Clinical testing of Belarusian aortic stent graft system

Abstract

Aim. The study looks at the results of clinical testing of the first Belarusian aortic stent graft system developed and manufactured by a team of specialists from RSPC "Cardiology", Minsk, Belarus, and Belarusian Technical University.Methods. The original system of aortic stent graft includes a delivery system and an aortic stent graft itself. It is used in surgical treatment of complicated and common aneurysms of the thoracic aorta, as well as in cases of concomitant thoracic aneurysms and heart pathology to be treated under cardiopulmonary bypass. Clinical testing of the stent graft was carried out according to the requirements of Ministry of Health of the Republic of Belarus on the basis of three different cardiac hospitals of the country. Results. All the three hospitals treated one patient each. The first patient underwent implantation of the stent graft into the descending thoracic aorta, with the thoracic aorta aneurysm isolated and the aortic valve replaced with bioprosthesis. The second patient underwent ascending aorta and aortic valve replacement with a conduit and implantation of aortic stent graft into the descending thoracic aorta. In the third patient the domestic aortic stent graft was implanted into the descending thoracic aorta with isolation of the thoracic aneurysm; aortic valve and ascending aorta were replaced with ‘MedEng' conduit and the aortic arch was also replaced, with the brachiocephalic arteries re-implanted in place. All the patients were followed-up for both early and long-term outcomes for more than 1 year and were examined by using CT angiography in the early postoperative period and after 1 year. Uncomplicated postoperative course was observed in all the patients. There were no complications in the long-term follow-up as well. CT angiography data confirmed good positioning of the stent graft and good isolation of the aneurysm lumen. Preoperative and postoperative СТ data of one patient are presented in the article.Conclusion. The Belarusian system of aortic stent graft successfully passed clinical testing and may be certified and used in clinical practice at a later time on the territory of Belarus.Received 21 June 2016. Accepted 11 November 2016.Funding: The research was financed by Ministry of Health Care of Republic of Belarus.Conflict of interest: The authors declare no conflict of interest.Author contributionsConceptualization and study design: Shket A.P.Material acquisition and analysis: Shket A.P., Nizhnikova O.G. Statistical data processing: Glybovskaya T.V.Article writing: Shket A.P., Krutov V.G.Review & editing: Ostrovskii Y.P.