Frozen Elephant Trunk—the Bologna experience

Leone, Alessandro; Murana, Giacomo; Coppola, Giuditta; Berardi, Marianna; Botta, Luca; Bartolomeo, Roberto Di; Marco, Luca Di; Pacini, Davide

doi:10.21037/acs.2020.03.05

Cited by 8 publications

(3 citation statements)

References 9 publications

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“…This is unsurprising considering the haemodynamic significance and anatomical positioning of the aortic arch and DTA, as well as the surgical and anaesthetic complexity of TAR. As of January 2020, over 30,000 hybrid arch FET prostheses have been implanted, and early mortality has ranged from 1.8 to 17.2% across various commercial and non-commercial device configurations ( 13 ). International data on the performance of Thoraflex Hybrid™ in terms of mortality are encouragingly positive.…”

Section: Discussionmentioning

confidence: 99%

What Is the Long-Term Clinical Efficacy of the Thoraflex™ Hybrid Prosthesis for Aortic Arch Repair?

Tan

Jubouri

Idhrees³

et al. 2022

Front. Cardiovasc. Med.

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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.

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Section: Discussionmentioning

confidence: 99%

What Is the Long-Term Clinical Efficacy of the Thoraflex™ Hybrid Prosthesis for Aortic Arch Repair?

Tan

Jubouri

Idhrees³

et al. 2022

Front. Cardiovasc. Med.

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“…The primary difference between the FET and CET is centred on how the dissected portion of the distal thoracic aorta (DTA) is managed. In the first stage of CET, the dissected proximal DTA is left unrepaired for an inevitable secondstage procedure, which introduces higher cumulative surgical risk and interval mortality, and it is likely to be unsuccessful in sealing the false lumen [6][7][8][9][10][11][12][13][14] . However, FET combines CET and thoracic endovascular aortic repair (TEVAR) into a single-step hybrid procedure using a hybrid prosthesis to replace the ascending aorta and arch and repair the dissected proximal DTA in the same operation [15] .…”

Section: Past To Present: An Overview Of Aortic Arch Surgical Repairmentioning

confidence: 99%

Total endovascular aortic arch repair: is it for everyone and where is its evidence?

2023

Vessel Plus

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Open total arch replacement (TAR) remains the mainstay management strategy for thoracic aortic diseases involving the aortic arch. TAR evolved from the 2-stage conventional elephant trunk (CET) technique to the hybrid frozen elephant trunk (FET) which combined open surgical repair (OSR) with thoracic endovascular aortic repair (TEVAR) into a 1-stage procedure. Although FET has been able to achieve superior results to CET, including excellent survival, it still carries a risk of certain complications that may even require secondary reintervention. The era of elephant trunk is being overtaken by the new generation of TEVAR devices being used for total endovascular aortic arch (or endoarch) repair. Total endoarch repair (TER) is currently indicated in patients deemed high-risk for open surgery; however, it has shown strong potential for becoming the gold stand treatment for aortic arch pathologies. Despite the minimally-invasive nature of TER providing an obvious advantage over OSR in certain cases, TER remains associated with comparable mortality rates and key complications such as technical failure, neurological injury, need for reintervention, and loss of or failure to achieve target vessel patency. Upon comprehensively searching the literature, the technical success of TER ranged from 91%-100%, mortality 0%-19%,

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“…The results of the literature clearly demonstrated the efficacy of FET in terms of false lumen thrombosis around the stent portion, true lumen expansion, and positive remodeling in downstream aortic segments in acute and chronic thoracic aortic dissections. 4 , 5 This primary intention using the branched single-anastomosis FET repair is much mitigated in favor of an intraoperative simplification that might facilitate persistent blood flow into the false lumen. The use of such simplification might foster early complex reinterventions like in the Michigan experience, where both patients required an open TAAA repair 1 year after primary arch intervention.…”

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confidence: 99%

Commentary: Novel interventions in complex aortic disease: A perfect storm to “B-SAFER”

2020

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Frozen Elephant Trunk—the Bologna experience

Cited by 8 publications

References 9 publications

What Is the Long-Term Clinical Efficacy of the Thoraflex™ Hybrid Prosthesis for Aortic Arch Repair?

What Is the Long-Term Clinical Efficacy of the Thoraflex™ Hybrid Prosthesis for Aortic Arch Repair?

Total endovascular aortic arch repair: is it for everyone and where is its evidence?

Commentary: Novel interventions in complex aortic disease: A perfect storm to “B-SAFER”

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