Selection Global Postmarket Registry Research Articles

The Impact of Endograft Selection on Outcomes Following Treatment Outside of Instructions for Use (IFU) in Endovascular Abdominal Aortic Aneurysm Repair (EVAR).

BackgroundEndovascular aneurysm repair (EVAR) has become the treatment modality of choice in patients with abdominal aortic aneurysms. This has resulted in endograft utilization within instructions for use (IFU) and in cases with proximal neck anatomy outside of IFU.PurposeTo identify whether graft selection influences outcomes following EVAR outside of IFU.MethodologyA retrospective analysis was conducted from previously published data for 636 patients, collated from the Endurant Stent Graft Natural Selection Global Post-Market Registry (ENGAGE) and the Global Registry for Endovascular Aortic Treatment (GREAT). Patients were recruited into the ENGAGE registry between 2009 and 2011 and into the GREAT registry between August 2010 and October 2016. In ENGAGE, they received the Medtronic Endurant stent graft (Medtronic Vascular Inc, Dublin, Ireland) for infrarenal AAA repair while patients analyzed in GREAT received the Gore Excluder stent-graft (W. L. Gore & Associates, Flagstaff, Arizona). Analyses were performed to evaluate all-cause mortality, aneurysm-related mortality, endoleak occurrence, and surgical reintervention rates between the two cohorts.ResultsOf the 636 patients, 225 were from ENGAGE (mean age 73 years) and 411 were from GREAT (mean age 75 years). 17.8% were treated outside of IFU in the ENGAGE registry, while 12.4% were treated outside IFU in the GREAT cohort. Five-year freedom from all-cause mortality was similar in both cohorts (65.6% vs. 63.8%). The rate of type IA endoleak development was lower in the Excluder cohort, although this may have been impacted by the fact that only endoleaks that underwent reintervention were recorded within GREAT analysis (Endurant 10.6% vs. Excluder 7.0%). The reintervention rate was 16% at five years following the Endurant aortic graft while it was 13.3% at five years with the Excluder.ConclusionTreatment outside of IFU, be it with a suprarenal or an infrarenal fixation device, is associated with worse outcomes. This analysis reinforces the importance of the consideration of either fenestrated or open repair in those aneurysms that fail to satisfy IFU while endovascular repair in such a setting should be reserved as a last resort strategy.

The Impact of Endograft Selection on Mid-Term Outcomes in Female Patients Following Endovascular Aortic Aneurysm Repair (EVAR) for Abdominal Aortic Aneurysm (AAA).

BackgroundAbdominal aortic aneurysms (AAA) are far more common in male than female gender, although they appear to have a more aggressive pathophysiology in females. Given the lower incidence of AAA in females, it has been difficult to assess the impact of graft selection for endovascular aortic aneurysm repair (EVAR) in this cohort.PurposeTo identify whether graft selection influences outcomes following AAA endoluminal repair in female patients.MethodologyA retrospective analysis of published data for 711 female patients was conducted, collating data from three cohorts - Endurant Stent Graft Natural Selection Global post-market registry (ENGAGE), Global Registry for Endovascular Aortic Treatment (GREAT) and U.S. Zenith multicenter trial in combination with the Zenith female registry. Patients were recruited into the ENGAGE registry between 2009 and 2011, the GREAT registry between August 2010 and October 2016, and into the Zenith registry between 2000 and 2003. Patients from ENGAGE received the Medtronic Endurant stent graft for infrarenal AAA repair, patients analysed in GREAT received the Gore Excluder stent graft and the Zenith group received the Cook Zenith stent graft. Analyses were performed to evaluate all-cause mortality, aorta-related mortality, endoleak occurrence and surgical reintervention rates between the three cohorts.ResultsOf the 711 females, 133 were from ENGAGE (mean age 76 years), 538 were from GREAT (mean age 75 years) and 40 were from Zenith (mean age 74 years). The rates of co-morbidities between the three groups were broadly similar except for atherosclerotic disease which was more commonly observed in those treated with the GORE Excluder. The rate of endoleaks was lower when the Excluder stent was utilised as compared to the other two stents (Excluder 6.7% vs. Zenith 12.5% vs. Endurant 35.3%) even considering the limited follow-up of the Zenith group to two years as compared to five years for both ENGAGE and GREAT. All-cause mortality was similar in all three groups across the period examined while aorta-related mortality was uncommon. Reintervention rate was 15% at two years following the utilisation of the Zenith aortic graft while the rate of intervention at five years was broadly similar between ENGAGE and GREAT.ConclusionThe newer generation, lower profile aortic endografts appear to have provided a safe and successful tool in the management of AAA in female patients, despite more complex aortic anatomy with shorter infrarenal neck length and larger aortic neck angulation.

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

Data from a prospective, observational, international, multicenter, single-arm registry (Endurant Stent Graft Natural Selection Global postmarket registry [ENGAGE]) enlisted between March 2009 and April 2011 In patients >80 years (290 [23%]) vs <80 years (973 [77%]) who underwent endovascular aneurysm repair (EVAR), there were no significant differences in 30-day mortality (1.4% vs 1.2%), major adverse event rates (5.2% vs 3.6%), or freedom from secondary intervention during 5 years (89% vs 83%). However, age >80 years, pulmonary disease, large aneurysm diameter, and renal insufficiency were significantly associated with all-cause mortality. Freedom from all-cause mortality was significantly lower in the group >80 years (53%) than in the younger group (72%). EVAR can be performed in patients >80 years with no significant difference in midterm aneurysm-related deaths compared with younger patients. EVAR can be safely performed with acceptable morbidity rates in octogenarians.

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.

Female sex is associated with comparable 5-year outcomes after contemporary endovascular aneurysm repair despite more challenging anatomy

BackgroundWomen with abdominal aortic aneurysms less often meet anatomic criteria for endovascular repair and experience worse perioperative and long-term survival. MethodsWe compared long-term survival, aneurysm-related mortality, and rates of endoleaks and reinterventions between male and female patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) using 2:1 propensity score matching. ResultsThere were 1130 male patients and 133 female patients, yielding 399 patients after matching (266 male patients, 133 female patients). Female patients were older, with smaller aneurysms, smaller iliac arteries, and shorter, more angulated necks, and they were more often treated outside the device instructions for use (all P < .001). Through 5 years, female patients experienced overall mortality comparable to that of well-matched male patients (34% vs 38%, respectively; hazard ratio, 0.89 [0.61-1.29]; P = .54) and lower aneurysm-related mortality (0% vs 3%; P = .047). Female patients experienced higher rates of any postoperative type IA endoleak through 5 years (10% vs 1%; P < .001) but comparable rates of secondary endovascular procedures (14% vs 16%; P = .40). Female sex was independently associated with significantly higher risk of long-term type IA endoleaks (hazard ratio, 4.8 [1.2-20.8]; P = .04), even after accounting for anatomic factors. No female patient experienced aneurysm rupture during follow-up, and only one female patient underwent conversion to open repair. ConclusionsDespite more challenging anatomy, female patients in the ENGAGE registry had long-term outcomes comparable to those of male patients. However, female patients experienced higher rates of type IA endoleaks. Although standard endovascular aneurysm repair remains a viable solution for most women, whether high-risk patients may be better served with open surgery, custom-made devices, EndoAnchors (Aptus Endosystems, Sunnyvale, Calif), or chimneys is worthy of further study.

Incidence, natural course, and outcome of type II endoleaks in infrarenal endovascular aneurysm repair based on the ENGAGE registry data

ObjectiveThe purpose of this study was to report the incidence, natural history, and outcome of type II endoleaks in the largest prospective real-world cohort to date. MethodsPatients were extracted from the prospective Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). Two groups were analyzed: first, patients with an isolated type II endoleak; and second, patients with a type II endoleak who later presented with a type I endoleak. A health status analysis between patients with an early type II endoleak and patients with no endoleak was performed. Second, an attempt was made to identify risk factors in patients with a type II endoleak who later presented with a type I endoleak. ResultsThrough 5 years of follow-up, a total of 197 (15.6%) patients with isolated type II endoleaks were identified. Most were detected within the first 30 days (n = 73 [37.1%]) and through the first year (n = 73 [37.1%]), with the remainder being detected after 1 year of follow-up (n = 51 [25.8%]). Patients with a type II endoleak had a higher incidence of aneurysm growth and more secondary endovascular procedures (15.4% vs 7.5% at 5 years; P < .001). Overall survival was higher in the isolated type II endoleak group compared with patients with no endoleak (77.2% vs 67.0% at 5 years; P = .010). Twenty-two patients (10%) with a type II endoleak were diagnosed with a late type I endoleak (type IA, n = 10; type IB, n = 12), with a secondary intervention rate of 67.5% through 5 years. There was no difference in health status scores between patients with an early type II endoleak and patients without any type of endoleak at 1-year follow-up. ConclusionsIn the ENGAGE registry, isolated type II endoleaks are present in 15.6% of patients during follow-up. The majority do not require secondary intervention, and an early isolated type II endoleak does not have an impact on health status through 1 year. However, a small group of patients with a type II endoleak will present with a type I endoleak, resulting in a high secondary intervention rate and significant risk of aneurysm-related complications.

Patients with large neck diameter have a higher risk of type IA endoleaks and aneurysm rupture after standard endovascular aneurysm repair

ObjectiveStandard endovascular aneurysm repair (EVAR) is the most common treatment of abdominal aortic aneurysms (AAAs). EVAR has been increasingly used in patients with hostile neck features. This study investigated the outcomes of EVAR in patients with neck diameters ≥30 mm in the prospectively maintained Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE). MethodsThis is a retrospective study comparing patients with neck diameters ≥30 mm with patients with neck diameters <30 mm. The primary end point was type IA endoleak (EL1A). Secondary end points included secondary interventions to correct EL1A, aneurysm rupture, and survival. ResultsThis study included 1257 patients (mean age, 73.1 years; 89.4% male) observed for a median 4.0 years (interquartile range, 2.7-4.8 years). A total of 97 (7.7%) patients had infrarenal neck diameters ≥30 mm and were compared with the remaining 1160 (92.3%) with neck diameters <30 mm. At baseline, there were no differences between groups regarding demographics and comorbidities other than cardiac disease, which was more frequent in the ≥30-mm neck diameter group (P = .037). There were no significant differences between the groups regarding neck length, angulation, thrombus, or calcification. Mean preoperative AAA diameter was 64.6 ± 11.3 mm in the ≥30-mm neck diameter group and 60.0 ± 11.6 mm in the <30-mm neck diameter group (P < .001). Stent graft oversizing was significantly less in the ≥30-mm neck diameter group (12.2% ± 8.9% vs 22.1% ± 11.9%; P <. 001). Five patients (5.2%) in the ≥30-mm neck diameter group and 30 (2.6%) with neck diameters <30 mm developed EL1A, yielding a 4-year freedom from EL1A of 92.4% vs 96.6%, respectively (P = .09). Oversizing was 21.8% ± 13.0% for patients developing EL1A and 21.3% ± 12.4% for the remaining cohort (P = .99). In adjusting for neck length, AAA diameter, and device oversizing, patients with neck diameter ≥30 mm were at greater risk for development of EL1A (hazard ratio, 3.0; 95% confidence interval, 1.0-9.3; P = .05). Secondary interventions due to EL1A did not differ between groups (P = .36). AAA rupture occurred in three patients with neck diameter ≥30 mm (3.1%) and in eight patients with neck diameter <30 mm (0.7%; hazard ratio, 5.1; 95% confidence interval, 1.4-19.2; P = .016); two cases were EL1A related in each group. At 4 years, overall survival was 61.6% for the ≥30-mm neck diameter group and 75.2% for the <30-mm neck diameter group (P = .009), which remained significant on correcting for sex and AAA diameter (P = .016). ConclusionsIn this study, patients with infrarenal neck diameter ≥30 mm had a threefold increased risk of EL1A and fivefold risk of aneurysm rupture after EVAR as well as worse overall survival. This may influence the choice of AAA repair and underlines the need for regular computed tomography-based imaging surveillance in this subset of patients. Furthermore, these results can serve as standards with which new, possibly improved technology, such as EndoAnchors (Medtronic, Santa Rosa, Calif), can be compared.

Overstenting the hypogastric artery during endovascular aneurysm repair with and without prior coil embolization: A comparative analysis from the ENGAGE Registry

BackgroundEndovascular aneurysm repair of aortoiliac or iliac aneurysms is often performed with stent graft coverage of the origin of the hypogastric artery (HA) to ensure adequate distal seal. It is considered common practice to perform adjunctive coiling of the HA to prevent a type II endoleak. Our objective was to question the necessity of pre-emptive coiling by comparing the outcomes of HA coverage with and without prior coil embolization. MethodsData from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE), which prospectively enrolled 1263 endovascular aneurysm repair patients between March 2009 and April 2011 from multiple centers worldwide, were used for this study. We identified patients in whom the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) covered one or both HAs and grouped them into cases in which prior HA embolization—coils or plugs—was performed (CE) and cases in which HA embolization was not performed (NE). The occurrence of covered HA-related endoleak and secondary interventions were compared between groups. ResultsIn 197 patients, 225 HAs were covered. Ninety-one HAs were covered after coil embolization (CE group), and 134 HAs were covered without prior coil embolization (NE group). Both groups were similar at baseline and had comparable length of follow-up to last image (665.2 ± 321.7 days for CE patients; 641.6 ± 327.6 days for NE patients; P = .464). Importantly, both groups showed equivalent iliac morphology concerning common iliac artery proximal, mid, and distal dimensions and tortuosity, making them suitable for comparative analysis. During follow-up, HA-related endoleaks were sparse and occurred equally often in both groups (CE 5.5% vs NE 3.0%; P = .346). Secondary intervention to resolve an HA-related endoleak was performed twice in the CE group and three times in the NE group. Late non-HA-related endoleaks occurred more often in the CE group compared with the NE group, (25.0% vs 15.0%; P = .080). Secondary interventions for other reasons than HA-related endoleaks occurred in 7.5% of NE cases and 15.4% of CE cases (P = .057), mostly for occlusions in the ipsilateral iliac limb. During follow-up, 19 NE patients and 9 CE patients died, which is not significantly different (P = .225), and no deaths were related directly or indirectly to HA coverage. Also, no reports of gluteal necrosis and bowel ischemia were made. ConclusionsThis study shows that HA coverage with the Endurant endograft without prior coil embolization does not increase the incidence of endoleak or related secondary interventions. These findings together with the already available evidence suggest that omission of coil embolization may be a more resource-effective strategy whenever HA coverage is required.

Performance of the Endurant stent graft in challenging anatomy

This study aimed to compare perioperative and postoperative outcomes after endovascular repair of abdominal aortic aneurysms (AAAs) in patients with various neck morphologic features. Data from the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) were used for the analyses. Patients were categorized into three different groups according to proximal aortic neck anatomy: regular (REG), intermediate (INT), and challenging (CHA). REG was defined as AAAs with a proximal neck ≥15 mm combined with a suprarenal angulation (α) ≤45 degrees and an infrarenal neck angulation (ß) ≤60 degrees. INT was defined as AAAs with a proximal neck of 10 to 15 mm combined with α ≤45 degrees and ß ≤60 degrees or with a proximal neck of >15 mm combined with α ≤60 degrees and ß = 60 to 75 degrees or α = 45 to 60 degrees and ß ≤75 degrees. CHA was defined as infrarenal necks that exceed at least one of the three defining factors. Overall, 925 patients (75.9%) had REG anatomy, 189 patients (15.5%) had INT anatomy, and 104 patients (8.5%) had CHA anatomy. Patient demographics and risk factors were similar. There was a significant difference in AAA diameter between the REG and CHA groups (59.4 mm vs 65.2 mm; P < .001). Technical success was similar among groups (REG 99.1% vs INT 99.5% vs CHA 97.1%). There were no differences in mortality or the need for secondary procedures within 30 days or at 1 year. A significantly higher rate of type I endoleaks within 30 days was seen in CHA compared with REG (adjusted odds ratio, 0.15; 95% confidence interval, 0.05-0.46) and INT (adjusted odds ratio, 0.08; 95% confidence interval, 0.01-0.70), but there was no difference at 1-year follow-up. This real-world, global experience shows promising results and indicates that endovascular AAA repair with the Endurant stent graft (Medtronic Vascular, Santa Rosa, Calif) is safe and effective in patients with challenging aortic neck anatomy. However, long-term follow-up of patients is required to confirm results.

Predictive factors for limb occlusions after endovascular aneurysm repair

Greater flexibility and smaller sizes for introducer sheaths in the newest stent grafts increase the feasibility of endovascular aneurysm repair but raise concerns about long-term limb patency. The aim of the study was to determine the incidence of and predictive factors for limb occlusion after use of the Endurant stent graft (Medtronic Inc, Minneapolis, Minn) for abdominal aortic aneurysm. The Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) prospectively included 1143 patients treated with bifurcated devices who were observed for up to 2 years. Limb occlusions were evidenced by computed tomography, angiography, or ultrasound. To predict stent graft limb occlusion, a two-step model-building technique was applied. We first identified predictors from a total of 47 covariates obtained at baseline and in the periprocedural period. Subsequently, we reduced the set of potential predictors to key factors that are clinically meaningful. To handle large numbers of covariates, we used the Classification And Regression Tree (CART) method. Forty-two stent graft limbs occluded in 39 patients (3.4% of the patients). At 2 years, the rate of freedom from stent graft limb occlusion calculated by Kaplan-Meier plot was 97.9% (standard error [SE], 0.33%). Of the 42 occlusions, 13 (31%) were observed within 30 days and 30 (71%) within 6 months. The strongest independent predictors were distal landing zone on the external iliac artery, external iliac artery diameter ≤10 mm, and kinking. High-risk vs low-risk patients were identified according to a decision tree based on the strongest predictors. Freedom from stent graft limb occlusion was 96.1% (SE, 0.64%) in high-risk patients vs 99.6% (SE, 0.19%) in low-risk patients. After Endurant stent grafting, the incidence of limb occlusion was low. Classifying patients as high risk vs low risk according to the algorithm used in this study may help define specific strategies to prevent limb occlusion and improve the overall results of endovascular aneurysm repair using the latest generation of stent grafts.

Risk Factors for Proximal Neck Complications After Endovascular Aneurysm Repair Using the Endurant Stentgraft

To assess the incidence and risk factors for proximal aneurysm neck related complications with a late generation device for endovascular abdominal aneurysm repair (EVAR). Data were retrieved from a prospective registry (Endurant Stent Graft Natural Selection Global Postmarket Registry) involving 79 institutions worldwide. The risk factors tested were age, gender, surgical risk profile, proximal neck length (<10mm), diameter (>30mm), supra- and infrarenal angulation (>60° and 75°), mural thrombus/calcification (>50%) and taper (>10%), and AAA diameter (>65mm). Two neck related composite endpoints were used, for intra-operative (type-1a endoleak, conversion, deployment/retrieval complication or unintentional renal coverage) and post-operative (type-1a endoleak or migration) adverse events. Independent risk factors were identified using multivariable backwards modeling. The study included 1263 patients (mean age 73, 10.3% female) from March 2009 to May 2011. Twenty three (1.8%) intra-operative adverse events occurred. Neck length <10mm (OR 4.9, 95% CI 1.1-22.6) and neck thrombus/calcification >50% (OR 4.8, 95% CI 1.7-13.5) were risk factors for intra-operative events. The planned 1 year follow up visit was reached for the entire cohort, and the 2 year visit for 431 patients. During this time, 99 (7.8%) events occurred. Female gender (HR 1.9, 95% CI 1.1-3.2), aneurysm diameter >65mm (HR 2.8, 95% CI 1.9-4.2), and neck length <10mm (HR 2.8, 95% CI 1.1-6.9) were significant post-operative risk factors. Neck angulation, neck taper, large diameter neck, and presence of thrombus/calcification were not predictors of adverse outcome in this study. These results support the adequacy of this device in the face of adverse neck anatomy, and confirm neck length as the most relevant anatomical limitation for EVAR. Additionally, the study confirms the decline in early to mid-term intervention rates with a newer generation device in a large patient sample. Lastly, it suggests that neck related risk factors affect outcome and impact on prognosis in varying degrees.

Clinical application and early outcomes of the aortouni-iliac configuration for endovascular aneurysm repair

The objective of this study was to review the current anatomic indications for and early results of aortouni-iliac (AUI) devices for endovascular aneurysm repair. A total of 128 patients receiving an Endurant (Medtronic Inc, Minneapolis, Minn) AUI device in the U.S. Investigational Device Exemption trial (44 patients) or the Endurant Stent Graft Natural Selection Global Postmarket Registry (84 patients) were reviewed. Preoperative computed tomography imaging of patients in the Investigational Device Exemption trial and case report forms of Registry patients were used to determine anatomic indications. Baseline characteristics and early results were compared with those of 1305 patients receiving a bifurcated (BIF) device in sister studies. The indication for the AUI device was unclear from case report forms in two Registry cases. The remaining 126 patients had a unilateral iliac occlusion in 30 (23%), a severely narrowed aortic segment in 58 (45%), severe iliac occlusive disease in 28 (22%), severe iliac tortuosity in 29 (23%), or complex iliac aneurysms in 19 (15%). Two patients had a previous aortobifemoral graft; 38 patients (30%) had multiple indications. The AUI cohort included more women than the BIF group did (19% vs 10%; P < .01) and had more severe comorbidities. Successful deployment was achieved in all AUI cases. The 30-day mortality was 2% (BIF cohort, 1%; P = .21). More AUI patients underwent repair under general anesthesia (81% vs 64%; P < .01), and procedures were longer (110.9 ± 54.9 minutes vs 99.2 ± 44.3 minutes; P = .02). Except for longer intensive care unit stays (19.6 ± 80.0 hours vs 9.0 ± 34.8 hours; P = .01) and higher myocardial infarction rates (4% vs 1%; P < .01), outcomes of the AUI cohort were similar to those of the BIF cohort. There were no migrations, ruptures, fractures, or open conversions at up to 1-year follow-up. The AUI configuration extends endovascular aneurysm repair feasibility to several hostile anatomic conditions. Despite increased comorbidities in the recipient patient population and associated higher rates of postoperative myocardial infarction and respiratory complications, early outcomes with the new generation of AUI devices are acceptable and comparable to those after treatment with BIF configurations.

Outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians

This study determined outcome and quality of life (QOL) in octogenarians, compared with patients aged <80 years, 1 year after endovascular aortic aneurysm repair (EVAR). From March 2009 until April 2011, 1263 patients in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) registry with an abdominal aortic aneurysm were treated with EVAR using the Endurant endograft (Medtronic Cardiovascular, Santa Rosa, Calif). The patients were grouped according to those aged ≥80 years (290 [22.9%]) and those aged <80 years (973 [77.1%]) at the time of the procedure. QOL was assessed using composite EuroQoL 5-Dimensions Questionnaire (EQ-5D) index scores. Baseline, perioperative, and follow-up data were analyzed at 1 year. Octogenarians had poorer anatomic characteristics. The technical success rate was almost 99% for both cohorts, with no deaths. The duration of the implant procedure was significantly longer in the elderly patients (P = .002), with significant differences in overall (P < .001) and postprocedure (P < .001) hospital stays in favor of the younger group. At 1 year, there was a significant difference in all-cause mortality (P = .002) and in the number of major adverse events (P = .003), including secondary rupture (P = .01), to the detriment of octogenarians. There were no significant differences in conversion to open surgery or in overall secondary endovascular procedures. The octogenarians scored lower in their overall health care perception (P < .001) but with no significant difference in the EQ-5D index. Compared with the group aged <80 years, they had still not completely recovered their QOL after 1 year (P = .01). Octogenarians are more difficult to treat by EVAR than younger patients due to poorer anatomic suitability and a higher incidence of complications. Recovery of QOL in octogenarians takes longer (>12 months) than expected.

Comparison of the Endurant Bifurcated Endograft vs. Aortouni-iliac Stent-Grafting in Patients With Abdominal Aortic Aneurysms: Experience From the ENGAGE Registry

To compare the 1-year outcomes after repair of abdominal aortic aneurysms (AAA) with the bifurcated vs. aortouni-iliac (AUI) configuration of the Endurant stent-graft. The study population comprised 1172 patients (1053 men; mean age 73.1±8.1 years, range 43-93) with unruptured infrarenal AAAs treated as part of the Endurant Stent Graft Natural Selection Global Post-market Registry (ENGAGE; ClinicalTrials.gov identifier NCT00870051). The primary outcome measure was treatment success at 12 months, defined by the composite of successful endograft deployment and the absence of type I/III endoleak, migration, rupture, or conversion to open surgery. Secondary outcome measures included endoleak, graft patency, migration, secondary procedures, and all-cause mortality. Among 1172 patients in ENGAGE, 1089 (92.9%) were treated with a bifurcated device and 83 (7.1%) received an AUI with femorofemoral bypass. Both groups were comparable with regard to demographics and baseline comorbidities, with the exception of a higher rate of cardiopulmonary disease in the AUI group. Successful deployment was achieved in all patients in the both groups. Postoperative complications occurred more frequently in the AUI patients, and the AUI group had an increased length of hospital stay (p=0.01). Endoleaks were more frequent in the AUI group at the conclusion of the procedure, a difference that vanished by 30 days. At 1 year, there were no incidences of graft kinking or stent fracture in either group. The rate of secondary procedures (5.3% in AUI patients and 4.9% for bifurcated cases) and all-cause mortality (10.5% and 8.6%, respectively) were similar in the two groups at 30 days and 1 year. The results of endovascular aneurysm repair with an Endurant AUI device appear similar to that after a bifurcated endovascular repair, with the exception of an increased length of hospital stay in the AUI group. An AUI device should be considered as an option in patients with anatomy unsuitable for a bifurcated repair.

Commentary on ‘Early Results from the ENGAGE Registry: Real World Performance of the Endurant Stent Graft for Endovascular AAA Repair in 1262 Patients’

The Endurant (Medtronic, Santa Rosa, California, USA) Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) is unprecedented because of its magnitude. In this report, the authors describe early results in 1262 patients treated with the Endurant stent-graft in 79 sites around the world. This large registry clearly demonstrates the commitment of the manufacturer to provide ‘real world’ data to the vascular community. We seem to move away from randomised trials comparing open and endovascular repair (EVAR) to focus on advances in EVAR. Clearly, we have reached a point of acceptance between two validated techniques in the treatment of infrarenal abdominal aortic aneurysms. The authors document perioperative (30 days) outcomes for the total patient cohort, but also provide 1-year follow-up results for 39.6% (500/1262) of the patients. It is no surprise that the results are excellent. Most of the currently available third-generation stent-grafts would probably match these outcomes. Complications leading to higher re-intervention rates compared to open repair usually occur after the first year or even only after 3e5 years postoperatively.1e3 We do not contest the quality of the results, and the authors do acknowledge that longer-term results need to be awaited, but the conclusion is overrated. As mentioned, we completely agree with the magnitude of the effort (unprecedented), but not that the results are (already?) promising (what?) or that the graft is safe and effective yet. Not that we doubt on the quality of the graft, but technically speaking we just need longerterm outcomes before having proven safety and effectiveness. Unfortunately, such premature conclusions are drawn too easy with new generation stent-grafts (or with current new concept stent-grafts). The ENGAGE registry aims at reporting ‘real world’ results, by its magnitude and the many centres throughout the world. Nevertheless, we would argue that these are still larger and experienced centres. It actually positively surprises us that only 17.9% of the patients were treated outside instructions for use (IFU) criteria, in

Thirty-day outcome and quality of life after endovascular abdominal aortic aneurysm repair in octogenarians based on the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE)

To determine 30-day outcome and quality of life after elective endovascular abdominal aortic aneurysm repair in octogenarians. From March 2009 to May 2011, 1200 patients with abdominal aortic aneurysms were treated with endovascular aneurysm repair (EVAR) using the Endurant stent graft were included in the Endurant Stent Graft Natural Selection Global Postmarket Registry (ENGAGE) registry. Among these, 926 (77%) were aged <80 years, and 274 (23%) were aged ≥ 80 years. Quality of life was assessed using composite EuroQoL 5-Dimensions Questionnaire index scores. Gender was unequally distributed, with more female patients among the octogenarians (P = .043). Octogenarians had a significantly higher American Society of Anesthesiologists classification (P < .001) and differed significantly in baseline risk factors. The younger cohort was more likely to smoke (P < .001) and be alcoholics (P = .005). Octogenarians had larger aortic aneurysm (P = .010) and left iliac artery diameters (P = .017) and greater infrarenal neck angulation (P = .01). The technical success rate was >99% for both cohorts. Octogenarians were more often operated on under general anesthesia (P = .028), had a longer procedure duration (P = .001), and an increased length of hospitalization; both total (P < .001) and postprocedure (P < .001). All-cause mortality and major adverse event rates were similar in the two groups (P = .835 and P = .186, respectively). There was no difference in the number of secondary endovascular procedures or aneurysm rupture at 30 days. At discharge, both groups had reduced health status dimensions, except anxiety/depression, when compared with baseline. At 30 days, the octogenarian group had a lower composite EuroQoL 5-Dimensions Questionnaire index compared with the younger group, indicating a slower recovery (0.83 ± 0.20 vs 0.87 ± 0.16; P = .003). Octogenarians can be safely treated using the Endurant stent graft with a high technical rate of success, low perioperative mortality, and no reduction in quality of life. Octogenarians did, however, appear to recover more slowly than younger patients with respect to certain quality of life components. Long-term data are needed to confirm these results.