Maurizio De Luca

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.

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.

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.

Treatment of Morbid Obesity with the Transcend® Implantable Gastric Stimulator (IGS®): A Prospective Survey

Background: The implantable gastric stimulator (IGS), a pacemaker-like device, has been found to be safe and effective to induce and maintain weight loss. We present our experience with 20 morbidly obese patients. Methods: Between September 20 and November 22, 2002, 20 patients (F/M 12/8), mean age 40.3 years (23-62) underwent IGS implantation. Mean BMI was 40.9 (33.9-48.2), mean weight 115.0 kg (87.0-137.0) and mean excess weight (EW) 51.3 kg (35.6-70.1).Co-morbitidies were: 3 cases of hypertension, 1 diabetes, 1 dislipidemia and 1 depression. Mean operative time was 58.5 min (37-85). The IGS was actived 30 days after implantation. Patients were advised to follow a low calorie diet and behavior modification (to avoid fat and to ingest more liquids during meals, to chew slowly, to eat vegetables before main meals, and to perform exercise daily). Results: Mean ± standard error percent excess weight loss (%EWL) was: 10.6±1.8 at 1 month; 15.0±2.3 at 2 months; 16.6±2.6 at 3 months; 18.1±3.5 at 4 months; 15.5±3.5 at 6 months; 18.9±3.5 at 8 months; and 23.8±5.0 at 10 months. There were no intra-operative surgical or long-term complications. There were 3 intra-operative gastric penetrations, observed by gastroscopy, without sequelae. One patient with hypertension ceased his medical therapy at the 4th month. Conclusion: IGS can be implanted laparoscopically with minimal perioperative complications. The observed weight loss is comparable to other noninvasive procedures. If weight loss is maintained, IGS could be considered as a first choice therapy in the treatment of morbid obesity in selected patients.

Bariatric surgery in class i obesity: A position statement from the international federation for the surgery of obesity and metabolic disorders (IFSO)

Class I obesity conveys an increased risk of comorbidities, impairs physical and mental health-related quality of life, and it is associated to an increased psychosocial burden, particularly in women. The need for effective and safe therapies for class I obesity is great and not yet met by nonsurgical approaches. Eligibility to bariatric surgery has been largely based on body mass index (BMI) cut points and limited to patients with more severe obesity levels. However, obese patients belonging to the same BMI class may have very different levels of health, risk, and impact of obesity on quality of life. Individual patients in class I obesity may have a comorbidity burden similar to, or greater than, patients with more severe obesity. Therefore, the denial of bariatric surgery to a patient with class I obesity suffering from a significant obesity-related health burden and not achieving weight control with nonsurgical therapy simply on the basis of the BMI level does not appear to be clinically justified. A clinical decision should be based on a more comprehensive evaluation of the patient’s current global health and on a more reliable prediction of future morbidity and mortality. After a careful review of available data about safety and efficacy of bariatric surgery in patients with class I obesity, this panel reached a consensus on ten clinical recommendations.

Postoperative Management of Laparoscopic Gastric Banding

Background:The authors investigated the postoperative management of morbidly obese patients treated by laparoscopic adjustable gastric banding (LAGB) with the Lap-Band® System. Methods: The 3-year postoperative band management is presented in 379 morbidly obese patients, divided according to intra-operative band filling and quartiles of maximum postoperative band filling. Results: LAGB resulted in a 40.8±24.5 percent excess weight loss (%EWL). Stoma stenosis occurred in 87 patients (23.0%), pouch dilatation in 52 (13.7%) and esophageal dilatation in 22 (5.8%). Most bandrelated complications were controlled by simple band deflation. The mean number of postoperative band adjustments was 2.3±1.7, and mean maximum band filling after surgery was 2.8±1.2 ml. Weight loss at 3 years was identical in 205 patients who had the band completely unfilled at surgery and in 174 patients who had the band filled with 1 to 3 ml of sterile saline.The rate of band-related complications was significantly lower in the first group. No differences in %EWL were observed between quartiles of maximum band filling after surgery.The rate of band-related complications increased with increasing levels of postoperative maximum band filling. In patients with the band filled with <3.0 ml of sterile saline at 6 months, the inflation of further saline produced a dose-related increase in the rate of weight loss. In patients with the band filled with ≥ 3.0 ml of sterile saline at 6 months, the inflation of further saline was associated with a reduced %EWL. Conclusion: Postoperative adjustability of the LapBand® was useful in the treatment of band-related complications and was able to significantly influence the rate of weight loss. On the other hand, aggressive postoperative band filling was associated with an increased rate of complications.

Solitary necrotic nodule of the liver misinterpreted as malignant lesion: considerations on two cases.

In our experience, we document 2 cases of a rare and non‐tumoral lesion of the liver misinterpreted as necrotic tumor: necrotic solitary nodule. In the first clinical case, ultrasound (US) showed a polylobated lesion (35 × 35 × 38 mm) at segment 8. Color‐doppler identified a compression of celiac axis (Dunbar syndrome). Arteriography revealed a subtotal stenosis of celiac tripod soon after the emergence of the left gastric artery. FNAB‐CT showed a highly cellulated tissue with a necrotic core surrounded by a fibersclerotic tissue. The patient underwent surgery: cholecystectomy and correction of Dunbar syndrome. US follow‐up showed a progressive reduction in diameter of the lesion (24 × 25 × 25 mm at 24 months), suggesting in this case the role of ischemic injury in the pathogenesis of the lesion.

Two Years of Practice in Adjustable Silicone Gastric Banding (LAP-BAND™): Evaluation of Variations of Body Mass Index, Percentage Ideal Body Weight and Percentage Excess Body Weight

Background: In the treatment of morbid obesity, surgery had been the only method of obtaining a good and enduring weight loss. Although the procedure of choice is still a matter of debate, among gastric restriction procedures LAP-BAND™ has become our first choice. Methods: We report the results from 62 morbidly obese patients operated in the period October 1994-December 1996. Their characteristics were: mean age 35.6 years, mean body weight 130.6 kg, mean height 162.3 cm, mean body mass index (BMI) 49.9 kg/m2, mean percentage ideal body weight (%IBW) 215.7 and mean excess weight (EW) 69.57 kg. Results: Twenty-four months after surgery we found a mean BMI of 39.3, a mean %IBW of 168.6 and a mean % EW loss of 88.5. We removed the band in two patients: one after 9 months because of stoma stenosis and pouch enlargement in a woman who had been lost at follow-up, and the other for gastric slippage occurring after 18 months due to incorrect fixation of the band. Conclusion: Our results led us to consider LAP-BAND™ as the surgical approach for severe obesity among those patients selected for gastric restriction; indeed, it was very safe as well as effective and was rarely followed by complications.

Weight loss and changes in use of antidiabetic medication in obese type 2 diabetics after laparoscopic gastric banding

BACKGROUND Interest in bariatric surgery is growing as an effective method for long-term metabolic control in morbidly obese patients with type 2 diabetes. We analyzed the weight loss and changes in use of diabetic medication in obese patients with type 2 diabetes treated with laparoscopic adjustable gastric banding (LAGB). METHODS From 1993 to 2005, 1791 morbid obese patients underwent LAGB at our institution. Of the 1791 patients, 394 (22%) had type 2 diabetes mellitus at baseline. Of the 394 patients with diabetes, 52 were receiving diabetic medication. The median follow-up period for the drug-treated diabetic patients was 3 years (range .25-9). RESULTS The drug-treated diabetic patients were older (age 47.6 +/- 7.5 versus 37.5 +/- 10.7 years, P <.001), weighed more (body mass index 49.1 +/- 9.5 versus 45.6 +/- 7.5 kg/m(2), P 0.001), and were more frequently affected by co-morbidities than the nondiabetic patients at surgery. The percentage of excess weight loss 1 year after surgery was less (32.4% +/- 14.1% versus 41.1% +/- 19.9%, P <.01) for the drug-treated diabetic patients than for the nondiabetic patients. This difference was maintained for 5 years of follow-up. A significant decline occurred in the use of both oral diabetic medication and insulin after surgery. Of the 52 patients treated with oral antidiabetic medication at baseline, 33 required oral antidiabetic medication at the end of follow-up. Of the 6 patients who also required insulin at baseline, 2 did so at the end of follow-up. The use of diabetic medication had increased in 4 patients (7.7%), was unchanged in 12 (23.1%), had decreased in 17 (32.7%), and was suspended in 19 (36.5%) of 52 patients. CONCLUSION The amount of weight loss after LAGB was less in drug-treated diabetic patients than in nondiabetic patients. However, LAGB was associated with a sustained reduction in the use of diabetic medication.

High Ghrelin Concentration is Not a Predictor of Less Weight Loss in Morbidly Obese Women Treated with Laparoscopic Adjustable Gastric Banding

Background: We analyzed the role of high plasma ghrelin concentrations at surgery as a negative predictor of weight loss in morbidly obese patients treated with laparoscopic gastric banding (LAGB). Methods: Fasting plasma ghrelin concentrations were measured in 113 women before LAGB, and 16 of them were identified as having ghrelin concentrations clearly higher than expected according to the BMI levels. The 2-year postoperative outcome of these 16 patients was compared to the outcome of the remaining subjects. Results: Mean fasting plasma ghrelin concentration in the group with hyperghrelinemia was 82.3±23.1 pg/ml and in women with normal ghrelin was 27.1±11.3 pg/ml (P <0.001). No differences in age, age at onset of obesity or degree of obesity were observed between the two groups. Women with hyperghrelinemia had a weight gain during the waiting time similar to women with normal ghrelin. The prevalence of comorbities and eating behavior disturbances was similar in the two groups, but depression was 2.5 fold more prevalent in the hyperghrelinemic women than in the women with normal ghrelin. The %EWL after LAGB surgery was similar in women with high and normal ghrelin concentrations, with no differences in levels of postoperative band filling. No differences in band-related complications or revisional surgery rate were observed between the two groups. Conclusion: A high fasting ghrelin concentration at baseline did not significantly affect the outcome after LAGB in morbidly obese women, in terms of weight loss and complications rate.