Treatment Strategies for Type 2 Endoleaks after Endovascular Aneurysm Repair

Endovascular aneurysm repair (EVAR) is recognized as a minimally invasive alternative to open surgical repair of abdominal aortic aneurysms. However, endoleaks complicate nearly 20–25% of EVAR procedures. We discuss the detection and classification of endoleaks. In addition, we describe different strategies for Type 2 endoleak repair.     

One-year safety and effectiveness of the Alto abdominal stent graft in the ELEVATE IDE trial

ObjectiveThis study reports the results of a prospective, multicenter trial designed to evaluate the safety and effectiveness of the polymer based Endologix Alto Stent Graft System in treating abdominal aortic aneurysms (AAAs), with sealing 7 mm below the top of the fabric in aortic neck diameters from 16 to 30 mm.MethodsSeventy-five patients were treated with Alto devices between March 2017 and February 2018 in 16 centers in the United States for infrarenal AAAs (max diameter ≥5.0 cm in diameter or size increase by 0.5 cm in 6 months or diameter ≥1.5 times the adjacent normal aorta). Patients were followed for 30 days, 6 months, and 1 year by clinical evaluation and computed tomography and abdominal x-ray imaging. Treatment success was defined as technical success and freedom from AAA enlargement, migration, type I or III endoleak, AAA rupture or surgical conversion, stent graft stenosis, occlusion, kink, thromboembolic events, and stent fracture attributable to the device requiring secondary intervention through 12 months. Preoperative characteristics, perioperative variables, follow-up clinical evaluations, and radiographic examination results through the first 1 year were analyzed.ResultsThe mean patient age was 73 years, with 93% of patients being male. The 30-day major adverse event rate was 5.3%. At 1 year, the primary endpoint was met with a treatment success rate of 96.7%. Through 1-year post-treatment, all-cause mortality was 4.0%. No AAA-related mortality occurred. AAA enlargement was 1.6%, type I endoleak rate was 1.4%, with 100% freedom from type III endoleaks, device migration, device fracture, stent occlusion, or AAA rupture. The device-related secondary intervention rate was 2.7%.ConclusionsThis prospective study demonstrates the Endologix Alto is safe and effective in treating AAAs with appropriate anatomy at 1 year. The safety endpoint is met by a 5.3% 30-day major adverse event rate, whereas the effectiveness endpoint is met by a treatment success rate of 96%.     

Early pyrexia after endovascular aneurysm repair: are cultures needed?

INTRODUCTION

The post-implantation syndrome after endovascular aneurysm repair (EVAR) is increasingly recognised. However, when non-vascular trainees are responsible for the care of these patients out of hours, many are investigated if pyrexial. This study assesses the role of microbiological investigations in pyrexia after endovascular aneurysm repair.

PATIENTS AND METHODS

The notes of 75 EVAR patients were reviewed retrospectively. The incidence of postoperative pyrexia and infective complications were calculated and the result of any cultures obtained.

RESULTS

Overall, 58 (77.3%) patients were pyrexial with 48 h of stent insertion. Twenty-four had blood cultures and 12 had urine cultures taken within 48 h of surgery. All of these cultures were negative. However, of those with a pyrexia after 48 h, one of nine blood cultures and two of 11 urine cultures grew organisms. Five pyrexial patients and one apyrexial patient developed a wound infection (a non-significant difference, P = 1.00).

CONCLUSIONS

Pyrexia within 48 h of EVAR is common. Microbiological investigation in the first 48 h in these patients is unrewarding. After 48 h, cultures are more likely to show growth. Although each patient must be assessed clinically for signs of sepsis, blood and urine cultures within 48 h of EVAR are generally unnecessary.     

Life-table Analysis of Primary and Assisted Success Following Endoluminal Repair of Abdominal Aortic Aneurysms: the Role of Supplementary Endovascular Intervention in Improving Outcome

AIM: the aim of this study was to analyse the effect of supplementary endovascular intervention on the outcome of primary endoluminal repair of abdominal aortic aneurysm (AAA). METHODS: between May 1992 and December 1998, 266 patients underwent endoluminal repair of AAA. Minimum period of follow-up was 6 months. Those patients in whom the endoprosthesis could not be deployed were converted to open repair at the primary operation. Patients developing an early endoleak, within 31 days, were treated by a period of observation and secondary endovascular intervention in persistent cases. Patients developing a late endoleak were treated similarly, without a period of observation. Outcome was analysed by the life-table method. Primary success was defined as exclusion of the aneurysm from the circulation resulting from the original operation. Assisted success occurred when aneurysms with endoleaks became excluded from the circulation as a result of supplementary endovascular intervention. RESULTS: endoluminal repair failed in 17 patients requiring conversion to open repair at the original operation. Supplementary endovascular intervention was undertaken in 26 patients, with early endoleaks (n=6) and late endoleaks (n=20). Interventions involved deployment of secondary endoluminal grafts within the primary grafts (n=22), and coil embolisation (n=4). Successful exclusion of the aneurysm sac was achieved in 22 of 26 (85%) patients undergoing supplementary endovascular procedures. Conditional cumulative incidence of primary graft failure and secondary graft failure in the presence of all-cause mortality at 6 years was 47% and 25% respectively. CONCLUSIONS: supplementary endovascular intervention is an important adjunct to endoluminal AAA repair with the potential to improve outcome and avoid conversion to open repair. Successful supplementary endovascular intervention was achieved in 85% of patients in whom it was attempted. Life-table analysis showed these supplementary procedures to be durable in the long term.     

腹主动脉瘤腔内修复术中特殊近端锚定区的处理

目的探讨腹主动脉瘤腔内修复术（EVAR）中特殊近端锚定区的处理方法。方法1997年7月至2005年7月对41例特殊类型腹主动脉瘤（瘤颈过短、严重成角、严重钙化、附壁血栓、形态不规则等）的腔内修复术中，根据情况分别采用近端裸支架跨肾动脉技术、覆盖部分肾动脉并肾动脉支架成形技术、针对成角选择合理产品、近端裸支架内支撑技术、近端延长支架型血管内支撑技术、“凹口”状支架型血管保留肾动脉技术来处理特殊近端锚定区的病变。结果41例EVAR中原发性近端Ⅰ型内漏发生率17．1％（7／41），随诊发现原发性内漏4例自愈，3例转化为持续性内漏，另发现4例继发性内漏。术后30d近端Ⅰ型内漏发生率17.1％（7／41）。无中转开腹手术及术中瘤体破裂、肾梗死等情况发生。结论对特殊近端锚定区的病例，通过相关技术处理可以使之适合腔内治疗。     

A propensity score-matched comparison of two commercially available iliac branch devices in patients with similar clinical and anatomic preoperative features

ObjectiveThe objective of this study was to compare the perioperative and midterm results of Zenith Bifurcated Iliac Side (ZBIS; Cook Medical, Bloomington, Ind) and Gore Iliac Branch Endoprosthesis (IBE; W. L. Gore & Associates, Flagstaff, Ariz) iliac branch devices (IBDs) in treatment of dilated iliac bifurcations in patients with similar anatomic and clinical preoperative features.MethodsBetween July 2007 and May 2018, 190 IBDs were implanted at two high-volume Italian vascular and endovascular centers. Among the series, preoperative propensity score matching based on preoperative anatomic and clinical factors was performed, and two homogeneous groups were created: group 1, 35 Cook ZBIS IBD implants; and group 2, 35 Gore IBE devices. Early results were analyzed in terms of technical success, death, conversion to open surgery, and occurrence of major local and systemic complications. Follow-up results were analyzed in terms of patency of the IBD, freedom from type I and type III endoleaks, aneurysm-related reintervention, and aneurysm-related death.ResultsTechnical success was achieved in all implants from both groups. Perioperative IBD-related complications and major complications occurred in one case from group 1 (P = .49). No perioperative mortality was recorded in the two groups. Mean postoperative follow-up was 46.7 months in group 1 (standard deviation, ± 36.3) and 20.8 months in group 2 (standard deviation, ± 15.9; P < .0001). None of the IBDs or target hypogastric arteries occluded during follow-up in this series. Estimated 36-month freedom from type I and type III endoleaks was 97% (standard error [SE], 0.03) in group 1 and 87% (SE, 0.09) in group 2 (P = .34; log-rank, 0.9). Estimated freedom from IBD-related reintervention was 97% (SE, 0.03) in group 1 and 93% (SE, 0.06) in group 2 (P = .81; log-rank, 0.05). The estimated rates of overall survival at 36 months from the IBD implantation were 95% (SE, 0.04) in group 1 and 88% (SE, 0.08) in group 2 (P = .03; log-rank, 4.7); freedom from aneurysm-related death was 100% in group 1 and 93% (SE, 0.06) in group 2 (P = .19; log-rank, 1.7).ConclusionsThe propensity score-matched comparison between the Cook ZBIS and Gore IBE devices showed similar, satisfying perioperative and midterm results in the experience of two high-volume Italian vascular centers.     

Secondary interventions after endovascular abdominal aortic aneurysm repair

BACKGROUND: One adverse outcome of endovascular abdominal aortic aneurysm (AAA) repair (EVAR) is a significantly increased incidence of secondary interventions (SIs) required compared with traditional open aortic repair. We present a consecutive series of EVARs using a single endograft to identify the incidence and types of SIs performed. METHODS: From February 1, 2000, to January 31, 2005, we repaired 136 AAAs with the Zenith (Cook, Bloomington, Indiana) endograft. All patients met the same strict anatomic inclusion and exclusion criteria. Follow-up lasted from 1.5 to 61 months (median 36). The indications for SI group A were procedural and technical errors, for group B were aortic morphology, and for group C were device failures. RESULTS: Twenty-one SIs were required in 17 of 136 patients (12.5%). Three patients required multiple interventions. Nine patients were in group A, four were in group B, and six were in group C. All but 4 patients required SIs for late (>30 days) complications. CONCLUSIONS: Although it is a viable alternative to open aortic repair, EVAR is associated with a significantly higher rate of SIs. To maintain the efficacy of EVAR, patients must be followed-up in a vigilant graft surveillance protocol for life.     

Mortality analysis of endovascular aneurysm sealing versus endovascular aneurysm repair

BackgroundEndovascular aneurysm sealing (EVAS), using the Nellix endovascular aneurysm sealing system, has been associated with high reintervention and migration rates. However, prior reports have suggested that EVAS might be related to a lower all-cause mortality compared with endovascular aneurysm repair (EVAR). In the present study, we examined the 5-year all-cause mortality trends after EVAS and EVAR.MethodsWe compared the 333 EVAS patients in the EVAS-1 Nellix U.S. investigational device exemption trial with 16,497 infrarenal EVAR controls from the Vascular Quality Initiative, treated between 2014 and 2016, after applying the exclusion criteria from the investigational device exemption trial (ie, hemodialysis, creatinine >2.0 mg/dL, rupture). As a secondary analysis, we stratified the patients by aneurysm diameter (<5.5 cm and ≥5.5 cm). We calculated propensity scores after adjusting for demographics, comorbidities, and anatomic characteristics and applied inverse probability weighting to compare the risk-adjusted long-term mortality using Kaplan-Meier and Cox regression analyses.ResultsAfter weighting, the EVAS group had experienced similar 5-year mortality compared with the controls from the Vascular Quality Initiative (EVAS vs EVAR, 18% vs 14%; hazard ratio [HR], 1.1; 95% confidence interval [CI], 0.71-1.7; P = .70). The subgroup analysis demonstrated that for patients with an aneurysm diameter of <5.5 cm, EVAS was associated with higher 5-year mortality compared with EVAR (19% vs 11%; HR, 2.4; 95% CI, 1.7-4.7; P = .013). In patients with an aneurysm diameter of ≥5.5 cm, EVAS was associated with lower mortality within the first 2 years (2-year mortality: HR, 0.29; 95% CI, 0.13-0.62; P = .002). However, compared with EVAR, EVAS was associated with higher mortality between 2 and 5 years (HR, 1.9; 95% CI, 1.2-3.0; P = .005), with no mortality difference at 5 years (18% vs 17%; HR, 0.82; 95% CI, 0.4-1.4; P = .46).ConclusionsWithin the overall population, EVAS was associated with similar 5-year mortality compared with EVAR. EVAS was associated with higher mortality for those with small aneurysms (<5.5 cm). For those with larger aneurysms (≥5.5 cm), EVAS was initially associated with lower mortality within the first 2 years, although this advantage was lost thereafter, with higher mortality after 2 years. Future studies are required to evaluate the specific causes of death and to elucidate the potential beneficial mechanism behind sac obliteration that leads to this potential initial survival benefit. This could help guide the development of future grafts with better proximal fixation and sealing that also incorporate sac obliteration.     

覆膜支架腔内隔绝和开腹手术治疗腹主动脉瘤破裂疗效比较

目的比较开腹手术和腔内隔绝术治疗腹主动脉瘤破裂的手术效果。方法 2000年3月-2011年7月,收治48例腹主动脉瘤破裂患者,其中40例行腹动脉瘤切除、人工血管移植术治疗(开腹组),8例行覆膜支架腔内隔绝术治疗(腔内隔绝组)。两组患者性别、年龄、瘤颈长度≤2 cm构成比、瘤颈成角≥60°构成比、髂外动脉严重扭曲构成比、术前收缩压、术前合并症组间比较差异无统计学意义(P>0.05),具有可比性。术后对两组患者输血量、手术时间、重症监护时间、术后并发症、二期手术率、术后24 h内死亡率和术后30 d内死亡率进行比较。结果两组术后24 h死亡率、术后30 d死亡率以及非移植物相关并发症发生率比较差异均无统计学意义(P>0.05);但组间手术时间、输血量、重症监护时间、二期手术率及移植物相关并发症发生率比较差异均有统计学意义(P<0.05)。结论腔内隔绝术对解剖条件良好的腹主动脉瘤破裂患者是一种可行的手术方式,在输血量、手术时间、重症监护时间方面与传统开腹手术相比具有明显优势。     

腹主动脉瘤破裂行腔内修复术1例

患者女,80岁,因急性脑梗死伴腹痛9h入院。查体:下腹部左侧触及6～7cm搏动性包块,右侧中枢性面瘫,右上肢肌力0级,疼痛刺激无反应,右下肢外旋,可屈曲,无自主运动;左侧肢体肌力Ⅳ级,左侧Babinski征阳性,右侧病理征未引出。既往有糖尿病、高血压及腹主动脉瘤病史。     

Comparison of commercially available versus customized branched-fenestrated devices in the treatment of complex aortic aneurysms

Objective

To evaluate and compare the early outcomes of patients treated for complex aortic aneurysms using a commercially available Zenith fenestrated endograft (ZFEN) or an advanced customized fenestrated-branched endovascular repair, which includes custom-made device or off-the-shelf p-branch devices available for use in a physician-sponsored investigational device exemption (PSIDE).

Association between surgical repair of aortic aneurysms and the diagnosis of intracranial aneurysms

ObjectiveAortic aneurysms (AAs) and intracranial aneurysms (IAs) share several clinical risk factors, a genetic predisposition, and molecular signaling pathways. Nonetheless, associations between IAs and AAs remain to be thoroughly validated in large-scale studies. In addition, no effective medical therapies exist for unruptured IAs or AAs.MethodsData for this nationwide, population-based, retrospective, cohort study described herein were obtained from the National Health Insurance Research Database in Taiwan. The study outcomes assessed were (1) the cumulative incidence of IAs, which was compared between AA and patients without an AA and (2) the cumulative incidence of IAs in patients with AAs during the 13-year follow-up period, which was further compared among those who underwent open surgical repair (OSR), endovascular aneurysm repair or nonsurgical treatment (NST).ResultsOur analyses included 20,280 patients with an AA and 20,280 propensity score-matched patients without an AA. Compared with the patients without an AA, patients with AA exhibited a significantly increased risk of an IA diagnosis (adjusted hazard ratio [HR], 3.395; P < .001). Furthermore, 6308 patients with AAs were treated with surgical intervention and another 6308 propensity score-matched patients with AAs were not. Patients with an AA who underwent OSR had a significantly lower risk of being diagnosed with an IA than patients with an AA who underwent endovascular aneurysm repair or NST (adjusted HR, 0.491 [P < .001] and adjusted HR, 0.473 [P < .001], respectively).ConclusionsWe demonstrated an association between IAs and AAs, even after adjusting for several comorbidities. We also found that OSR was associated with fewer recognized IAs than NST.     

Results from the Prospective Registry of Endovascular Treatment of Abdominal Aortic Aneurysms (RETA): Mid Term Results to Five Years

OBJECTIVES: To assess the mid-term outcomes up to 5 years following endovascular repair of abdominal aortic aneurysms (EVAR), following its initial introduction into practice in the UK. DESIGN: A prospective voluntary Registry of Endovascular Treatment of Aneurysms (RETA) collected demographic and risk factor data, short term (30 day) outcomes and follow up outcomes up to 5 years from the 41 centres that initially undertook EVAR in the UK. RESULTS: Short term outcomes (30 days): 90.4% of aneurysms were successfully excluded, 6.1% had persistent endoleaks and 5.8% of patients had died. Follow up was obtained from 30 days up to 5 years (mean 3.1 years). Returns rates for requested follow up data were 87% at 1 year and 77, 65, 52 and 51% at 2, 3, 4 and 5 years, respectively. Ninety percent of deaths at follow up were unrelated to the stent-graft or aneurysm. Persistent proximal type I endoleak was associated with significant mortality both from attempted open repair or from rupture if untreated. Other endoleaks were more benign. Complications related to the aneurysm or device occurred at an average rate of 15% per annum. The most common complications were secondary endoleaks or graft migration. Endovascular treatment was preferred if treatment was necessary for graft complications. The cumulative freedom from secondary procedure (Kaplan-Meier) were 87, 77, 70, 65 and 62% at 1, 2, 3, 4 and 5 years of follow up, respectively. CONCLUSIONS: Registry data provides useful information to guide the design of more formal trials. Collecting follow up from voluntarily submitted data is difficult. The registry data remains well ahead of the trial data, but indicate that long term follow up is required in these trials, because of the high rate of complications seen at follow up.     

肾动脉下腹主动脉瘤腔内修复术42例分析

目的 探讨肾动脉下腹主动脉瘤腔内修复术的价值。方法 中山大学附属第一医院自2001年12月至2005年4月．共手术治疗42例肾动脉下腹主动脉瘤病人。采用单侧或双侧股动脉入路植入带膜支架对肾动脉下腹主动脉瘤进行腔内修复。结果42例肾动脉下腹主动脉瘤病人接受了血管腔内修复术，手术全部成功。围手术期死亡2例，其中1例为术前腹主动脉瘤破裂休克时间较长，已经合并急性肾功能不全；另1例为术后出现脑血管意外，2例均在术后3d死亡。其余40例随访1-40个月，全部存活。结论 肾动脉下腹主动脉瘤腔内修复术是一种安全、有效的治疗方法，长期疗效仍有待进一步观察。     

Emergency Endovascular Repair for Ruptured Abdominal Aortic Aneurysms: Feasibility and Comparison of Early Results with Conventional Open Repair

PURPOSE: To assess the feasibility of endovascular aortic repair (EVAR) on patients presenting with a ruptured abdominal aortic aneurysm (AAA) in a teaching hospital, and to compare there post-operative outcomes with contemporaneous patients treated with open repair (OR). METHODS: A series of consecutive of patients presenting ruptured AAA with retro/intraperitoneal haematoma were included in the study. EVAR was attempted whenever possible. In all other cases (severe haemodynamic instability, adverse anatomy, device unavailability), ruptured AAA were treated by OR. RESULTS: Thirty-seven patients were enrolled between January 2001 and July 2004. Seventeen (46%) patients were treated using adapted designed aortoiliac endografts (eight bifurcated, eight aorto-uniiliac, one iliac extension). Twenty (54%) patients unfit for EVAR because of severe haemodynamic instability (n=8), adverse anatomical configuration (n=7), or unavailability of an appropriate endograft (n=5) were treated by OR. Twenty-seven (73%) had a retrospective suitable anatomy for EVAR. Three early conversions from EVAR to OR were performed. Blood loss, operating time, and intensive care stay were significantly decreased in EVAR patients (respectively: 156 min+/-60, 1520 ml+/-1175, 3 days for EVAR; vs. 222 min+/-82, 3075 ml+/-1750, 13 days for OS; P<.01). The 30-day mortality rate was 23.5% for EVAR vs. 50% for OR (P=0.09). CONCLUSION: EVAR of ruptured AAA is feasible for selected patients based on haemodynamic and morphologic criteria, and should be associated with improved immediate outcomes as compared with OR. These results should be tempered by the fact that these patients have heavy comorbidities which explains the absence of difference in mid-term mortality rates between the two groups, but should also encourage surgical institutions that are managing such life-threatening emergencies to introduce EVAR as part of their therapeutic arsenal for ruptured AAA.     

Endovascular Repair of Abdominal Aortic Aneurysms with Aortocaval Fistula

OBJECTIVES: To examine the risk of high-flow type II endoleak following endovascular repair of abdominal aortic aneurysm with aortocaval fistula. DESIGN: Case reports. SUBJECTS: Two patients with abdominal aortic aneurysms with aortocaval fistula. METHODS: Both patients had an endovascular repair of their aortic aneurysms. RESULTS: The aneurysms were successfully treated in both patients, without any endoleak on completion angiography. Apart from a transient type II lumbar endoleak in one of the patients, no endoleak was found after 3 and 12 month follow-up. Seven other cases have been published, reporting one type II and one type Ic endoleak. CONCLUSION: We found no evidence that endovascular repair of abdominal aortic aneurysm with aortocaval fistula is associated with a higher incidence of persistent endoleak.