Luca Busetto

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 (∼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/m2 ; 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/m2 (range 24-73) and %EWL was 33.9±18.7 (range 0-87). BMI loss was 4.9±12.7 kg/m2 (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.

Laparoscopic Adjustable Silicone Gastric Banding (Lap-Band®): How To Avoid Comlications

Background: The laparoscopic application of LAPBAND 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.

Outcome Predictors in Morbidly Obese Recipients of an Adjustable Gastric Band

Background: The authors investigated the outcome predictors in obese patients who underwent laparoscopic adjustable banding with the Lap-Band®. Methods:The 3-year excess weight loss (EWL) and rate of band-related complications (pouch dilatation and port leackage) were analyzed in 260 morbidly obese patients, according to several possible predictive characteristics. Success rate (EWL >50%), failure rate (EWL < 20%) and weight regain rate (regain of >10%EWL between 1 and 3 yrs) were considered. Results: The Lap-Band® produced a 43.0±22.3% EWL, corresponding to a BMI reduction from 46.6±7.0 to 36.8±6.6 kg/m2. Success rate was 35.7%, failure rate was 14.1% and weight regain rate was 20.7%. Pouch dilatation occurred in 32 patients (12.3%), band erosion in 2 (0.8%), port leakage in 74 (28.5%), and port twisting in 2 (0.8%). Major band-related surgery was requested in 11 patients (4.2%) and minor port-related surgery in 62 patients (23.9%). Significant success predictors were found to be age <40 years and BMI <50 kg/m2. Significant failure predictors were found to be male sex and non-sweet eating behavior. Significant weight regain predictors were found to be BMI <50 kg/m2 and the occurrence of a port leakage. Port leakage was significantly more frequent in women and in patients with BMI <50 kg/m2. The prevalence of pouch dilatation was threefold higher in women than in men. Conclusions: Lap-Band® was associated with a good outcome and with a low rate of severe complications. The outcome was more influenced by physiological and technical reasons than by psychological or behavioural factors.

Predictors of drop-out in overweight and obese outpatients.

OBJECTIVE:To investigate the impact on drop-out rates of several baseline clinical characteristics of a sample of overweight and obese outpatients.DESIGN:Retrospective clinical trial.SUBJECTS:The charts of 383 patients aged 15–82 y attending an outpatient clinic for the treatment of obesity were examined from the first clinical evaluation until 1 y of diet ambulatory treatment.MEASUREMENTS:We characterised the participants at baseline on the basis of their somatic characteristics, socioeconomic status, obesity-related diseases and dietary habits. The most significant factors resulting in univariate statistical analysis (waist, body mass index (BMI), full-time job, depressive syndrome, number of obesity-related diseases, daily frequency of fruit consumption) were then examined as independent variables in direct multiple logistic regression with the dependent variable drop-out.RESULTS:The 1-y drop-out rate was 77.3%. A total of 87 patients completed the follow-up study. The noncompleter patients had slightly lower BMI and waist circumference mean values, and they were further regularly employed in full-time jobs, while the completer patients were principally pensioners and housewives. Drop-outs had a lower number of obesity-related diseases and as a result were less depressed. By the logistic regression, full-time job is the best predictor of premature withdrawal (odds ratio=2.40). Age, gender, anthropometric measurements, lifestyle and dietary habits did not result as significant predictors of drop-out.CONCLUSION:The overweight and obese outpatients at higher risk of ambulatory treatment drop-out are more likely to work full hours, have less obesity-related complications and be less depressed. In our study, the full-time job condition seems to be the strongest predictor of premature withdrawal.

Weight loss and postoperative complications in morbidly obese patients with binge eating disorder treated by laparoscopic adjustable gastric banding.

Background: The authors investigated the outcome of morbidly obese patients with binge eating disorder (BED) treated surgically with laparoscopic adjustable gastric banding. Methods: The 5-year outcomes of 130 patients with BED and 249 patients without BED are described. The diagnosis of BED was made preoperatively and all patients with BED were supported with psychological therapy. Results: Patients with and without BED had similar BMI levels before surgery. More patients with than without BED had depressive symptoms and associated minor disturbances of eating behavior (night eating and grazing). Percent excess weight loss (%EWL) in the first 5 years after surgery was similar in patients with and without BED. The percentage of BED patients showing %EWL >50% at the 5-year evaluation was 23.1, and 25.7% in non-BED patients. The percentage of patients showing weight regain in the last 4 years of follow-up was similar in binge eaters (20.8%) and in non-binge eaters (22.5%). The 5-year frequency of gastric pouch and esophageal dilatation was significantly higher in binge eaters than in non-binge eaters (25.4 vs 17.7 %, P<0.05 and 10.0 vs 4.8%, P<0.05, respectively). Binge eaters underwent a higher number of postoperative band adjustments than non-binge eaters (3.0±2.1 vs 2.6±1.9, P<0.05) and the maximum band fill after surgery was higher in the BED patients than in non-BED patients (3.2±1.2 vs 2.8±1.3 ml, P<0.01). Conclusion: Morbidly obese patients with BED supported by adequate psychological treatment can have good outcomes after gastric banding.

European Guidelines for Obesity Management in Adults

Obesity is a chronic metabolic disease characterised by an increase of body fat stores. It is a gateway to ill health, and it has become one of the leading causes of disability and death, affecting not only adults but also children and adolescents worldwide. In clinical practice, the body fatness is estimated by BMI, and the accumulation of intra-abdominal fat (marker for higher metabolic and cardiovascular disease risk) can be assessed by waist circumference. Complex interactions between biological, behavioural, social and environmental factors are involved in regulation of energy balance and fat stores. A comprehensive history, physical examination and laboratory assessment relevant to the patients obesity should be obtained. Appropriate goals of weight management emphasise realistic weight loss to achieve a reduction in health risks and should include promotion of weight loss, maintenance and prevention of weight regain. Management of co-morbidities and improving quality of life of obese patients are also included in treatment aims. Balanced hypocaloric diets result in clinically meaningful weight loss regardless of which macronutrients they emphasise. Aerobic training is the optimal mode of exercise for reducing fat mass while a programme including resistance training is needed for increasing lean mass in middle-aged and overweight/obese individuals. Cognitive behavioural therapy directly addresses behaviours that require change for successful weight loss and weight loss maintenance. Pharmacotherapy can help patients to maintain compliance and ameliorate obesity-related health risks. Surgery is the most effective treatment for morbid obesity in terms of long-term weight loss. A comprehensive obesity management can only be accomplished by a multidisciplinary obesity management team. We conclude that physicians have a responsibility to recognise obesity as a disease and help obese patients with appropriate prevention and treatment. Treatment should be based on good clinical care, and evidence-based interventions; should focus on realistic goals and lifelong multidisciplinary management.

Progress in Implantable Gastric Stimulation: Summary of Results of the European Multi-Center Study

BackgroundThe Implantable Gastric Stimulator (IGS®), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. The LOSS (Laparoscopic Obesity Stimulation Survey) is a prospective non-randomized trial which enrolled 69 patients involving 11 investigator centers in 5 European Countries. In 19 patients, ghrelin was analyzed.MethodsBetween January 2002 and December 2003, 69 patients (F/M 49/20), mean age 41 years (18–65) underwent IGS implantation. Mean BMI was 41 (35–57), mean weight 115.0 kg (65–160) and mean excess weight (EW) 52 kg (13–89). The IGS was actived 30 days after implantation. In a subset of 19 patients studied further, 0, 6, and 12 months appetite and satiety score were evaluated and 0 and 6 months ghrelin profile was analyzed.ResultsThe mean ± standard error %EWL was: 8.6±1.8 at 1 month, 15.8±2.3 at 3 months, 17.8±2.6 at 6 months, 21.0±3.5 at 10 months, and 21.0±5.0 at 15 months. There were no intraoperative surgical or long-term complications. 7 intra-operative gastric penetrations occurred, observed by gastroscopy, without sequelae. 1 patient required a reoperation to remove a retained lead needle. In the subset of 19 patients, appetite was reduced and post-prandial and inter-prandial satiety was increased after IGS implantation. In the 19 patients, despite weight reduction, ghrelin did not increase.ConclusionIGS can be implanted laparoscopically with minimal perioperative complications. Appetite is reduced and satiety is increased after the implantation. Ghrelin levels could be one of the mechanisms explaining weight loss and weight maintenance in IGS patients. If weight loss is maintained, IGS could be considered a good option for selected patients.

Visceral fat loss evaluated by total body magnetic resonance imaging in obese women operated with laparascopic adjustable silicone gastric banding

OBJECTIVE: To investigate the changes of visceral fat, as compared with total and subcutaneous adipose tissue (AT) in obese patients operated with laparascopic adjustable silicone gastric banding (LAP-BAND).SUBJECTS: Six premenopausal morbid obese (body mass index range: 41.4–44.2 kg/m2) women, aged 38–42 y, operated with LAP-BAND, evaluated before, 8 weeks after, and 24 weeks after surgery.MEASUREMENTS: Fat distribution was analysed by total body multi-slices MRI. Total AT, gluteo-femoral subcutaneous AT, abdominal subcutaneous AT, and abdominal visceral AT volumes were measured. FM was calculated from MRI-determined total AT volume and AT density.RESULTS: A weight loss of 9.9±3.8 kg was observed in the first 8 weeks after LAP-BAND (0–8 weeks), and a further weight loss of 7.1±4.9 kg in the subsequent 16 weeks (8–24 weeks). Total AT showed a statistically significant reduction of 6.2±4.0 l in 0–8 weeks and a further significant reduction of 7.7±3.9 l in 8–24 weeks (P<0.01 from baseline). A similar trend was observed for both abdominal and gluteo-femoral subcutaneous AT. Visceral AT showed a statistically significant reduction of 1.0±0.9 l in the 0–8 weeks (P<0.05) and a further non-significant reduction of 0.6±0.7 l in 8–24 weeks (P<0.05 from baseline). In 0–8 weeks, the relative reduction of visceral AT was higher than the relative reduction of both total AT and gluteo-femoral subcutaneous AT. A highly significant correlation was observed between the reduction of total AT and the reduction of both abdominal and gluteo-femoral subcutaneous AT. By contrast, in 0–8 weeks, the reduction of total AT and the reduction of visceral AT were not correlated. In a subsequent analysis, both observations collected in the first 8 weeks after LAP-BAND and observations collected in the last 16 weeks are simultaneously considered, leading to a total of 12 time periods (two time periods for each individual patient). In order to identify factors associated with preferential visceral fat reduction, we calculated for each of the 12 time periods the difference between the percentage changes of visceral AT and the percentage changes of total AT. The relationship between this difference and several other variables were investigated by simple correlation analysis. The only variables found to be associated were the initial visceral AT volume, the absolute level of weight loss (kg) per week of observation, and the relative level of weight loss (%) per week of observation.CONCLUSION: In the phase of rapid weight loss following LAP-BAND, a preferential mobilization of visceral fat, as compared with total and subcutaneous AT, can occur. However, this preferential visceral fat reduction occurs only in those patients presenting higher levels of visceral fat deposition at baseline and higher levels of weight loss.

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.

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.