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P-05: The TANTALUS®: Meal-activated gastric electrical stimulation improves glycemic control in obese subjects with type 2 diabetes
Abstracts: 2009 Poster Session / Surgery for Obesity and Related Diseases 5 (2009) S24 –S57
Methods: All data was retrospectively collected and entered into an electronic database. Preoperative data points included age, body mass index, gender, number of comorbid conditions, and the presence of diabetes, oral hypoglycemic agents, insulin usage, and hemoglobin A1c values (HbA1c). Data points and laboratory values were compared between RYGB and LABG at operation and at one year. Results: A total of 36 bariatric patients at least 60 years old at time of surgery with one year follow-up at a single center were analyzed (19 LAGB, 17 RYGB). The two groups were comparable based on age, initial BMI, and preoperative A1C. There was one sudden death at 1 month in the RYGB group with no known cause. Using MANOVA fit model to compare changes in BMI, number of oral hypoglycemics, presence of DM, and insulin requirement, there were significant (p⬍.05) differences in BMI, number of hypoglycemics, presence of DM, and HbA1c. However, the insulin requirement between the two groups was not statistically significant. Conclusion: RYGB is more effective than LAGB in achieving diabetes remission and improvement at one year in patients over 60 years of age. Further assessment is necessary to determine if RYGB’s superior remission of DM is sustainable.
RYGB PreOp RYGB 1 Yr LAGB PreOp LAGB 1 Yr
Average BMI
Average number of oral hypoglycemics
Type 2 diabetes
Patients with continued insulin requirement
HbA1c
47.5 33.9 49.7 42.2
2.3 0.35 2.2 1.5
100% 24% 100% 68%
100% 17% 47% 32%
7.9% 6.2% 7.2% 7.0%
P-04.
GASTRIC BALLOON EFFICIENCY ON WEIGHT LOSS (WL) WITH A MULTIDISCIPLINARY MEDICAL FOLLOWS UP Vianna Costil, ND; Poˆle Sante´, Centre des me´decins spe´cialistes, Paris la De´fense, France. Background: This study shows the effectiveness of an air-filled HELIOSPHERE® or water-filled BIB® gastric balloons on Weight Loss (WL) and Excess Weight Loss (EWL) and their results after removal and at 6 months after extraction. Methods: 117 patients are included in a prospective, comparative and non-randomized study. Both types of gastric balloons were implanted for 6 months then removed.Throughout their use and after extraction, medical follow-up by a gastroenterologist, nutritionist and psychiatrist were done to help modify alimentary habits and behavior. Results: 85 extractions were done. EWL was 51.9 ⫾ 1.0 % and WL 10.2 ⫾ 1.6 kg. After 1 year of multidisciplinary medical follow-up (included portage period), 19 patient results show an EWL of 53.2 ⫾ 19.5% and a WL of 13.4 ⫾ 6.41 kg. Between both HELIOSPHERE® and BIB® gastric balloons, the weight loss was very similar (10.1 kg vs/ 10.4 kg) but adverse events, such as nausea and vomiting (p⬍0.05) and retrosternal burning (15.6% vs 31.4% N.S), were less with the HELIOSPHERE®. 6 month after removal, EWL was still 50% showing an excellent efficiency of gastric balloons coupled with medical management. However, if the long-term follow-up is neglected, weight regain can be significant. Conclusion: Gastric balloon can help overweight and obese patients for whom bariatric surgery may be contraindicated, reduce weight. Behavior change is essential to avoid weight regain.
S25
P-05.
THE TANTALUS®: MEAL-ACTIVATED GASTRIC ELECTRICAL STIMULATION IMPROVES GLYCEMIC CONTROL IN OBESE SUBJECTS WITH TYPE 2 DIABETES Arthur Bohdjalian, MD1; Laurent Bresler2; David Nocca, MD, PhD3; Pierre Goudet4; Ahmad Assalia5; Michael Kisser6; Nicola Scopinaro, Professor of Surgery7; Rudolf A. Weiner, MD8; 1Surgery, Medical University of Vienna, Vienna, Austria; 2Hopital Universitaire de Brabois, Nancy, France; 3Hopital Saint-Eloi, Montpellier, France; 4Hopital General, Dijon, France; 5Rambam Medical Center, Haifa, Israel; 6Hietzing Hospital, Vienna, Austria; 7Azienda Ospedaliera Universitaria ‘San Martino’, Genova, Italy; 8Krankenhaus Sachsenhausen, Frankfurt/Main, Germany. Background: The TANTALUS System delivers meal-activated therapy that has been demonstrated to improve glycemic control and body weight in Type 2 Diabetes Mellitus (T2DM) subjects. Improvement in metabolic co-morbidities and glycemic status are presented for subjects that were prospectively enrolled and followed for 6 months under open-label protocols. Methods: 34 overweight and obese subjects (21/13, M/F; BMI: 37⫾1 kg/m2) with T2DM, on oral anti-diabetic medications, but with poor glycemic control were implanted laparoscopically with the TANTALUS System. The system applies GCM (Gastric Contractility Modulation) signals to the antrum of the stomach in synchrony with the native electrical activity. Results: To date, 27 subjects have completed 6 months of treatment. The following table summarizes the mean values of major clinical metabolic parameters at baseline and at the end of 6 months. Adverse events were consistent with those associated with similar laparoscopic procedures and were primarily related to the procedure not to the device or to the stimulation. Conclusion: This specific and unique meal-activated stimulation is well tolerated and can positively affect glycemic status, weight and related metabolic co-morbidities. Baseline 6 months Change N HbA1c (%) 8.3 Weight(kg) 108.4 Waist circumference (cm) 122.1 Fasting blood glucose (mg/dl) 176 Blood pressure (mmHg) 147/92 HDL (mg/dl) 36.7 LDL (mg/dl) 166 Triglyceride (mg/dl) 240
7.3 -1.0 103.8 -4.6 116.7 -5.4 153 -23 130/82 -17/-10 40.0 3.3 147 -19.5 197 -42.9
27 27 27 23* 25** 18** 7** 15**
p-value ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.01 ⬍0.001 ⬍0.05 NS ⬍0.05
* Data is available from 23 subjects ** Analysis of metabolic parameters include only subjects that had abnormal values at baseline for the given parameters as defined for metabolic syndrome.
P-06.
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: WHO BENEFITS MORE? Konstantinidis, MD, PhD, FACS, Marina Chaida, Msc, MmedSci, ANutr; Anna Chatzidimitriou, Msc, CPsychol; Efterpi Chiotakakou, PhD; Robotic, Bariatric and Laparoscopic Clinic of Dr. Konstantinidis, Athens Medical Centre, Athens, Greece.
Methods: All data was retrospectively collected and entered into an electronic database. Preoperative data points included age, body mass index, gender, number of comorbid conditions, and the presence of diabetes, oral hypoglycemic agents, insulin usage, and hemoglobin A1c values (HbA1c). Data points and laboratory values were compared between RYGB and LABG at operation and at one year. Results: A total of 36 bariatric patients at least 60 years old at time of surgery with one year follow-up at a single center were analyzed (19 LAGB, 17 RYGB). The two groups were comparable based on age, initial BMI, and preoperative A1C. There was one sudden death at 1 month in the RYGB group with no known cause. Using MANOVA fit model to compare changes in BMI, number of oral hypoglycemics, presence of DM, and insulin requirement, there were significant (p⬍.05) differences in BMI, number of hypoglycemics, presence of DM, and HbA1c. However, the insulin requirement between the two groups was not statistically significant. Conclusion: RYGB is more effective than LAGB in achieving diabetes remission and improvement at one year in patients over 60 years of age. Further assessment is necessary to determine if RYGB’s superior remission of DM is sustainable.
RYGB PreOp RYGB 1 Yr LAGB PreOp LAGB 1 Yr
Average BMI
Average number of oral hypoglycemics
Type 2 diabetes
Patients with continued insulin requirement
HbA1c
47.5 33.9 49.7 42.2
2.3 0.35 2.2 1.5
100% 24% 100% 68%
100% 17% 47% 32%
7.9% 6.2% 7.2% 7.0%
P-04.
GASTRIC BALLOON EFFICIENCY ON WEIGHT LOSS (WL) WITH A MULTIDISCIPLINARY MEDICAL FOLLOWS UP Vianna Costil, ND; Poˆle Sante´, Centre des me´decins spe´cialistes, Paris la De´fense, France. Background: This study shows the effectiveness of an air-filled HELIOSPHERE® or water-filled BIB® gastric balloons on Weight Loss (WL) and Excess Weight Loss (EWL) and their results after removal and at 6 months after extraction. Methods: 117 patients are included in a prospective, comparative and non-randomized study. Both types of gastric balloons were implanted for 6 months then removed.Throughout their use and after extraction, medical follow-up by a gastroenterologist, nutritionist and psychiatrist were done to help modify alimentary habits and behavior. Results: 85 extractions were done. EWL was 51.9 ⫾ 1.0 % and WL 10.2 ⫾ 1.6 kg. After 1 year of multidisciplinary medical follow-up (included portage period), 19 patient results show an EWL of 53.2 ⫾ 19.5% and a WL of 13.4 ⫾ 6.41 kg. Between both HELIOSPHERE® and BIB® gastric balloons, the weight loss was very similar (10.1 kg vs/ 10.4 kg) but adverse events, such as nausea and vomiting (p⬍0.05) and retrosternal burning (15.6% vs 31.4% N.S), were less with the HELIOSPHERE®. 6 month after removal, EWL was still 50% showing an excellent efficiency of gastric balloons coupled with medical management. However, if the long-term follow-up is neglected, weight regain can be significant. Conclusion: Gastric balloon can help overweight and obese patients for whom bariatric surgery may be contraindicated, reduce weight. Behavior change is essential to avoid weight regain.
S25
P-05.
THE TANTALUS®: MEAL-ACTIVATED GASTRIC ELECTRICAL STIMULATION IMPROVES GLYCEMIC CONTROL IN OBESE SUBJECTS WITH TYPE 2 DIABETES Arthur Bohdjalian, MD1; Laurent Bresler2; David Nocca, MD, PhD3; Pierre Goudet4; Ahmad Assalia5; Michael Kisser6; Nicola Scopinaro, Professor of Surgery7; Rudolf A. Weiner, MD8; 1Surgery, Medical University of Vienna, Vienna, Austria; 2Hopital Universitaire de Brabois, Nancy, France; 3Hopital Saint-Eloi, Montpellier, France; 4Hopital General, Dijon, France; 5Rambam Medical Center, Haifa, Israel; 6Hietzing Hospital, Vienna, Austria; 7Azienda Ospedaliera Universitaria ‘San Martino’, Genova, Italy; 8Krankenhaus Sachsenhausen, Frankfurt/Main, Germany. Background: The TANTALUS System delivers meal-activated therapy that has been demonstrated to improve glycemic control and body weight in Type 2 Diabetes Mellitus (T2DM) subjects. Improvement in metabolic co-morbidities and glycemic status are presented for subjects that were prospectively enrolled and followed for 6 months under open-label protocols. Methods: 34 overweight and obese subjects (21/13, M/F; BMI: 37⫾1 kg/m2) with T2DM, on oral anti-diabetic medications, but with poor glycemic control were implanted laparoscopically with the TANTALUS System. The system applies GCM (Gastric Contractility Modulation) signals to the antrum of the stomach in synchrony with the native electrical activity. Results: To date, 27 subjects have completed 6 months of treatment. The following table summarizes the mean values of major clinical metabolic parameters at baseline and at the end of 6 months. Adverse events were consistent with those associated with similar laparoscopic procedures and were primarily related to the procedure not to the device or to the stimulation. Conclusion: This specific and unique meal-activated stimulation is well tolerated and can positively affect glycemic status, weight and related metabolic co-morbidities. Baseline 6 months Change N HbA1c (%) 8.3 Weight(kg) 108.4 Waist circumference (cm) 122.1 Fasting blood glucose (mg/dl) 176 Blood pressure (mmHg) 147/92 HDL (mg/dl) 36.7 LDL (mg/dl) 166 Triglyceride (mg/dl) 240
7.3 -1.0 103.8 -4.6 116.7 -5.4 153 -23 130/82 -17/-10 40.0 3.3 147 -19.5 197 -42.9
27 27 27 23* 25** 18** 7** 15**
p-value ⬍0.001 ⬍0.001 ⬍0.001 ⬍0.01 ⬍0.001 ⬍0.05 NS ⬍0.05
* Data is available from 23 subjects ** Analysis of metabolic parameters include only subjects that had abnormal values at baseline for the given parameters as defined for metabolic syndrome.
P-06.
LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING: WHO BENEFITS MORE? Konstantinidis, MD, PhD, FACS, Marina Chaida, Msc, MmedSci, ANutr; Anna Chatzidimitriou, Msc, CPsychol; Efterpi Chiotakakou, PhD; Robotic, Bariatric and Laparoscopic Clinic of Dr. Konstantinidis, Athens Medical Centre, Athens, Greece.