Retrospective Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. May 16, 2021; 13(5): 115-124
Published online May 16, 2021. doi: 10.4253/wjge.v13.i5.115
Impact of intragastric balloon on blood pressure reduction: A retrospective study in Eastern North Carolina
Gbeminiyi Olanrewaju Samuel, Karissa Lambert, Elijah Asagbra, Glenn Harvin, Eric Ibegbu
Gbeminiyi Olanrewaju Samuel, Glenn Harvin, Eric Ibegbu, Division of Gastroenterology, East Carolina University, Greenville, NC 27834, United States
Karissa Lambert, Department of Internal Medicine, Brody School of Medicine, East Carolina University, Greenville, NC 27834, United States
Elijah Asagbra, Department of Health Services and Information Management, East Carolina University, College of Allied Health Sciences, Greenville, NC 27834, United States
Author contributions: Samuel GO and Lambert K collected and managed data, communicated with institutional review board, prepared study initiation activities, and helped with the writing of the manuscript; Asagbra E analyzed the data and helped with writing of the manuscript; Harvin G reviewed and helped with writing of the manuscript; Ibegbu E managed and provided data, reviewed and helped with writing of the manuscript; all authors have read and approved the final manuscript.
Institutional review board statement: This study was exempt from Institutional Review Board review after Institutional Review Board review (UMCIRB 19-001002).
Informed consent statement: A waiver of informed consent was obtained as the data are anonymized and the risk of the identification is low.
Conflict-of-interest statement: No relevant conflicts of interest exist for all authors.
Data sharing statement: Statistical codes, and dataset available from the corresponding author at
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
Corresponding author: Gbeminiyi Olanrewaju Samuel, MD, Academic Fellow, Division of Gastroenterology, East Carolina University, 2100 Stantonsburg Road, Greenville, NC 27834, United States.
Received: August 25, 2020
Peer-review started: August 25, 2020
First decision: December 11, 2020
Revised: December 26, 2020
Accepted: April 7, 2021
Article in press: April 7, 2021
Published online: May 16, 2021
Research background

In the United States, about a third of adults have hypertension, which is the most modifiable risk factor for heart disease and stroke. The prevalence of obesity and hypertension in eastern North Carolina are comparable, with obesity being an established risk factor for hypertension. Lifestyle interventions and pharmacological agents often are not sufficient to achieve enough weight loss. Bariatric surgery offers the most effective weight reduction intervention, however patients with higher body mass index may have higher surgical morbidity and mortality, longer hospitalization, and high rates of 30-d readmission due to co-morbidities. Minimally invasive non-surgical options like the intragastric balloon may bridge a critical gap in the treatment of obesity.

Research motivation

The weight loss mechanism of the intragastric balloon therapy is restrictive, and this leads to weight reduction due to reduced food intake from early post-prandial satiety. Weight loss helps to lower the risk of potentially serious obesity-related health problems like heart disease, stroke, hypertension, diabetes and osteoarthritis. Aside from long-term health benefits, weight reduction is cost-effective and promotes substantial health-care cost savings.

Research objectives

Our study focused on the impact of intragastric balloon therapy (IGBT) on blood pressure reduction. IGBT leads to statistically significant weight and systolic blood pressure reduction at 6-mo. Also, the degree of weight reduction by IGBT is sufficient to effect improvement in comorbidities.

Research methods

A retrospective chart review was conducted from January 1, 2016 to January 31, 2019 of consecutive adults who received IGBT in a gastroenterology private practice in eastern North Carolina. The balloon was introduced into the stomach under endoscopic guidance, and while in the region of the gastric body, inflation with saline was performed at increments of 50 mL until target volume between 500 to 650 mL of saline was attained depending on the patient's gastric capacity. No procedural complications were noted during endoscopic placement and removal of the balloon.

Of the 172 patients who had IGBT at baseline, 11 patients (6.4%) requested early balloon removal due to foreign body sensation (n = 1), and/or intolerable gastrointestinal adverse events (n = 10). The reported gastrointestinal adverse events were nausea, vomiting, abdominal pain, and diarrhea. Eventually, 6-mo follow-up data were available for only 140 patients. As a result, only the 140 available at the 6-mo follow-up were included in the analysis. Univariate, bivariate, and multivariate statistical analyses were performed. Specifically, scatterplots were created to show the relationship between weight and blood pressure, and paired two-sample t-test was carried out to determine if there was a significant reduction in weight before and after the IGBT. Multiple regressions were also performed to examine the association between participants’ total body weight and blood pressure. The outcome variables for the multiple regression were systolic and diastolic blood pressure measured as continuous variables. This was followed by logistic regression analyses to determine the association between total body weight and hypertension at 6-mo post-implantation. The outcome variables for the logistic regression were systolic blood pressure–non-hypertensive (140 mmHg or less) or hypertensive (greater than 140 mmHg), and diastolic blood pressure-non-hypertensive (90 mmHg or less) or hypertensive (greater than 90 mmHg). All authors had access to the study data and reviewed and approved the final manuscript. All statistical analyses were done using STATA 14®.

Research results

Weight is an important factor for predicting the systolic blood pressure of the study participants (β = 0.1350, P < 0.000). Conversely, weight was not significantly associated with the diastolic blood pressure of the study participants (β = 0.0295, P < 0.138). On average, the percent total body weight loss at 6-mo is 11.97 after IGBT. The logistic regression performed revealed that weight (β = 0.0140, P < 0.000) and age (β = 0.0534, P < 0.000) are important factors in determining systolic blood pressure after IGBT. The results specifically indicated that for every unit increase in weight, the log odds of SBP will increase by 1.4%. Also, for every unit increase in age, the log odds of SBP will increase by 5.34%.

IGBT can be an effective short-term weight reduction modality with a relatively little risk of adverse event. Due to its improvement on systolic blood pressure, IGBT may help reduce cardiovascular risk. Study limitations include the retrospective analysis of a single-center and the absence of a control group. In addition, the follow-up period was only at the six-month time period of balloon removal, and therefore, weight loss sustainability cannot be concluded.

Research conclusions

IGBT engenders short-term weight reduction modality with a relatively little risk of adverse event. Its improvement on systolic blood pressure may help reduce cardiovascular risk.

Research perspectives

Given the increasing global prevalence of obesity, it is envisioned that bariatric devices such as intragastric balloons will continue to evolve. Though intragastric balloons can bring about short-term morbidity/mortality benefits, the long-term benefits are questionable. Further studies will focus on promoting the long-term weight benefits of intragastric balloons.