Endurant stent graft demonstrates promising outcomes in challenging abdominal aortic aneurysm anatomy.

OBJECTIVE: We aimed to assess the 5-year safety and effectiveness outcomes of patients enrolled in the Endurant Stent Graft Natural Selection Global Post Market Registry (ENGAGE) who were treated outside the approved indications for use (IFU) of the Endurant stent graft. METHODS: Our primary outcome measure was 12-month treatment success, defined as successful endograft delivery and deployment and the absence of type I or III endoleak, stent migration or limb occlusion, late conversion, and abdominal aortic aneurysm diameter increase or rupture. Secondary outcome measures included 30-day all-cause mortality, major adverse events, secondary procedures, technical observations, aneurysm-related mortality, and all-cause mortality within 12 months. RESULTS: Demographic characteristics of ENGAGE patients treated outside (225 [17.8%]) and within (1038 [82.2%]) the IFUs were similar, except that female patients comprised a much higher percentage of the outside IFU group (19.1% vs 8.7%; P < .001). The outside IFU group presented with lower rates of coronary artery disease and cardiac revascularization and a greater number of symptomatic patients compared with the within IFU group (21.3% vs 15.0%; P = .020). Technical success was achieved in more than 99% of all patients. The outside and within IFU groups showed a comparable and low occurrence of uncorrected type I (0.9% vs 1.2%; P = 1.00) and type III endoleak (0.4% vs 0.3%; P = .54) immediately after device implantation. The 5-year freedom from type IA endoleaks was 89.4% vs 96.7% (P < .0001) for those patients outside and within the IFUs, respectively, although both groups had similar type III endoleaks through 5 years (P = .61). Stent graft limb occlusion estimated overall survival, and freedom from aneurysm-related mortality and endovascular interventions were comparable in both patient groups through the 5-year follow-up. The Kaplan-Meier estimates at 5 years showed a trend for low but increased need for type I or III endoleak correction procedures in the outside IFU group compared with the within IFU group (7.2% vs 5.2%; P = .099). CONCLUSIONS: Differences were not observed in all-cause mortality, aneurysm-related mortality, and secondary procedures between within and outside IFU patients through a 5-year follow-up in the ENGAGE registry. Proximal necks with angulation or diameters outside the IFUs were the most common reasons for patients identified as being outside IFU, and the cohort had increased incidence of type IA endoleaks. Despite the challenges presented from the broad range of aortic and abdominal aortic aneurysm morphologies, the Endurant stent graft showed promising 5-year outcomes.

Analysis of Midterm Outcomes of Endovascular Aneurysm Repair in Octogenarians From the ENGAGE Registry.

PURPOSE: To assess periprocedural results and secondary endovascular procedure outcomes over 5 years in patients aged ≥80 vs <80 years undergoing endovascular aneurysm repair (EVAR). MATERIALS AND METHODS: Data from the Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE) were used for the analyses. A total of 1263 consecutive patients were enrolled in the prospective, observational, single-arm registry and divided into 2 groups according to age: ≥80 years (290, 22.9%) and <80 years (973, 77.1%). Baseline patient characteristics, risk scores according to the Society for Vascular Surgery (SVS) reporting standards, American Society of Anesthesiologists (ASA) classification, quality of life assessments [EuroQol 5 (EQ5D) index], and treatment outcomes, including all-cause mortality, aneurysm-related mortality, major adverse events, secondary endovascular procedures, and endoleaks were compared between groups. RESULTS: Octogenarians were classified into the highest category of the SVS risk stratification system; however, this did not result in a significant difference in the 30-day mortality [1.4% (4/290) vs 1.2% (12/973) for controls; p=0.85] or major adverse event rates [5.2% (15/290) vs 3.6% (35/973), p=0.23]. Multivariable analysis confirmed that age ≥80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality, whereas diameter was the only parameter associated with increased aneurysm-related mortality. The differences in freedom from secondary endovascular procedures over 5 years between octogenarians and controls did not reach statistical significance (88.5% vs 83.2%, p=0.07). CONCLUSION: EVAR can be performed in individuals aged ≥80 years with no statistically significant difference in midterm aneurysm-related deaths compared with younger patients. The findings in this elderly patient cohort show that EVAR can be safely performed with acceptable morbidity rates in octogenarians.

Editor's Choice - Five Year Outcomes of the Endurant Stent Graft for Endovascular Abdominal Aortic Aneurysm Repair in the ENGAGE Registry.

OBJECTIVE/BACKGROUND: Endovascular abdominal aortic aneurysm repair (EVAR) is commonly used to treat abdominal aortic aneurysm (AAA). However, the incidence of long-term complications and the need for re-interventions after EVAR remain a concern. Newer generation stent grafts have encouraging short and mid-term outcomes, but thorough analysis of their long-term performance is necessary. METHODS: The ENGAGE registry includes a total of 1263 patients with AAA enrolled from March 2009 to April 2011 at 79 centres across 30 countries. The aim of this study is to present standard EVAR outcomes in the registry after five years. RESULTS: A significant proportion of the ENGAGE patients presented with challenging features, such as 15.2% with an AAA diameter >7 cm, 12.0% with proximal neck lengths <15 mm, and 10.2% with infrarenal neck angles >60°. Of the 1263 enrolled subjects, 17.8% were implanted outside of the instructions for use for the device. At the five year follow up, the Kaplan-Meier overall survival rate was 67.4% and the freedom from aneurysm related mortality was 97.8%. Freedom from aneurysm rupture, secondary procedures, and conversion to open repair at five years were 98.6%, 84.3%, and 97.9% respectively. The five year freedom from type IA endoleaks was 95.2% and for type III endoleaks 97.4%. Aneurysm sac diameter at five years was observed to have either decreased ≥5 mm in diameter or remained stable in 89.4% of the patients. CONCLUSION: Five year follow up of patients in the ENGAGE registry demonstrates sustained safety, effectiveness, and durability in an international cohort that is reflective of real world experience. Additional follow up is expected through to 10 years.

Endovascular correction of a distal re-entry in an abdominal aorta dissection.

The re-entries are still a problem for the endovascular treatment of aortic dissections. A 60-year-old man was treated for an abdominal aortic dissection using aortic monoiliac endograft until the left iliac external artery and a femoro-femoral bypass with occlusion of the right common iliac artery and the left hypogastric artery. In his third year of follow-up, a re-entry tear in the right hypogastric ostium was diagnosed with pressurization of the aortic and common iliac aneurysmatic sac, that required correction. A self-expandable covered stent in a 'U' configuration was implanted, connecting the right external and internal iliac arteries, with preservation of the pelvic circulation, and exclusion of the aneurysmatic sac. In conclusion, the use of a flexible stent graft is a safe alternative, and simplifies some procedures in complex circumstances.

Outcome of endovascular abdominal aortic aneurysm repair in patients with conditions considered unfit for an open procedure: a report on the EUROSTAR experience.

OBJECTIVE: Endovascular abdominal aortic aneurysm repair (EAR) can be performed in patients whose conditions were previously considered unfit for conventional treatment of the aneurysm. However, because the life span in this category of patients often is limited because of serious comorbidity, the efficacy of EAR in prolonging life expectancy remains uncertain. This study involves the evaluation of preoperative risk classification and an assessment of the outcome of interventions. METHODS: The data of 3075 patients, who underwent operation in 101 European institutions that collaborated in the EUROSTAR Registry, were assessed. Only the patients who had been prospectively enrolled in the registry were used for this analysis. Patient characteristics, operative risk factors, procedural details, and types of devices were correlated with preoperative estimates of operative risk, early and late mortality, complications, and primary and secondary outcome success rates. In addition, the intermediate-term survival rates in patients with unfit conditions with EAR (observed series) and with conservative approaches of the aneurysms (rupture rates as derived from the literature) were compared in a mathematical model. RESULTS: Of the overall study group, 2525 patients were at "normal" risk for a surgical procedure (group A), 399 patients had conditions that were considered unfit for open surgery (group B), and 151 patients had conditions that were unfit for general anesthesia (group C). Both unfit categories had significantly more comorbid factors and larger aneurysms than did the patients in good medical condition. Differences were observed in comorbidities between the two high-risk categories, groups B and C. Factors that influenced the abdominal approach (previous laparotomies, hostile abdomen, and obesity) and local anatomic factors (eg, retroperitoneal fibrosis, inflammatory aneurysm, dissections, and enterostomy) were present in 19% of the patients with conditions that were unfit for open surgery and in only 1% of the category unfit for anesthesia. In contrast, severe pulmonary disease was present in 33% of the patients with conditions that were unfit for anesthesia as opposed to 11% of the patients with conditions that were unfit for open surgery. The early and late mortality rates were significantly higher in the unfit categories (groups B and C). Life table results showed a 3-year survival rate of 83% in patients at normal operative risk and of 68% in patients with unfit conditions (P =.0001). An independent correlation with late death was shown for the clinical classification into high-risk groups B and C, pulmonary disease, team experience of less than 60 procedures, and the diameter of the aneurysm. In groups B and C, aneurysms smaller than 6.0 cm were associated with a 2-year survival rate of 80% and larger aneurysms with a rate of 68% (P =.02). This difference was caused by an increased non-aneurysm-related mortality rate in the group with aneurysms of more than 6 cm. The mathematical model showed an advantage of EAR with regard to the reduction of the death rate in patients with unfit conditions as compared with no intervention after 1 year. The advantage of EAR was observed in patients with AAAs between 5 and 6 cm and with larger aneurysms. CONCLUSION: Early and late mortality rates were increased in patients with the preoperative clinical diagnosis "unfit for open surgery and general anesthesia" as compared with patients at "normal" operative risk. EAR appeared of potential benefit in patients with unfit conditions, regardless of the aneurysm diameter. The life expectancy of patients at high risk who are considered for EAR should be longer than 1 year before any realistic gain in life span can be anticipated.