(1) Background: Percutaneous coronary interventions (PCI) in patients with acute coronary syndrome (ACS) are performed with titanium-nitride-oxide-coated stents (TiNOSs) or drug-eluting stents (DESs). The initial completion of this prospective systematic literature review (SLR) of prospective randomized controlled trials (RCTs) showed that TiNOSs are non-inferior to DESs in major adverse cardiac event (MACE) rates and present a lower risk of recurrent myocardial infarction (MI) at 1-year follow-up. This iteration of the SLR protocol performs the critical assessment of 5-year follow-up outcomes with clinical validity and generalizability assessments. (2) Methods: The previously described SLR and meta-analysis protocol, per PRISMA, Cochrane methods, and GRADE, was applied to 5-year follow-up outcomes. (3) Results: Three RCTs were eligible, comprising 1620 patients with TiNOS vs. 1123 with DES. The pooled risk ratios (RRs) and 95% confidence intervals were MACE 0.82 [0.68, 0.99], MI 0.58 [0.44, 0.78], cardiac death (CD) 0.46 [0.28, 0.76], ischemia-driven target lesion revascularization (TLR) 1.03 [0.79, 1.33], probable or definite stent thrombosis (ST) 0.32 [0.21, 0.59], and all-cause mortality (TD) 0.84 [0.63, 1.12]. The evidence certainty was high in MACE, CD, MI, and ST, and moderate in TLR and TD. (4) Conclusions: TiNOSs in ACS at 5-year follow-up appear safer than DESs and equally efficacious. The pooled RRs stratified by clinical presentation and stent type will be required to test this meta-analysis’s clinical validity and generalize its results to patient populations with varying proportions of clinical presentations and DES options.

Objectives: Dalbavancin is a lipoglycopeptide antibiotic approved for the treatment of acute bacterial skin and skin structure infections. However, several studies have suggested that it is used mostly for off-label indications. We aimed to describe the use of dalbavancin in patients who received at least one dose of the antibiotic in France. Methods: Prospective, observational, multicentre study conducted in France from September 2018 to April 2020. The primary outcome was the clinical response at 30 days after the last dalbavancin dose.Results: A total of 151 patients in 16 centres were included in this study. The main infection sites were bone and joint infections (55.0%), multisite infections (15.9%), and vascular infections (14.6%), and the primary pathogens were coagulase-negative staphylococci ( N = 82), Staphylococcus aureus ( N = 51), and enterococci ( N = 27). Most patients (71.5%) received three previous antibiotic treatments. The number of dalbavancin injections per patient was 1 in 26 patients (17.2%), 2 in 95 patients (62.9%), 3 in 17 patients (11.3%), and more than 3 in 13 patients (8.6%), with a mean cumulative dose of 3089 +/- 1461 mg per patient. Among the 129 patients with a complete follow-up, clinical success was achieved in 119 patients (92.2%). At least 1 adverse event was reported in 67 patients (4 4.4%), including 12 (7.9%) patients with dalbavancin-related adverse events.Conclusions: The results of the study showed that dalbavancin is used mostly for off-label indications and in heavily pretreated patients in France. The clinical response at 30 days after the last dose was favourable in most patients, with a good safety profile.(c) 2023 Elsevier Ltd and International Society of Antimicrobial Chemotherapy. All rights reserved.

(1) Background: Practice guidelines define drug-eluting stents (DES) as the standard of care in coronary percutaneous coronary intervention (PCI), including in acute coronary syndrome (ACS). This is based on comparisons with bare-metal stents (BMS). However, non-drug-eluting titanium-nitride-oxide-coated stents (TiNOS) have not been taken into account. The objective of this study is to determine whether TiNOS can be used as an alternative to DES in ACS. (2) Methods: A prospective systematic literature review (SLR), conducted according to the PRISMA guidelines, was performed, wherein multiple literature databases from 2018 and 2022 were searched. Prospective, randomised, controlled trials comparing outcomes after PCI with TiNOS vs. DES in any coronary artery disease (CAD) were searched. Clinical outcomes were meta-analytic pooled risk ratios (RR) of device-oriented Major Adverse Cardiac Events (MACE) and their components. The analysis stratified outcomes reported with ACS-only vs. ACS jointly with chronic coronary syndrome (CCS). (3) Results: Five RCTs were eligible, comprising 1855 patients with TiNOS vs. 1363 with DES at a 1-year follow-up. Three enrolled patients presented with ACS only and two with ACS or CCS. The latter accounted for most of the patients. The one-year pooled RRs in those three RCTs were as follows: MACE 0.93 [0.72, 1.20], recurrent myocardial infarction (MI) 0.48 [0.31, 0.73], cardiac death (CD) 0.66 [0.33, 1.31], clinically driven target lesion revascularization (TLR) 1.55 [1.10, 2.19], and stent thrombosis (ST) 0.35 [0.20, 0.64]. Those results were robust to a sensitivity analysis. The evidence certainty was high in MACE and moderate or low in the other endpoints. (4) Conclusions: TiNOS are a non-inferior and safe alternative to DES in patients with ACS.

(1) Background: Three antimicrobial absorbable sutures have different triclosan (TS) loads, triclosan release kinetics and hydrolysis times. This in vitro study aims to analyse and compare their antimicrobial pharmacodynamics. (2) Methods: Time-kill assays were performed with eight triclosan-susceptible microorganisms common in surgical site infections (SSIs) and a segment of each TS. Microbial concentrations were measured at T0, T4, T8 and T24 h. Similar non-triclosan sutures (NTS) were used as controls. Microbial concentrations were plotted and analysed with panel analysis. They were predicted over time with a double-exponential model and four parameters fitted to each TS × microorganism combination. (3) Results: The microbial concentration was associated with the triclosan presence, timeslot and microorganism. It was not associated with the suture material. All combinations shared a common pattern with an early steep concentration reduction from baseline to 4–8 h, followed by a concentration up to a 24-h plateau in most cases with a mild concentration increase. (4) Conclusions: Microorganisms seem to be predominantly killed by contact or near-contact killing with the suture rather than the triclosan concentration in the culture medium. No significant in vitro antimicrobial pharmacodynamic difference between the three TS is identified. Triclosan can reduce the suture microbial colonisation and SSI risk.

Randomised controlled clinical trials (RCTs) report a lower incidence rate of surgical site infections (SSIs) with triclosan sutures (TSs) compared with non-triclosan sutures (NTSs). Do triclosan sutures modify the microbial diversity of culture-confirmed SSIs (ccSSIs)? If so, this would support the association between TS antimicrobial activity and the SSI incidence rate. This prospective systematic literature review (PROSPERO CRD42019125099) was conducted according to PRISMA. RCTs that compared the incidence of SSIs with TSs and NTSs and reported microbial counts from SSI cultures per suture group were eligible. The microbial species were grouped by genus, and the association between genera and sutures was tested. The pooled relative risk (RR) of ccSSIs was also calculated. Twelve RCTs were eligible. No publication bias was identified. The microorganism count was 180 in 124 SSIs with TSs versus 246 in 199 SSIs with NTSs. No significant difference in microbial diversity was found, but statistical power was low for test results to support or challenge the association between the antimicrobial activity of TSs and the reduced rate of SSIs. The RR of the ccSSIs was significant and consistent with comprehensive meta-analyses. The certainty of the pooled RR was moderate.

(1) Background: Sutures with triclosan (TS) are used to reduce the risk of surgical site infections (SSI), but most clinical trials are inconclusive. The traceability of SSI risk to antimicrobial activity in operated tissues is needed. (2) Objectives: This study aimed to predict triclosan antistaphylococcal activity in operated tissues. (3) Methods: Three TS were exposed to static water for 30 days, and triclosan release was recorded. Polyglactin TS explanted from sheep seven days after cardiac surgery according to 3Rs provided ex vivo acceleration benchmarks. TS immersion up to 7 days in ethanol-water cosolvency and stirring simulated tissue implantation. Controls were 30-day immersion in static water. The release rate over time was measured and fitted to a predictive function. Antistaphylococcal activity and duration were measured by time-kill analysis with pre-immersed polyglactin TS. (4) Fifteen to 60-fold accelerated in vitro conditions reproduced the benchmarks. The rate prediction with double-exponential decay was validated. The antistaphylococcal activity was bactericidal, with TS pre-immersed for less than 12 h before then S. aureus began to grow. The residual triclosan level was more than 95% and played no detectable role. (5) Conclusions: Polyglactin, poliglecaprone, and polydioxanone TS share similar triclosan release functions with parametric differences. Polyglactin TS is antistaphylococcal in surgical conditions for 4 to 12 h.

Background: Randomized clinical trials (RCTs) comparing percutaneous coronary interventions (PCI) with titanium-nitride-oxide coated stents (TiNOS) versus drug-eluting stents (DES) in coronary artery disease (CAD) have been published. Objectives: To compare the efficacy and safety of PCI with TiNOS versus DES at 1 and 5-year follow-up, in all CAD including acute coronary syndrome (ACS). Methods: A prospective systematic literature review and meta-analysis of RCTs were conducted according to published methods (Cochrane, PRISMA, GRADE). Medline, Embase, Cochrane database, Web of Science were searched on March 08, 2018. Fixed-effects Mantel-Haenszel pooled risk ratios (RR), TiNOS over DES, with 95% confidence intervals (CI) were computed with sensitivity analysis. Results: Five RCTs were eligible with n = 1,855 TiNOS vs. n = 1,363 DES at 1-year and n = 783 vs. n = 771 at 5-year follow-up. One-year RRs in ACS patients: Major Adverse Cardiac Events (MACE) 0.93 [0.72, 1.20], recurrent myocardial infarction (MI) 0.42 [0.28, 0.63], probable or definite stent thrombosis (ST): 0.35 [0.20, 0.64]. Estimates were robust to sensitivity analysis. Certainty of evidence was high in MACE, moderate in MI and ST due to the limited number of cases. Data were insufficient to draw conclusions about stable CAD patients and 5-year outcomes. Conclusions: This meta-analysis showed in ACS patients, similar risk of MACE with TiNOS and DES, at 1-year follow-up, and suggested a lower risk of MI and ST with TiNOS than with DES. These two safety signals in MI and ST with the current use of DES require further investigations. SLR registration: PROSPERO CRD42018090622 https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=90622

Background: This study estimated the short-term clinical safety and efficacy of hemispherical with flattened pole cobalt-chromium metal-back with porous outer hydroxyapatite coating dual-mobility acetabular cup (HFPC-DM-HA) in primary total hip arthroplasty. Methods: Single-center retrospective observational cohort study of consecutive patients undergoing total hip arthroplasty with a HFPC-DM-HA 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires. Results: Sampling frame: 361 patients including 59 patients (16.3%) in the cohort. 6 patients (10%) lost to follow-up. Median age 77.5 years (range: 67 ; 92), 32% female, median BMI 25.2 kg.m -2 (18.4 to 56.8). Clinical indications: Primary THA in all patients, resulting from primary osteoarthritis in 80% of them. Median follow-up 3.0 years (2.7 to 4.1). Primary endpoint: 2-year implant survival rate: 97% [87, 99]. Prosthetic dislocation: 0%. Secondary endpoint: Modified HHS (pain & functional subscore) improved from baseline 39.7 [34.6, 44.7] to 75.8 [72.1, 79.6] at 1-year and to 86.7 [83.7, 89.7] at 2-year follow-up (p<0.0001). Conclusions: The authors deemed the short-term outcomes of this acetabular cup in primary total hip arthroplasty to be satisfactory. Study registration: clinicaltrials.gov NCT04209374.

Background: This study estimated the short-term clinical safety and efficacy of hemispherical with flattened pole cobalt-chromium metal-back dual-mobility acetabular cup with porous outer hydroxyapatite coating and anchoring screw and pods (HFPC-DMR-HA) or cement fixation (HFPC-DM-CEM), in revision or complex total hip arthroplasty.Methods: Single-center retrospective observational cohort study of consecutively operated patients who underwent THA with an HFPC-DMR-HA or HFPC-DM-CEM cup 2 years prior to study start. Prospective 2-year follow-up with letter and phone questionnaires.Results: Sampling frame: 203 patients including 9.85% in the two cohorts with 15 HFPC-DMR-HA and 5 HFPC-DM-CEM. 3 (20%) and 2 (40%) patients were lost to follow-up, respectively. Median age was 85.6 years (range: 45.1 ; 93.3) and 78.8 (range: 68.8 ; 86.9). Median follow-up (years): HFPC-DMR-HA: 2.3, HFPC-DM-CEM: 3.3. Clinical indications: HFPC-DMR-HA 67% revision & 33% primary THAs, HFPC-DM-CEM 100% revision. Primary endpoint: 2-year implant survival rate: HFPC-DMR-HA 93% [59, 99], HFPC-DM-CEM 100%. Prosthetic dislocation: HFPC-DMR-HA 1 (6.7%), HFPC-DM-CEM 0%. Secondary endpoint: Modified HHS (pain & functional subscore) improved with HFPC-DMR-HA from baseline 26.8 [14.9, 38.7] to 82.2 [73.5, 90.9] at 2-year follow-up (p<0.0001); HFPC-DM-CEM from 41.6 [24.9, 58.3] to 80.7 [55.8, 100].Conclusions: The authors deemed the short-term outcomes with these acetabular cups in revision or complex total hip arthroplasty to be satisfactory.Study registration: clinicaltrials.gov NCT04209426.

Overweight and obesity are known to impact male fertility and are commonly associated with abdominal obesity and metabolic disorders. The association between abdominal obesity or metabolic syndrome with male reproduction has not been fully investigated. Moreover, many factors may interfere with the evaluation of the impact of metabolic syndrome on male fertility. Thus, tobacco is known to alter the spermatic parameters and phenomena linking smoking with metabolic syndrome are therefore complex. The main objective of this study has been to investigate the potential association of metabolic syndrome with male idiopathic infertility given smoking status. The data of this study concerned infertile (n = 96) and fertile (n = 100) men under 45 years of age who have been recruited in the ALIFERT case-control study. Body mass index and waist circumference were measured. Serum triglycerides, cholesterol (total, high density lipoprotein, and low density lipoprotein cholesterol) and fasting blood glucose were assayed. Metabolic syndrome has been diagnosed in the presence of at least three of the following criteria: increased waist circumference, high triglycerides, fasting glucose or arterial blood pressure and low high density lipoprotein cholesterol. The present study reports that infertile men are in poorer health condition compared to fertile men and are more often smokers. The results of this study suggested metabolic syndrome and smoking to be independent risk factor for idiopathic infertility. Metabolic syndrome and smoking should systematically be checked at the beginning of medical care in infertile males and personal and multifaceted coaching should be proposed to deal jointly with smoking and metabolic disorders. NCT01093378 ALIFERT. Registered: March 25, 2010.

Introduction: Drug-eluting stents (DES) have mostly replaced bare-metal stents in percutaneous coronary interventions (PCI). Platforms and Eluted drugs have evolved to improve efficacy and reduce a...

Whether you need a new tool or just inspiration, Seven Web Frameworks in Seven Weeks explores modern options, giving you a taste of each with ideas that will help you create better apps. You'll see frameworks that leverage modern programming languages, employ unique architectures, live client-side instead of server-side, or embrace type systems. You'll see everything from familiar Ruby and JavaScript to the more exotic Erlang, Haskell, and Clojure. The rapid evolution of web apps demands innovative solutions: this survey of frameworks and their unique perspectives will inspire you and get you thinking in new ways to meet the challenges you face daily. This book covers seven web frameworks that are influencing modern web applications and changing web development: Sinatra, CanJS, AngularJS, Ring, Webmachine, Yesod, Immutant. Each of these web frameworks brings unique and powerful ideas to bear on building apps. Embrace the simplicity of Sinatra, which sheds the trappings of large frameworks and gets back to basics with Ruby. Live in the client with CanJS, and create apps with JavaScript in the browser. Be declarative with AngularJS; say what you want, not how to do it, with a mixture of declarative HTML and JavaScript. Turn the web into data with Ring, and use Clojure to make data your puppet. Become a master of advanced HTTP with Webmachine, and focus the power of Erlang. Prove web theorems with Yesod; see how Haskell's advanced type system isn't just for academics. Develop in luxury with Immutant, an enlightened take on the enterprise framework.Seven Web Frameworks will influence your work, no matter which framework you currently use. Welcome to a wider web.What You Need: You'll need Windows, MacOS X or Linux, along with your favorite web browser. Each chapter will cover what you need to download and which language versions are required.

Improvement of the microbial strain by subjecting the genetic material to mutagenic agents offers an opportunity to reduce the production cost. This study aims to enhance the δ-endotoxin production of Bacillus thuringiensis strain S24 that is 2-fold more toxic than the commercialized strain HD1 against Ephestia kuehniella (Lepidoptera: Pyralidae) larvae through random mutagenesis. B. thuringiensis mutants were generated from the S24 strain by using nitrous acid, as chemical mutagenic agent. Three mutants (M29, M12 and M20) proved to be the most promising δ-endotoxin producer among 30 mutants analyzed in a screening program performed in shake flasks using a complex medium based on starch and soya bean. These mutants demonstrated an improvement of δ-endotoxin production of up to 21 and 74% compared with the parental wild strain S24 and HD1, respectively. The characterization of the over-producing mutants showed that their colony morphology, crystal shape, plasmid and protein patterns, cry gene content and toxicity are not affected by mutagenesis treatment. However, the crystal protein patterns of three under-producing mutants (M21, M14 and M11) were different to that of the parental wild strain. The high potentiality of the over-producing mutants makes them excellent candidates as biological agents for the control of pyralid stored-product pests.

Background: A systematic literature review (SLR) and meta-analysis of surgical site infections (SSIs) after surgical incision closure with triclosan-coated sutures (TS) compared with non-antibacterial coated sutures (NTS) published previously by the authors suggested that fewer SSIs occurred in the TS study arm. However, the results were vulnerable to the removal of one key randomized controlled trial (RCT) because of insufficient data. Furthermore, recently published RCTs highlighted the need for an update of the SLR to challenge the robustness of results. Methods: The protocol for the new SLR included more stringent tests of robustness than used initially and the meta-analysis was updated with the results of two new RCTs as well as the count of patients and SSIs by U.S. Centers for Disease Control and Prevention (CDC) incision class. Results: The updated SLR included 15 RCTs with 4,800 patients. No publication bias was suggested in the analysis. The predominant effect estimated a relative risk of 0.67 (95% CI: 0.54-0.84, p=0.00053) with an overall lower frequency of SSI in the TS arm than in the NTS arm. Results were robust to sensitivity analysis. Conclusions: The two additional peer-reviewed double-blind RCTs of this update confirmed the predominant effect found in the authors' previous meta-analysis and established the robustness of conclusions that were lacking previously. This SLR and meta-analysis showed that the use of triclosan antimicrobial sutures reduced the incidence of SSI after clean, clean-contaminated, and contaminated surgery. The two additional peer-reviewed double blind RCTs reinforced the evidence level of this SLR (CEBM level 1a).

Surgical InfectionsVol. 15, No. 6 Letter to Surgical InfectionsOpen AccessSystematic Literature Review Update of the PROUD Trial: Potential Usefulness of a Collaborative DatabaseFrederic C. DaoudFrederic C. DaoudSearch for more papers by this authorPublished Online:15 Dec 2014https://doi.org/10.1089/sur.2014.129AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail To the Editor:The PROUD trial, which is registered in Germany and is examining the effects of suture type on surgical site infection (SSI), was published shortly before our systematic literature review [1,2]. The methods met the eligibility criteria of our review protocol. An extraction of literature databases returned no other new relevant study. The meta-analysis was updated with the 16th trial (Fig. 1). It presented a relative weight of 17.1% and did not introduce significant publication bias (Egger regression p=0.085) or heterogeneity (Q-test p=0.112). The results were consistent with those of the 15-trial meta-analysis. The random-effects risk ratio (RR) was 0.71 with a 95% confidence interval (CI) of 0.58–0.87 (p<0.0012). Sensitivity analysis confirmed the robustness of the results. The three trials with the highest relative weight after the PROUD trials had to be removed jointly for the pooled RR to become non-significant: 0.79, 95% CI 0.79–1.01, p<0.057 [3–5]. That trial considerably strengthened the polydioxanone subgroup but had little effect on the results of covariable analysis.FIG. 1. Random-effects pooled relative risk of surgical site infection in 16 randomized controlled trials of different suture materials.The data that could be pooled from the 16 trials so far did not enable an explanation of the large variations in RR across trials. Moreover, publications did not describe the treatments and outcomes of the SSIs systematically, so the impact of suture type on burden-of-illness could not be estimated.Leveraging source data of current trials could be attempted through a collaborative database of individual data that should include treatments and outcomes of SSIs that could be retrieved from patient charts. Individual level meta-analysis would increase the power to detect covariables that explain the large differences in RRs across trials and would also enable estimation of burden-of-illness.If this approach proves to yield more knowledge from current trials, ongoing and future trials could consider participating in this collaborative effort in order to leverage the contribution of their own findings to the overall evidence.Author Disclosure StatementThis letter is the sole responsibility of the author. No external funding or other form of support was received from non-profit or for-profit entities.References1 Daoud FC, Edmiston CEJr, Leaper D. Meta-analysis of prevention of surgical site infections following incision closure with triclosan-coated sutures: Robustness to new evidence. Surg Infect 2014;15:165–181. Link, Google Scholar2 Diener MK, Knebel P, Kieser M, et al.. Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: The randomised controlled PROUD trial. Lancet 2014 Apr 4. DOI: 10.1016/S0140-6736(14)60238-5 [Epub ahead of print]. Crossref, Google Scholar3 Galal I, El-Hindawy K. Impact of using triclosan-antibacterial sutures on incidence of surgical site infection. Am J Surg 2011;202:133–138. Crossref, Medline, Google Scholar4 Thimour-Bergström L, Roman-Emanuel C, Scherstén H, et al.. Triclosan-coated sutures reduce surgical site infection after open vein harvesting in coronary artery bypass grafting patients: A randomized controlled trial. Eur J Cardiothorac Surg 2013;44:931–938. Crossref, Medline, Google Scholar5 Justinger C, Slotta JE, Ningel S, et al.. Surgical-site infection after abdominal wall closure with triclosan-impregnated poliydioxanone sutures: Results of a randomized clinical pathway facilitated trial (NCT00998907). Surgery 2013;154:589–595. Crossref, Medline, Google ScholarFiguresReferencesRelatedDetailsCited byAlternatives to antibiotics for prevention of surgical infection25 January 2017 | British Journal of Surgery, Vol. 104, No. 2 Volume 15Issue 6Dec 2014 InformationCopyright 2014, Mary Ann Liebert, Inc.To cite this article:Frederic C. Daoud.Systematic Literature Review Update of the PROUD Trial: Potential Usefulness of a Collaborative Database.Surgical Infections.Dec 2014.857-858.http://doi.org/10.1089/sur.2014.129creative commons licensePublished in Volume: 15 Issue 6: December 15, 2014Online Ahead of Print:October 15, 2014PDF download

The study objective was to ascertain outcomes with the Swedish adjustable gastric band (SAGB) on an intention-to-treat basis in multiple centers across the French social health insurance system. SAGB results at 3-year follow-up are reported. The noncomparative, observational, prospective, consecutive cohort study design sought a 500-patient minimum recruitment geographically representative of continental France. Safety (adverse events [AEs], device-related morbidity, and mortality) and effectiveness (change in body mass index [BMI, kilograms per square meter], percentage excess weight loss, comorbidities, quality of life [QoL]) were assessed. Adjustable gastric band survival was calculated. Thirty-one surgeons in 28 multidisciplinary teams/sites enrolled patients between September 2, 2007 and April 30, 2008. SAGB was successfully implanted in 517 patients: 88.0 % female; mean age, 37.5 years; obesity duration, 15.3 years (baseline: mean BMI, 41.0; comorbidities, 773 in 74.3 % of patients; Bariatric Analysis and Reporting Outcome System (BAROS), 1.4; EuroQoL 5-Dimensions (EQ-5D), 0.61; EuroQoL-visual analog scale (EQ-VAS), 52.3). At 3 years: BMI, 32.2 (mean change, -9.0; p < 0.0001); excess weight loss, 47.4 %; comorbidities, 161 in 27.2 %; BAROS, 3.6 (+2.2, p < 0.0001); EQ-5D, 0.84 (+0.22, p < 0.0001); EQ-VAS, 73.4 (+21.4, p < 0.0001). SAGB-induced weight loss was associated with substantially improved QoL. One death occurred and was unrelated to the treatment. No AE was reported in 68.3 % of patients, and no confirmed device-related AE in 77.0 %. Overall AE rate was 0.19 per patient year. Device retention was 87.0 %. Analysis of patients lost to follow-up showed a nonsignificant effect on overall study results. In a prospective, consecutive cohort, "real-world", nationwide study, the Swedish Adjustable Gastric Band was found safe and effective at 3-year follow-up.

Background. It has been estimated that 750,000 to 1 million surgical-site infections (SSIs) occur in the United States each year, causing substantial morbidity and mortality. Triclosan-coated sutures were developed as an adjunctive strategy for SSI risk reduction, but a recently published systematic literature review and meta-analysis suggested that no clinical benefit is associated with this technology. However, that study was hampered by poor selection of available randomized controlled trials (RCTs) and low patient numbers. The current systematic review involves 13 randomized, international RCTs, totaling 3,568 surgical patients.Methods. A systematic literature search was performed on PubMed, Embase/Medline, Cochrane database group (Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Health Economic Evaluations Database/Database of Health Technology Assessments), and www.clinicaltrials.gov to identify RCTs of triclosan-coated sutures compared with conventional sutures and assessing the clinical effectiveness of antimicrobial sutures to decrease the risk for SSIs. A fixed- and random-effects model was developed, and pooled estimates reported as risk ratio (RR) with a corresponding 95% confidence interval (CI). Publication bias was assessed by analyzing a funnel plot of individual studies and testing the Egger regression intercept.Results. The meta-analysis (13 RCTs, 3,568 patients) found that use of triclosan antimicrobial-coated sutures was associated with a decrease in SSIs in selected patient populations (fixed effect: RR = 0.734; 95% CI: 0.590-0.913; P = .005; random-effect: RR = 0.693; 95% CI: 0.533-0.920; P = .011). No publication bias was detected (Egger intercept test: P = .145).Conclusion. Decreasing the risk for SSIs requires a multifaceted "care bundle" approach, and this meta-analysis of current, pooled, peer-reviewed, randomized controlled trials suggests a clinical effectiveness of antimicrobial-coated sutures (triclosan) in the prevention of SSIs, representing Center for Evidence-Based Medicine level la evidence.

Lifelong immunosuppression increases morbidity and mortality in liver transplantation. Discontinuation of immunosuppressive drugs could lessen this burden, but the safety, applicability, and clinical outcomes of this strategy need to be carefully defined. We enrolled 102 stable liver recipients at least 3 years after transplantation in a single-arm multicenter immunosuppression withdrawal trial. Drugs were gradually discontinued over a 6 to 9-month period. The primary endpoint was the development of operational tolerance, defined as successful immunosuppressive drug cessation maintained for at least 12 months with stable graft function and no histopathologic evidence of rejection. Out of the 98 recipients evaluated, 57 rejected and 41 successfully discontinued all immunosuppressive drugs. In nontolerant recipients rejection episodes were mild and resolved over 5.6 months (two nontolerant patients still exhibited mild gradually improving cholestasis at the end of follow-up). In tolerant recipients no progressive clinically significant histological damage was apparent in follow-up protocol biopsies performed up to 3 years following drug withdrawal. Tolerance was independently associated with time since transplantation (odds ratio [OR] 1.353; P = 0.0001), recipient age (OR 1.073; P = 0.009), and male gender (OR 4.657; P = 0.016). A predictive model incorporating the first two clinical variables identified subgroups of recipients with very high (79%), intermediate (30%-38%), and very low (0%) likelihood of successful withdrawal. Conclusion: When conducted at late timepoints after transplantation, immunosuppression withdrawal is successful in a high proportion of carefully selected liver recipients. A combination of clinical parameters could be useful to predict the success of this strategy. Additional prospective studies are now needed to confirm these results and to validate clinically applicable diagnostic biomarkers. (Hepatology 2013;58:1824–1835)

L’objectif de l’étude consistait à contrôler les résultats du Swedish adjustable gastric band (SAGB, anneau gastrique ajustable suédois) sur la base de l’intention de traiter dans plusieurs centres au sein du système français de sécurité sociale. Les résultats de suivi à 3 ans avec le SAGB sont présentés. Le plan de cette étude de cohorte non comparative, observationnelle, prospective et consécutive a visé le recrutement d’un minimum de 500 patients géographiquement représentatifs du territoire français métropolitain. L’innocuité (événements indésirables [EI], morbidité liée au dispositif, et mortalité) et l’efficacité (variation de l’indice de masse corporelle [IMC, kilogrammes par mètre carré], perte de poids en excès en pourcentage, comorbidités, qualité de vie [QoL]) ont été évaluées. La survie avec anneau gastrique ajustable a été calculée. Trente-et-un chirurgiens de 28 équipes / sites multidisciplinaires ont recruté des patients entre le 2 septembre 2007 et le 30 avril 2008. Un SAGB a été implanté avec succès chez 517 patients : 88,0 % de femmes ; âge moyen, 37,5 ans ; durée d’obésité, 15,3 ans (valeurs à l’inclusion : IMC moyen, 41,0 ; comorbidités, 773 chez 74,3 % des patients ; système d’analyse bariatrique et de notification des résultats (Bariatric Analysis and Reporting Outcome System, BAROS), 1,4 ; EuroQoL 5-Dimensions (EQ-5D), 0,61 ; échelle visuelle analogique EuroQoL (EQ-EVA), 52,3). À 3 ans : IMC, 32,2 (variation moyenne, −9,0 ; p < 0,0001) ; perte de poids en excès, 47,4 %; comorbidités, 161 chez 27,2 % ; BAROS, 3,6 (+2,2, p < 0,0001) ; EQ-5D, 0,84 (+0,22, p < 0,0001) ; EQ-EVA, 73,4 (+21,4, p < 0,0001). La perte de poids induite par le SAGB était associée à une amélioration substantielle de la QoL. Un décès est survenu, sans rapport avec le traitement. 68,3 % des patients n’ont rapporté aucun EI, et 77,0 % aucun EI confirmé et lié au dispositif. Le taux global d’EI était de 0,19 par patients-année. La conservation du dispositif était de 87,0 %. L’analyse des patients perdus de vue a montré un effet non significatif sur les résultats globaux de l’étude. Le Swedish Adjustable Gastric Band est apparu sûr et efficace dans le suivi à 3 ans d’une étude nationale de cohorte consécutive, prospective et dans la population générale.

This study aimed to establish a payer-perspective cost-effectiveness and budget impact model of adjustable gastric banding (AGB) and gastric bypass (GBP) vs. conventional treatment (CT) in patients with a body mass index (BMI) ≥ 35 kg.m−2 and type 2 diabetes mellitus (T2DM) in Austria, Italy, and Spain.