Ave, CESAR, morituri te salutant! (Hail, CESAR, those who are about to die salute you!)

Abstract

Expanded abstract Citation: Peek GJ, Mugford M, Tiruvoipati R, Wilson A, Allen E, Thalanany MM, Hibbert CL, Truesdale A, Clemens F, Cooper N, Firmin RK, Elbourne D: Effi cacy and economic assessment of conventional ventilatory support versus extracorporeal membrane oxygenation for severe adult respiratory failure (CESAR): a multicentre randomised controlled trial. Lancet 2009, 374:1351-1363. [1]. Background: Severe acute respiratory failure in adults causes high mortality despite improvements in ventilation techniques and other treatments (e.g., steroids, prone positioning, bronchoscopy, and inhaled nitric oxide). Methods: Objective: We aimed to delineate the safety, clinical efficacy, and cost-eff ectiveness of extracorporeal membrane oxygenation (ECMO) compared with conventional ventilation support. Design: Randomized controlled trial. Setting: UK-based multicenter trial from July 2001 to August 2006. Subjects: 180 adults aged 18–65 years with severe (Murray score >3.0 or pH <7.20) but potentially reversible respiratory failure. Exclusion criteria were: high pressure (>30 cm H2 O of peak inspiratory pressure) or high FiO2 (>0.8) ventilation for more than 7 days; intracranial bleeding; any other contraindication to limited heparinization; or any contraindication to continuation of active treatment. Intervention: Subjects were randomly assigned in a 1:1 ratio to receive continued conventional management or referral to consideration for treatment by ECMO. Outcomes: The primary outcome was death or severe disability at 6 months after randomization or before discharge from hospital. Primary analysis was by intention to treat. Only researchers who did the 6-month follow-up were masked to treatment assignment. Data about resource use and economic outcomes (quality-adjusted life-years) were collected. Studies of the key cost generating events were undertaken, and we did analyses of cost-utility at 6 months after randomization and modeled lifetime cost-utility. Results: 766 patients were screened; 180 were enrolled and randomly allocated to consideration for treatment by ECMO (n=90 patients) or to receive conventional management (n=90). 68 (75%) patients actually received ECMO; 63% (57/90) of patients allocated to consideration for treatment by ECMO survived to 6 months without disability compared with 47% (41/87) of those allocated to conventional management (relative risk 0.69; 95% CI 0.05-0.97, p=0.03). Referral to consideration for treatment by ECMO led to a gain of 0.03 quality-adjusted life-years (QALYs) at 6-month follow-up. A lifetime model predicted the cost per QALY of ECMO to be £19 252 (95% CI 7622-59 200) at a discount rate of 3.5%. Conclusions: We recommend transferring of adult patients with severe but potentially reversible respiratory failure, whose Murray score exceeds 3.0 or who have a pH of less than 7.20 on optimum conventional management, to a centre with an ECMO-based management protocol to signifi cantly improve survival without severe disability. This strategy is also likely to be cost-eff ective in settings with similar services to those in the UK. (ISRCTN47279827