Gastric Band Adjustments: Benefits of Fluoroscopy-Guided Adjustments

| November 11, 2010

by Jaime Ponce, MD, and Adam B. Smith DO, FACOS

Dr. Ponce is from Dalton Surgical Group, PC, Dalton, Georgia, and Dr. Smith is from Dr. Smith Laparoscopy, Bariatrics, and Surgery, Fort Worth, Texas.

Financial Disclosure: Dr. Ponce is a consultant, speaker, and proctor for, and has received research funds from, Ethicon Endo-Surgery and Allergan, Inc. and uses both the Realize Band and the Lap-Band in his private practice. Dr. Smith is a consultant, speaker, and proctor for Allergan, Inc.

Bariatric Times. 2010;7(11):8–12

Abstract
Fluoroscopy-guided adjustment is a management tool available to bariatric surgeons when adjusting gastric bands to better understand some anatomic features and barium flow through the stoma. The method can achieve earlier restriction, establish the possible cause of reflux, assist in the management of pouch dilatation, and potentially detect complications earlier. Radiation exposure can be minimized with experience and appropriate coding can allow for reimbursement. This article reviews fluoroscopy-guided band adjustment strategies and benefits.

Introduction
The growing incidence of obesity poses medical risks for an increasing number of individuals, establishing obesity as a major public health concern.[1,2] There is a general consensus that bariatric surgery is the most effective and durable treatment for severe obesity and bariatric procedures are increasingly recommended for patients with a high risk of obesity-related comorbidities or mortality.[1,2] In addition to durable weight loss, bariatric surgery provides amelioration of various obesity-associated comorbidities and reduction of mortality in patients with morbid obesity.[3–5]

Laparoscopic adjustable gastric banding (LAGB) is well established as a safe and effective procedure, providing multiple unique features compared to other bariatric surgery options.[6–9] A Medline search for “laparoscopic adjustable gastric banding” yields over 800 peer-reviewed reports that demonstrate outcomes comparable, and in some respects superior, to those of alternative bariatric procedures. Throughout the body of literature, LAGB is proven to be a widely applicable, reversible, and adjustable system for weight loss in patients with morbid obesity. In one recent analysis, the American Society of Metabolic and Bariatric Surgery (ASMBS) Consensus Conference determined that weight loss after LAGB is approximately 50 percent of excess body weight and that the operative morbidity of the LAGB procedure is approximately five percent.[10,11]

Based on such data, LAGB is considered a primary option for the treatment of morbid obesity.[10–14] A number of refinements in LAGB placement techniques are now routinely used during the surgical procedure, making LAGB one of the most standardized surgical interventions for obesity.[15,16] Current surgical practices have reduced complications, and LAGB is considered the safest, least invasive operative procedure for severe obesity.[14,17,18] One of the critical components of successful management of patients who have undergone LAGB is appropriate band adjustments.[16,19,20] This article reviews current practices in LAGB adjustments, with a focus on the use of fluoroscopy guidance.

Band Adjustability
With LAGB, the stoma size is adjusted without reoperation using an outpatient procedure involving either injecting or aspirating saline fluid from the inner band balloon. This adjustment takes approximately five minutes and is done through a subcutaneous access port connected to the gastric band.[6] When the band is optimally adjusted, patients experience early satiety following meals and prolonged satiety with reduced appetite even after long periods between eating. Band adjustments decrease caloric intake for sustained weight reduction,[19] which contributes to both physiological and psychological help for patients. Studies have documented the importance of regular follow-up of patients with LAGB.[19–21]
The concept of color-coded eating zones described by Dixon et al[19] is a useful visual aid to include when educating patients about expected outcomes of band adjustment. Under this guidance, if the patient remains hungry, is able to consume large portions of food, and tends to eat between meals, he or she is considered to be in the “yellow zone,” which indicates that the band may be too loose and fluid should be added. Conversely, if the patient is experiencing trouble eating solid foods, having pain or difficulty swallowing, or experiencings food regurgitation, he or she is in the “red zone,” indicating that the band is too tight and fluid should be removed. If the patient is satisfied with eating small portions of solid food, experiences prolonged periods of satiety, and is losing weight, he or she is in the “green zone” and no adjustment is necessary.[19] One should note that the “green zone” may be narrow, and even minor adjustments of 0.2mL of fluid may be sufficient to impact the degree of restriction. Similarly, small adjustments may cause some patients to experience significant dysphagia when swallowing solid foods. Therefore, continuous close follow up and precise adjustments are required to achieve and maintain the optimal volume of fluid in the band.

Methods of Band Adjustment
The first step in band adjustment is accessing the subcutaneous port. In most cases, the port is accessed through simple palpation while the patient is in a relaxed, supine position with his or her legs uncrossed and arms behind the head. If the port is too deep and cannot be accessed via palpation, ultrasound or fluoroscopy imaging techniques may be used to facilitate port location. When imaging techniques are employed, the orientation of the port is initially assessed by the shape of the port. The appearance of an oval instead of circular-shaped port indicates rotation, which may be corrected using digital manipulation.

Once the port is accessed, the next step in band adjustment is deciding the amount of fluid to inject. Generally, two approaches to determining the need for adjustment and the extent of adjustment required prevail.[20,21] The first approach, the in-office adjustment, uses a clinical algorithm to make band adjustment decisions based on the patient’s weight loss and symptoms.[20]

According to the band manufacturers and depending on the band type, the first adjustment can be anywhere from 1 to 6.5mL at approximately 4 to 6 weeks after band placement.[22,23] After the first adjustment, the patient should be able to drink water comfortably before leaving the office. The patient is then monitored over time for weight loss and symptoms indicating a need for additional adjustment. Based on these clinical factors, further adjustments are performed with up to 1.0mL fluid added or removed each time until adequate restriction is achieved. In-office adjustments are inexpensive and require minimal time; however, they may necessitate several office visits to achieve optimal restriction due to the potential imprecise nature of the adjustment.[20,21]

The second adjustment strategy incorporates additional information derived from radiographic assessments into band adjustment decisions. In this approach, after it is determined that the patient clinically needs an adjustment, the specific amount of fluid to add or remove is verified with the assistance of a barium swallow using fluoroscopy-guided band adjustment technique.[20] Although radiographic adjustments may involve greater time and financial resources, in some situations, they require fewer visits due to stoma flow imaging made with fluoroscopy guidance.[21]

Radiological Studies of Gastric Bands
As the number of LAGB procedures increases, radiology is  being used more frequently for optimal band adjustment, band position, and complication assessment.[24,25] In general, fluoroscopy-guided band adjustment and evaluations for complications are performed in an anteroposterior projection using barium suspensions.[24] At some centers, a routine radiologic evaluation is performed 4 to 6 weeks after LAGB placement (Figure 1). Such radiographic studies can assist in stomal adjustment width to achieve optimal weight loss, as well as to identify major complications that can only be detected and diagnosed fluoroscopically.[25]

In one series of 92 patients undergoing LAGB surgery, radiographic assessment was performed one day after LAGB placement to ensure proper band position and to assess the components of the band system.[25] A second radiographic assessment was performed 6 to 8 weeks following surgery to evaluate the functional width of stomal passage and adjust to the stomal width to 3 to 4mm. Thereafter, patients with sufficient weight loss were radiographically examined again at 12 months while those with insufficient weight loss or suspected complications were re-examined earlier in the follow up.[25] In these assessments, all patients were found to have correct band placement one day post surgery and the average stomal width was 4mm±1mm in diameter secondary to postoperative mucosal swelling. By the 6-to 8-week follow up, the average functional diameter of the stoma was 9mm±2mm, and each patient was adjusted to the desired 3 to 4mm by injection of 3.0 to 3.5mL of saline into the port. The authors concluded that radiographic assessment was important in managing weight loss through optimal stoma adjustment and in detecting various postoperative complications.[25]

Radiography has been proven to detect complications, such as band slippage or malposition, perforation, overly tight restriction of the stoma, hiatal hernia, and intragastric perforation (Figure 2).[24,25] For example, concentric pouch dilatation can result from functional stenosis of the band stoma and prestenotic dilatation of a part of the stomach fundus.[25] However, the diagnosis of a chronic concentric pouch dilatation must be differentiated from eccentric band herniation with anterior or posterior prolapse. Definitively identifying the underlying cause of concentric pouch dilatation can be challenging and may require additional oblique radiographic views, port puncture, or loosening of the band.[24]

Fluoroscopy-Guided Band Assessment
Fluoroscopy-guided band assessments evaluate the band position, pouch anatomy, flow through the stoma, and the presence of hiatal hernia, esophageal dilatation, and other complications such as asymptomatic erosions. In addition, this technique can be used to access difficult ports.[24] Fluoroscopy is a critical adjunct to clinical assessment to avoid delaying anatomic or behavioral intervention when needed. Frequently, patients are classified as nonadherent based solely on clinical assessment. However, fluoroscopic examination of patients who are not demonstrating sufficient levels of weight loss reveals band slippage, pouch dilatation, or hernia. In such cases, a simple test could avoid misleading clinical assessments leading to a patient’s guilt and delay in weight loss.

During the assessment, the clinician is guided with a fluoroscopic view of a small barium swallow, providing immediate assessment of the status of the esophagus and the stomach pouch, the diameter of the stoma, and the gastric-emptying rate.[20] During fluoroscopy-guided adjustments, the patient is usually standing in a vertical position and the band is tightened to slow the barium flow without causing obstruction or significant reflux. Since the objective of the adjustment is to optimally restrict the band without obstructing the flow, the patient will need to tolerate water before adjustment is completed. This approach is especially helpful during the first adjustments to get them into the “green zone.”

Fluoroscopy-guided band adjustments may be done using a fluoroscopy table either at the hospital radiology facility or in an outpatient center or office-based practice with portable equipment. Hospital unit adjustments are subject to radiology unit logistics and may be more expensive and time consuming. Therefore, other options for fluoroscopy-guided band adjustments may also be considered,  such as an outpatient radiology facility or an outpatient surgery center with a portable C-arm imaging system. Such facilities often have easier access, and are less expensive than the hospital radiology unit. Such facilities are also more patient friendly in that the outpatient facilities are smaller, usually have easier access for patients (e.g., easier parking, patients are able to go in-out faster, designed for outpatient services). High-volume bariatric surgery practices may justify the addition of an in-office portable C-arm system to allow adjustments to be made with fluoroscopy-guided barium swallow and radiology-assisted port access whenever needed. This arrangement also permits adjustments to be made in the office or clinic where patients have access to the required follow up.

Although in-office, fluoroscopy-guided adjustments are not immediately available to all surgeons and may involve upfront expenses, many practices find the investment worthwhile. Despite lack of data on the relative cost-effectiveness of fluoroscopy-guided adjustment, potential additional benefits to the patient may warrant the time and resources to employ this technique.

Good clinical experience and judgment can allow for many adjustments to be performed without fluoroscopy. If fluoroscopy is not used routinely, it still should be performed at least at regular intervals to detect complications at early stage, ideally before they become symptomatic, in order to provide early and more effective treatment.

It is important to note that in some instances there is a significant difference between what one sees radiologically and what the patient tolerates, and a given diameter may not necessarily correspond to the clinical restriction experienced by the patient. In these particular circumstances, achieving a specific diameter should not be the goal of the adjustment, but a small-to-moderate adjustment should be done on clinical grounds.
If a patient clinically is in the “green zone,” even with a very large stoma diameter by fluoroscopy, a band should be left alone and the physician should encourage the patient to continue with the follow up to determine the need for adjustment when clinically indicated. Also, it is important to recognize that in many patients food tolerance is often different at different times of the day, with more difficulty in the morning and less difficulty in the afternoon and evening. That is why in our facility we elect to perform barium swallows in the afternoon rather than early in the morning. In our experience, many patients will show more delayed or increased restrictions in the morning, which may falsely guide us to not adjust the band as much as they will need.

Fluoroscopy-Guided Adjustment Benefits
Fluoroscopy-guided adjustment offers an additional diagnostic tool, augmenting routine patient, symptom-driven assessment. This technique may prove useful in identifying complications and providing a route to optimize band adjustments.[26,27] For example, in a recent study,[28 80] percent of patients thought they should receive a band fill despite reporting reflux, dysphagia, and regurgitation symptoms. Thirty-one percent of patients had abnormalities that were noted during fluoroscopy. Band slippage was detected in three patients who did not report complaints that would have prompted radiologic evaluation. Ultimately, the routine use of fluoroscopy led to a change in the course of management in 12 percent of patients.[28]

One of the obvious benefits of radiographic assessment is that it provides direct visualization of the anatomy and band position.[20] This enables the clinician to detect potential complications that may be missed if a patient shows no symptoms, such as outlet stenosis, esophageal or gastric prolapse, pouch dilation, band slippage, or band erosion.[20,27] The direct view of the anatomy and function allows for immediate corrective interventions, even in asymptomatic patients.[29] Many of the early signs detected by fluoroscopy can be corrected by fluid removal, followed by reinstallation of fluid after follow-up imaging after 2 to 4 weeks. The detection of more serious complications (e.g., anterior, posterior, or severe concentric slips) allows for surgical correction under nonurgent conditions.[28] Fluoroscopy-guided adjustment also allows the clinician to adjust the volume of saline added or removed based on the individual patient effect.

Fluoroscopy provides immediate feedback regarding the flow of oral contrast through the band during inflation. Conversely, in-office adjustment without radiological guidance is based purely on patient symptoms and weight loss, and general adjustments are made without individualized information regarding the volume of fluid to be added or removed.[27] Individualized band adjustment based on fluoroscopic guidance may reduce the number of follow-up visits required for further adjustments due to either insufficient tightening to achieve satiety or for fluid removal due to dysphagia. In many cases, adequate restriction can be achieved with fewer adjustments under fluoroscopic guidance, and this may translate into better positive feedback with some patients. One recent series of 141 patients who underwent LAGB followed by fluoroscopy-guided adjustments found that a mean of 4.1 (range, 0–10) adjustments achieved excess weight loss of 35.3 percent (range, 2.1–81.0), 44.4 percent (range 13.6–98.9), and 52.1 percent (range 13.3–80.1) at 6 to 12, 12 to 18, and 18 to 23-month follow up, respectively.[27] In the practice of the first author of this article (Ponce), fluoroscopy-guided adjustments allowed a greater proportion of patients to achieve hunger reduction with fewer adjustments.

Clinicians can also use fluoroscopy guidance to evaluate reflux to differentiate between a need for band adjustments and complications.[27] For example, a patient can present with acid reflux, and radiographic assessment can determine if the patient’s symptoms indicate the presence of a hiatus hernia or simple stoma tightness. Another scenario with valuable radiologic input is the patient that has true pouch dilatation and presents clinically in the “yellow zone.” Without the fluoroscopic view of the pouch, usually more fluid is added with potential creation of a more severe problem. Pouch and esophageal dilatation can be identified earlier and a patient assessment that is more detailed can be performed later to assess inappropriate eating behavior. Similarly, use of radiography can differentiate between a “red zone” band that simply requires fluid to be removed for stoma tightness versus a hiatal hernia or band slippage. Finally, the use of fluoroscopy during adjustments also provides important information on the LAGB system itself. Radiographic guidance can reduce the risk of injury to the port or catheter during port access.[27] Specific radiographic criteria for adjustment are summarized in Table 1.[20]

Operator Risk of Radiation Exposure
Little information exists regarding radiation exposure to the operator during band adjustments using fluoroscopy. One study documented that in experienced operators with more than one year of experience with band adjustments, the annual hand exposure to radiation was well below the federally regulated annual exposure limit for extremities.[30] Overall hand exposure times for experienced clinicians averaged 10.34 seconds compared to 25.8 seconds for inexperienced clinicians. The inexperienced operators had a 2.5-times higher radiation exposure, and may benefit from the use of lead-protected gloves.

Reimbursement of Fluoroscopy-Guided Adjustments
Reimbursement of fluoroscopy-guided band adjustments is feasible. Radiography-guided office adjustments can be reimbursed using a combination of current procedural terminology (CPT) codes. Table 2 includes codes.[31]

Conclusions
Regardless of type of band adjustment and whether the adjustment is performed in an office or hospital setting, patient education and support are critical to successful outcomes of the LAGB.[21] To meet the clinical objectives of LAGB procedures, adherence to a well-structured postsurgical management plan that includes optimal band adjustment is as important as proper surgical techniques.[20] In certain situations, such as when palpation is inadequate, fluoroscopy-guided band adjustment provides valuable advantages to patients. When band adjustments are performed under fluoroscopy guidance, patients may potentially require fewer adjustments, complications may be reduced or promptly detected, and this technique can assist in patient management and counseling. In conclusion. the individualized use of radiographically-guided adjustments, such as those performed by experienced surgeons, may be part of optimizing care for selected patients and yield improved outcomes.[28]

References
1.    Elder KA, Wolfe BM. Bariatric surgery: a review of procedures and outcomes. Gastroenterology. 2007;132:2253–2271.
2.    Zhao Y, Encinosa W. Bariatric surgery utilization and outcomes in 1998 and 2004. Statistical Brief #23: Healthcare Utilization Project. http://www.hcup- us.ahrq.gov/reports/statbriefs/sb23.pdf Accessed August 12, 2010.
3.    Sjöström L, Gummesson A, Sjöström CD, et al. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med. 2007;357:741–752.
4.    Dixon JB, O’Brien PE, Playfair J, et al. Adjustable gastric banding and conventional therapy for type 2 diabetes: a randomized controlled trial. JAMA. 2008;299:316–323.
5.    Adams TD, Gress RE, Smith SC, et al. Long-term mortality after gastric bypass surgery. N Engl J Med. 2007;357:753–761
6.    Ponce J, Dixon JB. Laparoscopic adjustable gastric banding. Surg Obes Relat Dis. 2005;1:310–316.
7.    Jan JC, Hong D, Pereira N, Patterson EJ. Laparoscopic adjustable gastric banding versus laparoscopic gastric bypass for morbid obesity: a single-institution comparison study of early results. J Gastrointest Surg. 2005;9:30–39.
8.    Jan JC, Hong D, Bardaro SJ, July LV, Patterson EJ. Comparative study between laparoscopic adjustable gastric banding and laparoscopic gastric bypass: single-institution, 5-year experience in bariatric surgery. Surg Obes Relat Dis. 2007;3:42–50.
9.    Angrisani L, Lorenzo M, Borrelli V. Laparoscopic adjustable gastric banding versus Roux-en-Y gastric bypass: 5-year results of a prospective randomized trial. Surg Obes Relat Dis. 2007;3:127–132.
10.    Ponce J, Fromm R, Paynter S. Outcomes after laparoscopic adjustable gastric band repositioning for slippage or pouch dilation. Surg Obes Relat Dis. 2006;2:627–631.
11.    Buchwald H. Consensus conference statement bariatric surgery for morbid obesity: health implications for patients, health professionals, and third-party payers. Surg Obes Relat Dis. 2005;1:371–381.
12.    Spivak H, Hewitt MF, Onn A, Half EE. Weight loss and improvement of obesity-related illness in 500 U.S. patients following laparoscopic adjustable gastric banding procedure. Am J Surg. 2005;189:27–32.
13.    Sarker S, Myers J, Serot J, Shayani V. Three-year follow-up weight loss results for patients undergoing laparoscopic adjustable gastric banding at a major university medical center: Does the weight loss persist? Am J Surg. 2006;191:372–376.
14.    Chapman AE, Kiroff G, Game P, et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery. 2004;135:326–351.
15.    O’Brien PE, Dixon JB, Laurie C, Anderson M. A prospective randomized trial of placement of the laparoscopic adjustable gastric band: comparison of the perigastric and pars flaccida pathways. Obes Surg. 2005;15:820–826.
16.    Ponce J, Paynter S, Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg. 2005;201:529–535.
17.    Morino M, Toppino M, Forestieri P, et al. Mortality after bariatric surgery: analysis of 13,871 morbidly obese patients from a national registry. Ann Surg. 2007;246:1002–1007.
18.    Ren CJ, Fielding GA. Laparoscopic adjustable gastric banding: surgical technique. J Laparoendosc Adv Surg Tech A. 2003;13:257–263.
19.    Dixon JB, O’Brien PE. Permeability of the silicone membrane in laparoscopic adjustable gastric bands has important clinical implications. Obes Surg. 2005;15:624–629.
20.    Favretti F, O’Brien PE, Dixon JB. Patient management after LAP-BAND placement. Am J Surg. 2002;184:38S–41S.
21.    Shen R, Dugay G, Rajaram K, et al. Impact of patient follow-up on weight loss after bariatric surgery. Obes Surg. 2004;14:514–519.
22.    REALIZE Adjustable Gastric Bands [instructions for use]. Cincinnati, OH: Ethicon Endo-Surgery, Inc.; 2008.
23.    LAP-BAND AP™ Adjustable Gastric Banding System with OMNIFORM™ Design [directions for use]. Santa Barbara, CA: Allergan; 2010.
24.    Prosch H, Tscherney R, Kriwanek S, Tscholakoff D. Radiographical imaging of the normal anatomy and complications after gastric banding. Br J Radiol. 2008;81:753–757.
25.    Wiesner W, Schob O, Hauser RS, Hauser M. Adjustable laparoscopic gastric banding in patients with morbid obesity: radiographic management, results, and postoperative complications. Radiology. 2000;216:389–394.
26.    Gulkarov I, Wetterau M, Ren CJ, Fielding GA. Hiatal hernia repair at the initial laparoscopic adjustable gastric band operation reduces the need for reoperation. Surg Endosc. 2008;22:1035–1041.
27.    Sarker S, Myers JA, Shayani V. Superior weight loss with patient-driven, fluoroscopically guided band adjustment following laparoscopic adjustable gastric banding. JSLS. 2005;9:269–271.
28.    Kroh M, Brethauer S, Duelley N, et al. Surgeon-performed fluoroscopy conducted simultaneously during all laparoscopic adjustable gastric band adjustments results in significant alterations in clinical decisions. Obes Surg. 2010;20:188–192.
29.    Moser F, Gorodner MV, Galvani CA, et al. Pouch enlargement and band slippage: two different entities. Surg Endosc. 2006;20:1021–1029.
30.    Stegemann L, Trigilio-Black CM, Seger MV, et al. Operator hand radiation exposure during adjustable gastric band adjustment under fluoroscopy [Abstract P-12]. Surg Obes Relat Dis. 2009;5:S27–S28.
31.    Current Procedural Terminology (CPT) 2010. Chicago, Il: American Medical Association; 2009.
32.    Ponce J. Surgical implantation and adjustment technique with the Realize Band System. Surg Obes Relat Dis. 2009;5:104–110.

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