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The Minimizing Adverse Haemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox (MATRIX) programme was designed to assess the comparative safety and effectiveness of radial versus femoral access and of bivalirudin versus unfractionated heparin with optional glycoprotein IIb/IIIa inhibitors in patients with the whole spectrum of acute coronary syndrome undergoing invasive management. Here we describe the prespecified final 1-year outcomes of the entire programme. MATRIX was a programme of three nested, randomised, multicentre, open-label, superiority trials in patients with acute coronary syndrome in 78 hospitals in Italy, the Netherlands, Spain, and Sweden. Patients with ST-elevation myocardial infarction were simultaneously randomly assigned (1:1) before coronary angiography to radial or femoral access and to bivalirudin, with or without post-percutaneous coronary intervention infusion or unfractionated heparin (one-step inclusion). Patients with non-ST-elevation acute coronary syndrome were randomly assigned (1:1) before coronary angiography to radial or femoral access and, only if deemed eligible to percutaneous coronary intervention after angiography (two-step inclusion), entered the antithrombin type and treatment duration programmes. Randomisation sequences were computer generated, blocked, and stratified by intended new or current use of P2Y12 inhibitor (clopidogrel vs ticagrelor or prasugrel), and acute coronary syndrome type (ST-elevation myocardial infarction, troponin-positive, or troponin-negative non-ST-elevation acute coronary syndrome). Bivalirudin was given as a bolus of 0·75 mg/kg, followed immediately by an infusion of 1·75 mg/kg per h until completion of percutaneous coronary intervention. Heparin was given at 70–100 units per kg in patients not receiving glycoprotein IIb/IIIa inhibitors, and at 50–70 units per kg in patients receiving glycoprotein IIb/IIIa inhibitors. Clinical follow-up was done at 30 days and 1 year. Co-primary outcomes for MATRIX access and MATRIX antithrombin type were major adverse cardiovascular events, defined as the composite of all-cause mortality, myocardial infarction, or stroke up to 30 days; and net adverse clinical events, defined as the composite of non-coronary artery bypass graft-related major bleeding, or major adverse cardiovascular events up to 30 days. The primary outcome for MATRIX treatment duration was the composite of urgent target vessel revascularisation, definite stent thrombosis, or net adverse clinical events up to 30 days. Analyses were done according to the intention-to-treat principle. This trial is registered with ClinicalTrials.gov, number NCT01433627. Between Oct 11, 2011, and Nov 7, 2014, we randomly assigned 8404 patients to receive radial (4197 patients) or femoral (4207 patients) access. Of these 8404 patients, 7213 were included in the MATRIX antithrombin type study and were randomly assigned to bivalirudin (3610 patients) or heparin (3603 patients). Patients assigned to bivalirudin were included in the MATRIX treatment duration study, and were randomly assigned to post-procedure infusion (1799 patients) or no post-procedure infusion (1811 patients). At 1 year, major adverse cardiovascular events did not differ between patients assigned to radial access compared with those assigned to femoral access (14·2% vs 15·7%; rate ratio 0·89, 95% CI 0·80–1·00; p=0·0526), but net adverse clinical events were fewer with radial than with femoral access (15·2% vs 17·2%; 0·87, 0·78–0·97; p=0·0128). Compared with heparin, bivalirudin was not associated with fewer major adverse cardiovascular (15·8% vs 16·8%; 0·94, 0·83–1·05; p=0·28) or net adverse clinical events (17·0% vs 18·4%; 0·91, 0·81–1·02; p=0·10). The composite of urgent target vessel revascularisation, stent thrombosis, or net adverse clinical events did not differ with or without post-procedure bivalirudin infusion (17·4% vs 17·4%; 0·99, 0·84–1·16; p=0·90). In patients with acute coronary syndrome, radial access was associated with lower rates of net adverse clinical events compared with femoral access, but not major adverse cardiovascular events at 1 year. Bivalirudin with or without post-procedure infusion was not associated with lower rates of major adverse cardiovascular events or net adverse clinical events. Radial access should become the default approach in acute coronary syndrome patients undergoing invasive management. Italian Society of Invasive Cardiology, The Medicines Company, Terumo, amd Canada Research Chairs Programme.

Drug-eluting stents combining an ultrathin cobalt-chromium stent platform with a biodegradable polymer eluting sirolimus have been shown to be non-inferior or superior to thin-strut, durable-polymer, everolimus-eluting stents in terms of 1 year safety and efficacy outcomes. In the randomised, single-blind, multicentre, non-inferiority BIOSCIENCE trial, we compared biodegradable-polymer sirolimus-eluting stents with durable-polymer everolimus-eluting stents in patients with chronic stable coronary artery disease or acute coronary syndromes. Here, we assess the final 5-year clinical outcomes of BIOSCIENCE with regards to the primary clinical outcome of target lesion failure, which was a composite of cardiac death, target vessel myocardial infarction, and clinically indicated target lesion revascularisation. The primary analysis was done by intention to treat. The BIOSCIENCE trial is registered with ClinicalTrials.gov, number NCT01443104. 2008 (95%) of 2119 patients recruited between March 1, 2012, and May 31, 2013, completed 5 years of follow-up. Target lesion failure occurred in 198 patients (cumulative incidence 20·2%) treated with biodegradable-polymer sirolimus-eluting stents and in 189 patients (18·8%) treated with durable-polymer everolimus-eluting stents (rate ratio [RR] 1·07, 95% CI 0·88–1·31; p=0·487). All-cause mortality was significantly higher in patients treated with biodegradable-polymer sirolimus-eluting stents than in those treated with durable-polymer everolimus-eluting stents (14·1% vs 10·3%; RR 1·36, 95% CI 1·06–1·75; p=0·017), driven by a difference in non-cardiovascular deaths. We observed no difference between groups in cumulative incidence of definite stent thrombosis at 5 years (1·6% in both groups; 1·02, 0·51–2·05; p=0·950). 5-year risk of target lesion failure among all-comer patients undergoing percutaneous coronary intervention is similar after implantation of ultrathin-strut, biodegradable-polymer, sirolimus-eluting stents or thin-strut, durable-polymer, everolimus-eluting stents. Higher incidences of all-cause and non-cardiovascular mortality in patients treated with biodegradable-polymer stents eluting sirolimus than in those treated with durable-polymer stents eluting everolimus warrant careful observation in ongoing clinical trials. Clinical Trials Unit of the University of Bern and Biotronik.

Key Points Ureteral stents are associated with complications including infection, encrustation, haematuria and discomfort that can be caused by tissue irritation The role of bacterial adhesion and biofilm formation on stents in stent-associated UTIs is unclear and development of UTIs and their treatment might depend on patient immune status Encrustation and calcification are common problems that can lead to severe complications, which can be prevented by implementing electronic systems to monitor stent dwell times Metal stents are a good alternative to polymer stents in the treatment of extrinsically caused ureteral obstruction; flexible and drug-eluting metal designs could help ameliorate discomfort and stenosis, respectively Biodegradable ureteral stents could avoid complications, such as encrustation, but flaws in their biocompatibility still need to be addressed Future stent design will focus on biodegradable and metal stents that elute drugs to prevent complications and are engineered to treat specific urological conditions In this Review, Lange et al . give an overview of the main complications associated with commonly used ureteral stents and discuss novel stent designs based on metal or biodegradable materials that could help ameliorate patient discomfort and overcome current problems, such as encrustation and stenosis. Ureteral stents are one of the most commonly used devices in the treatment of benign and malignant urological diseases. However, they are associated with common complications including encrustation, infection, pain and discomfort caused by ureteral tissue irritation and possibly irregular peristalsis. In addition, stent migration and failure due to external compression by malignancies or restenosis occur, albeit less frequently. As these complications restrict optimal stent function, including maintenance of adequate urine drainage and alleviation of hydronephrosis, novel stent materials and designs are required. In recent years, progress has been made in the development of drug-eluting expandable metal stents and biodegradable stents. New engineering technologies are being investigated to provide stents with increased biocompatibility, decreased susceptibility to encrustation and improved drug-elution characteristics. These novel stent characteristics might help eliminate some of the common complications associated with ureteral stenting and will be an important step towards understanding the behaviour of stents within the urinary tract.

Introduction Stent migration is a significant clinical problem in palliation of malignant strictures in the esophagus and gastro-esophageal junction (GEJ). We have compared a newer design of a fully-covered stent to a widely used semi-covered stent using migration >20 mm as the primary outcome variable. Effects on dysphagia, quality of life (QoL) and re-intervention frequency were also investigated. Methods Patients with dysphagia due to non-curable esophagus/GEJ cancer were randomized to receive either a more recent design of a fully-covered stent (n = 48) or a conventional semi-covered stent (n = 47). Chest x-ray, dysphagia and QoL were studied at baseline, one week, four weeks and three months thereafter. Results There were no significant differences either in stent migration distance or in the migration frequency. Stent migration during the total study period occurred in 37.2 % in the semi-covered group compared to 20.0 % for the fully-covered group. Dysphagia was measured with Watson and Ogilvie scores and with the dysphagia module in the QoL scale (QLQ-OG25). On average, there was a tendency to better dysphagia relief for the fully-covered design as scored with the two latter dysphagia instruments (p= 0.081 and p= 0.067) at three months and towards more re-interventions in the semi-covered group (p= 0.083). Conclusion In spite of its somewhat lower intrinsic radial force, the fully-covered stent was comparable to the conventional semi-covered stent with regard to stent migration. The data further suggest a potential benefit of the fully-covered stent in improving dysphagia in patients with longer life expectancy.

Background Failure after total knee arthroplasty (TKA) may be related to emerging technologies, surgical techniques, and changing patient demographics. Over the past decade, TKA use in Korea has increased substantially, and demographic trends have diverged from those of Western countries, but failure mechanisms in Korea have not been well studied. Questions/purposes We determined the causes of failure after TKA, the risk factors for failure, and the trends in revision TKAs in Korea over the last 5 years. Methods We retrospectively reviewed 634 revision TKAs and 20,234 primary TKAs performed at 19 institutes affiliated with the Kleos Korea Research Group from 2008 to 2012. We recorded the causes of failure after TKA using 11 complications from the standardized complication list of The Knee Society, patient demographics, information on index and revision of TKAs, and indications for index TKA. The influences of patient demographics and indications for index TKA on the risk of TKA failure were evaluated using multivariate regression analysis. The trends in revision procedures and demographic features of the patients undergoing revision TKA over the last 5 years were assessed. Results The most common cumulative cause of TKA failure was infection (38%) followed by loosening (33%), wear (13%), instability (7%), and stiffness (3%). However, the incidence of infections has declined over the past 5 years, whereas that of loosening has increased and exceeds that of infection in the more recent 3 years. Young age (odds ratio [OR] per 10 years of age increase, 0.41; 95% confidence interval [CI], 0.37–0.49) and male sex (OR, 1.88; 95% CI, 1.42–2.49) were associated with an increased risk of failure. The percentage of revision TKAs in all primary and revision TKAs remained at approximately 3%, but the annual numbers of revision TKAs in the more recent 3 years increased from that of 2008 by more than 23%. Conclusions Despite a recent remarkable increase in TKA use and differences in demographic features, the causes and risk factors for failures in Korea were similar to those of Western countries. Infection was the most common cause of failure, but loosening has emerged as the most common cause in more recent years, which would prompt us to scrutinize the cause and solution to reduce it. Level of Evidence Level IV, therapeutic study. See the Instructions for Authors for a complete description of levels of evidence.

Background and aimsMigration of duodenal covered self-expandable metallic stents (C-SEMS) is the main cause of stent dysfunction in patients with malignant gastric outlet obstruction. However, the ideal method to prevent migration has not been clarified. We aimed to evaluate the feasibility and safety of duodenal C-SEMS fixation in this experimental study.MethodsWe used the over-the-scope clip (OTSC), suture, and clip methods to fix duodenal C-SEMS and evaluated the gripping force of each device and invasion depth based on pathological findings.ResultsThe OTSC and suturing systems had a significantly higher mean gripping force compared with the clipping system (OTSC vs. clip: 13.2 vs. 1.0 Newtons [N], P < 0.001; suture vs. clip: 8.5 vs. 1.0 N, P < 0.001). OTSC compression was stronger compared with suturing (OTSC vs. suture: 13.2 vs. 8.5 N, P = 0.006). The submucosal layer, but not the muscle layer, was compressed more widely and deeply by OTSC compared with clips based on pathological findings by hematoxylin and eosin staining.ConclusionBoth OTSC and suturing methods used for duodenal C-SEMS fixation were feasible compared with the clipping method. The pathological evaluation of invasion depth indicated that OTSC may be safe even for preventive use. This study suggested that these methods can be applied clinically for duodenal C-SEMS fixation.

Background Hemophilic arthropathy, resulting from recurrent joint bleeding in patients with hemophilia, often necessitates total hip arthroplasty (THA) to alleviate pain and improve joint function. However, the unique challenges posed by hemophilia, including coagulopathy and compromised bone health, result in increased risks of complications such as bleeding, infection, and prosthesis loosening. Methods A systematic search of PubMed, Cochrane Library, EMBASE, and Web of Science was conducted up to September 2024. Studies reporting prosthesis survival or complications in hemophilia patients undergoing THA were included. Methodological quality was assessed using the Methodological Index for Non-Randomized Studies (MINORS) criteria. Results Fourteen retrospective cohort studies, encompassing 190 THA cases, were included. A total of 190 THA cases were involved, of which 175 prostheses survived, with aseptic loosening (57%) being the leading cause of failure. Complications included bleeding (34.8%), infections (19.7%), and aseptic loosening (15.1%). Key risk factors included reduced bone mineral density, recurrent hemarthrosis, and immune dysfunction (HIV) due to clotting factor infusions. Strategies such as preoperative optimization of clotting factors and bone quality were highlighted as crucial for improving outcomes. Conclusions This paper confirms the findings of previous studies that THA is an effective treatment for advanced-stage haemophilic arthropathy, offering significant pain relief and improved function. However, its high rate of complications has to be reduced with a correct perioperative hemostasis and a good surgical technique. This type of surgery should only be performed in centers specialized in the treatment of haemophilia by a team of surgeons expert in the implantation of hip prostheses.

Background The incidence of intertrochanteric hip fracture is expected to increase as the global population ages. It is one of the most important causes of mortality and morbidities in the geriatric population. The incidence of reverse oblique and transverse intertrochanteric (AO/OTA 31-A3) fractures is relatively low; however, the incidence of implant failure in AO/OTA 31-A3 fractures is relatively high compared with that in AO/OTA 31-A1 and A2 fractures. To date, the risk factors for implant failure in AO/OTA 31-A3 fractures treated with proximal femoral nail antirotation (PFNA) have remained ambiguous. The purpose of this study was to identify the predictive factors of implant failure in AO/OTA 31-A3 fractures treated with PFNA. Methods The data of all patients who underwent surgery for trochanteric fractures at our institution between January 2006 and February 2018 were retrospectively reviewed. All AO/OTA 31-A3 fractures treated with PFNA were included. Logistic regression analysis of potential predictors of implant failure was performed. Potential predictors included age, sex, body mass index, fracture type, reduction method, status of posteromedial support and lateral femoral wall, reduction quality, tip-apex distance and position of the helical blade in the femoral head. Results One hundred four (9.3%) patients with AO/OTA 31-A3 fractures were identified. Forty-five patients with AO/OTA 31-A3 fractures treated with PFNA were suitable for our study. Overall, implant failure occurred in six (13.3%) of forty-five patients. Multivariate analysis identified poor reduction quality (OR, 28.70; 95% CI, 1.91–431.88; p  = 0.015) and loss of posteromedial support (OR, 18.98; 95% CI, 1.40–257.08; p  = 0.027) as factors associated with implant failure. Conclusions Poor reduction quality and loss of posteromedial support are predictors of implant failure in reverse oblique and transverse intertrochanteric fractures treated with PFNA.

Background Femoral neck fractures are one of the problems in clinical treatment. The prognosis is uncertain. Currently, No internal fixation method is superior to other internal fixation methods in the treatment of femoral neck fractures. Therefore, the internal fixation system needs to be further explored. The aim of this study was to compare clinical outcomes of femoral neck dynamic compression locking system (DCLS) and multiple cannulated compression screws(MCCS) in the treatment of femoral neck fractures. Methods A prospective analysis of 54 cases of femoral neck fractures treated with either a DCLS ( n  = 28) or MCCS ( n  = 26) was conducted between December 2015 and November 2017 in authors’ hospitals. The perioperative and postoperative parameters of the two groups were recorded and evaluated. Results Fifty-four patients were followed up for 24–47 months. The etiology was caused by a fall. There was no significant difference in follow-up time, operation time, incision length, surgical blood loss, the incidence of perioperative and postoperative healing complications, and mobility in the two groups (all P  > 0.05). The Harris score, fracture healing time, femoral neck shortening, partial weight-bearing time and complete weight-bearing time were significantly better in the DCLS group than in the MCCS group (all P  < 0.05). The fracture healing rate in the DCLS group was higher than that in the MCCS group. Conclusions The DCLS and MCCS might be equally effective in terms of operation time, incision length, surgical blood loss, the incidence of perioperative and postoperative healing complications, and mobility in the treatment of femoral neck fractures. However, the DCLS is superior to the MCCS in Harris score, fracture healing time, femoral neck shortening, weight-bearing time and fracture healing rate. So, DCLS deserves further study.

Background The Orbera intragastric balloon (IGB) has been approved by the US Food and Drug Administration for use in patients with a body mass index (BMI) between 30 and 40 kg/m 2 and is in wide use worldwide as a primary and bridge obesity management tool. The balloon filling volume (BFV) ranges between 400 and 700 mL of saline. Our objective was to determine whether there is an association between BFV and clinically relevant endpoints, namely weight loss outcomes, balloon tolerability, and adverse events. Methods A systematic review of studies investigating the use of the Orbera IGB system for obesity treatment was performed. Data was examined using random effects modelling and meta-regression analyses. Results Forty-four studies ( n  = 5549 patients) reported BFV and % total body weight loss (TBWL) at 6 months. Pooled %TBWL at 6 months was 13.2% [95% CI 12.3–14.0]. A funnel plot demonstrated a low risk of publication bias. Meta-regression showed no statistically significant association between filling volume and %TBWL at 6 months ( p  = 0.268). Higher BFV was associated with lower rates of esophagitis (slope = −0.008, p  < 0.001) and prosthesis migration (slope = −0.015, p  < 0.001). There was no association between BFV and early removal ( p  = 0.1), gastroesophageal reflux symptom ( p  = 0.64), or ulcer rates ( p  = 0.09). Conclusions No association was observed between Orbera IGB filling volume and weight loss outcomes. Higher volumes appear to be associated with lower migration and esophagitis rates; thus, a balloon filling volume of 600–650 mL is recommended.