A retrospective multicenter cohort study of the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19.

BACKGROUND: Patients with critical COVID-19 have a high risk of thromboembolism, but intensified thromboprophylaxis has not been proven beneficial. The activity of low-molecular-weight heparins can be monitored by measuring anti-Factor Xa. We aimed to study the association between anti-Factor Xa values and death, thromboembolism, and bleeding in patients with critical COVID-19. METHOD: This retrospective cohort study included adult patients with critical COVID-19 admitted to an intensive care unit at three Swedish hospitals between March 2020 and May 2021 with at least one valid peak and/or trough anti-Factor Xa value. Within the peak and trough categories, patients' minimum, median, and maximum values were determined. Logistic regressions with splines were used to assess associations. RESULTS: In total, 408 patients had at least one valid peak and/or trough anti-Factor Xa measurement, resulting in 153 patients with peak values and 300 patients with trough values. Lower peak values were associated with thromboembolism for patients' minimum (p = 0.01), median (p = 0.005) and maximum (p = 0.001) values. No association was seen between peak values and death or bleeding. Higher trough values were associated with death for median (p = 0.03) and maximum (p = 0.002) values and with both bleeding (p = 0.01) and major bleeding (p = 0.02) for maximum values, but there were no associations with thromboembolism. CONCLUSIONS: Measuring anti-Factor Xa activity may be relevant for administrating low-molecular-weight heparin to patients with critical COVID-19. Lower peak values were associated with an increased risk of thromboembolism, and higher trough values were associated with an increased risk of death and bleeding. Prospective studies are needed to confirm the results. TRIAL REGISTRATION: The study was retrospectively registered at Clinicaltrials.gov, NCT05256524, February 24, 2022.

The impact of a structured weight-loss treatment on physical fitness in patients with psoriatic arthritis and obesity compared to matched controls: a prospective interventional study.

OBJECTIVES: To evaluate the effects of weight loss treatment on physical fitness in patients with psoriatic arthritis (PsA) and obesity compared to matched controls. METHODS: In total, 46 patients with PsA (CASPAR) and BMI ≥ 33 kg/m2 and 52 obese persons were included in this 12-month prospective open intervention study with a very low energy diet (640 kcal/day), followed by structured reintroduction of an energy-restricted diet and brief support for physical activity. The primary outcome was muscle strength assessed with hand-grip strength (Grippit) and leg muscle strength (timed stand test). Secondary outcomes were cardiorespiratory fitness, body composition, and physical functioning (SF-36PCS). Outcomes were assessed at baseline, 6 (M6), and 12 months (M12). Nonparametric statistics were used. RESULTS: Median weight reduction at M6 was 18.9 kg in patients and 23.0 kg in controls, (p = 0.546). At M12, patients' median weight loss from baseline was 16.1 kg, corresponding with significant loss of total fat mass (- 30.1%), and lean mass (total - 7.0%, arm - 13.7%, and leg - 6.0%). Leg muscle strength improved in patients and controls at M6 (p < 0.001) and remained improved at M12 (p < 0.01), while hand-grip strength was unchanged in both groups. Cardiorespiratory fitness increased in controls at M6 (p = 0.018) and M12 (p = 0.028) but not in patients. Physical functioning improved in both groups at M6 (p < 0.001) and remained improved at M12 (p = 0.008) and (p < 0.01), respectively. CONCLUSION: The intervention resulted in positive effects on body weight and total body fat. Despite reduced lean body mass, the muscle strength did not deteriorate in patients with PsA and controls. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02917434, registered on September 21, 2016-retrospectively registered.

Oral health profile of postbariatric surgery individuals: A case series.

OBJECTIVES: To describe the oral health profile of individuals who had undergone gastric bypass surgery (GBP) or sleeve gastrectomy (SG) to generate hypotheses for further studies. MATERIAL AND METHODS: Fourteen individuals treated with GBP or SG surgery ≥ 2 years ago and with observed and/or perceived oral problems were recruited to a case series. The documentation included clinical and radiographic examinations, biomedical sampling, and self-reported diet and questionnaires. The results are presented descriptively. RESULTS: The age range was 31 to 66 years and all had a BMI > 25 (range 25.4-44.7). Only four participants were fully dentate. Eleven out of 14 individuals exhibited severe decay. A majority had poor oral hygiene and high bacterial counts. The flow rates of unstimulated saliva were extremely low and hyposalivation was present in ten of the fourteen cases. Most perceived several oral health problems, such as chewing difficulty and tooth hypersensitivity. CONCLUSIONS: Individuals who had undergone GBP or SG surgery had poor clinically diagnosed oral health and perceived oral health problems. Longitudinal studies are needed to monitor the patients' oral health, from before bariatric surgery to long-term postoperatively.

Peanuts in the air - clinical and experimental studies.

BACKGROUND: Allergic reactions to food allergens usually occur after ingestion. However, fear of reactions to airborne peanut is a common concern for people with peanut allergy. There are no scientific reports on severe reactions with airborne peanut allergen. OBJECTIVE: To investigate the occurrence of allergic reactions in peanut-allergic children undergoing airborne peanut challenge and to determine levels of airborne peanut protein in a separate experimental evaluation. METHODS: Eighty-four children with peanut allergy underwent an airborne peanut challenge, 0.5 m from a bowl of peanuts for 30 min under controlled conditions. In a separate experiment, airborne peanut proteins from roasted and dry-roasted peanuts were collected at varying distances and at varying times with an electret SensAbues filter connected to an air pump. Collected airborne peanut proteins were extracted, dissolved and detected by ELISA. Basophil activation test was used to confirm biological activity. RESULTS: No moderate/severe allergic reactions to airborne peanut allergens were observed. Two children (2%) had mild rhino-conjunctivitis which required no treatment. The IgE-antibodies to peanut or Ara h 2 did not predict a reaction. In the experimental set-up, biological active peanut proteins were detected, in a very low amount, in median 166 ng/ml for dry-roasted and 33 ng/ml for roasted peanuts and decreased dramatically when the collection occurred at a greater distance (0.5-2 m) from the peanut source. Increased exposure time did affect the amount of collected peanut protein at 0 m, and the highest median was obtained after 60 min (p = .012); for time trend p = .0006. CONCLUSIONS AND CLINICAL RELEVANCE: Allergic reactions to airborne peanut proteins are rare and cannot be predicted by high levels of IgE-antibodies to peanut or Ara h 2. Only small amounts of biologically active peanut proteins were detected in the air and seem unlikely to trigger moderate/severe allergic reactions.

Weight loss is associated with sustained improvement of disease activity and cardiovascular risk factors in patients with psoriatic arthritis and obesity: a prospective intervention study with two years of follow-up.

BACKGROUND: Obesity is overrepresented in patients with psoriatic arthritis (PsA) and associated with increased disease activity. We have previously shown in 41 patients with PsA (Caspar criteria) and obesity (body mass index; BMI ≥33 kg/m2) that weight loss treatment with Very Low Energy Liquid Diet (VLED), 640 kcal/day during 12-16 weeks, followed by a structured reintroduction of an energy restricted diet resulted in a median weight loss of 18.6% and concomitantly a significant improvement of the disease activity in joints, entheses and skin. The objectives of this follow-up were to study the effects of the weight loss treatment on disease activity in longer term (12 and 24 months) and to study the effects on cardiovascular risk factors. METHODS: The patients were assessed with 66/68 joints count, Leeds enthesitis index (LEI), body surface area, blood pressure, BMI, questionnaires and fasting blood samples at the 12- and 24-month visits. RESULTS: In total, 39 and 35 PsA patients attended the 12- and the 24-month visits, respectively. Median weight loss since baseline was 16.0% (IQR 10.5-22.4) and 7.4% (IQR 5.1-14.0) at the 12- and 24-months follow-up. The 66/68 swollen/tender joints score, LEI, CRP and HAQ score were still significantly reduced at the 12- and 24-month visits compared to baseline. The number of patients with Minimal Disease Activity increased from 28.2% (11/39) at baseline, to 38.5% (15/39; p = 0.008) and 45.7% (16/35; p = 0.016) at the 12- and 24-month visits. The weight loss was also associated with improved levels of serum lipids, glucose and urate and the antihypertensive treatment was reduced or stopped in five patients during the follow-up. CONCLUSIONS: Weight loss treatment, with VLED included in the program, was associated with long-term improvement of measures of disease activity, self-reported function and markers of the metabolic syndrome after 24-months follow-up. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02917434 , Registered September 28, 2016- Retrospectively registered.

Mortality and morbidity of low-grade red blood cell transfusions in septic patients: a propensity score-matched observational study of a liberal transfusion strategy.

BACKGROUND: Red blood cell (RBC) transfusions are associated with risks including immunological reactions and volume overload. Current guidelines suggest a restrictive transfusion strategy in most patients with sepsis but based on previous randomized controlled trials and observational studies, there are still uncertainties about the safety in giving low-grade RBC transfusions to patients with sepsis. METHODS: Critically ill patients with severe sepsis or septic shock admitted to a university hospital intensive care unit between 2007 and 2018 that received less or equal to 2 units of RBCs during the first 5 days of admission were propensity score matched to controls. Outcomes were 90- and 180-day mortality, highest acute kidney injury network (AKIN) score the first 10 days, days alive and free of organ support the first 28 days after admission to the intensive care unit and highest sequential organ failure assessment score (SOFA-max). RESULTS: Of 9490 admissions, 1347 were diagnosed with severe sepsis or septic shock. Propensity-score matching resulted in two well-matched groups with 237 patients in each. The annual inclusion rate in both groups was similar. The median hemoglobin level before RBC transfusion was 95 g/L (interquartile range 88-104) and the majority of the patients were transfused in first 2 days of admission. Low-grade RBC transfusion was associated with increased 90- and 180-day mortality with an absolute risk increase for death 9.3% (95% confidence interval: 0.6-18%, P = 0.032) and 11% (95% confidence interval: 1.7-19%, P = 0.018), respectively. Low-grade RBC transfusion also correlated with increased kidney, circulatory and respiratory failure and higher SOFA-max score. CONCLUSIONS: Low-grade RBC transfusion during the first 5 days of admission was associated with increased mortality and morbidity in a liberal transfusion setting. The results support the current practice of a restrictive transfusion strategy in septic critically ill patients.

Nocturnal eating but not binge eating disorder is related to less 12 months' weight loss in men and women with severe obesity: A retrospective cohort study.

There is a paucity of studies on the frequency of binge-eating disorder (BED) and nocturnal eating (NE) and their potential role as barriers in non-surgical weight loss treatment in subjects with severe obesity (body mass index [BMI] ≥35 kg m2 ). The aim was to identify BED and NE, and their effect on weight loss treatment. In total, 1132 (727 women, 405 men), BMI ~41 kg/m2 were patients in a 12-month weight loss programme at a specialist clinic. The questionnaire for eating and weight patterns-revised was completed by the patients before start of treatment. BED was diagnosed in 5.1% of men and 12.4% of women. NE prevalence was 13.5% and 12.7%, respectively. Mean (±SEM) 12-month weight loss was less in patients with NE compared to those without (-11.0 ± 1.5 vs -14.6 ± 0.7 kg, P = .008) but did not differ in patients with and without BED, (-12.3 ± 1.9 vs -14.2 ± 0.6 kg, P = .24). Factors associated with dropout were BED (odds ratio, OR 1.57, 95% confidence interval (CI) 1.14-2.17; P = .006) and previous weight loss attempts (OR 1.35, 95% CI 1.0-1.7; P = .02). BED did not seem to hinder weight loss whereas NE resulted in less weight loss in patients with severe obesity who completed a 12-month treatment programme. Previous weight loss attempts affect both dropout and ability to lose weight.

Prevalence of polycystic ovary syndrome in women with severe obesity - Effects of a structured weight loss programme.

OBJECTIVE: Existing data are contradictory on the prevalence of polycystic ovary syndrome (PCOS) and metabolic syndrome (MetS) in women with severe obesity (body mass index [BMI] ≥ 35 kg/m2 ), and there are few studies investigating the effect of weight reduction in women with severe obesity and PCOS. The aim was to study the prevalence of PCOS and MetS among women with severe obesity and to evaluate the effect of a 12-months weight loss programme on the prevalence of PCOS and MetS. DESIGN/PARTICIPANTS: In total, 298 women with severe obesity were enrolled whereof 246 women had complete screening data for PCOS and MetS before commencing treatment. Weight loss intervention included very low energy diet. At 12-months follow-up, 72 women with complete data remained and were re-examined with baseline parameters. RESULTS: At baseline, the prevalence of PCOS was 25.6% and in this group, the prevalence of MetS was 43.4% in PCOS vs 43.3% in controls (ns). At 12-months follow-up, weight loss in women with PCOS was 12.3 ± 10.7 kg (P < .001) and in non-PCOS 13.9 ± 13.4 kg (P < .001) with no between group difference. Women without PCOS decreased in total bone mass. CONCLUSIONS: Polycystic ovary syndrome occurs in one out of four women with severe obesity. The prevalence of MetS does not differ between women with or without PCOS with severe obesity. There was a significant weight loss in both groups but no difference between groups regarding change in metabolic parameters.

Weight loss improves disease activity in patients with psoriatic arthritis and obesity: an interventional study.

BACKGROUND: Obesity is over-represented in patients with psoriatic arthritis (PsA) and associated with higher disease activity, poorer effect of treatment and increased cardiovascular morbidity. Studies on the effects of weight loss are however needed. This study aimed to prospectively study the effects of weight loss treatment with very low energy diet (VLED) on disease activity in patients with PsA (CASPAR criteria) and obesity (body mass index BMI ≥ 33 kg/m2). METHODS: VLED (640 kcal/day) was taken during 12-16 weeks, depending on pre-treatment BMI. Afterwards, an energy-restricted diet was gradually reintroduced. Weight loss treatment was given within a structured framework for support and medical follow-up. Treatment with conventional synthetic and/or biologic disease-modifying anti-rheumatic drugs was held constant from 3 months before, until 6 months after baseline. Patients were assessed with BMI, 66/68 joints count, Leeds enthesitis index, psoriasis body surface area (BSA), questionnaires and CRP at baseline, 3 and 6 months. Primary outcome was the percentage of patients reaching minimal disease activity (MDA) and secondary outcomes were reaching Psoriatic Arthritis Response Criteria (PsARC) and American College of Rheumatology (ACR) response criteria. RESULTS: Totally 41/46 patients completed the study, 63% women, median age 54 years (IQR 48-62). At baseline increased BMI was associated with higher disease activity and poorer function. The median weight loss was 18.7 kg (IQR 14.6-26.5) or 18.6% (IQR 14.7-26.3) of the baseline weight. A majority of the disease activity parameters improved significantly after weight loss, including 68/66 tender/swollen joints count, CRP, BSA, Leeds enthesitis index, HAQ and patient VAS for global health, pain and fatigue. A larger weight loss resulted in more improvement in a dose-response manner. The percentage of patients with MDA increased from 29 to 54%, (p = 0.002). PsARC was reached by 46.3%. The ACR 20, 50 and 70 responses were 51.2%, 34.1% and 7.3% respectively. CONCLUSIONS: Short-term weight loss treatment with VLED was associated with significant positive effects on disease activity in joints, entheses and skin in patients with PsA and obesity. The study supports the hypothesis of obesity as a promotor of disease activity in PsA. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02917434 , registered on September 21, 2016-retrospectively registered.

Gastrointestinal function and eating behavior after gastric bypass and duodenal switch.

BACKGROUND: Duodenal switch provides greater weight loss than gastric bypass in severely obese patients; however, comparative data on the changes in gastrointestinal symptoms, bowel function, eating behavior, dietary intake, and psychosocial functioning are limited. METHODS: The setting for the present study was 2 university hospitals in Norway and Sweden. Participants with a body mass index of 50-60 kg/m(2) were randomly assigned to gastric bypass (n = 31) or duodenal switch (n = 29) and followed up for 2 years. Of the 60 patients, 97% completed the study. Their mean weight decreased by 31.2% after gastric bypass and 44.8% after duodenal switch. At inclusion and 1 and 2 years of follow-up, the participants completed the Gastrointestinal Symptom Rating Scale, a bowel function questionnaire, the Three-Factor Eating Questionnaire-R21, a 4-day food record, and the Obesity-related Problems scale. RESULTS: Compared with the gastric bypass group, the duodenal switch group reported more symptoms of diarrhea (P = .0002), a greater mean number of daytime defecations (P = .007), and more anal leakage of stool (50% versus 18% of participants, respectively; P = .015) after 2 years. The scores for uncontrolled and emotional eating were significantly and similarly reduced after both operations. The mean total caloric intake and intake of fat and carbohydrates were significantly reduced in both groups. Protein intake was significantly reduced only after gastric bypass (P = .008, between-group comparison). Psychosocial function was significantly improved after both operations (P = .23, between the 2 groups). CONCLUSION: Gastrointestinal side effects and anal leakage of stool were more pronounced after duodenal switch than after gastric bypass. Both procedures led to reduced uncontrolled and emotional eating, reduced caloric intake, and improved psychosocial functioning.

Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial.

BACKGROUND: Gastric bypass and duodenal switch are currently performed bariatric surgical procedures. Uncontrolled studies suggest that duodenal switch induces greater weight loss than gastric bypass. OBJECTIVE: To determine whether duodenal switch leads to greater weight loss and more favorable improvements in cardiovascular risk factors and quality of life than gastric bypass. DESIGN: Randomized, parallel-group trial. (ClinicalTrials.gov registration number: NCT00327912) SETTING: 2 academic medical centers (1 in Norway and 1 in Sweden). PATIENTS: 60 participants with a body mass index (BMI) between 50 and 60 kg/m(2). INTERVENTION: Gastric bypass (n = 31) or duodenal switch (n = 29). MEASUREMENTS: The primary outcome was the change in BMI after 2 years. Secondary outcomes included anthropometric measures; concentrations of blood lipids, glucose, insulin, C-reactive protein, and vitamins; and health-related quality of life and adverse events. RESULTS: Fifty-eight of 60 participants (97%) completed the study. The mean reductions in BMI were 17.3 kg/m(2) (95% CI, 15.7 to 19.0 kg/m(2)) after gastric bypass and 24.8 kg/m(2) (CI, 23.0 to 26.5 kg/m(2)) after duodenal switch (mean between-group difference, 7.44 kg/m(2) [CI, 5.24 to 9.64 kg/m(2)]; P < 0.001). Total cholesterol concentration decreased by 0.24 mmol/L (CI, -0.03 to 0.50 mmol/L) (9.27 mg/dL [CI, -1.16 to 19.3 mg/dL]) after gastric bypass and 1.07 mmol/L (CI, 0.79 to 1.35 mmol/L) (41.3 mg/dL [CI, 30.5 to 52.1 mg/dL]) after duodenal switch (mean between-group difference, 0.83 mmol/L [CI, 0.48 to 1.18 mmol/L]; 32.0 mg/dL [CI, 18.5 to 45.6 mg/dL]; P ≤ 0.001). Reductions in low-density lipoprotein cholesterol concentration, anthropometric measures, fat mass, and fat-free mass were also greater after duodenal switch (P ≤ 0.010 for each between-group comparison). Both groups had reductions in blood pressure and mean concentrations of glucose, insulin, and C-reactive protein, with no between-group differences. The duodenal switch group, but not the gastric bypass group, had reductions in concentrations of vitamin A and 25-hydroxyvitamin D. Most Short Form-36 Health Survey dimensional scores improved in both groups, with greater improvement in 1 of 8 domains (bodily pain) after gastric bypass. From surgery until 2 years, 10 participants (32%) had adverse events after gastric bypass and 18 (62%) after duodenal switch (P = 0.021). Adverse events related to malnutrition occurred only after duodenal switch. LIMITATION: Clinical experience was greater with gastric bypass than with duodenal switch at the study centers. CONCLUSION: Duodenal switch surgery was associated with greater weight loss, greater reductions of total and low-density lipoprotein cholesterol concentrations, and more adverse events. Improvements in other cardiovascular risk factors and quality of life were similar after both procedures. PRIMARY FUNDING SOURCE: South-Eastern Norway Regional Health Authority.

Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch.

BACKGROUND: Bariatric surgery is widely performed to induce weight loss. OBJECTIVE: The objective was to examine changes in vitamin status after 2 bariatric surgical techniques. DESIGN: A randomized controlled trial was conducted in 2 Scandinavian hospitals. The subjects were 60 superobese patients [body mass index (BMI; in kg/m(2)): 50-60]. The surgical interventions were either laparoscopic Roux-en-Y gastric bypass or laparoscopic biliopancreatic diversion with duodenal switch. All patients received multivitamins, iron, calcium, and vitamin D supplements. Gastric bypass patients also received a vitamin B-12 substitute. The patients were examined before surgery and 6 wk, 6 mo, and 1 y after surgery. RESULTS: Of 60 surgically treated patients, 59 completed the follow-up. After surgery, duodenal switch patients had lower mean vitamin A and 25-hydroxyvitamin D concentrations and a steeper decline in thiamine concentrations than did the gastric bypass patients. Other vitamins (riboflavin, vitamin B-6, vitamin C, and vitamin E adjusted for serum lipids) did not change differently in the surgical groups, and concentrations were either stable or increased. Furthermore, duodenal switch patients had lower hemoglobin and total cholesterol concentrations and a lower BMI (mean reduction: 41% compared with 30%) than did gastric bypass patients 1 y after surgery. Additional dietary supplement use was more frequent among duodenal switch patients (55%) than among gastric bypass patients (26%). CONCLUSIONS: Compared with gastric bypass, duodenal switch may be associated with a greater risk of vitamin A and D deficiencies in the first year after surgery and of thiamine deficiency in the initial months after surgery. Patients who undergo these 2 surgical interventions may require different monitoring and supplementation regimens in the first year after surgery. This trial was registered at ClinicalTrials.gov as NCT00327912.

Body composition, dietary intake, and energy expenditure after laparoscopic Roux-en-Y gastric bypass and laparoscopic vertical banded gastroplasty: a randomized clinical trial.

OBJECTIVE: To assess body composition, eating pattern, and basal metabolic rate in patients undergoing obesity surgery in a randomized trial. INTRODUCTION: There is limited knowledge regarding how different bariatric surgical techniques function in terms of altering body composition, dietary intake, and basic metabolic rate. METHODS: Non-superobese patients were randomized to laparoscopic Roux-en-Y gastric bypass (LGBP, n = 37) or laparoscopic vertical banded gastroplasty (LVBG, n = 46). Anthropometry, dual-energy x-ray absorptiometry (DEXA), computed tomography (CT), indirect calorimetry, and reported dietary intake were registered prior to and 1 year after surgery. RESULTS: Follow-up rate was 97.6%. LGBP patients had significantly greater reduction of waist circumference and sagittal diameter compared with LVBG. DEXA demonstrated a larger reduction of body fat in all compartments after LGBP, especially at the trunk (P<0.001). CT demonstrated more reduction of the visceral fat (P=0.016). Patients were able to eat all types of food after LGBP, although about 30% claimed they avoided fats. LGBP patients decreased their proportion of dietary fat significantly more than those operated on with LVBG (P = 0.005), who consumed more sweet foods and avoided whole meat and vegetables. Lean tissue mass (LTM) was proportionally less reduced, especially in men, after LGBP. The decreases in BMR postoperatively reflected the lower body mass in a pattern that did not differ among the groups. CONCLUSION: LGBP patients demonstrated better outcomes compared with LVBG patients in terms of body composition. Energy expenditure developed as expected postoperatively. A "steering" away from fatty foods after LGBP may be an important mechanism of action in gastric bypass.