73
Views
0
CrossRef citations to date
0
Altmetric
Device Profile

Thoraflex Hybrid Prosthesis (THP): the profile

ORCID Icon, , , , , , , & show all
Pages 165-177 | Received 03 Nov 2023, Accepted 29 Feb 2024, Published online: 05 Mar 2024

References

  • Olsson C, Thelin S, Ståhle E, et al. Thoracic aortic aneurysm and dissection: increasing prevalence and improved outcomes reported in a nationwide population-based study of more than 14,000 cases from 1987 to 2002. Circulation. 2006;114(24):2611–2618. doi: 10.1161/CIRCULATIONAHA.106.630400
  • McClure RS, Brogly SB, Lajkosz K, et al. Epidemiology and management of thoracic aortic dissections and thoracic aortic aneurysms in Ontario, Canada: a population-based study. J Thorac Cardiovasc Surg. 2018;155(6):2254–2264.e4. doi: 10.1016/j.jtcvs.2017.11.105
  • Oladokun D, Patterson BO, Sobocinski J, et al. Systeminc review of the growth rates and influencing factors in thoracic aortic aneurysms. Eur J Vasc Endovasc Surg. 2016;51(5):674–681. doi: 10.1016/j.ejvs.2016.01.017
  • Melo R GE, Silva Duarte G, Lopes A, et al. Incidence and prevalence of thoracic aortic aneurysms: a systematic review and meta-analysis of population-based studies. Semin Thorac Cardiovasc Surg. 2022;34(1):1–16. doi: 10.1053/j.semtcvs.2021.02.029
  • Nakhaei P, Bashir M, Jubouri M, et al. Aortic remodeling, distal stent-graft induced new entry and endoleak following frozen elephant trunk: a systematic review and meta-analysis. J Card Surg. 2022;37(11):3848–3862. doi: 10.1111/jocs.16918
  • Jubouri M, Ansari DM, Zaqout F, et al. Total arch replacement versus proximal aortic replacement in acute type a aortic dissection: aggressive versus conservative. J Card Surg. 2022;37(12):4267–4268. doi: 10.1111/jocs.16916
  • Borst HG, Walterbusch G, Schaps D. Extensive aortic replacement using “elephant trunk” prosthesis. Thorac Cardiovasc Surg. 1983;31(1):37–40. doi: 10.1055/s-2007-1020290
  • Kato M, Ohnishi K, Kaneko M, et al. New graft-implanting method for thoracic aortic aneurysm or dissection with a stented graft. Circulation. 1996;94:II188–93.
  • Mousavizadeh M, Bashir M, Jubouri M, et al. Zone proximalization in frozen elephant trunk: what is the optimal zone for open intervention? A systematic review and meta-analysis. J Cardiovasc Surg (Torino). 2022;63(3):265–274. doi: 10.23736/S0021-9509.22.12292-5
  • Tan SZ, Jubouri M, Bashir M. Endovascular aortic arch repair: a comparison of outcomes and current trends. Asian Cardiovasc Thorac Ann. 2023;31(7):589–595. doi: 10.1177/02184923221140756
  • Tan SZCP, Jubouri M, Mohammed I, et al. What is the long-term clinical efficacy of the Thoraflex™ hybrid prosthesis for aortic arch repair? Front Cardiovasc Med. 2022 Feb 22;9:842165. doi: 10.3389/fcvm.2022.842165
  • Jubouri M, Kayali F, Saha P, et al. Incidence of distal stent graft induced new entry vs. Aortic remodeling associated with frozen elephant trunk. Front Cardiovasc Med. 2022;9:875078. doi: 10.3389/fcvm.2022.875078
  • Ma WG, Zheng J, Sun LZ, et al. Open stented grafts for frozen elephant trunk technique: technical aspects and Current outcomes. Aorta (Stamford). 2015 Aug 1;3(4):122–135. doi: 10.12945/j.aorta.2015.14-062
  • Terumo aortic announces US FDA approval for Thoraflex Hybrid device [Internet]. 2023 [cited 2023 Oct 20]. Available from: https://www.terumo.com/newsrelease/detail/20220420/5186
  • ThoraflexTM hybrid [Internet]. 2023 [cited 2023 Oct 20]. Available from: https://terumoaortic.com/products/thoraflex-hybrid/
  • Acharya M, Sherzad H, Bashir M, et al. The frozen elephant trunk procedure: indications, outcomes and future directions. Cardiovasc Diagn Ther. 2022 Oct;12(5):708–721. doi: 10.21037/cdt-22-330
  • Preventza O, Liao JL, Olive JK, et al. Neurologic complications after the frozen elephant trunk procedure: a meta-analysis of more than 3000 patients. J Thorac Cardiovasc Surg. 2020 Jul;160(1):20–33.e4.
  • Tian DH, Ha H, Joshi Y, et al. Long-term outcomes of the frozen elephant trunk procedure: a systematic review. Ann Cardiothorac Surg. 2020 May;9(3):144–151.
  • Shrestha M, Kaufeld T, Beckmann E, et al. Total aortic arch replacement with a novel 4-branched frozen elephant trunk prosthesis: single-center results of the first 100 patients. J Thorac Cardiovasc Surg. 2016 Jul 1;152(1):148–159.e1. doi: 10.1016/j.jtcvs.2016.02.077
  • Beckmann E, Martens A, Korte W, et al. Open total arch replacement with trifurcated graft and frozen elephant trunk. Ann Cardiothorac Surg. 2020 May;9(3):170–177.
  • Mariscalco G, Bilal H, Catarino P, et al. Reflection from UK aortic group: frozen elephant trunk technique as optimal solution in type a acute aortic dissection. Semin Thorac Cardiovasc Surg. 2019 Dec 1;31(4):686–690. doi: 10.1053/j.semtcvs.2019.03.010
  • Masiello P, Mastrogiovanni G, Presutto O, et al. Frozen elephant trunk procedure for complex aortic arch surgery: the Salerno experience with thoraflex hybrid. J Card Surg. 2022 Jan;37(1):107–114.
  • Chu MWA, Losenno KL, Dubois LA, et al. Early clinical outcomes of hybrid arch frozen elephant trunk repair with the thoraflex hybrid graft. Ann Thorac Surg. 2019 Jan 1;107(1):47–53. doi: 10.1016/j.athoracsur.2018.07.091
  • Shimamura J, Abazid R, Gelinas J, et al. Five-year outcomes of hybrid arch frozen elephant trunk repair with novel multibranched hybrid graft. Annals Thoracic Surgery Short Reports. 2023;1(4):599–603. doi: 10.1016/j.atssr.2023.06.009
  • Coselli JS, Roselli EE, Preventza O, et al. Total aortic arch replacement using a frozen elephant trunk device: results of a 1-year US multicenter trial [published online ahead of print, 2022 Sep 6]. J Thorac Cardiovasc Surg. 2022;S0022-5223(22):00921–7. doi: 10.1016/j.jtcvs.2022.08.029
  • Al-Tawil M, Jubouri M, Tan SZ, et al. Thoraflex hybrid vs. AMDS: to replace the arch or to stent it in type a aortic dissection? Asian Cardiovasc Thorac Ann. 2023;31(7):596–603. doi: 10.1177/02184923221147442
  • Wisniewski K, Motekallemi A, Dell’aquila AM, et al. Single-center experience with the thoraflex™ hybrid prosthesis: indications, implantation technique and results. Front Cardiovasc Med. 2022 May 30;9:924838.
  • Fiorentino M, de Beaufort HWL, Sonker U, et al. Thoraflex hybrid as frozen elephant trunk in chronic, residual type a and chronic type B aortic dissection. Interact Cardiovasc Thorac Surg. 2021;32(4):566–572. doi: 10.1093/icvts/ivaa305
  • Chivasso P, Mastrogiovanni G, Bruno VD, et al. Systematic total arch replacement with thoraflex hybrid graft in acute type a aortic dissection: a single centre experience. Front Cardiovasc Med. 2022 Oct 14;9:997961.
  • Kayali F, Jubouri M, Tan SZ, et al. Aortic remodeling in aortic dissection after frozen elephant trunk: overcoming the challenges. J Cardiovasc Surg (Torino). 2022;63(4):434–438. doi: 10.23736/S0021-9509.22.12385-2
  • Adams B. Implantation of frozen elephant trunk (FET)-surgical technique-Thoraflex. Cardiovasc Diagn Ther. 2023;13(3):550–556. doi: 10.21037/cdt-22-506
  • Ouzounian M, Hage A, Chung J, et al. Hybrid arch frozen elephant trunk repair: evidence from the Canadian thoracic aortic collaborative. Ann Cardiothorac Surg. 2020;9(3):189–196. doi: 10.21037/acs-2020-fet-22
  • Geragotellis A, Surkhi AO, Jubouri M, et al. Endovascular reintervention after frozen elephant trunk: where is the evidence? J Cardiovasc Surg (Torino). 2022;63(4):425–433. doi: 10.23736/S0021-9509.22.12393-1
  • Berger T, Weiss G, Voetsch A, et al. Multicentre experience with two frozen elephant trunk prostheses in the treatment of acute aortic dissection†. Eur J Cardiothorac Surg. 2019;56(3):572–578. doi: 10.1093/ejcts/ezz037
  • Kreibich M, Berger T, Rylski B, et al. Aortic reinterventions after the frozen elephant trunk procedure. J Thorac Cardiovasc Surg. 2020;159(2):392–9 e1. doi: 10.1016/j.jtcvs.2019.02.069
  • Jubouri M, Bashir M, Tan SZCP, et al. What is the optimal timing for thoracic endovascular aortic repair in uncomplicated type B aortic dissection? J Card Surg. 2022;37(4):993–1001. doi: 10.1111/jocs.16190
  • Tan SZCP, Mohammed I, Bashir M. Frozen elephant trunk sizing: a 30,000-feet perspective with thoraflex hybrid stent graft. AORTA. 2022 Aug;10(4):182–190. doi: 10.1055/s-0042-1756667
  • Jubouri M, Abdelhaliem A. BioGlue and E-Vita Open NEO graft oozing: long-term solution or band aid? J Card Surg. 2022;37(3):561–562. doi: 10.1111/jocs.16181
  • Damberg A, Schälte G, Autschbach R, et al. Safety and pitfalls in frozen elephant trunk implantation. Ann Cardiothorac Surg. 2013 Oct;2(5):66976–66676.
  • Kandola S, Abdulsalam A, Field M, et al. Frozen elephant trunk repair of aortic aneurysms: how to reduce the incidence of endoleak and reintervention. JTCVS Tech. 2020 Sep 1;3:13–20. doi: 10.1016/j.xjtc.2020.06.015
  • Burdess A, Mani K, Tegler G, et al. Stent-graft induced new entry tears after type B aortic dissection: how to treat and how to prevent? J Cardiovasc Surg. 2018 Nov;59(6). doi: 10.23736/S0021-9509.18.10570-2
  • Kreibich M, Bünte D, Berger T, et al. Distal Stent Graft–Induced New Entries After the Frozen Elephant Trunk Procedure. Ann Thorac Surg. 2020 Oct 1;110(4):1271–1279. doi: 10.1016/j.athoracsur.2020.02.017
  • Berger T, Graap M, Rylski B, et al. Distal aortic failure following the frozen elephant trunk procedure for aortic dissection. Front Cardiovasc Med. 2022 Jun 6;9. doi: 10.3389/fcvm.2022.911548
  • Murana G, Costantino A, Campanini F, et al. Distal stent graft-induced new entry (dSINE) after frozen elephant trunk: a scoping review. Cardiovasc Diagn Ther. 2023 Apr;13(2):408–417.
  • Czerny M, Eggebrecht H, Rousseau H, et al. Distal stent graft–induced new entry after TEVAR or FET: insights into a new disease from EuREC. Ann Thorac Surg. 2020 Nov 1;110(5):1494–1500. doi: 10.1016/j.athoracsur.2020.02.079
  • Fillinger MF, Greenberg RK, McKinsey JF, et al. Reporting standards for thoracic endovascular aortic repair (TEVAR). J Vascular Surg. 2010 Oct;52(4):1022–1033.e5. doi: 10.1016/j.jvs.2010.07.008
  • Dohle DS, Tsagakis K, Janosi RA, et al. Aortic remodelling in aortic dissection after frozen elephant trunk. Eur J Cardiothorac Surg. 2015 24;49(1):111–117. doi: 10.1093/ejcts/ezv045
  • Takagi H, Umemoto T. A meta-analysis of total arch replacement with frozen elephant trunk in acute type a aortic dissection. Vasc Endovascular Surg. 2016 Jan 14;50(1):33–46.
  • Di Bartolomeo R, Pantaleo A, Berretta P, et al. Frozen elephant trunk surgery in acute aortic dissection. J Thorac Cardiovasc Surg. 2015;149(2 Suppl):S105–S109. doi: 10.1016/j.jtcvs.2014.07.098
  • Usai MV, Ibrahim A, Oberhuber A, et al. Quantification of volume changes in the descending aorta after frozen elephant trunk procedure using the Thoraflex hybrid prosthesis for type a aortic dissection. J Thorac Dis. 2021;13(1):60–66. doi: 10.21037/jtd-20-2356
  • Mehanna M, Elhamami M, Abolkasem A, et al. Aortic remodelling and false lumen changes after the frozen elephant trunk technique using the thoraflex hybrid stented graft for aortic dissection. Egypt Heart J. 2021 Aug 26;73(1):74.
  • Berger T, Kreibich M, Morlock J, et al. True-lumen and false-lumen diameter changes in the downstream aorta after frozen elephant trunk implantation. Eur J Cardiothorac Surg. 2018;54(2):375–381. doi: 10.1093/ejcts/ezy031
  • Wada T, Yamamoto H, Takagi D, et al. Aortic remodeling, reintervention, and survival after zone 0 arch repair with frozen elephant trunks for acute type A aortic dissection: Midterm results. JTCVS Tech. 2022;14:29–38. doi: 10.1016/j.xjtc.2022.05.013
  • Rhee R, Gupta A, Vechvitvarakul S, et al. Risk factors predictive of unfavorable distal aortic remodeling after surgical repair of type a thoracic aortic dissection. J Cardiovasc Surg (Torino). 2020;61(3):323–331. doi: 10.23736/S0021-9509.19.10784-7
  • Bashir M, Abo Aljadayel H, Mousavizadeh M, et al. Correlation of coagulopathy and frozen elephant trunk use in aortic arch surgery: a systematic review and meta-analysis. J Card Surg. 2021;36(12):4699–4714. doi: 10.1111/jocs.16001
  • Kreibich M, Siepe M, Beyersdorf F, et al. Spontaneous leakage of the Thoraflex™ frozen elephant trunk prosthesis. Interact Cardiovasc Thorac Surg. 2019;28(2):327–329. doi: 10.1093/icvts/ivy238
  • Ibrahim M, Chung JC, Ascaso M, et al. In-hospital thromboembolic complications after frozen elephant trunk aortic arch repair [published online ahead of print, 2022 Aug 17]. J Thorac Cardiovasc Surg. 2022;S0022-5223(22):00851–0. doi: 10.1016/j.jtcvs.2022.08.005
  • Kayali F, Qutaishat S, Jubouri M, et al. Kinking of Frozen Elephant Trunk Hybrid Prostheses: Incidence, Mechanism, and Management. Front Cardiovasc Med. 2022;9:912071. doi: 10.3389/fcvm.2022.912071
  • Ius F, Fleissner F, Pichlmaier M, et al. Total aortic arch replacement with the frozen elephant trunk technique: 10-year follow-up single-centre experience. Eur J Cardiothorac Surg. 2013;44(5):949–957. doi: 10.1093/ejcts/ezt229
  • Harky A, Fok M, Bashir M. Which is the optimal frozen elephant trunk? A systematic review and meta-analysis of outcomes in 2161 patients undergoing Thoracic Aortic aneurysm surgery Using E-vita OPEN PLUS hybrid stent graft versus Thoraflex™ hybrid prosthesis. Braz J Cardiovasc Surg. 2020;35(4):427–436.
  • Di Marco L, Votano D, Leone A, et al. Frozen elephant trunk: assets and liabilities of a challenging technique. Vessel Plus. 2020;4:32. doi: 10.20517/2574-1209.2020.23
  • Montagner M, Kofler M, Heck R, et al. Initial experience with the new type a arch dissection stent: restoration of supra-aortic vessel perfusion. Interact Cardiovasc Thorac Surg. 2021;33(2):276–283. doi: 10.1093/icvts/ivab085
  • Umana-Pizano JB, Nissen AP, Sandhu HK, et al. Acute type a dissection repair by high-volume vs low-volume Surgeons at a high-volume aortic center. Ann Thorac Surg. 2019;108(5):1330–1336. doi: 10.1016/j.athoracsur.2019.04.040
  • Society for Cardiothoracic Surgery in Great Britain, Ireland Bridgewater B, Keogh B, et al. Sixth national adult cardiac surgical database report 2008. Demonstrating Quality. [cited 2022 Sep 1]. Available from: https://scts.org/_userfiles/pages/files/sixthnacsdreport2008withcovers.pdf
  • Bashir M, Harky A, Fok M, et al. Acute type a aortic dissection in the United Kingdom: surgeon volume-outcome relation. J Thorac Cardiovasc Surg. 2017;154(2):398–406.e1. doi: 10.1016/j.jtcvs.2017.02.015
  • Preventza O. In type a aortic dissection repair, an effective team approach and relational coordination are more important for patients’ outcomes than surgeon volume. J Thorac Cardiovasc Surg. 2017;154(2):407–408. doi: 10.1016/j.jtcvs.2017.02.034

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.