Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial

Christopher C. Thompson, Barham K. Abu Dayyeh, Vladimir Kushnir, Robert F. Kushner, Pichamol Jirapinyo, Alan B. Schorr, Louis J. Aronne, Anastassia Amaro, David L. Jaffe, Allison R. Schulman, Dayna Early, Adam C. Stein, Reem Sharaiha, Steven A. Edmundowicz, J. Matthew Bohning, Michael D. Jensen, Alpana P. Shukla, Caroline Apovian, Dong Wook Kim, Daniel TranAmir Zarrinpar, Michele B. Ryan, Meredith Young, Abigail Lowe, Miki Haas, Heidi Goldsmith, Jennifer McCrea, Shelby Sullivan

Research output: Contribution to journalArticle

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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 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.

Original languageEnglish (US)
Pages (from-to)1348-1354
Number of pages7
JournalSurgery for Obesity and Related Diseases
Volume15
Issue number8
DOIs
StatePublished - Aug 2019

Fingerprint

Randomized Controlled Trials
Obesity
Weight Loss
Therapeutics
Fistula
Life Style
Body Mass Index
Quality of Life
Aspirations (Psychology)
Social Adjustment
Time and Motion Studies
Feeding Behavior
Random Allocation
Electrolytes
Morbidity
Weights and Measures
Food
Equipment and Supplies
Pharmaceutical Preparations
Feeding and Eating Disorders

Keywords

  • Aspiration therapy
  • Diet
  • Endoscopic bariatric therapy (EBT)
  • Metabolic
  • Obesity

ASJC Scopus subject areas

  • Surgery

Cite this

Thompson, C. C., Abu Dayyeh, B. K., Kushnir, V., Kushner, R. F., Jirapinyo, P., Schorr, A. B., ... Sullivan, S. (2019). Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial. Surgery for Obesity and Related Diseases, 15(8), 1348-1354. https://doi.org/10.1016/j.soard.2019.04.026

Aspiration therapy for the treatment of obesity : 4-year results of a multicenter randomized controlled trial. / Thompson, Christopher C.; Abu Dayyeh, Barham K.; Kushnir, Vladimir; Kushner, Robert F.; Jirapinyo, Pichamol; Schorr, Alan B.; Aronne, Louis J.; Amaro, Anastassia; Jaffe, David L.; Schulman, Allison R.; Early, Dayna; Stein, Adam C.; Sharaiha, Reem; Edmundowicz, Steven A.; Bohning, J. Matthew; Jensen, Michael D.; Shukla, Alpana P.; Apovian, Caroline; Kim, Dong Wook; Tran, Daniel; Zarrinpar, Amir; Ryan, Michele B.; Young, Meredith; Lowe, Abigail; Haas, Miki; Goldsmith, Heidi; McCrea, Jennifer; Sullivan, Shelby.

In: Surgery for Obesity and Related Diseases, Vol. 15, No. 8, 08.2019, p. 1348-1354.

Research output: Contribution to journalArticle

Thompson, CC, Abu Dayyeh, BK, Kushnir, V, Kushner, RF, Jirapinyo, P, Schorr, AB, Aronne, LJ, Amaro, A, Jaffe, DL, Schulman, AR, Early, D, Stein, AC, Sharaiha, R, Edmundowicz, SA, Bohning, JM, Jensen, MD, Shukla, AP, Apovian, C, Kim, DW, Tran, D, Zarrinpar, A, Ryan, MB, Young, M, Lowe, A, Haas, M, Goldsmith, H, McCrea, J & Sullivan, S 2019, 'Aspiration therapy for the treatment of obesity: 4-year results of a multicenter randomized controlled trial', Surgery for Obesity and Related Diseases, vol. 15, no. 8, pp. 1348-1354. https://doi.org/10.1016/j.soard.2019.04.026
Thompson, Christopher C. ; Abu Dayyeh, Barham K. ; Kushnir, Vladimir ; Kushner, Robert F. ; Jirapinyo, Pichamol ; Schorr, Alan B. ; Aronne, Louis J. ; Amaro, Anastassia ; Jaffe, David L. ; Schulman, Allison R. ; Early, Dayna ; Stein, Adam C. ; Sharaiha, Reem ; Edmundowicz, Steven A. ; Bohning, J. Matthew ; Jensen, Michael D. ; Shukla, Alpana P. ; Apovian, Caroline ; Kim, Dong Wook ; Tran, Daniel ; Zarrinpar, Amir ; Ryan, Michele B. ; Young, Meredith ; Lowe, Abigail ; Haas, Miki ; Goldsmith, Heidi ; McCrea, Jennifer ; Sullivan, Shelby. / Aspiration therapy for the treatment of obesity : 4-year results of a multicenter randomized controlled trial. In: Surgery for Obesity and Related Diseases. 2019 ; Vol. 15, No. 8. pp. 1348-1354.
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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 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.",
keywords = "Aspiration therapy, Diet, Endoscopic bariatric therapy (EBT), Metabolic, Obesity",
author = "Thompson, {Christopher C.} and {Abu Dayyeh}, {Barham K.} and Vladimir Kushnir and Kushner, {Robert F.} and Pichamol Jirapinyo and Schorr, {Alan B.} and Aronne, {Louis J.} and Anastassia Amaro and Jaffe, {David L.} and Schulman, {Allison R.} and Dayna Early and Stein, {Adam C.} and Reem Sharaiha and Edmundowicz, {Steven A.} and Bohning, {J. Matthew} and Jensen, {Michael D.} and Shukla, {Alpana P.} and Caroline Apovian and Kim, {Dong Wook} and Daniel Tran and Amir Zarrinpar and Ryan, {Michele B.} and Meredith Young and Abigail Lowe and Miki Haas and Heidi Goldsmith and Jennifer McCrea and Shelby Sullivan",
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TY - JOUR

T1 - Aspiration therapy for the treatment of obesity

T2 - 4-year results of a multicenter randomized controlled trial

AU - Thompson, Christopher C.

AU - Abu Dayyeh, Barham K.

AU - Kushnir, Vladimir

AU - Kushner, Robert F.

AU - Jirapinyo, Pichamol

AU - Schorr, Alan B.

AU - Aronne, Louis J.

AU - Amaro, Anastassia

AU - Jaffe, David L.

AU - Schulman, Allison R.

AU - Early, Dayna

AU - Stein, Adam C.

AU - Sharaiha, Reem

AU - Edmundowicz, Steven A.

AU - Bohning, J. Matthew

AU - Jensen, Michael D.

AU - Shukla, Alpana P.

AU - Apovian, Caroline

AU - Kim, Dong Wook

AU - Tran, Daniel

AU - Zarrinpar, Amir

AU - Ryan, Michele B.

AU - Young, Meredith

AU - Lowe, Abigail

AU - Haas, Miki

AU - Goldsmith, Heidi

AU - McCrea, Jennifer

AU - Sullivan, Shelby

PY - 2019/8

Y1 - 2019/8

N2 - 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.

AB - 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.

KW - Aspiration therapy

KW - Diet

KW - Endoscopic bariatric therapy (EBT)

KW - Metabolic

KW - Obesity

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