- Email: [email protected]
P-88 Direct and indirect costs and potential cost savings of laparoscopic adjustable gastric banding among obese patients with diabetes
402
Abstracts: Poster Session 2011 / Surgery for Obesity and Related Diseases 7 (2011) 372– 416
implantation group of 500 patients had 0 complications requiring reoperation. This difference is significant (p ⬍ 0.05). Conclusion: Port implantation utilizing mesh fixation results in lower complication rates than suture fixation. P-88
DIRECT AND INDIRECT COSTS AND POTENTIAL COST SAVINGS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING AMONG OBESE PATIENTS WITH DIABETES Eric A. Finkelstein, PhD1; Benjamin T. Allaire2; Marco D. DiBonaventura, MD4; Somali M. Burgess, MD3; 1 Health Services and Systems Research Program, Duke-NUS Graduate Medical School, Singapore, Singapore; 2Public Health Economics, RTI International, RTP, NC, United States; 3Gobal Health Outcomes Strategy and Research, Allergan Inc, Irvine, CA, United States; 4Health Economics and Outcomes Research, Kantar Health, New York, NY, United States Background: Employers and insurers are concerned about the cost implications of coverage for laparoscopic adjustable gastric banding (LAGB). The objective of this study was to estimate the time to breakeven and 5-year return on investment (ROI) for LAGB among obese individuals with diabetes, a group who may be most likely to benefit from the procedure, taking both direct and indirect costs and cost savings into account. Methods: Estimates of direct cost savings were available from the literature. Indirect cost savings were generated by quantifying the relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on the job productivity) using cross-sectional data and then simulating indirect cost savings based on these multipliers and the reductions in direct medical costs. Results: The time to breakeven was estimated to be 9 quarters, both with and without the inclusion of indirect costs. However, after five years, net savings increase from $26,570 (⫾$9,160) to $34,160 (⫾$10,240) when indirect cost savings were included in the analysis. Conclusion: This study presented a novel approach for including absenteeism and presenteeism estimates in cost-benefit analyses. Application of the approach to gastric banding among surgery eligible patients with diabetes revealed that inclusion of indirect costs improves the business case for the procedure. P-89
INTERIM WEIGHT LOSS RESULTS (2-YEAR) OF ADJUSTABLE GASTRIC BANDING (APEX) STUDY – A PROSPECTIVE MULTI-CENTER OPEN-LABEL LONGITUDINAL PATIENT OBSERVATIONAL STUDY Robert Cywes, MD, PhD1; Jaime Ponce, MD, FACS2; George Woodman, MD3; Pavlos Papasavas, MD, FACS4; Kent Sasse, MD, MPH, FACS5; Ted Okerson, MD, FACP6; 1 Jacksonville Surgical Associates, PA, Jacksonville, FL, United States; 2Gastric Band Institute, Chattanooga, TN, United States; 3 Midsouth Bariatrics, Memphis, TN, United States; 4Connecticut Surgical Group, Hartford, CT, United States; 5Western Surgical, Reno, NV, United States; 6Global Medical Affairs, Allergan, Inc, Irvine, CA, United States Background: Laparoscopic Adjustable Gastric Banding has been established as a safe and effective treatment to reduce weight in
severely obese patients. The aim of this report is to summarize the 2-year prospective outcomes after surgical placement of the LAPBAND AP® device. Methods: The APEX study is an ongoing 5-year prospective multicenter open-label study to assess the progressive weight reduction, change in co-morbidities and Obesity and Weight-Loss Quality of Life results after implantation of the LAP-BAND AP® system (NCT00501085). All patients provided informed consent, and 453 subjects were evaluable. These data represent an interim analysis of the subjects who have completed at least the 48-week post-operative visit. Results: 81% of the patients were female, with a mean age of 43 years, 87% Caucasian, 9% African-American and 3% Hispanic. 101/453 (23%) subjects experienced at least one Adverse Event (AE), with 46/453 (9.9%) experiencing at least one Serious Adverse Event (SAE), with 19.4% of the AEs and 56.3% of the SAEs being unrelated to the device. 9 subjects required device explantation. Mean baseline BMI and mean excess weight was 44.2 kg/m2 and 120 pounds respectively. At 48 weeks the mean % excess weight loss (%EWL) was 46% (n⫽371), and at 2 years was 52% (n⫽159). Mean change from baseline in 48-week and 2-year BMI was ⫺8.4 and ⫺9.3 kg/m2, respectively. Conclusion: These interim data demonstrate that the LAP-BAND AP® system represents a safe and effective method to provide progressive weight loss for up to two years. P-90
EFFECT OF ADJUSTABLE GASTRIC BANDING ON OBESITY AND WEIGHT-LOSS QUALITY OF LIFE (OWLQOL): 2-YEAR INTERIM RESULTS OF THE APEX STUDY John Dixon, MBBS, PhD, FRACGP, FRCPE1; Daniel B. Jones, MD, MS, FACS2; Adam B. Smith, DO, FACOS3; Trace Curry, MD4; Ted Okerson, MD, FACP5; 1Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia; 2Harvard Medical School, Boston, MA, United States; 3Fort Worth Lap-Band, Fort Worth, TX, United States; 4Center for Metabolic and Bariatric Surgery, Cincinnati, OH, United States; 5Global Medical Affairs, Allergan, Inc, Irvine, CA, United States Background: Laparoscopic Adjustable Gastric Banding has been established as a safe and effective treatment to reduce weight in severely obese patients (⬎40 kg/m2 or ⬎35 kg/ m2 with ⬎ one co-morbidity). The aim of this report is to summarize the 2-year prospective outcomes based on the Obesity and Weight-Loss Quality of Life (OWLQOL) instrument after surgical placement of the LAP-BAND AP® device. Methods: The APEX study is an ongoing 5-year prospective open-label study to assess the progressive weight reduction, change in co-morbidities and OWLQOL results after implantation of the LAP-BAND AP® system (NCT00501085). These data represent an interim analysis of the 155 evaluable subjects (155/ 453) who have completed the 2-year post-operative visit. The well-validated OWLQOL was prospectively provided pre-implantation and at all post-operative visits. Results: Clinically significant improvements in all questions of the OWLQQOL were observed after implantation and adjustment of the LAP-BAND AP®. Mean absolute change in score from base-
Abstracts: Poster Session 2011 / Surgery for Obesity and Related Diseases 7 (2011) 372– 416
implantation group of 500 patients had 0 complications requiring reoperation. This difference is significant (p ⬍ 0.05). Conclusion: Port implantation utilizing mesh fixation results in lower complication rates than suture fixation. P-88
DIRECT AND INDIRECT COSTS AND POTENTIAL COST SAVINGS OF LAPAROSCOPIC ADJUSTABLE GASTRIC BANDING AMONG OBESE PATIENTS WITH DIABETES Eric A. Finkelstein, PhD1; Benjamin T. Allaire2; Marco D. DiBonaventura, MD4; Somali M. Burgess, MD3; 1 Health Services and Systems Research Program, Duke-NUS Graduate Medical School, Singapore, Singapore; 2Public Health Economics, RTI International, RTP, NC, United States; 3Gobal Health Outcomes Strategy and Research, Allergan Inc, Irvine, CA, United States; 4Health Economics and Outcomes Research, Kantar Health, New York, NY, United States Background: Employers and insurers are concerned about the cost implications of coverage for laparoscopic adjustable gastric banding (LAGB). The objective of this study was to estimate the time to breakeven and 5-year return on investment (ROI) for LAGB among obese individuals with diabetes, a group who may be most likely to benefit from the procedure, taking both direct and indirect costs and cost savings into account. Methods: Estimates of direct cost savings were available from the literature. Indirect cost savings were generated by quantifying the relationship between medical expenditures and absenteeism and between medical expenditures and presenteeism (reduced on the job productivity) using cross-sectional data and then simulating indirect cost savings based on these multipliers and the reductions in direct medical costs. Results: The time to breakeven was estimated to be 9 quarters, both with and without the inclusion of indirect costs. However, after five years, net savings increase from $26,570 (⫾$9,160) to $34,160 (⫾$10,240) when indirect cost savings were included in the analysis. Conclusion: This study presented a novel approach for including absenteeism and presenteeism estimates in cost-benefit analyses. Application of the approach to gastric banding among surgery eligible patients with diabetes revealed that inclusion of indirect costs improves the business case for the procedure. P-89
INTERIM WEIGHT LOSS RESULTS (2-YEAR) OF ADJUSTABLE GASTRIC BANDING (APEX) STUDY – A PROSPECTIVE MULTI-CENTER OPEN-LABEL LONGITUDINAL PATIENT OBSERVATIONAL STUDY Robert Cywes, MD, PhD1; Jaime Ponce, MD, FACS2; George Woodman, MD3; Pavlos Papasavas, MD, FACS4; Kent Sasse, MD, MPH, FACS5; Ted Okerson, MD, FACP6; 1 Jacksonville Surgical Associates, PA, Jacksonville, FL, United States; 2Gastric Band Institute, Chattanooga, TN, United States; 3 Midsouth Bariatrics, Memphis, TN, United States; 4Connecticut Surgical Group, Hartford, CT, United States; 5Western Surgical, Reno, NV, United States; 6Global Medical Affairs, Allergan, Inc, Irvine, CA, United States Background: Laparoscopic Adjustable Gastric Banding has been established as a safe and effective treatment to reduce weight in
severely obese patients. The aim of this report is to summarize the 2-year prospective outcomes after surgical placement of the LAPBAND AP® device. Methods: The APEX study is an ongoing 5-year prospective multicenter open-label study to assess the progressive weight reduction, change in co-morbidities and Obesity and Weight-Loss Quality of Life results after implantation of the LAP-BAND AP® system (NCT00501085). All patients provided informed consent, and 453 subjects were evaluable. These data represent an interim analysis of the subjects who have completed at least the 48-week post-operative visit. Results: 81% of the patients were female, with a mean age of 43 years, 87% Caucasian, 9% African-American and 3% Hispanic. 101/453 (23%) subjects experienced at least one Adverse Event (AE), with 46/453 (9.9%) experiencing at least one Serious Adverse Event (SAE), with 19.4% of the AEs and 56.3% of the SAEs being unrelated to the device. 9 subjects required device explantation. Mean baseline BMI and mean excess weight was 44.2 kg/m2 and 120 pounds respectively. At 48 weeks the mean % excess weight loss (%EWL) was 46% (n⫽371), and at 2 years was 52% (n⫽159). Mean change from baseline in 48-week and 2-year BMI was ⫺8.4 and ⫺9.3 kg/m2, respectively. Conclusion: These interim data demonstrate that the LAP-BAND AP® system represents a safe and effective method to provide progressive weight loss for up to two years. P-90
EFFECT OF ADJUSTABLE GASTRIC BANDING ON OBESITY AND WEIGHT-LOSS QUALITY OF LIFE (OWLQOL): 2-YEAR INTERIM RESULTS OF THE APEX STUDY John Dixon, MBBS, PhD, FRACGP, FRCPE1; Daniel B. Jones, MD, MS, FACS2; Adam B. Smith, DO, FACOS3; Trace Curry, MD4; Ted Okerson, MD, FACP5; 1Baker IDI Heart and Diabetes Institute, Melbourne, VIC, Australia; 2Harvard Medical School, Boston, MA, United States; 3Fort Worth Lap-Band, Fort Worth, TX, United States; 4Center for Metabolic and Bariatric Surgery, Cincinnati, OH, United States; 5Global Medical Affairs, Allergan, Inc, Irvine, CA, United States Background: Laparoscopic Adjustable Gastric Banding has been established as a safe and effective treatment to reduce weight in severely obese patients (⬎40 kg/m2 or ⬎35 kg/ m2 with ⬎ one co-morbidity). The aim of this report is to summarize the 2-year prospective outcomes based on the Obesity and Weight-Loss Quality of Life (OWLQOL) instrument after surgical placement of the LAP-BAND AP® device. Methods: The APEX study is an ongoing 5-year prospective open-label study to assess the progressive weight reduction, change in co-morbidities and OWLQOL results after implantation of the LAP-BAND AP® system (NCT00501085). These data represent an interim analysis of the 155 evaluable subjects (155/ 453) who have completed the 2-year post-operative visit. The well-validated OWLQOL was prospectively provided pre-implantation and at all post-operative visits. Results: Clinically significant improvements in all questions of the OWLQQOL were observed after implantation and adjustment of the LAP-BAND AP®. Mean absolute change in score from base-