Daniel B. Leslie

Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: the Diabetes Surgery Study randomized clinical trial.

IMPORTANCE Controlling glycemia, blood pressure, and cholesterol is important for patients with diabetes. How best to achieve this goal is unknown. OBJECTIVE To compare Roux-en-Y gastric bypass with lifestyle and intensive medical management to achieve control of comorbid risk factors. DESIGN, SETTING, AND PARTICIPANTS A 12-month, 2-group unblinded randomized trial at 4 teaching hospitals in the United States and Taiwan involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher, body mass index (BMI) between 30.0 and 39.9, C peptide level of more than 1.0 ng/mL, and type 2 diabetes for at least 6 months. The study began in April 2008. INTERVENTIONS Lifestyle-intensive medical management intervention and Roux-en-Y gastric bypass surgery. Medications for hyperglycemia, hypertension, and dyslipidemia were prescribed according to protocol and surgical techniques that were standardized. MAIN OUTCOMES AND MEASURES Composite goal of HbA1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg. RESULTS All 120 patients received the intensive lifestyle-medical management protocol and 60 were randomly assigned to undergo Roux-en-Y gastric bypass. After 12-months, 28 participants (49%; 95% CI, 36%-63%) in the gastric bypass group and 11 (19%; 95% CI, 10%-32%) in the lifestyle-medical management group achieved the primary end points (odds ratio [OR], 4.8; 95% CI, 1.9-11.7). Participants in the gastric bypass group required 3.0 fewer medications (mean, 1.7 vs 4.8; 95% CI for the difference, 2.3-3.6) and lost 26.1% vs 7.9% of their initial body weigh compared with the lifestyle-medical management group (difference, 17.5%; 95% CI, 14.2%-20.7%). Regression analyses indicated that achieving the composite end point was primarily attributable to weight loss. There were 22 serious adverse events in the gastric bypass group, including 1 cardiovascular event, and 15 in the lifestyle-medical management group. There were 4 perioperative complications and 6 late postoperative complications. The gastric bypass group experienced more nutritional deficiency than the lifestyle-medical management group. CONCLUSIONS AND RELEVANCE In mild to moderately obese patients with type 2 diabetes, adding gastric bypass surgery to lifestyle and medical management was associated with a greater likelihood of achieving the composite goal. Potential benefits of adding gastric bypass surgery to the best lifestyle and medical management strategies of diabetes must be weighed against the risk of serious adverse events. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00641251.

Postgastric bypass hyperinsulinemic hypoglycemia syndrome: characterization and response to a modified diet

BACKGROUND Some alarming cases of hypoglycemic episodes in patients who have undergone Roux-en-Y gastric bypass have been reported. The syndrome of hyperinsulinemic hypoglycemia with nesidioblastosis after Roux-en-Y gastric bypass has been previously reported and is controversial. It has been suggested that subtotal or total pancreatectomy might be needed to control the symptoms in these patients. We have identified a similar cohort of patients with hyperinsulinemic hypoglycemia for whom we have reviewed patient characteristics and measured the glucose and insulin response to mixed meals. METHODS We reviewed the charts of 14 patients identified by clinic follow-up who reported episodes consistent with hyperinsulinemic hypoglycemia (lightheadedness or loss of consciousness after a high-carbohydrate meal). All patients were given a mixed meal consisting of high carbohydrates on day 1 and a low-carbohydrate meal on day 2. The plasma glucose and serum insulin levels were measured before (fasting) and 30, 60, 90, 120, 150, and 180 minutes after the meal. RESULTS After a high-carbohydrate meal, 12 of 14 patients demonstrated hyperglycemia associated with hyperinsulinemia at 30 minutes. These patients subsequently became hypoglycemic while the serum insulin was rapidly declining. After reaching a nadir at 120 minutes, the plasma glucose level corrected spontaneously. After a low-carbohydrate mixed meal, the patients demonstrated very little change in plasma glucose and only a modest increase in serum insulin. Of the 12 patients treated with a low-carbohydrate diet, 6 had substantive symptom improvement, and 10 exhibited at least some improvement. CONCLUSION The hyperinsulinemic hypoglycemia noted in some patients after Roux-en-Y gastric bypass has many similarities to the dumping syndrome. A low-carbohydrate diet successfully improved symptoms in most of our patients. Approaches to treatment should involve a low-carbohydrate diet and alpha-glucosidase inhibitors rather than pancreatectomy.

Effect of Reversible Intermittent Intra-abdominal Vagal Nerve Blockade on Morbid Obesity The ReCharge Randomized Clinical Trial

IMPORTANCE Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01327976.

Risk for Hospital Readmission following Bariatric Surgery

Background and Objectives Complications resulting in hospital readmission are important concerns for those considering bariatric surgery, yet present understanding of the risk for these events is limited to a small number of patient factors. We sought to identify demographic characteristics, concomitant morbidities, and perioperative factors associated with hospital readmission following bariatric surgery. Methods We report on a prospective observational study of 24,662 patients undergoing primary RYGB and 26,002 patients undergoing primary AGB at 249 and 317 Bariatric Surgery Centers of Excellence (BSCOE), respectively, in the United States from January 2007 to August 2009. Data were collected using standardized assessments of demographic factors and comorbidities, as well as longitudinal records of hospital readmissions, complications, and mortality. Results The readmission rate was 5.8% for RYGB and 1.2% for AGB patients 30 days after discharge. The greatest predictors for readmission following RYGB were prolonged length of stay (adjusted odds ratio [OR], 2.3; 95% confidence interval [CI], 2.0–2.7), open surgery (OR, 1.8; CI, 1.4–2.2), and pseudotumor cerebri (OR, 1.6; CI, 1.1–2.4). Prolonged length of stay (OR, 2.3; CI, 1.6–3.3), history of deep venous thrombosis or pulmonary embolism (OR, 2.1; CI, 1.3–3.3), asthma (OR, 1.5; CI, 1.1–2.1), and obstructive sleep apnea (OR, 1.5; CI, 1.1–1.9) were associated with the greatest increases in readmission risk for AGB. The 30-day mortality rate was 0.14% for RYGB and 0.02% for AGB. Conclusion Readmission rates are low and mortality is very rare following bariatric surgery, but risk for both is significantly higher after RYGB. Predictors of readmission were disparate for the two procedures. Results do not support excluding patients with certain comorbidities since any reductions in overall readmission rates would be very small on the absolute risk scale. Future research should evaluate the efficacy of post-surgical managed care plans for patients at higher risk for readmission and adverse events.

Comparative effectiveness of bariatric surgery and nonsurgical therapy in adults with type 2 diabetes mellitus and body mass index <35 kg/m2

BACKGROUND Outcomes of bariatric surgery in patients with a body mass index (BMI) <35 kg/m(2) have been an active area of investigation. We examined the comparative effectiveness of Roux-en-Y gastric bypass (RYGB) to routine medical management (nonsurgical controls; NSCs) in achieving appropriate targets defined by the American Diabetes Association for type 2 diabetes mellitus (T2DM) in patients with class I obesity (BMI 30.0-34.9 kg/m(2)) T2DM at 1 year. METHODS We identified patients undergoing RYGB (N = 17) with both class I obesity and T2DM and compared them to similar NSC (N = 17) treated in the Primary Care Center. Data were collected at baseline and 1 year for systolic blood pressure (SBP), as well as blood levels for low-density lipoprotein (LDL) cholesterol and hemoglobin A1c (HbA1c). RESULTS After RYGB, BMI decreased from 34.6 ± 0.8 kg/m(2) to 25.8 ± 2.5 kg/m(2) (P < .001) and HbA1c decreased from 8.2 ± 2.0% to 6.1 ± 2.7% (P < .001). The NSC cohort had no significant change in either BMI or HbA1c. SBP and LDL did not significantly change in either group. The RYGB group had a decrease in medication use compared to the NSC group (P < .001). The RYGB group ceased the use of antihypertensive and antihyperlipidemia medications by 1 year despite abnormal values. CONCLUSION RYGB can be performed in patients with both a BMI <35 kg/m(2) and T2DM with better weight loss, glycemic control, and fewer antihyperglycemic medications than NSC. Inappropriate cessation of medications may partially explain the persistent increase in both SBP and LDL after RYGB.

Benefits and complications of the duodenal switch/biliopancreatic diversion compared to the Roux-en-Y gastric bypass

BACKGROUND Despite providing superb excess weight loss and increased resolution of comorbid diseases, such as type 2 diabetes mellitus, compared to other bariatric procedures, the duodenal switch/ biliopancreatic diversion (DS/BD) has not gained widespread acceptance among patients and physicians. In this study, we investigated outcomes, symptoms and complications among postsurgical DS patients compared to RYGB patients. METHODS We used propensity scores to retrospectively match patients who underwent DS/BD between 2005 and 2010 to comparable Roux-en-Y gastric bypass (RYGB) patients. We then reviewed patient charts, and surveyed patients using the University of Minnesota Bariatric Surgery Outcomes Survey tool to track outcomes, comorbid illnesses and complications. RESULTS One hundred ninety consecutive patients underwent primary DS/BD between 2005 and 2010 at the University of Minnesota Medical Center. There were 178 patients available for follow-up (93.7%) who were matched to 139 RYGB patients. Type 2 diabetes, hypertension, and hyperlipidemia all significantly improved in each group. Improvements were significantly higher in the DS/BD group. Percent total weight loss was not different between groups. Loose stools and bloating symptoms were more frequently reported among DS/BD patients. With the exception of increased emergency department visits among DS/BD patients (P < .01), overall complication rates were not significantly different between DS/BD and RYGB. There was no difference in mortality rates between the groups. CONCLUSION The DS/BD is a robust procedure that engenders both superior weight loss and improvement of major comorbidities. Complication and adverse event rates are similar to those of RYGB.

Gastric bypass after liver transplantation

Few data are available for assessing the outcomes of bariatric surgery for patients who have undergone orthotopic liver transplantation (OLT). The University of Minnesota bariatric surgery database and transplant registry were retrospectively reviewed to identify patients who had undergone OLT and then open Roux‐en‐Y gastric bypass (RYGB) surgery between 2001 and 2009. Comorbidity‐appropriate laboratory values, body mass indices (BMIs), histopathology reports, and immunosuppressive regimens were collected. Seven patients were identified with a mean age of 55.4 ± 8.64 years and a mean follow‐up of 59.14 ± 41.49 months from the time of RYGB. The mean time between OLT and RYGB was 26.57 ± 8.12 months. The liver disease etiologies were hepatitis C (n = 4), jejunoileal bypass surgery (n = 1), hemangioendothelioma (n = 1), and alcoholic cirrhosis (n = 1). There were 2 deaths for patients with hepatitis C 6 and 9 months after bariatric surgery due to multiple‐organ dysfunction syndrome and metastatic esophageal squamous carcinoma, respectively. One patient with hepatitis C required a reversal of the RYGB because of malnutrition and an inability to tolerate oral intake. Four of the 7 patients had type 2 diabetes mellitus (T2DM), 4 had hypertension, and 6 patients had dyslipidemia. All patients were on immunosuppressive medications, but only 4 were on corticosteroids. Glycemic control was improved in all surviving patients with T2DM. The mean BMI was 34.27 ± 5.51 kg/m2 before OLT and 44.34 ± 6.08 kg/m2 before RYGB; it declined to 26.47 ± 5.53 kg/m2 after RYGB. In conclusion, in this case series of patients undergoing RYGB after OLT, we observed therapeutic weight loss, improved glycemic control, and improved high‐density lipoprotein levels in the presence of continued dyslipidemia. RYGB may have contributed to the death of 1 patient due to multiple‐organ dysfunction syndrome. Liver Transpl 19:1324–1329, 2013.

Case-matched outcomes in bariatric surgery for treatment of type 2 diabetes in the morbidly obese patient.

Objective: To compare the relative efficacy of medical management, the duodenal switch (DS), and the laparoscopic adjustable gastric band (LAGB) to the Roux-en-Y gastric bypass (RYGB) for treatment of type 2 diabetes mellitus (T2DM). Background: The RYGB resolves T2DM in a high proportion of patients and is considered the standard operation for T2DM resolution in morbidly obese patients. However, no data exist comparing the efficacy of medical management and other bariatric operations to the RYGB for treatment of T2DM in comparable patient populations. Methods: We performed a retrospective case-matched study of morbidly obese patients with T2DM who had undergone medical management (nonsurgical controls [NSC]; N = 29), LAGB (N = 30), or DS (N = 27) and were compared with matched T2DM patients who had undergone RYGB. Matching was performed with respect to age, sex, body mass index, and hemoglobin A1C (HbA1C). Outcomes assessed were changes in body mass index, HbA1C, and diabetes medication scores at 1 year. Results: The Roux-en-Y gastric bypass produced greater weight loss, HbA1C normalization, and medication score reduction compared to both NSC and LAGB-matched cohorts. Duodenal switch produced greater reductions in HbA1C and medication score than RYGB, despite no greater weight loss at 1 year. Surgical complications were rarely life threatening. Conclusions: This study provides an important perspective about the comparative efficacy of LAGB, DS, and NSC to the RYGB for treatment of T2DM among obese patients. After 1 year of follow-up, RYGB is superior to NSC and LAGB with respect to weight loss and improvement in diabetes whereas DS is superior to RYGB in reducing HbA1C and medication score.

Duodenal switch operative mortality and morbidity are not impacted by body mass index.

Objective:This report examines the ≤30-day postoperative mortality and morbidity in our first 190 duodenal switch (DS) patients. Background Data:DS is the most weight loss effective and the most difficult to perform bariatric procedure. Indeed, certain surgeons have advocated a 2-stage approach to minimize complications, especially in the super obese (body mass index [BMI] ≥50 kg/m2). Methods:DS procedures were performed (n = 190) by either open (n = 168) or laparoscopic/robotic surgery in an academic setting: common channel 75 to 125 cm, sleeve gastrectomy (∼100 mL gastric pouch), closed duodenal stump, end-to-side duodenoileostomy hand-sewn in 2 layers, with most staple lines oversewn, and all mesentery defects closed. Results:For the 190 patients, 149 were female (78%) and the mean age was 43 years (range, 16–71). Mean preoperative weight 151.4 kg (range, 74.1–332.7); mean preoperative BMI 53.4 kg/m2 (range, 32–107), with 100 (52.6%) of the patients super obese (BMI ≥50 kg/m2). Seventy-four patients had concurrent procedures, eg, cholecystectomy (n = 22), ventral or umbilical hernia repair (n = 19), and hiatus hernia repair (n = 10). Mean operating room time was 337 minutes (range, 127–771); mean hospitalization time was 6 days (range, 2–38). There were no deaths. Serious ≤30-day complications (n = 18 in 14 patients) consisted of 2 leaks (1.0%), which responded to drainage, and intra-abdominal bleeding (n = 3), splenectomy (n = 1), acute pancreatitis (n = 2), gastric outlet obstruction (n = 1), acute renal failure (n = 2), pneumonia (n = 2), respiratory failure (n = 3), acute myocardial infarction (n = 1), and duodenoileostomy stricture requiring endoscopic dilation (n = 1). The serious complication rate in patients with a BMI <50 kg/m2 was 6.7% (6 of 90) and 12% (12 of 100) with a BMI ≥50 kg/m2 (NS). Surgical site infections occurred in 7 patients with a BMI <50 kg/m2 and in 12 with a BMI ≥50 kg/m2 (NS). Overall complication rate in patients with a BMI <50 kg/m2 was 14.4% (13 of 90) and 24% (24 of 100) with a BMI ≥50 kg/m2 (NS). Conclusions:With attention to careful surgical technique, DS can be performed relatively safely in the morbidly and super morbidly obese, and does not require a 2-stage procedure.

Small Bowel Obstruction and Internal Hernias during Pregnancy after Gastric Bypass Surgery

Small bowel obstruction (SBO) is a recognized complication of Roux-en-Y gastric bypass (RYGB) surgery. Internal hernia (IH) a potential problem associated with RYGB, can have severe consequences if not diagnosed. We present two cases of SBO due to IH during pregnancy after laparoscopic RYGB (LRYGB). Both patients underwent an antecolic, antegastric LRYGB. In both patients a Petersen’s type IH was found. We reviewed the cases reported in the literature of SBO during pregnancy after RYGB. IH should always be ruled out in pregnant patients with previous RYGB and abdominal pain. Prompt surgical intervention is mandatory for a good outcome.