Objective: To assess the incidence, outcomes, and predictors of type III endoleaks (TIIIELs) in patients treated with different generations of Endologix unibody devices for abdominal aortic aneurysm (AAA). Methods: Patients treated with unibody endografts between 1999 and 2020 in a single unit were prospectively enrolled, retrospectively analyzed, and stratified according to device generation. The primary outcome was the incidence of TIIIEL in patients treated with unibody devices. Secondary outcomes included: (1) TIIIEL incidence among the different device generations; (2) comparison of type IIIa (TIIIaELs) and type IIIb endoleaks (TIIIbELs) incidence, treatment, and complications; (3) risk factor analysis for TIIIEL; (4) overall survival and survival free from TIIIEL. Results: A total of 872 patients who underwent endovascular aortic repair (EVAR) were analyzed. The cumulative incidence of TIIIEL was 4.8% (42/872). The incidence among different generations was 2.4% (10/414), 21.7% (15/69), and 4.6% (16/341), and 2.1% (1/48) for Powerlink, AFXs, AFXd, and AFX2. Freedom from TIIIEL by device generation was significantly lower in the AFXs group (p<0.001). Type III endoleaks was higher in urgent EVAR (p=0.011), large AAA (p<0.001), angulated and calcified necks (p=0.002), and when more than one modular component or non-proprietary extension was used (p<0.001). AFXs was found as independent risk factor for TIIIEL (hazard ratio [HR]=3.1, p=0.003), while the use of a single component decreased the risk (HR=0.3, p=0.005). Finally, every 10-mm increase in AAA diameter resulted in a 2-fold increase in TIIIEL risk (HR=2.0, p<0.001). Conclusion: The first generation of AFX endograft was associated with an increase in TIIIEL risk by 3.1 times, claiming a strict and careful follow-up in patients implanted with this device. Clinical Impact The old-generation of unibody endograft AFXs was associated with an increase in TIIIEL risk by 3.1 times. Angulated and calcified neck, large aneurysms and the use of nonproprietary graft extension were found as independent risk factors for TIIIEL. Patients implanted with these devices and with these anatomical features should be intensively monitored during follow-up.
Our goal was to achieve complete proximal sealing in severe aortic neck angulation (SNA) during endovascular aneurysm repair (EVAR) of a patient with an abdominal aortic aneurysm (AAA) unfit for surgery. An 82-year-old patient with an infrarenal AAA of 9.8 cm with an SNA of 90° was admitted for acute coronary syndrome. Following coronary treatment, the patient was considered unfit for surgery and therefore was evaluated for EVAR. Aneurysm sac exclusion was obtained with the deployment of a Powerlink bifurcated graft (Endologix Inc, Irvine, CA) inside a Relay thoracic endograft (Bolton Medical, Florida) placed just below the most distal renal artery. At 6 months, computed tomographic angiography confirmed correct graft placement, complete aneurysm exclusion, and a reduction in the aneurysmal sac. In AAA patients with an SNA at high risk of EVAR failure, the adaptability of a thoracic endograft could be considered for proximal sealing.
Endovascular success depends heavily upon anatomical suitability for secure graft placement. Common iliac artery (CIA) aneurysms frequently extend close to the iliac bifurcation, requiring distal fixation in the external iliac artery (EIA), in turn excluding the internal iliac artery (IIA). The preservation of circulation to at least one IIA artery is highly recommended. We report an endovascular technique for complete preservation of the hypogastric arteries of an aorto-iliac aneurysm extending into the iliac bifurcation and hypogastric artery. A left CIA aneurysm involving the iliac bifurcation was excluded with a covered Fluency stent-graft (Bard Inc., New Jersey, USA) deployed from the EIA into the IIA followed by the internal deployment of a Luminex uncovered stent (Bard Inc.) extended into one branch of the hypograstric artery. IVUS evaluation was essential in determining precise aneurysm and sealing zone measurements. Complete preservation of hypogastric circulation was achieved. The placement of the uncovered stent effectively extended the sealing zones without covering either of the hypogastric distal branches and concurrently corrected the Fluency stent kinking due to severe arterial tortuosity. In CIA aneurysms involving the IIA, an uncovered stent can extend the sealing zones, whilst maintaining complete preservation of pelvic circulation and offers support to the covered stent-graft. IVUS seems necessary for precise neck evaluation.
The aim of this study was to investigate the early outcomes of a novel off the shelf pre-loaded inner branched thoraco-abdominal endograft (E-nside) in the treatment of aortic pathologies.Data from a physician initiated national multicentre registry on patients treated with the E-nside endograft, were prospectively collected and analysed. Pre-operative clinical and anatomical characteristics, procedural data, and early outcomes (90 days) were recorded in a dedicated electronic data capture system. The primary endpoint was technical success. Secondary endpoints were early mortality (90 days), procedural metrics, target vessel patency, endoleak rate, and major adverse events (MAEs) at 90 days.In total, 116 patients from 31 Italian centres were included. Mean ± standard deviation (SD) patient age was 73 ± 8 years and 76 (65.5%) were male. Aortic pathologies included degenerative aneurysm in 98 (84.5%), post-dissection aneurysm in five (4.3%), pseudoaneurysm in six (5.2%), penetrating aortic ulcer or intramural haematoma in four (3.4%), and subacute dissection in three (2.6%). Mean ± SD aneurysm diameter was 66 ± 17 mm; aneurysm extent was Crawford I - III in 55 (50.4%), IV in 21 (19.2%), pararenal in 29 (26.7%), and juxtarenal in four (3.7%). The procedure setting was urgent in 25 (21.5%) patients. Median procedural time was 240 minutes (interquartile range [IQR] 195, 303), with a median contrast volume of 175 mL (IQR 120, 235). The endograft's technical success rate was 98.2% and the 90 day mortality rate was 5.2% (n = 6; 2.1% for elective repair and 16% for urgent repair). The 90-days cumulative MAE rate was 24.1% (n = 28). At 90 days, there were 10 (2.3%) target vessel related events (nine occlusions and one type IC endoleak) and one type 1A endoleak requiring re-intervention.In this real life, non-sponsored registry, the E-nside endograft was used for the treatment of a broad spectrum of aortic pathologies, including urgent cases and different anatomies. The results showed excellent technical implantation safety and efficacy, as well as early outcomes. Longer term follow up is needed to better define the clinical role of this novel endograft.
BACKGROUND: To assess the long-term safety and effectiveness of endovascular aneurysm repair (EVAR) treatment with unibody endograft deployed on aortic bifurcation (anatomical fixation).METHODS: A retrospective, observational, single-center study of patients treated from 1999 to 2002 with unibody bifurcated endograft. Follow-up protocol required clinical and doppler-ultrasound at 1 and 6 months and annually thereafter, computed tomography angiography at 1-, 6- and 12-months and then every year. Primary endpoints included technical and treatment success, survival and freedom from late EVAR failure; secondary endpoints were freedom from late open conversion (LOC), freedom from late re-interventions and endoleaks.RESULTS: Seventy-three patients, mean age of 73±6 years were enrolled. Median follow-up was 6±0.5 years. Technical success was 98.6% (N.=71/73; causes of failure: 1 open conversion and 1 type Ib endoleak). A treatment success of 96% (N.=69/72) was recorded due to endoleaks (N.=2; 1 type Ia and 1 type Ib) and limb occlusion (N.=1). Survival at 1, 5, 10, 15 and 18 years was 90%, 58%, 40%, 32% and 23% respectively. One aneurysm-related death for infection of the endograft was registered. EVAR failure was 14% (N.=10/71). Three LOC were recorded and freedom from reinterventions at 1, 5, 10 and 18 years was 99%, 91%, 86% and 86%. Fourteen endoleaks were recorded: Ia (N.=6; 42.8%), Ia+Ib (N.=1; 7.1%), Ib (N.=2; 14.2%) and II (N.=5; 35.6%). Four endoleaks were observed, 9 endovascular correction and 1 LOC were required. Endoleaks free survival of 90% at 1-year and 75% at the end of the study. Aneurysm sac shrinkage was observed in 79% (N.=56/71).CONCLUSIONS: This small, retrospective cohort of anatomically fixed EVAR demonstrated long-term safety and effectiveness. The design of the unibody graft did not substantially change and newer generation should guarantee the same performance.
