Safety and efficacy of bariatric surgery in patients with advanced fibrosis.

BACKGROUND: Bariatric surgery is performed safely in non-alcoholic fatty liver disease (NAFLD) patients with minimal fibrosis (stage 1-2). However, the safety and potential benefits of bariatric surgery for NAFLD with advanced fibrosis (stage 3-4) remain unclear. This study was designed to compare the safety and efficacy of bariatric surgery in patients with biopsy proven advanced fibrosis to those with minimal fibrosis. METHODS: All patients who underwent bariatric surgery between 2005 and 2014 and had evidence of NAFLD with fibrosis score 3-4 (advanced fibrosis) based on the staging system defined by Kleiner et al. on intraoperative liver biopsy were included and compared with patients who had fibrosis score 1-2 (minimal fibrosis). The groups were compared for length of hospital stay after bariatric surgery and incidence of postoperative complications over a follow-up period of 1 year. An improvement in hepatic function tests before and 1 year after surgery was used as a parameter to evaluate for NAFLD improvement. RESULTS: Ninety-nine patients with F3-4 (group 1) and 198 patients with F1-2 (group 2) were included. Mean age (51.9 vs 50.1 years) and body mass index (46.4 vs 46.5 kg m-2) were similar in the two groups. Median serum aspartate aminotransferase (43 vs 30 U l-1; normal 10-40 U l-1) and alanine aminotransferase (40.5 vs 34 U l-1; normal 10-50 U l-1) were significantly higher in group 1 and improved 1 year after surgery. Median length of hospital stay after surgery was higher in group 1 than that in group 2 (4 days vs 3 days; P-value=0.002). The proportion of patients developing postoperative complications over 1 year was similar in both groups (36.4% vs 32.8%; P-value=0.54). CONCLUSIONS: Advanced fibrosis does not increase the risk of developing postoperative complications in medically optimized patients undergoing bariatric surgery. Improvement in serum transaminase levels suggests a reduction in hepatic necroinflammatory activity following bariatric surgery.

How safe is metabolic/diabetes surgery?

Although recent studies have shown the impressive antidiabetic effects of laparoscopic Roux-en-Y gastric bypass (LRYGB), the safety profile of metabolic/diabetes surgery has been a matter of concern among patients and physicians. Data on patients with type 2 diabetes who underwent LRYGB or one of seven other procedures between January 2007 and December 2012 were retrieved from the American College of Surgeons National Surgical Quality Improvement Program database and compared. Of the 66 678 patients included, 16 509 underwent LRYGB. The composite complication rate of 3.4% after LRYGB was similar to those of laparoscopic cholecystectomy and hysterectomy. The mortality rate for LRYGB (0.3%) was similar to that of knee arthroplasty. Patients who underwent LRYGB had significantly better short-term outcomes in all examined variables than patients who underwent coronary bypass, infra-inguinal revascularization and laparoscopic colectomy. In conclusion, LRYGB can be considered a safe procedure in people with diabetes, with similar short-term morbidity to that of common procedures such as cholecystectomy and appendectomy and a mortality rate similar to that of knee arthroplasty. The mortality risk for LRYGB is one-tenth that of cardiovascular surgery and earlier intervention with metabolic surgery to treat diabetes may eliminate the need for some later higher-risk procedures to treat diabetes complications.

Improved acylated ghrelin suppression at 2 years in obese patients with type 2 diabetes: effects of bariatric surgery vs standard medical therapy.

OBJECTIVE: Roux-en-Y gastric bypass (RYGB) produces more durable glycemic control than sleeve gastrectomy (SG) or intensive medical therapy (IMT). However, the contribution of acylated ghrelin (AG), a gluco-regulatory/appetite hormone, to improve glucose metabolism and body composition in patients with type 2 diabetes (T2D) following RYGB is unknown. DESIGN: STAMPEDE (Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently) was a prospective, randomized controlled trial. SUBJECTS: Fifty-three (body mass index: 36±3 kg m(-2), age: 49±9 years) poorly controlled patients with T2D (HbA1c (glycated hemoglobin): 9.7±2%) were randomized to IMT, IMT+RYGB or IMT+SG and underwent a mixed-meal tolerance test at baseline, 12, and 24 months for evaluation of AG suppression (postprandial minus fasting) and beta-cell function (oral disposition index; glucose-stimulated insulin secretion × Matsuda index). Total/android body fat (dual-energy X-ray absorptiometry) was also assessed. RESULTS: RYGB and SG reduced body fat comparably (15-23 kg) at 12 and 24 months, whereas IMT had no effect. Beta-cell function increased 5.8-fold in RYGB and was greater than IMT at 24 months (P<0.001). However, there was no difference in insulin secretion between SG vs IMT at 24 months (P=0.32). Fasting AG was reduced fourfold following SG (P<0.01) and did not change with RYGB or IMT at 24 months. AG suppression improved more following RYGB than SG or IMT at 24 months (P=0.01 vs SG, P=0.07 vs IMT). At 24 months, AG suppression was associated with increased postprandial glucagon-like peptide-1 (r=-0.32, P<0.02) and decreased android fat (r=0.38; P<0.006). CONCLUSIONS: Enhanced AG suppression persists for up to 2 years after RYGB, and this effect is associated with decreased android obesity and improved insulin secretion. Together, these findings suggest that AG suppression is partly responsible for the improved glucose control after RYGB surgery.

Attenuated improvements in adiponectin and fat loss characterize type 2 diabetes non-remission status after bariatric surgery.

AIM: To identify the metabolic determinants of type 2 diabetes non-remission status after bariatric surgery at 12 and 24 months. METHODS: A total of 40 adults [mean ± sd body mass index 36 ± 3 kg/m(2) , age 48 ± 9 years, glycated haemoglobin (HbA1c) 9.7 ± 2%) undergoing bariatric surgery [Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)] were enrolled in the present study, the Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial. Type 2 diabetes remission was defined as HbA1c <6.5% and fasting glucose <126 mg/dl (i.e. <7 mmol/l) without antidiabetic medication. Indices of insulin secretion and sensitivity were calculated from plasma glucose, insulin and C-peptide values during a 120-min mixed-meal tolerance test. Body fat, incretins (glucagon-like polypeptide-1, gastric inhibitory peptide, ghrelin) and adipokines [adiponectin, leptin, tumour necrosis factor-α, high-sensitivity C-reactive protein (hs-CRP)] were also assessed. RESULTS: At 24 months, 37 patients had available follow-up data (RYGB, n = 18; SG, n = 19). Bariatric surgery induced type 2 diabetes remission rates of 40 and 27% at 12 and 24 months, respectively. Total fat/abdominal fat loss, insulin secretion, insulin sensitivity and ß-cell function (C-peptide0-120 /glucose0-120 × Matsuda index) improved more in those with remission at 12 and 24 months than in those without remission. Incretin levels were unrelated to type 2 diabetes remission, but, compared with those without remission, hs-CRP decreased and adiponectin increased more in those with remission. Only baseline adiponectin level predicted lower HbA1c levels at 12 and 24 months, and elevated adiponectin correlated with enhanced ß-cell function, lower triglyceride levels and fat loss. CONCLUSIONS: Smaller rises in adiponectin level, a mediator of insulin action and adipose mass, characterize type 2 diabetes non-remission up to 2 years after bariatric surgery. Adjunctive strategies promoting greater fat loss and/or raising adiponectin may be key to achieving higher type 2 diabetes remission rates after bariatric surgery.

Ghrelin suppression is associated with weight loss and insulin action following gastric bypass surgery at 12 months in obese adults with type 2 diabetes.

Roux-en-Y gastric bypass (RYGB) surgery reverses type 2 diabetes mellitus (T2DM) in approximately 80% of patients. Ghrelin regulates glucose homeostasis, but its role in T2DM remission after RYGB surgery is unclear. Nine obese T2DM subjects underwent a mixed meal tolerance test before and at 1 and 12 months after RYGB surgery. Changes in ghrelin, body weight, glucagon-like polypeptide-1 (GLP-1, glucose tolerance and insulin sensitivity (IS) were measured. At 1 month, body weight, glycaemia and IS were improved, while ghrelin concentrations were reduced (p < 0.05). After 12 months, body weight and fasting glucose were reduced (30 and 16%, respectively; p < 0.05) and IS was enhanced (threefold; p < 0.05). Ghrelin suppression improved by 32% at 12 months (p < 0.05), and this was associated with weight loss (r = 0.72, p = 0.03), enhanced IS (r = -0.78, p = 0.01) and peak postprandial GLP-1 (r = -0.73, p = 0.03). These data suggest that postprandial ghrelin suppression may be part of the mechanism that contributes to diabetes remission after RYGB surgery.

Three years of operation of North America's first nutrient recovery facility.

The first full-scale nutrient recovery installation in North America became operational in May 2009 at the Clean Water Service's Durham Advanced Wastewater Treatment Plant in Tigard, Oregon. Recovering ammonia and phosphorus from the dewatering side stream as struvite has a positive impact on plant operations. Significantly reducing the phosphorus recycle lowers the phosphorus loading on the plant, stabilizes biological phosphorus removal, reduces the amount of chemicals needed to remove phosphorus, reduces both the dry tonnes of biosolids generated and the phosphorus content of the biosolids, and provides revenue from the sale of the struvite. To increase struvite production and to decrease struvite potential in the digestion system, the Waste Activated Sludge Stripping To Remove Internal Phosphorus (WASSTRIP™) process was implemented full-scale in summer 2011. Results indicate a potential 60% increase in struvite production is achievable.

Gastrointestinal surgery for obesity and diabetes: weight loss and control of hyperglycemia.

Obesity is associated with a variety of weight-related metabolic comorbidities. Bariatric surgery (metabolic/gastrointestinal surgery) not only achieves significant and sustainable weight loss, but also induces extraordinary effects on nearly all obesity-related comorbidities, particularly remission of type 2 diabetes mellitus (T2DM). The mechanisms underlying such effects are slowly being elucidated, and it appears that the metabolic benefits of bariatric surgery are not only attributable to weight loss, but there are also weight independent mechanisms at play. This article outlines the metabolic effects of the most commonly performed bariatric procedures, with a particular emphasis on how they affect glucose metabolism and T2DM.

Clinical considerations for the management of residual diabetes following bariatric surgery.

Residual diabetes following bariatric surgery is increasingly recognized despite initial weight loss. It occurs more commonly following banding and sleeve gastrectomy procedures than with gastric bypass, is associated with long duration and advanced stages of diabetes and is exacerbated by weight regain. Long-term diabetes management following various gastric restrictive surgery (i.e. lap banding) requires targeting weight loss, insulin resistance and insulin secretion defects with antidiabetic agents that have weight negative or neutral effects. In contrast, re-emergence of hyperglycaemia following gastric bypass may require targeting ß-cell failure with insulin analogues. Revisional bariatric surgery is also a consideration. On the basis of our experience, we propose a clinical approach for long-term management of diabetes following various bariatric procedures in the presence and absence of weight regain that is based on recognized pathophysiological effects of these procedures on diabetes remission.

Bariatric surgery for treatment of obesity.

This article focuses on recent trends and outcomes of bariatric surgery. The outcomes discussed include perioperative morbidity and mortality, weight loss, long-term complications and the impact of bariatric surgery on comorbidities, cardiovascular risk and mortality.

Panel report: best practices for the surgical treatment of obesity.

BACKGROUND: Bariatric surgery is a rapidly growing field. Advances in surgical technologies and techniques have raised concerns about patient safety. Bariatric surgeons and programs are under increased scrutiny from regulatory agencies, insurers, and public health officials to provide high quality and safe care for bariatric patients at all phases of care. METHODS: During the 2009 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), a panel of experts convened to provide updated information on patient safety and best practices in bariatric surgery. The following article is a summary of this panel presentation. RESULTS AND CONCLUSIONS: Weight loss surgery is a field that is evolving and adapting to multiple external pressures. Safety concerns along with increasing public scrutiny have led to a systematic approach to defining best practices, creating standards of care, and identifying mechanisms to ensure that patients consistently receive the best and most effective care possible. In many ways, bariatric surgery and multidisciplinary bariatric surgery programs may serve as a model for other programs and surgical specialties in the near future.

A focus on surgical preoperative evaluation of the bariatric patient--the Cleveland Clinic protocol and review of the literature.

Bariatric surgery is well established as a safe and effective treatment for morbid obesity and related metabolic diseases. As an elective procedure, it is critical that individuals considering bariatric surgery should be carefully selected, extensively evaluated, and optimized in order to achieve optimal outcomes. This patient population has unique and challenging issues, including an extensive range of potential medical, psychiatric, and psychological comorbidities, and often patients have unrealistic expectations of the surgery. Therefore, a multidisciplinary, comprehensive and timely assessment preoperatively is of great importance. Individual bariatric units utilise different preoperative patient evaluation protocols. There is at present no uniformly accepted or recommended practice. In this article we describe what we believe are the essential components of a preoperative bariatric surgery evaluation, with supporting evidence for each recommendation. We also present a protocol currently in practice at a high volume bariatric center of excellence; the Bariatric and Metabolic Institute in the Cleveland Clinic, Ohio.

Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes.

CONTEXT: Hyperglycemia resolves quickly after bariatric surgery, but the underlying mechanism and the most effective type of surgery remains unclear. OBJECTIVE: To examine glucose metabolism and beta-cell function in patients with type 2 diabetes mellitus (T2DM) after two types of bariatric intervention; Roux-en-Y gastric bypass (RYGB) and gastric restrictive (GR) surgery. DESIGN: Prospective, nonrandomized, repeated-measures, 4-week, longitudinal clinical trial. PATIENTS: In all, 16 T2DM patients (9 males and 7 females, 52+/-14 years, 47+/-9 kg m(-2), HbA1c 7.2+/-1.1%) undergoing either RYGB (N=9) or GR (N=7) surgery. OUTCOME MEASURES: Glucose, insulin secretion, insulin sensitivity at baseline, and 1 and 4 weeks post-surgery, using hyperglycemic clamps and C-peptide modeling kinetics; glucose, insulin secretion and gut-peptide responses to mixed meal tolerance test (MMTT) at baseline and 4 weeks post-surgery. RESULTS: At 1 week post-surgery, both groups experienced a similar weight loss and reduction in fasting glucose (P<0.01). However, insulin sensitivity increased only after RYGB, (P<0.05). At 4 weeks post-surgery, weight loss remained similar for both groups, but fasting glucose was normalized only after RYGB (95+/-3 mg 100 ml(-1)). Insulin sensitivity improved after RYGB (P<0.01) and did not change with GR, whereas the disposition index remained unchanged after RYGB and increased 30% after GR (P=0.10). The MMTT elicited a robust increase in insulin secretion, glucagon-like peptide-1 (GLP-1) levels and beta-cell sensitivity to glucose only after RYGB (P<0.05). CONCLUSION: RYGB provides a more rapid improvement in glucose regulation compared with GR. This improvement is accompanied by enhanced insulin sensitivity and beta-cell responsiveness to glucose, in part because of an incretin effect.

The Salivary Mycobiome Contains 2 Ecologically Distinct Mycotypes.

A broad range of fungi has been detected in molecular surveys of the oral mycobiome. However, knowledge is still lacking on interindividual variability of these communities and the ecologic and clinical significance of oral fungal commensals. In this cross-sectional study, we use internal transcribed spacer 1 amplicon sequencing to evaluate the salivary mycobiome in 59 subjects, 36 of whom were scheduled to receive cancer chemotherapy. Analysis of the broad population structure of fungal communities in the whole cohort identified 2 well-demarcated genus-level community types (mycotypes), with Candida and Malassezia as the main taxa driving cluster partitioning. The Candida mycotype had lower diversity than the Malassezia mycotype and was positively correlated with cancer and steroid use in these subjects, smoking, caries, utilizing a removable prosthesis, and plaque index. Mycotypes were also associated with metabolically distinct bacteria indicative of divergent oral environments, with aciduric species enriched in the Candida mycotype and inflammophilic bacteria increased in the Malassezia mycotype. Similar to their fungal counterparts, coexisting bacterial communities associated with the Candida mycotype showed lower diversity than those associated with the Malassezia mycotype, suggesting that common environmental pressures affected bacteria and fungi. Mycotypes were also seen in an independent cohort of 24 subjects, in which cultivation revealed Malassezia as viable oral mycobiome members, although the low-abundance Malassezia sympodialis was the only Malassezia species recovered. There was a high degree of concordance between the molecular detection and cultivability of Candida, while cultivation showed low sensitivity for detection of the Malassezia mycotype. Overall, our work provides insights into the oral mycobiome landscape, revealing 2 community classes with apparently distinct ecologic constraints and specific associations with coexisting bacteria and clinical parameters. The utility of mycotypes as biomarkers for oral diseases warrants further study.

Application and comparison of dynamic models to assess impact of loading variations on performance of denitrification filters.

Dynamic models were developed using two software packages to evaluate performance of a denitrification filter pilot under variable flow and nitrate loading conditions. Two data periods, including one at constant rate hydraulic loading and one under diurnal flow conditions, were used to calibrate the models. Two additional test periods, one with high nitrate loadings and the second with peak hydraulic loadings and intermittent methanol usage were used to validate the models. The paper presents the results and compares the features of the two models.

New applications for endoscopy: the emerging field of endoluminal and transgastric bariatric surgery.

Endoluminal and transgastric procedures are evolving concepts that combine the skills and techniques of flexible endoscopy with minimally invasive surgery. Precisely how this technology and skill set will be applied in the field of general surgery is not yet known, but the treatment of obesity with an endoluminal or transgastric procedure holds great promise. As the demand for bariatric surgery increases, efforts will be directed toward developing less morbid and less costly treatment options that can provide substantial weight loss and resolution of comorbid conditions. Natural orifice bariatric procedures may include short-term weight loss in preparation for a definitive laparoscopic procedure, revisional procedures to reduce stoma or pouch size or repair fistulas, or primary therapy that provides durable weight loss. The latter application will undoubtedly appeal to patients and referring physicians if it can be performed as an outpatient procedure with significantly less morbidity than a laparoscopic procedure. Early preclinical and clinical work has been published in this area, but many technical obstacles must be overcome before a primary endoluminal or transgastric bariatric procedure can be offered. This article reviews the endoluminal and transgastric technology currently available, the endoluminal procedures currently performed, and the future of these technologies with respect to bariatric surgery.

A complication of Roux-en-Y gastric bypass: intestinal obstruction.

BACKGROUND: Intestinal obstruction is a significant and increasingly recognized complication after laparoscopic and open gastric bypass. MATERIALS AND METHODS: The medical records of 3,463 patients who had gastric bypass during the study period from July 1997 to December 2004 at a single bariatric center were evaluated. 1,120 patients had retrocolic, retrogastric Roux limb placement and 2,343 patients had antecolic, antegastric. RESULTS: 40 patients had 44 intestinal obstructions (1.27%). The onset ranged from 1 day to 7 years postoperatively (mean 16.9 months). Internal hernia at the transverse mesocolon defect was the most common cause. 36 (3.2%) obstructions were observed in retrocolic, retrogastric vs. 8 (0.3%) in antecolic, antegastric approach. Internal hernia repair at mesocolinic effect (n = 11), jejunojejunostomy mesenteric defect repair (n = 7), lysis of adhesions (n = 16) were the most common procedures. A total of 70.5% were done laparoscopically. CONCLUSIONS: A high index of suspicion is needed to diagnose bowel obstruction after gastric bypass. Radiological imaging of the abdomen has significant limitations. Surgical exploration should be performed without delay. Diagnostic laparoscopy is a safe and effective therapy. We recommend closing all mesenteric defects to prevent internal hernias. The antecolic, antegastric technique reduces the incidence of internal hernias.

Bariatric surgery improves cardiac function in morbidly obese patients with severe cardiomyopathy.

BACKGROUND: Longstanding morbid obesity can be associated with severe cardiomyopathy. However, the safety and efficacy of bariatric surgery in patients with severe cardiomyopathy has not been studied, and the effect of surgical weight loss on postoperative cardiac function is also unknown. In addition, morbidly obese patients have significantly increased mortality associated with cardiac transplantation, often precluding them from becoming recipients. METHODS: A retrospective study of patients with a left ventricular ejection fraction < or =35% who underwent bariatric surgery (1998-2005) was performed. Short-term morbidity/mortality, length of stay, excess weight loss, pre- and postoperative left ventricular ejection fraction, and New York Heart Association (NYHA) functional class were assessed. RESULTS: A total of 14 patients (10 men and 4 women) with a mean preoperative body mass index of 50.8 +/- 2.04 kg/m(2) underwent bariatric surgery (10 underwent laparoscopic Roux-en-Y gastric bypass, 1 open Roux-en-Y gastric bypass, 2 sleeve gastrectomy, and 1 laparoscopic gastric banding). The complications were pulmonary edema in 1, hypotension in 1, and transient renal insufficiency in 2. The median length of stay was 3.0 days (range 2-9). The mean excess weight loss at 6 months was 50.4%, with a decrease in the mean body mass index from 50.8 +/- 2.04 kg/m(2) to 36.8 +/- 1.72 kg/m(2). The mean left ventricular ejection fraction at 6 months had significantly improved from 23% +/- 2% to 32% +/- 4% (P = .04), correlating with improved functional capacity, as measured by the NYHA classification. Preoperatively, 2 patients (14%) had an NYHA classification of IV, 6 (43%) a classification of III, and 6 (43%) a classification of II. At 6 months postoperatively, no patient had an NYHA classification of IV, 2 (14%) had a classification of III, and 12 (86%) an NYHA classification of II. Two patients had undergone cardiac transplant evaluations preoperatively and underwent successful transplantation after weight loss. CONCLUSION: The results of our study have shown that bariatric surgery for patients with cardiomyopathy is feasible and effective. Surgically induced weight loss results in both subjective and objective improvement in cardiac function. In addition, surgical weight loss can provide a bridge to transplantation in patients who were prohibited secondary to their morbid obesity.

High-temperature high-pressure calorimeter for studying gram-scale heterogeneous chemical reactions.

We present an instrument for measuring pressure changes and heat flows of physical and chemical processes occurring in gram-scale solid samples under high pressures of reactive gases. Operation is demonstrated at 1232 °C under 33 bars of pure hydrogen. Calorimetric heat flow is inferred using a grey-box non-linear lumped-element heat transfer model of the instrument. Using an electrical calibration heater to deliver 900 J/1 W pulses at the sample position, we demonstrate a dynamic calorimetric power resolution of 50 mW when an 80-s moving average is applied to the signal. Integration of the power signal showed that the 900 J pulse energy could be measured with an average accuracy of 6.35% or better over the temperature range 150-1100 °C. This instrument is appropriate for the study of high-temperature metal hydride materials for thermochemical energy storage.

Treatment of refractory gastroesophageal reflux disease with radiofrequency energy (Stretta) in patients after Roux-en-Y gastric bypass.

BACKGROUND: Morbid obesity is associated with gastroesophageal reflux disease (GERD), which, in most cases, completely resolves after Roux-en-Y gastric bypass (RYGB). Patients with persistent or recurrent symptoms have limited surgical options. This study sought to evaluate the application of the Stretta procedure for patients with refractory GERD. METHODS: The medical records of all patients who underwent Stretta for refractory GERD after RYGB were reviewed. Demographic, preoperative, and postoperative reflux data were collected. Data are presented as mean +/- standard error of the mean. The t-test was used for comparison purposes. RESULTS: Of 369 patients, 7 received Stretta 27 +/- 6 months after RYGB. All were women with a mean age of 49 +/- 2 years. All the patients had experienced prebypass GERD symptoms for a duration of 45 +/- 8 months. The mean prebypass body mass index was 45 +/- 2 kg/m(2), and this was reduced to 29 +/- 2 kg/m(2) after laparoscopic RYGB (p < 0.001). Before Stretta, all patients underwent a 48-h Bravo pH study, which demonstrated reflux with a mean fraction time of 7% +/- 2% for pH lower than 4. After Stretta, five patients had complete resolution of their symptoms, with normalization of pH studies (mean fraction time of 3% +/- 0% for pH < 4). The follow-up period after Stretta was 20 +/- 2 months. One patient did not have adequate relief of symptoms after Stretta, and one patient was lost to follow-up evaluation. CONCLUSION: Stretta is a valid option in the treatment of persistent GERD for patients who have undergone gastric bypass. Further study is required to evaluate the long-term efficacy of this procedure.

Laparoscopic sleeve gastrectomy as an initial weight-loss procedure for high-risk patients with morbid obesity.

BACKGROUND: The surgical treatment of obesity in the high-risk, high-body-mass-index (BMI) (>60) patient remains a challenge. Major morbidity and mortality in these patients can approach 38% and 6%, respectively. In an effort to achieve more favorable outcomes, we have employed a two-stage approach to such high-risk patients. This study evaluates our initial outcomes with this technique. METHODS: In this study, patients underwent laparoscopic sleeve gastrectomy (LSG) as a first stage during the period January 2002-February 2004. After achieving significant weight loss and reduction in co-morbidities, these patients then proceeded with the second stage, laparoscopic Roux-en-Y gastric bypass (LRYGBP). RESULTS: During this time, 126 patients underwent LSG (53% female). The mean age was 49.5 +/- 0.9 years, and the mean BMI was 65.3 +/- 0.8 (range 45-91). Operative risk assessment determined that 42% were American Society of Anesthesiologists physical status score (ASA) III and 52% were ASA IV. The mean number of co-morbid conditions per patient was 9.3 +/- 0.3 with a median of 10 (range 3-17). There was one distant mortality and the incidence of major complications was 13%. Mean excess weight after LSG at 1 year was 46%. Thirty-six patients with a mean BMI of 49.1 +/- 1.3 (excess weight loss, EWL, 38%) had the second-stage LRYGBP. The mean number of co-morbidities in this group was 6.4 +/- 0.1 (reduced from 9). The ASA class of the majority of patients had been downstaged at the time of LRYGB. The mean time interval between the first and second stages was 12.6 +/- 0.8 months. The mean and median hospital stays were 3 +/- 1.7 and 2.5 (range 2-7) days, respectively. There were no deaths, and the incidence of major complications was 8%. CONCLUSION: The staging concept of LSG followed by LRYGBP is a safe and effective surgical approach for high-risk patients seeking bariatric surgery.