White G H, Yu W, May J, Stephen M S, Waugh R C
Department of Vascular Surgery, Royal Prince Alfred Hospital, University of Sydney, Australia.
J Endovasc Surg. 1994 Sep;1:16-24. doi: 10.1583/1074-6218(1994)001<0016:ANNBEG>2.0.CO;2.
The aim of this study was to determine the feasibility of endoluminal grafting of aneurysms using a new design of nonstented endograft.
Initial studies were undertaken in bench models and by implantation of endografts into animal vessels. Between May 1992 and June 1994, endoluminal repair of aneurysms was undertaken in 47 patients (44 male, 3 female). A new balloon-expandable endoluminal graft was developed and has now been studied in 25 of these 47 cases. This graft does not require adjunctive use of a vascular stent because of its unique construction, which incorporates metallic implants (graft attachment device or "GAD") into the graft material. The design is applicable to endovascular grafting of occlusive arterial disease, as well as aneurysms. All patients were investigated by duplex scan, calibrated angiogram, and angio-CT scan and then allocated into groups that we defined according to the following criteria: group I, considered suitable for transfemoral implantation of a straight tube graft (n = 12); group II, unsuitable for transfemoral tube graft because of short neck of aneurysm, absent distal neck, or diseased iliac arteries (n = 10); and group III, peripheral aneurysms (n = 3). All patients were followed by clinical examination, duplex scan, and CT scan, with selective use of angiography.
Intraluminal deployment of the graft was achieved in all 25 patients; however, 3 patients from group II subsequently required conversion to open procedures because of the following complications: (1) partial graft thrombosis resulting from inadvertent omission of systemic anticoagulation during deployment (n = 1); and (2) unsuccessful deployment of the contralateral limb of a bifurcated graft in the iliac artery (n = 2). Successful endoluminal repair was achieved in 100% of patients in groups I and III, compared to 70% in group II.
These preliminary results (in a series of high-risk patients) have demonstrated that endoluminal abdominal aortic aneurysms repair with this graft can be achieved reliably and with low morbidity in patients who fulfill the selection criteria (group I) and in peripheral aneurysms (group III) but the results were less satisfactory in aneurysms that do not have a good proximal or distal neck or in patients with diseased iliac arteries (group II). Further modification of the bifurcated version in this graft design, together with improvements in access techniques and graft materials, is required for successful endoluminal grafting in a wider range of patients.
本研究的目的是确定使用一种新设计的无支架腔内移植物进行动脉瘤腔内移植的可行性。
最初的研究在实验台上进行，并将腔内移植物植入动物血管。1992年5月至1994年6月，对47例患者（44例男性，3例女性）进行了动脉瘤腔内修复。研发了一种新型球囊可扩张腔内移植物，目前已在这47例患者中的25例中进行了研究。这种移植物由于其独特的结构，不需要辅助使用血管支架，该结构将金属植入物（移植物附着装置或“GAD”）融入移植物材料中。该设计适用于闭塞性动脉疾病以及动脉瘤的血管腔内移植。所有患者均通过双功扫描、校准血管造影和血管CT扫描进行检查，然后根据以下标准分为我们定义的组：第一组，被认为适合经股动脉植入直管移植物（n = 12）；第二组，由于动脉瘤颈部短、无远端颈部或髂动脉病变而不适合经股动脉管形移植物（n = 10）；第三组，周围动脉瘤（n = 3）。所有患者均通过临床检查、双功扫描和CT扫描进行随访，并选择性地使用血管造影。
所有25例患者均成功实现了移植物的腔内植入；然而，第二组的3例患者随后因以下并发症需要转为开放手术：（1）植入过程中因疏忽未进行全身抗凝导致部分移植物血栓形成（n = 1）；（2）分叉移植物的对侧肢体在髂动脉中植入失败（n = 2）。第一组和第三组的所有患者均成功实现了腔内修复，而第二组为70%。
这些初步结果（在一系列高危患者中）表明，对于符合选择标准的患者（第一组）和周围动脉瘤（第三组），使用这种移植物进行腔内腹主动脉瘤修复可以可靠地实现，且发病率较低，但对于近端或远端颈部不佳的动脉瘤或髂动脉病变的患者（第二组），结果不太令人满意。为了在更广泛的患者中成功进行腔内移植，需要对这种移植物设计中的分叉版本进行进一步改进，同时改进接入技术和移植物材料。
