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Background The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery. Methods/design NOTACS is an adaptive, international, multicentre, parallel group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1280 patients. Results This manuscript provides detailed descriptions of the design of the NOTACS trial and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery. Discussion This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the final analysis in order to preserve scientific integrity under an adaptive design framework. A previous version of this SAP was published prior to the interim analysis (Dawson, 2022). The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials (Gamble, 2017). Trial registration ISRCTN14092678 . (13 May 2020).

Background The NOTACS trial will assess the efficacy, safety and cost-effectiveness of high-flow nasal therapy (HFNT) compared to standard oxygen therapy (SOT) on the outcomes of patients after cardiac surgery. Methods/design NOTACS is an adaptive, international, multicentre, parallel-group, randomised controlled trial, with a pre-planned interim sample size re-estimation (SSR). A minimum of 850 patients will be randomised 1:1 to receive either HFNT or SOT. The primary outcome is days alive and at home in the first 90 days after the planned surgery (DAH90), with a number of secondary analyses and cost-effectiveness analyses also planned. The interim SSR will take place after a minimum of 300 patients have been followed up for 90 days and will allow for the sample size to increase up to a maximum of 1152 patients. Results This manuscript provides detailed descriptions of the design of the NOTACS trial, and the analyses to be undertaken at the interim and final analyses. The main purpose of the interim analysis is to assess safety and to perform a sample size re-estimation. The main purpose of the final analysis is to examine the safety, efficacy and cost-effectiveness of HFNT compared to SOT on the outcomes of patients after cardiac surgery. Discussion This manuscript outlines the key features of the NOTACS statistical analysis plan and was submitted to the journal before the interim analysis in order to preserve scientific integrity under an adaptive design framework. The NOTACS SAP closely follows published guidelines for the content of SAPs in clinical trials. Trial registration ISRCTN14092678 . Registered on 13 May 2020.

A tool that focuses on papers — not researcher behaviour — can help readers, editors and institutions assess which publications to trust. A tool that focuses on papers — not researcher behaviour — can help readers, editors and institutions assess which publications to trust.

Too often, journal assessments of potentially unreliable research are superficial, opaque and prolonged. Changes to the guidance given by the Committee on Publication Ethics could tighten up the process. Too often, journal assessments of potentially unreliable research are superficial, opaque and prolonged. Changes to the guidance given by the Committee on Publication Ethics could tighten up the process.

Background. An urgent UK investigation was launched to assess risk of invasive Mycobacterium chimaera infection in cardiothoracic surgery and a possible association with cardiopulmonary bypass heater-cooler units following alerts in Switzerland and The Netherlands. Methods. Parallel investigations were pursued: (1) identification of cardiopulmonary bypass–associated M. chimaera infection through national laboratory and hospital admissions data linkage; (2) cohort study to assess patient risk; (3) microbiological and aerobiological investigations of heater-coolers in situ and under controlled laboratory conditions; and (4) whole-genome sequencing of clinical and environmental isolates. Results. Eighteen probable cases of cardiopulmonary bypass–associated M. chimaera infection were identified; all except one occurred in adults. Patients had undergone valve replacement in 11 hospitals between 2007 and 2015, a median of 19 months prior to onset (range, 3 months to 5 years). Risk to patients increased after 2010 from <0.2 to 1.65 per 10000 person-years in 2013, a 9-fold rise for infections within 2 years of surgery (rate ratio, 9.08 [95% CI, 1.81–87.76]). Endocarditis was the most common presentation (n = 11). To date, 9 patients have died. Investigations identified aerosol release through breaches in heater-cooler tanks. Mycobacterium chimaera and other pathogens were recovered from water and air samples. Phylogenetic analysis found close clustering of strains from probable cases. Conclusions. We identified low but escalating risk of severe M. chimaera infection associated with heater-coolers with cases in a quarter of cardiothoracic centers. Our investigations strengthen etiological evidence for the role of heater-coolers in transmission and raise the possibility of an ongoing, international point-source outbreak. Active management of heater-coolers and heightened clinical awareness are imperative given the consequences of infection.

Objectives Preoperative anaemia is associated with increased morbidity and mortality. We sought to determine the relative frequencies of the different causes of anaemia including absolute and functional iron deficiency, and the association of different haematological parameters, including plasma hepcidin, a key protein responsible for iron regulation, with outcomes after cardiac surgery. Methods Prospective observational study between January 2012 and 2013; 200 anaemic cardiac surgical patients were recruited and 165 were studied. Detailed blood and bone marrow analysis was performed. Primary outcome was days alive and out of hospital. Results Mean (SD) haemoglobin (Hb) was 102 (8) g/L for women and 112 (11) g/L for men. Regarding outcomes, 137 (83%) patients were transfused at least one unit of red blood cells; 30-day mortality was 1.8% (three patients). Functional iron deficiency was diagnosed in 78 patients (47%). Plasma hepcidin concentration was the only haematological variable associated with outcome, with mean days alive and out of hospital 2.7 (95% CI 0.4 to 5.1) days less if hepcidin ≥20 ng/mL compared with <20 ng/mL (p=0.024). Multivariable analysis showed that the association between hepcidin and outcome was independent of risk (European System for Cardiac Operative Risk Evaluation), transfusion and Hb. Conclusions Functional iron deficiency was the most common cause of anaemia but was not associated with outcome. The only haematological parameter that was associated with outcome was hepcidin concentration, which is a novel finding and introduces further complexity into our understanding of the role of iron and its regulation by hepcidin. We propose that future research should target patients with elevated hepcidin.

ObjectivesTo determine the relative contributions of patient risk profile, local and individual clinical practice on length of hospital stay after cardiac surgery.DesignTen-year audit of prospectively collected consecutive cardiac surgical cases. Case-mix adjusted outcomes were analysed in models that included random effects for centre, surgeon and anaesthetist.SettingUK centres providing adult cardiac surgery.Participants10 of 36 UK specialist centres agreed to provide outcomes for all major cardiac operations over 10 years. After exclusions (duplicates, cases operated by more than one consultant, deaths and procedures for which the EuroSCORE risk score for cardiac surgery is not appropriate), there were 107 038 cardiac surgical procedures between April 2002 and March 2012, conducted by 127 consultant surgeons and 190 consultant anaesthetists.Main outcome measureLength of stay (LOS) up to 3 months postoperatively.ResultsThe principal component of variation in outcomes was patient risk (represented by the EuroSCORE and remaining patient heterogeneity), accounting for 95.43% of the variation for postoperative LOS. The impact of the surgeon and centre was moderate (intra-class correlation coefficients ICC=2.79% and 1.59%, respectively), whereas the impact of the anaesthetist was negligible (ICC=0.19%). Similarly, 96.05% of the variation for prolonged LOS (>11 days) was attributable to the patient, with surgeon and centre less but still influential components (ICC=2.12% and 1.66%, respectively, 0.17% only for anaesthetists). Adjustment for year of operation resulted in minor reductions in variation attributable to surgeons (ICC=2.52% for LOS and 2.23% for prolonged LOS).ConclusionsPatient risk profile is the primary determinant of variation in LOS, and as a result, current initiatives to reduce hospital stay by modifying consultant performance are unlikely to have a substantial impact. Therefore, substantially reducing hospital stay requires shifting away from a one-size-fits-all approach to cardiac surgery, and seeking alternative treatment options personalised to high-risk patients.

Adverse neurological complications, including postoperative delirium (POD) and stroke, remain one of the major risks after cardiac surgery. A lack of comprehensive knowledge about their causes and neuroprotective strategies has hindered the development of effective interventions to reduce these events. Personalised cerebral autoregulation (CA)-oriented blood pressure monitoring aims to identify blood pressure targets tailored to each individual patient, thereby reducing brain injury. The PRECISION study aims to assess whether perioperative duration and magnitude of mean arterial pressure (MAP) deviation from an individual's CA limits are associated with adverse neurological complications. This international, multicentre, prospective cohort study is conducted at two Swiss and one British hospital. Patients aged 65 years or older undergoing elective primary or re-operative coronary artery bypass graft and/or valvular and/or ascending aorta surgery requiring cardiopulmonary bypass are included. Preoperatively, the patient's baseline of physical, cognitive and mental status is established. Intraoperatively, near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are recorded in real-time to generate NIRS-derived and TCD-derived CA indices. The primary endpoint is POD, assessed daily on postoperative days 0 to 7 or up to discharge, whichever occurs earlier with the 3D-Confusion Assessment Method (3D-CAM) or CAM-Intensive Care Unit. Secondary endpoints include a composite neurological outcome of POD and overt stroke, postoperative neurocognitive disorders, major morbidity and mortality. Associations between neurologic outcomes, neurobiomarkers and genetic variation will be explored.A total of 500 participants is required to achieve 90% power to find a statistically significant effect of the area under the curve MAP

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