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Learning objectives One in three of us will be diagnosed with atrial fibrillation (AF) at some point in our lives.1 Over 1.2 million individuals in the UK have been diagnosed with AF, and thousands still remain undiagnosed.2 3 Due to the ageing population, the number of individuals with AF in Europe will double in the next 50 years,3 contrasting with a fall in the incidence of myocardial infarction and stroke over recent decades.4 This shift in cardiovascular epidemiology is important as AF associates with a myriad of cardiovascular and non-cardiovascular complications (figure 1), and contributes to a 1.5-fold to 2.0-fold increase in all-cause mortality.5 Figure 1 Clinical events in the atrial fibrillation population. Cerebrovascular complications in red, other cardiovascular events in blue and other risks in green. Relative risk and 95% CIs are illustrated based on Odutayo et al. 5 The risk of ischaemic stroke in patients with AF is three to five times higher,6 with AF found in up to 30% of patients admitted with ischaemic stroke, and associated with a higher risk of fatal outcome.7 The risk of AF-related stroke can be mitigated through anticoagulation, with a 66% risk reduction with vitamin K antagonists (VKAs) and at least similar effectiveness with non-VKA.8 Stroke rates in patients with adequately anticoagulated AF are similar to those of patients without documented AF,9 with only 1 …

BackgroundPatients with Fabry disease (FD) on reduced dose of agalsidase-beta or after switch to agalsidase-alfa show a decline in chronic kidney disease epidemiology collaboration-based estimated glomerular filtration rate (eGFR) and a worsened plasma lyso-Gb3 decrease. Hence, the most effective dose is still a matter of debate.MethodsIn this prospective observational study, we assessed end-organ damage and clinical symptoms in 78 patients who had received agalsidase-beta (1.0 mg/kg) for >1 year, which were assigned to continue this treatment (agalsidase-beta, regular-dose group, n=17); received a reduced dose of agalsidase-beta and subsequent switch to agalsidase-alfa (0.2 mg/kg) or a direct switch to 0.2 mg/kg agalsidase-alfa (switch group, n=22); or were re-switched to agalsidase-beta after receiving agalsidase-alfa for 12 months (re-switch group, n=39) with a follow-up of 88±25 months.ResultsNo differences for clinical events were observed for all groups. Patients within the re-switch group started with the worst eGFR values at baseline (p=0.0217). Overall, eGFR values remained stable in the regular-dose group (p=0.1052) and decreased significantly in the re-switch and switch groups (pConclusionsOur data suggest that a re-switch to high dosage of agalsidase results in a better biochemical response, but not in a significant renal amelioration especially in classical males.

Learning objectives Specialist outpatient clinics were first established by cardiologists with a broader involvement in valve disease including inpatient opinions and care (figure 1).1 2 This article will concentrate on the core outpatient clinic. Figure 1 Roles of a specialist valve clinic. This includes the clinical and organisational aims of the valve clinic itself and the broader aims of a comprehensive valve service. GP, general practitioner, MDT, multidisciplinary team meeting. Guidelines3–5 now recommend prophylactic surgery for severe mitral regurgitation caused by prolapse provided that repair can be virtually guaranteed at close to zero risk. This has led to discussion of service requirements and quality standards to define ‘heart valve centres’.6 7 Valve clinics are important in a heart valve centre since their core aim is to follow patients and refer to a surgeon before significant left ventricular (LV) decompensation or adverse clinical events supervene. However, valve clinics can also improve care in district hospitals with no onsite cardiac surgery or transcatheter programmes. It is easy to see valve care almost exclusively in terms of surgery or interventional procedures since these dominate cost, commercial concerns, news items and in consequence governmental and regulatory discussions. However, the majority of patients in hospital services are initially managed conservatively (figure 2).8–11 Furthermore, a large proportion of patients with valve disease are undiagnosed or being seen within the community and better methods of detection and …

Background:The Observational and Medical Outcomes Partnerships (OMOP) common data model (CDM) provides a framework for standardising health data.Objectives:To map national biologic registry data collected from different European countries to the OMOP CDM.Methods:Five biologic registries are currently being mapped to the OMOP CDM: 1) the Czech biologics register (ATTRA), 2) Registro Español de Acontecimientos Adversos de Terapias Biológicas en Enfermedades Reumáticas (BIOBADASER), 3) British Society for Rheumatology Biologics Register for Rheumatoid Arthritis (BSRBR-RA), 4) German biologics register ‘Rheumatoid arthritis observation of biologic therapy’ (RABBIT), and 5) Swiss register ’Swiss Clinical Quality Management in Rheumatic Diseases’ (SCQM).Data collected at baseline are being mapped first. Details that uniquely identify individuals are mapped to the person table, with the observation_period table defining the time a person may have had clinical events recorded. Baseline comorbidities are mapped to the condition_occurrence CDM table, while baseline medications are mapped to the drug_exposure CDM table. This mapping is summarised in Figure 1.Figure 1.Overview of initial mappingResults:A total of 64,901 individuals are included in the 5 registries being mapped to the OMOP CDM, see table 1. The number of unique baseline conditions being mapped range from 17 in BSRBR-RA to 108 in RABBIT, while the number of baseline medications range from 26 in ATTRA to 802 in BSRBR-RA. Those registries which captured more comorbidities or medications generally allowed for these to be inputted as free text.Table 1.Summary of initial code mappingRegistryNumber of individualsNumber of mapped baseline conditionsNumber of mapped baseline medicationsATTRA5,3262626BIOBADASER6,4963051BSRBR-RA21,69517802RABBIT13,06210878SCQM18,3222633Conclusion:Due to differences in study design and data capture, the baseline information captured on comorbidities and drugs across registries varies greatly. However, these data have been mapped and mapping biologic registry data to the OMOP CDM is feasible. The adoption of the OMOP CDM will facilitate collaboration across registries and allow for multi-database studies which include data from both biologic registries and other sources of health data which have been mapped to the CDM.Disclosure of Interests:Edward Burn: None declared, Lianne Kearsley-Fleet: None declared, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Martin Schaefer: None declared, Doreen Huschek: None declared, Anja Strangfeld Speakers bureau: AbbVie, BMS, Pfizer, Roche, Sanofi-Aventis, Jakub Zavada Speakers bureau: Abbvie, UCB, Sanofi, Elli-Lilly, Novartis, Zentiva, Accord, Markéta Lagová: None declared, Delphine Courvoisier: None declared, Christoph Tellenbach: None declared, Kim Lauper: None declared, Carlos Sánchez-Piedra: None declared, Nuria Montero: None declared, Jesús-Tomás Sanchez-Costa: None declared, Daniel Prieto-Alhambra Grant/research support from: Professor Prieto-Alhambra has received research Grants from AMGEN, UCB Biopharma and Les Laboratoires Servier, Consultant of: DPA’s department has received fees for consultancy services from UCB Biopharma, Speakers bureau: DPA’s department has received fees for speaker and advisory board membership services from Amgen

ObjectivesN-terminal pro-B-type natriuretic peptide (NT-pro-BNP) is an unfavourable factor responsible for poor outcomes in the cardiovascular diseases. Nevertheless, the prognostic role of NT-pro-BNP in type B aortic dissection (TBAD) remains unclear. The aim of the current study was to investigate the relationship between NT-pro-BNP levels and in-hospital and long-term adverse prognosis in patients with TBAD.DesignA retrospective multicentre study.SettingLiutie Central Hospital, Nanfang Hospital and Huiyang Hospital in China.ParticipantsA total of 657 consecutive patients with TBAD were enrolled in the study. NT-pro-BNP was measured at admission and included patients were divided into three groups according to the tertiles of NT-pro-BNP (pg/mL): 312 (n=219).Primary and secondary outcome measuresLong-term mortality and in-hospital major adverse clinical events.ResultsOverall, in-hospital death occurred in 27 patients (4.1%), which was significantly higher in upper tertiles of NT-pro-BNP (0.5% vs 4.1% vs 7.8%, p210 pg/mL had 81.5% sensitivity and 58.6% specificity for predicting in-hospital death (area under the curve= 0.774, 95% CI 0.692 to 0.855; p210 pg/mL compared with patients with NT-pro-BNP ≤210 pg/mL (log-rank=26.92, p210 pg/mL was independently associated with long-term death (adjusted HR 2.47, 95% CI 1.45 to 4.22, p=0.001).ConclusionsNT-pro-BNP resulted as an independent predictor of adverse prognosis in patients with TBAD, thus could be used as a potential risk-stratification tool.

Objective To examine morbidity among children with sickle-cell disease (SCD) during and after travel to a tropical area. Design Observational study. Setting Tertiary care children; Robert Debre Hospital, Paris, France. Population Children with SCD younger than 18 years old and managed in the SCD referral centre at the Robert Debre Hospital who travelled to a tropical or subtropical area between 1 June 2009 and 31 December 2009. Main outcome To assess morbidity, we used the number of clinical events requiring medical consultation during the trip as the primary outcome and the number of hospitalisations required after returning as the secondary outcome. Results Thirty-nine children were included. The median age was 7.8 years (4.3–11.7 years). All of the children and their parents attended a pretravel visit focusing on the prevention of travel-related diseases. Twelve children (30%) consulted a physician while they were abroad. Thirteen children (33%) were hospitalised, and 23 children (59%) consulted a physician while they were abroad or within 3 months after returning to France. Considering the 3 months before and after travel, the number of children hospitalised after travel (n=12, 30.7%) was significantly higher than the number hospitalised before (n=4, 10.2%; p=0.01). One child was hospitalised for multifocal osteoarthritis as a complication of Salmonella enterica septicaemia of gastrointestinal origin. Conclusions Travels to tropical areas are associated with high morbidity in children with SCD. Salmonella infection is a particularly significant threat, and empirical antibiotic therapy should be prescribed routinely for traveller9s diarrhoea in this population.

Clinical decision rules (CDRs) for paediatric head injury (HI) exist to identify children at risk of traumatic brain injury. Those of the highest quality are the Canadian assessment of tomography for childhood head injury (CATCH), Children's head injury algorithm for the prediction of important clinical events (CHALICE) and Pediatric Emergency Care Applied Research Network (PECARN) CDRs. They target different cohorts of children with HI and have not been compared in the same setting. We set out to quantify the proportion of children with HI to which each CDR was applicable.Consecutive children presenting to an Australian paediatric Emergency Department with HIs were enrolled. Published inclusion/exclusion criteria and predictor variables from the CDRs were collected prospectively. Using these we determined the frequency with which each CDR was applicable.1012 patients (69.9%) were enrolled with 949 available for analysis. Mean age was 6.8 years (21%2 years). 95% had initial Glasgow Coma Scale 15. CT rate was 12.8% and neurosurgery rate was 0.7%. No CDR was applicable to all patients. CHALICE was applicable to the most (97%, 95% CI 96% to 98%) and CATCH to the fewest (26%, 95% CI 24% to 29%). PECARN was applicable to 76% (95% CI 70% to 82%) aged2 years, and 74% (95% CI 71% to 77%) aged 2-18 years.Each CDR is applicable to a different proportion of children with HI. This makes a direct comparison of the CDRs difficult. Prior to selection of any for implementation they should undergo validation outside the derivation setting coupled with an analysis of their performance accuracy, usability and cost effectiveness.

The children's head injury algorithm for the prediction of important clinical events (CHALICE) is one of the strongest clinical prediction rules for the management of children with head injuries. The authors set out to determine the impact of this rule on the proportion of head injured patients receiving a CT scan in a major Australian paediatric emergency department.Retrospective cohort study.Tertiary paediatric hospital emergency department in Australia (67 000 patients/year).All head injured patients presenting to the emergency department in 2004.Actual proportion of head injured patients receiving a CT scan compared with the proportion had the CHALICE algorithm been applied.There were 1091 head injuries of all severities during the study period. 18% of head injured patients had a Glasgow Coma Scale15, 19% a CT scan and 1.4% neurosurgical intervention. Application of the CHALICE algorithm would result in 46% receiving a CT scan. 303 patients who fit CHALICE criteria did not have a CT scan. These patients were managed with admission for observation or discharge and head injury instructions. Only five of these (1.6% or 0.5% of total head injuries) received a CT scan on representation for ongoing symptoms, four of which showed abnormalities on CT scan.Application of the CHALICE rule to this non-UK dataset would double the proportion of CT scans, with an apparent small gain in delayed pick-up of CT abnormalities. The role of expectant observation in hospital or at home needs to be defined.

Objectives Relationship between atrial fibrillation (AF) and inflammation was shown in previous studies. However, there was limited data about the association between the periodontitis and AF in the long-term follow-up. The aim of this study was to evaluate the impact of periodontitis on long-term clinical outcomes in patients with AF. Methods The Kosin University echocardiography, ECG and periodontitis database were reviewed from 2013 to 2015 to identify patients with AF. Those patients were divided into two groups according to the presence of periodontitis and clinical events including any arrhythmic attack, thromboembolic and bleeding and death were collected during a median of 18 months. Results Among 227 patients with AF, 47 (20.7%) patients had periodontitis. Major adverse cardiac events (MACE) were significantly higher in patients with periodontitis compared with those without periodontitis (p

Objective: To analyse antiphospholipid (aPL) antibody-positive patients using the 2006 revised antiphospholipid syndrome (APS) classification criteria. Methods: A descriptive study of 200 aPL-positive patients identified in a local, hospital-based registry, analysing demographic, clinical and aPL characteristics. Patients were analysed for (1) fulfilment of the 1999 original (Sapporo) and 2006 revised APS classification criteria; (2) non-criteria aPL features (for all aPL-positive patients, based on the 2006 revised criteria definitions); and (3) non-aPL thrombosis risk factors at the time of the clinical events (for patients with APS, based on the 2006 revised criteria stratifications). Results: Of the 200 patients, 183 patients had sufficient data for analysis. Of these, 39 (21%) patients did not meet the laboratory requirement of the original 1999 criteria. Of 81 patients with APS who met the 1999 classification criteria, 47 (58%) also met the 2006 revised criteria. Of 63 asymptomatic (no vascular or pregnancy events) aPL-positive patients who met the laboratory requirement of the 1999 classification criteria, 38 (60%) also met the laboratory requirement of the 2006 revised criteria. More than 50% of the patients with APS with vascular events had identifiable non-aPL thrombosis risk factors at the time of clinical events. Conclusions: Only 59% of the patients meeting the 1999 APS Sapporo classification criteria met the 2006 APS classification criteria. The revised criteria will have positive implications in APS research by way of limiting the inclusion of a heterogeneous group of patients and also by way of providing a risk-stratified approach.

The difficulties in achieving stable international normalised ratios (INRs) are a common concern in clinical practice and have been related to thromboembolic and bleeding risks in a number of clinical trials in patients with atrial fibrillation.1 The paper by Grzymala-Lubanski and colleagues fills an important gap since it provides an in-depth analysis of the clinical impact of warfarin treatment quality in the specific population of patients with mechanical heart valve prostheses, who are at particular risk of thromboembolism and bleeding.2 The time in therapeutic range (TTR) of 72% in the paper by Grzymala-Lubanski and colleagues is consistent with trials performed in atrial fibrillation. However, adherence to treatment is often better in clinical trials than in real life. In addition, this analysis was based on INR management by the Auricula network which uses a computerised dosing system allowing for good INR stability. In Sweden, TTR rates were among the highest in recent international clinical trials on atrial fibrillation. Therefore, it is likely that warfarin treatment quality is less satisfactory in other countries than in Sweden. The relationship between warfarin treatment quality and outcome has seldom been studied in the specific subgroup of patients with mechanical heart valve prostheses. A study published in 2002 found a strong relationship between poor INR stability and all-cause mortality in 1272 patients and this remained significant in multivariable analysis.3 The strength of the paper by Grzymala-Lubanski and colleagues is to confirm and expand these findings in a much larger patient sample and in a contemporary setting with regard to the type of prosthesis and target INRs. The quality of the SWEDEHEART registry is widely acknowledged and the prospective collection of clinical events through the Auricula network ensures …

Commentary on : Easter JS, Bakes K, Dhaliwal J, et al. Comparison of PECARN, CATCH, and CHALICE rules for children with minor head injury: a prospective cohort study. Ann Emerg Med 2014;64:145–52.e5.[OpenUrl][1][CrossRef][2][PubMed][3] The recognition of significant traumatic intracranial injuries is important and cranial CT is the gold standard for their diagnosis. However, CT bears risks associated with ionising radiation-induced malignancies, in particular in children. Three high-quality clinical decision rules (CDR) have been developed to assist with decision-making on whether or not to use a cranial CT scan in children who sustain a trauma to the head1: the Canadian Assessment of Tomography for Childhood Head injury (CATCH)2 the Children's Head injury Algorithm for the prediction of Important Clinical Events (CHALICE)3 and the rule developed by the Pediatric Emergency Care Applied Research Network (PECARN).4 They differ significantly in their predictor variables and suggested course of action. They have been derived using different outcomes, inclusion and exclusion criteria and have focused on different severities … [1]: {openurl}?query=rft.jtitle%253DAnn%2BEmerg%2BMed%26rft.volume%253D64%26rft.spage%253D145%26rft_id%253Dinfo%253Adoi%252F10.1016%252Fj.annemergmed.2014.01.030%26rft_id%253Dinfo%253Apmid%252F24635987%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1016/j.annemergmed.2014.01.030&link_type=DOI [3]: /lookup/external-ref?access_num=24635987&link_type=MED&atom=%2Febmed%2F20%2F1%2F33.atom

Introduction Long-term video-EEG monitoring aids epilepsy management. Anti-epileptic drug reduction is often performed to increase event capture. Patient safety is paramount given the risk of injury or fatality. We completed 3 audit cycles of response times to seizures in our unit. Methods ▸ First audit cycle (2012) – ten patients, 15 events – unit used for diagnosis only ▸ Epilepsy surgery business case approved (July 2013) – additional healthcare professional (HCP) employed to observe patient and room layout modified. Drug reduction regimens implemented. ▸ Second cycle (2014) - five patients, 24 events ▸ Third cycle (2014–15) – 33 patients, 117 events Results Cycle 1: HCP responded to 9 of 14 clinically identifiable events (64%). Median 47 s, mean 317 s (range 18 s–28 minutes). No assessment of cognition. Cycle 2: Response to 19 of 20 clinical events (95%). Median 12 s, mean 25 s (range 0–106 s). Orientation (6/24), motor task (3/24), and speech (2/24) assessed. Recall not assessed. Cycle 3: Response to 104 of 106 clinical events (98%). Median 10 s, mean 35 s (range 0–150 s). Orientation (57/117), motor task (21/117), speech (90/117) and recall (33/117) assessed. Conclusions Each cycle shows improved HCP response. Education and proforma introduction has improved interaction between HCPs and patients but ongoing improvements are needed.

Background Idiopathic pulmonary fibrosis (IPF) is a chronic interstitial lung disease characterised by progressive loss of lung function. Its clinical course is variable but ultimately fatal. There is a need for a multicentre patient registry incorporating longitudinal clinical data and biological samples to improve understanding of the natural history of IPF and contemporary practice patterns. Methods/design The Idiopathic Pulmonary Fibrosis–PRospective Outcomes (IPF-PRO) registry is a national IPF registry in the USA. This registry will enrol approximately 300 patients with newly diagnosed IPF over 2 years at approximately 14 tertiary pulmonary care sites. Participants will be followed for 3–5 years and will receive usual care, as defined by their physician. Clinical data from the year prior to diagnosis will be collected from medical record review on enrolment. Subsequently, data on diagnostic evaluations, pulmonary function tests, physical examinations, laboratory data and clinical events will be collected at routine clinical visits and via a call centre. Participants will complete patient-reported outcome questionnaires at enrolment and then at approximately 6-month intervals. Blood samples for cellular, genetic and transcriptomic analyses will be collected at the same intervals. Results The first results from the IPF-PRO registry will be presented in 2015. Conclusions The IPF-PRO registry will improve understanding of the natural history of IPF, its impact on patients and current practice in the diagnosis and care of patients with IPF. The registry will establish a repository of biological samples from a well-characterised patient population for future research. Clinical trial number NCT01915511.

In this issue of Heart there are several articles of particular interest to clinicians caring for patients with cardiovascular disease. Bicuspid Aortic Valve Disease The association of bicuspid aortic valve disease with aortic dilation is now well recognised. However, it has been less clear whether all patients with a bicuspid aortic valve are at risk of progressive aortic dilation and adverse clinical events or whether we can identify a high risk subgroup. In a comparative study of aortic anatomy, Detaint and colleagues ( See page 126 ) found a high prevalence of aortic dilation in adults with a bicuspid aortic valve. Although the average rate of aortic dilation was similar to Marfan syndrome patients, there was marked variability in the rate of progression with many patients with a bicuspid aortic valve having no evidence for progression aortic dilation. In an accompanying editorial, Professor Della Corte ( See …

About 10-20% of patients dying suddenly or resuscitated from ventricular fibrillation do not have demonstrable heart disease. These people are often young and tragically in some cases sudden death is the first and only clinical event. One of the three main electrophysiological diagnoses to be considered in these situations is the Brugada syndrome. A case of Brugada syndrome is described, together with an example of the classic electrocardiographic manifestations and a discussion of the possible aetiology, diagnosis and management of this condition.

Myocardial infarction (MI) initiates a complex process of repair and adaptation that may lead to adverse remodelling. Left ventricular (LV) remodelling involves both cellular and extracellular components of the myocardium and includes changes on a molecular, cellular and interstitial level with subsequent alterations in the size, shape and function of the LV.1 LV remodelling may be a part of the physiological response to cardiac injury, and in this context, it may be considered as a physiological or adaptive process (adaptive remodelling). On the other hand, while a balanced and incidental response may be beneficial, adverse remodelling is associated with extensive and persistent maladaptive changes within the LV with progressive loss of cardiac function and subsequently, clinical deterioration. Early identification of patients at risk of adverse remodelling is essential to guide treatment and follow-up in this important group of patients with a high risk of adverse clinical events. In the current issue of the Journal, Urbano-Moral et al 2 present an interesting study addressing the ability of circulating biomarkers to predict adverse LV remodelling (see page 1153) . The study was performed in 112 consecutive patients surviving for 6 months, with acute ST-elevation myocardial infarction, successfully revascularized by percutaneous coronary intervention. LV remodelling …

Introduction Apart from clinical events, health-related quality (HRQoL) is an important outcome in high-risk cardiovascular patients. As body mass index has been associated with clinical events (“obesity paradox”), we investigated the relationship between body mass index and health-related quality of life. Methods Patients were included with hypercholesterolaemia and an indication for statin therapy in 1961 primary care practices. HRQoL was assessed with the Short Form (SF)-12 health status instrument at baseline, after 6 and after 12 months. Physicians assessed patient body mass index (BMI). A mixed-effects regression model accounting for the three measurement points was used to investigate (a) the association between BMI and HRQoL at baseline, and (b) the association between change in BMI and change in HRQoL. Results A total of 5082 patients (2165 females) were included. The mean change in BMI within 12 months was 0.05 (SD: 1.11) kg/m2. At baseline, BMI was inversely associated with physical and mental SF-12 summary scores (β [95% CI]=−0.3 [−0.4 to −0.2], and −0.1[−0.1 to 0.0]). An increase in BMI of 1 kg/m2 within 12 months was associated with a significant decrease in physical but not mental SF-12 scores (0.3 [−0.4 to −0.1]). Due to an interaction with gender, the association between change in BMI and physical SF-12 scores was only prevalent in women (β=−0.5 [−0.7 to -0.2], p

Introduction A range of techniques have been described to achieve successful cannulation at ERCP, and when training in ERCP it is often difficult to select the optimum approach .1 There are potential advantages to a wire-led approach and we have evaluated this in our unit in a training setting. Aim To evaluate cannulation success rates for trainers and trainees using a wire-led technique as the default approach. Methods A prospective evaluation was done with 2 experienced trainers and 2 trainees (previous experience of 50–100 ERCPs each). The sphincterotome was pre-loaded with a hydrophilic wire (in limited cases loop tip wire was used) and cannulation started with the wire extending 3–5 mm out of cannula. Attempts were then made to advance the wire deep into the bile duct before injecting any contrast or pushing the cannula through the ampulla. Trainees were allowed 6 min for cannulation attempts. If the wire-led approach failed then other techniques were used. Wire-led cannulation was considered successful only if no other techniques were required. Only cases with a ‘virgin ampulla’ were including in this study. Results 85 cases were included over a 4 month period. Trainees were present in 51/85 (60%) cases. Overall biliary cannulation success was 78/85 (92%). Success rate was 45/51 (88%) if a trainee was present and 33/34 (97%), if no trainee was present. Independent success for trainees was 25/51 (49%), mostly using the wire-led technique (21/25) 84%. In cases where a trainer took over from a trainee, the wire-led approach was still successful in 13/26 (50%). Overall success with the wire-led approach alone was 57/85(67%); other approaches used in remaining cases included pre-cut sphincterotomy, locked PD wire, and PD stent. A peri-ampullary diverticulum was the most common cause for failure of wire-led technique; other common causes included stricture, floppy ampulla, or an impacted stone. Median cannulation time was 6.5 min (IQR 4–10 min) overall and 5 min (IQR 3–10 min) for consultant-only cases. Immediate complications included false passage of wire (1 case, no further clinical events) and late complications: post ERCP pancreatitis (1 case, hospital stay 3 days, no further clinical events). Conclusion Wire-led biliary cannulation, with selective usage of additional techniques, may allow a cannulation rate of >90% in cases with a virgin ampulla. The technique appears to be a useful training tool and has a low complication rate. Reference Gastrointest Endoscopy Clin N Am 2012 Jul;22(3):417–34 Disclosure of Interest None Declared.

Commentary on the paper by Reed et al (see page 859) Over the last year the problem of radiological investigation of the acutely head injured child has been much featured in this journal. We were not so much concerned with what to do with the severely injured—such children are, invariably, intubated and mechanically ventilated, and the most pressing question is to identify whether they need immediate surgery. Head computed tomography (CT) is the obvious investigation. Rather, the real problem arises in the uncooperative 1 to 8 year old who just won’t lie still long enough for CT—is it really worth getting one even if it means endotracheal intubation and a brief anaesthetic, or will a skull x ray suffice, or should the child be admitted for observation until we are sure all is well? Dunning et al reviewed 16 previously published papers and provided us with a meta-analysis of variables that predict significant intracranial injury in minor head trauma.1 Kupperman commented on this report and presented the broader context of what should or shouldn’t be done in the emergency department with this information.2 Later in the year the CHALICE (children’s head injury algorithm for the identification of significant clinical events) study group presented the implications of applying United Kingdom National Institute of Clinical Excellence (NICE) guidelines to the emergency department management of exactly such children.3 The authors reported the theoretical impact of advocating early CT in place of skull x ray and admission. Data from 10 965 children attending three hospitals between February 2000 and August 2002 were used in the model. Twenty five per cent of the patients had a skull x ray, 0.9% had head CT, and 3.7% were admitted. The authors calculated that adherence to the NICE guidelines would have resulted in a …

Introduction/Purpose The goal of the Penumbra System ® Separator 3D Trial (3D RCT) is to assess the safety and effectiveness of the 3D as a component of the Penumbra System ® in the revascularisation of large vessel occlusion in acute ischaemic stroke. The novel Separator 3D, with intraluminal chambers to secure clot, should provide more effective clot removal with the large inner diameter aspiration catheters. Materials and Methods The 3D RCT is a prospective, multicentre, randomised, concurrent controlled, non-inferiority study. Up to 230 patients from 18 to 85 years old who present with large vessel occlusion (≥2.5mm) within 8 hours of symptom onset and are refractory to or not eligible for IV rtPA therapy are eligible. Patients with an NIHSS score of 8 or greater are randomised (1:1) to treatment with the Penumbra System including the 3D device or the Penumbra System alone. The primary endpoints are revascularisation of the target vessel as defined by a TICI score of 2 or 3 and incidence of 24-hour serious adverse events (SAEs). An independent, blinded Core Lab will review and assess imaging scans for TICI scores and ICH. A Clinical Event Committee/Data Safety Monitoring Board will evaluate SAEs and monitor safety. Secondary endpoints include good 90-day neurological and functional outcomes (NIHSS, mRS scores), all cause mortality, and incidence of symptomatic intracranial haemorrhage. Results To date, 25 centres are screening, and 80 patients are enrolled, of which 49 are randomised. Conclusion The Separator 3D Trial will determine if inclusion of a novel 3 dimensional clot retriever as a component of the Penumbra System ® provides efficient revascularisation with acceptable safety. Disclosures D. Frei: 3; C; Penumbra, Inc. A. Siddiqui: None. R. Nogueira: None. E. Mualem: 5; C; Penumbra, Inc. S. Sit: 5; C; Penumbra, Inc. 6; C; Penumbra, Inc. A. Bose: 4; C; Penumbra, Inc. 5; C; Penumbra, Inc.

The Authors’ reply We thank Glenie et al for their correspondence.1 We agree with the points raised and reiterate the importance of recognising obstruction of a catheter by proximal thrombus. Massive intracoronary thrombus is a rare occurrence during PCI and is often associated with significant major adverse clinical events. Managing this condition will often demand a more sophisticated device other than a simple aspiration catheter. There …

Background Umbilical cord is a potential portal of entry for invasive bacteria causing neonatal sepsis and death from serious infections. Studies have used a single swab covering tip, stump and base region for identifying umbilical cord colonization. Information for bacteriological profile of the cord evaluating variation from tip, stump and base is lacking. As a pilot for a large randomized controlled trial of Chlorhexidine intervention the present study aimed to evaluate the variation in colonization at three sites of cord tip/stump/base. Methods Newborns enrolled from hospitals in Delhi (n=56) and Pemba (n=68), three swabs were collected one each from tip, stump and base of the cord. Swabs were sent to laboratory within 6 hours of collection for identification of pathogens. Results Positivity for bacterial colonization at tip was lower than stump and base. Highest positivity for bacterial growth was found at base (Delhi 0hr-16%; 24hrs-23%; Pemba 0hr-20%) followed by stump (Delhi 0hr-7%; 24hrs-27%; Pemba 0hr-11%). Percentage of newborns with positivity at tip was lowest with 5–6%, 3% and 1.97% among Delhi 0hr, 24hrs and Pemba 0hr respectively. At 24hr, the bacterial colonization for stump and base combination increased from 5% (at baseline) to 21.4%. Conclusion With non-significant variation between the three sites for bacterial isolation, for clinical trials evaluating association of colonization with clinical outcomes taking two swabs (one from tip and other from stump and base of the cord) should be adequate. Association between bacterial isolation at each of two sites with clinical events and mortality needs investigation.

A Scottish health authority might have placed patients at risk by failing to take action on critical incident reviews for five years after “losing” the information. NHS Ayrshire and Arran has been accused by the Scottish Information Commissioner Kevin Dunion of the most serious failings in record management and information recovery he has seen in his nine years in office. The problem came to light only when a charge nurse, Rab Wilson, asked for copies of reports from 2005 onwards into serious adverse events that were not being made routinely available to staff. As a result, …

Background The previous studies found a strong relationship between plaque progression and the estimated risk of clinical events using the PROCAM score, and C-reactive protein (CRP) could contribute to predict the risk of coronary disease. Objective To explore whether PROCAM score is associated with coronary stenosis in Chinese patients, and whether CRP can improve PROCAM score9s predictive performance for coronary stenosis. Methods We derived the in-hospital patients data from Shanghai East hospital (China) between December 2008 and December 2009, and they completed the coronary angiography examination, and 353 patients with the completed PROCAM score data. Results The average age of patients were 55.72±5.83 years old, and 58.9 percent of them were male. There was a significantly linear risk gradients between PROCAM score groups and the moderate- and high-grade coronary stenosis (p=0.000), and it was also positive correlated with the number of diseased coronary vessels (the correlation coefficient=0.333, p=0.000). In logistic regression analysis, PROCAM score groups showed positive associated with the risk of moderate- or high-grade coronary stenosis (all p Conclusions PROCAM score is closely positive associated with risk of moderate- or high-grade coronary stenosis in Chinese patients, and it is firstly feasible to apply Western PROCAM score for Chinese, and CRP can mildly improve the PROCAM score9s predictive ability for moderate-grade coronary stenosis.

Objectives and Background Clinical decision rules aid clinicians with the management of head injured patients. This study aimed to identify clinical decision rules for children with minor head injury and compare their diagnostic accuracy for detection of intracranial injury (ICI) and injury requiring neurosurgical intervention (NSI). Methods Relevant studies were identified by an electronic search of key databases. Papers in English were included with a cohort of at least 20 children suffering minor head injury (GCS 13–15). Studies of a decision rule derived to identify patients at risk of ICI or NSI had to include a proportion of the cohort undergoing imaging. Study quality was assessed using the QUADAS checklist. Results 16 publications, representing 14 cohorts, with 79 740 patients were included. Only four rules were tested in more than one cohort. Of the validated rules the paediatric emergency care applied research network (PECARN) rule was most consistent (sensitivity 98%; specificity 58%). For neurosurgical injury all had high sensitivity (98–100%) but the children9s head injury algorithm for the prediction of important clinical events (CHALICE) rule had the highest specificity (86%) in its derivation cohort. The positive predictive value (PPV) for each rule were calculated. Of the large cohorts studied (>10 000 subjects) CHALICE had PPV of 5.4% compared with 2.0% for PECARN for ICI. For NSI the PPV calculated were 4.2% and 0.4% respectively. Conclusion Of the current decision rules for minor head injury the PECARN rule appears the best for children and infants, with the largest cohort, highest sensitivity and acceptable specificity for clinically significant ICI. Application of this rule in the UK would probably result in an unacceptably high rate of CT scans per injury, and continued use of the CHALICE- based NICE guidelines represents an appropriate alternative.

Background Inter-hospital transfer of neonates is increasingly performed by regionalised dedicated transport services. It has been suggested that the risk of adverse events during the transfer episode can be reduced if transfers are performed by dedicated transport teams. Aim To categorise and quantify adverse events that occur during emergency inter-hospital transfers of neonates when transferred by a regionalised dedicated neonatal transfer service. Methods Adverse event data was prospectively collected over a 13 month period between September 2009 and October 2010 during each emergency neonatal transfer performed by our service. Adverse events were categorised into clinical and non-clinical events. Results During the study period, a total of 1289 emergency transfers were undertaken of which adverse event forms were recorded in 560 transfers. In 52% (n=261) of the transfers one or more adverse event was recorded. 179 non-clinical and 152 clinical adverse events were documented with more than one clinical event recorded in a few transfers. Table 1 shows the numbers, percentages and the broad categories of the adverse events. Conclusion Many of the adverse events are potentially preventable. 60% of non-clinical adverse events relate to a delay in emergency transfers due to various reasons. 50% of clinical adverse events related to ventilation difficulties (either related to inappropriate endo-tracheal tube position or over ventilation). We recommend that an outreach education programme by the regionalised transfer service should target these issues.

Background Although C-reactive protein (CRP) has been proposed as a useful biomarker for predicting atherothrombosis, the association of CRP levels and clinical outcomes after drug-eluting stent (DES) implantation has not been defined. Objectives To assess the predictive value of CRP after drug-eluting stent (DES) implantation, especially the association of CRP levels with adverse clinical events, such as stent thrombosis, death, myocardial infarction (MI) and so on. Methods We evaluated 2048 consecutive patients who underwent successful DES implantation. The primary outcomes were stent thrombosis, death, myocardial infarction (MI), and target vessel revascularisation. Results After 2 years of follow-up, there were 11 stent thrombosis, 72 deaths, 113 MI, 133TVR. In multivariable Cox proportional-hazards models, the high CRP remained predictive of adverse cardiac events, elevated levels of CRP were significantly associated with increased risks of stent thrombosis (HR 4.08; 95% CI 1.91 to 11.44; p Conclusions Elevated CRP levels were significantly associated with major coronary events after DES implantation, such as stent thrombosis, death, and MI, demonstrating the additive impacts of active inflammation and myocardial injury on prognosis after DES implantation.

As a medical educationalist and part time general practitioner, I was comfortable reading the first three paragraphs of this case presentation,1 couched in familiar descriptors of a patient’s signs and symptoms. My attention was caught by the issues of the termination choices that Andrea G faced. Initially, the unusual features of her case engaged the amateur clinical detective within me. It soon became apparent, however, that most of this case presentation was a description of clinical events and diagnostic and management dilemmas that are outside my competence, my experience, …

We have every confidence in the clinical safety of our services. There is no evidence in the trust’s adverse clinical event reporting system to support allegations made in the article by Gornall about poor clinical practices allegedly witnessed by Peter Bousfield.1 Mr Bousfield would have had a duty to report through this system in the course of his practice, …

To the editor: We read with interest the paper presented by Brieger et al 1 and feel that it is most worthy of comment. The authors describe the development and internal validation of a risk score for patients with non-ST elevation acute coronary syndrome (NSTEACS), from a global registry, that predicts inpatient freedom-from-events. They present an alternative concept to ACS risk characterisation—rather than the identification of high-risk subjects who merit more intensive management, they elect to create a model that can assist healthcare workers identify lower-risk patients who may benefit less from such treatments. They argue that this is important because the discriminative performance of ACS risk scores designed to identify patients at higher risk of adverse outcomes is limited when applied to patients at lower risk of adverse events. We believe that several key points deserve clarification.

In thinking about this debate I suggest two broad themes to consider before turning to precise clinically based contraindications. The first is that if hormone replacement therapy really is so good for you why do so few women take it? The figures may be changing slightly, but at present in the United Kingdom fewer than 15% of eligible women are thought to start the treatment and fewer than 5% persist with it for more than a couple of years. When patients reject our advice doctors tend to lapse into omnipotence and berate them for their ignorance or fecklessness. It is therefore of great interest that Isaacs et al recently published the results of a study of 1200 women doctors aged between 40 and 60: they found that 40% of those who were postmenopausal had never even tried hormone replacement therapy.1 Is it that our medical colleagues are feckless and ignorant, or is there something they know that Toozs-Hobson and Cardozo and I don't? The second consideration is the very real lack of solid data on which to base decisions about recommending universal prescription of hormone replacement therapy. It would be wonderful to have to hand the results of at least one randomised prospective trial that evaluated the outcome of treatment in terms of clinical events such as rates of fracture or heart attacks. All …

Acyclovir has been shown to shorten the course of chickenpox in otherwise healthy children by 25–33% according to three placebo controlled trials in the United States.1 2 3 All clinical events monitored were favourably affected by acyclovir, with the most important differences being reductions in degree and duration of fever, constitutional illness score, and number of residual lesions present at the 28 day follow up examination. No appreciable adverse events were reported. These studies also identified two subsets of patients particularly suitable for acyclovir therapy: adolescents and children who acquired chickenpox from a family member. The main controversy regarding use of acyclovir is not its clinical usefulness, which is scientifically incontestable, but whether treatment is needed for a relatively benign disease. To fully appreciate the impact of acyclovir on chickenpox you need to make daily visits to treated subjects and controls, as our research nurse clinicians …

A serial study of peripheral blood T lymphocytes in 27 patients with clinically definite multiple sclerosis and 11 healthy controls was carried out over a 12 month period. This showed that contrary to many previous reports, relapses were not consistently associated with reduced numbers of peripheral blood suppressor T lymphocytes or any other T cells. Persistently low T cells numbers, including both the helper and suppressor T cell subsets, were, however, associated with disease activity as measured by the development of increased disability during the course of the study. This was true both for the patients with relapsing/remitting disease and those with progressive disease. The importance of carrying out a serial study was emphasised by the consistent and significant differences that were detected between individuals in both the control and the patient groups. A serial study is the most reliable means by which clinical events can clearly be correlated with laboratory estimations. The association in this study between the development of increased disability and persistently low levels of peripheral blood T lymphocytes suggest that both may be related to the underlying disease process in multiple sclerosis.

Children with homozygous sickle cell (SS) disease and with sickle cell-haemoglobin C (SC) disease, aged 6 1/2 to 8 1/2 years, were examined by fluorescein angiography/angioscopy to determine the presence of retinal nonperfusion. The haematological and clinical features of children with and without nonperfusion were compared. Retinal vessel closure was significantly correlated with low total haemoglobin, and high fetal haemoglobin, reticulocyte, and irreversibly sickled cell counts in SS disease, and with high reticulocyte count in SC disease. No relationships were apparent between vessel closure and other haematological indices or clinical events in either genotype.

The role of 4-channel EEG taped monitoring in the management of patients with severe epilepsy has been evaluated, by examining the recordings from 100 consecutive patients referred for monitoring. Six main reasons for referral have been identified and in 80% of subjects the relevant clinical event was recorded, leading directly to a change in treatment in 57% of cases. This technique has proved to be cost effective and reliable and is particularly valuable in the identification of pseudo seizures.

Three probable cases of neuropathy in alcoholics are described. They are very atypical for three reasons. First, each developed an acute asymmetrical neuropathy for the first time well after ceasing to drink, and after routine saturation with the vitamin B group. Secondly, none had previously suffered from neuropathy while still drinking. If this puzzling reversal of the usual order of clinical events has been noticed before, no record has been found in the literature. Further study by psychiatrists treating alcoholics aided by their neurological colleagues is suggested.