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The aim of this study was to compare the 2-year outcomes of de novo versus postendovascular lesion treatment of femoropopliteal occlusions included in a national, multicenter, observational, prospective registry based on the treatment of critical Limb-threatening IschaeMia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE) registry.From January 2018 to December 2019, 541 patients from 43 centers have been enrolled in the LIMBSAVE registry. Of these patients, 460 were included in the present study: 341 (74.1%) with de novo lesions (DN group) and 119 (25.9%) with postendovascular treatment lesions (PE group). Initial outcome measures were assessed at 30 days after treatment. Furthermore, at the 2-year follow-up, the estimated outcomes of primary patency, primary-assisted patency, secondary patency, and limb salvage were analyzed with Kaplan-Meier curves and compared between groups with the log-rank test.Both groups were homogeneous in terms of demographic data, preoperative risk factors, and clinical presentation. However, compared with DN group, more patients in PE group had a great saphenous vein diameter of less than 3 mm (11.1% vs 21%; P = .007). Intraoperatively, both groups showed similar distal anastomosis sites: below-the-knee popliteal artery (63% DN group, 66.4% PE group) and tibial vessel (37% DN group, 33.6% PE group) (P = .3). The overall mean duration of follow-up was 11.6 months (range, 1-24 months). At the 2-year follow-up, there were no differences between the two groups in terms of primary patency (66.3% DN group vs 74.1% PE group; P = .9), primary-assisted patency (78.2% DN group vs 79.5% PE group; P = .2), secondary patency (85.1% DN group vs 91.4% PE group; P = .2), and limb salvage (95.2% DN group vs 95.1% PE group; P = .9).The LIMBSAVE registry did not show a worsening of overall patency and limb salvages rates at the 2-year follow-up in patients undergoing in situ saphenous bypass after a failed endovascular approach for long femoropopliteal occlusive disease. This finding is in contrast with what has been published in literature.

Objective: Management of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres.Methods: Eight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts’ responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers’ consistency was graded using Cohen's k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k.Results: Sixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage.Conclusion: Based on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues.

Introduction: Type III endoleaks post-endovascular aortic aneurysm repair (EVAR) warrant treatment because they increase pressure within the aneurysm sac leading to increased rupture risk. The treatment may be difficult with regular endovascular devices. Endovascular aneurysm sealing (EVAS) might provide a treatment option for type III endoleaks, especially if located near the flow divider. This study aims to analyze clinical outcomes of EVAS for type III endoleaks after EVAR. Methods: This is an international, retrospective, observational cohort study including data from 8 European institutions. Results: A total of 20 patients were identified of which 80% had a type IIIb endoleak and the remainder (20%) a type IIIa endoleak. The median time between EVAR and EVAS was 49.5 months (28.5–89). Mean AAA diameter prior to EVAS revision was 76.6±19.9 mm. Technical success was achieved in 95%, 1 patient had technical failure due to a postoperative myocardial infarction resulting in death. Mean follow-up was 22.8±15.2 months. During follow-up 1 patient had a type Ia endoleak, and 1 patient had a new type IIIa endoleak at an untreated location. There were 5 patients with aneurysm growth. Five patients underwent AAA-related reinterventions indications being: growth with type II endoleak (n=3), type Ia endoleak (n=1), and iliac aneurysm (n=1). At 1-year follow-up, the freedom from clinical failure was 77.5%, freedom from all-cause mortality 94.7%, freedom from aneurysm-related mortality 95%, and freedom from aneurysm-related reinterventions 93.8%. Conclusion: The EVAS relining can be safely performed to treat type III endoleaks with an acceptable technical success rate, a low 30-day mortality rate and no secondary ruptures at short-term follow-up. The relatively low clinical success rates, related to reinterventions and AAA enlargement, highlight the need for prolonged follow-up.

Purpose: To evaluate the outcomes of preserving the internal iliac artery (IIA) with iliac branched devices (IBDs) during acute endovascular repair of ruptured aortoiliac aneurysms. Material and Methods: This is a multicenter retrospective review of all consecutive patients undergoing acute endovascular repair of ruptured aortoiliac aneurysm with an IBD at 8 aortic centers between December 2012 and June 2020. A control group was used where the IIA was intentionally occluded from the same study period. The main outcome measures were 30-day mortality, major adverse events, technical success, and clinical success. Secondary outcomes were buttock claudication, primary patency, primary-assisted and secondary patency of the IBD, occurrence of endoleak types I/III, and reintervention. Values are presented as numbers and percentages or interquartile range in parenthesis. Results: Forty-eight patients were included in the study: 24 with IBD and 24 with IIA occlusion. There was no difference in demographics, cardiovascular risk factors, and aneurysm extent. Twenty (83%) of them were hemodynamically stable during the procedure as opposed to 14 (58%, p=.23) with the IIA occlusion. Technical success was achieved in all cases with a procedure time of 180 (133–254) minutes, 45 (23–65) of which were from IBD. There were 2 (8%) deaths during the first 30 days and 2 (8%) major complications unrelated to the IBD, whereas in the IIA occlusion, the figures were 10 (42%) and 7 (29%), respectively. No patient in the IBD group developed buttock claudication compared to 8 (57%, pConclusion: IBD is a valid alternative for maintaining the pelvic circulation for endovascular aortic aneurysm repair of ruptured aortoiliac aneurysms. The technical success and midterm outcomes are very satisfactory but require patient selection particularly regarding hemodynamic stability. The reintervention rate is considerable, mandating continuous follow-up. Clinical Impact This multicenter study demonstrates that ruptured aortoiliac aneurysms do not necessarily require mandatory occlusion of hypogastric arteries. Iliac branch devices are shown to be a valid alternative in highly selected cases, with good midterm results, even if reinterventions are required in a significant proportion of patients.

Introduction To compare endoleak outcomes after thoracic endovascular aneurysm repair (TEVAR) with different stent-graft generations into long-term follow-up. Design retrospective, observational, and single-center cohort study. Methods TEVAR procedures performed between November 1995 and December 2020 were analyzed. The primary endpoint of this study was the freedom from endoleak (type I/III) in four stent-graft generations during the follow-up period. The first generation (GEN1) included: Vanguard; AneuRx and Talent; Stentor; Excluder; Endologix; EndoFit. The second generation (GEN2) included: TAG and TX. The third (GEN3) included: Relay Plus; Valiant Captivia; Zenith Alpha and custom-made. The fourth (GEN4) included: Relay Pro; Conformable C-TAG; Navion; E-Vita; Najuta; Nexus; standard and custom-made thoraco-abdominal devices. Nonaortic and aorta-related survival was considered as secondary outcome. Results A total of 509 TEVAR were included with a 44.3 ± 42.5 months mean follow-up. Freedom from endoleak at 5 years was 65.6%, 61.4%, 76.2%, and 69.1% for GEN1, GEN2, GEN3, and GEN4, respectively ( p = 0.368). The first two generations demonstrated a higher endoleak rate when compared with the two most recent ones (27.2 vs 18.2%, respectively; p = 0.043). GEN1 was an independent risk factor ( p = 0.014) and GEN4 was an independent protective factor ( p = 0.001) for endoleak. GEN1 was found to be a risk factor for type-Ia endoleak ( p = 0.059). GEN4 demonstrated a protective association regarding type-Ib endoleak ( p = 0.012). Overall survival was 75.3%, 44.4%, 27.2%, and 17.6% at 1, 5, 10, and 15 years, respectively. Survival distinguished as non-related versus aortic-related was 86.7% vs 23.5%, 52.7% vs 9.8%, 32.9% vs 2.0%, 21.2% vs 0% at 1, 5, 10, and 15 years, respectively ( p< 0.000). Conclusion Endoleak occurred in a non-negligible percentage of TEVAR patients. A significant reduction of endoleak incidence over evolving stent-grafts generations was registered. Newer stent-graft generations demonstrated better long-term endoleak. Data about long-term outcomes require ongoing updates to prove both the reliability and the durability of newer stent-graft generations.

Arch pathology represents one of the last frontiers in aortic aneurysms endovascular management. Several companies recently developed dedicated branched and fenestrated endografts specifically designed for the aortic arch, aiming to overcome some of the issues associated with standard thoracic endograft and supra-aortic vessels extra-anatomical debranching. This study aimed to evaluate early outcomes obtained with a custom-made fenestrated endograft approved for thoracic aortic aneurysms exclusion.All consecutive patients treated with the Najuta endograft (Kawasumi Laboratories, Inc, Tokyo, Japan) in Italy were prospectively enrolled and included in the study population. Anatomical characteristics and perioperative data were retrospectively analyzed. Study endpoints were technical success, 30-day clinical success, overall survival, supra-aortic vessel patency, endoleak and need for reintervention or surgical conversion.During the period 2018-2022, seventy-six patients received a Najuta endograft in Italy and were enrolled in the study. Median age was 72 (IQR 69-76) years and 80.3% were male. Most of the patients received treatment for atherosclerotic aneurysms (80.3%) while the others for post-dissection aneurysms (7.9%), penetrating aortic ulcer (9.2%), or type I endoleak correction after previous thoracic endovascular repair (2.6%). Overall, 161 supra-aortic vessels were preserved through a dedicated fenestration. Technical success was achieved in 74/76 (97.4%) of procedures; both failures were associated with endoleak detection at final angiography (one type I and one type III endoleak). Two distal migrations occurred during the implanting procedure. Clinical success at 30 days was 94.7%. Two early reinterventions were needed within 30 days after index procedure: in one case an aortic false lumen coils embolization was performed, since distal re-entry caused enlargement of the post dissection thoracic aneurysm. The other procedure consisted of a femoral pseudoaneurysm repair. Median follow-up was 7 (IQR 3-15) months; no supra-aortic vessel occlusions occurred and no patients needed surgical conversion.Early results suggest that in selected patients with aortic arch pathology needing a proximal landing, an endovascular approach with the Najuta system is safe and effective, especially for those at high surgical risk. A strict follow-up with high-quality computed tomography angiography images and eventual long-term complications evaluation is needed to confirm these initial experience findings.

An occult endoleak (OE) may be the underlying cause of aneurysm sac expansion after EVAR. The aim of this study is to describe intraoperative findings of OE during surgical endograft explantations.This is a retrospective, multicentre analysis of all open conversions (OC) after EVAR from 1997 to 2020 in 12 vascular centres. We excluded patients with a preoperative diagnosis of endograft infection, endograft thrombosis, and thoracic-EVAR. An OE was defined as an endoleak revealed during OC not shown on preoperative imaging, which was likely the real cause for sac enlargement. We reported the number of OE, and we described the type of OE in relation to the initial alleged or associated endoleak. A separate analysis of patients with an initial diagnosis of endotension was also performed.An OE was found in 32/255 patients (12.5%). In the 78.1% of the cases (25/32) a type II endoleak hid a type I or III endoleak. Endotension was the initial diagnosis of 26/255 patients (10.2%). In 4/26 cases (15.4%), a type I or II OE was revealed. In 5/26 cases (19.2%) an endograft infection was found intraoperatively. In 2/26 cases we found an angiosarcoma. Fifteen cases of endotension (57.7%) remained unexplained.OE represent a not negligible cause of EVAR failure. A type II endoleak associated with sac enlargement may actually conceal a higher-flow endoleak. In most of the cases, the initial diagnosis of endotension remains unexplained. However, endotension sometimes conceals severe underlying pathologies such as infections.

Objective: The introduction of new endograft models improved long-term results of abdominal aortic aneurysm (AAA) endovascular repair (EVAR), but most of them maintained an old and unchanged design: a short body and long legs shifting up the flow divider. This study assessed the long-term results of EVAR with unimodular endoprosthesis fixed at the aorto-iliac bifurcation (Anatomical FiXation), in a large, unselected cohort. Materials and Methods: In a single-center, retrospective cohort study, 623 patients selectively treated between 1999 and 2016, were analyzed. Follow-up protocol included at least a computed tomography angiography within 3 months and a duplex ultrasound and clinical exam yearly. All enrolled patients were analyzed by 2020. The primary outcomes were technical success, clinical success, and survival. Secondary outcomes included survival-free from late-open-conversion (LOC), reintervention, and endoleaks. Results: Median age was 74±11 years and the follow-up 93±54 months. The technical success was achieved in 99.4% and the 30-day clinical success was 98.4%. A 5-year clinical success of 97.7% was registered and at 10 years success was 96.7%. The overall survival at 1, 5, 10, and 15 years was 92.4%, 79.5%, 64.9%, and 45.5%, respectively. Six (0.98%) AAA-related death were registered, 3 caused by infection of the endograft and 3 for secondary rupture. LOCs were 9 (1.47%) and reintervention-free survival at 1, 5, 10, and 15 years were 88.4%, 78.0%, 76.2%, and 74.6%, respectively. Freedom from endoleaks was 88.8% at 1 year and 72.7% at 15 years. A total of 63 high-flow endoleaks were registered (43 type I, 7 type IIIa, 12 type IIIb, and 1 type Ib+IIIb). No migrations were recorded, and the graft limb thrombosis rate was 1.14%. From a multivariate analysis resulted that long-term clinical success appeared to be reduced in patients affected by diabetes [odds ratio (OR) 0.24; p=0.04] and in presence of calcified and thrombotic iliac accesses (OR 0.16; p=0.006). Conclusion: EVAR with the Anatomical FiXation was confirmed to be safe, feasible, and effective to prevent AAA rupture in the long term as well. However, the overall survival remains afflicted by cardiovascular accident. The original concept of unibody bifurcated design allowed a very low rate of graft thrombosis and zeroed the risk of migration and related reintervention.

Mid-term durability of branches has already been established, and BF-branched and fenestrated endovascular repair has shown comparable results with open repair in the treatment of thoracoabdominal aortic aneurysms (TAAAs). Nevertheless, target vessel instability remains the most frequent adverse event after complex endovascular aortic repair. Type III endoleaks from directional branches have been reported with a low incidence, but risk factors for this complication have not been investigated yet.This was a dual-center observational retrospective cohort study. Data were collected prospectively for each patient treated with branched endovascular repair between April 2008 and December 2019. The primary outcome was to assess potential risk factors for branch disconnection and fracture. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details. A Cox regression hazard analysis was performed to evaluate the influence of preoperative aneurysm diameter and target vessel angulation on the outcome during follow-up.Two hundred ninety-five target visceral vessels (TVVs) in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 TVVs). The median follow-up was 32.5 months (interquartile range, 14.2-50.1 months). Twelve type III endoleaks from directional branches were detected (4.2%; 5 bridging stent graft fractures and 7 disconnections). Five type III endoleaks involved the celiac trunk (one fracture and four disconnections), five the superior mesenteric artery (four fractures and one disconnection), and two the renal arteries (both disconnections). The median time to type III endoleak was 22.2 months (interquartile range, 10.9-37.6 months). Preoperative TAAA diameter (P = .028), preoperative TVV angulation (P = .037), the use of a BeGraft stent graft as bridging stent graft (P = .001), and different stent types on the same vessel (P = .048) were associated with type III endoleak at univariable analysis. Using a BeGraft stent graft (P = .010) was the only significant factor predisposing to type III endoleak at multiple logistic regression. The Cox regression analysis showed a two-fold increased risk for type III endoleak for every 10-mm increase in preoperative TAAA diameter (hazard ratio, 2.00; 95% confidence interval, 1.08-3.72; P = .028) and a 1.5 increased risk every 12° increase of preoperative TVV angulation (hazard ratio, 1.47; 95% confidence interval, 1.02-2.10; P = .037).Type III endoleaks from directional branches are a non-negligible complication after branched endovascular repair, with a relevant incidence. They tended to be clustered on specific patients, and aneurysm diameter and TVV angulation are strictly associated with the outcome. Different stent types on the same vessel should be avoided whenever possible. An intensified follow-up should be adopted for patients with large aneurysms, implanted with first-generation BeGraft, or who have been already diagnosed with type III endoleaks.

The objective of this study was to assess the primary endpoint defined as the detection of micro-embolic signals (MES) by the use of transcranial Doppler (TCD) in patients with asymptomatic carotid stenosis (≥70%) scheduled for carotid endarterectomy. The secondary endpoint consisted of testing the association of MES with stenosis severity, histopathological, and ultrasound characteristics.This was a single-center, single-arm, prospective, observational trial. Computed tomography angiography and ultrasound assessment (Geroulakos classification) were mandatory as well as being under best medical therapy. MES number and characteristics were investigated in Holter mode TCD-X device with a standard 1.5 MHz probe. The time points of evaluation were: 24 hours preoperative, 24 hours postoperative, and 30 days postoperative. The histopathological analysis was performed according to the modified American Heart Association classification. One-way analysis of variance tested MES differences over time. Univariable and multivariable logistic regression tested variables potentially associated with MES.A total of 120 patients demonstrated a significant reduction of the mean number of MES (3.35 ± 10.04 and 0.82 ± 2.39; pre- and post-carotid endarterectomy, respectively), becoming undetectable at 30 days (P = .001). Hypoechogenic plaques assessed by ultrasound were a significant risk factor for MES (P = .001). The features of plaque vulnerability, such as hemorrhagic component (P = .011), neovascularization (P = .025), signs of inflammation (P = .027), and rupture of the fibrous cap (P = .002) were predictors of MES. Cap rupture was the only predictor in the multivariate analysis (odds ratio, 5.98; P = .030). The stenosis severity was not associated with MES (P = .95) CONCLUSIONS: Patients under best medical therapy had a preoperative embolic activity becoming no more detectable after surgery. Both ultrasound and histologic markers of vulnerability were predictors of MES, and stenosis severity was not associated. TCD gives better insight into the real embolic risk, and future studies should evaluate clinical results coming from its implementation with standard imaging techniques.gov registration number NCT05134493.

AIMS The aim of this study was to report the 30-day technical and clinical success with endovascular repair using the ultra-low-profile Ovation stent graft in patients judged to be outside the instructions for use (IFU) for conventional endografts, while amenable to treatment within the IFU for Ovation. METHODS AND RESULTS One hundred and twenty-two patients (78.65±7.67 years; 111 male) were enrolled. Patients were evaluated as being outside the IFU for standard endografts because of the absence of a suitable proximal aortic neck in 109 cases (89.3%), of inadequate access vessels in 13 (10.7%), or both in 111 (90.9%). Mean aneurysm (abdominal aortic aneurysm [AAA]) diameter was 52.96±10.1 mm; mean aortic neck length was 7.75±6.05 mm. Technical success (98.4%) was achieved in all but two patients due to a type Ia endoleak. At completion angiography, 15 (12.3%) patients presented a type II endoleak. All patients underwent 30-day follow-up. Primary clinical success at one month was 96.8%, assisted clinical success 98.4%. There were no type I endoleaks, while 12 (9.8%) type II endoleaks were still evident, in the absence of sac expansions. Two patients (1.6%) presented an asymptomatic limb occlusion. CONCLUSIONS Our experience suggests that, in a selected population of patients with challenging anatomy outside the IFU for conventional endografts, endovascular aneurysm repair (EVAR) using the Ovation stent graft can be performed safely with satisfactory immediate outcomes.

Introduction: The aim of this study was to present the short-term and 2-year outcomes after use of the Bentley BeGraft as bridging stent-graft (BSG) for reno-visceral target vessel (TV) during fenestrated endovascular aortic repair (FEVAR) from a contemporary multicentric experience. Methods: A retrospective review of all consecutive patients who underwent elective FEVAR at 7 institutions located in Italy from 2015 to 2021 was performed. The main outcomes of interest for this study were technical success and TV instability, defined in accordance with current reporting standards. Patients’ survival was also assessed. Results: Overall, 81 patients received elective FEVAR during the study period. Mean age of patients was 78 years, and 89% were men. Most patients were treated for a juxta-pararenal abdominal aortic aneurysm (AAA) (68%), and 23% had already received an infrarenal aortic reconstruction. Most endografts had 3-vessel or 4-vessel design (27% and 55%, respectively), and a Cook endograft was used in 73% of cases. Overall, 266 Bentley BeGraft were implanted, of which 44 (16.5%) in the celiac trunk, 69 (26%) in the superior mesenteric artery, 79 (29.5%) in the right renal artery, and 74 (28%) in the left renal artery. Technical success was 94%, with 5 instances of technical failure that were recorded and required an additional intraoperative procedure. The early mortality rate was 4%, and acute kidney injury occurred in 14 cases with 1 requiring definitive hemodialysis. Survival at 6, 12, and 24 months in the overall cohort was 98.8%, 95.3%, and 83.4%, respectively. Freedom from TV instability at 6, 12, and 24 months in the overall cohort was 98.4%, 97.9%, and 97.2%, respectively. Events of TV instability included 3 cases of type 1C endoleak and 3 cases of type 3C endoleak, while no events of BSG fracture or thrombosis were noted. Five out of 6 cases of TV instability occurred in renal arteries, and they were all successfully treated by endovascular means. Conclusions: The data from this multicentric study show favorable short-term and 2-year outcomes of the Bentley BeGraft as BSG for reno-visceral TV during FEVAR, with low rates of TV-related endoleak and no stent occlusion up to 2 years. Clinical Impact The data from this multicentric study show satsfactory outcomes up to two years of follow-up for the Bentley BeGraft when used for brdiging reno-visceral vessels during fenestrated endovascular aortic repair. Further research will be needed to identify predictors of stent-related reinterventions and ascertain the long-term durability.

Objectives: To evaluate the feasibility of a standardized single-renal scallop stent-graft. Design: Preclinical, single-center, real-world, all-comers, retrospective cohort study. Methods: A total of 1347 abdominal aortic aneurysm (AAA) repairs (endovascular and open) performed between 2010 and 2020 were screened for elective treatment and retrievable preoperative high-quality computed tomography angiography (CTA) performed Results: Of the total, 24.7% (n=135) was feasible with prototype #10. The study versus control group sealing zones were shorter (p=0.008), with a smaller surface (p=0.009) and a higher alpha angle (p=0.039). The length and surface area increased by about 25% and 23%, respectively, (both pConclusions: The use of single-renal scalloped stent-graft might be feasible in a considerable number of AAA patients. The breakthrough stands in treating hostile AAAs presenting in mismatched renal arteries, keeping the complexity of the repair as similar as possible to standard endovascular repair with a remarkable improvement in sealing. Clinical Impact The anatomic feasibility of a single renal stent graft for the treatment of “hostile” abdominal aortic aneurysm (AAA) with mismatched renal arteries was evaluated. The experimental device could be feasible in a considerable number of patients with AAA, approaching 25%, and demonstrate significant improvements in sealing. As far as we know, this is the first paper to report the prevalence of mismatched renal arteries in a large cohort of AAA patients in the real world, while proposing a dedicated device. The breakthrough is to keep the complexity of the repair as close as possible to standard endovascular repair

Purpose: To analyze the learning curve for thoracic endovascular aortic repair (TEVAR) in a single center over a period of 25 years. Materials and Methods: In total, 390 consecutive standard TEVAR procedures undertaken between 1996 and 2021 were included in a retrospective, observational, single-center study. Cumulative sum charts were elaborated for the entire center experience (primary outcome) as well as for the first and second implanting physicians. Data on procedural variables (contrast volume, operative and fluoroscopy time), 30-day major adverse events (MAEs) and clinical success, and endoleak and reintervention rates were secondary outcomes and subdivided into 4 quartiles of experience (Q1–Q4) or presented as first 2 versus latest 2 quartiles (Q1–Q2 vs Q3–Q4). Results: The mean follow-up was 4.3±4.0 years. The center’s learning curve was achieved after 75 procedures, and it was similar for the first implanting physician. The surgeon coming thereafter had a significantly shorter curve (10 TEVARs). Comparing Q1–Q2 with Q3–Q4, 30-day MAEs (16.1 vs 11.3%, p=0.164), 30-day mortality (11.4% vs 3.6%, p=0.003), and intraoperative additional maneuvers (21.5% vs 13.3%, p=0.033) were reduced along with an improvement in clinical success (85.9% vs 90.3%, p=0.190). From Q1 to Q4, operative time (139.8±65.5 to 76.7±43.7 min, p=0.001), fluoroscopy time (15.1±8.8 to 7.1±5.1 min, pConclusion: The learning curve shortened significantly over time with non-negligible clinical outcome improvements, suggesting that specific endovascular training is mandatory to become an effective TEVAR performer. Clinical Impact For the first time in literature, the standard TEVAR’s learning curve has been evaluated at a single vascular surgery center over a period of 25 years. The learning curve for the center and the first physician historically undertaking TEVAR was achieved at the 75th treated patient. The learning curve of the surgeons coming thereafter was significantly shorter (10 cases). This quarter-century demonstrated that intraoperative learning-related variables were associated with long-term clinical outcomes and all have improved over time. Centers approaching TEVAR for the first time and training program providers could use these data to aim to offer better clinical outcomes.

Objective: The aim of this study was to evaluate aortic remodelling and associated complications in patients treated by thoracic endovascular aneurysm repair (TEVAR) for blunt traumatic aortic injuries (BTAI). Methods: This was a retrospective, observational, multicentre study. Remodelling was considered as aortic diameter variations of >2 mm and distal graft and aortic axis angle modification measured by computed tomography angiography (CTA). The predefined levels of measurement were the proximal end of the graft (D1: landing in zone [LZ] 2; D2: LZ 3); distal end (D3); and control measurement (D4) 15 mm beyond D3. Survival, procedure, graft, and/or radiation exposure related complications were registered. CTA was required within three months and at one, six, and 10 years post-operatively. Results: Between 2004 and 2017 52 patients were treated; 47 were included for remodelling analysis (five immediate deaths were excluded); median age was 47 years (range 20–80 years). Mean TEVAR oversizing was 19.6% ± 9.7% (range 5%–35%). Following a median follow up of 67.4 ± 56.1 months (range 14–153 months) survival at one, three, six, and 10 years was 90.4% (standard error [SE] 4.1%), 88.3% (SE 4.5%) 84.8% (SE 5.5%), and 84.8% (SE 5.5%), respectively. There were no procedure/graft related complications except for one late intramural haematoma that required re-intervention. Freedom from aortic remodelling at one, six, and 10 years was 85.1% (SE 5.2%), 30.9% (SE 8.6%), and 24.7% (SE 8.8%), respectively. The increase in D1/D2 and D3 diameters were influenced by time from intervention (both p

Endovascular repair of aortic arch lesions requires revascularization of epiaortic vessels in case of coverage. The objective of this study was to compare the outcomes of surgical bypass versus endovascular reconstruction with a chimney graft.A retrospective analysis of a multicenter register between January 2005 and December 2019 was performed. A total of 127 patients were included and divided into 2 groups: thoracic endovascular aortic repair + surgical debranching (n = 72) and thoracic endovascular aortic repair + chimney stenting (n = 55). The main end points were major neurologic sequelae and type IA endoleak. Propensity score matching was performed to analyse baseline variables related to these outcomes.The mean follow-up was 35.6 months for the debranching group and 34.1 for the chimney group (P = 0.65). The incidence of stroke was higher in the chimney group although not statistically significant (7.3% vs. 4.1%; P = 0.46); for both groups, a wide angle between the ostium of the target vessel and the aorta and landing in Ishimaru Zone 0 was found to be the main predictors for major neurologic sequelae (P = 0.002 and P = 0.003, respectively). During follow-up, 9 (12.5%) type IA endoleaks occurred in the debranching group and 12 (21.8%) in the chimney group (P = 0.14). Aortic diameter larger than 66 mm and arch angle46° had a strong association with proximal endoleak incidence (P = 0.001 and P = 0.011, respectively) CONCLUSIONS: Surgical debranching showed better results than chimney stenting in terms of major neurologic events incidence and type IA endoleak, although the difference between the groups was not statistically significant. Further research with larger cohorts is needed to establish the indications for these procedures.

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.

Objective Target vessel instability is a relevant complication after thoracoabdominal aortic aneurysms branched endovascular aortic repair (BEVAR). Long-term bridging stent-graft (BSG) durability has already been established, but the incidence of long-term complications as component fractures was not deeply investigated. This paper aims to assess BSG fracture incidence and risk factors after BEVAR. Methods This was a dual-center observational retrospective cohort study. Data of each patient treated with BEVAR between April 2008 and December 2019 were prospectively collected. The primary outcome was the incidence of BSG fracture during follow-up. A logistic regression analysis was performed, including preoperative and postoperative measurements as well as intraoperative details to identify potential risk factors. Results Two hundred ninety-five target visceral vessels in 91 patients were considered suitable for cannulation. Technical success was 96.9% (286/295 target visceral vessels). The median follow-up was 32.5 months (interquartile range, 14.3-50.1 months). Five BSG fractures (1.75%; 5/286) were detected. Four BSG fractures involved the superior mesenteric artery, and one the celiac trunk. Four different types of fractured stents were detected during follow-up: two Advanta, one BeGraft, one Fluency, and one Viabahn. The median time to BSG fracture was 28.2 months (interquartile range, 11.7-50.8 months). The use of multiple stents (P = .030) and different stent types on the same vessel (P = .004) were associated with BSG fracture at univariable analysis. Using bare-metal stents for distal relining (P = .045) was the only significant factor predisposing to BSG fracture at multiple logistic regression. Conclusions BSG fracture is a rare but severe complication after BEVAR. It is not related to the stent type used as bridging stent, and it is hardly predictable based on preoperative anatomy. Using multiple and different stents on the same vessel and relining the bridging stents with bare-metal stents may increase BSG fracture risk. A strict computed tomography angiography follow-up remains the best strategy to detect target vessel instability.

Purpose To evaluate the Covera Plus (Bard, Tempe, Arizona) covered stent as a bridging stent in branched thoraco-abdominal endovascular aneurysm repair (BEVAR). Materials and Methods Retrospective analysis of 112 self-expandable stents was performed at 2 university centers between August 2017 and March 2019. Thirty-one consecutive BEVAR procedures were studied (21 males; mean age, 75 years; 29 American Society of Anesthesiologists grade III/IV) with 119 patent target vessels (7 did not receive the studied device). Primary endpoints were technical success, branch instability, and primary/secondary clinical success. Secondary endpoints included primary/secondary patency and any adverse events. Results Technical success was 100%. Median follow-up was 12 months (interquartile range, 6–14 months). Branch instability was registered twice (2/112), due to immediate renal occlusion and type Ic endoleak; no additional events occurred during the follow-up. Primary clinical success was 84%. There were 2 immediate deaths, 1 upper limb ischemia, 1 hemorrhage from splenic artery, and 1 type Ic endoleak; these last 3 events were successfully treated, with a secondary clinical success of 100% that was maintained during the follow-up. One late death occurred. Primary patency was 99% (111/112) and 100% (105/105) within 30 days and at the end of the study period,respectively. Adverse events included 4 acute kidney injuries and 2 spinal cord ischemia. No type I/III endoleaks, occlusion, fracture, or dislodging were diagnosed after 30 days. Conclusions The stent graft seems safe and effective for bridging in BEVAR with low branch instability and high patency rate. Longer follow-up is required to confirm these promising results.

The aim was to demonstrate contemporary outcomes of in situ saphenous vein bypass using a valvulotome.Analysis of two year outcomes of a multicentre registry based on the treatment of critical Limb Ischaemia with infragenicular Bypass adopting in situ SAphenous VEin technique (LIMBSAVE). Between January 2018 and December 2019, 541 patients in 43 centres were enrolled. In all patients an innovative valvulotome was used. Early outcomes were assessed. Two year outcomes according to Kaplan-Meier curves in terms of patency and limb salvage were evaluated. Associations between patient and procedure variables were analysed with univariable and multivariable analyses.In all cases, a valvulotome was able to lyse the valves. Vein injury due to the in situ technique was 3.5%. Thirty day mortality and major amputation rates were 3% and 0.9%, respectively. Mean follow up was 12.1 months. Two year estimated primary patency, primary assisted patency, secondary patency, and limb salvage were 69.1%, 81.4%, 86.5%, and 94.5%, respectively. Multivariable analysis showed an association between pre-operative vein diameter3 mm and lower primary patency (hazard ration [HR] 14.3, p.001), primary assisted patency (HR 9.4, p = .002), secondary patency (HR 7.2, p = .007), and limb salvage (HR 7.8, p = .005) rates. Distal anastomosis to a tibial or foot vessel was also associated with lower primary patency (HR 4.8, p = .033), and primary assisted patency (HR 6, p = .011) rates. Use of a suprafascial tributary collateral as a graft was associated with lower primary patency (HR 6.7, p = .013), and primary assisted patency (HR 4.2, p = .042) rates.Vein diameter3 mm, distal anastomosis on a tibial or foot vessel, and use of a suprafascial tributary collateral as a graft were significantly associated with loss of patency and limb loss during follow up.

The aim of this study is to compare early and follow-up outcomes of late open conversions (LOC, with complete or partial endograft explantation) and semi-conversions (SC, with endograft preservation) after endovascular aneurysm repair in a multicenter experience.All LOC and SC performed from 1997 to 2020 in 11 vascular centers were compared. Endograft infections or thrombosis were excluded. Primary endpoints were early mortality and long-term survival estimates. Secondary endpoints were differences in postoperative complication rates and conversion-related complications during follow-up.In the considered period, 347 patients underwent surgery for endovascular aneurysm repair complications. Among these, 270 were operated on for endoleaks (222 LOC, 48 SC). The two groups were homogeneous in terms of American Society of Anesthesiologists score (LOC, 3.2 ± 0.7; SC, 3 ± 0.5; P = .128) and main endograft characteristics (suprarenal fixation, bifurcated/aorto-uni-iliac configuration). The mean age was 75 ± 8 years for LOC and 79 ± 7 years for SC (P = .009). Reasons for LOC were: 62.2% (138/222) type I endoleak, 21.6% (48/222) type II endoleak, 7.7% (17/222) type III endoleak, and 8.5% (19/222) endotension. Indications for SC were: 64.6% (31/48) type II endoleak, 33.3% (16/48) type I endoleak, and 2.1% (1/48) type III endoleak. Thirty-day mortality was 12.2% (27/222) in the LOC group, and 10.4% (5/48) in the SC group (P = .73). Postoperative complication rate was higher in the LOC group (45.5% vs 29.2%; P = .04). The estimated survival rate after LOC was 80% at 1 year and 64% at 5 years; after SC, it was 72% at 1 year and 37% at 5 years (log-rank P = .01). During the median follow-up of 21.5 months (interquartile range, 2.4-61 months), an endoleak after SC was found in the 38.3% of the cases; sac growth was recorded in the 27.7% of SC patients.SC has an early benefit over LOC in terms of reduced postoperative complications but has a significantly inferior mid-term survival. The high rates of persistent and/or recurrent endoleaks reduce SC durability.

Background The diabetic foot ulcer (DFU) is a high prevalence complication that significantly impairs the health-related quality of life (HRQoL) and is characterized by prolonged hospital length of stay (LOS). The impact of the micro-fragmented autologous adipose tissue injection at the minor amputation wound in the case of DFU (MiFrAADiF) on HRQoL and LOS compared to the standard care has not been determined yet. Methods This was a two-arm, 6-month, individually randomized controlled single-center clinical trial. A 1:1 randomization to local injection of autologous micro-fragmented adipose tissue (treatment group; n=57) or standard clinical care (control group; n=57) was performed. The primary objective was the HRQoL. The secondary endpoint was the LOS. HRQoL was assessed with the Medical Outcomes Study 36-item Short-Form Health Survey which provides 2 scores focused on physical (PCS) and mental functioning (MCS). The trial was registered in ClinicalTrials.gov (NCT03276312). Results The type of treatment (p=0.009) and the time elapsed since surgery (p= 0.0000) demonstrated a significant improvement on PCS. The MCS improvements resulted in a non-significant association with treatment (p= 0.21). The time elapsed since surgery showed a significant influence on the MCS (p= 0.0000). The mean LOS was 16.2 days and 24.4 days for the treatment and the control group respectively (p= 0.025). Conclusions The MiFrAADiF trial demonstrated a significant improvement in terms of physical HRQoL and a significant reduction of the hospital length of stay after injection of micro-fragmented autologous adipose tissue in diabetic patients' minor amputations wound.

Purpose: To define the learning curve of a widely employed stent-graft for thoracic endovascular repair (TEVAR) by analyzing procedural variables and their impact on long-term outcomes. Materials and Methods: Standard TEVARs for each major aortic thoracic disease were included excluding procedures using thoracoabdominal, arch fenestrated/branched devices and/or chimneys. The primary outcome was the learning curve analysis using the cumulative sum chart method. The secondary outcomes, presented as early (Q1–Q2) versus latest (Q3–Q4) quartiles of experience, were 30-day major adverse events (MAEs); procedural details (additional maneuvers, operative and fluoroscopy time, and contrast volume); 30-day clinical success; endoleak; aorta-related reintervention; and overall and aorta-related survival. Results: Between November 2005 and September 2021, 220 consecutive TEVAR procedures involving the Relay endograft (Terumo Aortic, Sunrise, FL, USA) were performed and included in the present analysis. The mean follow-up was 4.5 ± 3.9 years. The learning curve was reached after 10 patients. Secondary outcomes improved significantly over experience. Thirty-day MAE occurrence was 14.5% versus 11.8% (p=0.550). Additional maneuvers (p=0.009), access-vessel additional maneuvers (p=0.010), operative time (p=0.004), Relay Plus (p=0.001), and implantation of multiple stent-grafts (p=0.034) were independent risk markers for MAEs. Operative time (125.9 ± 66.7 vs 86.7 ± 48.5 minutes, pConclusion: In a high-volume center with a consistent previous endovascular experience, the Relay graft presented satisfactory long-term results with a short learning curve supporting its reliability. Clinical Impact The manuscript addresses the understanding of how many TEVAR procedures with a currently implanted device have been required to reach the learning curve for an endovascular skilled center. Our TEVAR experience with the Relay stent-graft (Terumo Aortic) demonstrated that ten implantations were required to achieve the device-related learning curve. The fifteen-year analyzed period showed that intraoperative learning-related variables were associated with long-term clinical outcomes and both improved over time. The Relay stent-graft presented satisfactory long-term results along with a short learning curve in a high-volume endovascular center supporting its ongoing implantation.

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.

Objective At our institution, we adopted routinely ultrasound guided approach for all percutaneous procedures. The objective of this study was to describe the predictors of access site failures (ASFs) in patients undergoing percutaneous aorto iliac revascularization and to also evaluate whether other factors such as time period or different vascular devices may influence outcomes in terms of ASFs. Methods We reviewed all consecutive percutaneous revascularizations performed for aortoiliac occlusion or stenosis at our institution from 2011 to 2020. All procedure were performed using an ultrasound (US) guided common femoral access. The primary outcome was ASFs, defined as bleeding or groin hematomas that required transfusions; pseduoaneurysm (diagnosed by US); retroperitoneal hematoma; artery laceration or ruptured (diagnosed intraoperatively); and thrombosis. Multivariable logistic regression was used to determine predictors of ASFs. Results A total of 502 femoral arteries were accessed under DUS guidance with no failure in sheath placement. Technical success was achieved in 498 of 502 procedures (99.2%). ASFs occurred in 21 patients (7%); but year of procedure appear to be associated with an excess of ASFs as rates were different between the first and second period of the study (10.9% vs 4.8%, P = .04). Results of multivariable logistic regression model indicated that independent predictors of ASFs were common femoral artery (CFA) calcification peripheral artery calcium scoring system (PACCS) grade (odds ratio [OR], 8.7; 95% confidence interval [CI], 5.5-13.7), and CFA diameter (OR, 0.46; 95% CI, 0.25-0.85). Compared to patients with successful percutaneous access, ASFs resulted in longer post-op lengths of stay (P = Conclusion Percutaneous US guided access can be safely performed in patients undergoing endovascular procedures for aorto iliac revascularization with TASC C and D lesions. CFA calcification PACCS grade greater than 3 and smaller femoral vessel diameter are independent risk factors for ASFs.

A 78-year-old woman presented with type IIIC and IIID endoleaks after endovascular treatment for a thoracoabdominal aortic aneurysm. Mating between the ruptured segments of superior mesenteric artery stent graft was performed. After failed attempts at relining the right renal artery stent graft, a hybrid approach was used to connect the side branch to the target vessel: a stent graft was deployed into the side branch of the main graft and it was temporarily occluded with a balloon. After opening the sac, a stent graft was deployed into the right renal artery and the two stent grafts were connected with a running suture. Follow-up examination performed 1 month postoperatively by computed tomography imaging confirmed the effectiveness of this treatment. Key Words: Thoracoabdominal, Hybrid technique, Multibranched graft, BEVAR

Purpose: To report preliminary outcomes of Viabahn Balloon-Expandable Endoprosthesis (VBX) stent-graft as bridging stent for renal arteries in fenestrated endovascular aneurysm repair (FEVAR). Materials and Methods: Between 2018 and 2019, patients undergoing FEVAR at 3 referral Italian university hospitals were prospectively collected. During the study period, VBX was the first-line choice as bridging stent for renal arteries. Procedural and anatomical data were analyzed, including renal artery (RA) configuration. A dedicated software (3Mensio, Vascular Imaging, Bilthoeven, The Netherlands) was used and RA anatomy classified as follow: upward-oriented in case of any angle >30° above the horizontal or transverse axis perpendicular to the aortic axis, downward-oriented if there was an angle >30° measured below the transverse axis and downward + upward in case of an angle 90°. Primary endpoints were technical success, defined as complete deployment of the fenestrated endograft without target vessel (TV) loss, limb stenosis or occlusion and type I or III endoleak, and freedom from target artery instability (TAI), defined by target vessel-related death, occlusion, rupture or reintervention for stenosis, endoleak or disconnection. Secondary endpoints were target artery patency rate and freedom from reinterventions. Results: A total of 26 elective FEVAR for juxta/pararenal aneurysm (20), thoracoabdominal type II (3) and type IV (3) were included. Fifty-one RA were planned for revascularization. Of these, 32 were downward, 10 horizontal, 6 upward, 4 were downward + upward. Technical success was achieved in 88.5% (23/26) of patients and 94.2% (48/51) of the TVs. One occlusion (2.1%) occurred within 30 days in a patient with previous endovascular aortic repair and suprarenal fixation. During follow-up (median 10 months), there was 1 type IC endoleak after 6 months (2.1%) in a patient with upward plus downward arterial orientation. Freedom from TAI was 96.1% (CI = 0.89 to 1.04) at first month and 92.3% (CI = 0.82 to 1.03) at 6 months. No aneurysm-related mortality and renal insufficiency occurred during follow-up. Conclusion: The use of VBX as bridging stent of RA in FEVAR is safe and feasible. Previous EVAR and tortuosity of RA may be a challenging on target vessel fate.

Background Concern exists about durability of stent grafts used to bridge aortic grafts to visceral and renal arteries during fenestrated and branched endovascular aneurysm repair (F/B-EVAR). There are no guidelines regarding the ideal technique for joining target vessels (TVs). Methods We systematically reviewed data published from 2014 to 2019 using PRISMA guidelines and PICO models. Keywords were searched in MEDLINE, EMBASE, and Cochrane Library. All articles were screened by two authors (a third author in case of discrepancies). Only original articles regarding F/B-EVAR in complex aortic aneurysm, reporting the number and type of TVs mated, the onset of bridging stent complications, and reinterventions on TVs were included. Analysis included quality assessment scoring, types of stent grafts, and complications related to bridging stents. Results 19 studies were included with 2,796 patients and 9556 TV; 4,797 renal arteries (50.2%), 4,174 visceral arteries (43.6%), and undefined TV (n = 585; 6.1%) were bridged. Balloon-expandable stent-grafts (B-EXP) were used in 40.9% and self-expandable (S-EXP) in 22.7% and undefined stents in 36.3%. The included studies had quality assessment scores ranging between 11/15 and 15/15, with high grade of accordance on reporting general results, but a low grade of accordance on reporting detailed data. Despite study heterogeneity, high-volume analysis confirmed a higher rate of complication in renal arteries than visceral arteries, 6% (95% CI 4–8) vs. 2% (95% CI 1–3), respectively. The rate of reinterventions was similar, 3% (95% CI 2–4) and 2% (95% CI 1–3). S-EXP versus B-EXP stent complication was 4% (95% CI 2–7) vs. 3% (95% CI 2–5), respectively. Conclusions This systematic review underlines the low grade of accordance in reporting detailed data of bridging stents in F/B-EVAR. Renal TVs were more prone to complications, with an equivalent reintervention rate to visceral TVs. As to B-EVAR, the choice of B-EXP over S-EXP is still uncertain.

Purpose To evaluate the efficacy of endovascular repair of popliteal artery aneurysms (PAAs) with a wire-interwoven nitinol stent. Materials and Methods This is a prospective, descriptive, and analytical study. From January 2016 to December 2018, 28 consecutive patients (29 lower limbs) were treated for a PAA with the deployment of the Supera stent (Abbott Vascular, Illinois). Twenty-three (79.3%) PAAs were asymptomatic; 6 (20.7%) presented with symptoms. The mean diameter and length of the aneurysm were 26.8 mm (20–40 mm) and 47.1 mm (23–145 mm) respectively. The primary endpoint was the prevention of embolic symptoms. The secondary endpoints were aneurysm exclusion, aneurysm diameter decrease, freedom from reintervention, and preservation of preoperative runoff vessels. Results Technical success was 100%, with a median of 2.4 run-off vessels at completion angiography, without any loss of run-off vessels. A double Supera stent was deployed in 10 cases. At completion angiography, a median of 2.4 runoff vessels were present, without any loss of runoff vessels. The mean follow-up time was 24.3 (12–35) months. Primary endpoints were reached in 100% of the cases and vessels run off was preserved in all cases. In 2 PAAs, complete sac thrombosis was witnessed at 6-month follow-up, while at 12-month follow-up, it was seen in 10 of 29 (34.4%) limbs. In all the other cases the diameter of the aneurysm remained stable, with a freedom from sac enlargement of 100%. No fractures or stent thromboses were detected. Conclusions For endovascular repair of PAAs, the use of a thick interwoven-wire stent, that could work like a multilayer flow modulator showed encouraging mid-term results with no cases of stent fracture, occlusion or aneurysm increase.

Background Almost 38% of all patients with end-stage chronic kidney disease (CKD) have peripheral arterial disease of the lower limbs that can lead to chronic limb threatening ischemia (CLTI). The aim of this study was to assess the impact of several factors to conduct a stratification of the amputation risk in CKD patients with CLTI receiving endovascular revascularization. Methods Observational, retrospective, single-center study of patients treated from 2010 to 2016. The primary endpoint was the major amputation. The study included adult CKD dialysis patients affected by CLTI (rest pain and/or trophic lesions) with indication to endovascular revascularization and excluded for open repair. Results A total of 82 patients were considered (58 men [70.7%], 24 women [29.3%] mean age 70.4 ±15.0 years). The number of major amputations was 28 (34.1%). The arterial lesion severity (TASC II-classification) and the trophic lesions extension (WIfI classification) were significantly associated with major amputation (OR and 95%CI, 1.20 [1.07-1.34], p= .001; 2.65 [1.49-4.72], p= 0.001; respectively). Based on the abovementioned characteristics, a prognostic score was proposed to predict the major amputation risk. A score ≥23 was associated with a 67.6% probability of amputation in the following 12 months. Conclusions The CLTI revascularization is associated with poor outcomes in CKD patients. The present clinical score provided a pragmatic tool to calculate the major amputation risk. An elevated score could facilitate the decision-making process in order to perform an endovascular treatment vs conservative approach.

Purpose: To evaluate intravascular ultrasound (IVUS) safety and efficacy to detect visceral stenting issues during complex endovascular aneurysm repair through branched and fenestrated repair (B-FEVAR). Materials and Methods: A single-center retrospective analysis of 33 bridging stents assessed intraoperatively using IVUS between January and September 2020 was performed. Ten aortic aneurysm patients [7 thoracoabdominal / 1 pararenal / 2 juxtarenal; 3 females; mean age 73 years [range 70–77 years]) were included. Eight BEVAR (5 standard; 2 custom-made) and 2 FEVAR (custom-made) were performed. The study assessed the safety and efficacy of IVUS utilization to detect immediate branch instability after visceral stenting in the case of B-FEVAR. The primary safety endpoint was defined as the absence of IVUS-related adverse events. The primary efficacy endpoint was defined as the composite of technical success of the IVUS-assessment in each target visceral vessels (TVVs), the rate of IVUS-findings divided as prompting additional maneuvers or not, and the incidence of postoperative computed tomography angiography findings compared with intraoperative assessment. Results: There were no IVUS-related adverse events. The technical success of the IVUS-assessment was achieved in all TVVs. No technical issues compromised the evaluation of the intended vessel. Among the 7 findings identified by IVUS, 3 were suspected at the angiography. In all, 57% (4/7) had normal final angiography. IVUS was able to detect a 12% (4/33) intraoperative branch instability not identified/suspected at the completion angiography. The IVUS assessment led to an immediate revision in 5 (15%) vessels. A total of 57% (4/7) of the issues were detected in patients undergoing primary BEVAR. The remaining 43% (3/7) was detected in patients undergoing secondary intervention for branch instability. Conclusion: IVUS was safe as an adjunctive imaging technique to assess completion after B-FEVAR. It demonstrated efficacy in the detection of intraoperative issues missed by angiography. Further investigations are required to validate these promising results.

The unibody (Powerlink/AFX/AFX2) Endovascular AAA device (Endologix Inc., CA, USA) presents a unique design with its long main body and two innate limbs. The device is designed to be deployed and sits on the native aortoiliac bifurcation and represents the only one-piece bifurcated endograft designed to use anatomical fixation for endograft stabilization. According to published literature, the unibody device seems to represent a valid choice in the treatment of abdominal aortic aneurysms. This particular device would seem to satisfactorily perform even in the treatment of more compressed aneurysms (also in off-label association with parallel grafts) and in occlusive pathologies. Ongoing studies will provide new real-life data in a large and unselected patient population to better understand the device’s advantages and limitations.

Objective The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. Methods To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularisation TIPI 2 – 3. Safety and clinical success rate were collected at one month. Results One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 – 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 – 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. Conclusion Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

Bellosta et al1 recently demonstrated a significantly higher incidence of acute limb ischemia (ALI) in COVID-19 patients. In addition, an increased failure rate after revascularization occurred. The colleagues must be complemented for their clinical and scientific com- mitments. The increased thromboembolic complica- tions in COVID-19 patients have been reported even in those receiving anticoagulant therapy and in nonathero- sclerotic patients.1-3 More than 27,000 COVID-19 cases were registered in our region (Emilia-Romagna). Our unit represents the unique vascular surgery service in the province of Modena. As a tertiary COVID center, we did not observe ALI in such patients. It must be taken into account that Bellosta et al1 provide care in an Italian region with a higher incidence of COVID-19 (Lombardia). However, this difference of incidence in northern Italy remains unclear. We observed two COVID-19 patients with concomitant pulmonary embolism (PE) and aortic floating thrombus (AFT; Fig). They were asymptomatic for peripheral embolism and without a source for the PE. Because of the PE, anticoagulant therapy and low- dose antiplatelet therapy were initiated. A significant reduction of the AFT was observed with resolution of the PE in both patients. The AFT is a rare but serious clin- ical condition able to cause dramatic peripheral embo- lism.4 Aortic stent implantation, abnormal coagulation function, and aortic diseases were reported as predictors of AFT.4 Medical therapy was proposed as the treatment of choice in asymptomatic AFT patients.4 Following the plethora of procoagulant modifications described in COVID-19 patients and the above-mentioned trends to intrastent thrombus relapse, we preferred to avoid inva- sive procedures.4,5 Indeed, the AFT may be a more common source of ALI in COVID-19. The preoperative workup reported by Bellosta et al1 did not include thoracic computed tomography (CT) angiog- raphy. COVID-19 patients are usually diagnosed by means of CT scans, and our observations were possible thanks to the use of contrast medium. Finally, thoracoabdominal CT angiography should be considered a routine evaluation in COVID-19 patients presenting with embolic complications. Clearly, further investigations are required: the throm- botic mechanism; the type, dose, and duration of the anti- coagulant therapy; and the indications for and timing of surgical management of thrombus and emboli.1-3,5

Objectives: The aim was to report indications, technical aspects, and outcomes of a multicentre experience of late open conversions (LOCs) after endovascular abdominal aneurysm repair (EVAR), in order to identify risk factors which may influence early morbidity and mortality rates, and long term survival. Methods: Ten vascular centres retrospectively reviewed all patients requiring LOC (≥30 days from initial EVAR, undergoing total or partial endograft explantation) from 1996 to 2017. Baseline characteristics, endograft data, indications, procedural details, post-operative outcomes, and follow up data were reviewed and analysed. Results: Included patients totalled 232 (90.1% males, mean age 74.3 ± 7.9 years). The number of LOC per year significantly increased during the study period, reaching 22 in 2017 (correlation r = 0.867, p