Ischaemic preconditioning of the spinal cord to prevent spinal cord ischaemia during endovascular repair of thoracoabdominal aortic aneurysm: first clinical experience

Branzan, Daniela; Etz, Christian D.; Moche, Michael; Aspern, Konstatin Von; Staab, Holger; Fuchs, Johann; Bergh, Florian Then; Scheinert, Dierk; Schmidt, Andrej

doi:10.4244/eij-d-18-00200

Cited by 62 publications

(45 citation statements)

References 18 publications

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“…One means of occluding arteries in the clinical setting has been termed ‘minimally invasive staged segmental artery coil embolisation’ (MIS²ACE), which was proved feasible in 2015 20. A consecutive case series of over 50 patients lends credence to its safety 21. This is thus the ideal time to carry out such a trial, where the need to test efficacy, effectiveness and safety are paramount but before it has gained acceptance despite lack of evidence.…”

Section: Introductionmentioning

confidence: 99%

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

Petroff

Czerny

Kölbel³

et al. 2019

BMJ Open

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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.

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Section: Introductionmentioning

confidence: 99%

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

Petroff

Czerny

Kölbel³

et al. 2019

BMJ Open

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“…This highlights the importance of preoperative planning and the division of endovascular TAAA repairs into different stages, especially in patients at high risk for SCI. Further studies will highlight the role of other staging methods, such as minimally invasive segmental artery embolization with coils proposed by Etz et al 12 The use of our modified Embograft might play a role in reducing the number of proximal thoracic embolization sessions, with possible clinical and economic advantages. The price of this custom-made device is the same as a standard Zenith Alpha thoracic stent-graft, and at the moment, the cost of embolotherapy in this situation is not known.…”

Section: Discussionmentioning

confidence: 89%

A Modified Proximal Stent-Graft for Spinal Cord Preconditioning During Staged Endovascular Repair of Thoracoabdominal Aortic Aneurysms

et al. 2020

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Purpose: To describe a new custom-made thoracic device able to seal against the aortic wall and occlude intercostal arteries for spinal cord preconditioning during the first thoracic stage of a thoracoabdominal endovascular repair. Technique: The custom-made device, based on the Zenith Alpha stent-graft, combines different features from 2 previously described devices: the outer part is designed with a bell-bottom configuration similar to the “Embo” stent-graft, while the inner part mimics the “2 in 1” design. The outer stent-graft is designed to span the entire length of the thoracic aorta and cover as many intercostal arteries as possible during the first stage to effectively precondition the spinal cord. The sutured inner component is customizable in diameter and 20 to 40 mm shorter than the outer stent-graft. The technique has been used in 5 patients. Conclusion: The use of this new custom-made thoracic stent-graft might represent an additional tool for effectively preconditioning the spinal cord during fenestrated and branched staged procedures whenever a proximal thoracic proximal component is needed.

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“…The interval between first embolization and final exclusion of the TAAA was a mean 83±62 days. 7,8 In addition, these lengthy procedures expose both patient and operator to significant radiation and contrast. No major complications were reported in this study, but there are anecdotal reports of SCI after intercostal embolization.…”

Section: Discussionmentioning

confidence: 99%

“…However, the patients needed between 1 and 5 staging procedures before the main operation, which occurred after a mean 83 days. 7,8 Furthermore, MISACE is not always easy to do in a large aneurysm, and the operator needs special skills and patience to be successful.…”

Section: Introductionmentioning

confidence: 99%

New Technique for Preconditioning of the Spinal Cord Before Endovascular Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms

2019

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Purpose: To propose a new simplified technique to occlude multiple segmental arteries for staging and preconditioning of the spinal cord to decrease the potential for spinal cord ischemia after thoracic and thoracoabdominal aortic aneurysm repair. Technique: A thoracic stent-graft that flares out to a maximum of 51 mm is deployed in a standard fashion covering all segmental arteries where graft-wall apposition occurs in the first ~20 cm of the aneurysm. The segmental arteries are always closed at their ostia in contrast to selective coil embolization, where there is a risk of more peripheral closure. Follow-up imaging shows thrombus lining the stent-graft–covered portion of the aneurysm and secondary proximal segmental artery occlusion. Conclusion: A new and fast way of staging and preconditioning the spinal cord using a modified stent-graft prior to definitive repair might be an alternative to segmental artery embolization.

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Ischaemic preconditioning of the spinal cord to prevent spinal cord ischaemia during endovascular repair of thoracoabdominal aortic aneurysm: first clinical experience

Cited by 62 publications

References 18 publications

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

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

A Modified Proximal Stent-Graft for Spinal Cord Preconditioning During Staged Endovascular Repair of Thoracoabdominal Aortic Aneurysms

New Technique for Preconditioning of the Spinal Cord Before Endovascular Repair of Descending Thoracic and Thoracoabdominal Aortic Aneurysms

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