Endovascular Reconstruction from Aortic Valve to Aortic Arch Using One-Piece Valved-Fenestrated Stent Graft with a Branch: A Proof-of-Concept Study
Keywords:endovascular repair; aortic root lesion; stent-graft
Objective: To explore the feasibility of endovascular reconstruction of aortic root including aortic valve, sinus of valsalva and ascending aorta by a single stent-graft, a novel valved stent-graft with two fenestrae for preserving the coronary arteries was designed and performed in-vitro on a pig heart based circulation simulating system.
Methods: Pig hearts were harvested from 30 healthy adult female pigs weighing between 60-65 kilograms. Before sacrifice, all the pigs received aortic computed tomography angiography (CTA) examinations and morphologic parameters of aortic root were measured. Then we customized the valved stent-grafts according to the CTA measurements. After the pig heart was fixed on the special platform according to the original orientation and connected to the circulation system, the stent graft was delivered through transapical access and covered the segment from aortic annulus to proximal part of aortic arch under DSA (digital subtraction angiography) guidance. Then changes of coronary flow before and after the procedure and fenestration alignment with coronary ostia were analyzed.
Results: The overall technical success rate was 100%. The valve functions tested by ultrasound were in good condition under 120 mmHg circulation pressure. The flow of left coronary artery (LCA) did not decrease, but increased after the stent-graft implantation (340 ± 2.06 mL/min versus 288 ± 5.29 mL/min, P < .05). Similarly, the flow of right coronary artery (RCA) also increased (392 ± 9.17 mL/min versus 348 ± 8.01 mL/min; P < .05). The final angiography confirmed that both coronary arteries were patent. When generally observed from outer wall of valsalva sinus, both RCA and LCA orifices were aligned with the fenestrae. In 4 cases, the autologous valve leaflets blocked nearly 20% of the LCA fenestra’s area, but the flow did not significantly decrease in these cases.
Conclusion: Stimulated on a pig heart-based circulation simulation system, the one-piece valved-fenestrated stent graft with a branch could be delivered via the transapical access and deployed accurately, which achieved endovascular reconstruction of aortic valve, sinus of valsalva and ascending aorta while preserving the coronary artery perfusion by fenestrations. More in-vivo experiments on animal models are mandatory to further verify its efficacy and safety.
Bonow RO, Leon MB, Doshi D, Moat N. 2016. Management strategies and future challenges for aortic valve disease. Lancet 387:1312-23.
Chava S, Gentchos G, Abernethy A, Leavitt B, Terrien E, Dauerman HL. 2017. Routine CT angiography to detect severe coronary artery disease prior to transcatheter aortic valve replacement. J Thromb Thrombolysis 44:154-60.
Eltchaninoff H, Durand E, Avinee G, et al. 2018. Assessment of structural valve deterioration of transcatheter aortic bioprosthetic balloon-expandable valves using the new European consensus definition. EuroIntervention 14:e264-71.
Feuchtner GM, Schachner T, Friedrich G, Antretter H, Bonatti J, Zur ND. 2005. Acute aortic dissection with coronary ostium involvement and aortic valve regurgitation: three-dimensional visualization with multislice computed tomography. J Thorac Cardiovasc Surg 130:587-8.
Gulyaeva AS, Roshchevskaya IM. 2012. Morphology of moderator bands (septomarginal trabecula) in porcine heart ventricles. Anat Histol Embryol 41:326-32.
Mangieri A, Jabbour RJ, Montalto C, et al. 2017. Single-antiplatelet therapy in patients with contraindication to dual-antiplatelet therapy after transcatheter aortic valve implantation. Am J Cardiol 119:1088-93.
Smith CR. 2018. Emergency cardiac surgery following TAVI: implications for the future. Eur Heart J 39:685-6.
Wang C, Lachat M, Regar E, von Segesser LK, Maisano F, Ferrari E. 2018. Suitability of the porcine aortic model for transcatheter aortic root repair. Interact Cardiov Thorac Surg 26:1002-8.
Wipper S, Lohrenz C, Ahlbrecht O, et al. 2015. Transcardiac endograft delivery for endovascular treatment of the ascending aorta: a feasibility study in pigs. J Endovasc Ther 22:375-84.
How to Cite
Author Disclosure & Copyright Transfer Agreement
In order to publish the original work of another person(s), The Heart Surgery Forum® must receive an acknowledgment of the Author Agreement and Copyright Transfer Statement transferring to Forum Multimedia Publishing, L.L.C., a subsidiary of Carden Jennings Publishing Co., Ltd. the exclusive rights to print and distribute the author(s) work in all media forms. Failure to check Copyright Transfer agreement box below will delay publication of the manuscript.
A current form follows:
The author(s) hereby transfer(s), assign(s), or otherwise convey(s) all copyright ownership of the manuscript submitted to Forum Multimedia Publishing, LLC (Publisher). The copyright transfer covers the exclusive rights to reproduce and distribute the article and the material contained therein throughout the world in all languages and in all media of expression now known or later developed, including but not limited to reprints, photographic reproduction, microfilm, electronic data processing (including programming, storage, and transmission to other electronic data record(s), or any other reproductions of similar nature), and translations.
However, Publisher grants back to the author(s) the following:
- The right to make and distribute copies of all or part of this work for use of the author(s) in teaching;
- The right to use, after publication in The Heart Surgery Forum, all or part of the material from this work in a book by the author(s), or in a collection of work by the author(s);
- The royalty-free right to make copies of this work for internal distribution within the institution/company that employs the author(s) subject to the provisions below for a work-made-for-hire;
- The right to use figures and tables from this work, and up to 250 words of text, for any purpose;
- The right to make oral presentations of material from this work.
Publisher reserves the right to grant or refuse permission to third parties to republish all or part of the article or translations thereof. To republish, such third parties must obtain written permission from the Publisher. (This is in accordance with the Copyright Statute, United States Code, Title 17. Exception: If all authors were bona fide officers or employees of the U.S. Government at the time the paper was prepared, the work is a “work of the US Government” (prepared by an officer or employee of the US Government as part of official duties), and therefore is not subject to US copyright; such exception should be indicated on signature lines. If this work was prepared under US Government contract or grant, the US Government may reproduce, royalty-free, all or portions of this work and may authorize others to do so, for official US Government purposes only, if the US Government contract or grant so requires.
I have participated in the conception and design of this work and in the writing of the manuscript and take public responsibility for it. Neither this manuscript nor one with substantially similar content under my authorship has been published, has been submitted for publication elsewhere, or will be submitted for publication elsewhere while under consideration by The Heart Surgery Forum, except as described in an attachment. I have reviewed this manuscript (original version) and approve its submission. If I am listed above as corresponding author, I will provide all authors with information regarding this manuscript and will obtain their approval before submitting any revision. I attest to the validity, accuracy, and legitimacy of the content of the manuscript and understand that Publisher assumes no responsibility for the validity, accuracy, and legitimacy of its content. I warrant that this manuscript is original with me and that I have full power to make this Agreement. I warrant that it contains no matter that is libelous or otherwise unlawful or that invades individual privacy or infringes any copyright or other proprietary right. I agree to indemnify and hold Publisher harmless of and from any claim made against Publisher that relates to or arises out of the publication of the manuscript and agree that this indemnification shall include payment of all costs and expenses relating to the defense of any such claim, including all reasonable attorney’s fees.
I warrant that I have no financial interest in the drugs, devices, or procedures described in the manuscript (except as disclosed in the attached statement).
I state that the institutional Human Subjects Committee and/or the Ethics Committee approved the clinical protocol reported in this manuscript for the use of experimental techniques, drugs, or devices in human subjects and appropriate informed consent documents were utilized.
Furthermore, I state that any and all animals used for experimental purposes received humane care in USDA registered facilities in compliance with the “Principles of Laboratory Animal Care” formulated by the National Society for Medical Research and the “Guide for the Care and Use of Laboratory Animals” prepared by the Institute of Laboratory Animal Resources and published by the National Institutes of Health (NIH Publication No. 85-23, revised 1985).