scholarly journals Midterm outcomes of 455 patients receiving the AFX2 endovascular graft for the treatment of abdominal aortic aneurysm: A retrospective multi-center analysis

PLoS ONE ◽  
2021 ◽  
Vol 16 (12) ◽  
pp. e0261623
Author(s):  
Raymond Vetsch ◽  
Harvey E. Garrett ◽  
Christopher L. Stout ◽  
Alan R. Wladis ◽  
Matt Thompson ◽  
...  

Since being introduced into clinical practice the AFX family of endografts has undergone labelling updates, design and manufacturing changes to address a Type III failure mode. The published literature on the performance of the current endograft–AFX2 –is limited to small series with limited follow up. The present study reports the largest series of patients implanted with AFX2 for the treatment of abdominal aortic aneurysms. The study was a retrospective, 5 center study of patients receiving an AFX2 endograft from January 2016 until Dec 2020. Electronic case report forms were provided to four of the centers, with one additional site providing relevant outcomes in an independent dataset. Relevant outcomes were reported via Kaplan-Meier analysis and included all-cause mortality, aneurysm-related mortality, post EVAR aortic rupture, open conversion, device related reinterventions and endoleaks. Among a cohort of 460 patients, 405 underwent elective repair of an AAA, 50 were treated for a ruptured AAA, and 5 were aorto-iliac occlusive disease cases. For the elective cohort (mean age 73.7y, 77% male, mean AAA diameter 5.4cm), the peri-operative mortality was 1.7%. Freedom from aneurysm-related mortality was 98.2% at 1,2,3 and 4 years post-operatively, there were no post-operative aortic ruptures, and 2 patients required open conversion. Freedom from Type Ia endoleaks was 99.4% at 1, 2, 3 and 4 years. Freedom from Type IIIa and Type IIIb endoleaks were 100% and 100% (year 1), 100% and 99.6% (year 2), 99.4% and 99.6% (year 3), 99.4% and 99.6% (year 4) respectively. Freedom from all device-related reintervention (including Type II endoleaks) at 4 y was 86.8%. The AFX2 endograft appears to perform to a satisfactory standard in terms of patient centric outcomes in mid-term follow up. The Type Ia and Type III endoleaks rates at 4y appear to be within acceptable limits. Further follow up studies are warranted.

Vascular ◽  
2015 ◽  
Vol 24 (3) ◽  
pp. 227-232 ◽  
Author(s):  
Ziheng Wu ◽  
Liang Xu ◽  
Dieter Raithel ◽  
Lefeng Qu

Objective To evaluate the safety, efficacy and durability of endovascular repair for proximal para-anastomotic aneurysms after previous open abdominal aortic aneurysms prosthetic reconstruction and share our experience. Methods We retrospectively reviewed the data of all patients with previous open abdominal aortic aneurysms prosthetic reconstruction who underwent endovascular repair for proximal para-anastomotic aneurysms between May 2003 and January 2013 in our center (Nuremberg South Hospital). Key clinical outcomes included technical success rate, peri-operative morbidity and mortality, mid-term complications, reinterventions and open conversion rates. Results Totally, 24 patients of proximal para-anastomotic aneurysm were treated by endovascular repair. Successful deployments of stent graft were achieved in all patients (100%). Median hospital stay was 6.7 days. One patient had minor type Ia endoleak and one patient developed wound infection. There were no early open conversions and deaths. During a median follow-up of 43 months (range, 7–67 months), computed tomography angiography revealed type Ia endoleaks in four patients (16.7%). The overall reintervention and open conversion rates during follow-up were 16.7% (4/24) and 4.2% (1/24), respectively. Estimates of freedom from reintervention were 91.7% at 1 year, 87.1% at 3 years and 80.9% at 5 years. There was significant difference in freedom from reintervention between proximal para-anastomotic aneurysms patients treated with tube and unibody bifurcated stent grafts (p = 0.034). The cumulative mortality rate was 12.5% (3/24), actuarial analysis for all patients estimated survival rates of 95.8% at 1 year and 87.3% at 5 years. Conclusions Proximal para-anastomotic aneurysms are severe complications after abdominal aortic aneurysm open reconstruction. Closer follow-up and prompt treatment are necessary. Endovascular treatment for proximal para-anastomotic aneurysms is effective, safe and durable. Unibody bifurcated stent graft proved to be suitable for most proximal para-anastomotic aneurysms with various anatomical features.


2018 ◽  
Vol 17 (1) ◽  
pp. 66-70
Author(s):  
Erol Kurç ◽  
Onur Sokullu ◽  
Serdar Akansel ◽  
Murat Sargın

Abstract Despite technological advances, the long-term outcomes of endovascular aortic aneurysm repair (EVAR) are still debatable. Although most endograft failures after EVAR can be corrected with endovascular techniques, open conversion may still be required. A 70-year-old male patient presented at the emergency unit with abdominal pain. Twice, in the third and fourth years after the first repair, a stent graft had been placed over a non-adhesive portion of the stent graft due to type Ia endoleaks. In the most recent admission, a CT scan showed type III endoleak and ruptured aneurysm sac. On this occasion the patient underwent late open conversion. The failure was repaired with total preservation of the main endovascular graft body and interposition of a bifurcated dacron graft. This case demonstrates that lifelong radiographic surveillance should be considered in this subset of patients. Late open conversion following EVAR of ruptured abdominal aortic aneurysms can be performed safely.


2019 ◽  
Vol 8 ◽  
pp. 204800401984550 ◽  
Author(s):  
Rocco Giudice ◽  
Ottavia Borghese ◽  
Giorgio Sbenaglia ◽  
Carlo Coscarella ◽  
Claudia De Gregorio ◽  
...  

Objectives The aim of this study was to present a single-centre experience with EndoAnchors in patients who underwent endovascular repair for abdominal aortic aneurysms with challenging proximal neck, both in the prevention and treatment of endograft migration and type Ia endoleaks. Methods We retrospectively analysed 17 consecutive patients treated with EndoAnchors between June 2015 and May 2018 at our institution. EndoAnchors were applied during the initial endovascular aneurysm repair procedure (primary implant) to prevent proximal neck complications in difficult anatomies (nine patients), and in the follow-up after aneurysm exclusion (secondary implant) to correct type Ia endoleak and/or stent-graft migration (eight patients). Results Mean time for anchors implant was 23 min (range 12–41), with a mean of 5 EndoAnchors deployed per patient. Six patients in the secondary implant group required a proximal cuff due to stent-graft migration ≥10 mm. Technical success was achieved in all cases, with no complications related to deployment of the anchors. At a median follow-up of 13 months (range 4–39, interquartile range 9–20), there were no aneurysm-related deaths or aneurysm ruptures, and all patients were free from reinterventions. CT-scan surveillance showed no evidence of type Ia endoleak, anchors dislodgement or stent-graft migration, with a mean reduction of aneurysm diameter of 0.4 mm (range 0–19); there was no sac growth or aortic neck enlargement in any case. Conclusions EndoAnchors can be safely used in the prevention and treatment of type Ia endoleaks in patients with challenging aortic necks, with good results in terms of sac exclusion and diameter reduction in the mid-term follow-up.


2021 ◽  
Vol 108 (Supplement_4) ◽  
Author(s):  
A Roesti ◽  
A Isaak ◽  
G Gemayel ◽  
E Mujagic ◽  
L Briner ◽  
...  

Abstract Objective Endovascular repair (EVAR) has become the standard of care for treatment of abdominal aortic aneurysms. However, a significant number of EVAR remains outside the IFU, especially in cases of severe proximal angulation (>60 degrees), resulting in failure. The new device GORE EXCLUDER Conformable AAA Endoprosthesis (W. L. Gore & Associates, Flagstaff, Ariz) has been designed to accommodate neck angulation, due to conformability and angulation control. The aim of this multicenter study is to report the initial results of this device. Methods From March 2019 to January 2021, the data of all consecutive patients with AAA treated with the Gore Excluder Conformable endograft at 4 vascular centers were reviewed. Patients were followed using a standardized protocol, with CT-scan at 1, 6 and 12 months, and then yearly. The primary endpoint was technical success and secondary outcomes were postoperative morbidity, rate of endoleak (EL) and any aneurysm-related re-interventions during follow-up. Results Among the 32 patients included, most were men with a mean age of 77 years old (range 60-92). Half of patients were smokers and 72% had hypertension. The mean diameter of AAA was 62 mm (47-90). The mean length of aortic neck was 26 mm (10-69), the mean diameter 23 mm (16-31) and the median neck angulation was 81 degrees (range 40-110). The mean procedural duration was 102 min (54-153) with a mean time of scopy of 24 min (8-47) and a total volume of contrast of 101 ml (40-165). Thirteen iliac branch device have been used in 7 patients. The technical success was 97% with 1 type Ia EL (3%). In the post-operative period, 4 medical and 3 surgical complications were observed. Two reinterventions were needed with an iliac stenting for a stenosis and a correction of a femoral false aneurysm. During the mean follow-up of 7 months, 2 type Ia ELs were observed. One spontaneously resolved and the other one was followed. One distal limb extension was succesfully implanted at 3 months for a type Ib EL for a total rate of reintervention of 9%. No migration was observed. No death occured. Conclusion The use of the Gore Excluder Conformable endograft seems to be safe and effective in difficult anatomies and especially high angulation. It allows for precise deployment without the need for additional contrast or operation time. Longer follow-up and more patients are required to confirm these excellent initials results.


2020 ◽  
pp. 145749692091726
Author(s):  
A. Sonetto ◽  
S. Laukontaus ◽  
L. Vikatmaa ◽  
P. Aho ◽  
M. Venermo

Introduction: Endovascular aneurysm sealing represents an alternative to advanced technology devices for compromised patients with abdominal aortic aneurysms. We report our results of 15 fragile patients with very low-quality infrarenal necks treated with endovascular aneurysm sealing. Material and methods: All patients treated with Nellix device in our hospital between June 2015 and October 2016 were retrospectively reviewed. The primary endpoints are the following: overall survival and freedom from reintervention rates. The secondary endpoints are the following: technical success; 30-day mortality; abdominal aortic aneurysm–related mortality; and freedom from endoleak rate, complications, and surgical conversion rate. Results: Nellix was used in 15 patients, median age 75.5 years, of which 67% were unfit for open surgery. Mean aneurysm diameter was 60 mm. One-third (5/15) of the patients were inside the Nellix instructions for use. Technical success rate was 93.3%. No perioperative complications existed, and 30-day mortality was 0%. Median follow-up was 35 (interquartile range: 11–37) months. Survival rates at 1 and 3 years were 80% and 59.3%. Abdominal aortic aneurysm–related mortality occurred in 3 of 15 cases. Freedom from rupture rates at 1 and 3 years were 92.9% and 66%. Freedom from endoleak rates at 1 and 3 years were 92.9% and 74.5%. Freedom from reintervention rates at 1 and 3 years were 86.7% and 70.6%, with a dramatic drop to 37.1% at 4 years of follow-up. Three open surgery conversions were needed. There were no statistically significant differences in results between patients treated inside and outside instructions for use. Conclusion: The endovascular aneurysm sealing has shown encouraging short-term results, but its safety and effectiveness during time is questionable, because this system still carries high rates of reintervention, conversions for type IA endoleaks, and secondary aneurysm ruptures.


2007 ◽  
Vol 14 (5) ◽  
pp. 609-618 ◽  
Author(s):  
Peter Ziegler ◽  
Efthimios D. Avgerinos ◽  
Thomas Umscheid ◽  
Theodosios Perdikides ◽  
Wolf J. Stelter

Purpose: To present a 7-year single-center clinical experience with fenestrated endografts and side branches. Methods: Between April 1999 and August 2006, 63 patients (57 men; mean age 70.5611.6 years, range 25–89) received custom-designed Zenith fenestrated endoprostheses for a variety of aneurysms (59 abdominal, 1 thoracoabdominal, and 3 thoracic). They were all unsuitable for standard EVAR owing to short aortic necks and high risk for open surgery. Results: Nineteen tube grafts and 44 composite bifurcated grafts with a total of 122 fenestrations and 58 side branches were used. Technical success was achieved in 55 (87.3%) patients and in 118 (96.7%) vessels. Treatment success was 93.7%. The mean follow-up was 23±18 months (median 14, range 6–77). Overall, 9 (7.4%) visceral branches were lost: 4 intraoperative, 2 perioperative, and 3 late. There were 12 (19.0%) endoleaks identified: 5 (7.9%: 4 type Ia and 1 fenestration-related type III) primary and 7 (11.1%: 4 type II, 1 type I, and 2 type III) secondary endoleaks; 4 resolved, 4 were treated, and 4 are under observation. At 77 months, 75.3% of patients were free of a reintervention. All reinterventions were performed within the first 14 months. Fourteen cases of renal impairment were seen [6 permanent (only 1 on dialysis) and 8 transient]. One (1.6%) conversion and 1 (1.6%) rupture were recorded; aneurysm-related mortality was 4.8% (3/63). Conclusion: The favorable outcomes in this study, which encompasses the team's learning curve with fenestrated endografts and side branches, support the use of these devices in selected patients.


2020 ◽  
pp. 152660282095727
Author(s):  
Aleksandra C. Zoethout ◽  
Arshad Sheriff ◽  
Clark J. Zeebregts ◽  
Michel M. P. J. Reijnen ◽  
Andrew Hill ◽  
...  

Purpose To assess the incidence of migration after endovascular aneurysm sealing (EVAS) in conjunction with chimney grafts (chEVAS) for repair of abdominal aortic aneurysms (AAAs). Materials and Methods A retrospective, observational cohort study was conducted of 31 patients (mean age 75.7 years; 27 men) treated for juxtarenal AAA between April 2013 and December 2018 at single centers in New Zealand and the Netherlands. The majority of patients received >1 chimney graft (13 single, 13 double, and 5 triple) during chEVAS. Six patients had only the first postoperative scan, so the migration analysis was based on 25 patients. Results Median seal length assessed on the first postoperative computed tomography scan was 36.5 mm. The assisted technical success rate was 93.5% with 2 technical failures. Median time to final imaging follow-up was 17 months in 25 patients. At the latest follow-up, there were no cases of caudal migration >10 mm. Freedom from caudal movement of 5 to 9 mm was estimated as 86.1% at 1 year and 73.9% at 2 years; freedom from clinically relevant migration (movement requiring reintervention) was 100% at both time intervals. However, at 3 years there were 2 cases of caudal movement of 5 to 9 mm and a type Ia endoleak warranting reintervention. No correlation between migration and aneurysm growth (p=0.851), endoleak (p=0.562), or the number of chimney grafts (p=0.728) was found. During follow-up, 2 patients (7%) had aneurysm rupture and 10 (33%) had reinterventions. Eight patients (27%) died; 2 were aneurysm-related (7%) and due to the consequences of a reintervention. Conclusion In the 2 years following chEVAS, there was no caudal migration >10 mm, but nearly a quarter of patients had caudal movement of 5 to 9 mm. A trend was observed toward ongoing migration that required intervention at 3-year follow-up. chEVAS is technically challenging and should be considered only for patients with no viable alternative treatment option.


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