Safety of the laparoscopic adjustable gastric band: 7-year data from a U.S. center of excellence.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has become one of the most common weight-loss procedures performed in the United States. The authors' high-volume academic medical center has gathered a database of almost 3,000 patients who have undergone LAGB since January 2001. The goal of this series, the largest to date on LAGB outcomes at a single institution, was to assess complications associated with LAGB. METHODS: A retrospective analysis was performed using longitudinal data from adult patients who underwent LAGB between 1 January 2001, and 29 February 2008. General and band-related complications were reported for all patients. Death and reoperation for weight gain (LAGB followed by either a second band insertion or a gastric bypass) also were reported. RESULTS: Of the 2,965 patients who received LAGB during the study period, 2,909 met the criteria for inclusion in this analysis, and 363 (12.2%) experienced one or more complications. The most common complications were band slip (4.5%) and port-related problems (3.3%). Other complications were rare. Only seven patients (0.2%) had band erosion. Eleven patients (0.4%) underwent reoperation for weight gain. A total of 10 deaths (0.34%) occurred during the study period. Three patients died within 30 days of surgery. Two of these deaths (0.06%) were related to surgery, and one resulted from a motor vehicle accident. Seven patients died of causes unrelated to surgery during the course of the study. CONCLUSIONS: The LAGB technique is a relatively safe procedure with few early or late complications. Few LAGB patients undergo reoperation for weight gain, and mortality is very rare.

Hiatal hernia repair at the initial laparoscopic adjustable gastric band operation reduces the need for reoperation.

BACKGROUND: Intractable reflux, either due to gastric prolapse or concentric pouch dilatation has been the most common indication for reoperation or band removal after laparoscopic adjustable gastric banding (LAGB). We have previously found that a simple hiatal hernia repair (HHR) leads to remission of these symptoms minimizing the need for band removal. We have subsequently added crural repair/HHR at the initial operation, where indicated. In this study compare the rate of reoperation in patients who underwent LAGB alone, or with concurrent HHR. METHODS: A retrospective review of a prospective database of all patients undergoing LAGB was performed to determine the incidence of reoperation in the two groups. RESULTS: Between July 2001 and August of 2006, 1298 patients underwent LAGB and 520 patients underwent LAGB with concurrent HHR (LAGB/HHR). The mean initial weight and BMI were 128 kg (range, 71.1-245.7 kg) and 45.4 kg/m(2) (range, 28-75 kg/m(2)). Average follow-up for the LAGB and LAGB/HHR groups was 24.8 and 20.5 months, respectively. Rate of reoperation for HHR alone, or with band slip or concentric pouch dilatation, for LAGB and LAGB/HHR groups was 5.6% and 1.7% respectively (p < 0.001). Total reoperation rate for slip, HHR and pouch dilatation was 7.9% and 3.5%, respectively (p < 0.001). There was no significant difference in rate of slip repair alone between the two groups: 2.3% and 1.7%, respectively (p < 0.44). CONCLUSIONS: Adding HHR to LAGB where indicated significantly reduces reoperation rate. Every effort should be made to detect and repair HHR during placement of the band, as it will decrease future need for reoperation.

Gastric banding as a salvage procedure for patients with weight loss failure after Roux-en-Y gastric bypass.

BACKGROUND: This study reviews outcomes after laparoscopic adjustable gastric band (LAGB) placement in patients with weight loss failure after Roux-en-Y gastric bypass (RYGBP). METHODS: All data was prospectively collected and entered into an electronic registry. Characteristics evaluated for this study included pre-operative age and body mass index (BMI), gender, conversion rate, operative (OR) time, length of stay (LOS), percentage excess weight loss (EWL), and postoperative complications. RESULTS: 11 patients (seven females, four males) were referred to our program for weight loss failure after RYGBP (six open, five laparoscopic). Mean age and BMI pre-RYGBP were 39.5 years (24-58 years) and 53.2 kg/m(2) (41.2-71 kg/m(2)), respectively. Mean EWL after RYGBP was 38% (19-49%). All patients were referred to us for persistent morbid obesity due to weight loss failure or weight regain. The average time between RYGBP and LAGB was 5.5 years (1.8-20 years). Mean age and BMI pre-LAGB were 46.1 years (29-61 years) and 43.4 kg/m(2) (36-57 kg/m(2)), respectively. Vanguard (VG) bands were placed laparoscopically in most patients. There was one conversion to open. Mean OR time and LOS were 76 minutes and 29 hours, respectively. The 30-day complication rate was 0% and mortality was 0%. There were no band slips or erosions; however, one patient required reoperation for a flipped port. The average follow-up after LAGB was 13 months (2-32 months) with a mean BMI of 37.1 kg/m(2 )(22.7-54.5 kg/m(2)) and an overall mean EWL of 59% (7-96%). Patients undergoing LAGB after failed RYGBP lost an additional 20.8% EWL (6-58%). CONCLUSION: Our experience shows that LAGB is a safe and effective solution to failed RYGBP.

Treatment with lavender aromatherapy in the post-anesthesia care unit reduces opioid requirements of morbidly obese patients undergoing laparoscopic adjustable gastric banding.

BACKGROUND: Parenteral administration of opioids and NSAIDs has been the mainstay for postoperative pain control in patients undergoing laparoscopic adjustable gastric banding (LAGB). Both classes of drugs, however, are associated with serious adverse effects. An addition of complimentary analgesic techniques may decrease requirement for traditional analgesics, thus reducing the incidence of side-effects. We designed the study to evaluate the effectiveness of Lavender aromatherapy in reducing opioid requirements after LAGB. METHODS: A prospective randomized placebo controlled study was carried out on 54 patients undergoing LAGB. Upon arrival to the post-anesthesia care unit (PACU), patients in the study group were treated with lavender oil, which was applied to the oxygen face mask; the control group patients received nonscented baby oil. Postoperative pain was treated with morphine. Numerical rating scores (0-10) were used to measure the level of pain at 5, 30, and 60 min. Sedation was evaluated using the Observer Assessment of Alertness/Sedation scale (0-5). Data analyzed included the amount of opioids, NRS, OAA/S, PACU discharge time, as well as the incidence of side-effects. RESULTS: The two groups were comparable with regard to patient characteristics, intraoperative drug use, and surgical time. Significantly more patients in the Placebo group (PL) required analgesics for postoperative pain (22/27, 82%) than patients in the Lavender group (LAV) (12/26, 46%) (P = .007). Moreover, the LAV patients required significantly less morphine postoperatively than PL patients: 2.38 mg vs 4.26 mg, respectively (P = .04). There were no differences in the requirements for post-operative antiemetics, antihypertensives, or PACU discharge time. CONCLUSIONS: Our results suggest that lavender aromatherapy can be used to reduce the demand for opioids in the immediate postoperative period. Further studies are required to assess the effect of this therapy on clinically meaningful outcomes, such as the incidence of respiratory complications, delayed gastric emptying, length of hospital stay, or whether this therapy is applicable to other operations.

Glucose Metabolism After Gastric Banding and Gastric Bypass in Individuals With Type 2 Diabetes: Weight Loss Effect.

OBJECTIVE: The superior effect of Roux-en-Y gastric bypass (RYGB) on glucose control compared with laparoscopic adjustable gastric banding (LAGB) is confounded by the greater weight loss after RYGB. We therefore examined the effect of these two surgeries on metabolic parameters matched on small and large amounts of weight loss. RESEARCH DESIGN AND METHODS: Severely obese individuals with type 2 diabetes were tested for glucose metabolism, ß-cell function, and insulin sensitivity after oral and intravenous glucose stimuli, before and 1 year after RYGB and LAGB, and at 10% and 20% weight loss after each surgery. RESULTS: RYGB resulted in greater glucagon-like peptide 1 release and incretin effect, compared with LAGB, at any level of weight loss. RYGB decreased glucose levels (120 min and area under the curve for glucose) more than LAGB at 10% weight loss. However, the improvement in glucose metabolism, the rate of diabetes remission and use of diabetes medications, insulin sensitivity, and ß-cell function were similar after the two types of surgery after 20% equivalent weight loss. CONCLUSIONS: Although RYGB retained its unique effect on incretins, the superiority of the effect of RYGB over that of LAGB on glucose metabolism, which is apparent after 10% weight loss, was attenuated after larger weight loss.

Fatal complications of bariatric surgery.

BACKGROUND: Bariatric surgery is an increasingly used method to treat morbid obesity. The mortality rate among patients undergoing bariatric operations is generally quoted as between 0.05-2.0%. Our focus was not on mortality rates but rather on the reasons patients die following the procedures. In New York City, deaths that are due to predictable complications of appropriate therapy are certified as therapeutic complications. METHODS: We retrospectively reviewed all deaths investigated by the Office of the Chief Medical Examiner in New York City between 1997 and 2005 in which bariatric surgery had been performed. We report the fatal complications, the interval between surgery and death, the type of procedure, and coexisting morbidities. RESULTS: Autopsies were performed on 95% of these fatalities. There were 97 deaths due to therapeutic complications of the operations. The interval between the initial surgery and death ranged from several hours to years. The most common complication was an anastomotic leak with subsequent infection. A high percentage of deaths occurred after discharge (40%) and/or >30 days after surgery (37%). There were 8 deaths from complications of bariatric surgery that occurred >1 year after surgery. CONCLUSIONS: Studies that report the mortality rate during hospitalization or within 30 days of surgery, underestimate the actual incidence. Bariatric surgery carries both short- and long-term risks.

Objective comparison of complications resulting from laparoscopic bariatric procedures.

BACKGROUND: Several surgical treatment options for morbid obesity exist. Currently, there are no studies that objectively compare complication rates after laparoscopic bariatric operations performed at a single institution. We objectively classify and compare complications resulting from laparoscopic adjustable gastric banding (LABG), Roux-en-Y gastric bypass (RYGB), and biliopancreatic diversion (BPD) with duodenal switch (DS). STUDY DESIGN: A retrospective review of a prospective database of all patients undergoing laparoscopic bariatric operation was performed. Complications were categorized according to severity score using a well-described classification system and compared between procedures. RESULTS: From September 2000 to July 2003, 780 laparoscopic bariatric operations were performed: 480 LAGB, 235 RYGB, and 65 BPD+/-DS. There was one late death. Total complication rates were: 9% for LAGB, 23% for RYGB, and 25% for BPD+/-DS. Complications resulting in organ resection, irreversible deficits, and death (grades III and IV) occurred at rates of 0.2% for LAGB, 2% for RYGB, and 5% for BPD+/-DS. LAGB group had a statistically significant lower overall complication rate, both by incidence and severity, as compared with other groups (p < 0.001). After controlling for differences of admission body mass index, gender, and race, the LAGB group had an almost three and a half times lower likelihood of a complication compared with the RYGB group (odds ratio, 3.4; 95% CI, 2.2-5.3, p < 0.001) and had an over three and a half times lower likelihood of a complication compared with the BPD with DS group (odds ratio, 3.6; 95% CI, 1.8-7.1, p < 0.001). There was no statistically significant difference between complication rates of RYGB and BPD+/-DS. CONCLUSIONS: Bariatric operation complication rates range from 9% to 25%; very few complications are serious. Laparoscopic adjustable gastric banding is the safest operation in terms of complication rate and severity when compared with laparoscopic Roux-en-Y gastric bypass or laparoscopic malabsorptive operations.

Factors influencing patient choice for bariatric operation.

BACKGROUND: No study has surveyed the factors that influence morbidly obese patients' preference for a particular bariatric operation. METHOD: 469 consecutive patients in 2 major bariatric surgery centers in the United States (US, 124) and Australia (AU, 345) were prospectively studied to determine referral pattern and reason for their choice of operation. RESULTS: The predominant operation was laparoscopic adjustable gastric banding (LAGB) in both US (75%) and AU (83%) centers. Gender (70% female), BMI (45 kg/m2) and age (42.5 years) were similar in both cohorts. In Australia, 53% had referral initiated by primary doctors and 25% by another patient, while in the US, 43% by another patient and 27% by the Internet. Safety of the operation (43%) was the highest-rated factor in choosing LAGB. LAGB being "least invasive" was most significant in the US (46%), and "surgical safety" in Australia (45%). In the US, Rouxen-Y gastric bypass was preferred due to "lack of a foreign body" (31%) and "inability to cheat" (28%), while in Australia, "dumping" was the most significant reason (50%). Duodenal switch (BPD/DS) was selected in 11% of patients, primarily because of "durability of the weight loss" (51%). Surprisingly, only 1 patient in the US group selected BPD/DS because the pylorus remains intact. CONCLUSION: Safety and invasiveness had the greatest impact on patient choice for bariatric operation in two different countries. This information may help clinicians better understand their patients' concerns, and their treatment choices.

Laparoscopic bariatric surgery in super-obese patients (BMI>50) is safe and effective: a review of 332 patients.

BACKGROUND: Bariatric surgery in super-obese patients (BMI >50 kg/m(2)) can be challenging because of difficulties in exposure of visceral fat, retracting the fatty liver, and strong torque applied to instruments, as well as existing co-morbidities. METHODS: A retrospective review of super-obese patients who underwent laparoscopic adjustable gastric banding (LAGB n=192), Roux-en-Y gastric bypass (RYGBP n=97), and biliopancreatic diversion with/without duodenal switch (BPD n= 43), was performed. 30 day peri-operative morbidity and mortality were evaluated to determine relative safety of the 3 operations. RESULTS: From October 2000 through June 2004, 331 super-obese patients underwent laparoscopic bariatric surgery, with mean BMI 55.3 kg/m(2). Patients were aged 42 years (13-72), and 75% were female. When categorized by operation (LAGB, RYGBP, BPD), the mean age, BMI and gender were comparable. 6 patients were converted to open (1.8%). LAGB had a 0.5%, RYGBP 2.1% and BPD 7.0% conversion rate (P=0.02, all groups). Median operative time was 60 min for LAGB, 130 min for RYGBP and 255 min for BPD (P<0.001, all groups). Median length of stay was 24 hours for LAGB, 72 hours for RYGBP, and 96 hours for BPD (P <0.001). Mean %EWL for the LAGB was 35.3+/-12.6, 45.8+/-19.4, and 49.5+/-18.6 with follow-up of 87%, 76% and 72% at 1, 2 and 3 years, respectively. Mean %EWL for the RYGBP was 57.7+/-15.4, 54.7+/-21.2, and 56.8+/-21.1 with follow-up of 76%, 33% and 54% at 1, 2 and 3 years, respectively. Mean %EWL for the BPD was 60.6+/-15.9, 69.4+/-13.0 and 77.4+/-11.9 with follow-up of 79%, 43% and 47% at 1, 2 and 3 years, respectively. The difference in %EWL was significant at all time intervals between the LAGB and BPD (P<0.004). However, there was no significant difference in %EWL between LAGB and RYGBP at 2 and 3 years. Overall perioperative morbidity occurred in 27 patients (8.1%). LAGB had 4.7% morbidity rate, RYGBP 11.3%, and BPD 16.3% (P=0.02, all groups). There were no deaths. CONCLUSION: Laparoscopic bariatric surgery is safe in super-obese patients. LAGB, the least invasive procedure, resulted in the lowest operative times, the lowest conversion rate, the shortest hospital stay and the lowest morbidity in this high-risk cohort of patients. Rates of all parameters studied increased with increasing procedural complexity. However, the difference in %EWL between RYGBP and LAGB at 2 and 3 years was not statistically significant.

Laparoscopic adjustable gastric band.

Only a fraction of morbidly obese patients have come forward for bariatric surgery. This article confirms that the laparoscopic adjustable gastric band (LAGB) is a safe, effective, primary weight-loss operation for morbidly obese patients. The LAGB offers a simple, genuinely minimally invasive approach, with the potential to be attractive to many more patients. The key questions are whether it is effective in the longterm and whether it is safe. The midterm data confirm that, so far, LAGB is living up to its early promise as an effective tool. LAGB surgery is safe, and the change to the pars-flaccida approach will lead to even higher patient satisfaction and lower incidence of band removal.

Removal of peri-gastric fat prevents acute obstruction after Lap-Band surgery.

BACKGROUND: Acute postoperative gastroesophageal obstruction is a potential complication after laparoscopic adjustable gastric banding (LAGB). Utilizing the pars flaccida technique may increase the incidence due to the incorporation of perigastric fat, particularly in patients with greater visceral obesity. Removal of peri-gastric fat pads may be necessary to avoid postoperative obstruction. We present our experience of 267 LAGB operations using the LapBand System and the incidence of postoperative obstruction, before and after incorporating routine removal of peri-gastric fat pads. METHODS: A retrospective review of a prospective database of 267 consecutive Lap-Band placements between July 2001 and November 2002 was conducted. RESULTS: All operations were completed laparoscopically using the pars flaccida technique, and all patients underwent esophagogram the morning after surgery. From July 2001 to May 2002, 143 Lap-Band placements were performed, with 11 patients (8%) having abnormal postoperative esophagograms. There were 43 males/100 females with mean BMI 48.3 (range 35 to 78.9). Complete esophageal obstruction was seen in 5 of these patients, all of whom underwent laparoscopic revision. Significantly delayed emptying was seen in the 6 remaining patients, who were managed conservatively with intravenous fluids from 2-7 days. In these 11 patients, there were 6 males/5 females with mean BMI 47.1 (range 37.3-57.9). Subsequently, removal of peri-gastric fat pads was routinely performed during Lap-Band placement. From June 2002 to November 2002, there were 43 males/81 females with mean BMI 48 (range 35-79); these 124 Lap-Band placements were performed with no abnormal postoperative esophagograms. CONCLUSION: Routine removal of peri-gastric fat pads when using the pars flaccida technique for Lap Band surgery appears to prevent postoperative esophageal obstruction.

Endoscopy plays an important preoperative role in bariatric surgery.

BACKGROUND: The role of upper endoscopy (EGD) in obese patients prior to bariatric surgery is controversial. The aim of this study was to evaluate the diagnostic yield and cost of routine EGD before bariatric surgery. METHODS: The medical records of consecutive obese patients who underwent EGD prior to bariatric surgery between May 2000 and September 2002 were reviewed. Two experienced endoscopists reviewed all EGD reports, and findings were divided into 4 groups based on predetermined criteria: group 0 (normal study), group 1 (abnormal findings that neither changed the surgical approach nor postponed surgery), group 2 (abnormal findings that changed the surgical approach or postponed surgery), and group 3 (results that were an absolute contraindication to surgery). Clinically important findings included lesions in groups 2 and 3. The cost of EGD (430.72 US dollars) was estimated using the endoscopist fee under Medicare reimbursement. RESULTS: During the 28-month study period, 195 patients were evaluated by EGD prior to bariatric surgery. One or more lesions were identified in 89.7% of patients, with 61.5% having a clinically important finding. The prevalence of endoscopic findings using the classification system above was as follows: group 0 (10.3%), group 1 (28.2%), group 2 (61.5%), and group 3 (0.0%). Overall, the most common lesions identified were hiatal hernia (40.0%), gastritis (28.7%), esophagitis (9.2%), gastric ulcer (3.6%), Barrett's esophagus (3.1%), and esophageal ulcer (3.1%). The cost of performing routine endoscopy on all patients prior to bariatric surgery was 699.92 US dollars per clinically important lesion detected. CONCLUSIONS: Routine upper endoscopy before bariatric surgery has a high diagnostic yield and has a low cost per clinically important lesion detected.

Impact of patient follow-up on weight loss after bariatric surgery.

BACKGROUND: Postoperative follow-up after bariatric surgery is important. Because of the need for adjustments, follow-up after gastric banding may have a greater impact on weight loss than after Roux-en-Y gastric bypass. We reviewed all patients at 1 year after these two operations. METHODS: During the first year after surgery, laparoscopic adjustable gastric banding (LAGB) patients were followed every 4 weeks and Roux-en-Y gastric bypass (RYGBP) patients were followed at 3 weeks postoperatively and then every 3 months. The number of follow-up visits for each patient was calculated, and 50% compliance for follow-up and weight loss was compared. RESULTS: Between October 2000 and September 2002, 216 LAGB and 139 RYGBP operations were performed. Of these patients, 186 LAGB patients and 115 RYGBP patients were available for 1-year follow-up. Age and BMI were similar for each group. Overall excess weight loss (EWL) after LAGB was 44.5%. 130 (70%) returned 6 or less times in the first year and achieved 42% EWL. 56 patients (30%) returned more than 6 times and had 50% EWL (P=0.005). Overall %EWL after RYGBP was 66.1%. 53 patients (46%) returned 3 or less times in the first year, achieving 66.1% EWL. 62 patients (54%) returned more than 3 times after surgery and achieved 67.6% EWL (P=NS). CONCLUSION: Patient follow-up plays a significant role in the amount of weight lost after LAGB, but not after RYGBP. Patient motivation and surgeon commitment for long-term follow-up is critical for successful weight loss after LAGB surgery.

Radiologic assessment of the upper gastrointestinal tract: does it play an important preoperative role in bariatric surgery?

BACKGROUND: The role of upper GI series (UGIS) before bariatric surgery is controversial. The aim of this study was to evaluate the diagnostic yield and cost of routine UGIS prior to bariatric surgery. METHODS: The medical records of consecutive obese patients who underwent UGIS before bariatric surgery between April 2001 and October 2002 were reviewed. UGIS reports were reviewed by 2 experienced gastroenterologists, and the findings were divided into 4 groups based on predetermined criteria: group 0 (normal study), group 1 (abnormal findings that neither changed the surgical approach nor postponed surgery), group 2 (abnormal findings that changed the surgical approach or postponed surgery), and group 3 (results which were an absolute contraindication to surgery). Clinically important findings included lesions in groups 2 and 3. The cost of an upper GI series (154.80 USD) was estimated from the published 2002 New York State Medicare reimbursement schedule. RESULTS: During the 18-month study period, 171 patients were evaluated by UGIS prior to bariatric surgery. One or more lesions were identified in 48.0% of patients, with only 5.3% having clinically important findings. The prevalence of radiologic findings using the classification system above was as follows: group 0 (52.0%), group 1 (42.7%), group 2 (5.3%), and group 3 (0.0%). The most common findings identified were esophageal reflux (21.6%) and hiatal hernias (18.7%). The cost of performing routine UGIS on all patients before bariatric surgery was 2,941.20 USD per clinically important finding detected. CONCLUSIONS: Routine preoperative upper GI series before bariatric surgery had a low diagnostic yield, rarely revealing pathology that changed the surgical approach or postponed surgery.

Controversies in bariatric surgery: evidence-based discussions on laparoscopic adjustable gastric banding.

Laparoscopic adjustable gastric banding (LAGB) is a surgical option that involves placing a silicone band circumferentially around the uppermost aspect of the stomach. The band creates a small proximal pouch that empties slowly resulting in early satiety and a decreased appetite. The band is attached to an access port that is secured to the rectus muscle and can be accessed percutaneously in the office with a needle. Injection of saline into the port results in tightening of the band. This is performed on an individual basis according to weight loss and appetite. Band adjustments are required approximately 5-6 times in the first year and 2-3 times in the second year. Weight loss is gradual, averaging 1-2 lb/week during the first 2 years after surgery.

Serum fat-soluble vitamin deficiency and abnormal calcium metabolism after malabsorptive bariatric surgery.

Weight loss after biliopancreatic diversion or duodenal switch is due to decreased calorie absorption secondary to fat malabsorption. Fat malabsorption may also cause essential fat-soluble vitamin deficiencies, which may have severe clinical consequences and alter calcium metabolism. Serum vitamins A, D, E, and K, zinc, parathyroid hormone, corrected calcium, and alkaline phosphatase levels were measured in a cohort of patients who had previously undergone biliopancreatic diversion. Two bariatric surgery units were involved in the study: New York University School of Medicine (New York, NY), and the Wesley Medical Center (Brisbane, Australia). A total of 170 patients completed the study. The incidence of vitamin A deficiency was 69%, vitamin K deficiency 68%, and vitamin D deficiency 63% by the fourth year after surgery. The incidence of vitamin E and zinc deficiency did not increase with time after surgery. The incidence of hypocalcemia increased from 15% to 48% over the study period with a corresponding increase in serum parathyroid hormone values in 69% of patients in the fourth postoperative year. There is a progressive increase in the incidence and severity of hypovitaminemia A, D, and K with time after biliopancreatic diversion and duodenal switch. Calcium metabolism is affected with an increasing incidence of secondary hyperparathyrodisim and evidence of increased bone resorption in 3% of patients. Long-term nutritional monitoring is necessary after malabsorptive operations for morbid obesity.

US experience with the LAP-BAND system.

Laparoscopic adjustable gastric banding is the most commonly performed operation for morbid obesity in Europe and Australia and has been shown to result in significant long-term weight loss. The US Food and Drug Administration (FDA)-monitored clinical trial results with the LAP-BAND system (INAMED Health, Santa Barbara, CA) did not reproduce the results of studies performed elsewhere in the world. This article reviews data from the first and second FDA clinical trials as well as data from continuing US clinical experience. Four American surgeons at 4 centers have performed more than 500 LAP-BAND procedures not included in the first 2 FDA clinical trials. Of these patients, 115 have been followed for at least 9 months, and 43 have been followed for at least 12 months. A retrospective analysis of prospective data gathered from these patients is presented. The percent excess weight loss was 35.6% at 9 months and 41.6% at 12 months. The average body mass index decreased from 47.5 to 38.8 in 9 months and from 47.5 to 37.3 in 12 months. There were no deaths related to the insertion of the device. Of 15 complications requiring operative management (13%) in 12 patients, there were 8 port displacements or tubing breaks (7%), 2 elective explantations (2%), 2 cases of gastric prolapse (2%), 1 gastric pouch dilatation (<1%), 1 port abscess (<1%), and 1 hemorrhage (<1%). Clinical experience with the LAP-BAND system in the United States shows the device to be a safe and effective treatment for morbid obesity, with results comparable to the international data. The combination of proper surgical technique and close patient follow-up with frequent band adjustments, performed in a comprehensive bariatric program setting, may make the LAP-BAND system a powerful surgical tool in the treatment of morbid obesity.

Laparoscopic adjustable gastric banding: surgical technique.

Laparoscopic adjustable gastric banding is an effective and safe surgical treatment for morbid obesity. Initial experience with the Lap-Band system (Inamed Health, Santa Barbara, California) in the United States and Australia has demonstrated that surgical technique can affect outcomes in terms of weight loss, quality of life, and complication rates. Placement of the gastric band by means of the perigastric technique is associated with high rates of gastric prolapse, food intolerance, and weight loss failure that frequently lead to band explantation. In the pars flaccida technique, band placement higher on the stomach results in the formation of a smaller pouch and lower rates of gastric prolapse, which may contribute to greater weight loss and improved quality of life. This article describes the technical aspects of the pars flaccida approach in the laparoscopic placement of adjustable gastric bands.

Impact of laparoscopic adjustable gastric banding on pregnancy, maternal weight, and neonatal health.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a proven method for weight reduction. Less is known about pregnancies in patients after LAGB. METHODS: Information was gathered, through database and survey, on women who underwent LAGB at NYU Medical Center between 2001 and 2008 then became pregnant. RESULTS: Pregnancy occurred in 133 women, resulting in 112 babies, including six sets of twins. The average pre-pregnancy body mass index (BMI) was 32.7. Average weight gain was 11.5 kg, but was higher for those with pre-pregnancy BMI <30.0 compared to BMI >30.0 (16.4 vs 8.6 kg). Of singleton pregnancies, 89% were carried to full term, with cesarean section in 45%. Those with pre-pregnancy BMI <30.0 had a lower rate of cesarean section (35.71%), but it was not statistically significant (p = 0.55). Average birth weight was 3,268.6 g. Eight percent of babies from singleton pregnancies were low birth weight (<2,500 g), and seven percent were high birth weight (>4,000 g). Average Apgar scores at 1 and 5 min were 8.89 and 9.17. Four percent of patients developed gestational diabetes, and 5% developed pre-eclampsia. Band adjustments were performed in 71% of patients. Weight gain was higher in those who had their bands loosened in the first trimester (p = 0.063). Three patients had intrapartum band slips; one required surgery during pregnancy. CONCLUSIONS: LAGB is tolerable in pregnancy with rare intrapartum band slips. Weight gain is less in those with higher pre-pregnancy BMI and those who had their bands filled or not adjusted. Babies born to these mothers are as healthy as the general population.