- Email: [email protected]
Incidence of Cholecystectomy following Bariatric Surgery
2017 Quickshot Abstracts / Surgery for Obesity and Related Diseases 13 (2017) S52–S65
(BMI) and the different categories compared to LRYGB in terms of %EWL postoperatively. Results: A total of 450 patients were included in our analysis; 158 patients underwent LSG and 292 underwent LRYGB. The 4-year follow-up rates for LSG and LRYGB were 63% and 58%, respectively. Major and minor complication rates at 30 days (defined by ASMBS guidelines) for LSG and LRYGB were 0.6 and 0.6 % vs. 1.4 and 5.5 %, respectively (p 4 0.05). Overall major and minor complication rates for LSG and LRYGB were 5.7 and 0% vs. 11 and 4.1 %, respectively (p 4 0.05). Readmission and reoperation rates at 30 days for LSG and LRYGB were 0 % vs. 3.4 and 1.4 %, respectively (p 4 0.05). Median operative times were 104 and 79 minutes for LRYGB and LSG, respectively (p o 0.05). LRYGB resulted in significantly greater %EWL than LSG at 3, 6, 12, 24, 36, and 48 months (Table) . However, LSG patients with BMI o 40 achieved similar %EWL compared to LRYGB up to 24 months postoperatively. Conclusion: In our center, LSG and LRYGB shared a similar safety profile. In addition, LRYGB patients achieved significantly greater %EWL compared to LSG . However, LSG patients with BMI o 40 achieved similar weight loss compared to LRYGB patients in the first two years postoperatively.
A525
EARLY EXPERIENCE WITH LOW-DOSE PHENTERMINE FOR PREOPERATIVE BARIATRIC WEIGHT LOSS: A PROSPECTIVE RANDOMIZED TRIAL John Morton1; Habib Khoury2; Dan Azagury1; Homero Rivas3; 1 Stanford School of Medicine, Stanford CA; 2Stanford School of Medicine, San Francisco CA; 3Stanford School of Medicine, Palo Alto CA Introduction: In 2016, a low dose (8mg) phentermine weight loss drug was FDA approved. Mandated preoperative weight loss with a specific time frame remains a requirement for many bariatric surgery patients. There are limited Level 1 data for pre-operative weight loss for bariatric surgery. Here we present the first randomized trial examining the impact of adjuvant pharmaceutical therapy upon preoperative weight loss. Methods: 24 patients in one month consented to participate in the study with an enrollment goal of 70 patients. Study participants were randomized to low-dose phentermine (Lomaira®) or placebo. Treatment was designated to be completed within a 60-90 day preoperative time period. Patients and surgeons were blinded regarding treatment assignment. Demographic and clinical data were collected at the patients’ consult visit. On a weekly basis, dietary intake and physical activity were assessed with the HealthWatch 360 smartphone application and weight loss was recorded via a digital, connected scale. CT scans to assess liver
S63
volume and serological exams were scheduled at initial consult and again at preoperative visit. Mann-Whitney and Wilcoxon ttests were used to assess weight loss. Results: 14 and 10 patients were assigned to the Low-Dose Phentermine (LDP) treatment and placebo groups respectively. LDP and Placebo patients were on average 26 and 29 days respectively into their treatment. LDP patients were on average 43.42 ± 3.9 years old, and Placebo patients were on average 46.33 ± 3.5 (p¼0.5974). LDP and Placebo patients had similar BMI (50.0 ± 2.3 vs. 47.0 ± 3.0, p¼0.4259) and systolic blood pressure (136.4 ± 5.4 vs. 144.8 ± 8.8 mmHg, p¼0.4025) at the first clinic visit. There were no differences between LDP and Placebo patients in initial liver volume (2131 vs. 2273 CC, p¼0.8480) or daily caloric intake (1678 ± 215 vs. 1517 ± 224 calories, p¼0.6888). LDP patients showed significant weight loss in terms of a change in BMI within a month of treatment (-1.4, p¼0.0066), unlike Placebo patients (-0.3, p¼0.2852). Additionally, there was a significant difference between LDP and Placebo patients in percentage of excess body weight loss within one month (6.3 ± 1.5% vs. 1.4 ± 1.5%, p¼0.0465). Only one patient in the treatment group discontinued treatment, due to a feeling of noncardiac chest discomfort. Conclusions: This first randomized, double-blinded pharmaceutical pre-operative weight loss trial demonstrates in preliminary results that Low Dose Phentermine is a safe and effective in delivering significant weight loss within a month of treatment.
A526
INCIDENCE OF CHOLECYSTECTOMY FOLLOWING BARIATRIC SURGERY Maria Altieri1; Jie Yang2; Lizhou Nie2; Salvatore Docimo2; Mark Talamini2; Aurora Pryor2; 1Stony Brook University Medical Center, Rocky Point NY; 2Stony Brook Hospital, Stony Brook NY Introduction: Cholecystectomy is the most commonly performed procedure in the United States. Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Methods: Following IRB approval, the SPARCS administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least four years (up to 2014). Patients who underwent cholecystectomy at the time of the initial procedure were excluded (n¼140 for LAGB, 1186 for RYGB, and 36 for SG). Univariate and multivariate analysis was used to identify risk factors for subsequent cholecystectomy. P-valueo0.05 was considered significant. Results: During this time period, there were 15,327 LAGB procedures, 19,674 RYGB, and 1,578 SG. There were 977 (6.4%) patients who underwent cholecystectomy following LAGB, 1903 (9.7%) patients following RYGB, and 167 (10.6%) following SG. Majority of follow-up cholecystectomies were performed at the same institutions (50.34% for LAGB, 55.61% for
S64
2017 Quickshot Abstracts / Surgery for Obesity and Related Diseases 13 (2017) S52–S65
RYGB, and 51.61% for SG, p¼0.6). Time to cholecystectomy was 1152.2þ/-837.4 days following LAGB, 920þ/-814.9 days following RYGB, and 984.4þ/-784 days following SG. LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (OR 0.46 95% CI 0.31-0.69, po0.001 for LAGB and OR 0.5 95% CI 0.34-0.73, po0.0001 for RYGB), Risk factors for a subsequent cholecystectomy included younger age, Commercial insurance, Caucasian, having a cardiac complication, or absence of liver disease (po0.05). Conclusions: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.4%, 9.7% and 10.6%. Following accounting for other variables, patients following either LAGB and RYGB were less likely to undergo a subsequent cholecystectomy. Patients should be counseled pre-operatively about this risk. A527
LONG-TERM WEIGHT AND METABOLIC OUTCOMES OF PATIENTS MANAGED THROUGH GASTRIC BYPASS AND TRADITIONAL CARE IN A PATIENT-CENTERED MEDICAL HOME (PCMH) Scott Monte1; Courtney Cardinal1; Caitlin Hoar2; Sarah Reed1; Nicole Albanese1; Joseph Caruana3; David Jacobs1; 1State University of New York at Buffalo, Buffalo NY; 2Buffalo Medical Group, Williamsville NY; 3Synergy Bariatrics, a department of ECMC Purpose: Gastric bypass (GB) has been widely studied and reproducibly shows benefit in weight loss, blood pressure, cholesterol, and glucose and medication requirements. Mortality is under 0.5%. Paradoxically, less than 1% of people with obesity seek consultation. This should be of interest to providers in health care models where health outcomes and cost are paramount. While there is importance in adding to an already substantial evidence base for GB, this study aims to bring awareness by presenting Usual Care and GB outcomes through the lens of a PCMH. Methods: A retrospective review was conducted by combining data from one PCMH and one bariatric surgery center in Buffalo, NY. Subjects having GB were matched with non-surgery controls by gender, age±5-years and BMI±5 kg/m2. The primary outcome was the difference in excess body weight loss (EBWL) over 7-years follow-up. EBWL is defined as percentage of excess weight lost where excess weight is calculated as the total pounds above ideal body weight. Secondary outcomes included changes in diabetes and hypertension disease status and medication use. Results: 162 RYGB and 187 control subjects were included in the primary outcome analysis. RYGB subjects had significantly greater EBWL versus matched counterparts that continued over 7-years follow-up (34.5±13.1% vs. -1.84±21.7%; po0.0001). Fasting plasma glucose (154±69 vs. 95±14;po0.01) and HbA1C (8.3±1.6 vs. 6.2±1.0;po0.05) were significantly reduced up to three years after RYGB whereas controls tended to increase in these values over the same period. Insulin and Metformin were discontinued in over 50% of subjects after RYGB whereas Insulin was never discontinued and Metformin was stopped in 15%. RYGB subjects with baseline hypertension reduced systolic (133± 15 vs. 126±14;po0.01) and diastolic (80±10 vs. 77±9;po0.05) blood pressure significantly up to three years after RYGB whereas controls tended to increase over the same period. RYGB subjects were off all anti-hypertensives in 34% of cases versus 5% controls.
Conclusions: PCMH providers can expect that people with obesity in their population will not lose weight and rather gain over at least a 7-year period. They will have worsening blood pressure and diabetes control despite continuing medication therapies. People undergoing GB will lose and maintain approximately 35% excess body weight over at least 7-years while significantly improving disease status and reducing medication requirements for at least 3-years. These data in conjunction with large-scale clinical trial experiences should be integrated into PCMH administrative planning and presented to all patients meeting eligibility requirements for surgery. A529
A JOINT SURVEY REPORT ON 446,000 MINI-GASTRIC BYPASSES (MGB) AND ONE-ANASTOMOSIS GASTRIC BYPASSES (OAGB) BY 134 SURGEONS FROM 420 COUNTRIES Kuldeepak Kular1; Mervyn Deitel2; 1Chief Surgeon, Kular Hospital, Bija, Ludhiana Punjab India; 2Editor-in-Chief Emeritus, Obesity Surgery, Toronto, ON Ontario Background: MGB consists of a lesser curvature tube (vertical pouch), starting from below crow’s foot up to left of angle of His, with the gastric tube anastomosed to jejunum 180 200 cm distal to Treitz’ ligament. The OAGB variant consists of a 2.5 cm laterolateral gastrojejunostomy between pouch and afferent jejunal loop, with afferent loop suspended above the anastomosis by a continuous suture, with apex of the jejunal loop sutured to the bypassed stomach. Methods: Data on the MGB and its OAGB variant were analyzed by an online SurveyMonkey® questionnaire filled out by experienced surgeons of the MGB-OAGB Club in Sept 2016. These surgeons kept accurate records, because MGB and OAGB had met with prejudice. Results: There were 134 out of a possible 144 respondents (96%) from 24 countries, with a total of 37,094 MGBs and 9,203 OAGBs. Mean data on MGB and OAGB follows: Pre-op BMI 45.2, 44.3; Operative time (min) 8.2, 9.7; Bypass length (cm) 175, 220; Hospital stay (days) 2.6, 2.2; Post-op leaks (%) 0.4, 0.3; 30day Mortality (%) 0.03, 0.01; EWL 1 yr 73.8%, 84.6%; 5-yr 72.9%, 79.0%; 7-yr 67.1%, 67.5%; 5-yr diabetes resolution (%) 92.1, 85.0; sleep apnea resolve (%) 86.7, 93.2; hypertension resolve 69.0, 79.6; nutritional complications requiring hospitalization (%) 0.6, 1.2. MGB had 0.07% GE bile reflux requiring revision; OAGB had no GE bile reflux. Conclusions: At 5 yr, 85.1% of MGB patients had EWL 450%, and 87.4% of OAGBs had EWL 450%. MGB-OAGB have become the third most common bariatric operations internationally (Obes Surg 2015;25:2165), and are increasing. They are favorable for safety, resolution of co-morbidities (especially diabetes), short learning curve, and durable weight loss. A530
LINEAR VERSUS CIRCULAR-STAPLED GASTROJEJUNOSTOMY IN ROUX-EN-Y GASTRIC BYPASS Alexander Barr; Melissa Helm; Tammy Kindel; Matthew Goldblatt; Jon Gould; Medical College of Wisconsin, Wauwatosa, Milwaukee WI
(BMI) and the different categories compared to LRYGB in terms of %EWL postoperatively. Results: A total of 450 patients were included in our analysis; 158 patients underwent LSG and 292 underwent LRYGB. The 4-year follow-up rates for LSG and LRYGB were 63% and 58%, respectively. Major and minor complication rates at 30 days (defined by ASMBS guidelines) for LSG and LRYGB were 0.6 and 0.6 % vs. 1.4 and 5.5 %, respectively (p 4 0.05). Overall major and minor complication rates for LSG and LRYGB were 5.7 and 0% vs. 11 and 4.1 %, respectively (p 4 0.05). Readmission and reoperation rates at 30 days for LSG and LRYGB were 0 % vs. 3.4 and 1.4 %, respectively (p 4 0.05). Median operative times were 104 and 79 minutes for LRYGB and LSG, respectively (p o 0.05). LRYGB resulted in significantly greater %EWL than LSG at 3, 6, 12, 24, 36, and 48 months (Table) . However, LSG patients with BMI o 40 achieved similar %EWL compared to LRYGB up to 24 months postoperatively. Conclusion: In our center, LSG and LRYGB shared a similar safety profile. In addition, LRYGB patients achieved significantly greater %EWL compared to LSG . However, LSG patients with BMI o 40 achieved similar weight loss compared to LRYGB patients in the first two years postoperatively.
A525
EARLY EXPERIENCE WITH LOW-DOSE PHENTERMINE FOR PREOPERATIVE BARIATRIC WEIGHT LOSS: A PROSPECTIVE RANDOMIZED TRIAL John Morton1; Habib Khoury2; Dan Azagury1; Homero Rivas3; 1 Stanford School of Medicine, Stanford CA; 2Stanford School of Medicine, San Francisco CA; 3Stanford School of Medicine, Palo Alto CA Introduction: In 2016, a low dose (8mg) phentermine weight loss drug was FDA approved. Mandated preoperative weight loss with a specific time frame remains a requirement for many bariatric surgery patients. There are limited Level 1 data for pre-operative weight loss for bariatric surgery. Here we present the first randomized trial examining the impact of adjuvant pharmaceutical therapy upon preoperative weight loss. Methods: 24 patients in one month consented to participate in the study with an enrollment goal of 70 patients. Study participants were randomized to low-dose phentermine (Lomaira®) or placebo. Treatment was designated to be completed within a 60-90 day preoperative time period. Patients and surgeons were blinded regarding treatment assignment. Demographic and clinical data were collected at the patients’ consult visit. On a weekly basis, dietary intake and physical activity were assessed with the HealthWatch 360 smartphone application and weight loss was recorded via a digital, connected scale. CT scans to assess liver
S63
volume and serological exams were scheduled at initial consult and again at preoperative visit. Mann-Whitney and Wilcoxon ttests were used to assess weight loss. Results: 14 and 10 patients were assigned to the Low-Dose Phentermine (LDP) treatment and placebo groups respectively. LDP and Placebo patients were on average 26 and 29 days respectively into their treatment. LDP patients were on average 43.42 ± 3.9 years old, and Placebo patients were on average 46.33 ± 3.5 (p¼0.5974). LDP and Placebo patients had similar BMI (50.0 ± 2.3 vs. 47.0 ± 3.0, p¼0.4259) and systolic blood pressure (136.4 ± 5.4 vs. 144.8 ± 8.8 mmHg, p¼0.4025) at the first clinic visit. There were no differences between LDP and Placebo patients in initial liver volume (2131 vs. 2273 CC, p¼0.8480) or daily caloric intake (1678 ± 215 vs. 1517 ± 224 calories, p¼0.6888). LDP patients showed significant weight loss in terms of a change in BMI within a month of treatment (-1.4, p¼0.0066), unlike Placebo patients (-0.3, p¼0.2852). Additionally, there was a significant difference between LDP and Placebo patients in percentage of excess body weight loss within one month (6.3 ± 1.5% vs. 1.4 ± 1.5%, p¼0.0465). Only one patient in the treatment group discontinued treatment, due to a feeling of noncardiac chest discomfort. Conclusions: This first randomized, double-blinded pharmaceutical pre-operative weight loss trial demonstrates in preliminary results that Low Dose Phentermine is a safe and effective in delivering significant weight loss within a month of treatment.
A526
INCIDENCE OF CHOLECYSTECTOMY FOLLOWING BARIATRIC SURGERY Maria Altieri1; Jie Yang2; Lizhou Nie2; Salvatore Docimo2; Mark Talamini2; Aurora Pryor2; 1Stony Brook University Medical Center, Rocky Point NY; 2Stony Brook Hospital, Stony Brook NY Introduction: Cholecystectomy is the most commonly performed procedure in the United States. Bariatric surgery predisposes patients to development of cholelithiasis and therefore the need of a subsequent cholecystectomy. The purpose of our study is to assess the incidence of cholecystectomy following three of the most common bariatric procedures. Methods: Following IRB approval, the SPARCS administrative longitudinal database was used to identify all patients undergoing Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG), and Laparoscopic Adjustable Gastric Banding (LAGB) between 2004-2010 through the use of ICD-9 and CPT codes. Through the use of a unique identifier patients were followed to evaluate for the need of a subsequent cholecystectomy over at least four years (up to 2014). Patients who underwent cholecystectomy at the time of the initial procedure were excluded (n¼140 for LAGB, 1186 for RYGB, and 36 for SG). Univariate and multivariate analysis was used to identify risk factors for subsequent cholecystectomy. P-valueo0.05 was considered significant. Results: During this time period, there were 15,327 LAGB procedures, 19,674 RYGB, and 1,578 SG. There were 977 (6.4%) patients who underwent cholecystectomy following LAGB, 1903 (9.7%) patients following RYGB, and 167 (10.6%) following SG. Majority of follow-up cholecystectomies were performed at the same institutions (50.34% for LAGB, 55.61% for
S64
2017 Quickshot Abstracts / Surgery for Obesity and Related Diseases 13 (2017) S52–S65
RYGB, and 51.61% for SG, p¼0.6). Time to cholecystectomy was 1152.2þ/-837.4 days following LAGB, 920þ/-814.9 days following RYGB, and 984.4þ/-784 days following SG. LAGB and RYGB were less likely to have a subsequent cholecystectomy compared to SG (OR 0.46 95% CI 0.31-0.69, po0.001 for LAGB and OR 0.5 95% CI 0.34-0.73, po0.0001 for RYGB), Risk factors for a subsequent cholecystectomy included younger age, Commercial insurance, Caucasian, having a cardiac complication, or absence of liver disease (po0.05). Conclusions: The rate of cholecystectomy following LAGB, RYGB, and SG was 6.4%, 9.7% and 10.6%. Following accounting for other variables, patients following either LAGB and RYGB were less likely to undergo a subsequent cholecystectomy. Patients should be counseled pre-operatively about this risk. A527
LONG-TERM WEIGHT AND METABOLIC OUTCOMES OF PATIENTS MANAGED THROUGH GASTRIC BYPASS AND TRADITIONAL CARE IN A PATIENT-CENTERED MEDICAL HOME (PCMH) Scott Monte1; Courtney Cardinal1; Caitlin Hoar2; Sarah Reed1; Nicole Albanese1; Joseph Caruana3; David Jacobs1; 1State University of New York at Buffalo, Buffalo NY; 2Buffalo Medical Group, Williamsville NY; 3Synergy Bariatrics, a department of ECMC Purpose: Gastric bypass (GB) has been widely studied and reproducibly shows benefit in weight loss, blood pressure, cholesterol, and glucose and medication requirements. Mortality is under 0.5%. Paradoxically, less than 1% of people with obesity seek consultation. This should be of interest to providers in health care models where health outcomes and cost are paramount. While there is importance in adding to an already substantial evidence base for GB, this study aims to bring awareness by presenting Usual Care and GB outcomes through the lens of a PCMH. Methods: A retrospective review was conducted by combining data from one PCMH and one bariatric surgery center in Buffalo, NY. Subjects having GB were matched with non-surgery controls by gender, age±5-years and BMI±5 kg/m2. The primary outcome was the difference in excess body weight loss (EBWL) over 7-years follow-up. EBWL is defined as percentage of excess weight lost where excess weight is calculated as the total pounds above ideal body weight. Secondary outcomes included changes in diabetes and hypertension disease status and medication use. Results: 162 RYGB and 187 control subjects were included in the primary outcome analysis. RYGB subjects had significantly greater EBWL versus matched counterparts that continued over 7-years follow-up (34.5±13.1% vs. -1.84±21.7%; po0.0001). Fasting plasma glucose (154±69 vs. 95±14;po0.01) and HbA1C (8.3±1.6 vs. 6.2±1.0;po0.05) were significantly reduced up to three years after RYGB whereas controls tended to increase in these values over the same period. Insulin and Metformin were discontinued in over 50% of subjects after RYGB whereas Insulin was never discontinued and Metformin was stopped in 15%. RYGB subjects with baseline hypertension reduced systolic (133± 15 vs. 126±14;po0.01) and diastolic (80±10 vs. 77±9;po0.05) blood pressure significantly up to three years after RYGB whereas controls tended to increase over the same period. RYGB subjects were off all anti-hypertensives in 34% of cases versus 5% controls.
Conclusions: PCMH providers can expect that people with obesity in their population will not lose weight and rather gain over at least a 7-year period. They will have worsening blood pressure and diabetes control despite continuing medication therapies. People undergoing GB will lose and maintain approximately 35% excess body weight over at least 7-years while significantly improving disease status and reducing medication requirements for at least 3-years. These data in conjunction with large-scale clinical trial experiences should be integrated into PCMH administrative planning and presented to all patients meeting eligibility requirements for surgery. A529
A JOINT SURVEY REPORT ON 446,000 MINI-GASTRIC BYPASSES (MGB) AND ONE-ANASTOMOSIS GASTRIC BYPASSES (OAGB) BY 134 SURGEONS FROM 420 COUNTRIES Kuldeepak Kular1; Mervyn Deitel2; 1Chief Surgeon, Kular Hospital, Bija, Ludhiana Punjab India; 2Editor-in-Chief Emeritus, Obesity Surgery, Toronto, ON Ontario Background: MGB consists of a lesser curvature tube (vertical pouch), starting from below crow’s foot up to left of angle of His, with the gastric tube anastomosed to jejunum 180 200 cm distal to Treitz’ ligament. The OAGB variant consists of a 2.5 cm laterolateral gastrojejunostomy between pouch and afferent jejunal loop, with afferent loop suspended above the anastomosis by a continuous suture, with apex of the jejunal loop sutured to the bypassed stomach. Methods: Data on the MGB and its OAGB variant were analyzed by an online SurveyMonkey® questionnaire filled out by experienced surgeons of the MGB-OAGB Club in Sept 2016. These surgeons kept accurate records, because MGB and OAGB had met with prejudice. Results: There were 134 out of a possible 144 respondents (96%) from 24 countries, with a total of 37,094 MGBs and 9,203 OAGBs. Mean data on MGB and OAGB follows: Pre-op BMI 45.2, 44.3; Operative time (min) 8.2, 9.7; Bypass length (cm) 175, 220; Hospital stay (days) 2.6, 2.2; Post-op leaks (%) 0.4, 0.3; 30day Mortality (%) 0.03, 0.01; EWL 1 yr 73.8%, 84.6%; 5-yr 72.9%, 79.0%; 7-yr 67.1%, 67.5%; 5-yr diabetes resolution (%) 92.1, 85.0; sleep apnea resolve (%) 86.7, 93.2; hypertension resolve 69.0, 79.6; nutritional complications requiring hospitalization (%) 0.6, 1.2. MGB had 0.07% GE bile reflux requiring revision; OAGB had no GE bile reflux. Conclusions: At 5 yr, 85.1% of MGB patients had EWL 450%, and 87.4% of OAGBs had EWL 450%. MGB-OAGB have become the third most common bariatric operations internationally (Obes Surg 2015;25:2165), and are increasing. They are favorable for safety, resolution of co-morbidities (especially diabetes), short learning curve, and durable weight loss. A530
LINEAR VERSUS CIRCULAR-STAPLED GASTROJEJUNOSTOMY IN ROUX-EN-Y GASTRIC BYPASS Alexander Barr; Melissa Helm; Tammy Kindel; Matthew Goldblatt; Jon Gould; Medical College of Wisconsin, Wauwatosa, Milwaukee WI