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.

One Anastomosis Gastric Bypass Versus Single Anastomosis Duodenoileostomy with Sleeve: Comparative Analysis of 30-Day Outcomes Using the MBSAQIP.

INTRODUCTION/PURPOSE: One anastomosis gastric bypass (OAGB) and single anastomosis duodenoileostomy with sleeve (SADI-S) are two highly effective bariatric procedures that have been recently endorsed by the American Society of Metabolic and Bariatric Surgery (ASMBS). We compared the outcomes and safety profiles of SADI-S and OAGB using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database. MATERIALS AND METHODS: Retrospective analysis on patients who underwent SADI-S or OAGB obtained from the MBSAQIP database 2020-2021. Patients who underwent concurrent procedures (besides EGD) or had missing data were removed. Variables included age, sex, body mass index, American Society of Anesthesiologists (ASA) class, and pertinent medical comorbidities. Data were analyzed for 30-day postoperative morbidity, mortality, reoperation, reintervention, and readmissions. p values were calculated using Student's t-test or Fisher analysis. RESULTS: A total of 694 and 1068 patients respectively underwent SADI-S or OAGB. Statistically significant comorbidities included age (42.2 ± 10.8 vs. 43.7 ± 12.2), BMI (50.6 ± 9.1 vs. 45.3 ± 7.1), ASA 2 (66 (9.5%) vs. 165 (15.4%)), ASA 4 [69 (9.9%) vs. 20 (1.9%)], and immunosuppressive therapy [24 (3.5%) vs. 17 (1.6%)]. Clavien-Dindo-based analysis highlighted that SADI-S had higher grade 2 (p = 0.005) and grade 4b (p = 0.001) complications. Patients who underwent SADI-S were twice as likely to be readmitted within 30 days (3.7% vs. 1.9%; p = 0.021). CONCLUSION: SADI-S had higher readmission rates and higher Clavien-Dindo grade 2 and 4b complications. To note, SADI-S patients had higher BMIs. Further studies are needed to determine the long-term complications and efficacy of both operations.

Impact of Adjunctive Pharmacotherapy With Intragastric Balloons for the Treatment of Obesity.

BACKGROUND: We conducted this study to compare the weight loss outcome of intragastric balloons (IGBs) in conjunction with pharmacotherapy vs IGB and intensive lifestyle changes alone. METHODS: This was a multicenter, non-randomized, retrospective study involving 4 academic hospitals. Patients underwent IGB placement with or without concomitant anti-obesity pharmacotherapy. The primary outcome was percent total weight loss (TBWL) after IGB placement at 6 and 12 months. RESULTS: This study included 102 patients, with 23 patients (mean age 46.6 years, 82.6% female) treated with IGB/pharmacotherapy and 79 patients (mean age 46.0 years, 88.6% female) treated with IGB/lifestyle modifications. Patients had a 100% follow-up rate at 6 and 12 months. At 6 months following IGB placement, both groups achieved a similar %TBWL. At 12 months, %TBWL was greater in the IGB/pharmacotherapy group (12.6% ± 1.2 vs 9.7% ± 0.7, P = .04). 65.2% of patients achieved ≥10% TBWL at 12 months in the IGB/pharmacotherapy group, compared to 38.0% in the IGB/lifestyle group (P < .05). The proportion of patients that achieved ≥15% weight loss at 12 months was also significantly different between the IGB/pharmacotherapy and IGB/lifestyle groups (30.4% vs 20.3%, P < .05). DISCUSSION: IGB with concomitant use of pharmacotherapy did not improve weight loss while the IGB was in place compared to IGB and lifestyle changes. However, patients receiving IGB with pharmacotherapy did have greater weight loss and diminished weight regain after balloon removal compared to those receiving just IGB and lifestyle changes.

Sensing free sulfur dioxide in wine.

Sulfur dioxide (SO(2)) is important in the winemaking process as it aids in preventing microbial growth and the oxidation of wine. These processes and others consume the SO(2) over time, resulting in wines with little SO(2) protection. Furthermore, SO(2) and sulfiting agents are known to be allergens to many individuals and for that reason their levels need to be monitored and regulated in final wine products. Many of the current techniques for monitoring SO(2) in wine require the SO(2) to be separated from the wine prior to analysis. This investigation demonstrates a technique capable of measuring free sulfite concentrations in low volume liquid samples in white wine. This approach adapts a known colorimetric reaction to a suspended core optical fiber sensing platform, and exploits the interaction between guided light located within the fiber voids and a mixture of the wine sample and a colorimetric analyte. We have shown that this technique enables measurements to be made without dilution of the wine samples, thus paving the way towards real time in situ wine monitoring.

The First Modified Delphi Consensus Statement for Resuming Bariatric and Metabolic Surgery in the COVID-19 Times.

The purpose of this study was to achieve consensus amongst a global panel of expert bariatric surgeons on various aspects of resuming Bariatric and Metabolic Surgery (BMS) during the Coronavirus Disease-2019 (COVID-19) pandemic. A modified Delphi consensus-building protocol was used to build consensus amongst 44 globally recognised bariatric surgeons. The experts were asked to either agree or disagree with 111 statements they collectively proposed over two separate rounds. An agreement amongst ≥ 70.0% of experts was construed as consensus as per the predetermined methodology. We present here 38 of our key recommendations. This first global consensus statement on the resumption of BMS can provide a framework for multidisciplinary BMS teams planning to resume local services as well as guide future research in this area.

Safety and Effectiveness of an Intragastric Balloon as an Adjunct to Weight Reduction in a Post-Marketing Clinical Setting.

BACKGROUND AND OBJECTIVES: Obesity and its related comorbidities are associated with serious health risks. This trial evaluated the safety and effectiveness of the ORBERA® Intragastric Balloon System (IGB) as an adjunct to lifestyle intervention in a post-marketing clinical setting. METHODS AND MATERIALS: In this multicenter study, 258 adults with a body mass index of 30-40 kg/m2 were treated with the IGB as an adjunct to weight reduction and followed for up to 12 months. The primary objective was to demonstrate in a post-marketing clinical setting that the incidence of device and procedure-related serious adverse events (SAEs) after 26 weeks of IGB treatment is no greater than 15%. RESULTS: The incidence of device and procedure-related SAEs was 8.9% with a 1-sided upper limit confidence interval of 12.4%, compared with the 9.6% overall SAE rate seen in the US pivotal study; therefore, the primary safety endpoint was met. The key secondary effectiveness endpoint was also met with a mean maximum %TBWL of 12.5 being achieved at the time of IGB removal (26 weeks). CONCLUSIONS: The post-marketing safety and effectiveness profile of the IGB are consistent with what was observed in the US pivotal study. No new risks were identified. CLINICAL TRIAL REGISTRATION: CLINICAL TRIALS.GOV NCT02828657.

The Relationship Between Clinical and Quantitative Measures of Pain Sensitization in Knee Osteoarthritis.

OBJECTIVES: Pain sensitization in knee osteoarthritis (OA) is associated with greater symptom severity and poorer clinical outcomes. Measures that identify pain sensitization and are accessible to use in clinical practice have been suggested to enable more targeted treatments. This merits further investigation. This study examines the relationship between quantitative sensory testing (QST) and clinical measures of pain sensitization in people with knee OA. METHODS: A secondary analysis of data from 134 participants with knee OA was performed. Clinical measures included: manual tender point count (MTPC), the Central Sensitization Inventory (CSI) to capture centrally mediated comorbidities, number of painful sites on a body chart, and neuropathic pain-like symptoms assessed using the modified PainDetect Questionnaire. Relationships between clinical measures and QST measures of pressure pain thresholds (PPTs), temporal summation, and conditioned pain modulation were investigated using correlation and multivariable regression analyses. RESULTS: Fair to moderate correlations, ranging from -0.331 to -0.577 (P<0.05), were identified between MTPC, the CSI, number of painful sites, and PPTs. Fair correlations, ranging from 0.28 to 0.30 (P<0.01), were identified between MTPC, the CSI, number of painful sites, and conditioned pain modulation. Correlations between the clinical and self-reported measures and temporal summation were weak and inconsistent (0.09 to 0.25). In adjusted regression models, MTPC was the only clinical measure consistently associated with QST and accounted for 11% to 12% of the variance in PPTs. DISCUSSION: MTPC demonstrated the strongest associations with QST measures and may be the most promising proxy measure to detect pain sensitization clinically.

Clinical safety and effectiveness of a swallowable gas-filled intragastric balloon system for weight loss: consecutively treated patients in the initial year of U.S. commercialization.

BACKGROUND: Obesity is the most common chronic disease in the United States today. Additional therapies are needed to improve obesity treatment. OBJECTIVE: A swallowable, gas-filled intragastric balloon system was approved for the treatment of obesity by Food and Drug Administration in September 2016 and commercialization started January 2017. A registry was made available to physicians to capture evidence of safety and effectiveness with use. SETTING: United States private clinics, surgery centers, and hospitals. METHODS: This study is a retrospective analysis of a prospective registry of patients with body mass index (BMI) ≥25 kg/m2 that initiated therapy in the first year. Data on demographics, procedural timing, weight loss, adverse events, and device deficiencies were captured. RESULTS: The final analysis comprised 1343 patients across 108 treating physicians (mean age 45.7 ± 10.8 yr, 78.6% female, baseline BMI of 35.4 ± 5.4 kg/m2). Nonserious and serious adverse events were reported in 14.2% and .15% of patients, respectively. There were 7 balloon deflations, none caused obstruction. Weight loss in the indicated use (BMI 30-40 kg/m2) was 9.7 ± 6.1 kg and 10.0 ± 6.1% total body weight loss (TBWL). Weight loss in other BMI categories was 8.2 ± 5.6 kg or 10.3 ± 7.0% total body weight loss for BMI 25 to 29.9 kg/m2 and 11.6 ± 7.8 kg or percent total body weight loss 9.3 ± 6.0 for BMI >40 kg/m2. CONCLUSIONS: This swallowable gas-filled intragastric balloon system is safe and effective at inducing weight loss and offers physicians another tool for patients whose obesity has been resistant to noninvasive treatments.

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.

Thyroid Crisis in a Patient With Burn Injury.

Thyroid crisis is an exacerbation of hyperthyroidism that results in severe systemic disturbances and could be fatal. Similarly, severe burn injury also has a hypermetabolic response as part of its presentation. When these two conditions are present concurrently, one must be cognizant that the patient requires urgent optimization of their hyperthyroid status before surgery, and continuous monitoring in an intensive care unit setting. We offer a systematic approach to managing these patients.

Mortality in paediatric burns victims: A retrospective review from 2009 to 2012 in a single centre.

BACKGROUND: Childhood mortality is high in low- and middle-income countries. Burns are one of the five leading causes of childhood injury mortality in South Africa (SA). While there is an abundance of literature on burns in the developed world, there are far fewer publications dealing with childhood mortality related to burns in Africa and SA. OBJECTIVE: To describe the mortality of children admitted to a dedicated paediatric burns unit, and investigate factors contributing to reducing mortality. METHODS: A retrospective review was performed of patients admitted to the Johnson and Johnson Paediatric Burns Unit, Chris Hani Baragwanath Academic Hospital, Johannesburg, SA, between May 2009 and April 2012. RESULTS: During the study period, 1 372 patients aged ≤10 years were admitted to the unit. There were 1 089 admissions to the general ward and 283 admissions to the paediatric burns intensive care unit (PBICU). The overall mortality rate was 7.9% and the rate for children admitted to the PBICU 29.3%; 90.8% of deaths occurred in children aged ≤5 years. Of children admitted with an inhalational injury, 89.5% died. No child with a burn injury >60% of total body surface area (TBSA) survived. CONCLUSIONS: Our overall mortality rate was 7.9%, and the rate declined significantly over the 3-year study period from 11.7% to 5.1%. Age ≤5 years, the presence of inhalational injury, burn injury >30% of TBSA and admission to the PBICU were significant risk factors for mortality.

Mitochondrial cytochrome c synthase: CP motifs are not necessary for heme attachment to apocytochrome c.

The function of holocytochrome c synthase (HCCS, also called heme lyase) is to attach covalently the heme cofactor to cytochromes c in the mitochondria of animals, fungi and protozoa. Little is known about how the protein functions but CP motifs, commonly found in heme-binding proteins, are present. Here we examine holocytochrome c production by Saccharomyces cerevisiae HCCS in the Escherichia coli cytoplasm with emphasis on the conserved CP motifs long implicated in heme transfer by this enzyme. Unexpectedly, the two motifs, both towards the N-terminus, were not required for activity. Mutations in HCCS on the C-terminal side of the CP motifs, known to cause disease states in humans (microphthalmia with linear skin defects) abolished or drastically attenuated holocytochrome c production.