Simultaneous EUS-guided portosystemic pressure measurement and liver biopsy sampling correlate with clinically meaningful outcomes.

BACKGROUND AND AIMS: The measurement of the portosystemic pressure gradient (PSG) in patients with advanced liver disease is helpful to assess the severity of portal hypertension (PH) and predict adverse clinical outcomes. EUS-guided PSG (EUS-PSG) measurement is a novel tool to assess PSG in all patients with advanced liver disease. We sought to assess the safety, feasibility, and technical success of simultaneous EUS-PSG measurement and EUS-guided liver biopsy sampling using a single-center experience. METHODS: Patients with suspected liver disease or cirrhosis were enrolled prospectively from 2020 to 2021. EUS-PSG was measured by calculating the difference between the mean portal pressure and the mean hepatic vein pressure. PH was defined as PSG >5 mm Hg and clinically significant PH as PSG ≥10 mm Hg. The primary outcomes were procedural technical success rate and correlation of EUS-PSG with fibrosis stage obtained from concurrent EUS-guided liver biopsy sampling and the correlation of EUS-PSG with patients' imaging, clinical, and laboratory findings. The secondary outcome was occurrence of procedural adverse events (AEs). RESULTS: Twenty-four patients were included in the study. PSG measurement and EUS-guided liver biopsy sampling were successful in 23 patients (technical success rate of 96%) and 24 patients (100% success), respectively. Analysis revealed a significant association between both PSG and liver stiffness measured on transient elastography (P = .011) and fibrosis-4 score (P = .026). No significant correlation was found between the fibrosis stage on histology and measured PSG (P = .559). One mild AE of abdominal pain was noted. Additionally, EUS-PSG was predictive of clinically evident PH. CONCLUSIONS: Simultaneous EUS-PSG measurement and EUS-guided liver biopsy sampling were both feasible and safe and correlated with clinically evident PH and noninvasive markers of fibrosis.

Five-Year Outcomes of Endoscopic Sleeve Gastroplasty for the Treatment of Obesity.

BACKGROUND AND AIMS: The growing burden of obesity as a chronic disease necessitates a multifaceted approach to management. There has been an increase in the number of available endoscopic therapies for weight management with endoscopic sleeve gastroplasty (ESG) proving to be one of the best options. The long-term efficacy of ESG for management of obesity is not known. This study sought to assess the long-term safety and efficacy of ESG for treatment of obesity. METHODS: This was a prospective cohort study. Participants underwent ESG in a single academic center, and were prospectively enrolled. All procedures were performed by the same therapeutic endoscopist. Patients with a body mass index of >30 kg/m2 (or >27 with comorbidities), who underwent ESG from August 2013 to August 2019 for treatment of obesity were enrolled. Patients were followed for up to 5 years after their procedure. The primary outcome was weight loss at 5 years after the procedure (% total body weight loss, TBWL) RESULTS: 216 patients (68% female) with a mean age of 46±13 years, and mean BMI of 39±6 kg/m2 underwent ESG. Out of 216 patients, 203, 96, and 68 patients were eligible for a 1-, 3-, and 5-year follow up, with complete follow-up rates of 70%, 71%, and 82%, respectively. At 5 years, mean TBWL was 15.9% (95% CI, 11.7-20.5, p < .001) and 90 and 61% of patients maintained 5 and 10% TBWL, respectively. There was an overall rate of 1.3% moderate adverse events (AEs), without any severe or fatal AEs. CONCLUSIONS: Our results suggest that ESG is safe and effective for treatment of obesity, with durable long-term results for at least up to 5 years after the procedure. This procedure should be considered as a reliable option for treatment of obesity.

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.

Management of Psoriasis with a XemaTop Topical Compounded Formula: A Case Report.

Skin conditions such as psoriasis and eczema negatively impact the patient's quality of life; the primary goal of topical treatments is to minimize the disease-specific symptoms. This case report discusses the management of two refractory psoriasis skin lesions in an adult male using a topical compounded formula. The psoriasis symptoms were assessed quantitatively using two validated research instruments, the Psoriasis Symptom Inventory, and an adapted Numeric Rating Scale. A qualitative assessment was also performed by evaluating the digital photographs taken by the patient during the course of treatment. The compounded formula containing zinc pyrithione, clobetasol propionate, and cyanocobalamin in the Professional Compounding Centers of America's proprietary base PCCA XemaTop, applied topically for three weeks, significantly reduced the patient's self-reported psoriasis symptoms and improved his overall condition by 81.2%. This successful case report is important evidence for healthcare professionals when considering new, innovative topical compounded formulas for managing skin conditions such as psoriasis and eczema.

Endoscopic Sleeve Gastroplasty for Obesity: a Multicenter Study of 248 Patients with 24 Months Follow-Up.

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is a technique for managing mild to moderately obese patients. We aimed to evaluate the long-term outcomes, reproducibility, and predictors of weight response in a large multicenter cohort. METHODS: Patients who underwent ESG between January 2013 and December 2015 in three centers were retrospectively analyzed. All procedures were performed using the Apollo OverStitch device (Apollo Endosurgery, Austin, TX). We performed per protocol (PP) and intention-to-treat (ITT) analyses, where patients lost to follow-up were considered failures. Multivariable linear and logistic regression analyses were performed. RESULTS: We included 248 patients (mean age 44.5 ± 10 years, 73% female). Baseline BMI was 37.8 ± 5.6 kg/m2. At 6 and 24 months, 33 and 35 patients were lost to follow-up, respectively. At 6 and 24 months, %TBWL was 15.2 [95%CI 14.2-16.3] and 18.6 [15.7-21.5], respectively. Weight loss was similar between centers at both follow-up intervals. At 24 months, % of patients achieving ≥10% TBWL was 84.2 and 53% with PP and ITT analyses, respectively. On multivariable linear regression analysis, only %TBWL at 6 months strongly predicted %TBWL at 24 months (adjusted for age, gender, and baseline BMI, ß = 1.21, p < 0.001). The odds of achieving ≥10%TBWL at 24 months if a patient achieved <10%TBWL at 6 months is 0.18 [0.034-0.84]. Five (2%) serious adverse events occurred. CONCLUSIONS: ESG effectively induces weight loss up to 24 months in moderately obese patients. Failure to achieve adequate weight loss can be predicted early, and patients should be offered adjunctive therapies to augment it.