Emma J. Patterson

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.)

Early Results of Laparoscopic Biliopancreatic Diversion with Duodenal Switch: A Case Series of 40 Consecutive Patients

Background: Biliopancreatic diversion with duodenal switch (BPD-DS) is an operation which provides one of the greatest maintained weight losses of any bariatric procedure.We looked at the safety and efficacy of laparoscopic BPD-DS for morbid obesity. Methods: A 150-200 ml sleeve gastrectomy was created and anastomosed to the distal 250 cm of divided ileum. The median length of the common channel was 100 cm. All patients were prospectively followed up to 12 months. Results: 40 consecutive patients underwent laparoscopic BPD-DS as a primary procedure for morbid obesity. Median patient body mass index (BMI) was 60 kg/m2 (range 42-85 kg/m2). Mean age was 43 ± 1 years (± SEM), with 12 males and 28 females. One patient was converted to open laparotomy (2.5%). Median operative time was 210 ± 9 minutes (range 110-360 minutes) with a significant correlation between BMI and operative time (p = 0.04). Median length of stay was 4 days (range 3- 210 days). There was one 30-day mortality (2.5%). Major morbidities occurred in 6 patients (15%), including 1 anastomotic leak (2.5%), 1 venous thrombosis (2.5%), 4 staple-line hemorrhages (10%) and 1 subphrenic abscess (2.5%). Median follow-up at 6 months (range 1-12 months) resulted in 46% ± 2% excess weight loss (EWL) and at 9 months 58% ± 3% EWL. Conclusion: Laparoscopic BPD-DS is a complex, yet feasible, procedure resulting in effective weight loss with an acceptable morbidity. A BMI >65 was associated with increased morbidity and mortality. A long-term study is needed to confirm efficacy and proper patient selection.

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.

Evidence Supporting Routine Polysomnography Before Bariatric Surgery

Background: Obstructive sleep apnea (OSA) is common in morbidly obese patients, with a reported prevalence from 12 to 40%. Preoperative diagnosis of OSA is important for both perioperative airway management and the prevention of postoperative pulmonary complications. BMI has been reported to be an independent risk factor, and has been used recently in scoring systems to help predict OSA. Our hypothesis was that OSA is highly prevalent in patients presenting for bariatric surgery, and that BMI alone is not a good predictor of the presence or absence of sleep apnea. Methods: A cross-sectional study was undertaken of the last 170 consecutive patients presenting for bariatric surgery in a single surgeons practice. Clinical and demographic data were available from our prospective database, and polysomnography results were reviewed retrospectively. Sleep apnea was noted as present or absent, and graded from mild to severe. The patient population was stratified by BMI into severely obese (BMI 35-39.9), morbidly obese (BMI 40-49.9), super-obese (BMI 50-59.9), and super-super-obese (BMI ≥ 60). Results: OSA had been diagnosed before surgical consultation in 26 of the 170 patients (15.3%). Sleep studies were not available in 7 patients (4.1%). The remaining 137 patients (80.6%) had sleep data available, and 105 (76.6%) had sleep apnea (based on American Board of Sleep Medicine criteria).There was no correlation of sleep apnea with BMI. The overall prevalence of OSA in this cohort was 77% (131/170). Conclusions: In this large patient cohort, sleep apnea was prevalent (77%) independent of BMI, and most cases were not diagnosed before bariatric surgical consultation.These data support the use of routine screening polysomnography before bariatric surgery.

Laparoscopic Reoperative Bariatric Surgery: Experience from 27 Consecutive Patients

Background: 10 to 25% of patients undergoing bariatric surgery will require a revision, either for unsatisfactory weight loss or for complications. Reoperation is associated with a higher morbidity and has traditionally been done in open fashion.The purpose of this study was to determine the safety and efficacy of reoperative surgery using a laparoscopic approach. Methods: A retrospective review of medical records over a 22-month period was conducted. 27 consecutive obesity surgery patients, who had undergone a laparoscopic revision, were identified. 26 of the 27 patients were women. The average age was 40.3 years (range 20 to 58 years) and average original preoperative body mass index (BMI) was 51.6 kg/m2 (range 42 to 66.5).The 27 primary bariatric operations consisted of vertical banded gastroplasty (12), gastric band placement (9) and gastric bypass (6). 17 of them were open procedures. After the primary surgery, the lowest average BMI was 37.6 kg/m2 (range 21 to 52), which increased to 42.7 kg/m2 (range 29 to 56) before reoperation. 24 of the 27 reoperations were indicated for insufficient weight loss. On average, revision was undertaken 52 months after the primary procedure (range 12 to 240 months). Results: 24 of the 27 laparoscopic reoperations were conversions to a gastric bypass. A second reoperation was indicated for insufficient weight loss on four occasions. In one case, conversion to open surgery was required. The average operative time was 232 ± 18.5 minutes (range 120 to 480) and length of hospital stay was 3.7 days (range 1 to 9). 22% percent of patients (6) experienced complications, including pneumothorax, gastric remnant dilation, gastrojejunostomy stenosis, port-site hernia and protein malnutrition. There was no mortality in the study.The average BMI was 35.9 kg/m2 (range 27 to 45.5) 8 months after surgery (range 1 to 22 months). Compared with a preoperative BMI of 42.7 kg/m2, the weight loss was statistically significant (p<0.001). Conclusion: Our results compare favorably with those reported for open reoperative bariatric surgery. A laparoscopic approach may be considered a feasible and safe alternative to an open operation.

Laparoscopic pancreatic resection: single-institution experience of 19 patients

BACKGROUND The number of laparoscopic pancreatic resections reported in the surgical literature has been remarkably low. Few substantive data are available concerning current indications and outcomes after laparoscopic pancreatectomy. The purpose of this article is to review the recent indications, complications, and outcomes after laparoscopic pancreatic resection. STUDY DESIGN A retrospective analysis of the Mount Sinai hospital records was performed for all patients who underwent laparoscopic distal pancreatectomy or enucleation between the time of the first resection in November 1993 until the time of this study in March 2000. RESULTS In the 19 patients (6 men) the mean age was 53 years (range 22 to 83 years). In 16 patients (84%) the entire procedure was done by laparoscopy; one operation was converted to a hand-assisted technique; and two cases were converted to open. Median operating time was 4.4 hours (range 1.6 to 6.6 hours), and median intraoperative blood loss was 200 mL. Postoperative complications included three pancreatic leaks (16%), one case of superficial phlebitis, and one prolonged ileus for 7 days (total morbidity of 26%). There were no deaths. The median length of postoperative hospital stay was 6 days (range 1 to 26 days). CONCLUSIONS This represents the largest single-institution experience with laparoscopic pancreatic resection. The considerable morbidity rate is comparable to recently published open series, and is likely inherent in pancreatic surgery, rather than the technical approach. Laparoscopic pancreatic surgery resulted in shorter hospital stays and appears to be safe for benign diseases.

Baseline characteristics of participants in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study

Baseline characteristics of participants in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2) study Steven H. Belle, Ph.D., M.Sc.Hyg.*, Paul D. Berk, M.D., William H. Chapman, M.D., Nicholas J. Christian, Ph.D., Anita P. Courcoulas, M.D., M.P.H., F.A.C.S., Greg F. Dakin, M.D., David R. Flum, M.D., M.P.H., F.A.C.S., Mary Horlick, M.D., Wendy C. King, Ph.D., Carol A. McCloskey, M.D., James E. Mitchell, M.D., Emma J. Patterson, M.D., John R. Pender, M.D., Kristine J. Steffen, Pharm.D., Ph.D., Richard C. Thirlby, M.D., Bruce M. Wolfe, M.D., F.A.C.S., Susan Z. Yanovski, M.D., for The LABS Consortium University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania Columbia University Medical Center, New York, New York East Carolina University, Greenville, North Carolina University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania Weill Cornell University Medical Center, New York, New York University of Washington, Seattle, Washington National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland Neuropsychiatric Research Institute, Fargo, North Dakota Legacy Good Samaritan Hospital, Portland, Oregon Virginia Mason Medical Center, Seattle, Washington Oregon Health and Science University, Portland, Oregon Received January 23, 2013; accepted January 29, 2013

The Relationship of BMI with Demographic and Clinical Characteristics in the Longitudinal Assessment of Bariatric Surgery (LABS)

BACKGROUND The relationship between body mass index (BMI) and demographic/clinical characteristics of patients undergoing bariatric surgery is poorly characterized. BMI is often used to characterize patient risk in bariatric surgery. However, its relationship with other risk factors has not been well characterized. METHODS The Longitudinal Assessment of Bariatric Surgery-1 was a study of the 30-day outcomes in patients undergoing bariatric procedures at 10 clinical centers in the United States. The sample for this study included participants with a BMI > or =40 kg/m(2) and no history of undergoing a bariatric procedure from March 1, 2005 to March 26, 2007. This analysis examined the relationships between BMI strata and several demographic/clinical characteristics. RESULTS Of 2559 patients (23% male, 10% black, 9% age > or =60 yr) with a BMI of > or =40 kg/m(2), 29% had a BMI of 50 to <60 kg/m(2) and 12% a BMI of > or =60 kg/m(2). The percentage of men and blacks increased with greater BMI category and the percentage of older patients (age > or =60 yr) decreased. Patients with a greater BMI were more likely to have a history of several co-morbid conditions (hypertension, diabetes, congestive heart failure, asthma, poor functional status, sleep apnea, pulmonary hypertension, venous thromboembolism, or venous edema with ulcerations) than were patients with a BMI of 40-50 kg/m(2) after adjusting for age, race, sex, and ethnicity. CONCLUSION A greater BMI was associated with several patient characteristics that have been linked to less weight loss, more adverse outcomes, and increased healthcare use in previous studies. Outcomes analyses should consider the potential for the confounding of BMI with demographic and clinical characteristics.

The Optimal Surgical Management of the Super Obese Patient: The Debate

Optimal management of the super-obese patient (body mass index >50 kg/M2) undergoing weight loss surgery in the new era of laparoscopic treatment is more controversial than ever before. Newer laparoscopic options for treatment of the super obese, including laparoscopic adjustable gastric banding, sleeve gastrectomy, and staging of gastric bypass, are technically easier and may be safer. Concerns that weight loss may be suboptimal or that the procedures will require revision, or both, make these choices controversial. Open access/conversion for established procedures such as long-limb gastric bypass and biliopancreatic diversion with or without duodenal switch are the traditional alternatives when laparoscopic access fails or is deemed too difficult to undertake. The following debate was presented by invited experts in laparoscopic and open bariatric surgery at the 2005 Annual Meeting of the Society of American Gastrointestinal and Endoscopic Surgeons in Florida. The presenters put forth arguments for the various modern options for treatment of the super obese, which are presented in written form. Interactive audience response technology provided a mechanism for polling the audience before and after the presentations. A review of the audiences responses provides insight into the decision-making considerations of a population of laparoscopically oriented bariatric surgeons.

Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity

BACKGROUND Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. METHODS After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. RESULTS Our patient population included 26 women and 4 men aged 26-59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. CONCLUSION In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.