Characteristics and Outcomes for Recipients of NVX-CoV2373: A Real-World Retrospective Study in Germany.

Real-world evidence supports SARS-CoV-2 vaccination strategies during the COVID-19 pandemic. This real-world retrospective study utilized the German Disease Analyzer database to characterize recipients of NVX-CoV2373 and explore vaccination outcomes. Recipients (≥12 years) of NVX-CoV2373 as a primary series or booster in Germany were vaccinated between March and December 2022. Outcomes included demographics and clinical characteristics of recipients, tolerability/reactogenicity-related events within 7 and 14 days post-vaccination, and protection from COVID-19. Overall, there were 597 recipients (mean age ~60 years) of NVX-CoV2373; 81% were vaccinated by a general practitioner, and 68% had a Standing Committee on Vaccination (STIKO) high-risk factor. The most common baseline comorbidities were chronic neurological (36%) and chronic intestinal (21%) diseases. Among recipients with metabolic disease (~11%), 65% had diabetes. Tolerability/reactogenicity-related symptoms were recorded in ~1% of recipients. There were no sick-leave notes associated with NVX-CoV2373. After 10 months (median, 7 months) of follow-up, 95% (95% CI, 93-95) of recipients were estimated to be protected from COVID-19. Outcomes were similar across the primary series, booster, and STIKO populations. Tolerability and COVID-19 protection support the use of NVX-CoV2373 as a primary/booster vaccination for all authorized populations, including high-risk.

Characterizing Food Policy Councils' Network Partnerships and COVID-19 Responses.

The COVID-19 pandemic pushed millions of Americans into food insecurity. Food policy councils (FPCs) across the country played a vital role in organizing coordinated food responses across multiple sectors. We used a social network analysis (SNA) approach to investigate: (1) the network of partnering organizations and agencies within FPCs; (2) how the characteristics of FPCs' network partnerships (i.e., degree, coreness, and density) related to programmatic, policy, and advocacy actions in response to the pandemic; and (3) how FPCs' use of a racial or social equity framework shifted their network partnerships and responses. Local government agencies and food supply chain actors were core in FPCs' network partnerships, while public utilities, correctional facilities, social justice groups, and others were non-core partners. Network density was more likely to be associated with any action by FPCs, and it was especially pronounced for advocacy actions taken by FPCs; trends were similar among FPCs that reported using a racial or social equity framework. The findings begin to uncover core actors in FPCs' partnerships and opportunities to establish new partnerships, particularly with social justice groups. The results also suggest that network density (interconnectedness) may be more important than other network characteristics when responding to food-related needs.

Cultural context index: A geospatial measure of social determinants of health in the United States.

Minority populations will continue to grow in the United States. Such pluralism necessitates iterative, geospatial measurements of cultural contexts. Our objective in this study was to create a measure of social determinants of health in geographic areas with varying ethnic, linguistic, and religious diversity in the United States. We extracted geographic information systems data based on community characteristics that have known associations with population health disparities from 2015 to 2019. We used principal component analysis to construct a Cultural Context Index (CCI). We created the CCI for 73,682 census tracts across 50 states and five inhabited territories. We identified hot and cold spots that are the highest and lowest CCI quintile, respectively. Hot spots census tracts were mostly located in metropolitan areas (84.8%), in the Southern census region (41.5%), and also had larger Black and Hispanic populations. The census tracts with the greatest need for culturally competent health care also had the sickest populations. Census tracts with a CCI rank of 5 ('greatest need') had higher prevalences of self-reported poor physical health (17.2%) and poor mental health (17.4%), compared to either the general population (13.9% and 14.5%) or to CCI rank of 1 ('lowest need') (11.9% and 10.8%). The CCI can pinpoint census tracts with a need for culturally competent health care and inform supply-side policy planning as healthcare and social service providers will inevitably come in contact with consumers from different backgrounds.

Use of Telemedicine in Adults with Type 1 Diabetes: Do Age and Use of Diabetes-Related Technology Matter?

Objective: Older adults are generally less proficient in technology use compared with younger adults. Data on telemedicine use during the COVID-19 pandemic in older persons with type 1 diabetes (T1D) and the association of telemedicine with the use of diabetes-related technology are limited. We evaluated care delivery to older adults compared with younger adults with T1D in a prepandemic and pandemic period. Methods: Data from electronic health records were evaluated for visit types (in-person, phone, and video) from two sequential 12-month intervals: prepandemic (April 2019-March 2020) and pandemic (April 2020-March 2021). Results: Data from 2,832 unique adults with T1D were evaluated in two age cohorts: younger (40-64 years) and older (≥65 years). Half of each group used continuous glucose monitoring (CGM), whereas 54% of the younger and 37% of the older cohort used pump therapy (p < 0.001). During the pandemic compared with the prepandemic period, visit frequency increased in both the younger (0.65 vs. 0.76 visits/patient/quarter; p < 0.01) and older (0.72 vs. 0.80 visits/patient/quarter; p < 0.01) cohorts. During the pandemic, older adults used more phone visits compared with younger adults (48% vs. 32%; p = 0.001). Patients using either pump therapy or CGM were more likely to use video visits compared with phone visits in both younger (41% vs. 24%; p < 0.001) and older cohorts (53% vs. 42%; p < 0.001). Conclusions: Adults using diabetes-related technologies, independent of age, accessed more video visits than those not using devices. Telemedicine visits appeared to maintain continuity of care for younger and older adults with T1D, supporting the future of a hybrid-care model.

The potential epidemiologic, clinical, and economic impact of requiring schools to offer Physical Education (PE) classes in Mexico City.

BACKGROUND: Many schools have been cutting physical education (PE) classes due to budget constraints, which raises the question of whether policymakers should require schools to offer PE classes. Evidence suggests that PE classes can help address rising physical inactivity and obesity prevalence. However, it would be helpful to determine if requiring PE is cost-effective. METHODS: We developed an agent-based model of youth in Mexico City and the impact of all schools offering PE classes on changes in weight, weight-associated health conditions and the corresponding direct and indirect costs over their lifetime. RESULTS: If schools offer PE without meeting guidelines and instead followed currently observed class length and time active during class, overweight and obesity prevalence decreased by 1.3% (95% CI: 1.0%-1.6%) and was cost-effective from the third-party payer and societal perspectives ($5,058 per disability-adjusted life year [DALY] averted and $5,786/DALY averted, respectively, assuming PE cost $50.3 million). When all schools offered PE classes meeting international guidelines for PE classes, overweight and obesity prevalence decreased by 3.9% (95% CI: 3.7%-4.3%) in the cohort at the end of five years compared to no PE. Long-term, this averted 3,183 and 1,081 obesity-related health conditions and deaths, respectively and averted ≥$31.5 million in direct medical costs and ≥$39.7 million in societal costs, assuming PE classes cost ≤$50.3 million over the five-year period. PE classes could cost up to $185.5 million and $89.9 million over the course of five years and still remain cost-effective and cost saving respectively, from the societal perspective. CONCLUSION: Requiring PE in all schools could be cost-effective when PE class costs, on average, up to $10,340 per school annually. Further, the amount of time students are active during class is a driver of PE classes' value (e.g., it is cost saving when PE classes meet international guidelines) suggesting the need for specific recommendations.

Impact of Diabetes Duration on Functional and Clinical Status in Older Adults With Type 1 Diabetes.

OBJECTIVE: Adults with type 1 diabetes (T1D) are aging successfully. The impact of diabetes duration on clinical and functional status as people age with T1D is not well known. RESEARCH DESIGN AND METHODS: We performed a cross-sectional study of older adults (age ≥65 years) with T1D. RESULTS: We evaluated 165 older adults, mean age 70 ± 10 years. After adjustment for age, sex, and A1C, longer duration of T1D, ≥50 years, was associated with a higher likelihood of depression (odds ratio [OR] 2.8; P = 0.008), hypoglycemia unawareness (OR 2.6; P = 0.01), lower scores on 6-Minute Walk Test (OR 0.99; P = 0.01) and the Physical Component Summary (PCS) of Short Form-36 (SF-36) (OR 0.96; P = 0.02), and greater daily medication use (OR 1.1; P = 0.004) compared with those with duration <50 years. CONCLUSIONS: In older adults with T1D, duration of diabetes impacts clinical and functional status, independent of age and glycemic control, and should be considered in development of management strategies for safety and success.

The Attitude of Practitioners Towards Endoscopic Sleeve Gastroplasty.

BACKGROUND AND AIM: Despite widespread adoption and encouraging results seen over the last 5 years, no consensus exists regarding the endoscopic sleeve gastroplasty (ESG) technique, training, or preprocedure and postprocedure management of the patient. The aim of our survey was to assess practice trends and preferences of bariatric endoscopists with respect to ESG. METHODS: Using a digital platform, we conducted a worldwide survey by emailing a link with an electronic questionnaire to 1200 bariatric endoscopists trained to perform endoscopic suturing using the Apollo Overstitch suturing device (Apollo Endosurgery). RESULTS: We received 221 responses that were included in the analysis. Fifty-one responders (36.4%) required 1 to 10 procedures, and 37 (26.4%) needed 11 to 20 procedures to become proficient at ESG. Ninety-six (68.6%) stated that lower body mass index thresholds should be adopted for Asian and Arab patients. There was no consensus on the ideal number of sutures, with 45 (32.1%), 42 (30%), 36 (25.7%), 13 (9.3%), and 4 (2.9%) recommending 4 to 6, 5 to 7, 6 to 8, 7 to 9, and 8 to 12 sutures, respectively. The primary barriers to establishing an endobariatric program were the inability to establish a cash pay model, 77 (95.1%); lack of institutional support, 61 (75.3%); and difficulty in establishing an ambulatory surgical center/hospital to perform ESG, 73 (90.1%). CONCLUSIONS: ESG practice trends remain heterogenous among practitioners in regard to indication, technique, and preprocedure and postprocedure management. Specific ESG guidelines are warranted, and this survey will assist in providing the framework for these guidelines to be written.

Usefulness of CGM-Derived Metric, the Glucose Management Indicator, to Assess Glycemic Control in Non-White Individuals With Diabetes.

OBJECTIVE: To assess the relationship between the glucose management indicator (GMI) and HbA1c in non-White individuals with diabetes. RESEARCH DESIGN AND METHODS: We performed a retrospective analysis of continuous glucose monitoring metrics in individuals with diabetes divided by race into non-White and White cohorts. RESULTS: We evaluated 316 individuals (non-White n = 68; White n = 248). Although GMI was not different (7.6 vs. 7.7; P = not significant) between the cohorts, HbA1c was higher in the non-White cohort (8.7% vs. 8.1%; P = 0.004). HbA1c higher than GMI by ≥0.5% was more frequently observed in the non-White cohort (90% vs. 75%; P = 0.02). In the non-White cohort only, duration of hypoglycemia was longer among those with HbA1c higher than GMI by ≥0.5% compared with those with HbA1c and GMI within 0.5%. CONCLUSIONS: A differential relationship between HbA1c and GMI in non-White versus White individuals with diabetes was observed. In non-White individuals, a greater difference between HbA1c and GMI was associated with higher risk of hypoglycemia.

Transoral outlet reduction: could additional sutures cause more harm?

BACKGROUND: The double purse-string pattern (DPSP) of transoral outlet reduction (TORe) should conceivably result in a more robust scaffolding for the gastrojejunal anastomosis (GJA). However, there is a paucity of literature pertaining to post-TORe stenosis as an adverse event. Our aim was to determine the rate of stenosis, its potential predictors, and other complications of DPSP TORe. METHODS: We performed a retrospective analysis of a prospectively maintained database of 129 consecutive patients who underwent DPSP TORe between December 2015 and August 2019. RESULTS: The adverse event rate of TORe was 17.1 % (n = 22), with a 13.3 % (n = 17) rate of stenosis. Stenosis was not significantly associated with any baseline characteristics. GJA diameter pre- and post-TORe, the difference between these values, and procedure duration were not predictive of stenosis. Of patients who developed stenosis, 10 (58.8 %) responded to endoscopic balloon dilation and 7 (41.2 %) required stent placement. CONCLUSION: As the DPSP technique is a challenging procedure, with high complication rate and limited benefit, it should not be used for TORe.

Association of Cognitive Function and Retinal Neural and Vascular Structure in Type 1 Diabetes.

CONTEXT: Cognitive dysfunction is a growing and understudied public health issue in the aging type 1 diabetic population and is difficult and time-consuming to diagnose. Studies in long duration type 1 diabetes have reported the presence of proliferative diabetic retinopathy was associated with cognitive dysfunction. OBJECTIVE: This study assessed whether structural and vascular abnormalities of the retina, representing an extension of the central nervous system, are associated with cognitive impairment and other complications of type 1 diabetes. METHODS: An observational cross-sectional study of individuals with 50 or more years of type 1 diabetes (Joslin Medalist Study) was conducted at a university hospital in the United States. The study included 129 participants with complete cognitive testing. Validated cognitive testing measures included psychomotor speed, and immediate, and delayed memory. Optical coherence tomography (OCT) and OCT angiography (OCTA) were performed to obtain neural retinal layer thicknesses and vascular density for superficial (SCP) and deep retinal capillary plexus (DCP). Multivariable modeling was adjusted for potential confounders associated with outcomes in unadjusted analyses. RESULTS: Decreased vessel density of the SCP and DCP was associated with worse delayed memory (DCP: P = .002) and dominant hand psychomotor speed (SCP: P = .01). Thinning of the retinal outer nuclear layer was associated with worse psychomotor speed both in nondominant and dominant hands (P = .01 and P = .05, respectively). Outer plexiform layer thickness was associated with delayed memory (P = .04). CONCLUSION: These findings suggest that noninvasive retinal imaging using OCT and OCTA may assist in estimating the risks for cognitive dysfunction in people with type 1 diabetes.

Endoscopic sleeve gastroplasty plus liraglutide versus endoscopic sleeve gastroplasty alone for weight loss.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) has been shown to be effective for inducing weight loss. The efficacy of liraglutide, a glucagon-like peptide-1 agonist, to augment weight loss after ESG is unknown. This study aims to evaluate the efficacy of ESG and liraglutide (ESG-L) compared with ESG alone. METHODS: This was a retrospective study of prospectively collected data from patients undergoing ESG at 3 outpatient clinics in Brazil between November 2017 and July 2018. Liraglutide was offered to all patients 5 months after ESG. Patients who opted to take liraglutide (ESG-L) were matched 1:1 to patients who declined it (ESG). The primary outcome was percent total body weight loss (%TBWL), and percent excess weight loss (%EWL) 7 months after initiation of liraglutide (12 months after ESG). The secondary outcome was change in percent body fat 12 months after ESG. ESG technique and postprocedure follow-up were identical at all 3 sites. RESULTS: Propensity score matching yielded 26 matched pairs. Adjusted comparisons between the 2 groups showed that patients who opted to take liraglutide had a superior mean %TBWL 7 months after initiation of liraglutide (ESG-L) compared with those who declined it (ESG) (24.72% ± 2.12% vs 20.51% ± 1.68%, respectively; P < .001). ESG-L had a statistically greater reduction in percent body fat compared with ESG (7.85% ± 1.26% vs 10.54% ± 1.88%, respectively; P < .001) at 12 months. CONCLUSIONS: Addition of liraglutide at 5 months results in superior weight loss and improved efficacy as demonstrated by decreased body fat 12 months after ESG. Further studies are imperative to determine optimal dose, timing, and duration of liraglutide.

Efficacy of Liraglutide to Prevent Weight Regain After Retrieval of an Adjustable Intra-gastric Balloon-a Case-Matched Study.

PURPOSE: Weight regain after balloon retrieval is a concern with all intra-gastric balloons (IGBs). The aim of this study was to evaluate the efficacy of liraglutide, a glucagon-like peptide-1 (GLP-1) agonist, to prevent weight regain following IGB retrieval. MATERIALS AND METHODS: This was a case-matched study of patients undergoing Spatz3 adjustable IGB (Spatz FGIA, Inc. NY, USA) at three outpatient clinics in Brazil between November 2015 and January 2019. Seventy-seven patients that opted to take liraglutide following IGB retrieval (IGB-L) were matched 1:1 to 198 patients that declined the medication-IGB-Alone (IGB-A). Propensity score adjustment was performed at the time of balloon retrieval on factors known to influence the choice of liraglutide. Weight and percent body fat (%BF) was measured at baseline and 9 months after IGB retrieval. % BF is defined as the total mass of fat divided by total body mass, multiplied by 100. The primary outcome was weight regain, and the secondary outcome was change in %BF 9 months after IGB retrieval. RESULTS: Propensity score matching yielded 53 matched pairs. Weight regain to the starting point was not observed in either group. There was significantly less weight regain in IGB-L compared to IGB-A, - 1.15 ± 0.94 kg versus - 0.66 ± 0.99 kg (p = 0.010) 9 months after balloon retrieval. Additionally, %BF decline in IGB-L was superior to IGB-A - 10.83 ± 1.50 versus - 7.94 ± 2.02 (p < 0.01). There was no difference in weight regain or decline in %BF based on liraglutide dose. CONCLUSION: Liraglutide has an additive benefit with respect to efficacy and a reduction in body fat when commenced after IGB retrieval. Future randomized control studies will be needed to determine the optimal dose and duration of liraglutide to achieve superior outcomes.

Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial.

BACKGROUND: Even though 1 in 5 Americans experience some form of mental illness each year, 80% have been shown to discontinue psychotherapy prematurely. The traditional psychotherapy service delivery model, consisting of isolated clinical sessions, lacks the ability to keep patients engaged outside clinical sessions. Newer digital mental health platforms can address the clinical need for a robust tool that tracks mental well-being and improves engagement in patients with depressive symptoms. OBJECTIVE: The primary goals of this feasibility study were to (1) assess compliance among providers and their patients with a digital mental health platform protocol, and (2) examine the usability and fidelity of a mobile app through structured participant feedback. METHODS: A sample of 30 participants was recruited for a 5-week study from a community-based mental health clinic in Baltimore, Maryland, USA. Inclusion criteria were: aged 18 years or older, having access to a smartphone, and having at least mild-to-moderate depression and/or anxiety as measured by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales, respectively. Eligible participants were randomized into one of two study arms: (1) the intervention arm or (2) the waitlist control arm. Participants in the intervention arm were asked to download the Rose app and were prompted to complete clinical assessments (PHQ-9 and GAD-7) every other week, daily mood and anxiety Likert scales, and daily journal entries. The participants in the waitlist arm served as controls for the study and completed the clinical assessments only. Both arms engaged in weekly psychotherapy sessions, with participant in-app input informing the psychotherapy process of the intervention arm, while those in the waitlist control arm continued their standard care. Outcomes of interest included adherence to completion of in-app assessments and usability of the Rose mobile app assessed through the modified Mobile Application Rating Scale. RESULTS: Over the study period, a sample of 30 participants used the Rose app 2834 times to complete clinical assessments. On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week. Nearly all participants (29/30, 97%) completed all PHQ-9 and GAD-7 in-app scales during the study. Subjective impressions showed that 73% (22/30) of participants found the mobile app to be engaging and in line with their needs, and approximately 70% (21/30) of participants reported the app functionality and quality of information to be excellent. Additionally, more than two-thirds of the participants felt that their knowledge and awareness of depression and anxiety management improved through using the app. CONCLUSIONS: Steady compliance and high app ratings showcase the utility of the Rose mobile mental health app in augmenting the psychotherapy process for patients with mood disorders and improving mental health knowledge. Future studies are needed to further examine the impact of Rose on treatment outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04200170; https://clinicaltrials.gov/ct2/show/NCT04200170.

Angiotensin II Blood Levels Are Associated with Smaller Hippocampal and Cortical Volumes in Cognitively Normal Older Adults.

BACKGROUND: There is emerging evidence about possible involvement of the renin-angiotensin system (RAS) in the pathogenesis of Alzheimer's disease (AD) and decline of cognitive function. However, little is known about associations with brain biomarkers. OBJECTIVE: Our study aimed to examine associations between blood ACE-1 and ANG II levels and brain MRI based volumes in non-demented participants, and whether these associations were mediated by blood pressure. METHODS: This cross-sectional study was conducted in 34 older participants from the Baltimore Experience Corps Trial (BECT) Brain Health Sub-study (BHS). Blood ANGII and ACE-1 levels were measured by ELISA and brain MRI volumes were generated using FreeSurfer 6.0. Multiple linear regression analysis, adjusting for intracranial volume and confounders, was used to determine associations between log transformed ANGII and ACE-1 levels and MRI volumes (mm3). RESULTS: Participants were predominantly female (76%), African-American (94%), with mean age of 66.9 and education of 14.4 years. In the fully adjusted model we observed significant inverse associations between log ANGII levels and total grey matter (ß=Angiotensin II associated with smaller hippocampus14,935.50, ±7,444.83, p = 0.05), total hippocampus (ß=-129.97, ±105.27, p = 0.03), rostral middle frontal (ß= -1580.40, ±584.74, p = 0.02), and supramarginal parietal (ß= -978.90, ±365.54, p = 0.02) volumes. There were no associations between ANGII levels and total white matter or entorhinal cortex volumes, or ACE-1 levels and any brain volumes. CONCLUSION: We observed that increased blood ANGII levels were associated with lower total grey matter, hippocampal, rostral middle frontal, and supramarginal parietal volumes, which are associated with cognitive domains that decline in preclinical AD.

Can following formula-feeding recommendations still result in infants who are overweight or have obesity?

BACKGROUND: Studies show that by 3 months, over half of US infants receive formula, and guidelines play a key role in formula feeding. The question then is, what might happen if caregivers follow guidelines and, more specifically, are there situations where following guidelines can result in infants who are overweight/have obesity? METHODS: We used our "Virtual Infant" agent-based model representing infant-caregiver pairs that allowed caregivers to feed infants each day according to guidelines put forth by Johns Hopkins Medicine (JHM), Children's Hospital of Philadelphia (CHOP), Children's Hospital of the King's Daughters (CHKD), and Women, Infants, and Children (WIC). The model simulated the resulting development of the infants from birth to 6 months. The two sets of guidelines vary in their recommendations, and do not provide studies that support amounts at given ages. RESULTS: Simulations identified several scenarios where caregivers followed JHM/CHOP/CHKD and WIC guidelines, but infants still became overweight/with obesity by 6 months. For JHM/CHOP/CHKD guidelines, this occurred even when caregivers adjusted feeding based on infant's weight. For WIC guidelines, when caregivers adjusted formula amounts, infants maintained healthy weight. CONCLUSIONS: WIC guidelines may be a good starting point for caregivers who adjust as their infant grows, but the minimum amounts for JHM/CHKD/CHOP recommendations may be too high. IMPACT: Our virtual infant simulation study answers the question: can caregivers follow current formula-feeding guidelines and still end up with an infant who is overweight or has obesity? Our study identified several situations in which unhealthy weight gain and/or weight loss could result from following established formula-feeding recommendations. Our study also suggests that the minimum recommended amount of daily formula feeding should be lower for JHM/CHOP/CHKD guidelines to give caregivers more flexibility in adjusting daily feeding levels in response to infant weight. WIC guidelines may be a good starting point for caregivers who adjust as their infant grows. In order to understand how to adjust guidelines, we can use computational simulation models, which serve as "virtual laboratories" to help overcome the logistical and ethical issues of clinical trials.

Efficacy and Safety of Endoscopic Sleeve Gastroplasty: A Systematic Review and Meta-Analysis.

BACKGROUND & AIMS: Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic sleeve gastroplasty (ESG) is a seemingly less invasive option for patients with obesity. We performed a systematic review and meta-analysis to evaluate the efficacy and safety of ESG in adults. METHODS: We searched MEDLINE, Embase, Web of Science, and Cochrane Library through July 2019. Investigated outcomes included the percent total body weight loss (TBWL), body mass index reduction, percent excess weight loss (EWL), and adverse events. RESULTS: We extracted data from 8 original studies, published from 2016 through 2019, which included a total of 1772 patients. At 6 months, mean TBWL was 15.1% (95% CI, 14.3-16.0), mean decrease in body mass index was 5.65 kg/m2 (95% CI, 5.07-6.22), and mean excess weight loss was 57.7% (95% CI, 52.0-63.4). Weight loss was sustained at 12 months and 18-24 months with a TBWL of 16.5% (95% CI, 15.2-17.8) and 17.2% (95% CI, 14.6-19.7), respectively. The pooled post-ESG rate of severe adverse events was 2.2% (95% CI, 1.6%-3.1%), including pain or nausea requiring hospitalization (n = 18, 1.08%), upper gastrointestinal bleeding (n=9, 0.56%), and peri-gastric leak or fluid collection (n = 8, 0.48%). CONCLUSIONS: In a systematic review and meta-analysis, we found ESG to produce clinically significant weight loss that was reproducible among independent centers and to have a low rate of severe adverse events. ESG appears to be an effective intervention for patients with obesity, although comparative studies and randomized controlled trials are necessary. PROSPERO Identifier: CRD42019121921.

Endoscopic sleeve gastroplasty versus high-intensity diet and lifestyle therapy: a case-matched study.

BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is a safe and effective minimally invasive bariatric procedure. This study compared weight loss in patients undergoing ESG with that of matched patients undergoing high-intensity diet and lifestyle therapy (HIDLT). METHODS: In this case-matched study, patients were matched 2/3:1 (HIDLT/ESG) by age, sex, and body mass index (BMI). One hundred five patients (30 men) who underwent ESG + low-intensity diet and lifestyle therapy (LIDLT) between 2016 and 2018 were compared with 281 patients (92 men) who underwent HIDLT at the Johns Hopkins Medical Institutions from 2013 to 2014. Weight was evaluated 1, 3, 6, and 12 months after beginning HIDLT or post-ESG to determine the mean percent total body weight loss (%TBWL). RESULTS: Mean age across both cohorts was 48.0 ± 12.1, and baseline BMI was 40.0 ± 7.7 kg/m2. In multivariable analysis controlling for age, sex, and baseline BMI, the mean %TBWL at 1, 3, 6, and 12 months was significantly higher in patients undergoing ESG than matched patients undergoing HIDLT. Specifically, at 3 months, the mean %TBWL in the ESG cohort was 14.0% compared with 11.3% in the HIDLT cohort (P <.011), and at 12 months the mean %TBWL in the ESG cohort was 20.6% versus 14.3% in the HIDLT cohort (P < .001). ESG patients with baseline BMI ≤40 kg/m2 continued to show significantly greater %TBWL than those of the same BMI group in the HIDLT group at 1, 3, 6, and 12 months after intervention (3 months, coefficient = 3.43 [P < .001]; 12 months, coefficient = 8.14 [P < .001]). CONCLUSIONS: Through 12 months of follow-up, patients who underwent ESG achieved significantly greater weight loss than patients enrolled in HIDLT. ESG appears to be a valuable alternative for patients who experience difficulty complying with HIDLT.

Endoscopic sleeve gastroplasty versus intragastric balloon insertion: efficacy, durability, and safety.

BACKGROUND: Intragastric balloon (IGB) placement and endoscopic sleeve gastroplasty (ESG) are reported to be safe and effective endoscopic bariatric therapies. This study aimed to compare the patient demographics and therapeutic outcomes between the IGB and ESG procedures. METHODS: This was a retrospective review of prospectively collected data from consecutive patients between December 2015 and October 2017 who underwent IGB or ESG at a single academic center. Fluid-filled IGBs implanted for a 6-month duration were used. IGB and ESG patients were subjected to identical post-procedure dietary instructions and follow-up protocols. Body weight was recorded at 1, 3, 6, and 12 months post-procedure. RESULTS: A total of 47 patients underwent IGB insertion and 58 underwent ESG. The IGB cohort had a lower baseline body mass index (BMI) than the ESG (34.5 vs. 41.5 kg/m2; P < 0.001) and a significantly lower proportion of men (2.1 % vs. 41.4 %; P < 0.001). IGB patients showed a mean (standard deviation [SD]) percentage total body weight loss (%TBWL) that was significantly lower than ESG patients at 1 month (6.6 % [2.6 %] vs. 9.9 % [2.4 %]; P < 0.001), 3 months (11.1 % [4.4 %] vs. 14.3 % [4.6 %]; P = 0.004), 6 months (15.0 % [7.6 %] vs. 19.5 % [5.7 %]; P = 0.01), and 12 months (13.9 % [9.0 %] vs. 21.3 % [6.6 %]; P = 0.005). The IGB cohort also experienced significantly more adverse events compared with the ESG (17 % vs. 5.2 %; P = 0.048). CONCLUSIONS: IGB placement and ESG result in clinically meaningful weight loss. However, ESG appears to provide clinically superior and more enduring weight loss with fewer adverse events compared with an IGB.