Italian guidelines for the management of adult individuals with overweight and obesity and metabolic comorbidities that are resistant to behavioral treatment.

AIM: This guideline (GL) is aimed at providing a clinical practice reference for the management of adult patients with overweight or obesity associated with metabolic complications who are resistant to lifestyle modification. METHODS: Surgeons, endocrinologists, gastroenterologists, psychologists, pharmacologists, a general practitioner, a nutritionist, a nurse and a patients' representative acted as multi-disciplinary panel. This GL has been developed following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A systematic review and network meta-analysis was performed by a methodologic group. For each question, the panel identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as "critical" and "important" were considered in the systematic review of evidence. Those classified as "critical" were considered for clinical practice recommendations. Consensus on the direction (for or against) and strength (strong or conditional) of recommendations was reached through a majority vote. RESULTS: The present GL provides recommendations about the role of both pharmacological and surgical treatment for the clinical management of the adult patient population with BMI > 27 kg/m2 and < 40 kg/m2 associated with weight-related metabolic comorbidities, resistant to lifestyle changes. The panel: suggests the timely implementation of therapeutic interventions in addition to diet and physical activity; recommends the use of semaglutide 2.4 mg/week and suggests liraglutide 3 mg/day in patients with obesity or overweight also affected by diabetes or pre-diabetes; recommends semaglutide 2.4 mg/week in patients with obesity or overweight also affected by non-alcoholic fatty liver disease; recommends semaglutide 2.4 mg/week as first-line drug in patients with obesity or overweight that require a larger weight loss to reduce comorbidities; suggests the use of orlistat in patients with obesity or overweight also affected by hypertriglyceridemia that assume high-calorie and high-fat diet; suggests the use of naltrexone/bupropion combination in patients with obesity or overweight, with emotional eating; recommends surgical intervention (sleeve gastrectomy, Roux-en-Y gastric bypass, or metabolic gastric bypass/gastric bypass with single anastomosis/gastric mini bypass in patients with BMI ≥ 35 kg/m2 who are suitable for metabolic surgery; and suggests gastric banding as a possible, though less effective, surgical alternative. CONCLUSION: The present GL is directed to all physicians addressing people with obesity-working in hospitals, territorial services or private practice-and to general practitioners and patients. The recommendations should also consider the patient's preferences and the available resources and expertise.

[Telemedicine in stroke-pertinent to stroke care in Germany]. / Telemedizin in der Schlaganfallversorgung ­ versorgungsrelevant für Deutschland.

BACKGROUND AND OBJECTIVE: Telemedical stroke networks improve stroke care and provide access to time-dependent acute stroke treatment in predominantly rural regions. The aim is a presentation of data on its utility and regional distribution. METHODS: The working group on telemedical stroke care of the German Stroke Society performed a survey study among all telestroke networks. RESULTS: Currently, 22 telemedical stroke networks including 43 centers (per network: median 1.5, interquartile range, IQR, 1-3) as well as 225 cooperating hospitals (per network: median 9, IQR 4-17) operate in Germany and contribute to acute stroke care delivery to 48 million people. In 2018, 38,211 teleconsultations (per network: median 1340, IQR 319-2758) were performed. The thrombolysis rate was 14.1% (95% confidence interval 13.6-14.7%) and transfer for thrombectomy was initiated in 7.9% (95% confidence interval 7.5-8.4%) of ischemic stroke patients. Financial reimbursement differs regionally with compensation for telemedical stroke care in only three federal states. CONCLUSION: Telemedical stroke care is utilized in about 1 out of 10 stroke patients in Germany. Telemedical stroke networks achieve similar rates of thrombolysis and transfer for thrombectomy compared with neurological stroke units and contribute to stroke care in rural regions. Standardization of network structures, financial assurance and uniform quality measurements may further strengthen the importance of telestroke networks in the future.

Patient-centredness in acute stroke care - a qualitative study from the perspectives of patients, relatives and staff.

BACKGROUND AND PURPOSE: Although patient-centredness is considered a key component of high-quality neurological care, it is unclear to what extent it can or should be implemented during the acute phase. Using acute stroke as an example, the aim was to identify critical junctures for patient-centredness along the acute care pathway from the perspectives of patients, relatives and staff. METHODS: A qualitative multi-method study was conducted including 27 non-participant observations and 37 semi-structured interviews with patients, relatives and staff. Junctures were defined as critical when mentioned (as problematic) in two or three information sources (i.e. observations, staff interviews, or patient and relative interviews), as potentially critical when mentioned in one, and as uncritical when not mentioned. RESULTS: Post-procedure communication after thrombectomy, patients' stay at the stroke unit and decision-making around transfer, discharge and rehabilitation were identified as critical junctures for patient-centredness. Arrival at the emergency department and the (thrombectomy) treatment itself were identified as uncritical junctures, whilst history-taking and treatment preparation, the treatment decision and patients' stay at the intensive care unit were identified as potentially critical junctures. CONCLUSIONS: In acute stroke care, patients, relatives and staff prioritize fast over patient-centred decision-making in the most time-critical phases, especially before and during treatment. This is reversed after the procedure, when difficulties arise implementing a patient-centred approach in clinical practice. To improve patient-centredness where it is most needed, clear guidelines and accessible resources are recommended. Future research should investigate whether insights from acute phases of stroke care are applicable to other neurological conditions as well.

Predictors of fat-free mass loss 1 year after laparoscopic sleeve gastrectomy.

PURPOSE: Laparoscopic sleeve gastrectomy (LSG) is one of the most frequently performed bariatric surgery interventions because of its safety and efficacy. Nevertheless, concerns have been raised on its detrimental effect on patient nutritional state that can ultimately lead to the loss of fat-free mass (FFM). There is interest in identifying predictors for the early identification of patients at risk of this highly unwanted adverse because they could benefit of nutritional preventive interventions. Therefore, we investigated whether anthropometric parameters, body composition or resting energy expenditure (REE) measured before surgery could predict FFM loss 1 year after LSG. METHODS: Study design was retrospective observational. We retrieved data on body weight, BMI, body composition and REE before and 1 year after LSG from the medical files of 36 patients operated on by LSG at our institutions. Simple regression, the Oldham's method and multilevel analysis were used to identify predictors of FFM loss. RESULTS: Averaged percentage FFM loss 1 year after LSG was 17.0 ± 7.7% with significant differences between sexes (20.8 ± 6.6 in males and 12.2 ± 6.1% in females, p < 0.001). FFM loss was strongly predicted by pre-surgery FFM and this effect persisted also after correcting for the contribution of sex. CONCLUSIONS: High FFM values before surgery predict a more severe FFM loss after LSG. This factor could also account for the higher FFM loss in men than in women. Our finding could help in the early identification of patient requiring a nutritional support after LSG.

Multiple symmetric lipomatosis: a rare disease and its possible links to brown adipose tissue.

AIM: Aim of this study is an updated review of our case series (72 patients) as well as available literature on the Multiple Symmetric Lipomatosis (MSL), a rare disease primarily involving adipose tissue, characterized by the presence of not encapsulated fat masses, symmetrically disposed at characteristic body sites (neck, trunk, proximal parts of upper and lower limbs). DATA SYNTHESIS: The disease is more frequent in males, associated to an elevated chronic alcohol consumption, mainly in form of red wine. Familiarity has been reported and MSL is considered an autosomic dominant inherited disease. MSL is associated to severe clinical complications, represented by occupation of the mediastinum by lipomatous tissue with a mediastinal syndrome and by the presence of a somatic and autonomic neuropathies. Hyper-alphalipoproteinemia with an increased adipose tissue lipoprotein-lipase activity, a defect of adrenergic stimulated lipolysis and a reduction of mitochondrial enzymes have been described. The localization of lipomatous masses suggests that MSL lipomas could originate from brown adipose tissue (BAT). Moreover, studies on cultured pre-adipocytes demonstrate that these cells synthetize the mitochondrial inner membrane protein UCP-1, the selective marker of BAT. Surgical removal of lipomatous tissue is to date the only validated therapeutic approach. CONCLUSIONS: MSL is supposed to be the result of a disorder of the proliferation and differentiation of human BAT cells.

Determinants of health-related quality of life in morbid obese candidates to gastric banding.

OBJECTIVE: To analyse determinants of self reported health-related quality of life (HR-QoL) in morbid obese patients candidates to laparoscopic adjustable gastric banding (LAGB). METHODS: Determinants of HR-QoL were investigated in 383 morbid obese patients (82 M and 301 F) with BMI≥40 kg/m² (BMI≥35 kg/m² if complicated obesity) and age 18-60 years. HR-QoL was determined with the SF-36 questionnaire. Determinants of the two summary measures of SF-36 (physical component and mental component) were analysed by stepwise multiple linear regression analysis with age, BMI, physical comorbidites, mental comorbidites and eating behaviour disorders as independent variables. Physical comorbities (diabetes, hypertension, hypertriglyceridemia, low HDL, sleep apnea and osteoarthritis) were coded as present or absent on the basis of simple diagnostic clinical criteria; mental comorbidities (depression) and eating behaviour disorders (binge eating, sweet eating and nibbling) on the basis of an unstructured clinical interview. RESULTS: Mean age was 38.8±10.2 years and mean BMI was 41.5±5.4 kg/m². Scores in the eight SF-36 subscales were lower in women than in men and lower than in the general Italian population. However, 18.4-43.5% of the participants had HR-QoL levels above the normative values, depending on the scale. In both genders, low scores in the mental component of the SF-36 were associated to the presence of depression and eating behaviour disorders and not to physical comorbidities or BMI levels. Low physical self-perceived well being was associated to high BMI levels in men and to depression, hypertension and hypertriglyceridemia in women. CONCLUSION: HR-QoL was poor in morbid obese candidates to LAGB, particularly in women, and was negatively affected more by mental comorbidites and eating behaviour disorders than by physical comorbidities or BMI levels.

Changes in total body and limb composition and muscle strength after a 6-8 weeks sojourn at extreme altitude (5000-8000 m).

AIM: Weight loss at extreme altitudes affects quantitative changes in fat-free mass (FFM), muscle mass and fat mass. No studies to date have focused on regional body composition and physical performance using reference methods after stays at extreme altitudes. The aim of this study was to investigate the changes in total and regional body composition, and muscle strength induced by the extreme altitudes. METHODS: Eight men aged 38.8±5.8 who took part in two different Italian expeditions on Mt. Everest (group A) and on Gasherbrum II (group B). Before and after the expedition all participants underwent anthropometric measurements, total and regional body composition assessment by DEXA, and handgrip and knee extensor strength measurements by dynamometry. RESULTS: The variations in body composition mainly involved FFM, with a similar loss in group A (-2.4±1.9 kg; P<0.05) and group B (-2.4±1.2 kg; P<0.05). Most of the FFM loss involved the limbs (-2.1±1.4 kg; P<0.01), and especially the upper limbs (-1.6±1.1 kg; P<0.01). The isotonic knee extensor strength declined in 6 of the 8 study participants, with a mean drop of -4.4±6.1 kg. CONCLUSIONS: In conclusion, our study evidence that extreme altitudes induce weight loss due mainly to a loss of fat-free mass in the limb.

[Obesity and Eating Disorders. Indications for the different levels of care. An Italian Expert Consensus Document]. / Documento di Consensus. Obesità e Disturbi dell'Alimentazione Indicazioni per i diversi livelli di trattamento.

This paper is an Italian Expert Consensus Document on multidimensional treatment of obesity and eating disorders. The Document is based on a wide survey of expert opinion. It presents, in particular, considerations regarding how clinicians go about choosing the most appropriate site of treatment for a given patient suffering from obesity and/or eating disorders: outpatient, partial hospitalization, residential rehabilitation centre, inpatient hospitalization. In a majority of instances obesity and eating disorders are long-term diseases and require a multiprofessional team-approach. In determining an initial level of care or a change to a different level of care, it is essential to consider together the overall physical condition, medical complications, disabilities, psychiatric comorbidity, psychology, behaviour, family, social resources, environment, and available services. We first created a review manuscript, a skeleton algorithm and two rating scales, based on the published guidelines and the existing research literature. As the second point we highlighted a number of clinical questions that had to be addressed in the specific context of our National Health Service and available specialized care units. Then we submitted eleven progressive revisions of the Document to the experts up to the final synthesis that was approved by the group. Of course, from point to point, some of the individual experts would differ with the consensus view. The document can be viewed as an expert consultation and the clinical judgement must always be tailored to the particular needs of each clinical situation. We will continue to revise the Document periodically based on new research information and on reassessment of expert opinion to keep it up-to-date. The Document was not financially sponsored.

Obesity treatment in elderly outpatients: predictors of efficacy and drop-out.

OBJECTIVE: Obesity is increasing in the elderly and it is associated with an increased risk of medical complications, decline in physical function and disability. Very few studies specifically evaluated the outcome of obesity treatment in the aging patients. Aim of this work is therefore the evaluation of the efficacy of medical therapy in a group of obese patients >or=65 years old. METHODS: The study has been performed on the clinical records of obese outpatients treated at the medical branch of the Unit for Medical and Surgical Therapy of Obesity at the University of Padova. Patients were recruited from January 1st, 2001 to June 30th, 2006 in order to have patients with at least one year of potential follow-up. In particular two groups were enrolled: 100 patients >or=65 years old and 200 patients <65 years old. The baseline characteristics, the prescriptions and the treatment outcome were compared. RESULTS: Mean age of the elderly patients was 69.1+/-3.7 years (range 65-80 years). We did not find any significant difference between elderly and adult patients in the sex distribution (female patients 76% in the elderly group and 72% in the adult group; p=0.276) and in the severity of overweight (body mass index: 37.8+/-6.0 kg/m2 in the elderly; 37.2+/-6.3 kg/m2 in adults; p=0.425). The elderly group was characterized by a higher incidence of comorbidities and a lower incidence of eating behavior disorders at baseline. No significant differences in the dietary prescription were found, whereas physical activity was prescribed in 27/100 elderly patients (27%) and in 97/200 (48%) adults patients (p<0.000). Weight loss was evaluated by analyzing the percentage of patients reaching at least a 10% weight loss from baseline after 12 months of treatment. In elderly patients still in active treatment after 12 months, only 5/28 (18%) patients reached the specified goal, whereas in adult patients still in treatment, 18/47 (38%) patients reached the goal (p<0.05). Lower age at baseline, female sex, and lower body mass index were found to be the only significant predictors of 10% weight loss in logistic regression. In our experience, drop-out rate after 12 months was similar in adults (77%) and in older patients (72%). In a multivariate Cox regression model, the risk of drop-out was reduced by married or widowed status, the prescription of physical activity at baseline, and the presence of type 2 diabetes. The risk of drop-out was increased by the presence of osteoarthritis. Even after adjustments for these confounding variables, age did not play any significant role as drop-out predictor. CONCLUSION: Advanced age seems to be a predictor of poor response to treatment in obese outpatients treated by conventional medical therapy. Drop-out rate was not significantly influenced by age.

Pre-operative Very Low Calorie Ketogenic Diet (VLCKD) vs. Very Low Calorie Diet (VLCD): Surgical Impact.

BACKGROUND: Pre-operative diet may play an important role as far as patients' fitness for surgery, post-operative outcomes, and successful weight loss. Our aim was to compare surgical outcome and weight loss in two groups of patients who were offered two different pre-operative kinds of diet: very low calorie diet (VLCD) and very low calorie ketogenic diet (VLCKD). METHODS: Patients candidate for bariatric surgery (laparoscopic sleeve gastrectomy) were registered and assessed according to pre- and post-diet BMI, operative time, hospital stay, drainage output, and hemoglobin (Hb) levels. Patients' preference influenced the type of diet. RESULTS: From January to December 2016, 178 patients (139 F and 39 M) were enrolled in this study. The mean age was 43 years. In total, 72 patients were on VLCKD while 106 patients on VLCD. Pre-diet mean BMI was 46.3 ± 6.3 kg/m2 for VLCKD group and 43.1 ± 6.9 kg/m2 for VLCD group, while immediately pre-op BMI were 43.9 ± 5.9 kg/m2 and 41.9 ± 6.8 kg/m2, respectively. Drainage output and hemoglobin levels after surgery resulted significantly correlated with diet induced BMI reduction (141.2 ± 75.8 vs. 190.7 ± 183.6 ml, p = 0.032; 13.1 ± 1.2 vs. 12.7 ± 1.5 g/l, p = 0.04). The percentage of patients requiring a hospital stay longer than anticipated (> 3 days) was 2.8% in the VLCKD group and 10.4% in the VLCD group (p = 0.048). CONCLUSIONS: In our experience, VLCKD showed better results than VLCD on surgical outcome, influencing drainage output, post-operative hemoglobin levels, and hospital stay.

Predictors of low bone mineral density in the elderly: the role of dietary intake, nutritional status and sarcopenia.

OBJECTIVES: The aims of this study were to investigate the relationship between sarcopenia, dietary intake, nutritional indices and hip bone mineral density (BMD) in the elderly, and to estimate the risk of low BMD due to specific independent predictor thresholds. SUBJECTS AND METHODS: Body mass index (BMI), serum albumin, energy and protein intake were studied in 352 elderly outpatients (216 women aged 73.5+/-5.3 years and 136 men aged 73.9+/-5.6 years). BMD at different hip sites and appendicular skeletal muscle mass (ASMM) were assessed by dual-energy X-ray absorptiometry. RESULTS: The prevalence of osteoporosis was 13% in men and 45% in women, while the prevalence of sarcopenia (50%) and hypoalbuminemia (5%) were similar in both genders. BMI, albumin and ASMM were significantly associated with BMD in both genders: so was protein intake, but only in men. By multiple regression analysis, the variables that retained their independent explanatory role on total hip BMD, were BMI and protein intake in men, and BMI and albumin in women. By logistic regression analysis, men risked having a low BMD with a BMI <22 (OR=12) and a protein intake <65.7 g/day (OR=3.7). Women carried some risk already in the BMI 25-30 class (OR=5), and a much greater risk in the BMI <22 class (OR=26). Albumin <40 g/l also emerged as an independent risk factor (OR=2.6). CONCLUSIONS: BMI in both genders, albumin in women and protein intake in men have an independent effect on BMD. BMI values <22 are normal for younger adults but carry a higher risk of osteoporosis in the elderly, particularly in women. Age-related sarcopenia does not seem to be involved in bone mass loss.

Differences in dietary patterns between older and younger obese and overweight outpatients.

BACKGROUND: Transitions from Mediterranean to Western eating habits has been observed, particularly in young people. Thus little information is available on food patterns consumption in overweight/obese Italian elderly. OBJECTIVES: To describe dietary patterns in a sample of obese/overweight adults, providing differences between older and younger outpatients. METHODS: Dietary patterns, anthropometric measurements, obesity onset, history of weight and demographic data were obtained in a retrospective survey, according to age groups (< 35 y, 35-64 y, >or= 65 y) and gender in 395 outpatients. RESULTS: Main differences in dietary patterns have been observed across age groups. Older outpatients reported higher frequency of consumption of fresh fruit and vegetables, and lower daily consumption of sweet high-fat foods. All the participants reported eating cereals. The frequency of consumption of white meat and fish was higher in the oldest age group. The consumption of moderate amount of red wine at mealtime was common in older male patients only; the frequency of consumption of cheese did not differ across age groups, but compared to normal-weight Italian population was higher in older-aged female. CONCLUSION: Our study provides evidence of two different dietary patterns: a western diet which may have influenced weight gain in the younger patients and an Italian Mediterranean diet in the older ones. Despite its healthy effect, Mediterranean diet style did not prevent older obese patients from additional weight gain. Information on dietary habits may be useful to improve weight management and obesity prevention even in older subjects.

Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months.

BACKGROUND: Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare. METHODS: Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed. RESULTS: Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months. CONCLUSION: During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01448785.

Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation.

OBJECTIVE: To determine possible preoperative predictors for obtaining clinically meaningful weight loss with gastric electrical stimulation (GES) using the "Three-Factor Eating Questionnaire" (TFEQ) as well as epidemiological data. METHODS: Ninety-seven obese participants in a prospective multicenter randomized study conducted in nine European centers were implanted laparoscopically with the abiliti® closed-loop GES system (CLGES). Five clinical variables and three preoperative TFEQ factor scores (F1-cognitive-restraint, F2-disinhibition, and F3-hunger) were analyzed in order to determine predictors of weight loss success defined as excess weight loss (EWL) > 30% and failure defined as EWL < 20% at 12 months post-surgery. RESULTS: The mean 12-month %EWL with CLGES was 35.1 ± 19.7%, with a success rate of 52% and a failure rate of 19%. Significant predictors of success were body mass index (BMI) < 40 kg/m2 and age ≥ 50 years, increasing probability of success by 22 and 29%, respectively. A low F1-cognitive-restraint score was a significant predictor of failure (p = 0.004). The best predictive model for success included F1-cognitive-restraint, F2-disinhibition, BMI < 40, and age ≥ 50 (p = 0.002). CONCLUSION: This retrospective analysis has shown that age, preoperative BMI, and F1-cognitive-restraint and F2-disinhibition scores from a preoperatively administered TFEQ are predictive of weight loss outcomes with CLGES and may be used for patient selection. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01448785.

BioEnterics Intragastric Balloon: The Italian Experience with 2,515 Patients.

BACKGROUND: The temporary use of the BioEnterics Intragastric Balloon (BIB) in morbidly obesity is increasing worldwide. The aim of this study is the evaluation of the efficacy of this device in a large population, in terms of weight loss and its influence on co-morbidities. METHODS: Data were retrospectively recruited from the data-base of the Italian Collaborative Study Group for Lap-Band and BIB (GILB). After diagnostic endoscopy, the BIB was positioned and was filled with saline (500-700 ml) and methylene blue (10 ml). Patients were discharged with diet counselling ( approximately 1000 Kcal) and medical therapy. The BIB was removed after 6 months. Positioning and removal were performed under conscious or unconscious sedation. Mortality, complications, BMI, %EWL, BMI loss and co-morbidities were evaluated. RESULTS: From May 2000 to September 2004, 2,515 patients underwent BIB (722M/1,793F; mean age 38.9+/-14.7, range 12-71; mean BMI 44.4+/-7.8 kg/m(2) ; range 28.0-79.1; and mean excess weight 59.5+/-29.8 kg, range 16-210). BIB positioning was uncomplicated in all but two cases (0.08%) with acute gastric dilation treated conservatively. Overall complication rate was 70/2,515 (2.8%). Gastric perforation occurred in 5 patients (0.19%), 4 of whom had undergone previous gastric surgery: 2 died and 2 were successfully treated by laparoscopic repair after balloon removal. 19 gastric obstructions (0.76%) presented in the first week after positioning and were successfully treated by balloon removal. Balloon rupture (n=9; 0.36%) was not prevalent within any particular period of BIB treatment, and was also treated by BIB removal. Esophagitis (n=32; 1.27%) and gastric ulcer (n=5; 0.2%) presented in patients without a history of peptic disease and were treated conservatively by drugs. Preoperative co-morbidities were diagnosed in 1,394/2,471 patients (56.4%); these resolved in 617/1,394 (44.3%), improved (less pharmacological dosage or shift to other therapies) in 625/1,394 (44.8%), and were unchanged in 152/1,394 (10.9%). After 6 months, mean BMI was 35.4+/-11.8 kg/m(2) (range 24-73) and %EWL was 33.9+/-18.7 (range 0-87). BMI loss was 4.9+/-12.7 kg/m(2) (range 0-25). CONCLUSIONS: BIB is an effective procedure with satisfactory weight loss and improvement in co-morbidities after 6 months. Previous gastric surgery is a contraindication to BIB placement.

Obesity, Muscular Strength, Muscle Composition and Physical Performance in an Elderly Population.

OBJECTIVE: To evaluate the association between BMI levels, muscular strength, muscle composition and physical performance in the elderly. DESIGN: Italians subjects from the Progetto Veneto Anziani (ProVA) study were analyzed. SETTING: The ProVa was a population study focused on chronic diseases and functional limitations in Italian subjects aged ≥65 years living in two Northeast Italian cities. PARTICIPANTS: The ProVa study included 3099 subjects. ProVa participants with unknown information on BMI or disability status were excluded. The final sample was thus represented by 1.188 men, and 1.723 women. MEASUREMENTS: Physical performance was measured with the Short Physical Performance Battery (SPPB) and leg muscular strength with dynamometry. Fat distribution and skeletal muscle composition were measured in an abdominal single-scan magnetic resonance (MRI) in a randomly selected sample of 348 subjects. Study population was stratified by BMI classes. RESULTS: An association between BMI levels and SPPB was observed. Normal weight subjects showed the best SPPB scores (8.29±0.03), with significant differences compared to underweight (7.50±0.15; p<0.001), overweight (8.12±0.02; p<0.001), class I (7.72±0.04; p<0.001), class II (6.67±0.09; p<0.001) and class III obesity (5.88±0.24; p<0.001). This pattern was not modified by adjustment for possible confounders. Compared to normal weight subjects (22.9±0.1 kg), leg muscular strength was higher in overweight (23.8±0.1; p<0.001) and in class I obesity (24.5±0.1; p<0.001), but it was reduced in class II (21.4±0.3; p<0.001) and class III (19.8±0.9; p<0.001). The association between BMI and impaired physical performance was not affected by adjustment for muscular strength. An inverse association between SPPB scores and fat infiltration in skeletal muscle was observed in patients with abdominal MRI. CONCLUSION: A poor physical performance was observed in overweight and obese elderly subjects. Leg strength was reduced only in subjects with severe obesity. Physical performance was negatively influenced by the degree of fat infiltration in skeletal muscle.

The influence of a new timing strategy of band adjustment on the vomiting frequency and the food consumption of obese women operated with laparoscopic adjustable silicone gastric banding (LAP-BAND).

OBJECTIVE: To evaluate the effects of a new timing strategy of band adjustment on the short-term outcome of obese women operated with adjustable silicone gastric banding. SUBJECTS: The outcome of 30 women without binge-eating disorder operated with laparoscopic adjustable silicone gastric banding with a wider intraoperatory band calibration (LAP-BAND) was compared to that of 30 body mass index-matched women without binge-eating disorder previously operated with adjustable silicone gastric banding (ASGB) applied by laparotomy with the usual intraoperatory band calibration. The patients were evaluated 3, 6 and 12 months after surgery. MEASUREMENTS: (1) weight loss; (2) total daily energy intake; (3) percent as liquid, soft or solid food; (4) vomiting frequency; (5) rate of postoperative percutaneous band adjustments; (6) rate of band-related complications. RESULTS: Both the weight loss and the daily energy intake did not differ between patients with LAP-BAND and patients with ASGB. After surgery, the patients with LAP-BAND ate more solid food and less liquid food than the patients with ASGB. Vomiting frequency was higher in patients with ASGB than in patients with LAP-BAND. The total number of percutaneous band adjustments was higher in women with LAP-BAND than in women with ASGB. Band inflation because of weight stabilization was performed in six (20.0%) women with ASGB and in 19 (63.3%) women with LAP-BAND. Neostoma stenosis occurred in one woman with ASGB, but in none of the women with LAP-BAND. One patient with LAP-BAND presented band slippage. CONCLUSIONS: The wider intraoperatory band calibration performed in patients with LAP-BAND did not reduce the short-term efficacy of adjustable silicone gastric banding. This new timing strategy of band adjustment required more postoperative percutaneous band inflations, but it improved the eating pattern of the patients (low vomiting frequency and high intake of solid food).

Bariatric analysis and reporting outcome system (BAROS) applied to laparoscopic gastric banding patients.

BACKGROUND: The definition of success and failure of a bariatric procedure should include weight loss as well as improvement in comorbidity and quality of life assessment. The Bariatric Analysis and Reporting Outcome System (BAROS), introduced by Oria and Moorhead in 1997, seems to provide a standard for comparison in the surgical treatment of morbid obesity. METHODS: 180 morbidly obese and super-obese patients, who underwent laparoscopic gastric banding (lap-band) at our institutions and had a follow-up >18 months (19-55 months) were evaluated with BAROS. RESULTS: The patients were divided into four outcome groups (failure, fair, good, and excellent) based on a scoring table that adds or subtracts points while evaluating three main areas: percentage of excess weight loss, changes in medical conditions, and assessment of quality of life. Points were deducted for complications and reoperative surgery. CONCLUSIONS: The BAROS outcome system has proved to be a useful instrument in evaluating midterm results in our series of lap-band patients.

Variation in lipid levels in morbidly obese patients operated with the LAP-BAND adjustable gastric banding system: effects of different levels of weight loss.

BACKGROUND: A moderate weight loss is known to improve the lipid levels in simple obesity. The extent of weight loss needed to achieve a clinically meaningful effect on lipid abnormalities in morbid obesity is little understood. We analyzed the effects of different levels of body weight loss on the lipid levels of morbidly obese patients operated with the LAP-BAND System. METHODS: 225 morbidly obese patients (172 F and 53 M) in which a complete lipid profile has been collected both before and 12-18 months after surgery were studied. The changes of the lipid profile were analyzed according to different levels of percent weight loss (%WL: <10%, 10-20%, 20-30%, >30%). RESULTS: Mean weight loss was 30.7+/-15.2 kg, corresponding to a 23.1+/-9.7% reduction of body weight. A large variability in the weight loss was observed. A significant difference in the change of the lipid parameters between the group with <10%WL and the group with 10-20%WL was observed for total-cholesterol (+10.0+/-17.2% vs -0.7+/-14.7%; p<0.05), for the LDL (+18.7+/-26.3% vs +3.1+/-22.9%; p<0.05), and for the triglycerides (+7.7+/-26.3% vs -21.9+/-25.4%; p<0.05). No further significant differences were found between the two groups with greater weight loss (20-30%WL and >30%WL) and the group with 10-20%WL, the only exception being the percent change in triglycerides levels, i.e. higher in the group with %WL >30 (-33.6+/-31.5% vs -21.9+/-25.4%; p<0.05). CONCLUSION: A moderate weight loss of 10-20% of initial body weight produced the maximal effects on the lipid levels in morbid obesity.

Laparoscopic adjustable silicone gastric banding (Lap-Band): how to avoid complications.

BACKGROUND: The laparoscopic application of LAP-BAND is gaining widespread acceptance as a gastric restrictive procedure. At the same time the reported morbidities (i.e., gastric perforation, stomach and/or band slippage) are cause for some concern. METHODS: From September 1993 until May 1997, 260 patients underwent LAP-BAND at the Department of Surgery at the University of Padova, Italy. RESULTS: The mortality rate was zero and the morbidity rate requiring reoperation was 3.4% (stomach slippage, gastric perforation, erosion). In order to avoid complications the key points of the technique are reviewed: (1) reference points for dissection (equator of the balloon, left crus); (2) retrogastric tunnel within the layers of the phrenogastric ligament; (3) embedment of the band; (4) proper outlet calibration; and (5) retention sutures. CONCLUSIONS: Attention to technical details is of paramount importance for a safe, standardized and effective operation.