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Major adverse cardiovascular events are frequently observed in patients undergoing major non-cardiac surgery during the peri-operative period. At this time, the possibility to predict cardiovascular events remains limited, despite the introduction of several algorithms to calculate the risk of adverse events, mainly death and major adverse cardiovascular events (MACE) based on the clinical history, risk factors (sex, age, lipid profile, serum creatinine) and non-invasive cardiac exams (electrocardiogram, echocardiogram, stress tests). The cardiac-specific biomarkers natriuretic peptides (NPs) and cardiac troponins (cTn) have been proposed as additional tools for risk prediction in the peri-operative period, particularly for the identification of myocardial injury in patients undergoing major non-cardiac surgery. The prognostic information from the measurement of BNP/NT-proBNP and hs-cTn is independent and complementary to other important indicators of risk, also including ECG and imaging techniques. Elevated levels of cardiac-specific biomarkers before surgery are associated with a markedly higher risk of MACE during the peri-operative period. BNP/NT-proBNP and hs-cTn should be measured in all patients during the clinical evaluation before surgery, particularly during intermediate- or high-risk surgery, in patients aged >65 years and/or with comorbidities. Several questions remain to be assessed in dedicated clinical studies, such as how to optimize the management of patients with raised cardiac specific biomarkers before surgery, and whether a strategy based on biomarker measurement improves patient outcomes and is cost-effective.

Insuline-Naaïve type 2 diabetic patients: a multidimensional evaluation on the role of glycated albumin Introduction: glycated Albumin (GA) is an innovative glycemic marker, that could be used in the clinical practice, as an add-on strategy, to the traditional glycemic monitoring systems, such as glycated haemoglobin (Hb1Ac) and fasting plasma glucose (FPG). The study aims at presenting the results of a multidimensional analysis conducted in Italy, exploring the main clinical, economic, ethical, social and organizational implications, related to the introduction of GA. Methods: an Health Technology Assessment (HTA) approach was implemented. The analysis considered the Italian National Healthcare Service (NHS) perspective, and assumed a 12-month time horizon, focusing on type 2 diabetes patients insulin-naïve, assuming oral therapy. The 9 HTA dimensions (derived from the Core Model developed by the European Network of HTA – EUnetHTA) were deployed, considering scientific evidence, health economics tools and qualitative approaches, through the administration of specific questionnaires to 15 diabetes experts. Results: literature reported better GA safety and efficacy profiles, thus being a predictor of the relative risk for diabetes complications development, and increasing the therapeutic success after 3 months of therapy (97.0% versus 71.6%). From an economic point of view, GA introduction resulted in an economic advantage of 1.06% and in a better tradeoff between costs sustained and efficacy gained. Considering a 7-item Likert Scale (ranging from -3 to +3), negative perceptions emerged with regard to equity aspects (0.13 versus 0.72) due to GA limited accessibility, whereas it would improve both patients (2.17 versus 1.33) and care givers (1.50 versus 0.83) quality of life. In the short term, GA required training courses and equipment update, whereas, in the long term, it could be considered the preferable solution from an organizational perspective (0.30 Conclusions: the results of this study demonstrated GA strategic relevance, its economic sustainability and feasibility, versus 0.01). as well as the potential clinical pathway improvement.

The issue of the appropriateness in laboratory medicine has been discussed from several years in association to the parallel onset of two aspects: 1) the significant increase in tests demand and utilization, thanks to the development of laboratory automation and information laboratory systems (LIS), that allow to provide timely and reliable results to clinicians; 2) the opportunity, thanks to new pathophysiological knowledge and new technologies to introduce new and more sophisticated tests in clinical practice, providing a relevant support to the clinician in the management of patients, according to the improved vision of personalized medicine. As a consequence, the potential inappropriateness in test utilization and the need to manage demand and to reduce the redundant testing have received increasing concern. Several papers, in the recent literature, demonstrated that the inappropriateness in laboratory test utilization may represent a potential source of errors, and interesting strategies have been proposed and progressively adopted in order to limit this problematic outcome. An essential issue is to assure appropriateness not only in test request, but in all steps of the testing cycle. In particular, some of the more relevant issues has been linked to: rationalization of laboratory test ordering prescription, thanks to development of a computerized clinical decision support systems; implementation of the reflexing tests rule; definition of the minimum retesting interval according to the clinical and pathophysiological criteria; timely revision of the available panel tests in order to delete those considered obsolete from clinical and analytical point-of-view and, finally, improving the education in demand management. The “clinical laboratory stewardship” seems to be the new and shared strategy, that guarantees not only the appropriate utilization and interpretation of laboratory tests improving efficacy and providing efficiency but, more importantly, the future of the discipline and the role of laboratory professionals in the context of new and more complicated clinical and economical scenarios.

Current guidelines worldwide recommend cardiac troponins I (cTnI) and T (cTnT) as the biomarkers of choice for the differential diagnosis of acute coronary syndrome (ACS), and the measurement of the 99th upper reference population limit (URL) value for cardiac troponins, with an imprecision of ≤10 CV%. Measuring the 99th URL of cTnI and cTnT is a challenging analytical task due to low biomarker concentrations present in healthy subjects. Therefore, since the year 2006, several manufacturers have established new generation cTnI and cTnT immunoassays with an improved analytical sensitivity in accordance with the quality specifications described in international guidelines, the more recent of which state that only immunoassays that meet the required quality specifications should be considered "high-sensitivity" methods. For the early diagnosis of ACS, and for the stratification of cardiovascular risk in cardiac patients and the general population, high-sensitivity methods should be employed. It is therefore important for laboratory professionals and clinicians to gain a thorough understanding of the analytical performances of immunoassay methods for cTnI and cTnT, especially at low to normal concentration ranges. The aim of the present study was to analyze critical aspects related to definition, analytical performance, pathophysiological interpretations, and the clinical relevance of high-sensitivity cardiac troponin assays.

Dyslipidemias represent a major contributor to cardiovascular risk in Western countries, including Italy, that can be modified. After examining familial dyslipidemias and describing the essential issues for clinical and laboratory diagnostics, the paper considers the laboratory testing in detail. The preanalytical sources of variability (biological, sample collection and handling) are reviewed and essential indications to reduce them are given. About the analytical variability, the paper examines the methods routinely used for measuring the basic lipid parameters (total, LDL and HDL cholesterol, triglycerides and apolipoproteins A-I and B) and describes the state of art of the standardization of these analytes. The last section of the document deals with the reporting of laboratory results. The main indications of the document are the following: A) report the desirable values established by the European guidelines besides the measured concentrations; b) make always clear that the reported values are decisional cut points and not reference limits; c) add a note stating that the reported desirable values refer to individuals at low risk; d) report as critical values lipid concentrations deserving rapid clinical attention, i.e., total cholesterol, [8,00 mmol/L (310 mg/dL); LDL cholesterol, [4,90 mmol/L (190 mg/dL); triglycerides, [10,0 mmol/L (880 mg/dL).

Introduction We studied associations of the stress hormones copeptin and cortisol with outcome and organ dysfunction after out-of-hospital cardiac arrest (OHCA). Methods Plasma was obtained after consent from next of kin in the FINNRESUSCI study conducted in 21 Finnish intensive care units (ICUs) between 2010 and 2011. We measured plasma copeptin (pmol/L) and free cortisol (nmol/L) on ICU admission (245 patients) and at 48 hours (additional 33 patients). Organ dysfunction was categorised with 24-hour Sequential Organ Failure Assessment (SOFA) scores. Twelve-month neurological outcome (available in 276 patients) was classified with cerebral performance categories (CPC) and dichotomised into good (CPC 1 or 2) or poor (CPC 3 to 5). Data are presented as medians and interquartile ranges (IQRs). A Mann–Whitney U test, multiple linear and logistic regression tests with odds ratios (ORs) 95% confidence intervals (CIs) and beta (B) values, repeated measure analysis of variance, and receiver operating characteristic curves with area under the curve (AUC) were performed. Results Patients with a poor 12-month outcome had higher levels of admission copeptin (89, IQR 41 to 193 versus 51, IQR 29 to 111 pmol/L, P = 0.0014) and cortisol (728, IQR 522 to 1,017 versus 576, IQR 355 to 850 nmol/L, P = 0.0013). Copeptin levels fell between admission and 48 hours (P P = 0.847). Cortisol levels did not change between admission and 48 hours (P = 0.313), independently of outcome (P = 0.221). The AUC for predicting long-term outcome was weak for copeptin (0.62, 95% CI 0.55 to 0.69) and cortisol (0.62, 95% CI 0.54 to 0.69). With logistic regression, admission copeptin (standard deviation (SD) increase OR 1.4, 95% CI 1.03 to 1.98) and cortisol (SD increase OR 1.5, 95% CI 1.1 to 2.0) predicted ICU mortality but not 12-month outcome. Admission factors correlating with SOFA were shockable rhythm (B −1.3, 95% CI −2.2 to −0.5), adrenaline use (B 1.1, 95% CI 0.2 to 2.0), therapeutic hypothermia (B 1.3 95% CI 0.4-2.2), and copeptin (B 0.04, 95% CI 0.02 to 0.07). Conclusions Admission copeptin and free cortisol were not of prognostic value regarding 12-month neurological outcome after OHCA. Higher admission copeptin and cortisol were associated with ICU death, and copeptin predicted subsequent organ dysfunction.

This document is issued by the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and a number of other National Scientific Societies and Associations in order to promote a coordinated plan for implementing the standardization of glycated hemoglobin (HbA1c) measurement in Italy according to the recommendations by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Changes in reporting HbA1c results, new units, how to relate old and new units, a timeline for changes and definition of the analytical goals are the main issues discussed. Clin Chem Lab Med 2010;48:623–6.