Abstracts of IFSO-APC2015

OBES SURG (2015) 25:1307–1350 DOI 10.1007/s11695-015-1744-1

ABSTRACTS

Abstracts of IFSO-APC2015 TOP5-1 LAP-BAND® FOR BMI 30–40: 5-YEAR HEALTH OUTCOMES FROM THE MULTICENTER PIVOTAL STUDY John DIXON(1)*, Laura EATON(2), Vernon VINCENT(3) and Robert MICHAELSON(4). (1)

Obesity Research, Baker IDI Heart and Diabetes Institute, Melbourne, Australia; (2)Clinical Research Consultant, Apollo Endosurgery. Austin, USA; (3)Consultant to Professional Education and Medical Affairs, Apollo Endosurgery, Austin, USA; (4)Bariatric Surgeon, Northwest Weight Loss Surgery, Everett., USA. Introduction: The shortcomings of BMI for patient selection are clear, especially in the Asia-Pacific region. We performed a 5-year multicenter study to evaluate the safety and effectiveness of the LAP-BAND® System surgery (LBS) in patients with obesity with a body mass index (BMI) of 30–39.9 kg/m2. The early phase of the pivotal study allowed the LBS to be approved for use BMI>30 in the US in 2011. It was already approved at this level elsewhere. AIM: To present broad health outcome data including weight change, patient reported outcomes, comorbidity change, and complications during the 5 year study. Materials and Methods: The study was conducted at seven U.S. private practice clinical trial sites. Methods: We enrolled 149 BMI 30–39.9 subjects into a 5-year, multicenter, longitudinal, prospective post-approval study. Key health outcome measures include weight loss; objective changes in cardio-metabolic risk factors; Generic (SF-36) and obesity specific (IWQOL-Lite) quality of life measures (QOL); Beck depression inventory II; three factor eating; and binge eating assessment questionnaires. QOL measures were compared with community norms (CN). Analysis was based on ITT with all data at all time points assessed. Adverse events, complications, and LBS explantations are also reported. Results: 108 (72.4 %) of participants completed the 5 year study. Greater than 76.9 % of subjects achieved at least 30 % excess weight loss (EWL) by month 4 and at every subsequent time point in the 5-year study. Percentage weight loss was 18.4±8.4, 20.0±9.2, 19.0±10.8, 18.8±11.6, and 17.9±12, for years 1–5 respectively. There was no statistical change in weight between these time points. All markers of the metabolic syndrome improved significantly and these changes sustained for 5 years. Both QOL tools and the BDI II showed statistically significant—clinically meaningful improvements which were sustained throughout the study period. SF-36 scores were below CN values for 6 of 8 domains at baseline and exceeded CN in all 8 domains from years 1–5. Three factor eating scores indicated sustained favorable change in hunger, disinhibition and cognitive restraint, throughout the study, while binge eating prevalence fell and remained low. No deaths or unanticipated adverse device effects were reported. Seventeen bands were removed during the study (11.4 %) of these 8 were removed for adverse events or surgical complications, 3 replaced simultaneously for proximal pouch dilatation, and 6 were removed at patient request at the end of the study. Conclusion: This study easily exceeded efficacy and safety endpoints. All beneficial effects are sustained through to 5-years. The explant rate of 11.4 % is clearly below the safety indicator of 32.5 % at 5 years. Weight loss of 18–20 % is sustained throughout. The changes in the three factor

eating questionnaire support the gut-rain satiety hypothese of the mechanism of action with now clear evidence that restriction is not a key mechanism of action. The changes in Quality of Life and symptoms of depression are highly clinically meaningful and sustained. All changes in cardiometabolic risk are also sustained. These results were achieved in seven US practices supporting the broader application of findings. The LBS is safe and effective for people with BMI 30–39.9 with demonstrated improvements in weight loss, comorbidities, and quality of life, and with a low explant rate through 5 years following treatment.

TOP5-2 PRE-OP BIO-DEMOGRAPHIC PROFILE OF PATIENTS ENROLLED IN A LARGE SCALE INTERNATIONAL DIATETIC SURGERY STUDY William HOYOIS(1), Wei-Jei LEE(1)*, Shu-Chun CHEN(1), Kazunori KASAMA(2), Kyung Yul HUR(3), Muffazal LAKDAWALA(4), Simon K-H WONG(5), Anton CHEN(6), Davide LOMANTO(7), Weu WANG(8), Ming-Hsien LEE(9) and Tien-Chou SUNG(10). (1)

Min-Sheng General Hospital, Taiwan; (2)Yotsuya Medical Cube, Japan; Soonchunhyang University Hospital, Korea; (4)Saifee Hospital, India; (5) Prince of Wales Hospital, Hong Kong; (6)Khoo Teck Puat Hospital, Singapore; (7)National University of Singapore Hospital, Singapore; (8) Taipei Medical University Hospital, Taiwan; (9)China Medical University Hospital, Taiwan; (10)Chiayi Christian Hospital, Taiwan. (3)

Introduction: The Asian Diabetes Surgery Study (ADSS) is an initiative by several bariatric and metabolic surgery centers in Asia to study the long term effects of bariatric surgery on diabetic patients. Our aim here is to compare the bio-demographic measures that were collected before surgery (pre-op) at the various centers, draw a profile of the typical patient entering the study, and highlight the differences that occur between countries or regions. Materials and Methods: The ADSS was launched in 2010 by Professor Wei-Jei of Taiwan who had been collecting data about Type-2 diabetes bariatric surgery patients at his center since the early 2000s. He invited doctors at major centers in India, Japan, Korea, Singapore, Hong Kong, and Taiwan to collect data following his model, and to pool that data for research. Only patients previously diagnosed with diabetes Type-2 were enrolled in the project. Not all centers joined the project at the same time, but there is now a sizeable Bcore^ of international patients that have been followed for 5 years. Results: As of September 2014, the data of 1795 patients from 12 centers in 6 countries had been entered in the data base. Of these, 1217 are from 6 centers in Taiwan, 179 from 1 center in Korea, 141 from 1 center in Japan, 78 from 2 centers in Singapore, 121 from 1 center in India, and 59 from 1 center in Hong Kong. Data collected pre-op included BMI, HbA1C level, duration of diabetes, gender, age, and the type of surgery performed. Once entered in the register, similar data for these patients are introduced after each follow-up visit. The average BMI of patients in Taiwan was 39.25 (±8.14), 25.22 (±7.1) in Korea, 41.47 (±8.32) in Japan, 42.31 (±7.41) in Singapore, 38.77 (±5.36) in Hong Kong, and 43.41 (±8.0) in India. Average HbA1C levels were 8.29 (±1.77) in Taiwan, 9.21 (±1.75) in Korea, 8.13 (±1.87) in Japan, 7.91 (±1.59) in Singapore, 8.59 (±1.82) in Hong Kong, and 8.47 (±2.25) in India. The average age (in years) of patients

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was 39.5 in Taiwan, 46 in Korea, 45 in Japan, 45 in Singapore, 42 in Hong Kong, and 51 in India. Conclusion: The ADSS is an ongoing project that is following nearly 2000 diabetic patients who underwent metabolic surgery. The goal of the project is to study the long term effect of metabolic surgery on Type-2 diabetics. Although patients from Taiwan currently account for nearly 68 % of the total, the project is a valuable tool to study the relation between diabetes and surgery across populations and ethnicities in Asia. Results are quite consistent across nations with the average patient in his or her early 40s, a BMI in the low 40s, and HbA1c between 8 and 8.5 before surgery. Some of the results, like the low average BMI in Korea or the higher average age in India, may reflect a deliberate policy adopted by a Center in a country or cultural differences towards surgery.

TOP5-3 CHANGES IN INSULIN RESISTANCE AND BETA CELL FUNCTION FOLLOWING METABOLIC SURGERY FOR TYPE 2 DIABETES MELLITUS Shirley Yuk Wah LIU(1), Simon Kin Hung WONG(1), Candice Chuen Hing LAM(1) and Enders Kwok Wai NG(1) (1)

Chinese University of Hong Kong, Hong Kong

Introduction: Glycemic response and diabetic remission following metabolic surgery for type 2 diabetes mellitus (T2DM) result from improvement in both insulin resistance and beta cell function. This study aims to elucidate the trend of improvement in insulin resistance and beta cell function after laparoscopic sleeve gastrectomy (LSG) and laparoscopic gastric bypass (LGB) for the treatment of T2DM. Materials and Methods: We conducted a prospective observational study on consecutive morbidly obese patients undergoing LSG and LGB for T2DM. The modified Homeostasis Model Assessment (HOMA) with fasting C-peptide (FCP) was used to measure insulin resistance (HOMA-IR-CP) and beta cell function (HOMA-%B-CP) before operation, at 6 weeks, 6 months, 12 months and 24 months after surgery. Incretin-independent beta cell secretory function was also assessed using 1 mg intravenous glucagon stimulation for measuring the percentage increase in fasting C-peptide levels (%FCPI) at 6 min. Results: Between 2010 and 2014, 52 T2DM patients (23 males and 29 females) with mean age of 42.3±11.5 years received LSG (n=42) and LGB (n=10). Their mean preoperative body weight, body-mass-index and waist circumference were 104.6±19.0 kg, 38.9±5.9 kg/m2 and 121.6±13.2 cm respectively. The mean duration of T2DM was 9.4± 6.8 years and the mean preoperative fasting C-peptide was 3.5±2.0 ng/ml. After surgery, glycosylated hemoglobin (HbA1c) levels reduced significantly from 8.3±1.7 % preoperatively to 6.3±1.3 % at 6-month, 6.2± 1.3 % at 12-month and 6.7±1.3 % at 24-month follow-up (P