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Summary: Together with colleagues from different disciplines, including cardiologists, interventional radiologists and vascular surgeons, committee members of the of the German Society of Angiology ( Deutsche Gesellschaft für Angiologie [ DGA]), developed a novel algorithm for the endovascular treatment of peripheral chronic total occlusive lesions (CTOs). Our aim is to improve patient and limb related outcomes, by increasing the success rate of endovascular procedures. This can be achieved by adherence to the proposed crossing algorithm, aiding the standardization of endovascular procedures. The following steps are proposed: (i) APPLY Duplex sonography and if required 3D techniques such as computed tomography or magnetic resonance angiography. This will help you to select the optimal access site. (ii) EVALUATE the CTO cap morphology and distal vessel refilling sites during diagnostic angiography, which are potential targets for a retrograde access. (iii) START with antegrade wiring strategies including guidewire (GW) and support catheter technology. Use GW escalation strategies to penetrate the proximal cap of the CTO, which may usually be fibrotic and calcified. (iv) STOP the antegrade attempt depending on patient specific parameters and the presence of retrograde options, as evaluated by pre-procedural imaging and during angiography. (v) In case of FAILURE, consider advanced bidirectional techniques and reentry devices. (vi) In case of SUCCESS, externalize the GW and treat the CTO. Manage the retrograde access at the end of the endovascular procedure. (vii) STOP the procedure if no progress can be obtained within 3 hours, in case of specific complications or when reaching maximum contrast administration based on individual patient’s renal function. Consider radiation exposure both for patients and operators. In this manuscript we systematically follow and explain each of the steps (i)–(vi) based on practical examples from our daily routine. We strongly believe that the integration of this algorithm in the daily practice of endovascular specialists, can improve vessel and patient specific outcomes.

The optimal treatment for patients with asymptomatic carotid artery stenosis is under debate. Since best medical treatment (BMT) has improved over time, the benefit of carotid endarterectomy (CEA) or carotid artery stenting (CAS) is unclear. Randomised data comparing the effect of CEA and CAS versus BMT alone are absent. We aimed to directly compare CEA plus BMT with CAS plus BMT and both with BMT only.SPACE-2 was a multicentre, randomised, controlled trial at 36 study centres in Austria, Germany, and Switzerland. We enrolled participants aged 50-85 years with asymptomatic carotid artery stenosis at the distal common carotid artery or the extracranial internal carotid artery of at least 70%, according to European Carotid Surgery Trial criteria. Initially designed as a three-arm trial including one group for BMT alone (with a randomised allocation ratio of 2·9:2·9:1), the SPACE-2 study design was amended (due to slow recruitment) to become two substudies with two arms each comparing CEA plus BMT with BMT alone (SPACE-2a) and CAS plus BMT with BMT alone (SPACE-2b); in each case in a 1:1 randomisation. Participants and clinicians were not masked to allocation. The primary efficacy endpoint was the cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years. The primary safety endpoint was any stroke or death from any cause within 30 days after CEA or CAS. The primary analysis was by intention-to treat, which included all randomly assigned patients in SPACE-2, SPACE-2a, and SPACE-2b, analysed using meta-analysis of individual patient data. We did two-step hierarchical testing to first show superiority of CEA and CAS to BMT alone then to assess non-inferiority of CAS to CEA. Originally, we planned to recruit 3640 patients; however, the study had to be stopped prematurely due to insufficient recruitment. This report presents the primary analysis at 5-year follow-up. This trial is registered with ISRCTN, number ISRCTN78592017.513 patients across SPACE-2, SPACE-2a, and SPACE-2b were recruited and surveyed between July 9, 2009, and Dec 12, 2019, of whom 203 (40%) were allocated to CEA plus BMT, 197 (38%) to CAS plus BMT, and 113 (22%) to BMT alone. Median follow-up was 59·9 months (IQR 46·6-60·0). The cumulative incidence of any stroke or death from any cause within 30 days or any ipsilateral ischaemic stroke within 5 years (primary efficacy endpoint) was 2·5% (95% CI 1·0-5·8) with CEA plus BMT, 4·4% (2·2-8·6) with CAS plus BMT, and 3·1% (1·0-9·4) with BMT alone. Cox proportional-hazard testing showed no difference in risk for the primary efficacy endpoint for CEA plus BMT versus BMT alone (hazard ratio [HR] 0·93, 95% CI 0·22-3·91; p=0·93) or for CAS plus BMT versus BMT alone (1·55, 0·41-5·85; p=0·52). Superiority of CEA or CAS to BMT was not shown, therefore non-inferiority testing was not done. In both the CEA group and the CAS group, five strokes and no deaths occurred in the 30-day period after the procedure. During the 5-year follow-up period, three ipsilateral strokes occurred in both the CAS plus BMT and BMT alone group, with none in the CEA plus BMT group.CEA plus BMT or CAS plus BMT were not found to be superior to BMT alone regarding risk of any stroke or death within 30 days or ipsilateral stroke during the 5-year observation period. Because of the small sample size, results should be interpreted with caution.German Federal Ministry of Education and Research (BMBF) and German Research Foundation (DFG).

OBJECTIVES To assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith® t-Branch® Thoracoabdominal Endovascular Graft (William Cook Europe, Bjaeverskov, Denmark). METHODS This post-market, observational study was conducted at 3 European sites with ambispective enrollment from 2012-2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal arteries (RRA). Follow-up was through 2 years per sites' standard of care. Procedural and 1-year results were reported previously. RESULTS Eighty patients (mean age 71.0±7.4 years, 70.0% men) were enrolled; 6 patients had symptomatic TAAAs and 15 patients had contained ruptures. Technical success was achieved in 98.8% (79/80) of patients. Median follow-up was 22.2 months (IQR: 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including 2 aortic ruptures (1 study aneurysm and 1 non-study aneurysm) and 6 deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, 4 patients had 5 imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency were 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months. A total of 298 vessels were targeted of which 12 were occluded over the study period. CONCLUSIONS Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms.

Introduction: Antegrade wire-catheter crossing remains the primary approach for femoropopliteal interventions. Nonetheless, data reporting on crossing failure are limited. Aim of this study is to identify risk factors for antegrade crossing failure in patients with femoropopliteal chronic total occlusions (CTOs). Methods: This is a single-center, retrospective analysis. Patients with femoropopliteal CTOs treated between May 2018 and February 2020 were included into this study. Primary endpoint of this analysis was primary crossing success defined as successful antegrade crossing without the use of retrograde access, crossing or re-entry devices. The assisted crossing success was additionally analyzed. A logistic regression analysis identified risk factors for failed primary antegrade crossing. Results: Data from 300 patients were analyzed. The majority (n=183, 61%) presented with lifestyle limiting claudication. The mean lesion length was 180 mm [interquartile range (IQR) 100–260 mm], whereas the median CTO length was 100 mm (IQR=50–210 mm). A chronic total occlusion crossing approach based on plaque morphology (CTOP) type I configuration was observed in 9% (n=26) of the lesions, type II in 61% (n=183), type III in 8% (n=25), and type IV in 66 CTOs (n= 66, 22%). Severe calcification based on the Peripheral Arterial Calcium Scoring Scale (PACSS), Peripheral Academic Research Consortium (PARC), and 360° grading systems was identified in 17%, 24%, and 28% of the lesions, respectively. A contralateral femoral access was used in 278 cases (93%). The primary crossing success amounted to 70% (n=210). The use of a re-entry device in 28 patients (9%) or of a combined antegrade–retrograde approach in 11% (n=34) of the cases increased the assisted crossing success to 89% (n=267). The presence of calcification (odds ratio [OR]=4.2, 95% CI=1.7–10.2) or of circumferential calcium (OR=2.5, 95% CI=1.3–4.9), a CTOP class ΙΙΙ or ΙV (OR=1.9, 95% CI=1.4–2.6), a proximal superficial femoral artery (SFA) occlusion (OR=3.5, 95% CI=1.7–7.4) and a CTO at P3 (OR=4.1, 95% CI=1.5–10.8) were associated with an increased risk for antegrade crossing failure. Conclusions: In this study, chronic total occlusions (CTO) morphology, calcification burden, and lesion’s location were identified as independent risk factors for failed antegrade crossing. Nonetheless, the use of alternative crossing strategies significantly increased the overall crossing success.

Introduction Peri-procedural embolic events are the Achilles’ heel of carotid stenting. To overcome this complication, transcervical access to the carotid artery was introduced. In this study we describe our “our life” experience with the transcervical approach in a community hospital. Material and Methods All carotid stent procedures between January 2010 and December 2020 were included in this retrospective analysis. The transcervical approach was compared to the transfemoral approach. In both procedures open-cell, closed-cell design and hybrid stents were used. In-hospital stroke was the primary outcome measure. Results A total of 340 procedures were performed, in 184 patients the transfemoral approach was used and in 156 patients the transcervical approach was used. In 12 patients (3.5%) an in-hospital stroke was diagnosed, 4 in the transfemoral group (2.2%) and 8 in the transcervical group (5.1%) (P = 0.14). In the multivariate analyses a symptomatic lesion was associated with in-hospital stroke. Neither type of access nor cell design was associated with increased risk of in-hospital stroke. Conclusions In contrast to previous studies, we could not confirm the advantages of the transcervical approach. However, conclusions should be carefully drawn, since this study is retrospective and was performed with multiple surgeon and different kind of stents.

Purpose: We hypothesized that extending the proximal landing zone with the chimney technique could be beneficial in patients with a hyperangulated proximal aortic neck, defined as more > 60 degrees. Material and Methods: We retrospectively analyzed the outcome of prospectively collected data of patients treated by endovascular aneurysm repair (EVAR) for infrarenal aortic aneurysm with a hyperangulated proximal aortic neck. In all, 104 out of 130 patients were treated without (Group A) and 24 with the chimney endovascular aortic repair (ChEVAR, Group B). Primary outcome was technical and clinical success according to the reporting standards of the Society of Vascular Surgery. Results: The use of the chimney technique was associated with a significantly longer operation duration (167 vs. 93 min, p < .001), longer fluoroscopy time (44 vs.30 min, p = < .001), and larger amount of contrast medium used (149 vs. 127 ml, p = .03) but did not significantly improve technical (79.2% vs. 87.7%) and clinical success (54.2% vs. 68.9%). Aneurysm-related mortality was higher in group B (8.3% vs. = 0%, p < .001). Type IA endoleak was high in both groups at completion angiography (11.3% in Group A vs. 12.5% in Group B) and at follow-up (10.4% in Group A vs. 4.5% in Group B) without significant difference between the groups. Conclusions: Our data did not show a benefit of the primary use of the chimney technique in patients with a hyperangulated and short neck, although more studies are required to support this conclusion. Other strategies or new technologies are required for improving EVAR results in aneurysm patients with severe angulated proximal and short neck.

Summary: Background: Ruptured juxtarenal aortic aneurysms (RJAAA) represent a special challenge in clinical practice, but the evidence to guide therapeutic decision-making is scarce. The aim of this study was to present two different approaches, open surgical (OAR) and chimney endovascular repair (CHEVAR), for treating patients with RJAAA. Patients and methods: This retrospective two-center study included all patients per center undergoing OAR or CHEVAR for RJAAA between February 2008 and January 2020. Juxtarenal aortic aneurysms were defined as having an infrarenal neck of 2–5 mm, measured after three-dimensional reconstruction of the computed tomography angiography scan. Results: 12 OAR patients (10 male, median age 73 years [58–90 years]) and 6 CHEVAR patients (all male, median age 74 years [59–83 years]) were included. In the OAR group, the proximal aortic clamping was suprarenal in 7 and interrenal in 5 patients. Cold renal perfusion was used in 4 patients, in 2 with suprarenal aortic clamping and in 2 with interrenal aortic clamping. 3 CHEVAR patients received a single renal chimney, the other 3 received double renal chimneys. Technical success was 12/12 in the OAR group 5/6 in the CHEVAR group. In-hospital mortality and 30-day mortality were 3/12 after OAR and 0/6 after CHEVAR. 2 OAR patients required transient dialysis. Median in-hospital stay was 14 (10–63) and 8 (6–21) days and median follow-up (FU) was 20 (3–37) and 30 (7–101) months, respectively. No further deaths occurred during FU. One OAR patient and 4 CHEVAR patients required aortic reinterventions. Conclusions: RJAAAs are rare. Both OAR and CHEVAR can represent adequate treatments for RJAAAs. OAR is the traditional approach, but CHEVAR has - in a high-volume center - promising early results with nonetheless a need for continuous FU to prevent reinterventions. Defining the studied aortic pathology precisely is essential for future research in order to draw valid conclusions.

Objectives The objective is to assess the performance of the Eluvia polymer coated drug eluting stent (DES) compared to a bare metal stent (BMS) platform in patients with femoropopliteal arterial disease. Methods This is a retrospective, single-center analysis. Patients treated with the Eluvia DES (group Eluvia) or the EverFlex BMS (group BMS) for femoropopliteal disease between January 2013 and December 2019 were included. Primary measure outcome of this analysis was the overall mortality. The PTX specific mortality, the primary patency, the amputation free survival (AFS), and the target lesion revascularization (TLR) rates were additionally evaluated. Results A total of 124 patients were treated by BMS deployment, while the Eluvia platform was preferred in 75 subjects. In both groups the majority presented with lifestyle limiting claudication (BMS: 84% vs Eluvia: 73%, p = 0.73). Chronic total occlusions were more frequent in patients treated by BMS (BMS: 71% vs Eluvia: 84%, p = 0.027), whereas the calcification burden (BMS: 81% vs Eluvia: 76%, p = 0.43) and the median lesion length (in mm, IQR) (BMS: 160 (100 to 240) vs Eluvia: 140 (80 to 229), p = 0.17) were comparable. At 24 months, the overall survival (BMS: 93% vs Eluvia: 89%, hazard ratio (HR): 1.20, 95% confidence interval (CI): 0.55 to 2.64, p = 0.64) and the PTX specific survival (BMS: 95% vs Eluvia: 95%, HR: 1.28, 95% CI: 0.41 to 4.02, p = 0.67) did not differ significantly between the two platforms. No significant difference was observed regarding the 24 months primary patency rate (BMS: 66% vs Eluvia: 78%, HR: 0.65, 95% CI: 0.37 to 1.15, p = 0.18), the freedom from TLR (BMS: 83% vs Eluvia: 89%, HR: 0.81, 95% CI: 0.39 to 1.68, p = 0.572), and the AFS (BMS: 93 vs Eluvia: 89%, HR: 1.20, 95% CI: 0.55 to 2.64). The Cox regression analysis revealed a higher mortality risk among patients with chronic limb-threatening ischemia (CLTI) (HR: 3.14, 95% CI: 1.61 to 6.14, p = 0.008), chronic obstructive pulmonary disease (COPD) (HR: 4.65, 95% CI: 2.14 to 10.09, p = 0.001), in octagenerians (HR: 4.40, 95% CI: 1.92 to 10.44, p = 0.005), and in patients not on statins at baseline (HR: 2.44, 95% CI: 1.19 to 4.99, p=0.014). Conclusions In this cohort, the use of the Eluvia DES did not increase the risk for mortality compared to BMS deployment. CLTI, COPD, advanced age, and the lack of statin therapy at baseline were associated with a higher risk for death.

Purpose To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy. Materials and Methods A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications. Results The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears. Conclusion Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.

Objective Until today, no dedicated bridging stent graft (BSG) has been available for use in fenestrated and branched endovascular aneurysm repair (F/BEVAR). The purpose of this study was to evaluate the clinical performance of the well-known Advanta/iCast V12 (Getinge Maquet, Rastatt, Germany) and the new Viabahn VBX (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent graft in F/BEVAR. Methods Retrospective analysis of prospectively collected data was performed. Inclusion criteria were treatment with fenestrated or branched endografts for complex aortic diseases, implantation of at least one VBX stent graft as a BSG in one of the target vessels, and clinical or radiologic follow-up of 6 months. The primary end point of the study was technical success of all BSGs, defined as placement of the BSG in the desired position with absence of endoleak on final angiography. Secondary end points were freedom from perioperative major adverse events and freedom from reinterventions and mortality at 6 months. Procedural and postoperative data were analyzed. Results Between December 2017 and July 2018, there were 50 patients (40 male; mean age, 71 years) included. A total of 145 VBX stent grafts were implanted, followed by 57 Advanta V12, 29 Viabahn, and 28 bare-metal stents. There were 126 branches (celiac trunk, 27; superior mesenteric artery, 25; renal arteries, 74) sealed exclusively with VBX. Technical success rate was 98.6%. There were six device-related reinterventions due to type IC endoleaks (n = 4), target vessel stenosis distal to the BSG, and stent graft occlusion in a left renal artery in one case. The perioperative and aneurysm-related mortality was 0%; the 6-month all-cause mortality was 2%. Conclusions The used BSGs demonstrated promising preliminary results in F/BEVAR. Further evaluation is mandatory to determine durability of the VBX.

Objectives Endovascular therapy using balloon expandable stents has become the treatment standard for most iliac atherosclerotic lesions. We aimed to assess the safety and performance of the Dynamic stainless-steel balloon-expanding stent system in this location. Methods BIODYNAMIC is a retrospective single center study including consecutive patients with iliac lesions treated with the Dynamic stent system. Not included were implantations inside an endograft. The primary endpoint was freedom from major adverse limb events (MALE) at 12 months, defined as index limb amputation or target lesion revascularization (TLR). Secondary endpoints were procedure success, ankle brachial index (ABI) and Rutherford class change, mortality and freedom from TLR after 12 months. Results Within two years, 182 patients with 234 lesions in the common iliac artery were enrolled. Rutherford class 5 and 6 were present in 11.5% of patients, average stent diameter was 8.0 ± 0.5 mm and stented length 40.0 ± 15.3 mm. The primary endpoint was reached in 96.2% (225/234) of the cases, with six TLR (2.6%) and three target limb amputations (1.3%). Procedure success was obtained in all but three patients (98.4%). In paired analysis, ABI improved by 0.25 ± 0.21 from baseline to 0.90 ± 0.16 post-procedure and Rutherford class improved by −1.75 ± 1.53. There were four non-device–related deaths (2.2%). Freedom from TLR was 97%, 95.3%, 94% and 92.7% at 24, 36, 48 and 60 months, respectively. Conclusion The Dynamic balloon-expandable stent system proved to be safe and effective in a population with common iliac artery lesions.

Purpose: To evaluate if the elderly could benefit from the implantation of iliac branch devices (IBDs) to preserve the patency of the internal iliac artery (IIA) in aneurysms involving the iliac bifurcation. Materials and Methods: From January 2005 to April 2017, 804 patients enrolled in the pELVIS registry underwent endovascular aneurysm repair with 910 IBDs due to aneurysmal involvement of the iliac bifurcation. Among the 804 patients, 157 (19.5%) were octogenarians (mean age 82.9±2.5 years; 157 men) with 171 target IIAs for preservation. Outcomes at 30 days included technical success, death, conversion to open surgery, and major complications. Outcomes evaluated in follow-up were patency of the IBD and target vessels, type I and type III endoleaks, aneurysm-related reinterventions, aneurysm-related death, and overall patient survival. Kaplan-Meier analyses were employed to evaluate the late outcome measures; the estimates are presented with the 95% confidence interval (CI). Results: Technical success was 99.4% with no intraoperative conversions or deaths (1 bridging stent could not be implanted, and the IIA was sacrificed). Perioperative mortality was 1.9%. The overall perioperative aneurysm-related complication rate was 8.9% (14/157), with an early reintervention rate of 5.1% (8/157). Median postoperative radiological and clinical follow-up were 21.8 months (range 1–127) and 29.3 months (range 1–127), respectively. Estimated rates of freedom from occlusion of the IBD, the IIA, and the external iliac artery at 60 months were 97.7% (95% CI 96.1% to 99.3%), 97.3% (95% CI 95.7% to 98.9%), and 98.6% (95% CI 97% to 99.9%), respectively. Estimated rates of freedom from type I and type III endoleaks and device migration at 60 months were 90.9% (95% CI 87% to 94.3%), 98.7% (95% CI 97.5% to 99.8%), and 98% (95% CI 96.4% to 99.6%), respectively. Freedom from all cause reintervention at 60 months was 87.4% (95% CI 82.6% to 92.2%). The estimated overall survival rate at 60 months was 59% (95% CI 52.4% to 65.6%). Conclusion: IBD implantation in octogenarians provided acceptable perioperative mortality and morbidity rates, with satisfying long-term freedom from IBD-related complications and should be considered a feasible repair option for selected elderly patients affected by aneurysms involving the iliac bifurcation.

Purpose: To report the outcomes of bypass grafting (BG) vs endovascular therapy (EVT) in patients with non-dialysis-dependent chronic kidney disease (CKD) and chronic limb-threatening ischemia (CLTI). Materials and Methods: The CRITISCH Registry is a prospective, national, interdisciplinary, multicenter registry evaluating the current practice of all available treatment options in 1200 consecutive CLTI patients. For the purposes of this analysis, only the 337 patients with non-dialysis-dependent CKD treated by either BG (n=86; median 78 years, 48 men) or EVT (n=251; median age 80 years, 135 men) were analyzed. The primary composite outcome was amputation-free survival (AFS); secondary outcomes were overall survival (OS) and amputation-free time (AFT). All outcomes were evaluated in Cox proportional hazards models; the results are reported as the hazard ratio (HR) and 95% confidence interval (CI). Results: The Cox regression analysis revealed a significantly greater hazard of amputation or death after BG (HR 1.78, 95% CI 1.05 to 3.03, p=0.028). The models for AFT and overall survival also suggested a higher hazard for BG, but the differences were not significant (AFT: HR 1.66, 95% CI 0.78 to 3.53, p=0.188; OS: HR 1.41, 95% CI 0.80 to 2.47, p=0.348). The absence of runoff vessels (HR 1.73, 95% CI 1.15 to 2.60, p=0.008) was associated with a decreased AFS. The likelihood of amputation was higher in male patients (HR 2.21, 95% CI 1.10 to 4.45, p=0.027) and was associated with a lack of runoff vessels (HR 1.95, 95% CI 0.96 to 3.95, p=0.065) and myocardial infarction (HR 3.74, 95% CI 1.23 to 11.35, p=0.020). Death was more likely in patients without runoff vessels (HR 1.76, 95% CI 1.11 to 2.80, p=0.016) and those with a higher risk score (HR 1.73, 95% CI 1.03 to 2.91, p=0.038). Conclusion: This analysis suggested that BG was associated with poorer AFS than EVT in patients with non-dialysis-dependent CKD and CLTI. Male sex, previous myocardial infarction, and the absence of runoff vessels were additionally identified as predictors of poorer outcomes.

Purpose: To report the 36-month outcomes from the prospective, multicenter, single-arm IN.PACT Global Study ( ClinicalTrials.gov identifier NCT01609296) evaluating the performance of the IN.PACT Admiral drug-coated balloon (DCB) in real-world patients with femoropopliteal occlusive disease. Materials and Methods: The IN.PACT Global Study was conducted at 64 international sites and enrolled 1535 patients with complex lesions, which included bilateral disease, multiple lesions, de novo in-stent restenosis, long lesions, and chronic total occlusions. The predefined full clinical cohort included 1406 patients (mean age 68.6 years; 67.8% men) with claudication or rest pain treated with the study DCB. Mean lesion length was 12.09±9.54 cm; 18.0% had in-stent restenosis, 35.5% were totally occluded, and 68.7% were calcified. Freedom from clinically-driven target lesion revascularization (CD-TLR) was evaluated through 36 months. The safety composite endpoint was freedom from device- and procedure-related death through 30 days and freedom from major target limb amputation and clinically-driven target vessel revascularization within 36 months. All safety and revascularization events were reviewed by an independent clinical events committee. Results: The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was 76.9%. The composite safety endpoint was achieved in 75.6% of patients. The 36-month all-cause mortality rate was 11.6%, and the major target limb amputation rate was 1.0%. The Kaplan-Meier estimate of freedom from CD-TLR through 36 months was significantly lower in patients with chronic limb-threatening ischemia (CLTI) compared with claudicants (67.6% vs 78.0%; p=0.003). Lesions affecting both the superficial femoral artery (SFA) and popliteal artery had lower Kaplan-Meier freedom from CD-TLR through 36 months (69.2%) than either isolated SFA (79.7%) or popliteal artery lesions (76.5%; log- rank p

Objective Endovascular aneurysm repair has gained field over open surgery for the treatment of abdominal aortic aneurysm. However, type Ia endoleak represents a common complication especially in hostile neck anatomy that is recently faced using endoanchors. We conducted a systematic review and meta-analysis to collect and analyse all the available comparative evidence on the outcomes of the endosuture aneurysm repair in patients with or without hostile neck in standard endovascular aneurysm repair. Methods The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the prospective and retrospective studies reporting primary use of the Heli-FX EndoAnchor implants were considered eligible for inclusion in this study. The main study outcomes (technical success of endoanchor implantation, incidence of type Ia endoleak, aortic stent graft migration and the percentage of patients who presented regression or expansion of aneurysm sac throughout the follow-up) were subsequently expressed as proportions and 95% confidence intervals. Results Eight studies with a total of 968 patients were included in a pooled analysis. The technical success of the primary endoanchor fixation was 97.12% (95%CI: 92.98–99.67). During a mean six months follow-up period, a pooled rate of 6.23% (95%CI: 0.83–15.25) of the patients developed a persistent type Ia endoleak despite the primary implantation. Migration of the main graft was reported in five studies, in which a 0.26% (95%CI = 0.00–1.54) of the patients required an additional proximal aortic cuff. Regression of the aneurysm sac was observed at 68.82% (95%CI: 51.02–84.21). An expansion of the aneurysm sac was found in 1.93% (95%CI: 0.91–3.24) of the participants. The overall survival rate was 93.43% (95%CI: 89.97–96.29) at a mean six months follow-up period. Conclusions Endosuture aneurysm repair with the Heli-FX EndoAnchor implants seems to be technically feasible and safe either for prevention or for repair of intraoperative type Ia endoleak. Despite the primary implants of endoanchors, few cases of persistent type Ia endoleak and migration are still conspicuous. Long-term follow up is needed to determinate the role of this therapeutic option in the treatment of aortic aneurysms.

Extrakranielle Aneurysmen der A. carotis sind sehr selten. Aufgrund des thrombembolischen Risikos sowie der Rupturgefahr besteht haufig die Indikation zur operativen Versorgung. Ziel dieser Arbeit ist es, eine Ubersicht uber die verschiedenen Ursachen und den damit verbunden Therapieoptionen des Karotisaneurysmas unter Berucksichtigung des aktuellen Wissensstands zu geben. Literaturrecherche in Medline (PubMed) mit den Schlusselwortern „extracranial carotid artery aneurysm“, „pseudoaneurysm of carotid artery“ fur Publikationen der letzten 25 Jahre. Die Atiologie des Karotisaneurysmas ist ein wichtiger Faktor fur die spatere Lokalisation und dessen Ausdehnung sowie fur die nachfolgende operative Therapie. Arteriosklerotische Wandveranderungen werden als hauptursachlich fur Aneurysmen der proximalen A. carotis interna gewertet, gefolgt von Postdissektionsaneurysmen und Pseudoaneurysmen nach Thrombendarteriektomie und Patchplastik der A. carotis. Symptomatische Aneurysmen stellen eine dringende Operationsindikation dar, wahrend symptomfreie Aneurysmen mit begleitender oraler Antikoagulation oder dualer Thrombozytenaggregation des Patienten zunachst duplexsonographisch kontrolliert werden konnen. Eine erganzende Bildgebung mittels CT- oder MR-Angiographie hilft bei der Eingriffsplanung. „Golden standard“ ist die offene chirurgische Resektion bei geringem intraoperativen Schlaganfallrisiko (0–2 %) und akzeptablem intraoperativen Nervenverletzungsrisiko (1–7 %) mit anschliesender Rekonstruktion mittels Venen- oder Kunststoffinterponat. Vor allem fur weit kranial gelegene Aneurysmen der A. carotis interna, multimorbide Patienten oder bei narbig verandertem Operationsgebiet ist die endovaskulare Therapie mittels Stenting oder Coil-Embolisation eine Alternative. Postoperativ empfiehlt sich eine lebenslange Thrombozytenaggregationshemmung und bei Stenting die duale Plattchenhemmung analog zur CAS. Das gewahlte Therapiekonzept des extrakraniellen Karotisaneurysmas bleibt eine Einzelfallentscheidung. Bevorzugt wird das Aneurysma reseziert und durch autologes Venenmaterial oder ein Kunststoffinterponat ersetzt. Bei schwierigen anatomischen Verhaltnissen, wie z. B. schadelbasisnahen Aneurysmen, kann eine endovaskulare Intervention, z. B. die Stentgraft-Versorgung oder die Coil-Embolisation als Alternative erwogen werden.

Purpose: To report the 12-month results of a multicenter, prospective, randomized controlled trial to determine if the ZILVER PTX paclitaxel-eluting stent was noninferior in terms of safety and efficacy compared with surgical bypass. Materials and Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs surgical bypass surgery using a prosthetic graft ( ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.4%) or the bypass treatment group (107, 48.6%). Most of the lesions were occlusions (208, 94.5%); the mean lesion length was 247.1±69.3 mm. The primary outcome measure was primary patency at 12 months, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex-derived peak systolic velocity ratio

Objective Recent guidelines recognize the role of chimney endovascular aneurysm repair (ChEVAR) in the treatment of complex aortic disorders. The optimal configuration and number of visceral vessels that can be incorporated is still controversial. We aim to review outcomes from a multi-institutional decade-long experience with ChEVAR. Methods Patients undergoing ChEVAR with multiple (≥2) chimney branches were selected from a prospectively maintained database at the two academic university hospitals. All patients were poorly suited for fenestrated or branched endograft repair (F/BEVAR) and deemed poor-risk for open surgery. Results Forty-nine multiple ChEVAR were performed in 44 men and 5 women, with complete outcome data at a mean follow-up of 18 months. Overall, 2 patients died during follow-up (4%) with no aneurysm-related mortality and two ruptures after ChEVAR (4.1%) due to a type Ib endoleak from iliac limb pullout and persistent gutter-flow, both repaired with endovascular means. No stroke or spinal cord ischemia was noted during the follow-up period. Reintervention was undertaken in eight patients (16.3%) with five reinterventions for persistent gutter-flow and four chimney graft-associated. Three-vessel ChEVAR was performed in 16 patients, with two-vessel ChEVAR in 33 patients for a total of 114 chimney branches (mean 2.3 chimneys per patient). There were 21 superior mesenteric artery (SMA), 45 right renal, 46 left renal artery (LRA), and two accessory LRA chimneys placed. Antegrade configuration of chimney branches was chosen in 43 patients (88%). There were no significant differences between three-vessel and two-vessel ChEVAR upon univariate analysis in aneurysm size (65.6 vs 60.5 mm; p = 0.059), iliac diameter (7.3 vs 7.1 mm; p = 0.85), or endograft oversizing (30 vs 32.5%; p = 0.43). Three-vessel ChEVAR was associated with a larger aneurysm neck diameter (28.4 vs 25.0 mm; p = 0.021), shorter native infrarenal neck (0.5 vs 3.37 mm; p = 0.002) as well as longer seal zone (36.33 vs 22.67 mm; p = 0.005) compared with two-vessel ChEVAR. At follow-up, there were no significant differences in gutter area between three-vessel and two-vessel ChEVAR (18.9 vs 15.7 mm3; p = 0.73) nor the rate of persistent gutter-flow (12.5 vs 9.1%; p = 0.71). Conclusion Reintervention to multiple chimney grafts and for persistent gutter-flow is higher compared to single chimneys and demands close surveillance. However, based upon this combined transantlantic experience, we believe multiple ChEVAR provides a reasonable and safe option for complex aortic aneurysm repair when open or custom endografts are not available or indicated based on their Instructions For use, even when triple chimney grafts are required. The optimal configuration for multiple ChEVAR still warrants further study, although theoretical preliminary advantages may exist for a combination of antegrade and retrograde chimneys.

Introduction: The combination of intravascular lithotripsy (IVL) and drug-coated balloon (DCB) angioplasty for calcified peripheral lesions is associated with promising short-term results. However, data regarding the 12 months performance of this treatment option is missing. This study reports on the outcomes of IVL and DCB angioplasty for calcified femoropopliteal disease. Methods: Patients treated with IVL and DCB for calcified femoropopliteal lesions between February 2017 and September 2020 were included into this study. The primary outcome measure of this analysis was primary patency. Secondary patency, freedom from target lesion revascularization (TLR) and overall mortality were additionally analyzed. Results: Fifty-five ( n = 55) patients and 71 lesions were analyzed. Most patients presented with long-term limb-threatening ischemia ( n = 31, 56%), 47% ( n = 26) were diabetics, and 66% ( n = 36) had long-term kidney disease. The median lesion length was 77 mm (interquartile range: 45-136), and 20% ( n = 14) of the lesions were chronic total occlusions (CTOs). Eccentric calcification was found in 23% of the vessels ( n = 16), and circumferential calcium (peripheral arterial calcium scoring system [PACSS] Class 3 and 4) was present in 78% ( n = 55) of the treated lesions. The technical success after IVL amounted to 87% ( n = 62) and the procedural success to 97% ( n = 69). A flow-limiting dissection was observed in 2 cases (3%). Both the rates of target lesion perforation and distal embolization were 1% ( n = 1). A bail-out scaffold was deployed in 5 lesions (7%). At 12 months the Kaplan-Meier estimate of primary patency was 81%, the freedom from TLR was 92% and the secondary patency 98%. The overall survival amounted to 89%, while the freedom from major amputation to 98%. The presence of eccentric disease, CTOs, or PACSS Class 4 did not increase the risk for loss of patency or TLR. Conclusions: In this challenging cohort of patients, the use of IVL and DCB for calcified femoropopliteal lesions was associated with promising 12 months outcomes and an excellent safety profile.

Purpose Chimney endovascular abdominal aortic aneurysm repair (CHEVAR) has predominantly been described as an alternative technique for the management of urgent presentations of degenerative pararenal aortic aneurysms (dPAAs). However, the role of CHEVAR in the treatment of asymptomatic patients remains unknown. The aim of current multinational study was to evaluate the outcomes of elective CHEVAR of dPAAs. Material and Methods Retrospective analysis of 267 consecutive dPAA patients treated with elective CHEVAR at 13 European and US centers from 2008 to 2014. Primary endpoints were 30 days and out of hospital CHEVAR-related mortality. Secondary endpoints included persistent type Ia endoleak or endotension, angiographically confirmed occlusion and/or high-grade chimney graft (CG) or involved splanchnic vessel stenosis identified at index procedure and/or during follow-up, as well as CHEVAR-related re-intervention. Results Mean follow-up time was 25.5±13.3 months. The 442 visceral vessels were involved and mean number of CGs per patient was 1.63±0.7. 436 targeted vessels were successfully cannulated. The aortic graft intentionally covered 6 renal arteries and immediate technical success was 98.6%. The 30 days mortality was 1.9% (n=5), while the in-hospital complication rate was 10.1% (n=27) including 3 strokes, 1 permanent dialysis, and 1 intestinal ischemia. No 30 day type Ia endoleaks were detected and 3.2% of CGs (n=14, including the intentionally covered) had evidence of occlusion and/or stenosis. The overall CHEVAR-related mortality was 2.2% (n=6). Freedom from primary and secondary type Ia endoleak/endotension rates at 3 years was 93.0% and 98.0%, respectively. Primary and secondary CG patency was 87.0% and 89.0%. Primary and secondary endovascular freedom from any endpoint at 3 years was 81.0% and 94.0% respectively. Conclusion Elective use of CHEVAR in the management of dPAAs seems to be durable. These results are comparable to published outcomes with other total endovascular strategies, which justifies an expanded role for CHEVAR in the treatment of asymptomatic patients presenting with dPAAs.

To report outcomes following endovascular revascularisation for severe aorto-iliac occlusive disease (AIOD) using covered (CS) or bare metal (BMS) stent(s).This was a retrospective cohort study including patients who underwent treatment with CS or BMS for AIOD between November 2012 and March 2020 in 12 European centres. Outcome measures included death, freedom from target lesion revascularisation (TLR), major amputation, and major adverse cardiac and cerebrovascular events (MACCE).Overall, 252 patients (53% males; mean age 65 ± 10 years) were included (102 with a bare metal and 150 with a covered aortic stent); 122 (48%) presented with chronic limb threatening ischaemia (CLTI). Severe arterial calcification was noted in65% of patients, 70% presented with Trans-Atlantic Societies Consensus (TASC) D lesions, 32% and 46% had aortic or iliac chronic total occlusion (CTO), respectively. Median follow up was 17 months (range 6 - 40; none lost to follow up). Median inpatient stay was two days (range two to four). During the first 30 days, two patients died (both with covered aortic stents, because of cardiovascular events), none required TLR, two (1%) patients had a major amputation (all presented with CLTI), and three (1%) had a MACCE. At 17 months, mortality (BMS 14% vs. CS 7%, hazard ratio [HR] 0.97, 95% confidence interval [CI] 0.42 - 2.26, p = .94, log rank test) and TLR (11% vs. 10%, HR 1.98, 95% CI 0.89 - 4.43, p = .095) did not differ statistically significantly between the two groups; only three patients had a major limb amputation during late follow up (all with a covered stent). In a multivariable model, the use of an aortic CS did not influence TLR. In a conditional Cox regression, however, the concomitant use of aortic and iliac CSs was associated with improved freedom from TLR.Endovascular reconstruction with aortic CSs or BMSs for severe AIOD showed comparable midterm performance. The use of both aortic and iliac CSs seems to be associated with reduced TLR.

Item does not contain fulltext OBJECTIVE: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. METHODS: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. RESULTS: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. CONCLUSIONS: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

Objectives: Intravascular lithotripsy (IVL) followed by drug-coated balloon (DCB) angioplasty might be a valuable alternative to surgery for calcified common femoral artery (CFA) atherosclerotic disease. Nonetheless, the 12 months performance of this treatment strategy remains unknown. This study reports on the 12 months outcomes of IVL with adjunctive DCB angioplasty for calcified CFA lesions. Methods: This is a retrospective single-center, single-arm study. Consecutive patients treated by IVL and DCB for calcified CFA disease between February 2017 and September 2020 were evaluated. The primary measure outcome of this analysis was primary patency. Procedural technical success (Results: Thirty-three (n=33) patients were included in this study. The majority presented with lifestyle limiting claudication (n=20, 61%), 52% (n=17) of the patients had chronic kidney disease (CKD) and 33% (n=11) had diabetes. The procedural technical success was 97% (n=32). A flow-limiting dissection post IVL was observed in 2 patients (6%) and a peripheral embolization in a single patient (3%), while the bail-out stenting rate amounted to 12% (n=4). No perforation was observed. The median length of hospital stay was 2 days (interquartile range 2–3). At 12 months, the primary patency was 72%. The freedom from TLR and the secondary patency rates were 94% and 88%, respectively. The 12-month survival amounted to 100% and 75% (n=25) of the patients were asymptomatic or presented with mild claudication. The presence of chronic limb-threatening ischemia (CLTI) (hazard ratio [HR], 0.92; confidence interval (CI); 0.18–4.8, p=0.7) or CKD (HR, 1.30; 95% CI, 0.29–5.8; p=0.72), as well as the use of a 7 mm IVL catheter (HR, 0.59; 95% CI, 0.13–2.63; p=0.49) or of high-dose DCB (HR, 0.68; 95% CI, 0.13–3.53; p=0.65) did not influence the primary patency. Conclusions: In this study, the combination of IVL and DCB angioplasty for calcified CFA disease was associated with low risk for periprocedural complications, acceptable 12 months clinical outcomes, and low rates of reinterventions. Clinical Impact Intravascular lithotripsy in combination with DCB angioplasty can be an alternative to surgery in highly selected patients with CFA atherosclerotic disease. In this Cohort the combination therapy lead to acceptable clinical results and low reintervention rates at 12 months.

The mid-term results after treatment of isolated popliteal lesions have been limited. The aim of the present study was to report the mid-term outcomes after endovascular treatment of isolated atherosclerotic popliteal artery lesions.A multicenter (15 hospitals in five countries) retrospective cohort study was performed. Between June 2016 and June 2021, 651 consecutive patients who had been treated for isolated popliteal lesions using endovascular methods exclusively were included in the present study. Six techniques were identified, including plain balloon angioplasty (PTA; n = 286; 43.9%), drug-coated balloon angioplasty (n = 98; 15.1%), stenting with low-chronic outward force (COF) stents (n = 84; 12.9%), stenting with high-COF stents (n = 76; 11.7%), atherectomy alone (n = 17; 2.6%), and directional atherectomy with drug-coated balloons (n = 90; 13.8%). The primary outcomes measures were primary and secondary patency and freedom from clinically driven target lesion revascularization (F-CDTLR).The mean patient age was 74.5 years. Most of the patients (n = 409; 62.9%) had had chronic limb-threatening ischemia. Popliteal occlusion was found in 400 cases (61.4%). High-grade calcification was present in 36.7% of cases. Immediate technical success was 94.8%. The median follow-up was 26 months (range, 6-42 months). The actuarial rate for all patients at 26 months (per outcome measure) was as follows: primary patency, 73.9%; secondary patency, 88%; and F-CDTLR, 76.5%. When comparing PTA vs all other treatments in an adjusted regression analysis, the F-CDTLR was 75.2% for PTA vs 76.5% for all other treatment (hazard ratio, 1.06; 95% confidence interval, 0.75-1.48; P = .46, adjusted regression). The difference in secondary patency also was not statistically significant (85.7% for PTA vs 88%; P = .20). Adjusted Kaplan-Meier analysis revealed that the estimated primary patency was inferior for PTA in pairwise comparisons vs other treatments (P .001 vs atherectomy; P = .002 vs directional atherectomy with drug-coated balloons; and P = .002 vs low-COF stenting).The results from our study have shown that endovascular treatment of isolated popliteal lesions is safe and associated with acceptable patency and F-CDTLR in the mid-term.

Summary Background Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding UK Medical Research Council and Health Technology Assessment Programme.

Endovascular repair of abdominal aortic aneurysm (AAA) remains a challenging clinical scenario when there is a short or nonexistent segment of healthy infrarenal aorta. This study sought to determine the safety and effectiveness of endosuture aneurysm repair (ESAR) using the Endurant II/IIs endograft (Medtronic Vascular, Santa Rosa, Calif) in conjunction with Heli-FX EndoAnchors (Medtronic Vascular) in the treatment of short-neck AAA.In this subgroup analysis, 70 patients were identified from the Aneurysm Treatment Using the Heli-FX EndoAnchor System Global Registry (ANCHOR) who had an infrarenal neck length 10 mm down to 4 mm based on core laboratory measurements. Primary outcomes included technical success of the index procedure, rate of type IA endoleak at 1 month and 12 months, and rate of secondary procedures at 12 months.In this short-neck cohort (n = 70), the average neck length and diameter were 6.9 ± 1.6 mm and 25.7 ± 4.0 mm, respectively. Investigators reported an overall procedural success rate of 97.1% and a technical success rate of 88.6%. The duration of the implant procedure, EndoAnchor implantation, and total fluoroscopy time was 148.0 ± 80.0 minutes, 17.1 ± 11.5 minutes, and 35.3 ± 22.0 minutes, respectively, and an average of 5.5 ± 2.1 EndoAnchors were implanted per patient. Through the 30-day follow-up, type IA endoleaks were reported in four patients, of which three resolved spontaneously by the 12-month follow-up. There was an additional type IA endoleak through the 12-month follow-up that has not resulted in AAA enlargement or required a secondary procedure. The Kaplan-Meier estimate for freedom from secondary endovascular procedures and all-cause mortality is 95.4% and 92.7% through 365 days, respectively. No patient in the short-neck cohort experienced main body stent migration, increase in maximum aneurysm diameter, or aneurysm rupture or required conversion to open surgical repair through 12 months.In this analysis of the short-neck cohort from ANCHOR, the Endurant II/IIs endograft in conjunction with Heli-FX EndoAnchor implants (ESAR) appears to be a safe and effective treatment option with a high technical success rate and low incidence of type IA endoleaks and secondary interventions. Despite the complex and hostile anatomies, the ESAR method required short procedure and fluoroscopy times. These short-term outcomes suggest that ESAR could be complementary to therapies currently available for treatment of hostile AAA anatomy and a viable off-the-shelf endovascular treatment option for patients with short-neck AAAs, although long-term follow-up is critically important.

Purpose: To compare balloon-expandable covered stents (BECS) available for use as renal chimney grafts to the Advanta V12 approved for use with the Endurant endograft. Materials and Methods: A silicone model was manufactured based on preoperative computed tomography angiography (CTA) scans of a patient with a 7-cm juxtarenal aneurysm treated with an Endurant bifurcated endograft and an Advanta V12 covered stent for the 6-mm-diameter right renal artery. The model was placed in a flow box filled with a 37°C blood-mimicking solution equipped with a pulsatile pumping system (140/60 mm Hg). The tested BECS were the Advanta V12, the VBX, and the BeGraft+. A 36-mm-diameter Endurant II endograft with a 16-mm-diameter contralateral limb and a 6×59-mm BECS chimney graft were used in 9 consecutive tests (3 for each combination). After each implantation, the model was placed in the CT scanner, and 2 radiologists blinded to the test device independently measured the gutter areas and the patent chimney graft lumen at the level of the Endurant’s suprarenal stent, at the level of the chimney’s maximum curvature, and 10 mm inside the renal artery. The intraclass correlation coefficients (ICC) were calculated to assess interreader reliability. Results: The mean gutter areas were 19.3±7, 20.2±8, and 22.3±8 mm2 for the Advanta, VBX, and BeGraft+, respectively (all p>0.05). At the level of the aortic endograft’s suprarenal stent struts, the mean diameter of the Advanta V12, VBX, and BeGraft+ were 4.46±0.3, 4.12±0.4, and 4.12±0.3 mm, respectively (all p>0.05). At the level of the maximum chimney graft angulation, the mean diameters were 3.77±0.3, 4.16±0.1, and 3.74±0.3 mm, respectively (all p>0.05). In the right renal artery, the mean diameters were 3.91±0.2, 4.05±0.9, and 4.3±0.4 mm, respectively (all p>0.05). The ICCs varied between 0.7 and 0.9, indicating good agreement between readers. Conclusion: These in vitro findings showed comparable results between the Advanta V12 and the available BECS used in conjunction with the Endurant endograft according to the instructions for use. Further clinical evaluation is needed to confirm these results.

Purpose: To investigate 2 generations of balloon-expandable covered stents as potential bridging devices using an in vitro model of stent-graft fenestrations. Materials and Methods: Twenty BeGraft and 20 BeGraft+ cobalt-chromium stents covered in expanded polytetrafluoroethylene (ePTFE) in 6- and 8-mm diameters were tested in sheets mimicking stent-graft fenestrations. Microscopy and radiography were employed to evaluate stent morphology after flaring. In vitro bench tests measured maximum pullout (perpendicular displacement) and the shear stress (axial displacement) forces needed to dislocate the stents. Results: No alteration of ePTFE coverage was detected in the flared stents. Digital radiography and computed tomography showed marked alteration of the stent geometry, which was more pronounced in the BeGraft group. No fractures were detected. Median (minimum–maximum) pullout forces for the 6-mm stent-grafts were 17.1 N (15.8–19.6) for the BeGraft device and 30.4 N (20.2–31.9) for the BeGraft+ device (p=0.006). Median (minimum–maximum) pullout forces for the 8-mm stent-grafts were 11.3 N (11–12.1) for the BeGraft device and 21.8 N (18.2–25.5) for the BeGraft+ device (p

Objectives Leriche syndrome, defined as a chronic obliteration of a segment of the infrarenal aorta and the iliac arteries, represents a challenging pathology. Surgical reconstruction represents the standard treatment option. However, the endovascular therapy is gaining ever greater applicability in several vascular territories comparable with the open repair results. The aim of the present study was to evaluate the role of endovascular repair in patients with chronic Leriche syndrome. Methods Between January 2008 and September 2016, 82 patients with Leriche syndrome underwent surgical and endovascular repair at two European vascular centers. After risk stratification, 40 patients were matched based on chronic TASC D obstructive arterial disease with involvement of the aortic bifurcation and bilateral iliac arteries, the age, and the cardiovascular risk factors identifying finally 20 patients who underwent surgical repair (open group) and 20 patients who were treated by deployment of stents/stent-grafts in the aortic and iliac segment (endo group). Kaplan–Meier estimation for patency and freedom from reintervention were calculated and univariate analyses were performed. Results Estimated primary patency rate was 100% vs. 84% at one year for the open group vs. endovascular group, respectively ( p = .05). Freedom from reintervention was 100% vs. 89% at one year for the open group vs. endo group ( p = .09). During the entire follow-up of 34.9 ± 23.1 months, five reinterventions were performed for the endo group vs. two for the open group ( p = .212). Additionally, the major adverse cardiac and cerebrovascular events were 5/20 vs. 2/20 for the endovascular vs. open group, respectively ( p = .212). The postoperative ankle–brachial index improved in 0.66 in the endo group vs. 0.71 in the open group ( p = .624). Conclusions Endovascular techniques for the treatment of complex chronic Leriche lesions seem not to be associated with better early or mid-term outcomes compared to surgical repair.

Introduction The aim was to describe possible management of a persistent gutter related type Ia endoleak after treatment of a symptomatic pararenal aortic aneurysm with the chimney endovascular technique. Report A 77 year old man with a symptomatic 6 cm pararenal aortic aneurysm was referred. Computed tomography angiography (CTA) showed a pararenal aortic aneurysm with involvement of both renal arteries and extension up to the superior mesenteric artery. The patient underwent treatment by placement of triple chimney grafts and an abdominal stent graft. Completion angiography showed a gutter related type Ia endoleak. As the type Ia endoleak persisted at the three month CTA follow up and according to the PERICLES registry classification of endoleaks, a type B causative mechanism was detected. Embolization of the gutters was performed with coils and onyx, leading to complete resolution of the gutters on completion angiography. The 10 month post-operative magnetic resonance angiogram showed no further evidence of any endoleak and complete exclusion of the aneurysm. Conclusion Treatment of persistent type B gutter related endoleaks after triple chimney endovascular aneurysm repair can be performed with the placement of coils and adjunctive use of fluid agents., Highlights • A 15 mm sealing zone and 30% oversizing are crucial in chimney EVAR (Ch-EVAR) to avoid endoleaks. • Most gutter related endoleaks after Ch-EVAR will resolve spontaneously. • When an endoleak appears, conservative management is reasonable. • Gutter embolization is recommended if a type Ia endoleak persists after three months.

Purpose Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device. Materials and Methods We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success. Results Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases. Conclusions The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.

BACKGROUND The aim of this study was to report early outcomes of patients with non-dialysis-dependent chronic kidney disease (NDD-CKD) after revascularization for critical limb-threatening ischemia (CLTI). METHODS Perioperative data of patients from the CRITISCH (critical limb ischemia) Registry, who also had NDD-CKD (stages 3 and 4), were compared to their counterparts with normal renal function (NRF) or mild renal insufficiency (stages 1 and 2). Patient characteristics and type of first-line treatment were assessed. Amputation-free survival was the primary composite endpoint. Secondary endpoints included major adverse cardiovascular and cerebral events (MACCE) and hemodynamic failure of revascularization. Multivariable logistic regression determined risk factors for the endpoints. RESULTS 424 patients with NDD-CKD were identified. Endovascular revascularization (ER) was performed in 251 patients (59.2%). Eighty-six patients (20.3%) underwent bypass surgery (BS) and 29 patients (6.8%) femoral artery patchplasty (FAP). Conservative treatment (CT) was offered to 46 patients (10.9%); 12 patients (2.8%) underwent primary major amputation (PMA). Logistic regression analysis showed an increased early risk for amputation/death (OR=1.92, 95% CI: 1.09-3.40), death (OR=5.53, 95% CI: 1.92-15.90) and hemodynamic failure of the revascularization (OR=1.80, 95% CI: 1.19-2.72) compared to patients with NRF. Patients with NDD-CKD also seem to carry a higher risk for MACCE (OR=1.82, 95% CI: 0.99-3.36). NDD-CKD was not a risk factor for limb loss alone (OR=1.05, 95% CI: 0.49-2.22). CONCLUSIONS NDD-CKD was an independent risk factor for early postoperative mortality, morbidity and reduced patency, but not for limb loss. Robust follow-up is necessary to monitor for such events, as well as to prevent readmission.

Purpose: Bridging stents undergo millions of cycles during respiratory movements of the kidneys throughout the patient’s life. Thus, understanding the response of fabric and endoskeleton of the stent to cyclic loading over the time is crucial. In this study, we compare the fatigue resistance of the Viabahn Balloon-Expandable stent-graft (VBX) with the widely used Advanta V12/iCast under prolonged stress induction. Materials and Methods: A polyester test sheet with 10 fenestrations was used simulating a fenestrated endograft. Five 6×59 mm VBX stent-grafts and five 6×58 mm Advanta stent-grafts were implanted into 6×6 mm fenestrations. The stents were flared with a 10×20 mm PTA (percutaneous transluminal angioplasty) catheter and connected with a fatigue stress machine. All stent-grafts were evaluated by microscopy and radiography at baseline and after regular intervals until 50,000,000 cycles were applied, simulating a life span of approximately 75 months. Freedom from fracture (FF), freedom from initial polytertafluoroethylene (PTFE) changes (FIC), and from PTFE breakpoint (FBP, all-layer defect) were calculated. Results: Digital radiographic images did not show any stent fracture in both groups after 50,000,000 cycles. The VBX stent-graft was free from any all-layer defects at the conclusion of 50,000,00 cycles resulting in a significant higher FBP compared with Advanta V12 (50,000,000 vs 33,400,000; pConclusions: In fatigue tests simulating respiration movements, VBX and Advanta V12 performed equally well in terms of fracture resistance and freedom from initial PTFE changes. VBX maintained freedom from PTFE breakpoint throughout the full 50,000,000 cycles. All-layers defects were detected only in Advanta and were mainly caused by penetration of the nitinol ring through the PTFE.

Summary: Background: Isolated femoral artery revascularisation (iFAR) represents a well-established surgical method in the treatment of peripheral arterial disease (PAD) involving common femoral artery disease. Data for iFAR in multilevel PAD are inconsistent, particularly in patients with critical limb ischemia (CLI). The aim of the study was to evaluate the outcome of iFAR in CLI regarding major amputation and reintervention and to identify associated risk factors for this outcome. Patients and methods: The data used have been derived from the German Registry of Firstline Treatment in Critical Limb Ischemia (CRITISCH). A total of 1200 patients were enrolled in 27 vascular centres. This sub-analysis included patients, which were treated with iFAR with/without concomitant iliac intervention. For detection of risk factors for the combined endpoint of major amputation and/or reintervention, selection of variables for multiple regression was conducted using stepwise forward/backward selection by Akaike’s information criterion. Results: 95 patients were included (mean age: 72 years ± 10.82; 64.2% male). Of those, 32 (33.7%) participants reached the combined endpoint. Risk factor analysis revealed continued tobacco use (odds ratio [OR] 2.316, confidence interval [CI] 0.832–6.674), TASC D-lesion (OR: 2.293, CI: 0.869–6.261) and previous vascular intervention in the trial leg (OR: 2.720, CI: 1.037–7.381) to be associated with reaching the combined endpoint. Conclusions: iFAR provides a reasonable, surgical option to treat CLI. Lesion length (TASC D) seems to have a negative impact on outcome. Further research is required to better define the future role of iFAR for combined femoro-popliteal lesions in CLI – best in terms of a randomised controlled trial.

Objective In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting. Methods We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure. Results All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively. Conclusions The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting.

Popliteal artery aneurysm (PAA) is a rare disease with a prevalence of 0.1% to 1%. Within previous years, endovascular repair (ER) of PAAs has been performed more frequently despite the lack of high-level evidence compared with open surgical repair (OSR). In 2014, the POPART registry was initiated to validate the current treatment options for PAA repair.POPART is a multinational multicenter registry of the peri- and postoperative outcomes of ER and OSR for PAAs. Data sets were recorded using the online survey tool SurveyMonkey (available at: https://www.surveymonkey.com/). Regular monitoring and plausibility checks of the data sets are performed to ensure reliability. The aim of the present study was to report the findings from the POPART registry, which includes data from 41 centers.From June 2014 to August 2019, 794 cases had been recorded in the POPART registry. OSR had been performed in 662 patients and ER in 106 patients; 23 patients had been treated conservatively. Of the 106 patients in the primary ER group, 4 had required conversion to OSR. The ER patients were significantly older (ER, median, 71 years; OSR, median, 67 years; P .05). No other significant differences were present in the demographic data, comorbidities, or aneurysm morphology between the two groups. Of the 662 patients in the OSR group, 50.3% were symptomatic compared with 29.2% of the 106 patients in the ER group (P .05). Emergency treatment because of acute ischemia, critical ischemia, or rupture was necessary for 149 patients (22.5%) in the OSR group and 11 patients (10.3%) in the ER group. The most frequent postoperative complications were impaired wound healing (OSR, n = 47 [7.1%]; ER, n = 3 [2.8%]; P.05) and major bleeding (OSR, n = 26 [3.9%]; ER, n = 3 [2.8%]; P.05). The in-hospital length of stay was significantly longer for the OSR group than for the ER group (median, 10 days; range, 3-65 days; vs median, 7 days; range, 1-73 days). The overall patency for the OSR and ER groups after 12 and 24 months was 83.2% and 44.7% (P .005) and 74.2% and 29.1% (P .005), respectively. The outcomes with a prosthetic graft vs an autologous vein were significantly poorer in the OSR group (primary patency, 71.4% vs 88.1% at 12 months).To evaluate new treatment techniques such as ER for PAAs, real-world data are of essential importance. The present analysis of the first results for the POPART registry shows good perioperative results for endovascular treatment of PAA in asymptomatic patients with good outflow vessels. The perioperative complication rate is low and the postoperative hospital stay is shorter than after OSR. However, the patency rates after 12 and 24 months are low in the ER group compared to patients treated with open repair. More follow-up data is required for further interpretation; the completion of the data sets in the registry is ongoing.