Endurant Stent Graft for Treatment of Abdominal Aortic Aneurysm Inside and Outside of the Instructions for Use for the Proximal Neck: A 14-Year, Single-Center Experience.

Aim: To assess the medium and long-term performance of the Endurant stent graft in a cohort of consecutive patients treated with this device for an abdominal aortic aneurysm (AAA) both inside and outside of the instructions for use (IFU) and to find factors influencing the outcomes. Methods: Our observational, retrospective, single-center study included all patients who consecutively underwent endovascular aneurysm repair with the Endurant stent graft from February 2009 to January 2023. Patients with an AAA to treat according to current guidelines were included. Patients were divided into two groups: Group 1 inside of the IFUs and Group 2 outside of the IFUs for the proximal aortic neck. Patients were followed up after the procedure with computed angiography tomography, ultrasound examination, and interviews. Aneurysm-related mortality, procedure-related reinterventions, and type IA and III endoleaks were considered primary endpoints. Secondary endpoints included aneurysmal sac variations and graft thrombosis. Results: A total of 795 patients were included, 650 in Group 1 and 145 in Group 2; 732 were males, and the mean age was 74 ± 8. Anamnestic baseline did not differ between the two groups. Neck length, width, and angulation were different between the two groups (all p < 0.001). A total of 40 patients had a ruptured AAA, while 56 were symptomatic. At a mean follow-up of 43 ± 39 months, aneurysm-related mortality was less than 1%, and 82 endoleak (10.5%) were observed. Overall endoleak rate and type 1A endoleak, as well as procedure-related reintervention, were significantly more frequent in Group 2. Sac regression of at least 5 mm was observed in 65.9% of cases. AAAs larger than 60.5 mm carried a higher risk of endoleak (HR: 1.025; 95% CI: 1.013-1.37; p < 0.001) and proximal necks shorter than 13.5 mm carried a higher type 1A risk (HR: 0.890; 95% CI: 0.836-0.948; p < 0.001). Patients without chronic obstructive pulmonary disease and taking lipid-lowering drugs had an overall more consistent sac-shrinking rate. Conclusions: The Endurant stent graft proves safe and reliable. Out-of-IFU treatment has poorer medium and long-term outcomes. Some conditions influence medium and long-term reintervention risk and sac behavior. Patients with bigger aneurysms, proximal necks shorter than 13.5 mm, and chronic obstructive pulmonary disease should be more carefully evaluated during follow-up. Consistent follow-up is in keeping low aneurysm-related mortality. Personalized risk profiles and peri and postoperative management strategies are needed.

Endovascular treatment of an aortocaval fistula caused by a late type II endoleak.

An aortocaval fistula (ACF) is a rare complication of abdominal aortic aneurysms (AAAs) and constitute <1% of all AAAs, which increases from 2% to 6.7% in ruptured AAAs. Unlike other aortic ruptures, most ACFs are not associated with significant blood loss on admission. The traditional treatment strategy has been open surgery, which is associated with a high mortality rate. Endovascular repair has been performed; however, the results are difficult to interpret due to the low incidence of ACFs and the absence of cases reported with a long follow-up duration. We report the case of a 78-year-old man with previous endovascular aneurysm repair performed in 2015, who presented to our emergency department 6 years later with abdominal pain. A computed tomography angiography scan showed type Ia, Ib, and II endoleaks and an ACF. The endoleaks were selectively treated, and the ACF was covered with a polytetrafluoroethylene endograft inserted in the inferior vena cava. In our single-case experience with a medium-term follow-up of 24 months, our treatment was safe and effective for ACF closure, with no further signs of endoleak or graft thrombosis. We conducted a literature review of reported cases in which a covered stent graft was used for ACF treatment. Although no guidelines are currently available regarding this rare late complication after endovascular aneurysm repair, using a covered stent placed in the inferior vena cava to treat an ACF could be a viable option in selected cases.

A Multicenter Experience of Three Different "Iliac Branched" Stent Grafts for the Treatment of Aorto-Iliac And/Or Iliac Aneurysms.

BACKGROUND: The aim of study was to assess the safety and effectiveness of 3 different commercial iliac branch devices (IBDs): the Zenith Branch Iliac Endovascular Graft; the Gore Excluder Iliac Branch System and the E-liac Stent Graft System for the treatment of aorto-iliac or iliac aneurysms. METHODS: From January 2017 to February 2020, a retrospective reviewed was conducted on a total of 96 patients. Primary endpoint was IBD instability rate at 24 months. Secondary endpoints included onset of any endoleaks, buttock claudication, IBD-related reintervention and all-death rates, postoperative acute kidney, and changes in maximum diameter from baseline of the aortic aneurysmal sac. RESULTS: At 24 months, the branch instability rate was similar among the 3 IBDs employed [Jotec 1/24 (4.1%), Gore 1/12 (8.3%), Cook 6/47 (12.7%), P-value = 0.502]. As well, no statistical difference in terms of branch occlusion and branch-related endoleaks was observed. The Jotec group showed a significant decrease in maximum diameter from the baseline of the aortic aneurysmal sac when compared to the Gore group alone. No other differences were found relevant to the onset of any endoleaks, reinterventions, and all-death rates. At 24 months, the Kaplan-Meier estimate of survival freedom from any branch instability was 95.8%, 91.6%, and 86.8% for Jotec, Gore and Cook groups, respectively. CONCLUSIONS: The use of IBDs represents a safe method for preserving patency of the IIA during treatment of aorto-iliac or iliac aneurysms providing a low rate of IBD instability.

How the First Year of the COVID-19 Pandemic Impacted Patients' Hospital Admission and Care in the Vascular Surgery Divisions of the Southern Regions of the Italian Peninsula.

Background: To investigate the effects of the COVID-19 lockdowns on the vasculopathic population. Methods: The Divisions of Vascular Surgery of the southern Italian peninsula joined this multicenter retrospective study. Each received a 13-point questionnaire investigating the hospitalization rate of vascular patients in the first 11 months of the COVID-19 pandemic and in the preceding 11 months. Results: 27 out of 29 Centers were enrolled. April-December 2020 (7092 patients) vs. 2019 (9161 patients): post-EVAR surveillance, hospitalization for Rutherford category 3 peripheral arterial disease, and asymptomatic carotid stenosis revascularization significantly decreased (1484 (16.2%) vs. 1014 (14.3%), p = 0.0009; 1401 (15.29%) vs. 959 (13.52%), p = 0.0006; and 1558 (17.01%) vs. 934 (13.17%), p < 0.0001, respectively), while admissions for revascularization or major amputations for chronic limb-threatening ischemia and urgent revascularization for symptomatic carotid stenosis significantly increased (1204 (16.98%) vs. 1245 (13.59%), p < 0.0001; 355 (5.01%) vs. 358 (3.91%), p = 0.0007; and 153 (2.16%) vs. 140 (1.53%), p = 0.0009, respectively). Conclusions: The suspension of elective procedures during the COVID-19 pandemic caused a significant reduction in post-EVAR surveillance, and in the hospitalization of asymptomatic carotid stenosis revascularization and Rutherford 3 peripheral arterial disease. Consequentially, we observed a significant increase in admissions for urgent revascularization for symptomatic carotid stenosis, as well as for revascularization or major amputations for chronic limb-threatening ischemia.

Efficacy and Safety of Jotec E-Ventus BX Stent Graft for Iliac Branch Device Procedure: A Retrospective Clinical Study.

BACKGROUND: The endovascular aneurysm repair (EVAR) is a successful treatment for aorto-iliac aneurysms. The success of EVAR is enhanced by the use of devices that maintain the patency of targeted arteries namely the iliac branch device (IBD) With this study we aimed to evaluate the association between the use of Jotec E-ventus during EVAR with IBD and prognosis in patients with aorto-iliac aneurysms. METHODS: This is a retrospective, multicentric study enrolling patients referred to our Vascular Surgery Units from January 2015 to January 2020. All patients underwent EVAR with IBD using Jotec E-ventus as bridging stent. Primary endpoint was the development of types I and III endoleaks. Secondary endpoint was the onset of device occlusion with loss of vascular patency. RESULTS: We studied 32 patients (mean age 71.7±4.5y). Of these, 25 patients were treated with standard EVAR procedure whereas 7 were treated with isolated IBD due to extension of disease involving iliac bifurcation. Median follow-up lasted 15[IQR11-27] months. During follow-up, incidence rates for endoleaks and occlusion were 3.98(95%CI 0.48-14.41) and 1.99(95%CI 0.05-11.12) per 100 pts/year. CONCLUSIONS: Jotec E-ventus during EVAR is associated with a low rate of severe complications in a small cohort of patients with aorto-iliac aneurysms.

A cross-sectional study evaluating hospitalization rates for chronic limb-threatening ischemia during the COVID-19 outbreak in Campania, Italy.

The expansion of coronavirus disease 2019 (COVID-19) prompted measures of disease containment by the Italian government with a national lockdown on March 9, 2020. The purpose of this study is to evaluate the rate of hospitalization and mode of in-hospital treatment of patients with chronic limb-threatening ischemia (CLTI) before and during lockdown in the Campania region of Italy. The study population includes all patients with CLTI hospitalized in Campania over a 10-week period: 5 weeks before and 5 weeks during lockdown (n = 453). Patients were treated medically and/or underwent urgent revascularization and/or major amputation of the lower extremities. Mean age was 69.2 ± 10.6 years and 27.6% of the patients were women. During hospitalization, 21.9% of patients were treated medically, 78.1% underwent revascularization, and 17.4% required amputations. In the weeks during the lockdown, a reduced rate of hospitalization for CLTI was observed compared with the weeks before lockdown (25 vs 74/100,000 inhabitants/year; incidence rate ratio: 0.34, 95% CI 0.32-0.37). This effect persisted to the end of the study period. An increased amputation rate in the weeks during lockdown was observed (29.3% vs 13.4%; p < 0.001). This study reports a reduced rate of CLTI-related hospitalization and an increased in-hospital amputation rate during lockdown in Campania. Ensuring appropriate treatment for patients with CLTI should be prioritized, even during disease containment measures due to the COVID-19 pandemic or other similar conditions.

A multicenter "real-world" study of the valiant NAVION stent graft.

BACKGROUND: The aim of the present study was to evaluate early results of thoracic endovascular aortic repair (TEVAR) using the Valiant Navion™ stent graft in a "real-world" scenario. METHODS: All patients who underwent TEVAR with the Valiant Navion™ endograft between November 2018 and November 2019 were included in this retrospective multicenter study (six European centers). The primary endpoints were technical success, incidence of major adverse events (MAEs), access failure, deployment failure, deployment accuracy, and rate of intraoperative endoleaks (ELs). RESULTS: One hundred-sixteen patients with varying thoracic aortic diseases were included. Eighteen patients (15.5%) were treated for an off-label condition. The technical success rate was 100%, without any access or deployment failures. The proximal and distal deployment accuracy rates were 99.1% and 97.4%, respectively. There were no intraoperative MAEs, including death. Two (1.7%) type Ib ELs were detected at the first postoperative CTA, all of which were in off-label procedures and related to the short length of the sealing neck. No type III ELs were detected. The median hospitalization time was 8 days (IQR 4-12), including a median intensive care unit stay of 1 day (IQR 1-2). The in-hospital mortality rate was 4.3%. At a median follow-up time of 98 days (IQR 39-187), there were no aortic-related mortalities or new onset of endoleaks. CONCLUSION: Our initial experience with the Valiant Navion™ endograft in a wide variety of aortic diseases showed safe early outcomes, especially for on-label procedures.