External Validation of a Novel Comprehensive Trifecta System in Predicting Oncologic and Functional Outcomes of Partial Nephrectomy: Results of a Multicentric Series.

BACKGROUND: To validate a novel trifecta for evaluating outcomes of partial nephrectomy (PN) on a multicentric dataset. METHODS: Between 2007 and 2020, three renal cancer databases were queried for patients with solitary renal masses who underwent PN (n = 649). Trifecta was estimated for overall cohort and contributing centers. Overall survival (OS), cancer-specific survival (CSS) and end-stage renal disease (ESRD) probabilities were assessed by Kaplan-Meier. Cox regression was used to identify predictors of OS, CSS, ESRD. For all analyses, a p < 0.05 was considered significant. RESULTS: At a median follow-up of 22.7 months (IQR 12.5-76.5) overall trifecta was 76.7% [Centre A; (n = 230; 68.6%), B (n = 68; 77.3%), C (n = 200; 88.4%); p = 0.001). On Kaplan-Meier, patients achieving trifecta exhibited higher OS (p = 0.024), higher CSS (p = 0.015) and lower ESRD rates (p = 0.024). On multivariable analysis, age (HR 1.04; 95% CI 1.01-1.08) and trifecta (HR 0.34; 95% CI 0.15-0.76) were independent predictors of OS while pT stage (HR 1.95; 95% CI 0.45-8.43) and trifecta (HR 0.33; 95% CI 0.16-0.67) were predictors of CSS (each p < 0.01). Preoperative CKD stage ≥ 3a (HR 13.1; 95% CI 4.07-42.6) and trifecta (HR 0.41; 95% CI 0.19-0.87) were independent predictors of ESRD (each p < 0.05). CONCLUSIONS: On external validation, trifecta was an independent predictor of all PN endpoints, regardless of hilar control and ischemia duration.

Novel Diagnostic Biomarkers of Prostate Cancer: An Update.

OBJECTIVE: In recent years, several biomarkers alternative to standard prostate specific antigen (PSA) for prostate cancer (PCa) diagnosis have become available. The aim of this systematic review is to assess the current knowledge about alternative serum and urinary biomarkers for the diagnosis of PCa. MATERIAL AND METHODS: A research was conducted in Medline, restricted to English language articles published between December 2014 and June 2018 with the aim to update previously published series on PCa biomarkers. The preferred reporting items for systematic reviews and meta-analyses (PRISMA) criteria were used for selecting studies with the lowest risk of bias. RESULTS: Emerging role and actual controversies on serum and urine alternative biomarkers to standard PSA for PCa diagnosis, staging and prognosis assessment, such as prostate health index (PHI), PCA3, ConfirmMDx, Aberrant PSA glycosylation, MiPS, miRNAs are critically presented in the current review. CONCLUSION: Although the use of several biomarkers has been recommended or questioned by different international guidelines, larger prospective randomized studies are still necessary to validate their efficacy in PCa detection, discrimination, prognosis and treatment effectiveness. To date, only PHI and 4Kscore have shown clinical relevance for discriminating more aggressive PCa. Furthermore, a new grading classification based on molecular features relevant for PCa risk-stratification and tailoring treatment is still needed.

A simplified way for the urgent treatment of somatic pain in patients admitted to the emergency room: the SUPER algorithm.

Somatic pain is one of the most frequent symptoms reported by patients presenting to the emergency department (ED), but, in spite of this, it is very often underestimated and under-treated. Moreover, pain-killers prescriptions are usually related to the medical examination, leading to a delay in its administration, thus worsening the patient's quality of life. With our study, we want to define and validate a systematic and homogeneous approach to analgesic drugs administration, testing a new therapeutic algorithm in terms of earliness, safety, and efficacy. 442 consecutive patients who accessed our ED for any kind of somatic pain were enrolled, and then randomly divided into two groups: group A follow the normal process of access to pain-control drugs, and group B follow our SUPER algorithm for early administration of drugs to relieve pain directly from triage. We excluded from the study, patients with abdominal pain referred to the surgeon, patients with headache, recent history of trauma, history of drug allergies, and life-threatening conditions or lack of cooperation. Drugs used in the study were those available in our ED, such as paracetamol, paracetamol/codeine, ketorolac-tromethamine, and tramadol-hydrochloride. Pain level, risk factors, indication, and contraindication of each drug were taken into account in our SUPER algorithm for a rapid and safe administration of it. The Verbal Numeric Scale (VNS) and the Visual Analog Scale (VAS) were used to verify the patient's health and perception of it. Only 59 patient from group A (27.1 %) received analgesic therapy (at the time of the medical examination) compared to 181 patients (100 %) of group B (p < 0.001). Group B patients, received analgesic therapy 76 min before group A subjects (p < 0.01), resulting in a significant lower VNS (7.31 ± 1.68 vs 4.75 ± 2.3; p < 0.001), and a superior VAS after discharge (54.43 ± 22.16 vs 61.30 ± 19.13; p < 0.001) compared to group A subjects. No significant differences concerning side effects were observed between group A and group B patients. Early administration of a pain-control therapy directly from triage is safe and effective, and significantly improves patients perceptions of their own health.

Prevalence of virulent Helicobacter pylori strains in patients affected by idiopathic dysrhythmias.

Helicobacter pylori virulent strains have been shown to affect cardiovascular diseases through molecular mimicry mechanisms. Silent autoimmune myocarditis has been hypothesized to be the cause of idiopathic dysrhythmias (IA). The aim of this study is to assess the prevalence of virulent H. pylori strains in patients affected by IA. In this study,54 patients (40 men, mean age 44 ± 17 years) affected by IA and 50 healthy subjects (34 men, mean age 45 ± 9) were evaluated. IA, defined as dysrhythmias with no evidence of other cardiac pathology, were either supraventricular (SVA, 23 patients; mean age 45 ± 15 years) or ventricular (VA, 31 patients; mean age 42 ± 18 years). H. pylori infection and gastrointestinal (GI) symptoms were evaluated. H. pylori strains expressing the cytotoxin-associated gene A (cagA) and the vacuolating-cytotoxin A (vacA) were also assessed through western blot. The prevalence of H. pylori is similar in IA patients and in controls (42 vs. 44%; p > 0.05); H. pylori infection is observed in 48 and 39% of the patients are affected by SVA and VA, respectively. The prevalence of CagA-positive strains is increased in IA patients compared to controls (65 vs. 42%; p < 0.01); similarly, the prevalence of VacA-positive strains is also increased in IA patients (74 vs. 46%; p < 0.006). Excluding belching, infected patients did not show any difference in GI symptoms, when compared to non-infected subjects. From this study it is concluded that there is an epidemiological link between CagA and VacA-positive H. pylori strains in IA patients.

Comparison of diagnostic accuracy between three different rules of interpreting high sensitivity troponin T results.

With the introduction of high sensitivity troponin-T (hs-TnT) assay, clinicians face more patients with 'positive' results but without myocardial infarction. Repeated hs-TnT determinations are warranted to improve specificity. The aim of this study was to compare diagnostic accuracy of three different interpretation rules for two hs-TnT results taken 6 h apart. After adjusting for clinical differences, hs-TnT results were recoded according to the three rules. Rule1: hs-TnT >13 ng/L in at least one determination. Rule2: change of >20 % between the two measures. Rule3: change >50 % if baseline hs-TnT 14-53 ng/L and >20 % if baseline >54 ng/L. The sensitivity, specificity and ROC curves were compared. The sensitivity analysis was used to generate post-test probability for any test result. Primary outcome was the evidence of coronary critical stenosis (CCS) on coronary angiography in patients with high-risk chest pain. 183 patients were analyzed (38.3 %) among all patients presenting with chest pain during the study period. CCS was found in 80 (43.7 %) cases. The specificity was 0.62 (0.52-0.71), 0.76 (0.66-0.84) and 0.83 (0.74-0.89) for rules 1, 2 and 3, respectively (P < 0.01). Sensitivity decreased with increasing specificity (P < 0.01). Overall diagnostic accuracy did not differ among the three rules (AUC curves difference P = 0.12). Sensitivity analysis showed a 25 % relative gain in predicting CCS using rule 3 compared to rule 1. Changes between two determinations of hs-TnT 6 h apart effectively improved specificity for CCS presence in high-risk chest pain patients. There was a parallel loss in sensitivity that discouraged any use of such changes as a unique way to interpret the new hs-TnT results.

Efficacy and safety of vernakalant in recent-onset atrial fibrillation after the European medicines agency approval: systematic review and meta-analysis.

Vernakalant is an emergent antiarrhythmic drug that, in preclinical studies, has demonstrated high efficacy in restoring sinus rhythm and safety in patients with rapid recent-onset atrial fibrillation. The aim of this work was to evaluate the efficacy and safety of vernakalant for cardioversion of recent-onset atrial fibrillation. PubMed, EMBASE, Clinical Trials Registry, and European Medicines Agency public reports were searched for randomized clinical trials, until May 2011, of vernakalant compared with controls (placebo/other antiarrhythmic drug) in enrolled patients with high ventricular rate atrial fibrillation. Five randomized trials that met inclusion criteria enrolled a total of 1099 patients. Among these, 810 had recent-onset atrial fibrillation. When compared with controls (placebo/other oral antiarrhythmic drugs), vernakalant was associated with a significant increase in cardioversion within 90 minutes from drug infusion (relative risk, 8.4; 95% confidence interval, 4.4-16.3; P < .00001). Compared with controls, vernakalant was not associated with a significant difference in serious adverse events (relative risk, 0.9; 95% confidence interval, 0.6-1.4; P = .64). The authors conclude that compared with controls, vernakalant is effective and safe for rapidly converting recent-onset atrial fibrillation. Questions remain surrounding safety because 1 unpublished trial was discontinued for this reason. Further cost-effective analysis and comparison with other antiarrhythmic agents, such as class I antiarrhythmic agents, should be investigated, especially in the emergency department.

Utility of routine thyroid-stimulating hormone determination in new-onset atrial fibrillation in the ED.

INTRODUCTION: Hyperthyroidism is a relative uncommon but important cause of atrial fibrillation. The aim of this study was to investigate the utility of routine thyroid-stimulating hormone (TSH) determination in the emergency department (ED) in patients presenting to the ED with stable, new-onset atrial fibrillation. We derive a set of clinical criteria in which TSH is likely to be normal and therefore thyroid function evaluation deferrable to a different time from ED visit. METHODS: Cross-sectional observational study in a university hospital. Thyroid-stimulating hormone was measured in all patients admitted to the ED observational unit for new-onset atrial fibrillation in a 30 consecutive months' period. Patients' clinical characteristics and treatment received in the ED were recorded. Recursive partitioning analysis technique was used to determine which predictors were associated with a TSH level less than 0.35 µIU/mL. RESULTS: Of 433 patients enrolled, 47 (10.8%) had a low TSH. Thyroid-stimulating hormone highly correlated with FT3 and FT4 levels (P < .001) confirming its good predictive value as screening tool. Recursive partitioning analysis showed that previous thyroid disease (P < .01), stroke/transient ischemic attack (P < .01), and hypertension (P = .10) were associated with low TSH. The final model had sensitivity of 93% and specificity of 31%, corresponding to a negative likelihood ratio of 0.02 (0.01-0.07). CONCLUSION: Hyperthyroidism is present in nearly 10% of new-onset atrial fibrillation. Although thyroid function screening is recommended in all patients, a simple model that included previous thyroid disease, stroke, and hypertension might help to identify those patients at high risk (low TSH) in the ED.

Predictive value of NT-proBNP for cardioversion in a new onset atrial fibrillation.

OBJECTIVE: To detect the clinical use of N-terminal pro B-type natriuretic peptide (NT-proBNP) values for predicting cardioversion in a new onset atrial fibrillation (AF) in the emergency department. METHODS: NT-proBNP was measured in 200 patients admitted to the emergency department, in the observational unit with primary diagnosis of a new onset AF (<2 weeks). Cohort was divided into rate-control and rhythm-control groups according to the strategy used by the admitting physician. Patients treated with electric cardioversion were excluded. Primary endpoint was conversion to sinus rhythm during hospital admission. RESULTS: In rhythm and rate controls, NT-proBNP was lower in patients who restored sinus rhythm (P<0.001). Same result was observed even when logistic regression was used to adjust for differences at baseline clinical characteristics. NT-proBNP of less than 450 pg/ml was associated with cardioversion in both the groups (likelihood ratio of 0.19 for rate control, and 0.27 for rhythm control) whereas a value of more than 1800 pg/ml was associated with persistent AF at discharge (likelihood ratio of 2.02 and 2.01, respectively). CONCLUSION: In the acute setting of a new onset AF, NT-proBNP seems to predict cardioversion in rate-control and rhythm-control strategies when it is less than 450 pg/ml or more than 1800 pg/ml. In this ranges of values it might help to allocate resources and plan for patient admission and further management. There is a grey area (450-1800 pg/ml) in which NT-proBNP did not seem to be clinically useful.