Five-year report of a multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysms

OBJECTIVE: Compare long-term results of endovascular treatment and standard open repair of abdominal aortic aneurysms in a multicenter, concurrent-controlled trial. METHODS: 334 subjects were treated with standard open repair (control, n = 99) or the original EXCLUDER Bifurcated Endoprosthesis (test, n = 235). Five-year clinical evaluations and corelab radiographic results are analyzed. RESULTS: Overall and aneurysm-related survival are similar. There have been ten open conversions, most frequently for enlarging sacs without endoleak. Two patients died after conversion. Including reinterventions and complications of reinterventions as adverse events, there is significant, persistent long-term reduction in major adverse events. At 5 years, corelab reported 0% limb narrowing, 0% trunk migration, 0% component (contralateral leg, aortic extender, and iliac extender) migration, 0% fracture, endoleak in 3% (2 type II/68), and aneurysm growth (>5 mm compared to baseline) in 38% (30/78) of the test group. There are no aneurysm ruptures in either test or control group. CONCLUSIONS: After 5 years follow-up, endovascular repair is a safer and effective treatment compared with open surgical repair for abdominal aortic aneurysms. Major adverse events are less frequent with the endograft despite the need for late reinterventions. Aneurysm expansion is observed in nearly two-fifths of patients but is not associated with endoleak or aneurysm rupture. Multicenter clinical trials are evaluating a newer version of this device designed to avoid this high rate of sac expansion.     

Systematic review of clinical trials comparing open and endovascular treatment of abdominal aortic aneurysm

Objective: Endovascular repair (EVAR) using stent‐graft device is a new treatment for abdominal aortic aneurysm (AAA) that is gaining more and more popularity. This systematic review compares the new minimally invasive endovascular treatment with the conventional open repair aiming to provide more evidence for clinical decision on choice of treatment for aneurysm patients. Methods: Electronic search on MEDLINE, EMBASE and Cochrane Library and manual search on bibliographies was performed to identify studies published from 1991 to 2004 comparing clinical outcomes of patients who underwent EVAR and open repair. Quality of clinical studies was assessed by modified Evans and Pollok score and those scores below 50 were excluded. Systematic analysis was performed for short‐, mid‐ and long‐term clinical outcomes. The effect size of the clinical parameters was estimated by relative risk, weighted mean difference and standard mean difference. Results: 27 clinical studies and 7226 patients were included in this systematic review. Three studies were randomized control studies and the rest were comparative studies. Systematic review showed patients after EVAR had significantly lower 30‐day mortality, shorter hospital and intensive care unit stay, less blood loss or blood transfusion, fewer cardiac and respiratory complications, less colonic ischaemia, and fewer overall operative morbidities. But EVAR carried a significant higher frequency of early secondary procedures and graft‐related complications. The 1–5‐year mortality between the two groups was similar. Patients receiving EVAR required more late secondary procedures and the cost related to EVAR was higher. Systematic review on quality of life could not be performed as there was a large variation on method of measurement. Conclusions: EVAR offers significant benefit to aneurysm patients in the early postoperative period. However, it does not show an advantage over open repair in mid‐ and long‐term outcome. Furthermore, EVAR might carry more morbidity and higher cost in the long term. Prospective randomized control studies focusing on long‐term outcome of EVAR and open repair aneurysm patients as well as on studies on newer generation devices are needed to provide more information for clinical decisions.     

Pro- and anti-inflammatory cytokine release in open versus endovascular repair of abdominal aortic aneurysm

BACKGROUND: Pro- and anti-inflammatory cytokine release occurs with abdominal aortic aneurysm (AAA) repair although the relative contribution of each is currently poorly understood. Ischaemia-reperfusion injury is thought to play a greater role following open (OR) than endovascular (ER) repair, with resultant greater perioperative morbidity. METHODS: Thirty-two patients undergoing OR (n = 16) and ER (n = 16) of AAA were studied. Systemic venous (SV) blood was taken at induction (baseline), 0 h (last clamp off), 4, 24, 72 and 144 h, and femoral venous (FV) blood (indwelling catheter; lower torso venous effluent) at 0, 4 and 24 h. The cytokines interleukin (IL) 6, IL-8 and IL-10 were measured in these samples. RESULTS: In OR, SV and FV IL-6 increased from baseline to a peak at 24 h (SV 589 pg/ml (P = 0.001 versus baseline) and FV 848 pg/ml (P = 0.05)) before declining at 144 h. In ER, there was a similar pattern but the increase was smaller (24 h: SV 260 pg/ml (P = 0.003 versus baseline) and FV 319 pg/ml (P = 0.06)) at all equivalent timepoints compared with OR. IL-8 peaked earlier (4 h) from baseline in both groups before declining by 144 h, and significant differences between SV and FV were seen only in the OR group. IL-10 levels peaked in both groups at 24 h before declining at 144 h, and there were no significant locosystemic differences between the groups. CONCLUSION: Venous pro-inflammatory cytokine changes (IL-6) are consistent with significantly greater lower-torso reperfusion injury in patients undergoing OR. Smaller responses were seen after ER (IL-6 and IL-8), although both groups showed a similar anti-inflammatory response (IL-10); this pro- and anti-inflammatory imbalance may account for the increased morbidity associated with OR.     

Disparate outcome after endovascular treatment of small versus large abdominal aortic aneurysm

OBJECTIVES: The size of an abdominal aortic aneurysm is the most important parameter for determining whether repair is appropriate. This decision, however, must be considered in the context of long-term outcome of treatment, balancing risk for rupture with mortality from the initial procedure and all subsequent secondary procedures necessary when durability is not ideal. Information on the results of endovascular repair of small versus large aneurysms has not been available. METHODS: Preoperative imaging studies and postoperative outcome were assessed in 700 patients who underwent endovascular repair of abdominal aortic aneurysm over 6 years at a single institution. Patients were divided into two groups: 416 patients (59.4%) with aneurysms smaller than 5.5 cm in diameter and 284 patients (40.6%) with aneurysms 5.5 cm or larger in diameter. Outcome variables were assessed with the Kaplan-Meier method and the log-rank test. RESULTS: Patients with small and large aneurysms were comparable with regard to all baseline parameters assessed, with the single exception of a small increase in age (2.3 years) in patients with large aneurysms (P =.031). While there were no differences in rate of type II endoleaks, mid-term changes in sac diameter, or aneurysm rupture between the two groups, at 24 months patients with large aneurysms had more type I leaks (6.4% +/- 2.3% vs 1.4% +/- 0.6%; P =.011), device migration (13% +/- 4.0% vs 4.4% +/- 1.8%; P =.006), and conversion to open surgical repair (8.2% +/- 3.2% vs 1.4% +/- 1.1%; P =.031). Of greatest importance, at 24 months patient survival was diminished (71% +/- 4.6% vs 86% +/- 2.8%; P <.001) and risk for aneurysm-related death was increased (6.1% +/- 2.6% vs 1.5% +/- 1.0%; P =.011) in the group with large aneurysms. CONCLUSIONS: Outcome after endovascular repair of abdominal aortic aneurysm depends on size; results appear inferior in patients with larger aneurysms. These differences attain importance when choosing between observation and repair, balancing risk for rupture against size-dependent outcome.     

Simultaneous endovascular exclusion of thoracic aortic aneurysm with open abdominal aortic aneurysm repair.

BACKGROUND: The treatment of aneurysms at multiple sites within the aorta is problematic. METHODS: Between March 2002 and June 2003 in the Department of General, Vascular and Transplant Surgery, Medical University of Warsaw six patients with coexisting abdominal and descending thoracic aortic aneurysms underwent simultaneous open abdominal aortic aneurysm (AAA) repair and endoluminal thoracic aortic aneurysm (TAA) repair. The indication for a combined procedure was a diagnosed descending TAA and AAA with no significant risk factors for open aortic surgery or technical contraindications for endovascular treatment of TAA. RESULTS: One patient died in the peri-operative period while the other five patients all recovered well after surgery and were discharged with both aneurysms excluded. CONCLUSION: Endovascular treatment of TAA combined with a simultaneous open AAA repair is an efficient and relatively safe treatment modality in patients with TAA and AAA disqualified from endovascular repair. The fact that thoracotomy is not a necessity significantly lowers the complication rate in these patients.     

腔内修复与开放手术治疗腹主动脉瘤的疗效比较

目的 比较腹主动脉瘤开放手术和腔内治疗的效果.方法 对223例分别行开放手术和腔内修复的腹主动脉瘤患者的临床资料进行回顾性分析,对手术相关情况、围手术期及随访中并发症发生率、生存率、生存质量以及与住院相关的费用进行了对比分析.结果 腔内修复组手术时间、术中出血量、输血量均少于开放手术组(P<0.01);两组围手术期并发症比较无显著差异(P>0.05);SF-36量表评估显示术后6个月开放手术组生活质量优于腔内治疗组,两组术后2年生存率比较无显著差异(P>0.05),但腔内修复组并发症发生率高于开放手术组(P<0.01).住院费用腔内修复组明显高于开放手术组(P<0.01).结论 腹主动脉瘤腔内修复具有手术时间短、微创的特点,但具有较高的远期并发症;开放手术组术后6个月健康生存质量优于腔内修复组.     

腹主动脉瘤腔内修复与开放手术疗效比较

目的 比较腹主动脉瘤开放手术和腔内治疗的效果.方法 对2002年1月至2007年7月收治的223例分别行开放手术和腔内修复的腹主动脉瘤患者进行网顾性分析.手术组141例,男性118例,女性23例;腔内治疗组82例,男性66例,女性16例.对手术相关情况、围手术期并发症发生率、病死率、随访中并发症发生率等进行对比分析.结果 腔内修复组手术时间、术中出血量、输血量均少于开放手术组(P<0.01),围手术期并发症两组无显著差异(P>0.05),SF-36量表评估显示术后6个月开放手术组优于腔内治疗组,术后2年生存率两组无明显差异(P>0.05),但腔内修复组并发症发生率高于开放手术组(P<0.01).住院费用腔内修复组明显高于开放手术组(P<0.01).结论 腹主动脉瘤腔内修复具有手术时间短、微创的特点,但具有较高的远期并发症,开放手术组6个月健康生存质量优于腔内修复组.     

腔内修复术与开放手术治疗腹主动脉瘤的对比分析

目的 对比分析传统开放手术与血管腔内修复术治疗腹主动脉瘤的疗效.方法 回顾性分析我科2009年至2012年经外科治疗的43例肾动脉下腹主动脉瘤患者的临床资料,行腔内治疗患者25例,行传统手术的18例,对比分析两组患者术前、术中情况,术后并发症及6个月内死亡情况.结果 两组患者在手术时间、术中失血及输血量方面,两组差异均有统计学意义（t值分别为8.377,5.124,5.043,P均＜0.001）;术后30d内并发症比较,差异有统计学意义（X2=0.09,P＜0.05）;术后6个月内死亡率比较,差异无统计学意义（x2=4.21,P＞0.05）.结论 血管腔内修复术比传统手术创伤小,手术时间短,术中失血及输血量少,术后短期并发症发生率低,但中远期死亡率无明显差别.     

高风险患者腹主动脉瘤手术与腔内治疗效果的比较

目的 比较高风险患者腹主动脉瘤(abdominal aortic aneurysm,AAA)手术治疗(opensurgical repair,OSR)与腔内治疗(endovascular aneurysm repair,EVAR)的效果,探讨高风险患者AAA治疗方式的选择.方法 利用(customized probability index,CPI)危险评分方法[1]筛选出我院1998年至2008年高风险患者55例,比较OSR组(20例)与EVAR组(35例)围手术期及术后近期结果.结果 OSR组随访率100%,平均随访6年3个月.EVAR组随访率94%,平均随访5年10个月.(1)手术时间高风险患者EVAR组(3.1±0.6)h短于OSR组[(4.9±0.9)h(P<0.05)];(2)EVAR组术中出血、ICU时间和住院时间均短于OSR组(P<0.01);(3)围手术期死亡率EVAR组(2.86%)明显低于OSR组(15.00%);(4)术后并发症发生率EVAR组(17%)明显低于OSR组(40%);(5)EVAR组术后并发症主要为内漏(8.57%);(6)OSR组并发症主要为心脏相关性疾病(25%).结论 EVAR对于高风险患者AAA的治疗可以更少的导致围手术期心血管事件的发生,降低围手术期的死亡率和并发症发生率.CPI可以相对准确评估血管手术围手术期死亡率和并发症的发生率,可用于指导围手术期的治疗策略.