Scientific Evidence for the Updated Guidelines on Indications for Metabolic and Bariatric Surgery (IFSO/ASMBS).

The 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) updated the indications for Metabolic and Bariatric Surgery (MBS), replacing the previous guidelines established by the NIH over 30 years ago. The evidence supporting these updated guidelines has been strengthened to assist metabolic and bariatric surgeons, nutritionists, and other members of multidisciplinary teams, as well as patients. This study aims to assess the level of evidence and the strength of recommendations compared to the previously published criteria.

Food Supplements Marketed Worldwide: A Comparative Analysis Between the European and the U.S. Regulatory Frameworks.

In recent decades, a new health paradigm emerged which increasingly places diet and nutrition at the center of citizens' healthcare. The resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure product safety and preserve the health of citizens. Dietary supplements (DS) are products which are increasingly occupying a significant market share in Western countries, contributing to meeting the nutritional and physiological needs of a large portion of the global population. Food supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwide. This search aimed of comparing the legislative frameworks currently in force in the European Union (EU) and in the United States (USA), the two main markets in which DS are purchased, to focus on the strengths, similarities and possible shortcomings, against the backdrop of a global market which often transcends the regulatory barriers of individual countries. Both in the EU and the USA, food supplements are governed by specific regulations to ensure their safety and quality. However, the regulatory approaches differ sharply in some cases. It is expected that more and more operators will launch new DS in Western markets. As a result, it is crucial for competent authorities in food safety to deepen and develop additional regulatory tools aimed to control and safeguard the DS market.

The resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure food safety and safeguard the health of citizensFood supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwideBoth in the EU and the USA, the two main markets in which DS are purchased, food supplements are governed by specific regulations to ensure their safetyNevertheless, the regulatory approaches differ sharply in some casesAs a result, it is crucial for competent authorities to develop additional regulatory tools aimed to control and safeguard the DS market.

Therapeutic Strategies to Combat Increasing Rates of Multidrug Resistant Pathogens.

The emergence of antimicrobic-resistant infectious pathogens and the consequent rising in the incidence and prevalence of demises caused by or associated to infections which are not sensitive to drug treatments is one of today's major global health challenges. Antimicrobial resistance (AMR) can bring to therapeutic failure, infection's persistence and risk of serious illness, in particular in vulnerable populations such as the elderly, patients with neoplastic diseases or the immunocompromised. It is assessed that AMR will induce until 10 million deaths per year by 2050, becoming the leading cause of disease-related deaths. The World Health Organisation (WHO) and the United Nations General Assembly urgently call for new measures to combat the phenomenon. Research and development of new antimicrobial agents has decreased due to market failure. However, promising results are coming from new alternative therapeutic strategies such as monoclonal antibodies, microbiome modulators, nanomaterial-based therapeutics, vaccines, and phages. This narrative review aimed to analyse the benefits and weaknesses of alternative therapeutic strategies to antibiotics which treat multidrug-resistant bacterial infections.

Dietary management and access to treatment for patients with glucose deficiency syndrome type 1: an overview review with focus on the European regulatory framework.

BACKGROUND: Glut-1 deficiency Syndrome (GLUT-1 DS) is a rare disease caused by a mutation in the SLC2A1 gene that codes for the glucose transporter protein GLUT-1 DS. Currently, there is no indicated drug therapy for this condition and ketogenic diet (KD) is the most effective remedy to treat it. OBJECTIVE: The objective of this study was to review the published literature that evaluated the effectiveness of KD in the dietary management of GLUT-1 DS syndrome, describing the state-of-the-art the treatment pathway for patients with GLUT-1 DS syndrome in light of the current European regulatory framework within the National Health Services. METHODS: The literature search was carried out on September 10, 2023, and all studies conducted in humans diagnosed with GLUT-1 deficiency syndrome and treated with KD were included. RESULTS: A total of 156 scientific papers have been extracted. Applying the exclusion criteria, 38 articles have been considered eligible. In 29 out of 38 studies, the main outcome for determining the efficacy of KD was the measurement of the number of epileptic seizures, demonstrating that patients treated with KD experienced improvements with a clear reduction in the number of epileptic attacks. Currently, in the European Union, only one country provides full reimbursement by the national health system for KD. DISCUSSION: Although they are crucial for the treatment of GLUT-1 DS, according with current food regulations, KD are not evaluated on the basis of an unambiguous efficacy result, but only on the basis of safety. As a result, it is desirable to carry out clinical studies in the coming years based on the determination of efficacy in target populations, also in view of the marketing of these products on the European market.

Staple Line Reinforcement during Sleeve Gastrectomy with SeamGuard: Single-Center Retrospective Case-Control Study over a 5-Year Period.

Introduction: Various techniques and reinforcements have been proposed over the years in order to prevent leaks and bleeding after sleeve gastrectomy (LSG). The aim of this study was to retrospectively compare the staple line complication (SLC) rate in patients who underwent LSG with the use of bioabsorbable membrane (GORE® SEAMGUARD®, GoR) for staple line versus those who received no reinforcement. Methods: Data on all consecutive patients undergoing LSG between 1 January 2014 and 31 December 2018 were retrospectively reviewed. Patients were divided into two groups: the GoR+ group if the SeamGuard (GoR) was used and the GoR- group if no reinforcement was applied on the staple line. Preoperative demographics and rate of SLC were compared between groups. All cases of SLC coming from other centers were also reviewed. Results: A total number of 626 LSGs were performed at our institution during the study period. GoR was applied in 450 (71.9%) cases (GoR+ group), while NR was used in 176 (28.1%) patients (GoR- group). Two (1.13%) cases of leaking and two (1.13%) cases of bleeding occurred in the GoR- group, while no SLC was recorded in patients who received GoR (p < 0.05). Thirteen cases of SLC coming from other institutions were treated at our hospital; all these cases were performed without any SLR. Conclusion: In our case series, the use of GoR reduced the rate of SLC after LSG. In all cases of SLC coming from other institutions, no reinforcement had been applied on the staple line during LSG.

The importance of antibiotic treatment duration in antimicrobial resistance.

Antimicrobial resistance (AMR) poses a significant threat to global health, leading to increased deaths from drug-resistant infections and escalates healthcare costs. Often termed a "silent pandemic," AMR occurs when pathogens become resistant to antimicrobial drugs, enabling their proliferation and spread. Inappropriate antibiotic usage is a major contributor to this phenomenon, which also extends to fungal infections. In particular, the duration of antibiotic therapy is a crucial aspect, with evidence suggesting that prolonged use can heighten bacterial resistance and harm the human microbiota. In fact, studies comparing short-term versus long-term antibiotic therapies show no significant difference in traditional treatments. In addition, therapeutic drug monitoring allows personalized antibiotic regimens, optimizing dosage and duration to minimize resistance and adverse effects. As a result, clinicians should regularly reassess treatment effectiveness, utilizing techniques like antibiotic timeout and de-escalation therapy to avoid prolonged antibiotic use and mitigate resistance. All these strategies are crucial to prevent and counter the phenomenon of antimicrobial resistance.

Tracking progress on antimicrobial resistance by the quadripartite country self-assessment survey (TrACSS) in G7 countries, 2017-2023: opportunities and gaps.

Antimicrobial resistance (AMR) poses serious challenges to the healthcare systems worldwide. Multiple factors and activities contribute to the development and spread of antimicrobial-resistant microorganisms. Monitoring progress in combating AMR is fundamental at both global and national levels to drive multisectoral actions, identify priorities, and coordinate strategies. Since 2017, the World Health Organization (WHO) has collected data through the Tracking AMR Country Self-Assessment Survey (TrACSS). TrACSS data are published in a publicly-available database. In 2023, 71 (59.9%) out of 177 responding countries reported the existence of a monitoring and evaluation plan for their National Action Plan (NAP) on AMR, and just 20 countries (11.3%) the allocation of funding to support NAP implementation. Countries reported challenges including limited financial and human resources, lack of technical capacity, and variable political commitment. Even across the Group of Seven (G7) countries, which represent some of the world's most advanced economies, many areas still need improvement, such as full implementation of infection prevention and control measures, adoption of WHO access/watch/reserve (AWaRe) classification of antibiotics, effective integration of laboratories in AMR surveillance in the animal health and food safety sectors, training and education, good manufacturing and hygiene practices in food processing, optimising pesticides use and environmental residues of antimicrobial drugs. Continuous and coordinated efforts are needed to strengthen multisectoral engagement to fight AMR.

Antimicrobial Resistance in Gonorrhea.

Antimicrobial resistance is a global public health emergency. The World Health Organization recently highlighted the growing number of new sexually transmitted infections such as gonorrhea, syphilis, and Chlamydia, which are resistant to common antibiotics. The phenomenon is also on the rise due to increasing intercontinental travel. Emerging antibiotic-resistant strains of gonorrhea are particularly associated with international spread from Southeast Asian travelers. Infection with Neisseria gonorrhoeae can cause a wide spectrum of associated diseases such as dermatitis, arthritis and septic arthritis, and pelvic inflammatory disease, and can even lead to serious health consequences for the individual. Natural infection confers no immunity, and vaccination is not available currently, although in several countries, it has been reported that the antimeningococcal vaccine may protect against gonorrhea. Implementing all necessary preventive measures is crucial, as well as appropriate and timely diagnostic methods and effective antimicrobial therapeutic treatments in the correct modalities to avoid the increase of forms of gonorrhea that are resistant to common antibiotics and difficult to eradicate.

Three-dimensional Versus Two-dimensional Laparoscopic Bariatric Surgery: A Systematic Review and Meta-analysis.

Three-dimensional (3D) laparoscopy has several advantages in gastrointestinal surgery. This systematic review determined whether similar benefits exist for bariatric surgical procedures by systematically searching the MEDLINE, Embase, and Scopus databases. Six studies including 629 patients who underwent 2D (386) and 3D (243) laparoscopic bariatric surgeries were selected. Operative time was significantly shorter in patients undergoing 3D laparoscopic gastric bypass (pooled standardized mean difference [SMD] 1.19, 95% confidence interval [CI] 2.22-0.15). Similarly, a shorter hospital stay was detected both during sleeve gastrectomy (SMD 0.42, 95% CI 0.70-0.13) and gastric bypass (SMD 0.39, 95% CI 0.64-0.14) with 3D laparoscopy. The study showed the potential benefit of 3D imaging in preventing intra- and postoperative complications. Despite the limited evidence, surgeons may benefit from 3D laparoscopy during bariatric surgery.

Advances in Therapeutic Strategies for the Management of Clostridioides difficile Infection.

The infection caused by Clostridioides difficile represents one of the bacterial infections with the greatest increase in incidence among nosocomial infections in recent years. C. difficile is a Gram-positive bacterium able to produce toxins and spores. In some cases, infection results in severe diarrhoea and fulminant colitis, which cause prolonged hospitalisation and can be fatal, with repercussions also in terms of health economics. C. difficile is the most common cause of antibiotic-associated diarrhoea in the healthcare setting. The problem of bacterial forms that are increasingly resistant to common antibiotic treatments is also reflected in C. difficile infection (CDI). One of the causes of CDI is intestinal dysmicrobialism induced by prolonged antibiotic therapy. Moreover, in recent years, the emergence of increasingly virulent strains resistant to antibiotic treatment has made the picture even more complex. Evidence on preventive treatments to avoid recurrence is unclear. Current guidelines indicate the following antibiotics for the treatment of CDI: metronidazole, vancomycin, and fidaxomycin. This short narrative review provides an overview of CDI, antibiotic resistance, and emerging treatments.

Implementation of updated enhanced recovery after bariatric surgery guidelines: adapted protocol in a single tertiary center.

The aim of this study is to evaluate the effects of an adapted protocol of enhanced recovery after bariatric surgery (ERABS) on outcomes. This is a single-center observational study comparing patients managed according to adapted ERABS protocol (March-May 2022) with a control group of old method (January 2021-February 2022). Totally, 253 bariatric patients were included in the study (n = 68) and control (n = 185) groups. Patients were mostly females (57.3% vs 70.2%; p = 0.053), of mean age 38.8 years and body mass index 41 ± 6.53 vs. 44.60 ± 7.37 kg/m2 (p = 0.007) in study and control groups, respectively. The majority (90.5%) underwent primary bariatric surgery. Adapted ERABS protocol compliance was 98.5%. The study group had shorter hospital stay (mean 2.86 ± 0.51 vs. 4.03 ± 0.28 days; p < 0.001), similar rates of total (3% vs. 2.7%, p = 0.92) and major complications (1.5% vs. 0, p = 0.10). Readmission rates were similar (1.5% vs 1.6%, p = 0.92). Applied only in the study group, early ambulation (p < 0.001), opioid restriction, and preventing postoperative nausea and vomiting (PONV), resulted in satisfactory scores (mean total visual analogue score 1.93 ± 0.80, morphine milligram equivalent 34.0 ± 14.5, and mean total PONV grade 0.17 ± 0.36). In conclusion, implementing adapted ERABS guidelines improved patients' postoperative care, raising awareness to pain management. Length of stay was shortened without safety compromise. Efforts to abandon old-school routines seem worthwhile, even if ERABS is partially implemented.

A Short Update on the Use of Monoclonal Antibodies in COVID-19.

Monoclonal antibodies in the prophylaxis and treatment of COVID-19 have been crucial in reducing severe infections when vaccines were unavailable. However, as the virus and its variants have changed over time, the effectiveness of monoclonal antibodies has been questioned. This technical note highlights the need to assess the antiviral activity of these antibodies against new variants and adapt treatment strategies accordingly. On the one hand, in vitro studies have suggested reduced susceptibility of the latest variants to monoclonal antibodies, whereas clinical data still show benefits in reducing severe illness and mortality, indicating that laboratory results do not always mirror real-world outcomes. As a result, although resistance to monoclonal antibodies can develop over time, they could still have an important role in COVID-19 treatment, especially when used in combination, and ongoing research aims to identify effective antibodies against new variants.

Anti-CGRP mAbs for the Preventive Treatment of Migraine: An Overview Review and a Cost Saving Analysis in the Global Scenario.

Objectives: Migraine is a neurological disease with a high frequency of incidence. The new monoclonal antibodies selective for the calcitonin gene-related peptide and its ligand (anti-CGRP mAbs) have been marketed both in the USA and EU based on the positive efficacy results in the prevention of migraine. This search has been carried out with the aim of collecting real-world evidence on the effectiveness of anti-CGRP mAbs, performing a cost-savings analysis, and comparing performances among anti-CGRP mAbs medicines marketed in the American and European market. Methods: The literature review has been performed in PubMed database on 31 December 2022; the cost of the unitary dose of anti-CGRP mAbs has been extracted consulting an American national database. Results: The results confirm efficacy and good tolerability of anti-CGRP mAbs, determining a difference in the purchase price. In fact, all extracted studies showed a protective risk factor exposure in monthly migraine days reduction for all the anti-CGRP mAbs, whereas the cost analysis showed that using eptinezumab, in a quarter there is a cost saving of at least $425 per patient, compared with the other anti-CGRP mAbs. Conclusions: With equal efficacy and equal safety, anti-CGRP mAbs should be prescribed also regard to the cost established at the negotiation, making sure to guarantee the best treatment to the patients, but at the same time impacting as little as possible to the healthcare services resources.

The Impact of Antimicrobial Resistance in Cystic Fibrosis.

The phenomenon of antimicrobial resistance (AMR) is a critical global health challenge, with prospects indicating its potential to become the leading cause of death worldwide in the coming years. Individuals with pre-existing conditions, such as neoplastic disease undergoing chemotherapy, those on immunosuppressive therapy, and individuals with rare diseases like cystic fibrosis (CF), face heightened challenges due to AMR. CF is a rare disease caused by a deficiency in the synthesis of the Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) channel protein, resulting in multi-organ clinical symptoms, particularly in the respiratory system. PwCF experience recurrent pulmonary exacerbations triggered by bacterial or viral infections, making them particularly vulnerable to the impact of AMR. This review delves into the complex relationship between AMR and climate dynamics, focusing on the unique challenges faced by individuals with CF. It discusses the methods employed to measure AMR, its global impact on antibiotic resistance, and the specific microbial communities present in the CF airway. The review also explores the intricacies of antimicrobial resistance within the context of cystic fibrosis, emphasizing the urgent need for research in this field.

Reports of Gastric Banding and Bowel Obstruction: A Narrative Review of the Literature.

The utilization rates of laparoscopic gastric banding (LAGB) declined worldwide from 42.3% in 2008 to 1.8% in 2018. Rates of complications requiring removal may reach 40-50% in the medium to long term. Bowel obstruction is a rare but severe complication that occurs after LAGB. A comprehensive literature search in PubMed was carried out to identify all available case reports of intestinal obstruction after gastric banding. The search terms were as follows: "intestinal obstruction", "small bowel obstruction", "gastric band", "gastric banding", "gastric band complications", and "laparoscopic gastric band obstruction". The Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) flowchart was used. Forty-three case reports were included in our review. Laparotomy was necessary in 18/43 (41%) of patients. Vomit was not always reported, while abdominal pain was constantly present. A CT scan was the preferred diagnostic tool. The main causes of occlusion were found to be the erosion of the gastrointestinal tract or internal hernia due to a loose tube loop. Forty-six percent of cases occurred within 5 years from insertion. Even if rare, small bowel obstruction after LAGB requires surgical intervention often with an open approach. The absence of vomit masks symptoms, but an obstruction must be always suspected in the case of severe colicky abdominal pain. A CT scan is recommended for making diagnoses.

Systematic review and meta-analysis of postoperative outcomes after combined stoma reversal and incisional hernia repair versus stoma reversal alone.

BACKGROUND: The optimal management and timing of the abdominal wall reconstruction concomitantly performed with stoma closure are controversial. This study aims to compare short-term postoperative outcomes after concurrent stoma reversal (SR) with incisional hernia repair (IHR) and SR alone. METHODS: PubMed/MEDLINE, Scopus and Web of Science databases were consulted to identify comparative studies. Random and common-effect models were used for the pooled analysis of the proportions and means. RESULTS: Three studies met the inclusion criteria and a total of 504 patients who underwent simultaneous SR and IHR (N.=200) or SR alone (N.=304) were included in the meta-analysis. Postoperative morbidity increased after combined stoma and hernia surgery with a pooled OR for Surgical Site Occurrence (SSO) and severe postoperative complications (Clavien-Dindo ≥III) of 1.72 (95% CI 1.02-2.90) and 3.83 (95% CI 1.46-10.02), respectively. No significant difference was found between the two groups in terms of mortality (OR: 1.66; 95% CI 0.64-4.27), length of hospital stay (OR: 1.37; 95% CI 0.73-3.47). and readmission rate (OR: 1.17; 95% CI 0.67-2.06). CONCLUSIONS: There is limited evidence suggesting that synchronous repair of SR and IH appears to be associated with a higher risk of SSO and severe postoperative complications. Therefore, a stepwise approach may be considered the best strategy in this setting.

From mass vaccination to personalized vaccinology? The COVID-19 case. Commentary.

In recent times, especially as a result of the experience gained worldwide with the COVID19 pandemic vaccination campaigns, the personalization of vaccination strategies is becoming increasingly important. This does not yet mean bringing precision medicine and genomics approaches into immunization campaigns, but where there is more than one vaccine against the same disease, there is a need to identify criteria for personalizing vaccination.Vaccination strategies based on prescription appropriateness - whenever is possible - can lead to more effective immune response, reduced rates of adverse events, increased public confidence in vaccination and higher vaccination coverage, contributing to a decrease of morbidity and mortality related to preventable diseases.

The impact of SARS-CoV-2 infection in patients with cystic fibrosis undergoing CFTR channel modulators treatment: a literature review.

Several risk factors for Coronavirus-2019 (COVID-19) disease have been highlighted in clinical evidence. Among the various risk factors are advanced age, metabolic illness such as diabetes, heart disease, and diseases of the respiratory system. Cystic Fibrosis (CF) is a rare disease with autosomal recessive transmission, characterised by a lack of synthesis of the CFTR channel protein, and multi-organ clinical symptoms mainly affecting the respiratory tract with recurrent pulmonary exacerbations. In view of the pathophysiological mechanisms, CF disease should be in theory considered a risk factor for SARS-CoV2 or severe COVID-19. However, recent clinical evidence seems to point in the opposite direction, suggesting that CF could be a protective factor against severe COVID-19. Possibly, the lack of presence or function of the CFTR channel protein could be linked to the expression of the membrane glycoprotein ACE-2, a key enzyme for the endocellular penetration of SARS-CoV-2 and related to the pathophysiology of COVID-19 disease. Furthermore, CFTR channel modulating agents could indirectly influence the expression of ACE-2, playing an important role in restoring the proper functioning of mucociliary clearance and the pulmonary microbiome in the host response to SARS-CoV-2 infection. In this review, the authors attempt to shed light on these important associations of issues that are not yet fully elucidated.

Retrospective observational study on the impact of the Covid-19 pandemic on the prescription of medications for the treatment of Attention Deficit/Hyperactivity Disorder. Comparison of a European and an American cohort.

BACKGROUND: Attention Deficit Hyperactivity Disorder (ADHD) is a neuropsychological disorder that affects the development of children and adolescents. The causes are not fully known although the origin of the disorder appears to depend on a combination of environmental, social, biochemical, and genetic factors. There is substantial evidence the Covid-19 pandemic caused an increase in mental disorders and therefore in spending related to the treatment of diseases. METHOD: We conducted a retrospective cohort study in two international centers of very different origins and cultures, one in Europe (Italy) and one in Central America (Costa Rica), to assess the impact of the Covid-19 pandemic on ADHD medication prescriptions and its costs. The analysis resulting from mining the databases in each individual nation allowed for the actual amounts of defined daily dose (DDD) prescribed and dispensed between the years 2019 and 2022 of methylphenidate and atomoxetine. RESULTS: The data show that the Italian ADHD medications DDDs and expenditure are aligned with the results in Costa Rica. It was found that from the year 2019 to the year 2022, both methylphenidate and atomoxetine prescriptions grew steadily, confirming a much higher incidence of the condition than in pre-pandemic periods. CONCLUSIONS: Our study shows that the global pandemic had an influence on the increase in the number of ADHD medication prescriptions. Individuals with ADHD are a population of individuals who may be particularly vulnerable to the distress caused by the pandemic, restrictions, and severe physical removal measures that have occurred in recent years.