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

Tan, Sven Z C P; Jubouri, Matti; Idhrees, Mohammed; Bashir, Mohamad

doi:10.3389/fcvm.2022.842165

Cited by 23 publications

(62 citation statements)

References 35 publications

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“…Re-interventions are a critical aspect of analysis when comparing TEVAR therapeutic options with the FET, the current gold standard for aortic arch reconstruction ( 8 ). As a new innovative treatment option for endovascular repair, aortic arch TEVAR provides many advantages over traditional open surgical intervention, not least the plethora of benefits associated with minimally invasive procedures ( 3 ).…”

Section: Discussionmentioning

confidence: 99%

RELAYTM Branched–International Results of Vessel Patency and Reintervention

Singh

Surkhi

Tan

et al. 2022

Front. Cardiovasc. Med.

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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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Section: Discussionmentioning

confidence: 99%

RELAYTM Branched–International Results of Vessel Patency and Reintervention

Singh

Surkhi

Tan

et al. 2022

Front. Cardiovasc. Med.

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“…However, evidence in the literature clearly support Thoraflex Hybrid's superiority of clinical outcomes over its competitors. This is no different when it comes to aortic remodeling, as Thoraflex Hybrid has been proven to promote excellent FLT and is associated with significant positive changes in aortic diameters [9,10,59]. This is evident in multiple studies, one of which is is Mehanna et al [37] which featured Spearman rank correlation tests to assess the correlation of their results.…”

Section: Discussionmentioning

confidence: 99%

“…Other complications of the FET procedure are, but not limited to, endoleak, spinal cord injury (SCI), renal complications, cerebrovascular events and graft kinking. Yet, it is important to note that the incidence of the above postoperative events is lower with FET compared to conventional arch replacement techniques [9,10,11].…”

Section: Introductionmentioning

confidence: 99%

“…Several commercial FET HPs exist on the global market, these include Thoraflex Hybrid (Terumo Aortic, Inchinnan, Scotland, UK), E-Vita (JOTEC GmbH, Hechingen, Germany), J Graft Frozenix (Lifeline Co, Ltd, Tokyo, Japan) and Cronus (MicroPort Medical Co, Ltd, Shanghai, China). However, overall evidence in the literature seem to suggest that the Thoraflex Hybrid (or THP) is the superior FET devices on the arch prosthesis market [9,10]. Nevertheless, the literature also describes controversial evidence on the association between the aforementioned commercially-available FET devices and clinical outcomes.…”

Section: Introductionmentioning

confidence: 99%

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Aortic remodeling, distal stent-graft induced new entry and endoleak following frozen elephant trunk: A systematic review and meta-analysis

Jubouri

Nakhaei

Bashir

et al. 2022

Preprint

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Background: The introduction of the frozen elephant trunk (FET) technique for total arch replacement (TAR) has revolutionized the field of aortovascular surgery. However, although FET yields excellent results, the risk of certain complications requiring secondary intervention remains present, negating its one-step hybrid advantage over conventional techniques. This systematic review and meta-analysis sought to evaluate controversies regarding the incidence of FET-related complications, with a focus on aortic remodeling, distal stent-graft induced new entry (dSINE) and endoleak, in patients with type A aortic dissection (TAAD) and/or thoracic aortic aneurysm. Materials and methods: A comprehensive literature search was conducted using multiple electronic databases including EMBASE, Scopus, and PubMed/MEDLINE to identify evidence on TAR with FET in patients with TAAD and/or aneurysm. Studies published up until January 2022 were included, and after applying exclusion criteria, a total of 43 studies were extracted. Results: A total of 5068 patients who underwent FET procedure were included. The pooled estimates of dSINE and endoleak were 2% (95% CI 0.01-0.06, I = 78%) and 3% (95% CI 0.01-0.11, I = 89%), respectively. The pooled rate of secondary thoracic endovascular aortic repair (TEVAR) post-FET was 7% (95% CI 0.05-0.12, I = 89%) whilst the pooled rate of false lumen thrombosis at the level of stent-graft was 91% (95% CI 0.75-0.97, I = 92%). After subgroup analysis, heterogeneity for dSINE and endoleak resolved among European patients, where Thoraflex Hybrid and E-Vita stent-grafts were used (both I = 0%). In addition, heterogeneity for secondary TEVAR after FET resolved among Asians receiving Cronus (I = 15.1%) and Frozenix stent grafts (I = 1%). Conclusion: Our results showed that the FET procedure in patients with TAAD and/or aneurysm is associated with excellent results, with a particularly low incidence of dSINE and endoleak as well as highly favorable aortic remodeling. However the type of stent-graft and the study location were sources of heterogeneity, emphasizing the need for multicenter studies directly comparing FET grafts. Finally, Thoraflex Hybrid can be considered the primary FET device choice due to its superior results.

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“…As mentioned previously, although the single-step FET procedure does yield excellent results, particularly positive aortic remodeling, there remain several complications associated with it, only one of which is graft kinking. These were addressed in 2 recent studies by Tan et al ( 38 ) and Jubouri et al ( 39 ) who proved the efficacy of FET and the well-established Thoraflex Hybrid as the superior FET HP available commercially.…”

Section: Managementmentioning

confidence: 99%

Kinking of Frozen Elephant Trunk Hybrid Prostheses: Incidence, Mechanism, and Management

Kayali

Qutaishat

Jubouri

et al. 2022

Front. Cardiovasc. Med.

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IntroductionKinking of the Frozen Elephant Trunk (FET) stent graft is one of the most devastating complications of the FET procedure. It can present post-operatively with reduced arterial pressures in the lower limbs and intermittent claudication. However, it can also be visualized intra-operatively by the surgeons. Unresolved kinking of the stent graft can result in intraluminal thrombus formation and subsequent multi-organ septic emboli.AimsThe main scope of this review is to collate, summarize and present all the evidence in the literature on kinking of FET stent grafts.MethodsWe carried out a comprehensive literature search on multiple electronic databases including PubMed, EMBASE, Ovid, and Scopus to collate all research evidence on the incidence, mechanism, and management of FET graft kinking.ResultsIncidence of kinking is variable, ranging from 0% to 8% in the literature, with varying rates associated with each stent graft type. The Thoraflex HybridTM prosthesis seemed to be the most commonly used and superior graft, and out of all the 15 cases of kinking reported in the literature, 5 (33.3%) were associated with just the Frozenix graft which had the highest incidence. There are multiple theories regarding the mechanism of kinking, including the direction of blood flow, the length of the stent grafts used, and the position of the prosthesis in relation to the flexure of the aorta. Multiple reparative management techniques have been suggested in the literature and include total endovascular repair, open repair, balloon dilatation, and deploying a second stent graft.ConclusionGraft kinking is one of the most critical complications of the FET technique. Its life-threatening sequelae warrant appropriate follow-up of these patients post-operatively, in addition to time management if kinking is suspected. Given the limited evidence in the literature, future studies should incorporate graft kinking into their outcomes reporting.

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

Cited by 23 publications

References 35 publications

RELAYTM Branched–International Results of Vessel Patency and Reintervention

RELAYTM Branched–International Results of Vessel Patency and Reintervention

Aortic remodeling, distal stent-graft induced new entry and endoleak following frozen elephant trunk: A systematic review and meta-analysis

Kinking of Frozen Elephant Trunk Hybrid Prostheses: Incidence, Mechanism, and Management

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