30-Day Postoperative Outcomes in Patients With Limited Mobility - A Propensity Score-Matched Comparative Analysis.

INTRODUCTION: There is limited data correlating preoperative mobility limitations with clinical outcomes in bariatric patients. This study uses propensity score matching (PSM) to compare 30-day outcomes between patients with preoperative limited mobility (LM) versus patients without (non-LM). METHODS: Using the 2016-2018 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database, patients undergoing primary laparoscopic sleeve gastrectomy or gastric bypass were identified. Two cohorts were defined using preoperative LM status. To adjust for confounders, 1:1 PSM was performed using 25 preoperative characteristics, and balance was assessed with standardized mean difference. Preoperative patient demographics and postoperative 30-day outcomes were compared in both matched and unmatched cohorts. RESULTS: 453,146 patients were identified, of which 6942 (1.47%) were LM and 464,555 were non-LM. 1:1 PSM matched 6624 LM to 6624 non-LM patients with good balance for all covariates. LM had higher rates of unplanned intubation (0.4% vs 0.7%, P < .01), unplanned admission to ICU (1.4% vs 2.5%, P < .01), readmissions (4.1% vs 4.9%, P = .036), unplanned reoperation (1.5% vs 2.0%, P = .02), and 30-day mortality (0.2% vs 0.5%, P = .02). Complications including acute renal failure, intra/postoperative myocardial infarction, venous thrombosis, and pulmonary embolism were not significantly different between the matched groups. CONCLUSION: After adjusting for confounders, patients with preoperative limited mobility have higher rates of intubation, ICU admission, reoperation, readmission, and mortality. Prudent pre-operative candidate selection, counseling, and risk mitigation strategies are needed when a patient with limited mobility status is being considered for bariatric surgery.

Conversion of laparoscopic sleeve gastrectomy to Roux-en-Y gastric bypass: patterns predicting persistent symptoms after revision.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is the most common bariatric operation performed. However, it is not without its drawbacks and patients may develop gastroesophageal reflux (GERD) after LSG. There are limited data available to guide treatment choice for patients suffering these sequelae. OBJECTIVE: This study was undertaken to evaluate the success of conversion to Roux-en-Y gastric bypass (RYGB) in treating GERD symptoms after LSG. SETTING: Single bariatric center, United States. METHODS: Analysis of a prospectively maintained clinical database was performed. Outcomes studied included heartburn-related quality of life score (GERD-HRQL), anti-secretory usage, and body mass index (BMI). RESULTS: A total of 54 patients met inclusion criteria during the review period. Of these, 41 patients (76%) underwent conversion for indication including GERD. Mean BMI at conversion was 33.8 ± 5.61 and was found to be significantly reduced at 12 months after conversion (n = 26; 63%; P < .001) and at long-term follow-up (n = 37; 90%) (P ≤ .001; mean follow-up period: 33.3 mo). Mean GERD-HRQL at time of conversion was 31.5 ± 11.4. Conversion to RYGB produced a significant reduction of HRQL at 6 months after conversion (n = 30; 73%) (mean: 5.6, P < .001) and long-term follow-up (n = 38; 93%) (mean: 7.3, P < .001. mean follow-up period: 15.1 mo). Prior to conversion, 32 patients (78%) required antisecretory therapy for GERD and after conversion, 12 of these patients (38%) required antisecretory therapy (P < .001). These 12 patients were found to exhibit a significantly (P = .005) smaller decrease in GERD-HRQL after revision compared with their peers who were liberated from antisecretory therapy. Preoperative symptoms were compared between these 2 groups. Delayed onset of GERD symptoms after LSG (>3 mo) was found to be a significant risk factor for continued antisecretory dependence after conversion to RYGB. CONCLUSION: Conversion of LSG to RYGB quantitatively reduces GERD symptoms, and results in a modest but significant amount of weight loss. While there was a significant improvement in HRQL after revision, a subgroup of patients continued to be antisecretory-dependent and showed a limited improvement in HRQL. This limited response was predicted by a gradual onset of GERD symptoms prior to revision. An interval of 3 months or greater between LSG and onset of symptoms was found to be a significant risk factor for limited response to conversion.

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.

Median Arcuate Ligament Syndrome and Its Associated Conditions.

The risk factors and associated conditions of median arcuate ligament syndrome (MALS) have not been well characterized in the literature. In this study, we aim to investigate the presentation and outcomes of MALS patients with an emphasis on the prevalence of other uncommon disorders. To this end, data of patients with MALS who underwent surgery between 2013 and 2018 were collected and compiled into a retrospective database and analyzed. Eleven patients were identified. Seven of these eleven patients underwent diagnostics to evaluate gastric emptying. Five of these seven patients (71.4%) had radiographic evidence of delayed gastric emptying. Four of the eleven patients (36.4%) were found to have anatomic abnormalities of their visceral vasculature. Two of the eleven patients (18.2%) were found to have connective tissue disorders, both with Ehlers-Danlos syndrome. Three of the eleven (27.3%) had a diagnosis of postural orthostatic tachycardia syndrome. This is the first case series reporting on an association between MALS and delayed gastric emptying. We also explored the relationship between MALS and visceral vascular abnormalities, Ehlers-Danlos syndrome, and postural orthostatic tachycardia syndrome. It is notable that these conditions are more prevalent in the MALS population than in the general population, suggesting a possible pathophysiologic relationship.

Association of Wearable Activity Monitors With Assessment of Daily Ambulation and Length of Stay Among Patients Undergoing Major Surgery.

Importance: Early postoperative ambulation is vital to minimizing length of stay (LOS), but few hospitals objectively measure ambulation to predict outcomes. Wearable activity monitors have the potential to transform assessment of postoperative ambulation, but key implementation data, including whether digitally monitored step count can identify patients at risk for poor efficiency outcomes, are lacking. Objectives: To define the distribution of digitally measured daily step counts after major inpatient surgical procedures, to assess the accuracy of physician assessment and ordering of ambulation, and to quantify the association of digitally measured step count with LOS. Design, Setting, and Participants: Prospective cohort study at Cedars-Sinai Medical Center, an urban tertiary referral center. Participants were patients undergoing 8 inpatient operations (lung lobectomy, gastric bypass, hip replacement, robotic cystectomy, open colectomy, abdominal hysterectomy, sleeve gastrectomy, and laparoscopic colectomy) from July 11, 2016, to August 30, 2017. Interventions: Use of activity monitors to measure daily postoperative step count. Main Outcomes and Measures: Operation-specific daily step count, daily step count by physician orders and assessment, and a prolonged LOS (>70th percentile for each operation). Results: Among 100 patients (53% female), the mean (SD) age was 53 (18) years, and the median LOS was 4 days (interquartile range, 3-6 days). There was a statistically significant increase in daily step count with successive postoperative days in aggregate (r = 0.55; 95% bootstrapped CI, 0.47-0.62; P < .001) and across individual operations. Ninety-five percent (356 of 373) of daily ambulation orders were "ambulate with assistance," although daily step counts ranged from 0 to 7698 steps (0-5.5 km) under this order. Physician estimation of ambulation was predictive of the median step count (r = 0.66; 95% bootstrapped CI, 0.59-0.72; P < .001), although there was substantial variation within each assessment category. For example, daily step counts ranged from 0 to 1803 steps (0-1.3 km) in the "out of bed to chair" category. Higher step count on postoperative day 1 was associated with lower odds of prolonged LOS from 0 to 1000 steps (odds ratio [OR], 0.63; 95% CI, 0.45-0.84; P = .003), with no further decrease in odds after 1000 steps (OR, 0.99; 95% CI, 0.75-1.30; P = .80). Conclusions and Relevance: In this study, digitally measured step count up to 1000 steps on postoperative day 1 was associated with lower probability of a prolonged LOS. Wearable activity monitors improved the accuracy of assessment of daily step count over the current standard of care, providing an opportunity to identify patients at risk for poor efficiency outcomes.

Single-stage revision from gastric band to gastric bypass or sleeve gastrectomy: 6- and 12-month outcomes.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is increasingly requiring revisional surgery for complications and failures. Removal of the band and conversion to either laparoscopic Roux-en-y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) is feasible as a single-stage procedure. The objective of this study is to compare the safety and efficacy of single-stage revision from LAGB to either LRYGB or LSG at 6 and 12 months postoperatively. METHODS: Retrospective analysis was performed on patients undergoing single-stage revision between 2009 and 2014 at a single academic medical center. Patients were reassessed for weight loss and complications at 6 and 12 months postoperatively. RESULTS: Thirty-two patients underwent single-stage revision to LRYGB, and 72 to LSG. Preoperative BMIs were similar between the two groups (p = 0.27). Median length of stay for LRYGB was 3 days versus 2 for LSG (p = 0.14). Four patients in the LRYGB group required reoperation within 30 days, and two patients in the LSG group required reoperation within 30 days (p = 0.15). There was no difference in ER visits (p = 0.24) or readmission rates (p = 0.80) within 30 days of operation. Six delayed complications were seen in the LSG group with three requiring intervention. At 6 months postoperatively, percent excess weight loss (%EWL) was 50.20 for LRYGB and 30.64 for LSG (p = 0.056). At 12 months, %EWL was 51.19 for LRYGB and 34.89 for LSG (p = 0.31). There was no difference in diabetes or hypertension medication reduction at 12 months between LRYGB and LSG (p > 0.07). CONCLUSION: Single-stage revision from LAGB to LRYGB or LSG is technically feasible, but not without complications. The complications in the bypass group were more severe. There was no difference in readmission or reoperation rates, weight loss or comorbidity reduction. Revision to LRYGB trended toward higher rate and greater severity of complications with equivalent weight loss and comorbidity reduction.

Bariatric surgery as a possible risk factor for spontaneous intracranial hypotension.

OBJECTIVE: To evaluate a possible link between bariatric surgery and spontaneous intracranial hypotension. METHODS: The frequency of bariatric surgery was examined in a group of 338 patients with spontaneous intracranial hypotension and compared with a group of 245 patients with unruptured intracranial aneurysms. RESULTS: Eleven (3.3%) of the 338 patients with spontaneous intracranial hypotension had a history of bariatric surgery compared with 2 (0.8%) of the 245 patients with intracranial aneurysms (p = 0.02). Among the 11 patients with spontaneous intracranial hypotension after bariatric surgery, the mean age at the time of bariatric surgery was 40.8 years (range, 26-53 years) and the mean age at the time of onset of spontaneous intracranial hypotension was 45.6 years (range, 31-59 years). Weight at the time of bariatric surgery ranged from 95 to 166 kg (mean, 130 kg) (body mass index range: 34.9-60.1 kg/m(2); mean: 44.6). Weight at the time of onset of symptoms of spontaneous intracranial hypotension ranged from 52 to 106 kg (mean, 77.5 kg) (body mass index range: 19.2-32.1 kg/m(2); mean: 26.4). The mean weight loss from bariatric surgery to onset of spontaneous intracranial hypotension was 52.5 kg (range, 25-98 kg). Time interval from bariatric surgery to onset of symptoms of spontaneous intracranial hypotension ranged from 3 to 241 months (mean, 56.5 months). CONCLUSIONS: This case-control study shows that bariatric surgery is a potential risk factor for spontaneous intracranial hypotension.

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.

Use of a disposable acupressure device as part of a multimodal antiemetic strategy for reducing postoperative nausea and vomiting.

BACKGROUND: There is still controversy regarding the optimal strategy for managing postoperative nausea and vomiting (PONV) in high-risk surgical populations. Although acustimulation at the P6 acupoint has been demonstrated to be effective in preventing PONV, the effect of this nonpharmacologic therapy on the patient's recovery with respect to resumption of normal activities of daily living has not been previously assessed when it is used as part of a multimodal antiemetic regimen. Therefore, we designed this randomized, sham-controlled, and double-blind study to assess the efficacy of a disposable acupressure device (Pressure Right®; Pressure Point Inc., Grand Rapids, MI) on the incidence of emetic episodes and quality of recovery when used in combination with ondansetron and dexamethasone for antiemetic prophylaxis. METHODS: One hundred ASA physical status I and II patients undergoing major laparoscopic procedures were randomly assigned to either a control group (n = 50) receiving a "sham" acustimulation device or an acupressure group (n = 50) receiving a disposable Pressure Right device placed bilaterally at the P6 point 30 to 60 minutes before induction of anesthesia. All patients received a standardized general anesthetic. A combination of ondansetron, 4 mg IV, and dexamethasone, 4 mg IV, was administered during surgery for antiemetic prophylaxis in both study groups. The incidence of nausea and vomiting and the need for "rescue" antiemetic therapy were assessed at specific time intervals for up to 72 hours after surgery. The recovery profiles and quality of recovery questionnaires were evaluated at 48 hours and 72 hours after surgery. Patient satisfaction with the management of their PONV was assessed at the end of the 72-hour study period. RESULTS: The 2 study groups did not differ in their demographic characteristics or risk factors for PONV. The incidence of vomiting at 24 hours was significantly decreased in the acupressure group (10% vs 26%, P = 0.04, 95% confidence interval for absolute risk reduction 1%-31%). The overall incidence of vomiting from 0 to 72 hours after surgery was also significantly decreased from 30% to 12% in the acupressure group (P = 0.03, 95% confidence interval 2%-33%). Furthermore, adjunctive use of the acupressure device seemed to enhance patient satisfaction with their PONV management and quality of recovery at 48 hours after surgery. However, the recovery times to hospital discharge, resumption of normal physical activities, and return to work did not differ significantly between the 2 study groups. CONCLUSION: Use of the Pressure Right acupressure device in combination with antiemetic drugs provided a reduction in the incidence of vomiting from 0 to 72 hours after surgery with an associated improvement in patient satisfaction with their PONV management. However, recovery and outcome variables failed to demonstrate any improvement with the addition of the acupressure device.

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.

The use of oral granisetron versus intravenous ondansetron for antiemetic prophylaxis in patients undergoing laparoscopic surgery: the effect on emetic symptoms and quality of recovery.

Based on comparative studies in patients receiving emetogenic chemotherapy, it has been suggested that granisetron would be more effective than ondansetron for the prevention of postdischarge nausea and vomiting (PDNV). However, there have been no direct comparisons of these two popular 5-HT3 antagonists with respect to PDNV and quality of recovery. We designed this randomized, double-blind study to compare the antiemetic efficacy of oral granisetron (1 mg) to a standard IV dose of ondansetron (4 mg) when administered for antiemetic prophylaxis as part of a multimodal regimen in a laparoscopic surgical population. A total of 220 patients undergoing laparoscopic surgery with a standardized general anesthetic technique were enrolled in this prospective study at two major medical centers. Patients were randomly assigned to one of two prophylactic treatment groups: the control (ondansetron) group received an oral placebo 1 h before surgery and ondansetron, 4 mg IV, at the end of the surgery, and the granisetron group received granisetron, 1 mg per os, 1 h before surgery, and normal saline, 2 mL IV, at the end of the surgery. The early recovery profiles, requirement for rescue antiemetics, incidence of PDNV, and the side effects were recorded over the 48 h study period. In addition, nausea scores were assessed using an 11-point verbal rating scale at specific intervals in the postoperative period. The quality of recovery and patient satisfaction scores were recorded at 48 h after surgery. The demographic characteristics were similar in the two prophylaxis treatment groups, as well as the recovery times to patient orientation, oral intake, and hospital discharge. The incidences of PDNV, requirements for rescue antiemetics, and quality of recovery did not differ between the two study groups. The antiemetic drug acquisition costs to achieve comparable patient satisfaction with ondansetron and granisetron were US 25.65 dollars and 47.05 dollars, respectively. Therefore, ondansetron (4 mg IV) was more cost-effective than granisetron (1 mg per os) for routine antiemetic prophylaxis as part of a multimodal regimen in patients undergoing either outpatient or inpatient laparoscopic surgery.