[ANMCO/SIC/SIT Consensus document: The future of telemedicine in heart failure]. / Documento di consenso ANMCO/SIC/SIT: Il futuro della telemedicina nello scompenso cardiaco.

Telemedicine applied to heart failure patients is a tool for recording, remote transmission, storage and interpretation of cardiocirculatory parameters and/or diagnostic images, useful, as emphasized by the latest guidelines, to allow for intensive home monitoring in patients with advanced heart failure or during the vulnerable post-acute phase to improve the prognosis and quality of life for patients.Recently, several meta-analyses have shown that the patterns of care supported by telemedicine are not only effective, but also economically advantageous. The benefit is unquestionable with a 30-35% reduction in mortality and a 15-20% reduction in hospitalizations. Patients implanted with cardiac devices can also benefit from an integrated remote clinical management as all modern devices can transmit technical and diagnostic data. However, telemedicine can bring benefits to the patient with heart failure only if it is part of a shared and integrated, multidisciplinary and multiprofessional "Chronic Care Model". Moreover, the future development of remote telemonitoring programs in our country goes through the primary use of products certified as medical device, field validation of organizational solutions proposed, a legislative and administrative adaptation to new care methods and the widespread growth of competence in clinical care to remotely manage the complexity of chronicity.With this consensus document the Italian Cardiology reaffirms its willingness to contribute to the government of the tumultuous and fragmented technological development, proposing a new phase of qualitative assessment, standardization of processes and testing the application of telemedicine to heart failure.

Medical error and systems of signaling: conceptual and linguistic definition.

In recent years the issue of patient safety has been the subject of detailed investigations, particularly as a result of the increasing attention from the patients and the public on the problem of medical error. The purpose of this work is firstly to define the classification of medical errors, which are distinguished between two perspectives: those that are personal, and those that are caused by the system. Furthermore we will briefly review some of the main methods used by healthcare organizations to identify and analyze errors. During this discussion it has been determined that, in order to constitute a practical, coordinated and shared action to counteract the error, it is necessary to promote an analysis that considers all elements (human, technological and organizational) that contribute to the occurrence of a critical event. Therefore, it is essential to create a culture of constructive confrontation that encourages an open and non-punitive debate about the causes that led to error. In conclusion we have thus underlined that in health it is essential to affirm a system discussion that considers the error as a learning source, and as a result of the interaction between the individual and the organization. In this way, one should encourage a non-guilt bearing discussion on evident errors and on those which are not immediately identifiable, in order to create the conditions that recognize and corrects the error even before it produces negative consequences.

Prospectively electrocardiogram-triggered high-pitch spiral acquisition coronary computed tomography angiography for assessment of biodegradable vascular scaffold expansion: comparison with optical coherence tomography.

BVS polymeric struts are transparent to the light so that the vessel wall contour can be easily visualized using optical coherence tomography (OCT). Therefore OCT represents a unique tool for both the evaluation of the resorption process and for the assessment of acute BVS mechanical failure. Similarly, the metal-free struts allow unrestricted coronary computed tomography angiography (CCTA), thus this non invasive method might become the gold standard for a non invasive assessment of BVS. In this case we show the ability of CCTA, performed with a low X-Ray dose, to provide a good evaluation of scaffold expansion. The quantitative measurements were in agreement with those obtained with OCT.

Acute insulin resistance assessed by the homeostatic model assessment in acute coronary syndromes without previously known diabetes.

We assessed the incidence and the prognostic role for early death of acute insulin resistance (by means of homeostatic model assessment [HOMA] index) in 1350 patients with acute coronary syndrome (ACS) consecutively admitted to our intensive cardiac care unit (ICCU). The incidence of HOMA positivity was 5% (68 of 1350), with the highest percentage of HOMA positivity among ST-segment elevation myocardial infarction (STEMI). Patients with HOMA positivity showed a higher body mass index (P = .003), lower values of admission and discharge left-ventricular ejection fraction (LVEF; P < .001 and P = .003, respectively), and higher levels of peak troponin I (Tn I; P < .001). The HOMA index was an independent predictor of early death (odds ratio 1.724, 95% confidence interval 1.252-2.375, P = .001). In patients with ACS and without previously known diabetes, acute insulin resistance (HOMA index) is associated with a larger myocardial damage (ie, higher values of peak Tn I and lower LVEF) and a greater inflammatory activation (indicated by correlation with leukocyte count). The HOMA positivity was an independent predictor of in-ICCU mortality.

EXCAVATOR: detecting copy number variants from whole-exome sequencing data.

We developed a novel software tool, EXCAVATOR, for the detection of copy number variants (CNVs) from whole-exome sequencing data. EXCAVATOR combines a three-step normalization procedure with a novel heterogeneous hidden Markov model algorithm and a calling method that classifies genomic regions into five copy number states. We validate EXCAVATOR on three datasets and compare the results with three other methods. These analyses show that EXCAVATOR outperforms the other methods and is therefore a valuable tool for the investigation of CNVs in largescale projects, as well as in clinical research and diagnostics. EXCAVATOR is freely available at http://sourceforge.net/projects/excavatortool/.

Identification of change-points in the relationship between food groups in the Mediterranean diet and overall mortality: an 'a posteriori' approach.

BACKGROUND: Adherence to Mediterranean diet has been shown to be associated with a better health and greater survival. The aim of the present study was to identify change-points in the relationship between food groups composing Mediterranean diet and overall mortality. METHODS: The population of the Greek EPIC prospective cohort study (23,349 adult men and women in the Greek EPIC sample who had not previously been diagnosed as having cancer, coronary heart disease or diabetes mellitus at enrolment) was analysed. Segmented logistic regression analysis was conducted to examine the association between each of the food groups contributing to the Mediterranean diet score and overall mortality. RESULTS: This analysis allowed the determination of the following change-points: among men: 1 change-point for vegetables, legumes, cereals, fish and seafood and dairy products and 2 change-points for fruit and nuts, meat and meat products and ethanol; among women: 1 change-point for legumes and fish and seafood and 2 change-points for the remaining food groups. These cut-off points were used to construct an 'a posteriori' score that may be better in capturing the health-promoting potential of the traditional Mediterranean diet. CONCLUSION: Identification of change-points in the relationship between components of the Mediterranean diet and mortality can be used to increase the discriminatory ability of a widely used Mediterranean diet score in relation to mortality.

Intraaortic balloon pump: incidence and predictors of complications in the Florence registry.

BACKGROUND: The intraaortic balloon pump (IABP) is the most commonly used mechanical circulatory support for patients with acute coronary syndromes and cardiogenic shock. Nevertheless, IABP-related complications are still frequent and associated with a poor prognosis. HYPOTHESIS: To prospectively assess the incidence and predictors of complications in patients treated with IABP. METHODS: A total of 481 patients treated with IABP were prospectively enrolled in our registry (the Florence Registry). At multivariable logistic regression analysis the following variables were independent predictors for complications (when adjusted for age >75 years, eGFR and time length of IABP support): use of inotropes (OR 2.450, P < 0.017), nadir platelet count (1000/µL step; OR 0.990, P < 0.001), admission lactate (OR 1.175, P = 0.003). Nadir platelet count showed a negative correlation with length of time of IABP implantation (r-0.31; P < 0.001). A nadir platelet count cutoff value of less than 120,000 was identified using a receiver operating characteristic (ROC) curve for the development of complications (area under the curve [AUC] 0.70; P < 0.001). RESULTS: Complications were observed in the 13.1%, among whom 33 of 63 showed major bleeding. The incidence of complications was higher in patients aged >75 years (P = 0.015) and in those who had an IABP implanted for more than 24 hours (P = 0.001). Patients with complications showed an in Intensive Cardiac Care Unit (ICCU) mortality higher than patients who did not (44.4% vs 17.2%, P < 0.001). CONCLUSIONS: In consecutive patients treated with IABP support, the degree of hemodynamic impairment and the decrease in platelet count were independent predictors of complications, whose development was associated with higher in-ICCU mortality.

Cost and cost-effectiveness of cardiac surgery in elderly patients.

OBJECTIVE: Cost-effectiveness of heart surgery for elderly patients is still poorly defined. We evaluated outcome, quality of life (QoL), cost, and cost-effectiveness of octogenarians undergoing cardiac surgery. METHODS: One thousand six hundred forty octogenarians undergoing various cardiac surgical procedures were prospectively studied between January 1998 and January 2009 and compared with similar patients aged 70 to 79 years. Several questionnaires were used to assess QoL. Six hundred age- and sex- matched healthy octogenarians and three hundred forty patients older than 80 years with medically treated valvular or coronary artery disease were healthy and unoperated control groups, respectively. In-hospital costs were obtained from the hospital's financial accounting department and cost-effectiveness was estimated and expressed as cost/QoL-adjusted life year (QALY) and cost-effectiveness ratio. RESULTS: Significant improvements occurred in elderly patients in Role Physical (P < .001), Bodily Pain (P < .001), General Health (P = .004), Social Functioning (P < .001), and Role Emotional (P < .001), whereas Physical Functioning, Vitality, and Mental Health did not change (difference not signficant). Total direct costs were $5293 higher in the octogenarian group. Cost-effectiveness was $1391/QALY for elderly surgical patients, $516/QALY for younger cardiac surgical patients (P < .001 vs elderly), $897/QALY for untreated control group, and $641/QALY for healthy control group (P < .001 vs elderly surgical patients). The cost-effectiveness ratio for octogenarians was $94,426. CONCLUSIONS: Our findings confirm that cardiac surgery in elderly patients remains controversial from a cost-effectiveness standpoint, making econometric analysis an important component for any future evaluation of novel cardiovascular therapies. Our findings need to be confirmed by additional multicenter studies.

Assessment of a continuous blood gas monitoring system in animals during circulatory stress.

BACKGROUND: The study was aimed to determine the measurement accuracy of The CDI™ blood parameter monitoring system 500 (Terumo Cardiovascular Systems Corporation, Ann Arbor MI) in the real-time continuous measurement of arterial blood gases under different cardiocirculatory stress conditions METHODS: Inotropic stimulation (Dobutamine 2.5 and 5 µg/kg/min), vasoconstriction (Arginine-vasopressin 4, 8 and 16 IU/h), hemorrhage (-10%, -20%, -35%, and -50% of the theoretical volemia), and volume resuscitation were induced in ten swine (57.4 ± 10.7 Kg).Intermittent blood gas assessments were carried out using a routine gas analyzer at any experimental phase and compared with values obtained at the same time settings during continuous monitoring with CDI™ 500 system. The Bland-Altman analysis was employed. RESULTS: Bias and precision for pO2 were - 0.06 kPa and 0.22 kPa, respectively (r2 = 0.96); pCO2 - 0.02 kPa and 0.15 kPa, respectively; pH -0.001 and 0.01 units, respectively ( r2 = 0.96). The analysis showed very good agreement for SO2 (bias 0.04,precision 0.33, r2 = 0.95), Base excess (bias 0.04,precision 0.28, r2 = 0.98), HCO3 (bias 0.05,precision 0.62, r2 = 0.92),hemoglobin (bias 0.02,precision 0.23, r2 = 0.96) and K+ (bias 0.02, precision 0.27, r2 = 0.93). The sensor was reliable throughout the experiment during hemodynamic variations. CONCLUSIONS: Continuous blood gas analysis with the CDI™ 500 system was reliable and it might represent a new useful tool to accurately and timely monitor gas exchange in critically ill patients. Nonetheless, our findings need to be confirmed by larger studies to prove its reliability in the clinical setting.

Atrial fibrillation after cardiac surgery: incidence, risk factors, and economic burden.

OBJECTIVE: To evaluate the incidence of postoperative atrial fibrillation (POAF), the predisposing factors, the results of treatment before discharge, and the impact on duration and costs of hospitalization. DESIGN: A prospective observational study. METHODS: Patients who underwent cardiac surgery from January 1, 2007 to December 31, 2007. INTERVENTIONS: Electrocardiography was continuously monitored after surgery. Patients with symptomatic new-onset atrial fibrillation or lasting >15 minutes were treated with amiodarone and with DC shock in prolonged cases. RESULTS: POAF occurred in 29.7%, with the higher incidence between the 1st and 4th postoperative day. Age (p < 0.001), atrial size >40 mm (p < 0.001), previous episodes of AF (p < 0.001), female sex (p = 0.010), and combined valve and bypass surgery (p = 0.012) were multivariate predictors of POAF at logistic regression. Sinus rhythm was restored by early treatment in 205 of 215 patients. This was associated with a low incidence of cerebrovascular events (<0.5%) and with a limited increase of average length of hospitalization (24 hours) in patients with POAF. CONCLUSIONS: The overall incidence of POAF in the authors' center is close to 30%; 95.3% of patients were discharged in sinus rhythm. The increase in length and costs of hospitalization (on average, 1.0 day with a burden of about €1,800/patient) were significantly lower than in previous investigations.

Preoperative cardiac assessment in patients undergoing aortic surgery: analysis of factors affecting the cardiac outcomes.

BACKGROUND: The purpose of this study was to evaluate the effectiveness of a standardized preoperative cardiac assessment in reducing the rate of perioperative cardiac complications in patients undergoing aortic surgery, paying particular attention to the analysis of the factors affecting perioperative cardiac outcomes. METHODS: Between January 2005 and August 2008, a total of 531 elective interventions for abdominal aortic aneurysms were performed at our institution. All patients underwent preoperative evaluation on an outpatient basis, which included a standardized cardiac assessment protocol to evaluate perioperative cardiac risk. A surgical (open or endovascular) intervention was performed in all patients and perioperative (<30 days) results in terms of overall and cardiac mortality and morbidity rates were recorded. RESULTS: Preoperative electrocardiogram, transthoracic echocardiography, and cardiology consultation were performed in all patients. In 348 cases (65.5%), further evaluation of cardiac functional capacity with noninvasive stress testing was recommended. A positive noninvasive stress test was noted in 86 (24.7%) of 348 patients and coronary angiography was performed in 34 (39.5%) of 86 patients. Thirteen of these patients underwent successful coronary revascularization (11 percutaneous transluminal coronary angioplasty, two coronary artery bypass graft) before vascular surgery. Thirty-day overall rate and cardiac mortality rate were 1.1% and 0.6%, respectively, and 30-day overall and cardiac morbidity rates were 11.5% and 6.8%, respectively. Univariate analysis demonstrated that in patients aged >80 years, chronic renal failure, congestive heart failure, valvular heart disease, positive noninvasive stress testing, and open surgical treatment significantly affected 30-day cardiac morbidity; however, only valvular heart disease and positive noninvasive stress testing maintained their significance with multivariate analysis (p = 0.005; 95% CI, 1.6-14.4; and p = 0.02; 95% CI, 1.2-8.1, respectively). None of the examined factors significantly affected 30-day cardiac mortality. CONCLUSION: In our experience, the use of a routine preoperative cardiac assessment allowed us to obtain satisfactory perioperative results in patients undergoing abdominal aortic surgery. Very few patients, however, require cardiac revascularization before abdominal aortic surgery. Patients with positive stress test may benefit from an endovascular treatment if anatomically feasible.

A new post-PCI scoring system for in-hospital mortality in STEMI patients.

OBJECTIVE: To develop a scoring system for predicting in-hospital mortality among ST-elevation myocardial infarction (STEMI) patients submitted to percutaneous intervention (PCI) on intensive cardiac care unit admission by using early and readily available clinical, angiographic and laboratory data. DESIGN: Prospective monocentric observational study in which we used discriminant analysis to develop a final scoring system, with prospective validation. SETTING: Intensive cardiac care unit in Florence, a tertiary center. POPULATION: Five hundred and fifty-eight unselected patients with STEMI (group A) consecutively admitted from 1 January 2004 to 31 December 2006. A control group (group B) comprising 183 STEMI patients admitted from 1 January 2007 to 30 September 2007. MAIN OUTCOMES AND MEASURES: In-hospital death. RESULTS: In group A the discriminant variables were admission Killip class, admission lactic acid, admission ejection fraction, admission troponin I (TnI), admission hemoglobin (Hb), ST-segment reduction post-PCI, systolic blood pressure on admission and chronic renal failure. We elaborated a scoring system, the Florence admission STEMI risk score, which shows an agreement of 95.7% between the observed and the estimated outcome on a statistical basis in the survival and death subgroups. We applied this score to group B (C statistics = 0.986). CONCLUSION: The Florence admission STEMI risk score incorporates anamnestic (chronic renal failure), laboratory (lactic acid, TnI and Hb), procedural and post-procedural data (ST-segment reduction post-PCI, Killip class) as well as data strictly related to infarct size (ejection fraction, TnI). This scoring system is likely to be a simple and practical tool at the bedside for risk evaluation in patients with STEMI submitted to primary PCI.

[Dealing with error in cardiology]. / L'errore in cardiologia.

A commonly used definition describes an error as a harmful or potentially harmful occurrence for the patient. Although over the last years the evolution of medicine has been characterized by remarkable technological advances, the percentage of errors in clinical practice has not changed since the '40s. In this setting, the aim of our review is to assess how errors develop in real life in modern cardiology and how they can be identified early, corrected, and possibly prevented. In our opinion, the more a healthcare system (i.e., a cardiology ward or a hospital) is capable of facing its error, the safer it is. In our daily practice, errors can be distinguished in "clinical errors" (mainly related to knowledge) and "system errors" (mainly referring to healthcare organization; i.e., the integrated cardiac network). Bearing in mind the high frequency and consequences, cardiologists should consider errors as among the main determinants of quality of care, which the whole team has to deal with. Time and resources should be spent to identify the best approaches to cope with errors, tailored for each cardiology team. Ultimately, the care of a patient with heart disease should be viewed holistically and not as the afinalistic sum of procedures, no matter how technically developed.

Prognostic role of insulin resistance as assessed by homeostatic model assessment index in the acute phase of myocardial infarction in nondiabetic patients submitted to percutaneous coronary intervention.

BACKGROUND AND OBJECTIVES: Little information is available on the relation between insulin resistance and acute myocardial infarction. METHODS: In 253 consecutive nondiabetic patients with ST elevation myocardial infarction (STEMI) submitted to percutaneous coronary intervention, we assessed the prevalence of insulin resistance by homeostatic model assessment (HOMA) index and its prognostic role in early and late mortality. RESULTS: Insulin resistance was detectable in 52.9% of patients. Anterior STEMI was more frequent in insulin-resistant patients (P = 0.040), who showed higher values of probrain natriuretic peptide (P = 0.010), creatinine (P < 0.001), creatinine phosphokinase and creatinine phosphokinase-MB (MB, isoenzyme present in the myocardium; P = 0.016 and P = 0.003, respectively). At backward stepwise logistic regression analysis, the following variables were independent predictors for intra-intensive cardiac care unit mortality: HOMA index [hazard ratio 1.40; 95% confidence interval (CI) 1.02-1.95; P = 0.049]; C-peptide (hazard ratio 3.14; 95% CI 1.40-24.80; P = 0.001) and lactic acid (hazard ratio 2.50; 95% CI 1.41-4.44; P = 0.002). At long-term follow-up (Cox regression analysis), neither fasting glycaemia nor HOMA index resulted in predictors for mortality. CONCLUSION: In nondiabetic STEMI patients submitted to percutaneous coronary intervention, insulin resistance, as assessed by HOMA index, is quite common and helps in the early prognostic stratification, as it represents an independent predictor of in-hospital mortality.

Stroke risk in atrial fibrillation patients on warfarin. Predictive ability of risk stratification schemes for primary and secondary prevention.

Atrial fibrillation (AF) patients are widely heterogeneous in terms of ischaemic stroke risk, and several risk stratification schemes have been developed. We performed a prospective study on 662 AF patients on long-term oral anticoagulant therapy (OAT), evaluating the agreement among the different schemes and their correlation with adverse events recorded during follow-up. Patients at low risk were similarly distributed among the different models. Instead, patients classed at moderate risk were 49.2% by CHADS(2) score, 27.6% by NICE and 2.3% by ACCP. As a consequence patients classed at high risk were 46.1% by CHADS(2), 69.8% by NICE and 95.3% by ACCP. CHADS(2 )and NICE scores were associated to the best predictive accuracy. A separate analysis was performed for patients on treatment for secondary prevention, and we observed that they were included in high risk groups by all models, except for 14 patients (6.3%) classed at moderate risk by CHADS(2) even though these patients are at very high risk and the use of aspirin could be unsafe for them. During follow-up 32 major bleeding (1.35 per 100 patient/years) and 39 thrombotic events (1.64 per 100 patient/years) were observed. Among patients on OAT for secondary prevention, both bleeding and thrombotic events mostly occurred in high-risk patients. Even if the absolute rate of adverse events is low, this finding seems to confirm the high stroke risk of this group of patients. For patients on secondary prevention there is no need for further stratification and warfarin should be the treatment of choice.