcomes were primary patency of the bypass conduits and limb salvage. Time to loss of patency was evaluated using Kaplan-Meier methods and a Cox proportional hazards model determined risk-adjusted predictors of patency and limb salvage. RESULTS: Sixty patients underwent lower extremity bypass with 65 cryopreserved vessels (23 superficial femoral arteries, 41 saphenous veins, 1 femoral vein). Thirty-eight procedures were reoperations. There were 21 inflow, 44 outflow, and 44 infrainguinal procedures. Preexisting comorbidities did not differ significantly between those who lost patency and those who did not. The mean WIT among the entire cohort was 892.3 ± 389.1 minutes (range, 158.0-1434.0 minutes). The median follow-up was 394 days. Kaplan-Meier analysis demonstrated an overall 1-year primary patency rate of 51%. Primary patency at 1 year was 67% and 41% for inflow and outflow procedures, respectively, and did not differ significantly between the two groups (P = .15). Donor-to-recipient ABO incompatibility was not associated with loss of primary patency. The 1-year amputation-free survival was 74%. Primary patency significantly decreased with each hourly increase in WIT on risk-adjusted analysis (hazard ratio, 1.1; P = .02). CONCLUSIONS: Higher cryopreserved vessel WIT was associated with increased risk-adjusted loss of primary patency in this cohort. At 1 year, the overall primary patency was 51% and amputation-free survival was 74%. Vascular surgeons should be aware that WIT may affect outcomes for lower extremity bypass.

Statin use and site-specific risk of colorectal cancer in individuals with hypercholesterolemia from the National Health Insurance Service-National Health Screening Cohort (NHIS-HEALS).

BACKGROUND AND AIMS: We investigated the association between statin use and site-specific risk of colorectal cancer in individuals with hypercholesterolemia. METHODS AND RESULTS: This study is based on the National Health Insurance Service-National Health Screening Cohort, conducted during 2002-2015. Statin users were classified as high and low users according to medication possession ratio (MPR). Statin nonusers comprised participants who did not use statins during the entire follow-up period. In total, 17,737 statin users and 13,412 statin nonusers were included in the analysis, with a median follow-up period of 12.7 years. Cox proportional hazards regression models were adopted after stepwise adjustment for confounders to investigate prospective association between statin usage and colorectal cancer risk. In total, 378 (2.3%) of 16,588 male participants and 239 (1.6%) of 14,561 female participants had colorectal cancer during the follow-up period. Compared to nonusers, fully adjusted hazard ratios (HRs) (95% confidence intervals [95% CIs]) for colorectal cancer risk in high statin users were 0.56 (0.42-0.75) in men and 0.64 (0.46-0.90) in women. In men, the fully adjusted HRs for proximal and rectal cancer for high users were 0.29 (0.15-0.56) and 0.52 (0.35-0.78), respectively, compared to those for nonusers. In women, statistical significance was seen only in rectal cancer (HR 0.43 [0.25-0.72]) but not in proximal or distal colon cancer. CONCLUSIONS: High statin users with hypercholesterolemia were associated with lower risk of overall colorectal cancer, especially proximal colon cancer in men and rectal cancer in both sexes.

Assessment of Losartan 50 mg on Survival of Post-Dialysis Euvolemic Hypertensive Patients: Findings from HELD Trial.

AIMS AND OBJECTIVE: To estimate the effect of losartan 50 mg on survival of post-dialysis euvolemic hypertensive patients. METHODOLOGY: A single center, prospective, single-blind randomized trial was conducted to estimate the survival of post-dialysis euvolemic hypertensive patients when treated with lorsartan 50 mg every other day. Post-dialysis euvolemic assessment was done by a body composition monitor. Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm, and the follow-up duration was twelve months. The primary end point was achieving targeted blood pressure (BP) of <140/90 mm Hg and maintaining for 4 weeks, whereas secondary end point was all cause of mortality. Pre-, intra-, and post-dialysis session BP measurements were recorded, and survival trends were analyzed using Kaplan-Meier analysis. RESULTS: Of the total 229 patients, 96 (41.9%) were identified as post-dialysis euvolemic hypertensive. Final samples of 88 (40.1%) patients were randomized into standard (n = 44) and intervention arms (n = 44), and 36 (81.8%) patients in each arm completed a follow-up of 12 months. A total of eight patients passed away during the 12-month follow-up period (6 deaths among standard arm and 2 in intervention arm). However, the probability of survival between both arms was not significant (p = 0.13). Cox regression analysis revealed that chances of survival were higher among the patients in the intervention (OR 3.17) arm than the standard arm (OR 0.31); however, the survival was found not statistically significant. CONCLUSION: There was no statistical significant difference in 1 year survival of post-dialysis euvolemic hypertensive patients when treated with losartan 50 mg.

The Charlson Comorbidity and Barthel Index predict length of hospital stay, mortality, cardiovascular mortality and rehospitalization in unselected older patients admitted to the emergency department.

BACKGROUND AND AIMS: The Charlson Comorbidity Index (CCI) is the most widely used assessment tool to report the presence of comorbid conditions. The Barthel index (BI) is used to measure performance in activities of daily living. We prospectively investigated the performance of CCI or BI to predict length of hospital stay (LOS), mortality, cardiovascular (CV) mortality and rehospitalization in unselected older patients on admission to the emergency department (ED). We also studied the association of CCI or BI with costs. METHODS: We consecutively enrolled 307 non-surgical patients ≥ 68 years presenting to the ED with a wide range of comorbid conditions. Baseline characteristic, clinical presentation, laboratory data, echocardiographic parameters and hospital costs were compared among patients. All patients were followed up for mortality, CV mortality and rehospitalization within the following 12 months. A multivariate analysis was performed. RESULTS: Mortality was increased for patients having a higher CCI or BI with a hazard ratio around 1.17-1.26 or 0.75-0.81 (obtained for different models) for one or ten point increase in CCI or BI, respectively. The prognostic impact of a high CCI or BI on CV mortality and rehospitalization was also significant. In a multiple linear regression using the same independent variables, CCI and BI were identified as a predictor of LOS in days. Multiple linear regression analysis did not confirm an association between CCI and costs, but for BI after adjusting for multiple factors. CONCLUSION: CCI and BI independently predict LOS, mortality, CV mortality, and rehospitalization in unselected older patients admitted to ED.

Influencing factors of pregnancy loss and survival probability of clinical pregnancies conceived through assisted reproductive technology.

BACKGROUND: Pregnancies following assisted reproductive technology (ART) may have elevated potential risk of pregnancy loss (PL) when compared to natural conception. However, rare studies comprehensively analyzed the IVF/ICSI cycle-dependent factors for loss of clinical pregnancy. Therefore, we aimed to determine the ART subgroup-specific risks of PL throughout pregnancy and explore different risk factors for early miscarriage and late miscarriage among pregnancies conceived through ART. METHODS: A retrospective cohort study was launched in two infertility treatment centers in Nanjing and Changzhou including 5485 IVF/ICSI embryo transfer cycles with known outcomes after clinical pregnancy by the end of 2015. Cox proportional hazards regression analysis was performed to estimate the hazard ratios and their 95% confidence intervals. The associations between survival time during pregnancy and demographics and clinical characteristics of clinical pregnancies were estimated using the Kaplan-Meier method and the Log-rank test. RESULTS: The overall PL rate in current ART population was 12.5%. Among the 685 pregnancy loss cycles, a total of 460 ended as early miscarriage, 191 as late miscarriage. We found couples in ART pregnancies demonstrated a significantly increased risk of PL as maternal age (HR = 1.31, Ptrend < 0.001) grows. Pregnancies received controlled ovarian hyperstimulation (COH) protocol like GnRH antagonist protocol (HR = 3.49, P < 0.001) and minimal stimulation protocol (HR = 1.83, P < 0.001) had higher risk of PL than GnRH-a long protocol. Notably, in contrast to fresh cycle, women who received frozen cycle embryo had a significant increased risk of early miscarriage (P < 0.001), while frozen cycle was linked with lower risk of late miscarriage (P = 0.045). In addition, four factors (maternal age, COH protocol, cycle type and serum hCG level 14 days after transfer) had independent impact on miscarriage mainly before 12 weeks of gestational age. CONCLUSIONS: With these findings in this study, clinicians may make it better to evaluate a patient's risk of PL based on the maternal age at the time of treatment, COH protocol, cycle type and serum hCG level 14 days after transfer and the gestational week of the fetus, and we hope that it contributes to future study on its etiology and guide the clinical prevention and treatment.

Survival rate and predictors of mortality in patients hospitalised with heart failure: a cohort study on the data of Persian registry of cardiovascular disease (PROVE).

OBJECTIVES: Heart failure (HF) has a high rate of hospitalisation and mortality. We examined its risk factors, survival rate and the predictors. METHODS: In this prospective cohort study, demographic, clinical and treatment data of 1223 patients hospitalised with HF were extracted from the Persian Registry Of cardio Vascular diseasE (PROVE)/HF registry. Survival rate and HR and their association with other variables were assessed. RESULTS: 835 (68.3%) were censored, while 388 (31.7%) patients were deceased. Mean age and frequency of hypotension during hospitalisation, tachycardia, pulmonary hypertension and anaemia, hyponatremia, heart valve disease and renal disease of the deceased patients was significantly higher than censored patients (15.2vs6.1%, 51.1vs40.1%, 24.4vs16.7%, 39.0vs31.8%, respectively, p<0.05). ACE inhibitor (ACEI)/angiotensin receptor blocker (ARB) (89.8%vs82.1%, respectively) and beta blocker (BB) (81.1%vs75.5%, respectively) were higher in follow-up in the censored group (p<0.001 and 0.02, respectively). Crude Cox regression analysis identified age, tachycardia, hypotension, anaemia, pulmonary hypertension and heart valve disease as predictors of mortality (HR >1) and using ACEI/ARB and BB as predictors of life (HR <1, p<0.05). After adjustment, all variables lost their significance, except BB (HR 0.63, p=0.03) and tachycardia (HR 1.74, p=0.01) and New York Heart Association (NYHA) class IV (HR 1.90, p=0.04) became significant predictors. CONCLUSIONS: We found a high mortality rate (31.7%). As NYHA class IV and tachycardia were significant predictors of mortality after adjustment, an effective measure can be treatment of underlying diseases, which deteriorate patients' conditions. Monitoring of medications for at-risk group, especially BB that predicts life, is important.

Nonprocedural Symptomatic Infarction and In-Stent Restenosis After Intracranial Angioplasty and Stenting in the SAMMPRIS Trial (Stenting and Aggressive Medical Management for the Prevention of Recurrent Stroke in Intracranial Stenosis).

BACKGROUND AND PURPOSE: The purpose of this study was to investigate the frequency of symptomatic in-stent restenosis (ISR) and its contribution to nonprocedural symptomatic infarction in the SAMMPRIS trial (Stenting and Aggressive Medical Management for the Prevention of Recurrent Stroke in Intracranial Stenosis). METHODS: Patients without a periprocedural primary end point were followed up to determine the occurrence of any of the following events: ischemic stroke, cerebral infarct with temporary signs, or transient ischemic attack in the territory of the stented artery. Vascular imaging performed after these events was reviewed for ISR. Annual rates for symptomatic ISR were calculated using Kaplan-Meier estimates. RESULTS: Of 183 patients in the stenting group without a periprocedural primary end point, 27 (14.8%) had a symptomatic infarction (stroke or cerebral infarct with temporary signs) and 16 (8.7%) had transient ischemic attack alone in the territory during a median follow-up of 35.0 months. Of the 27 patients with infarctions, 17 (9.3%) had an ischemic stroke and 10 (5.5%) had a cerebral infarct with temporary signs alone. Adequate vascular imaging to evaluate ISR was available in 24 patients with infarctions (showing ISR in 16 [66.7%]) and in 10 patients with transient ischemic attack alone (showing ISR in 8 [80%]). The 1-, 2-, and 3-year rates (with 95% confidence limits) for symptomatic ISR in the SAMMPRIS stent cohort were 9.6% (6.1%-14.9%), 11.3% (7.5%-17.0%), and 14.0% (9.6%-20.2%), respectively. CONCLUSIONS: Symptomatic ISR occurred in at least 1 of 7 patients in SAMMPRIS by 3 years of follow-up and was likely responsible for the majority of nonprocedural cerebral infarctions. CLINICAL TRIAL REGISTRATION: URL: https://clinicaltrials.gov. Unique identifier: NCT00576693.

Serum glucose, cholesterol and blood pressure levels in Japanese type 1 and 2 diabetic patients: BioBank Japan.

BACKGROUND: Evidence of characteristics of Japanese patients with diabetes from a large-scale population is necessary. Few studies have compared glycaemic controls, complications and comorbidities between type 1 and 2 diabetic patients. This paper focuses on illustrating a clinical picture of Japanese diabetic patients and comparing glycaemic control and prognoses between type 1 and 2 diabetes using multi-institutional data. METHODS: The BioBank Japan Project enrolled adult type 1 and 2 diabetic patients between fiscal years 2003 and 2007. We have presented characteristics, controls of serum glucose, cholesterol and blood pressure, prevalence of complications and comorbidities and survival curves. We have also shown glycaemic controls according to various individual profiles of diabetic patients. RESULTS: A total of 558 type 1 diabetic patients and 30,834 type 2 diabetic patients participated in this study. The mean glycated haemoglobin A1c was higher in type 1 diabetes than in type 2 diabetes. In the type 1 diabetic patients, the glycated haemoglobin A1c had no consistent trend according to age and body mass index. The Kaplan-Meier estimates represented a longer survival time from baseline with type 1 diabetes than with type 2 diabetes. Compared with type 1 diabetic patients, type 2 diabetic patients had double the prevalence of macrovascular complications. CONCLUSIONS: This work has revealed detailed plasma glucose levels of type 1 and 2 diabetic patients according to age, body mass index, blood pressure, serum cholesterol levels and smoking and drinking habits. Our data have also shown that the prognosis is worse for type 2 diabetes than for type 1 diabetes in Japan.