Thoraflex™ Hybrid
Conforming Arch Surgery to the Gold Standard
Flexible. Effective. Transformative.
*Per IFU
Remodelling and Aneurysmal Regression with Thoraflex™ Hybrid
Remodelling describes the process of stabilisation of the overall aortic dimensions by slow obliteration of the false lumen and maintenance of true lumen patency1. It is important because:
False Lumen patency can lead to Aortic Expansion. 2
Increased Risks
Hazard Ratio
Late Mortality Type A Dissections 2
Hazard Ratio
Late Mortality Type B Dissections 2
Figure (i): Intra-aortic pressure in (a) a Healthy Aorta, (b) a Fully Perfused Aorta, (c) a Partially Thrombosed False Lumen Aorta, (d) a Full Thrombosed False Lumen Aorta. 3
Functional Advantages of the FET*
(In cases of acute aortic syndrome)
Distal Entry Tears
Obliterate distal entry tears in the aortic arch or descending thoracic aorta 4
False Lumen Thrombosis
Induce False Lumen Thrombosis resulting in positive aortic remodelling and improved freedom from distal redo 4
Downstream Stabilisation
Downstream Stabilisation, providing an ideal artificial proximal landing zone for potential secondary downstream thoracic endovascular aortic repair (TEVAR) 5
Thoraflex Hybrid Features
Sinusoidal Wave Shape Ring
Independent Ring Stent Design
Multiple turns of nitinol wire.
Anatomic Conformity
Allows for better arch curvature and anatomic conformity 6, 7
Sinusoidal Wave Shape
Sinusoidal wave shape ring reduces radial force on the aortic wall & minimises risk of intimal injury 6, 7
Acute & Chronic Dissection
Acute Dissection
"In our experience, FET in acute AAD achieved a high rate of FL thrombosis and positive aortic remodeling in most patients. " 8, †
Chronic Dissection
"The results of our series show that the remodelling of the stented segment of the descending aorta takes longer in CAD* patients compared with AAD* patients. Nevertheless, FL* thrombosis rate is 100% within 2 years post surgery."
Acute Dissection
Figure ii: Volumetric (ml) assessment of cases with Acute Dissection.9 (10/48 patients)
Chronic Dissection
Figure iii: Volumetric (ml) assessment of cases with Chronic Dissection.9 (20/48 patients)
Aortic Diameter & Aneurysm
Mean Preoperative Aortic Diameter
(Zone 3/4)
-23.2%
Mean Postoperative Aortic Diameter
(Zone 3/4)
Aneurysm Sac Regression around FET*
(29/40 patients) 11
"Computed tomography follow-up demonstrated positive distal aortic remodelling with aneurysmal regression and stabilised aortic dimensions in patients with aortic dissection." 9
Features & Benefits
Thoraflex™ Hybrid
Discover how each of the key features and benefits are integrated into Thoraflex Hybrid to ensure the highest quality and performance possible.
References
* FET = Frozen Elephant Trunk.
HA = Healthy Aorta. FPA = Fully Perfused FL Aorta. PTA = Partially Thrombosed FL Aorta. FTA = Fully Thrombosed FL Aorta. FL = False Lumen. FET = Frozen Elephant Trunk. AAD = Acute Aortic Dissection. CAD = Chronic Aortic Dissection.
Rathore KS et al. (2021) “Distal Aortic Remodeling after Type A Dissection Repair: An Ongoing Mirage.” Journal of Chest Surgery, 54 (6), pp439-448.
Li D et al. (2016) “False Lumen Status in Patients With Acute Aortic Dissection: A Systematic Review and Meta-Analysis.” Journal of the American Heart Association, 5 (5),pp 1-9.
Moretti S et al. (2023) “Comparative Analysis of Patient-Specific Aortic Dissections through Computational Fluid Dynamics Suggests Increased Likelihood of Degeneration in Partially Thrombosed False Lumen”. Bioengineering, March; 10( 316): pp1–27.
Pacini D et al. (2018) “Aortic remodeling in acute type A aortic dissection after frozen elephant trunk implantation.” Indian Journal of Thoracic and Cardiovascular Surgery, 35 ( 2), pp112–117.
Capitain A et al. (2024) “Thoracic endovascular aortic repair completion following frozen elephant trunk: how it’s done and device selection”. Expert Review of Medical Devices, 21 (8), pp 671–677.
Ma W et al. (2015) “Open Stented Grafts for Frozen Elephant Trunk Technique: Technical Aspects and Current Outcomes.” AORTA, 3(4), pp122-135.
Chauvette V et al. (2021) “Review of frozen elephant trunk repair with the Thoraflex Hybrid device.” Future Cardiology,17 (7), pp1171-1181.
Borghese O et al. (2024) “Frozen Elephant Trunk Procedure for Acute Type a Aortic Dissection: Analysis of Distal Aortic Remodeling According to the Society for Vascular Surgery (SVS)/Society of Thoracic Surgeons (STS) Reporting Standard.” Annals of Vascular Surgery,108, pp346-3549.
Shimamura J et al. (2023) “Five-Year Outcomes of Hybrid Arch Frozen Elephant Trunk Repair With Novel Multibranched Hybrid Graft.” Annals of Thoracic Surgery Short Reports, 1 (4), pp599-603.
Shrestha M et al. (2016) “Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-centre results of the first 100 patients.” Journal of Thoracic & Cardiovascular Surgery, 152 (1), pp148-159.
Chu M et al. (2019) “Early Clinical Outcomes of Hybrid Arch Frozen Elephant Trunk Repair With the Thoraflex Hybrid Graft.” Annals of Thoracic Surgery, 107, pp-47-53.
Images
Fig. i from Reference No. 3, by Moretti S. et al., © 2023, licensed under CC BY 4.0 (creativecommons.org/licenses/by/4.0), original at https://www.mdpi.com/2170158.
Figs. ii and iii from Reference. No. 8, by Shimamura J. et al., © 2023, licensed under CC BY 4.0 (creativecommons.org/licenses/by/4.0), original at https://www.annalsthoracicsurgeryshortrep.org/article/S2772-9931(23)00222-X/fulltext
Product Disclaimer
Product availability subject to regulatory approval.
An EU Declaration of Conformity may be requested from regulatoryaffairsuk@terumoaortic.com
Instructions for Use
View the eIFU for more information on use, indications, contraindications, warnings/precautions and availability within your market.
