Roselli Eric E, Greenberg Roy K, Pfaff Kathryn, Francis Catherine, Svensson Lars G, Lytle Bruce W
Department of Thoracic and Cardiovascular Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA.
J Thorac Cardiovasc Surg. 2007 Jun;133(6):1474-82. doi: 10.1016/j.jtcvs.2006.09.118. Epub 2007 May 2.
To establish the safety and efficacy of endovascular repair of thoracoabdominal aortic aneurysms.
Between May 2004 and February 2006, patients with thoracoabdominal aneurysms considered high risk for conventional surgery were enrolled in a prospective trial to evaluate a novel endovascular grafting system. Devices were custom designed for each patient using high-resolution computed tomography. Patient data included mortality, morbidity, procedural details, and surrogate end points for endovascular repair. These were collected at hospital discharge and at 1, 6, and 12 months.
Seventy-three patients underwent endovascular repair of thoracoabdominal aortic aneurysms for type I, II, or III (n = 28), or for type IV (n = 45) thoracoabdominal aneurysms. Mean aneurysm size was 7.1 cm (range 4.5-11.3 cm). General anesthesia was used in 47% of patients and regional anesthesia in 53%. There were no conversions to open surgery nor ruptures post-treatment. Technical success was achieved in 93% of patients (68/73). Thirty-day mortality was 5.5% (4/73). Major perioperative complications occurred in 11 (14%) patients and included paraplegia (2.7%, 2/73), new onset of dialysis (1.4%, 1/73), prolonged ventilator support (6.8%, 5/73), myocardial infarction (5.5%, 4/73), and minor hemorrhagic stroke (1.4%; 1/72). A majority of patients had no complications. Mean length of stay was 8.6 days. At follow-up, 6 deaths had occurred. There were no instances of stent migration nor aneurysmal growth.
Endovascular repair of aortic aneurysms involving the visceral segment in nonsurgical candidates is feasible. Known complications of repair are not eliminated, but morbidity and mortality appeared low relative to the high-risk population studied. Further refinement of device design, delivery technique, and patient selection is ongoing. Assessment of durability will require longer follow-up.
确立胸腹主动脉瘤血管腔内修复术的安全性和有效性。
在2004年5月至2006年2月期间,将被认为传统手术风险高的胸腹主动脉瘤患者纳入一项前瞻性试验,以评估一种新型血管腔内移植系统。使用高分辨率计算机断层扫描为每位患者定制设备。患者数据包括死亡率、发病率、手术细节以及血管腔内修复的替代终点。这些数据在出院时以及1个月、6个月和12个月时收集。
73例患者接受了胸腹主动脉瘤的血管腔内修复,其中I型、II型或III型(n = 28)或IV型(n = 45)胸腹主动脉瘤患者。动脉瘤平均大小为7.1厘米(范围4.5 - 11.3厘米)。47%的患者使用全身麻醉,53%使用区域麻醉。没有转为开放手术的情况,治疗后也没有破裂。93%的患者(68/73)实现了技术成功。30天死亡率为5.5%(4/73)。11例(14%)患者发生了主要围手术期并发症,包括截瘫(2.7%,2/73)、新出现的透析需求(1.4%,1/73)、延长呼吸机支持时间(6.8%,5/73)、心肌梗死(5.5%,4/73)和轻微出血性卒中(1.4%;1/72)。大多数患者没有并发症。平均住院时间为8.6天。随访时发生了6例死亡。没有支架移位或动脉瘤增大的情况。
对于非手术候选患者,涉及内脏段的主动脉瘤血管腔内修复是可行的。修复已知的并发症并未消除,但相对于所研究的高风险人群,发病率和死亡率似乎较低。设备设计、输送技术和患者选择的进一步优化正在进行中。耐久性评估需要更长时间的随访。