Gastric band is safe and effective at three years in a national study subgroup of non-morbidly obese patients

Aim

To analyze the 3-year outcomes of lower body mass index (BMI) (<35 kg/m²) adjustable gastric band (AGB) recipients across multiple sites in the French health insurance system.

Methods

From prospectively collected data on a cohort of 517 morbidly obese Swedish Adjustable Gastric Band^® (SAGB) patients (Clinical Trials Web database, #{"type":"clinical-trial","attrs":{"text":"NCT01183975","term_id":"NCT01183975"}}NCT01183975), a retrospective analysis of a subgroup of 29 low-BMI patients was conducted. Patients had a severe obesity-related comorbidity, had undergone a prior bariatric procedure requiring reintervention, or had a maximum adult BMI≥40. Safety (mortality, adverse events) and effectiveness (BMI change, excess weight loss [EWL, %], total body weight loss [%TBWL], quality of life [QoL], and comorbidities) were evaluated.

Results

Multiple surgical teams/sites enrolled patients and performed SAGB procedures between September 2, 2007 and April 30, 2008. Of 29 low-BMI patients (mean age, 41.3 ± 10.3 years), 89.7% were female, and obesity duration was 13.6 ± 7.3 years. Mean BMI was 31.5 ± 3.7; there were 37 comorbidities in 15/29 patients. At 3-year follow-up, BMI was 29.4 ± 4.9 (mean change, -2.3 ± 6.2; P = 0.069); total cohort EWL, 7.3 ± 74.8%; TBWL, 6.2 ± 18.8%; BMI≥30 to <35 EWL, 38.8 ± 48.0%; there were 7 comorbidities in 15/29 patients (P < 0.031). There were 20 adverse events in 13 patients (44.8%); SAGBs were retained in 25/29 (86.2%) at 3 years.

Conclusions

In a retrospective analysis of a subgroup of BMI<35 kg/m² patients, some following a prior bariatric procedure, SAGB was found to be safe and effective at 3-year follow-up.For over 2 decades, since publication of the 1991 National Institutes of Health (NIH) consensus conference statement (1), the cutoff point for bariatric surgery has been morbid obesity (body mass index [BMI, kg/m²]≥40 or ≥35 with comorbidities), also termed class II obesity by the World Health Organization (WHO) (2). This demarcation of access to bariatric surgery was based on the observation that an increase in BMI leads to an increase in the risk of comorbid illness and premature death. Yet, investigation of the potential value of bariatric surgery as a safe and effective treatment for overweight (BMI 25-<30) and obesity class I (BMI≥30 to <35) patients has been under way since the publication of the NIH statement. In 1992 and 1995 landmark studies (3,4), Pories et al theorized that bariatric procedures might be safe and as beneficial for weight loss and comorbidity reduction in non-morbidly obese patients as it was in the morbidly obese (5). In the last half decade, the least-invasive, lowest-risk restrictive procedures, such as adjustable gastric banding (AGB), have been employed at the forefront of exploring surgical options for the <35 BMI patient.Adjustable gastric banding comprised the vast majority, nearly 90%, of bariatric procedures performed in morbidly obese patients in France prior to 2008 (6). To assess the national social insurance-supported use of the Swedish Adjustable Gastric Band (SAGB) (7,8), the French government commissioned a prospective, 31-center, “real-life,” observation of SAGB safety and effectiveness in class II and III obese patients (9). Between September 2, 2007 and April 30, 2008, patients were selected and underwent SAGB implantation in rural and urban centers. SAGB weight-loss effectiveness analyzed on an intent-to-treat basis at the 3-year study endpoint was comparable to that of AGB findings summarized by global meta-analyses (10,11). Under the “real-world” SAGB study protocol requirement of consecutive recruitment and surgeon discretion, 29 patients (5.6% of 517) were included in the national SAGB study who presented with a BMI<35 and a severe obesity-related comorbidity, and/or had experienced a prior complicated bariatric surgery requiring revision, and/or had previously sustained a maximum adult BMI≥40. With the aim of contributing safety and effectiveness findings to the growing <35 BMI evidence base, we report 3-year outcomes for the French low-BMI SAGB study group.     

Chemoselective synthesis of multifunctional ferrocene-containing derivatives by the cross Rauhut–Currier reaction

A simple protocol has been developed for the chemoselective synthesis of ferrocene-containing Rauhut–Currier adducts from 1-ferrocenyl-2-nitroethene and vinyl ketones using 20 mol% of triphenylphosphine. Multifunctional ferrocene derivatives were obtained in moderate to high yields (51–92%) by the coupling between the α-position of vinyl ketones and the β-position of the nitroalkene. The study of the Rauhut–Currier reaction under the described conditions showed that the strong electron-donating group at the β-position of nitroalkenes plays a significant role in the reaction outcome due to prevention of polymerization and stabilization of the zwitterionic intermediate. Additionally, a preparative synthesis of 4-ferrocenyl-3-methylene-5-nitropentan-2-one was carried out and its synthetic transformations showed easy conversion to other useful building blocks.

A simple method has been developed for the chemoselective synthesis of ferrocene-containing Rauhut–Currier adducts from 1-ferrocenyl-2-nitroethene and vinyl ketones catalyzed by triphenylphosphine.     

Fertility-sparing surgery for patients with malignant ovarian germ cell tumors: 10 years of clinical experience from a tertiary referral center

Archives of Gynecology and Obstetrics - To describe a case series of patients with malignant ovarian germ cell tumors (MOGCT) treated exclusively with fertility-sparing surgery (FSS) with or...     

Revealing the Pb Whisker Growth Mechanism from Al-Alloy Surface and Morphological Dependency on Material Stress and Growth Environment

Spontaneous metallic Pb whisker formation from Pb and Bi containing Al-alloy’s surfaces is a newly discovered phenomenon. The whiskers display unique formations, growth and morphology, which give the opportunity to be applied for specialized sensor and electronics applications. Within this work, the impact of environmental conditions (gas composition and moisture) is investigated and correlated with the modification of whisker evolution and growth dynamics. Furthermore, the residual stress state of the aluminum matrix using deep cryogenic treatment is modified and used to further increase whisker nucleation and growth by up to three- and seven-fold, respectively, supported by quantitative results. The results of this paper indicate the possibility to manipulate the whisker not only in terms of their kinetics but also their morphology (optimal conditions are 20% O₂ and 35% humidity). Such features allow the tailoring of the whisker structure and surface to volume ratio, which can be optimized for different applications. Finally, this research provides new insight into the growth dynamics of the whiskers through in situ and ex situ measurements, providing further evidence of the complex nucleation and growth mechanisms that dictate the spontaneous growth of Pb whiskers from Al-alloy 6026 surfaces with growth velocities up to 1.15 µm/s.     

The Dose-Response Effects of Consuming High Fructose Corn Syrup-Sweetened Beverages on Hepatic Lipid Content and Insulin Sensitivity in Young Adults

Increased hepatic lipid content and decreased insulin sensitivity have critical roles in the development of cardiometabolic diseases. Therefore, our objective was to investigate the dose-response effects of consuming high fructose corn syrup (HFCS)-sweetened beverages for two weeks on hepatic lipid content and insulin sensitivity in young (18–40 years) adults (BMI 18–35 kg/m²). In a parallel, double-blinded study, participants consumed three beverages/day providing 0% (aspartame: n = 23), 10% (n = 18), 17.5% (n = 16), or 25% (n = 28) daily energy requirements from HFCS. Magnetic resonance imaging for hepatic lipid content and oral glucose tolerance tests (OGTT) were conducted during 3.5-day inpatient visits at baseline and again at the end of a 15-day intervention. During the 12 intervening outpatient days participants consumed their usual diets with their assigned beverages. Significant linear dose-response effects were observed for increases of hepatic lipid content (p = 0.015) and glucose and insulin AUCs during OGTT (both p = 0.0004), and for decreases in the Matsuda (p = 0.0087) and Predicted M (p = 0.0027) indices of insulin sensitivity. These dose-response effects strengthen the mechanistic evidence implicating consumption of HFCS-sweetened beverages as a contributor to the metabolic dysregulation that increases risk for nonalcoholic fatty liver disease and type 2 diabetes.     

Insulin sensitivity and blood pressure in black and white children

Although insulin sensitivity is correlated with high blood pressure in adults, it is unclear whether such a relationship exists in children across ethnic groups. Therefore, the aims of the study were to establish (1) if body composition and insulin sensitivity were related to blood pressure in children, and (2) if any differences in blood pressure between white and black children were explained by body composition and/or insulin sensitivity. Insulin sensitivity and the acute insulin response were established by the minimal model and body composition by dual-energy X-ray absorptiometry. Blood pressure was recorded in the supine position. Body composition, fasting insulin (P<0.01), and the acute insulin response (P<0.05) were positively related to systolic blood pressure but not to diastolic blood pressure, and insulin sensitivity (P<0.001) was negatively related to systolic blood pressure but not to diastolic blood pressure. Insulin sensitivity was negatively associated with systolic and diastolic blood pressure after adjustment for body composition (P<0.01). Black children had higher systolic (110+/-9.2 versus 105+/-8.5 mm Hg, P=0.01) and diastolic (59+/-7.0 versus 54+/-8.0 mm Hg, P<0.01) blood pressure than did white children. The ethnic difference in blood pressure was not explained by body composition, fasting insulin, acute insulin response, or insulin sensitivity. In conclusion, the relationship between insulin sensitivity and systolic blood pressure is evident early in life. Black ethnicity and low insulin sensitivity contribute independently to higher blood pressure in children.     

Altered effective connectivity during working memory performance in schizophrenia: a study with fMRI and structural equation modeling

The present study aimed to explore altered effective connectivity in schizophrenic patients while performing a 2-back working memory task. Twelve right-handed, schizophrenic patients treated with typical or atypical antipsychotics and 6 healthy control subjects were studied with fMRI while performing a "2-back" working memory task. Effective connectivity within a cortical-subcortical-cerebellar network for mnemonic information processing was assessed and compared between both groups. The path model included cortico-cortical connections comprising the parietal association cortex, ventrolateral prefrontal cortex (VLPFC), and the dorsolateral prefrontal cortex (DLPFC) as well as a cortico-cerebellar feedback loop comprising prefrontal cortex, contralateral cerebellum, and thalamus. Group differences were analyzed with a stacked models approach. Relative to normal controls, both patient groups revealed a pattern of reduced connectivity within the prefrontal-cerebellar and the cerebellar-thalamic limbs but enhanced connectivity in the thalamo-cortical limb of the cortical-cerebellar circuit. Moreover, a direct comparison of both treatment groups revealed enhanced connectivity in the interhemispheric connections between the cortical association areas in patients treated with atypical antipsychotics. However, right prefrontal and left parieto-frontal path coefficients were lower in the patient group receiving atypical antispychotic drugs. The findings suggest that the relationship between pathology in cortical-subcortical cerebellar networks and associated functional connectivity is complex and may include aspects of increased and decreased levels of connectivity consistent with the notion of "cognitive dysmetria" in schizophrenia. The observed pronounced connectivity within thalamo-cortical projections could be attributed to a compensatory increase of thalamic input in the presence of disrupted effective connectivity within the preceding limb of the cortical-cerebellar circuitry. The study demonstrated the feasibility of structural equation modeling for the investigation of group and treatment-related differences in effective connectivity and provides a promising approach to further disentangle the relationship between altered functional capacity and associated fMRI signal changes.