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.

Primary sleeve gastrectomy compared to sleeve gastrectomy as revisional surgery: weight loss and complications at intermediate follow-up.

INTRODUCTION: The laparoscopic adjustable gastric band (LAGB) can be revised to sleeve gastrectomy (LSG) for various reasons. Data are limited on the safety and efficacy of single-stage removal of LAGB and creation of LSG. METHODS: A retrospective review of cases was performed from 2010 to 2013. From the primary LSG group, a control group was matched in a 2:1 ratio. RESULTS: Thirty-two patients underwent single-stage revision from LAGB to LSG, with a control group of 64. The most common indication for revision was insufficient weight loss (62.5%). Operative time for revision and control groups was 134 and 92 min, respectively (p < 0.0001). Hospital stay was 3.22 and 2.59 days, respectively (p = 0.02). Overall, the 30-day complication rate for revision and control patients was 14.71 and 6.25%, respectively (p = 0.20). There were no leaks, one stricture (3.13%) in the revision group, and one reoperation for bleeding in the control group (1.56%). For patients with BMI >30 at surgery, change in BMI at 12 months for revision and control was 8.77 and 11.58, respectively (p = 0.02). CONCLUSION: Single-stage revision can be performed safely, with minimal increases in hospital stay and 30-day complications. Weight loss is greater in those who undergo primary LSG compared to those who undergo LSG as revision.

Clinical outcomes of the Realize Adjustable Gastric Band-C at 2 years in a United States population.

BACKGROUND: In 2008, the Realize Band (RB) adopted a precurved design (RB-C). We present 2-year outcomes data from the first multiinstitutional study of RB-C. The objective of this study was to analyze weight loss and safety data from bariatric practices in the United States, including academic, nonacademic, public, and private. METHODS: The study included adult RB-C patients with a preoperative body mass index (BMI)≥40 kg/m(2) or >35 kg/m(2) with co-morbidity. Exclusions included RB-C's label contraindications for use. Outcomes parameters were percent excess weight loss (%EWL), BMI change, number and volume of band adjustments, and adverse events. RESULTS: A total of 231 patients met inclusion/exclusion criteria. Of these, 161 had 24-month data available. Mean %EWL was 44.4%±26.9% (P<.0001). BMI decreased from 44.1±5.7 kg/m(2) to 35.3±6.9 kg/m(2) (P<.0001). Percent EWL varied by preoperative BMI (P = .0002), bariatric practice (P<.0001), aftercare frequency (P = .0004), and band fill frequency (P = .0271), but %EWL was not influenced by gender, race, or age (P>.20 each). Adverse events were dysphagia (21.2%), gastroesophageal reflux (21.6%), and vomiting (30.7%). Incidence of pouch dilation, esophageal dilation, and slippage was ≤1%. Revisions (2.2%) were for unbuckled band, tube kinking, slippage, and suspected band leak (1 each). No erosions, explants, or mortality were reported. CONCLUSION: RB-C appears to be as well tolerated and effective as the first generation RB for weight loss. The near 45% EWL at 2 years is consistent with other high-quality publications on the RB. Preoperative BMI and frequency of postoperative care, including frequency of band fills, influence %EWL. Significant weight loss is achievable with RB-C despite variable postoperative management practices. The low morbidity and the absence of mortality at 24 months reflect positively on the RB-C characteristics.

Clinical outcomes of the REALIZE adjustable gastric band-C at one year in a U.S. population.

BACKGROUND: In 2008, the REALIZE Band (RB) adopted a precurved design (RB-C). The present study is the first multi-institutional report of RB-C outcomes. Our objective was to analyze the 1-year weight loss and safety data from adult RB-C patients treated at multiple U.S. centers (7 typical U.S. bariatric practices, including academic, nonacademic, public, and private practice). METHODS: Patients implanted with the RB-C (preoperative body mass index ≥ 40 kg/m(2) or >35 kg/m(2) with co-morbidity) were recruited. The exclusion criteria included the RB-C label contraindications for use. The outcomes parameters were the percentage of excess weight loss (%EWL), change in body mass index, number and volume of band adjustments, and incidence of complications. RESULTS: Of the 239 patients enrolled in the 2-year study, 158 had 1-year data available for analysis in November 2010. The mean %EWL was 39.2% ± 20.5% (range -7.7 to -116.8, P < .0001). The body mass index decreased from 44.4 ± 5.5 kg/m(2) to 36.4 ± 5.8 kg/m(2) (P < .0001). The variability in the %EWL was significant among the study centers (P < .0001). The average band fill volume at 1 year was 8.0 ± 2.0 mL (range .0-11.1). The total fill volume was >11 mL in 1 patient. No band erosions/migrations, explants, or deaths occurred. CONCLUSION: RB-C appears to be as safe and effective as the first-generation RB. The near 40% EWL at 1 year was consistent with other high-quality publications of the RB. Good weight loss results are achievable, despite the varying postoperative management practices. The low morbidity and the absence of mortality at 12 months reflect positively on the RB-C characteristics. Our findings suggest that the learning curve, related to the postoperative management of the RB-C, might vary by practice and that a greater frequency and smaller band fills might result in better weight loss at 12 months.

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.

Gastric electrical stimulation with the TANTALUS System in obese type 2 diabetes patients: effect on weight and glycemic control.

BACKGROUND: The TANTALUS System is an investigational device that consists of an implantable pulse generator connected to gastric electrodes. The system is designed to automatically detect when eating starts and only then deliver sessions of gastric electrical stimulation (GES) with electrical pulses that are synchronized to the intrinsic antral slow waves. We report the effect of this type of GES on weight loss and glucose control in overweight/obese subjects with type 2 diabetes mellitus (T2DM). This study was conducted under a Food and Drug Administration/Institutional Review Board-approved investigational device exemption. METHOD: Fourteen obese T2DM subjects on oral antidiabetes medication were enrolled and implanted laparoscopically with the TANTALUS System (body mass index 39 +/- 1 kg/m(2), hemoglobin A1c [HbA1c] 8.5 +/- 0.2%).Gastric electrical stimulation was initiated four weeks after implantation. Weight, HbA1c, fasting blood glucose, blood pressure, and lipid levels were assessed during the study period. RESULTS: Eleven subjects reached the 6-month treatment period endpoint. Gastric electrical stimulation was well tolerated by all subjects. In those patients completing 6 months of therapy, HbA1c was reduced significantly from 8.5 +/- 0.7% to 7.6 +/- 1%, p < .01. Weight was also significantly reduced from 107.7 +/- 21.1 to 102.4 +/- 20.5 kg, p < .01. The improvement in glucose control did not correlate with weight loss (R(2) = 0.05, p = .44). A significant improvement was noted in blood pressure, triglycerides, and cholesterol (low-density lipoprotein only). CONCLUSIONS: Short-term therapy with the TANTALUS System improves glucose control, induces weight loss, and improves blood pressure and lipids in obese T2DM subjects on oral antidiabetes therapy.

Effect of electrical stimulation of the LES on LES pressure in a canine model.

Gastric electrical stimulation modulates lower esophageal sphincter pressure (LESP). High-frequency neural stimulation (NES) can induce gut smooth muscle contractions. To determine whether lower esophageal sphincter (LES) electrical stimulation (ES) can affect LESP, bipolar electrodes were implanted in the LES of four dogs. Esophageal manometry during sham or ES was performed randomly on separate days. Four stimuli were used: 1) low-frequency: 350-ms pulses at 6 cycles/min; 2) high-frequency-1: 1-ms pulses at 50 Hz; 3) high-frequency-2: 1-ms pulses at 20 Hz; and 4) NES: 20-ms bipolar pulses at 50 Hz. Recordings were obtained postprandially. Tests consisted of three 20-min periods: baseline, stimulation/sham, and poststimulation. The effect of NES was tested under anesthesia and following IV administration of l-NAME and atropine. Area under the curve (AUC) and LESP were compared among the three periods, by ANOVA and t-test, P < 0.05. Data are shown as means +/- SD. We found that low-frequency stimulation caused a sustained increase in LESP: 32.1 +/- 12.9 (prestimulation) vs. 43.2 +/- 18.0 (stimulation) vs. 50.1 +/- 23.8 (poststimulation), P < 0.05. AUC significantly increased during and after stimulation. There were no significant changes with other types of ES. With NES, LESP initially rose and then decreased below baseline (LES relaxation). During NES, N(G)-nitro-l-arginine methyl ester increased both resting LESP and the initial rise in LESP and markedly diminished the relaxation. Atropine lowered resting LESP and abolished the initial rise in LESP. In conclusion, low frequency ES of the LES increases LESP in conscious dogs. NES has dual effect on LESP: an initial stimulation, cholinergically mediated, followed by relaxation mediated by nitric oxide.

Review of meta-analytic comparisons of bariatric surgery with a focus on laparoscopic adjustable gastric banding.

BACKGROUND: In a prior systematic review and meta-analysis of the large body of literature describing the laparoscopic adjustable gastric band (LAGB), outcomes for the Swedish Adjustable Gastric Band (SAGB) and Lap-Band (LB), in particular, were reviewed. This article summarizes those results and discusses them in relation to the 3 other published bariatric surgery meta-analyses (JAMA 2004;292:1724-37; Ann Intern Med 2005;142:547-59; and Surgery 2007;142:621-32). METHODS: In the gastric banding meta-analysis, systematic review included screening of 4,594 studies published in any language (Jan 1, 1998-April 30, 2006). Studies with at least 10 SAGB or LB patients reporting > or =30-day efficacy or safety outcomes were eligible for review; data were extracted from accepted studies. Weighted means analysis and random-effects meta-analysis of efficacy outcomes of interest were conducted. RESULTS: In the gastric banding meta-analysis, 129 studies (patients n = 28,980) were accepted (33 SAGB/104 LB studies). In 4,273 patients (36 treatment groups) in 33 SAGB studies, and in 24,707 patients (111 groups) in 104 LB studies, mean baseline age (39.1-40.2 yrs), body mass index ([BMI] 43.8-45.3 kg/m2), and sex (females 79.2%-82.5%) were similar. Three-year mean SAGB/LB excess weight loss (56.36%/50.20%) was significant, as was resolution of type 2 diabetes (61.45%/60.29%) and hypertension (62.95%/43.58%) (P < .05). Adverse event (AE) rates appeared comparable, and early mortality was equivalent (< or =.1%). DISCUSSION: In the SAGB and LB meta-analysis at 1, 2, and 3 years, weight loss, resolution of diabetes and hypertension, and adverse events appeared equivalent. All meta-analyses that assessed weight loss found that bariatric surgery produced clinically significant reductions in excess weight across procedures in the short term. One meta-analysis found that bariatric surgery produced significantly more weight loss than medical treatment in patients with BMI >40 kg/m2 in the short term, with malabsorptive procedures producing the greatest weight loss. All studies reporting on comorbidities showed significant resolution or improvement of type 2 diabetes mellitus ([T2DM] > or =60%), hypertension (> or =43%), and dyslipidemia (> or =70%). In one meta-analysis, surgery was found to be superior to medical therapy in resolving T2DM, hypertension, and dyslipidemia. Sleep apnea was significantly resolved/improved in > or =85% across procedures in the one meta-analysis that addressed this comorbidity. One meta-analysis found no differences in AEs between procedures; however, the laparoscopic approach was associated with significantly reduced AEs. In the 4 meta-analyses, mortality was low (.1%-1.11%) for all procedures. Bariatric surgery was observed to be a safe and highly effective therapy for morbid obesity. Heterogeneity in nomenclature, study methods, statistical detail, definitions of weight-loss success and comorbid disease resolution, and completeness of data sets did not allow for comparison of some variables. Initiatives including the Iowa Bariatric Surgery Registry (IBSR), the Longitudinal Assessment of Bariatric Surgery (LABS) consortium, the Surgical Review Corporation (SRC) Center of Excellence initiative, and the Bariatric Outcomes Longitudinal Database [BOLD] are working to improve data standardization, which, in turn, will facilitate summary and comparison of bariatric surgery outcomes.

Studies of Swedish adjustable gastric band and Lap-Band: systematic review and meta-analysis.

BACKGROUND: This is the first systematic review and meta-analysis of the large body of data describing the Swedish adjustable gastric band (SAGB) and Lap-Band (LB). METHODS: A systematic review was performed that included screening of studies published in any language (January 1, 1998 through April 30, 2006) identified through MEDLINE, Current Contents, or the Cochrane Library. Studies with > or =10 SAGB or LB patients reporting > or =30-day efficacy or safety outcomes were eligible for review; the data were extracted from the accepted studies. A weighted means analysis and random-effects meta-analysis of efficacy outcomes of interest were conducted. RESULTS: A total of 4592 bariatric surgery studies met the initial criteria. Of these studies, 129 (28,980 patients) were accepted (33 SAGB and 104 LB studies); most had a retrospective single-center design. For 4273 patients (36 treatment groups) in 33 SAGB studies and 24,707 patients (111 groups) in 104 LB studies, the mean baseline age (39.1-40.2 yr), body mass index (43.8-45.3 kg/m2), and gender (women 79.2-82.5%) were similar. A laparoscopic technique was used in > or =88% and a pars flaccida technique in > or =41% of both groups. Early mortality was equivalent for SAGB/LB (< or =.1%). The 3-year mean SAGB and LB excess weight loss (56.36% and 50.20%, respectively) and body mass index reduction (-11.99 and -11.81 kg/m2, respectively) from baseline were statistically significant (P <.05), as was the resolution of diabetes (61.45% and 60.29%, respectively) and hypertension (62.95% and 43.58%, respectively). Although scant and inconsistently reported data precluded direct statistical comparisons, the complication rates for the 2 devices appeared comparable. In 8 directly comparative studies, meta-analysis found a significantly greater absolute weight loss (P <.05) with the SAGB at 2 years (48.4 versus 41.9 kg, mean difference -4.84, 95% confidence interval -9.47 to -0.22), although no difference was found in the percentage of excess weight loss or change in body mass index. CONCLUSION: In a systematic review of the published world SAGB and LB data, at 1, 2, and 3 years, the weight loss, resolution of diabetes and hypertension, and complications appeared comparable.

The TANTALUS system for obesity: effect on gastric emptying of solids and ghrelin plasma levels.

BACKGROUND: Gastric electrical stimulation (GES), using the implantable TANTALUS System, is being explored as a treatment for obesity. The system delivers nonstimulatory electrical signals synchronized with gastric slow waves, resulting in stronger contractions. We hypothesized that this GES may enhance gastric emptying and as a result affect plasma ghrelin and insulin homeostasis. The aim was to test the effect of GES on gastric emptying of solids and on ghrelin and insulin blood levels in obese subjects. METHODS: The system consists of 3 pairs of gastric electrodes connected to an implantable pulse generator. Gastric emptying test (GE) of solids was performed twice, on separate days, a few weeks after implantation, before and after initiation of stimulation. Blood samples for ghrelin and insulin were taken at baseline and at 15, 30, 60 and 120 min after the test meal. RESULTS: There were 11 females, 1 male, mean age 39.1 +/- 8.9 years, mean BMI 41.6 +/- 3.4. Data is available from 11 subjects; GE was normal in 9 subjects and accelerated in 2 subjects. GES significantly accelerated GE compared to control: percent retention at 2 hours 18.7 +/- 12.2 vs 31.9 +/- 16.4, respectively (P < 0.01). Overall, there was no significant change in ghrelin or insulin profile after food intake. Ghrelin levels fell significantly at 60 min compared to baseline during stimulation (P = 0.014) and control (P = 0.046). CONCLUSION: GES results in a significant acceleration of gastric emptying of solids in obese subjects. GES did not have a significant effect on postprandial ghrelin levels when compared to control.

Device-related reoperations after laparoscopic adjustable gastric banding.

Laparoscopic adjustable gastric banding (LAGB) is considered a relatively safe weight loss procedure with low morbidity. When complications occur, obstruction, erosion, and port malfunction require reoperation. We retrospectively reviewed our experience with 270 consecutive patients who underwent LAGB. Device-related reoperations were performed in 26 (10%) patients. Reoperations were related to the band in 13, to port/tubing in 11, and related to both in 2 patients. Of the 15 band-related problems, it was removed in 5 (2%): slippage (3), intra-abdominal abscess (1), and during emergent operation for bleeding duodenal ulcer (1). Revision or immediate replacement was performed in 10 (4%): slippage (5), obstruction (4), and leak from the reservoir (1). Port/tubing problems were the reason for reoperations in 13 (5%): infection (5), crack at tubing-port connection (6), and port rotation (2). Port removal for infection was followed later by port replacement (average 9 months). Overall, slippage occurred in 8 (3%), obstruction in 4 (1.5%), leak from reservoir in 7 (3%), and infection in 5 (2%) patients. Fifteen device-related problems occurred during our first 100 cases and 12 subsequently (P = 0.057). Permanent LapBand loss was only 5 per cent, leading to overall rate of 95 per cent of LapBand preservation as a restrictive device.

Analysis of causes and prevention of early readmission to surgical intensive care.

The purpose of this study was to analyze causes of early readmission to the surgical intensive care unit (SICU), to determine whether readmission can be predicted or prevented, and to compare outcomes of patients readmitted to the SICU with patients not requiring readmission. All patients admitted to the Cedars-Sinai SICU from January 1, 1996, to December 31, 2001, were included. Clinical data was prospectively collected in an on-line computer system. The charts of all early readmission patients were retrospectively reviewed. SICU and hospital outcomes were abstracted from a computerized data warehouse. During the study period, 10,840 patients were admitted to the SICU including 97 (0.89%) early readmissions. SICU admission APACHE II and SAPS I scores, SICU and hospital length of stay, and mortality were significantly higher in readmitted patients compared to patients not requiring readmission. The majority of early SICU readmissions were due to respiratory and neurologic deterioration. Upon review, 62 per cent of all readmissions met appropriate SICU discharge criteria and were not predictable while only 5 per cent of SICU discharge were felt to have been premature. Patient outcomes are adversely affected by early readmission to the SICU. Careful neurologic assessment, meticulous attention to respiratory care transfer orders, and prompt respiratory therapy on floor care may significantly decrease the need for early readmission to the SICU.