Coppi G, Pacchioni R, Moratto R, Gennai S, Farello G A, Bergamaschi G, Rabbia C, Rossato D, Ponzio F, Stancanelli V, Piccinini E
Divisione di Chirurgia Vascolare, Ospedale Sant'Agostino, Modena, Italy.
J Endovasc Surg. 1998 Aug;5(3):206-15. doi: 10.1583/1074-6218(1998)005<0206:EWTSEA>2.0.CO;2.
To report the outcome of an Italian multicenter trial of endovascular abdominal aortic aneurysm (AAA) exclusion using the Stentor device.
Between April 1995 and July 1996, 66 patients (63 men; average age 69 years, range 53 to 84) with infrarenal AAAs meeting the inclusion criteria were enrolled. The average diameter of the aneurysm was 4.6 cm (range 4.2 to 7). Three (4.5%) of the 66 AAAs were anastomotic aneurysms.
Sixteen (25%) tubular and 50 (76%) bifurcated endograft procedures were attempted; 4 (6.1%) were converted and 1 terminated owing to technical faults with the bifurcated graft's second limb. One tube graft was too short and failed to exclude an anastomotic aneurysm. Sixty (91%) endograft procedures were completed successfully. Six (9.1%) vascular complications occurred, three in one patient who subsequently died of pulmonary embolism 72 hours postoperatively (1.5% mortality). There were four (6.1%) proximal endoleaks; two sealed spontaneously in < 1 month, and a third was converted (7.6% conversion rate). The fourth is being observed. Clinical success (aneurysm exclusion with no death or endoleak) at 30 days was 86.3% (57/66). In the 23-month follow-up of 57 eligible patients, 2 patients died of unrelated causes and 1 graft limb thrombosed, requiring a crossover femoral bypass. One patient was converted to surgical repair at 5 months postoperatively when increasing aneurysm size signaled an undisclosed endoleak (1.8% late conversion rate). Five other secondary endoleaks were treated with endovascular techniques.
The Stentor was technically feasible in 10% to 40% of AAA candidates in this study, although deployment of the second limb was problematic in the bifurcated device. Introduction of the second-generation Vanguard endograft brought this study to an end.
报告一项使用Stentor装置进行血管内腹主动脉瘤（AAA）封堵的意大利多中心试验结果。
在1995年4月至1996年7月期间，纳入了66例符合纳入标准的肾下腹主动脉瘤患者（63例男性；平均年龄69岁，范围53至84岁）。动脉瘤的平均直径为4.6厘米（范围4.2至7厘米）。66例腹主动脉瘤中有3例（4.5%）为吻合口动脉瘤。
尝试进行了16例（25%）管状和50例（76%）分叉型腔内修复术；4例（6.1%）因技术问题中转，1例因分叉型移植物第二支的技术故障而终止。1例管状移植物过短，未能封堵吻合口动脉瘤。60例（91%）腔内修复术成功完成。发生了6例（9.1%）血管并发症，其中3例发生在1例患者身上，该患者术后72小时死于肺栓塞（死亡率1.5%）。有4例（6.1%）近端内漏；2例在1个月内自行封闭，第3例中转（转化率7.6%）。第4例正在观察中。30天时的临床成功率（动脉瘤封堵且无死亡或内漏）为86.3%（57/66）。在对57例符合条件的患者进行的23个月随访中，2例患者死于无关原因，1例移植物肢体血栓形成，需要进行交叉股动脉旁路移植术。1例患者在术后5个月时因动脉瘤增大提示存在未发现的内漏而中转至手术修复（晚期转化率1.8%）。另外5例继发性内漏采用血管内技术治疗。
在本研究中，Stentor在10%至40%的腹主动脉瘤候选患者中技术上可行，尽管分叉型装置中第二支的部署存在问题。第二代Vanguard腔内移植物的引入使本研究结束。
