Tazaki Junichi, Inoue Kanji, Higami Hirooki, Higashitani Nobuya, Toma Masanao, Saito Naritatsu, Kawatou Masahide, Kimura Takeshi
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
PTMC Institute, Kyoto, Japan.
J Vasc Surg. 2017 Nov;66(5):1340-1348.e5. doi: 10.1016/j.jvs.2017.03.432. Epub 2017 Jun 2.
Thoracic endovascular aortic repair (TEVAR) for thoracic aortic aneurysms (TAAs) is in rapid expansion due to its minimal invasiveness. However, TEVAR for an arch aneurysm with a straight stent graft needs surgical reconstruction for supra-aortic vessels. A branched stent graft pioneered by Inoue (branched Inoue Stent Graft [ISG]) has been expected to resolve this problem, but its utility remains to be established in the real clinical setting. This study evaluated the long-term clinical outcome of branched ISGs for TAAs.
Among 217 consecutive patients who underwent TEVAR with ISGs between March 2003 and September 2013, 89 patients with TAAs were treated with implantation of the branched ISG (single branch: n = 64; double branch: n = 18; triple branch: n = 7). The primary end point was freedom from aneurysm-related death. Secondary end points included periprocedural adverse events, freedom from all-cause death and major adverse events (composite of aneurysm-related death, surgical conversion, aneurysm rapture, persistent type I or III endoleak, graft infection, graft occlusion, graft migration, and aneurysm expansion), changes of aneurysm diameter, stroke, and any endovascular reintervention during follow-up.
All deployments of branched ISGs were successful. The 30-day mortality was 4.5% (single branch, 3.1%; double branch, 0%; triple branch, 29%), and periprocedural stroke was 16% (single branch, 7.8%; double branch, 33%; triple branch, 42%). At 1 and 5 years, freedom from aneurysm-related death was 93% and 93%, respectively, and freedom from all-cause death was 85% and 59%, respectively. Survival free of major adverse events was 76% at 5 years. The cumulative incidence of stroke was 11% at 5 years. Three patients underwent surgical conversion because of persistent type I endoleak. One branch graft occlusion was observed at the left subclavian artery in a patient who received a double-branched graft.
Periprocedural outcome of the single-branched ISG was acceptable, and long-term safety and efficacy were demonstrated. However, the procedural complications of the multibranched ISG leave room for improvement.
由于其微创性,胸主动脉瘤(TAA)的胸主动脉腔内修复术(TEVAR)正在迅速发展。然而,使用直型覆膜支架对主动脉弓部动脉瘤进行TEVAR需要对上主动脉血管进行外科重建。由井上发明的分支型覆膜支架(分支型井上覆膜支架[ISG])有望解决这一问题,但其在实际临床环境中的效用仍有待确定。本研究评估了分支型ISG治疗TAA的长期临床结果。
在2003年3月至2013年9月期间连续接受ISG治疗的217例患者中,89例TAA患者接受了分支型ISG植入治疗(单分支:n = 64;双分支:n = 18;三分支:n = 7)。主要终点是无动脉瘤相关死亡。次要终点包括围手术期不良事件、无全因死亡和主要不良事件(动脉瘤相关死亡、手术转换、动脉瘤破裂、持续性I型或III型内漏、移植物感染、移植物闭塞、移植物移位和动脉瘤扩张的综合)、动脉瘤直径变化、中风以及随访期间的任何血管腔内再次干预。
分支型ISG的所有植入均成功。30天死亡率为4.5%(单分支,3.1%;双分支,0%;三分支,29%),围手术期中风发生率为16%(单分支,7.8%;双分支,33%;三分支,42%)。在1年和5年时,无动脉瘤相关死亡的比例分别为93%和93%,无全因死亡的比例分别为85%和59%。5年时无主要不良事件的生存率为76%。5年时中风的累积发生率为11%。3例患者因持续性I型内漏接受了手术转换。在一名接受双分支移植物的患者中,观察到左锁骨下动脉一处分支移植物闭塞。
单分支ISG的围手术期结果是可以接受的,并证明了其长期安全性和有效性。然而,多分支ISG的手术并发症仍有改进空间。