Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.

Safety and effectiveness of LAP-BAND AP System: results of Helping Evaluate Reduction in Obesity (HERO) prospective registry study at 1 year.

BACKGROUND: Laparoscopic adjustable gastric banding has several distinctive features, including band adjustability, easy reversibility, and lack of malabsorption, which contribute to its widespread use. The LAP-BAND AP System (LBAP; Allergan, Inc.), a redesigned and improved version of the original device, was approved by the US Food and Drug Administration in 2006. Because of limited information on LBAP, this study prospectively assesses the efficacy and safety of LBAP in real-world settings at clinical centers located in North America, Europe, and Australia. STUDY DESIGN: This interim report of the ongoing 5-year prospective, observational, international, multicenter registry, Helping Evaluate Reduction in Obesity (HERO) Study (NCT00953173), describes clinical efficacy and safety of LBAP in real-world settings at 1 year. RESULTS: One thousand one hundred and six patients were implanted with LBAP and 1-year data were available from 834 patients for efficacy analysis. At 1 year, the mean (SD) percentage of excess weight loss was 39.8% (22.3%), of weight loss was 16.9% (9.0%), and the mean (SD) body mass index decreased to 37.7 (7.0) kg/m(2) from 45.1 (6.9) kg/m(2) at baseline. Patients with type 2 diabetes mellitus or hypertension showed significant improvements at 1 year post LBAP (both p < 0.005). The most common device-related complications were port displacement (n = 20 [1.8%]), pouch dilation (n = 12 [1.1%]), band slippage (n = 7 [0.6%]), and band erosion (n = 5 [0.5%]). Eighteen (1.6%) patients had the device explanted. CONCLUSIONS: At 1 year post LBAP, progressive weight loss was associated with improvement and/or resolution of comorbid conditions and was safe and well tolerated. Patient follow-up continues.

Port fixation during gastric banding: 4-year outcome using a synthetic mesh.

BACKGROUND: Laparoscopic adjustable gastric banding surgery is one of the most popular procedures for patients with morbid obesity. Although it is one of the least invasive surgical treatments for obesity, the most common reasons for reoperation are complications arising from the subcutaneous reservoir (port) used to adjust the band. Mesh fixation of the port, in which the port is sutured to a piece of mesh and then placed without anchoring sutures onto the fascia is a method of securing the port. The purpose of the present study was to review the experience of a single surgeon (S.B.) with mesh fixation in >500 patients during a 4-year period and to assess the safety and efficacy of this technique in private practice in United States. METHODS: A total of 564 patients underwent laparoscopic gastric banding during a 4-year period from January 2007 to January 2011. During these operations, the subcutaneous port was affixed to the fascia by suturing the port to a small piece of polypropylene mesh and then placing the port onto the fascia without any additional anchoring sutures or staples. RESULTS: Of 564 patients, only 2 required reoperation to reposition the subcutaneous port, for a .3% port flip rate. We also report the findings during elective reoperation for plastic surgery or revision surgery. CONCLUSION: Mesh fixation of the subcutaneous port is simple, inexpensive, and highly effective and has an extremely low complication rate.

Effect of early weight loss on type 2 diabetes mellitus after 2 years of gastric banding.

OBJECTIVE: Laparoscopic adjustable gastric banding (LAGB) is an established bariatric surgical procedure that produces meaningful weight loss and improvements in patients with type 2 diabetes mellitus (T2DM) and a body mass index (BMI) ≥ 30 kg/m2. This study examined the effect of LAGB on T2DM status in severely obese patients with T2DM. METHODS: This was a 2-year interim analysis of patients with T2DM who required daily hypoglycemic medication at baseline (N = 89) in the 5-year, open-label, prospective, observational LAP-BAND AP® EXperience (APEX) trial. Type 2 diabetes mellitus status was classified as "remission," "improved," "stable," or "worse" based on physician- and patient-reported changes in T2DM control and changes in hypoglycemic medication use. RESULTS: At baseline, 89 (22.5%) of 395 patients required daily hypoglycemic medication; 66 patients had data available after 2 years. Remission of T2DM occurred in 32 (48.5%) patients, improvement occurred in 31 (47.0%) patients, and no change occurred in 3 (4.5%) patients. Overall, 95.5% of patients experienced remission or improvement in T2DM status. Duration of T2DM in patients with remission or improvement after 2 years was 4.0 and 6.7 years, respectively (P = 0.082 between groups), and was associated with change in T2DM status (logistic regression, P = 0.069). Baseline BMI, change in BMI, and percent weight loss were not significantly different between the T2DM response groups. Percent excess weight loss was numerically, but not statistically significantly, greater in remitted (-56.1%) compared with the improved response (-42.9%) group (P = 0.134), and was correlated with change in T2DM status (logistic regression, P = 0.052). After 2 years, patients experienced remission or improvement of other obesity comorbidities. The rate of revisional surgery or explantation was 3.4%, and it was not significantly different between patients with and without T2DM (P = 0.687). CONCLUSION: Shorter duration of T2DM and greater percent excess weight loss were associated with an increased likelihood of remission or improvement in T2DM status through LAGB after 2 years. Laparoscopic adjustable gastric banding is a potential adjunctive treatment for obese patients with T2DM.

Revisional surgery after heller myotomy for treatment of achalasia: a comparative analysis focusing on operative approach.

Surgical myotomy is the gold standard in therapy for achalasia, but treatment failures occur and require revisional surgery. A MEDLINE search of peer-reviewed articles published in English from 1970 to December 2008 was performed using the following terms: esophageal achalasia, Heller myotomy, and revisional surgery. Thirty-three articles satisfied our inclusion criteria. A total of 12,727 patients, with mean age of 43.3 years (males 46% and females 50%), underwent Heller myotomy (open 94.8% and laparoscopic 5.2%). Revisional surgery was performed in 6.19%. Procedures performed included revision of the original myotomy or creation of a new myotomy with or without an antireflux procedure or esophagectomy. Reasons for reoperation were incomplete myotomy (51.8%), onset of reflux (34%), megaesophagus (16.2%), and esophageal carcinoma (3.04%). Systematic review of the literature for revisional surgery following Heller myotomy revealed a 6.19% rate of reoperation with a low mortality rate.

Interim results at 48 weeks of LAP-BAND AP experience (APEX) study: prospective, multicenter, open-label longitudinal patient observational study.

BACKGROUND: The development of laparoscopic adjustable gastric banding marked a breakthrough in minimally invasive bariatric surgery. The unique features of gastric banding, including device adjustability, lack of malabsorption, and easy reversibility, have contributed to its widespread use. Since Food and Drug Administration approval of the first laparoscopic adjustable gastric band, the device design has undergone engineering improvements. The LAP-BAND AP (LBAP) system received Food and Drug Administration approval in 2006. Little is known about the safety and efficacy of this new system. Our objective was to prospectively assess the efficacy and safety of the LBAP system in real-world clinical settings at 50 clinical centers throughout the United States. METHODS: In an open-label 5-year evaluation, 508 severely or morbidly obese patients from 50 centers in the United States underwent surgery using the LBAP system. The present interim report describes the results from 323 patients after ≥ 48 weeks of follow-up. RESULTS: By week 48, the patients had experienced a mean percentage of excess weight loss of 46% and a mean ± standard deviation reduction in the body mass index of 8.4 ± 3.69 kg/m(2). Sixteen patients (3.1%) experienced a severe device- or procedure-related adverse event. There were no deaths. CONCLUSION: These 48-week interim data demonstrate that the LBAP system offers a safe and effective therapy to reduce weight in severely obese patients.

Safety and effectiveness of bariatric surgery: Roux-en-y gastric bypass is superior to gastric banding in the management of morbidly obese patients: a response.

BACKGROUND: The recent article by Guller, Klein, Hagen was reviewed and discussed by the authors of this response to critically analyze the validity of the conclusions, at a time when patients and providers depend on peer reviewed data to guide their health care choices. The authors of this response all have high volume bariatric surgery practices encompassing experience with both gastric bypass and gastric banding, and have made significant contributions to the peer reviewed literature. We examined the assumptions of the paper, reviewed the main articles cited, provided more evidence from articles that were included in the materials and methods of the paper, but not cited, and challenge the conclusion that Roux-en-Y gastric bypass is superior to gastric banding. RESULTS AND DISCUSSION: The paper by Guller et al was subject to significant bias. The authors did not demonstrate an understanding of gastric banding, selectively included data with unfavorable results towards gastric banding, did not provide equal critique to the literature on gastric bypass, and deliberately excluded much of the favorable data on gastric banding. CONCLUSION: The paper's conclusion that gastric bypass is the procedure of choice is biased, unsubstantiated, not supported by the current literature and represents a disservice to the scientific and health care community.

Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States.

BACKGROUND: The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. METHODS: A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. RESULTS: Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 + or - 9.4 years (range 18-61), and the preoperative body mass index was 44.5 + or - 4.7 kg/m(2). The mean hospital stay was 1.2 + or - 1.3 days. At 3 years, the average excess weight loss was 41.1% + or - 25.1% or a decrease in the body mass index of 8.2 kg/m(2) (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A(1)c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. CONCLUSION: The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.

Safe and rapid laparoscopic access--a new approach.

Despite numerous recent technical advances in minimally invasive surgical technique, the potential exists for serious morbidity during initial laparoscopic access. Safe access depends on adhering to well-recognized principles of trocar insertion, knowledge of abdominal anatomy, and recognition of hazards imposed by previous surgery. Applying these principles, we describe a safe, rapid, and cost-effective technique for laparoscopic access using readily available instruments. This technique emphasizes identification and incision of the point at which the midline abdominal fascia is fused with the base of the umbilicus, and the importance of the application of countertraction directly at the point of insertion. This method allows penetration under direct vision with minimal controlled axial force, and without the requirement for fascial sutures or other cumbersome aspects of the traditional open technique. While previous reports describe techniques for laparoscopic access entry based on similar anatomic and surgical principles, we describe an alternative method not yet discussed in the surgical literature.