Christopher C Thompson1, Barham K Abu Dayyeh2, Vladimir Kushnir3, Robert F Kushner4, Pichamol Jirapinyo5, Alan B Schorr6, Louis J Aronne7, Anastassia Amaro8, David L Jaffe9, Allison R Schulman10, Dayna Early11, Adam C Stein12, Reem Sharaiha7, Steven A Edmundowicz13, J Matthew Bohning14, Michael D Jensen15, Alpana P Shukla7, Caroline Apovian16, Dong Wook Kim16, Daniel Tran17, Amir Zarrinpar18, Michele B Ryan19, Meredith Young11, Abigail Lowe13, Miki Haas20, Heidi Goldsmith21, Jennifer McCrea21, Shelby Sullivan13. 1. Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: ccthompson@hms.harvard.edu. 2. Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota. 3. Interventional Research, Washington University St. Louis, St. Louis, Missouri. 4. Division of Endocrinology, Metabolism and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 5. Division of Gastroenterology, Brigham and Women's Hospital, Boston, Massachusetts. 6. Division of Endocrinology, St. Mary Medical Center, Langhorne, Pennsylvania. 7. Weill Cornell Medical College, New York, New York. 8. Division of Endocrinology, University of Pennsylvania, Philadelphia, Pennsylvania. 9. Division of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania. 10. University of Michigan, Ann Arbor, Michigan. 11. Washington University, St. Louis, Missouri. 12. Division of Gastroenterology and Hepatology, Northwestern University School of Medicine, Chicago, Illinois. 13. University of Colorado Denver, Denver, Colorado. 14. Division of Gastroenterology, St. Mary Medical Center, Langhorne, Pennsylvania. 15. Division of Endocrinology, Diabetes, Metabolism and Nutrition, Mayo Clinic, Rochester, Minnesota. 16. Nutrition and Weight Management Center, Boston Medical Center, Boston, Massachusetts. 17. Center for Wellness and Weight Loss Surgery, Howard University, Washington, D.C. 18. Division of Gastroenterology, University of California, San Diego, California. 19. Brigham and Women's Hospital, Boston, Massachusetts. 20. Drexel University College of Medicine, Philadelphia, Pennsylvania. 21. Aspire Bariatrics, Inc., King of Prussia, Pennsylvania.
Abstract
BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receivingAspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.
RCT Entities:
BACKGROUND: The AspireAssist is the first Food and Drug Administration-approved endoluminal device indicated for treatment of class II and III obesity. OBJECTIVES: We earlier reported 1-year results of the PATHWAY study. Here, we report 4-year outcomes. SETTING: United States-based, 10-center, randomized controlled trial involving 171 participants with the treatment arm receiving Aspiration Therapy (AT) plus Lifestyle Therapy and the control arm receiving Lifestyle Therapy (2:1 randomization). METHODS: AT participants were permitted to continue in the study for an additional year up to a maximum of 5 years providing they maintained at least 10% total weight loss (TWL) from baseline at each year end. For AT participants who continued the study, 5 medical monitoring visits were provided at weeks 60, 68, 76, 90, and 104 and thereafter once every 13 weeks up to week 260. Exclusion criteria were a history of eating disorder or evidence of eating disorder on a validated questionnaire. Follow-up weight, quality of life, and co-morbidities were compared with the baseline levels. In addition, rates of serious adverse event, persistent fistula, withdrawal, and A-tube replacement were reported. All analyses were performed using a per-protocol analysis. RESULTS: Of the 82 AT participants who completed 1 year, 58 continued to this phase of the trial. Mean baseline body mass index of these 58 patients was 41.6 ± 4.5 kg/m2. At the end of first year (at the beginning of the follow-up study), these 58 patients had a body mass index of 34.1 ± 5.4 kg/m2 and had achieved an 18.3 ± 8.0% TWL. On a per protocol basis, patients experienced 14.2%, 15.3%, 16.6%, and 18.7% TWL at 1, 2, 3, and 4 years, respectively (P < .01 for all). Forty of 58 patients (69%) achieved at least 10% TWL at 4 years or at time of study withdrawal. Improvements in quality of life scores and select cardiometabolic parameters were also maintained through 4 years. There were 2 serious adverse events reported in the second through fourth years, both of which resolved with removal or replacement of the A tube. Two persistent fistulas required surgical repair, representing approximately 2% of all tube removals. There were no clinically significant metabolic or electrolytes disorders observed, nor any evidence for development of any eating disorders. CONCLUSIONS: The results of this midterm study have shown that AT is a safe, effective, and durable weight loss alternative for people with class II and III obesity and who are willing to commit to using the therapy and adhere to adjustments in eating behavior.
Authors: Francesco Maria Carrano; Miroslav P Peev; John K Saunders; Marcovalerio Melis; Valeria Tognoni; Nicola Di Lorenzo Journal: Obes Surg Date: 2020-02 Impact factor: 4.129
Authors: Andrea Telese; Vinay Sehgal; Cormac G Magee; S Naik; S A Alqahtani; L B Lovat; Rehan J Haidry Journal: Clin Transl Gastroenterol Date: 2021-06-18 Impact factor: 4.488
Authors: Jan Král; Evžen Machytka; Veronika Horká; Jana Selucká; Filip Doleček; Julius Špičák; Viktorie Kovářová; Martin Haluzík; Marek Bužga Journal: Nutrients Date: 2021-11-26 Impact factor: 5.717