Filling the Void: A Review of Intragastric Balloons for Obesity.

Endoscopic bariatric therapies are predicted to become much more widely used in North America for obese patients who are not candidates for bariatric surgery. Of all the endoscopic bariatric therapies, intragastric balloons (IGBs) have the greatest amount of clinical experience and published data supporting their use. Three IGBs are FDA approved and are now commercially available in the USA (Orbera, ReShape Duo, and Obalon) with others likely soon to follow. They are generally indicated for patients whose BMI ranges from 30 to 40 mg/kg2 and who have failed to lose weight with diet and exercise. IGBs have been shown to be safe, effective, and relatively straightforward to place and remove. Accommodative symptoms commonly occur within the initial weeks post-placement; however, major complications are rare. Gastric ulceration can occur in up to 10% of patients, while balloon deflation with migration and bowel obstruction occurs in <1% of patients. The effectiveness of the Orbera and ReShape Duo IGBs ranges from 25 to 50% EWL (excess weight loss) after 6 months of therapy. The use of IGBs is likely to grow dramatically in the USA, and gastroenterologists and endoscopists should be familiar with their indications/contraindications, efficacy, placement/removal, and complications.

Nursing care of the super bariatric patient: challenges and lessons learned.

PURPOSE: The purpose of this article is to describe the care of a "super bariatric" patient. DESIGN AND METHODS: We used a case study approach to describe the complex interdisciplinary care challenges posed in the care of a super bariatric patient at a Veterans Administration Hospital in the Midwest. FINDINGS: Nurses and other healthcare providers discovered ways to provide high-quality patient-centered care under challenging conditions and also ensure the safety and well-being of nursing staff and other providers. CONCLUSIONS/CLINICAL RELEVANCE: An interdisciplinary, patient-centered approach with advance planning and coordination is necessary to ensure the delivery of safe, high-quality nursing care to veterans with complex health problems who are "super bariatric."

Managing Weight With Technology.

More than 30% of the world's population is overweight or obese. That is double the percentage in 1980, and it is getting worse [1].That excess weight has been linked to numerous health conditions, notably type 2 (adult-onset) diabetes, the prevalence of which has also nearly doubled since 1980 [2]. Eating less and exercising more is good advice, but it doesn't work for everyone. Other options such as gastric bypass surgeries and systemic weight-loss drugs are also not suitable for everyone, and can carry risks of their own.

Fluid-Filled Versus Gas-Filled Intragastric Balloons as Obesity Interventions: a Network Meta-analysis of Randomized Trials.

BACKGROUND: Four commercially available intragastric balloons have been used for the management of obesity and underwent randomized controlled trials (RCTs), and we aimed to compare them using a network meta-analysis approach. METHODS: Several databases were queried from inception to May 26, 2017, and we included RCTs enrolling patients treated with Orbera, Heliosphere, ReShape Duo, and Obalon compared with another balloon, sham, or open-label control group. Two investigators independently abstracted data. A random effects frequentist network meta-analysis and relative ranking of agents using surface under the cumulative ranking probabilities were performed. RESULTS: We included 15 trials at low risk of bias (only two were head-to-head). Compared to control groups, the two fluid-filled devices were associated with significant outcome (% total body weight loss) at 6 months: Orbera, 6.72% (95% CI, 5.55, 7.89) and ReShape Duo 4% (95% CI 2.69, 5.31). Only one of the two gas-filled devices was associated with significant outcome at 6 months: Obalon 3.3% (95% CI 2.30, 4.30), and not the second: Heliosphere 6.71% (95% CI - 0.82, 14.23). Fluid-filled devices had the highest likelihood of superiority in achieving the outcome at 6 months (96.8%) and at 12 months (96.6%). The quality of evidence was high for comparisons against control. CONCLUSIONS: Fluid-filled balloons are more likely to produce weight loss compared to gas-filled balloons or lifestyle intervention. However, they may be associated with a higher rate of intolerance and early removal. This information will aid clinicians in device selection and engaging patients in shared decision-making.

Aspiration Therapy As a Tool to Treat Obesity: 1- to 4-Year Results in a 201-Patient Multi-Center Post-Market European Registry Study.

PURPOSE: The objective of this post-market study was to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics. MATERIALS AND METHODS: The AspireAssist® System (Aspire Bariatrics, Inc. King of Prussia, PA) is an endoscopic weight loss therapy utilizing a customized percutaneous endoscopic gastrostomy tube and an external device to aspirate approximately 30% of ingested calories after a meal, in conjunction with lifestyle counseling. A total of 201 participants, with body mass index (BMI) of 35.0-70.0 kg/m2, were enrolled in this study from June 2012 to December 2016. Mean baseline BMI was 43.6 ± 7.2 kg/m2. RESULTS: Mean percent total weight loss at 1, 2, 3, and 4 years, respectively, was 18.2% ± 9.4% (n/N = 155/173), 19.8% ± 11.3% (n/N = 82/114), 21.3% ± 9.6% (n/N = 24/43), and 19.2% ± 13.1% (n/N = 12/30), where n is the number of measured participants and N is the number of participants in the absence of withdrawals or lost to follow-up. Clinically significant reductions in glycated hemoglobin (HbA1C), triglycerides, and blood pressure were observed. For participants with diabetes, HbA1C decreased by 1% (P < 0.0001) from 7.8% at baseline to 6.8% at 1 year. The only serious complications were buried bumpers, experienced by seven participants and resolved by removal/replacement of the A-Tube, and a single case of peritonitis, resolved with a 2-day course of intravenous antibiotics. CONCLUSION: This study establishes that aspiration therapy is a safe, effective, and durable weight loss therapy in people with classes II and III obesity in a clinical setting. TRIAL REGISTRATION: ISRCTN 49958132.

Assessment of change in body fat percentage with DXA and eight-electrode BIA in centrally obese women.

PURPOSE: To compare estimates of change in percent body fat (Delta%BF) between DXA and BIA8 in abdominally obese women. METHODS: Six-month longitudinal study of 106 women (baseline: age 48.2 +/- 7.6 yr; BMI 30.4 +/- 2.9 kg.m; %BFDXA 45.8 +/- 3.6%) participating in an exercise-oriented behavior-change program (walking and bicycling). Fatness was measured by DXA and Tanita BC-418 (BIA8). Agreement between methods was assessed, and regression analysis was used to find predictors of the deviation between methods for estimating changes in fat mass percentage. RESULTS: The methods differed significantly, both at baseline and follow-up (-5.0 and -4.4%BF, respectively; both P < 0.001). The mean Delta%BF was -1.1 +/- 2.5%BFDXA and -0.5 +/- 2.2%BFBIA8 (mean difference between methods 0.6 +/- 1.8%BF; P < 0.001; 95% limits of agreement -3.0 to 4.2%BF), with a range of -14.8 to 3.3%BFDXA and -9.4 to 3.5%BFBIA8. Approximately 49% of the variation in the difference between methods was explained by variations in age (beta = -0.05; P = 0.006), DeltaBMI (beta = 0.98; P < 0.001), and Delta%BFDXA (beta = -0.71; P < 0.001), indicating that the larger the change, the greater the discrepancy between methods. CONCLUSION: The difference between methods regarding Delta%BF was statistically significant, but it was of small magnitude. However, with increasing Delta%BF, increasing discrepancies were observed, implying that the BIA equipment may have limited validity for detecting larger fat losses. Both clinicians and researchers may benefit from awareness of this potential limitation.

Effect of a powered drive on pushing and pulling forces when transporting bariatric hospital beds.

Powered drives designed to assist with moving hospital beds are commercially available but no studies have evaluated whether they reduce the push and pull forces likely contributing to injury in caregivers. This study measured hand forces of 10 caregivers maneuvering a manual and powered bariatric bed through simulated hospital environments (hallway, elevator, and ramp). Peak push and pull forces exceeded previously established psychophysical limits for all activities with the manual bed. For the powered bed, peak forces were significantly (p < 0.05) lower for all tasks, and below psychophysical limits. Powered drive reduced peak forces between 38% (maneuvering into elevator) and 94% (descending ramp). Powered drive also reduced stopping distance by 55%. When maneuvering, the integral of hand force was 34% lower with powered drive, but average forces during straight-line pushing did not differ between beds. Powered drive may reduce the risk of injury or the number of caregivers needed for transport.

A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single-center, single-surgeon experience.

BACKGROUND: Elipse™ is the least invasive IGB for weight loss that needs no sedation or endoscopy. It is a swallowable capsule filled with 550 mL of fluid, which stays in the stomach for 16 weeks and is excreted from the gastrointestinal tract. Kuwait is one of the first countries to start using Elipse™ as a weight loss device. This study aims to evaluate the efficacy and safety of Elipse™ intragastric balloon (IGB). MATERIALS AND METHODS: This is a single-center prospective pilot study of 51 Elipse™ insertions at our clinic. The patients were followed for 4 months to monitor their weight and body mass index (BMI) at 1, 2, and 4 months. Total weight loss, % excess weight loss (%EWL), % total body weight loss (%TBWL), and change in BMI and waist circumference (WC) were recorded at the end of the study. A short survey was administered to evaluate symptoms, complications, and overall satisfaction. RESULTS: Fifty-one patients participated, of which five had Elipse™ removed because of intolerance. One case vomited the balloon; one had early deflation. The total weight loss was 8.84 kg, %TBWL 10.44%, %EWL 40.84%, change in BMI 3.42 kg/m2, and the total WC reduction 8.62 cm. Symptoms after insertion were severe, whereas those during excretion were mild and self-limiting. No serious complications were recorded, and the overall satisfaction was above average. CONCLUSION: Our data proves that Elipse™ is a safe and effective device for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. Larger studies are needed to support our findings.

Design and validation of a low cost, high-capacity weighing device for wheelchair users and bariatrics.

Accessible high-capacity weighing scales are scarce in healthcare facilities, in part due to high device cost and weight. This shortage impairs weight monitoring and health maintenance for people with disabilities and/or morbid obesity. We conducted this study to design and validate a lighter, lower cost, high-capacity accessible weighing device. A prototype featuring 360 kg (800 lbs) of weight capacity, a wheelchair-accessible ramp, and wireless data transmission was fabricated. Forty-five participants (20 standing, 20 manual wheelchair users, and five power wheelchair users) were weighed using the prototype and a calibrated scale. Participants were surveyed to assess perception of each weighing device and the weighing procedure. Weight measurements between devices demonstrated a strong linear correlation (R2 = 0.997) with absolute differences of 1.4 ± 2.0% (mean±SD). Participant preference ratings showed no difference between devices. The prototype weighed 11 kg (38%) less than the next lightest high-capacity commercial device found by author survey. The prototype's estimated commercial price range, $500-$600, is approximately half the price of the least expensive commercial device found by author survey. Such low cost weighing devices may improve access to weighing instrumentation, which may in turn help eliminate current health disparities. Future work is needed to determine the feasibility of market transition.

Initial clinical experience with telemetrically adjustable gastric banding.

BACKGROUND: The feasibility and safety of laparoscopic adjustable gastric banding for treatment of morbid obesity has been demonstrated in a large number of studies. Access port-related complications constitute a significant part of all complications related to gastric banding. Further, adjustment of hydraulic gastric bands can be fairly lengthy, uncomfortable, and is not a precise procedure. A study was performed to assess the usefulness and efficacy of a new type of band adjusted telemetrically without the need for an access port. The initial worldwide results of the first telemetrically adjustable gastric band for morbid obesity (EASYBAND EndoArt Medical Technologies, Switzerland) in two German academic centers are described herein. METHODS: EASYBAND is a purely mechanical gastric band, in which adjustment is achieved by means of an embedded micromotor, controlled by an external control unit using telemetry. The exact band diameter is displayed continuously during adjustment on the external control unit screen. Thirty-seven patients, means 36 +/- 8 (range: 22-60) years, 7 (19%) men and 30 (81%) women, with a mean body mass index (BMI) of 44.1 +/- 4.5 (range: 35.6-59.6), were implanted using the standard laparoscopic technique during the period from June 2005 to October 2005. Prospective data were collected on all morbidly obese patients who underwent laparoscopic telemetrically adjustable gastric banding (LTAGB). RESULTS: No serious adverse events occurred during the operative period or immediately postoperatively in relation to the device. A mean of 3.0 +/- 0.6 adjustments per patients were performed during the follow-up schedule at one, three and six months. The band diameter was set to 29 mm (fully open) at implantation, 24.5 mm +/- 0.5 mm at one month, 23.3 mm +/- 0.7 mm at three months, and 23.0 mm +/- 1.0 mm at six months. The mean percent excess weight loss was 10.2% +/- 4.5% at one month, 23.8% +/- 8.8% at three months, and 30.2% +/- 10.5% at six months. CONCLUSION: This initial study shows that the new telemetrically adjustable gastric banding device is implanted and operated safely, allows for atruamatic band adjustments with superior patient comfort, and leads to early excess weight loss comparable to that achieved by other gastric bands. Longer-term follows and larger population studies are needed to establish the final safety and performance profile of the telemetric gastric band.

Design with dignity.

Adapting facilities to accomodate obese patients calls for thoughtful design that allows for comfort flexibility and safety--and, above all, is respectful to the individual.

The practice of bariatric surgery at academic medical centers.

The growing demand for laparoscopic bariatric surgery has led to an increase in the development of new bariatric surgical practices. Proper hospital facilities and an experienced bariatric surgical team are necessary to ensure optimal patient results. We surveyed academic centers participating in the University HealthSystem Consortium to examine the current practice of bariatric surgery. The survey questioned (1) availability of resources and equipment designed for the morbidly obese, (2) accidents, equipment problems, and workers' compensation relating to the care of bariatric surgical patients, (3) credentialing of bariatric surgeons, and (4) suggestions for improvements in the bariatric surgery program. Twenty-five institutions that perform bariatric surgery responded. Although the majority of institutions noted that they had basic bariatric equipment, some organizations did not have facility resources such as high-weight operating room tables and computed tomography scanners or transfer devices. Twenty-eight percent of institutions reported having accidents or equipment problems and 40% of institutions had workers' compensation claims relating to the care of bariatric patients. With regard to credentialing, 60% of institutions required the surgeons to have performed a minimum number of procedures prior to granting privileges. Suggested improvements included the need for more specialized bariatric equipment, enhancement of the education of all members of the bariatric surgical team, and designation of a bariatric physician who would coordinate care. This survey of bariatric surgery practices at academic medical centers demonstrates that the practice of bariatric surgery could be improved with regard to availability of bariatric equipment and resources and credentialing of surgeons.