Laparoscopic Gastric Band Adjustments

| May 2, 2007 | 0 Comments

by Jaime Ponce, MD, FACS

Dr. Ponce is Director for Bariatric Surgery, Dalton Surgical Group, PC, Hamilton Medical Center, Dalton, Georgia.

Introduction

One of the key features of the laparoscopic adjustable gastric band (LAGB) procedure is its adjustability.[1,2] The success of this procedure is directly dependent upon the optimal use of this capability. An adjustment (also known as a “fill” or “unfill”) is the injection or aspiration of saline fluid from the inner balloon through a subcutaneous access port connected to the gastric band.

Indications for Band Adjustment

At the time of the surgical placement of the LAP-BAND®, no fluid is injected into the band, so it is left empty. Approximately six weeks after the placement of the band, the first adjustment should be considered, based on the patient’s degree of satiety, size of food portions, and rate of weight loss, as well as the presence of any symptoms that may suggest over-tightness of the band. Thereafter, additional fluid should be injected only when any of the following conditions are present:

• Insufficient sensation of prolonged satiety between meals
• Insufficient weight loss (ideal rate of weight loss is 0.5–1.0Kg per week during the first year)
• Insufficient restriction of solid food (ideal portion size is fi–1 cup of solid food).

Patients should always be instructed to follow the appropriate rules of eating with a restrictive bariatric surgical procedure: Eat three small meals per day; choose solid proteins first; eat slowly, taking small bites and chewing thoroughly; and consume no liquids with meals.[3] The adjustment should not induce obstructive symptoms, such as vomiting, heartburn, or chest discomfort, nor should it provoke maladaptive eating behaviors, such as consuming high-calorie liquids or very soft foods. If any of these symptoms occur after an adjustment, always consider removing fluid from the band. Other indications for fluid removal may include pregnancy, the presence of acute serious diseases, major surgery, travel to remote locations, chemotherapy, or any other circumstance in which temporary release of the gastric restriction might be helpful.

Band Adjustment Techniques

Successful adjustment of the band begins with proper placement of the access port during surgery. The port should be placed in a very consistent location (usually in the epigastrium, on top of the anterior rectus muscle fascia) and secured by four nonabsorbable sutures so that the position of the tubing in relation to the port is in a predictable orientation. This consistent placement of the port allows for easier and safer access during adjustments.
Each band adjustment requires (1) access to the subcutaneous port and (2) injection or removal of fluid.
Access to the subcutaneous port. In most cases, the port can be accessed by simple palpation. The patient should be in a relaxed, supine position, with legs uncrossed and arms behind the head. Lifting the legs can sometimes aid palpation of the port. In our experience, more than 95 percent of ports can be accessed with this palpation technique.

However, if the port is too deep or is rotated and cannot be accessed by palpation, then fluoroscopy should be used to assist in locating and accessing the port. Another option that may be used to facilitate port location is ultrasound. Using these imaging techniques, the orientation of the port is initially assessed by the shape of the port: An oval (rather than circular) shape indicates that the port is rotated. Often, the port can be digitally manipulated to correct a rotation. Once the port has been righted, its location can be marked with a dot on the skin with a pen.
We recommend using sterile technique and a long Huber-tip needle. Regular or spinal needles are not appropriate for use in band adjustments because they are likely to cause a port leak. The needle should be introduced perpendicular to the skin. If the tubing position is known and predictable, then the needle should be inserted away from the tubing and “walked” to the center of the access port to prevent accidental puncturing of the tube.

After accessing the port, an efflux of fluid will occur if a smaller (9.75cm or 10.0cm) size LAP-BAND® System has been used; however, if the LAP-BAND® VG System has been used, the efflux of fluid is not likely to be seen, since the internal pressure in this product is lower.
Injection of predetermined amounts of fluid. Once the port has been successfully accessed, the next step involves deciding how much fluid to inject into the band. Most practices using this technique, have found that injection of 1mL of fluid is appropriate for the initial adjustment, which takes place approximately six weeks after the surgical placement of the band. After this adjustment, the patient should be able to drink water comfortably before leaving the office and is then monitored over time for indications of need of additional adjustment (as outlined above). If further adjustment is indicated, then up to 0.2–0.5mL of fluid is added per adjustment until adequate restriction is obtained and no indications of adjustment are observed. It is advisable also to have patients undergo an annual barium swallow study to assess the esophagus, stomach pouch, and band position/orientation. This method, in which predetermined fluid amounts are injected (without the aid of radioactive imaging), is simple, quick, cost-effective, and, if the practice is able to offer an “open-door” policy for patients to return if needed, can be very effective.

Injection of fluoroscopy-determined amounts of fluid

Another option is to determine the amount of fluid to inject using radiographic assistance. The fluoroscopic view of a small barium swallow permits immediate assessment of the status of the esophagus and stomach pouch, diameter of the stoma, and gastric emptying rate. The amount of fluid is guided by the barium flow through the stoma. In most cases, fluid can be injected to restrict the flow without causing obstruction. It is important to always asses the barium flow with the patient standing in a vertical position and to assess the degree of restriction by having the patient drink a glass of water and verify that the restriction does not cause discomfort.

Fluoroscopy-guided adjustments can be performed using a portable C-arm imaging system or a more stable fluoroscopy table. While fluoroscopy is not immediately available to all surgeons and may involve significant up-front expenses, many practices find the investment worthwhile. In many cases, adequate restriction can be achieved with fewer adjustments when fluoroscopy is used, and, more importantly, important complications, such as outlet stenosis, esophageal or gastric pouch dilatation, reflux, gastric prolapse, band erosion, or malposition of the band, can be detected and immediate corrective steps (usually including removal of fluid from the band) can be taken.

Follow-up and Management

Follow-up visits should be scheduled every 4 to 8 weeks during the first postoperative year, and then every three months during the second year. After this, yearly visits are recommended if the patient’s condition is stable.
Band adjustments provide both physiological and psychological help for patients. On the day of a patient’s band adjustment, it is important to forego extensive counseling and, instead, to explain that assistance is needed in the form of an adjustment and discuss expected outcomes if the band becomes too tight or too loose.

We have found that the concept of “Eating Zones” described by O’Brien and Dixon[4] is a useful visual to incorporate into patient education sessions. According to this concept, if the patient remains hungry all the time, is able to consume large portions of food, and can eat steak or bread comfortably, he or she is considered to be in the “Yellow Zone,” indicating that the band is too loose and an addition of fluid to the band is required. If, on the other hand, the patient is experiencing trouble eating solid foods, pain or difficulty in swallowing, or food regurgitation, he or she is considered to be in the “Red Zone,” indicating that the band is too tight and removal of fluid from the band is required. 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 considered to be in the appropriate “Green Zone,” and no band adjustment is necessary (Figure 1).

It is important to recognize that the Green Zone can be narrow, and sometimes even the addition or removal of 0.2mL of fluid is sufficient to make a difference in the degree of restriction. Even with small adjustments, some patients develop significant dysphagia when swallowing solid foods. In most of these cases, it is necessary to place the patient in an intensive follow-up program that includes weekly visits, maintenance of a food journal, and small (0.1–0.2mL) band adjustments until the patient enters the “Green Zone.” Continuous, close follow-up is generally required to keep the patient in this state. In some cases in which patients are having extreme difficulty in entering the Green Zone, we have found it helpful to conduct an “eating workshop” in which the nurse and dietitian observe the patient eating, so that they can provide guidance to maximize the patient’s understanding of the eating rules.

Different LAP-BAND® Sizes

The LAP-BAND® is available in three sizes: 9.75cm, 10cm, and the VG. For technical purposes, the 9.75-cm and 10-cm bands are essentially very similar. They have the same design and each holds a maximum of 4mL of saline, so they achieve very similar reductions in stoma area. Because the pressure inside these bands is under higher pressure, fluid tends to efflux into the syringe when the system is accessed through the port.

The LAP-BAND® System VG has a different balloon shape that allows for concentric inflation and minimizes the potential for creases/folds. In the VG band, the size of the stoma is significantly larger than that of the standard-size bands, and the pressure inside the VG band is lower, so efflux of fluid does not occur spontaneously after accessing the port with a needle. It is important to prime the VG band at the time of initial placement by replacing the air that holds the band at a “resting” pressure with saline. This maneuver usually leaves a resting volume of 3 to 4mL of saline in the band. After this appropriate priming, the capacity of the VG band is 10mL, and this volume approximates the stoma area of the smaller bands inflated with 4mL (Figure 2).

One of the problems we have encountered in our practice is a large number of patients who have had bands implanted overseas. While the LAP-BAND® is the only band currently approved by the United States Food and Drug Administration (FDA) for use in the US, there are more than six different types of bands available internationally, and the design, volume capacity, size, and pressure vary from type to type. We recommend that surgeons who have not been trained on these other bands not try to adjust them using the same parameters described for the LAP-BAND®.

Where Should Band Adjustments Be Performed?

Band adjustments ideally should be performed in the office or clinic, where patients have easy access to the required follow-up. Office adjustments are usually performed using the palpation technique and injecting a predetermined amount of fluid according to the appropriate indications. In some cases, the port cannot be accessed through palpation alone, so the patient is taken to the radiology facility for a fluoroscopic-assisted adjustment. In most hospitals, this process is difficult: It is expensive, time-consuming, and must conform to the radiologist’s schedule. Other fluoroscopy options are either an outpatient radiology facility or an outpatient surgery center that has a mobile C-arm imaging system (usually used by pain management services). These outpatient facilities usually allow easier access, are more patient- and doctor-friendly, and are less expensive.

Our practice now has taken the step of purchasing a C-arm to be used in our office. The availability of this in-office imaging system allows us to perform adjustments with fluoroscopy-guided barium swallow (Figure 3) and port access under x-ray whenever needed. We believe that \this purchase makes sense in a high-volume practice. X-ray–guided office adjustments can improve reimbursement using a combination of the following CPT codes5:

• 76000—Fluoroscopy up to one hour, physician time
• 76003—Fluoroscopic guidance for needle placement
• 74246—Radiology examination, gastrointestinal tract, upper, air contrast, with specific high-density barium
• 90782—Diagnostic injection, subcutaneous port
• S2083—Adjustment of gastric band diameter via subcutaneous port by injection or aspiration of saline (HCPCS Level II Code).

The benefits we have seen with the availability of fluoroscopy in the office include the following:

• May require fewer adjustments to achieve restriction
• Acts as an additional diagnostic tool in certain situations, such as the following:
* Can help differentiate between a band in the “Yellow Zone” and pouch dilatation
* Can help differentiate between a tight band in the “Red Zone” and a hiatal hernia or slippage
* Can help detect the presence of esophageal dilatation.
• Provides immediate visualization of the anatomy and band position
• Can improve reimbursement for band adjustments.
Whether band adjustments are performed by manual palpation or through the assistance of fluoroscopy, and whether they take place in the office or in a hospital or outpatient radiology facility, the most important factor for improved outcomes is the availability of the practice staff for patient education and support and the frequency of follow-up visits.

Disclaimer

This is one surgeon’s opinion; variations exist that may be as effective. Patients should always follow the protocol defined by their surgeon and/or bariatric program.

References

1. Ponce J, Dixon JB. 2004 ASBS consensus conference. Laparoscopic adjustable gastric banding. Surg Obes Relat Dis 2005;1:310–16.
2. Ponce J, Paynter S, and Fromm R. Laparoscopic adjustable gastric banding: 1,014 consecutive cases. J Am Coll Surg 2005;201:529–35.
3. Favretti F, O’Brien PE, and Dixon JB. Patient management after LAP-BAND placement. Am J Surg 2002;184:38S–41S.
4. Dixon JB, O’Brien PE. Permeability of the silicone membrane laparoscopic adjustable gastric bands has important clinical implications. Obes Surg 2005;15:624–9.
5. Napora T, Ren CJ. Coding for laparoscopic adjustable gastric banding: Best practice guidelines. Bariatric Times 2006:8:14–5.

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