IntroductionSpinal cord injury (SCI) including permanent paraplegia constitutes a common complication after repair of thoracoabdominal aortic aneurysms. The staged-repair concept promises to provide protection by inducing arteriogenesis so that the collateral network can provide a robust blood supply to the spinal cord after intervention. Minimally invasive staged segmental artery coil embolisation (MIS2ACE) has been proved recently to be a feasible enhanced approach to staged repair.Methods and analysisThis randomised controlled trial uses a multicentre, multinational, parallel group design, where 500 patients will be randomised in a 1:1 ratio to standard aneurysm repair or to MIS2ACE in 1–3 sessions followed by repair. Before randomisation, physicians document whether open or endovascular repair is planned. The primary endpoint is successful aneurysm repair without substantial SCI 30 days after aneurysm repair. Secondary endpoints include any form of SCI, mortality (up to 1 year), length of stay in the intensive care unit, costs and quality-adjusted life years. A generalised linear mixed model will be used with the logit link function and randomisation arm, mode of repair (open or endovascular repair), the Crawford type and the European System for Cardiac Operative Risk Evaluation (euroSCORE) II as fixed effects and the centre as a random effect. Safety endpoints include kidney failure, respiratory failure and embolic events (also from debris). A qualitative study will explore patient perceptions.Ethics and disseminationThis trial has been approved by the lead Ethics Committee from the University of Leipzig (435/17-ek) and will be reviewed by each of the Ethics Committees at the trial sites. A dedicated project is coordinating communication and dissemination of the trial.Trial registration numberNCT03434314.
OBJECTIVES
Concomitant aortic root enlargement (ARE) at the time of surgical aortic valve replacement can be performed to avoid patient–prosthesis mismatch, an important predictor of adverse long-term outcome.
METHODS
We performed a single-centre, retrospective analysis of 4120 patients receiving isolated aortic valve replacement, of whom 171 (4%) had concomitant ARE between January 2005 and December 2015. The analysis of postoperative outcome and early mortality was performed. Owing to inequality of the groups, patients were matched 1:1.
RESULTS
The mean age of all 4120 patients was 68.8 ± 10.5 years, and comorbidities were equally balanced after matching. The mean aortic cross-clamp time, cardiopulmonary bypass time and total operative time were prolonged by 19, 20 and 27 min in the ARE group, respectively. Early mortality was not statistically significantly different with 1.4% in the surgical aortic valve replacement and 1.8% in the ARE group. Postoperative complications were <5% in all matched 338 patients: bleeding (3% vs 3%), pericardial effusion (3.0% vs 4.2%), sternal instability (1.8% vs 0%) and sternal wound infection (3.0% vs 1.2%). A significant higher number of patients had respiratory failure after ARE (unmatched: 17.1% vs 9.9%, P < 0.001; matched: 18.3% vs 9.5%, P = 0.028). Factors independently associated with overall mortality were age [hazard ratio (HR) 1.71], chronic obstructive pulmonary disease (HR 1.47), diabetes (HR 1.82), atrial fibrillation (HR 2.14) and postoperative respiratory failure (HR 2.84).
CONCLUSIONS
ARE can be performed safely in experienced centres with no significant increase in the risk of early postoperative surgical complications and early mortality. However, the surgeon and the intensive care unit team should be aware of an increased risk for postoperative respiratory failure in ARE patients.
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