Does endovascular duration impact clinical outcomes in aortic arch repair? The RELAY™ branched international stance

Abstract

BackgroundThe high mortality and morbidity rates in surgical aortic arch repair are a barrier to therapy for a considerable proportion of patients with aortic arch aneurysm or dissection. There is hence a demand for the development and adoption of a minimally invasive alternative to aortic arch repair, such as thoracic endovascular aortic repair (TEVAR). Procedural duration is a key factor in the pathogenesis of complications in surgical aortic arch repair. Herein, we evaluate whether endovascular duration impacts neurological outcomes, target vessel patency, and reintervention rates in aortic arch TEVAR with RELAY™ Branched (Terumo Aortic, Inchinnan, UK), which is specifically developed for on-label use within the aortic arch.MethodsProspective data was collected between January 2019 and January 2022 on the clinical outcomes of TEVAR for aortic arch dissection and aneurysm with RELAY™ single-, double-, and triple branched endoprostheses from centers across Europe. They were then retrospectively analyzed with descriptive and distributive analysis. Follow-up data on the incidence of disabling stroke (DS), target vessel patency, and reintervention from 30 days and 6-, 12-, and 24 months postoperative was included in the analysis.Results147 (99.3%) of all 148 cases were successful. Over the 24 month follow-up period, in total 6 (4.1%) patients suffered DS, 24 (16.3%) required reintervention, and target vessel patency was exhibited in 118 (80.2%) patients. The modal endovascular duration was 100–150 min (in 64.6%, n = 95 cases). Analysis revealed that endovascular duration was associated with a lower likelihood of reintervention at 30 days, 6-, and 12 months (P = 0.011, P = 0.019, P = 0.037), a greater likelihood of target vessel patency at 6- and 24 months (P = 0.032, P = 0.035). No relationship between endovascular duration and DS was revealed.DiscussionThe data demonstrates that RELAY™ Branched is associated with promising clinical outcomes for on-label aortic arch TEVAR. The underlying mechanism linking endovascular duration and reintervention rates, or target vessel patency is likely multifactorial and complex. Given that TEVAR is carried out under general anesthetic only, it is unlikely that prolonged procedural duration has any major effect over neurological outcomes for arch TEVAR.

Branched and Fenestrated Aortic Endovascular Grafts

“…Tan et al reported on multicenter data from Europe in 148 patients who underwent treatment of arch pathology with the Terumo Relay Branch device from 2019 to 2022. 18 Technical success was achieved in 99.3% of cases. There was one mortality following the procedure but was not thought to be device or procedure related.…”

Endovascular aortic arch repair: A comparison of outcomes and current trends

“…27 It is worth pointing out that while the Inoue™ system requires bilateral brachial and left carotid percutaneous access for arch vessel cannulation (increasing the risk of causing particulate embolization), devices such as RELAY™ Branched do not. 7,27 In total, 6 (15.8%) transient cerebrovascular complications and 1 case of SCI occurred post-EAR with Zenith™ in Haulon and colleague's series (including TIA, stroke, meningeal haemorrhage). 22 Similarly, O'Callaghan et al reported a 36% (n = 6) postoperative stroke rate (one of which resulted in death).…”

“…In contrast to TEVAR of the thoracic aorta or endovascular repair of the abdominal aorta, endovascular surgeons must contend with the both the mediolateral-anteroposterior tortuosity of the aortic arch, and considerable hemodynamic shear forces during endoprosthesis alignment and deployment. 7 Notably, the curvature of the aortic arch has been shown to inhibit torque control over intraluminal instrumentation. Kölbel et al suggest the deployment of buddy wiring or establishing through-and-through guidewire control to tackle this.…”

“…Inadvertent embolization of particulate matter by intraluminal instrumentation may lead to stroke, while extension of the entry tear to the arch vessels may jeopardise cerebral or upper limb perfusion. 7 Additionally, the loss of left subclavian artery (LSA) patency secondary to embolization or inadequate revascularisation has been associated with posterior circulation stroke and vertebrobasilar insufficiency, while spinal cord ischaemia may be caused by extensive coverage of the intercostal branches of the descending thoracic aorta. 9,18 LSA patency post-EAR is associated with reduced rates of cerebral and spinal ischaemic injury.…”

“…6 Furthermore, consideration must be given towards neurological complications: although arch TEVAR does not require the use of HCA, intraluminal manipulation has been associated with embolic stroke, while endovascular coverage of the arch branches and intercostal arteries has been linked with ischaemic stroke and spinal cord injury (SCI). 7 Given the choice of branched endoprostheses available, a comparative evaluation of the design and clinical efficacies of RELAY™ Branched and Zenith™ Alpha is needed.…”