BackgroundThe widespread adoption of the frozen elephant trunk (FET) technique for total arch reconstruction (TAR) in aortic arch aneurysm and dissection has led to the development of numerous commercial single-piece FET devices, each with its own unique design features. One such device, Thoraflex™ Hybrid (Terumo Aortic, Glasgow, Scotland), has enjoyed widespread use since its introduction. We present and appraisal of its long-term clinical efficacy, based on international data.Materials and MethodsPre-, intra-, and postoperative data associated with Thoraflex™ Hybrid implantations for aortic arch dissection, aneurysm, and penetrating atherosclerotic ulcer (PAU) up to April 2019 was gathered and is presented herein. Follow-up data at discharge, 3-, 6-, 12-, 24-, 36-, 48-, 60-, 72-, and 84- months post-implantation are included.ResultsData associated with 931 cases of Thoraflex™ Hybrid implantation are included. Mean age at implantation was 63 ± 12 years. 55% of patients included were male. Aortic dissection accounted for 48% (n = 464) of cases. Mean cardiopulmonary bypass and circulatory arrest durations were 202 +72 and 69 ± 50 min, respectively. 30-day mortality was 0.6% (n = 6), while overall mortality was 14 (1.5%). Freedom from adverse events at 84 months was 95% (n = 869). Postoperative complications included neurological deficit, multi-organ failure, cardiorespiratory compromise, and infection.DiscussionThoraflex™ Hybrid's unique design is advantageous in comparison to market alternatives. Our data is consistent with that reported in literature and suggests Thoraflex™ Hybrid is associated with favourable rates of mortality and morbidity.ConclusionThoraflex™ Hybrid remains a central player in the aortic arch prosthesis market. Its use it widespread and is associated with favourable design features and clinical outcomes relative to market alternatives.
BackgroundThe introduction of the frozen elephant trunk (FET) technique for total arch replacement (TAR) has revolutionized the field of aortivascular surgery by allowing hybrid repair of complex aortic pathologies in a single step through combining an open surgical approach with an endovascular one. FET has been associated with favorable aortic remodeling, however, its is also associated with development of distal stent graft induced new entry (dSINE) tears postoperatively. The rate of aortic remodeling and the incidence of dSINE have been linked together, in addition, there seems to be a relationship between these two variables and FET insetion length as well as graft size.AimsThe scope of this review is to highlight the rate of aortic remodeling as well the incidence of dSINE associated with different FET devices available commercially. This review also aimed to investigate the relationship between aortic remodeling, dSINE, FET insertion length and FET graft size.MethodsWe conducted a comprehensive literature search using multiple electronic databases including PubMed, Ovid, Scopus and Embase in order to collate all research evidence on the above mentioned variables.ResultsThoraflex™ Hybrid Plexus seems to yield optimum aortic remodeling by promoting maximum false thrombosis as well true lumen expansion. Thoraflex Hybrid™ is also associated with the lowest incidence of dSINE post-FET relative to the other FET devices on the market. Aortic remodeling and dSINE do influence each other and are both linked with FET graft length and size.ConclusionThe FET technique for TAR shows excellent aortic remodeling but is associated with a considerable risk of dSINE development. However, Thoraflex™ Hybrid has demonstrated itself to be the superior FET device on the aortic arch prostheses market. Since aortic remodeling, dSINE, FET insertion length and stent graft size are all interconnect, the choice of FET device length and size must be made with great care for optimum results.
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.
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