Development of innovative system of universal stent graft for endovascular treatment of aneurysm and aortic displacement in various locations

Abstract

This study presents the technology of developing a universal stent graft for endovascular treatment of aneurysms and aortic dissection of various localizations, without considering the vessel diameter. A self-expanding nitinol stent was used as the frame of the main trunk of the stent graft. During the study, several variants of the aortic linear graft were manufactured and tested. The optimal stiffness and diameter of the nitinol wire were selected based on the results. When creating a bifurcation module, special attention was paid to simplifying the positioning and “intravascular assembly” of the structure. Implantable modules have been developed for the prosthetics of the main branches of the aorta. Dacron, optimal in terms of fiber structure, was chosen as the material of the woven shell of the graft. Linear extensibility, compactness of the pile, and tensile strength during fenestration were evaluated. To determine the heparin-controlled surgical porosity, experimental samples of stent grafts were tested on a stand simulating arterial blood flow. The wall material of the developed device had a heparin-controlled surgical porosity of 50–150 mL/min/cm² at 120 mm Hg with the possibility of maintaining a controlled endolic. The graft wall created a pressure gradient of no more than 3 mm Hg, and the flow velocity indicators were quite sufficient for adequate perfusion of vital organs. After the inactivation of heparin, blood permeability became zero. The implantation technique of the developed product was implemented on a silicone aortic phantom simulating aneurysm expansion with and without dissection. The phantom contour was filled with a solution simulating the rheological properties of native blood. Pulsating blood flow was simulated using a perfusion pump. Under X-ray control, a stent graft was installed on five large biological samples (sheep). Implantation was performed in the aortic arch with prosthetics of the brachiocephalic trunk and the suprarenal aorta with prosthetics of the visceral branches. With the experiment, we hope that the result will allow us to minimally invasively help patients suffering from aneurysms of any localization.

Keywords

aneurysm / aneurysmal dilation / aortic dissection / endoprosthetics / endovascular treatment of aneurysms / universal modular stent graft / implantation / implantable modules

References

[1] Abugov SA, Ponomarenko VB. Aortic aneurysm: diagnosis and treatment. Therapeutic archive. 2010;82(9):59–63. (In Russ.).

[2] Абугов С.А., Пономаренко В.Б. Аневризма аорты: диагностика и лечение // Терапевтический архив. 2010. Т. 82, № 9. С. 59–63.

[3] Bazhenova YV, Drantusova NS, Shanturov VA, Podashev BI. Computed tomography in the diagnosis of aortic aneurysm. Siberian medical journal (Irkutsk). 2014;130(7):37–41. (In Russ.).

[4] Баженова Ю.В., Дрантусова Н.С., Шантуров В.А., Подашев Б.И. Компьютерная томография в диагностике аневризм аорты // Сибирский медицинский журнал (Иркутск). 2014. Т. 130, № 7. С. 37–41.

[5] Belov YV, Rybakov KN, Gubarev IA, et al. Surgical treatment of patients with aortic valve defect in combination with ascending aorta expansion less than 5 cm (literature review). Moscow Surgical Journal. 2019;(5):38–45. (In Russ.). DOI: 10.17238/issn2072-3180.2019.5.38-45

[6] Белов Ю.В., Рыбаков К.Н., Губарев И.А., и др. Хирургическое лечение больных пороком аортального клапана в сочетании с расширением восходящей аорты менее 5 см // Московский хирургический журнал. 2019. № 5. С. 38–45. DOI: 10.17238/issn2072-3180.2019.5.38-45

[7] van Puijvelde GHM, Foks AC, van Bochove RE, et al. CD1d deficiency inhibits the development of abdominal aortic aneurysms in LDL receptor deficient mice. PLoS One. 2018;13(1):e0190962. DOI: 10.1371/journal.pone.0190962

[8] van Puijvelde G.H.M., Foks A.C., van Bochove R.E., et al. CD1d deficiency inhibits the development of abdominal aortic aneurysms in LDL receptor deficient mice // PLoS One. 2018. Vol. 13, No. 1. ID e0190962. DOI: 10.1371/journal.pone.0190962

[9] Lisina EV, Volkova SYu. Anevrizma aorty kak sluchainaya nakhodka. Universitetskaya meditsina Urala. 2019;5(2):62–63. (In Russ.).

[10] Лисина Е.В., Волкова С.Ю. Аневризма аорты как случайная находка // Университетская медицина Урала. 2019. Т. 5, № 2. С. 62–63.

[11] Kuz’michev DE, Skrebov RV, Shakirov II, Vil’tsev IM. Postmortal’naya diagnostika anevrizmy aorty. Zdravookhranenie Yugry: opyt i innovatsii. 2019;(1):42–44. (In Russ.).

[12] Кузьмичев Д.Е., Скребов Р.В., Шакиров И.И., Вильцев И.М. Постмортальная диагностика аневризмы аорты // Здравоохранение Югры: опыт и инновации. 2019. № 1. C. 42–44.

[13] Yegemberdiyev TZh, Baubekov AA, Matkherimov AZh, et al. Preventive “before and after” surgical treatment of aortic aneurysms and peripheral arteries (literature review). Bulletin of surgery in Kazakhstan. 2018;(2):25–30.

[14] Yegemberdiyev T.Zh., Baubekov A.A., Matkherimov A.Zh., et al. Preventive “before and after” surgical treatment of aortic aneurysms and peripheral arteries (literature review) // Bulletin of surgery in Kazakhstan. 2018. No. 2. P. 25–30.

[15] Gaponov DP, Chernov II, Gorbunov MG, et al. Hybrid surgical procedures of dissected thoracoabdominal aortic aneurysm. Astrakhan medical journal. 2014;9(3):130–134. (In Russ.).

[16] Гапонов Д.П., Чернов И.И., Горбунов М.Г., и др. Гибридное хирургическое лечение расслаивающей торакоабдоминальной аневризмы аорты // Астраханский медицинский журнал. 2014. Т. 9, № 3. С. 130–134.

[17] Chupin AV, Deryabin SV, Chigasov VA. Embolization of the internal iliac artery during endovascular repair of abdominal aortic aneurysms. Angiology and vascular surgery. 2019;25(4):82–89. (In Russ.).

[18] Чупин А.В., Дерябин С.В., Чигасов В.А. Эмболизация внутренней подвздошной артерии при эндопротезировании аневризмы брюшной аорты // Ангиология и сосудистая хирургия. 2019. Т. 25, № 4. С. 82–89.

[19] Timaran DE, Knowles M, Ali T, Timaran CH. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair. J Vasc Surg. 2017;66(2):354–359. DOI: 10.1016/j.jvs.2016.11.064

[20] Timaran D.E., Knowles M., Ali T., Timaran C.H. Fenestrated endovascular aneurysm repair among octogenarians at high and standard risk for open repair // J Vasc Surg. 2017. Vol. 66, No. 2. P. 354–359. DOI: 10.1016/j.jvs.2016.11.064

[21] Manunga J, Sullivan T, Garberich R, et al. Single-center experience with complex abdominal aortic aneurysms treated by open or endovascular repair using fenestrated/branched endografts. J Vasc Surg. 2018;68(2):337–347. DOI: 10.1016/j.jvs.2017.11.093

[22] Manunga J., Sullivan T., Garberich R., et al. Single-center experience with complex abdominal aortic aneurysms treated by open or endovascular repair using fenestrated/branched endografts // J Vasc Surg. 2018. Vol. 68, No. 2. Р. 337–347. DOI: 10.1016/j.jvs.2017.11.093

[23] Arakelyan VS, Papitashvili VG. Aneurysms of the descending thoracic and thoracoabdominal aorta: results of open surgeries. Annals of Surgery. 2016;21(5):300–305. (In Russ.). DOI: 10.18821/1560-9502-2016-21-5-300305

[24] Аракелян В.С., Папиташвили В.Г. Аневризмы нисходящего грудного и торакоабдоминального отделов аорты: результаты открытых вмешательств // Анналы хирургии. 2016. Т. 21, № 5. С. 300–305. DOI: 10.18821/1560-9502-2016-21-5-300305

[25] Kawatou M, Minakata K, Sakamoto K, et al. Comparison of endovascular repair with branched stent graft and open repair for aortic arch aneurysm. Interact Cardiovasc Thorac Surg. 2017;25(2):246–253. DOI: 10.1093/icvts/ivx111

[26] Kawatou M., Minakata K., Sakamoto K., et al. Comparison of endovascular repair with branched stent graft and open repair for aortic arch aneurysm // Interact Cardiovasc Thorac Surg. 2017. Vol. 25, No. 2. Р. 246–253. DOI:10.1093/icvts/ivx111

[27] Belov YuV, Charchyan ER, Stepanenko AB, et al. Surgical treatment of thoracoabdominal aortic aneurysms. Pirogov Russian Journal of Surgery. 2015;(12):33–38. (In Russ.). DOI: 10.17116/hirurgia20151233-38

[28] Белов Ю.В., Чарчян Э.Р., Степаненко А.Б., и др. Хирургическое лечение больных с торакоабдоминальными аневризмами аорты // Хирургия. Журнал им. НИ Пирогова. 2015. № 12. С. 33–38. DOI: 10.17116/hirurgia20151233-38

[29] Svetlikov АV, Galkin PA. Stentgrafting of aortic aneurysms: past, current situation and future. The hospital. 2014;(1):33–40. (In Russ.)

[30] Светликов А.В., Галкин П.А. Эндопротезирование аневризм аорты — новая парадигма в истории сосудистой хирургии или тупиковый путь: прошлое, настоящее и будущее // Клиническая больница. 2014. № 1. С. 33–40.

[31] Shin SH, Starnes BW. Bifurcated-bifurcated aneurysm repair is a novel technique to repair infrarenal aortic aneurysms in the setting of iliac aneurysms. J Vasc Surg. 2017;66(5):1398–1405. DOI: 10.1016/j.jvs.2017.02.044

[32] Shin S.H., Starnes B.W. Bifurcated-bifurcated aneurysm repair is a novel technique to repair infrarenal aortic aneurysms in the setting of iliac aneurysms // J Vasc Surg. 2017. Vol. 66, No. 5. Р. 1398–1405. DOI: 10.1016/j.jvs.2017.02.044

[33] Gallitto E, Gargiulo M, Faggioli G, et al. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair. J Vasc Surg. 2017;66(6):1659–1667. DOI: 10.1016/j.jvs.2017.04.063

[34] Gallitto E., Gargiulo M., Faggioli G., et al. Impact of iliac artery anatomy on the outcome of fenestrated and branched endovascular aortic repair // J Vasc Surg. 2017. Vol. 66, No. 6. Р. 1659–1667. DOI: 10.1016/j.jvs.2017.04.063

[35] Lee MJ, Daniels SL, Drake TM, Adam IJ. Risk factors for ischaemic colitis after surgery for abdominal aortic aneurysm: a systematic review and observational meta-analysis. Int J Colorectal Dis. 2016;31(7):1273–1281. DOI: 10.1007/s00384-016-2606-6

[36] Lee M.J., Daniels S.L., Drake T.M., Adam I.J. Risk factors for ischaemic colitis after surgery for abdominal aortic aneurysm: a systematic review and observational meta-analysis // Int J Colorectal Dis. 2016. Vol. 31, No. 7. Р. 1273–1281. DOI: 10.1007/s00384-016-2606-6

[37] Shutze Sr WP, Shutze R, Dhot P, et al. Sex as an independent risk factor for long-term survival after endovascular aneurysm repair. J Vasc Surg. 2019;69(4):1080–1089. DOI: 10.1016/j.jvs.2018.07.057

[38] Shutze Sr W.P., Shutze R., Dhot P., et al. Sex as an independent risk factor for long-term survival after endovascular aneurysm repair // J Vasc Surg. 2019. Vol. 69, No. 4. Р. 1080–1089. DOI: 10.1016/j.jvs.2018.07.057

RIGHTS & PERMISSIONS

Maystrenko D.N., Generalov M.I., Ivanov A.S., Oleshchuk A.N., Kokorin D.M., Nikolaev D.N., Maystrenko A.D., Popova A.A., Molchanov O.E., Stanzhevsky A.A.