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Abstract The purpose of this paper is to analyse the impact of European Regional Development Fund (ERDF) regulations over two programming periods (2000–2006 and 2007–2013) in terms of separate waste collection rates of Italian regions. We analyse longitudinal data for 20 NUTS-2 Italian regions over two EU policy cycles (2000–2006 and 2007–2013), by means of a Difference-in-differences estimation method. The estimates suggest that ERDF regulations in both programming periods had no relevant impact on the achievement of cohesion policy goals for separate collection at the regional level. Subsequently, we analyse data for 103 NUTS-3 Italian provinces over 2000–2013 by means of two statistical tools: The Theil index (TI), and the Moran index (MI), and find that proximity effects at provincial scale cause positive social contagion of pro-environmental attitudes toward separate collection. Our results make a case for the relevance of 'cultural' policy measures fostering environmentally responsible attitudes as a possible pre-condition for effective implementation of ERDF-funded separate collection projects in low-performing regions. Highlights • We analyze the impact of European Regional Development Fund on separate collection. • We implement a Difference in differences analysis on Italian Regions. • We show a failure on the two EU programmes on separate collection process. [ABSTRACT FROM AUTHOR]

We analyze the impact of Regulation (EC) No 1080/2006 on separate collection rate of Italian regions. We exploit longitudinal data for 20 NUTS-2 Italian regions and eighteen years (from 1996 to 2013). We identify regions which are exposed to “Convergence” objective as the treatment group and regions which are not exposed to this objective as the control group and use a Difference in differences estimation. The estimates suggest that the Regulation (EC) No 1080/2006 has not influenced the convergence process among the Italian regions. The main policy implications are discussed. [ABSTRACT FROM AUTHOR]

Abstract: Introduction: The aim of this study was to assess the impact of laparoscopic thermoablation (LTA) and laparoscopic resection (LR) as neoadjuvant therapy before orthotopic liver transplantation (OLT) for hepatocellular carcinoma (HCC). Methods: From June 2005 to November 2010, 50 consecutive patients affected by HCC with liver cirrhosis were treated with LTA under ultrasound guidance or LR. Of them, 10 patients (mean age, 58.3 ± 5.59 years; male:female, 8:2) underwent OLT. They were mostly Child-Pugh class A (80%). Results: A LTA of 12 nodules was achieved in 7 patients and an LR of 3 HCC nodules in the other 3 subjects. The mean length of surgery was 163 minutes (range; 60–370). The mean hospital stay was 6.1 days. Transient mild postoperative liver failure was reported in 1 case. Complete tumor necrosis was observed in 10 thermoablated nodules (83.3%) via spiral computerized tomographic scan at 1 month after treatment; the resected patients showed absence of recurrence. All patients underwent OLT after a mean interval of 7 months. The histology of the native liver showed complete necrosis in 9/12 thermoablated nodules (75%); a recurrence at surgical site occurred in 1 patient in the resection group. Conclusions: Laparoscopic ultrasound can be used in potential OLTs candidates to accurately stage HCC in advanced cirrhosis with minimal morbidity. LTA and LR proved to be safe and effective techniques for HCC patients, representing a valid “bridge” to OLT. [Copyright &y& Elsevier]

Background: Liver transplantation (OLT) can entail a high risk of blood loss requiring transfusions, which increase morbidity and mortality. In recent years many efforts have been spent to improve the surgical and anesthetic management to decrease transfusion rates during OLT. Preoperative predictors for transfusion in OLT, remain uncertain. Methods: We retrospectively reviewed the 219 OLT performed from 2005 to 2011 focusing on blood product (BP) transfusions. Statistical analysis sought the impact of transfusions on OLT outcomes to identify possible independent predictors of higher BP requirements. Results: The 1- and 3-year survival rates were 86.6% and 76.45% for patients and 81.0% and 71.8% for grafts respectively. The mean intra- and perioperative red blood cell (RBC) transfusion rates were 12.3 ± 11.7 U and 15.5 ± 13.0 U respectively. A statistical analysis demonstrated a significant influence of BP transfusion on post-OLT complications and survivals. Multivariate logistic regression analysis showed the Model for End-Stage Liver Disease (MELD) score to be the only independent predictor of perioperative RBC transfusions. Conclusions: Our results confirmed the link between intra- and perioperative transfusions and outcome of OLT patients. MELD score resulted the only independent variable associated with increased perioperative RBC transfusions. [ABSTRACT FROM AUTHOR]

Abstract: Severe renal dysfunction may occur after orthotopic liver transplantation (OLT). In this study, we retrospectively analyzed a single-center series of adult liver recipients (n = 62) seeking to identify patients prone to develop renal dysfunction during follow-up. Liver recipients (age range, 53.54 ± 8.19 years; female/male: 21/41) who underwent a first OLT from a brain dead donor were enrolled according to strict criteria. We enrolled only liver recipients with 5 serum creatinine (SCr) measurements after hospital discharge and at least 1 measurement/year with a follow-up period of not less than 2 years. We estimated glomerular filtration rate (eGFR) using the formula developed by the Mayo Clinic. The average rate of SCr change after OLT was 0.0065 ± 0.013 mg/dL/mo. By calculating the per-patient slope, the average rate of SCr change was 0.000165 ± 0.000383 mg/dL (0.000007 ± 0.000017 mg/dL/mo). In regression models evaluated with SCr as the dependent variable versus post-OLT time, no significance was observed (P = .130). The average rate of eGFR change after OLT was −0.462 ± 0.883 mL/min/mo. By calculating the per-patient slope, the average rate of eGFR change was −0.009 ± 0.0026 mL/min (−0.0004 ± 0.0012 mL/min/mo). In the regression models evaluated with eGFR as dependent variable versus post-OLT time, no significance occurred (P = .168). By applying the regression prediction to SCr at 3 to 5 versus the 1 to 2 post-OLT measurements, we noted 3 male liver recipients (MLR) whose SCr values were significantly higher than the predicted values: MLR1: P = .048 at measurement 4; MLR2: P = .019 at measurement 4; and MLR3: P = .017 at measurement 5. Conversely, we did not observed a significant difference between observed versus predicted eGFR values. Clinical decisions on immunosuppressive treatments for liver recipients should be determined also on the basis of the series of post-OLT kidney function, which should be studied with rigorous evaluation of fitted regression models. [Copyright &y& Elsevier]

Abstract: In the organ transplantation area the application of the evidence-based medicine (EBM) methods may be limited by several, heterogeneous conditions, eg, mandatory laws and protocols, logistic concerns, as well as donor/recipient matching. In this report we have described the results of a first EBM-oriented course for surgeons and health personnel in a regional transplantation center under the Italian Continuing Medical Education (CME) program. The course was formally approved for 25 credits. It included a maximum of 70 medical and nursing staff registrants; 50 of the spots were reserved for our transplantation center. The course was scheduled in 10 sessions from June to November 2010. Each session was composed of 2 phases: (1) first, computer-assisted education including slide presentations (2 hours); and (2) subsequent discussion led by experts (1.5 hours). The registered participants were expected to be able to correctly answer a multiple-choice, 10-question questionnaire at the end of each session. The majority of the participants considered the course relevant to their need to be updated and effective to improve their clinical skills. The requirements to obtain credits by the Italian CME program for live events were overall presence ≥80% and correct responses in the postsession questionnaires ≥70%. However, among the initially registered participants 31.5% failed at least one of these requirements. The main reason for failure was exceeding the maximum number of absences. Paradoxically, the absences were largely caused by the simultaneous execution of surgical/medical transplantation procedures. For professional figures engaged in complex medical activities, the Italian CME program should consider different threshold limits for the maximum number of absences allowed at live events. [Copyright &y& Elsevier]

Abstract: In many Western countries a “minimum volume rule” policy has been adopted as a quality measure for complex surgical procedures. In Italy, the National Transplant Centre set the minimum number of orthotopic liver transplantation (OLT) procedures/y at 25/center. OLT procedures performed in a single center for a reasonably large period may be treated as a time series to evaluate trend, seasonal cycles, and nonsystematic fluctuations. Between January 1, 1987 and December 31, 2006, we performed 563 cadaveric donor OLTs to adult recipients. During 2007, there were another 28 procedures. The greatest numbers of OLTs/y were performed in 2001 (n = 51), 2005 (n = 50), and 2004 (n = 49). A time series analysis performed using R Statistical Software (Foundation for Statistical Computing, Vienna, Austria), a free software environment for statistical computing and graphics, showed an incremental trend after exponential smoothing as well as after seasonal decomposition. The predicted OLT/mo for 2007 calculated with the Holt-Winters exponential smoothing applied to the previous period 1987–2006 helped to identify the months where there was a major difference between predicted and performed procedures. The time series approach may be helpful to establish a minimum volume/y at a single-center level. [Copyright &y& Elsevier]

Abstract: The usage of a computerized system to organize data and ease the activity procedures of liver transplantation is useful in clinical transplantation. Preliminary cognitive research on systems of clinical transplantation database concerning medical reports was performed to verify their development level. The survey highlighted that, so far, there has been no experimentation that can be applied to a medical report type devoted to liver transplantation. Regulations in force substantially point out that the medical report ought to contain all items that have to be taken into account in handling the patient from pretransplantation to follow-up. The Department of Transplantation of Genoa chose its medical report model for liver transplantation. The medical report model included the following items: personal data; case history; diagnosis; initial examination for prelisting; fitness for transplantation; assistance context; clinical data including subjective, objective, and instrumental parameters; pharmacological therapies; informed consent, evaluation of fitness; nursing data; counseling and clinical evaluations according to protocols and guidelines of the national transplantation centers. If the computing is well trained, it is supposed to help maintain a whole data view provided it is supplied information in an adequate way. Immediate clinical procedural advantages and useful scientific observations may be obtained from a high-quality database. In fact, all functions have to be applied to specific clinical, administrative needs to be remotely shared and conveniently integrated with each other to make the liver transplantation medical report an easy and handy instrument for inputting and handling data. It must be a precise, complete instrument that may be accessible in real time from any site connected with the intranet network, be unchangeable, and be protected to ensure certification and forensic medicine value. [Copyright &y& Elsevier]

Abstract: Patients diagnosed with acute alcoholic hepatitis (AAH) are routinely managed medically and not considered suitable for orthotopic liver transplantation (OLT). The eligibility for OLT in these patients has been questioned due to the social stigma associated with alcohol abuse, based on the fact that AAH is “self-induced” with an unacceptably high recidivism rate. Many centers in Europe and the United States require abstinence periods between 6 and 12 months before OLT listing. AAH outcomes in the literature are poor, in particular due to patient noncompliance during the immediate 3 months preceeding OLT. Between January 1997 and December 2007, 246 patients were evaluated in our center for alcoholic liver disease: 133 (54%) were listed for OLT (I-OLT), including 110 (83%) who underwent transplantation and 8 (6%) still listed as well as 15 (11%) removed from consideration. One hundred thirteen (46%) patients had no indication for OLT (NO I-OLT), including 18 (16%) who died, 81 (71%) still monitored, and 14 (12%) lost to follow-up. Patient survival rates post-OLT were 79%, 74%, 68%, and 64% at 1, 3, 5, and 10 years, respectively. Explant (native liver) pathologic examination revealed AAH in 8 (7.2%) patients who underwent OLT. In this group, patient survival and the post-OLT recidivism rate were statistically identical to the overall group of transplant recipients. [Copyright &y& Elsevier]

Abstract: Sirolimus (SRL) is an mTOR inhibitor that has been shown, in contrast to calcineurin inhibitors (CNI), to inhibit cancers in experimental models. Since February 2005, we introduced SRL in liver transplant patients in group a, in whom the primary disease was hepatocellular carcinoma (HCC) associated with hepatitis B virus (HBV), hepatitis C virus (HCV), alcoholic or autoimmune liver cirrhosis, and group b, HCC-negative patients who developed posttransplantation cancers de novo. Of 18 patients in group a, 11 received SRL ab initio (subgroup a1), starting for 10 patients at 66.1 ± 29.2 days after surgical healing and after 10 days in 1 case; the remaining 7 patients (subgroup a2) received SRL at 31.2 ± 24.2 months. Three patients in group b, included 1 with Kaposi''s sarcoma, 1 with bladder cancer, and 1 with thyroid cancer. In this group, SRL was introduced at 80.8 ± 40.4 months. In all patients but one, who received a single 5 mg loading dose, SRL was started at 2 mg/d and adjusted to 6 to 8 ng/mL blood levels. CNI drugs, present as primary therapy, were gradually tapered to low levels and eventually stopped. The following observations were drawn from this initial experience: (1) 4/21 (19.0%) patients had to discontinue SRL because of early and late side effects: thrombocytopenia (n = 2) and headache with leukopenia and leg edema associated with knee joint arthralgia (n = 2); (2) 14 patients (11 in group a and 3 in group b) are still on SRL monotherapy; (3) 1 HCC recurrence and 1 de novo pancreatic adenocarcinoma were observed at 14 and 16 months, respectively (at the time of transplantation, both patients were beyond the MIlan HCC criteria), and (4) 1 patient, from subgroup a1, died after 99 days due to pneumonitis and possible relation to SRL lung toxicity. In conclusion, SRL appeared to be an effective immunosuppressant that could be used as monotherapy in liver transplant patients. Any conclusion on SRL anticancer effects can only come from randomized large studies after long follow-up. [Copyright &y& Elsevier]

Abstract: Since February 2002, the United Network for Organ Sharing (UNOS) proposed to adopt a modified version of the Model for End-Stage Liver Disease (MELD) to assign priority on the waiting list for orthotopic liver transplantation (OLT). In this study, we evaluated the impact of MELD score on liver allocation in a single center series of 198 liver recipients (mean age of patients, 52.21 ± 8.92 years), considering the relationship between clinical urgency derived from MELD score (overall MELD, 18.7 ± 6.83; MELD <15 in 69 patients, MELD ≥15 in 129 patients) and geographical distribution of cadaveric donors (inside/outside Liguria Region, 125/73). The waiting time for OLT was 230 ± 248 days, whereas the 3-month and 1-year patient survivals were 87.37% and 79.79%, respectively. No difference was observed for MELD score retrospectively calculated for patients who underwent OLT before February 2002 (n = 71) compared with MELD score calculated for patients who received a liver thereafter (18.26 ± 6.68 vs 18.94 ± 6.92; P = .504). No significant difference was found in waiting time before and after adoption of MELD score (213 ± 183 vs 238 ± 278 days; P = .500), or by stratifying patients for MELD <15/≥15 (225 ± 234 vs 232 ± 256 days; P = .851). Using the geographical distribution of donors as a grouping variable (outside vs inside Liguria Region), no significance occurred for MELD score (19.68 ± 7.42 vs 18.17 ± 6.42; P = .135) or waiting time (211 ± 226 vs 242 ± 261 days; P = .394). In our series, more OLTs were performed among sicker patients and no differences were found in the management of livers procured from cadaveric donors outside or inside Liguria Region. However, further efforts are needed to reduce the waiting time among patients with higher MELD scores. [Copyright &y& Elsevier]

Abstract: Torque Teno Virus (TTV), a nonenveloped human virus of the Circoviridae family, is hepatotropic, causing liver damage, cirrhosis, and, rarely, fulminant hepatitis. It prevails in 10% to 75% of blood donors due to environmental differences, independent of chronic hepatitis B virus (HBV)/HCV hepatitis, cryptogenic cirrhosis, alcoholic cirrhosis, and in fulminant hepatitis non-A-G. Reports about the efficacy of clinical alpha interferon are rare. In July 2007, a 65-year-old man who was serologically negative for A-E viruses presented with acute liver failure due to a ruptured hepatic artery aneurysm and underwent orthotopic liver transplantation (OLT). Immunosuppression was based on cyclosporine and steroids. At postoperative day 20, there was persistent hypertransaminasemia with otherwise normal liver function. A percutaneous hepatic biopsy documented pattern suggestive of a viral etiology. Multiple tests for hepatotropic viruses in the donor and the recipient from the pre- and post-OLT periods remained negative. Only the TTV qualitative test, assessed by polymerase chain reaction (PCR) on patient sera, was positive. Immunosuppressive therapy was not changed; no antiviral therapy was undertaken. At 6 months posttransplantation, transaminase levels spontaneously normalized and the clinical situation was unchanged. No complications were observed; the patient is in good clinical condition. No graft rejection was observed. In histologically proven non-A-E viral hepatitis, it is important to consider TTV as an incidental pathogenic agent. It may be useful to extend virological tests to TTV among transplant recipients and donors and to gain further knowledge about this virus. [Copyright &y& Elsevier]

Abstract: We retrospectively evaluated the impact of our strategy for patients with hepatocellular carcinoma (HCC) according to an intention-to-treat analysis and drop-out probability. We evaluated only patients within the Milan criteria. We analyzed the outcomes of neoadjuvant strategies for HCC, organ allocation policy, and systematic application of strategies to increase the deceased donor pool as the current tendency to expand transplantability criteria for those patients. Kaplan-Meier survival probability rates at 1, 3, and 5 years according to an intention-to-treat analysis were 87.02%, 74.53%, and 65.93% for transplanted patients (n = 108), and 50%, 14.29%, and 14.29% for the excluded or waiting list group (n = 13), respectively (P < .0001). Drop-out risk at 3, 6, and 12 months was 2.40%, 8.59%, and 16.54%, respectively. During the same period, the mortality probability rates at 3, 6, and 12 months among patients without HCC awaiting orthotopic liver transplantation (OLT) were 3.60%, 9.50%, and 18.34%, respectively. Drop-out rate was lower among patients treated before OLT (P < .0001). On the basis of the neoadjuvant treatment results to reduce drop-out risk, we suggest avoiding the high priority for the HCC cohort, particularly within the first 6 months from entrance on the waiting list, because this approach can reduce the chances of patients with end-stage liver disease (ESLD) alone. [Copyright &y& Elsevier]