Impact of intragastric balloon on blood pressure reduction: A retrospective study in Eastern North Carolina.

BACKGROUND: Obesity has evolved into a global pandemic. The prevalence of obesity and hypertension in eastern North Carolina are comparable, if not higher, than the national prevalence. In the United States, an estimated 34% of adults have hypertension, the most modifiable risk factor for heart disease and stroke. Lifestyle and pharmacological interventions often do not provide sustained weight loss in obese patients. Bariatric surgery offers an effective weight reduction with short-and long-term health improvements; however, a higher body mass index is associated with higher surgical morbidity and mortality, longer hospitalization, and increasing rates of 30-day readmission due to co-morbidities. Intragastric balloon may bridge a critical gap in the treatment of obesity. The objective of this paper is to showcase the impact of endoscopic bariatric therapy on blood pressure reduction. AIM: To investigate the impact of intragastric balloon on blood pressure reduction. METHODS: A retrospective chart review was conducted from January 1, 2016 to January 31, 2019 of consecutive adults who received intragastric balloon therapy (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. A cohort study design was used for data analysis. A total of 172 patients had the Orbera® intragastric balloon placed. 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®. RESULTS: The study included 15% males and 85% females. 50% of the patients were white and just over 22% were non-white, and about 27% declined to give their race. The average baseline patients' weight prior to IGBT was 231.61 Lbs. (SD = 46.53 Lbs.). However, the average patients' weight after IGBT at the 6-mo follow-up was 203.88 Lbs. (SD = 41.04 Lbs.). Hence, on average, the percent total body weight loss at 6-mo is 11.97 after IGBT. The logistic regression performed revealed that weight (ß = 0.0140, P < 0.000) and age (ß = 0.0534, P < 0.000) are important factors in determining systolic blood pressure after IGBT. None of the other demographic characteristics or indicated comorbidities were found to be significant. CONCLUSION: 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.

Effectiveness of Online Aftercare Programs Following Intragastric Balloon Placement for Obesity Is Similar to Traditional Follow-up: a Large Propensity Matched US Multicenter Study.

BACKGROUND: The combination of intragastric balloons (IGB) with comprehensive lifestyle and behavioral changes is critical for ongoing weight loss. Many community and rural practices do not have access to robust obesity resources, limiting the use of IGBs. Online aftercare programs were developed in response to this need, delivering lifestyle coaching to maximize effectiveness. How these programs compare to traditional follow-up is currently unknown. METHODS: Using propensity scoring (PS) methods, two large prospective databases of patients undergoing IGB therapy were compared to estimate the difference in percent total body weight loss (%TBWL) between groups while identifying predictors of response. RESULTS: Seven hundred fifty-eight unique patients across 78 different participating practices (online n = 437; clinical registry n = 321) was analyzed. The mean %TBWL at balloon removal was 11% ± 6.9 with an estimated treatment difference (ETD) between online and traditional follow-up of - 1.5% TBWL (95% CI - 3-0.4%; p = 0.125). Three months post-balloon removal, the combined %TBWL was 12.2% ± 8.3 with an ETD of only 1% TBWL (95%CI - 3-3%; p = 0.08). On multivariable linear regression, each incremental follow-up was associated with increased %TBWL (ß = 0.6% p = 0.002). CONCLUSION: Online IGB aftercare programs provide similar weight loss compared with traditional programs. Increased lifestyle coaching whether in person or remotely is associated with more %TBWL at removal and during follow-up. Close follow-up for clinical symptoms is still warranted.

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

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 (ß = 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.

Retrograde jejunoduodenogastric intussusception due to a replacement percutaneous gastrostomy tube presenting as upper gastrointestinal bleeding.

Percutaneous endoscopic gastrostomy (PEG) tube complications can be serious or life threatening. Retrograde intussusception is a very rare complication of PEG tubes with only 9 cases reported in the literature. We describe a case of retrograde intussusception, associated with the use of a Foley catheter as a replacement gastrostomy tube, presenting with upper gastrointestinal bleeding. To our knowledge, this is the first reported case of PEG-related retrograde intussusception successfully managed in a non-surgical manner. Retrograde intussusception likely occurred due to migration of the replacement tube with resultant securing and invagination of the proximal jejunum when the gastrostomy tube was anchored to the abdominal wall.