- Email: [email protected]
Avoiding postoperative complications with the LAP-BAND system
The American Journal of Surgery 184 (2002) 31S–37S
Avoiding postoperative complications with the LAP-BAND system Hadar Spivak, M.D.a,*, Franco Favretti, M.D.b a
San Jacinto Methodist Hospital, 4301 Garth Road, Suite 209, Baytown, Texas, 77521 USA b Obesity Center, University of Padua, Italy, and Regional Hospital, Vicenza, Italy
Abstract The most frequently occurring complications associated with the LAP-BAND (INAMED Health, Santa Barbara, CA) include gastric prolapse, stoma obstruction, esophageal and gastric pouch dilatation, erosion, and access port problems. This article describes the causes of these complications and details some points for their prevention and treatment. As techniques for placement of the LAP-BAND have evolved, complication rates have declined. For example, occurrence of gastric prolapse was reduced from the initially reported rates of 22% to less than 5%. The emergence of many problems, such as gastric pouch dilatation or prolapse, can be minimized with proper operative technique and close postoperative management and follow-up. As with other major surgical procedures, particularly those performed in the bariatric population, complications associated with the LAP-BAND system are unavoidable but are rarely life-threatening if managed appropriately. Surgeons and patients should adopt strategies that will help avoid complications and be sensitive to any indication of their emergence. © 2002 Excerpta Medica Inc. All rights reserved.
Placement of the LAP-BAND system (INAMED Health, Santa Barbara, CA) is the most frequently performed bariatric procedure in many countries outside the United States. It is an effective tool for helping patients achieve excess weight loss (EWL) and has a low rate of complications— especially serious complications—when placed with recently described surgical techniques [1–7]. Approximately 80,000 patients have undergone the procedure worldwide. As with other major surgical procedures, particularly those performed in the bariatric population, complications associated with the LAP-BAND system are unavoidable but are rarely life-threatening if managed appropriately (Table 1) [2,7,8 –14]. Importantly, as techniques for placement of the LAP-BAND have evolved, complication rates have declined. For example, occurrence of gastric prolapse dropped from the initially reported rates of 22% to less than 5% [1,2,7]. Although results from the US Food and Drug Administration (FDA)–monitored study show relatively high rates for some complications, this may be attributed to the relatively few number of procedures performed by each surgeon and their lack of experience with adjustment of the band [8]. The emergence of many problems, such as gastric
* Corresponding author: Tel.: ⫹1-281-837-8130; fax: ⫹1-281-4285546 E-mail address: [email protected]
pouch dilatation or prolapse, can be minimized with proper operative technique and close postoperative management and follow-up. Therefore, surgeons and patients should adopt strategies that will help avoid complications and be sensitive to any indication of their emergence. This article examines the causes of the most frequent complications associated with the LAP-BAND, including gastric prolapse, stoma obstruction, esophageal and gastric pouch dilatation, erosion, and access port problems. It also details some points for their prevention and treatment.
Gastric prolapse One of the most significant complications associated with the LAP-BAND has been gastric prolapse. Gastric prolapse is the postoperative development of an overly large upper gastric pouch and is characterized by food intolerance, epigastric pain, and reflux. The complication can manifest immediately during the early postoperative period or emerge many months later. Gastric prolapse can occur anteriorly or posteriorly. Of the 3 techniques described for placement of the LAP-BAND, the perigastric technique may have the highest rate of prolapse [6,15]. In addition, prolapse that occurs with the perigastric technique is often a posterior prolapse (Fig. 1), which is much harder to repair [11]. Posterior prolapse is characterized by the posterior part
0002-9610/02/$ – see front matter © 2002 Excerpta Medica Inc. All rights reserved. doi:10.1016/S0002-9610(02)01177-7
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H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S
Table 1 Complications of laparoscopic adjustable gastric banding from various studies*
FDA Trial A [8] (n ⫽ 299) Belachew et al 2002 [9] (n ⫽ 763) Cadiere et al 2000 [10] (n ⫽ 652) Dargent et al 1999 [11] (n ⫽ 500) Favretti et al 2002 [7] (n ⫽ 830) Fielding et al 1999 [12] (n ⫽ 335) O’Brien et al 1999 [2] (n ⫽ 302) Vertruyen 2002 [13] (n ⫽ 543) Weiner et al 1999 [14] (n ⫽ 184)
Gastric prolapse/ pouch dilatation† (%)
Esophageal dilatation (or dysmotility) (%)
Erosion (%)
Access port problems (%)
24
10‡
1
6
8
NR
0.9
2.6
3.8
NR
0.3
2.7
5
NR
0.6
1
10
NR
0.5
11
3.6§
NR
0
1.5
9
NR
NR
3.6
4.6
NR
1
3.0
2.2§
NR
1.1
3.2
FDA ⫽ US Food and Drug Administration; NR ⫽ not reported. * Other articles in this supplement may cover additional studies. † Many investigators did not distinguish between true prolapse and gastric pouch dilatation, therefore, these categories are combined. ‡ Includes 8 patients with dysmotility. § Prolapse only is reported. (Note: Not all complications shown required surgical correction.)
of the fundus moving through the band, resulting in the creation of a large posterior gastric pouch. The band is pushed lower and anteriorly, and its orientation is changed clockwise. Anterior prolapse occurs when the anterior part of the stomach prolapses through the band to create a large anterior gastric pouch. With increased distention of this upper pouch, more of the gastric fundus is pulled anteriorly. The band changes its position counterclockwise and becomes more horizontally oriented, but its posterior aspect remains in close proximity to the gastroesophageal junction (GEJ). Both posterior and anterior pouch dilatation lead to excessive stomach tissue inside the ring and obstruction between the upper pouch and lower stomach. The lower incidence of gastric prolapse [1,2,5] compared with the FDA study is due mainly to 3 refinements in surgical technique: 1. A reduction in the size of the gastric pouch from the originally suggested 25 to 50 mL to less than 15 mL, thus creating a “virtual” pouch [1–7]. The smaller pouch has less ability to stretch and pull gastric fundus from below the LAP-BAND. 2. The appropriate placement of the gastric-to-gastric sutures, as described elsewhere in this supplement (see Fielding and Allen [16]). 3. The positioning of the posterior aspect of the band, which should be high and in close proximity to the GEJ. That is, the gastric pouch should be created anteriorly, with the band situated posteriorly at the
GEJ. This anatomic tendency for high posterior position is clearly evident in the pars flaccida and combined pars flaccida-perigastric techniques; however, surgeons experienced with the perigastric technique have always recommended a high posterior position as well [7]. Prolapse should be considered when patients who have had a normal postoperative period begin to experience changes in their eating ability (eg, an increase in their sense of restriction or obstruction). Typical symptoms, which can emerge either suddenly or gradually, are increased difficulty in swallowing solid or liquid food, vomiting, dysphagia lasting more than a few hours, and reflux. The surgeon’s first response should be to deflate the band system via the access port, give intravenous hydration as needed, and determine whether the patient can swallow liquids. If the patient exhibits substantial improvement, he or she can be sent home and instructed to resume eating slowly. However, if no improvement occurs, or if symptoms return after deflation, the presence of prolapse can be positively identified with an esophagogram. True prolapse (as opposed to gastric pouch dilatation) does not respond to these conservative measures and indicates the need for laparoscopic or open exploration of the abdomen. The options for treatment in descending order of preference are as follows: (1) repositioning of the band, (2) removal of the band and replacement with a new one, and, as a last resort, (3) removal of the band without replacement [17].
H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S
Fig. 1. Posterior gastric prolapse/slippage.
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Fig. 3. Stoma obstruction due to a band positioned too low, shown immediately after surgery.
Fig. 2. Depending on the orientation of the retrogastric tunnel, a different amount of fundus is encompassed by the band. (Reproduced with permission from Favretti F, Cadiere GB, Segato G, et al. Laparoscopic adjustable silicone gastric banding (LAP-BAND): how to avoid complications. Obes Surg 1997;7:352– 8 [5].)
Stoma obstruction Stoma obstruction is defined as an obstruction to the flow of food from the gastric pouch to the rest of the stomach.
Symptoms include dysphagia, substernum and chest pain, gastric pain, inability to swallow, and new onset of reflux. Stoma obstruction can occur early or late in the postoperative period.
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Stoma obstruction in the early postoperative period has a number of possible causes. After band placement using the pars flaccida approach, stoma obstruction is most often associated with smaller bands applied over a thick GEJ area. After band placement using the perigastric or combined pars flaccida-perigastric approach, stoma obstruction is usually caused by the incorporation of too much tissue inside the band. In some cases, the band is positioned too distally from the GEJ, causing a large amount of fundus and stomach wall to be encompassed by the band (Fig. 2). Because the circumference of the band is fixed, obstruction results (Fig. 3). In other cases, especially in heavy male patients with thick GEJ areas, the smaller sized band (9.7 or 10 cm) may be placed around too much tissue. A longer band may be needed in these patients; alternatively, the surgeon can perform a delicate dissection, thinning out the area where the band will be placed. Early stoma obstruction also can be initiated by postoperative edema of the area incorporated by the band due to hematoma or postoperative reaction. All of these mechanisms serve to narrow the stoma and simulate the effect of an overtight band. Patients with early stoma obstruction typically complain of an inability to swallow their postoperative liquid diet. In severe cases, patients will vomit through their first postoperative night and may even be unable to swallow their own saliva. These patients usually report severe nausea with thick, yellow-whitish vomitus, without bile. A postoperative contrast study in these cases often reveals complete obstruction or near-complete obstruction with minimal flow from the esophagus and gastric pouch to the portion of the stomach below the band. Tertiary esophageal contractions (uncoordinated contractions) are usually evident. For patients with complete obstruction, intervention is warranted, consisting of exploratory laparoscopy to reposition the band or thin the GEJ (or both). For patients with near-complete or partial obstruction, initial treatment can be conservative, consisting of rehydration and reassurance in an inpatient setting. Patients with partial or near-complete obstruction who receive conservative treatment often improve significantly within several days. When they are able to tolerate a liquid diet— defined as the ability to drink enough water to remain hydrated—they can be discharged and followed as outpatients. If they do not improve clinically within a few days, they can be managed with exploratory laparoscopy as described earlier. Conservative treatment of complete obstruction carries risk, because these patients have repeated aspiration and can develop pulmonary complications. Additionally, an overtight band may cause ischemia or necrosis to the occluded tissue. Late stoma obstructions are usually related either to gastric pouch dilatation, prolapse, or erosion, and should be managed as described later. The problem also can occur in association with pouchitis or esophagitis caused by bad eating habits. In most of these cases, a deflation of the band, a few days of liquid diet, and medical treatment with a proton-pump inhibitor can prove salutary.
Esophageal and gastric pouch dilatation Esophageal and gastric pouch dilatation have been reported in many series [6,18 –23]. The most likely cause of dilatation is overinflation of the LAP-BAND combined with patients who do not comply with instructions regarding oral intake. Inappropriate intake can stretch the gastric pouch; eventually, the pouch, and even the esophagus, may dilate as occurs in other restrictive procedures. Although these changes are usually reversible if the problem is detected sufficiently early, failure to address the issue will result in an atonic pouch and, potentially, a large, atonic esophagus. Gastric pouch dilatation should be viewed as a preprolapse condition that can be alleviated with prompt diagnosis and treatment. Its management typically involves complete deflation of the band and, after 2 to 3 months, slow reinflation, with the surgeon being careful not to reach the previous point of overinflation. If dilatation proves to be nonreversible after deflation, the surgeon probably is dealing with prolapse. Thus, the same surgical considerations for gastric prolapse are valid here. Close follow-up is important so that adjustments occur as necessary. The rationale for adjustment should be the patient’s loss of a sense of restriction and satiety, rather than the cessation of weight loss. No more than 0.5 mL of solution should be added at each adjustment session. Patients who fail to lose weight often have bands that are overinflated. This results in the patient’s inability to take solid food and subsequent conversion to a high-caloric liquid diet. In this situation, the appropriate treatment is deflation of the band back to where the patient is comfortable eating a solid diet. An overly restrictive band may lead to dilatation. In the pars flaccida and pars flaccida–perigastric combined approach, the vast majority of bands are inflated with 1.5 to 2.5 mL of saline; in the perigastric approach, bands may be filled with up to 3.5 mL of solution. Periodic esophageal imaging may help detect dilatation and therefore should be conducted at least once in the first postoperative year. The issue of office versus radiologic adjustment has been debated, because many physicians find relying on clinical criteria alone to be problematic. However, patient outcomes as reported in comparable series using one or the other technique are similar, suggesting that the venue for adjustment may be at the surgeon’s discretion [24,25]. Esophageal dilatation is a serious concern seen in 10% of patients in the FDA clinical trial of the LAP-BAND (Table 1) [8]. The pathophysiology involves esophageal and gastric pouch reaction to distal restriction with dilatation. If left untreated for an extended period of time, esophageal dilatation can be irreversible and problematic. It is therefore important to perform periodic esophagograms to detect the condition and treat it appropriately. Esophageal dilatation is associated with an overinflated band or one that is placed too low. On esophagogram, it usually is seen in tandem with gastric pouch dilatation.
H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S
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Fig. 4. Esophageal and gastric pouch dilatation due to a malpositioned band. The band had to be removed.
Fig. 5. Chronic band erosion 9 months after surgery. The contrast media surrounds the band.
When esophageal dilatation is detected soon after its occurrence, deflation of the band usually reverses it. Once the condition has resolved, the band then can be slowly reinflated. In most cases, after the initial band deflation, the esophagus immediately returns to normal size and motility. If an upper gastrointestinal x-ray series shows a persisting enlargement of the esophagus with difficult passage of the contrast media through the deflated band, it means that the band is malpositioned and that the device is encompassing too much gastric tissue (Fig. 4). Removal or repositioning of the band is usually required in these cases. In a series of 830 patients, 92 cases (11%) of esophageal and gastric pouch dilatation were reported (Favretti, unpublished data). Of these 92 cases, 83 were caused by gastric prolapse/slippage, and 9 were caused by malposition of the band [7]. Of the 83 cases of gastric prolapse/slippage, 66 responded to conservative treatment and the remainder (n ⫽ 17) required surgical intervention. The 9 malpositioned bands all required surgical correction because the esophageal and gastric prolapse did not resolve with band deflation.
1) [8]. Erosion—the invasion or violation of gastric wall integrity by the LAP-BAND— has either an acute or chronic presentation. Acute erosion is characterized by free leakage of gastric contents into the peritoneum, similar to when perforation of the gastric lining leads to peritonitis. The relationship of this “gastric perforation” to the surgical procedure is evident, and emergency surgery is indicated. In chronic erosion, the band abrades constantly and slowly against the lumen and is eventually engulfed by the stomach, where it is exposed to gastric content (Fig. 5). Many patients are asymptomatic and present only with a nonfunctioning band and no restriction to the flow of food. If adjustment of the band is attempted, the surgeon will discover a rupture of the band’s inner tube. Imaging studies typically reveal bizarre positioning of the band as well as leakage. In many cases, the first indication of possible erosion is an infection at the access port site. The connecting tube provides drainage of gastric content to the port site, which causes the infection. Erosion should be ruled out at the first sign of port infection. A number of authorities attribute some incidences of erosion to small, undetected injuries to the gastric wall that occur during placement of the band and progress later to actual erosion or necrosis due to pressure of the band [21]. Therefore, meticulous, gentle, and careful operative dissection may avoid at least some of these erosion problems. If
Erosion Erosion is a serious complication that occurred in 1% of patients in the FDA clinical trial of the LAP-BAND (Table
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H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S
the surgeon suspects that an injury to or perforation of the lumen has occurred during surgery, the injury should be addressed, and serious consideration should be made as to whether placement should proceed at that time. Another consideration during surgery is avoiding placement of gastric-to-gastric sutures over the locking mechanism (buckle). This area protrudes and can cause pressure necrosis to the fundus that covers it. Instead, the surgeon should place all the gastric-to-gastric sutures to the left side of the locking mechanism. Some authors [25–27] have described techniques for band removal (usually for gastric bands other than the LAP-BAND) with an oral endoscope, regardless of whether the band is contained completely within the gastric lumen. If such an advanced endoscopic technique is not available, surgery (laparoscopic or open) is necessary to retrieve the band and to repair the stomach wall. The surgical approach is the same even if the erosion is high enough to be considered esophageal.
during office adjustments. A location should be selected that does not cause discomfort or aesthetic problems or interfere with daily life. The selected position also should offer protection of the port tube from abdominal wall movements, which over time may cause breakage of the port tube or the connection between the tube and the port. Furthermore, placement should contribute to stabilization of the port so that it does not rotate and, in case of breakage, should allow for easy location of the broken tube without the need for exploratory laparoscopy. Many surgeons prefer placement in the left upper quadrant; others select the subxiphoid region. One good approach to access port placement is to tunnel the tube from the left subcostal trocar site to the subxiphoid area and connect to the access port at the subxiphoid area. This facilitates suturing of the port to the fascia to secure its position and also results in easy access for adjustments. In addition, it is well tolerated by patients.
Conclusion Gastric necrosis Gastric necrosis is very rare; in a series of 400 patients implanted with the LAP-BAND, only 1 case (0.25%) was reported [28]. Neither author of this review has encountered the complication in their own combined experience of more than 1,500 LAP-BAND procedures. Gastric necrosis may occur early in the postoperative period or later, when it is likely the result of long-term undetected prolapse. Prolapse or gastric pouch dilatation can cause the band to exert continuous pressure against the gastric wall, which, in turn, may decrease the blood supply to the fundus. This pressure also may result from overinflation of the LAP-BAND. The combination of a decreased blood supply and continuous pressure may lead to necrosis of the gastric wall. Even in the absence of prolapse, an overdistended gastric pouch by itself can impair blood supply, which can progressively lead to gastric wall necrosis. The theoretical link between prolapse and necrosis is why true gastric prolapse should be considered a surgical emergency. Repair of gastric necrosis requires exploratory laparotomy and implementation of traditional surgical approaches.
Port problems The access port is an essential component of the LAPBAND, and its placement requires careful attention. Improper placement may lead to rotation of the port up to 180° or breaking at the tube junction [18,29]. Such events may result in discomfort to the patient, difficulty in accessing the port for adjustment, and, potentially, the need for additional surgery. The placement of the port should allow easy access
Complications associated with the LAP-BAND, as placed using recently described surgical approaches, appear to be no greater than those of other surgical procedures for the treatment of obesity. When problems do occur, they are rarely life threatening if managed correctly. Surgeons cannot completely avoid complications, but if the procedure is performed correctly and follow-up is optimal, one can expect a relatively low morbidity rate.
References [1] Belachew M, Legrand M, Vincent V, et al. Laparoscopic adjustable gastric banding. World J Surg 1998;22:955–963. [2] O’Brien PE, Brown WA, Smith A, et al. Prospective study of a laparoscopically placed, adjustable gastric band in the treatment of morbid obesity. Br J Surg 1999;86:113–118. [3] Allen JW, Coleman MG, Fielding GA. Lessons learned from laparoscopic gastric banding for morbid obesity. Am J Surg 2001;182:10 – 14. [4] Rubin M, Benchetrit S, Lustigman H, et al. Laparoscopic gastric banding with LAP-BAND for morbid obesity: two-step technique may improve outcome. Obes Surg 2001;11:315–317. [5] Favretti F, Cadiere GB, Segato G, et al. Laparoscopic adjustable silicone gastric banding (LAP-BAND): how to avoid complications. Obes Surg 1997;7:352–358. [6] Weiner R, Bockhorn H, Rosenthal R, Wagner D. A prospective randomized trial of different laparoscopic gastric banding techniques for morbid obesity. Surg Endosc 2001;15:63– 68. [7] Favretti F, Cadiere GB, Segato G, et al. Laparoscopic banding: selection and technique in 830 patients. Obes Surg 2002;12:385–390. [8] US Food and Drug Administration, Center for Devices and Radiological Health. LAP-BAND Adjustable Gastric Banding (LAGB) System—P000008. Available at http: //www.fda.gov/cdrh/pdf/ p000008.htm. Accessed August 23, 2002. [9] Belachew M, Belva PH, Desaive C. Long-term results of laparoscopic adjustable gastric banding for the treatment of morbid obesity. Obes Surg 2002;12:564 –568.
H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S [10] Cadiere GB, Himpens J, Vertruyen M, et al. Laparoscopic gastroplasty (adjustable silicone gastric banding). Semin Laparosc Surg 2000;7:55– 65. [11] Dargent J. Laparoscopic adjustable gastric banding: lessons from the first 500 patients in a single institution. Obes Surg 1999;9:446 – 452. [12] Fielding GA, Rhodes M, Nathanson LK. Laparoscopic gastric banding for morbid obesity: surgical outcome in 335 cases. Surg Endosc 1999;13:550 –554. [13] Vertruyen M. Experience with LAP-BAND system up to 7 years. Obes Surg 2002;12:569 –572. [14] Weiner R, Wagner D, Bockhorn H. Laparoscopic gastric banding for morbid obesity. J Laparoendosc Adv Surg Tech A 1999;9:23–30. [15] Fielding GA. Reduction in incidence of gastric herniation with LAPBAND: experience in 620 cases. Obes Surg 2000;10:136. [16] Fielding GA, Allen JW. A step-by-step guide to placement of the LAP-BAND adjustable gastric banding system. Am J Surg 2002; 184(suppl):26S–30S. [17] Spivak H, Rubin M. Laparoscopic salvage of a slipped LAP-BAND. Proceedings of the 19th Annual Meeting of the American Society for Bariatric Surgery; June 24 –28, 2002; Las Vegas, Nevada. [18] Angrisani L, Lorenzo M, Santoro T, et al. Follow-up of LAP-BAND complications. Obes Surg 1999;9:276 –278. [19] Chelala E, Cadiere GB, Favretti F, et al. Conversions and complications in 185 laparoscopic adjustable silicone gastric banding cases. Surg Endosc 1997;11:268 –271. [20] Niville E, Dams A. Late pouch dilation after laparoscopic adjustable gastric and esophagogastric banding: incidence, treatment, and outcome. Obes Surg 1999;9:381–384.
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[21] Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc 2002;16:230 –233. [22] Wiesner W, Schlumpf R, Schob O, et al. Gastric pouch dilatation: complications after laparoscopic implantation of a silicone gastric band in pathologic obesity. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 1998;169:479 – 483. [23] Wiesner W, Schob O, Hauser RS, Hauser M. Adjustable laparoscopicgastric banding in patients with morbid obesity: radiographic management, results, and postoperative complications. Radiology 2000; 216:389 –394. [24] Blake M, Fazio V, O’Brien P. Assessment of nutrient intake in association with weight loss after gastric restrictive procedures for morbid obesity. Aust N Z J Surg 1991;61:195–199. [25] Mittermair RP, Weiss H, Nehoda H, Aigner F. Uncommon intragastric migration of the Swedish adjustable gastric band. Obes Surg 2002;12:372–375. [26] Baldinger R, Mluench R, Steffen R, et al. Conservative management of intragastric migration of Swedish adjustable gastric band by endoscopic retrieval. Gastrointest Endosc 2001;53:98 –101. [27] Weiss H, Nehoda H, Labeck B, et al. Gastroscopic band removal after intragastric migration of adjustable gastric band: a new minimal invasive technique. Obes Surg 2000;10:167–170. [28] Chevallier JM, Zinzindohoue F, Elian N, et al. Adjustable gastric banding in a public university hospital: prospective analysis of 400 patients. Obes Surg 2002;12:93–99. [29] Furbetta F, Gambinotti G, Robortella EM. 28-month experience with the lap-band technique: results and critical points of the method. Obes Surg 1999;9:56 –58.
Avoiding postoperative complications with the LAP-BAND system Hadar Spivak, M.D.a,*, Franco Favretti, M.D.b a
San Jacinto Methodist Hospital, 4301 Garth Road, Suite 209, Baytown, Texas, 77521 USA b Obesity Center, University of Padua, Italy, and Regional Hospital, Vicenza, Italy
Abstract The most frequently occurring complications associated with the LAP-BAND (INAMED Health, Santa Barbara, CA) include gastric prolapse, stoma obstruction, esophageal and gastric pouch dilatation, erosion, and access port problems. This article describes the causes of these complications and details some points for their prevention and treatment. As techniques for placement of the LAP-BAND have evolved, complication rates have declined. For example, occurrence of gastric prolapse was reduced from the initially reported rates of 22% to less than 5%. The emergence of many problems, such as gastric pouch dilatation or prolapse, can be minimized with proper operative technique and close postoperative management and follow-up. As with other major surgical procedures, particularly those performed in the bariatric population, complications associated with the LAP-BAND system are unavoidable but are rarely life-threatening if managed appropriately. Surgeons and patients should adopt strategies that will help avoid complications and be sensitive to any indication of their emergence. © 2002 Excerpta Medica Inc. All rights reserved.
Placement of the LAP-BAND system (INAMED Health, Santa Barbara, CA) is the most frequently performed bariatric procedure in many countries outside the United States. It is an effective tool for helping patients achieve excess weight loss (EWL) and has a low rate of complications— especially serious complications—when placed with recently described surgical techniques [1–7]. Approximately 80,000 patients have undergone the procedure worldwide. As with other major surgical procedures, particularly those performed in the bariatric population, complications associated with the LAP-BAND system are unavoidable but are rarely life-threatening if managed appropriately (Table 1) [2,7,8 –14]. Importantly, as techniques for placement of the LAP-BAND have evolved, complication rates have declined. For example, occurrence of gastric prolapse dropped from the initially reported rates of 22% to less than 5% [1,2,7]. Although results from the US Food and Drug Administration (FDA)–monitored study show relatively high rates for some complications, this may be attributed to the relatively few number of procedures performed by each surgeon and their lack of experience with adjustment of the band [8]. The emergence of many problems, such as gastric
* Corresponding author: Tel.: ⫹1-281-837-8130; fax: ⫹1-281-4285546 E-mail address: [email protected]
pouch dilatation or prolapse, can be minimized with proper operative technique and close postoperative management and follow-up. Therefore, surgeons and patients should adopt strategies that will help avoid complications and be sensitive to any indication of their emergence. This article examines the causes of the most frequent complications associated with the LAP-BAND, including gastric prolapse, stoma obstruction, esophageal and gastric pouch dilatation, erosion, and access port problems. It also details some points for their prevention and treatment.
Gastric prolapse One of the most significant complications associated with the LAP-BAND has been gastric prolapse. Gastric prolapse is the postoperative development of an overly large upper gastric pouch and is characterized by food intolerance, epigastric pain, and reflux. The complication can manifest immediately during the early postoperative period or emerge many months later. Gastric prolapse can occur anteriorly or posteriorly. Of the 3 techniques described for placement of the LAP-BAND, the perigastric technique may have the highest rate of prolapse [6,15]. In addition, prolapse that occurs with the perigastric technique is often a posterior prolapse (Fig. 1), which is much harder to repair [11]. Posterior prolapse is characterized by the posterior part
0002-9610/02/$ – see front matter © 2002 Excerpta Medica Inc. All rights reserved. doi:10.1016/S0002-9610(02)01177-7
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H. Spivak and F. Favretti / The American Journal of Surgery 184 (2002) 31S–37S
Table 1 Complications of laparoscopic adjustable gastric banding from various studies*
FDA Trial A [8] (n ⫽ 299) Belachew et al 2002 [9] (n ⫽ 763) Cadiere et al 2000 [10] (n ⫽ 652) Dargent et al 1999 [11] (n ⫽ 500) Favretti et al 2002 [7] (n ⫽ 830) Fielding et al 1999 [12] (n ⫽ 335) O’Brien et al 1999 [2] (n ⫽ 302) Vertruyen 2002 [13] (n ⫽ 543) Weiner et al 1999 [14] (n ⫽ 184)
Gastric prolapse/ pouch dilatation† (%)
Esophageal dilatation (or dysmotility) (%)
Erosion (%)
Access port problems (%)
24
10‡
1
6
8
NR
0.9
2.6
3.8
NR
0.3
2.7
5
NR
0.6
1
10
NR
0.5
11
3.6§
NR
0
1.5
9
NR
NR
3.6
4.6
NR
1
3.0
2.2§
NR
1.1
3.2
FDA ⫽ US Food and Drug Administration; NR ⫽ not reported. * Other articles in this supplement may cover additional studies. † Many investigators did not distinguish between true prolapse and gastric pouch dilatation, therefore, these categories are combined. ‡ Includes 8 patients with dysmotility. § Prolapse only is reported. (Note: Not all complications shown required surgical correction.)
of the fundus moving through the band, resulting in the creation of a large posterior gastric pouch. The band is pushed lower and anteriorly, and its orientation is changed clockwise. Anterior prolapse occurs when the anterior part of the stomach prolapses through the band to create a large anterior gastric pouch. With increased distention of this upper pouch, more of the gastric fundus is pulled anteriorly. The band changes its position counterclockwise and becomes more horizontally oriented, but its posterior aspect remains in close proximity to the gastroesophageal junction (GEJ). Both posterior and anterior pouch dilatation lead to excessive stomach tissue inside the ring and obstruction between the upper pouch and lower stomach. The lower incidence of gastric prolapse [1,2,5] compared with the FDA study is due mainly to 3 refinements in surgical technique: 1. A reduction in the size of the gastric pouch from the originally suggested 25 to 50 mL to less than 15 mL, thus creating a “virtual” pouch [1–7]. The smaller pouch has less ability to stretch and pull gastric fundus from below the LAP-BAND. 2. The appropriate placement of the gastric-to-gastric sutures, as described elsewhere in this supplement (see Fielding and Allen [16]). 3. The positioning of the posterior aspect of the band, which should be high and in close proximity to the GEJ. That is, the gastric pouch should be created anteriorly, with the band situated posteriorly at the
GEJ. This anatomic tendency for high posterior position is clearly evident in the pars flaccida and combined pars flaccida-perigastric techniques; however, surgeons experienced with the perigastric technique have always recommended a high posterior position as well [7]. Prolapse should be considered when patients who have had a normal postoperative period begin to experience changes in their eating ability (eg, an increase in their sense of restriction or obstruction). Typical symptoms, which can emerge either suddenly or gradually, are increased difficulty in swallowing solid or liquid food, vomiting, dysphagia lasting more than a few hours, and reflux. The surgeon’s first response should be to deflate the band system via the access port, give intravenous hydration as needed, and determine whether the patient can swallow liquids. If the patient exhibits substantial improvement, he or she can be sent home and instructed to resume eating slowly. However, if no improvement occurs, or if symptoms return after deflation, the presence of prolapse can be positively identified with an esophagogram. True prolapse (as opposed to gastric pouch dilatation) does not respond to these conservative measures and indicates the need for laparoscopic or open exploration of the abdomen. The options for treatment in descending order of preference are as follows: (1) repositioning of the band, (2) removal of the band and replacement with a new one, and, as a last resort, (3) removal of the band without replacement [17].
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Fig. 1. Posterior gastric prolapse/slippage.
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Fig. 3. Stoma obstruction due to a band positioned too low, shown immediately after surgery.
Fig. 2. Depending on the orientation of the retrogastric tunnel, a different amount of fundus is encompassed by the band. (Reproduced with permission from Favretti F, Cadiere GB, Segato G, et al. Laparoscopic adjustable silicone gastric banding (LAP-BAND): how to avoid complications. Obes Surg 1997;7:352– 8 [5].)
Stoma obstruction Stoma obstruction is defined as an obstruction to the flow of food from the gastric pouch to the rest of the stomach.
Symptoms include dysphagia, substernum and chest pain, gastric pain, inability to swallow, and new onset of reflux. Stoma obstruction can occur early or late in the postoperative period.
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Stoma obstruction in the early postoperative period has a number of possible causes. After band placement using the pars flaccida approach, stoma obstruction is most often associated with smaller bands applied over a thick GEJ area. After band placement using the perigastric or combined pars flaccida-perigastric approach, stoma obstruction is usually caused by the incorporation of too much tissue inside the band. In some cases, the band is positioned too distally from the GEJ, causing a large amount of fundus and stomach wall to be encompassed by the band (Fig. 2). Because the circumference of the band is fixed, obstruction results (Fig. 3). In other cases, especially in heavy male patients with thick GEJ areas, the smaller sized band (9.7 or 10 cm) may be placed around too much tissue. A longer band may be needed in these patients; alternatively, the surgeon can perform a delicate dissection, thinning out the area where the band will be placed. Early stoma obstruction also can be initiated by postoperative edema of the area incorporated by the band due to hematoma or postoperative reaction. All of these mechanisms serve to narrow the stoma and simulate the effect of an overtight band. Patients with early stoma obstruction typically complain of an inability to swallow their postoperative liquid diet. In severe cases, patients will vomit through their first postoperative night and may even be unable to swallow their own saliva. These patients usually report severe nausea with thick, yellow-whitish vomitus, without bile. A postoperative contrast study in these cases often reveals complete obstruction or near-complete obstruction with minimal flow from the esophagus and gastric pouch to the portion of the stomach below the band. Tertiary esophageal contractions (uncoordinated contractions) are usually evident. For patients with complete obstruction, intervention is warranted, consisting of exploratory laparoscopy to reposition the band or thin the GEJ (or both). For patients with near-complete or partial obstruction, initial treatment can be conservative, consisting of rehydration and reassurance in an inpatient setting. Patients with partial or near-complete obstruction who receive conservative treatment often improve significantly within several days. When they are able to tolerate a liquid diet— defined as the ability to drink enough water to remain hydrated—they can be discharged and followed as outpatients. If they do not improve clinically within a few days, they can be managed with exploratory laparoscopy as described earlier. Conservative treatment of complete obstruction carries risk, because these patients have repeated aspiration and can develop pulmonary complications. Additionally, an overtight band may cause ischemia or necrosis to the occluded tissue. Late stoma obstructions are usually related either to gastric pouch dilatation, prolapse, or erosion, and should be managed as described later. The problem also can occur in association with pouchitis or esophagitis caused by bad eating habits. In most of these cases, a deflation of the band, a few days of liquid diet, and medical treatment with a proton-pump inhibitor can prove salutary.
Esophageal and gastric pouch dilatation Esophageal and gastric pouch dilatation have been reported in many series [6,18 –23]. The most likely cause of dilatation is overinflation of the LAP-BAND combined with patients who do not comply with instructions regarding oral intake. Inappropriate intake can stretch the gastric pouch; eventually, the pouch, and even the esophagus, may dilate as occurs in other restrictive procedures. Although these changes are usually reversible if the problem is detected sufficiently early, failure to address the issue will result in an atonic pouch and, potentially, a large, atonic esophagus. Gastric pouch dilatation should be viewed as a preprolapse condition that can be alleviated with prompt diagnosis and treatment. Its management typically involves complete deflation of the band and, after 2 to 3 months, slow reinflation, with the surgeon being careful not to reach the previous point of overinflation. If dilatation proves to be nonreversible after deflation, the surgeon probably is dealing with prolapse. Thus, the same surgical considerations for gastric prolapse are valid here. Close follow-up is important so that adjustments occur as necessary. The rationale for adjustment should be the patient’s loss of a sense of restriction and satiety, rather than the cessation of weight loss. No more than 0.5 mL of solution should be added at each adjustment session. Patients who fail to lose weight often have bands that are overinflated. This results in the patient’s inability to take solid food and subsequent conversion to a high-caloric liquid diet. In this situation, the appropriate treatment is deflation of the band back to where the patient is comfortable eating a solid diet. An overly restrictive band may lead to dilatation. In the pars flaccida and pars flaccida–perigastric combined approach, the vast majority of bands are inflated with 1.5 to 2.5 mL of saline; in the perigastric approach, bands may be filled with up to 3.5 mL of solution. Periodic esophageal imaging may help detect dilatation and therefore should be conducted at least once in the first postoperative year. The issue of office versus radiologic adjustment has been debated, because many physicians find relying on clinical criteria alone to be problematic. However, patient outcomes as reported in comparable series using one or the other technique are similar, suggesting that the venue for adjustment may be at the surgeon’s discretion [24,25]. Esophageal dilatation is a serious concern seen in 10% of patients in the FDA clinical trial of the LAP-BAND (Table 1) [8]. The pathophysiology involves esophageal and gastric pouch reaction to distal restriction with dilatation. If left untreated for an extended period of time, esophageal dilatation can be irreversible and problematic. It is therefore important to perform periodic esophagograms to detect the condition and treat it appropriately. Esophageal dilatation is associated with an overinflated band or one that is placed too low. On esophagogram, it usually is seen in tandem with gastric pouch dilatation.
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Fig. 4. Esophageal and gastric pouch dilatation due to a malpositioned band. The band had to be removed.
Fig. 5. Chronic band erosion 9 months after surgery. The contrast media surrounds the band.
When esophageal dilatation is detected soon after its occurrence, deflation of the band usually reverses it. Once the condition has resolved, the band then can be slowly reinflated. In most cases, after the initial band deflation, the esophagus immediately returns to normal size and motility. If an upper gastrointestinal x-ray series shows a persisting enlargement of the esophagus with difficult passage of the contrast media through the deflated band, it means that the band is malpositioned and that the device is encompassing too much gastric tissue (Fig. 4). Removal or repositioning of the band is usually required in these cases. In a series of 830 patients, 92 cases (11%) of esophageal and gastric pouch dilatation were reported (Favretti, unpublished data). Of these 92 cases, 83 were caused by gastric prolapse/slippage, and 9 were caused by malposition of the band [7]. Of the 83 cases of gastric prolapse/slippage, 66 responded to conservative treatment and the remainder (n ⫽ 17) required surgical intervention. The 9 malpositioned bands all required surgical correction because the esophageal and gastric prolapse did not resolve with band deflation.
1) [8]. Erosion—the invasion or violation of gastric wall integrity by the LAP-BAND— has either an acute or chronic presentation. Acute erosion is characterized by free leakage of gastric contents into the peritoneum, similar to when perforation of the gastric lining leads to peritonitis. The relationship of this “gastric perforation” to the surgical procedure is evident, and emergency surgery is indicated. In chronic erosion, the band abrades constantly and slowly against the lumen and is eventually engulfed by the stomach, where it is exposed to gastric content (Fig. 5). Many patients are asymptomatic and present only with a nonfunctioning band and no restriction to the flow of food. If adjustment of the band is attempted, the surgeon will discover a rupture of the band’s inner tube. Imaging studies typically reveal bizarre positioning of the band as well as leakage. In many cases, the first indication of possible erosion is an infection at the access port site. The connecting tube provides drainage of gastric content to the port site, which causes the infection. Erosion should be ruled out at the first sign of port infection. A number of authorities attribute some incidences of erosion to small, undetected injuries to the gastric wall that occur during placement of the band and progress later to actual erosion or necrosis due to pressure of the band [21]. Therefore, meticulous, gentle, and careful operative dissection may avoid at least some of these erosion problems. If
Erosion Erosion is a serious complication that occurred in 1% of patients in the FDA clinical trial of the LAP-BAND (Table
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the surgeon suspects that an injury to or perforation of the lumen has occurred during surgery, the injury should be addressed, and serious consideration should be made as to whether placement should proceed at that time. Another consideration during surgery is avoiding placement of gastric-to-gastric sutures over the locking mechanism (buckle). This area protrudes and can cause pressure necrosis to the fundus that covers it. Instead, the surgeon should place all the gastric-to-gastric sutures to the left side of the locking mechanism. Some authors [25–27] have described techniques for band removal (usually for gastric bands other than the LAP-BAND) with an oral endoscope, regardless of whether the band is contained completely within the gastric lumen. If such an advanced endoscopic technique is not available, surgery (laparoscopic or open) is necessary to retrieve the band and to repair the stomach wall. The surgical approach is the same even if the erosion is high enough to be considered esophageal.
during office adjustments. A location should be selected that does not cause discomfort or aesthetic problems or interfere with daily life. The selected position also should offer protection of the port tube from abdominal wall movements, which over time may cause breakage of the port tube or the connection between the tube and the port. Furthermore, placement should contribute to stabilization of the port so that it does not rotate and, in case of breakage, should allow for easy location of the broken tube without the need for exploratory laparoscopy. Many surgeons prefer placement in the left upper quadrant; others select the subxiphoid region. One good approach to access port placement is to tunnel the tube from the left subcostal trocar site to the subxiphoid area and connect to the access port at the subxiphoid area. This facilitates suturing of the port to the fascia to secure its position and also results in easy access for adjustments. In addition, it is well tolerated by patients.
Conclusion Gastric necrosis Gastric necrosis is very rare; in a series of 400 patients implanted with the LAP-BAND, only 1 case (0.25%) was reported [28]. Neither author of this review has encountered the complication in their own combined experience of more than 1,500 LAP-BAND procedures. Gastric necrosis may occur early in the postoperative period or later, when it is likely the result of long-term undetected prolapse. Prolapse or gastric pouch dilatation can cause the band to exert continuous pressure against the gastric wall, which, in turn, may decrease the blood supply to the fundus. This pressure also may result from overinflation of the LAP-BAND. The combination of a decreased blood supply and continuous pressure may lead to necrosis of the gastric wall. Even in the absence of prolapse, an overdistended gastric pouch by itself can impair blood supply, which can progressively lead to gastric wall necrosis. The theoretical link between prolapse and necrosis is why true gastric prolapse should be considered a surgical emergency. Repair of gastric necrosis requires exploratory laparotomy and implementation of traditional surgical approaches.
Port problems The access port is an essential component of the LAPBAND, and its placement requires careful attention. Improper placement may lead to rotation of the port up to 180° or breaking at the tube junction [18,29]. Such events may result in discomfort to the patient, difficulty in accessing the port for adjustment, and, potentially, the need for additional surgery. The placement of the port should allow easy access
Complications associated with the LAP-BAND, as placed using recently described surgical approaches, appear to be no greater than those of other surgical procedures for the treatment of obesity. When problems do occur, they are rarely life threatening if managed correctly. Surgeons cannot completely avoid complications, but if the procedure is performed correctly and follow-up is optimal, one can expect a relatively low morbidity rate.
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[21] Szold A, Abu-Abeid S. Laparoscopic adjustable silicone gastric banding for morbid obesity: results and complications in 715 patients. Surg Endosc 2002;16:230 –233. [22] Wiesner W, Schlumpf R, Schob O, et al. Gastric pouch dilatation: complications after laparoscopic implantation of a silicone gastric band in pathologic obesity. Rofo Fortschr Geb Rontgenstr Neuen Bildgeb Verfahr 1998;169:479 – 483. [23] Wiesner W, Schob O, Hauser RS, Hauser M. Adjustable laparoscopicgastric banding in patients with morbid obesity: radiographic management, results, and postoperative complications. Radiology 2000; 216:389 –394. [24] Blake M, Fazio V, O’Brien P. Assessment of nutrient intake in association with weight loss after gastric restrictive procedures for morbid obesity. Aust N Z J Surg 1991;61:195–199. [25] Mittermair RP, Weiss H, Nehoda H, Aigner F. Uncommon intragastric migration of the Swedish adjustable gastric band. Obes Surg 2002;12:372–375. [26] Baldinger R, Mluench R, Steffen R, et al. Conservative management of intragastric migration of Swedish adjustable gastric band by endoscopic retrieval. Gastrointest Endosc 2001;53:98 –101. [27] Weiss H, Nehoda H, Labeck B, et al. Gastroscopic band removal after intragastric migration of adjustable gastric band: a new minimal invasive technique. Obes Surg 2000;10:167–170. [28] Chevallier JM, Zinzindohoue F, Elian N, et al. Adjustable gastric banding in a public university hospital: prospective analysis of 400 patients. Obes Surg 2002;12:93–99. [29] Furbetta F, Gambinotti G, Robortella EM. 28-month experience with the lap-band technique: results and critical points of the method. Obes Surg 1999;9:56 –58.