Single centre mid-term experience with E-liac branched device from Artivion®.

INTRODUCTION: The use of iliac branch device (IBD) is increasing due to the less invasive character and accumulated experience of physicians in this endovascular technique. Clinical data regarding the E-liac stent graft from Artivion®, however, are scarce. This study shows the mid-term outcomes of the E-liac stent graft from a large single centre. METHODS: Patients treated with IBD for (aorto-)iliac aneurysms between September 2015 and December 2022 with follow-up in our centre were included. (Post)operative (technical success, reintervention, 30-day mortality) and mid-term outcomes (endoleak, reintervention, hypogastric patency, mortality) were analysed. RESULTS: Sixty-three patients (60 male, median age 70 years (IQR 66-;76)) were treated with 82 E-liac stent grafts for aorto-iliac aneurysms with a median follow-up of 38 months (IQR 22-51). The technical success rate was 95%. 97.6% of the interal iliac arteries remained patent during follow-up. No 30-day mortality was encountered. During follow-up one patient had an endoleak type 1b of both hypogastric arteries, however the patient refused additional interventions. One other patient had a type 2 endoleak with contained rupture. Paliative treatment was chosen because of the patient's severe comorbidities. One (1.6%) IBD-related reintervention was performed with relining of the stent graft. Secondary patency of the interal iliac artery was 95.1% and the mortality was 25.4% during follow-up. CONCLUSIONS: This study shows high technical success rates for the E-liac stent graft, with corresponding good mid-term outcomes. The E-liac stent graft is a feasible, safe and effective stent graft in the treatment of aorto-iliac aneurysms.

Single-Center Experience With Inner-Branched Endograft for the Treatment of Pararenal Abdominal Aortic Aneurysms.

PURPOSE: To report a single-center result of patients with pararenal aneurysms treated with inner-branched endograft. MATERIALS AND METHODS: This retrospective study analyzed prospectively collected data of patients treated with elective inner-branched endovascular aneurysm repair (iBEVAR) using an Artivion® E-xtra custom-made endograft. Primary endpoints were clinical and technical success after iBEVAR. Secondary endpoints were overall survival, target vessel patency during follow-up, aneurysm-related mortality, and freedom from reintervention. RESULTS: Over a 56-month period, a total of 23 patients (19 men; 72.3±7.2 years) were treated with iBEVAR with a mean follow-up of 15 months. Technical success was achieved in 96% of procedures, incorporating 87 inner branches. Two (8.3%) intraoperative complications (target vessel dissection) were reported, without additional reinterventions needed. Two (8.3%) patients died within 30 days after initial procedure. One due to respiratory failure and the other from an ischemic stroke. During follow-up, 3 patients (13%) required reintervention, either to repair a type I or type III endoleak (n=2) or to place an iliac-branched device, that did not succeed during the initial iBEVAR procedure (n=1). Primary target vessel patency and freedom from reintervention during follow-up was, respectively, 98.9% and 87%. We revealed no aneurysm-related mortality. Overall survival was 78.3%. CONCLUSION: The present study confirms previous findings that iBEVAR on the Artivion® E-xtra design platform is an effective and safe procedure achieving high technical success rate in the treatment of pararenal abdominal aortic aneurysms. CLINICAL IMPACT: Inner branched stent-graft configuration combines the benefits of FEVAR and outer-branched stent-graft technology. Implementation of inner branches in stent-grafts is gradually becoming more widespread for the treatment of aneurysms. This report supports the safe and high technical success rate of inner branched stent-grafts in treatment of pararenal abdominal aortic aneurysms.

Outcomes of Omniflow® II prosthesis used for revascularization in the femoral tract both in infected and non-infected setting.

BACKGROUND: Evidence regarding the outcomes of Omniflow® II prosthesis in peripheral arterial revascularization at different anatomical sites and for different indications is scarce. Therefore, the aim of this study was to evaluate the outcomes of the Omniflow® II used at various positions within the femoral tract both in infected and non-infected setting. METHODS: Patients who underwent reconstructive lower leg vascular surgery with implantation of an Omniflow® II from 2014 until 2021 at five medical centers were retrospectively included (N.=142). Patients were subdivided into the following categories: femoro-femoral crossover (N.=19), femoral interposition (N.=18), femoro-popliteal (above-the-knee [N.=25; AK] or below-the-knee [N.=47; BK]), and femoro-crural bypass grafts (N.=33). Primary outcome was primary patency and secondary outcomes included primary assisted patency, secondary patency, major amputation, vascular graft infection, and mortality. Outcomes were compared according to different subgroups and the surgical setting (infected versus non-infected). RESULTS: The median follow-up was 35.0 (17.5-54.3) months. Three years primary patency of 58% was observed for femoro-femoral crossover bypass, 75% for femoral interposition graft, 44% for femoro-popliteal above-the-knee bypass, 42% for femoro-popliteal below-the-knee bypass, and 27% in the femoro-crural position (P=0.006). Freedom from major amputation at three years were 84% for femoro-femoral crossover bypass, 88% for femoral interposition bypass, 90% for femoro-popliteal AK bypass, 83% for femoro-popliteal BK bypass, and 50% for femoro-crural bypass (P<0.001). CONCLUSIONS: This study demonstrates the safety and feasibility of the use of Omniflow® II for femoro-femoral crossover-, femoral interposition-, and femoro-popliteal (AK and BK) bypass. Omniflow® II seems to be less suitable for femoro-crural bypass with a significantly lower patency compared to other positions.

Use of Omniflow® II Biosynthetic Graft for the Treatment of Vascular Graft and Endograft Infections.

BACKGROUND: Vascular graft/endograft infection is a rare but life-threatening complication of cardiovascular surgery and remains a surgical challenge. Several different graft materials are available for the treatment of vascular graft/endograft infection, each having its own advantages and disadvantages. Biosynthetic vascular grafts have shown low reinfection rates and could be a potential second best after autologous veins in the treatment of vascular graft/endograft infection. Therefore, the aim of our study was to evaluate the efficacy and morbidity of Omniflow® II for the treatment of vascular graft/endograft infection. METHODS: A multicenter retrospective cohort study was performed to evaluate the use of Omniflow® II in the abdominal and peripheral region to treat vascular graft/endograft infection between January 2014 and December 2021. Primary outcome was recurrent vascular graft infection. Secondary outcomes included primary patency, primary assisted patency, secondary patency, all-cause mortality, and major amputation. RESULTS: Fifty-two patients were included with a median follow-up duration of 26.5 (10.8-54.8) months. Nine (17%) grafts were implanted in intracavitary position and 43 (83%) in peripheral position. Most grafts were used as femoral interposition (n = 12, 23%), femoro-femoral crossover (n = 10, 19%), femoro-popliteal (n = 8, 15%), and aorto-bifemoral (n = 8, 15%) graft. Fifteen (29%) grafts were implanted extra-anatomically and 37 (71%) in situ. Eight patients (15%) presented with reinfection during follow-up, most of these patients received an aorto-bifemoral graft (n = 3, 38%). Intracavitary vascular grafting had a 33% (n = 3) reinfection rate and peripheral grafting 12% (n = 5; P = 0.025). The estimated primary patencies at 1, 2, and 3 years were 75%, 72%, and 72% for peripherally located grafts and 58% (at all timepoints) for intracavitary grafts (P = 0.815). Secondary patencies at 1, 2, and 3 years were 77% (at all timepoints) for peripherally located prostheses and 75% (at all timepoints) for intracavitary prostheses (P = 0.731). A significantly higher mortality during follow-up was observed in patients who received an intracavitary graft compared to patients with a peripheral graft (P = 0.003). CONCLUSIONS: This study highlights the efficacy and safety of the Omniflow® II biosynthetic prosthesis for the treatment of vascular graft/endograft infection, in absence of suitable venous material, with acceptable reinfection, patency, and freedom of amputation prevalences, especially in replacing peripheral vascular graft/endograft infection. However, a control group with either venous reconstruction or another alternative graft is needed to make firmer conclusions.

Treatment of Aortoiliac Aneurysms: Compatibility of the E-liac Stent Graft (Artivion®, Iliac Branch Device) with Endurant II or IIs (Medtronic®, EVAR).

PURPOSE: Iliac branch devices (IBD) are widely used to treat aortoiliac aneurysms with an unfit distal landing zone for standard endovascular aneurysm repair (EVAR). The aim of this retrospective study was to examine the treatment of aortoiliac aneurysms with the combination of the Endurant II(s) stent graft system (Medtronic®) and the E-liac stent graft (Artivion®). MATERIALS AND METHODS: Data of all patients who underwent an EVAR combined with unilateral or bilateral IBD between January 2015 and January 2020 were analyzed. Primary outcomes were technical success at implantation (successful EVAR with IBD extension placement and patency of the grafts without type 1 or type 3 endoleak), and type 1b/3 endoleak, hypogastric artery patency and IBD-related reinterventions during follow-up. Secondary outcomes were all type 1 endoleak, all reinterventions, rupture, and mortality during follow-up. RESULTS: A total of 38 patients were treated with a combination of EVAR with IBD. Technical success was 94.7% (n = 36/38). The 30-day survival was 100%. Median follow-up time was 31 months (range 8-56). During follow-up, no patients developed type 1b or type 3 endoleak and all hypogastric arteries at the side of IBD remained patent. The overall reintervention rate at 12 months follow-up was 5.3% (n = 2/38) and the IBD-related reintervention rate was 2.6% (n = 1/38). CONCLUSION: The combination of the Endurant II(s) and the E-liac stent graft system is an effective and safe procedure for patients with an aortoiliac aneurysm. We confirm the high hypogastric artery patency rate using IBD. Furthermore, these devices have a high technical success rate even when it is combined with an Endurant II(s) EVAR main body.

Long-Term Outcome for Covered Endovascular Reconstruction of Aortic Bifurcation for Aortoiliac Disease: A Single-Center Experience.

PURPOSE: The gold standard for the treatment of complex (TASC II C and D) atherosclerotic aortoiliac lesions is still open surgical repair. Endovascular techniques have a lower mortality and morbidity rate but this comes at the cost of worse patency rates when compared with open repair. Improved short- and mid-term results have been reported using the covered endovascular reconstruction of aortic bifurcation (CERAB) technique. The aim of this study was to report our initial experience with the CERAB technique and report long-term patency rates. MATERIALS AND METHODS: All patients treated with the CERAB technique between 2012 and 2018 were prospectively registered in an institutional database and included in this study. Patient demographics, characteristics, symptoms, procedural, and follow-up details were collected and analyzed retrospectively. Perioperative complications and reinterventions were also identified. The Kaplan-Meier survival method was used to assess cumulative rates of patency. RESULTS: A total of 44 patients were treated with the CERAB technique and included in this study. The majority of the treated aortoiliac occlusions were classified as complex: TASC II C (n=7; 15.9%) or TASC II D (n=25; 56.8%). Primary patency rate at 60 months was 83.3%, assisted primary patency was 90.9% and secondary patency 95%. No significant differences were found in patency rates comparing noncomplex (TASC II A and B) and complex (TASC II C and D) aortoiliac lesions. Seven patients (15.9%) required at least one additional procedure to maintain either assisted primary patency or secondary patency during follow-up. The 30-day complication rate in this series was 20.5% (n=9), of which 55.6% (n=5) were minor complications. All major 30-day complications (n=4) occurred during or directly after the CERAB procedure. Thirty-day mortality was 0%. No limb occlusions occurred within 30 days of the procedure. CONCLUSION: Good long-term patency rates can be achieved with the CERAB technique to treat aortoiliac stenosis or occlusions while maintaining advantages associated with endovascular interventions. This remains true even when a CERAB is used to treat complex aortoiliac lesions. An endo-first approach to treat complex aortoiliac lesions seems viable.

Up to 10-year follow-up after EVAR with the Endurant stent graft system: a single-center experience.

BACKGROUND: Endovascular aneurysm repair (EVAR) has become the preferred treatment for infrarenal abdominal aortic aneurysms (AAA) over open surgical repair. The Endurant stent graft is widely used, and large registries report low rates of aneurysm-related mortality and reinterventions at midterm follow-up. Reports of long-term follow-up are limited. The aim of this study is to report our experiences and share our results, reintervention rate and mortality at long-term follow-up after using the Endurant stent graft. METHODS: All consecutive patients treated between 2009 and 2013 with the Medtronic Endurant I and II stent graft for an infrarenal AAA in an elective setting were included. Primary outcomes were overall and aneurysm-related survival and reintervention rates. RESULTS: One hundred sixty-five consecutive patients (median age 74; IQR: 68-79) with an aneurysm diameter of 62 mm (IQR: 58-70) and neck length of 29 mm (IQR: 21-40) were electively treated with the Endurant I or II stent graft. One hundred thirty-four patients (81.2%) were treated inside IFU (instructions for use) and 31 (18.8%) outside IFU. At median follow-up of 76 months (IQR: 50-97), 60 patients (36.4%) were deceased. Kaplan-Meier estimates at 10 years follow-up of overall survival and freedom from aneurysm-related mortality were respectively 48.5% (CI: 43.7-53.3%) and 97.3% (CI: 95.7-98.9%). Freedom from reintervention was 86.0% with an CI: 83.1-88.9% at 5 years follow-up and 75.6% with a CI: 70.2-81.0% at 10 years follow-up. A total of 25 (15.2%) patients had an EVAR-related reintervention; indications were endoleak (EL) type 1A (N.=11), EL type 1B (N.=3), EL type 2 (N.=6), EL type 3 (N.=1) and limb occlusion (N.=4). We found no significant differences in outcome between the inside and outside IFU groups. At 5 years follow-up 92.6% of patients had stable or decreased diameter, and 7.4% had an increased diameter. CONCLUSIONS: This large cohort single-center study demonstrates the effectiveness and safety of the Endurant stent graft system at long-term follow-up with low reintervention rates and aneurysm-related mortality.