Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population

Eric J. Vargas, Carl M. Pesta, Ahmad Bali, Eric Ibegbu, Fateh Bazerbachi, Rachel L. Moore, Vivek Kumbhari, Reem Z. Sharaiha, Trace W. Curry, Gina DosSantos, Ramsey Schmitz, Abhishek Agnihotri, Aleksey A. Novikov, Tracy Pitt, Margo K. Dunlap, Andrea Herr, Louis Aronne, Erin Ledonne, Hoda C. Kadouh, Lawrence J CheskinManpreet S. Mundi, Andres Acosta, Christopher J. Gostout, Barham K. Abu Dayyeh

Research output: Contribution to journalArticle

Abstract

Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1–6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24–12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P <.05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P <.05). Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

Original languageEnglish (US)
JournalClinical Gastroenterology and Hepatology
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Weight Loss
Population
Safety
Body Weight
Pancreatitis
Comorbidity
Obesity
Pragmatic Clinical Trials
Databases
Blood Pressure
United States Food and Drug Administration
Dehydration
Intravenous Infusions
Health Personnel
LDL Cholesterol
Endoscopy
Linear Models
Serotonin
Hemoglobins
Body Mass Index

Keywords

  • Balloon
  • Bariatric Surgery
  • Endoscopy
  • Obesity
  • Overweight
  • SF-IGB
  • SNRI
  • SSRI

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology

Cite this

Vargas, E. J., Pesta, C. M., Bali, A., Ibegbu, E., Bazerbachi, F., Moore, R. L., ... Abu Dayyeh, B. K. (Accepted/In press). Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2018.01.046

Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. / Vargas, Eric J.; Pesta, Carl M.; Bali, Ahmad; Ibegbu, Eric; Bazerbachi, Fateh; Moore, Rachel L.; Kumbhari, Vivek; Sharaiha, Reem Z.; Curry, Trace W.; DosSantos, Gina; Schmitz, Ramsey; Agnihotri, Abhishek; Novikov, Aleksey A.; Pitt, Tracy; Dunlap, Margo K.; Herr, Andrea; Aronne, Louis; Ledonne, Erin; Kadouh, Hoda C.; Cheskin, Lawrence J; Mundi, Manpreet S.; Acosta, Andres; Gostout, Christopher J.; Abu Dayyeh, Barham K.

In: Clinical Gastroenterology and Hepatology, 01.01.2018.

Research output: Contribution to journalArticle

Vargas, EJ, Pesta, CM, Bali, A, Ibegbu, E, Bazerbachi, F, Moore, RL, Kumbhari, V, Sharaiha, RZ, Curry, TW, DosSantos, G, Schmitz, R, Agnihotri, A, Novikov, AA, Pitt, T, Dunlap, MK, Herr, A, Aronne, L, Ledonne, E, Kadouh, HC, Cheskin, LJ, Mundi, MS, Acosta, A, Gostout, CJ & Abu Dayyeh, BK 2018, 'Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population', Clinical Gastroenterology and Hepatology. https://doi.org/10.1016/j.cgh.2018.01.046
Vargas, Eric J. ; Pesta, Carl M. ; Bali, Ahmad ; Ibegbu, Eric ; Bazerbachi, Fateh ; Moore, Rachel L. ; Kumbhari, Vivek ; Sharaiha, Reem Z. ; Curry, Trace W. ; DosSantos, Gina ; Schmitz, Ramsey ; Agnihotri, Abhishek ; Novikov, Aleksey A. ; Pitt, Tracy ; Dunlap, Margo K. ; Herr, Andrea ; Aronne, Louis ; Ledonne, Erin ; Kadouh, Hoda C. ; Cheskin, Lawrence J ; Mundi, Manpreet S. ; Acosta, Andres ; Gostout, Christopher J. ; Abu Dayyeh, Barham K. / Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population. In: Clinical Gastroenterology and Hepatology. 2018.
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abstract = "Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80{\%} female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7{\%} of patients, at a median of 8 weeks after placement (range, 1–6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95{\%} CI, 1.24–12.41). Total body weight lost at 3 months was 8.5{\%} ± 4.9{\%} (n = 204), at 6 months was 11.8{\%} ± 7.5{\%} (n = 199), and at 9 months was 13.3{\%} ± 10{\%} (n = 47). At 6 months, total body weight losses of 5{\%}, 10{\%}, and 15{\%} were achieved by 88{\%}, 62{\%}, and 31{\%} of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P <.05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P <.05). Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.",
keywords = "Balloon, Bariatric Surgery, Endoscopy, Obesity, Overweight, SF-IGB, SNRI, SSRI",
author = "Vargas, {Eric J.} and Pesta, {Carl M.} and Ahmad Bali and Eric Ibegbu and Fateh Bazerbachi and Moore, {Rachel L.} and Vivek Kumbhari and Sharaiha, {Reem Z.} and Curry, {Trace W.} and Gina DosSantos and Ramsey Schmitz and Abhishek Agnihotri and Novikov, {Aleksey A.} and Tracy Pitt and Dunlap, {Margo K.} and Andrea Herr and Louis Aronne and Erin Ledonne and Kadouh, {Hoda C.} and Cheskin, {Lawrence J} and Mundi, {Manpreet S.} and Andres Acosta and Gostout, {Christopher J.} and {Abu Dayyeh}, {Barham K.}",
year = "2018",
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language = "English (US)",
journal = "Clinical Gastroenterology and Hepatology",
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TY - JOUR

T1 - Single Fluid-Filled Intragastric Balloon Safe and Effective for Inducing Weight Loss in a Real-World Population

AU - Vargas, Eric J.

AU - Pesta, Carl M.

AU - Bali, Ahmad

AU - Ibegbu, Eric

AU - Bazerbachi, Fateh

AU - Moore, Rachel L.

AU - Kumbhari, Vivek

AU - Sharaiha, Reem Z.

AU - Curry, Trace W.

AU - DosSantos, Gina

AU - Schmitz, Ramsey

AU - Agnihotri, Abhishek

AU - Novikov, Aleksey A.

AU - Pitt, Tracy

AU - Dunlap, Margo K.

AU - Herr, Andrea

AU - Aronne, Louis

AU - Ledonne, Erin

AU - Kadouh, Hoda C.

AU - Cheskin, Lawrence J

AU - Mundi, Manpreet S.

AU - Acosta, Andres

AU - Gostout, Christopher J.

AU - Abu Dayyeh, Barham K.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1–6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24–12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P <.05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P <.05). Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

AB - Background & Aims: The Orbera intragastric balloon (OIB) is a single fluid-filled intragastric balloon approved for the induction of weight loss and treatment of obesity. However, little is known about the effectiveness and safety of the OIB outside clinical trials, and since approval, the Food and Drug Administration has issued warnings to health care providers about risk of balloon hyperinflation requiring early removal, pancreatitis, and death. We analyzed data on patients who have received the OIB since its approval to determine its safety, effectiveness, and tolerance in real-world clinical settings. Methods: We performed a postregulatory approval study of the safety and efficacy of the OIB, and factors associated with intolerance and response. We collected data from the Mayo Clinic's database of patient demographics, outcomes of OIB placement (weight loss, weight-related comorbidities), technical aspects of insertion and removal, and adverse events associated with the device and/or procedure, from 8 centers (3 academic, 5 private, 4 surgeons, and 4 gastroenterologists). Our final analysis comprised 321 patients (mean age, 48.1 ± 11.9 y; 80% female; baseline body mass index, 37.6 ± 6.9). Exploratory multivariable linear and logistic regression analyses were performed to identify predictors of success and early balloon removal. Primary effectiveness outcomes were percentage of total body weight lost at 3, 6, and 9 months. Primary and secondary safety outcomes were rates of early balloon removal, periprocedural complications, dehydration episodes requiring intravenous infusion, balloon migration, balloon deflation or hyperinflation, pancreatitis, or other complications. Results: Four patients had contraindications for placement at the time of endoscopy. The balloon was safely removed in all instances with an early removal rate (before 6 months) in 16.7% of patients, at a median of 8 weeks after placement (range, 1–6 mo). Use of selective serotonin or serotonin-norepinephrine re-uptake inhibitors at the time of balloon placement was associated with increased odds of removal before 6 months (odds ratio, 3.92; 95% CI, 1.24–12.41). Total body weight lost at 3 months was 8.5% ± 4.9% (n = 204), at 6 months was 11.8% ± 7.5% (n = 199), and at 9 months was 13.3% ± 10% (n = 47). At 6 months, total body weight losses of 5%, 10%, and 15% were achieved by 88%, 62%, and 31% of patients, respectively. Number of follow-up visits and weight loss at 3 months were associated with increased weight loss at 6 months (β = 0.5 and 1.2, respectively) (P <.05). Mean levels of cholesterol, triglycerides, low-density lipoprotein, and hemoglobin A1c, as well as systolic and diastolic blood pressure, were significantly improved at 6 months after OIB placement (P <.05). Conclusions: In an analysis of a database of patients who received endoscopic placement of the OIB, we found it to be safe, effective at inducing weight loss, and to reduce obesity-related comorbidities in a real-world clinical population. Rates of early removal (before 8 weeks) did not differ significantly between clinical trials and the real-world population, but were affected by use of medications.

KW - Balloon

KW - Bariatric Surgery

KW - Endoscopy

KW - Obesity

KW - Overweight

KW - SF-IGB

KW - SNRI

KW - SSRI

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