White R A, Donayre C E, Walot I, Kopchok G E, Wilson E, Heilbron M, Hussain F, deVirgilio C, Buwalda R, Fogarty T J
Department of Surgery, Harbor-UCLA Medical Center, Torrance, California 90509, USA.
Ann Surg. 1997 Sep;226(3):381-9; discussion 389-91. doi: 10.1097/00000658-199709000-00017.
The authors analyzed a single group's experience treating abdominal aortic aneurysms (AAAs) with a new self-expanding, modular, bifurcated device.
Successful exclusion of AAAs by prototype devices has led to several controlled clinical trials evaluating prostheses designed and manufactured specifically for this application.
Sixteen patients (15 males, 1 female) of American Society of Anesthesiologists grade 2 through 4 and average age of 72 years had AAAs (average 57-mm diameter) treated as part of a phase I Food and Drug Administration-approved trial.
All patients were treated successfully with no surgical conversions. No endoleaks or aneurysm enlargement was noted either predischarge by contrast computed tomography or on follow-up at 1 month by duplex ultrasound examination. At 6 months, 12 of 13 patients who were observed for this interval had no endoleaks, whereas one patient (patient 3) showed a small area of extravasation that appeared to arise from the device in an area that was traumatized at the time of deployment. One procedure-related mortality (6%) occurred in a patient who died of septic complications secondary to a gangrenous gallbladder diagnosed 1 day after the procedure. There were no device-related mortalities. Complications included two iliac artery dissections, two groin wound infections, and two transient elevations of serum creatinine. Other significant variables including median procedure length (5 hours), intensive care unit stay (1 day), hospitalization postprocedure (4.5 days), and blood loss (1100 mL) all decreased as the study progressed. Blood replacement in all but three patients was accomplished by autotransfusion or banked-autologous blood replacement. At 6-month follow-up in 13 patients, the maximum diameter of the aneurysm decreased by an average of 5.6 mm (range, 0-15 mm), and the maximal cross-sectional area decreased an average of 20.3% (range, 0-72%).
This study suggests that endovascular prosthesis exclusion of AAAs using a self-expanding modular device may be effective in many patients who are otherwise surgical candidates for repair if further clinical studies confirm these observations.
作者分析了使用一种新型自膨胀、模块化、分叉装置治疗腹主动脉瘤（AAA）的单组经验。
原型装置成功排除AAA已促使开展多项对照临床试验，以评估专门为此应用设计和制造的假体。
16例患者（15例男性，1例女性），美国麻醉医师协会分级为2至4级，平均年龄72岁，患有AAA（平均直径57毫米），作为美国食品药品监督管理局批准的I期试验的一部分接受治疗。
所有患者均成功接受治疗，无手术转换情况。在出院前通过对比计算机断层扫描或术后1个月通过双功超声检查均未发现内漏或动脉瘤增大。在6个月时，在此期间接受观察的13例患者中有12例无内漏，而1例患者（患者3）在装置的一个在部署时受到创伤的区域出现了一小片似乎由装置引起的外渗。1例与手术相关的死亡（6%）发生在1例患者身上，该患者在手术后1天被诊断为坏疽性胆囊炎，继发感染性并发症死亡。无与装置相关的死亡。并发症包括2例髂动脉夹层、2例腹股沟伤口感染和2例血清肌酐短暂升高。随着研究进展，其他重要变量包括中位手术时间（5小时）、重症监护病房停留时间（1天）、术后住院时间（4.5天）和失血量（1100毫升）均有所减少。除3例患者外，所有患者均通过自体输血或库存储存自体血替代完成血液置换。在13例患者的6个月随访中，动脉瘤的最大直径平均减小5.6毫米（范围为0至15毫米），最大横截面积平均减小20.3%（范围为0至72%）。
本研究表明，如果进一步的临床研究证实这些观察结果，使用自膨胀模块化装置通过血管内假体排除AAA对许多原本适合手术修复的患者可能有效。
