ASMBS issues updated LAGB management consensus statement
The American Society of Metabolic and Bariatric Surgery (ASMBS) has published a consensus statement on laparoscopic adjustable gastric band (LAGB) management, that is replacing the existing American Society for Metabolic and Bariatric Surgery (ASMBS) LAGB adjustment credentialing guidelines for physician extenders with consensus statements that reflect the current state of LAGB management1. Reported in SOARD, the “American Society of Metabolic and Bariatric Surgery consensus statement on laparoscopic adjustable gastric band management”, was published in behalf of the ASMBS Integrated Health Clinical Issues Committee.
To update the previous guidelines, a modified Delphi process using a 2-stage consensus building approach was conducted. Seven multidisciplinary clinicians (two surgeons, three nurse practitioners, one registered dietician and one psychologist) with clinical experience and knowledge in LAGB management served as the core team leading the Delphi study. The authors acknowledged that the consensus statement lacks rigorous scientific evidence and is based on current clinical knowledge, expert opinion and published peer-reviewed scientific evidence.
“Lap-Band management continues to be an important part of many metabolic and bariatric surgery practices, including my own,” stated Dr Christine Ren-Fielding, the primary author of the Consensus Statement and a Professor of Surgery at NYU Grossman School of Medicine, Director of the NYU Langone Weight Management Program and Chief of the Division of Bariatric Surgery. “Our objective was to yield a consensus intended to guide Lap-Band management and practice utilising current evidence-based knowledge and professional experience, to support and further encourage practices to help patients achieve the best outcomes after surgery. It is critical that bariatric practices be trained and capable of providing comprehensive care to these patients.”
The LAGB evidence was transformed into questions using the population, intervention, control and outcomes (PICO) format when possible. For each question, supporting literature was used to draft consensus statements. The Delphi method included two rounds of electronic questionnaires.
Prior to Delphi round 1, 49 metabolic and bariatric surgery (MBS) providers were invited to participate in the questionnaire of consensus statements through an e-mail invitation. All responses were anonymous. Thirty-nine of the invited participants (80%) responded and were e-mailed Delphi round 1 consensus statements.
After round 1, 13 of the consensus statements (38%) did not reach 75% agreement. The Delphi team slightly modified 4 of the 13 statements by eliminating nonessential words. In Delphi round 2, 13 statements with the results from Delphi round 1 were sent to 39 participants with the same instructions as for the first round. The raw data were collected by ASMBS staff and collated in the same manner as for round 1.
There was consensus among 81% of LAGB experts who agreed that preoperative psychopathology may predict postoperative psychopathology. Up to 70% of the general population have psychiatric disorders, most commonly depression, anxiety, and binge eating disorder (BED). Although studies have shown a reduction in depression after LAGB surgery, longer-term studies suggest that initial reductions in depression may deteriorate over time [7,9]. Results of studies on anxiety after LAGB are inconclusive. Preoperative psychological evaluations by experienced mental health providers should identify psychological risk factors that may impact postoperative LAGB outcomes. Mental health providers should be part of the MBS team to minimize or prevent psychiatric disorders postoperatively.
Consensus among 84% of the Delphi panel agreed that psychosocial issues (e.g., disordered eating, substance abuse, suicide, depression, lack of social support and body image/excess skin) can have a negative impact on outcomes. True BED, which includes both the consumption of excessively large amounts of food (objective binge eating) and loss of control (LOC) of eating episodes, is physically difficult after LAGB surgery because of the limited gastric capacity. However, LOC eating can continue after LAGB in the form of continuous grazing or nibbling on small amounts of food within a 24-hour period. Furthermore, LOC eating is the most common maladaptive eating behaviour associated with poor outcomes in the LAGB literature. Another possible acquired or problematic LAGB eating behaviour is chewing and spitting out food contents. Maladaptive behaviours have been shown to negatively affect weight loss. MBS providers should refer patients to mental health providers when maladaptive eating behaviours are suspected or identified. Therapy should include a personalised treatment plan with close monitoring of eating behaviours through a combination of psychological and nutrition counselling.
MBS providers also should routinely screen patients for substance abuse, emotional stability, and social support. Although substance abuse and suicide are not common among LAGB patients, awareness of behaviour change and emotional stability, including psychosocial situations and relationships, is critical.
Consensus experts (97%) agreed that LAGB patients with behaviour-related symptoms or diagnoses should undergo postoperative therapy with counselling and appropriate medication in combination with support groups. Support group attendance has been shown to improve outcomes postoperatively [8,12]. Psychological and behavioural interventions can promote long-term success after MBS by slowing or preventing weight recurrence. Furthermore, access to mental health providers with MBS expertise should be provided to all MBS personnel who manage LAGB patients.
Clinical nutrition assessments and evaluations should be conducted by a registered dietician for routine follow-up care and in situations where individuals are experiencing dietary complications associated with LAGB management.
As new LAGB eating experiences evolve, self-monitoring of eating patterns and behaviours should be reported during nutrition counselling and corrected when maladaptive behaviours are identified. LAGB adjustment may be part of the treatment plan for maladaptive eating behaviours. In addition, behavioural health counselling with support group attendance is critical for successful therapy. Diet quality and adequacy should be evaluated by a registered dietician when symptoms of vomiting, regurgitation, reflux, dysphagia, or food intolerances delay diet progression. This includes micronutrient status, macronutrient composition, energy requirements, food choices, fibre content, and food textures and intolerances related to diet progression and weight change.
Advancement to solid foods 2 months after LAGB placement increases satiety and nutritional quality and daily multivitamin and mineral supplement is recommended for patients with LAGBs to cover potential micronutrient insufficiencies. Patients with persistent vomiting should be evaluated for thiamine deficiency and electrolyte replacement in addition to LAGB adjustment. Most important, prescribing multivitamin and mineral supplements in a powder, liquid or chewable formulation may prevent pill esophagitis. Proper LAGB device management, nutrition and mental health counselling have been shown to decrease or eliminate adverse symptoms of regurgitation, reflux, dysphagia, and many food intolerances that impact diet progression and eating behaviours.
As part of ongoing LAGB management, excessive or insufficient weight loss and weight recurrence should include a comprehensive nutrition assessment by a registered dietician. A detailed appraisal of the percentage of protein, fat, and carbohydrate intake compared with total energy requirements is the cornerstone of a successful treatment plan. Energy requirements should be adjusted based on goals, weight change, and weight maintenance over time.
Identification and management of complications
The most common complications are band slip/prolapse, GERD, oesophageal dilatation associated with LAGB management, band erosion, device failure and leak. No consensus was reported (51% round 1, 71% round 2) regarding nonoperative management of LAGBs as the best treatment option for long-term complications such as band slip/prolapse, GERD and oesophageal dilatation. In addition, no consensus was reached (43% round 1, 58% round 2) regarding LAGB removal as the best option for band slip/prolapse, GERD and oesophageal dilatation.
The authors noted that there are several reasons why the Delphi panel may have reported a mixed response in treatment options. For example, grouping the complications together into a single consensus statement may have biased the results as opposed to individually identifying each LAGB complication and treatment option. In addition, the treatment options for LAGB complications may include a spectrum from conservative treatment (i.e., medication for GERD, band loosening, nutrition counselling, and behavioural therapy) as opposed to band removal.
Consensus among 97% of the Delphi panel indicated that pharmacology is important to review and manage in patients with LAGBs. Consistent with the evidence, MBS providers should evaluate patient medications that may lead to weight gain, such as mood-stabilising medications, antidepressants, antipsychotic medications, seizure medications, steroids, antihistamines, beta-blockers, and diabetic medications. The benefit of these medications should be weighed against the likelihood of weight gain.
MBS providers should consult with the patient’s other healthcare providers to discuss the risks verses benefits of using alternative medications that are less likely to cause weight gain. A complete medication review should be part of every patient encounter. Long-term follow-up data indicate that some degree of weight recurrence in the years following MBS is common. Adjunct pharmacotherapy is one consideration for treating weight recurrence after LAGB surgery, which is consistent with the 95% consensus among those participating in the Delphi study. The data suggest that patients are more likely to be prescribed anti-obesity medications after weight recurrence than at their plateau.
However, patients receiving anti-obesity medications at their plateau show more weight loss than patients prescribed medication after weight recurrence. Furthermore, patients with LAGBs should be evaluated for psychosocial, environmental, and eating behaviour changes that may contribute to weight recurrence. Optimising medical management of patients is critical to LAGB management and preventing weight-related complications.
Paediatric patients: They observed that 74% of LAGB experts in Delphi rounds 1 and 2 agreed that paediatric patients show early improvement in psychological health after LAGB surgery. Despite a lack of FDA approval for LAGB surgery in the paediatric population, evidence in several investigational studies under institutional review board protocols and internationally have shown safety and efficacy after LAGB surgery in young patients. Potential advantages of LAGB treatment for paediatric patients with obesity involve band adjustability, low anatomic complication rates, preservation of the gastrointestinal track, improved overall health status, and the option of band removal, if indicated. Long-term evidence has consistently shown improvement in such patients’ quality of life, psychological health, non-alcoholic fatty liver disease, and resolution of metabolic syndrome by successfully lowering body mass index.
LAGB treatment for young patients is not universally supported by some in the medical community. Insufficient weight loss compared with other MBS procedures (i.e., sleeve gastrectomy and Roux-en-Y gastric bypass), patient dissatisfaction with LAGB weight loss outcomes, and other complications resulting in reoperation are cited in the evidence.
Thus, severity of obesity and co-morbid complications must be factored into decisions regarding patient selection and timing of LAGB intervention for young patients. Additionally, pediatricians, surgeons, behavioural health clinicians, and registered dieticians must work together with patients and families for ongoing support, education, and LAGB management. Paediatric patients must be involved with their own healthcare and LAGB management to optimise band effectiveness and to prevent LAGB complications.
Pregnancy: During pregnancy, LAGB management is critical because of the anatomic and physiologic changes that occur during each trimester. They report no consensus on LAGB management during pregnancy within either Delphi round 1 or 2 among the Delphi panel. This supports the literature that shows mixed opinions on LAGB adjustments during pregnancy.
Over the years, some providers have reported removing all LAGB fluid at the beginning of pregnancy, whereas others removed all LAGB fluid at delivery. In the case of severe nausea, vomiting, gastroesophageal reflux, or other symptomatic concerns, fluid removal or loosening of the LAGB is supported in more recent practice. A tailored approach to LAGB adjustments is the most common method of LAGB management during pregnancy. This allows patients and providers to monitor weight gain, nutritional adequacy, and foetal growth for a healthy pregnancy outcome. Regarding device-related complications, band slippage is one risk that should be discussed with patients prior to conception, during pregnancy, and postpartum. This evidence supports LAGB placement as safe and well tolerated during pregnancy with close LAGB monitoring.
Follow-up assessment of LAGB patients
A Delphi panel consensus of 80% acknowledges that experienced providers (i.e., surgeons, primary care physicians, registered dieticians, behavioural health specialists, nurse practitioners, nurses, and physician assistants) should be part of the multidisciplinary team in LAGB management. Providers should have training and experience with the specific LAGB fluid volumes, adjustment schedules or algorithms, and potential complications. Management of LAGBs also requires provider competency in understanding physiologic mechanisms (i.e., vagus nerve, hormones, and gut motility) affected by LAGB placement and fluid volume adjustments.
Assessment of LAGBs should occur at least yearly, and more often as needed (e.g., active adjustment for weight loss or complications). Providers who manage patients with LAGBs should conduct a detailed assessment prior to any LAGB adjustment, including knowledge of the band size and type, date of and response to last adjustment and review of current band fluid volume. Evaluation of dietary patterns, behaviours and nutrient composition is paramount to discern symptoms of hunger, dysphagia, dehydration, reflux, or vomiting prior to LAGB adjustments. For patients who had LAGBs placed, it is be important to consider a regular diagnostic assessment of the LAGB for complications, which may or may not be associated with symptoms. At 71% Delphi panel agreement, it seems reasonable for clinicians to consider some regularly scheduled diagnostic evaluation (i.e., upper gastrointestinal radiologic study) of patients with long-term LAGB management.
Skilled providers recognise when fluid in the LAGB should be titrated (i.e., increased or decreased) or remain constant based on the patient’s assessment of weight, symptoms associated with the LAGB placement, the patient’s ability to adopt positive eating behaviours, and emotional stability. There was Delphi consensus and literature agreement that it is reasonable to consider fluid addition when a patient tolerates large portions of solid foods, feels a lack of satiety, or senses that hunger and appetite are not well controlled. There was only 40% (round 1) and 35% (round 2) agreement that LAGB adjustment should be considered when a patient experiences minimal weight loss or weight gain. However, there is literature support to consider the addition of fluid with minimal weight loss or weight gain given that weight loss is an important and desired outcome, in addition to the consideration or context of other factors.
Furthermore, the Delphi results indicated consensus that fluid removal and a referral to an MBS surgeon should take place when a patient experiences significant dysphagia, vomiting, regurgitation, reflux, or symptoms of heartburn. Fluid removal also should be considered with new onset or persistence of chest pain, in addition to potential work-up for evaluating the onset of chest pain symptoms in reference to Delphi panel comments.
Maladaptive eating behaviours, feelings of uneasiness with eating, and an inability to tolerate solid-food textures are also considerations for LAGB fluid removal, in addition to referrals for nutrition and mental health counselling.
The ASMBS stresses that it is not a credentialing body and this consensus statement is intended to guide LAGB management and practice with current evidence based knowledge and professional experience. “Future research would be helpful in preventing potential mechanical, anatomic, maladaptive eating, and behavioural health symptoms and complications,” the statement concluded.
1. Dugay G, Ren CJ. Laparoscopic adjustable gastric band (Lap-Band) adjustments in the office is reasonable—the first 200 cases. Obes Surg 2003;13:537
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