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Background: Fractional flow reserve (FFR) or non-hyperaemic pressure ratios are recommended to assess functional relevance of intermediate coronary stenosis. Both diagnostic methods require the placement of a pressure wire in the coronary artery during invasive coronary angiography. Quantitative flow ratio (QFR) is an angiography-based computational method for the estimation of FFR that does not require the use of pressure wires. We aimed to investigate whether a QFR-based diagnostic strategy yields a non-inferior 12-month clinical outcome compared with an FFR-based strategy., Methods: FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial comparing a QFR-based with an FFR-based diagnostic strategy for patients with intermediate coronary stenosis. Enrolment was performed in 34 centres across 11 European countries. Patients aged 18 years or older with either chronic coronary syndrome or stabilised acute coronary syndrome, and with at least one intermediate non-culprit stenosis (40-90% diameter stenosis by visual estimate; referred to here as a study lesion), were randomly assigned (1:1) to the QFR-guided or the FFR-guided group. Randomisation was done using a concealed web-based system and was stratified by diabetes and presence of a left anterior descending coronary artery study lesion. The primary endpoint was a composite of death, myocardial infarction, and unplanned revascularisation at 12 months. The predefined non-inferiority margin was 3·4% and the primary analysis was performed in the intention-to-treat population. The trial was registered with ClinicalTrials.gov (NCT03729739) and long-term follow-up is ongoing., Findings: Between Nov 6, 2018, and July 21, 2023, 2000 patients were enrolled and randomly assigned to the QFR-guided strategy (1008 patients) or the FFR-guided strategy (992 patients). The median age was 67·3 years (IQR 59·9-74·7); 1538 (76·9%) patients were male and 462 (23·1%) were female. Median follow-up time was 365 days (IQR 365-365). At 12 months, a primary endpoint event had occurred in 67 (6·7%) patients in the QFR group, and in 41 (4·2%) patients in the FFR group (hazard ratio 1·63 [95% CI 1·11-2·41]). The event proportion difference was 2·5% (90% two-sided CI 0·9-4·2). The upper limit of the 90% CI exceeded the prespecified non-inferiority margin of 3·4%. Therefore, QFR did not meet non-inferiority to FFR. A total of 18 (1·8%) patients in each group experienced an adverse procedural event, the most frequent being procedure-related myocardial infarction, which occurred in ten (1·0%) patients in the QFR group and seven (0·7%) in the FFR group. One patient in the QFR group died in relation to the index procedure., Interpretation: The results of the FAVOR III Europe trial do not support the use of QFR if FFR is available to guide revascularisation decisions in patients with intermediate coronary stenosis. This finding could have implications for current clinical guidelines recommending QFR for this purpose., Funding: Medis Medical Imaging Systems and Aarhus University., Competing Interests: Declaration of interests BKA reports an institutional research grant from Medis Medical Imaging and free licences for the QFR application from Medis Medical Imaging during the trial. GCam reports institutional research grants from SMT, Medis Medical Imaging, Abbott Vascular, GADA, Siemens, and GE Healthcare outside the present work. TR reports consultant and proctoring honoraria from Boston Scientific, EPS Vascular, and Cardirad. BES is supported by the H H Sheikh Khalifa bin Hamad Al-Thani Research Programme; has received research grants to the institution from Boston Scientific, the B Braun Foundation, the German Center for Cardiovascular Research (DZHK), the German Heart Research Foundation, Edwards Lifesciences, the Iten-Kohaut Foundation, and the OPO Foundation; has received consulting and speaker fees from Abbott Vascular, Abiomed, and Boston Scientific; and received free licences for the QFR application from Medis Medical Imaging during the trial. LDS reports consulting fees from Abbott Vascular, Boston Scientific, and Philips outside the submitted work. JE reports serving as a speaker or advisory board member for Abbott, Boston Scientific, Medis Medical Imaging, and Philips. RL-P received a free licence for the QFR software from Medis Medical Imaging during the trial. UL reports research grants to the institution from Abbott, Amgen, Bayer, and Novartis. RSD reports an institutional research grant from Medis Medical Imaging and free licences for the QFR application from Medis Medical Imaging during the trial. HM-R reports consultancy fees from Medis Medical Imaging and speaker fees from Philips and Abbott. LK received free licences for the QFR application from Medis Medical Imaging during the trial. JA reports teaching grants from Biotronik and Medis Medical Imaging. YSA reports consulting fees from Boston Scientific and Shockwave. TL served as a Medis technical and research support consultant in Haga Hospital (The Hague, Netherlands) and performed beta testing of software from Medis Medical Imaging, neither of which was study related, and received a free licence for the QFR application from Medis Medical Imaging during the trial. KL received free licences for the QFR application from Medis Medical Imaging during the trial; speaker fees and travel support from BMS and Boston Scientific; speaker fees from DGK; and served as an advisory board member for BMS. GCas received a free licence for the QFR application from Medis Medical Imaging during the trial. SB reports institutional research grants from Medis Medical Imaging, SMT, Abbott, Siemens, Insight Lifetech, and Amgen; free licences for the QFR application from Medis Medical Imaging during the trial; speaker's fee from SMT, Medis Medical Imaging, Abbott, and Siemens; and advisory board activities for Siemens. NTO reports institutional research grants from Abbott and from Shockwave. RS reports an institutional research grant from Abbott; institutional research contract with Medis Medical Imaging; and speaker and consultation fees from Abbott and Fondazione Menarini. EHC reports institutional research grants from Abbott, Biosensors, Meril, and Medis Medical Imaging; and speaker fees from Abbott and EPS. NRH reports Institutional research grants from Abbott, B Braun, Biosensors, Boston Scientific, and Medis Medical Imaging; and speaker fees from Abbott and EPS. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Background and Aim: Diabetes has been shown in last decades to be associated with a significantly higher mortality among patients with ST-segment elevation myocardial infarction (STEMI) treated with primary PCI (PPCI). Therefore, the aim of current study was to evaluate the impact of diabetes on times delays, reperfusion and mortality in a contemporary STEMI population undergoing PPCI, including treatment during the COVID pandemic., Methods and Results: The ISACS-STEMI COVID-19 is a large-scale retrospective multicenter registry involving PPCI centers from Europe, Latin America, South-East Asia and North-Africa, including patients treated from 1st of March until June 30, 2019 and 2020. Primary study endpoint of this analysis was in-hospital mortality. Secondary endpoints were postprocedural TIMI 0-2 flow and 30-day mortality. Our population is represented by 16083 STEMI patients. A total of 3812 (23,7 %) patients suffered from diabetes. They were older, more often males as compared to non-diabetes. Diabetic patients were less often active smokers and had less often a positive family history of CAD, but they were more often affected by hypertension and hypercholesterolemia, with higher prevalence of previous STEMI and previous CABG. Diabetic patients had longer ischemia time, had more often anterior MI, cardiogenic shock, rescue PCI and multivessel disease. They had less often out-of-hospital cardiac arrest and in-stent thrombosis, received more often a mechanical support, received less often a coronary stent and DES. Diabetes was associated with a significantly impaired postprocedural TIMI flow (TIMI 0-2: 9.8 % vs 7.2 %, adjusted OR [95 % CI] = 1.17 [1.02-1.38], p = 0.024) and higher mortality (in-hospital: 9.1 % vs 4.8 %, Adjusted OR [95 % CI] = 1.70 [1.43-2.02], p < 0.001; 30-day mortality: 10.8 % vs 6 %, Adjusted HR [95 % CI] = 1.46 [1.26-1.68], p < 0.001) as compared to non-diabetes, particularly during the pandemic., Conclusions: Our study showed that in a contemporary STEMI population undergoing PPCI, diabetes is significantly associated with impaired epicardial reperfusion that translates into higher in-hospital and 30-day mortality, particularly during the pandemic., (Copyright © 2024 The Italian Diabetes Society, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.)

Background: Use of Intra-Aortic Balloon Pump (IABP) in combination with Impella has been described as an alternative strategy for mechanical circulatory support (MCS) in patients with cardiogenic shock (CS). We provide a systematic review aimed to explore the effectiveness of this paired MCS approach., Methods: We conducted a comprehensive systematic search in MEDLINE, Scopus, and Cochrane databases to identify all studies that investigated dual MCS with IABP and Impella., Results: Our search strategy identified 12 articles, including 1 randomized controlled trial, 1 retrospective study, 1 case series, 7 case report and 2 animal studies. Rationale for this combined MCS strategy stems from an observed reduction in myocardial oxygen demand/supply ratio compared to the use of each device alone, without determining significant variations in left ventricular work. Nonetheless, this combined approach also leads to a 30-40 % decline in Impella flow, increasing the risk of bleeding, Impella displacement, as well as triggering positioning and pressure alarms. Additionally, hemolytic risk data yielded inconclusive results. Importantly, there were no notable disparities in mortality rates when comparing the combined strategy to the use of each device individually., Conclusion: At the current state-of-the-art, there are no conclusive data demonstrating net clinical benefits of combining Impella with IABP. Considering the substantial risks of morbidity associated, we recommend against its use in clinical practice., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Jacopo Farina reports administrative support was provided by University Hospital Arcispedale Sant'Anna of Ferrara Department of Cardiology. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: The role of quantitative flow ratio (QFR) in the treatment of nonculprit vessels of patients with myocardial infarction (MI) is a topic of ongoing discussion., Objectives: This study aimed to investigate the predictive capability of QFR for adverse events and its noninferiority compared to wire-based functional assessment in nonculprit vessels of MI patients., Methods: The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial randomized 1,445 older MI patients to culprit-only (n = 725) or physiology-guided complete revascularization (n = 720). In the culprit-only arm, angiographic projections of nonculprit vessels were prospectively collected, centrally reviewed for QFR computation, and associated with endpoints. In the complete revascularization arm, endpoints were compared between nonculprit vessels investigated with QFR or wire-based functional assessment. The primary endpoint was the vessel-oriented composite endpoint (VOCE) at 1 year., Results: QFR was measured on 903 nonculprit vessels from 685 patients in the culprit-only arm. Overall, 366 (40.5%) nonculprit vessels showed a QFR value ≤0.80, with a significantly higher incidence of VOCEs (22.1% vs 7.1%; P < 0.001). QFR ≤0.80 emerged as an independent predictor of VOCEs (HR: 2.79; 95% CI: 1.64-4.75). In the complete arm, QFR was used in 320 (35.2%) nonculprit vessels to guide revascularization. When compared with propensity-matched nonculprit vessels in which treatment was guided by wire-based functional assessment, no significant difference was observed (HR: 0.57; 95% CI: 0.28-1.15) in VOCEs., Conclusions: This prespecified subanalysis of the FIRE trial provides evidence supporting the safety and efficacy of QFR-guided interventions for the treatment of nonculprit vessels in MI patients. (Functional Assessment in Elderly MI Patients With Multivessel Disease [FIRE]; NCT03772743)., Competing Interests: Funding Support and Author Disclosures The data supporting this paper are accessible upon reasonable request to the FIRE Study Executive Committee. Sahajanand Medical Technologies Ltd, Medis Medical Imaging Systems, Eukon S.r.l., Siemens Healthineers, General Electric Healthcare, and Insight Lifetech provided unrestricted funding to the study sponsor for the conduction of the trial. These companies had no involvement in the trial design, data collection, analysis, interpretation, or writing of the manuscript. Dr Campo has received research grants and personal fees from Abbott Vascular, GADA, Menarini, Amgen, Daichii-Sankyo, and Sanofi outside of the submitted work. Dr Moreno has received speaker/consulting fees from Abbott Vascular, AMGEN, AstraZeneca, Biosensors, Biotronik, Boston Scientific, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, and Philips outside of the submitted work. Dr Barbato declares speaker fees from Abbott Vascular, Boston Scientific, Insight Lifetech, outside of the submitted work. Dr Biscaglia has received funding from the Italian Health Minister (Ricerca Finalizzata 2021, GR-2021-12372516) for the conduction of the Functional Coronary Angiography Guided Revascularization in STEMI trial; and has received personal fees from Abbott Vascular outside of the submitted work., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: The potential benefit on long term outcomes of Percutaneous Coronary Intervention (PCI) on Unprotected Left Main (ULM) driven by IntraVascular UltraSound (IVUS) remains to be defined., Methods: IMPACTUS LM-PCI is an observational, multicenter study that enrolled consecutive patients with ULM disease undergoing coronary angioplasty in 13 European high-volume centers from January 2002 to December 2015. Major Adverse Cardiovascular Events (MACEs) a composite of cardiovascular (CV) death, target vessel revascularization (TVR) and myocardial infarction (MI) were the primary endpoints, while its single components along with all cause death the secondary ones., Results: 627 patients with ULM disease were enrolled, 213 patients (34%) underwent IVUS-guided PCI while 414 (66%) angioguided PCI. Patients in the two cohorts had similar prevalence of risk factors except for active smoking and clinical presentation. During a median follow-up of 7.5 years, 47 (22%) patients in the IVUS group and 211 (51%) in the angio-guided group underwent the primary endpoint (HR 0.42; 95% CI [0.31-0.58] p < 0.001). After multivariate adjustment, IVUS was significantly associated with a reduced incidence of the primary endpoint (adj HR 0.39; 95% CI [0.23-0.64], p < 0.001), mainly driven by a reduction of TVR (ad HR 0.30, 95% CI [0.15-0.62], p = 0.001) and of all-cause death (adj HR 0.47, 95% CI [0.28-0.82], p = 0.008). IVUS use, age, diabetes, side branch stenosis, DES and creatinine at admission were independent predictors of MACE., Conclusions: In patients undergoing ULM PCI, the use of IVUS was associated with a reduced risk at long-term follow-up of MACE, all-cause death and subsequent revascularization., Competing Interests: Declaration of competing interest None., (Copyright © 2024. Published by Elsevier B.V.)

Background: Cardiac magnetic resonance (CMR) plays a pivotal diagnostic role in myocardial infarction with nonobstructive coronary arteries (MINOCA). To date, a prognostic stratification of these patients is still lacking., Objectives: This study aims to assess the prognostic role of CMR in MINOCA., Methods: The authors assessed 437 MINOCA from January 2017 to October 2021. They excluded acute myocarditis, takotsubo syndromes, cardiomyopathies, and other nonischemic etiologies. Patients were classified into 3 subgroups according to the CMR phenotype: 1) presence of late gadolinium enhancement (LGE) and abnormal mapping (M) values (LGE+/M+); 2) regional ischemic injury with abnormal mapping and no LGE (LGE-/M+); and 3) nonpathological CMRs (LGE-/M-). The primary outcome was the presence of major adverse cardiovascular events (MACE). The mean follow-up was 33.7 ± 12.0 months and CMR was performed on average at 4.8 ± 1.5 days from the acute presentation., Results: The final cohort included 198 MINOCA; 116 (58.6%) comprised the LGE+/M+ group. During follow-up, MACE occurred significantly more frequently in MINOCA LGE+/M+ than in the LGE+/M- and normal-CMR (LGE-/M-) subgroups (20.7% vs 6.7% and 2.7%; P = 0.006). The extension of myocardial damage at CMR was significantly greater in patients who developed MACE. In multivariable Cox regression, %LGE was an independent predictor of MACE (HR: 1.123 [95% CI: 1.064-1.185]; P < 0.001) together with T2 mapping values (HR: 1.190 [95% CI: 1.145-1.237]; P = 0.001)., Conclusions: In MINOCA with early CMR execution, the %LGE and abnormal T2 mapping values were identified as independent predictors of adverse cardiac events at ∼3.0 years of follow-up. These parameters can be considered as high-risk markers in MINOCA., Competing Interests: Funding Support and Author Disclosures Dr Bucciarelli-Ducci has received speaker fees from Circle Cardiovascular Imaging, Bayer, Siemens Healthineers; and is the Chief Executive Officer (part-time) for the Society for Cardiovascular Magnetic Resonance. Dr Paolisso is supported by a research grant from the CardioPaTh PhD Program. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Femoral access site-related bleeding represent a prognostically impactful issue in interventional cardiology. The impact of a combined use of ultrasound guidance for femoral access and vascular closure device deployment for arteriotomy closure in femoral artery procedures on bleeding complications is still largely unknown. A systematic review was conducted on Pubmed (Medline), Cochrane library and Biomed Central databases between March and April 2023. A total of 9 studies have been selected, of namely 4 registries, 4 prospective studies and one randomized clinical trial. A systematic use of US guidance to access femoral artery resulted feasible and not time consuming, reduced venipuncture and increased first attempt success. Combination of US guidance and deployment of VCD's had the capacity to further decrease vascular and bleeding combination, especially in those patients at a higher risk of post-procedural bleeding. Ultrasound can be easily used during closure device deployment to reduce device failure and major vascular complications., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Background: Observational studies suggest that bariatric-metabolic surgery might greatly improve non-alcoholic steatohepatitis (NASH). However, the efficacy of surgery on NASH has not yet been compared with the effects of lifestyle interventions and medical therapy in a randomised trial., Methods: We did a multicentre, open-label, randomised trial at three major hospitals in Rome, Italy. We included participants aged 25-70 years with obesity (BMI 30-55 kg/m 2 ), with or without type 2 diabetes, with histologically confirmed NASH. We randomly assigned (1:1:1) participants to lifestyle modification plus best medical care, Roux-en-Y gastric bypass, or sleeve gastrectomy. The primary endpoint of the study was histological resolution of NASH without worsening of fibrosis at 1-year follow-up. This study is registered at ClinicalTrials.gov, NCT03524365., Findings: Between April 15, 2019, and June 21, 2021, we biopsy screened 431 participants; of these, 103 (24%) did not have histological NASH and 40 (9%) declined to participate. We randomly assigned 288 (67%) participants with biopsy-proven NASH to lifestyle modification plus best medical care (n=96 [33%]), Roux-en-Y gastric bypass (n=96 [33%]), or sleeve gastrectomy (n=96 [33%]). In the intention-to-treat analysis, the percentage of participants who met the primary endpoint was significantly higher in the Roux-en-Y gastric bypass group (54 [56%]) and sleeve gastrectomy group (55 [57%]) compared with lifestyle modification (15 [16%]; p<0·0001). The calculated probability of NASH resolution was 3·60 times greater (95% CI 2·19-5·92; p<0·0001) in the Roux-en-Y gastric bypass group and 3·67 times greater (2·23-6·02; p<0·0001) in the sleeve gastrectomy group compared with in the lifestyle modification group. In the per protocol analysis (236 [82%] participants who completed the trial), the primary endpoint was met in 54 (70%) of 77 participants in the Roux-en-Y gastric bypass group and 55 (70%) of 79 participants in the sleeve gastrectomy group, compared with 15 (19%) of 80 in the lifestyle modification group (p<0·0001). No deaths or life-threatening complications were reported in this study. Severe adverse events occurred in ten (6%) participants who had bariatric-metabolic surgery, but these participants did not require re-operations and severe adverse events were resolved with medical or endoscopic management., Interpretation: Bariatric-metabolic surgery is more effective than lifestyle interventions and optimised medical therapy in the treatment of NASH., Funding: Fondazione Policlinico Universitario A Gemelli, Policlinico Universitario Umberto I and S Camillo Hospital, Rome, Italy., Competing Interests: Declaration of interests GM reports consulting fees from Novo Nordisk, Fractyl, and Recor. She is also scientific adviser for Metadeq, Keyron, GHP Scientific, and Jemyll, these all being unpaid positions. FR reports receiving research grants from Ethicon and Medtronic; receiving consulting fees from Novo Nordisk, Ethicon, and Medtronic; serving on the scientific advisory board of and receiving consultancy fees from GI Dynamics; and is a former director and current scientific advisor of Metadeq, Keyron, and GHP Scientific, these all being unpaid positions. All other authors declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Aims: To investigate in-hospital and long-term prognosis in T2DM patients presenting with acute myocardial infarction (AMI) treated with SGLT2-I versus other oral anti-diabetic agents (non-SGLT2-I users)., Methods: In this multicenter international registry all consecutive diabetic AMI patients undergoing percutaneous coronary intervention between 2018 and 2021 were enrolled and, based on the admission anti-diabetic therapy, divided into SGLT-I users versus non-SGLT2-I users. The primary endpoint was defined as a composite of cardiovascular death, recurrent AMI, and hospitalization for HF (MACE). Secondary outcomes included i) in-hospital cardiovascular death, recurrent AMI, occurrence of arrhythmias, and contrast-induced acute kidney injury (CI-AKI); ii) long-term cardiovascular mortality, recurrent AMI, heart failure (HF) hospitalization., Results: The study population consisted of 646 AMI patients (with or without ST-segment elevation): 111 SGLT2-I users and 535 non-SGLT-I users. The use of SGLT2-I was associated with a significantly lower in-hospital cardiovascular death, arrhythmic burden, and occurrence of CI-AKI (all p < 0.05). During a median follow-up of 24 ± 13 months, the primary composite endpoint, as well as cardiovascular mortality and HF hospitalization were lower for SGLT2-I users compared to non-SGLT2-I patients (p < 0.04 for all). After adjusting for confounding factors, the use of SGLT2-I was identified as independent predictor of reduced MACE occurrence (HR=0.57; 95%CI:0.33-0.99; p = 0.039) and HF hospitalization (HR=0.46; 95%CI:0.21-0.98; p = 0.041)., Conclusions: In T2DM AMI patients, the use of SGLT2-I was associated with a lower risk of adverse cardiovascular outcomes during index hospitalization and long-term follow-up. Our findings provide new insights into the cardioprotective effects of SGLT2-I in the setting of AMI., Registration: Data are part of the observational international registry: SGLT2-I AMI PROTECT., Clinicaltrials: gov Identifier: NCT05261867., Competing Interests: Competing interests The authors declare that they have no competing interests., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

The occurrence of a sustained monomorphic ventricular tachycardias (SMVT) in patients with underlying structural heart disease (SHD) is considered related to poor prognosis. The purpose of our work was to evaluate if these patients could benefit from radiofrequency (RF) ablation, and the defibrillator (ICD) implantation could be deferred during follow-up. We reviewed consecutive patients with well-tolerated SMVT, SHD and left ventricular ejection fraction over 30%. These patients were treated by RF ablation and were discharged without ICD. The primary outcome was a composite of all-cause death and recurrence of SMVT; the secondary outcome was death from all causes. Sixty-two patients were selected. After a median follow-up of 38.8 months, the primary outcome occurred in 24 (38.7%) and the secondary in 11 (17.7%) patients. The annual mortality rate was 4.3% and no patient died from sudden death. RF ablation as a first-choice therapy seems to represent an effective and beneficial therapeutic approach., (Copyright © 2022 Elsevier Inc. All rights reserved.)

With the prevalence of obesity alarmingly increasing, it is of primary interest to identify those factors predicting the success of anti-obesity therapeutic strategies currently adopted in clinical practice, and in particular, those of bariatric procedures showing the greatest success in terms of weight loss and maintenance in both the short and long term. Given sex-related differences in psychosocial status, hormonal homeostasis, and body fat distribution, it is likely that the response to different weight management strategies differs by sex. The objective was to elucidate the effect of sex on different bariatric procedures' efficacy and safety outcomes. Searches of PubMed, Cochrane, and Embase databases were performed, followed by hand-searching of reference lists from all relevant articles. We included all the studies evaluating the effect of bariatric procedures on body mass index loss (BMIL), and/or percentage excess weight loss (%EWL), and/or percentage excess body mass index loss, and/or percentage of responders, and/or short-/long-term complications and co-morbidity resolution, broken down by sex. Twenty-seven studies with a total of 114,919 patients were included. Men were more likely to achieve greater BMIL, consistent with higher male baseline BMI, and women were 2.87 times more likely to be classified as weight responders (95% confidence interval [CI]: 1.90-4.34), as well as to perform better in terms of %EWL (95% CI: .13-.54). Upon subgroup analysis based on bariatric procedure, women were more likely to be successful in terms of %EWL upon bioenteric intragastric balloon (BIB) placement (.72, 95% CI: .42-1.02). There was no sex difference regarding investigated co-morbidity resolution (hypertension, diabetes, and obstructive sleep apnea syndrome) or occurrence of short-term complications, whereas women were more likely to develop long-term complications, with an odds ratio of 1.97 (95% CI: 1.57-2.49). Sex does not have a clear effect on efficacy outcomes of bariatric procedures. Differentiating by procedure, BIB may be more effective in women, although results are discordant based on the weight loss outcome considered. If the short-term postoperative complication rate is similar across both sexes, long-term complications occur more frequently in women. To clarify the real effect of sex on bariatric procedure-derived health benefits, it is crucial to report sex-stratified results in future studies, as well as evaluate body composition changes that go beyond simple body weight reduction., (Copyright © 2022 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Coronavirus disease 2019 (COVID-19) has spread worldwide determining dramatic impacts on healthcare systems. Early identification of high-risk parameters is required in order to provide the best therapeutic approach. Coronary, thoracic aorta and aortic valve calcium can be measured from a non-gated chest computer tomography (CT) and are validated predictors of cardiovascular events and all-cause mortality. However, their prognostic role in acute systemic inflammatory diseases, such as COVID-19, has not been investigated., Objectives: The aim was to evaluate the association of coronary artery calcium and total thoracic calcium on in-hospital mortality in COVID-19 patients., Methods: 1093 consecutive patients from 16 Italian hospitals with a positive swab for COVID-19 and an admission chest CT for pneumonia severity assessment were included. At CT, coronary, aortic valve and thoracic aorta calcium were qualitatively and quantitatively evaluated separately and combined together (total thoracic calcium) by a central Core-lab blinded to patients' outcomes., Results: Non-survivors compared to survivors had higher coronary artery [Agatston (467.76 ​± ​570.92 vs 206.80 ​± ​424.13 ​mm 2 , p ​< ​0.001); Volume (487.79 ​± ​565.34 vs 207.77 ​± ​406.81, p ​< ​0.001)], aortic valve [Volume (322.45 ​± ​390.90 vs 98.27 ​± ​250.74 mm 2 , p ​< ​0.001; Agatston 337.38 ​± ​414.97 vs 111.70 ​± ​282.15, p ​< ​0.001)] and thoracic aorta [Volume (3786.71 ​± ​4225.57 vs 1487.63 ​± ​2973.19 mm 2 , p ​< ​0.001); Agatston (4688.82 ​± ​5363.72 vs 1834.90 ​± ​3761.25, p ​< ​0.001)] calcium values. Coronary artery calcium (HR 1.308; 95% CI, 1.046-1.637, p ​= ​0.019) and total thoracic calcium (HR 1.975; 95% CI, 1.200-3.251, p ​= ​0.007) resulted to be independent predictors of in-hospital mortality., Conclusion: Coronary, aortic valve and thoracic aortic calcium assessment on admission non-gated CT permits to stratify the COVID-19 patients in-hospital mortality risk., (Copyright © 2021 Society of Cardiovascular Computed Tomography. Published by Elsevier Inc. All rights reserved.)

Background and Aims: SARS-Cov-2 predisposes patients to thrombotic complications, due to excessive inflammation, endothelial dysfunction, platelet activation, and coagulation/fibrinolysis disturbances. The aim of the present study was to evaluate clinical characteristics and prognostic impact of SARS-CoV-2 positivity among STEMI patients undergoing primary percutaneous coronary intervention (PPCI)., Methods: We selected SARS-CoV-2 positive patients included in the ISACS-STEMI COVID-19, a retrospective multicenter European registry including 6609 STEMI patients treated with PPCI from March 1st until April 30th, in 2019 and 2020. As a reference group, we randomly sampled 5 SARS-Cov-2 negative patients per each SARS-CoV-2 positive patient, individually matched for age, sex, and hospital/geographic area. Study endpoints were in-hospital mortality, definite stent thrombosis, heart failure., Results: Our population is represented by 62 positive SARS-CoV-2 positive patients who were compared with a matched population of 310 STEMI patients. No significant difference was observed in baseline characteristics or the modality of access to the PCI center. In the SARS-CoV-2 positive patients, the culprit lesion was more often located in the RCA (p < 0.001). Despite similar pre and postprocedural TIMI flow, we observed a trend in higher use of GP IIb-IIIa inhibitors and a significantly higher use of thrombectomy in the SARS-CoV-2 positive patients. SARS-CoV-2 positivity was associated with a remarkably higher in hospital mortality (29% vs 5.5%, p < 0.001), definite in-stent thrombosis (8.1% vs 1.6%, p = 0.004) and heart failure (22.6% vs 10.6%, p = 0.001) that was confirmed after adjustment for confounding factors., Conclusions: Our study showed that among STEMI patients, SARS-CoV-2 positivity is associated with larger thrombus burden, a remarkably higher mortality but also higher rates of in-stent thrombosis and heart failure., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background and Aims: The potential impact of coronary atherosclerosis, as detected by coronary artery calcium, on clinical outcomes in COVID-19 patients remains unsettled. We aimed to evaluate the prognostic impact of clinical and subclinical coronary artery disease (CAD), as assessed by coronary artery calcium score (CAC), in a large, unselected population of hospitalized COVID-19 patients undergoing non-gated chest computed tomography (CT) for clinical practice., Methods: SARS-CoV 2 positive patients from the multicenter (16 Italian hospitals), retrospective observational SCORE COVID-19 (calcium score for COVID-19 Risk Evaluation) registry were stratified in three groups: (a) "clinical CAD" (prior revascularization history), (b) "subclinical CAD" (CAC >0), (c) "No CAD" (CAC = 0). Primary endpoint was in-hospital mortality and the secondary endpoint was a composite of myocardial infarction and cerebrovascular accident (MI/CVA)., Results: Amongst 1625 patients (male 67.2%, median age 69 [interquartile range 58-77] years), 31%, 57.8% and 11.1% had no, subclinical and clinical CAD, respectively. Increasing rates of in-hospital mortality (11.3% vs. 27.3% vs. 39.8%, p < 0.001) and MI/CVA events (2.3% vs. 3.8% vs. 11.9%, p < 0.001) were observed for patients with no CAD vs. subclinical CAD vs clinical CAD, respectively. The association with in-hospital mortality was independent of in-study outcome predictors (age, peripheral artery disease, active cancer, hemoglobin, C-reactive protein, LDH, aerated lung volume): subclinical CAD vs. No CAD: adjusted hazard ratio (adj-HR) 2.86 (95% confidence interval [CI] 1.14-7.17, p=0.025); clinical CAD vs. No CAD: adj-HR 3.74 (95% CI 1.21-11.60, p=0.022). Among patients with subclinical CAD, increasing CAC burden was associated with higher rates of in-hospital mortality (20.5% vs. 27.9% vs. 38.7% for patients with CAC score thresholds≤100, 101-400 and > 400, respectively, p < 0.001). The adj-HR per 50 points increase in CAC score 1.007 (95%CI 1.001-1.013, p=0.016). Cardiovascular risk factors were not independent predictors of in-hospital mortality when CAD presence and extent were taken into account., Conclusions: The presence and extent of CAD are associated with in-hospital mortality and MI/CVA among hospitalized patients with COVID-19 disease and they appear to be a better prognostic gauge as compared to a clinical cardiovascular risk assessment., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Investigations demonstrated a decrease of admissions for myocardial infarction (MI) during the CoronaVirus Disease-19 (COVID-19) outbreak. No study has evaluated the time required to reverse this downward curve of MI admissions., Methods: This is a retrospective analysis on patients (N = 2415) admitted to the Emergency Departments for acute MI in nine Italian centers. Primary endpoint was the incidence rates (IRs) of MI admissions in the post-lockdown COVID-19 period (case-period: from May 4 to July 12, 2020) vs. the following control periods: January 1-February 19, 2020 (pre-lockdown period); February 20-May 3, 2020 (intra-lockdown period); May 4-July 12, 2019 (inter-year non-COVID-19 period)., Results: IR of admissions for MI in the post-lockdown period was higher than the intra-lockdown period (IR ratio, IRR: 1.60, 95% CI 1.42-1.81; p = 0.0001), was lower than the pre-lockdown period (IRR: 0.86, 0.77-0.96; p = 0.009) and similar to the inter-year non-COVID-19 period (IRR: 0.96, 0.87-1.07; p = 0.47). Within the case period, the increase in MI admissions was more pronounced in earlier vs later weeks (IRR 1.19, 95% CI 1.02-1.38, p = 0.024) and, compared to the inter-year control period, was significant for non ST-segment elevation MI (IRR: 1.25, 95% CI 1.08-1.46, p = 0.004), but was not observed for ST-segment elevation MI (STEMI), where hospitalizations were reduced (IRR 0.76, 95% CI 0.65-0.88, p = 0.0001)., Conclusions: Our study first indicates an increase in the number of admissions for MI after the removal of the national lockdown for COVID-19 in Italy. This increase was prevalent in the first weeks following the lockdown removal, but was under-represented in STEMI patients., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: Sleeve gastrectomy (SG) leads to esophageal mucosal damage in an elevated percentage of cases, configuring a clinical condition of Barrett's esophagus (BE) in a proportion as high as 15-18.8%. BE may rarely evolve into esophageal adenocarcinoma (EAC)., Objectives: To raise awareness of BE as a precancerous lesion which may progress toward malignancy after this popular bariatric procedure., Setting: Bariatric referral centers, Italy., Methods: All patients referred to our bariatric center who developed an EAC after SG between 2012 and 2019 were reviewed and consecutively included in this study. The available scientific literature regarding this complication is additionally reviewed., Results: The 3 male patients comprised in this case series underwent laparoscopic SG between 2012 and 2015 in different bariatric referral centers. Age and body mass index at baseline ranged from 21-54 years and 43.1-75.6 kg/m 2 , respectively. All patients were lost to follow-up early after surgery (3.7 ± 1.4 months), and were diagnosed with EAC at a mean of 27.3 ± 7.6 months after SG. The 4 reported cases in the scientific literature developed an EAC at a mean of 32.5 ± 23 months from SG. Overall, a diagnosis of EAC was made approximately 30.3 ± 17.1 months postoperatively, which seems relatively and worryingly early after surgery., Conclusion: Although the rate and probability of progression from BE to EAC is still not well defined, assuming that the rising popularity and execution of SG leads to a growth in the BE incidence, then the preoperative identification and stratification of cancer risk factors in this subset of patients is strongly encouraged. Clinical and endoscopic follow-ups are essential to allow for prevention and early diagnosis and for epidemiologic data collection purposes., (Copyright © 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The impact of sleeve gastrectomy (SG) on gastroesophageal reflux disease (GERD) is still greatly debated. Most of the current evidence available is solely based on symptom evaluation or medication use, while a minority have implemented objective functional measurements., Objective: To better comprehend the pathophysiological mechanisms involved in the genesis of GERD after SG., Setting: University Hospital, Italy., Methods: A total of 21 patients affected by morbid obesity and eligible for SG were prospectively enrolled in the present study. Patients were evaluated by means of endoscopy, high-resolution manometry (HRM), 24-hour pH monitoring, and the Gastroesophageal Reflux Disease Health-Related Quality of Life questionnaire., Results: Follow-up was completed at least 1 year post operation (mean follow-up, 14.3 ± 2.1 mo) by 19 patients. Body mass index decreased from 41.2 ± .9 to 26.8 ± .8 kg/m 2 (P < .001). Distal contractile integral significantly decreased from 2772.8 ± 399.9 mm Hg/s/cm to 2060.4 ± 338.9 mm Hg/s/cm (P = .01). The 24-hour pH monitoring showed an overall reduction tendency of acid reflux, although this was not statistically significant. All analyzed endoscopic findings withstood substantial pejorative modifications after SG (P < .01). Distal contractile integral values at baseline predicted postoperative Z-line upward migration; HRM, distal latency, and DeMeester score at baseline predicted the development of erosive esophagitis at follow-up, by bootstrap estimates of a logistic regression., Conclusions: Postoperative GERD-related esophageal sequelae should be carefully considered after SG. Our results demonstrate how acid reflux does not seem to play a relevant role in the pathophysiology of post-SG GERD. Baseline HRM can help stratify the risk of developing erosive esophagitis and Z-line upward migration after SG, while postoperative endoscopic surveillance should be encouraged regardless of the presence or absence of symptoms., (Copyright © 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Biliopancreatic diversion (BPD) is more effective than Roux-en-Y gastric bypass (RYGB) on both insulin resistance and diabetes., Objectives: Because the major difference between the 2 procedures resides in the length of jejunal bypass, we investigated the role of the jejunum in insulin resistance., Setting: University hospital in Italy., Methods: Insulin sensitivity (IS) and secretion were measured before and 4 weeks after RYGB or BPD in 16 patients. A translational study was also conducted in 6 pigs, by isolating a jejunal loop with its vascular and nerve supply (Thiry-Vella loop [TVL]). TVL was doubly stomatized and bowel continuity restored by a side-to-side jejuno-jejunostomy. At baseline and 4 weeks postoperatively a glucose bolus was injected either in the stomach or in the TVL. Whole-body IS and jejunal heat shock proteins (HSPs) were measured. Primary porcine hepatocyte cultures were incubated with plasma or individual HSPs., Results: Whole-body IS increased from 353.5 ± 26.7 to 442.0 ± 37.4 (P < .05) after RYGB and from 312.4 ± 14.9 to 441.2 ± 15.9 mL/m -2 /min -1 (P < .001) after BPD. Hepatic IS was unchanged after RYGB, while it increased from .3 ± .01 to .4 ± .1 (μM/pM) - 1 (P < .01) after BPD. Total insulin secretion rate remained unchanged after RYGB but decreased (from 58.3 ± 23.6 to 33.1 ± 7.8 nmol/m -2 , P < .05) after BPD. Jejunectomy in pigs enhanced IS (.3 ± .01 versus .2 ± .01 mM/pM, P < .001), while injection of glucose into TVL reduced it (.1 ± .01 versus .3 ± .01 mM/pM, P < .0001). The jejunum secreted HSPs, Hsp70, and GRP78, which impaired insulin signaling in hepatocyte cultures., Conclusions: This study shows that jejunal bypass in both humans and pigs improves IS. Injection of glucose into the TVL in pigs determines insulin resistance. In response to glucose, the jejunum secretes HSPs that impair insulin signaling., (Copyright © 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Catecholaminergic polymorphic ventricular tachycardia (CPVT) is a rare channelopathy involving cardiac calcium metabolism that often shows up at an early age with misleading clinical symptoms, such as emotion- or exercise-related syncope with a normal resting electrocardiogram. In addition, it might be the underlying cause of sudden cardiac arrest in children or young adults. The particular pathophysiology of CPVT makes it particularly challenging for both resuscitation and the subsequent intensive care management after return of spontaneous circulation (ROSC)., Case Report: We describe a case of sudden cardiac arrest in an 11-year-old girl affected by CPVT, with a particular focus on the most challenging aspects of resuscitation and intensive care management in light of other experiences found in the literature. A warning about the prodysrythmicity of mild hypothermia induced in the context of post-ROSC targeted temperature management in this particular population of patients and its possible physiopathological basis are discussed. WHY SHOULD AN EMERGENCY PHYSICIAN BE AWARE OF THIS?: CPVT is a rare but potentially lethal cause of stress-related syncope and sudden cardiac arrest in children and young adults. The diagnosis of CPVT requires a high level of suspicion and an interdisciplinary approach, including some adjustments during resuscitation and post-cardiac arrest care., (Copyright © 2020 Elsevier Inc. All rights reserved.)

We have compared the anti-proliferative activity in vitro, of R 2 SnGala (1-3) [R = Me, n-Bu, Ph] and novel R 3 SnGala (4, 5) [R = Me, n-Bu] with D-(+)-Galacturonic acid [HGala; Gala q- , q = (2) and (1) for R 2 SnGala and R 3 SnGala, respectively] compounds, towards human tumor cell lines of intestinal carcinoma (HCT-116) and breast adenocarcinoma (MCF-7). The new synthesized 4 and 5 compounds were characterized, in solution, by 1 H, 13 C and 119 Sn NMR, that showed that HGala acts as monoanionic moiety and evidenced the dynamic behavior of the compounds, due to inter-conversions involving the anomeric carbon atom of the ligand. Cell viability, apoptosis induction and cell cycle distribution were analyzed by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) colorimetric assay and flow cytometry, respectively. The cytotoxicity of the compounds, in the micro-submicromolar range, changed in the order of the organotin(IV) moieties, according to 5 > 3 > 2, while 1 and 4, containing Me n Sn(IV) (n = 2,3) moieties, were ineffective. Compound 5 showed peculiar cytotoxic effects. It did not cause time dependent inhibition of cell growth nor accumulated into the cells. Cell death induced by the active 2, 3, and 5, was shown to be apoptotic by measuring the exposure of phosphatidylserine to the outer membrane and the loss of mitochondrial potential. All the cytotoxic compounds induced an accumulation of cells in the subG0/G1phase, while only 2 and 3 perturbed the cell cycle confining viable cells in G0/G1phase. Finally, none of the compounds investigated affected the viability of normal intestinal or liver cells, indicating selectivity towards tumor cells., (Copyright © 2018. Published by Elsevier Inc.)

Background: Sleeve gastrectomy (SG) has grown into the most popular bariatric operation. Nevertheless, a scarcity of long-term outcomes are available., Objectives: This study aims at evaluating the long-term percent weight loss (%WL), excess weight loss (%EWL), weight regain (WR), and co-morbidity resolution rates in a single-center cohort undergoing SG as a primary procedure, with a minimum 10-year follow-up., Setting: University hospital, Italy., Methods: One hundred eighty-two morbidly obese patients with body mass index (BMI) 46.6 ± 7.3 kg/m 2 underwent SG. Obesity-related co-morbidities (type 2 diabetes, hypertension, sleep apnea, gastroesophageal reflux disease) were investigated. Predictors of dichotomous dependent-variable diabetes remission were computed using a binomial logistic regression., Results: Patient retention rate was 77%. Mean %WL was 30.9, %EWL was 52.5%, and WR (≥25% maximum WL) occurred in 10.4%. Baseline BMI significantly (P = .001) and linearly predicted %EWL (10 yr %EWL = 18.951 + initial BMI × .74); the super-obese subgroup generated substantially greater WL compared with those with BMI <50 kg/m 2 (%EWL 48.0 ± 18.5 versus 61.5 ± 23.2; P < .001). Type 2 diabetes remission occurred in 64.7%; 42.9% patients developed de novo gastroesophageal reflux disease symptoms postoperatively (P < .0001)., Conclusions: SG generates sustained WL and co-morbidity resolution up to 10 years postoperatively. Although a notable portion of patients experience WR, mean %WL persists to exceed 30%, translating in adequate WL also in the long term. Additionally, WR does not seem to impact negatively on co-morbidity resolution. SG represents a safe and effective bariatric operation, which easily grants the possibility to proceed to revisional bariatric surgery in patients with WR or failure to WL., (Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: The postoperative development or worsening of gastroesophageal reflux disease (GERD) represents the major drawback of laparoscopic sleeve gastrectomy (SG). A GERD diagnosis is often based only on symptoms and proton pump inhibitors (PPI) intake, while objective tests like esophagogastroduodenoscopy and pH measurements are performed less frequently., Objectives: To evaluate the association between reflux symptoms and GERD-related esophageal lesions., Settings: University hospital, Rome, Italy., Methods: A comprehensive clinical control entailing GERD symptoms, PPI intake, and esophagogastroduodenoscopy was proposed to all patients who underwent SG between June 2007 and February 2011, irrespective of the presence of GERD symptoms. One hundred forty-four of 219 patients agreed to take part in the study (follow-up rate: 65.8%)., Results: After a mean follow-up of 66 months, GERD symptoms and PPI intake were recorded in 70.2% and 63.9% of patients, respectively. Mean visual analogue scale score was 2.9 ± 3.3. The overall frequency of erosive esophagitis was 59.8%, while nondysplastic Barrett's esophagus was detected in 13.1%. The frequency of esophageal biliary reflux was 68%. GERD symptoms and visual analogue scale score were not significantly associated with the development of erosive esophagitis and Barrett's esophagus and the severity of the esophageal lesions. Moreover, the frequency of erosive esophagitis and Barrett's esophagus in patients consuming PPI were similar to that of patients without PPI., Conclusion: Symptoms investigation alone is not a reliable tool to diagnose GERD after SG. The use of objective diagnostic tests, such as esophagogastroduodenoscopy, should be carefully considered in the postoperative follow-up schedule of SG patients., (Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: Aphasia is a common presentation of ischemic stroke, often diagnosed in the acute setting using tools such as the NIH Stroke Scale (NIHSS). Due to the vascular distribution of the middle cerebral artery, it is often accompanied by other symptoms such as weakness, sensory loss, or visual changes. Isolated aphasia due to ischemia is possible, but language problems mimicking aphasia syndromes can also be seen with other diagnoses such as metabolic abnormalities or dementia. In this study, we determine the incidence of aphasia-only strokes using the NIHSS, and factors associated with a higher likelihood of ischemia., Patients and Methods: Over a 2year period, 788 patients presented to our Emergency Department with symptoms of acute stroke. Data were collected regarding patient demographics, medical history, presenting symptoms (based on NIHSS), work-up results, and final diagnosis. The incidence of aphasia-only stroke was calculated. Student's t-tests and chi square analysis were used to determine factors associated with ischemia., Results: Of 788 patients, 21 (3%) presented with isolated "aphasia". None of the 21 had infarcts on neuroimaging. Three (14%) were diagnosed with possible transient ischemic attacks and the rest with stroke mimics. Toxic/metabolic disturbances were the most common mimics (39%). Prior history of stroke or transient ischemic attack was associated with ischemia over mimic (p=0.023)., Conclusions: Strokes affecting language without motor or sensory deficits are uncommon. In the acute setting, isolated "aphasia" is most often due to a stroke mimic; however can occur rarely, particularly in those with prior history of ischemia., (Copyright © 2017 Elsevier B.V. All rights reserved.)

Aims: To describe the clinical characteristics, contemporary trends of in-hospital management and outcome of patients admitted for an acute coronary syndrome (ACS) with associated atrial fibrillation (AF)., Methods: We analyzed data from four Italian nationwide prospective registries, conducted between 2001 and 2014, including consecutive ACS patients., Results: Out of 16,803 ACS patients, 1019 (6.1%) presented with concomitant AF: 668 with non-ST elevation (NSTE)-ACS and 351 with ST-elevation myocardial infarction (STEMI). As compared to no-AF patients, those with AF were older and had significantly more prior cardiac events and comorbidities (all p<0.005). A progressive increase occurred over time in the rates of coronary angiography and percutaneous coronary intervention, both in NSTE-ACS (p for trend=0.0002 and 0.0008, respectively) and STEMI patients with AF at admission (both p for trend <0.0001), with trends similar to those observed in non-AF patients. Among STEMI patients, in-hospital mortality decreased by 50% in those without AF (7.5% in 2001 to 3.3% in 2014, p<0.0001), with a similar decrease in those with AF (20% vs 10.7%, p=0.20), even though not statistically significant. At multivariable analysis, AF on admission was not an independent predictor of in-hospital mortality [odds ratio (OR): 0.82; 95% confidence intervals (CI): 0.52-1.30; p=0.41 for NSTE-ACS, and OR: 1.07; 95% CI: 0.73-1.57; p=0.74 for STEMI]., Conclusions: Over the last 14years, the in-hospital management of ACS patients with AF has significantly improved as for patients without AF, with comparable effect in terms of outcome., (Copyright © 2017. Published by Elsevier B.V.)

Background: Morbidly obese patients are affected by gastroesophageal reflux disease (GERD) and hiatal hernia (HH) more frequently than lean patients. Because of conflicting results, the indication to sleeve gastrectomy (SG) in patients with GERD is still debated., Objectives: To evaluate the incidence of GERD on the basis of clinical, endoscopic, and histologic data in patients undergoing SG., Settings: University hospital, Rome, Italy., Methods: From July 2007 to January 2010, 162 patients underwent primary SG. Preoperatively all patients underwent visual analogue scale (VAS) evaluation of GERD symptoms, proton pump inhibitors (PPIs) consumption recording, and esophagogastroduodenoscopy (EGD). Stomach resection started 6 cm from pylorus on a 48Fr bougie. Staple line was reinforced by an oversewing suture. A postoperative clinical control with VAS evaluation, PPI consumption, and EGD was proposed to all patients. Three patients were excluded because of the occurrence of major postoperative complications., Results: A total of 110 patients accepted to take part in the study (follow-up rate: 69.1%). At a mean 58 months of follow-up, incidence of GERD symptoms, VAS mean score, and PPI intake significantly increased compared with preoperative values (68.1% versus 33.6%: P<.0001; 3 versus 1.8: P = .018; 57.2% versus 19.1%: P<.0001) At EGD, an upward migration of the "Z" line and a biliary-like esophageal reflux was found in 73.6% and 74.5% of cases, respectively. A significant increase in the incidence and in the severity of erosive esophagitis (EE) was evidenced, whereas nondysplastic Barrett's esophagus (BE) was newly diagnosed in 19 patients (17.2%). No significant correlations were found between GERD symptoms and endoscopic findings., Conclusion: In the present series the incidence of EE and of BE in SG patients was considerably higher than that reported in the current literature, and it was not related to GERD symptoms. Endoscopic surveillance after SG should be advocated irrespective of the presence of GERD symptoms., (Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Late-onset UC represents an important issue for the near future, but its outcomes and relative therapeutic strategies are yet poorly studied., Aim: To better define the natural history of late-onset ulcerative colitis., Methods: In a multicenter retrospective study, we investigated the disease presentation and course in the first 3 years in 1091 UC patients divided into 3 age-groups: diagnosis ≥65years, 40-64 years, and <40years. Disease patterns, medical and surgical therapies, and risk factors for disease outcomes were analyzed., Results: Chronic active or relapsing disease accounts for 44% of patients with late-onset UC. Across all age-groups, these disease patterns require 3-6 times more steroids than remitting disease, but immunomodulators and, to a lesser extent, biologics are less frequently prescribed in the elderly. Advanced age, concomitant diseases and related therapies were found to be inversely associated with the use of immunomodulators or biologics, but not with surgery., Conclusions: The conclusion that late-onset UC follows a mild course may apply only to a subset of patients. an important percentage of elderly patients present with more aggressive disease. Since steroid use and surgery rates did not differ in this subgroup, lower use of immunosuppressive therapy and biologics may reflect concerns in prescribing these therapies in the elderly., (Copyright © 2016. Published by Elsevier Ltd.)

Background: Laparoscopic sleeve gastrectomy (SG) has gained great popularity as a stand-alone bariatric procedure because short- and mid-term outcomes in terms of weight loss and resolution of co-morbidities have been very positive. However, long-term results from large series still are sparse., Objectives: To evaluate the long-term clinical outcomes of SG in a large series of patients undergoing SG as a stand-alone procedure., Setting: University hospital in Italy., Methods: A retrospective analysis of prospectively collected data from 182 patients undergoing SG between 2006 and 2008 in the authors' institution. Long-term outcomes at 6 and 7 years were analyzed in terms of weight loss and co-morbidities resolution., Results: Mean initial body mass index (BMI) was 45.9±7.3 kg/m(2). Major postoperative complications occurred in 8 patients (5.4%): 4 leaks, 2 bleeding, 1 abdominal collection, and 1 dysphagia. All complications were managed conservatively. One hundred forty-eight patients (81.4%) completed the 72-month (6-year) follow-up. Thirty-seven patients (25%) reached a follow-up of 84 months. At year 6 follow-up the mean BMI and the mean percentage of excess weight loss (%EWL) were 30.2 kg/m(2) and 67.3%, respectively. Mean total body weight loss was 44.9 kg, while a %EWL >50 was registered in 123 patients (83.1%). Preoperative BMI did not significantly influence postoperative %EWL. Remission of type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea syndrome, and gastroesophageal reflux disease symptoms occurred in 83.8%, 59.7%, 75.6%, and 64.7% of patients, respectively., Conclusion: %EWL and resolution of co-morbidities appear to be sustained 6 and 7 years after SG. Preoperative BMI is not predictive for weight loss outcomes., (Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Laparoscopic sleeve gastrectomy (LSG) is an approved primary procedure for morbid obesity, but it is associated with serious complications, such as staple line leaks and bleeding. The objective of this study was to assess the effectiveness of staple line reinforcement (SLR) in reducing leaks and bleeding after LSG., Methods: A total of 1162 patients underwent LSG (305 males, 857 females). The mean age was 43.7 years and the mean body mass index was 48 kg/m(2). The patients were divided into 6 groups based on the type of SLR, including a no-SLR control group, with evaluation of leaking and bleeding risk and correlation of patients' characteristics with complications., Results: A total of 189 patients underwent LSG without reinforcement. The SLR method was oversewing in 476 patients, bovine pericardium in 312, synthetic polyester in 76, glycolide/trimethylene copolymer in 63, and thrombin matrix in 46. The overall leak frequency was 2.8%; higher with synthetic polyester (7.8%), 4.8% with no reinforcement, and lower with bovine pericardium strips (.3%; P<.01). Postoperative hemorrhage occurred in 35 patients (3%), with a higher frequency being observed without SLR (13.7%; P = .02). Only diabetes was a risk-factor for a leak (P< .01)., Conclusion: SLR with bovine pericardium strips significantly reduced the leak risk. Postoperative bleeding was significantly lower with all SLR-methods, although there was no significant difference among the various techniques. Patients with type II diabetes had a higher risk of staple line leak after LSG. Further randomized, controlled studies are needed to improve our understanding of the efficacy of SLR during LSG., (© 2013 American Society for Bariatric Surgery Published by American Society for Metabolic and Bariatric Surgery All rights reserved.)

Three new triorganotin(IV) complexes of valproic acid (vp1, Me3Sn-valproate; vp2, Bu3Sn-valproate; vp3, Ph3Sn-valproate) have been synthesized and investigated by spectroscopic and biological methods. An anionic, monodentate valproate ligand was observed, ester-like coordinating the tin atom on a tetra-coordinated, monomeric environment. The structures, though, can distort towards a penta-coordination, as a consequence of a long range O···Sn interaction. Crystallographic and NMR findings confirm this situation both in solid state and solution. Biological finding evidenced a clear cytotoxic action of the complexes in hepatocellular carcinoma cell cultures: one of the complexes induced an 80% cell viability reduction after 24h treatment in HepG2 cells. This effect was accompanied by the appearance of biochemical signs of apoptosis. In Chang liver cells, the same compound induced only modest effects, suggesting a potential use as anti-cancer drug. Preliminary evaluations on hyperacetylation state of histone H3 in tributyltin-valproate treated HepG2 cells showed an increase in Ac-H3 (histone H3 acetylated at lys-9 and lys-14), suggesting that the compound maintains the deacetylation inhibition activity of its ligand valproate., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Background: The aim of this study was to evaluate the long-term effects of laparoscopic sleeve gastrectomy (LSG) on type 2 diabetes mellitus (T2DM) and other related co-morbidities in severely obese patients., Methods: From May 2003 to July 2008, 33 morbidly obese diabetic patients (20 with body mass index [BMI]>50 kg/m(2)) underwent LSG. A total of 23 females and 10 males participated, with a mean age of 49.3±8 years, mean preoperative BMI of 52.1±8.5 kg/m(2), mean fasting plasma glucose (FPG) of 143.2±47.9 mg/dL, mean glycosylated hemoglobin (HbA1c) of 7.3%±1.4%, and a mean T2DM duration of 7 years. All patients had a 36-month follow-up, and 13 had a 60-month follow-up., Results: Twenty-nine patients (87.8%) discontinued antidiabetic medications 3 months after LSG, (mean BMI of 42.8±7.8 kg/m(2); FPG of 104.5±22.1 mg/dL; HbA1c of 5.3%±.4%). At 36 months, 22 of 26 LSG patients (84.6%) had normal FPG and HbA1c values without antidiabetic therapy. At the 60-month follow-up, 10 of 13 patients (76.9%) had normal FPG and HbA1c values without antidiabetic therapy. The Framingham risk score decreased significantly from 9.7% preoperatively to 4.7% postoperatively. No new diabetic retinopathy occurred during the whole period of observation., Conclusions: This study confirms the efficacy of LSG in the treatment of T2DM and indicates that, at both 36- and 60-month follow-ups, LSG can provide a significant percentage of treated patients with a prolonged remission of T2DM, with diminished cardiac risk factors and no development of diabetic retinopathy. These results compare favorably with those reported after standard medical therapy., (Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Gastroesophageal reflux disease (GERD) with or without hiatal hernia (HH) is now recognized as an obesity-related co-morbidity. Roux-en-Y gastric bypass has been proved to be the most effective bariatric procedure for the treatment of morbidly obese patients with GERD and/or HH. In contrast, the indication for laparoscopic sleeve gastrectomy (SG) in these patients is still debated. Our objective was to report our experience with 97 patients who underwent SG and HH repair (HHR). The setting was a university hospital in Italy., Methods: From July 2009 to December 2011, 378 patients underwent a preoperative workup for SG. In 97 patients, SG was performed with HHR. The clinical outcome was evaluated considering GERD symptom resolution or improvement, interruption of antireflux medications, and radiographic evidence of HH recurrence., Results: Before surgery, symptomatic GERD was present in 60 patients (15.8%), and HH was diagnosed in 42 patients (11.1%). In 55 patients (14.5%), HH was diagnosed intraoperatively. The mean follow-up was 18 months. GERD remission occurred in 44 patients (73.3%). In the remaining 16 patients, antireflux medications were diminished, with complete control of symptoms in 5 patients. No HH recurrences developed. "De novo" GERD symptoms developed in 22.9% of the patients undergoing SG alone compared with 0% of patients undergoing SG plus HHR., Conclusion: SG with HHR is feasible and safe, providing good management of GERD in obese patients with reflux symptoms. Small hiatal defects could be underdiagnosed at preoperative endoscopy and/or upper gastrointestinal contrast study. Thus, a careful examination of the crura is always recommended intraoperatively., (Copyright © 2013 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

The 2008 National Research Council report "Phthalates and Cumulative Risk Assessment: Tasks Ahead," rejected the underlying premises of TEQ-like approaches - e.g., chemicals are true congeners; are metabolized and detoxified similarly; produce the same biological effects by the same mode of action; exhibit parallel dose response curves - instead asserting that cumulative risk assessment should apply dose addition (DA) to all chemicals that produce "common adverse outcomes" (CAOS). Published mixtures data and a human health risk assessment for phthalates and anti-androgens were evaluated to determine how firmly the DA-CAOS concept is supported and with what level of statistical certainty the results may be extrapolated to lower doses in humans. Underlying assumptions of the DA-CAOS concept were tested for accuracy and consistency against data for two human pharmaceuticals and its logical predictions were compared to human clinical and epidemiological experience. Those analyses revealed that DA-CAOS is scientifically untenable. Therefore, an alternative approach was developed - the Human-Relevant Potency-Threshold (HRPT) - that appears to fit the data better and avoids the contradictions inherent in the DA-CAOS concept. The proposed approach recommends application of independent action for phthalates and other chemicals with potential anti-androgenic properties at current human exposure levels., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Background: Type 2 diabetes mellitus (T2DM) and obesity are diseases of epidemic proportions. Long-term realistic weight loss by nonsurgical methods has a variable effect on glycemic control, and only a proportion of patients with T2DM have a worthwhile response. Laparoscopic sleeve gastrectomy (LSG) has been proposed as an advantageous bariatric procedure for patients with a lower body mass index (BMI). Our objective was to compare the effects of LSG and medical therapy on patients with T2DM and a BMI of <35 kg/m(2)., Methods: A total of 18 nonmorbidly obese patients with T2DM, diagnosed according to the American Diabetes Association guidelines, were consecutively enrolled. Of these patients, 9 underwent LSG (group A) and 9 underwent conventional medical therapy (group B). The 2 groups were matched for BMI, glycated hemoglobin (HbA1c) and C-peptide levels, pretrial therapy type, and number of patients with a T2DM duration of >10 years., Results: In group A, T2DM resolution was achieved in 8 (88.8%) of the 9 patients (T2DM duration 5.2 yr). Hypertension was controlled in all 8 of 9 patients. Dyslipidemia was corrected. In 1 patient, obstructive sleep apnea syndrome improved. In group B, all 9 patients continued to have T2DM and required hypertensive and hypolipemic therapies throughout the observation period. At baseline, 3 patients were affected by obstructive sleep apnea syndrome and remained affected 1 year later., Conclusion: The results of the present study have confirmed the efficacy of LSG in the treatment of nonmorbidly obese T2DM patients, with a remission rate of 88.8% without undesirable excessive weight loss. The results in this group of patients add to those obtained by us in patients with a BMI >35 kg/m(2)., (Copyright © 2012 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Several studies have demonstrated a high rate of type 2 diabetes mellitus (T2DM) resolution after sleeve gastrectomy. Different prognostic factors have been hypothesized for T2DM remission after bariatric surgery. Our objectives were to analyze the role of T2DM duration as an independent prognostic factor for remission., Methods: From January 2008 to September 2010, 56 obese patients with T2DM underwent sleeve gastrectomy. Group A consisted of 16 patients who had lived with T2DM for >10 years (12 women and 4 men, mean body mass index 42.7 kg/m2). Group B included 40 obese patients who had lived with T2DM for <10 years (29 women and 11 men, mean body mass index 44.9 kg/m2)., Results: In group A, 43.7% were treated with oral hypoglycemics, 6.3% with insulin, and 50% with oral hypoglycemics and insulin. In group B, 87.5% were treated with oral hypoglycemics, 5% with dietary therapy, and 7.5% with insulin. The preoperative average glycemia, glycosylated hemoglobin, and C-peptide value was 206.2 mg/dL, 9.5%, and 2.8 μg/L in group A and 134 mg/dL, 7.1%, and 4.5 μg/L in group B, respectively (P < .05 for all). The T2DM remission rate in all 56 patients was 80.3%. However, in group B, the resolution rate was 100%, but in group A, the resolution rate was 31%. Patients without complete remission were more sensitive to lower doses of antidiabetic drugs., Conclusion: Sleeve gastrectomy is effective in the treatment of obese patients with T2DM. The duration of T2DM seems to be of paramount importance as a prognostic factor, with 10 years representing a cutoff between a 100% rate of remission and significantly lower rates of remission., (Copyright © 2011 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Bowel ultrasound has been shown to be a useful tool to evaluate patients with inflammatory bowel disease, especially Crohn's disease. However, such data are still scarce in ulcerative colitis patients., Aims: To establish the value of bowel ultrasound in moderate to severe ulcerative colitis patients, and compare these data with endoscopic findings., Patients and Methods: Endoscopic, ultrasound and C-reactive protein data from 51 patients with moderate to severe ulcerative colitis observed during a 3-year period were retrospectively obtained and analysed., Results: All patients displayed pathological thickness (>4 mm) of the colon wall. This value strongly correlated with C-reactive protein values (p=0.0001) and the endoscopic score (p<0.0001). Also, a strong correlation (p<0.0001) was found between CRP values and endoscopic score., Conclusions: Bowel ultrasound, in expert hands, may represent a useful adjunctive (or first line) tool for the evaluation of patients with moderate to severe ulcerative colitis., (Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: There is at present a relative lack of knowledge concerning drug-related colitides, although these may be not infrequent entities in clinical practice., Aims: To assess the frequency and the clinical-pathological subtypes of drug-related colitides in a gastrointestinal pathology referral centre., Methods: All charts of endoscopic biopsy samples referred for colitis in a eight-year period were reviewed. To be classified as drug related colitis, patients' charts should report the use of any drug in a two month period before colonoscopy and no other obvious cases of colitis be present. For analysis, we considered only patients taking one drug in this period., Results: We found 122 cases of drug-related colitis out of 3877 charts reviewed (3% of the overall colitis group). These cases were represented by microscopic colitis (50%), eosinophil rich infiltrate of the left colon (34%), ischemic colitis (11%), pseudomembranous colitis (3%), apoptotic colopathy (2%). The drugs most frequently associated with these colitides were represented by non-steroidal anti-inflammatory drugs., Conclusion: It is important to raise awareness concerning drug-related colitides, to avoid diagnostic errors and provide a better therapeutic approach to patients with these conditions., (Copyright © 2011 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: The long-term effectiveness of drug eluting stents (DESs) in a real-world setting of female patients is currently unclear., Methods and Results: We analyzed long-term follow-up (up to 3 years) data from all female patients with de novo lesions enrolled in a prospective web-based multicenter registry (REAL Registry; study period, July 2002-June 2006) including all 15 hospitals performing PCI in the Emilia-Romagna region of Italy. Among the 3549 women without ST elevation myocardial infarction, 2434 were treated with BMSs alone and 1115 with DESs alone. At 3 years, use of DESs was associated with a lower propensity score adjusted incidence of MACE [cardiac mortality, non-fatal myocardial infarction and target vessel revascularization (TVR); 19.5% vs. 24.4%; HR 0.75, p=0.006)] and TVR (11.6% vs. 15.6%; HR 0.68, p=0.004) compared with BMSs. No difference was apparent in terms of adjusted 3-year cardiac mortality or myocardial infarction. Nevertheless, after the first 6 months of follow-up, a non significantly increased risk of myocardial infarction and stent thrombosis was found in the DES group., Conclusions: In this real-world female registry, the use of DESs was associated with a 3-year reduction of TVR and MACE in comparison with the use of BMSs. However, the observed (non-significant) increment of late AMI makes performing larger studies to clarify the long-term safety of DESs mandatory., (Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.)

Objectives: This study aims to evaluate whether results of "off-hours" and "regular-hours" primary angioplasty (primary percutaneous coronary intervention [pPCI]) are comparable in an unselected population of patients with ST-segment elevation acute myocardial infarction treated within a regional network organization., Background: Conflicting results exist on the outcome of off-hours pPCI., Methods: We analyzed in-hospital and 1-year cardiac mortality among 3,072 consecutive ST-segment elevation myocardial infarction (STEMI) patients treated with pPCI between January 1, 2004, and June 30, 2006, during regular-hours (weekdays 8:00 AM to 8:00 PM) and off-hours (weekdays 8:01 PM to 7:59 AM, weekends, and holidays) within the STEMI Network of the Italian Region Emilia-Romagna (28 hospitals: 19 spoke and 9 hub interventional centers)., Results: Fifty-three percent of patients were treated off-hours. Baseline findings were comparable, although regular-hours patients were older and had more incidences of multivessel disease. Median pain-to-balloon (195 min, interquartile range [IQR]: 140 to 285 vs. 186 min, IQR: 130 to 280 min; p = 0.03) and door-to-balloon time (88 min, IQR: 60 to 122 vs. 77 min, IQR: 48 to 116 min; p < 0.0001) were longer for off-hours pPCI. However, unadjusted in-hospital (5.8% off-hours vs. 7.2% regular-hours, p = 0.11) and 1-year cardiac mortality (8.4% off-hours vs. 10.3% regular-hours, p = 0.08) were comparable. At multivariate analysis, off-hours pPCI did not predict an adverse outcome either for the overall population (odds ratio [OR]: 0.70, 95% confidence interval [CI]: 0.49 to 1.01) or for patients directly admitted to the interventional center (OR: 0.79, 95% CI: 0.52 to 1.20)., Conclusions: When pPCI is performed within an efficient STEMI network focused on reperfusion, the clinical effectiveness of either off-hours or regular-hours pPCI is comparable., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Diorganotin(IV) complexes of N-acetyl-L-cysteine (H(2)NAC; (R)-2-acetamido-3-sulfanylpropanoic acid) have been synthesized and their solid and solution-phase structural configurations investigated by FTIR, Mössbauer, (1)H, (13)C and (119)Sn NMR spectroscopy. FTIR results suggested that in R(2)Sn(IV)NAC (R = Me, Bu, Ph) complexes NAC(2-) behaves as dianionic tridentate ligand coordinating the tin(IV) atom, through ester-type carboxylate, acetate carbonyl oxygen atom and the deprotonated thiolate group. From (119)Sn Mössbauer spectroscopy it could be inferred that the tin atom is pentacoordinated, with equatorial R(2)Sn(IV) trigonal bipyramidal configuration. In DMSO-d(6) solution, NMR spectroscopic data showed the coordination of one solvent molecule to tin atom, while the coordination mode of the ligand through the ester-type carboxylate and the deprotonated thiolate group was retained in solution. DFT (Density Functional Theory) study confirmed the proposed structures in solution phase as well as the determination of the most probable stable ring conformation. Biological investigations showed that Bu(2)SnCl(2) and NAC2 induce loss of viability in HCC cells and only moderate effects in non-tumor Chang liver cells. NAC2 showed lower cytotoxic activity than Bu(2)SnCl(2), suggesting that the binding with NAC(2-) modulates the marked cytotoxic activity exerted by Bu(2)SnCl(2). Therefore, these novel butyl derivatives could represent a new class of anticancer drugs., (2010. Published by Elsevier Inc.)

Background: An association has been described in case reports between celiac disease and inflammatory bowel diseases. The aim of the present study is to assess the prevalence of celiac disease in a large series of Italian patients with inflammatory bowel disease., Methods: The Italian Group for Inflammatory Bowel Disease conducted a multicentre study between January 2002 and December 2004, in which 22 gastroenterology centres in Italy enrolled 1711 consecutive outpatients with inflammatory bowel disease. 860 (50.2%) had Crohn's disease (415 females, mean age 40, range 18-75), 791 (46.2%) had ulcerative colitis (371 females, mean age 40, range 18-80), and 60 (3.5%) had indeterminate colitis (27 females, mean age 40, range 18-78). All patients underwent serological testing for anti-endomysial antibodies and anti-tissue transglutaminase antibodies; if positive upper GI endoscopy with duodenal biopsy was performed., Results: Nine of the 1711 patients (0.5%) had serological and histological findings compatible with the diagnosis of celiac disease; six of them had ulcerative colitis and three had Crohn's disease., Conclusions: Overall we found a lower risk of celiac disease in our cohort of inflammatory bowel disease patients than in the general population; prevalence of celiac disease was higher in patients with ulcerative colitis than in those with Crohn's disease., (2009 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.)

Background: Thiopurines are the most commonly used immunomodulatory drugs in inflammatory bowel diseases., Aim: To evaluate the use, the therapeutic and safety profiles of thiopurines in a large sample of IBD patients., Methods: We reviewed 3641 case histories of IBD patients. Thiopurines were prescribed in 582 patients (16.0%); the analysis was performed on the 553 (267 ulcerative colitis, 286 Crohn's disease) with exhaustive clinical data., Results: The main indications for treatment were steroid-dependence (328/553, 59.3%) and steroid-resistance (113/553, 20.7%). Thiopurines were started when CD were younger than UC patients (p<0.001) but earlier from diagnosis in UC than in CD patients (p=0.003). Efficacy was defined as optimal (258/553, 46.6%), partial (108/553, 19.5%), absent (85/553, 15.4%) and not assessable (102/553, 18.4%). Efficacy was independent of disease type, location/extension or duration and age at starting. Side effects were observed in 151/553 (27.3%) patients, leading to drug discontinuation in 101 (18.3%). 15 out of the 130 (11.5%) patients who took thiopurines for more than 4 years relapsed, more frequently in CD than in UC (OR=3.67 95% C.I. 0.98-13.69; p=0.053)., Conclusions: Thiopurines confirm their clinical usefulness and acceptable safety profile in managing complicated IBD patients. The majority of patients treated for longer than 4 years maintain response. No clinical and demographic predictive factors for efficacy and side effects were identified.