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Background Pharmacological therapies of proven efficacy in coronavirus disease 2019 (COVID-19) are still lacking. We have identified IFNβ-1a as the most promising drug to be repurposed for COVID-19. The rationale relies on the evidence of IFNβ anti-viral activity in vitro against SARS-CoV-2 and animal models resembling SARS-CoV-2 infection and on a recent clinical trial where IFNβ was indicated as the key component of a successful therapeutic combination. Methods This is a randomized, controlled, open-label, monocentric, phase II trial (INTERCOP trial). One hundred twenty-six patients with positive swab detection of SARS-CoV-2, radiological signs of pneumonia, and mild-to-moderate disease will be randomized 2:1 to IFNβ-1a in addition to standard of care vs standard of care alone. No other anti-viral drugs will be used as part of the regimens, both in the control and the intervention arms. IFNβ-1a will be administered subcutaneously at the dose of 44 mcg (equivalent to 12 million international units) three times per week, at least 48 h apart, for a total of 2 weeks. The primary outcome is the time to negative conversion of SARS-CoV-2 nasopharyngeal swabs. Secondary outcomes include improvement or worsening in a clinical severity score measured on a 7-point ordinal scale (including transfer to intensive care unit and death), oxygen- and ventilator-free days, mortality, changes in pulmonary computed tomography severity score, hospital stay duration, reduction of viral load measured on nasopharyngeal swabs, number of serious adverse events, and changes in biochemical markers of organ dysfunction. Exploratory outcomes include blood cell counts, cytokine and inflammatory profile, peripheral mRNA expression profiles of interferon-stimulated genes, and antibodies to SARS-CoV-2 and to IFNβ-1a. INTERCOP is the first study to specifically investigate the clinical benefits of IFNβ-1a in COVID-19 patients. Discussion Potential implications of this trial are multifaceted: should the primary outcome be fulfilled and the treatment be safe, one may envisage that IFNβ-1a be used to reduce the infectivity of patients with mild-to moderate disease. In case IFNβ-1a reduced the duration of hospital stay and/or ameliorated the clinical status, it may become a cornerstone of COVID-19 treatment. Trial registration EudraCT 2020-002458-25. Registered on May 11, 2020 ClinicalTrials.gov Identifier: NCT04449380

BACKGROUND Most models for outcome prediction in heart failure are under-utilized because complex or including non-routine clinical use variables. We aimed to develop a prognostic score for patients with stable heart failure, including only easily obtainable parameters. METHODS In 376 outpatients with heart failure (ejection fraction ≤40%), twelve variables were individually correlated with 5-year mortality. Those resulted significant predictors of cardiac and overall mortality were used to obtain a risk score. It was validated on a different sample of 325 patients previously enrolled in other clinical studies, according to tertiles of score. RESULTS Previous acute decompensated heart failure, atrial fibrillation, ejection fraction

The prospective evidence for the associations of gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) with risk of cancer in the general population is uncertain. We conducted a systematic review and meta-analysis of published prospective observational studies evaluating the associations of baseline levels of GGT and ALT with risk of overall (incidence and/or mortality) and site-specific cancers. Relevant studies were identified in a literature search of MEDLINE, EMBASE, Web of Science, reference lists of relevant studies to April 2014 and email contact with investigators. Study specific relative risks (RRs) were meta-analyzed using random effects models. Fourteen cohort studies with data on 1.79 million participants and 57,534 cancer outcomes were included. Comparing top versus bottom thirds of baseline circulating GGT levels, pooled RRs (95% confidence intervals) were 1.32 (1.15-1.52) for overall cancer, 1.09 (0.95-1.24) for cancers of the breast and female genital organs, 1.09 (1.02-1.16) for cancers of male genital organs, 1.94 (1.35-2.79) for cancers of digestive organs and 1.33 (0.94-1.89) for cancers of respiratory and intrathoracic organs. For ALT, corresponding RRs for overall cancer were 0.96 (0.94-0.99) and 1.65 (1.52-1.79) in European and Asian populations, respectively. There was an increased risk of cancers of the digestive organs 2.44 (1.23-4.84). The pooled RR for overall cancer per 5 U/L increment in GGT levels was 1.04 (1.03-1.05). Available observational data indicate a positive log-linear association of GGT levels with overall cancer risk. The positive association was generally evident for site-specific cancers. There are geographical variations in the association of ALT and overall cancer.

Aims: To evaluate the association between LOXIN, a new functional protective splicing isoform of the oxidized LDL receptor 1 (OLR1) gene, and the severity of coronary artery stenoses. Methods: We analyzed 100 consecutive patients with coronary artery disease (CAD) and 100 controls, all evaluated by a new molecular biology test using highly specific allele primers able to identify the single nucleotide variation (IVS4-14 A>G) in the OLR1 gene (Loxin Test - Technogenetics). All the patients and the controls underwent coronary angiography and, for quantitative evaluation, we used both vessel and stenosis score, and SYNTAX score to evaluate the severity of CAD. Moreover, we defined the prognostic localization of CAD as a critical stenosis (>50%) of the left main and/or proximal segment of left anterior descending artery (LAD). Finally, we evaluated a correlation with the presence of diabetes mellitus, dyslipidemia, hypertension, smoking and family history of CAD. Results: In this selected population, even though the 'AA nonrisk haplotype' is more frequent in the controls, we did not find any statistically significant correlation between the severity of CAD or the prognostic localization of critical stenosis and the difference of IVS4-14 A>G OLR1 genotype (P>0.05). CAD patients showed significantly higher frequencies of dyslipidemia and smoking (P

We explored the comprehension of the informed consent in 77 cancer patients previously enrolled in randomised phase II or phase III clinical trials, between March and July 2011, at the San Raffaele Scientific Institute in Milano. We asked participants to complete an ad hoc questionnaire and analysed their answers. Sixty-two per cent of the patients understood the purpose and nature of the trial they were participating in; 44% understood the study procedures and 40% correctly listed at least one of the major risks or complications related to their participation in the trial. We identified three factors associated with comprehension of the informed consent: age, education and type of tumour/investigator team. We suggest several possible improvements of how to obtain informed consent that will increase patient awareness, as well as the validity and effectiveness of the clinical trials.

PURPOSE To evaluate the association between the severity and angiographic localization of coronary artery stenoses and clinical control of major traditional risk factors (RF). METHODS We analyzed 500 patients without known cardiovascular disease, undergoing coronary angiography for the diagnosis of coronary artery disease (CAD), with one or more major traditional RF, all in optimal clinical control. For the quantitative evaluation of CAD, we used a vessel and stenosis score to evaluate the severity of CAD. Moreover, we defined the prognostic localization of CAD as a critical stenosis (≥50%) of the left main (LM) and/or the proximal segment of the left anterior descending coronary artery (LAD). RESULTS The presence of RF was as follows: one in 14.2%, two in 40.6%, three in 35%, and more than three in 10.2% of the patients. Prognostic localization of critical stenosis on the proximal segment of LAD and/or LM was found in 174 patients (34.8%). The severity of CAD and prognostic localization of critical stenosis was not correlated with all of the conventional RF evaluated or their association (P>0.05). CONCLUSION In this population with optimally controlled traditional RF, the severity of CAD or prognostic localization on LM and/or proximal LAD was not correlated with the major RF analyzed.

Beta-blockers have been shown to improve left ventricular (LV) function in patients with heart failure. The aim of this study is to non-invasively assess, by means of in vivo 31P-magnetic resonance spectroscopy (31P-MRS), the effects of beta-blockers on LV cardiac phosphocreatine and adenosine triphosphate (PCr/ATP) ratio in patients with heart failure. Ten heart failure patients on full medical therapy were beta-blocked by either carvedilol or bisoprolol. Before and after 3 months of treatment, exercise testing, 2D echocardiography, MRS, New York Heart Association (NYHA) class, ejection fraction (EF), maximal rate-pressure product and exercise metabolic equivalent system (METS) were evaluated. Relative concentrations of PCr and ATP were determined by cardiac 31P-MRS. After beta-blockade, NYHA class decreased (from 2.2 ± 0.54 to 1.9 ± 0.52, P = 0.05), whereas EF (from 33 ± 7 to 44 ± 6%, P = 0.0009) and METS (from 6.74 ± 2.12 to 8.03 ± 2.39, P = 0.01) increased. Accordingly, the mean cardiac PCr/ATP ratio increased by 33% (from 1.48 ± 0.22 to 1.81 ± 0.48, P = 0.03). Beta-blockade-induced symptomatic and functional improvement in patients with heart failure is associated to increased PCr/ATP ratio, indicating preservation of myocardial high-energy phosphate levels.

Type 2 diabetes is associated with risk of cancer. Hyperinsulinemia and insulin resistance may be the link with cancer, but whether this is independent of the diabetes status, obesity/visceral obesity and metabolic syndrome is uncertain and the present study wanted to address this issue. Fifteen-year all-cause, CVD and cancer mortality data were obtained through the Regional Health Registry in 2,011 out of 2,074 Caucasian middle-aged individuals of the Cremona Study, a population study on the prevalence of diabetes mellitus in Italy in which anthropometric and metabolic characteristics were collected. During the 15-year observation period, 495 deaths were registered: 221 CVD related and 180 cancer related. Age and sex were independently associated with all-cause, cancer and CVD mortality rates. Age- and sex-adjusted analysis showed that HOMA-IR, cigarette smoking and diabetes were independently associated with all-cause mortality; HOMA-IR, systolic blood pressure and fibrinogen were independently associated with CVD mortality; HOMA-IR and smoking habit were independently associated with cancer mortality. Individuals in the highest quintile of serum insulin had a 62% higher risk of cancer mortality (HR = 1.62 95% CI: 1.19-2.20; P

Objectives This study sought to assess the prevalence of normal levels of high sensitivity C-reactive protein (hsCRP) at the very onset of ST-segment elevation myocardial infarction (STEMI). Background Levels of hsCRP ≥2 mg/l identify individuals who benefit from lipid lowering and possibly anti-inflammatory agents, but how many patients develop infarction in spite of hsCRP levels Methods We studied 887 patients with unequivocally documented STEMI as the first manifestation of coronary disease and 887 matched control subjects from urban areas of Italy, Scotland, and China. Blood samples were obtained before reperfusion strategies Results hsCRP values were similar in samples obtained Conclusions The measurement of hsCRP, with a 2 mg/l cutoff, would not have predicted 41% of unequivocally documented STEMIs in 3 ethnic groups without evidence of previous coronary disease, thus indicating both its limitations as an individual prognostic marker and as an indicator of a generalized inflammatory pathogenetic component of STEMI. New specific prognostic and therapeutic approaches should be found for such a large fraction of patients at risk.

Purpose To identify by noninvasive means early retinal abnormalities that may predict diabetic macular edema. Methods The authors analyzed retrospectively data from consecutive patients with Type 1 (n = 16) or Type 2 (n = 23) diabetes who presented for routine follow-up of early retinopathy, had no clinical signs or symptoms of diabetic macular edema, and were evaluated with spectral-domain optical coherence tomography. Age- and gender-matched nondiabetic subjects provided normative data. Results Spectral-domain optical coherence tomography revealed in the macular region of diabetic patients small hyporeflective areas (median diameter, 55 μm) contained within discrete retinal layers that we named micropseudocysts (MPCs). Micropseudocysts are associated with vascular leakage. The patients showing MPCs had more frequently systemic hypertension and increased central foveal thickness than those without MPCs. The association with increased central foveal thickness was only in the patients with Type 2 diabetes. Conclusion Macular MPCs in patients with mild diabetic retinopathy appear to reflect leakage and can precede macular thickening. The association of MPCs with increased central foveal thickness in patients with Type 2 diabetes, but not in patients with Type 1 diabetes, points to a greater tendency to retinal fluid accumulation in patients with Type 2 diabetes. Studies in larger cohorts will determine the usefulness of MPCs in strategies to abort diabetic macular edema.

A fatty liver, which is a common feature in insulin-resistant states, can lead to chronic liver disease. It has been hypothesized that a fatty liver can also increase the rates of non-hepatic-related morbidity and mortality. Therefore, we wanted to determine whether the fatty liver index (FLI), a surrogate marker and a validated algorithm derived from the serum triglyceride level, body mass index, waist circumference, and γ-glutamyltransferase level, was associated with the prognosis in a population study. The 15-year all-cause, hepatic-related, cardiovascular disease (CVD), and cancer mortality rates were obtained through the Regional Health Registry in 2011 for 2074 Caucasian middle-aged individuals in the Cremona study, a population study examining the prevalence of diabetes mellitus in Italy. During the 15-year observation period, 495 deaths were registered: 34 were hepatic-related, 221 were CVD-related, 180 were cancer-related, and 60 were attributed to other causes. FLI was independently associated with the hepatic-related deaths (hazard ratio = 1.04, 95% confidence interval = 1.02-1.05, P < 0.0001). Age, sex, FLI, cigarette smoking, and diabetes were independently associated with all-cause mortality. Age, sex, FLI, systolic blood pressure, and fibrinogen were independently associated with CVD mortality; meanwhile, age, sex, FLI, and smoking were independently associated with cancer mortality. FLI correlated with the homeostasis model assessment of insulin resistance (HOMA-IR), a surrogate marker of insulin resistance (Spearman's ρ = 0.57, P < 0.0001), and when HOMA-IR was included in the multivariate analyses, FLI retained its association with hepatic-related mortality but not with all-cause, CVD, and cancer-related mortality. Conclusion: FLI is independently associated with hepatic-related mortality. It is also associated with all-cause, CVD, and cancer mortality rates, but these associations appear to be tightly interconnected with the risk conferred by the correlated insulin-resistant state. © 2011 American Association for the Study of Liver Diseases

"\"Objective Trimetazidine may have beneficial effects on left ventricular (LV) function in patients with systolic heart failure. The authors assessed whether long-term addition of trimetazidine to conventional treatment could improve, along with LV function, resting whole body energy metabolism in patients with chronic systolic heart failure. Design Single blind randomised study. Setting University Hospital. Patients 44 patients with systolic heart failure receiving full medical treatment. Interventions Indirect calorimetry and two-dimensional echocardiography at baseline and after 3 months. Main outcome measures Whole body resting energy expenditure (REE), percentage of predicted REE, LV ejection fraction (EF), NYHA class, quality of life. Results Trimetazidine increased EF compared with conventional therapy alone (from 35 +\\\/- 8% to 42 +\\\/- 11% vs from 35 +\\\/- 7% to 36 +\\\/- 6%; p=0.02, analysis of variance for repeated measures). NYHA class and quality of life also improved compared with conventional therapy (p

Objective: To assess the ischemic threshold and stress-induced left ventricular dysfunction after high fat (HFM) and high carbohydrate (HCM) meals in patients with stable coronary disease. Methods: Twelve patients (68 +/- 7 years) underwent stress (treadmill exercise testing) echocardiography after fasting (8 h), after HFM and HCM (2 h). Time to 1 mm ST-segment depression (time to 1 mm) and stress wall motion score index (WMSI) were evaluated. Before eating and just before exercise testing glucose, insulin, triglycerides, total cholesterol and FFA levels were measured. Results: Results are expressed as medians (Q1-Q3). HFM did not affect exercise variables compared to fasting, whereas HCM reduced the ischemic threshold [time to 1 mm from 376 (343-493) to 297 (180-420) s, p = 0.003]. Compared to fasting [1.47 (1.31-1.66)], stress WMSI was higher after HCM [1.56 (1.44-1.69)] (p = 0.04) but not after HFM [1.56 (1.30-1.63)]. Glycemia and insulinemia were significantly higher after HCM, compared to fasting and HFM. Conclusions: In patients with coronary disease, exercise testing after a high carbohydrate meal results in a lower ischemic threshold and greater ischemia magnitude. Conversely, compared to fasting, a high fat meal does not induce additional detrimental effects. Hyperglycemia and hyperinsulinemia were the only metabolic determinants identified as potential metabolic mechanisms of this phenomenon. (C) 2009 Elsevier Ireland Ltd. All rights reserved.

OBJECTIVE Some obese individuals have normal insulin sensitivity. It is controversial whether this phenotype is associated with increased all-cause mortality risk. RESEARCH DESIGN AND METHODS Fifteen-year all-cause mortality data were obtained through the Regional Health Registry for 2,011 of 2,074 Caucasian middle-aged individuals of the Cremona Study, a population study on the prevalence of diabetes in Italy. Individuals were divided in four categories according to BMI (nonobese: RESULTS Obese insulin-sensitive subjects represented 11% (95% CI 8.1–14.5) of the obese population. This phenotype had similar BMI but lower waist circumference, blood pressure, fasting glucose, triglycerides, and fibrinogen and higher HDL cholesterol than obese insulin-resistant subjects. In the 15-year follow-up, 495 deaths (cardiovascular disease [CVD]: n = 221; cancer: n = 180) occurred. All-cause mortality adjusted for age and sex was higher in the obese insulin-resistant subjects (hazard ratio 1.40 [95% CI 1.08–1.81], P = 0.01) but not in the obese insulin-sensitive subjects (0.99 [0.46–2.11], P = 0.97) when compared with nonobese insulin-sensitive subjects. Also, mortality for CVD and cancer was higher in the obese insulin-resistant subjects but not in the obese insulin-sensitive subjects when compared with nonobese insulin-sensitive subjects. CONCLUSIONS In contrast to obese insulin-resistant subjects, metabolically healthy obese individuals are less common than previously thought and do not show increased all-cause, cancer, and CVD mortality risks in a 15-year follow-up study.

Objectives We sought to evaluate at 5 years the occurrence of cardiac death; cardiac death, and/or myocardial infarction (MI); cardiac death, MI, and/or stroke; target vessel revascularization; and major adverse cardiac and cerebrovascular events following percutaneous coronary intervention (PCI) with drug-eluting stent (DES) versus coronary artery bypass graft (CABG) in unprotected left main coronary artery lesions. Background Preliminary results at 1 year showed comparable occurrence of major adverse cardiac and cerebrovascular events in our center between PCI and CABG. Methods All consecutive patients with an unprotected left main coronary artery stenosis electively treated with DES implantation versus CABG in our center, between March 2002 and July 2004, were analyzed. A propensity analysis was performed to adjust for baseline differences between the 2 cohorts. Results We included 249 patients in the study: 107 were treated with PCI and DES implantation and 142 with CABG. At 5-year clinical follow-up, no difference was found between PCI and CABG in the occurrence of cardiac death (adjusted odds ratio [OR]: 0.502; 95% confidence interval [CI]: 0.162 to 1.461; p = 0.24). The PCI group showed a trend toward a lower occurrence of the composite end point of cardiac death and MI (adjusted OR: 0.408; 95% CI: 0.146 to 1.061; p = 0.06). Percutaneous coronary intervention was associated with a lower rate of the composite end point of death, MI, and/or stroke (OR: 0.399; 95% CI: 0.151 to 0.989; p = 0.04). Indeed, CABG was correlated with lower target vessel revascularization (adjusted OR: 4.411; 95% CI: 1.825 to 11.371; p = 0.0004). No difference was detected in the occurrence of major adverse cardiac and cerebrovascular events (adjusted OR: 1.578; 95% CI: 0.825 to 3.054; p = 0.18). Conclusions At 5-year clinical follow-up, there was still no difference in the occurrence of major adverse cardiac and cerebrovascular events between elective PCI with DES implantation and CABG in unprotected left main coronary artery lesions in this single-center experience. There was an advantage of PCI in the composite end point of death, MI, and/or stroke, whereas a benefit in the need for reintervention was still found in CABG.

Background: Open repair of juxtarenal abdominal aortic aneurysms (JAAAs), which necessitates clamping above one (interrenal clamping, interRC) or both renal arteries (suprarenal clamping, supraRC), is associated with an increased risk of perioperative renal derangements. We reviewed our experience to investigate the impact of aortic clamping site during JAAA repair on peri- and postoperative glomerular. ltration rate (GFR). Methods: Between January 2001 and March 2006, 32 patients ( 28 male, four female; mean age 70.5 +/- 5.6 years) were submitted to elective open repair of JAAA. SupraRC was required in 12 patients and performed with cold renal perfusion (CRP) in five cases; interRC was required in 20 and performed with CRP in eight. GFRs were estimated through postoperative day 4 using the Cockcroft-Gault equation and compared to those of concurrent controls undergoing infrarenal AAA repair, matched 1: 1 by gender, age, aneurysm size, preoperative GFR, and left renal vein management. GFR values were also evaluated and compared between groups at a mean follow-up of 29.0 +/- 23.7 months. Renal dysfunction was defined as a decrease of GFR >= 20%. Statistics were determined as appropriate for the variables of interest. Results: No perioperative mortality was recorded and no differences in major complication rates were observed between groups (p = 0.16). Operative time was longer in JAAA patients (154 +/- 47 vs. 132 +/- 41 min, p = 0.019). Mean renal ischemia time was 16.7 +/- 7.7 min. Postoperatively, GFR values up to day 4 were significantly worse in JAAA patients compared to controls (p = 0.0007), with a fourfold risk of renal dysfunction at postoperative day 4 (34% vs. 9%, odds ratio [OR] 4.44, 95% confidence interval [CI] 1.1-18.1; p = 0.029). At univariate analysis, supraRC was found to be the only factor associated with perioperative renal dysfunction (OR = 11.3, 95% CI 2.0-63.1; p = 0.003). At follow-up, two patients with supraRC died and another two required dialysis permanently. When compared to those with interRC or infrarenal clamping, patients with supraRC showed a persistent renal dysfunction at follow-up (p = 0.005). Conclusion: Elective JAAA repair with renal ischemia time

Contexte La cure a ciel ouvert des anevrysmes juxtarenaux de l'aorte abdominale (AJAAs), qui necessite un clampage au-dessus d'une (clampage interrenal, CinterR) ou des deux arteres renales (clampage suprarenal, CsupraR), est associee a un plus grand risque d'insuffisance renale peri-operatoire. Nous avons passe en revue notre experience pour etudier l'impact de l'emplacement du clampage aortique pendant la reparation d'AJAA sur le taux de filtration glomerulaire (TFG) post- et peri-operatoire. Methodes Entre janvier 2001 et mars 2006, 32 patients (28 hommes, 4 femmes ; d'âge moyen 70,5±5,6) ont beneficie d'une cure elective a ciel ouvert d'un AJAA. Le CsupraR etait necessaire chez 12 patients et realise avec une perfusion renale a froid (PRF) dans cinq cas ; un CinterR etait necessaire chez 20 patients et realise avec PRF chez 8. Les TFGs etaient mesures le 4 e jour post-operatoire en utilisant l'equation de Cockcroft-Gault et compares a ceux de controles subissant une cure d'AAA infrarenal concomitantes, 1:1 assorti par genre, âge, et taille d'anevrysme, TFG preoperatoire, et gestion de veine renale gauche. Les valeurs de TFG etaient egalement evaluees et comparees entre ces groupes a un suivi moyen de 29,0±23,7 mois. L'insuffisance renale etait definie comme une diminution de TFG ≥20%. Les statistiques etaient determinees de facon appropriee pour les variables interessantes. Resultats Aucune mortalite peri operatoire n'etait enregistree et aucune difference des taux de complication majeure n'etait observee entre les groupes ( p=0,16 ). La duree operatoire etait plus longue chez les patients avec AJAA (154±47 contre 132±41min, p=0,019 ). Le temps d'ischemie renale moyen etait de 16,7±7,7min. En postoperatoire, le TFG evalue au 4 e jour etait significativement diminue chez les patients avec AJAA compares aux controles ( p=0,0007 ), avec un risque quadruple d'insuffisance renale au 4 e jour postoperatoire (34% contre 9%, odd ratio [OR] =4,44, intervalle de confiance a 95% [ic] 1,1-18,1 ; p=0,029 ). En analyse univariee, le CsupraR s'est avere le seul facteur lie a l'insuffisance renale peri-operatoire (OR=11,3, ic 2,0-63,1; p=0,003 ). Au cours du suivi, 2 patients ayant subi un CsupraR sont decedes et 2 autres ont necessite une dialyse de maniere permanente. Une fois compares a ceux a du CinterR ou infra renal, les patients au CsupraR presentaient une insuffisance renale persistante au cours du suivi ( p=0,005 ). Conclusion La cure elective d'AJAA avec un temps d'ischemie renale ≤30min est sure, mais le CsupraR induit une diminution significative du TFG peri-operatoire et a moyen terme. En revanche, le CinterR fournit des resultats semblables a ceux obtenus apres la cure d'un AAA infra renal, permettant un retour de la fonction renale postoperatoire aux valeurs preoperatoires.

Background: We investigated the possibility that transient coronary slow-flow as assessed during coronary angiography in patients with cardiac syndrome X may impair myocardial perfusion and the effects of this phenomenon on long-term prognosis. Methods: From 50 consecutive patients with cardiac syndrome X, we prospectively recruited 16 who exhibited coronary slow-flow during angiography. The remaining 34 patients served as controls. The slow-flow phenomenon was invariably worsened by nitrates and reversed by papaverine. During slow-flow, a dose of 99m-Tc-Methoxy-isobutyl-isonitrile (MIBI) was injected in 12 patients and SPECT imaging performed 1 h later. The perfusion study was repeated after 2 days at rest and, in 9 patients, at peak exercise after 10 +/- 4 days. Patients were then regularly followed-up. Results: All 12 patients had a significant MIBI defect in the regions served by the coronary artery that showed slow-flow just prior MIBI injection. After exercise, MIBI tomograms revealed a perfusion defect in 5 out of the 9 patients who underwent stress scanning. At 14 +/- 2 years follow-up, 1 patient with slow-flow had died and 4 developed significant coronary artery disease (CAD), while all patients of the control group were alive and none had developed significant CAD. Conclusions: These results show that the slow-flow phenomenon might be the cause of transient myocardial underperfusion in patients with angina and normal coronary arteries. Apparently, this phenomenon is associated with a worse cardiac prognosis. Therefore, patients with coronary slow-flow should be carefully followed-up. (C) 2008 Elsevier Ireland Ltd. All rights reserved.

OBJECTIVE: To evaluate the feasibility of the Adamkiewicz artery (AKA) detection by multidetector computed tomography (CT) data analysis without the need of a dedicated workstation, using low-cost hardware and the freeware OsiriX. METHODS: CT scans of 67 patients undergoing a thoracic or thoraco-abdominal aortic procedure between April 2006 and August 2008 were evaluated with respect to detection rate and AKA level and side using the OsiriX software version 3.2 on Mac OS X computer and compared to results obtained by standard workstation analysis, in a fully blinded analysis. The results were also compared with data compiled from a review of the English-language literature on this topic. RESULTS: (1) AKA identification showed a substantial agreement of 85.07% between the methods (k=0.636). (2) The comparison of AKA level showed a substantial agreement (weighted k=0.661), with consensus in 70.14%. (3) From the literature review, we found that recognition of the AKA was achieved in 466 of 555 cases (83.96%). (4) In 384 (83.3%) cases the AKA originated from a left intercostal artery. (5) The proposed method and literature-compiled data showed a similar AKA level distribution. CONCLUSIONS: Noninvasive AKA location with open-source software and low-cost hardware is feasible. The OsiriX software allows to effectively navigate through CT data not only to study the aorta, but also to detect the AKA, as in the case of the standard method and the literature data. Its availability and ease of use may contribute to make identification of the AKA part of the routine evaluation of CT scans in patients with aortic disease, even where dedicated workstations are not available, with potential benefits for planning therapeutic procedures. Objective: To evaluate the feasibility of the Adamkiewicz artery (AKA) detection by multidetector computed tomography (CT) data analysis without the need of a dedicated workstation, using low-cost hardware and the freeware OsiriX. Methods: CT scans of 67 patients undergoing a thoracic or thoraco-abdominal aortic procedure between April 2006 and August 2008 were evaluated with respect to detection rate and AKA level and side using the OsiriX software version 3.2 on Mac OS X computer and compared to results obtained by standard workstation analysis, in a fully blinded analysis. The results were also compared with data compiled from a review of the English-language literature on this topic. Results: (1) AKA identification showed a substantial agreement of 85.07% between the methods (k = 0.636). (2) The comparison of AKA level showed a substantial agreement (weighted k = 0.661), with consensus in 70.14%. (3) From the literature review, we found that recognition of the AKA was achieved in 466 of 555 cases (83.96%). (4) In 384 (83.3%) cases the AKA originated from a left intercostal artery. (5) The proposed method and literature-compiled data showed a similar AKA level distribution. Conclusions: Noninvasive AKA location with open-source software and low-cost hardware is feasible. The OsiriX software allows to effectively navigate through CT data not only to study the aorta, but also to detect the AKA, as in the case of the standard method and the literature data. Its availability and ease of use may contribute to make identification of the AKA part of the routine evaluation of CT scans in patients with aortic disease, even where dedicated workstations are not available, with potential benefits for planning therapeutic procedures.

Objective: Risk factors for perioperative and late mortality after thoracic endovascular aortic repair (TEVAR) remain ill-defined. In this study, we examined the prognostic significance of chronic kidney disease (CKD), a well-known predictor of death after thoracic aorta open repair, employing a stratification based on CKD stages derived from glomerular filtration rate (GFR) values. Methods: A prospective database was evaluated for 179 consecutive patients electively submitted to TEVAR between 1999 and 2007. Preoperative GFR was estimated by using the Cockcroft-Gault equation. Patient groups were stratified into four quartiles by baseline serum creatinine (SC) and GFR values, with quartile I being the lowest, and quartile IV the highest, and into the five CKD stages in reverse order (I GFR >= 90 ml/min/1.73 m(2); 1160-89; 11130-59; IV 15-29; V < 15). Prognostic significance of preoperative GFR values and CKD stages were investigated by means of univariate and multivariate analyses, and the Kaplan-Meier log-rank method. Results. A primary technical success was achieved in 166 of 179 patients (92.7%), and an initial clinical success in 158 (88.3%). Thirty-day mortality was 5% (nine cases). Paraplegia or paraparesis were observed in 11 (6.1%) patients, and completely resolved in six cases after cerebrospinal fluid drainage. Preoperative GFR quartiles and CKD stages were significant predictors of 30-day mortality (P=.004 and P

Purpose To compare the quantitative and qualitative visual performances of different multifocal intraocular lenses (IOLs) in an experimental model of the human eye. Setting University Hospital San Raffaele, Milan, Italy. Methods Five multifocal IOLs and 1 monofocal IOL were implanted in an optomechanical eye model with imaging capability. The comparative optical characterization of the imaging performance included aberrometry, simulated visual acuity testing at variable contrast for far and near distance, glare tests, and image records of optotype charts. Results The maximum recorded far visual acuity for the monofocal IOL was between 20/12.5 and 20/16; the multifocal IOLs decreased visual acuity by 1 to 2 lines. The difference tended to increase at reduced contrast. Full-contrast near visual acuity with multifocal IOLs ranged between 20/63 and 20/25; the near distance performance of the monofocal IOL without an additional correcting lens was worse by 1 to 3 lines of acuity with large pupils but was comparable with small pupils. Multifocal IOLs of different designs showed marked differences as a function of contrast, which tended to balance between far and near behaviors. Conclusions Multifocal IOLs of different optical designs were well characterized and distinguished by simulated contrast acuity testing in an experimental eye model, allowing quantitative comparison. Their overall visual performance, averaged over contrast and distance, was not superior to the performance of a monofocal IOL without an additional correcting lens.

Purpose: To compare the results of thoracic endovascular grafting of different aortic segments performed with commercially available stent-grafts. Methods: Between January 1999 and October 2006, 178 patients (150 men; mean age 69.4±10.2 years) underwent endovascular grafting of the thoracic aorta (68 hybrid procedures) with commercially produced stent-grafts from 4 manufacturers. Patients were divided into 3 groups according to the aortic segment involved: 64 aortic arch cases (37 hybrids for supra-aortic trunks revascularization), 100 descending thoracic aorta (DTA) cases (17 hybrid: 12 for access and 5 for associated abdominal aortic aneurysm), and 14 thoracoabdominal aorta (TaA) patients excluded from conventional repair (14 hybrids for renal and splanchnic revascularization). Results: The technical success was 93.8% (167/178). Overall 30-day mortality was 5.6% (10/178). There were 10 (5.6%) type I endoleaks. Initial clinical success was 88.2% (157/178). At a mean follow-up of 29.3±21.2 months, the midterm clinical success was 89.9% (160/178). In the arch group, the technical success was 85.9% (55/64). Thirty-day mortality was 6.3% (4/64). There were 8 (12.5%) type I endoleaks. Initial and midterm clinical success rates were 79.7% (51/64) and 85.9% (55/64), respectively. In the 100-patient DTA group, the technical success was 98.0%. Thirty-day mortality was 2.0%. The type I endoleak rate was 2.0%. Clinical success was 96.0% initially and 95.0% at midterm. All 14 of the TaA cases were completed successfully, but 30-day mortality was 28.6% (4/14). There were no type I endoleaks. Clinical success rates initially and at midterm were both 71.4% (10/14). Conclusion: Over the last 6 years, synergy between endovascular and surgical procedures allowed treatment of all segments of the thoracic aorta. Overall perioperative and medium-term results were reasonably favorable; however, they were more satisfactory when the descending thoracic aorta alone was involved. Hybrid procedures allowed treatment of all aortic segments, but they decreased the success rates significantly. Endovascular grafting is currently our preferred method of treating pathologies involving the DTA and aortic arch, while our data suggest limiting the use of stent-grafts to high-risk patients or compassionate indications when the thoracoabdominal aorta is involved.

The role of 3DTOF MRA in the follow up (FU) of coiled cerebral aneurysms is well established. Though CEMRA (Contrast Enhanced Magnetic Resonance Angiography) has demonstrated to be superior to 3DTOF MRA in showing aneurysms residual patency, its role is still debated. The aim of this study was to verify if there is an added value of CEMRA in the long term follow up of coiled treated aneurysms. Sixty-four cerebral aneurysms treated with GDC coils regularly followed up with 3DTOF and CEMRA at 3T every year for at least four years were included in the study. Both MR exams were evaluated and scored according to Montreal scale. Residual patency rates and modifications during follow up as depicted by the two techniques on the three item score of the Montreal scale (TO = total occlusion, NR = neck remnant and AR = aneurysm remnant) were registered along with management decisions. Intertechnique agreement was evaluated with respect to patency scoring in earlier and later stages of FU. Moreover the predictive value of earlier scores for both acquisitions with respect to management decision was assessed. At 1 year FU, TO to NR to AR score ratios were 31/23/10 and 22/31/11 for 3DTOF and CEMRA respectively, whereas at 4 years FU they evolved to 28/22/14 and 19/28/17 respectively. Fifteen patencies (all AR) out of 64 aneurysms were judged suitable of retreatment evaluation during FU and 8 retreatments were effectively performed after overall benefit/risk ratio considerations. All 15 reopenings were equally depicted by both techniques except one that was depicted earlier on CEMRA. Among the 9 TO at TOF MRA and NR at CEMRA at 1 year, 3 cases enlarged to NR at TOF at 4 years, most remained stable. Among the 22 cases judged NR at 1 years with both techniques, 3 cases showed enlargement at both techniques, while in other 3 cases AR was evident only at 3DCEMRA and they were not retreated. CEMRA superiority in depiction of intracranial aneurysms recanalization is confirmed by our data. Nevertheless a clear impact in patient management is apparently not evident. Evidence of occlusion at 3DTOF FU may not need the addition of a CEMRA study.

The prospective evidence for the associations of gamma glutamyltransferase (GGT) and alanine aminotransferase (ALT) with risk of cancer in the general population is uncertain. We conducted a systematic review and meta-analysis of published prospective observational studies evaluating the associations of baseline levels of GGT and ALT with risk of overall (incidence and/or mortality) and site-specific cancers. Relevant studies were identified in a literature search of MEDLINE, EMBASE, Web of Science, reference lists of relevant studies to April 2014 and email contact with investigators. Study specific relative risks (RRs) were meta-analyzed using random effects models. Fourteen cohort studies with data on 1.79 million participants and 57,534 cancer outcomes were included. Comparing top versus bottom thirds of baseline circulating GGT levels, pooled RRs (95% confidence intervals) were 1.32 (1.15-1.52) for overall cancer, 1.09 (0.95-1.24) for cancers of the breast and female genital organs, 1.09 (1.02-1.16) for cancers of male genital organs, 1.94 (1.35-2.79) for cancers of digestive organs and 1.33 (0.94-1.89) for cancers of respiratory and intrathoracic organs. For ALT, corresponding RRs for overall cancer were 0.96 (0.94-0.99) and 1.65 (1.52-1.79) in European and Asian populations, respectively. There was an increased risk of cancers of the digestive organs 2.44 (1.23-4.84). The pooled RR for overall cancer per 5 U/L increment in GGT levels was 1.04 (1.03-1.05). Available observational data indicate a positive log-linear association of GGT levels with overall cancer risk. The positive association was generally evident for site-specific cancers. There are geographical variations in the association of ALT and overall cancer.

Objective When used for epicardial ablation, unipolar devices do not predictably yield transmural scars. Bipolar radiofrequency proved highly effective on the animal model, but clinical experience is still initial. We describe acute electrophysiologic findings and follow-up results of epicardial ablation with a novel bipolar radiofrequency device. Methods A bipolar ablator was used to perform a simplified left atrial lesion set in 90 consecutive patients with atrial fibrillation undergoing open heart surgery. Pacing thresholds were assessed during surgery to validate 24 pulmonary vein encircling lines (12 patients). Follow-up was 100% complete. Results In 67 of 90 patients (84%), mitral valve disease was the main indication to surgery. Atrial fibrillation was continuous in 74 patients (82%) and intermittent in 16 patients (18%). Pacing threshold assessment showed a complete conduction block in 22 of 24 pulmonary vein couples (92%) after a single ablation and in all patients after doubling of the encircling lines. No complications related to the ablation procedure were recorded. The sinus rhythm restoration rate was 79% at 3 months, 87% at 6 months, and 89% (17/18 patients) at 1 year. Postablation organized arrhythmias consisted in right atrial flutter in 2 patients (2%) and left atrial flutter in 6 patients (7%). Conclusions Epicardial ablation with bipolar radiofrequency grants acute transmurality. A simplified lesion set proved highly effective in eliminating atrial fibrillation at 1-year follow-up. Our data suggest that addition of a lesion to the mitral annulus is advisable to prevent left atrial flutter.

Background. Progressive multifocal leukoencephalopathy (PML) remains a frequent and life-threatening complication of human immunodeficiency virus (HIV) infection in the era of highly active antiretroviral therapy (HAART). Although one-half of patients with this disease will survive, the outcome is unpredictable at diagnosis, and prognostic markers are needed. Methods. JC virus (JCV) DNA levels were measured in cerebrospinal fluid (CSF) samples obtained from 61 HIV-infected patients with PML, including 38 patients who were treated with HAART and 23 patients who did not receive HAART, with use of real-time polymerase chain reaction. The diagnostic reliability of the assay was evaluated by comparing CSF findings with histopathological findings in patients with PML or other HIV-related diseases of the central nervous system. The prognostic value was assessed by comparing JCV DNA levels with survival and other patient variables. Results. The assay had a diagnostic sensitivity of 76% and specificity of 100%. In the first CSF sample obtained after onset of PML symptoms, JCV DNA values ranged from undetectable to 7.71 log copies/mL (median, 3.64 log copies/mL). JCV DNA levels >3.64 log copies/mL correlated significantly with shorter survival and lower CD4 + cell counts in patients not receiving HAART. However, neither relationship was found in patients who were treated with HAART. The analysis of sequential CSF samples obtained from 24 patients demonstrated a marked decrease in JCV DNA levels over time in HAART-treated patients showing PML stabilization, but not in untreated or HAART-treated patients with progressively fatal disease. Conclusions. Measurement of JCV DNA levels in CSF samples may be a useful virological marker for management of PML in patients receiving HAART.

It is not known whether cytokine levels in sputum may be used as outcome measures after parenteral antibiotic therapy in cystic fibrosis (CF) patients. Here, we assessed the effects of antibiotic therapy on cytokine levels in sputum and serum obtained from young CF patients. Thirty-two CF patients (14 females; mean age, 18.6 years; range, 11.4-35.7 years), consecutively admitted at the CF Center of Milan for parenteral antibiotic therapy during pulmonary exacerbation, were enrolled in the study. Before and after 21 days (range, 5-41) of intravenous antibiotic treatment, all patients underwent routine laboratory determinations (including white blood cell (WBC) count and C-reactive protein (CRP)), a chest X-ray, pulmonary function tests (forced expiratory volume in 1 sec (FEV1) and forced vital capacity (FVC) as % predicted), and sputum cultures. Interleukin (IL)-6, IL-8, IL-10, and tumor necrosis factor (TNF)-alpha levels in serum and sputum samples were determined by means of immunometric assays. After therapy, FEV1 and FVC significantly improved (median increase of 7.5% and 8.5% predicted, respectively), while CRP and WBC count were significantly decreased (median values from 14 to 5.5 mg/dl and from 8,350 to 7,400 n/mm3, respectively). While levels of IL-6 and IL-10 in sputum were generally undetectable, IL-8 and TNF-alpha were always measurable, and IL-8 levels significantly decreased after antibiotic treatment (median values from 7,165 to 5,415 pg/ml). Following antibiotic therapy, IL-8 and TNF-alpha levels in sputum were inversely related with both FEV(1) and FVC. In conclusion, TNF-alpha and IL-8 levels in sputum of young CF patients with pulmonary exacerbation were always detectable and may be useful, noninvasive outcome measures to assess response to therapy in CF patients.

OBJECTIVE—Leptin and tumor necrosis factor (TNF)-α are associated with insulin resistance and cardiovascular disease. In vitro studies suggested that these effects may be mediated via overproduction of monocyte chemoattracting protein (MCP)-1/CCL2, which is a chemokine involved in the pathogenesis of atherosclerosis. RESEARCH DESIGN AND METHODS—In this study, fasting plasma leptin, soluble TNF-α receptor 2 (TNF-α-R2), and MCP-1/CCL2 concentrations were measured in 207 middle-aged women (age 61 ± 12 years, BMI 30.1 ± 6.6 kg/m2), including 53 patients with type 2 diabetes, 42 with impaired glucose tolerance, and 112 with normal glucose tolerance, to assess cross-sectionally their relationship with markers of atherosclerosis and, longitudinally over 7 years, whether their circulating levels were associated with cardiovascular disease (CVD) mortality. RESULTS—At baseline, leptin and TNF-α-R2 were not different among groups; meanwhile, MCP-1/CCL2 was increased in type 2 diabetes (P < 0.05). All showed significant associations with biochemical risk markers of atherosclerosis. In a univariate analysis, age, fasting insulin, leptin, and MCP-1/CCL2 were associated with CVD mortality at 7 years. When a multivariate analysis was performed, only age, leptin, and insulin retained an independent association with CVD mortality, with leptin showing a protective effect (hazard ratio 0.88; P < 0.02). CONCLUSIONS—In middle-aged women, MCP-1/CCL2, leptin, and TNF-α-R2 were all related to biochemical risk markers of atherosclerosis. MCP-1/CCL2 concentration was the only one to be increased in type 2 diabetes with respect to nondiabetic women and the only one to be associated with increased risk of CVD mortality after a 7-year follow-up period in the univariate analysis. In the multivariate analysis, neither MCP-1/CCL2 nor TNF-α-R2 was associated with CVD mortality, and inspection of the data showed that leptin, in both the univariate and multivariate analysis, was associated with a protective effect.

Study objective: To compare an unattended device for cardiorespiratory monitoring (POLYMESAM; MAP; Martinsried, Germany) [P-M] with classic nocturnal polysomnography (PSG) for diagnosis of obstructive sleep apnea (OSA) in children. Design: Clinical setting. Patients: Twelve children (age range, 3 to 6 years) with highly suspected uncomplicated OSA who underwent PSG and P-M on 2 consecutive laboratory nights in a balanced manner. Measurements: Respiratory indexes were compared for P-M (automated analysis), hand-scored revised P-M (P-Mrev), and PSG. Analysis of contingency for cutoff levels of respiratory disturbance index (RDI) of 5 and 10 and level of agreement between P-M, P-Mrev, and PSG by the concordance method were evaluated. Results: Nine of twelve children (75%) had a PSG RDI > 5, while 41.7% had an RDI > 10, indicating moderate-to-severe OSA. P-M sensitivity (78%) increased with the increase of the RDI cutoff, and P-Mrev sensitivity reached 100% at the cutoff of 10. The specificity was low for RDI > 5 and increased only modestly at RDI > 10 (P-Mrev, 57%). Seven of 12 children (increasing to 9 children with P-Mrev) and 9 of 12 children (increasing to 11 children with P-Mrev) were correctly classified by the P-M unit when cutoffs of 5 and 10 were considered, respectively. As far as the agreement level is concerned, P-M underestimated the incidence of obstructive hypopnea and overestimated the number of central apnea cases. P-Mrev improved the latter measure. Conclusion: Based on these data, the P-M device cannot be advocated for common use in a clinical setting, but it may have a role in urgent screening for highly suspected moderate-to-severe OSA. (CHEST 2003; 124:602– 607) Abbreviations: AHT total number of apnea and hypopnea events; CA central apnea; CI confidence interval; DE desaturation event; NPV negative predictive value; P-M POLY-MESAM; P-Mrev revised POLYMESAM; OA obstructive and mixed apnea; ODI oxygen desaturation index; OH obstructive hypopnea; OSA obstructive sleep apnea; PPV positive predictive value; RDI respiratory disturbance index; Sao2 arterial oxygen saturation; Sao2% percentage of arterial oxygen saturation

PURPOSE: The purpose of this article is to analyze cross-sectional images of a subretinal macular lesion, using optical coherence tomography (OCT) in eyes with adult-onset foveomacular vitelliform dystrophy (AOFVD), to compare thickness of the neurosensory retina over the lesion with best-corrected visual acuity (BCVA) of each eye, and to compare OCT tomograms of AOFVD patients with OCT of Best disease. DESIGN: Observational case series. METHODS: This is a retrospective study which took place in a clinical practice. Forty-three patients (72 eyes) with AOFVD and 12 patients (24 eyes) with Best's disease were studied. The observation procedures used were biomicroscopic fundus examination, fluorescein angiography (FA), indocyanine green angiography (ICGA), and optical coherence tomography (OCT). The main outcome measures were a description of the typical picture of AOFVD in OCT tomograms, the relationship between the neurosensory retinal thickness over the lesion, the BCVA expressed in decimal terms, and a comparison with description of OCT in Best disease. RESULTS: Of the 43 patients affected by AOFVD, 29 had bilateral macular lesions. Fluorescein angiography showed a central hypofluorescent spot surrounded by an irregular hyperfluorescent ring in 65 of the 72 eyes. Indocyanine green angiography demonstrated a central nonfluorescent spot and a hyperfluorescent area surrounding the central spot in 22 of 27 eyes examined. In all 72 eyes of 43 patients, OCT showed a well-defined central region of thickening in the reflective band representing the retinal pigment epithelium (RPE). The relationship between the thickness of neurosensory retina over the lesion and BCVA was significant ( P = .001, r 2 = 0.61). Optical coherence tomography in all 24 eyes with Best disease showed a well-defined central serous retinal detachment. CONCLUSION: In the 72 eyes with AOFVD, FA and ICGA presented different features. Instead, OCT tomograms showed a well-defined subretinal thickening of the RPE in all the eyes. The lack of difference in OCT patterns between cases with or without the hypofluorescent spot on angiography was useful for confirming the diagnosis of AOFVD. Moreover, a reduced visual acuity was evident in patients with a thinner neurosensory retinal layer over AOFVD lesion. Finally, OCT images were also useful for distinguishing AOFVD from Best disease.

Objective: We studied the hemostatic effects of tranexamic acid in patients undergoing elective surgery involving the thoracic aorta. Methods: In a double-blind, randomized fashion, 60 consecutive patients were assigned to two treatment groups: 30 patients (placebo group) received infusion of saline solution, and 30 (treatment group) received tranexamic acid (1 g before skin incision, an infusion of 400 mg/h during the operation, and 500 mg in the pump priming). Perioperative bleeding was considered as a primary outcome. Perioperative allogeneic transfusions, major thrombotic complications (myocardial infarction, pulmonary embolism, renal insufficiency), and surgical outcomes were also considered. Results: Patients treated with tranexamic acid showed significant reductions in postoperative bleeding, both in terms of the amount collected during the first 4 postoperative hours (median 307 mL, interquartile range 253-361 mL in the placebo group vs median 211 mL, interquartile range 108-252 mL in the treatment group, P =.002) and in terms of total bleeding (median 722 mL, interquartile range 574-952 mL in the placebo group vs median 411 mL, interquartile range 313-804 mL in the treatment group, P =.04). Consequently, the number of patients transfused differed significantly between groups (21 patients [72.4%] in the placebo group vs 13 [44.8%] in the treatment group, P =.033). Patients in the treatment group showed significant reductions in the total amount for the entire group of packed red cells transfused (13,500 mL in the treatment group vs 28,000 mL in the placebo group, P =.012) and in the total amount of allogeneic transfusions (23,400 mL in the treatment group vs 53,000 mL in the placebo group, P =.024). No differences in perioperative thrombotic complications were found. Conclusions: In this initial series of patients undergoing thoracic aortic surgery, tranexamic acid appeared effective in reducing perioperative bleeding, with a significant reduction in the need for allogeneic transfusions and without any increased risk of thrombotic complications. J Thorac Cardiovasc Surg 2002;123:1084-91

Objective. To investigate the prevalence of celiac disease in a large cohort of children and adolescents at the onset of type 1 diabetes and the occurrence of new cases during a 6-year follow-up. Methods. We prospectively studied, by repeated serologic screening, 274 consecutive patients at the onset of type 1 diabetes (age [mean ± standard deviation]: 8.28 ± 4.65 years) for 6 subsequent years. One patient had a diagnosis of celiac disease before the onset of diabetes. The immunoglobulin A-antiendomysium antibody test was selected as the screening test; patients with positive results (++ or +++) or with 2 consecutive weak positive tests (+) were considered appropriate for the jejunal biopsy. Results. At diabetes onset, 15 (5.5%) of 273 patients tested positive with the antiendomysium test; jejunal biopsy was performed in 10, and celiac disease was diagnosed in 9. The prevalence of biopsy-confirmed celiac disease at the manifestation of diabetes was 3.6% (10 of 274 patients). Twelve more patients with a negative antiendomysium antibody test at diabetes onset tested positive during the follow-up within 4 years; 10 of them had biopsies performed, and 7 had celiac disease. Therefore, the overall prevalence of biopsy-confirmed celiac disease in the entire cohort of patients was 6.2%. The age at diabetes onset in patients with and without celiac disease was not different (7.88 ± 5.69 vs 8.3 ± 4.58 years). The majority of cases of celiac disease were asymptomatic in their presentation, and no signs of overt malnutrition were documented. Conclusions. The prevalence of celiac disease in patients with type 1 diabetes is approximately 20 times higher than in the general population. Sixty percent of cases are already present at diabetes onset, mostly undetected, but an additional 40% of patients develop celiac disease a few years after diabetes onset. Extending screening programs for celiac disease after the onset of type 1 diabetes is recommended, even in the absence of clinical symptoms.

Aim The prognostic utility of myocardial perfusion scintigraphy (MPS) in patients with angiographically normal coronary arteries has not been evaluated yet. Our aim was to determine the prognostic role of positive MPS in patients with angina, positive exercise test and smooth coronary arteries (syndrome X). Methods A total of 156 patients with angina, positive exercise test, positive MPS and normal coronary arteries and 172 patients with angina and positive exercise test who had negative MPS were selected for study. The primary endpoint was combined all-cause mortality and hospitalizations for cardiac causes. The secondary endpoint was hospitalization for cardiac causes. Results Kaplan–Meier analysis showed a greater ( p =0.001) incidence of the primary endpoint in patients with positive MPS, compared to those with negative MPS. Additionally, Kaplan–Meier analysis for cardiovascular hospitalization showed a significant difference ( p =0.003) between the two groups. Cox regression analysis, adjusted for age, sex, BMI and antianginal therapy confirmed a significant risk increase for patients with positive MPS, with a hazard ratio (HR)=3.20 (CI 95%: 1.14–9.02; p =0.028). Cox analysis for cardiovascular hospitalization also showed a significant risk increase for patients with positive MPS (HR=3.19; CI 95%: 1.13–9.00; p =0.03). Finally, Cox analysis showed that patients with positive MPS tend to have a higher risk to remain symptomatic in the follow-up period (HR=1.614; CI 95%: 0.999–2.607; p =0.51). Conclusions This study shows that inducible myocardial hypoperfusion at MPS in patients with syndrome X could discriminate patients with a more severe prognosis, especially in terms of further hospitalization and symptomatic burden.

Purpose: To study retinal function in asymptomatic Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) and no clinical signs of diabetic macular edema. Methods: Thirty-six consecutive Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy and no diabetic macular edema and 28 healthy controls underwent a complete ophthalmologic examination, including spectral domain optical coherence tomography and microperimetry. Results: Seventy-one eyes (17 patients with Type 1 and 19 with Type 2 diabetes) were tested, and data from 36 (17 Type 1 and 19 Type 2) eyes were analyzed. Mean best-corrected visual acuity was 0.00 +/- 0.01 logMAR and 0.00 +/- 0.02 logMAR for Type 1 and Type 2 diabetic patients, respectively (P = 0.075). Mean central foveal thickness was 234.5 +/- 13.7 mm and 256.3 +/- 12.7 mm for Type 1 and Type 2 diabetic patients, respectively (P = 0.04); the central foveal thickness was statistically different compared with the control groups (P = 0.04 and P = 0.01, respectively). Mean retinal sensitivity was 18.9 +/- 0.5 dB and 17.7 +/- 0.4 dB for Type 1 and Type 2 diabetic patients, respectively; it was statistically different compared with control groups (P < 0.0001 and P < 0.0001, respectively). Conclusion: We demonstrated a significantly reduced sensitivity in both nonproliferative diabetic retinopathy groups without diabetic macular edema compared with healthy controls; this reduction was greater in Type 2 diabetic patients. Central foveal thickness was increased in all diabetic patients compared with healthy controls, despite the absence of diabetic macular edema. Purpose: To study retinal function in asymptomatic Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) and no clinical signs of diabetic macular edema. Methods: Thirty-six consecutive Type 1 and Type 2 diabetic patients with nonproliferative diabetic retinopathy and no diabetic macular edema and 28 healthy controls underwent a complete ophthalmologic examination, including spectral domain optical coherence tomography and microperimetry. Results: Seventy-one eyes (17 patients with Type 1 and 19 with Type 2 diabetes) were tested, and data from 36 (17 Type 1 and 19 Type 2) eyes were analyzed. Mean best-corrected visual acuity was 0.00 +/- 0.01 logMAR and 0.00 +/- 0.02 logMAR for Type 1 and Type 2 diabetic patients, respectively (P = 0.075). Mean central foveal thickness was 234.5 +/- 13.7 mm and 256.3 +/- 12.7 mm for Type 1 and Type 2 diabetic patients, respectively (P = 0.04); the central foveal thickness was statistically different compared with the control groups (P = 0.04 and P = 0.01, respectively). Mean retinal sensitivity was 18.9 +/- 0.5 dB and 17.7 +/- 0.4 dB for Type 1 and Type 2 diabetic patients, respectively; it was statistically different compared with control groups (P < 0.0001 and P < 0.0001, respectively). Conclusion: We demonstrated a significantly reduced sensitivity in both nonproliferative diabetic retinopathy groups without diabetic macular edema compared with healthy controls; this reduction was greater in Type 2 diabetic patients. Central foveal thickness was increased in all diabetic patients compared with healthy controls, despite the absence of diabetic macular edema.

Objective. The goal of this work was to assess retrospectively the role of wide/radical hysterectomy (RH) and pelvic lymph node dissection (LND) in endometrial cancer with cervical involvement. Methods. From 1984 to 1993, 82 patients with endometrial cancer and cervical involvement were surgically managed at our institution. Of 57 patients with stage II (59%) or III (41%) disease receiving no preoperative therapy, 22 (39%) had simple hysterectomy (SH) and 35 (61%) had RH. Forty-four patients (77%) had pelvic LND, and 38 (67%) had adjuvant radiotherapy (RT). Median follow-up was 70 months. Results. The 5-year disease-related survival (DRS) and recurrence-free survival (RFS) were 73 and 63%, respectively. Five-year DRS and RFS were 68 and 50%, respectively, in the SH group compared with 76% ( P = 0.1) and 71% ( P = 0.04) in the RH group. Distant recurrences occurred in 45% of patients with SH and in 23% with RH ( P = 0.08). Local recurrence rates did not differ significantly. Considering only stage II tumors, we did not observe any recurrence among patients with negative nodes who had RH, irrespective of the administration of adjuvant RT. By contrast, adjuvant RT improved local control (even if not significantly) in stage II patients who had SH. Five-year DRS of stage III patients was 47%, but it was improved by adjuvant RT in the subgroup of patients who had RH. Independent variables associated with prognosis were stage III disease, deep myometrial invasion, RH, and adjuvant RT. Conclusion. RH and adjuvant RT appear to improve prognosis in endometrial cancer with cervical involvement. In particular, radical surgery alone is therapeutic in stage II patients with negative nodes, irrespective of the administration of RT. By contrast, RT can possibly improve local control in stage II patients who previously had SH. Overall, stage III patients have a poor prognosis that can be improved by a combination of radical surgery and adjuvant RT; however, associated therapy directed to extrapelvic sites is probably needed in patients with extrauterine disease.

Background Many different doses and administration schemes have been proposed for the use of the antifibrinolytic drug tranexamic acid during cardiac surgery. This study evaluated the effects of the treatment using tranexamic acid during the intraoperative period only and compared the results with the effects of the treatment continued into the postoperative period. Methods Patients undergoing elective cardiac surgery with use of cardiopulmonary bypass (N = 510) were treated intraoperatively with tranexamic acid and then were randomized in a double-blind fashion to one of three postoperative treatment groups: group A: 169 patients, infusion of saline for 12 h; group B: 171 patients, infusion of tranexamic acid, 1 mg x kg(-1) x h(-1) for 12 h; group C: 170 patients, infusion of tranexamic acid, 2 mg x kg(-1) x h(-1) for 12 h. Bleeding was considered to be a primary outcome variable. Hematologic data, allogeneic transfusions, thrombotic complications, intubation time, and intensive care unit and hospital stay duration also were evaluated. Results No differences were found among groups regarding postoperative bleeding and outcomes; however, the group treated with 1 mg x kg(-1) x h(-1) tranexamic acid required more units of packed red blood cells because of a significantly lower basal value of hematocrit, as shown by multivariate analysis. Conclusions Prolongation of treatment with tranexamic acid after cardiac surgery is not advantageous with respect to intraoperative administration alone in reducing bleeding and number of allogeneic transfusions. Although the prevalence of postoperative complications was similar among groups, there is an increased risk of procoagulant response because of antifibrinolytic treatment. Therefore, the use of tranexamic acid during the postoperative period should be limited to patients with excessive bleeding as a result of primary fibrinolysis.

Background —Atrial fibrillation (AF) increases the morbidity of CABG. The pathophysiology is uncertain, and its prevention remains suboptimal. This prospective, randomized study was designed to define the role of cardiopulmonary bypass (CPB) and cardioplegic arrest in the pathogenesis of this complication. Methods and Results —Two hundred patients were prospectively randomized to (1) on-pump conventional surgery [(100 patients, 79 men, mean age 63 (40 to 77) years)] with normothermic CPB and cardioplegic arrest of the heart or (2) off-pump surgery [(100 patients, 82 men, mean age 63 (38 to 86) years)] on the beating heart. Heart rate and rhythm were continuously monitored with an automated arrhythmia detector during the first 72 hours after surgery. Thereafter, routine clinical observation was performed and continuous monitoring restarted in the case of arrhythmia. The association of perioperative factors with AF was investigated by univariate analysis. Significant variables were then included into a stepwise logistic regression model to ascertain their independent influence on the occurrence of AF. There were no significant baseline differences between groups. Thirty-nine patients in the on-pump group and 8 patients in the off-pump group had postoperative sustained AF ( P =0.001). Univariate analysis showed that CPB inclusive of cardioplegic arrest, postoperative inotropic support, intubation time, chest infection, and hospital length of stay were predictors of AF (all P Conclusions —CPB inclusive of cardioplegic arrest is the main independent predictor of postoperative AF in patients undergoing coronary revascularization.

Objective: The objective of this study was to find readily ascertainable intraoperative pathologic indicators that would discriminate a subgroup of early corpus cancers that would not require lymphadenectomy or adjuvant radiotherapy. Study Design: Between 1984 and 1993, a total of 328 patients with endometrioid corpus cancer, grade 1 or 2 tumor, myometrial invasion ≤50%, and no intraoperative evidence of macroscopic extrauterine spread were treated surgically. Pelvic lymphadenectomy was performed in 187 cases (57%), and nodes were positive in nine cases (5%). Adjuvant radiotherapy was administered to 65 patients (20%). Median follow-up was 88 months. Results: The 5-year overall cancer-related and recurrence-free survivals were 97% and 96%, respectively. Primary tumor diameter and lymphatic or vascular invasion significantly affected longevity. No patient with tumor diameter ≤2 cm had positive lymph nodes or died of disease. Conclusion: Patients who have International Federation of Gynecology and Obstetrics grade 1 or 2 endometrioid corpus cancer with greatest surface dimension ≤2 cm, myometrial invasion ≤50%, and no intraoperative evidence of macroscopic disease can be treated optimally with hysterectomy only. (Am J Obstet Gynecol 2000;182:1506-19.)

Diabetes mellitus frequently complicates cirrhosis but the pathogenic mechanisms are unknown. To assess the contribution of reduced insulin action and secretion, 24 cirrhotic-diabetic patients waiting for liver transplant because of an unresectable hepatocarcinoma underwent an oral glucose tolerance test (OGTT) to assess the beta-cell function and an insulin clamp combined with [3-(3)H]glucose infusion to measure whole body glucose metabolism before and 2 years after the transplant. Seven cirrhotic nondiabetic patients, 11 patients with chronic uveitis on similar immunosuppressive therapy, and 7 healthy subjects served as control groups. Cirrhotic patients showed a profound insulin resistance, and diabetics in addition also showed increased endogenous glucose production (P

Age, female sex, and obesity are well-known risk factors for gallstones; in contrast the possible role of type 2 diabetes mellitus (type-2 DM) is controversial. One reason for this discrepancy might be that type 2 DM is often accompanied by obesity. Therefore, the aim of this study was to evaluate the importance of obesity and of type 2 DM, separately and together, as risk factors for gallstones. In all, 203 obese patients with normal glucose tolerance (obese NGT), 446 obese patients with type 2 DM (obese type 2 DM), 269 lean patients with type 2 DM (lean type 2 DM) and 250 lean subjects with a normal glucose tolerance (lean NGT) were evaluated by ultrasonography for the presence of gallstones. At univariate analysis patients with gallstones (177) were older and were more frequently affected by both obesity and type 2 DM, and had higher triglycerides and fasting blood glucose levels. At multiple logistic regression analysis, only age and obesity, both in the presence or in absence of type 2 DM, were strongly associated with gallstones (P < 0.001); diabetes alone had a lower level of statistical significance (P = 0.07). These data suggest that obesity is a stronger risk factor for gallstones than type 2 DM.

The aim of this study was to evaluate the controversial specificity of the plasma amino acid (AA)-consumption test in detecting pancreatic diseases by using two different quantitative methods. A total of 55 subjects: 13 healthy subjects, 13 patients with chronic pancreatitis (three mild/moderate, eight severe), 13 patients with pancreatectomy and complete suppression of the exocrine pancreatic secretion, eight patients with chronic liver disease (five with impaired synthetic function), and eight patients with chronic renal failure. Total plasma AAs were quantified by a colorimetric method (p-benzoquinone) in all subjects, at 0, 30, 45, and 60 min during and 30 min after minute 60 of i.v. cerulein infusion (50 ng/kg/h). Either total and individual AAs were quantified by chromatography (high-performance liquid chromatography; HPLC) in 10 healthy subjects, 10 patients with pancreatectomy, and 10 with chronic pancreatitis at 0 and 60 min after the start of the cerulein infusion. For the colorimetric method, healthy subjects had maximal percentage decreases of total AA concentrations not significantly different from those of patients with pancreatectomy and significantly higher than those of patients with chronic pancreatitis (p0.0001) or chronic liver disease (p0.001). Pancreatic function, as assessed by fecal elastase-1 test, was not significantly correlated to the maximal percentage decrease in total plasma AAs. For the chromatographic method, total AA concentrations were not significantly correlated to those determined by colorimetry. The concentration of each of the individual plasma AAs varied considerably in each group. Fecal elastase-1 values were normal (or = 200 microg/g) in all patients without pancreatic disease and in only one of 11 patients with chronic pancreatitis and exocrine insufficiency. The type of method used can explain the different results of the AA-consumption test. This test is not very specific for the pancreas.

We evaluated ciliochoroidal effusion (CE) by ultrasound biomicroscopy (UBM) following diode endophotocoagulation at the end of the vitreoretinal surgery. The aim of our study was to assess any differences in the CE morphology following diode endophotocoagulation or transpupillary krypton photocoagulation, and to demonstrate the influence of diabetes and intravitreal surgery on CE formation. Sixty-six consecutive patients were divided in to four groups. Twenty-nine patients with proliferative retinopathy underwent transpupillary krypton photocoagulation; 11 diabetic patients underwent vitreoretinal surgery and diode endophotocoagulation; 18 nondiabetics underwent vitreoretinal surgery and diode endophotocoagulation; 8 consecutive nondiabetic patients were the control group and underwent vitreoretinal surgery, without laser treatment. UBM was performed in the four groups before and after laser treatment, if performed. We determined, by UBM, not only the presence, but also the thickness of CE. CE was present in all the patients treated by laser, diabetics and nondiabetics, and its thickness was not correlated with the number of laser spots (p = 0.28). CE was seen ultrasonically in all the patients undergoing transpupillary photocoagulation or endophotocoagulation, regardless of diabetes and surgical trauma.

Hypoglycaemia is an important complication of insulin treatment in Type 1 diabetes mellitus (DM). Pancreas transplantation couples glucose sensing and insulin secretion, attaining a distinctive advantage over insulin treatment. We tested whether successful transplantation can avoid hypoglycaemia in Type 1 DM. Combined kidney and pancreas transplanted Type 1 DM who complied with good function criteria (KP-Tx, n = 55), and isolated kidney or liver transplanted non-diabetic subjects on the same immunosuppressive regimen (CON-Tx, n = 14), underwent 1-day metabolic profiles in the first 3 years after transplantation, sampling plasma glucose (PC) and pancreatic hormones every 2 hours. KP-Tx had lower PG than CON-Tx in the night and in the morning and higher insulin concentrations throughout the day. KP-Tx had lower PC nadirs than CON-Tx (4.40 +/- 0.05 vs 4.96 +/- 0.16 mmol l(-1), ANOVA p = 0.001). Nine per cent of KP-Tx had hypoglycaemic values (PG less than or equal to 3.0 mmol l(-1)) in the profiles, both postprandial and postabsorptive, whereas none of CON-Tx did (p < 0.02). In conclusion, after pancreas transplantation, mild hypoglycaemia is frequent, although its clinical impact is limited. Compared to insulin treatment in Type 1 DM, pancreas transplantation improves but cannot eliminate hypoglycaemia. (C) 1998 John Wiley & Sons, Ltd.

ATIII is decreased in sepsis and/or shock and its baseline value correlates with mortality. The efficacy of ATIII therapy on mortality was assessed in a selected group of patients admitted to the intensive care unit (ICU) in a double-blind, randomized, multicenter study.120 patients admitted to the ICU with an ATIII concentration70% were randomized to receive ATIII (total dose 24000 units) or placebo treatment for 5 days; 56 patients had septic shock.ATIII concentrations in the treated group remained constant throughout the treatment period (range 97-102%). The Kaplan-Meier analysis showed no difference in overall survival between the two groups: 50 and 46% for ATIII and placebo, respectively. Septic shock and hemodynamic support were unbalanced in the two groups at admission. Therefore the Cox analysis was carried out after adjusting for these two variables. Treatment with ATIII decreases the risk of death with an odds ratio (OR) of 0.56. Of the covariates analyzed, septic shock and the baseline multiple organ failure score were negatively associated with survival and plasma activity level was positively associated with survival with an OR of 0.97 for each 1% increase in the ATIII plasma concentration at baseline.The results of ATIII treatment in this population of patients suggests that replacement therapy reduces mortality in the subgroup of septic shock patients only.

New magnetic resonance (MR) measures considered to be putative markers of demyelination and axonal loss were found to be more closely related to clinical disability than T2-weighted MR imaging (MRI) findings in patients with multiple sclerosis (MS). In this study, we evaluated the reproducibility of such measurements in order to assess their reliability for longitudinal studies in MS. The intra-observer coefficients of variation for repeated measurements did not significantly differ among the MR techniques studied [2.6% for T2-weighted MRI, 4.38% for unenhanced T1-weighted MRI, 3.65% for magnetisation transfer imaging (MTI) and 2.28% for spinal cord cross-sectional area at C5]. Our findings suggest that non-conventional MR techniques may be reliable outcome measures for clinical trials in MS.

PURPOSE To evaluate the frequency of peripheral vitreoretinal adhesions in the region of the vitreous base by ultrasound examination in relation to axial length of the eye and the age of the patient. Patient gender and the presence of visual symptoms also were considered. METHODS A total of 228 consecutive patients (445 eyes) underwent biometry, ultrasound examination, and biomicroscopic fundus examination. Their medical history also was taken. The patients were divided into three groups according to axial length of the eye ( 26.5 mm) and into three age groups (20-40 years, 41-60 years, and > 60 years). RESULTS No correlations was found between peripheral vitreoretinal adhesions and gender or between peripheral vitreoretinal adhesions and axial length of the eye. A significant correlation was found between peripheral vitreoretinal adhesions and age (P < 0.001). The proportion of adhesions increased with age (P < 0.001). The association between adhesions and presence of symptoms also was significant (P < 0.001). Multivariate analysis showed that only the presence of symptoms independently correlated with adhesions (relative risk, 1.71, 95%; confidence interval, 1.19, 2.46). CONCLUSION Our study shows that peripheral vitreoretinal adhesions, detected by ultrasound, were always associated with the presence of symptoms.

BACKGROUND: The aim of this study was to evaluate, according to functional response, the neuroendocrine and inflammatory status in patients with chronic heart failure before and after therapy with carvedilol. METHODS AND RESULTS: Serum tumor necrosis factor-α (TNF-α) soluble receptors (sTNF-R1 and sTNF-R2), interleukin (IL)-10 and IL-18, chromogranin A (CgA) and brain natriuretic peptide (pro-BNP) were measured in 37 New York Heart Association class II to IV heart failure patients, at baseline and after 6 months of therapy with carvedilol. Patients were divided in two groups according to whether, following carvedilol, left-ventricular ejection fraction (LVEF) had increased by at least 5% (17 patients) or not (20 patients). Baseline LVEF was higher in nonresponders (38 ± 5 vs. 31 ± 7%, P = 0.002). In responders, LVEF increased from 31 ± 7 to 51 ± 7% (P < 0.0001), whereas in nonresponders it decreased from 38 ± 5 to 33 ± 7%, (P = 0.02). sTNF-R1 (P = 0.019) and sTNF-R2 (P = 0.025) increased in nonresponders, whereas they did not change in responders. After carvedilol, IL-10 was significantly higher in responders (P = 0.03). Conversely, no significant IL-18 and CgA changes were observed in either group. CgA was not significantly different between groups at baseline and after carvedilol in either group, whereas pro-BNP significantly increased in nonresponders (from 438 ± 582 to 1324 ± 1664 pg/ml, P = 0.04) and decreased in responders (from 848 ± 1221 to 420 ± 530 pg/ml, P = 0.08). CONCLUSION: Increased inflammatory activation observed only in heart failure patients not improving left-ventricular function after carvedilol may indicate that inflammation, either as a direct cause or as a consequence, is associated with progressive ventricular dysfunction. © 2012 Italian Federation of Cardiology

SummaryThe association of cigarette smoking with the development of occlusive vascular disease is firmly established. Unfavourable changes in a series of variables held independent risk factors for the development of vascular lesions (HDL-cholesterol, haematocrit, white blood cell count, fibrinogen and plasminogen activator inhibitor-1 (PAI-1)) are thought to be directly influenced by cigarette smoking. However, the role played by the genotype in the effect of smoking on the above parameters has not been investigated. To control the genotype, we studied the relationship between cigarette smoking and a series of cardiovascular risk factors in 27 monozygotic twin pairs (7 male and 20 female pairs, mean age ± SD: 47.4 ± 12.9 yrs) with a life-long discordance for smoking. Smoking twins had a life-long dose of smoking (Brickman index) of 287.3 ± 241.5. Body mass index, blood pressure, haematocrit, haemoglobin and red blood cell counts, total cholesterol levels and the acute phase reactants α-acid glycoprotein and C-reactive protein were similar in smokers and non-smokers. Triglyceride was higher by 12.6% (9.5-35%, 95% confidence interval, p = 0.02) and HDL-cholesterol lower by 7.5% (0.2-15%, p = 0.04) in the smoking co-twins, who also had 8.4 % (-0.2-17%, p = 0.06) higher white blood cell counts and 4.1% (1.2-7%, p

Between 1989 and 1993, 62 patients underwent Whipple pancreatoduodenectomy and 75 pylorus-preserving pancreatoduodenectomy (PPPD); 35 patients in the first group and 37 in the second had pancreatic adenocarcinoma while 17 and 21 patients respectively had periampullary adenocarcinoma. The aim of this retrospective study was the comparison of operative outcome, nutritional recovery and survival of patients who underwent these two operations. No significant differences were found between the two groups in operative mortality or morbidity, duration of gastric aspiration and time to start of solid meals. Patients who underwent PPPD had a better nutritional recovery: the increase of both body-weight and serum albumin level at 6 months after discharge was significantly higher for those who had preservation of the whole stomach (P < 0.001 and P < 0.05 respectively). No significant difference in survival was found between the two procedures when patients with pancreatic or periampullary adenocarcinoma were analysed separately.