Log-rank Test Χ2 Research Articles

Mortality and Outcome in Elderly Patients Undergoing Emergent or Elective Cranial Surgery

Due to the aging population, the number of elderly patients in need of cranial surgery for various neurosurgical pathologies is growing. We sought to compare mortality and outcome of elderly patients undergoing cranial surgery with a younger population. This was a retrospective analysis of adult patients undergoing craniotomy or craniectomy for various indications. Patients were allocated to 4 age groups (<65 years, 65-74 years, 75-84 years, ≥85 years; groups 1-4, respectively). Primary outcome was 30-day mortality rate, whereas secondary outcome measurements were clinical outcome measured by the modified Rankin Scale score, morbidity (bleeding, infection, and thromboembolic complications), length of stay (LOS), and discharge location. We included 838 consecutive patients. Overall, 30-day mortality was 5.0% (n= 42), showing significant difference between the groups (2.8%, 7.3%, 7.5%, and 22.7% groups 1-4, respectively; P < 0.001). Mortality remained statistically significantly different between the groups also after stratification for elective or emergent surgery. Cumulative 30-day mortality-free rate was significantly different between the groups as well (log rank test χ2= 24.58, P < 0.001). Elderly patients showed significantly greater rates of bleeding (P= 0.003), longer LOS (P< 0.001), more discharges to rehabilitation facilities (P= 0.008), and a trend toward worst modified Rankin Scale score at follow-up (P= 0.08). After multivariate regression analysis, age (≥75 years) and lower preoperative Glasgow Coma Scale score (<14) were significantly associated with greater mortality rates, whereas postoperative thrombosis prophylaxis was a protective factor for mortality. In patients undergoing craniotomy or craniectomy, advanced age seems to be associated with greater mortality and bleeding rates, longer LOS, and more discharge to rehabilitation facilities.

Clinical and prognostic significance of C1q deposition in IgAN patients-a retrospective study

Background/AimIgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and is responsible for 45–50% of primary glomerular diseases in China. We are essentially dependent on the degree of proteinuria to determine prognosis and it has been reported that histopathologic lesions are risk factors for the progression of IgAN. The aim of this study was to investigate the clinicopathologic features and prognosis of IgAN with C1q deposition in adult Chinese patients. MethodsThe patients of primary IgAN diagnosed by renal biopsy from January 2002 to December 2018 at the Second Hospital of Shanxi Medical University were retrospectively analyzed and divided into C1q deposit group and C1q negative group according to glomerular immunofluorescence examination. We evaluated their serologic and histopathologic findings. We collected data of patients during January 1, 2015 to December 31, 2018 and performed the clinical follow-up until the patient's estimated glomerular filtration rate (eGFR) decreased by more than 30%, entering end-stage renal disease (ESRD). Kaplan-Meier survival analysis was used to evaluate the cumulative incidence of renal progression in two groups. Univariate and multivariate Cox proportional hazard regression models were used to analyze the effect of C1q deposition on the prognosis of patients with IgA nephropathy. ResultsThe baseline data of total 491 cases were available and 172 cases had the follow-up data. The baseline eGFR and plasma albumin (ALB) levels in C1q deposit group were lower than those in the C1q negative group, while the levels of serum creatinine (Scr), total cholesterol (TC), 24 h urine protein, low-density lipoprotein (LDL), β2 microglobulin, etc. were higher than those in C1q negative group (all P < 0.05). Pathological indexes: glomerular segment sclerosis and adhesion (S), renal tubular atrophy/interstitial fibrosis (T), and cell/fibroblastic crescent (C) scores in C1q deposit group were higher than those in C1q negative group (all P < 0.05). With a median follow-up time of 32.5 (24,42) months, a total of 18 patients (C1q deposit: 11; C1q negative: 7) developed to endpoints. Kaplan-Meier survival curve analysis showed that there was significant decrease in cumulative incidence of renal progression between the two groups (Log-rank test χ2 = 4.78, P = 0.029). Cox regression analysis showed that the risk of renal end-point events in IgAN patients with C1q deposit group was 6.35 times higher than that in C1q negative group (HR = 6.35, 95% CI: 1.21–33.30, P = 0.029). ConclusionThe clinical and renal pathological changes of IgAN patients with C1q deposition are more severe than those of C1q negative patients, and has a worse outcome. C1q deposition is an independent risk factor for the progression of renal function and contributes to a poor renal prognosis in adult IgAN patients.

Testing the effects of checklists on team behaviour during emergencies on general wards: An observational study using high-fidelity simulation

IntroductionClinical teams struggle on general wards with acute management of deteriorating patients. We hypothesized that the Crisis Checklist App, a mobile application containing checklists tailored to crisis-management, can improve teamwork and acute care management. MethodsA before-and-after study was undertaken in high-fidelity simulation centres in the Netherlands, Denmark and United Kingdom. Clinical teams completed three scenarios with a deteriorating patient without checklists followed by three scenarios using the Crisis Checklist App. Teamwork performance as the primary outcome was assessed by the Mayo High Performance Teamwork scale. The secondary outcomes were the time required to complete all predefined safety-critical steps, percentage of omitted safety-critical steps, effects on other non-technical skills, and users’ self-assessments. Linear mixed models and a non-parametric survival test were conducted to assess these outcomes. Results32 teams completed 188 scenarios. The Mayo High Performance Teamwork scale mean scores improved to 23.4 out of 32 (95% CI: 22.4–24.3) with the Crisis Checklist App compared to 21.4 (20.4–22.3) with local standard of care. The mean difference was 1.97 (1.34–2.6; p < 0.001). Teams that used the checklists were able to complete all safety-critical steps of a scenario in more simulations (40/95 vs 21/93 scenarios) and these steps were completed faster (stratified log-rank test χ2 = 8.0; p = 0.005). The self-assessments of the observers and users showed favourable effects after checklist usage for other non-technical skills including situational awareness, decision making, task management and communication. ConclusionsImplementation of a novel mobile crisis checklist application among clinical teams was associated in a simulated general ward setting with improved teamwork performance, and a higher and faster completion rate of predetermined safety-critical steps.

Eicosapentaenoic acid levels predict prognosis of peripheral artery disease caused by aortoiliac artery lesions

Background and aimEicosapentaenoic acid (EPA) has been reported to improve clinical outcome of high-risk atherosclerotic patients. We investigated whether endogenous EPA values predict prognosis of peripheral artery disease (PAD) patients. Methods and resultsThis retrospective study included 166 consecutive patients who had received endovascular therapy (EVT) for PAD caused by aortoiliac artery lesions. Patients were divided into 2 groups using median preoperative EPA value (57 μg/ml): LOW EPA (n = 83) and HIGH EPA (n = 83). We compared differences between the 2 groups in prevalence of major adverse limb events (MALE) which included target lesion revascularization (TLR), non-TLR, and major amputation, and major adverse events (MAE) which included MALE and all cause death. At a median follow-up period of 20 months, MALE had occurred in 24 LOW EPA patients (28.9%) and in 12 HIGH EPA patients (14.5%) (p = 0.04), and MAE had occurred in 41 LOW EPA patients (49.4%) and in 21 HIGH EPA patients (25.3%) (p < 0.01). Kaplan–Meier analysis showed prevalence of MALE and MAE was significantly higher in LOW EPA than in HIGH EPA (long-rank test χ2 = 8.5, p < 0.01, log-rank test χ2 = 13.2, p < 0.01, respectively). Multivariate Cox regression revealed preoperative EPA value < 57 μg/ml was an independent predictor for MALE (hazard ratio [HR]: 2.70; 95% CI: 1.35 to 5.4; p < 0.01) and MAE (HR: 2.86; 95% CI: 1.67 to 4.91; p < 0.01). ConclusionsEndogenous EPA value seems to be associated with risk of MALE and MAE after EVT in patients with PAD caused by aortoiliac artery lesions.

Calcineurin inhibitors in nephrotic syndrome secondary to podocyte gene mutations: a systematic review.

Calcineurin inhibitor (CNI) use in genetic steroid-resistant nephrotic syndrome (SRNS) is controversial as response rate is reported to be lower than non-genetic disease and no plausible mechanism of action is known. We reviewed PubMed for publications on CNI use in hereditary SRNS to determine (1) CNI response rate; (2) impact of response on renal outcome; and (3) clinical and molecular predictors of response. Variant pathogenicity was assessed according to American College of Medical Genetics criteria and patients were assigned to 1 of 4 categories based on estimated genotype contribution to phenotype. Cases with non-existing phenotype-to-genotype contribution were excluded. Subgroup analysis was performed for the possible and confirmed genetic cases. Data of 178 genetic SRNS cases from 22 studies were analyzed; 35% responded (fully or partially) to CNI with minimal change being the commonest biopsy pattern among responders. Full responders had superior kidney survival compared with partial and non-responders (log-rank test χ2 = 10.7; P < 0.01). WT1 variant carriers were most likely to respond to CNI compared with any other mutation [OR 4.7 (2.0-11.3); P < 0.01]. These findings support the current recommendation for using CNI as first-line treatment for children with SRNS whilst genetic analyses are pending. This would allow assessment of treatment response even in cases later established as genetic ensuring that benefits on kidney function are balanced with treatment toxicity.

Mid-term predictive value of calciprotein particles in maintenance hemodialysis patients based on a gel-filtration assay

Background and aimsCalciprotein particles (CPPs), nano-aggregates containing fetuin-A-bound calcium-phosphate, are associated with aortic stiffness and coronary calcification in maintenance hemodialysis patients. A novel gel-filtration assay can detect low-density small CPPs, which are actually a major form of circulating CPPs in vivo. We sought to investigate whether circulating CPP levels measured by gel-filtration method would accurately predict hard endpoints in maintenance hemodialysis patients. MethodsThis study used a prospective, multicenter, longitudinal, and observational design. One-hundred eight patients enrolled in this study were followed-up for about 2 years. We reported all-cause death and cardiovascular events, which included major adverse cardiac, cerebrovascular, and limb events. ResultsKaplan-Meier analysis showed no significant difference between patients with the higher (>median) and lower (<median) CPP levels with regard to all-cause death. However, the higher CPP group showed a higher incidence of cardiovascular events (log-rank test χ2 = 4.41, p = 0.036). Univariate Cox regression analysis revealed that CPP levels were not associated with all-cause death, but were significantly associated with higher incidence of cardiovascular events (hazard ratio (HR) 1.03, 95% confidence interval (CI) [1.02–1.05], p < 0.001) for every thousand CPP increase. Multivariate Cox regression analysis revealed that CPP levels were not associated with all-cause death, but were independently associated with cardiovascular events (HR 1.03, 95% CI [1.01–1.04], p < 0.001) for every thousand CPP. ConclusionsThis finding suggests a potential predictive value of CPPs in maintenance hemodialysis patients.

Study on the relationship between the extent of runoff lesions under the knee and the patency of femoropopliteal artery stent in patients with diabetes

Objective To evaluate the impact of runoff score on the patency of femoropopliteal artery (FPA) stent in patients with type 2 diabetes mellitus with ultrasonography. Methods A retrospective review of a database of 127 patients with type 2 diabetes mellitus (127 limbs) undergoing femoropopliteal stents in Xuanwu Hospital from January 2016 to July 2018 was made. Demographic characteristics and possible related risk factors were recorded. The extent of FPA disease and the runoff lesions below the knee (anterior tibial artery, posterior tibial artery, and peroneal artery) were preoperative evaluated and regular followed-up by color Doppler ultrasonography (CDU). Femoropopliteal artery lesions were graded according to the Trans-Atlantic Inter-Society Consensus (TASCII), and the runoff lesions below the knee were scored according to the Society for Vascular Surgery (SVS). The patency and the predictors for in-stent restenosis were assessed using a Kaplan-Meier and Cox proportional hazards model. Results Follow up period ranged from 1 month to 24 months.The total patency rates at the 3, 6, 12, 24 months were 91.5%, 70.9%, 45.7% and 31.7%, respectively. Post-procedural runoff score according to SVS criteria: 1-3 scores in 45 limbs, 3.5-5 scores in 37 limbs, 5.5-7 scores in 34 limbs, 7.5-10 scores in 11 limbs. The median runoff score was 4.Patients were stratified according to runoff scores (score ≤4 and >4 groups), and the difference of the patency rates between the two groups was statistically significant by Kaplan-Meier analysis and Log-rank test (χ2=10.825, P=0.001). The runoff score affected patency significantly on COX analysis (RR=1.155, P=0.006, 95%CI: 1.042-1.281). Conclusions Compromised runoff negatively affects the patency of FPA stent. High post-procedural runoff score is a main risk factor related to loss of patency. CDU is a reliable method for monitoring patients with femoropopliteal stenting. Key words: Ultrasonography; Diabetes; Femoropopliteal artery; Runoff score; Stent

Relationship of systemic pentraxin-3 values with coronary plaque components on optical coherence tomography and post-percutaneous coronary intervention outcomes in patients with stable angina pectoris

Background and aimsElevated pentraxin-3 (PTX3) values are associated with vulnerable plaque existence and poor outcomes in acute coronary syndrome patients. The clinical significance of PTX3 values in stable angina pectoris (SAP) patients is, however, undetermined. We investigated the relationship of systemic PTX3 values and coronary plaque components and post-percutaneous coronary intervention (PCI) outcomes in SAP patients. MethodsWe included 93 consecutive de-novo lesions in 93 SAP patients with a normal pre-PCI high-sensitivity cardiac troponin-T (<0.014 ng/mL), undergoing pre- and post-PCI optical coherence tomography (OCT). Systemic PTX3 values were obtained immediately pre- and post-PCI, at 24-h and 9-month post-PCI. ResultsPeak post-PCI PTX3 values correlated with thinnest fibrous cap thickness (r = −0.23, p = 0.03) and lipid length (r = 0.24, p = 0.03), and were higher in patients with lesions having OCT-derived thin-cap fibroatheroma (6.67 (3.19–7.33) vs. 3.13 (2.34–4.11) ng/mL, p = 0.04) and post-stenting irregular tissue protrusion (4.76 (3.31–6.80) vs. 2.98 (2.23–4.06) ng/mL, p = 0.003) than in those without. At 9-month follow-up, cardiac event-free survival was poorer in patients with a peak post-PCI PTX3 value ≥ 4.08 ng/mL (upper tertile) (log-rank test χ2 = 9.0; p = 0.003). Multivariate Cox regression analysis showed a peak post-PCI PTX3 value ≥ 4.08 ng/mL as an independent predictor of MACE (hazard ratio, 3.915; 95% CI, 1.129–13.583; p = 0.03). ConclusionsPeak post-PCI PTX3 values correlated with pre-PCI plaque characteristics and post-PCI outcomes, providing a good prognostic factor of outcomes in SAP patients undergoing elective PCI.

Differential mRNA expression combined with network pharmacology reveals network effects of Liangxue Tongyu Prescription for acute intracerebral hemorrhagic rats

Liangxue Tongyu Prescription (LTP) is a traditional Chinese medicine formula composed of 8 crude drugs that is widely used to treat acute intracerebral hemorrhage (AICH). To verify the efficacy of LTP on the survival time in the treatment of acute intracerebral hemorrhagic rats (AICHs), and to elucidate its network pharmacodynamic mechanism of multi-component, multi-target, and multi-signaling pathways. Survival analysis was used to evaluate the survival time of AICH rats induced by different doses of collagenase and the efficacy of three doses of LTP in the treatment of AICH rats. The Kaplan-Meier curves for survival time were produced and compared with the Log-rank test and Wilcoxon (Gehan) χ2. Differential mRNA-seq combined with network pharmacology was used to disclose the network effect mechanism of LTP on AICH, and the obtained differential genes were mapped into the predictive empirical compound-target network model (ECT network model) and the empirical compound-target-pathogenesis (disease) network model (ECTP network model). The median survival time of four different doses of LTP-treated groups (0.00 g/kg, 5.78 g/kg, 11.55 g/kg, 23.10 g/kg) for adult AICH rats by 0.18 U collagenase was 14 h, 37 h, 150 h, and 51 h respectively, and the 7-day survival rates were 33.3%, 41.7%, 50.0%, and 38.5%, of which the medium-dose group (MD) had a longer survival time and higher survival rate. Through further validation experiments, the MD group had a better efficacy trend with a median survival time of 168 h vs 23 h in the model control group (MC) (Wilcoxon Gehan Test, χ2 = 3.478, P = 0.062). The transcriptomic analysis of mRNA showed that 583 significant differential genes were found between the MC and MD group and 7 key therapeutic targets regulated by 29 compounds in LTP on AICH were screened out by VCT and VCTP network model. These targets were involved in 5 regulatory models or pathways. Our study confirmed the exact efficacy of the LTP in the treatment of AICH and revealed the potential pharmacodynamic components and mode of action of the LTP on AICH. Using differential transcriptome of mRNA combined with network pharmacology, we screened out 29 chemical compounds as the potential effective ingredients of LTP which acted on 7 targets of AICH involving 5 pathological pathways, mainly including repairing the brain function defect, improving neural function, protecting blood-brain barrier from damage, reducing inflammatory factors, and inhibiting apoptosis. The present study not only provides a new explanation for the 'multi-component, multi-target, multi-pathway' effects of the LTP on AICH but also screened out some major compounds of LTP and their potential targets which will facilitate the development of new drugs for AICH.

Incidencia de cáncer en pacientes con insuficiencia cardiaca con fracción de eyección reducida

Introduction and objectivesEvidence linking heart failure (HF) with a higher incidence of cancer has been suggested previously. However, there are no studies that only include patients with HF and reduced ejection fraction (HFrEF). MethodsTo assess outcomes and incidence of cancer in patients with HFrEF followed prospectively in the HF Unit of a Spanish hospital. ResultsThe study included a total of 485 patients with HFrEF and with no previous diagnosis of cancer were followed-up (median 54months, 79.2% men, mean age 66.5±12.5years [median 69]). A total of 50 new cases of cancer were identified, corresponding to an incidence rate of 21.5 per 1000 persons per year [95% confidence interval (CI) 20.2-22.6] and a cumulative incidence of 1288.6 cases per 100 000 persons per year. Compared with patients that do not have cancer in the follow-up, they are older (71.4 vs 66.0years, P=.004), an ischaemic origin of cardiomyopathy is more frequent (60% vs 44.4%, P<.001), and have more comorbidity. Chronic obstructive pulmonary disease (COPD), increasing age, and being a carrier of an implantable cardioverter defibrillator (ICD), were predictors of developing cancer in the multivariate analysis. Survival was lower in patients with a diagnosis of cancer (58% vs 26.2%, survival median of 57.1±2.2 vs 78.5±2.2months, respectively; log rank test χ2; 16.01; P<.001) with a survival median from cancer diagnosis to death of 24.0±6.5months. ConclusionsIncidence of cancer in patients with HFrEF is high. Its development is associated with COPD, increasing age and being an ICD carrier.

Glioblastoma and Increased Survival with Longer Chemotherapy Duration

The five-year survival rate for patients with glioblastoma (GBM) is low at approximately 4.7%. Radiotherapy plus concomitant and adjuvant temozolomide (TMZ) remains the standard of care. The optimal duration of therapy with TMZ is unknown. This study sought to evaluate the survival benefit of two years of treatment. This was a retrospective chart review of all patients diagnosed with GBM and treated with TMZ for up to two years between January 1, 2002 and December 31, 2011. The Kaplan-Meier method with log-rank test was used to estimate the progression-free survival (PFS) and the overall survival (OS). The results were compared to historical controls and data from previous clinical trials of patients treated up to one year. Data from 56 patients with confirmed GBM were evaluated. The OS probability was 54% (SE = 0.068) at one year, 28.3% (SE = 0.064) at two years, 17.8% (SE = 0.059) at three years, and 4% (SE = 0.041) at five years. Seven patients (12.5%) were treated with TMZ for two years. Their median time-to-progression was 28 months (95% CI = 5.0 - 28.0), and they had an increased survival probability at three years compared to other patients (log-rank test χ2 (1, N = 56) = 19.2, p < 0.0001). There may be an advantage for a longer duration of TMZ therapy among patients with GBM, but the sample size was too small for generalization. A multicenter prospective study is needed to identify optimal duration of TMZ therapy.

Oscillometric and Doppler Ankle Brachial Indexes as predictors of all-cause mortality in a Primary Care population.

Doppler Ankle Brachial Index (ABI), the non-invasive reference standard for peripheral arterial disease (PAD) in Primary Care, has proved good capacity to predict all-cause mortality. However, the role of oscillometric ABI is uncertain. This study aims to evaluate the ability of oscillometric and Doppler ABI to predict all-cause mortality in a Primary Care population. Oscillometric and Doppler ABI were measured in 203 consecutive subjects with ≥1 cardiovascular risk factors or intermittent claudication. Pathologic ABI was defined when ABI was ≤0.9 or ≥1.4, and when the oscillometer was unable to record a value (oscillometric error). All-cause mortality was ascertained through examination of electronic medical records or telephone contact. After analyzing 602.9 subjects/year, all-cause mortality was recorded in 17 (8.4%) patients. Kaplan-Meier survival curves for oscillometric (Log-Rank test χ2=66.02, P<0.001) and Doppler ABI (Log-Rank test χ2=42.30, P<0.001) showed that a pathologic ABI is associated with all-cause mortality. After adjusting for covariates, the hazard ratio in multivariable Cox regression were 4.52 (95% CI: 1.67-12.18, P=0.003) and 2.08 (95% CI: 0.83-5.18, P=0.117) for oscillometric and Doppler ABI models, respectively. When introducing oscillometric and Doppler ABI simultaneously in the Cox regression model, only oscillometric ABI was an independent predictor with a hazard ratio=7.90 (95% CI: 1.79-34.83, P=0.006). Regarding Doppler ABI, no significant differences were found in all-cause mortality between low ABI (≤0.9) and calcified ABI (≥1.4), (Log-Rank test χ2=0.98, P=0.322). Oscillometric ABI predicted all-cause mortality in a Primary Care population even better than Doppler ABI, irrespective of cardiovascular risk factors. Oscillometric ABI, due to a high feasibility, could routinely identify high-risk patients to implement preventive measures.

КОМБИНИРОВАННОЕ ЛЕЧЕНИЕ БОЛЬНЫХ НЕМЕЛКОКЛЕТОЧНЫМ РАКОМ ЛЁГКОГО С ПЕРСОНАЛИЗИРОВАННЫМ НАЗНАЧЕНИЕМ АДЪЮВАНТНОЙ ХИМИОТЕРАПИИ

Objective: To study the long-term results of the combined treatment of non-small cell lung cancer (NSCLC) using pre-surgery chemotherapy, radical surgery and personalized adjuvant chemotherapy based on the level of monoresistance genes. Methods: Four-year results of treatment of 72 patients of NSCLC II-III stage were analyzed. All patients underwent 2 courses of neoadjuvant chemotherapy (vinorelbine/carboplatin) and surgical treatment. Personalized adjuvant chemotherapy based on the levels of expression of monoresistance genes АВСС5, RRM1, TYMS, TOP1, TOP2α, TUBB3, BRCA1, and ERCC1 was performed in the main group (n=35). Three courses of adjuvant chemotherapy (vinorelbine/carboplatin) were performed in the control group (n=37). Results: In the main group the progression of the disease was observed in 14 out of 35, and in the control group – in 21 out of 37 patients. Relapsefree survival (RFS) in the main group was 60.0% (95% CI: 43.6-74.5), in the control group – 43.2% (95% CI: 28.7-59.1); Log-Rank test χ2 =3,071, р=0,080; RR=1,808 (95% CI: 0.918-3.561). The median RFS in the control group was 27 months (95% CI: 5.7-48.3). The overall survival rate in the main group was 77.1% (95% CI: 61.0-87.9), in the control group – 54.1% (95% CI: 38.4-69.0); Log-Rank test χ2 =2,813, p=0.094; RR=2,024 (95% CI: 0,870-4,709). Conclusion: The developed method of personalized prescribing adjuvant chemotherapy to patients with NSCLC based on the molecular genetic characteristics of the tumor improves relapse-free and overall survival. Keywords: Non-small cell lung cancer , monoresistance genes , personalized chemotherapy.

Prolonged remission is associated with a reduced risk of cardiovascular disease in patients with systemic lupus erythematosus: a GIRRCS (Gruppo Italiano di Ricerca in Reumatologia Clinica e Sperimentale) study.

Prolonged remission (PR), defined as a 5-year consecutive period of no disease activity based on SLEDAI-2K, has been reported to be associated with a lower damage accrual over time in patients with systemic lupus erythematosus (SLE), as the consequence of a lower activity burden. Since disease activity is considered to play a role in the incidence of cardiovascular disease (CVD), we investigated the relationship, if any, between PR and the occurrence of a subsequent first CV event in patients with SLE. Out of 488 patients consecutively admitted to two tertiary Italian centers from November 1, 2000, to December 31, 2016, the 294 patients, who had been followed at least for 5years, had not experienced any CV event at admission, and had been visited biannually during follow-up, were considered for the present study. The incidence of a first CV in patients who had achieved PR was compared with that registered in those who had not. Moreover, it was compared among PR patients subdivided into three groups: complete remission, clinical off-corticosteroids (offCR), and clinical on-corticosteroids remission (onCR). Kaplan-Meier curves and the log-rank test were used to analyze differences in event-free survival among groups. Cox regression was used to investigate disease and therapeutic features associated with the development of a first CV event. During 9years median follow-up time, 24 (8.1%) CV events occurred. Out of the 294 patients, 126 (42.8%) had achieved PR. Kaplan-Meier analysis revealed a greater overall CV event-free rate in these patients as compared to both those with a shorter lasting remission and those who had never remitted (log-rank test χ2 = 14.43; p = 0.0001). In addition, CV outcome did not differ among PR patients, irrespectively the type of remission achieved (p > 0.05). At multivariate analysis, hydroxychloroquine therapy and PR resulted to be protective (HR 0.19; HR 0.18), while arterial hypertension and antiphospholipid positivity increased the risk of a first CV event (HR 2.61; HR 2.47). The PR, whichever the subtype, is associated with a better CV outcome and should be considered as a treat-to-target goal in the CV risk management of the lupus patient.

Effect of Depth of Sedation in Older Patients Undergoing Hip Fracture Repair on Postoperative Delirium

Postoperative delirium is the most common complication following major surgery in older patients. Intraoperative sedation levels are a possible modifiable risk factor for postoperative delirium. To determine whether limiting sedation levels during spinal anesthesia reduces incident delirium overall. This double-blind randomized clinical trial (A Strategy to Reduce the Incidence of Postoperative Delirum in Elderly Patients [STRIDE]) was conducted from November 18, 2011, to May 19, 2016, at a single academic medical center and included a consecutive sample of older patients (≥65 years) who were undergoing nonelective hip fracture repair with spinal anesthesia and propofol sedation. Patients were excluded for preoperative delirium or severe dementia. Of 538 hip fractures screened, 225 patients (41.8%) were eligible, 10 (1.9%) declined participation, 15 (2.8%) became ineligible between the time of consent and surgery, and 200 (37.2%) were randomized. The follow-up included postoperative days 1 to 5 or until hospital discharge. Heavier (modified observer's assessment of sedation score of 0-2) or lighter (observer's assessment of sedation score of 3-5) propofol sedation levels intraoperatively. Delirium on postoperative days 1 to 5 or until hospital discharge determined via consensus panel using Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria. The incidence of delirium was compared between intervention groups with and without stratification by the Charlson comorbidity index (CCI). Of 200 participants, the mean (SD) age was 82 (8) years, 146 (73%) were women, 194 (97%) were white, and the mean (SD) CCI was 1.5 (1.8). One hundred participants each were randomized to receive lighter sedation levels or heavier sedation levels. A good separation of intraoperative sedation levels was confirmed by multiple indices. The overall incident delirium risk was 36.5% (n = 73) and 39% (n = 39) vs 34% (n = 34) in heavier and lighter sedation groups, respectively (P = .46). Intention-to-treat analyses indicated no statistically significant difference between groups in the risk of incident delirium (log-rank test χ2, 0.46; P = .46). However, in a prespecified subgroup analysis, when stratified by CCI, sedation levels did effect the delirium risk (P for interaction = .04); in low comorbid states (CCI = 0), heavier vs lighter sedation levels doubled the risk of delirium (hazard ratio, 2.3; 95% CI, 1.1- 4.9). The level of sedation did not affect delirium risk with a CCI of more than 0. In the primary analysis, limiting the level of sedation provided no significant benefit in reducing incident delirium. However, in a prespecified subgroup analysis, lighter sedation levels benefitted reducing postoperative delirium for persons with a CCI of 0. clinicaltrials.gov Identifier: NCT00590707.

Direct Fiber-Reinforced Interim Fixed Partial Dentures: Six-Year Survival Study.

Mechanical and optical studies of glass fiber composites have revealed great resistance and satisfactory bonds between the glass fibers and composite resins. This study aimed to evaluate the long-term survival of anterior and posterior direct glass fiber-reinforced composite (FRC) fixed partial dentures (FPD). Twenty-three patients (9 men, 14 women) aged 18 to 67 received 23 d-FRC-FPDs. The frameworks of the FPDs were unidirectional pre-impregnated glass fibers (ever Stick C&B). The retainers were inlay composite resin retainers (n1 = 19) and composite resin wings (n2 = 4). The FPD that used inlay retainers and composite resin wing retainers was called the hybrid design. The mean follow-up period was 4.91 years with 12-month check-ups performed by two independent operators. The survival rates of the glass fiber FPDs were determined. Six-year survival rates for the two types of FPDs were 94.7% for the inlay retainer type versus 25% for the hybrid type, with a statistically significant difference (log-rank test χ2 (1) = 11.422, p = 0.001). The inlay retainers were functional, with only one patient with a fracture line in the connector held by the glass fibers. Kaplan-Meier survival curves were drawn to show the difference between the two types of retainers. According to the results of this study, these long-term interim FRC-FPD were resistant enough to allow mastication, minimally invasive and also esthetic, with inlay composite retainers as the better solution.

DISEASES OF CIRCULATORY SYSTEM AND COMORBID TYPE II DIABETES MELLITUS IN THE CHORNOBYL ACCIDENT CONSEQUENCES CLEAN-UP WORKERS.

The study was focused on evaluation of peculiarities of the clinical manifestations of type II diabetesmellitus (TIIDM) in the Chornobyl nuclear power plant (ChNPP) accident clean-up workers (ACUW). The ChNPP ACUW of 1986-1987 period (n = 449, males) and 158 males not exposed to ion-izing radiation (the control group, CG) were involved in the study in 2013-2018. Diagnosis of cardiovascular disease(CVD) and type II diabetes mellitus (TIIDM) was established in accordance with diagnostic standards adopted inUkraine. All study subjects had no signs of CVD, and neither of endocrine disease nor of metabolic disorders beforethe accident. Clinical course of the TIIDM, depending on the disease severity, onset of angiopathy and polyneuropathy,prevalence of angina pectoris and heart failure were surveyed and analyzed. Concomitant TIIDM was associated witha higher incidence of angina pectoris and heart failure. According to the Kaplan-Meier method of survival estimatingthe accumulation of new TIIDM cases occurred faster in the ACUW compared with individuals in the CG, however withno statistical significance in subjects aged up to 60 years old (log-rank test χ2 = 4.89, p = 0.027). Mean age of theACUW having comorbid CVD and DM was (54.6 ± 9.7) years, whilst in the CG it was (59.9 ± 10.7) years (p = 0.005). The DM course in the ACUW was not significantly different from non-irradiated control both in sever-ity and such complications as angiopathy of retina and lower extremities, as well as manifestations of lower extrem-ity polyneuropathy. Clinical manifestations of CVD in the form of angina pectoris and heart failure were identical inthe ACUW and control group of patients having a comorbid TIIDM. The latter was a factor exacerbating the CVDcourse and leading to a higher prevalence of angina pectoris and heart failure both in the ACUW and in non-irritat-ed individuals. Accumulation of the new DM cases occurred more rapidly in ACUW vs. non-irradiated control, so theywere in average 5 years younger at the time of TIIDM manifestation than the control subjects.

A phase II prospective study on raltitrexed combined with concurrent radiotherapy for elderly esophageal carcinoma

Objective To evaluate the clinical effects and adverse reaction of raltitrexed combined with radiation for esophageal carcinoma in elderly patients. Methods Sixty patients were randomly divided into two groups by the envelope method, 30 patients in experimental group received raltitrexed combined with radiotherapy and 30 patients in control group received radiotherapy only. Patients in both groups received conventional radiotherapy with a total dose of 56-60 Gy/28-30 F. In experimental group, raltitrexed 2.6 mg/m2 was administered concurrently with the radiotherapy on d1 and d22. Two cycles of concurrent chemotherapy were administered during radiotherapy. The short-term effects, survival times and adverse reactions of the two groups were compared. Results The total effective rates of experimental group and control group were 93.3% and 73.3%, respectively, and there was statistically significant difference between the two groups (χ2=4.320, P=0.038). The median survival times of experimental group and control group was 24.0 months and 12.0 months, respectively, and there was statistically significant difference by Log-rank test (χ2=6.048, P=0.014). The major adverse reactions of grade 3-4 in experimental group and control group were radiation-induced esophagitis (10.0% vs. 3.3%; χ2=0.268, P=0.605), leukopenia (13.3% vs. 10.0%; χ2=0.000, P=1.000), thrombocytopenia (3.3% vs. 0; P=1.000), nausea and vomiting (6.7% vs.0; χ2=0.517, P=0.472), and the differences were not statistically significant. Conclusion Raltitrexed combined with radiotherapy can enhance the short-term effect and prolong the survival time for the elderly esophageal carcinoma patients, and the adverse reactions are mild. It is worthy of further clinical study. Key words: Esophageal neoplasms; Radiotherapy; Drug therapy; Radiation tolerance; Raltitrexed

Delivering tertiary centre specialty care to ALS patients via telemedicine: a retrospective cohort analysis

Objective: This study was undertaken to determine if ALS patients evaluated via telemedicine received the same quality of care as patients evaluated by traditional face-to-face encounters.Methods: A retrospective cohort study design was used. Participants were patients diagnosed with ALS that received multidisciplinary care at the tertiary Cleveland VA ALS Centre between 1 March 2008- and 31 anuary 2015. Participants were not randomised, but chose telemedicine based on preference, disability level or distance from the clinic. Telemedicine in this study consisted of a video conferencing platform enabling remote rather than face-to-face encounters with participants.Results: There was no significant association between receiving quality ALS care and the mode of care. There was a trend for telemedicine patients to utilise home health care less often than those that received clinic care (AOR 0.50; 95% CI 0.16–1.59). There was no significant difference in survival time between the two groups (log-rank test χ2 = 3.62, df = 1, p = 0.05). Patients receiving telemedicine had a higher probability of remaining stable or having <30% decrease in ALSFRS-R over time (log-rank test χ2 = 4.46, df = 1, p = 0.03). There was a significantly lower risk of disease progression for patients receiving telemedicine (HR = 0.39, 95% CI = 0.16–0.93).Conclusions: Patients managed by telemedicine received the same quality of care and had similar outcomes to those patients seen via traditional face-to-face encounters. Telemedicine is an effective platform for delivering high quality tertiary ALS care.

Impact of coronary plaque morphology assessed by optical coherence tomography on cardiac troponin elevation in patients with non-ST segment elevation acute coronary syndrome.

This study aimed to use optical coherence tomography (OCT) to study the relationship between plaque morphology prior to percutaneous coronary intervention (PCI) and post-PCI cardiac troponin (cTn) elevations in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). Furthermore, the relationship between these findings and the adverse cardiac events during follow-up was assessed. Association between post-PCI cTn elevations and OCT findings in NSTE-ACS patients is unclear. We evaluated 167 patients with stable or falling cTn values after admission who underwent PCI. Periprocedural myocardial injury (PMI) was defined as an cTn increase of more than 70× upper limit of normal (ULN) in troponin-negative patients before PCI, or more than new 70× ULN elevation from the previous nadir level in pre-PCI troponin-positive patients. Clinical and OCT findings were compared between patients with (n = 48, 29%) and without (n = 119, 71%) PMI. PMI was associated with age, prior PCI, low estimated glomerular filtration rate (eGFR), OCT-derived thin-cap fibroatheroma (TCFA), plaque rupture, and lipid length. In multivariable analysis, TCFA (odds ratio [OR], 2.88; P = 0.011), eGFR (OR, 0.97, P = 0.003), and lipid length (OR, 1.12, P = 0.020) were independent predictors of PMI. At a median follow-up of 38 months, event-free survival was significantly worse in patients with PMI (log-rank test χ2 = 6.47, P = 0.011). OCT analysis showed that PMI occurs more frequently in lesions with TCFA in NSTE-ACS patients, and may identify patients having a higher risk of adverse cardiac events during follow-up. © 2017 Wiley Periodicals, Inc.