Incidence and predictive factors for endograft limb patency of the fenestrated Anaconda endograft used for complex endovascular aneurysm repair.

OBJECTIVE: In the present study, we have described the incidence, risk factors, and outcomes of treatment of limb occlusion for patients who had undergone treatment of complex thoracoabdominal aortic aneurysms with the fenestrated Anaconda endograft (Terumo Aortic, Inchinnan, UK). METHODS: Between June 2010 and May 2018, 335 patients had undergone elective fenestrated aortic aneurysm repair at 11 participating centers using the fenestrated Anaconda endograft with a median follow-up of 14.3 months (interquartile range, 27.4 months). The primary outcome measure was freedom from limb occlusion. The secondary outcome measures were freedom from limb-related reintervention, secondary patency, and the risk factors associated with limb occlusion. RESULTS: Of the 335 patients, 30 (9.0%) had presented with limb occlusion during follow-up with a freedom from limb occlusion rate of 98.5%, 91.2%, and 81.7% at 30 days and 1 and 5 years, respectively. In 87% of the cases, no obvious cause for limb occlusion was documented. Primary occlusion had occurred within 30 days in 36.7% and within 1 year in 80.0%. Of the 30 patients, 23 (77%) had undergone an occlusion-related reintervention and 7 (23.3%) had been treated conservatively. The freedom from limb occlusion-related reintervention at 30 days and 1 and 5 years was 97.8%, 93.2%, and 88.6%, respectively. Secondary patency was 91.3% after 1 month and 86.2% after 1 and 5 years. Female sex (odds ratio [OR], 3.27; 95% confidence interval [CI], 1.28-8.34; P = .01) was a statistically significant predictor for limb occlusion. A greater proportion of thrombus in the aneurysm sac appeared to be protective for limb occlusion (0% vs <25%: OR, 0.22; 95% CI, 0.07-0.63; P = .01; 0% vs 25%-50%: OR, 0.20; 95% CI, 0.07-0.57; P = .00; and 0% vs >50%: OR, 0.08; 95% CI, 0.02-0.38; P = .00), as did iliac angulation (OR, 0.99; 95% CI, 0.98-1.00; P = .04). CONCLUSIONS: Limb occlusion remains a significant impediment of endograft durability for patients treated with the fenestrated Anaconda endograft, especially for female patients. In contrast, a high aneurysmal thrombus load and a high degree of iliac angulation appeared to be protective for limb occlusion, for which no obvious cause could be identified.

Outcomes after treatment of complex aortic abdominal aneurysms with the fenestrated Anaconda endograft.

OBJECTIVE: To date, information on the fenestrated Anaconda endograft is limited to case series with a small sample size. This study was performed to assess the technical and clinical outcome of this device in a large international case series. METHODS: All worldwide centers having treated more than 15 complex abdominal aortic aneurysms (AAA) or type IV thoracoabdominal aortic aneurysm patients with the fenestrated Anaconda endograft were approached. Main outcome parameters were procedural technical success, postoperative and follow-up clinical outcome for endoleaks, target vessel patency, reintervention rate, and patient survival. RESULTS: Three hundred thirty-five consecutive cases treated between June 2010 and May 2018 in 11 sites were included. Patients were treated for a short neck infrarenal (n = 98), juxtarenal (n = 191), suprarenal AAA (n = 27), or type IV thoracoabdominal aortic aneurysm (n = 19). Mean age was 73.6 ± 4.6 years (292 male). Endografts contained a total of 920 fenestrations, with a mean of 2.7 ± 0.8 fenestrations per case. Technical success was 88.4% (primary, 82.7%; assisted primary 5.7%). In 6.9% of cases, a procedural type IA endoleak was observed, spontaneously disappearing in 82.6% during early follow-up. The development of a type IA endoleak was associated with greater neck angulation (odds ratio [OR], 0.94; P = .01), three fenestrations (OR, 42.7; P = .01) and the presence of augmented proximal rings (OR, 0.17; P = .03). Median follow-up was 1.2 years (interquartile range, 0.4-2.6). The mean estimated glomerular filtration rate deteriorated from 67.6 ± 19.3 mL/min/1.73 m2 preoperatively to 59.3 ± 22.7 mL/min/1.73 m2 at latest follow-up (P = .00). The freedom from AAA growth were 97.9 ± 0.9% (n = 190) and 86.4 ± 3.0% (n = 68), with a freedom from AAA rupture of 99.7 ± 0.3% (n = 191) and 99.1 ± 0.7% (n = 68), at 1 and 3 years, respectively. The endoleak-free survival, excluding spontaneously resolved procedural endoleaks, at 1 and 3 years was 73.4 ± 2.6 (n = 143) and 65.6 ± 3.4% (n = 45), respectively. The target vessel patency at one and three years were 96.4 ± 0.7% (n = 493) and 92.7 ± 1.4% (n = 156), respectively. A total of 75 reinterventions were done in 64 cases (19.1%), of which 25 cases for an endoleak. The reintervention-free survival at 1 and 3 years were 83.6 ± 2.2% (n = 190) and 71.0 ± 3.7% (n = 68), respectively. No deaths during procedure, extending within 24 hours postoperatively, were observed. Within 30 days 14 patients (4.2%) died and during follow-up another 39 patients (11.6%) died. Three deaths were considered AAA related (one rupture, one endograft infection, and one bilateral renal artery occlusion). The estimated cumulative survival at 1 and 3 years were 89.8 ± 1.8% (n = 191) and 79.2 ± 3.0% (n = 68), respectively. CONCLUSIONS: The custom-made fenestrated Anaconda endograft is a valuable option for the treatment of a complex AAA. A procedural type IA endoleak is seen relatively frequently, but spontaneously resolves in most cases.

Endograft Conformability in Fenestrated Endovascular Aneurysm Repair for Complex Abdominal Aortic Aneurysms.

Purpose: To compare the impact of 2 commercially available custom-made fenestrated endografts on patient anatomy. Materials and Methods: The records of 234 patients who underwent fenestrated endovascular aneurysm repair for abdominal aortic aneurysm from March 2002 to July 2016 in 2 hospitals were screened to identify those who had pre- and postoperative computed tomography angiography assessments with a slice thickness of ≤2 mm. The search identified 145 patients for further analysis: 110 patients (mean age 72.4±7.1 years; 94 men) who had been treated with the Zenith Fenestrated (ZF) endograft and 35 patients (mean age 72.3±7.3 years; 30 men) treated with the Fenestrated Anaconda (FA) endograft. Measurements included aortic diameters at the level of the superior mesenteric artery (SMA) and renal arteries, target vessel angles, target vessel clock positions, and the target vessel tortuosity index. Variables were tested for inter- and intraobserver agreement. Results: There was a good agreement between observers in all tested variables. The native anatomy changed in both groups after endograft implantation. In the ZF group, changes were seen in the angles of the celiac artery (p=0.012), SMA (p=0.022), left renal artery (LRA) (p<0.001), and the right renal artery (RRA) (p<0.001); the aortic diameter at the SMA level (p<0.001); and the LRA (p<0.001) and RRA (p<0.001) clock positions. In the FA group, changes were seen in the angles of the LRA (p=0.001) and RRA (p<0.001) and in the SMA tortuosity index (p=0.044). Between group differences in changes were seen for the aortic diameters at the SMA and renal artery levels (p<0.001 for both) and the LRA clock position (p=0.019). Conclusion: Both custom-made fenestrated endografts altered vascular anatomy. The data suggest a higher conformability of the Fenestrated Anaconda endograft compared with the Zenith Fenestrated.

Outcome of Fenestrated Endovascular Aneurysm Repair in Octogenarians: A Retrospective Multicentre Analysis.

OBJECTIVE: An ageing population leads to more age related diseases, such as complex abdominal aortic aneurysms (AAA). Patients with complex AAAs and multiple comorbidities benefit from fenestrated endovascular aneurysm repair (FEVAR), but for the elderly this benefit is not completely clear. METHODS: Between 2001 and 2016 all patients treated for complex AAA by FEVAR at two tertiary referral centres were screened for inclusion. Group 1 consisted of patients aged 80 years and older and group 2 of patients younger than 80 years of age. The groups were compared for peri-operative outcome, as well as patient and re-intervention free survival, and target vessel patency during follow up. RESULTS: Group 1 consisted of 42 patients (median age 82 years; interquartile range [IQR] 81-83 years) and group 2 of 230 patients (median age 72 years; IQR 67-77 years). No differences were seen in pre-operative comorbidities, except for age and renal function. Renal function was 61.4 mL/min/1.73 m2vs.74.5 mL/min/1.73 m2 (p < .01). No differences were seen between procedures, except for a slightly longer operation time in group two. Median follow up was 26 and 32 months, respectively. No difference was seen between the groups for estimated cumulative overall survival (p = .08) at one, three, and five years, being 95%, 58%, and 42% for group 1, and 88%, 75%, and 61% for group 2, respectively. There was no difference seen between groups for the estimated cumulative re-intervention free survival (p = .95) at one, three, and five years, being 84%, 84%, and 84% in group 1, respectively, and 88%, 84%, and 82% in group 2, respectively. Ultimately, no difference was seen between groups for the estimated cumulative target vessel patency (p = .56) at one, three, and five years, being 100%, 100%, and 90% for group 1, and 96%, 93% and 92% for group 2, respectively. CONCLUSION: Age itself is not a reason to withhold FEVAR in the elderly, and choice of treatment should be based on the patient's comorbidities and preferences.

Early results with the custom-made Fenestrated Anaconda aortic cuff in the treatment of complex abdominal aortic aneurysm.

OBJECTIVE: The objective of this study was to investigate the feasibility of a specific custom-made fenestrated aortic cuff in the treatment of complex abdominal aortic aneurysms (AAAs). METHODS: Between 2013 and 2016, a total of 57 custom-made Fenestrated Anaconda (Vascutek, Inchinnan, Scotland, UK) aortic cuffs were placed in 38 centers worldwide. All centers were invited to participate in this retrospective analysis. Postoperative and follow-up data included the presence of adverse events, necessity for reintervention, and renal function. RESULTS: Fifteen clinics participated, leading to 29 cases. Median age at operation was 74 years (interquartile range [IQR], 71-78 years); five patients were female. Two patients were treated for a para-anastomotic AAA after open AAA repair, 19 patients were treated because of a complicated course after primary endovascular AAA repair, and 8 cases were primary procedures for AAA. A total of 76 fenestrations (mean, 2.6 per case) were used. Four patients needed seven adjunctive procedures. Two patients underwent conversion, one because of a dissection of the superior mesenteric artery and one because of perforation of a renal artery. Median operation time was 225 minutes (IQR, 150-260 minutes); median blood loss, 200 mL (IQR, 100-500 mL); and median contrast volume, 150 mL (IQR, 92-260 mL). Primary technical success was achieved in 86% and secondary technical success in 93%. The 30-day morbidity was 7 of 29 with a mortality rate of 4 of 29. Estimated glomerular filtration rate remained unchanged before and after surgery (76 to 77 mL/min/m2). Between preoperative and median follow-up of 11 months, estimated glomerular filtration rate was reduced statistically significantly (76 to 63 mL/min/m2). During follow-up, 9 cases had an increase in aneurysm sac diameter (5 cases >5 mm); 14 cases had a stable or decreased aneurysm sac diameter; and in 2 cases, no aneurysm size was reported. No type I endoleak was reported, and two cases with a type III endoleak were treated by endovascular means during follow-up. Survival, reintervention-free survival, and target vessel patency at 1 year were 81% ± 8%, 75% ± 9%, and 99% ± 1%, respectively. After 2 years, these numbers were 81% ± 8%, 67% ± 11%, and 88% ± 6%, respectively. During follow-up, the two patients with a type III endoleak needed endograft-related reinterventions. CONCLUSIONS: Treatment with this specific custom-made fenestrated aortic cuff is feasible after complicated previous (endovascular) aortic repair or in complex AAAs. The complexity of certain AAA cases is underlined in this study, and the Fenestrated Anaconda aortic cuff is a valid option in selected cases in which few treatment options are left.

Geometric changes over time in bridging stents after branched and fenestrated endovascular repair for thoracoabdominal aneurysm.

OBJECTIVE: The objective of this study was to assess long-term durability of bridging stents in branched and combined branched and fenestrated endovascular aneurysm repair (B/F-EVAR) for thoracoabdominal aortic aneurysm (TAAA) and pararenal abdominal aortic aneurysm. METHODS: A retrospective database analysis was performed of patients treated by B/F-EVAR for TAAA. Computed tomography angiography images were analyzed to assess patency, bridging stent angulation and migration, aneurysm diameter, and migration of the endograft. RESULTS: Twenty-eight patients with a median age of 70 years (interquartile range [IQR], 67-77 years) were included. Assisted technical success was 89%. Within 30 days postoperatively, five patients died. In the remaining 23 patients, median follow-up was 5.3 years (IQR, 2.9-7.2 years), and 1-, 3-, and 5-year estimated overall survival was 69%, 65%, and 44%, respectively. During follow-up, 12 of 47 (26%) branches occluded and 5 of 47 (11%) branches developed a 70% to 99% stenosis. The 1-, 3-, and 5-year estimated freedom from adverse events was 78%, 76%, and 59% for branch stents and 100%, 96%, and 90% for fenestration stents, respectively. The median distal bridging stent migration was 0.5 mm (IQR, -1.9 to 1.4; P > .05 mm). In 10 branches, migration >10 mm was seen, ranging from 14.1 mm sliding in to 23.0 mm sliding out. The angulation between branch and stent became 4 degrees more angulated (IQR, -14 to +2 degrees). In 23 branches, the angulation changed 10 degrees or more, leading to an occlusion in 7 branches, a 70% to 99% stenosis in 3 branches, and a 50% to 70% stenosis in 4 branches. In three cases, the endograft migrated >5 mm caudally, with a breach in a fenestration stent in one and a breach in a branch stent in another. CONCLUSIONS: The anatomic configuration of branches in B/F-EVAR of TAAAs and pararenal abdominal aortic aneurysms changes over time. The change in angle of branches and the bridging stent influences the likelihood of stenosis and occlusion. Follow-up of B/F-EVAR should include computed tomography angiography measurements of aortic diameter, endograft migration, target vessel stent length, and angulation to detect disconnection, stenosis, and occlusion.

Mid- and Long-Term Outcome of Currently Available Endografts for the Treatment of Infrarenal Abdominal Aortic Aneurysm.

Currently, there is a wide range of commercially available endografts for infrarenal abdominal aortic aneurysm (AAA) repair. Results of long-term follow up after endovascular aneurysm repair (EVAR) are limited. Thereby, the durability of these endografts and the difference between manufacturers is not fully clear. In this review, studies with mid- and long-term results, with a minimum median follow up of 36 months per endograft, were included describing results with Cook Zenith? Flex? endograft (Cook Medical Inc., Bloomington, Indiana) (n=6), Cordis Corporate INCRAFT? (Cordis Corporation, Freemont, California) (n=1), Gore? EXCLUDER? (W.L. Gore & Associates Inc., Flagstaff, Arizona) (n=3), Medtronic Endurant? (Medtronic plc, Santa Rosa, California) (n= 6), and Vascutek Anaconda? (Vascutek Ltd., Inchinnan, Scotland) (n=2). The assisted technical success varied between 83% and 100%, and the perioperative mortality, early reintervention, and early conversion rates were comparable for the studied endografts. At three-year follow up, the freedom from AAA-rupture and AAA-related death varied between 98% and 100%. The results demonstrated an increasing complication and reintervention rate over time. When adhering to the instruction for use, minor differences were seen during follow up between the endografts. Latest generation endografts continue to have good postoperative results, the reintervention-rate of 10-20% over time mandates an ongoing close patient follow up. The choice of a specific design depends on native patient anatomy and the experience of the implanting surgeon.

Fenestrated Endografts for Complex Abdominal Aortic Aneurysm Repair.

Since the introduction of fenestrated endovascular aneurysm repair (FEVAR) in 1996, great advances have been made in endograft development. Custom-made and off-the-shelf fenestrated and branched endografts have been used to treat patients with complex abdominal aortic and thoraco-abdominal aneurysms. Most experience has been gained with the Cook Zenith® fenestrated endograft (Cook Medical Inc., Limerick, Ireland). The Cook Zenith® endograft is customized with fenestrations, (fixed) inner or outer branches, or a combination of them, to cover a wide range of complex aneurysms. There are limitations to the number, location, and size of the fenestrations and to the maximal angulation of the aorta. Because the production of a custom-made fenestrated endograft takes several weeks, and is therefore not available for emergency cases, off-the-shelf fenestrated endograft were developed. One of these grafts was the Endologix Ventana™ (Endologix, Inc., Irvine, California). This endograft was withdrawn from enrollment due to a high reintervention rate. Vascutek Ltd. developed the custom-made Vascutek Fenestrated Anaconda™ endograft (Vascutek Ltd., Inchinnan, Scotland) to treat patients where other endografts were not suitable-like in a more tortuous aorta with an angulation up to 90°. Additionally, the unsupported proximal body enables a high number and large size of fenestrations if needed. First reports of custom-made fenestrated and (inner and outer) branched JOTEC E-xtra DESIGN ENGINEERING (JOTEC GmbH, Hechingen, Germany) for aortic aneurysms seem promising, but larger series need to be reported to be able to draw conclusions. Both custom-made Cook Zenith® and Vascutek Fenestrated Anaconda™ endografts have good reported clinical outcomes with a perioperative mortality between 4.1 and 6.7% and a reintervention rate of <10% at one year. Knowledge on the long-term outcome of both devices is still limited.

Endovascular Aneurysm Repair Complicated with Type Ia Endoleak and Presumable Infection Treated with a Fenestrated Endograft.

An 81-year-old patient presented to the emergency room 5 years after infrarenal endovascular aneurysm repair, with a Type Ia endoleak and a presumable infection of the graft material with Listeria monocytogenes. He was treated with a custom-made fenestrated endograft to seal the endoleak and lifelong antibiotic therapy to suppress the infection. Full explantation of graft material is not always preferable, and endovascular treatment combined with antibiotic suppressive therapy is in some cases an appropriate alternative.

A Case of Primary Aortoduodenal Fistula and Abdominal Aortic Aneurysm in a Patient with Chronic Q Fever.

A 70-year-old man was successfully treated for an aortoduodenal fistula originating from a Q fever-related abdominal aortic aneurysm. He had no known history of contact with cattle or sheep. Although the combination of abdominal aortic aneurysm and aortoduodenal fistula is rare, one should be suspicious of Q fever infection as the causative agent, and additional medical treatment should be initiated.