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Intragastric Balloon: 342 Patients Treated at a Multicenter Bariatric Practice
2017 Oral Abstract Presentations / Surgery for Obesity and Related Diseases 13 (2017) S7–S30
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Mubarak Mubarak Al Kandari5; Shehab Ekrouf6; Saud Al-Subei7; Roman Turro Arau8; Adelardo Caballero9; Adnan Sabahi10; Abdul Hamid Al Ghamde11; Hassan Al Naami12; Ahmed Al-Mulla13; Nagi Ismail5; Sebastien Kolmer14; Mohammed Alemadi4; Roberta Ienca15; Maribel Sanchez8; Rita Schiano di Cola16; 1Department of Surgical Science, Sapienza University, Rome California; 2Royal Hayat Hospital, Kuwait City, Kuwait; 3Pineta Grande Hospital, Castel Volturno Italy; 4 Al Emadi Hospital, Doha, Qatar; 5Sabah Hospital, Kuwait City, Kuwait; 6Amiri Hospital, Kuwait City, Kuwait; 7Faisal Clinic, Kuwait City, Kuwait; 8Centro Medico Teknon, Barcelona; 9Clinica la Luz, Madrid, Spain; 10Jeddah National Hospital, Jeddah, KSA; 11 GNP Hospital, Jeddah, Saudi Arabia; 12Al Manaa General Hospital, Dammam, KSA; 13Royal Hayat Hospital, Kuwait City, KW; 14IPCO Institute, Mulhouse, France; 15Dept Experimental Medicine, Sapienza Uni, Rome Italy; 16Pineta Grande Hospital, Castel Volturno Caserta Background: Intragastric balloons are recognized as safe and effective weight loss devices. The Elipse Balloon (Allurion Technologies, Natick, MA USA) is the first balloon that does not require any endoscopy or sedation. Objective: To evaluate post-market results in 13 international centers of excellence. Methods: The Elipse Balloon is enclosed in a small capsule that is swallowed and is filled with 550mL of liquid. The balloon remains in the stomach for approximately 4 months after which it spontaneously opens, empties, and is excreted. Patients receive nutritional counseling every 2 weeks. Approximately 1,500 balloons have been placed to date. Data were collected from large volume centers that treated patients with a BMI between 27-45 kg/m2. Results: 691 patients (152M/539F) with mean age of 35.9 ± 5.3 years, mean weight of 99.4 ± 10 kg, and mean BMI of 36.6 ± 4.8 kg/m were included. After 4 months, the mean weight loss was 13.5 kg, mean percent excess weight loss was 54.5%, and mean BMI reduction was 5.1 kg/m2. Total body weight loss was 14%. Eleven (1.5%) balloons were removed early due to intolerance. Two bowel obstructions occurred requiring laparoscopic removal of the balloon. One bowel obstruction occurred in a contraindicated patient with a history of multiple abdominal surgeries. Post-operative course was uneventful. Six empty balloons were vomited uneventfully. Conclusions: This multi-center experience with the Elipse Balloon indicates that it is a safe and effective method for weight loss.
A149
INTRAGASTRIC BALLOON: 342 PATIENTS TREATED AT A MULTICENTER BARIATRIC PRACTICE Shawn Garber; Spencer Holover; John Angstadt; Eric Sommer; Nikhilesh Sekhar; Wen-Ting Chiao; New York Bariatric Group, Roslyn Heights NY Background: The ReShape™ Integrated Dual Balloon (IDB) is a nonsurgical treatment for obesity recently introduced in the United States. We report on our continuing experience in a large multicenter bariatric practice. Methods: Following appropriate workup, the IDB was placed endoscopically in an outpatient setting. Patients were scheduled for monthly follow up visits. The balloon was scheduled for endoscopic removal at 6 months. All subjects successfully implanted
with the IDB were analyzed for baseline demographics, available weight loss data and safety profile. Results: Implanted subjects (n¼342) were 76% female with the following mean baseline values: age 45 (range 18-72), weight 231 lbs (range 152-450) and BMI 37.5 (range 27.8-65.7). The mean treatment duration for retrieved patients was 166 days (range 3-246) with 276 IDBs retrieved and 66 still implanted. All attempted implantations were successful without complications. Mean weight loss for 240 subjects with 120 days or more of treatment was 24.3 lbs (-8.5, 93), 10.5% of initial body weight (-3.2, 44.5%) and 36.2% of excess body weight (-14, 171%). 81% of patients lost ≥ 5% initial body weight and 49% more than 10% of initial body weight. For the 300 subjects with at least one weight value, last observation carried forward weight loss values were 23.0 lbs, 10.0% of initial weight and 34.2% of excess weight. Multivariable analysis demonstrated that greater weight loss was associated with older patients (p¼0.004), longer periods of IDB treatment (p¼0.02) and larger numbers of inperson and virtual follow-up visits (p¼0.001). Greater fill volume was also associated with greater weight loss (p¼0.07). Seven of 276 retrieved patients (2.5%) had gastric ulcer and all resolved with PPI treatment. Twenty-two of 342 (6.4%) were retrieved before 120 days due to intolerance; these patients had an average weight loss at retrieval of 7.7% of initial body weight. Seven of 342 (2.0%) had balloon deflation; two of these were dual balloon deflations with uneventful rectal passage. Three patients had gastric outlet obstruction requiring retrieval; one of these patients had gastric perforation requiring operative repair. Three patients had pancreatitis requiring hospitalization for resolution; two IDB’s were retrieved and one patient refused retrieval. Conclusions: The ReShape IDB is a safe and effective endoscopic intervention for weight loss in appropriate patients. 49% of our assessed patients lost at least 10% of initial body weight. Gastric ulceration, deflations, pancreatitis and early retrievals for intolerance occur infrequently and have no long term sequelae when promptly treated.
A150
A COMPARATIVE 100-PARTICIPANT 5-YEAR STUDY OF ASPIRATION THERAPY VERSUS ROUX-EN-Y GASTRIC BYPASS: FIRST YEAR RESULTS Erik Wilson1; Erik Norén, MD2; Linus Axelsson, MD2; Max Nyström, MD2; Jakob Gruvaes, MD2; Christian Paradis2;
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Mubarak Mubarak Al Kandari5; Shehab Ekrouf6; Saud Al-Subei7; Roman Turro Arau8; Adelardo Caballero9; Adnan Sabahi10; Abdul Hamid Al Ghamde11; Hassan Al Naami12; Ahmed Al-Mulla13; Nagi Ismail5; Sebastien Kolmer14; Mohammed Alemadi4; Roberta Ienca15; Maribel Sanchez8; Rita Schiano di Cola16; 1Department of Surgical Science, Sapienza University, Rome California; 2Royal Hayat Hospital, Kuwait City, Kuwait; 3Pineta Grande Hospital, Castel Volturno Italy; 4 Al Emadi Hospital, Doha, Qatar; 5Sabah Hospital, Kuwait City, Kuwait; 6Amiri Hospital, Kuwait City, Kuwait; 7Faisal Clinic, Kuwait City, Kuwait; 8Centro Medico Teknon, Barcelona; 9Clinica la Luz, Madrid, Spain; 10Jeddah National Hospital, Jeddah, KSA; 11 GNP Hospital, Jeddah, Saudi Arabia; 12Al Manaa General Hospital, Dammam, KSA; 13Royal Hayat Hospital, Kuwait City, KW; 14IPCO Institute, Mulhouse, France; 15Dept Experimental Medicine, Sapienza Uni, Rome Italy; 16Pineta Grande Hospital, Castel Volturno Caserta Background: Intragastric balloons are recognized as safe and effective weight loss devices. The Elipse Balloon (Allurion Technologies, Natick, MA USA) is the first balloon that does not require any endoscopy or sedation. Objective: To evaluate post-market results in 13 international centers of excellence. Methods: The Elipse Balloon is enclosed in a small capsule that is swallowed and is filled with 550mL of liquid. The balloon remains in the stomach for approximately 4 months after which it spontaneously opens, empties, and is excreted. Patients receive nutritional counseling every 2 weeks. Approximately 1,500 balloons have been placed to date. Data were collected from large volume centers that treated patients with a BMI between 27-45 kg/m2. Results: 691 patients (152M/539F) with mean age of 35.9 ± 5.3 years, mean weight of 99.4 ± 10 kg, and mean BMI of 36.6 ± 4.8 kg/m were included. After 4 months, the mean weight loss was 13.5 kg, mean percent excess weight loss was 54.5%, and mean BMI reduction was 5.1 kg/m2. Total body weight loss was 14%. Eleven (1.5%) balloons were removed early due to intolerance. Two bowel obstructions occurred requiring laparoscopic removal of the balloon. One bowel obstruction occurred in a contraindicated patient with a history of multiple abdominal surgeries. Post-operative course was uneventful. Six empty balloons were vomited uneventfully. Conclusions: This multi-center experience with the Elipse Balloon indicates that it is a safe and effective method for weight loss.
A149
INTRAGASTRIC BALLOON: 342 PATIENTS TREATED AT A MULTICENTER BARIATRIC PRACTICE Shawn Garber; Spencer Holover; John Angstadt; Eric Sommer; Nikhilesh Sekhar; Wen-Ting Chiao; New York Bariatric Group, Roslyn Heights NY Background: The ReShape™ Integrated Dual Balloon (IDB) is a nonsurgical treatment for obesity recently introduced in the United States. We report on our continuing experience in a large multicenter bariatric practice. Methods: Following appropriate workup, the IDB was placed endoscopically in an outpatient setting. Patients were scheduled for monthly follow up visits. The balloon was scheduled for endoscopic removal at 6 months. All subjects successfully implanted
with the IDB were analyzed for baseline demographics, available weight loss data and safety profile. Results: Implanted subjects (n¼342) were 76% female with the following mean baseline values: age 45 (range 18-72), weight 231 lbs (range 152-450) and BMI 37.5 (range 27.8-65.7). The mean treatment duration for retrieved patients was 166 days (range 3-246) with 276 IDBs retrieved and 66 still implanted. All attempted implantations were successful without complications. Mean weight loss for 240 subjects with 120 days or more of treatment was 24.3 lbs (-8.5, 93), 10.5% of initial body weight (-3.2, 44.5%) and 36.2% of excess body weight (-14, 171%). 81% of patients lost ≥ 5% initial body weight and 49% more than 10% of initial body weight. For the 300 subjects with at least one weight value, last observation carried forward weight loss values were 23.0 lbs, 10.0% of initial weight and 34.2% of excess weight. Multivariable analysis demonstrated that greater weight loss was associated with older patients (p¼0.004), longer periods of IDB treatment (p¼0.02) and larger numbers of inperson and virtual follow-up visits (p¼0.001). Greater fill volume was also associated with greater weight loss (p¼0.07). Seven of 276 retrieved patients (2.5%) had gastric ulcer and all resolved with PPI treatment. Twenty-two of 342 (6.4%) were retrieved before 120 days due to intolerance; these patients had an average weight loss at retrieval of 7.7% of initial body weight. Seven of 342 (2.0%) had balloon deflation; two of these were dual balloon deflations with uneventful rectal passage. Three patients had gastric outlet obstruction requiring retrieval; one of these patients had gastric perforation requiring operative repair. Three patients had pancreatitis requiring hospitalization for resolution; two IDB’s were retrieved and one patient refused retrieval. Conclusions: The ReShape IDB is a safe and effective endoscopic intervention for weight loss in appropriate patients. 49% of our assessed patients lost at least 10% of initial body weight. Gastric ulceration, deflations, pancreatitis and early retrievals for intolerance occur infrequently and have no long term sequelae when promptly treated.
A150
A COMPARATIVE 100-PARTICIPANT 5-YEAR STUDY OF ASPIRATION THERAPY VERSUS ROUX-EN-Y GASTRIC BYPASS: FIRST YEAR RESULTS Erik Wilson1; Erik Norén, MD2; Linus Axelsson, MD2; Max Nyström, MD2; Jakob Gruvaes, MD2; Christian Paradis2;