새로이 개발된 경피적 삽입술이 가능한 대동맥 인조혈관 스텐트의 임상 시험

Abstract

Purpose: To evaluate the feasibility, safety and effectiveness of a newly designed percutaneously implanted separate stent-graft (SSG) for the treatment of aortic aneurysms and dissections.

Materials and Methods: Using a percutaneous technique, SSG placement (in the descending thoracic aorta in 26 cases and infrarenal abdominal aorta in 24) was attempted in 50 patients with aortic aneurysms (n=27) or dissection (n=23). All SSGs were individually constructed using self-expandable nitinol stents and a Dacron graft, and were introduced through a 12 F sheath and expanded to a diameter of 20-34 mm. In all cases, vascular access was through the femoral artery. The clinical status of each patient was monitored, and postoperative CT was performed within one week of the procedure and at 3-6 month intervals afterwards.

Results: Endovascular stent-graft deployment was technically successful in 49 of 50 patients (98%). The one failure was due to torsion of the unsupported graft during deployment. Successful exclusion of aneurysms and the primary entry tears of dissections was achieved in all but three patients with aortic dissection. All patients in whom technical success was achieved showed complete thrombosis of the thoracic false lumen or aneurysmal sac, and the overall technical success rate was 92%. In addition, sixteen patients demonstrated complete resolution of the dissected thoracic false lumen (n=9) or aneurysmal sac (n=7). Immediate post-operative complications occurred at the femoral puncture site in one patient with an arteriovenous fistula, and in two, a new saccular aneurysm developed at the distal margin of the stent. No patient died, and there was no instance of paraplegia, stroke, side-branch occlusion or infection during the subsequent mean follow-up period of 9.4 (range, 2 to 26) months.

Conclusion: In patients with aortic aneurysm and dissection, treatment with a separate percutaneously inserted stent-graft is technically feasible, safe, and effective.