BackgroundSurgical intervention remains the mainstay treatment for aortic arch aneurysm and dissection, but the high mortality and morbidity rates have led to a need for the development of minimally invasive alternatives to arch reconstruction. RELAY™ Branched (Terumo Aortic, Inchinnan, UK) represents a viable option for complex endovascular aortic arch repair. We present multi-center data from Europe documenting the efficacy of the endograft in terms of its target vessel patency and reintervention rates.MethodsProspective data collected between January 2019 and January 2022 associated with patients treated with RELAY™ single-, double-, and triple-branched endoprostheses from centers across Europe was retrospectively analyzed with descriptive and distributive analysis. Follow up data from 30 days and 6-, 12-, and 24 months postoperatively was included. Patient follow up was evaluated in terms of target vessel patency and reintervention rates.ResultsTechnical success was achieved in 147 (99.3%) cases. Over 24 months period, target vessel patency was maintained in 80.2% (n = 118) of patients. Target vessel cannulation was achieved in 146 (99.3%) cases. Over the 24-month follow-up period, 30 reintervention procedures were required, of which 29 (97%) took place within the South Europe region which accounted for 19.6% (n = 29) of total cases. Zero reinterventions were required in patients that were treated with single- or triple-branched endoprostheses.DiscussionThe data presented herein demonstrates that RELAY™ Branched is a technically efficacious device for endovascular aortic arch repair and is associated with favorable target vessel patency and reintervention rates. Key design features of the endoprosthesis and good perioperative management can contribute greatly to mitigating reintervention and loss of vessel patency following endovascular aortic arch repair.
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.
Background While open surgical repair continues to be the mainstay option for aortic arch reconstruction, the associated mortality, morbidity, and high turn‐down rates have led to a need for the development of minimally invasive options for aortic arch repair. Though RELAY™ Branched (Terumo Aortic, Inchinnan, UK) represents a promising option for complex endovascular aortic arch repair, neurological complications remain a pertinent risk. Herein we seek to present multicenter data from Europe documenting the neurological outcomes associated with RELAY™ Branched. Methods Prospective data collected between January 2019 and January 2022 associated with patients treated with RELAY™ single‐, double‐, and triple‐branched endoprostheses from centers across Europe was retrospectively analyzed with descriptive and distributive analysis. Follow‐up data from 30 days and 6, 12, and 24 months postoperatively were included. Patient follow‐up was evaluated for the onset of disabling stroke (DS) and non‐disabling stroke (NDS). Results Technical success was achieved in 147 (99.3%) cases. Over 24 months period, in total, six (4.1%) patients suffered DS, and eight (5.4%) patients suffered NDS after undergoing aortic arch repair with RELAY™. All patients that developed postoperative DS had been treated with the double‐branched RELAY™ endoprosthesis. Discussion The data presented herein demonstrates that RELAY™ Branched is associated with favorable neurological outcomes and excellent technical success rates. Key design features of the endoprosthesis and good perioperative management can contribute greatly to mitigating neurological complications following endovascular aortic arch repair.
Introduction An abdominal aortic aneurysm (AAA) is a life-threatening abnormal dilation of the abdominal aorta that can be repaired either endovascularly or with open surgery. However, endovascular aortic repair (EVAR) has become the main treatment modality for AAA due to its more optimal results. EVAR devices can either be standard, fenestrated, or branched, with fenestrated EVAR (FEVAR) seemingly achieving superior prospects. Although EVAR is associated with excellent outcomes, it still carries a risk of certain complications requiring reintervention or ‘rescue’. Several commercial EVAR devices are available on the global market, nevertheless, the Fenestrated Anaconda developed by Terumo Aortic can be considered the superior device due to the wide range of endovascular solutions that it offers along with its unique custom-made approach, excellent results and its highly promising potential to be used as a ‘rescue’ device for failed competitor endografts. Materials and methods The current study represents a 9-year cross-sectional international analysis of a custom-made Fenestrated Anaconda™ device. For the statistical analysis, SPSS 28 for Windows and R were utilised. Pearson Chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at p < 0.05. Results Out of 5058 EVARs performed using the Fenestrated Anaconda, 2987 (59%) were ‘rescue’ procedures for migrated Gore ( n = 252) and Medtronic ( n = 2735) devices. The Fenestrated Anaconda™ was indicated as the reintervention device either due to unsuitable/complex anatomy for the competitor ( n = 2411) or based on surgeon preference ( n = 576). Overall, the Fenestrated Anaconda was utilised to rescue 3466 (68.5%) failed previous EVARs using competitor devices. Yet, the primary endovascular solution offered by the Fenestrated Anaconda was FEVAR (91.3%), with 112 (2.2%) devices using custom-made iliac stents. Discussion The use of the Fenestrated Anaconda endograft as a ‘rescue’ device to salvage failed competitor devices is well-established in the literature with excellent clinical outcomes achieved. The evidence in the literature also highlights the distinctive custom-made approach that the Fenestrated Anaconda offers which enables it to treat extremely complex aortic anatomy.
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