Background The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks. The planned roll-out in the UK will involve vaccinating people in high-risk categories with their first dose immediately, and delivering the second dose 12 weeks later. Here, we provide both a further prespecified pooled analysis of trials of ChAdOx1 nCoV-19 and exploratory analyses of the impact on immunogenicity and efficacy of extending the interval between priming and booster doses. In addition, we show the immunogenicity and protection afforded by the first dose, before a booster dose has been offered. Methods We present data from three single-blind randomised controlled trials—one phase 1/2 study in the UK (COV001), one phase 2/3 study in the UK (COV002), and a phase 3 study in Brazil (COV003)—and one double-blind phase 1/2 study in South Africa (COV005). As previously described, individuals 18 years and older were randomly assigned 1:1 to receive two standard doses of ChAdOx1 nCoV-19 (5 × 10 10 viral particles) or a control vaccine or saline placebo. In the UK trial, a subset of participants received a lower dose (2·2 × 10 10 viral particles) of the ChAdOx1 nCoV-19 for the first dose. The primary outcome was virologically confirmed symptomatic COVID-19 disease, defined as a nucleic acid amplification test (NAAT)-positive swab combined with at least one qualifying symptom (fever ≥37·8°C, cough, shortness of breath, or anosmia or ageusia) more than 14 days after the second dose. Secondary efficacy analyses included cases occuring at least 22 days after the first dose. Antibody responses measured by immunoassay and by pseudovirus neutralisation were exploratory outcomes. All cases of COVID-19 with a NAAT-positive swab were adjudicated for inclusion in the analysis by a masked independent endpoint review committee. The primary analysis included all participants who were SARS-CoV-2 N protein seronegative at baseline, had had at least 14 days of follow-up after the second dose, and had no evidence of previous SARS-CoV-2 infection from NAAT swabs. Safety was assessed in all participants who received at least one dose. The four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov , NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005). Findings Between April 23 and Dec 6, 2020, 24 422 participants were recruited and vaccinated across the four studies, of whom 17 178 were included in the primary analysis (8597 receiving ChAdOx1 nCoV-19 and 8581 receiving control vaccine). The data cutoff for these analyses was Dec 7, 2020. 332 NAAT-positive infections met the primary endpoint of symptomatic infection more t...

Background-Estimation of an individual patient's risk for postoperative dialysis can support informed clinical decision making and patient counseling. Methods and Results-To develop a simple bedside risk algorithm for estimating patients' probability for dialysis after cardiac surgery, we evaluated data of 449 524 patients undergoing coronary artery bypass grafting (CABG) and/or valve surgery and enrolled in Ͼ600 hospitals participating in the Society of Thoracic Surgeons National Database (2002Database ( -2004. Logistic regression was used to identify major predictors of postoperative dialysis. Model coefficients were then converted into an additive risk score and internally validated. The model also was validated in a second sample of 86 009 patients undergoing cardiac surgery from January to June 2005. Postoperative dialysis was needed in 6451 patients after cardiac surgery (1.4%), ranging from 1.1% for isolated CABG procedures to 5.1% for CABG plus mitral valve surgery. Multivariable analysis identified preoperative serum creatinine, age, race, type of surgery (CABG plus valve or valve only versus CABG only), diabetes, shock, New York Heart Association class, lung disease, recent myocardial infarction, and prior cardiovascular surgery to be associated with need for postoperative dialysis (c statisticϭ0.83). The risk score accurately differentiated patients' need for postoperative dialysis across a broad risk spectrum and performed well in patients undergoing isolated CABG, off-pump CABG, isolated aortic valve surgery, aortic valve surgery plus CABG, isolated mitral valve surgery, and mitral valve surgery plus CABG (c statisticϭ0.83, 0.85, 0.81, 0.75, 0.80, and 0.75, respectively). Conclusions-Our study identifies the major patient risk factors for postoperative dialysis after cardiac surgery. These risk factors have been converted into a simple, accurate bedside risk tool. This tool should facilitate improved clinician-patient discussions about risks of postoperative dialysis.

The patients in the general thoracic surgery database are elderly, gender balanced, and afflicted by multiple comorbid conditions. Mediastinal lymph node evaluation is common and the pneumonectomy rate is low. The length of stay is short and operative mortality is low, despite frequent postoperative events.

Thoracic surgeons participating in the Society of Thoracic Surgeons General Thoracic Database perform esophagectomy with a low mortality. We identified important predictors of major morbidity and mortality after esophagectomy for esophageal cancer. Volume alone is an inadequate proxy for quality assessment after esophagectomy.

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Background and Aims United Network for Organ Sharing (UNOS) recently implemented a national policy granting priority listing for liver transplantation (LT) in patients who achieved down‐staging of hepatocellular carcinoma (HCC) to Milan criteria. We aimed to evaluate the national experience on down‐staging by comparing two down‐staging groups with (1) tumor burden meeting UNOS down‐staging (UNOS‐DS) inclusion criteria and (2) “all‐comers” (AC‐DS) with initial tumor burden beyond UNOS‐DS criteria versus patients always within Milan. Approach and Results This is a retrospective analysis of the UNOS database of 3,819 patients who underwent LT from 2012 to 2015, classified as always within Milan (n = 3,276), UNOS‐DS (n = 422), and AC‐DS (n = 121). Median time to LT was 12.8 months in long wait regions, 6.5 months in mid wait regions (MWR), and 2.6 months in short wait regions (SWR). On explant, vascular invasion was found in 23.7% of AC‐DS versus 16.9% of UNOS‐DS and 14.4% of Milan (P = 0.002). Kaplan‐Meier 3‐year post‐LT survival was 83.2% for Milan, 79.1% for UNOS‐DS (P = 0.17 vs. Milan), and 71.4% for AC‐DS (P = 0.04 vs. Milan). Within down‐staging groups, risk of post‐LT death in multivariable analysis was increased in SWR or MWR (hazard ratio [HR], 3.1; P = 0.005) and with alpha‐fetoprotein (AFP) ≥ 100 ng/mL at LT (HR, 2.4; P = 0.009). The 3‐year HCC recurrence probability was 6.9% for Milan, 12.8% for UNOS‐DS, and 16.7% for AC‐DS (P < 0.001). In down‐staging groups, AFP ≥ 100 (HR, 2.6; P = 0.02) was the only independent predictor of HCC recurrence. Conclusions Our results validated UNOS‐DS criteria based on comparable 3‐year survival between UNOS‐DS and Milan groups. Additional refinements based on AFP and wait time may further improve post‐LT outcomes in down‐staging groups, especially given that reported 3‐year recurrence was higher than in those always within Milan criteria.

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Background-Use of an internal mammary artery (IMA) is a well-recognized, nationally endorsed quality indicator for evaluating the process of operative care for coronary artery bypass graft surgery.