Endovascular Graft Research Articles

*Comparison of Operative Characteristics and Outcomes after Infected Endovascular and Open-Surgical Abdominal Aortic Graft Excision

*Comparison of Operative Characteristics and Outcomes after Infected Endovascular and Open-Surgical Abdominal Aortic Graft Excision

Closure of a pseudo aneurysm developed after trauma in the brachial artery with endovascular stent graft: A case report

Aneurysm is defined as 50% enlargement of the normal diameter of the artery. The most common cause of true aneurysms is atherosclerosis. Pseudoaneurysms, on the other hand, occur as a result of the blood leaking from the tear in the arterial wall forming a thrombus formation and surrounding it with a fibrous capsule. In pseudoaneurysms, blood pools in a closed area. However, they may enlarge and rupture in the late period. Treatment options are thrombin injection, endovascular graft implantation, surgical ligation, and arterial bypass. In this case report, we present a patient with a stab wound to the axilla. Two years after the injury, a pseudoaneurysm developed in the left brachial artery. The pseudoaneurysm was treated with endovascular stent graft

Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-Modified Endovascular Grafts Prior to Initiation of an Investigation Device Exemption Trial

Fenestrated endovascular aortic repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal AAAs in patients high-risk for open repair. While availability of custom-devices is limited, physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ specific anatomy. Here, we present our PMEG experience, submitted to the US Food and Drug Administration with an Investigation Device Exemption trial application, which is now enrolling (clinicaltrials.gov NCT04746677).

Reinterventions After Physician-Modified Endovascular Grafts for Treatment of Juxtarenal Aortic Aneurysms are Nondetrimental to Long-Term Survival

Reintervention after endovascular aortic aneurysm repair is common. However, the frequency and effects of reintervention on mortality after physician-modified endografts (PMEGs) is unknown. In the present study, we have described the reinterventions after PMEG for treatment of juxtarenal aneurysms and their effect on survival.

Midterm Outcomes of Endovascular Repair of Aortic Arch Aneurysms with the Gore Thoracic Branch Endoprosthesis

Aortic aneurysms involving aortic arch vessels are anatomically unsuitable for standard thoracic endovascular repair (TEVAR) without cervical debranching of the arch vessels. Three year outcomes of a single branched thoracic endograft following previous publication of peri-operative and one year outcomes are reported. This was a multicentre feasibility trial of the GORE TAG Thoracic Branch Endoprosthesis (TBE), a thoracic endovascular graft incorporating a single retrograde branch for aortic arch vessel perfusion. The first study arm enrolled patients with an intact descending thoracic aortic aneurysm extending to the distal arch with left subclavian artery (LSA) incorporation (zone 2). The second arm enrolled patients with arch aneurysms requiring incorporation of the left carotid or innominate artery (zone 0/1) and extra-anatomic surgical revascularisation of the remaining aortic arch vessels. Outcomes at three years are reported. The cohort comprised 40 patients (31 zone 2, nine zone 0/1). The majority were male (52%). Mean follow up was 1 408 ± 552 days in the zone 2 and 1 187 ± 766 days in the zone 0/1 cohort. During three year follow up there was no device migration, fracture, or aortic rupture in either arm. In the zone 2 arm, freedom from re-intervention was 97% at one and three years but there were two side branch occlusions. Two patients had aneurysm enlargement > 5 mm without documented endoleak or re-intervention. Freedom from death at one and three years was 90% and 84%. In the zone 0/1 arm there were no re-interventions, loss of branch patency, or aneurysm enlargement at three years. Cerebrovascular events occurred in three patients during follow up: two unrelated to the device or procedure, and one of unknown relationship. Two patients in this arm died during the follow up period, both unrelated to the procedure or the aneurysm. Initial three year results of the TBE device for endovascular repair of arch aneurysms show favourable patency and durability with low rates of graft related complications.

Total Arch Thoracic Endovascular Aortic Repair Using Double Fenestrated Physician-Modified Stent-Grafts: 100 Patients

Objective: The aim was to evaluate early and medium-term outcomes of double fenestrated physician-modified endovascular grafts for total endovascular aortic arch repair. Methods: This single-center retrospective analysis of prospectively-collected data included 100 patients, from January 2017 to December 2021, undergoing thoracic endovascular aortic repair (TEVAR) for zone 0. The fenestrations were a proximal larger fenestration that incorporated the brach2iocephalic trunk and left common carotid artery and a distal smaller fenestration for the left subclavian artery (LSA). Only the LSA fenestration was stented. Results: The median duration for stent-graft modification was 23±6 minutes. Of the 100 patients, 70 were men. The mean patient age was 70±10.5 years. Indications for treatment included degenerative aortic arch aneurysm (n=32), dissecting aortic arch aneurysm after type A dissections (n=23) and (n=19) after type B dissections, acute complicated type B dissection (n=16), and other pathologies (n=10). Technical success rate was 97%. The 30 day mortality was 2% (n=2). Four patients (4%) had minor stroke with full recovery. One patient (1%) had a type IA endoleak, 1 patient (1%) had a type IB endoleak, and 2 patients (2%) have a type II endoleak from the LSA. Eight patients (8%) required reintervention: 1 type IA endoleak, 1 type IB endoleak, 1 retrograde type A dissection, and 5 because of access-related complications. During a mean follow-up of 24±7.2 months, there were no aortic rupture, paraplegia, and all supra-aortic trunks were patent. Conclusions: Double homemade fenestrated TEVAR is both feasible and effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The long-term durability will need to be assessed in studies with long-term follow-up. Clinical Impact Double homemade fenestrated TEVAR is effective for total endovascular aortic arch repair avoiding the need for anatomical and extra-anatomical surgical revascularization. The standout feature of this double fenestrated device is its simple handling during operation with the proximal fenestrations being directed to the orifices of the BT and LCCA automatically when the LSA fenestration is catheterized and secured by covered stent placement. The deployment algorithm actively steers the operator away from superfluous manipulations of the device within the arch and avoids guidewire manipulation in carotid arteries. The long-term durability will need to be assessed in studies with long-term follow-up.

Transrenal Aortic Aneurysmal Endoleak Sac Embolization

A 29-year–old man with Marfan syndrome was admitted with graft infection and an enlarging aneurysm sac causing left lung collapse (Fig 1). He had previously undergone aortic root replacement, fenestrated thoracoabdominal aortic aneurysm endovascular graft repair, and repeated endovascular embolization procedures for type 2 endoleaks.

Five-Year Experience With the Zenith Fenestrated Endovascular Graft for Treatment of Juxtarenal Abdominal Aortic Aneurysms at a Medium Volume Center

The use of fenestrated endovascular aortic repair (FEVAR) to treat abdominal aortic aneurysms involving the visceral arteries has increased worldwide with excellent results. The aim of this study was to evaluate the safety and effectiveness of the Zenith fenestrated endovascular graft (Cook Medical, Bloomington, IN) for the treatment of juxtarenal abdominal aortic aneurysms (AAAs) at a medium volume center. We performed a 5-year (2015-2020) retrospective analysis of all patients who had presented to our institution with juxtarenal AAAs and undergone FEVAR. Custom-made fenestrated stent grafts were designed with one to three fenestrations after analysis of computed tomography data sets. Renal alignment was performed with balloon-expandable stents. Follow-up included clinical examination, laboratory studies, mesenteric-renal duplex ultrasound, abdominal radiography, and computed tomography at hospital discharge, at 1, 6, and 12 months, and annually thereafter for ≤5 years. A total of 25 patients with juxtarenal AAAs had undergone FEVAR during the study period and were included in our analysis. Of the 25 patients, 18 were men and 7 were women, with a mean age of 71 ± 10 years. The mean aneurysm diameter was 60 ± 5 mm. A total of 53 visceral arteries required incorporation with fenestrations. Of these, 51 (96%) fenestrations were aligned by stents. Technical success was 100%. One intraoperative complication occurred. The patient developed bilateral common femoral artery plaque dissection and required common femoral artery endarterectomy. The mean length of hospital stay was 2.8 ± 1.5 days. No aneurysm ruptures or conversions were noted during a mean follow-up of 41 ± 15 months (range, 6-67 months). Of a total of 50 renal arteries targeted by fenestration, one renal artery occlusion (2%) and five cases of stenosis (10%) developed. Five patients (20%) required secondary interventions for renal artery stenosis or occlusion. One type I endoleak developed in 2 patients and one type II endoleak developed in 11 patients. One patient with a type II endoleak had experienced an increase in sac size at 1 year and underwent inferior mesenteric artery ligation. None of the patients died during the follow-up period. Our study has demonstrated that endovascular repair of juxtarenal AAAs with the Zenith fenestrated AAA stent graft at a medium volume center is safe and effective. Mortality and morbidity are low for properly selected patients treated at centers with experience in these procedures.

Off-the-Shelf Branched Endografts for the Treatment of Thoracoabdominal Aortic Aneurysms: Two-Year Target Vessel-related Outcomes

The objective was to assess clinical outcomes and target vessel patency through 2 years after thoracoabdominal aortic aneurysm (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe).

Single-Center Experience of Fenestrated Endovascular Aortic Repair Using Physician-modified Endovascular Grafts Before Initiation of an Investigation Device Exemption Trial

Fenestrated endovascular aneurysm repair (FEVAR) is an important option for complex abdominal aortic aneurysms (AAAs) and thoracoabdominal aneurysms in patients high-risk for open repair. Currently, the only US Food and Drug Administration (FDA)-approved fenestrated device is limited to juxtarenal AAAs. Custom-manufactured devices are only available at a handful of US centers. Physician-modified endografts (PMEGs) allow surgeons to build grafts for patients’ anatomy using standard stent grafts. Here, we present our single-center experience with PMEGs, submitted to the FDA with an Investigation Device Exemption trial application, which is now approved and enrolling (clinicaltrials.gov NCT04746677).

Midterm outcomes of aneurysm repair with the Cook Zenith Alpha abdominal endovascular graft

ObjectiveOutcome reports after endovascular aneurysm repair (EVAR) using the low-profile Zenith Alpha Abdominal Endovascular grafts (Cook Medical, Bjæverskov, Denmark) are sparse. We present results from a single-center cohort treated with the Zenith Alpha, from a period where the graft was the primary EVAR device choice. The aim of the study was to evaluate short- and midterm outcomes of patients treated with the Zenith Alpha. MethodsA retrospective single-center study was performed including all patients treated with the Zenith Alpha graft from October 1, 2015 to September 30, 2018. All patients underwent computed tomography angiography (CTA) imaging preoperatively as well as at 3 and 12 months postoperatively. Hereafter, patients were followed yearly with duplex ultrasound and clinical exams. Additional imaging was performed on indication. All CTAs were analyzed using three-dimensional reconstruction software (Aquarius, TeraRecon, Durham, NC). Data was extracted from electronic charts according to a protocol that remained unchanged until the end of the study (December 31, 2020). The following outcomes were assessed according to Society for Vascular Surgery/International Society of Cardiovascular Surgeons reporting criteria: aortic-related and all-cause mortality, reinterventions, instruction for use (IFU) violations, endoleaks (ELs), and aneurysm shrinkage. ResultsA total of 241 patients were treated with the Zenith Alpha, and 214 (89%) were asymptomatic repairs. Technical success was achieved in 238 patients (99%). One hundred fifty-seven patients (65%) received implantation outside IFU. The median hospital length of stay was 2 days (interquartile range, 2-3 days). The median clinical follow-up was 35.1 months (interquartile range, 28.8-47.5 months). The 4-year Kaplan-Meier estimate of freedom from reintervention was 66% (95% confidence interval, 59%-73%). The main reasons for reinterventions were iliac limb stenosis and occlusion (n = 30; 12%) and type 2 EL (n = 13; 5%). Overall, significantly more patients with grafts implanted outside distal IFU developed type 1B ELs (n = 10/11; P = .009). Aneurysm sac shrinkage was observed in 48 patients (25%) 1 year postoperatively. The Kaplan-Meier estimate of freedom from aortic-related mortality was 99% (95% confidence interval, 98%-100%) 4 years postoperatively. ConclusionsEVAR with the Zenith Alpha shows acceptable freedom from aortic-related mortality up to 4 years postoperatively. The majority of patients were treated outside IFU, and significantly more type 1B ELs appeared in this subgroup of patients. The leading cause for reintervention was impaired limb patency. The root cause for impaired limb patency requires further investigation.

Features of Diagnosis and Surgical Treatment of Abdominal Aortic Aneurysms with a Horseshoe Kidney

Introduction. Reconstructive surgery of abdominal aortic aneurysms, despite significant international experience, remains one of the most complex issues of current vascular surgery, especially due to anatomical variability of arterial blood supply of the kidneys and abnormalities in their development, among which the most common is a horseshoe kidney. Features of vascularization, placement of the renal isthmus relative to the main vessels, the choice of the optimal method of abdominal aortic aneurysm reconstruction cause a high risk of surgery. The issues of open and endovascular aortic grafting, possibility of crossing the isthmus of the horseshoe kidney, feasibility of reconstruction of additional renal arteries still remain controversial.
 The aim. Improvement of the diagnosis and surgical treatment of abdominal aortic aneurysms with a horseshoe kidney.
 Case presentation. In our observation, in a 61-year-old patient, by clinical examination, laboratory and diagnostic imaging the diagnosis of two infrarenal abdominal aortic aneurysms with a horseshoe kidney was confirmed, that has become a direct indication for surgical intervention: exclusion of infrarenal aortic aneurysms from the blood flow, abdominal aortic prosthetic grafting with reimplantation of the renal isthmus arteries into the prosthetic graft. This clinical case confirms the advantages of open surgical technique, using transperitoneal approach, which not only provided sufficient exposure of the operating area, but also allowed to perform optimal reconstruction of the abdominal aorta without crossing the functioning isthmus of the horseshoe kidney with preservation of blood flow through additional renal arteries.
 Conclusion. Careful preoperative assessment of the peculiarities of the blood supply of the horseshoe kidney with coexistent abdominal aortic aneurysms allows to optimize the tactics of surgical treatment, prevent the development of severe complications and achieve complete recovery of the patient.

Collapsed endograft and lower limb ischemia from type B dissection repaired with thoracic endovascular aortic graft and iliac stenting: A case report and review of the literature

The collapse of an abdominal aortic endograft is a rare event. We present the case of a 60-year-old man with an abdominal endograft who came to the emergency department with chest, back, abdominal, and lower extremity pain in addition to a cool left foot. On imaging, he was found to have a type B aortic dissection and a collapsed abdominal endograft. Subsequently, the patient was taken to the operating room and treated with a thoracic endovascular aortic repair, abdominal aortic cuff, and an iliac stent. Our study details this case and thoroughly reviews similar cases in the literature.

Early Diagnosis and Treatment of Nine Patients with Severe Multiple Injuries Accompanied by Traumatic Aortic Dissection during Emergency Treatment.

Objective This study is aimed at investigating the early diagnosis and efficacy of emergency treatments of nine patients with severe multiple injuries accompanied by traumatic aortic dissection (TAD). Methods Patients who sustained severe multiple injuries accompanied by TAD following a car accident (n = 6) and falls from a height (n = 3) were treated in the emergency department of our hospital from October 2017 to July 2021. Data of these patients, including seven men and two women (average age, 53 ± 15.2 years; range, 18–83 years) were analysed retrospectively. Upon hospital arrival, the multidisciplinary treatment (MDT) trauma team, composed of doctors and nurses, immediately performed resuscitation following the Green Channel Consultation and Treatment Process for Severe Multiple Injuries. Life-threatening injuries were managed urgently. Blood tests and blood preparation and bedside B-scan ultrasonography and CT were performed. Aortic computed tomography angiography (CTA) was conducted decisively in patients suspected of TAD so that endovascular graft exclusion (EVGE) with the aortic covered stent can be performed promptly, followed by emergency management, second-stage surgery, and intensive care according to the injury control strategy. Results This study included nine patients suffering from severe multiple injuries accompanied by Stanford type B TAD, with injury severity scores ranging from 35 to 43 points. Six patients underwent EVGE while receiving emergency treatment, whereas two patients who also had intracranial haemorrhage underwent selective EVGE. One case of TAD missed in the emergency department was detected 13 days after hospitalisation; therefore, the patient promptly underwent EVGE. Emergency procedures performed included exploratory laparotomy and splenectomy (n = 2), thoracic closed drainage (n = 5), haemothoracotomy (n = 3), second-stage fracture surgery (n = 4), and tracheotomy (n = 1). Postinjury complications included haemorrhagic shock, coagulation disorders, hyoxaemia, pulmonary infection, renal insufficiency, and hypoproteinaemia; however, all patients recovered after intensive care treatment. Aortic CTA after EVGE revealed the disappearance of the dissection and the resorption of the intermural haematoma. However, varying degrees of stenosis or occlusion were observed in the left subclavian artery. Nine patients with severe multiple injuries were treated satisfactorily by the MDT, without fatalities, and all patients were discharged for rehabilitation. Conclusion In this study, procedures including resuscitation, urgent aortic CTA for definitive diagnosis, prompt EVGE, emergency injury control surgery, second-stage definitive surgery, intensive care treatment, and rehabilitation were rationally performed by the emergency MDT trauma team. Overall, this continuous and seamless process is a key factor for the successful treatment of patients with severe multiple injuries accompanied by TAD.

Early Clinical Outcomes of Initial Launch of the Zenith Alpha Abdominal Endovascular Graft in Japan

Purpose: This study retrospectively evaluated the 12-month outcomes of the Zenith Alpha Abdominal Endovascular graft (Zenith Alpha AAA, Cook, Inc, Bloomington, Indiana), which was launched partially in Japan in March 2019, starting with 9 selected sites. Methods: A retrospective analysis was performed of all endovascular aneurysm repairs (EVAR) for abdominal aortic aneurysms using the Zenith Alpha AAA. Late complications were defined as any aneurysm-related events occurring >30 days after EVAR, including an aneurysm sac enlargement of >5 mm and any reinterventions performed. Endoleaks without sac enlargement or reinterventions were excluded from late complications. Results: During the study period, 79 EVARs using the Zenith Alpha AAA were performed. The mean age was 76.6±6.9 years old, 91.1% of patients were male, and the mean aneurysm diameter was 51.1±7.5 mm. Instructions for use violation was observed in 27 patients (34.2%), most frequently being a severely angulated proximal neck (>60°). There were 4 intraoperative complications, including 2 unintentional partial renal artery coverages caused by the premature anchoring of the exposed suprarenal stent barb to the aortic wall, which was a result of the design change of the top cap deletion. Since it was a partial coverage without flow impairment and since renal stenting was unsuccessful, it was left untreated and had no subsequent renal function impairment. During the mean follow-up of 444±123 days, 74 patients completed 12 months of follow-up. Freedom from late complications at 12 months was 90.8%, which included 2 limb occlusions (2.5%). Of 71 patients with a 12-month computed tomography scan, there was only 1 type 1a endoleak (1.3%), 1 sac enlargement of >5 mm (1.3%), and an aneurysm sac shrinkage of >5 mm was observed in 42.2% of patients. There was no type 3 endoleak during the follow-up. Conclusions: This study demonstrated that the new generation of low-profile Zenith Alpha AAA has satisfactory early clinical outcomes, comparable to those obtained with the conventional Zenith endovascular graft. Long-term follow-up is needed to determine whether these favorable outcomes persist.

Percutaneous Drainage for Aortic Graft Infection Post-aneurysm Repair: A Viable Option?

PurposeNon-operative management of aortic graft infection is usually only considered in a palliative context. We describe the safety, efficacy, and clinical outcomes of percutaneous drainage of aortic graft infections (AGI) following either open or endovascular repair of aneurysmal disease.MethodsTwelve consecutive patients (11 males, 1 female, mean age 72.7 ± 10.3 years, age range 52-88 years) between January 2010-July 2020 who underwent percutaneous drain insertion in either an infected aortic sac or periaortic abscess cavity following endovascular or open surgical graft repair were identified. Patient and procedural characteristics as well as clinical outcomes were determined.ResultsOf the 12 patients who underwent percutaneous drain insertion, five (41.7%) had undergone open abdominal aneurysm repair, one (8.3%) open thoracoabdominal aneurysmal repair, and six (50%) endovascular abdominal aneurysm repairs. Drain size ranged from 10-20 French. All were inserted under ultrasound (US), computed tomography (CT), and/or fluoroscopic guidance. Median duration of drain placement was 55.2 days (range 3-174). Five patients (41.7%) had the drain in place as a stabilizing bridge until or after definitive surgical explantation and aortic reconstruction. Seven patients (58.3%) were managed with drain placement and antibiotic therapy without surgical intervention. Six (50%) were alive at the most recent time of follow-up (median, 732 days, range 166-1650 days). Three patients (25%) died during follow-up with causes including erosion of aortic reconstruction into sigmoid colon, unrelated chronic obstructive pulmonary disease exacerbation, and severe clostridium difficile colitis and pseudomonal pneumonia (median 1244 days, range 992-1597 days). Three (25%) patients were lost to follow-up. No drain-related complications were noted.ConclusionPercutaneous drainage of AGI following endovascular or open aneurysm repair is a safe and viable management option either as a temporizing measure as a bridge to surgical graft explantation or as a non-surgical therapy for long term management.

Q Fever Masquerading as Legionnaires Disease in an Endovascular Stent Infection

Abstract Background Legionellosis in the setting of preexisting endovascular prosthetic graft may represent a Coxiella burnetii infection as antibody cross-reactivity exists. Methods We present a 63-year-old man status-post endovascular aneurysm repair (EVAR) with a history of ankylosing spondylitis, chronic obstructive pulmonary disease asthma, coronary artery disease with myocardial infarction, hypertension, and hyperlipidemia who presented with clinical symptoms of legionellosis. This was confirmed with a positive urine antigen test. Results He completed a 21-day course of azithromycin for Legionella. His leukocytosis and liver function tests normalized, but he had continued lethargy and a persistently elevated erythrocyte sedimentation rate and C-reactive protein. Imaging showed a radiographically infected EVAR graft (placed 10 months prior). The EVAR was explanted and the operating room cultures grew C. burnetii. Prolonged hydroxychloroquine and doxycycline therapy were required for vascular manifestations of Coxiella as azithromycin provides inappropriate coverage. Conclusions Persistent constitutional symptoms in the setting of an EVAR require expanded investigation, especially in the setting of legionellosis.

Physician-Modified Endovascular Grafts for Zone-2 Thoracic Endovascular Aortic Repair.

Objective This study aims to describe our technique and early experience with physician-modified endovascular grafts (PMEGs) for aortic arch diseases in zone 2. We used a total endovascular technique based on a single fenestrated endograft to preserve left subclavian artery (LSA) patency. Methods From December 2019 to August 2020, six consecutive patients with a variety of thoracic aortic diseases were treated with handmade fenestrated thoracic aortic grafts: four aortic dissections, one penetrating aortic ulcer, and one intramural hematoma. The planning, endograft modification, surgical technique, and follow-up of the patients were described. We evaluated immediate technical success and after 30 days, the LSA patency, Type-1 endoleak, and postoperative complications. Results Thoracic endovascular aortic repair (TEVAR) was performed for zone 2 in all cases. Immediate technical success, defined as successful alignment of the LSA with a covered stent and no Type-1 endoleak, was achieved in all cases. Patients had a 30-day follow-up computed tomography, which demonstrated LSA patency and no Type-I endoleaks. To date, no strokes, left arm ischemia, paraplegia, or conversions to open surgery have been reported; one patient operated for acute Type B dissection died during the early follow-up. Conclusion TEVAR for zone 2 with a PMEG to maintain LSA patency achieved technical success and early durability. It is expected that with longer follow-up and a larger number of cases, these results will be confirmed.

Proximal seal dilatation following fenestrated endovascular repair for complex abdominal aortic aneurysms

ObjectiveAlthough proximal neck dilatation following infrarenal endovascular aneurysm repair (EVAR) is common and is associated with proximal graft failure, little is known about sealing zone dilatation and its clinical relevance following fenestrated EVAR (FEVAR). We studied proximal seal dilatation (PSD) dynamics following FEVAR and assessed its clinical significance. MethodsWe included all consecutive patients treated for a juxta-/supra-renal aneurysm with fenestrated EVAR using the Zenith Fenestrated Endovascular Graft (Cook Medical, Bloomington, Ind) from 2008 to 2018 in two large teaching hospitals in the Netherlands. The primary outcome was PSD over time and was determined using a linear mixed-effects model. Secondary outcomes included associations for early PSD and difference in aortic dilatation at the level of the covered stent compared with the bare stent. Proximal seal-related adverse events were also obtained. ResultsOur cohort included 84 patients with a median computed tomography angiography follow-up time of 24.5 months (interquartile range [IQR], 17-42 months). Maximum aneurysm diameter was 60.1 mm (IQR, 56.9-67.2 mm). Mean proximal seal diameter at baseline was 26.2 mm (standard deviation [SD], ±2.8 mm), mean stent oversizing was 20.1% (SD, ±9.1%), and mean proximal seal length was 29.5 mm (SD, ±11.7 mm). Proximal seal dilatation of 1.7 mm (95% confidence interval [CI], 1.4-2.1 mm) was found in the first year, decelerating thereafter (second year, 0.9 mm/year; 95% CI, 0.7-1.1 mm/y). Over 10% PSD at 1 year occurred in 22 patients (27%) and was associated with stent graft oversizing (odds ratio, 1.1; 95% CI, 1.03-1.2; P = .008) and a lower number of target vessels (four fenestrations/ref two fenestrations: odds ratio, 0.13; 95% CI, 0.02-0.74; P = .029). At last available imaging, dilatation difference was higher at the level of the covered stent compared with the bare stent (3.0 mm [IQR, 1.3-5.1 mm] vs 1.6 mm [IQR, 0.8-2.5 mm]; P < .001). During the study period, only one patient (1.2%) developed a proximal seal-related adverse event (type IA endoleak). ConclusionsPSD is present following FEVAR, occurring at a faster rate in the first year and subsequently decelerating thereafter, similarly to neck dilatation after standard infrarenal EVAR. Although its clinical implication seems to remain limited in the first years following implantation, further research is required to assess the effect of PSD on long-term FEVAR outcomes.

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

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.