More lap band info from DK
Volume 85 • Number 4 • August 2005
Copyright © 2005 W. B. Saunders Company
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Laparoscopic Adjustable Gastric Banding: An Attractive Option
David A. Provost, MD a, b, ∗
a Division of Gastrointestinal and Endocrine Surgery, Department of Surgery, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75039, USA
b Clinical Center for the Surgical Management of Obesity, The University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Boulevard, Dallas, TX 75039, USA
* Correspondence. Division of Gastrointestinal and Endocrine Surgery, Department of Surgery, the University of Texas Southwestern Medical Center at Dallas, 5323 Harry Hines Blvd. Dallas, TX 75039.
| E-mail address: avid.provost@utsouthwestern.edu |
The author has performed consultant work for INAMED Health and United States Surgical Corporation and received educational support from United States Surgical.
PII S0039-6109(05)00067-8
Obesity is a major health issue posing a difficult therapeutic challenge for clinicians in the United States. According to the Centers for Disease Control, more than two thirds of Americans are overweight, and nearly one third are obese [1]. Researchers and physicians are beginning to realize that obesity is a chronic condition, like hypertension or diabetes, influenced by genetic, metabolic, and environmental factors. The pathogenesis of morbid obesity involves more than just a lack of willpower or a sedentary lifestyle. Obesity contributes to the development of numerous life-threatening or disabling disorders including coronary heart disease, hypertension, type 2 diabetes mellitus, hyperlipidemia, degenerative joint disease, obstructive sleep apnea, and many types of cancer. Heavier men and women have an increased risk of death [2]. An estimated $45 billion is spent annually in the United States treating diseases associated with obesity, with total costs to society estimated at $140 billion. Annual health care costs are 44% higher for patients who have a body mass index (BMI) higher than 35 than in patients who have a BMI between 20 and 24. Significant weight reduction in the morbidly obese has been demonstrated to improve or reverse comorbid illness, while benefiting psychologic, social, and economic well-being.
Tremendous resources are expended on diets and weight-reduction plans, with $30 billion annually spent on commercial weight-loss programs alone. Unfortunately, evidence demonstrating long-term success with medical, pharmacologic, diet, exercise, and behavioral therapies is absent. As a result, surgical procedures performed to treat morbid obesity have increased rapidly during the last decade, approaching 200,000 annually. Bariatric operations have been shown to produce sustained weight reduction with improvement or resolution in most obesity-related comorbidities [3], and two recent cohort trials have shown a survival benefit in patients undergoing Roux-en-Y gastric bypass (RYGB) [4], [5]. In a population-based cohort study, Flum and colleagues [5] demonstrated a 33% reduction in mortality at 15 years in patients who had had a gastric bypass operation despite an operative mortality that approached 2%. An ideal weight loss operation would be one that could provide weight-loss benefits similar to the RYGB, improvements in comorbidities and survival, and reductions in perioperative morbidity and mortality. Laparoscopic adjustable gastric banding (LAGB) may prove to be that procedure.
HISTORY OF GASTRIC BANDING
The development of purely restrictive weight-loss operations evolved in an attempt to avoid the perioperative and long-term morbidity of the jejuno-ileal bypass and the early experience with gastric bypass. Initial attempts at gastric partitioning to create a gastric pouch, leading to a sensation of fullness with ingestion of small portions of food, were unsuccessful because of early weight regain. The introduction of the vertical banded gastroplasty (VBG) by Mason [6] in 1982 demonstrated that restrictive procedures could safely produce sustained weight reduction. Open gastric banding, initially using polypropylene or polyester mesh wrapped around the proximal stomach to create a restrictive pouch, achieved little support because of frequent outlet obstruction and band erosion. The simplicity of the procedure and the elimination of the reliance on staples to create the gastric partition were appealing. Use of an adjustable band first was reported in animal studies in 1982 [7], followed by the initial placement of an adjustable gastric band in a human by Kuzmak and colleagues [8] in 1986. Rapid advances in laparoscopic surgery in the early 1990s stimulated modifications of the Kuzmak band for laparoscopic placement, leading to the initial placement of the Lap-Band (INAMED Health, Santa Barbara, California) in a human by Belachew and colleagues [9] in September 1993. The Lap-Band System became available to trained surgeons internationally in 1994, and LAGB subsequently became the most frequently performed weight-loss operation in Europe, Australia, and Latin America. Food and Drug Administration (FDA) clinical trials were initiated in 1995, leading to FDA approval of the Lap-Band in the United States in June 2001.
LAGB provides the benefits of minimally invasive surgery for the surgical management of morbid obesity, with significantly lower perioperative morbidity and mortality than with RYGB or VBG [10]. Ease of insertion extends laparoscopic benefits to the extremes of obesity, with rapid recovery and potential reversibility.
SURGICAL TECHNIQUE OF LAPAROSCOPIC ADJUSTABLE GASTRIC BAND PLACEMENT
The technique of LAGB placement has evolved from the initial descriptions by Belachew and colleagues [11] and Favretti and colleagues [12] as the result of attempts to minimize many of the late complications initially associated with the LAGB. The perigastric technique, as initially described, involved creating a window along the lesser curvature of the stomach 3 cm below the gastroesophageal junction (Fig. 1). This dissection was performed along the gastric wall medial to the neurovascular bundle of the lesser curvature. Attempts were made to maintain the dissection above the peritoneal reflection of the lesser omental bursa behind the stomach. The greater curvature dissection was performed superior to the first short gastric vessel. The dissection created a tunnel for band passage resulting in a 15- to 30-mL gastric pouch above the band. The greater curvature of the fundus was sutured over the band, typically with two sutures. The band stoma was then calibrated by injecting 1 to 2 mL saline into the inflatable balloon of the band, using a pressure gauge, the gastrostenometer, to determine proper pressure and position, to create a 12-mm stoma. With the perigastric technique, entry into or at the apex of the lesser omental sac posterior to the stomach creates a setting in which the posterior wall can slip through the band, creating a symptomatic prolapse [13], a complication reported in 23% of patients in the FDA A Trial [14]. The problem of gastric prolapse was compounded by the partial inflation of the band at the time of surgery, increasing the likelihood of early vomiting with disruption of the fixation sutures. The larger pouch predisposed development of pouch dilation, and dissection close to the gastric wall along the lesser curvature often resulted in deserosalization, which may have led to the high incidence of band erosion observed with this technique.
In response to these complications, the method of LAGB placement has evolved into the pars flaccida technique (Fig. 2). Principles of the pars flaccida technique include the creation of a very small proximal pouch, posterior dissection just below the crura above the reflection of the bursa omentalis, improved anterior suture fixation of the fundus and anterior gastric wall over the band, and complete deflation of the band at the time of placement [15]. Candidates for LAGB must meet the indications for surgery as recommended by the National Institutes of Health Consensus Development Conference [16]. Intensive preoperative education regarding the risks and benefits of LAGB and dietary counseling are provided. The patient is placed on the operating table supine with adequate padding. The surgeon may operate from the patient's right side or from between the legs. Five or six ports are used, including a Nathanson liver retractor placed in the epigastrium. Dissection of the angle of His is performed well above the level of the short gastric vessels, freeing the gastrophrenic peritoneal attachments just lateral to the gastroesophageal junction to expose the left crus. This dissection is facilitated by excising the anterior fat pad overlying the gastroesophageal junction. The thin area of the gastrohepatic ligament, or pars flaccida, over the caudate lobe is divided, permitting identification of the base of the right crus. The peritoneum along the inferomedial border of the crus is incised, and a grasper is gently passed behind the gastroesophageal junction to emerge behind the previously dissected angle of His. The band is inserted into the peritoneal cavity through a 15-mm trocar or, alternatively, may be passed through a 12-mm port site using the Ponce band passer. The end of the band is grasped by the grasper at the angle of His, and the tubing is pulled behind the gastroesophageal junction until the band encircles the proximal stomach. The tubing is passed through the band clasp, and the lock is seated. Gastrogastric sutures are placed to wrap the fundus and anterior gastric wall loosely over the band. At least three or four 2-0 sutures of braided polyester are placed from high on the fundus medially, stopping before the buckle of the band. Although the band is placed at the apex of the stomach, it is essential that the stomach, not the esophagus, be incorporated in the sutures superior to the band to achieve a sensation of satiety with meals. The end of the band tubing is brought out through a port site, the incision is lengthened, and a pocket is created subcutaneously on the anterior rectus sheath. The port is attached to the tubing, excess tubing is passed into the peritoneal cavity, and the port is secured to the anterior rectus sheath with permanent sutures. An upper gastrointestinal series is obtained postoperatively to document band position and to evaluate obstruction or gastroesophageal perforation. An overnight stay in the hospital is typical, although LAGB may be performed as an outpatient procedure.
Use of the pars flaccida technique has greatly decreased the incidence of gastric prolapse through the band, but incorporation of excessive perigastric fat within the band may result in postoperative outlet obstruction. This problem may be avoided by ensuring that the band rotates freely around the stomach before fixation and excising or incising the fat pad along the lesser curvature of the stomach [17]. Using the recently introduced Lap-Band VG System (INAMED Health, Santa Barbara, California), with a larger diameter, in patients who have large gastroesophageal fat pads may also minimize the incidence of postoperative obstruction.
POSTOPERATIVE MANAGEMENT OF THE LAPAROSCOPIC ADJUSTABLE GASTRIC BAND
Although proper surgical technique is essential to minimize late complications of the LAGB, weight loss depends on postoperative follow-up and appropriate band adjustments. Frequent adjustments often are necessary to maintain the proper degree of restriction. An inappropriately adjusted band leads to ineffective weight loss. As with the evolution of the technique of LAGB placement and the reduction in late complications, substantial changes in postoperative band management have contributed to improved weight loss.
Patients are discharged on a liquid diet for 2 weeks, which is transitioned to soft and pureed foods. Solid foods are prohibited to avoid emesis or feelings of undue fullness while the band settles into position and a pseudocapsule develops around the band [18]. Solid foods are initiated at 6 weeks. Feelings of satiety with small volumes of food are best achieved with solids. Softer foods and calorie-containing liquids are avoided. Patients are instructed to begin a graduated exercise program at discharge.
Initially, band adjustments were performed routinely with fluoroscopic guidance as needed based on weight loss, using the rate of contrast flow through the stoma as a guide for calibration. The frequency of adjustments was variable, often left to the patient's discretion. In the absence of established guidelines for band management, reported weight loss varied considerably among published series. A band adjusted too tightly leads to an aversion of solid foods, the ingestion of higher-calorie liquids and softer foods, and poor weight loss. Underappreciation of this observation often resulted in further tightening of the band. Poor weight loss, a high incidence of gastroesophageal reflux and esophageal dilation, pouch enlargement with obstruction, and frequent band extirpation were reported in several series [19], [20].
Adjustments should be performed only after evaluating the patient's weight loss, eating habits, and symptoms. A rapid loss of satiety, increased meal volume, and increasing hunger between meals are indications for adding fluid. Vomiting, reflux, heartburn, and frequent consumption of softer foods suggest the band is too tight. Adjustments can be performed easily in the office without the need for radiographic evaluation [18]. Although relying on clinical symptoms, some authors find the additional information gained from a contrast study beneficial and continue to perform adjustments under fluoroscopic guidance [21]. Patients should be evaluated every 4 to 6 weeks during the first postoperative year. Gradual weight loss, 0.5 to 1 kg/wk, is the goal. Shen and colleagues [22] have demonstrated that, unlike gastric bypass, weight loss after LAGB is dependent upon frequent follow-up, at 1 year, patients who had returned for more than six visits had excess weight loss (EWL) of 50%, compared with only 42% EWL in patients who had six or fewer visits [22].
RESULTS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING—PERIOPERATIVE COMPLICATIONS
A major advantage of the LAGB is its safety. An evidence-based review by the Australian Safety and Efficacy Register of New Interventional Procedures-Surgical found that LAGB was associated with a median overall morbidity rate of 11.3% with a mean short-term mortality of 0.05%, compared with a 23.6% morbidity and 0.5% mortality for RYGB [10]. Major perioperative complications are infrequent with LAGB. O'Brien and colleagues [13], in a series of 1065 patients including their initial experience with perigastric placement and the later pars flaccida approach, reported a 1.5% incidence of perioperative complications delaying discharge or requiring readmission. Complications included port site infection in 0.9%, early obstruction in 0.38%, and symptomatic deep venous thrombosis in 0.09%. There were no perioperative deaths. Chevallier and colleagues [23], in 1000 LAGB placed by perigastric and pars flaccida techniques, reported four gastroesophageal perforations (0.4%) of which two were recognized intraoperatively, early prolapse in 0.3%, pulmonary embolism in 0.2%, and acute respiratory distress syndrome in 0.2%. There were 12 conversions to an open procedure (10 in the first 50 cases) and no mortalities [23]. Weiner and colleagues [24], in 984 LAGB reported one gastric perforation in a patient with prior hiatal surgery and one early prolapse. There were no mortalities or conversions to an open procedure. Fielding and colleagues [25], reporting 335 cases placed by the perigastric technique, reported two reoperations for improper band positioning, one subphrenic abscess, and four wound infections requiring antibiotic therapy, with no mortalities.
Similar results have been published in contemporary series in the United States using the pars flaccida technique. Spivak and colleagues [26], in 271 patients, reported a 1.8% incidence of acute obstruction, one pulmonary embolism, and one trocar-site hemorrhage. Open conversion was required in three patients (1.1%), one of which occurred during simultaneous laparoscopic cholecystectomy after successful band placement. There were no mortalities. Mean operative time was 42 minutes, and mean hospital stay was 1 day. Ren and colleagues [27], in a two-institution experience with 445 patients, reported a 2.7% incidence of early obstruction, conversion for bleeding requiring splenectomy in one patient (0.2%), and a single mortality. Post-mortem examination revealed no cause of death. Mean length of hospital stay was 1.1 days.
Acute obstruction caused by outlet stenosis may be seen after pars flaccida placement of the Lap-Band. Shen and Ren [28] reported that removal of large perigastric fat pads reduced the incidence of early stomal obstruction from 8% (11/143) to 0% in 124 patients. Five of 11 early obstructions were managed by laparoscopic revision. Alternatively, early obstruction, after excluding prolapse, may be managed conservatively. Eliminating oral intake while waiting for resolution of perioperative edema avoids the need for reoperation in the majority of patients.
Although life-threatening perioperative complications are less frequent after LAGB than after laparoscopic RYGB, LAGB placement does require advanced laparoscopic skills. Higher complication rates have been reported in smaller series. Although LAGB placement is technically simpler than laparoscopic RYGB, a learning curve does exist. Shapiro and colleagues, despite advanced laparoscopic experience, noted significant reductions in operative time (79 versus 59 minutes) and early and late complications (37% versus 7%) when comparing the first 30 patients with the second 30 patients [29].
RESULTS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING—LATE COMPLICATIONS
The evolution of the technique of LAGB placement from the perigastric to the pars flaccida technique has greatly reduced the incidence of gastric prolapse, pouch dilatation, and erosion. Weiner and colleagues [24] reported a prolapse rate of 5.3% with the perigastric technique (17% in the first 100 patients), which was reduced to 0.2% with the pars flaccida technique. The incidence of erosion was 0.3%. Minor port-related complications occurred in 2.5%. No band extirpations were required in the 407 bands placed using the pars flaccida technique. Chevalier and colleagues [23] noted a reduction in the incidence of prolapse from 24% with the perigastric approach (91/378) to 2% with pars flaccida placement (13/622). Band erosion was detected in 0.3%, and 5.7% required port revision. O'Brien and Dixon [13], in a series of 1150 LAGB, reported a 31% rate of prolapse in their first 400 patients, 12% in the second 400 patients, and 3% in the last 350 patients treated. The incidence of erosion was 3.2%, all occurring in the first 500 patients. Dargent [30] compared the rate of prolapse in 511 LAGB placed by the perigastric technique with 462 patients subsequently undergoing LAGB by the pars flaccida approach, noting a decrease from 6.2% to 0.6%.
The improved results with the pars flaccida technique may be confounded by surgeon experience and length of follow-up. The rate of reoperations increases with longer follow-up, and LAGB with the pars flaccida approach were performed later in the surgeons' experience. O'Brien and Dixon [31] therefore performed a randomized, controlled trial comparing the perigastric and pars flaccida techniques. The rate of prolapse was significantly reduced with the pars flaccida technique (3% versus 10%, P < .04).
Late complications are comparable in United States series using the pars flaccida technique. In 445 patients, Ren and colleagues reported a prolapse rate of 3.1%, erosion in 0.2%, and port-related complications in 3% [27]. Two bands were removed for intra-abdominal abscesses at 2 and 3 months postoperatively. No cases of esophageal dilatation were observed. The overall incidence of band removal was 0.9%. Spivak and colleagues [26] reported a 1.8% incidence of prolapse, and a 7.3% incidence of minor port related complications; 6.6% of patients had gastric pouch dilation or esophageal dilation, which resolved with band deflation. There were no erosions or band removals. In a cohort of 207 patients who had diabetes, hypertension, or both with at least 1-ear follow-up, Ponce and colleagues [32] reported a prolapse rate of 3%, port infections in 2.4% (compared with an overall rate of 0.97% in all patients who had 1-year follow-up), erosion in 0.5%, and band removal in 1%.
It is apparent that the technique of band placement must be considered when evaluating late complication rates in reports of LAGB. Studies using the perigastric technique are of historical interest only. Contemporary results with the pars flaccida technique yield prolapse rates lower than 5%, erosions in fewer than 1%, port-related complications in 2% to 6%, and band extirpations in less than 3% of patients undergoing LAGB. Esophageal dilatation occurs only with overtightening of the band in response to fluid removal or with prolapse and is reported infrequently.
Life-threatening late complications after LAGB are infrequent. Almost all may be managed laparoscopically or by a local outpatient procedure. Erosions usually present insidiously, with failure of weight loss or port-site infection. Laparoscopic removal is standard. Although not advocated by most authors, O'Brien and Dixon [13] have reported simultaneous replacement of the Lap-Band at the time of removal for erosion in 12 patients without complication. Prolapse, which presents with symptoms of progressive reflux, vomiting, and dysphagia not responding to band deflation, may be readily diagnosed by an upper-gastrointestinal series. Laparoscopic repositioning or replacement is successful in most cases. Port disconnection or leakage can be managed as a local outpatient procedure. Introduction of a redesigned port seems to have decreased the frequency of this complication. Port-site infections may be minimized by perioperative antibiotic administration [24] and by sing proper aseptic techniques during band adjustment. After excluding band erosion, port infections are managed by removal of the port, dropping the band tubing back into the peritoneal cavity. After resolution of the local infection and wound healing, the port is replaced at a remote site, laparoscopically retrieving the tubing.
WEIGHT LOSS FOLLOWING LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING
Weight loss after LAGB clearly depends on proper band adjustments and a frequent adjustment schedule during the first 1 to 2 years postoperatively. The need for frequent adjustments results from the loss of perigastric fat within the band with weight loss, loosening the band and permitting increased intake. Weight loss after LAGB is significantly slower than after RYGB, so comparisons between the operations demonstrate superior weight loss with RYGB when only early results are reported. Potential benefits of the gradual weight loss observed with LAGB include a reduced incidence of nutritional deficiencies, hair loss, and cholelithiasis.
Vertruyen [33] reported 543 LAGB patients (mean preoperative BMI, 44) with 96% follow-up at a median of 36 months. Percent EWL was 38% at 12 months, 61% at 24 months, and 62% at 36 months. Weight loss was maintained at greater than 50% EWL for as long as 7 years. Bands were removed in 14 patients (2.6%), 6 of whom had maintained ideal body weight. Weiner and colleagues [24] reported an 8-year percent EWL of 59.3% in their first 100 LAGB patients who had perigastric placement (97% follow-up). If the five patients requiring band removal were included, percent EWL fell to 54%. Belachew and colleagues [34] reported 763 patients (mean preoperative BMI, 42) with a 90% follow-up at a minimum of 4 years. Percent EWL was 40% at 12 months, 50% at 24 months, and ranged between 50% and 60% at 48 months and beyond; 3.1% of patients required band removal. Angrisani and colleagues [35] from the Italian Collaborative Study Group for Lap-Band System registry, reported a 54.8% EWL in 381 of 573 patients who had LAGB placed with 5-year follow-up. Twenty-seven percent were lost to follow-up, 5.7% underwent band removal, 1.9% were converted to other bariatric procedures, and 1.2% died of unrelated causes. Dargent [36], in 500 LAGB placed with greater than 99% follow-up, reported 56% EWL at 1 year, 65% at 2 years, and 64% at 3 years. Band removal was required in 1%. O'Brien and colleagues [37] also reported excellent long-term results in 709 patients who underwent LAGB. Mean BMI was 45. Follow-up was 98.6%. Percent EWL was 47% at 1 year (492 patients), 53% at 2 years (336 patients), 53% at 3 years (273 patients), 52% at 4 years (112 patients), 54% at 5 years (32 patients), and 57% at 6 years (10 patients). Fewer than 2% had bands removed. These studies demonstrate excellent long-term results with the Lap-Band, with a mean EWL greater than 50% at 5 years and beyond. This experience compares favorably with the long-term results after RYGB [38], [39].
Because of high complication rates and poor weight loss in initial reports of LAGB in the United States [19], [40], it has been suggested that cultural and dietary differences make LAGB less suitable in Americans than in international populations. Perigastric placement and inadequate adjustment protocols contributed to these disappointing early results; contemporary series from the United States demonstrate results comparable to those of foreign series. Fox and colleagues [41] reported 105 patients (mean BMI, 46.7) who had LAGB placed in Mexico but were followed in a Tacoma, Washington clinic. Percent EWL was 61.1% at 1 year (50 patients), 74.8% at 2 years (35 patients), and 72.4% at 3 years (23 patients). Rubenstein and colleagues [42] reported their experience with 63 patients in the FDA B trial. All bands were placed with the perigastric technique. Mean percent EWL was 38.3% at 1 year, 46.6% at 2 years, and 53.6% at 3 years. Spivak and colleagues [26], in a cohort of 271 patients (mean BMI, 45.3), reported EWL of 40% at 12 months and 43% at 24 months. Ren and colleagues [27], in a multi-institutional report of early results, documented a 44.3% EWL at 1 year in 99 patients (mean preoperative BMI, 52.7). Ponce and colleagues [32] reported results in 413 patients (mean BMI, 46.2) with at least 1 year follow-up, demonstrating 41.2% EWL at 1 year (402 patients, 97.3% follow-up) and 63.3% at 2 years (91 patients, 94.8% follow-up). Jan and colleagues [43] compared weight loss in 154 LAGB patients (mean BMI, 50.9; mean age, 46 years) with 219 patients undergoing laparoscopic RYGB (mean BMI, 49.5; mean age, 42 years) between October 2000 and November 2003. EWL for LAGB and RYGB, respectively, was 36% versus 64% at 1 year, 45% versus 70% at 2 years, and 60% versus 57% at 3 years. As expected, weight loss was more rapid after gastric bypass, but the difference diminished considerably by 3 years because LAGB patients continued to lose weight whereas RYGB patients often had weight regain. At the University of Texas Southwestern Medical Center at Dallas, we placed 327 Lap-Bands (mean preoperative BMI, 49.2) from November 2001 through August 2004, with excellent early weight loss through September 2004 of 44% at 1 year and 61% at 2 years. Bands have been removed in 2.7% of patients.
These results demonstrate that, with the pars flaccida technique and appropriate band adjustments, LAGB is effective in Americans. The belief that Americans are different when it comes to weight-loss surgery and the LAGB seems to be a fallacy.
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN SPECIAL POPULATIONS
THE MASSIVELY OBESE
The ability to place a band laparoscopically in the massively superobese offers significant advantages in terms of perioperative morbidity and mortality compared with conventional open surgery. Although laparoscopic RYGB has been reported in the superobese, it is technically much more demanding. The increased risk of major perioperative complications with gastric bypass in patients in whom diagnostic imaging often is not possible complicates management. Although it has been suggested that LAGB is not as successful in the superobese, available data do not support this theory. Fielding [44] reported 76 patients who had a BMI of 60 or higher (median BMI, 69; range, 60–104) undergoing LAGB. There were no mortalities, and median hospital stay was 3 days. Six patients had prior VBG, five of whom subsequently required band removal for dysphagia. Fielding currently does not advocate LAGB as a revisional procedure for failed gastroplasties. Of the remaining 70 patients, 69 bands remain in place. EWL was 46.7% at 1 year, 56.6% at 2 years, 59.1% at 3 years, 60.4% at 4 years, and 61.4% at 5 years. More than 80% of patients maintained more than 50% EWL at all time points 2 years and beyond. In the series by Fox and colleagues [41] of Americans having LAGB in Mexico, 35 of the 100 patients were superobese (BMI ≥50). Percent EWL was 52.8% at 1 year, 67.5% at 2 years, and 65.8% at 3 years. These results compare favorably with the weight loss observed with RYGB [38] and long-limb RYGB [45].
EXTREMES OF AGE
With the aging of the population, the number of older patients seeking weight-loss surgery is increasing. Although there are clear benefits in quality of life and improvement in comorbid illness, improvements in longevity are less than in the younger population. Because increasing age has been demonstrated to be a major risk factor for mortality after gastric bypass [46], the reduced perioperative risk associated with LAGB makes it an attractive option in the older morbidly obese patient. Nehoda and colleagues [47] reported 68 patients age 50 years or older undergoing LAGB, with results and complications comparable with those in the younger cohort. One erosion in the older group required endoscopic removal, and one band was replaced for leakage (Swedish Adjustable Gastric Band, Ethicon Endosurgery, Cincinnati, Ohio). EWL was 68% at 12 months and 71% at 24 months. We have placed 60 LAGB in patients aged 60 years and older (mean age, 65 years; range, 60–76 years) without mortality. Although the incidence of prolapse and band extirpation has been higher than in the younger cohort, weight loss and reduction of comorbidities have been excellent.
ADOLESCENTS
The prevalence of overweight in the pediatric population in the United States has tripled during the last 30 years, and obesity-related conditions previously associated with adults such as hypertension, dyslipidemia, type 2 diabetes, and obstructive sleep apnea are becoming increasingly more prevalent in the pediatric age group. A recent consensus statement has established guidelines for bariatric surgery in adolescents [48]. Criteria include
- Attainment of physiologic maturity
A BMI of 40 or higher with serious obesity-related comorbidities or a BMI of 50 or higher with less severe comorbidities
Demonstrated decisional capacity
A supportive family environment
Lower perioperative morbidity and mortality, gradual weight loss with few nutritional complications, and reversibility make LAGB an appealing bariatric procedure in the overweight adolescent. Widhalm and colleagues [49] reported results of LAGB in eight adolescents (mean BMI, 49.1). There were no perioperative or late complications with short-term follow-up. At a mean follow-up of only 10 months, mean weight loss was 25 kg, or approximately 32.3% excess BMI lost. Dolan and Fielding [50] reported 17 adolescents (mean BMI, 42.2), aged 12 to 19 years, with a median follow-up of 25 months. There were no major perioperative complications. Late reoperations were required in two patients. One required laparoscopic repositioning of a prolapsed band; the second required replacement of a leaking port. EWL was 49.2% at 1 year and 69.3% at 2 years. More than 80% of adolescents had EWL of 50% or more by 24 months after surgery. Although experience is limited, as is experience with all bariatric surgical procedures in this age group, LAGB seems to be a safe and effective method for weight loss for obese adolescents. LAGB in adolescents should be performed only in a multidisciplinary weight-loss management program with providers experienced in meeting the unique physical and psychologic needs of the adolescent.
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING IN THE OBESE (BODY MASS INDEX 30–35)
The current guidelines for weight loss surgery (BMI ≥40 or ≥35 with comorbidities) were established by the National Institutes of Health consensus panel based on available evidence regarding the risks and benefits of surgery for obesity weighed against the risks of morbid obesity [16]. Since 1991, substantial knowledge has been gained regarding the health risks of morbid obesity. In addition, improvements in the safety and efficacy of bariatric surgery have been demonstrated. As a result, it has been suggested that the minimum weight requirements for obesity surgery be lowered. Angrisani and colleagues [51], for the Italian Collaborative Study Group for Lap-Band System, reported 210 patients who had a BMI of 35 or lower undergoing LAGB as a primary weight loss procedure. There were no perioperative complications. Late complications included six pouch dilations or prolapse requiring reoperation, two erosions, and four port complications. Eight bands were removed for complications (0.3%), including one removed for psychologic intolerance. EWL was 52.5% at 1 year, 61.3% at 2 years, 64.7% at 3 years, 68.8% at 4 years, and 71.9% at 5 years. Major comorbidities were present in only a few of the patients, with diabetes resolving in four of four patients and hypertension resolving in eight of nine patients. O'Brien and colleagues [52] reported a randomized, controlled trial of optimal medical therapy versus LAGB in 79 patients who had a BMI between 30 and 35. There were no perioperative complications in the 39 patients randomly assigned to surgical therapy. Reoperation was required for prolapse in two patients. Weight loss at 2 years was 71.5% EWL in the surgical group compared with 21.4% EWL in the controls (P < .001). LAGB resulted in significantly greater improvement in quality of life and all measures of the metabolic syndrome. Although primary bariatric procedures cannot currently be recommended for patients who have a BMI lower than 35 outside of institutional review board–approved protocols, the safety and controlled weight loss of the LAGB make it an ideal procedure for this population.
RESOLUTION OF COMORBIDITIES WITH LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING
Weight loss is a benefit of bariatric surgery, but improvements in comorbid illness and quality of life are the primary goals. Type 2 diabetes mellitus is a major contributor to the long-term morbidity associated with morbid obesity. Dolan and colleagues [53] reported that 65% of 49 diabetics with at least 6 months follow-up no longer required any diabetes medications after LAGB. Dixon and O'Brien [54] demonstrated normalization of glucose, hemoglobin A1c, and insulin resistance in 64% of type 2 diabetics and improvement in an additional 26% after LAGB. Ponce and colleagues [32], in a North American population undergoing LAGB, reported resolution of diabetes in 66% of diabetics at 1 year, increasing to 80% at 2 years as EWL increased from 39.2% to 52.6%. Hypertension resolved in 74% of patients at 2 years. O'Brien and Dixon [13] noted resolution or improvement on hypertension in 92% of patients undergoing LAGB. LAGB has also been demonstrated to improve lipid profiles, asthma, sleep apnea, menstrual irregularities and infertility, depression, joint and back pain, stress incontinence, self-esteem, and overall quality of life [13], [37], [55].
Early reports of an increased rate of gastroesophageal reflux (GERD) after LAGB [19] and an increased incidence of prolapse in patients who have hiatal hernia [56] has led some to question LAGB placement in the presence of a hiatal hernia. Reflux after LAGB is usually an indication of an overly tightened band or a sign of prolapse or pouch dilatation, a complication greatly reduced by the adoption of the pars flaccida approach. O'Brien reported total resolution of GERD in 89% of LAGB patients, improvement in 5%, no change in 2.5%, and aggravation of symptoms in 2.5% [13]. Dolan and colleagues [57] reported 62 patients undergoing crural repair of hiatal hernia at the time of LAGB placement. With a median follow-up of 14 months, there was one prolapse requiring laparoscopic repositioning. Only six patients required antireflux medications postoperatively. LAGB is an effective therapy for the management of GERD.
SUMMARY
More than 8 million persons in the United States have a BMI of 40 or higher, and an additional 23 million persons have a BMI between 35 and 40. Many of these persons have significant obesity-related comorbidities. Bariatric surgery remains the only effective treatment for morbid obesity. Despite the exponential increase in the number of weight-loss operations being performed, it is evident that, with 100,000 to 200,000 procedures performed annually, most patients suffering the complications of morbid obesity are not receiving the best available therapy. Although cost or lack of insurance coverage is a deterrent to many, many patients fail to seek surgical options because of fear of operative complications or death. LAGB provides a safer alternative, with an incidence of complications one half that after gastric bypass and one tenth the mortality [10]. Complications, unlike anastomotic leaks or intestinal obstruction, rarely are life threatening. Most are managed laparoscopically or by minor, outpatient procedures. Most importantly, weight loss has proven durable. Although long-term follow-up has yet to reach the 10-year mark, the number of published series and patients who have 5 years or more follow-up exceeds that of gastric bypass. Weight loss is comparable, at 50% to 60% EWL. Resolution of obesity-related comorbidities parallels the weight loss after LAGB. Despite initial reports, with refinements in surgical and band management techniques, results from centers in the United States are comparable with those of the best international series. LAGB is a safe and effective option for the morbidly obese patient seeking weight-loss surgery.
posted by LAPBAND BY JC @ 1:05 AM
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