Clinical algorithms for identifying and managing complications of laparoscopic adjustable gastric banding

by Jaime Ponce, MD, FACS; Jeffrey W. Allen, MD, FACS; Sunil Bhoyrul, MD, FACS, FRCS(Eng); Helmuth T. Billy, MD, FACS; Robert Cywes, MD, PhD; Emma J. Patterson, MD, FRCSC, FACS; Christine J. Ren-Fielding, MD, FACS; and Vafa Shayani, MD, FACS

Dr. Ponce is Director of Bariatric Surgery, Hamilton Medical Center, Dalton, Georgia; and Co-Director of Bariatric Surgery, Memorial Hospital, Chattanooga, Tennessee. Dr. Allen is Medical Director, Bariatric Surgery, Norton Healthcare, Louisville, Kentucky. Dr. Bhoyrul is Medical Director, Bariatric Surgery, Scripps Hospital, La Jolla, California. Dr. Billy is a surgeon at Ventura Advanced Surgical Associates, Ventura, California. Dr. Cywes is Palm Beach Children’s Hospital, Palm Beach, Florida. Dr. Patterson is from Oregon Weight Loss Surgery, Portland, Oregon. Dr. Ren-Fielding is Professor; Div Chief of Bariatric Surgery
Department of Surgery (Bariatric Division Dir) NYU Bariatric Surgery Associates, New York, New York. Dr. Shayani is Medical Director, Bariatric Institute of Greater Chicago, Chicago, Illinois.

Funding: Writing support provided by Allergan.

Disclosures: Dr. Ponce is a consultant for Allergan, Inc. (Irvine, California), Covidien (Mansfield, Massachusetts), and Reshape Medical (San Clemente, California). He has received research support from Reshape Medical and is a speaker for W.L. Gore & Associates (Flagstaff, Arizona). Dr. Allen is a proctor and consultant for Allergan, Inc. Dr. Bhoyrul has been a paid consultant for and recipient of research support from Allergan Inc. Dr. Billy is on the advisory board and is a speaker for Allergan, Inc. and TransEnterix, Durham, North Carolina. He is also a speaker for W.L. Gore & Associates, Inc. Dr. Cywes is on the executive council for Allergan, Inc., and is a consultant for Olympus (Center Valley, Pennsylvania) and Covidien.

Dr. Patterson is on the advisory board for Allergan, Inc., Irvine, California. Dr. Ren-Fielding is a consultant and speaker for Allergan, Inc. Dr. Shayani is a paid consultant for Allergan, Inc.
Bariatric Times. 2013;10(11):14–19.

ABSTRACT
Technical improvements and cumulative experience with laparoscopic adjustable gastric banding have significantly reduced the rates of complications over the past decade, although complications can and do still occur. Reasons may vary, from problems with the device, to surgical technique or suboptimal band positioning, to patient nondherence or other behavioral issues. However, in many cases, issues can be managed and resolved, with the goal of enabling patients to avoid reoperation where possible, retain the band, and continue on to achieve successful weight loss. This article discusses identification and management of some of the complications that may lead to unsuccessful weight loss or other unsatisfactory outcomes, such as ongoing symptoms or unresolved comorbidities, following laparoscopic adjustable gastric banding procedures. Treatment algorithms for managing these complications are presented.

INTRODUCTION
Since it first came into use in the 1990s, laparoscopic adjustable gastric banding (LAGB) has become widely recognized as an effective and safe option for surgical treatment of morbid obesity. Long-term studies have demonstrated the success of LAGB for weight loss in many patients, with associated improvement of comorbidities.[1–4]

Refinements in technique over time have significantly reduced the incidence of complications and improved outcomes.[1,5,6] However, as with any surgical procedure, complications can and do occur, with some that are distinctive to the LAGB procedure.[7] Depending on the complication, patients may require surgical revision, have unsatisfactory weight loss, or experience intolerable symptoms, which cause the patient and physician to question the benefits of retaining the band. But, in many cases, complications or underlying issues can be readily diagnosed and resolved, enabling the patient to keep the band and go on to successfully lose weight.[1,8,9]

Clinical algorithms may help physicians rule out or manage underlying problems prior to considering band explantation and help to avoid unnecessary removals. Many of these complications may interfere with band success.

In this article, we identify potential problems and discuss the management of the following:

•    Unsatisfactory weight loss due to complications that lead to loss of restriction, band erosion, pouch dilatation, or maladaptive eating behaviors
•    Other complications, such as slippage
•    Lack of improvement or recurrence of comorbidities.

1. UNSATISFACTORY WEIGHT LOSS
Consistent follow-up is a crucial factor in successful weight loss after LAGB surgery. In many cases, achieving successful outcomes may be as simple or as difficult as educating patients, ensuring continued motivation and commitment to dietary and lifestyle changes, and setting realistic expectations.

However, poor early weight loss or significant weight regain can also result from the following: A) loss of restriction due to technical or other problems (see Figure 1), or B) maladaptive eating resulting from physical, physiological, or behavioral issues. Again, early and regular follow-up is important to help identify any underlying problems.

1.1 Loss of restriction. Loss of restriction that causes a return of hunger and loss of satiety, can result directly from leaking or malfunction of the device, from band erosion, or from physiological esophageal problems. Rates of device-related problems (port, tubing, or band) from 5 to 21 percent have been reported in several long-term studies.[3,10–12] Some studies note that these issues were less common in later procedures due to improvements in band design and surgical techniques.[3,12]

1.1.1. Device malfunction/ leak—port. Port complications can occur from needle stick injury, connector erosion, and port breakdown/leak.

Diagnosis. Port complications usually result in leakage, leading to a lack of restriction. Generally a late complication, leakage may occur through a damaged port septum or the tubing leading into the port. Typically the leak is slow, becoming evident when the fluid volume on aspiration is less than the fill volume, combined with a loss of restriction. If a leak is suspected, fluid levels should be measured at each adjustment. For accessing the port, Huber (noncoring) needles should be used to reduce the risk of damage.

Treatment. Surgical replacement of the leaking port under local anesthesia, moderate or deep sedation, or general anesthesia should be performed.

Device malfunction/leak—tubing. Tubing complications can occur from cracks or breaks and disconnection.

Diagnosis. An abdominal x-ray can show if tubing has disconnected from the port. Diagnosing a leak from intra-abdominal tubing may be more difficult. To help locate a leak, dilute nonionic iodinated contrast can be injected into the port under fluoroscopy, although pain and infection from extravasated contrast have been known to occur. See also “Band” in following section.

Treatment. Depending on the location of the tubing break, either the port and tubing or all band components may require replacement.

Device malfunction/leak—band. Band complications can occur from band crease-fold failure (e.g., crack/leak/separation of balloon and shell), band unbuckling, and band aneurysm.

Diagnosis. As with the port, band leak or other problems may lead to ineffective restriction, with subsequent decrease in weight loss. To check a suspected band leak, measure how much saline is in the band and compare to how much there is supposed to be. If there is less, inject a certain amount, wait three minutes and reaspirate to see if it is a slow leak or a fast leak. Alternatively, a larger amount of saline, such as 1mL, can be injected and the level rechecked after a week.

An intradevice contrast study may show a large device leak but is often inaccurate due to the slow rate and volume of extravasation. The contrast agent can also trickle from the point of leak, along the tubing, making it difficult to see the actual leak site. Rarely, extravasated contrast can cause pain or infection. A contrast study can reveal a band aneurysm, if large, and may also show band unbuckling. Injection of dilute methylene blue into the port during laparoscopy is very helpful to locate a leak.

Treatment. Surgical removal and replacement of leaking or defective component via laparoscopy under general anesthesia should be performed.

1.1.2. Other reasons. See Figure 2.

Band erosion. Diagnosis. Erosion of a gastric band is an uncommon but well identified occurrence. Prevalence varies and has been reported at 0.09 percent to 1.0 percent of patients in post-2000 studies.[4] While erosion is often asymptomatic, symptoms may include weight regain or plateau and sudden loss of satiety, and less frequently, infection at the access port site or abdominal pain. Any patient presenting with delayed port infection (e.g., months to years after band placement) should have an upper GI endoscopy to determine if there is band erosion. If the port infection is early (within 1–2 weeks of surgery) this may not be necessary.

Technical considerations at time of band placement may play a role in the development of erosion. For example, excessive trauma of the gastric serosa due to thermal injury, instrument trauma, or electrocautery may contribute to erosion, as can overdissection of the stomach. Meticulous attention to detail is required when placing plication sutures over the anterior portion of the band, so as to avoid over tightening of the suture and causing tension of stomach tissue over the band. Postoperative reasons for erosions may include ischemia around the band, especially if overinflated; intake of overly large food boluses; excessive vomiting; use of anti-inflammatory medications, such aspirin and NSAIDs; intake of alcohol; and smoking.

Erosion is typically diagnosed by upper GI endoscopy, which provides good specificity if band erosion is seen. However, the sensitivity is not very high, as band erosion may be missed endoscopically if it is small or if the band has eroded outwards into the wrap as opposed to inwards into the gastroesophageal junction.

Treatment. Remove the whole band system in one stage so as not to disrupt a gastrocutaneous fistula (especially if presentation is port infection). If there is an associated port infection, treat with antibiotics and leave wound open or drained. Six months later, another band may be placed, or alternatively a Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or biliopancreatic diversion (BPD) performed.

Pouch dilatation. Diagnosis. Concentric pouch dilatation may result from excessive pressure in the pouch, which can be caused by band overinflation, the patient eating too fast or too much, vomiting, and regurgitation. Various studies have reported rates from less than 0.1 percent to 2.0 percent.[5,13] Pouch dilatation can be associated with hiatal hernia (see Section 2.2), prolapse, or esophageal dilatation (see next section). Eccentric pouch dilatation is caused by band slippage (see Section 2.1).

Symptoms of an enlarged pouch include a lack of satiety, heartburn, nocturnal reflux, regurgitation, and sometimes chest pain. Diagnosis is made with a barium swallow, which will show if there is slow or obstructed passage through the stoma and dilatation of the pouch.

Treatment. The band can be completely deflated to allow the pouch to return to normal. This approach is successful in the majority of patients. Additional patient education and counseling may help to reinforce the importance of optimal eating behaviors and portion size.

Repeat contrast study after a few weeks will show whether the pouch has returned to normal size and the band to its correct position. The band can then be refilled incrementally. If the pouch does not return to original size (e.g., after 8–10 weeks), surgery to reposition or remove the band will be necessary.

Esophageal dilatation. Diagnosis. Diagnosed by barium swallow, esophageal dilatation can be defined as a widening of the esophagus to a greater width than the vertebrae. It is most commonly caused by an overtight band or stoma obstruction due to incorrect band placement. (Also see Section 1.2.1 below.) GERD and dysphagia are typical symptoms. Esophageal dilatation can result in accumulation of food in the esophagus, which leads to loss of restriction and weight stabilization or gain. An esophagram showing esophageal dilatation with retained secretions may suggest esophageal dysmotility (see Figure 3 for algorithm).

Esophageal dilatation may also be observed in patients with normal band position and stomal diameter. In this case, the widening may be associated with poor eating habits and lack of satiety after band placement. Patients with a preexisting weakness in their lower esophageal sphincter may be at greater risk of esophageal dilatation.[14]

Treatment. In most cases where esophageal dilatation is solely due to an overtight band, symptoms may be resolved by deflation. If symptoms resolve, the band can be carefully and incrementally reinflated over a period of several months. Dietary evaluation and patient nutritional education may help to reinforce the importance of optimal eating behaviors and portion size, and should be undertaken before reinflation and continue on an ongoing basis. Upper GI exams should be repeated at each band inflation.

In some cases where dilatation is due to incorrect band placement or gastric slippage, band deflation may not resolve the issue. If symptoms do not resolve or they recur, band removal and possible conversion to other bariatric procedures may be necessary.

1.2. Maladaptive eating. See Figure 3. Symptoms caused by physical and physiological complications may lead to intolerance to solid foods, and patients often turn to soft, high-calorie foods, resulting in weight regain. Resolving the complication may alleviate symptoms in many cases, enabling those patients to follow a more optimal diet.

For some patients, behavioral and emotional issues are obstacles to adherence; addressing these issues is crucial for achieving weight loss success and to avoid potential complications from chronic poor nutritional and eating behaviors.

1.2.1. Physical reasons for maladaptive eating—band too tight. Diagnosis. If the band is too tight, patients may experience GERD, nocturnal reflux, dysphagia, regurgitation, aspiration, heartburn, and esophagitis caused by acid reflux, medications (pill esophagitis), or chronic regurgitation (>1/week). These symptoms may lead to or exacerbate poor food choices, including high-calorie liquids and foods high in fat that are easier to swallow.

Chronic stoma stenosis or occlusion, caused by an overly restrictive band, can result in chronic vomiting and lead to decreased esophageal tone and predisposing the patient to esophageal dilatation. Food may accumulate in a dilated esophagus or pouch, as though in a second stomach, leading to reduced satiety.

An esophagram will show the status of the esophagus, pouch, and stoma size. A dilated esophagus with lack of emptying through the band will show that the band is too tight and may suggest esophageal dysmotility, such as pseudoachalasia. Esophageal manometry will enable confirmation of pseudoachalasia.

Treatment. Loosen the band and follow the patient closely—once a month for 3 to 6 months. For esophageal dysmotility due to esophagitis, identify the etiology and treat it. Loosen the band completely, treat with PPI +/- sucralfate elixir, repeat esophagram in three weeks, and re-tighten if symptoms and radiology normalize. If symptoms return, consider exploration to revise band, repair hiatal hernia, or remove band and revise to a different bariatric operation.

Physical reasons for maladaptive eating—Esophageal dilatation. See Section 1.1.2.

1.2.2. Physiological reasons for maladaptive eating—low metabolism. Diagnosis. Measure the patient’s resting energy expenditure (REE). Basal metabolic rate is naturally lower in some people, and may also decrease following bariatric surgery.

Treatment. Place patient on a short-term, very low calorie diet (VLCD). Medical therapy with appetite suppressants, such as sympathomimetic medications, can be useful to help increase a patient’s BMR and reduce hunger. Educating patients on lifestyle changes such as appropriate types of exercise may also help to boost metabolism.
If these measures are not effective, consider conversion to RYGB.

1.2.3. Behavioral reasons for maladaptive eating. Behavioral reasons for maladaptive eating can include nonadherence, eating too fast or too much, and stress.

1.2.4. Psychological/emotional reasons for maladaptive eating. Psychological/emotional reasons for maladaptive eating can include self sabotage and other sabotage.

Diagnosis. Patient interview will most likely reveal behavioral, psychological, or emotional reasons for high-calorie intake and other poor eating behaviors.

Treatment. Consistent follow-up is a crucial factor for successful weight loss outcomes after surgery, enabling early identification of potential problems and continued patient education, motivation, and reassurance. Unrealistic expectations are a key contributor to lack of success, and these can be addressed at regular follow-ups. Behavioral, nutritional, or psychological counseling may provide patients with tools to help them adapt behaviors and manage lifestyle changes. Counseling may also help where there is a lack of family support, as this can also be a key factor in preventing success. Patients can also be encouraged to join a patient support group.

2. MANAGEMENT OF OTHER COMPLICATIONS See Figure 4.

2.1. Slippage. Diagnosis. Slippage is caused by the stomach sliding up through and above the band, typically leading to symptoms of nocturnal reflux, regurgitation, dysphagia, obstruction, night cough, and the development of poor eating behaviors. Rates have decreased dramatically since adoption of the pars flaccida technique, and have been reported at 1.4 percent to 4 percent since that time.[1,6,8,13] Symptoms are easily recognized, and the problem is diagnosed with an esophagram. The band orientation can be either more horizontal or tilted downward. The pouch will be asymmetrically enlarged, with pooling of contrast above the band.

Treatment. Slippage can be the result of a technical problem (perigastric placement or inadequate anterior fixation), and in these scenarios an appropriate band reposition and placement via pars flaccida technique is indicated.

Chronic slippage not related to a technical problem usually presenting several months to years after the primary band placement and can be associated with excessive vomiting due to behavioral reasons, an overly restricted stoma, food poisoning, GI virus, or pregnancy.

In cases of a chronic prolapse, band reposition is indicated when the patient has the following:
• Achieved good weight loss (>20% excess weight loss [EWL]) and improvement or resolution of comorbidities
• A good understanding of the follow-up process and is compliant
• Adopted positive changes in lifestyle

Band removal and conversion to another procedure is indicated when the patient has the following:
•    Not achieved good weight loss (<20% EWL) after appropriate intensive management
•    Suboptimal improvement of comorbidities
•    Not been able to understand or follow the eating process and lifestyle changes required.

Depending on the overall medical condition of the patient, a revisional surgery that includes conversion to a sleeve gastrectomy, RYGB, or duodenal switch could be considered.

2.2. Hiatal hernia. Diagnosis. Patients typically present with symptoms, such as GERD and nocturnal reflux, heartburn, night cough, aspiration, or dysphagia. Barium swallow study, chest computed tomography scan (CT), or esophagogastroduodenoscopy (EGD) are helpful for diagnosis. As the incidence of hiatal hernia is very high in morbidly obese patients, it is not always clear whether it was preexisting or occurred after LAGB. In one study, hiatal hernia was found to occur in 1.7 percent of patients who had no evidence of this condition prior to LAGB surgery.[15] Routine repair of existing hiatal hernias at time of band placement has been shown to reduce rates of reoperation for band slippage or concentric pouch dilatation, improve reflux, and reduce the need for reflux medications.[16,17]

Treatment. Slow (incremental) deflation of the band is recommended. Band deflation may result in resolution of reflux, and in adherent patients with adequate weight loss, continued observation without further intervention may be all that is necessary. Medications such as H2 receptor antagonists or proton-pump inhibitors (PPIs) can help to alleviate symptoms such as heartburn. PPIs may not be as effective for regurgitation or if the hiatal hernia is very large.[18,19]

If reflux continues to recur, the hiatal hernia should be repaired, and if there is good weight loss, repositioning of the band is recommended if necessary. If weight loss is unsatisfactory, other potential reasons for lack of weight loss have been ruled out, and the patient is not adherent, then conversion to another bariatric surgery (RYGB) and hiatal hernia repair should be considered.

2.3. Erosion. See Section 1.1.2.

3. INADEQUATE IMPROVEMENT IN COMORBIDITIES
See Figure 5. Weight loss following LAGB surgery is usually accompanied by improvements in, or normalization of, insulin sensitivity and glycemia, obesity-related dyslipidemia, type 2 diabetes, nonalcoholic fatty liver disease, sleep disturbance including obstructive sleep apnea and daytime sleepiness, ovulatory function and fertility in women with polycystic ovary syndrome, reflux disease, joint pain and disease, hypertension, and depression, among others. The degree of resolution or improvement is variable depending on several factors, including percentage of weight loss and severity and duration of the disease.

In cases where there is inadequate resolution or recurrence of comorbidities, these steps may help to resolve underlying issues before considering band removal.

If appropriate management has been exhausted (described in Section 1, Unsatisfactory Weight Loss), no technical complications have been identified (see Section 2, Other Complications) and the comorbidity has recurred, then depending on the overall medical condition of the patient, a revisional surgery should be considered that includes conversion to either a sleeve gastrectomy, RYGB, or duodenal switch.

Summary
These algorithms may serve as a clinical guide to help manage complications, optimize band function and successful weight loss, and avoid surgery or unnecessary removal of band.

Complication rates are generally low with LAGB and have improved significantly with experience, refinement of technique, and improvements in band design.1,4 Rates have been shown to be lower than the more invasive procedures, RYGB, sleeve gastrectomy, and BPD±DS.13 Importantly, patients lose weight with LAGB and experience resolution of preexisting comorbidities.[1,2] Numerous large, long-term studies have consistently reported approximately 50 percent excess weight loss after three years,1,20 and 60 percent or greater in some longer studies.[1,21]

Depending on the complication, a LAGB placement that appears to be failing can, in many cases, be salvaged and become successful. Consistent and frequent follow-up is essential for timely identification and resolution of problems, alleviating symptoms, and getting patients back on track for successful weight loss.

References
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Category: Past Articles, Review