Paraplegia prevention in aortic aneurysm repair by thoracoabdominal staging with ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE): trial protocol for a randomised controlled multicentre trial

Abstract

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.

Incidence, predictors, and outcomes of spinal cord ischemia in elective complex endovascular aortic repair: An analysis of health insurance claims

“…A total of 240 deaths occurred during the study follow-up. In-hospital mortality was 4.5% (40 patients) after a median length of 13 (8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25) days in the hospital. No statistically significant differences were observed in patients after F/BEVAR with one or two fenestrations or branches.…”

“…These measures involve cerebrospinal fluid (CSF) drainage, staged occlusion of segmental arteries to achieve ischemic preconditioning (minimally invasive staged segmental artery coil embolization), staged F/BEVAR procedures, permissive hypertension, pharmacologic intervention, and preservation or revascularization of collateral networks. 8 Besides one clinical trial that is currently recruiting, 9 high-quality evidence from controlled trials is still not available to recommend the best strategies for prevention, detection, or treatment of SCI. [10][11][12][13] Furthermore, it is not well established which patients are at highest risk for development of SCI.…”

Commentary: Cerebrospinal fluid drainage: One component of a successful distal aortic surgery program

“…20 Minimally invasive segmental artery coil embolization of intercostal arteries before thoracoabdominal aortic repair has been suggested to provoke collateral flow and reduce SCI and is currently being evaluated in a randomized trial. 21,22 In summary, CSFD along with other adjuncts are important strategies to protect against SCI during open descending and thoracoabdominal aneurysm repair. As with most complex aortic surgeries, it is difficult to attribute a team's success to a single factor.…”

Aneurysms and dissections - What is new in the literature of 2019/2020 - a European Society of Vascular Medicine annual review

“…In the latter situation the SCI rate was 6.4% with 0% permanent neurologic deficit. A novel approach for paraplegia prevention in AA repair by thoracoabdominal staging is the "minimally invasive staged segmental artery coil embolisation" (MIS 2 ACE) currently investigated in a multicenter trial [289]. Sonesson et al suggest as an alternative to tidious selective embolization of segmental arteries a more simplified approach using a short and large stentgraft where graft-wall apposition occurs [290].…”