Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms

Bertoglio, Luca; Grandi, Alessandro; Carta, Niccolò; Cambiaghi, Tommaso; Bilman, Victor; Melissano, Germano; Chiesa, Roberto

doi:10.1016/j.jvs.2021.04.066

Cited by 58 publications

(19 citation statements)

References 29 publications

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“…(2) Visceral vessel anatomy: (a) four indispensable arteries with normal diameters, (b) aortic diameter of >25 mm at the region of the branches, (c) distance between the corresponding arterial orifice and the cuff <50 mm, and the line between the arterial orifice as projected on to the vessel wall and the cuff deviating no more than 45° from the long axis of the aorta. (3) Access: (a) appropriated femoral/iliac access compatible with a 22F (8.5 mm outer diameter) delivery system, and (b) brachial or subclavian access compatible with the delivery profile of a 10F or 12F introducer sheath (3.3 or 4 mm outer diameter) ( 17 , 39 ).…”

Section: Discussionmentioning

confidence: 99%

Fenestrated and Branched Stent-Grafts for the Treatment of Thoracoabdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis

Zhang

Liu

et al. 2022

Front. Cardiovasc. Med.

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PurposeTo investigate the safety and efficacy of total endovascular repair for thoracoabdominal aortic aneurysms (TAAAs) with fenestrated and branched stent-grafts.MethodsThe MEDLINE, EMBASE, and Cochrane databases were searched between January 2001 and December 2021 to identify literature relevant to the use of fenestrated and branched endografts for the treatment of TAAAs. Studies with <4 cases and those on juxtarenal or pararenal aortic aneurysms were excluded. Meta-analyses were conducted to evaluate spinal cord ischemia (SCI), irreversible SCI, renal insufficiency, dialysis, endoleak, reintervention, target vessel patency, 30-day mortality and overall mortality. Fourteen studies comprising 1,114 patients (mean age 72.42 years, 847 men) were selected. The mean TAAA diameter was 67 mm. The Crawford TAAA classification was type I-III in 759 cases, type IV in 344 cases, and type V in 10 cases. Outcomes of the meta-analysis are reported as proportions and 95% confidence intervals (CIs).ResultsThe pooled rates for 30-day mortality and overall mortality were 6% and 18%, respectively. The pooled rate for technical success was 94% (95% CI, 93–96%), for SCI was 8% (95% CI, 7–10%), for irreversible SCI was 6% (95% CI, 4–7%), for reversible SCI was 5% (95% CI, 4–6%), for reversible SCI was 2% (95% CI, 2–3%), for renal insufficiency was 7% (95% CI, 5–10%), for dialysis was 3% (95% CI, 2–4%), for target vessel patency was 98% (95% CI, 97–99%), and for reintervention was 15% (95% CI, 9–24%).ConclusionFenestrated and branched endografts for the treatment of TAAAs are safe and effective with acceptable early results. Lifelong regular follow-up and additional prospective studies are necessary to substantiate whether this technique is valid.

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Section: Discussionmentioning

confidence: 99%

Fenestrated and Branched Stent-Grafts for the Treatment of Thoracoabdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis

Zhang

Liu

et al. 2022

Front. Cardiovasc. Med.

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“…Compared with the G-Branch endograft, a multibranched stent graft with four outer branches theoretically needs a larger visceral aortic lumen to allow enough room for branch expansion, target vessel cannulation and bridging stent implantation 8 13. The G-Branch endograft with proximal inner branch configuration may reduce the required aortic diameter, broadening its applicability for TAAA with a limited visceral aortic lumen.…”

Section: Discussionmentioning

confidence: 99%

“…One critical issue with these three endografts is the suboptimal anatomic feasibility rate in real-life cohorts of patients with TAAA. When using any of the three off-the-shelf devices, the overall treatment feasibility rate is 58%,8 suggesting the need for configuration improvement and size optimisation.…”

Section: Introductionmentioning

confidence: 99%

Protocol for GUo’s renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study)

Zhang

Rong

et al. 2022

BMJ Open

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IntroductionThe multibranched off-the-shelf stent graft is a promising treatment option for thoracoabdominal aortic aneurysm (TAAA). A commercially available, multibranched, off-the-shelf endograft called the t-Branch stent graft has demonstrated favourable midterm outcomes. Another two investigational off-the-shelf endografts, the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis and E-nside multibranch stent graft system, are still being developed. However, these three endografts have an unsatisfactory anatomic feasibility rate in patients with TAAA. Based on the concept of Guo’s renovisceral artery reconstruction-1, a novel, multibranched, off-the-shelf endograft with different configurations has been developed.Methods and analysisThis prospective, multicentre, single-arm, cohort study will enrol 73 patients with TAAA. Preoperative and postoperative clinical data, as well as CT angiography images at each follow-up timepoint, will be analysed to evaluate the safety and efficacy of this novel, multibranched, off-the-shelf endograft for the treatment of TAAA. The primary safety end point is the major adverse event rate within 30 days after index endovascular aortic repair, including all-cause death, hepatic failure, bowel necrosis, renal failure, stroke, permanent paraplegia, cardiac infarction and respiratory failure. The primary efficacy end point is the successful treatment rate within 12 months after procedure, which is a composite of immediate technical success and no secondary surgical intervention related to TAAA within 12 months after the procedure.Ethics and disseminationThe protocol has been reviewed and approved by the ethics committee of Chinese PLA General Hospital (reference number: 2021-NO.-007) and each participating hospital. The findings of this study will be disseminated through conference presentations, peer-reviewed journal publications and social media.Trial registration numberNCT05054985.

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“…Die Enside-Prothese (Artivion, Hechingen, Deutschland) zeigte in den Studien eine Gesamtmachbarkeitsrate innerhalb der IFU (instructions for use) von 43%, wobei die renoviszeralen Arterien sogar in 79% der Fälle als anschlussfähig beurteilt wurden [24]. Damit war die Gesamtmachbarkeitsrate zur Versorgung thorakoabdomineller Aortenaneurysmen vergleichbar mit anderen "off-the-shelf"-BE-VAR-Prothesen [25].…”

Section: Technische Aspekte Der Ibevarunclassified

Stellenwert der „inner Branches“ in der komplexen endovaskulären Aortenchirurgie

Lescan

2022

Zentralbl Chir

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ZusammenfassungDie komplexe endovaskuläre Therapie der Aorta mit fenestrierten und gebranchten Prothesen spielt eine wichtige Rolle in der heutigen Gefäßmedizin. Daraus resultieren innovative medizintechnische Lösungen, die für immer anspruchsvollere Aortenpathologien eingesetzt werden. Das Ziel dieser Arbeit war es, die zunehmende Bedeutung der „inner Branches“ in der komplexen Aortenchirurgie darzustellen. Die Vorteile und Grenzen dieser Technik sollten aufgezeigt und die aktuelle Datenlage zusammengefasst werden. Dazu wurden die „inner Branches“ (iBEVAR) den Standardverfahren (Fenestrationen [FEVAR], „outer Branches“ [BEVAR]) gegenübergestellt und ihre technischen Vor- und Nachteile erarbeitet. Kennzeichnend ist der weit verbreitete Einsatz der iBEVAR im Aortenbogen im Gegensatz zur thorakoabdominellen Aorta, was sich auch in der spärlichen Datenlage im thorakoabdominellen Abschnitt widerspiegelt. Die Letztere basiert auf kleineren retrospektiven Studien mit 1-jährigem Follow-up. Die seit 2 Jahren verfügbare thorakoabdominelle „off-the-shelf“-Prothese wird voraussichtlich zu einer weiteren Verbreitung der „inner Branches“ im thorakoabdominellen Abschnitt führen, wobei die von der Industrie geförderte Registerstudie wichtige Evidenz zur erörterten Technik bereitstellen könnte.

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Comparison of anatomic feasibility of three different multibranched off-the-shelf stent-grafts designed for thoracoabdominal aortic aneurysms

Cited by 58 publications

References 29 publications

Fenestrated and Branched Stent-Grafts for the Treatment of Thoracoabdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis

Fenestrated and Branched Stent-Grafts for the Treatment of Thoracoabdominal Aortic Aneurysms: A Systematic Review and Meta-Analysis

Protocol for GUo’s renovisceral Artery reconstruction-1: a prospective, multicentre, single-arm clinical trial to evaluate the safety and efficacy of a multibRANched sTEnt graft systEm for thoracoabdominal aortic aneurysm (GUARANTEE study)

Stellenwert der „inner Branches“ in der komplexen endovaskulären Aortenchirurgie

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