Anita P. Courcoulas

Perioperative safety in the longitudinal assessment of bariatric surgery.

BACKGROUND To improve decision making in the treatment of extreme obesity, the risks of bariatric surgical procedures require further characterization. METHODS We performed a prospective, multicenter, observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007. A composite end point of 30-day major adverse outcomes (including death; venous thromboembolism; percutaneous, endoscopic, or operative reintervention; and failure to be discharged from the hospital) was evaluated among patients undergoing first-time bariatric surgery. RESULTS There were 4776 patients who had a first-time bariatric procedure (mean age, 44.5 years; 21.1% men; 10.9% nonwhite; median body-mass index [the weight in kilograms divided by the square of the height in meters], 46.5). More than half had at least two coexisting conditions. A Roux-en-Y gastric bypass was performed in 3412 patients (with 87.2% of the procedures performed laparoscopically), and laparoscopic adjustable gastric banding was performed in 1198 patients; 166 patients underwent other procedures and were not included in the analysis. The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding was 0.3%; a total of 4.3% of patients had at least one major adverse outcome. A history of deep-vein thrombosis or pulmonary embolus, a diagnosis of obstructive sleep apnea, and impaired functional status were each independently associated with an increased risk of the composite end point. Extreme values of body-mass index were significantly associated with an increased risk of the composite end point, whereas age, sex, race, ethnic group, and other coexisting conditions were not. CONCLUSIONS The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics. In helping patients make appropriate choices, short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese. (ClinicalTrials.gov number, NCT00433810.)

Weight Change and Health Outcomes at 3 Years After Bariatric Surgery Among Individuals With Severe Obesity

IMPORTANCE Severe obesity (body mass index [BMI] ≥35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations. OBJECTIVE To report 3-year change in weight and select health parameters after common bariatric surgical procedures. DESIGN AND SETTING The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery. MAIN OUTCOMES AND MEASURES Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed. RESULTS At baseline, participants (N = 2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%). CONCLUSIONS AND RELEVANCE Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00465829.

Prevalence of Alcohol Use Disorders Before and After Bariatric Surgery

CONTEXT Anecdotal reports suggest bariatric surgery may increase the risk of alcohol use disorder (AUD), but prospective data are lacking. OBJECTIVE To determine the prevalence of preoperative and postoperative AUD, and independent predictors of postoperative AUD. DESIGN, SETTING, AND PARTICIPANTS A prospective cohort study (Longitudinal Assessment of Bariatric Surgery-2) of adults who underwent bariatric surgery at 10 US hospitals. Of 2458 participants, 1945 (78.8% female; 87.0% white; median age, 47 years; median body mass index, 45.8) completed preoperative and postoperative (at 1 year and/or 2 years) assessments between 2006 and 2011. MAIN OUTCOME MEASURE Past year AUD symptoms determined with the Alcohol Use Disorders Identification Test (indication of alcohol-related harm, alcohol dependence symptoms, or score ≥8). RESULTS The prevalence of AUD symptoms did not significantly differ from 1 year before to 1 year after bariatric surgery (7.6% vs 7.3%; P = .98), but was significantly higher in the second postoperative year (9.6%; P = .01). The following preoperative variables were independently related to an increased odds of AUD after bariatric surgery: male sex (adjusted odds ratio [AOR], 2.14 [95% CI, 1.51-3.01]; P < .001), younger age (age per 10 years younger with preoperative AUD: AOR, 1.31 [95% CI, 1.03-1.68], P = .03; age per 10 years younger without preoperative AUD: AOR, 1.95 [95% CI, 1.65-2.30], P < .001), smoking (AOR, 2.58 [95% CI, 1.19-5.58]; P = .02), regular alcohol consumption (≥ 2 drinks/week: AOR, 6.37 [95% CI, 4.17-9.72]; P < .001), AUD (eg, at age 45, AOR, 11.14 [95% CI, 7.71-16.10]; P < .001), recreational drug use (AOR, 2.38 [95% CI, 1.37-4.14]; P = .01), lower sense of belonging (12-item Interpersonal Support Evaluation List score per 1 point lower: AOR, 1.09 [95% CI, 1.04-1.15]; P = .01), and undergoing a Roux-en-Y gastric bypass procedure (AOR, 2.07 [95% CI, 1.40-3.08]; P < .001; reference category: laparoscopic adjustable gastric band procedure). CONCLUSION In this cohort, the prevalence of AUD was greater in the second postoperative year than the year prior to surgery or in the first postoperative year and was associated with male sex and younger age, numerous preoperative variables (smoking, regular alcohol consumption, AUD, recreational drug use, and lower interpersonal support) and undergoing a Roux-en-Y gastric bypass procedure.

Weight Loss and Health Status 3 Years after Bariatric Surgery in Adolescents

BACKGROUND Bariatric surgery is increasingly considered for the treatment of adolescents with severe obesity, but few prospective adolescent-specific studies examining the efficacy and safety of weight-loss surgery are available to support clinical decision making. METHODS We prospectively enrolled 242 adolescents undergoing weight-loss surgery at five U.S. centers. Patients undergoing Roux-en-Y gastric bypass (161 participants) or sleeve gastrectomy (67) were included in the analysis. Changes in body weight, coexisting conditions, cardiometabolic risk factors, and weight-related quality of life and postoperative complications were evaluated through 3 years after the procedure. RESULTS The mean (±SD) baseline age of the participants was 17±1.6 years, and the mean body-mass index (the weight in kilograms divided by the square of the height in meters) was 53; 75% of the participants were female, and 72% were white. At 3 years after the procedure, the mean weight had decreased by 27% (95% confidence interval [CI], 25 to 29) in the total cohort, by 28% (95% CI, 25 to 30) among participants who underwent gastric bypass, and by 26% (95% CI, 22 to 30) among those who underwent sleeve gastrectomy. By 3 years after the procedure, remission of type 2 diabetes occurred in 95% (95% CI, 85 to 100) of participants who had had the condition at baseline, remission of abnormal kidney function occurred in 86% (95% CI, 72 to 100), remission of prediabetes in 76% (95% CI, 56 to 97), remission of elevated blood pressure in 74% (95% CI, 64 to 84), and remission of dyslipidemia in 66% (95% CI, 57 to 74). Weight-related quality of life also improved significantly. However, at 3 years after the bariatric procedure, hypoferritinemia was found in 57% (95% CI, 50 to 65) of the participants, and 13% (95% CI, 9 to 18) of the participants had undergone one or more additional intraabdominal procedures. CONCLUSIONS In this multicenter, prospective study of bariatric surgery in adolescents, we found significant improvements in weight, cardiometabolic health, and weight-related quality of life at 3 years after the procedure. Risks associated with surgery included specific micronutrient deficiencies and the need for additional abdominal procedures. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; Teen-LABS ClinicalTrials.gov number, NCT00474318.).

The relationship of surgeon and hospital volume to outcome after gastric bypass surgery in Pennsylvania: a 3-year summary.

BACKGROUND This study explores the volume-outcome relationship for gastric bypass surgery for obesity to determine whether higher-volume hospitals, higher-volume surgeons, or both are associated fewer adverse outcomes. METHODS The Pennsylvania state discharge database was used to identify 4685 cases of gastric bypass surgery for obesity between 1999 and 2001. Statistical modeling analyses were used to determine whether mortality or adverse outcome rate was significantly related to hospital and surgeon volume; the data were controlled for risk factors such as age, gender, comorbidities, and others. RESULTS There were 28 deaths (0.6%) and 813 adverse outcomes (17.4%). There was a significant risk-adjusted relationship between surgeon volume and adverse outcome, and the same trend was observed for deaths. Surgeons who performed fewer than 10 procedures per year had a 28% risk of adverse outcome and a 5% risk of death, compared with 14% (P<.05) and 0.3% (P=.06), respectively, for high-volume surgeons. Hospital volume did not reach significance, but there was a striking interaction between surgeon and hospital volume; surgeons who performed 10 to 50 cases per year operating in low-volume hospitals had a 55% risk of adverse outcome (P<.01). CONCLUSION Risk-adjusted in-hospital adverse outcome is significantly lower when gastric bypass is performed by higher-volume surgeons.

Reversal of Type 2 Diabetes Mellitus and Improvements in Cardiovascular Risk Factors After Surgical Weight Loss in Adolescents

OBJECTIVES. Type 2 diabetes mellitus is associated with obesity, dyslipidemia, and hypertension, all well-known risk factors for cardiovascular disease. Surgical weight loss has resulted in a marked reduction of these risk factors in adults. We hypothesized that gastric bypass would improve parameters of metabolic dysfunction and cardiovascular risk in adolescents with type 2 diabetes mellitus. PATIENTS AND METHODS. Eleven adolescents who underwent Roux-en-Y gastric bypass at 5 centers were included. Anthropometric, hemodynamic, and biochemical measures and surgical complications were analyzed. Similar measures from 67 adolescents with type 2 diabetes mellitus who were treated medically for 1 year were also analyzed. RESULTS. Adolescents who underwent Roux-en-Y gastric bypass were extremely obese (mean BMI of 50 ± 5.9 kg/m2) with numerous cardiovascular risk factors. After surgery there was evidence of remission of type 2 diabetes mellitus in all but 1 patient. Significant improvements in BMI (−34%), fasting blood glucose (−41%), fasting insulin concentrations (−81%), hemoglobin A1c levels (7.3%–5.6%), and insulin sensitivity were also seen. There were significant improvements in serum lipid levels and blood pressure. In comparison, adolescents with type 2 diabetes mellitus who were followed during 1 year of medical treatment demonstrated stable body weight (baseline BMI: 35 ± 7.3 kg/m2; 1-year BMI: 34.9 ± 7.2 kg/m2) and no significant change in blood pressure or in diabetic medication use. Medically managed patients had significantly improved hemoglobin A1c levels over 1 year (baseline: 7.85% ± 2.3%; 1 year: 7.1% ± 2%). CONCLUSIONS. Extremely obese diabetic adolescents experience significant weight loss and remission of type 2 diabetes mellitus after Roux-en-Y gastric bypass. Improvements in insulin resistance, β-cell function, and cardiovascular risk factors support Roux-en-Y gastric bypass as an intervention that improves the health of these adolescents. Although the long-term efficacy of Roux-en-Y gastric bypass is not known, these findings suggest that Roux-en-Y gastric bypass is an effective option for the treatment of extremely obese adolescents with type 2 diabetes mellitus.

Risk of Suicide after Long-term Follow-up from Bariatric Surgery

PURPOSE Bariatric surgery is recognized as the treatment of choice for class III obesity (body mass index ≥40) and has been increasingly recommended for obese patients. Prior research has suggested an excess of deaths due to suicide following bariatric surgery, but few large long-term follow-up studies exist. We examined postbariatric surgery suicides by time since operation, sex, age, and suicide death rates as compared with US suicide rates. METHODS Medical data following bariatric operations performed on Pennsylvania residents between January 1, 1995 and December 31, 2004 were obtained from the Pennsylvania Health Care Cost and Containment Council. Matching mortality data from suicides between September 1, 1996 and December 28, 2006 were obtained from the Division of Vital Records, Pennsylvania State Department of Health. RESULTS There were 31 suicides (16,683 operations), for an overall rate of 6.6/10,000; 13.7 per 10,000 among men and 5.2 per 10,000 among women. About 30% of suicides occurred within the first 2 years following surgery, with almost 70% occurring within 3 years. For every age category except the youngest, suicide rates were higher among men than women. Age- and sex-matched suicide rates in the US population (ages 35-64 years) were 2.4/10,000 (men) and 0.7/10,000 (women). CONCLUSIONS Compared with age and sex-matched suicide rates in the US, there was a substantial excess of suicides among all patients who had bariatric surgery in Pennsylvania during a 10-year period. These data document a need to develop more comprehensive longer-term surveillance and follow-up methods in order to evaluate factors associated with postbariatric surgery suicide.

Perioperative Outcomes of Adolescents Undergoing Bariatric Surgery: The Teen–Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study

IMPORTANCE Severe obesity in childhood is a major health problem with few effective treatments. Weight-loss surgery (WLS) is being used to treat severely obese adolescents, although with very limited data regarding surgical safety for currently used, minimally invasive procedures. OBJECTIVE To assess the preoperative clinical characteristics and perioperative safety outcomes of severely obese adolescents undergoing WLS. DESIGN, SETTING, AND PARTICIPANTS This prospective, multisite observational study enrolled patients from February 28, 2007, through December 30, 2011. Consecutive patients aged 19 years or younger who were approved to undergo WLS (n = 277) were offered enrollment into the study at 5 academic referral centers in the United States; 13 declined participation and 22 did not undergo surgery after enrollment, thus the final analysis cohort consisted of 242 individuals. There were no withdrawals. MAIN OUTCOMES AND MEASURES This analysis examined preoperative anthropometrics, comorbid conditions, and major and minor complications occurring within 30 days of operation. All data were collected in a standardized fashion. Reoperations and hospital readmissions were adjudicated by independent reviewers to assess relatedness to the WLS procedure. RESULTS The mean (SD) age of participants was 17.1 (1.6) years and the median body mass index (calculated as weight in kilograms divided by height in meters squared) was 50.5. Fifty-one percent demonstrated 4 or more major comorbid conditions. Laparoscopic Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding were performed in 66%, 28%, and 6% of patients, respectively. There were no deaths during the initial hospitalization or within 30 days of operation; major complications (eg, reoperation) were seen in 19 patients (8%). Minor complications (eg, readmission for dehydration) were noted in 36 patients (15%). All reoperations and 85% of readmissions were related to WLS. CONCLUSIONS AND RELEVANCE In this series, adolescents with severe obesity presented with abundant comorbid conditions. We observed a favorable short-term complication profile, supporting the early postoperative safety of WLS in select adolescents. Further longitudinal study of this cohort will permit accurate assessment of long-term outcomes for adolescents undergoing bariatric surgery. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00474318.

Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial

IMPORTANCE Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). OBJECTIVE To compare the remission of T2DM following surgical and nonsurgical treatments. DESIGN, SETTING, AND PARTICIPANTS In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. INTERVENTIONS Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. MAIN OUTCOMES AND MEASURES Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. RESULTS Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P < .001). Mean (SE) reductions in percentage of body weight at 3 years were the greatest after RYGB at 25.0% (2.0%), followed by LAGB at 15.0% (2.0%) and lifestyle treatment at 5.7% (2.4%) (P < .01). CONCLUSIONS AND RELEVANCE Among obese participants with T2DM, bariatric surgery with 2 years of an adjunctive low-level lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01047735.

Relationship of psychiatric disorders to 6-month outcomes after gastric bypass

BACKGROUND Although most bariatric surgery patients undergo a preoperative psychological evaluation, the potential effect of psychiatric disorders on weight loss is not well understood. We sought to document the relationship of preoperative psychiatric disorders to the 6-month outcomes after gastric bypass. METHODS The Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) was used to assess current and lifetime Axis I clinical disorders, as well as Axis II personality disorders, before surgery. We used linear regression models to examine the relationship of psychiatric disorders to postoperative weight-related outcomes. RESULTS The sample (n = 207) was 83.1% female and 92.7% white. The preoperative body mass index (BMI) was 51.4 +/- 9.6 kg/m(2) and age was 45.8 +/- 9.5 years. After adjusting for the initial BMI, gender, race, and age, a lifetime Axis I disorder was associated with a smaller decrease in BMI (t = -3.7, df = 205, P <.001) at 6 months after surgery. The results of separate models for each class of disorder indicated that lifetime mood disorder was associated with a smaller decrease in BMI (t = -3.7, df = 205, P <.001), as was lifetime anxiety disorder (t = -2.6, df = 205, P = 0.009), but substance and eating disorders were not. In this sample, current Axis I clinical disorders and Axis II personality disorders were unrelated to outcomes at 6 months. Similar overall results were found when the percentage of weight loss and excess weight loss were predicted. CONCLUSION The results of our study have shown that patients who have ever had an Axis I clinical disorder, especially mood or anxiety, exhibit poorer weight outcomes 6 months after gastric bypass than those who have never had an Axis I disorder. Additional research with larger samples is needed to replicate these findings and examine more fully the effect of current clinical disorders and personality disorders on weight loss. Nevertheless, our results suggest that patients with current or past disorders might benefit from close monitoring or psychosocial intervention to improve their short-term outcomes. However, a greater duration of follow-up is needed to identify predictors of longer-term weight control.