Intragastric balloon for obesity treatment: results of a multicentric evaluation for balloons left in place for more than 6 months.

BACKGROUND: Obesity is a major risk factor for several chronic diseases. The BioEnterics(®) Intragastric Balloon (BIB(®)) is used worldwide as a short-term (6 months) treatment in morbid obese patients. However, removal of BIB(®) past 6 months is a common occurrence in clinical practice often as a result of patient factors. The aim of the present Italian multicentre cohort study was to evaluate the safety and efficacy of the BIB(®) left in situ for more than 6 months. MATERIALS AND METHODS: A total of eight Italian centres participated in the study. Participating centres received a standardised questionnaire designed to capture safety and efficacy data. Weight loss data, as well as date, and reason for removal of the BIB(®) after 6 months were recorded. Adverse events, including mortality and complications, operators' subjective technical notes and findings, and difficulties during removal procedure were also collected. RESULTS: Six hundred and eleven patients were included. In the majority of cases, patient extended BIB(®) treatment due to satisfactory weight loss (44 %). At 6 months, all patients achieved a BMI statistically lower than the initial BMI (p < 0.001). There was a non-significant trend towards greater BMIL % in patients who underwent removal up to 15 months versus the results achieved up to 6 months. No major complications were recorded. CONCLUSION: Extending the duration of BIB(®) use up to 14 months safely maintains weight loss and satiety with greater results than that up to 6 months, without complications.

Intragastric gastric band migration: erosion: an analysis of multicenter experience on 177 patients.

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) has proven to be a safe and effective surgical treatment for morbid obesity. It can be a simple, fast, reversible, anatomy-preserving procedure. Despite these advantages, its long-term efficacy came into question by the occurrence of complications such as intragastric band migration. Consistent information regarding this complication is still lacking. Treatment for migration is still being debated as well. Most of the inconsistencies of these data stem from the very low number of patients reported in single-center experiences or case reports. Lack of multicenter experience is evident. The aim of this study was to perform a retrospective analysis of data on intragastric migration in a large multicenter cohort of patients who underwent LAGB. METHODS: A retrospective multicenter study on LAGB patients was performed. Data had been entered into a prospective database of the Italian Group for LapBand(®) (GILB) since January 1997. Pars flaccida and perigastric positioning were considered along with different kinds of gastric bands by the same manufacturer. Time of diagnosis, mean body mass index (BMI), presentation symptoms, and conservative and surgical therapy of intragastric migration were considered. RESULTS: From January 1997 to December 2009, a total of 6,839 patients underwent LAGB and their data were recorded [5,660 females, 1,179 males; mean age 38.5 ± 18.2 years (range 21-62 years); mean BMI = 46.7 ± 7.7 kg/m(2) (range 37.3-68.3); excess weight (EW) 61.8 ± 25.4 kg (range 36-130); %EW 91.1 ± 32.4 % (range 21-112 %)]. A total of 177 of 6,839 (2.5 %) intragastric erosions were observed. According to the postoperative time of follow-up, the diagnosis of intragastric migration was made in 74 (41.8 %), 14 (7.9 %), 38 (21.4 %), 40 (22.6 %), 6 (3.4 %), and 4 (2.2 %) banded patients at 6-12, 24, 36, 48, 60, and 72 months after banding, respectively. Most of intragastric band migration during the first 2 years occurred in bands with no or a few milliliters of filling. In patients with late erosion, the bands were adjusted several times; no band was overfilled but one was filled to the maximum or submaximum with a maximum of two adjustments. Erosions diagnosed during the first 24 months were related to the experience of the surgical staff, while late erosions were not. CONCLUSIONS: Intragastric band migration or band erosion is a rare, disturbing, and usually not life-threatening complication of gastric banding. Its pathogenesis is probably linked to different mechanisms in early (technical failure in retrogastric passage) or late (band management) presentation. It is usually asymptomatic and there is no pathognomonic presentation. A wide range of therapeutic options are available, from simple endoscopic or laparoscopic removal to early or late band replacement or other bariatric procedure. More experience and more studies are needed to lower its presentation rate and definitively clarify its pathogenesis to address the right therapeutic option.

Combined use of lactoferrin and vitamin D as a preventive and therapeutic supplement for SARS-CoV-2 infection: Current evidence.

Lactoferrin is a multifunctional protein that exhibits anti-inflammatory, immune regulating and anti-infective properties. One of its receptor sites is located on severe acute respiratory syndrome coronavirus 2. The binding of lactoferrin with heparin sulfate proteoglycans may prevent the first contact between the virus and host cells, thus preventing subsequent infection. Given that lactoferrin may act as a natural mucosal barrier, an intranasal treatment together with its oral intake can be hypothesized to prevent the spread, infection and inflammation caused by coronavirus disease 2019 (COVID-19). Moreover, the literature reports that vitamin D plays an essential role in promoting immune response. With its anti-inflammatory and immunoregulatory properties, vitamin D is critical for activating the immune system's defenses, improving immune cell function. Different studies also demonstrate that lactoferrin is a potential activator of the vitamin D receptor. In this sense, the combined use of lactoferrin (through an association of oral intake and a nasal spray formulation) and vitamin D could represent a valuable therapy for COVID-19 treatment and prevention. However, further randomized clinical trials are needed before recommending/prescribing them.

Gastrointestinal Infection Could Be New Focus for Coronavirus Diagnosis.

It's not news to tell you that the coronavirus, known as COVID-19, is a worldwide pandemic. The initial outbreak of this novel virus in Wuhan in the Hubei province of China, first described in December 2019, has since moved on to being declared a pandemic by the World Health Organization. The classic description of COVID-19 is a respiratory illness that manifests with fever, dry cough, and dyspnea on exertion. However, gastrointestinal (GI) complication of COVID-19 is emerging as well. This was observed with similar viral respiratory illnesses, such as severe acute respiratory syndrome (SARS), which emerged in 2003, and the Middle East respiratory syndrome (MERS), which emerged in 2012. In a recently published, single-center case series of 138 consecutive hospitalized patients with confirmed COVID-19, investigators reported that approximately 10% of patients initially presented with GI symptoms, prior to the subsequent development of respiratory symptoms. Common and often very subtle symptoms included diarrhea, nausea, and abdominal pain, with a less common symptom being nonspecific GI illness. New studies are expanding our understanding of the possible fecal transmission of COVID-19. Assessment by polymerase chain reaction (PCR) has provided evidence of the virus in the stool and the oropharynx outside the nasopharynx and respiratory tract. Virus in the stool may be evident on presentation and last throughout the course of illness resolution for up to 12 days after the respiratory virus evidence is gone. In fact, in one of the most recent studies looking at 73 patients, approximately 24% remained positive in their stool for evidence of the virus, though not necessarily infection, after showing negative in respiratory samples. The Centers for Disease Control and Prevention (CDC) recommends that after two negative respiratory tests separated by ≥ 24 hours, patients can be dismissed from having transmissibility infection risk for COVID-19. The potential for fecal-oral transmission of COVID-19 needs to be strongly considered. Considering these cases and the lessons from SARS, many authors recommend that real-time reverse transcriptase-polymerase chain reaction (rRT-PCR) testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from feces should be performed routinely in SARS-CoV-2 patients.

Laparoscopic sleeve gastrectomy versus intragastric balloon: a case-control study.

AIM: To compare the efficacy of laparoscopic sleeve gastrectomy (LSG) and BioEnterics intragastric balloon (BIB) to lose weight and comorbidities after 12 months of follow-up before a more invasive bariatric procedure. METHODS: From January 2004 to December 2006, 40 patients underwent laparoscopic sleeve gastrectomy (LSG) as a first step in biliopancreatic diversion with duodenal switch. Controls (n = 80) were selected based on charts of patients who, during the same period, underwent BioEnterics intragastric balloon therapy. In both groups we considered: length of procedure, hospital stay, intraoperative or endoscopic complications, postoperative or postendoscopic complications, comorbidities at baseline, after 6 months (time of BIB removal), and after 12 months from baseline, and weight loss parameters [weight in kg, percentage excess weight less (%EWL), body mass index (BMI), and percentage excess BMI loss (%EBL)]. Results are expressed as mean +/- standard deviation. RESULTS: Mortality, intra- and postoperative complications (in LSG group), and intra- and postendoscopic complications (in BIB group) were absent. Mean operative time in the LSG group was 120 +/- 40 (range 60-200) min. Mean positioning time for BIB was 15 +/- 5 (range 10-25) min. BMI at baseline was 54.1 +/- 2.9 (range 45.1-55.9) kg/m(2) and 54.8 +/- 2.5 (range 45.1-56.2) kg/m(2) in BIB and LSG groups, respectively. At 6-month follow-up, mean BMI was 46.2 +/- 3.5 and 45.3 +/- 5.5 kg/m(2) in the BIB and LSG patients, respectively [p = not significant (ns)]. After 12 months BIB patients regained BMI, even if strictly followed with a diet regimen, while LSG patients continued to lose weight. Significant differences between groups were absent for the comorbidities considered. CONCLUSIONS: Laparoscopic sleeve gastrectomy and BioEnterics intragastric balloon are two valid options for producing weight loss as a first-step procedure. LSG has all the related risks of general anesthesia, laparoscopic surgery, and digestive anastomosis, whereas BIB presents a very low rate of minor complications, such as psychological intolerance. For all these reasons, at this time, BIB is considered a better option than LSG as a first-step procedure in the short term (12 months).

Intragastric balloon or diet alone? A retrospective evaluation.

BACKGROUND: Very few studies have reported results of the BioEnterics Intragastric Balloon (BIB) at > or =12 months follow-up. The aim of this study is the retrospective evaluation of the results of BIB placement compared to diet regimen alone. METHODS: From January 2005 to June 2006, 130 outpatients underwent a structured diet plan with simple behavioral modification at our institutions. Controls (n = 130) were selected from the charts of patients who, during the same period, underwent BIB treatment. Patients in the outpatient group were given a structured balanced diet with a caloric intake between 1,000 and 1,200. The approximate macronutrient distribution, according the "Mediterranean diet," was 25% protein (at least 60 g/day), 20-25% lipids, and 50-55% carbohydrates. In the BIB group, patients received generic counseling for eating behavior. In both groups, we considered weight loss parameters (kilograms, percentage of excess weight loss [%EWL], body mass index [BMI], percentage of excess BMI loss [%EBL]) at 6 and 24 months from baseline and comorbidities at baseline and after 24 months. Results are expressed as mean+/-standard deviation. Statistical analysis was done by Student's t-test and chi (2)-test or Fisher's exact test. p < .05 was considered significant. RESULTS: At the time of BIB removal (6 months), significantly better results in terms of weight loss in kilograms (16.7 +/- 4.7 vs. 6.6 +/- 2.6; p < 0.01), BMI (35.4 +/- 11.2 vs. 38.9 +/- 12.1; p < 0.01), %EBL (38.5 +/- 16.1 Vs 18.6 +/- 14.3; p < 0.01), and %EWL (33.9 +/- 18 vs. 24.3 +/- 17.0; p < 0.01) were observed in patients treated by intragastric balloon as compared to diet-treated patients. At 24 months from baseline, patient dropout was 1/130 (0.7%) and 25/130 (19.2%) in the BIB and diet groups, respectively (p < 0.001). At this time, patients treated with intragastric balloon have tended to regain weight, whereas diet-treated patients have already regained most of lost weight. CONCLUSIONS: Although the strength of this study may be limited by its retrospective design, the results indicate that, in the short-to-medium term, BIB is significantly superior to diet in terms of weight loss.

Multi-centre European experience with intragastric balloon in overweight populations: 13 years of experience.

BACKGROUND: The request to lose weight is expanding not only in obese and morbidly obese patients but also in overweight patients affected by co-morbidities as diabetes and hypertension and who do not tolerate diet regimen or lifestyle changes. The aim of this study is a multicenter evaluation of outcomes of intragastric balloon in overweight patients. METHODS: Patients (BMI 27-30 kg/m2) treated with a BioEnterics Intragastric Balloon (BIB) between 1996 and 2010 were extracted from the database of the participating centres in Rome (Italy), Liège (Belgium) and Madrid (Spain). Primary endpoints were the efficacy and safety at 6 and 42 months from balloon positioning. Secondary endpoints included resolution of co-morbidities. RESULTS: A total of 261 patients were included in this study. The most common indication for balloon placement was a psychological disorder (54%). Mean body mass index (BMI) fell from 28.6 ± 0.4 at baseline to 25.4 ± 2.6 kg/m2 at 6 months and to 27.0 ± 3.1 kg/m2 at 3 years from BIB removal. The mean %EWL was 55.6% at 6 months and 29.1% at 3 years. Forty-seven patients (18%) had complications associated with placement of the intragastric balloon (leak = 28, intolerance = 14, duodenal ulcer = 2, gastritis = 1, oesophagitis = 1, duodenal polyps = 1). The rate of patients with hypertension decreased from 29% at baseline to 16% at 3 years. Diabetes decreased from 15 to 10%, dyslipidaemia decreased from 20 to 18%, hypercholesterolaemia decreased from 32 to 21% and osteoarthropathy decreased from 25 to 13%. CONCLUSIONS: The intragastric balloon is safe and effective in overweight patients, helping to reduce progression to obesity and decreasing the prevalence of a number of important co-morbidities.

Effect of consecutive intragastric balloon (BIB®) plus diet versus single BIB® plus diet on eating disorders not otherwise specified (EDNOS) in obese patients.

BACKGROUND: Eating disorders are a group of conditions characterised by abnormal eating habits. Greater than 50 % of patients with eating disorders have an 'eating disorder not otherwise specified' (EDNOS). No specific tools exist to evaluate EDNOS, and patients are identified only with a diagnosis of exclusion from the other eating disorders. The BioEnterics® Intragastric Balloon (BIB®) is used worldwide as a short-term treatment option in obese patients. A new frequency score was used to evaluate the influence of double consecutive BIB® treatment compared with single BIB® treatment followed by diet on four categories of EDNOS (grazing, emotional eating, sweet-eating and after-dinner grazing). METHODS: A prospective study allocated 50 obese patients (age range 25-35, BMI range 40.0-44.9) into two groups: BIB® (6 months) followed by diet therapy (7 months; group A (N = 25)) and BIB® placement for 6 months followed by another BIB® for 6 months, with a 1-month interval between placement (group B (N = 25)). Baseline demographics were similar across both groups. RESULTS: At the time of removal of the first BIB® device, EDNOS scores in both groups were not significantly different, but decreased significantly from baseline. By the end of the study, all EDNOS scores were significantly lower in patients undergoing consecutive BIB®, compared with single BIB® followed by diet therapy. CONCLUSIONS: The placement of an intragastric balloon in obese patients allows for a reduction in the intensity of grazing, emotional eating, sweet-eating and after-dinner grazing. A more significant reduction in the EDNOS score was observed with two consecutive BIBs®.

Intragastric balloon followed by diet vs intragastric balloon followed by another balloon: a prospective study on 100 patients.

Aim of this study is to compare the efficacy of BioEnterics Intragastric Balloon (BIB®) followed by diet with BIB followed by another BIB. A prospective study was designed: a homogeneous group of 100 obese patients (age range 25-35, BMI range 40.0-44.9, M/F ratio 1/4) was allocated into two groups according to procedure: BIB (6 months) followed by diet therapy (7 months; group A = 50 pts), BIB positioning followed by another BIB after 1 month (group B = 50 pts). Baseline demographics were similar in both groups (Group A 10M/40F; mean age 31.4 ± 2.6; range 25-35; mean weight 106.3 ± 12.5 Kg; range 88-150; mean BMI 42.6±2.7 Kg/m(2); range 40.2-43.8; Group B 10M/40F; mean age 32.1 ± 2.1; range 25-35; mean weight 107.1 ± 11.9 Kg; range 90-150; mean BMI 42.9 ± 2.3; range 40.2-43.9). In both groups, weight loss parameters (Kg, BMI, and % EBL) were considered. Statistics were by Fisher's exact test (p < 0.05 was considered significant). At the time of 1st BIB removal, weight loss parameters in both groups were not significantly different: Group A: mean weight was 83.7±19.1 (range 52-151); mean BMI 34.2 ± 3.9 (range 32.4-43.8); and mean %EBL 43.5 ± 21.1 (range 0-68). Group B: mean weight was 84.9 ± 18.3 (range 50-148); mean BMI 34.8 ± 3.3 (range 32.4-43.8); and mean % EBL 45.2 ± 22.5% (range 0-68). At the study end, weight loss parameters were significantly lower in patients who underwent consecutive BIB (p < 0.05): mean BMI was 30.9 ± 7.2 Kg/m(2) (range 24-40), and 35.9 ± 9.7 Kg/m(2) (range 34-42); mean % EBL was 51.9 ± 24.6% (range 0-100) and 25.1 ± 26.2% (range 0-100) in group B and A, respectively. As compared with diet, a second intragastric balloon can be positioned without difficulties, achieving good results with continuous weight loss.