[Increased mortality in metal-on-metal versus non-metal-on-metal primary total hip arthroplasty at 10 years and longer follow-up: a systematic review and meta-analysis]. / Verhoogde mortaliteit bij patiënten met een metaal-op-metaal heupprothese.

OBJECTIVE: To determine the mortality and the morbidity in patients with metal-on-metal articulations (MOM THA) when compared to patients with non-metal-on-metal articulations (non-MOM THA) after primary total hip arthroplasty. DESIGN: Systematic review, meta-analyses and meta-regression (registration: PROSPERO 2014:CRD42014007417). METHOD: Search of PubMed, MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, AcademicSearchPremier, ScienceDirect, Wiley and clinical trial registers. We included randomised controlled trials and observational studies of primary total hip arthroplasty comparing MOM THA with non-MOM THA. We used meta-regression to identify and evaluate potential modifying variables such as follow-up duration. RESULTS: Forty-seven studies were included, comprising over 4,000 THA in randomised trials and over 500,000 THA in observational studies. For mortality, random effects analysis revealed a higher pooled risk difference (RD) of 0.7% (95%-CI: 0.0-2.3%; I-square 42%); the heterogeneity was explained by differences in follow-up. When restricted to studies with long term follow-up (i.e. 10 years or more), the RD for mortality was 8,5% (95%-CI: 5,8-11,2). Further subgroup analyses and meta-regression random effects models revealed no evidence for other modifying variables (study level covariates, e.g. resurfacing vs. non-resurfacing MOM) than follow-up duration. CONCLUSION: Meta-analysis suggests there may be an increased long-term risk of mortality associated with MOM THA compared to patients with non-MOM THA.

Hospital effect on infections after four major surgical procedures: outlier and volume-outcome analysis using all-inclusive state data.

BACKGROUND: Hospital volume is known to have a direct impact on the outcomes of major surgical procedures. However, it is unclear if the evidence applies specifically to surgical site infections. AIMS: To determine if there are procedure-specific hospital outliers [with higher surgical site infection rates (SSIRs)] for four major surgical procedures, and to examine if hospital volume is associated with SSIRs in the context of outlier performance in New South Wales (NSW), Australia. METHODS: Adults who underwent one of four surgical procedures (colorectal, joint replacement, spinal and cardiac procedures) at a NSW healthcare facility between 2002 and 2013 were included. The hospital volume for each of the four surgical procedures was categorized into tertiles (low, medium and high). Multi-variable logistic regression models were built to estimate the expected SSIR for each procedure. The expected SSIRs were used to compute indirect standardized SSIRs which were then plotted in funnel plots to identify hospital outliers. FINDINGS: One hospital was identified to be an overall outlier (higher SSIRs for three of the four procedures performed in its facilities), whereas two hospitals were outliers for one specific procedure throughout the entire study period. Low-volume facilities performed the best for colorectal surgery and worst for joint replacement and cardiac surgery. One high-volume facility was an outlier for spinal surgery. CONCLUSIONS: Surgical site infections seem to be mainly a procedure-specific, as opposed to a hospital-specific, phenomenon in NSW. The association between hospital volume and SSIRs differs for different surgical procedures.

Editor's Choice - Carotid Stenosis Treatment: Variation in International Practice Patterns.

OBJECTIVES: The aim was to determine current practice for the treatment of carotid stenosis among 12 countries participating in the International Consortium of Vascular Registries (ICVR). METHODS: Data from the United States Vascular Quality Initiative (VQI) and the Vascunet registry collaboration (including 10 registries in Europe and Australasia) were used. Variation in treatment modality of asymptomatic versus symptomatic patients was analysed between countries and among centres within each country. RESULTS: Among 58,607 procedures, octogenarians represented 18% of all patients, ranging from 8% (Hungary) to 22% (New Zealand and Australia). Women represented 36%, ranging from 29% (Switzerland) to 40% (USA). The proportion of carotid artery stenting (CAS) among asymptomatic patients ranged from 0% (Finland) to 26% (Sweden) and among symptomatic patients from 0% (Denmark) to 19% (USA). Variation among centres within countries for CAS was highest in the United States and Australia (from 0% to 80%). The overall proportion of asymptomatic patients was 48%, but varied from 0% (Denmark) to 73% (Italy). There was also substantial centre level variation within each country in the proportion of asymptomatic patients, most pronounced in Australia (0-72%), Hungary (5-55%), and the United States (0-100%). Countries with fee for service reimbursement had higher rates of treatment in asymptomatic patients than countries with population based reimbursement (OR 5.8, 95% CI 4.4-7.7). CONCLUSIONS: Despite evidence about treatment options for carotid artery disease, the proportion of asymptomatic patients, treatment modality, and the proportion of women and octogenarians vary considerably among and within countries. There was a significant association of treating more asymptomatic patients in countries with fee for service reimbursement. The findings reflect the inconsistency of the existing guidelines and a need for cooperation among guideline committees all over the world.

Hernia repair with polypropylene mesh is not associated with an increased risk of autoimmune disease in adult men.

PURPOSE: Synthetic mesh for herniorrhaphy has been placed under critical observation regarding the potential association of mesh placement and the subsequent development of autoimmune diseases. We sought to evaluate whether there is a link between synthetic polypropylene mesh repairs and the subsequent development of systemic/autoimmune disorders (SAID). STUDY DESIGN: Adult men undergoing hernia repair with mesh between January 2008 and December 2009 in New York State were identified using International Classification of Diseases, Ninth Revision, Modification procedure codes and Current Procedural Terminology Coding System, Fourth Edition codes. A control cohort of men undergoing colonoscopy was created with whom to compare outcomes. RESULTS: A total of 29,712 patients underwent hernia repair between January 2008 and December 2009. In the control cohort, 79,265 patients underwent colonoscopy. During the entire follow-up, 475 patients undergoing hernia repair and 1305 patients in the control cohort were diagnosed with autoimmune disease. When patients were matched based on demographics, comorbidities and procedure date, hernia repair was not associated with an increased risk of developing autoimmune disease over the entire follow-up time period. 1.6% of those in the hernia group vs. 1.7% of those in the colonoscopy group developed SAID [risk ratio (95% CI): hernia vs. colonoscopy 0.93(0.79-1.09)]. No association between mesh surgery and increased risks of SAID was found at any of the specified time points (6 months, 1 year, and 2-year follow-up). CONCLUSIONS: Mesh-based hernia repair was not associated with the development of autoimmune diseases compared to those undergoing routine screening colonoscopy.

Increased Mortality in Metal-on-Metal versus Non-Metal-on-Metal Primary Total Hip Arthroplasty at 10 Years and Longer Follow-Up: A Systematic Review and Meta-Analysis.

IMPORTANCE: There are concerns about increased mortality in patients with metal-on-metal bearings in total hip arthroplasty (THA). OBJECTIVE: To determine the mortality and the morbidity in patients with metal-on-metal articulations (MOM THA) compared to patients with non-metal-on-metal articulations (non-MOM THA) after primary total hip arthroplasty. DATA SOURCES: Search of PubMed, MEDLINE, EMBASE, Web of Science, Cochrane, CINAHL, AcademicSearchPremier, ScienceDirect, Wiley and clinical trial registers through March 2015, augmented by a hand search of references from the included articles. No language restrictions were applied. STUDY SELECTION: Two reviewers screened and identified randomised controlled trials and observational studies of primary total hip arthroplasty comparing MOM THA with non-MOM THA. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted study data and assessed risk of bias. Risk differences (RD) were calculated with random effect models. Meta-regression was used to explore modifying factors. MAIN OUTCOMES AND MEASURES: Difference in mortality and difference in morbidity expressed as revisions and medical complications between patients with MOM THA and non-MOM THA. RESULTS: Forty-seven studies were included, comprising 4,000 THA in randomised trials and over 500,000 THA in observational studies. For mortality, random effects analysis revealed a higher pooled RD of 0.7%, 95%, confidence interval (CI) [0.0%, 2.3%], I-square 42%; the heterogeneity was explained by differences in follow-up. When restricted to studies with long term follow-up (i.e. 10 years or more), the RD for mortality was 8.5%, 95%, CI [5.8%, 11.2%]; number needed to treat was 12. Further subgroup analyses and meta-regression random effects models revealed no evidence for other moderator variables (study level covariates, e.g. resurfacing vs. non-resurfacing MOM) than follow-up duration. The quality of the evidence presented in this meta-analysis was characterized as moderate according to the CLEAR-NPT (for non-pharmacological trials) and Cochrane risk of bias Table. CONCLUSIONS AND RELEVANCE: Meta-analysis suggests there may be an increased long-term risk of mortality and revision surgery for patients with MOM THA compared to patients with non-MOM THA. REGISTRATION: PROSPERO 2014:CRD42014007417.

Appraisal of evidence base for introduction of new implants in hip and knee replacement: a systematic review of five widely used device technologies.

OBJECTIVE: To determine the evidence of effectiveness and safety for introduction of five recent and ostensibly high value implantable devices in major joint replacement to illustrate the need for change and inform guidance on evidence based introduction of new implants into healthcare. DESIGN: Systematic review of clinical trials, comparative observational studies, and registries for comparative effectiveness and safety of five implantable device innovations. DATA SOURCES: PubMed (Medline), Embase, Web of Science, Cochrane, CINAHL, reference lists of articles, annual reports of major registries, summaries of safety and effectiveness for pre-market application and mandated post-market studies at the US Food and Drug Administration. STUDY SELECTION: The five selected innovations comprised three in total hip replacement (ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock cups) and two in total knee replacement (high flexion knee replacement and gender specific knee replacement). All clinical studies of primary total hip or knee replacement for symptomatic osteoarthritis in adults that compared at least one of the clinical outcomes of interest (patient centred outcomes or complications, or both) in the new implant group and control implant group were considered. Data searching, abstraction, and analysis were independently performed and confirmed by at least two authors. Quantitative data syntheses were performed when feasible. RESULTS: After assessment of 10,557 search hits, 118 studies (94 unique study cohorts) met the inclusion criteria and reported data related to 15,384 implants in 13,164 patients. Comparative evidence per device innovation varied from four low to moderate quality retrospective studies (modular femoral necks) to 56 studies of varying quality including seven high quality (randomised) studies (high flexion knee replacement). None of the five device innovations was found to improve functional or patient reported outcomes. National registries reported two to 12 year follow-up for revision occurrence related to more than 200,000 of these implants. Reported comparative data with well established alternative devices (over 1,200,000 implants) did not show improved device survival. Moreover, we found higher revision occurrence associated with modular femoral necks (hazard ratio 1.9) and ceramic-on-ceramic bearings (hazard ratio 1.0-1.6) in hip replacement and with high flexion knee implants (hazard ratio 1.0-1.8). CONCLUSION: We did not find convincing high quality evidence supporting the use of five substantial, well known, and already implemented device innovations in orthopaedics. Moreover, existing devices may be safer to use in total hip or knee replacement. Improved regulation and professional society oversight are necessary to prevent patients from being further exposed to these and future innovations introduced without proper evidence of improved clinical efficacy and safety.

Numerical study of the localization length critical index in a network model of plateau-plateau transitions in the quantum Hall effect.

We calculate numerically the localization length critical index within the Chalker-Coddington model of the plateau-plateau transitions in the quantum Hall effect. We report a finite-size scaling analysis using both the traditional power-law corrections to the scaling function and the inverse logarithmic ones, which provided a more stable fit resulting in the localization length critical index ν = 2.616 ± 0.014. We observe an increase of the critical exponent ν with the system size, which is possibly the origin of discrepancies with early results obtained for smaller systems.

EuroSCORE: a systematic review of international performance.

The validity of the cardiac surgical scoring system, EuroSCORE, has been assessed by several individual cardiac centres within and outside Europe. We chose to assess the overall international performance by systematic review of peer-reviewed literature. There were six studies meeting our criteria for assessment. Internationally, the evidence is highly suggestive that additive EuroSCORE performance generally over-estimates mortality at lower EuroSCOREs (EuroSCORE13). The effect of this could have serious misrepresentations for surgeons and hospitals operating on differing case-mixes. We suggest that further studies need to be performed on the logistic EuroSCORE calculation to ascertain whether predictive ability is improved. Overall, however, EuroSCORE is the most rigorously evaluated scoring system in cardiac surgery.