Advice of General Practitioner, of Surgeon, of Endocrinologist, and Self-determination: the Italian Road to Bariatric Surgery.

PURPOSE: Bariatric surgery (BS) is considered the most efficient treatment for severe obesity. International guidelines recommend multidisciplinary approach to BS (general practitioners, endocrinologists, surgeons, psychologists, or psychiatrists), and access to BS should be the final part of a protocol of treatment of obesity. However, there are indications that general practitioners (GPs) are not fully aware of the possible benefits of BS, that specialty physicians are reluctant to refer their patients to surgeons, and that patients with obesity choose self-management of their own obesity, including internet-based choices. There are no data on the pathways chosen by physicians and patients to undergo BS in the real world in Italy. METHODS: An exploratory exam was performed for 6 months in three pilot regions (Lombardy, Lazio, Campania) in twenty-three tertiary centers for the treatment of morbid obesity, to describe the real pathways to BS in Italy. RESULTS: Charts of 2686 patients (788 men and 1895 women, 75.5% in the age range 30-59 years) were evaluated by physicians and surgeons of the participating centers. A chronic condition of obesity was evident for the majority of patients, as indicated by duration of obesity, by presence of several associated medical problems, and by frequency of previous dietary attempts to weight loss. The vast majority (75.8%) patients were self-presenting or referred by bariatric surgeons, 24.2% patients referred by GPs and other specialists. Self-presenting patients were younger, more educated, more professional, and more mobile than patients referred by other physicians. Patients above the age of 40 years or with a duration of obesity greater than 10 years had a higher prevalence of all associated medical problems. CONCLUSIONS: The majority of patients referred to a tertiary center for the treatment of morbid obesity have a valid indication for BS. Most patients self-refer to the centers, with a minority referred by a GP or by specialists. Self-presenting patients are younger, more educated, more professional, and more mobile than patients referred by other physicians. Older patients and with a longer duration of obesity are probably representative of the conservative approach to BS, often regarded as the last resort in an endless story.

Psychological Aspects of Treatment with Intragastric Balloon for Management of Obesity: A Systematic Review of the Literature.

INTRODUCTION: Optimizing maintenance of weight loss for people with obesity following intragastric balloon (IGB) therapy hinges on the degree to which health care providers can recognize both the impact of emotional problems and mood difficulties on their capacity to self-manage, and requirements for additional support. However, there is limited research on the psychological correlates of IGB therapy. This systematic review, for the first time, attempts to identify and synthesize the empirical evidence for the reciprocal influence between psychological variables and IGB outcomes. METHODS: A literature search was performed in the PubMed, SCOPUS, MEDLINE, and Google Scholar databases. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed using rigorous inclusion criteria and screening by at least 2 reviewers. The selected articles were assessed for quality using the Strengthening the Reporting of Observational Studies Epidemiology (STROBE) checklist. Data were extracted to address the review aims and presented as a narrative synthesis. The review protocol was preregistered (Prospero CRD42019121291). RESULTS: A total of 16,179 titles, 14,369 abstracts, and 51 full-text articles were screened, of which 16 studies were included. Findings suggest that female gender, older age, basic educational level, and single/divorced civil status, together with lower levels of depression, binge eating, higher perceived quality of life, and motivation to change were predictors of enhanced IGB treatment outcomes. Dissatisfaction with treatment was higher in those with impaired obesity-related social-life difficulties. The IGB treatment was effective in reducing weight and improving depression, anxiety, eating disorder symptoms, and the overall life quality of patients with obesity - mainly within 6 months from the device positioning and in conjunction with conventional therapies. DISCUSSION/CONCLUSION: In line with the available literature on obesity and bariatric surgery interventions, poor mental health appears to be an important barrier for successful weight loss among patients with obesity undergoing IGB treatment. In order to improve the efficacy and effectiveness of the IGB therapy, more comprehensive and standardized studies are needed to provide insight into the psychological mechanisms maintaining weight management issues.

Pulmonary aspiration in adjustable gastric banding carriers undergoing a second surgical procedure. Considerations on personal experience and review of the literature.

BACKGROUND: The observation of a relatively high number of pulmonary aspirations (PA) among gastric band (GB) carriers undergoing a second surgery, prompted us to modify our strategy for GB patients candidate to further operation under general anesthesia. MATERIAL OF STUDY AND RESULTS: In January 2013, following the occurrence of PA at the induction of general anesthesia in 1 GB carrier undergoing a further operation, we reviewed our Data Base between January 2005 and 2013, to explore the rate of pulmonary aspiration in patients GB carriers undergoing a second surgery. Considering the rate (3/172 - 1.7%) too high in comparison with non-GB carriers, we decided to deflate the banding before any further surgery planned under general anesthesia. We then retrospectively reviewed the occurrence of PA after having changed the protocol. Since February 2013, through December 2016, 81 GB carriers underwent a second surgery and not a single episode of PA occurred (0/81). DISCUSSION: The occurrence of PA in patients with GB seems greater than in non-GB patients. Larger series should be examined to assess the incidence of PA among this specific population. Awareness of the increased risk is important to general anesthesiologists and surgeons, considering the increasing number of GB carriers who may be in need of surgery. Our result after adopting the deflation policy, even though not statistically significant, seems highly suggestive. CONCLUSION: We believe that, considering the potentially severe consequences of PA, the gastric band should be deflated before any planned procedure requiring general anesthesia. Further data are needed. KEY WORDS: Adjustable gastric banding, Aspiration Pneumonia, Bariatric surgery, Morbid obesity, Pulmonary Aspiration.

Laparoscopic Gastric Bypass with Fundectomy and Gastric Remnant Exploration (LRYGBfse): Results at 5-Year Follow-up.

BACKGROUND: The laparoscopic Roux-en-Y gastric bypass (LRYGB) is the gold standard treatment for morbid obesity. After LRYGB, the endoscopic access to the gastric remnant and pancreaticobiliary system is challenging. The laparoscopic gastric bypass with fundectomy and exploration of the gastric remnant (LRYGBfse) was introduced in an attempt to overcome this limitation. The purpose of this study was to analyze the medium-term outcomes and safety of LRYGBfse. METHODS: Observational prospective single-arm multicenter cohort study. Patients with BMI > 35 kg/m2 were included. Previous open abdominal surgery was an exclusion criterion. Postoperative 1, 2, 3, and 5-year weight loss, BMI decrease, and percentage of excess weight loss (%EWL) were recorded. Wilcoxon signed rank sum test was used for paired data. RESULTS: Among 653 enrolled patients, 229 completed the 5-year follow-up. Preoperative median body weight (kg) and BMI (kg/m2) were 133.4 kg (interquartile range (IQR) = 12.0) and 48.2 kg/m2 (IQR = 10.1), respectively. Median 5-year body weight, BMI, and %EWL were 83.7 (IQR = 17.3), 31.2 (IQR = 7.7), and 74.8 (IQR = 23.4), respectively, all significantly improved compared to baseline (p = 0.002, p = 0.001, and p = 0.012, respectively). Comorbid improvement or resolution was observed in 88% of the patients. No major intraoperative complications were reported. Postoperative overall morbidity and mortality rates were 1 and 0%, respectively. Banding removal was necessary in one patient 62 months after the index operation. CONCLUSIONS: The LRYGBfse seems safe and effective with durable results at 5-year follow-up. Endoscopic exploration of the gastric remnant is an additional valuable tool.

Long-term mortality and incidence of cardiovascular diseases and type 2 diabetes in diabetic and nondiabetic obese patients undergoing gastric banding: a controlled study.

BACKGROUND AND AIM: Aim of this retrospective study was to compare long-term mortality and incidence of new diseases [diabetes and cardiovascular (CV) disease] in morbidly obese diabetic and nondiabetic patients, undergoing gastric banding (LAGB) in comparison to medical treatment. PATIENTS AND METHODS: Medical records of obese patients [body mass index (BMI) > 35 kg/m(2) undergoing LAGB (n = 385; 52 with diabetes) or medical treatment (controls, n = 681; 127 with diabetes), during the period 1995-2001 (visit 1)] were collected. Patients were matched for age, sex, BMI, and blood pressure. Identification codes of patients were entered in the Italian National Health System Lumbardy database, that contains life status, causes of death, as well as exemptions, drug prescriptions, and hospital admissions (proxies of diseases) from visit 1 to September 2012. Survival was compared across LAGB patients and matched controls using Kaplan-Meier plots adjusted Cox regression analyses. RESULTS: Observation period was 13.9 ± 1.87 (mean ± SD). Mortality rate was 2.6, 6.6, and 10.1 % in controls at 5, 10, and 15 years, respectively; mortality rate was 0.8, 2.5, and 3.1 % in LAGB patients at 5, 10, and 15 years, respectively. Compared to controls, surgery was associated with reduced mortality [HR 0.35, 95 % CI 0.19-0.65, p < 0.001 at univariate analysis, HR 0.41, 95 % CI 0.21-0.76, p < 0.005 at adjusted analysis], similar in diabetic [HR 0.34, 95 % CI 0.13-0.87, p = 0.025] and nondiabetic [HR 0.42, 95 % CI 0.19-0.97, p = 0.041] patients. Surgery was also associated with lower incidence of diabetes (15 vs 48 cases, p = 0.035) and CV diseases (52 vs 124 cases, p = 0.048), and of hospital admissions (88 vs 197, p = 0.04). CONCLUSION: Up to 17 years, gastric banding is associated with reduced mortality in diabetic and nondiabetic patients, and with reduced incidence of diabetes and cardiovascular diseases.

MERTK rs4374383 polymorphism affects the severity of fibrosis in non-alcoholic fatty liver disease.

BACKGROUND & AIM: Homozygosity for a common non-coding rs4374383 G>A polymorphism in MERTK (myeloid-epithelial-reproductive tyrosine kinase) has been associated with the protection against fibrosis progression in chronic hepatitis C. The main study objective was to assess whether MERTK AA genotype influences liver fibrosis, and secondarily MERTK expression in patients with non-alcoholic fatty liver disease (NAFLD). We also investigated whether MERTK is expressed in human hepatic stellate cells (HSC) and in murine models of fibrogenesis. METHODS: We considered 533 consecutive patients who underwent liver biopsy for suspected non-alcoholic steatohepatitis (NASH) without severe obesity from two Italian cohorts. As controls, we evaluated 158 patients with normal liver enzymes and without metabolic disturbances. MERTK rs4374383 genotype was assessed by 5'-nuclease assays. MERTK expression was analysed in mouse models of fibrosis, and the effect of the MERTK ligand GAS6 were investigated in human HSC. RESULTS: Clinically significant fibrosis (stage F2-F4) was observed in 19% of patients with MERTK AA compared to 30% in those with MERTK GG/GA (OR 0.43, CI 0.21-0.88, p=0.02; adjusted for centre, and genetic, clinical-metabolic and histological variables). The protective rs4374383 AA genotype was associated with lower MERTK hepatic expression. MERTK was overexpressed in the liver of NAFLD patients with F2-F4 fibrosis and in in vivo models of fibrogenesis. Furthermore, exposure of cultured human HSC to the MERTK ligand GAS6, increased cell migration and induced procollagen expression. These effects were counteracted by inhibition of MERTK activity, which also resulted in apoptotic death of HSC. CONCLUSIONS: The rs4374383 AA genotype, associated with lower intrahepatic expression of MERTK, is protective against F2-F4 fibrosis in patients with NAFLD. The mechanism may involve modulation of HSC activation.

Statin use and non-alcoholic steatohepatitis in at risk individuals.

BACKGROUND & AIMS: Excess hepatic free cholesterol contributes to the pathogenesis of non-alcoholic steatohepatitis, and statins reduce cholesterol synthesis. Aim of this study was to assess whether statin use is associated with histological liver damage related to steatohepatitis. METHODS: The relationship between statin use, genetic risk factors, and liver damage was assessed in a multi-center cohort of 1201 European individuals, who underwent liver biopsy for suspected non-alcoholic steatohepatitis. RESULTS: Statin use was recorded in 107 subjects, and was associated with protection from steatosis, NASH, and fibrosis stage F2-F4, in a dose-dependent manner (adjusted p<0.05 for all). In 100 treated patients matched 1:1 for modality of recruitment, gender, presence of IFG or type 2 diabetes, PNPLA3 I148M risk alleles, TM6SF2 E167K variant, age, and BMI, statin use remained associated with protection from steatosis (OR 0.09, 95% C.I. 0.01-0.32; p=0.004), steatohepatitis (OR 0.25, 95% C.I. 0.13-0.47; p<0.001), and fibrosis stage F2-F4 (OR 0.42, 95% C.I. 0.20-0.8; p=0.017). Results were confirmed in a second analysis, where individuals were matched within recruitment center (p<0.05 for all). The protective effect of statins on steatohepatitis was stronger in subjects not carrying the I148M PNPLA3 risk variant (p=0.02 for interaction), as statins were negatively associated with steatohepatitis in patients negative (p<0.001), but not in those positive for the I148M variant (p=n.s.). CONCLUSIONS: Statin use was associated with protection towards the full spectrum of liver damage in individuals at risk of non-alcoholic steatohepatitis. However, the I148M PNPLA3 risk variant limited this beneficial effect.

Paradoxical dissociation between hepatic fat content and de novo lipogenesis due to PNPLA3 sequence variant.

CONTEXT: Nonalcoholic fatty liver disease (NAFLD) is an emerging epidemic disease characterized by increased hepatic fat, due to an imbalance between synthesis and removal of hepatic lipids. In particular, increased hepatic de novo lipogenesis (DNL) is a key feature associated with NAFLD. The genetic variations I148M in PNPLA3 and E167K in TM6SF2 confer susceptibility to NAFLD. OBJECTIVE: Here we aimed to investigate the contribution of DNL to liver fat accumulation in the PNPLA3 I148M or TM6SF2 E167K genetic determinants of NAFLD. PATIENTS AND METHODS: The PNPLA3 I148M and TM6SF2 E167K were genotyped in two well-characterized cohorts of Europeans. In the first cohort (Helsinki cohort; n = 88), we directly quantified hepatic DNL using deuterated water. In the second cohort (Milan cohort; n = 63), we quantified the hepatic expression of SREBP1c that we have found previously associated with increased fat content. Liver fat was measured by magnetic resonance proton spectroscopy in the Helsinki cohort, and by histological assessment of liver biopsies in the Milan cohort. RESULTS: PNPLA3 148M was associated with lower DNL and expression of the lipogenic transcription factor SREBP1c despite substantial increased hepatic fat content. CONCLUSIONS: Our data show a paradoxical dissociation between hepatic DNL and hepatic fat content due to the PNPLA3 148M allele indicating that increased DNL is not a key feature in all individuals with hepatic steatosis, and reinforces the contribution of decreased mobilization of hepatic triglycerides for hepatic lipid accumulation in subject with the PNPLA3 148M allele.

Transmembrane 6 superfamily member 2 gene variant disentangles nonalcoholic steatohepatitis from cardiovascular disease.

UNLABELLED: Excess hepatic storage of triglycerides is considered a benign condition, but nonalcoholic steatohepatitis (NASH) may progress to fibrosis and promote atherosclerosis. Carriers of the TM6SF2 E167K variant have fatty liver as a result of reduced secretion of very-low-density lipoproteins (VLDLs). As a result, they have lower circulating lipids and reduced risk of myocardial infarction. In this study, we aimed to assess whether TM6SF2 E167K affects liver damage and cardiovascular outcomes in subjects at risk of NASH. Liver damage was evaluated in 1,201 patients who underwent liver biopsy for suspected NASH; 427 were evaluated for carotid atherosclerosis. Cardiovascular outcomes were assessed in 1,819 controls from the Swedish Obese Subjects (SOS) cohort. Presence of the inherited TM6SF2 E167K variant was determined by TaqMan assays. In the liver biopsy cohort, 188 subjects (13%) were carriers of the E167K variant. They had lower serum lipid levels than noncarriers (P < 0.05), had more-severe steatosis, necroinflammation, ballooning, and fibrosis (P < 0.05), and were more likely to have NASH (odds ratio [OR]: 1.84; 95% confidence interval [CI]: 1.23-2.79) and advanced fibrosis (OR, 2.08; 95% CI: 1.20-3.55), after adjustment for age, sex, body mass index, fasting hyperglycemia, and the I148M PNPLA3 risk variant. However, E167K carriers had lower risk of developing carotid plaques (OR, 0.49; 95% CI: 0.25-0.94). In the SOS cohort, E167K carriers had higher alanine aminotransferase ALT and lower lipid levels (P < 0.05), as well as a lower incidence of cardiovascular events (hazard ratio: 0.61; 95% CI: 0.39-0.95). CONCLUSIONS: Carriers of the TM6SF2 E167K variant are more susceptible to progressive NASH, but are protected against cardiovascular disease. Our findings suggest that reduced ability to export VLDLs is deleterious for the liver.

The UCP2 -866 G>A promoter region polymorphism is associated with nonalcoholic steatohepatitis.

BACKGROUND & AIMS: Uncoupling protein 2 - UCP2 - regulates mitochondrial lipid fluxes and reactive oxygen species production by the respiratory chain. The -866 G>A UCP2 promoter region polymorphism has been linked to insulin resistance and lipid metabolism. The aim of this study was to assess whether the -866 G>A UCP2 polymorphism predisposes to nonalcoholic steatohepatitis in patients at risk, and the relationship with lipid metabolism and hepatic UCP2 expression. METHODS: We considered 688 Italian patients who underwent liver biopsy for suspected NASH, and 232 healthy controls. The UCP2 -866 G>A polymorphism was determined by allele specific oligonucleotide probes, hepatic UCP2 mRNA levels by quantitative real-time PCR. RESULTS: UCP2 A/A genotype was associated with a reduced risk of nonalcoholic steatohepatitis (Odds Ratio 0.49, 95% C.I. 0.26-0.90; P = 0.02; adjusted for age, sex, BMI, impaired fasting glucose or diabetes, PNPLA3 I148M alleles and recruitment centre). The A/A genotype was associated with reduced risk of steatosis grade G2-G3 and nonalcoholic steatohepatitis in patients without (P = 0.003 and P = 0.01 respectively), but not in those with (P = NS) impaired fasting glucose/diabetes. The UCP2 A/A genotype was associated with higher hepatic UCP2 mRNA levels (adjusted P = 0.008). Concerning the metabolic traits, the UCP2 A/A genotype was associated with higher total serum cholesterol levels (adjusted P = 0.03), but not with serum HDL, triglycerides or impaired fasting glucose/diabetes. CONCLUSIONS: UCP2 -866 A/A genotype is associated with increased hepatic UCP2 expression and reduced risk of nonalcoholic steatohepatitis, particularly in subjects with normal fasting glucose.

Three years durability of the improvements in health-related quality of life observed after gastric banding.

BACKGROUND: Improvements in health-related quality of life (HR-QoL) occur after bariatric surgery. However, sustainability of these changes over time remains debated. METHODS: Data collected in a prospective 3-year multicenter Italian study on changes of HR-QoL after laparoscopic adjustable gastric banding were used. HR-QoL has investigated with the SF-36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. RESULTS: A total of 230 patients (53 male and 177 female) were analyzed. Body mass index was 41.4±5.4 kg/m2 at baseline, declined to 33.8±5.8 kg/m2 12 months after surgery (P<.001), and further reduced to 31.9±5.1 kg/m2 36 months after surgery (P<.001 versus 12 months). Scores in the SF-36 subscales were lower than in the general Italian population at baseline. The physical component summary score was 51.9±11.6 at baseline, improved to 79.2±15.4 at 12 months (P<.001), and stabilized to 79.8±15.6 at 36 months. The mental summary score was 52.3±11.8 at baseline, improved to 75.2±17.3 at 12 months (P<.001), and stabilized to 74.2±17.5 at 36 months. A decline>10 points between 12 and 36 months in the summary scores was observed in 22.0% of the patients for PCS and in 26.8% for MCS. In a multiple linear regression analysis, deterioration in HR-QoL in the 12-36 months period was associated to the presence of better HR-QoL values at 12 months and to a more pronounced reduction of the self-perceived effect of the banding at 36 months. CONCLUSION: Improvements in HR-QoL observed in the first year after surgery maintained up to the third year after gastric banding.

[Psychiatric features before and after intervention: a study of patients affected by severe obesity undergoing adjustable gastric banding]. / Tratti psichiatrici pre- e post-intervento: studio di un campione di pazienti affetti da grave obesità sottoposti a bendaggio gastrico regolabile.

AIM: This study identifies psychological features and the evolution of psychiatric symptoms in a group of patients affected by obesity, who underwent adjustable gastric banding. MATERIALS AND METHODS: In this group, other than clinical visit, test SCL-90 is made in preoperative time. In postoperative SCL-90, TAS and BES were carried out. Patients evaluated before and after bariatric surgery were 220 and 115, respectively. SCL-90 test made before bariatric surgery showed high values (>0.7) for cluster related to somatization, interpersonal sensitivity, paranoid ideation, depression and obsessive compulsive disorder. DISCUSSION: Depression symptoms were more important in patients undergoing endogastric balloon placement (mean value of 0.9). Anxious symptoms showed a mean value of 0.73 in patients undergoing endogastric balloon placement as compared to a mean value of 0.52 in patients undergoing gastric banding. CONCLUSIONS: Our findings show that in patients undergoing bariatric surgery, depressive symptoms are more common preoperatively and normalize at follow-up. This confirms that a possible cause of depression is obesity. The present study also shows that anxious symptoms are lower in obese patients.

The I148M PNPLA3 polymorphism influences serum adiponectin in patients with fatty liver and healthy controls.

BACKGROUND: Reduced adiponectin is implicated in the pathogenesis of nonalcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH), and the I148M Patatin-like phospholipase domain-containing 3 (PNPLA3) polymorphism predisposes to NAFLD and liver damage progression in NASH and chronic hepatitis C (CHC) by still undefined mechanisms, possibly involving regulation of adipose tissue function. Aim of this study was to evaluate whether the I148M PNPLA3 polymorphism influences serum adiponectin in liver diseases and healthy controls. METHODS: To this end, we considered 144 consecutive Italian patients with NAFLD, 261 with CHC, 35 severely obese subjects, and 257 healthy controls with very low probability of steatosis, all with complete clinical and genetic characterization, including adiponectin (ADIPOQ) genotype. PNPLA3 rs738409 (I148M) and ADIPOQ genotypes were evaluated by Taqman assays, serum adiponectin by ELISA. Adiponectin mRNA levels were evaluated by quantitative real-time PCR in the visceral adipose tissue (VAT) of 35 obese subjects undergoing bariatric surgery. RESULTS: Adiponectin levels were independently associated with the risk of NAFLD and with the histological severity of the disease. Adiponectin levels decreased with the number of 148 M PNPLA3 alleles at risk of NASH both in patients with NAFLD (p = 0.03), and in healthy subjects (p = 0.04). At multivariate analysis, PNPLA3 148 M alleles were associated with low adiponectin levels (<6 mg/ml, median value) independently of NAFLD diagnosis, age, gender, BMI, and ADIPOQ genotype (OR 1.67, 95% c.i. 1.07-2.1 for each 148 M allele). The p.148 M PNPLA3 variant was associated with decreased adiponectin mRNA levels in the VAT of obese patients (p < 0.05) even in the absence of NASH. In contrast, in CHC, characterized by adiponectin resistance, low adiponectin was associated with male gender and steatosis, but not with PNPLA3 and ADIPOQ genotypes and viral features. CONCLUSIONS: The I148M PNPLA3 variant is associated with adiponectin levels in patients with NAFLD and in healthy subjects, but in the presence of adiponectin resistance not in CHC patients. The I148M PNPLA3 genotype may represent a genetic determinant of serum adiponectin levels. Modulation of serum adiponectin might be involved in mediating the susceptibility to steatosis, NASH, and hepatocellular carcinoma in carriers of the 148 M PNPLA3 variant without CHC, with potential therapeutic implications.

Improvement in health-related quality of life in first year after laparoscopic adjustable gastric banding.

BACKGROUND: We analyzed the health-related quality of life (HRQOL) and its determinants in the first year after laparoscopic adjustable gastric banding (LAGB). The setting was 10 Italian public and private bariatric surgery centers. METHODS: Data collected in an ongoing, prospective, 3-year multicenter Italian study on the changes in HRQOL after LAGB were used. HRQOL was investigated using the Medical Outcomes Study Short-Form 36 questionnaire. Hunger, satiety, and the self-perceived effects of LAGB were recorded. RESULTS: A total of 334 patients were enrolled. The follow-up rate was 92.2%. The percentage of excess weight loss was 39.6% ± 25.8%, with very few side effects or complications. Hunger in the morning (0-10 scale) was 4.5 ± 2.7 before surgery and 3.8 ± 2.4 after 1 year (P <.001). Satiety after a meal (0-10 scale) was 7.1 ± 2.7 before surgery and 8.2 ± 1.9 at 1 year (P <.001). The self-perceived effect of LAGB on caloric intake (0-10 scale) was 8.4 ± 1.9 after 1 year. The scores for the 8 Medical Outcomes Study Short-Form 36 subscales were significantly improved after surgery. The physical component summary score was 52.6 ± 11.9 at baseline and 79.1 ± 15.6 after 1 year (P <.001). The corresponding mental component summary scores were 52.2 ± 12.3 and 76.5 ± 17.2 (P <.001). Greater physical component summary improvement was independently associated with a low initial physical component summary (P <.001), high satiety (P = .002), a high percentage of excess weight loss (P = .013), and a high self-perceived effect of the LAGB (P = .026). Greater mental component summary improvement was associated with a low initial mental component summary (P <.001), high satiety (P <.001), a low frequency of heartburn (P = .004), and a high percentage of excess weight loss (P = .012). CONCLUSIONS: Significant improvements in HRQOL were observed in the first year after LAGB. A poor baseline HRQOL, a high efficacy of the banding in eating control, and better weight loss might influence HRQOL changes.

Inflammatory and prothrombotic parameters in normotensive non-diabetic obese women: effect of weight loss obtained by gastric banding.

Hypertension and diabetes are known risk factors for obesity-related thrombosis, but several studies have shown that obesity is characterised by a potentially prothrombotic inflammatory state because of activated coagulation and impaired fibrinolysis. In order to verify if obese patients-unaffected by hypertension, diabetes, dyslipidemia, cigarette smoking or inflammatory diseases-show increased prothrombotic markers and whether the weight loss induced by gastric banding normalises such parameters. Plasma levels of C reactive protein (CRP), fibrinogen, plasminogen activator inhibitor-1 (PAI-1), von Willebrand factor (VWF) and factor VII (FVII) were measured in 25 women with isolated obesity prior to, as well as 3, 6 and 12 months subsequent to gastric banding. Twenty-five healthy women served as a baseline control group. The obese women had higher CRP (p = 0.0001), fibrinogen (p = 0.014), PAI-1 (p = 0.003), VWF (p = 0.004) and FVII levels (p = 0.0001) than the normal controls, and their body mass index (BMI) positively correlated with CRP (r = 0.462, p = 0.02), fibrinogen (r = 0.426, p = 0.04) and PAI-1 (r = 0.468, p = 0.02). Twelve months after gastric banding, the median BMI had decreased from 40.0 to 34.9 (p = 0.0001); CRP from 4.18 to 1.69 µg/ml (p = 0.01); fibrinogen from 389 to 318 mg/dl (p = 0.0001); PAI-1 from 32.1 to 12.0 UI/ml (p = 0.003); VWF from 144 to 120% (p = 0.0001); and FVII from 134 to 112% (p = 0.002). Even in the absence of major cardiovascular risk factors, obese patients are characterised by a prothrombotic state. The weight loss induced by gastric banding decreases the parameters of inflammation, coagulation and impaired fibrinolysis, thus potentially reducing the thrombotic risk.

Treatment of band erosion: feasibility and safety of endoscopic band removal.

BACKGROUND: Band erosion is reported with a highly variable incidence (0.3-14%) after laparoscopic adjustable gastric banding. Removal of the band is mandatory because the patient regains weight and may become symptomatic, but no consensus exists about the best method, surgical or endoscopic, for this purpose. This study aimed to evaluate the feasibility and effectiveness of endoscopic management of band erosion. METHODS: In this study, 23 patients were treated for band erosion after gastric banding: 8 from the authors' series of 951 patients (incidence, 0.84%) and 15 referred to the authors' surgical department from other hospitals. The endoscopic method of band removal was used in 20 cases. Because of complications associated with erosion, three patients were submitted instead to laparoscopic removal. RESULTS: Endoscopic removal of the band was successful for 16 of 20 patients. Four cases required conversion of the procedure to surgery: in one case due to complications with the endoscopic cutting wire and in the three remaining cases due to dense perigastric adhesions blocking the band. The follow-up evaluation of the patients who had the endoscopic removal was uneventful, with quick discharge at resumption of oral feeding. The patients who underwent laparoscopic removal had a longer hospital stay, and one patient had a leak from the anterior gastrotomy. CONCLUSIONS: Despite a few complications, endoscopic removal seems to be the procedure of choice for the treatment of band erosion. It allows quick resumption of oral feeding and rapid discharge of patients and appears to be safer and more effective than laparoscopic removal. Conversion to surgery is unlikely but possible. Therefore, the authors always recommend that the procedure be performed in the operating room.

Impact of the metabolic syndrome on subcutaneous microcirculation in obese patients.

OBJECTIVES: Patients with the metabolic syndrome are at increased cardiovascular risk and display an augmented wall stiffness of the large-sized and medium-sized arteries, coupled with an endothelial dysfunction. Whether this is the case also for the small resistance arteries is unknown, however. It is also unknown whether and to what extent the hypothesized microvascular alterations are greater for magnitude than the ones characterizing obesity, that is the most common component of the metabolic syndrome. METHODS: In 14 lean healthy controls (age 48.7 +/- 2.4 years, mean +/- SEM), 13 obese participants and 12 individuals with the metabolic syndrome (Adult Treatment Panel III criteria), all age-matched with healthy controls, we assessed the small resistance arteries dissected from the abdominal subcutaneous tissue on a pressurized myograph. RESULTS: The media thickness, media cross-sectional area (CSA) and media-to-lumen ratio (M/L) of the small resistance arteries were markedly and significantly greater in metabolic syndrome than in controls (media thickness: 28.3 +/- 0.7 vs. 17.5 +/- 0.3 microm; CSA: 24 760.8 +/- 1459 vs. 16 170.7 +/- 843.6 microm and M/L: 0.12 +/- 0.01 vs. 0.064 +/- 0.002 a.u., respectively, P < 0.01 for all). Acetylcholine-induced relaxation was impaired in the vessels from metabolic syndrome participants compared with the lean healthy individuals (-48.8%, P < 0.01), whereas endothelium-independent vasorelaxation was similar in the two groups. The structural and functional microvascular alterations seen in metabolic syndrome were slightly, although not significantly, greater than the ones seen in uncomplicated obese participants. Stiffness of small arteries, as assessed by the stress/strain relationship, was also similar in the three groups of participants. CONCLUSION: Thus, metabolic syndrome is characterized by marked alterations in the structural and functional patterns of the small resistance arteries. These alterations, which are only slightly greater than the ones seen in obesity, may be responsible for the increased incidence of coronary and cerebrovascular events reported in metabolic syndrome.

Homozygosity for the patatin-like phospholipase-3/adiponutrin I148M polymorphism influences liver fibrosis in patients with nonalcoholic fatty liver disease.

UNLABELLED: Inherited factors play a major role in the predisposition to nonalcoholic fatty liver disease (NAFLD), and the rs738409 C-->G polymorphism of PNPLA3/adiponutrin, encoding for the isoleucine-to-methionine substitution at residue 148 (I148M) protein variant, has recently been recognized as a major determinant of liver fat content. However, the effect of the rs738409 polymorphism on the severity of liver fibrosis in patients with NAFLD is still unknown. In this study, we considered 253 Italian patients, 179 healthy controls, and 71 family trios with an affected child with NAFLD. Analyses were replicated in 321 patients from the United Kingdom. The rs738409 polymorphism was determined by TaqMan assays. Liver histology was scored according to Kleiner et al. Hepatic expression of genes regulating liver damage was assessed by real-time polymerase chain reaction in 52 patients. The rs738409 GG genotype was more prevalent in patients than in controls (14% versus 3%, adjusted odds ratio [OR] = 3.29, 95% confidence interval [CI] = 1.8-6.9), and in the family study, the G allele was overtransmitted to affected children (P = 0.001). In Italian and United Kingdom patients, adiponutrin genotype influenced alanine aminotransferase levels and the severity of steatosis. Adiponutrin genotype was associated with the expression of genes involved in the steatosis-related liver damage, including the proapoptotic molecule Fas ligand. In the whole series combined, adiponutrin genotype was associated with steatosis grade >1 (OR = 1.35, 95% CI = 1.04-1.76), nonalcoholic steatohepatitis (OR = 1.5, 95% CI = 1.12-2.04), and fibrosis stage >1 (OR = 1.5, 95% CI = 1.09-2.12), independent of age, body mass index, and diabetes. Adiponutrin genotype demonstrated a dose effect with heterozygote risk intermediate between CC and GG homozygotes. CONCLUSION: In patients with NAFLD, adiponutrin rs738409 C-->G genotype, encoding for I148M, is associated with the severity of steatosis and fibrosis and the presence of nonalcoholic steatohepatitis.

Injection port and connecting tube complications after laparoscopic adjustable gastric banding.

BACKGROUND: Port-site and connecting tube complications are usually considered minor problems in the follow-up of obese patients submitted to laparoscopic adjustable gastric banding (LAGB), but the incidence reported in literature ranges from 4.3% to 24%. These complications are mainly because of the mechanical stress of the port and the tube; therefore, their incidence might be time dependent and probably increase during the follow-up. METHODS: We evaluated retrospectively 489 obese patients submitted to LAGB from February 1998 to December 2005, considering all the complications of the connecting tube and port. Their clinical signs, imaging exams, operative reports, and hospitalization files were evaluated. RESULTS: The mean follow-up of the patients was 41 months. Seventy-one patients (14.5%) presented port and connecting tube complications that required 82 revisional operations. Fifty-four patients had system leaks, 3 had infection problems, and 14 mechanical problems, always requiring surgical revision. In five patients, the system leak was observed twice and required a second surgical repair, while one patient presented three times a leakage of the connecting tube and needed three surgical revisions. All cases of system leakage were related to significant weight regain. In one case of recurrent port infection, we had to remove the band. CONCLUSION: Port-site and connecting tube problems are the most common complications after LAGB. Although they are considered marginal complications, they usually cause weight regain; their correction often requires surgical revision and sometimes removal of the band.