The Enzen Trial: Analysis of EVAR Endoprosthesis Zenith and Endurant for Infrarenal Aortoiliac Aneurysms Regarding Outcomes, Endoleaks, and Reinterventions.

OBJECTIVE: The main objective of this paper is to analyze the outcomes regarding endoleaks, reinterventions, and death related to aneurysm complications in patients submitted to endovascular repair (EVAR) for abdominal aortoiliac aneurysm (AAA) using Endurant II (Medtronic) and Zenith Flex (Cook) endografts. METHODS: This was a prospective, consecutive cohort study of patients with AAA who underwent EVAR between January 2019 and December 2022. Two groups of patients were evaluated: Group Endurant (patients submitted to EVAR with the use of Endurant II) and Group Zenith (patients submitted to EVAR with the use of Zenith Flex). RESULTS: A total of 156 patients were evaluated. Group Zenith (67 patients, 42.9%) and Group Endurant (89 patients, 57.1%). The perioperative mortality was 5.1%, eight patients (six patients Group Zenith, and two patients Group Endurant, p=0.054). There were 28 patients (17.9%) submitted to urgent repair of the aneurysm (expansion or rupture), with no differences among the groups. There were 36 cases (23.1%) of later endoleak, with a higher incidence in Zenith group (23 patients, 34.3%) than Endurant group (13 patients, 14.6%, p=0.002), most of them Type II endoleak (21 patients, 13.4%). There were 12 cases of Type I endoleak, also with a higher prevalence in Zenith group (13.4%) than Endurant group (3.4%, p=0.002). Moreover, regarding limb graft occlusion (LGO), there were nine patients (5.8%), with a higher prevalence in Zenith group (9%) than Endurant group (3.4%, p=0.045). The overall survival in a Kaplan-Meier at 720 days was 82.3% in the Zenith group and 89.1% in the Endurant group, with no statistical significance among the groups (p=0.09). The freedom from reintervention rates in a Kaplan-Meier at 720 days was 82.8% in the Zenith group and 93.2% in the Endurant group (p=0.001). CONCLUSION: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, LGO and reinterventions than patients submitted to Endurant II endografts. The linear regression analysis showed that the presence of endoleaks, type of endograft device (Zenith graft) and limb graft occlusion were related to higher reintervention rates. CLINICAL IMPACT: In this present study, Zenith endograft had higher rates of endoleaks, aneurysms related mortality, limb graft occlusions and reinterventions than patients submitted to Endurant II endografts. The main impact and the innovation that this article provides is an opportunity to evaluate and choose the best endograft suitable for the patient with AAA during EVAR.

Long-term outcomes of the Endurant endograft in patients undergoing endovascular abdominal aortic aneurysm repair.

OBJECTIVE/BACKGROUND: To investigate the long-term outcomes after endovascular aneurysm repair (EVAR) in a real-world setting using the Endurant endograft (EG). METHODS: 184 EVAR candidates treated with the Endurant family EGs in a single vascular center were prospectively enrolled from January 2009 to December 2016. Kaplan-Meir estimates of long-term standardized primary and secondary outcome measures were performed. Per protocol, subgroup comparison analysis was performed in three groups: patients treated within instructions for use (in-IFU) vs patients treated outside IFU (outside-IFU), EVAR in patients receiving the Endurant proximal diameter 32 or 36 mm EG vs those receiving the <32 mm diameter EG and EVAR with various Endurant EG versions. RESULTS: The mean follow-up was 75.09 ± 37.9 months (range: 4.1-172 months). The median age of the patients was 72.96 ± 7.03 years (range: 55-88 years). A total of 177 patients were male (96.2%). Compliance with IFU was followed in 107 patients (58.2%). Overall survival was 69.5% and 48% at 5 and 8 years, respectively. Of the 102 all-cause deaths, 7 (6.9%) were aneurysm related. Six of these postimplant deaths occurred in patients presented with aneurysm rupture from type Ia or/and type Ib endoleak. At 5, 8, and 10 years of observation, freedom from aneurysm rupture, open surgical conversion, type I/III endoleak, any type of endoleak, aneurysm-related secondary intervention probabilities, and neck-related events were as follows: 98.1%, 95%, and 89.4%; 95.1%, 91.2%, and 85.7%; 93.6%, 87.3%, and 83.9%; 83.4%, 74%, and 70.9%; 89.8%, 76.7%, and 72%; and 96.3%, 90%, and 87.6%, respectively. Corresponding clinical success was 90%, 77.4%, and 68.4%, respectively. Patients treated outside-IFU had significantly higher risk of aneurysm rupture, open surgical conversion probability, occurrence of type I/III endoleak, and chance of reinterventions and lower clinical success probabilities compared with the in-IFU counterparts at 5 and 8 years. This statistical difference remained when type Ia endoleak or endoleak of any type was considered independently. In addition, it was stronger in patients having extreme anatomic boundaries (>1 hostile anatomic condition), when aneurysm-related death, aneurysm rupture, and clinical success at 5 years were considered. Overall proximal migration and limb occlusion were recorded in 1.1% and 4.9% of the patients, respectively. Overall reintervention rate was 17.4%. An increase in aneurysm sac diameter was observed in 12.5% of patients and was not related to IFU status. The Endurant version or the proximal EG diameter had no significant association with the chance of any complication or adverse event. CONCLUSIONS: The data confirmed the durability of the Endurant EG, achieving promising long-term outcomes in a real-world setting. However, its positive performance must be interpreted with caution in patients treated off-label especially those with extreme anatomic boundaries. In this cohort, some of EVAR advantages might be lost in the late future. Further similar studies are warranted.

Possible implications of device-specific variability in post-endovascular aneurysm repair sac regression and endoleaks for surveillance categorization.

OBJECTIVE: Significant sac regression during early surveillance has been shown to best predict reintervention-free long-term surveillance after endovascular aneurysm repair (EVAR). Furthermore, a persistent endoleak has been related to a worse outcome. Individualized surveillance algorithms based on these findings have been suggested. There are no studies comparing the performance of different stent grafts regarding sac regression, the presence of type II endoleaks, and their possible implications for individualized surveillance. The objective of this study was to evaluate device-specific differences and how these may affect patient categorization for surveillance. METHODS: Patients were treated electively with standard EVAR between 2005 and 2015 using three different devices (Zenith by Cook, Excluder by Gore, and Endurant by Medtronic). The data were reviewed retrospectively until 2020. Patients' computed tomography angiographies (CTAs) at 30 days and at 2 years were analyzed for freedom from endoleaks and for sac regression of ≥5 mm. Reinterventions during long-term surveillance were counted. Patients were categorized according to the presence of any endoleak and sac regression at 30 days and 2 years, and the probability of reintervention-free long-term surveillance was evaluated based on these findings. RESULTS: A total of 435 patients were treated for an abdominal aortic aneurysm with EVAR during the study period. At 30 days, 80.0% (n = 339) of the patients were free from endoleaks, and at 2 years, 78.9% (n = 273) were free from endoleaks. There was a significant difference in endoleak rate at 30 days and 2 years between the devices (P < .001 and P = .001). There was no significant difference in sac regression between the devices at 2 years (P = .096). The categorization at 30 days based on endoleak status had a sensitivity of 44.9%, specificity of 87.4%, and negative predictive value of 84.1% for finding a reintervention-requiring complication during long-term follow-up. The corresponding figures at 2 years were 63.3%, 91.4%, and 89.4%, respectively. The combination of freedom from endoleaks and sac regression of ≥5 mm in the 2-year CTA best predicted an uneventful long-term surveillance. Patients who met this criterion had a 95.6% probability (negative predictive value) of having a reintervention-free long-term surveillance. CONCLUSIONS: There are significant differences in the prevalence of endoleaks between devices at 30 days and 2 years, but there is no difference in sac regression. Patients with sac regression of ≥5 mm and no endoleaks in the 2-year CTA can be safely categorized for infrequent surveillance regardless of the stent graft model that has initially been used.

Outcomes of Endurant II Stent Graft According to Anatomic Severity Grade Score.

OBJECTIVES: This study's objective was to evaluate Endurant II (Medtronic Inc, Minneapolis, Minnesota) stent graft's early and midterm outcomes and compare the results according to the anatomic severity grade (ASG) scores. METHODS: This was a retrospective study of patients treated with the Endurant II stent graft between January 2013 and May 2021. The patients were divided into 2 independent groups, including those with a low ASG score (score <14) and a high ASG score (score >14). RESULTS: A total of 165 consecutive patients (89% males, age 74±8 years) were included. There were 110 (67%) patients in the low-score group and 55 (33%) patients in the high-score group. Technical success was achieved in all cases. Primary clinical success at 30 days was 100% and at 1 year was 96%. Median operative time was longer in the high-score group with no statistical significance (133 vs 120 minutes, p=0.116). The median dose area product of low-score patients (50.9 Gy·cm2; IQR 22.4-75.5 Gy·cm2) was significantly lower than high-score patients (85.0 Gy·cm2; IQR 46.5-127.9 Gy·cm2) with p=0.025. Median fluoroscopic time was lower in low-score patients (17 minutes; IQR 13-24 minutes) compared with high-score patients (19 minutes; IQR 16-23 minutes) without a significant difference at p=0.148. At a midterm follow-up of 32 months (range 2-63 months), combined complications (29% vs 8%, p<0.001) and implant-related complications (13% vs 4%, p=0.043) were higher in the high-score group. Systemic complications at 30 days were higher in the high-score group without a statistically significant difference (15% vs 11%, p=0.500). The Kaplan-Meier estimate of freedom from reintervention was significantly higher in the low-risk group at 1 (97% vs 90%), 2 (96% vs 88%), and 3 years (96% vs 85%) with (p=0.035). The cumulative survival rate was significantly higher in the low-score group than high-score group (p=0.001) at 1 (99% vs 87%), 2 (98% vs 85%), and 3 years (96% vs 82%). CONCLUSIONS: Endurant II endovascular aneurysm repair seems to be safe in both low-score and high-score patients. However, patients in the high-score group showed more implant-related complications and midterm mortalities than those in the low-score group.

Long-term Outcomes of the Endurant and Excluder Stent Grafts for Endovascular Aneurysm Repair in a Japanese Cohort.

PURPOSE: To compare the long-term outcomes of the most widely used third-generation stent grafts, the Endurant and Excluder stent grafts, in Japanese patients using a multicenter registry. MATERIALS AND METHODS: A retrospective analysis of endovascular aneurysm repairs for abdominal aortic and iliac artery aneurysms using either the Endurant or the Excluder stent grafts from January 2012 to July 2019 at 10 Japanese hospitals was performed. RESULTS: A total of 332 and 378 repairs using the Endurant and Excluder stent grafts, respectively, were analyzed. Although the patients' characteristics were generally similar in the two groups, the Endurant group exhibited significantly shorter (Endurant: 31.5±18.6 mm, Excluder: 37.4±21.0 mm; p<0.001), larger (Endurant: 22.4±4.2 mm, Excluder: 21.7±3.8 mm; p=0.029), and more reversed tapered (Endurant: 12.1%, Excluder: 5.8%; p=0.003) proximal necks. The incidence of instructions for use (IFU) violations was similar between the two groups (Endurant: 59.0%, Excluder: 54.5%; p=0.223). However, the Endurant group had significantly more proximal neck-related IFU violations (54.1% and 46.3%, respectively; p=0.039), more access-related IFU violations (8.1% and 4.0%, respectively; p=0.019), and fewer bilateral hypogastric artery embolizations (5.1% and 9.3%, respectively; p=0.035) compared with the Excluder group. The incidence of intraoperative (Endurant: 3.6%, Excluder: 3.7%; p=0.950) and perioperative complications (Endurant: 3.6%, Excluder: 3.4%, p=0.899) was equivalent in the two groups. However, there was a significantly higher incidence of postoperative type II endoleaks in the Excluder group (Endurant: 28%, Excluder: 46.0%, p<0.001). Aneurysm sac regression was more frequent in the Endurant group (Endurant: 40.7%, Excluder: 31.7%, p=0.013). The Endurant group also had significantly higher rates of sac increase (Endurant: 13.0%, Excluder: 7.7%, p=0.020). Kaplan-Meier curve and log-rank analyses revealed no statistical differences in late complications (p=0.868) and overall survival (p=0.926). CONCLUSIONS: There were no statistically significant differences between the Endurant and the Excluder stent grafts in terms of intraoperative, perioperative, and late complication rates; however, the anatomical characteristics of the patients were significantly different.

Endovascular Aneurysm Repair Using Physician-Modified Fenestrated Endurant Contralateral Limb for Internal Iliac Artery Preservation.

CLINICAL IMPACT: We developed a novel Endovascular aortic repair technique for internal iliac artery preservation using a physician modified Endurant contralateral limb. This procedure was safe and reliable for preserving internal iliac artery flow in 24 patients with common and internal iliac artery aneurysms. We believe that our technique has the potential to expand the anatomic indications for internal iliac artery preserving procedures.

Guessing the sequence of multiple relinings with AFX and nitinol-based cuff: "A riddle, wrapped in a mystery, inside an enigma".

OBJECTIVE: Knowing the structural and technical features of both the older and newer aortic endografts is an essential tool to understand off-the-shelf combinations of different devices used to treat challenging abdominal aortic aneurysm (AAA) anatomies or failures of previous endovascular aneurysm repairs (EVAR). METHODS: We present a case of a 72-year-old male with history of AAA and evidence of multiple past EVAR interventions who presented with abdominal pain. With no reliable surgical history, we attempted to delineate the types of different endograft parts implanted and the sequence of relining procedure based on plain X-ray projections and combined computed tomography along with intraoperative angiography. RESULTS: A tubular endograft was presented with a distal fracture of its endoskeleton, and relined with the same type unibody bifurcate. The latter was extended proximally with an AFX extension of a characteristic radiopaque continuous rim. Angiographic findings intraoperatively excluded the latter as part of the initial procedure. Moreover, an extra nitinol-based cuff was identified centrally. CONCLUSION: In diagnostic challenges involving multiple relining attempts of different endograft parts, careful analysis of the imaging findings, based on knowledge of the structural and technical features of both the older and newer endografts is necessary for proper diagnosis, identification of potential problems and complications and intervention planning, if needed.

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.

Five Year Patient Outcomes of Endovascular Abdominal Aortic Aneurysm Repair in the ENDURANT France Registry.

OBJECTIVE: Endovascular repair is the preferred method of treatment for infrarenal abdominal aortic aneurysms with numerous publications from multiple geographic regions showing excellent patient outcomes. Since the original ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) randomised control trial, studies of French specific population have also contributed significantly to the body of evidence in support of endovascular abdominal aortic repair. METHODS: In the ENDURANT France registry, 180 patients were consecutively enrolled from 20 French centres starting in 2012. Investigational sites included public and private practice and differing centre volumes to be as representative of real world French experience as possible. The aim of this study was to present the five year outcomes from this registry. RESULTS: Instructions for use (IFU) were respected in 97.8% (176/180) of patients. At five years, the Kaplan-Meier overall survival was 69.9% ± 3.5% and the freedom from aneurysm related death was 97.6% ± 1.2%. The freedom from Type IA endoleaks was 94.5% ± 1.7%, freedom from endoleaks of any type was 70.1 ± 3.4%, and freedom from secondary endovascular procedure 90.4% ± 2.6%. In addition, 61.6% (45/73) of patients exhibited sac shrinkage at five years. CONCLUSION: In this five year report of the Endurant France registry, survival, re-intervention, and freedom from endoleak rates were comparable to recent EVAR registries and there was a high sac shrinkage rate. Secondary procedure and aneurysm rupture were lower than those of ACE, the French RCT which included older generation devices. This prospective registry demonstrates favourable five year outcomes of the Endurant stent graft used within IFU.

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.

Long-term outcomes of standard endovascular aneurysm repair in patients with severe neck angulation.

OBJECTIVE: Severe neck angulation is associated with complications after endovascular aneurysm repair (EVAR). Newer endografts may overcome this limitation, but the literature lacks long-term results. We studied the long-term outcomes of EVAR in patients with severe neck angulation. METHODS: A retrospective case-control study of a prospective multicenter database was performed. All measurements were made with dedicated software with center lumen line reconstruction. A study group including patients with neck length >15 mm, infrarenal angle (ß) >75 degrees or suprarenal angle (α) >60 degrees, and neck length 10 to 15 mm with ß >60 degrees or α >45 degrees was compared with a control group matched for demographics and other morphologic neck features. The primary end point was type IA endoleak (EL1A). Secondary end points were freedom from neck-related secondary interventions, primary clinical success, and overall survival. RESULTS: Forty-five patients were included in the angulated neck group and compared with 65 matched patients. Median follow-up was 7.4 years (interquartile range, 4.8-8.5 years). In the angulated neck group, mean α was 51.4 degrees (±21.1 degrees) and the mean ß was 80.8 degrees (±15.6 degrees); in the nonangulated group, these were 17.9 degrees (±17.0 degrees) and 35.4 degrees (±20.0 degrees), respectively. At 7 years, five patients in the angulated neck group and two nonangulated patients developed EL1A, yielding a freedom from EL1A of 86.1% (n = 14; standard error [SE], 0.069) and 96.6% (n = 34; SE, 0.023), respectively (P = .056). After exclusion of a patient who developed an EL1A secondary to an endograft infection, this difference was significant: 86.1% (n = 14; SE, 0.069) in the angulated neck group and 98.2% (n = 34; SE, 0.018) in the nonangulated group (P = .016). At 7 years, freedom from neck-related secondary interventions was 91.7% (n = 14; SE, 0.059) and 91.6% (n = 29; SE, 0.029), respectively. The 7-year primary clinical success estimates were 41.2% (n = 11; SE, 0.085) and 56.6% (n = 20; SE, 0.072) for the angulated neck and nonangulated groups, respectively (P = .12). The 7-year survival rates were 44.3% (n = 18; SE, 0.076) vs 66.7% (n = 42; SE, 0.059) for the angulated neck and nonangulated groups, respectively (P = .25). Device integrity failure was not observed. CONCLUSIONS: Despite satisfactory results early and in the midterm, a higher rate of EL1A was identified among patients with severely angulated necks in the long term. However, mortality was not affected by this difference. These findings suggest that EVAR should be used judiciously in patients with extreme angulation of the proximal neck and highlight the need for close follow-up of EVAR, especially in the long term and in patients treated outside instructions for use.

Immediate Change in Suprarenal Neck Angulation After Endovascular Aneurysm Repair: Comparison of the Ovation Stent-Graft Inflatable Sealing Rings to a Conventional Self-Expanding Stent-Graft.

PURPOSE: To compare the immediate suprarenal neck angulation change between the Ovation stent-graft, with its inflatable sealing rings, and a stent-graft with a conventional sealing mechanism. METHODS: A case-control study was conducted in which 30 consecutive patients (mean age 67 years; all men) with abdominal aortic aneurysm (AAA) treated with the Ovation stent-graft (group O) were retrospectively compared with 24 patients (mean age 77 years; all men) contemporaneously treated with the Endurant stent-graft (group E) at 3 high-volume tertiary vascular centers. The variables recorded were the aortic neck length, preoperative and postoperative angulation, minimum and maximum diameters of the infrarenal neck, as well as the maximum AAA diameter. All patients had undergone preoperative and postoperative (within 30 days) computed tomographic angiography. Multiple regression analysis compared the relative contribution to neck angulation change of each geometric parameter and the type of endograft. Data are presented as the mean ± standard deviation. RESULTS: The mean preoperative suprarenal neck angulation in group O was 23.2°±18.0° compared with 23.8°±22.9° in group E (t test, p=0.91). The neck lengths were 29.2±14.6 and 23.2±11.0 mm in groups O and E, respectively (p=0.1). Similarly, the minimum and maximum neck diameters were 22.4±2.6 and 25±3.5 mm, respectively, in group O vs 23.3±3.6 mm and 27.0±5.7 mm, respectively, in group E (p=0.3 and 0.12, respectively). The maximum transverse diameters of the AAA in the 2 groups were comparable, that is, 57.0±9.0 mm in group O vs 53.2±11.1 mm in group E (p=0.17). The Ovation stent-graft caused greater decrease in the aortic neck angulation postoperatively compared with the Endurant device (13.2°±16.1° vs 6.1°±5.9°, p=0.04). Multiple regression analysis revealed that preoperative neck angulation (ß coefficient 0.37, p<0.001) and the type of endograft (ß coefficient -7.91, p=0.01) had significant influence on the postoperative neck angulation change. The intraclass correlation coefficient ranged from 0.951 to 0.990 for the preoperative measurements and from 0.911 to 0.999 for the postoperative measurements for each examiner or the total of estimates at the measurement time points. CONCLUSION: The Ovation stent-graft induces greater postoperative reduction in the AAA neck angulation compared to an endograft with stent-supported graft seal. Expanded research to infrarenal angle as well to greater angles and correlation to clinical events is justified.

[18F]FDG Uptake in Non-Infected Endovascular Grafts: A Retrospective Study.

Purpose: After endovascular aneurysm repair (EVAR), an increased [18F]FDG uptake may be observed at PET/CT, being common to both vascular graft/endograft infection (VGEI) and sterile post-surgical inflammation. Increased non-specific metabolic activity, due to foreign body reaction, can persist for several years after surgery, thus complicating the interpretation of PET/CT studies. In this paper, we aimed to assess [18F]FDG distribution at different time-points after the implant of abdominal Endurant® endografts in patients without suspicion of infection. Methods: We retrospectively evaluated [18F]FDG/CT in 16 oncological patients who underwent abdominal aortic aneurysm exclusion with Endurant® grafts. Patients had no clinical suspicion of infection and were followed up for at least 24 months after scan. [18F]FDG PET/CT scans were interpreted using both visual and semi-quantitative analyses. Results: The time between the EVAR procedure and [18F]FDG PET/CT ranged between 1 and 36 months. All grafts showed mild and diffuse [18F]FDG uptake without a focal pattern. Mean values of SUVmax were 2.63 ± 0.48 (95% CI 2.38-2.88); for SUVmean 1.90 ± 0.33 (95% CI 1.72-2.08); for T/B ratios 1.43 ± 0.41 (95% CI 1.21-1.65). SUVmax and SUVmean were not correlated to the time elapsed from the procedure, but we observed a declining trend in T/B ratio over time. Conclusions: Endovascular implant of Endurant® grafts does not cause a significant inflammatory reaction. The evidence of faint and diffuse [18F]FDG uptake along the graft can reliably exclude an infection, even in early post-procedural phases. Therefore, in patients with a low probability of VGEI, [18F]FDG PET/CT can also be performed immediately after EVAR.

Predictors and Consequences of Sac Shrinkage after Endovascular Infrarenal Aortic Aneurysm Repair.

Background: Aneurysm shrinkage has been proposed as a marker of successful endovascular aneurysm repair (EVAR). We evaluated the impact of sac shrinkage on secondary interventions, on survival and its association with endoleaks, and on compliance with instructions for use (IFU). Methods: This observational retrospective study was conducted on all consecutive patients receiving EVAR for an infrarenal abdominal aortic aneurysm (AAA) using exclusively Endurant II/IIs endograft from 2014 to 2018. Sixty patients were entered in the study. Aneurysm sac shrinkage was defined as decrease ≥5 mm of the maximum aortic diameter. Univariate methods and Kaplan-Meier plots assessed the potential impact of shrinkage. Results: Twenty-six patients (43.3%) experienced shrinkage at one year, and thirty-four (56.7%) had no shrinkage. Shrinkage was not significantly associated with any demographics or morbidity, except hypertension (p = 0.01). No aneurysm characteristics were associated with shrinkage. Non-compliance with instructions for use (IFU) in 13 patients (21.6%) was not associated with shrinkage. Three years after EVAR, freedom from secondary intervention was 85 ± 2% for the entire series, 92.3 ± 5.0% for the shrinkage group and 83.3 ± 9% for the no-shrinkage group (Logrank: p = 0.49). Survival at 3 years was not significantly different between the two groups (85.9 ± 7.0% vs. 79.0 ± 9.0%, Logrank; p = 0.59). Strict compliance with IFU was associated with less reinterventions at 3 years (92.1 ± 5.9% vs. 73.8 ± 15%, Logrank: p = 0.03). Similarly, survival at 3 years did not significantly differ between strict compliance with IFU and non-compliance (81.8 ± 7.0% vs. 78.6 ± 13.0%, Logrank; p = 0.32). Conclusion: This study suggests that shrinkage ≥5 mm at 1-year is not significantly associated with a better survival rate or a lower risk of secondary intervention than no-shrinkage. In this series, the risk of secondary intervention regardless of shrinkage seems to be linked more to non-compliance with IFU. Considering the small number of patients, these results must be confirmed by extensive prospective studies.

Type II Endoleak After Endovascular Aortic Aneurysm Repair Using the Endurant Stent Graft System for Abdominal Aortic Aneurysm with Occluded Inferior Mesenteric Artery.

PURPOSE: To evaluate the incidence of type II endoleak (EL-II) and aneurysm enlargement after endovascular aneurysm repair (EVAR) using the Endurant stent graft in patients with abdominal aortic aneurysm (AAA) with occluded inferior mesenteric artery (IMA). MATERIALS AND METHODS: Between 2012 and 2017, 103 patients who underwent EVAR using the Endurant stent graft for AAA with occluded IMA (50 patients with prophylactic embolized IMA and 53 with spontaneous occluded IMA) were retrospectively reviewed. The incidence of EL-II and aneurysm enlargement was evaluated. Predictive factors for persistent EL-II were evaluated based on patient characteristics, preprocedural anatomical characteristics, intraprocedural details, and postprocedural complications. RESULTS: Incidence rates of early EL-II and persistent EL-II were 6.8% (7/103 patients) and 4.9% (5/103 patients), respectively. Aneurysm enlargement was found in 10 patients (9.7%), including all 5 patients with persistent EL-II, 3 with de novo EL-II, and 2 with no EL-II. The rates of freedom from aneurysm enlargement at 1, 2, and 3 years were 98.7%, 97.0%, and 93.1% for the group without persistent EL-II, and 80.0%, 60.0%, and 20.0% for the group with persistent EL-II (p < 0.001), respectively. The maximum aneurysm diameter (odds ratio (OR), 1.16; 95% confidence interval (CI), 1.01-1.34; p = 0.0362) and the number of patent lumbar arteries (OR, 2.72; 95% CI, 1.07-6.90; p = 0.0357) were predictive of persistent EL-II. CONCLUSIONS: The incidence of EL-II after EVAR using the Endurant stent graft for AAA with occluded IMA was low, but most early EL-II persisted and resulted in aneurysm enlargement. Level of Evidence Level 4, Case Series.

Reverse slider technique using the Endurant stent graft for accurate proximal sealing in hostile neck endovascular aneurysm repair.

This report introduces the reverse slider technique to obtain proximal sealing effectively in endovascular aneurysm repair in short or angulated necks. It is the deployment process of the stent graft main body by repeatedly rotating and reversing the external slider with slight loosening of the suprarenal stent. This method helps obtain accurate placement of the proximal edge and effective sealing on the greater curvature side even in short and angulated necks. It is an effective method of extending the proximal sealing zone. It is gained by changing the deployment process with the Endurant stent graft (Medtronic, Santa Rosa, Calif) as an existing popular device.

Double fixation for abdominal aortic aneurysm repair using AFX body and Endurant proximal aortic cuff: mid-term results.

Our goal was to evaluate the use of an AFX main body combined with an Endurant proximal aortic cuff to treat selected patients with an abdominal aortic aneurysm (AAA) associated with anatomical challenges, such as a small distal aortic diameter and a hostile aortic neck. A retrospective analysis of prospectively collected data from 2 vascular institutions identified 14 elective patients with an AAA (all men, 73.5 ± 5.1 years) treated with the AFX main body combined with an Endurant proximal aortic cuff. Patients had a small distal aortic diameter (median 19 mm) and a short or angulated proximal aortic neck (median length 20 mm, range 9-26 mm, median angulation 41.5°, range 23-80°). Six patients (42.9%) had an aortic neck that did not meet the indications for use of the AFX proximal aortic cuff. Primary technical success was achieved in all patients with no 30-day device-related complications or deaths. During a median follow-up period of 13 months (range 6-28 months), no re-intervention was needed. The diameter of the aneurysmal sac decreased from 57.6 ± 5.6 mm preoperatively to 50.4 ± 4.9 mm (P < 0.001) postoperatively. There were no aneurysm-related deaths or ruptures. No migration, disconnection or type I or III endoleak was observed. In 5 of the 6 patients, the initial type II endoleak spontaneously resolved during follow-up, whereas that in the remaining patient persisted without any change in the diameter of the aneurysmal sac. In patients with complex AAA anatomical configurations combining a hostile aortic neck and a narrow aortic bifurcation, the use of an AFX main body combined with an Endurant proximal aortic cuff seems to be feasible with favourable mid-term results.

The Endurant stent graft for endovascular aneurysm repair.

Endovascular aneurysm repair (EVAR) has become an established therapy for many patients with abdominal aortic aneurysms. This minimally invasive procedure has lower operative mortality and similar long-term survival rates compared to open surgical treatment. However, several patients are still unsuitable for EVAR because of their aneurysm neck or iliac artery anatomy, and secondly, re-intervention rates are higher after EVAR than after open aneurysm exclusion. Current challenges in the development of new stent grafts are to make more patients eligible for EVAR, including patients with challenging anatomy, and to decrease re-intervention rates. A range of different stent grafts now exist, and in the search for a device with the widest applicability and the least complications, the Endurant stent graft is a recent addition. This device offers wider inclusion criteria. Despite this, first results show comparable complication rates compared to other stent grafts, and long-term follow-up studies are underway.