Abstract
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.
Highlights
MATERIALS AND METHODSThe surgical management of aortic arch and thoracic aortic diseases is invariably complex, and often associated with high rates of mortality and morbidity
The frozen elephant trunk (FET) technique evolved from the conventional elephant trunk technique pioneered by Borst et al and allows for the single-stage repair of the aortic arch and proximal descending thoracic aorta (DTA) (1)
Aortic dissection was the predominant indication for aortic repair (n = 464, 48%), of which 158 patients presented with acute type A aortic dissection (ATAAD) (35%) and 79 with acute TBAD (18%). 419 (45%) patients presented with aortic aneurysm, while 48 (5%) presented with penetrating atherosclerotic ulcer (PAU). 41 (4%) patients were known to be comorbid with Marfan syndrome, with an average age of 41 ± 13 years, and the youngest was 23 years old
Summary
MATERIALS AND METHODSThe surgical management of aortic arch and thoracic aortic diseases is invariably complex, and often associated with high rates of mortality and morbidity. Available FET devices provide a single-piece hybrid prosthesis for total arch reconstruction (TAR), negating the need for off-label implantation of commercial thoracic endovascular aortic repair (TEVAR) grafts antegrade through the aortic arch—a method described as being suboptimal and technically awkward, as well as being associated with stent migration, unstable proximal fixation, and type 1A endoleak (4). The 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, ThoraflexTM 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
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