Trends in prescribing and outcomes in obese versus non-obese patients receiving rivaroxaban therapy: an observational study using real-world data.

PURPOSE: To investigate real-world prescribing trends and clinical outcomes based on body mass index (BMI) categorization in patients who received rivaroxaban therapy. METHODS: This was a retrospective cohort study involving all patients who received rivaroxaban therapy across all Hamad Medical Corporation (HMC) hospitals from 2015 to 2020. RESULTS: The number of patients initiated on rivaroxaban therapy significantly increased from 152 (3.3%) in 2015 to 1342 (28.9%) in 2020 (p <0.001). Within BMI categories, a similar increasing trend was observed in underweight, normal, and overweight patients, while from 2018 to 2020, there was a decreasing trend in rivaroxaban prescribing in all obese classes. The prevalence rate of all-cause mortality differed significantly between the BMI groups, with the highest mortality being among morbidly obese patients (BMI ≥ 40 kg/m2) (p< 0.001). On the other hand, no significant differences were found between the BMI groups in terms of bleeding, pulmonary embolism, deep vein thrombosis and stroke incidences. Multivariate logistic regression analyses showed that the likelihood of all-cause mortality was significantly higher in overweight and all categories of obese patients compared to underweight patients: overweight (OR: 5.3, 95% CI: 2.3-11.9, p< 0.001); obese class 1 (OR: 5.4, 95% CI: 2.3 - 12.2, p< 0.001); obese class 2 (OR: 6.5, 95% CI: 2.7 - 15.6, p< 0.001); and obese class 3 (OR: 3.7, 95% CI: 1.6 - 8.7, p = 0.003). CONCLUSIONS: Rivaroxaban prescribing has significantly increased over the years across general population, with a noticeable decline in obese population during the last few years (from 2018 onwards). Furthermore, an appreciable association was evident between all-cause mortality and BMI of these patients.

Changes in Urinary Iodine Levels Following Bariatric Surgery.

OBJECTIVE: Obesity has become an epidemic in the United States. Although bariatric surgery can effectively achieve weight loss by altering the gastrointestinal tract, it commonly results in micronutrient deficiency, requiring supplementation. Iodine is an essential micronutrient for the synthesis of thyroid hormones. We aimed to investigate changes in urinary iodine concentrations (UIC) in patients following bariatric surgery. METHODS: 85 adults who underwent either laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass surgery were enrolled. At baseline and 3 months after surgery, we evaluated spot UIC and serum thyroid stimulating hormone (TSH), vitamin D, vitamin B12, ferritin, and folate levels. Participants provided a 24-hour diet recall for iodine-rich foods and information about multivitamin use at each time point. RESULTS: There was a significant increase in median UIC (201 [120.0 - 288.5] vs 334.5 [236.3 - 740.3] µg/L; P < .001), a significant decrease in mean body mass index (44.0 ± 6.2 vs 35.8 ± 5.9; P < .001) and a significant decrease in TSH levels (1.5 [1.2 - 2.0] vs 1.1 [0.7 - 1.6] uIU/mL; P < .001) at 3 months postoperatively compared to baseline. Body mass index, UIC, and TSH levels before and after surgery did not differ based on the type of weight loss surgery. CONCLUSION: In an iodine-sufficient area, bariatric surgery does not cause iodine deficiency nor clinically significant changes in thyroid function. Different surgical procedures with different anatomical alterations in the gastrointestinal tract do not significantly affect iodine status.

Vitamin D Deficiency in Patients with Morbid Obesity before and after Metabolic Bariatric Surgery.

BACKGROUND: Metabolic bariatric surgery (MBS) is the most effective treatment for severe obesity. Vitamin D deficiency is a common complication encountered both during preoperative workup and follow-up. AIM: To estimate the prevalence of vitamin D deficiency in patients undergoing MBS. METHODS: Prospectively maintained database of our university MBS center was searched to assess the rate of preoperative and postoperative vitamin D deficiency or insufficiency in patients undergoing MBS over a one-year period. RESULTS: In total, 184 patients were included, 85 cases of Sleeve Gastrectomy (SG), 99 Gastric Bypass (GB; 91 One Anastomosis and 8 Roux-en-Y). Preoperative vitamin D deficiency and insufficiency were respectively found in 61% and 29% of patients, with no significant difference between SG and GB. After six months, 15% of patients had vitamin D deficiency, and 34% had vitamin D insufficiency. There was no significant difference in the rate of vitamin D deficiency or insufficiency and the percentage of total weight loss (%TWL) at 1, 3, and 6 postoperative months between SG and GB. CONCLUSIONS: Preoperative vitamin D deficiency or insufficiency is common in MBS candidates. Regular follow-up with correct supplementation is recommended when undergoing MBS. Early postoperative values of vitamin D were comparable between SG and OAGB.

Prevalence and associated factors of secondary hyperparathyroidism after Roux-en-Y gastric bypass: A meta-analysis.

This study aimed to investigate the prevalence and factors associated with secondary hyperparathyroidism (SHPT) after Roux-en-Y gastric bypass (RYGB). We searched PubMed, EMBASE, and CENTRAL for relevant studies using search terms gastric bypass, RYGB and hyperparathyroidism. Thirty-four cohort studies with 4331 patients were incorporated into the final meta-analysis. Overall estimates of the prevalence of SHPT following RYGB were 39%. Subgroup analyses indicated the pooled prevalences of SHPT were 25%, 42%, 48%, and 54% for ≤1 year, >1 and ≤5 years, >5 and ≤10 years, and >10 years, respectively, after RYGB. Meta-regression showed that SHPT occurred was positively related to follow-up durations (p = 0.001). Additionally, SHPT prevalence was higher in studies in which calcium and vitamin D supplementation were considered inadequate than in those which were adequate (p = 0.002). SHPT is highly prevalent in individuals with obesity after RYGB. It seems to progress with time after surgery. Routine calcium and vitamin D supplementation post-RYGB together with targeted treatment of vitamin D deficiency, reasonable adjustment of the doses of supplementation with regular follow-up, and improved patient compliance, as well as long-term screening, are necessary to prevent the development of SHPT.

Investigating the prevalence of nutritional abnormalities in patients prior to and following bariatric surgery.

AIMS: Bariatric surgery remains an effective treatment for the condition of obesity. However it predisposes patients to nutritional deficiencies and related complications. The aim of this study was to identify nutritional abnormalities, weight loss, adherence to supplements, and presence of gastrointestinal symptoms in a cohort of bariatric surgical patients. METHODS: An analysis of the electronic medical records of patients attending a multidisciplinary private clinic in Sydney, Australia from August 2020 to August 2021 was conducted. Data on anthropometric measures, nutritional indices, adherence to supplements and gastrointestinal symptoms preoperatively and then at ≤6 months, 1 and 2 years or more postoperatively were collected. RESULTS: A total of 231 patients were included in the study. The majority of patients were female (76.2%), with a sleeve gastrectomy (78.8%). Average preoperative BMI was 43.4 ± 7.1 kg/m2 . Weight loss ≥2 years postsurgery was 33.5 ± 12.4 kg. The most common abnormalities preoperatively were: C-reactive protein (47.7%), vitamin D (39%), B12 (31%), parathyroid hormone (27.6%) and ferritin (12.7%). Vitamin B12 (23.2%), parathyroid hormone (23%), vitamin D (17.7%) and ferritin (15.9%) remained common abnormalities postoperatively. Adherence to multivitamins was 90% in the first year following surgery, declining to 77% at ≥2 years. Gastrointestinal symptoms were predominantly present in the initial stages following surgery, manifesting thiamin deficiency in 6.5% of patients. CONCLUSIONS: Despite achieving durable weight loss, nutritional and related abnormalities remain an ongoing challenge for bariatric surgery. Adherence to nutrient supplements, gastrointestinal symptoms and related complications are important considerations in addressing the problem.

Sociodemographic and Clinical Factors Associated with Severe Obesity in Adults.

BACKGROUND: In the last decades, obesity in general, including severe obesity (BMI ≥40 kg/m2), has increased disproportionately around the world, especially in low-income and lower-middle income regions. AIMS: To analyze sociodemographic and clinical characteristics of people with severe obesity in Mexico, as well as their associated factors. METHODS: A secondary analysis was carried out from the 2018-19 National Health and Nutrition Survey. Descriptive statistics and bivariate analyses by sex were used. Logistic models were estimated to identify the main factors associated with severe obesity. RESULTS: Of the total number of people with obesity in the country (2.2 million people), 3.6% had severe obesity, with an average age of 48.2. There were statistically significant differences by sex in the variables of age group, education, socioeconomic status, health insurance, hypertension, myocardial infarction, and heart failure. Being a woman, having hypertension, and hypertension/diabetes increased the odds of severe obesity. These associations were maintained when comparing people with a BMI <40 kg/m2, with those with a BMI ≥30 kg/m2 and a BMI <40 kg/m2. CONCLUSIONS: Severe obesity must appear on the Mexican political agenda. Data must be produced that can direct decision-making around the promotion of healthy lifestyles, and obesity prevention, treatment, and follow-up, based in people-centered care and through intersectoral strategies, multidisciplinary management, and holistic approaches.

Prevention and treatment of nutritional complications after bariatric surgery.

Obesity and the corresponding burden of related diseases is a major public health issue worldwide that is reaching pandemic proportions. Bariatric surgery is the only intervention that has been shown to result in substantial and lasting weight loss, and a decrease in overall mortality for patients with severe obesity. Consequently, the population of patients having undergone this procedure is increasing. Multifactorial weight-dependent and independent mechanisms underlying metabolic diseases could also drive preventable, but potentially life-threatening, long-term nutritional complications. However, given post-bariatric patients are prone to functional gastrointestinal symptoms and substantial weight loss, nutritional complications might be challenging. This Review is focused on the prevention and treatment of nutritional complications after bariatric surgery in the clinical setting.

Rare Variants in Genes Linked to Appetite Control and Hypothalamic Development in Early-Onset Severe Obesity.

Context: The hypothalamic circuit has an essential role in the regulation of appetite and energy expenditure. Pathogenic variants in genes involved in the hypothalamic leptin-melanocortin pathway, including melanocortin-4-receptor (MC4R), have been associated with monogenic obesity. Objective: To determine the rate and spectrum of rare variants in genes involved in melanocortin pathway or hypothalamic development in patients with severe early-onset obesity (height-adjusted weight >60% before age 10 years). Methods: We used a custom-made targeted exome sequencing panel to assess peripheral blood DNA samples for rare (minor allele frequency <0.5%), pathogenic/likely pathogenic variants in 24 genes related to the hypothalamic circuit in 92 subjects (51% males, median age 13.7 years) with early-onset severe obesity (median body mass index (BMI) Z-score + 4.0). Results: We identified a novel frameshift deletion in MC4R (p.V103Afs5*) in two unrelated patients and a previously reported MC4R variant (p.T112M) in one patient. In addition, we identified rare heterozygous missense variants in ADCY3 (p.G1110R), MYT1L (p.R807Q), ISL1 (p.I347F), LRP2 (p.R2479I, and p.N3315S) and a hemizygous missense variant in GRPR (p.L87M) (each in one patient), possibly contributing to the obesity phenotype in these patients. Altogether 8 % (7/92) of the subjects had rare pathogenic/likely pathogenic variants in the studied genes. Conclusions: Rare genetic variants within the hypothalamic circuit are prevalent and contribute to the development of severe early-onset obesity. Targeted exome sequencing is useful in identifying affected subjects. Further studies are needed to evaluate the variants' clinical significance and to define optimal treatment.

Relationship Between Modified Body Adiposity Index and A Body Shape Index with Biochemical Parameters in Bariatric Surgery Candidates.

BACKGROUND: Body mass index, an estimate of body fat percentage, has been previously shown to be associated with metabolic disorders. However, there is little data on the associations between a body shape index (ABSI) or modified body adiposity index (MBAI), which provide valuable definitions of body fat, with serum biochemical parameter levels. Therefore, this study was conducted to find either ABSI or MBAI associations with serum biochemical parameter levels in bariatric surgery candidates. METHODS: This cross-sectional study was conducted on 776 bariatric surgery candidates (age range 18-69 years) between November 2010 and September 2017. Demographic data, anthropometric indices, biochemical parameters, and body composition analysis data were drawn from the National Obesity Surgery Database, Iran. ABSI and MBAI were calculated using related equations. A stepwise multivariate linear regression was used to evaluate whether ABSI or MBAI was associated with each serum biochemical parameter. RESULTS: ABSI, age, and multivitamin/mineral supplementation (MVMS) were independently associated with serum vitamin D (ß = 24.374, SE 10.756, P value 0.026; ß = 0.022, SE 0.007, P value 0.002; ß = 0.639, SE 0.235, P value 0.008). However, a negative association was observed between MBAI and vitamin D (ß = - 0.037, SE 0.016, P value 0.025) in a model adjusted for age and MVMS. Additionally, MBAI and age showed a significant positive association with serum HDL-c (ß = 0.185, SE 0.085, P value 0.028; ß = 0.171, SE 0.033, P value < 0.001), although there was a negative association between male sex and HDL-c (ß = - 4.004, SE 0.891, P value < 0.001). CONCLUSION: ABSI and MBAI may be appropriate indices in predicting serum vitamin D and HDL-c levels.

Malnutrition in obesity before and after bariatric surgery.

Bariatric surgeries are considered the only effective way of weight loss therapy in morbidly obese patients, i.e. body mass index ≥ 35. However, micronutrient deficiencies and malnutrition are common after most bariatric procedures and thus, pre- and postoperative nutritional assessment and corrections are advised. The present review is presented in an effort to describe in some detail about prevalence, and mechanisms of macro- and micronutrient deficiencies in obese and post-bariatric surgery individuals. We also aimed to summarize the data on screening and supplementation of macro- and micronutrients before and after bariatric surgeries.

Perioperative Practices Concerning Sleeve Gastrectomy - a Survey of 863 Surgeons with a Cumulative Experience of 520,230 Procedures.

BACKGROUND: Sleeve Gastrectomy (SG) is the most commonly performed bariatric procedure worldwide. There is currently no scientific study aimed at understanding variations in practices concerning this procedure. The aim of this study was to study the global variations in perioperative practices concerning SG. METHODS: A 37-item questionnaire-based survey was conducted to capture the perioperative practices of the global community of bariatric surgeons. Data were analyzed using descriptive statistics. RESULTS: Response of 863 bariatric surgeons from 67 countries with a cumulative experience of 520,230 SGs were recorded. A total of 689 (80%) and 764 (89%) surgeons listed 13 absolute and relative contraindications, respectively. 65% (n = 559) surgeons perform routine preoperative endoscopy and 97% (n = 835) routinely use intraoperative orogastric tube for sizing the resection. A wide variation is observed in the diameter of the tube used. 73% (n = 627) surgeons start dividing the stomach at a distance of 3-5 cm from the pylorus, and 54% (n = 467) routinely use staple line reinforcement. Majority (65%, n = 565) of surgeons perform routine intraoperative leak test at the end of the procedure, while 25% (n = 218) surgeons perform a routine contrast study in the early postoperative period. Lifelong multivitamin/mineral, iron, vitamin D, calcium, and vitamin B12 supplementation is advocated by 66%, 29%, 40%, 38% and 44% surgeons, respectively. CONCLUSION: There is a considerable variation in the perioperative practices concerning SG. Data can help in identifying areas for future consensus building and more focussed studies.

Rivaroxaban Versus Warfarin for Stroke Prevention and Venous Thromboembolism Treatment in Extreme Obesity and High Body Weight.

Background: Limited clinical data exist describing the use of direct-acting oral anticoagulants (DOACs) in patients with body mass index (BMI) >40 kg/m2 or body weight >120 kg. Thus, DOAC therapy in this population remains controversial. Objectives: To investigate rivaroxaban as a safe and effective alternative to warfarin for venous thromboembolism (VTE) treatment and prevention of stroke in patients with atrial fibrillation identified as extremely obese or of high body weight. Methods: A retrospective chart review was performed at 2 academic medical centers in patients ≥18 years old and BMI >40 kg/m2 or weight >120 kg, newly initiated on warfarin or rivaroxaban for atrial fibrillation or VTE treatment. The primary end point was incidence of clinical failure, defined as VTE recurrence, stroke incidence, and mortality, within 12 months of initiation. Secondary end points included length of stay (LOS) and bleeding complications. Results: A total of 176 patients were included, with 84 and 92 patients in the rivaroxaban and warfarin arms, respectively. Clinical failure was lower in the rivaroxaban group but did not reach statistical significance when compared with warfarin (5% vs 13%; P = 0.06). LOS was significantly shorter in the rivaroxaban arm (2 days [1-3] vs 4 days [2-7], P < 0.0001). Percentage of bleeding complications was higher in the rivaroxaban arm but not statistically significant (8% vs 2%, P = 0.06). Conclusion and Relevance: Although not statistically significant, rivaroxaban trended toward a lower incidence of clinical failure while demonstrating a significantly shorter LOS when compared with warfarin for VTE treatment or atrial fibrillation in morbidly obese or high-body-weight patients.

The Role of Minimally Invasive and Endoscopic Technologies in Morbid Obesity Treatment: Review and Critical Appraisal of the Current Clinical Practice.

Bariatric surgery is the most effective treatment for morbid obesity. Availability of different procedures with low complication rates, performed through a minimally invasive approach, have caused profound positive effect on patient's quality of life and has led to their worldwide, rapid expansion of the field. The laparoscopic revolution has introduced the concept of lowering more and more the treatments' invasiveness, leading to a change in the researchers' mentality. They are now constantly looking for reducing patients' discomfort through new methodologies and devices: aim of this review is to provide an in-depth analysis of the most promising, innovative procedures offering an alternative approach to "classic" laparoscopic procedures. They are described from their original development phases to the most recent experimental and clinical evidence. This review will discuss as well their future perspectives, and includes endoluminal techniques and/or procedures based on alternative concepts, all representing an appealing alternative to surgical approach. We conducted a MEDLINE for articles, clinical trials, and a patent search relating to the minimally invasive management of obesity, excluding intragastric balloons, SILS, and NOTES, and we selected 77 articles. Results are reported for each procedure/device, and discussed both in these paragraphs and in the final, general discussion. The concept of minimally invasive procedures continues to change and evolve over time with novel technologies emerging every year.

Do Specialized Bariatric Multivitamins Lower Deficiencies After Sleeve Gastrectomy?

BACKGROUND: Vitamin and mineral deficiencies are common after a sleeve gastrectomy (SG). The aim of this study is to examine the effectiveness of a specialized bariatric multivitamin (WLS Optimum) for SG patients on deficiencies compared with a regular multivitamin (MVS) for up to 5 years. METHODS: Data of all patients who underwent a SG procedure in the Catharina Hospital Eindhoven (CZE) between July 2011 and July 2016 were collected and retrospectively analyzed. All patients who completed a preoperative blood test and at least one blood withdrawal during the first operative year were included in this study. RESULTS: This study included 970 patients; 291 patients in the WLS-user group and 679 patients in the non-WLS-user group. In favor of the user group, significantly less de novo deficiencies were found of vitamin B1 (2 years) and vitamin B6 (two and three), folic acid (1 and 2 years), and vitamin B12 (at 1 year). Binomial logistic regression showed a significant influence of multivitamin supplementation mainly on ferritin; vitamins B1, B6, B12, and D; and folic acid, (all p < 0.05). The total number of de novo deficiencies was significantly reduced during the whole study for all WLS Optimum users. CONCLUSIONS: Vitamin deficiencies are common, and postoperative nutritional management after SG is underestimated. The use of a specialized multivitamin supplement resulted in higher mean serum concentrations and less deficiencies of vitamin B1, folic acid, and vitamin B12. This study shows that SG patients benefit from the specialized multivitamin supplements, but adjustments are required for iron and vitamin B6 content.

Prevalence of Vitamin D Depletion, and Associated Factors, among Patients Undergoing Bariatric Surgery in Southern Brazil.

BACKGROUND: Hypovitaminosis D is common, before and after gastric bypass surgery. The prevalence of hypovitaminosis D in a large group of candidates for bariatric surgery in Brazil and South America has not been studied. OBJECTIVE: To evaluate the prevalence of hypovitaminosis D and associated factors in patients undergoing bariatric surgery in Southern Brazil. MATERIALS AND METHODS: Cross-sectional study involving all patients presenting for bariatric surgery at Hospital de Clínicas de Porto Alegre, from January 2013 to June 2018. Data were extracted from the patients' electronic medical records. Patients who were taking multivitamin supplements or vitamin D supplements, who had renal insufficiency, or had missing data for 25(OH) vitamin D [25(OH)D] levels were excluded. RESULTS: A total of 291 patients were included. Mean subjects' age was 44.9 (SD 10.7) years, and BMI 49.3 (SD 8.3) kg/m2; 76.6% of the study patients were women, and 87.3% were white. More than half the patients (55.3%) were vitamin D deficient (serum 25(OH)D ≤ 19.9 ng/ml), and 37.1% had insufficient levels (20-29.9 ng/mL). Mean vitamin D level was 19.2 ng/mL (SD 7.6). An inverse correlation was found between 25(OH)D levels and BMI. Vitamin D deficiency was more prevalent in patients with higher BMI [PR 1.02; CI 95% (1.00-1.03)], higher fasting glucose [PR 1.01; CI 95% (1.00-1.01)], in nonwhite patients [PR 1.58; CI 95% (1.30-1.92)] and during autumn/winter season [PR 1.41; CI 95% (1.14-1.75)]. CONCLUSIONS: Prevalence of vitamin D insufficiency and deficiency is very high among patients presenting for bariatric surgery in Southern Brazil, and the known associated factors are confirmed in this population.

A 5-Year Follow-up in Children and Adolescents Undergoing One-Anastomosis Gastric Bypass (OAGB) at a European IFSO Excellence Center (EAC-BS).

BACKGROUND: The children and adolescent population with obesity has increased worldwide, both in developing areas and in developed countries. Consequently, the prevalence of morbid obesity among this population has also increased, leading to an exponential growth of bariatric approaches in this population. Many surgeons fear eventual nutritional sequelae after malabsorptive approaches and prefer restrictive or mixed procedures. METHODS: A retrospective review of all the morbidly obese patients between 13 and 19 years, undergoing a one-anastomosis gastric bypass (OAGB) as bariatric procedure between 2004 and 2012, was performed. RESULTS: A total of 39 patients were included, 8 males (20.5%) and 31 females (79.5%), with a mean age of 17.8 ± 2 years (range 13-19 years). Mean preoperative weight was 114.3 ± 20.4 kg and mean BMI 42.2 ± 5.9 kg/m2. Preoperative comorbidities include only type 2 diabetes mellitus (T2DM) in 7.9% of the patients, hypertension in 10.3%, and dyslipidemia in 23.1%. Five years after surgery, mean BMI was 25.9 ± 5.3 kg/m2 and total weight loss 32.1 ± 15.7%. Remission rate of T2DM, hypertension and dyslipidemia was 100%. All the patients received multivitamin and vitamin D supplementation. Anemia secondary to iron deficiency occurred in one female, requiring intravenous iron supplementation during 1 year and later on oral supplementation. CONCLUSIONS: OAGB is a valid alternative for long-term weight loss and remission of comorbidities in childhood and adolescence. No cases of malnutrition or growth disorders were observed.

Comparative effectiveness, safety, and costs of rivaroxaban and warfarin among morbidly obese patients with atrial fibrillation.

BACKGROUND: There are limited data regarding clinical outcomes and healthcare resource utilization of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) who are morbidly obese (body mass index >40 kg/m2 or body weight >120 kg). METHODS: Using data from 2 US healthcare claims databases, we identified patients initiating rivaroxaban or warfarin who had ≥1 medical claim with an AF diagnosis, a diagnostic code for morbid obesity (ICD-9: 278.01, V85.4%; ICD-10: E66.01%, E66.2%, Z68.4%), and a minimum continuous enrollment of 12 months before and 3 months after treatment initiation. Patients were excluded if they had mitral stenosis, a mechanical heart valve procedure, an organ/tissue transplant, or an oral anticoagulant prescription prior to the index date. Rivaroxaban and warfarin patients were 1:1 propensity score matched. Conditional logistic regression was used to compare ischemic stroke/systemic embolism and major bleeding risk. Generalized linear models were used to compare healthcare resource utilization and costs. RESULTS: A total of 3563 matched pairs of morbidly obese AF patients treated with rivaroxaban or warfarin were identified. The majority (81.4%) of patients in the rivaroxaban cohort were receiving the 20 mg dose. The rivaroxaban and warfarin cohorts were well balanced after propensity score matching. The risks of ischemic stroke/systemic embolism and major bleeding were similar for rivaroxaban and warfarin users (stroke/systemic embolism: 1.5% vs 1.7%; odds ratio [OR]: 0.88; 95% confidence interval [CI]: 0.60, 1.28; P = .5028; major bleeding: 2.2% vs 2.7%; OR: 0.80; 95% CI: 0.59, 1.08; P = .1447). Total healthcare costs including medication costs per patient per year (PPPY) were significantly lower with rivaroxaban versus warfarin ($48,552 vs $52,418; P = .0025), which was primarily driven by lower hospitalization rate (50.2% vs 54.1%; P = .0008), shorter length of stay (7.5 vs 9.1 days; P = .0010), and less outpatient service utilization (86 vs 115 visits PPPY; P < .0001). CONCLUSIONS: Morbidly obese AF patients treated with rivaroxaban had comparable risk of ischemic stroke/systemic embolism and major bleeding as those treated with warfarin, but lower healthcare resource utilization and costs.

Fractures in Adults After Weight Loss from Bariatric Surgery and Weight Management Programs for Obesity: Systematic Review and Meta-analysis.

BACKGROUND: Weight loss interventions for obesity, such as bariatric surgery, are associated with reductions in bone mineral density and may increase the risk of fractures. We undertook a systematic review and meta-analysis of bariatric surgery and lifestyle weight management programs (WMPs) with fracture outcomes. METHODS: We searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials from 1966 to 2018, and our trial registry of WMP randomized controlled trials (RCTs). We included RCTs, non-randomized trials, and observational studies of bariatric surgery, and RCTs of WMPs. Studies had follow-up ≥ 12 months, mean group body mass index ≥ 30 kg/m2. The primary outcome measure was incidence of any type of fracture in participants, and the secondary outcome was weight change. We used random effects meta-analysis for trial data. RESULTS: Fifteen studies were included. Three small trials provided short-term evidence of the association between bariatric surgery and participants with any fracture (365 participants; RR 0.82; 95% CI 0.29 to 2.35). Four out of six observational studies of bariatric surgery demonstrated significantly increased fracture risk. Six RCTs of WMPs with 6214 participants, the longest follow-up 11.3 years, showed no clear effect on any type of fracture (RR 1.04; 95% CI 0.91 to 1.18), although authors of the largest RCT reported an increased risk of frailty fracture by their definition (RR 1.40; 95% CI 1.04 to 1.90). CONCLUSION: Bariatric surgery appears to increase the risk of any fracture; however, longer-term trial data are needed. The effect of lifestyle WMPs on the risk of any fracture is currently unclear.

Quality of Life One Year After Bariatric Surgery: the Moderator Role of Spirituality.

BACKGROUND: This study aimed to assess quality of life in obese patients 1 year after bariatric surgery taking into consideration the influence of socio-demographic, clinical, and psychological variables. METHODS: A sample of 90 patients undergoing bariatric surgery was assessed in two moments: before surgery and 1 year after surgery. RESULTS: Social support, problem-focused coping strategies, and quality of life increased after surgery, while eating disorder behaviour and impulsiveness decreased. The presence of eating disorder behaviour predicted worse physical and mental quality of life and higher satisfaction with social support predicted better physical and mental quality of life. In addition, higher impulsiveness predicted worse mental quality of life. Spirituality moderated the relationship between impulsiveness and mental/physical quality of life. CONCLUSIONS: Interventions should focus on promoting social support and coping strategies particularly spirituality since it played an important role in quality of life.

Willing to go the extra mile: Prospective evaluation of an intensified non-surgical treatment for patients with morbid obesity.

BACKGROUND & AIMS: Bariatric surgery has been well established and considered the treatment of choice in morbid obesity. However, some patients refuse surgery because long-term effects have not been fully elucidated, quality of life might change and lifelong supplementation with vitamins and trace elements may be required. Our aim was to exhaust non-surgical treatment modalities and to evaluate such an intensified treatment alternative. METHODS: A total of 206 patients (mean age = 46 years; BMI = 49 kg/m2) enrolled since 2013 into a non-surgical multimodality obesity treatment program covered by major health insurances were prospectively evaluated over a three year period. The 12-month treatment course comprised 57 h cognitive-behavioral therapy, 53.5 h physical exercise training, and 43.5 h nutritional therapy offered in small groups. Weight loss was induced by a formula-based, very low-calorie diet for 12 weeks in combination with a gastric balloon. The primary outcome was relative weight loss (RWL). Secondary outcome measures were waist-to-hip ratio, blood pressure, antihypertensive drug treatment, anti-diabetic medication, HbA1c, and quality of life. RESULTS: 166 Patients (81%) completed treatment. Mean (±SD) weight loss after 12 months for women and men were 28.8 kg (±14.7) and 33.7 kg (±19.5), respectively, among completers. RWL was 21.9% (±10.0) and excess weight loss (EWL) was 46.9% (±22.2), whereas intention-to-treat analysis revealed a RWL of 20.0% (±10.4) and an EWL of 42.9% (±22.9). Weight loss was accompanied by improved quality of life, lowered HbA1c values, and a significantly reduced need of antihypertensive and diabetes medications over the study period. Three year follow-up data from the first 78 patients (76% follow-up rate) revealed a RWL of 13% (±13.1) and an EWL of 27.2% (±28.8). The majority of patients (51%) maintained a RWL of 10% or more, and 44% had an EWL > 30%. CONCLUSIONS: In patients with morbid obesity, an intensified non-surgical multimodality treatment program may achieve significant and sustained weight loss accompanied by improvement of disease markers as well as quality of life for at least three years.