The Swedish Laparoscopic Adjustable Gastric Banding for Morbid Obesity: Radiologic Findings in 218 Patients

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1 K. J. Mortelé 1,2 P. Pattijn 3 P. Mollet 1 F. Berrevoet 3 U. Hesse 3 W. Ceelen 3 P. R. Ros 2 Received September 28, 2000; accepted after revision December 28, Department of Radiology, University Hospital Ghent, De Pintelaan 185, 9000 Ghent, Belgium. 2 Department of Radiology, Brigham and Women s Hospital, Harvard Medical School, 75 Francis St., Boston, MA Address correspondence to K. J. Mortelé. 3 Department of Surgery, University Hospital Ghent, 9000 Ghent, Belgium. AJR 2001;177: X/01/ American Roentgen Ray Society The Swedish Laparoscopic Adjustable Gastric Banding for Morbid Obesity: Radiologic Findings in 218 Patients OBJECTIVE. The objective of this study was to determine the prevalence and radiologic features of postoperative complications after Swedish laparoscopic adjustable gastric banding surgery and to emphasize the role of the radiologist in the follow-up of those patients, especially in the treatment of complications. MATERIALS AND METHODS. We reviewed the radiologic findings in 218 consecutive morbidly obese patients after laparoscopic placement of the Swedish gastric banding system. Radiographic studies of the stomach (obtained with liquid barium sulfate suspension) were performed before surgery and 1 month after band placement in every patient. Additional studies in symptomatic patients were performed when needed. RESULTS. Surgical complications found included misplacement of the band (five patients, 2.3%), slippage of the band (17 patients, 7.8%), and pouch enlargement (eight patients, 3.7%). Technical problems encountered were inversion of the access port (three patients, 1.4%), leakage of the device (two patients, 0.9%), and spontaneous decrease of the stoma size caused by gastritis (seven patients, 3.2%) or the hyperosmolar properties of the IV contrast material (12 patients, 5.5%). Intrinsic abnormalities of gastroesophageal tract seen included trapping of food in the stoma (four patients, 1.8%) and esophagitis (11 patients, 5%). CONCLUSION. Although, according to the available data, the gastric banding operation with the Swedish band meets the criteria of a low-risk laparoscopic alternative treatment of morbid obesity, the radiologic appearances of various complications may be seen on the images of patients who have undergone the procedure. The radiologist plays a key role in the early detection of those complications and treatment of specific abnormalities. L aparoscopic adjustable gastric banding, a restrictive surgical procedure performed on the stomach, is designed to induce weight loss by limiting food consumption in morbidly obese patients [1]. Developed and mainly performed in Europe, this technique has been used in approximately 10,000 patients [1, 2]. The Food and Drug Administration is supervising the clinical trials required for the procedure to gain approval to be performed in the United States [2]. Two different gastric banding devices are currently being used in clinical practice. The radiologic appearance of the oldest and still most commonly used device, the laparoscopic adjustable silicone gastric banding (LAP-BAND Adjustable Gastric Banding System; BioEnterics, Carpinteria, CA), has been recently described [1 5]. The initial clinical experiences and possible complications with a newer device, the Swedish adjustable gastric banding (SAG-BAND; Obtech Medical, Baar, Switzerland), have also been reported [6, 7]. Nevertheless, we do not know of any report published on the spectrum of radiologic findings and the optimal technique for use of contrast material to evaluate this type of gastric banding device. Therefore, the purpose of this report is to describe and illustrate the radiologic appearances of properly functioning Swedish gastric banding devices and the possible complications in a large group of patients and to delineate the role of the radiologist in adjusting the device, detecting postoperative complications, and conducting the follow-up of those patients. Materials and Methods Patient Population Between October 28, 1997 and November 4, 1999, 218 morbidly obese patients (175 women, 43 men) underwent bariatric surgery with the laparo- 77

2 Mortelé et al. Fig. 1. Drawing shows surgical procedure. Band (arrow) is looped around upper portion of stomach, thereby creating small upper pouch that communicates through stoma with remainder of stomach. Sutures (arrowheads) between serosa of stomach proximally and distally to band are placed to maintain correct position of band. scopically placed Swedish adjustable gastric banding system at the University Hospital Ghent, Belgium. The device was released for clinical use in Belgium on the basis of international data confirming the safety and efficacy of this technique. Before surgery, examinations were performed in all 218 consecutive patients, including laboratory tests such as hematologic profiles and endocrinologic tests, nutritional evaluations, and double-contrast upper gastrointestinal series. Psychiatric testing and gastroesophagoscopy were performed when indicated. All patients selected for surgery had a history of repeated failure with dietary regimens. Surgical Procedure and Device The surgical procedure of Swedish adjustable gastric banding consists of laparoscopic looping of a nonradiopaque silicone band around the fundus of the stomach, thereby creating a small proximal gastric pouch with a stoma to the remainder of the stomach [8]. Additional seroserosal stitching of the stomach is performed anteriorly to attach the band to the gastric wall (Fig. 1). The stoma size between the small upper pouch and the lower portion of the stomach is adjustable because the inner surface of the band is inflatable and connected by a thin silicone tube to a radiopaque access port with a self-sealing membrane. During the same surgical session, the access port is sutured in the anterior rectus sheath, typically below the caudal part of the left rib cage (Fig. 2). Adjustment Technique The device contains an inflatable inner surface that allows adjustment of the stoma size by puncturing the access port percutaneously and injecting or withdrawing fluid solution. Up to 8 ml of fluid solution can be injected before a complete closure of the Swedish band is obtained. Because stomal edema in the early postoperative period may temporarily decrease stoma size, the band is left empty at surgery. We performed the earliest initial band adjustment at 3 4 weeks after surgery. After this first adjustment, additional sessions were scheduled depending on the patient s ability to eat, weight loss curve, or manifestation of complications. The diagnosis of complications was based on clinical parameters, such as persistent vomiting, gastroesophageal reflux, dysphagia, or odynophagia. In our experience, optimal stoma size adjustment was best performed under fluoroscopic guidance in seven steps: (1) fluoroscopic examination of the whole gastric banding system to evaluate adequate positioning of the band and access port and to detect possible technical complications; (2) limited single-contrast upper gastrointestinal study with liquid barium sulfate suspension to judge the actual stoma size, volume of the upper gastric pouch, and passage rate of the barium suspension and to detect intrinsic abnormalities of the gastrointestinal tract (Fig. 3A); (3) fluoroscopic localization of the access port followed by aseptic cleaning of the skin; (4) puncture of the access port during fluoroscopic guidance using a special noncoring deflected tip (Huber tip) needle; (5) fluoroscopically guided injection or withdrawal of nonionic, isoosmolar contrast material 78 Fig. 2. Abdominal radiograph obtained from 34-year-old woman shows normal appearance of Swedish adjustable gastric banding system (SAG-BAND; Obtech Medical, Baar, Switzerland) consisting of contrast medium filled inflatable inner cuff (white arrow), connecting silicone tube (arrowhead), and subcutaneous sutured radiopaque access port (black arrow). (Visipaque 270 mg/dl; Nycomed-Amersham, Oslo, Norway) depending on the stoma size; and (6) evaluation of stoma size after adjustment with barium suspension (with the needle still in the access port, Fig. 3B). At this point, additional injection or withdrawal of contrast material might be indicated to adjust the stoma to the optimal size for the individual patient. In our study, the parameters used to determine optimal stoma size were the rate of passage of barium through the stoma, grade of retrograde filling of the upper gastric pouch, and presence or absence of gastroesophageal reflux. The seventh and final step was the removal of the needle. All adjustments were performed with the patient in the anteroposterior position when technically pos- sible. If the gastric fundus, filled with barium, was obscuring the stoma after the initial upper gastrointestinal series, the patient was moved to a slightly right posterior oblique position. All adjustments were made in 5 10 min. Optimal adjustment of the stoma was generally achieved in two to three sessions. During the first adjustment, 4 5 ml of contrast material was injected, which caused a significant decrease in stoma size. Thereafter, if no complications occurred, only one to two additional sessions with the injection of 1 2 ml of contrast medium were necessary to achieve optimal adjustment of the band. The time interval between these sessions and the amount of added fluid in each

3 Swedish Laparoscopic Adjustable Gastric Banding Fig. 3. Radiographs obtained from 20-year-old woman show results of band adjustment. A, Barium-enhanced upper gastroesophageal radiograph before adjustment shows mild narrowing of gastric lumen (arrows) at presumptive position of nonradiopaque band. B, Barium-enhanced upper gastrointestinal radiograph after adjustment (percutaneous injection of 5 ml isoosmolar contrast material into access port) shows opacification of band, significant reduction in stoma size (arrows), and retained oral contrast medium in upper pouch (arrowheads). A session were extremely variable and determined individually for each patient. Results Data concerning complications, their key clinical and radiologic features, and the possible therapeutic interventions are outlined in detail in the following sections. Surgical Complications Misplacement of the band. Of 218 patients, 213 (97.7%) were found to have correctly positioned bands without complications at the 1-month postoperative upper gastrointestinal series. However, in two asymptomatic patients, the band had not enclosed the stomach but only perigastric fat (Fig. 4). Confirmation of this complication was obtained at surgery. In three other patients, the band had been initially misplaced around the lower part of the stomach, causing severe gastric outlet obstruction (Fig. 5). These three patients presented with extensive vomiting during the early postoperative period ( 3 days after surgery). This complication, unfortunately, was caused by lack of experience of one of the surgeons. All five patients (2.3%) underwent a second operation to reposition the band. Slippage of the band. We defined slippage as the herniation of stomach from below the band upward, resulting in pouch enlargement. Patients with this complication presented with clinical findings such as stabilization of weight loss, which was caused by the enlarged upper gastric pouch; severe gastroesophageal reflux, especially when in the supine position, because of de- layed emptying of the pouch; and, in patients with severe cases of band slippage, stoma obstruction caused by dependent migration or rotation of the upper gastric pouch. The characteristic radiographic image was that of an enlarged upper pouch (predominantly left sided and posterior), horizontal orientation of the band, presence of an air fluid level in the pouch caused by the delayed emptying, and, in patients with severe band slippage, stoma obstruction. In our series, slippage was detected in 17 patients (7.8%). Twelve of them (5.5%) presented with severe slippage complicated by B acute stoma obstruction (Fig. 6). We obtained initial relief of symptoms by removing all contrast material from the band; an operation was required to reposition the device. In two of those patients, the withdrawal of contrast material did not improve stoma patency, and a second surgery was mandatory to relieve symptoms. In three patients, the slippage was moderate without obstruction and in two other patients, it was mild without horizontal orientation of the band or presence of an air fluid level) (Fig. 7). Both of the latter groups were treated conservatively. In those patients with mild to moderate Fig. 4. Misplaced band in 50-yearold man with insufficient weight loss 4 weeks after band placement. Bariumenhanced upper gastrointestinal radiograph reveals misplaced band. Note normal gastroesophageal junction with projection of band (arrows) to left of stomach. 79

4 Mortelé et al. Fig. 5. Misplaced band in 45-year-old woman presenting with severe vomiting. Barium-enhanced upper gastrointestinal radiograph obtained 2 days after surgery shows incorrect positioning of opacified band (arrows) around lower part of stomach. Fig. 6. Severe band slippage in 40year-old woman presenting with insufficient weight loss, reflux disease for weeks, and progressive decrease in ability to eat. Barium-enhanced upper gastrointestinal radiograph reveals extreme pouch enlargement on left side (arrowheads), rotation of band, and complete stoma obstruction (arrow). slippage, the band was emptied, and fluoroscopic reevaluation was performed 4 weeks later. If the slippage had disappeared, a conservative approach was initiated with repetitive reinjection of contrast material at a slow rate. If the slippage was still present, no adjustment was performed until the herniation spontaneously resolved. In the three patients with moderate slippage, although the herniation recurred after the repetitive reinjection, the conservative approach repeated emptying and reinflation stabilized the weight curve sufficiently. Pouch dilatation We defined pouch dilatation as a significant enlargement of the upper gastric pouch (Fig. 8A). The main clinical man- 80 ifestations of pouch dilatation are stabilization in the weight loss curve and gastroesophageal reflux disease. Pouch dilatation was present either in combination with band slippage or as a solitary finding. In our study, pouch dilatation as an only finding was detected in eight patients (3.7%). Its radiographic image is of an enlarged pouch with a correctly positioned band and normal stoma size. Pouch dilatation without slippage was treated conservatively in all patients by removing all the contrast material from the band and performing fluoroscopic reevaluation 4 6 weeks later. If the pouch appeared to be normal size, the band was reinflated slowly over the course of several sessions (Fig. 8B). Technical Complications Rotation and inversion of the injection port. In patients whose ports had rotated in an upright position, derotation was frequently achievable by positioning the patient in supine and oblique positions (Fig. 9). Slightly rotated ports were best accessed by supportive manual compression, most easily achieved with the patient in the supine position. In our study population, three (1.4%) of 218 patients presented with a complete inversion of the port, which could not be accessed for adjustment in any position. These completely inverted ports had to be repositioned surgically with the patients under local anesthesia. Leakage of the banding system. In our series, leakage of contrast material during adjustment was detected radiographically in two patients (0.9%). One patient had leakage from the connecting tube (Fig. 10), and another had leakage from the band itself (Fig. 11). In both patients, the leakage was clinically suspected because neither patient noticed any change in the ability to eat after the initial inflation. Both patients had surgery so that the leaking part of the device could be exchanged for a functioning part. Spontaneous decrease of stoma size. Spontaneous decrease of stoma size was caused by either gastric inflammation with mucosal thickening (seven patients) or spontaneous diffusion of fluid into the gastric band due to the presence of hyperosmolar contrast material in the band (12 patients). Patients whose decreased stoma size had been caused by gastric inflammation with mucosal thickening typically presented with moderate dysphagia and epigastric pain. A combined approach of partially emptying of the band (for 4 weeks) and orally administrating H2-receptor blockers ([800 mg of cimetidine daily], Tagamet; SmithKline Beecham Pharmaceuticals, Crawley, UK) was preferred. In our study population, spontaneous decrease of stoma size due to diffusion of fluid into the gastric band was caused the hyperosmolar contrast medium (Urografine 60%; Schering, Berlin, Germany) used to make initial adjustments. In those patients, various clinical manifestations were found. Seven patients presented with mild dysphagia or increased weight loss due to the decreased stoma size, although their banding systems were morphologically normal. In these patients, the hyperosmolar contrast medium was completely removed and replaced with an appropriate amount of an isoosmolar contrast agent. However, in five of the patients, the diffusion of fluid into the band had re-

5 Swedish Laparoscopic Adjustable Gastric Banding sulted in complete closure of the stoma and complications such as pouch dilatation or slippage. In these patients, the band was deflated, and the patient was reexamined after 4 weeks. In two of those five patients presenting with severe slippage, another operation was required to relieve symptoms. We discontinued use of the hyperosmolar contrast medium in March Intrinsic Abnormalities Food trapping in the band. Acute obstruction caused by food being trapped in the stoma was seen in four patients (1.8%) (Fig. 12). All of them presented with acute dysphagia and odynophagia immediately after a meal. Acute obstruction caused by food entrapped in the stoma was easily and rapidly relieved by completely emptying the inner cuff and reinflating the band after passage of the obstructing food elements. Esophagitis. Radiologic signs of esophagitis, including fuzzy delineation of the esophageal wall and small erosions, were judged to be present in 11 patients (5%). When the radiologic diagnosis was confirmed at endoscopy, patients who were experiencing dysphagia or odynophagia and whose systems had been optimally adjusted were treated by oral administration of H2-receptor blockers (800 mg of cimetidine daily). In patients with both esophagitis and a severe gastroesophageal reflux or decreased stoma size, a combined approach of partially emptying the band for 4 weeks and orally administrating H2-receptor blockers was preferred. Discussion It is well known that diets and medication are unsuccessful methods in curing morbid obesity, particularly when considering the long-term results [1]. Therefore, several types of bariatric surgical methods have been developed over the past two decades in an attempt A to induce weight loss in severely obese patients [1]. In 1993, the laparoscopic adjustable gastric banding operation was introduced in Europe [9, 10]. This technique has, in addition to a resulting weight loss comparable to that achieved by other surgical methods, four major advantages over other methods currently used in bariatric surgery. First, neither the stomach nor the intestines have to be opened; second, the complete operation can be performed laparoscopically; third, the stoma size can be optimally adjusted to suit the individ- B Fig. 7. Moderate band slippage in 42-year-old woman presenting with insufficient weight loss and nocturnal regurgitation. A, Barium-enhanced upper gastrointestinal radiograph shows pouch enlargement on left side (arrows) and horizontal placement of band (arrowhead) but passage of barium suspension through stoma. B, Laterolateral radiograph obtained after complete deflation of band reveals increased passage of contrast medium through stoma but persistent posterior herniation (arrows) of stomach. A B Fig. 8. Pouch enlargement in 41-year-old man with stabilization in his weight loss curve and gastroesophageal reflux disease. A, Barium-enhanced upper abdominal radiograph shows filiform passage of contrast medium at level of stoma (arrow) and significant enlargement of upper gastric pouch (arrowheads). B, Barium-enhanced upper abdominal radiograph obtained 4 weeks after deflation of band shows normalization of volume of upper gastric pouch (arrows). 81

6 Mortelé et al. Fig. 9. Rotation of the access port in asymptomatic 20-year-old woman. A, Abdominal radiograph focused on access port in upright position shows significant rotation of port (arrow). B, Subsequent radiograph taken of same patient in supine position shows spontaneous derotation of port (arrow). A B Fig. 10. Leakage of contrast medium in 23-year-old woman presenting with insufficient decrease in ability to eat after first adjustment. Focused abdominal radiograph reveals leakage of contrast medium (arrows) alongside connecting tube. ual patient by a minimally invasive approach; and finally, although the gastric banding operation is not without complications, these occur on a smaller scale and have a much lower risk compared with those stemming from partial stomach resections or gastric bypass procedures [11, 12]. When comparing the LAP-BAND Adjustable Gastric Banding System with the Swedish gastric banding device, major differences are observed that have an impact on the radiologic appearance and incidence of complications: The volume of the inflatable cuff within the band is approximately twice as great in the Swedish device as in the LAP-BAND (8 ml versus 4 ml); 82 the height of the Swedish band is greater than the LAP-BAND (2 cm versus 1 cm); and the Swedish band is not visible fluoroscopically and, therefore, requires the use of contrast material to evaluate positioning of the band. Because the volume of the inflatable cuff of the Swedish band is much greater, minimal adjustments can be performed more precisely, and the injection of small amounts of contrast medium does not cause the major change in the diameter of the stoma that is described with the LAP-BAND [1, 2]. Furthermore, because of its larger volume and height, the Swedish band should behave as a lower pressure system and therefore be less likely to cause erosion or migration. Indeed, unlike reported problems with the LAP-BAND, no erosion of the Swedish band was detected in our patients. Moreover, the most common complication in our series, slippage of the band, was present in 17 patients (7.8%). In only 5.5% of patients, however, did the slippage require a second operation. By contrast, in reporting the findings with the LAP-BAND in 23 patients, Szucs et al. [2] described an incidence of slippage resulting in additional surgery in 8.6% of patients. In the study by Hainaux et al. [1] involving 180 patients, there were 15 patients (8.3%) who had band slippage with stoma obstruction that required surgery. With the exception of the high- versus low-pressure system hypothesis, causative mechanisms by which this complication occurs are still unclear. Other suggested causes, such as insufficient seroserosal stitching, overeating, extensive vomiting, or overfilling of the band, need to be examined to determine their specific roles. Enlargement of the upper gastric pouch without slippage, which was detected in 3.6% of our patients, is believed to result directly from an inappropriate surgical technique [5]. To avoid the development of this complication, it is important for the surgeon to realize that the volume of the pouch created before surgery may increase as much as sevenfold during the first 2 3 years after the operation [13]. Deflation of the band for 4 6 weeks followed by repetitive injection of contrast medium at a slow rate resolved the dilatation in all patients and, therefore, in our experience, solitary pouch enlargement can be treated conservatively. The use of isoosmolar contrast material for opacification and evaluation of the Swedish

7 Swedish Laparoscopic Adjustable Gastric Banding Fig. 11. Leakage of contrast medium in 25-year-old woman with insufficient decrease in ability to eat after first adjustment. Barium-enhanced upper gastrointestinal radiograph obtained during second adjustment session shows leakage of injected contrast medium at level of gastric band (arrow). One temporary disadvantage of the use of contrast medium in our series was the spontaneous decrease in the diameter of the stoma caused by the hyperosmolar material within the inflatable cuff. However, since March 1999, when we began using an isoosmolar contrast medium for band adjustments, no new cases of spontaneous decrease of stoma size were detected. Therefore, to prevent diffusion of fluid in or out of the band, we highly recommend the use of nonionic isoosmolar contrast material. In comparing the incidence of technical complications in our series with those in previous reports on the LAP-BAND [1, 2], we find that our results are comparable or more promising. Direct leakage of the banding system, present in only 0.9% of our patients, was reported by Hainaux et al. [1] in 2.7% of patients. Furthermore, they mentioned the presence of leakage caused by the disconnection of the connection port in four (2.2%) additional patients, a complication not seen in our series. The number of our patients (1.4%) presenting with a completely inverted port is comparable with those previously reported with the LAP-BAND. In the series of Hainaux et al., three ports of 180 patients (1.6%) were impossible to access. In conclusion, this study suggests that, according to the available data, the SAG-BAND procedure meets the criteria of a low-risk laparoscopic alternative in the treatment of morbid obesity. Nevertheless, various complications may be detected on follow-up imaging studies. Because early detection and therapeutic intervention may be crucial, the radiologist should be aware of these possible complications and their radiologic appearances. The radiologist also plays an important role in the treatment and follow-up of these patients. Therefore, for the patient to obtain optimal benefit from the procedure, the radiologist should be familiar with the adequate adjustment methods and should know the techniques for coping with the potential technical difficulties. Fig. 12. Food trapped in band found in 48-year-old woman presenting with acute severe dysphagia and odynophagia immediately after eating. Barium-enhanced upper gastrointestinal radiograph reveals presence of intraluminal filling defect in stoma consistent with food entrapment (arrows). Subsequent complete deflation of band allowed obstructing food elements to pass. References band system revealed several advantages over the use of the saline used in other series [1, 2]. First, incorrect placement of the band, found in five of our patients, was diagnosed accurately and quickly. Second, osmotic-based leakage of the gastric banding system, expected with saline injection because of the semipermeability of the inflatable cuff, was completely eliminated. Third, direct leakage of the banding system, believed to result from either the silicone tube being punctured close to the port, poor handling of the inflatable balloon during surgery, or damage to the self-sealing membrane of the port caused by the use of inappropriate needles, was accurately depicted on fluoroscopy because of the contrast medium spillage. 1. Hainaux B, Coppens E, Sattari A, Vertruyen M, Hubloux G, Cadiere GB. Laparoscopic adjustable silicone gastric banding: radiological appearances of a new surgical treatment for morbid obesity. Abdom Imaging 1999;24: Szucs R, Turner MA, Kellum JM, DeMaria EJ, Sugerman HJ. Adjustable laparoscopic gastric band for the treatment of morbid obesity: radiological evaluation. AJR 1998;170: Pomerri F, Liberati L, Curtolo S, et al. Adjustable 83

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