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Wald D.S.,Queen Mary, University of London | Morris J.K.,Queen Mary, University of London | Wald N.J.,Queen Mary, University of London | Chase A.J.,Morriston Hospital | And 4 more authors.
New England Journal of Medicine | Year: 2013

BACKGROUND: In acute ST-segment elevation myocardial infarction (STEMI), the use of percutaneous coronary intervention (PCI) to treat the artery responsible for the infarct (infarct, or culprit, artery) improves prognosis. The value of PCI in noninfarct coronary arteries with major stenoses (preventive PCI) is unknown. METHODS: From 2008 through 2013, at five centers in the United Kingdom, we enrolled 465 patients with acute STEMI (including 3 patients with left bundle-branch block) who were undergoing infarct-artery PCI and randomly assigned them to either preventive PCI (234 patients) or no preventive PCI (231 patients). Subsequent PCI for angina was recommended only for refractory angina with objective evidence of ischemia. The primary outcome was a composite of death from cardiac causes, nonfatal myocardial infarction, or refractory angina. An intention-to-treat analysis was used. RESULTS: By January 2013, the results were considered conclusive by the data and safety monitoring committee, which recommended that the trial be stopped early. During a mean follow-up of 23 months, the primary outcome occurred in 21 patients assigned to preventive PCI and in 53 patients assigned to no preventive PCI (infarct-artery- only PCI), which translated into rates of 9 events per 100 patients and 23 per 100, respectively (hazard ratio in the preventive-PCI group, 0.35; 95% confidence interval [CI], 0.21 to 0.58; P<0.001). Hazard ratios for the three components of the primary outcome were 0.34 (95% CI, 0.11 to 1.08) for death from cardiac causes, 0.32 (95% CI, 0.13 to 0.75) for nonfatal myocardial infarction, and 0.35 (95% CI, 0.18 to 0.69) for refractory angina. CONCLUSIONS: In patients with STEMI and multivessel coronary artery disease undergoing infarctartery PCI, preventive PCI in noninfarct coronary arteries with major stenoses significantly reduced the risk of adverse cardiovascular events, as compared with PCI limited to the infarct artery. Copyright © 2013 Massachusetts Medical Society. Source

OBJECTIVES: Laparoscopic techniques have been slow to establish a role in pancreatic surgery. Worldwide, laparoscopic left pancreatectomy (LLP) is gaining in popularity; however, there remains little published data from the United Kingdom.We aimed to evaluate the results of LLP performed in a single UK pancreatic unit. METHODS: Patients undergoing LLP for lesions in the body and tail of the pancreas between April 2009 and April 2015 were identified. Patient records were reviewed retrospectively. RESULTS: Laparoscopic left pancreatectomy was performed on 46 patients, median age, 62 years (range, 19-84). The spleen was preserved in 27 patients (93% of planned), and 6 (13%) operations were converted to open. The overall morbidity rate was 39%; 28 patients had no complications. Significant complications were seen in 7 (15%) patients; this included 3 pancreatic fistula (6.5%) and 1 mortality (2%). Median length of stay was 6 days (range, 3-28). Histology revealed 15 neuroendocrine tumors, 8 adenocarcinomas, 4 mucinous cystadenomas, 1 intraductal papillary mucinous neoplasm, 2 metastases, and 16 other benign pathologies. CONCLUSIONS: Laparoscopic pancreatic surgery has a low risk of significant complications. Our results offer encouragement to identify LLP as the gold standard approach for premalignant lesions. Further work should clarify the outcomes for malignant lesions. Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved. Source

Rawat S.,Morriston Hospital | Dingley J.,University of Swansea
Anesthesia and Analgesia | Year: 2010

Background: Xenon (Xe) is an anesthetic with minimal side effects, now also showing promise as a neuroprotectant both in vitro and in vivo. Although scarce and expensive, Xe is insoluble and patient uptake is low, making closed circuits the optimum delivery method. Although the future of Xe anesthesia is uncertain, effective neuroprotection is highly desirable even if moderately expensive. A factor limiting Xe research in all these fields may be the perceived need to purchase special Xe anesthesia workstations that are expensive and difficult to service. We investigated the practicality of 1) true closed-circuit Xe delivery using an unmodified anesthesia workstation with gas monitoring/delivery attachments restricted to breathing hoses only, 2) a Xe delivery protocol designed to eliminate wastage, and 3) recovering Xe from exhaled gas. Methods: Sixteen ASA physical status I/II patients were recruited for surgery of >2 h. Denitrogenation with 100% oxygen was started during induction and tracheal intubation under propofol/remifentanil anesthesia. This continued after operating room transfer for 30 min. All fresh gases were then temporarily stopped, metabolic oxygen consumption then being replaced with 250-mL Xe boluses until FIXe = 50%. A basal oxygen fresh gas flow was thereafter restored with additional Xe given as required via the expiratory hose to maintain a FIXe ≥ 50%. At no time, apart from during circle flushes every 90 min, were the bellows allowed to completely fill and spill gas, ensuring the circle remained closed. On termination of anesthesia, the first 10 exhaled breaths were collected as was residual gas from the circle, allowing measurement of the Xe content of each. Results: Total Xe consumption, including initial wash-in and circle flushes, was 12.62 (5.31) L or 4.95 (0.82) L/h, mean (sd). However, consumption during maintenance periods was lower: 3 L/h at 1 h and 2 L/h thereafter. Of the total Xe used, 8.98% (5.94%) could be recovered at the end of the procedure. Conclusions: We report that closed-circuit Xe delivery can be achieved with a modified standard anesthesia workstation with breathing hose alterations only and that the protocol was very gas efficient, especially during the normally wasteful Xe wash-in. A Xe mixture of ≥50% was delivered for up to 341 min (5 h 41 min) and Xe consumption was 4.95 (0.82) L/h, maintenance being achieved with 2-3 L/h. With this degree of efficiency, Xe recovery/recycling at the end of anesthesia may be of little additional benefit. Copyright © 2009 International Anesthesia Research Society. Source

Mofidi A.,Morriston Hospital | Conditt M.A.,MAKO Corporation
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2014

Purpose: The purpose of this study was to analyse the accuracy of component placement during unicompartmental knee arthroplasty (UKA) using a robotic-assisted system. Methods: Two hundred and six patients (232 knees) who underwent medial robotic-assisted UKA were retrospectively studied. Femoral and tibial sagittal and coronal alignments were measured in the post-operative radiographs and were compared with the equivalent measurements collected during the intra-operative period by the robotic system. Mismatch between pre-planning and post-operative radiography was assessed against accuracy of the prosthesis insertion. Results: Robotic-assisted surgery for medial UKA resulted in an average difference of 2.2° ± 1.7° to 3.6° ± 3.3° depending on the component and radiographic view between the intra-operatively planned and post-operative measurements. Mismatch between pre-planning and post-operative radiography (inaccuracy) was related to improper cementing technique of the prosthesis in all measurements (except for tibial sagittal axis) rather than wrong bony cuts performed by the robotic arm. Conclusion: Robotic-assisted medial UKA results in accurate prosthesis position. Inaccuracy may be attributed to suboptimal cementing technique. Level of evidence: Comparative retrospective study, Level III. © 2014 Springer-Verlag Berlin Heidelberg. Source

Mikhail A.,Morriston Hospital | Farouk M.,Amgen
Advances in Therapy | Year: 2013

Biosimilars have been developed for several biologic therapeutic agents, including erythropoiesis-stimulating agents (ESAs). However, biosimilars cannot be assumed to be completely identical to the reference product, nor can two different biosimilars of the same reference product be considered equivalent. Accordingly, standards for approving biosimilars are distinct from those for generic versions of conventional pharmaceuticals. By late 2007, two biosimilar epoetins (HX575 and SB309) had been approved by the European Medicines Agency (EMA), following a series of pharmacokinetic and pharmacodynamic equivalence studies, as well as phase 3 clinical comparability evaluations. Additionally, the results of a limited number of postauthorization interventional or observational studies and quality comparisons were published subsequently on both products. The reported differences in glycosylation profiles between these epoetin biosimilars and their reference product, as well as the lack of long-term safety and efficacy evaluation, could indicate a need to develop a more comprehensive analysis of the available data, and to evaluate the post-authorization real-life data, in order to gain a better understanding of any potential implications of molecular structural or formulation differences on longterm safety and effectiveness. Switching between an original reference ESA and a biosimilar (and possibly also switching between biosimilar versions of the same product) should be regarded as a change in clinical management. Clinicians need to be fully involved in such decisions. Prescribing by brand name will prevent unintentional substitution by pharmacists and allow for effective pharmacovigilance, in accordance with recent EU directives. In this review, the authors have analyzed most of the published information on the two epoetin biosimilars, HX575 and SB309, to highlight the points that healthcare providers may need to consider when assessing an epoetin biosimilar. © The Author(s) 2012. This article is published with open access at Springerlink.com. Source

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