Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

Intragastric gastric band migration: erosion: an analysis of multicenter experience on 177 patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has proven to be a safe and effective surgical treatment for morbid obesity. It can be a simple, fast, reversible, anatomy-preserving procedure. Despite these advantages, its long-term efficacy came into question by the occurrence of complications such as intragastric band migration. Consistent information regarding this complication is still lacking. Treatment for migration is still being debated as well. Most of the inconsistencies of these data stem from the very low number of patients reported in single-center experiences or case reports. Lack of multicenter experience is evident. The aim of this study was to perform a retrospective analysis of data on intragastric migration in a large multicenter cohort of patients who underwent LAGB. METHODS: A retrospective multicenter study on LAGB patients was performed. Data had been entered into a prospective database of the Italian Group for LapBand(®) (GILB) since January 1997. Pars flaccida and perigastric positioning were considered along with different kinds of gastric bands by the same manufacturer. Time of diagnosis, mean body mass index (BMI), presentation symptoms, and conservative and surgical therapy of intragastric migration were considered. RESULTS: From January 1997 to December 2009, a total of 6,839 patients underwent LAGB and their data were recorded [5,660 females, 1,179 males; mean age 38.5 ± 18.2 years (range 21-62 years); mean BMI = 46.7 ± 7.7 kg/m(2) (range 37.3-68.3); excess weight (EW) 61.8 ± 25.4 kg (range 36-130); %EW 91.1 ± 32.4 % (range 21-112 %)]. A total of 177 of 6,839 (2.5 %) intragastric erosions were observed. According to the postoperative time of follow-up, the diagnosis of intragastric migration was made in 74 (41.8 %), 14 (7.9 %), 38 (21.4 %), 40 (22.6 %), 6 (3.4 %), and 4 (2.2 %) banded patients at 6-12, 24, 36, 48, 60, and 72 months after banding, respectively. Most of intragastric band migration during the first 2 years occurred in bands with no or a few milliliters of filling. In patients with late erosion, the bands were adjusted several times; no band was overfilled but one was filled to the maximum or submaximum with a maximum of two adjustments. Erosions diagnosed during the first 24 months were related to the experience of the surgical staff, while late erosions were not. CONCLUSIONS: Intragastric band migration or band erosion is a rare, disturbing, and usually not life-threatening complication of gastric banding. Its pathogenesis is probably linked to different mechanisms in early (technical failure in retrogastric passage) or late (band management) presentation. It is usually asymptomatic and there is no pathognomonic presentation. A wide range of therapeutic options are available, from simple endoscopic or laparoscopic removal to early or late band replacement or other bariatric procedure. More experience and more studies are needed to lower its presentation rate and definitively clarify its pathogenesis to address the right therapeutic option.

Laparoscopic adjustable gastric banding via pars flaccida versus perigastric positioning: technique, complications, and results in 2,549 patients.

AIM: Retrospective multicenter analysis of the results of two different approaches for band positioning: perigastric and pars flaccida. METHODS: Data were collected from the database of the Italian Group for LapBand (GILB). Patients operated from January 2001 to December 2004 were selected according to criteria of case-control studies to compare two different band positioning techniques: perigastric (PG group) and pars flaccida (PF group). Demographics, laparotomic conversion, postoperative complications, and weight loss parameters were considered. Data are expressed as mean +/- standard deviation. RESULTS: 2,549 patients underwent the LapBand System procedure [age: 40 +/- 11.7 years; sex: 2,130 female, 419 male; body mass index (BMI): 46.4 +/- 6.9 kg/m(2); excess weight (EW): 60.1 +/- 23.6 kg; %EW: 90.1 +/- 32.4]. During this period 1,343/2,549 (52.7%) were operated via the pars flaccida (PF group) and 1,206/2,549 (47.3%) via the perigastric approach (PG group). Demographics for both groups were similar. Thirty-day mortality was absent in both groups. Operative time was significantly longer in the PG group (80 +/- 20 min versus 60 +/- 40 min; p < 0.05). Hospital stay was similar in the two groups (2 +/- 2 days). Laparotomic conversion was significantly higher in the PG group (6 versus 2 patients; p < 0.001). Overall postoperative complication rate was 172/2,549 (6.7%) and was linked to gastric pouch dilation/slippage (67/172), intragastric migration/erosion (17/172), and tube/port failure (88/172). Gastric pouch dilation and intragastric migration were significantly more frequent in the PG group: 47 versus 20 (p < 0.001) and 12 versus 5 (p < 0.001), respectively. Patients eligible for minimum 3-year follow-up were 1,118/1,206 (PG group) and 1,079/1,343 (PF group). Mean BMI was 33.8 +/- 12.1 kg/m(2) (PG group) and 32.4 +/- 11.7 kg/m(2) (PF group) (p = ns), and mean percentage excess weight loss (%EWL) was 47.2 +/- 25.4 and 48.9 +/- 13.2 in PG and PF groups, respectively (p = ns). CONCLUSIONS: Significant improvement in LapBand System results with regard to laparotomic conversion and postoperative complication rate, with similar weight loss results, was observed in the pars flaccida group.

Laparoscopic adjustable gastric banding, the past, the present and the future.

The laparoscopic implantation of an adjustable gastric banding (LAGB) was first described in 1993. Thereafter, the LAGB underwent to a lot of modifications, revision and refinements to become as it is currently defined. This procedure quickly became one of the most common bariatric surgical operations in the world in the first decade of the 2000s but, over the last few years, it has turned into the fourth more common procedure. A series of more or less clear reasons, led to this decrease of LAGB. The knowledge of the history of the LAGB, of its evolution over the years and its limitations can be the key-point to recognize the reasons that are leading to its decline. The adjustability and the absolute reversibility characteristic of LAGB, make this surgical procedure a "bridge treatment" to allow the specific goal of eradicating obesity.

Teenagers with obesity: Long-term results of laparoscopic adjustable gastric banding.

BACKGROUND: Obesity is a rapidly spreading chronic disease worldwide. Long-term results are critical to assess the effectiveness of a bariatric procedure, particularly in young patients who have long life expectancy. METHODS: A retrospective study on adolescents with morbid obesity who underwent Laparoscopic Adjustable Gastric Banding (LAGB) at our institute from 1995 to 2018 was made. Primary endpoints were efficacy, in term of weight loss and comorbidity resolution, occurrence of complications and reoperations. RESULTS: Fifty-nine patients underwent LAGB between 1995 and 2018. Intra- and post-operative mortality was absent. The patients' presence at follow-up at 5, 10 and 15 years was 38/50 (76%), 18/25 (72%) and 5/8 (63%), respectively. At those times the mean excess weight loss percentage was 61.7 ±â€¯29.4, 48.1 ±â€¯50.4 and 55.8 ±â€¯51.2, respectively. Comorbidity resolution rates were 100% for patients with diabetes, 78% for patients with hypertension, 75% for joint pain suffers, 69% for patients with sleep apnea and 57% for patients with anxiety and depression. Total reoperation rate was 30.5%. The band was removed in 8 patients: 3 due to erosions, 3 by patients' choice and 2 conversions to other bariatric procedures. CONCLUSION: LAGB, in combination with the patients' close follow-up performed by an interdisciplinary team, can be an effective long-term surgical treatment for teenagers with morbid obesity. LEVEL OF EVIDENCE: Level IV.

Technical Details and Result of a Minimally Invasive Management of Gastric Band Erosions: a Series of 47 Patients.

INTRODUCTION: Laparoscopic adjustable gastric banding (LAGB) is proven to be a safe and effective treatment option for obesity in the long term. However, in recent decades, LAGB prevalence progressively decreased worldwide principally due to the incidence and the management of the complications. Understanding the optimal management of the complications becomes therefore of primary importance. The aim of this study is to describe a personal technical, laparoscopic solution of band erosion and to analyze outcomes in 47 patients. METHODS: From October 1995 to January 2019, 3697 LAGB were performed at our institution. Since November 2011, an original laparoscopic gastric banding removal technique was introduced. All the bands placed in these patients were Lap-Band AP System (Allergan, Irvin, CA). The data of the patients who underwent gastric band removal because of band erosion were retrieved from a prospectively collected institutional database, and used for the present retrospective evaluation. RESULT: Ninety-four patients (2.5% of the entire casuistic) with eroded band were diagnosed and treated at our institution. Forty-seven patients were treated with the laparoscopic gastric banding removal technique introduced in November 2011. All the operations have been performed laparoscopically with no conversion or intraoperative complications. There were neither major complications nor peri-operative (30 days) mortality. CONCLUSION: Proper preoperative management and a standardized minimally invasive technique could help to cope with erosion, the most frightening complication of LAGB. Understanding the optimal management of complications and safe reoperation techniques can contribute to a rational use of the LAGB, reversing the current declining tendency.

Laparoscopic adjustable gastric banding on 3566 patients up to 20-year follow-up: Long-term results of a standardized technique.

BACKGROUND: As obesity is a chronic disease, any bariatric procedure should be validated by long-term results. OBJECTIVE: To present our long-term results after laparoscopic adjustable gastric banding over a period of >20 years and to investigate the outcomes in terms of efficacy, complications, and reoperations. SETTING: Private practice, Italy. METHODS: From October 1995 to February 2018, 3566 laparoscopic adjustable gastric banding were performed by a single surgeon. Data were retrieved from a prospectively collected computer database and retrospectively analyzed. Furthermore, patients were stratified according to body mass index and age and results are evaluated for each subgroup. RESULTS: All the operations were performed laparoscopically without any mortality and/or major specific complications. Nine hundred twenty-six patients (71.6%) completed at least 10-years follow-up and 180 (58.4%) reached 15-years follow-up. There was a mean of 49%, 52.6%, and 59.2% of excess weight loss at 10, 15, and 20 years, respectively. Major late complications were pouch herniation-dilation (5.8%) and erosion (2.5%), both solved by a replicable, less invasive operation. Total reoperation rate was 24.1%. CONCLUSION: Our experience suggested that the combination of a standardized surgical technique and close patient follow-up, performed in collaboration with an interdisciplinary team, may make the laparoscopic adjustable gastric banding system a powerful long-term surgical tool in the treatment of morbid obesity. The best results were obtained in young patients with high body mass index but results were also satisfactory in elderly patients and in those with low body mass index.

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.

Codification of techniques for reoperation after Lap-Band.

BACKGROUND: The Lap-Band is a safe, reversible, minimally invasive, and effective bariatric technique, whose main late complications are herniation/dilation of the pouch, erosion/migration of the band, and problems with the adjustment system (subcutaneous access port and connection tubing). We describe the surgical timing and techniques for dealing with the principal complications. METHODS: Between October 1995 and September 2001, we treated 540 patients (mean age 43 years, mean BMI 42.6 kg/m(2)). All operations were completed laparoscopically, with no intra-operative complications or mortality. Late complications were: problems with the band adjustment system (n=35); herniation/dilations of the pouch (n=14); erosions/migration of the band into the stomach (n=3). RESULTS: We dealt successfully with all complications using a minimally invasive technique. Herniation/dilations of the pouch necessitated 15 successful repositionings of the band, and 2 removals of the band at the patients' request. Erosion/migration was treated by endo-laparoscopic band removal. Problems with the band adjustment system had to be corrected laparoscopically, under general anesthesia in 17 patients. CONCLUSION: While emphasizing the rarity of complications, we have codified re-operation techniques to help Lap-Band users solve them using a minimally invasive procedure. In particular, problems with the port and connection tubing system can be completely avoided with a transverse subcutaneous positioning in a straight line.

Functional gastric bypass with an adjustable gastric band.

BACKGROUND: To create a bond between the technique proposed and the patient, flexibility and adaptability are indispensable. Thus, we devised the functional gastric bypass, which can be activated and deactivated by inflating or deflating the Lap-Band. METHODS: The Lap-Band was positioned according to the standard technique, with the addition of a hand-sewn side-to-side gastroenterostomy between the gastric pouch and the intestine in the form of an Omega loop. Inflation or deflation of the Lap-Band allows activation or deactivation of the bypass. From October 1995 to December 2001, 545 Lap-Band operations were carried out. Between January 2001 and December 2001, functional gastric bypass was performed on 7 patients. Indications were: 1) prior failed Lap-Band treatment; 2) the first-choice operation for patients where non-restrictive surgery may be indicated. RESULTS: There was no morbidity or mortality. The functioning bypass was confirmed radiologically and clinically. CONCLUSION: In morbid obesity characterized by a variable relationship with food, the flexibility of the functional bypass allows adaptation to changes in the pathology itself and in the individual patient, which other surgical techniques cannot do. Surgical indications, proven feasibility, safety and efficacy await long-term documentation.

Does the intragastric balloon have a predictive role in subsequent LAP-BAND(®) surgery? Italian multicenter study results at 5-year follow-up.

BACKGROUND: The intragastric balloon has been reported to be a safe and effective tool for temporary weight loss. The aim of this study is the evaluation of the possible predictive role of intragastric balloon when used before laparoscopic adjustable gastric banding. METHODS: A longitudinal multicenter study was conducted in patients with body mass index (BMI)>35 kg/m(2) who underwent gastric banding with the BioEnterics Intragastric Balloon (BIB). After balloon removal (6 mo), patients were allocated into 2 group according to their percentage of excess weight loss (%EWL): group>25 (%EWL>25%) and group<25 (%EWL<25%). Patients from both group underwent laparoscopic adjustable gastric banding (LAGB) 1-3 months after BIB removal. The LAP-BAND AP band was placed in all patients via pars flaccida. Weight loss parameters were considered in both groups. RESULTS: From January 2005 to December 2009, 1357 patients were enrolled in this study. Mean BMI at time of BIB positioning was 44.9±8.4 (range 29-82.5). After 6 months, at time of removal, mean BMI was 39.4±7.3. According to the cutoff, patients were allocated into group A (n = 699) and group B (n = 658). At this time the mean BMI was 36.4±6.4 and 42.7±6.9 (P = .001) in groups A and B, respectively. At 1-year follow-up from LAGB, mean BMI was 35.8±6.5 and 40.0±7.4 (P<.001) in groups A and B, respectively. This significant difference was confirmed at 3- and 5-year follow-ups. A similar pattern was observed with the %EWL. CONCLUSION: Satisfactory results with BIB are predictive of a positive outcome of LASB at 1, 3, and 5 years after the procedure, and poor results do not inevitably indicate a negative outcome for gastric banding.

Safety and effectiveness of LAP-BAND AP System: results of Helping Evaluate Reduction in Obesity (HERO) prospective registry study at 1 year.

BACKGROUND: Laparoscopic adjustable gastric banding has several distinctive features, including band adjustability, easy reversibility, and lack of malabsorption, which contribute to its widespread use. The LAP-BAND AP System (LBAP; Allergan, Inc.), a redesigned and improved version of the original device, was approved by the US Food and Drug Administration in 2006. Because of limited information on LBAP, this study prospectively assesses the efficacy and safety of LBAP in real-world settings at clinical centers located in North America, Europe, and Australia. STUDY DESIGN: This interim report of the ongoing 5-year prospective, observational, international, multicenter registry, Helping Evaluate Reduction in Obesity (HERO) Study (NCT00953173), describes clinical efficacy and safety of LBAP in real-world settings at 1 year. RESULTS: One thousand one hundred and six patients were implanted with LBAP and 1-year data were available from 834 patients for efficacy analysis. At 1 year, the mean (SD) percentage of excess weight loss was 39.8% (22.3%), of weight loss was 16.9% (9.0%), and the mean (SD) body mass index decreased to 37.7 (7.0) kg/m(2) from 45.1 (6.9) kg/m(2) at baseline. Patients with type 2 diabetes mellitus or hypertension showed significant improvements at 1 year post LBAP (both p < 0.005). The most common device-related complications were port displacement (n = 20 [1.8%]), pouch dilation (n = 12 [1.1%]), band slippage (n = 7 [0.6%]), and band erosion (n = 5 [0.5%]). Eighteen (1.6%) patients had the device explanted. CONCLUSIONS: At 1 year post LBAP, progressive weight loss was associated with improvement and/or resolution of comorbid conditions and was safe and well tolerated. Patient follow-up continues.

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.

Safety and efficacy of laparoscopic adjustable gastric banding in the elderly.

OBJECTIVE: Bariatric surgery is not usually recommended in the elderly. The aim of this study is to evaluate the safety and efficacy of laparoscopic adjustable gastric banding (LAGB) in older patients registered in the database of the Italian Group for Lap-Band Gruppo Italiano Lap-Band (GILB). METHODS AND PROCEDURES: GILB is a centralized database which collects operative and follow-up data from 26 Italian surgical centers who utilize the Lap-Band System as a restrictive procedure. Patients > or =60 years were selected from the database of the GILB and analyzed according to co-morbidities, conversion, peri-operative complications, and weight loss. RESULTS: Of 5,290 patients, 216 (4.1%; 184F/32M) were > or =60 years old at surgery (mean age 64.1 +/- 4.0 years; range 60-83). Baseline BMI was similar in both sets of patients i.e., > or =60 and <60 years of age (44.2 +/- 7.6 kg/m(2) vs. 44.9 +/- 7.4 kg/m(2)). Patients > or =60 years of age were more frequently affected by co-morbidities than patients <60 years of age. Two cases of operative mortality were observed in patients <60 years old (0.04%) and one in patients > or =60 years old (0.46%). The proportion of patients requiring revision surgery was comparable as well. Weight loss was significantly lower in elderly patients. Despite their lower weight loss, patients > or =60 years of age experienced a significant improvement of obesity-related co-morbidities (they showed improvement 1 year after surgery in 100% of cases of diabetes or sleep apnoea, 67.1% of cases of hypertension, and 34.9% of cases of osteoarthritis). DISCUSSION: LAGB may be performed safely in patients > or =60 years old. Weight loss in older patients seems unsatisfactory if compared to younger subjects. However, the majority of elderly patients show an improvement in obesity-related co-morbidities.