Continued sac perfusion of popliteal artery aneurysms after ligation and bypass. Relevance of duplex ultrasound surveillance and treatment.

AIM: Conventional management of popliteal artery aneurysms (PAA) through a medial approach may be lon term ineffective. We report our long term rate of continued sac perfusion after ligation and bypass, combined to duplex ultrasound (DUS) surveillance protocol. PATIENTS AND METHODS: Follow-up data of 24 PAA (mean diameter 37.5 ± 8.8 mm) treated by ligation and bypass with eventual adjunctive procedures (direct sac embolization or resection) were collected. The endpoints of the study were the long term rate of continued sac perfusion and the freedom from any reintervention. RESULTS: Twentyfour PAA were treated in 20 patients. Long term follow-up was complete for 19 graft (79.1%). During a median follow-up of 71.2 months (4-168), persistent sac flow was found in 5 legs (26.3%), 4 to 36 months after surgery, without enlargement or rupture. The cumulative Kaplan-Meier survival free from PAA reperfusion at 1, 3, and 6 years was 91.5%, 77.5%, and 71.5%, respectively. Basing on DUS surveillance, late additional procedures were required in 5 patients (25%), to treat sac reperfusion or preserve graft patency. The cumulative Kaplan-Meier survival free from any reintervention at 1, 3, and 6 years was 91.5%, 72.8%, and 67%, respectively. CONCLUSIONS: Conventional management of PAA through a medial approach may be associated to progressive sac expansion. The DUS surveillance protocol remains strongly recommended to detect sac perfusion and suggest the timing of reintervention before rupture occurs. Adjunctive intraoperative procedures could improve the long term results, but further studies on large series are needed. KEY WORDS: Acrylic glue, Duplex ultrasound study, Femoropopliteal bypass, Popliteal artery aneurysm, Ultrasoundguided embolization.

Surgical approach to the suprarenal abdominal aorta.

AIM: The surgical approach to the pararenal aorta can be performed through a midline laparotomy or retroperitoneal approach. The current paper reports the techniques for the suprarenal aortic approach, through the review of technical literature on this topic. METHODS: Forty-six out of 82 technical papers regarding the surgical approach to the suprarenal aorta were reviewed, focusing on relevant technical details, such as the position of patient, type of incision, aortic approach and anatomical limitations. RESULTS: The left retroperitoneal abdominal approach offers numerous advantages, mainly observing some modifications of the original technique (9th intercostal space incision, short radial frenotomy, section of the inferior mesenteric artery). The traditional transperitoneal access, through a midline or bilateral subcostal incision with retroperitoneal medial visceral rotation, is best indicated when an unrestricted approach to the right iliac arteries is needed, but it can be more challenging in patients with "hostile abdomen", for which a retroperitoneal route is probably more appropriate. A more aggressive surgical approach through a 7th-9th space thoracolaparotomy, combined with semicircunferential frenotomy, should be strongly recommended to provide a safe suprarenal aortic aneurysm repair in high risk patients, who often require adjunctive procedures, such as selective visceral perfusion and left heart bypass. CONCLUSIONS: Many technical options can be used to approach the suprarenal aorta, but none can be "radicalized". The surgical strategy must be individualized according to the anatomo-clinical characteristics of the patient and aneurysm morphology as well. KEY WORDS: Abdominal aorta, Aortic aneurysm, Surgical approach.

Carotid artery revascularization using second generation stents versus surgery: a meta-analysis of clinical outcomes.

INTRODUCTION: Meta-analyses and emerging randomized data indicate that second-generation ('mesh') carotid stents (SGS) may improve outcomes versus conventional (single-layer) stents but clinically-relevant differences in individual SGS-type performance have been identified. No comparisons exist for SGS versus carotid endarterectomy (CEA). EVIDENCE ACQUISITION: Thirty-day death (D), stroke (S), myocardial infarction (M), and 12-month ipsilateral stroke and restenosis in SGS studies were meta-analyzed (random effect model) against CEA outcomes. Eligible studies were identified through PubMed/EMBASE/COCHRANE. Forest plots were formed for absolute adverse evet risk in individual studies and for relative outcomes with each SGS deign versus contemporary CEA outcomes as reference. Meta-regression was performed to identify potential modifiers of treatment modality effect. EVIDENCE SYNTHESIS: Data were extracted from 103,642 patients in 25 studies (14 SGS-treated, 41% symptomatic; nine randomized controlled trial (RCT)-CEA-treated, 37% symptomatic; and two Vascular Quality Initiative (VQI)-CEA-treated, 23% symptomatic). Casper/Roadsaver and CGuard significantly reduced DSM versus RCT-CEA (-2.70% and -2.95%, P<0.001 for both) and versus VQI-CEA (-1.11% and -1.36%, P<0.001 for both). Gore stent 30-day DSM was similar to RCT-CEA (P=0.581) but increased against VQI-CEA (+2.38%, P=0.033). At 12 months, Casper/Roadsaver ipsilateral stroke rate was lower than RCT-CEA (-0.75%, P=0.026) and similar to VQI-CEA (P=0.584). Restenosis with Casper/Roadsaver was +4.18% vs. RCT-CEA and +4.83% vs. VQI-CEA (P=0.005, P<0.001). CGuard 12-month ipsilateral stroke rate was similar to VQI-CEA (P=0.850) and reduced versus RCT-CEA (-0.63%, P=0.030); restenosis was reduced respectively by -0.26% and -0.63% (P=0.033, P<0.001). Twelve-month Gore stent outcomes were overall inferior to surgery. CONCLUSIONS: Meta-analytic integration of available clinical data indicates: 1) reduction in stroke but increased restenosis rate with Casper/Roadsaver, and 2) reduction in both stroke and restenosis with CGuard MicroNET-covered stent against contemporary CEA outcomes at 30 days and 12 months used as a reference. This may inform clinical practice in anticipation of large-scale randomized trials powered for low clinical event rates (PROSPERO-CRD42022339789).

Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Background: Single-cohort studies suggest that second-generation stents (SGS; "mesh stents") may improve carotid artery stenting (CAS) outcomes by limiting peri- and postprocedural cerebral embolism. SGS differ in the stent frame construction, mesh material, and design, as well as in mesh-to-frame position (inside/outside). Objectives: To compare clinical outcomes of SGS in relation to first-generation stents (FGSs; single-layer) in CAS. Methods: We performed a systematic review and meta-analysis of clinical studies with FGSs and SGS (PRISMA methodology, 3302 records). Endpoints were 30-day death, stroke, myocardial infarction (DSM), and 12-month ipsilateral stroke (IS) and restenosis (ISR). A random-effect model was applied. Results: Data of 68,422 patients from 112 eligible studies (68.2% men, 44.9% symptomatic) were meta-analyzed. Thirty-day DSM was 1.30% vs. 4.11% (p < 0.01, data for SGS vs. FGS). Among SGS, both Casper/Roadsaver and CGuard reduced 30-day DSM (by 2.78 and 3.03 absolute percent, p = 0.02 and p < 0.001), whereas the Gore stent was neutral. SGSs significantly improved outcomes compared with closed-cell FGS (30-day stroke 0.6% vs. 2.32%, p = 0.014; DSM 1.3% vs. 3.15%, p < 0.01). At 12 months, in relation to FGS, Casper/Roadsaver reduced IS (−3.25%, p < 0.05) but increased ISR (+3.19%, p = 0.04), CGuard showed a reduction in both IS and ISR (−3.13%, −3.63%; p = 0.01, p < 0.01), whereas the Gore stent was neutral. Conclusions: Pooled SGS use was associated with improved short- and long-term clinical results of CAS. Individual SGS types, however, differed significantly in their outcomes, indicating a lack of a "mesh stent" class effect. Findings from this meta-analysis may provide clinically relevant information in anticipation of large-scale randomized trials.

Long-term results of treatment of infrarenal aortic aneurysms with low-profile stent grafts in a multicenter registry.

OBJECTIVE: In recent years, manufacturers have developed new stent grafts with lower profiles to increase the endovascular aneurysm repair applicability. As reported by the current European Society for Vascular Surgery guidelines, long-term evaluation of such low-profile platforms is strongly recommended. This study aims to report outcomes beyond 5 years from a multicenter registry, including a real-world cohort of patients electively treated with low-profile stent grafts. METHODS: A retrospective data collection of patients who had undergone elective implantation of low-profile endograft ≤16 Fr. (Zenith LP, Ovation, Incraft) was performed in nine centers. The primary endpoint was a long-term primary clinical success. Secondary endpoints were survival rate, freedom from abdominal aortic aneurysm (AAA)-related death, freedom from type I to III endoleak, limb patency, and freedom from all reinterventions. The Kaplan-Meier curves were stratified for investigative devices. A multivariate analysis evaluated predictors of primary clinical success and reintervention rate. RESULTS: A total of 619 patients were enrolled (Ovation, n = 373; Incraft, n = 111; and Zenith LP, n = 135), with a mean follow-up of 56.8 ± 22.8 months. The overall primary and the secondary clinical success rate at 8 years was 72.1% and 93.8%, respectively. At 8 years, overall survival was 53.2%, freedom from AAA-related death was 94.4%, freedom from reintervention was 74%, freedom from type I/III endoleak was 86.9%, and limb patency was 90.4%. A significantly worse primary clinical success of the Zenith LP was recorded as dependent on more limb-related events. No differences between platforms were registered in the rate of AAA-related deaths, open conversion, sac enlargement, and type I/III endoleaks (P = .26). Multivariate analysis identified iliac tortuosity (hazard ratio, 2.053) and Zenith LP (hazard ratio, 3.818) as significant independent predictors of clinical failure and reintervention. CONCLUSIONS: Low-profile stent grafts have acceptable long-term outcomes. Overall survival and AAA-related death were in line with those reported for traditional devices. Long-term surveillance and reintervention, when necessary, remain crucial to guarantee durability.

1-Year Results From a Prospective Experience on CAS Using the CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: The aim of this study was to evaluate the 1-year safety and efficacy of a dual-layered stent (DLS) for carotid artery stenting (CAS) in a multicenter registry. BACKGROUND: DLS have been proved to be safe and efficient during short-term follow-up. Recent data have raised the concern that the benefit of CAS performed with using a DLS may be hampered by a higher restenosis rate at 1 year. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system at 20 centers. The primary endpoint was the occurrence of death and stroke at 1 year. Secondary endpoints were 1-year rates of transient ischemic attack, acute myocardial infarction, internal carotid artery (ICA) restenosis, in-stent thrombosis, and external carotid artery occlusion. RESULTS: At 1 year, follow-up was available in 726 patients (99.04%). Beyond 30 days postprocedure, 1 minor stroke (0.13%), four transient ischemic attacks (0.55%), 2 fatal acute myocardial infarctions (0.27%), and 6 noncardiac deaths (1.10%) occurred. On duplex ultrasound examination, ICA restenosis was found in 6 patients (0.82%): 2 total occlusions and 4 in-stent restenoses. No predictors of target ICA restenosis and/or occlusion could be detected, and dual-antiplatelet therapy duration (90 days vs 30 days) was not found to be related to major adverse cardiovascular event or restenosis occurrence. CONCLUSIONS: This real-world registry suggests that DLS use in clinical practice is safe and associated with minimal occurrence of adverse neurologic events up to 12-month follow-up.

Could Gender Impact on Immediate and Long-term Carotid Artery Stenting Outcome? Insight from an Italian Single Center Experience.

BACKGROUND: Carotid artery stenting (CAS) has become a valid alternative to carotid endarterectomy in stroke prevention. However, female gender is still considered as an independent risk factor for CAS procedures, potentially limiting immediate and long-term benefits. Aim of present study was to evaluate gender differences in CAS submitted patients from an Italian high-volume center. MATERIAL AND METHODS: a retrospective monocentric study has been conducted on 568 patients (366 males and 202 females), submitted to CAS, between January 2000 and December 2019. Besides gender sex, clinical anatomical, and procedural data were collected as possible factors determining the outcome, when associated to sex gender itself. Primary endpoint of this study consisted in evaluating the technical and procedural success ratio, and the incidence of major and minor stroke, transient ischemic attack, acute myocardial infarction (AMI) peri-procedurally and at medium and long term, between the male and the female population. Secondary endpoint of this study consisted in evaluating the percentage ratio of minor complications happening peri-procedurally in both genders. RESULTS: Male patients were more likely to be octogenarians, clinical history of coronary artery disease, and smokers, while diabetes was more frequent in female patients. Anatomical and plaque morphology features were not different between the two groups. Technical success was obtained in all but two patients (99,6%), while procedural success was 95% (538/566 patients). During the peri-procedural time, no major stroke, 16 minor strokes (2,81%, 2,45% males vs. 3,45% females, P= 0,48), and 11 transient ischemic attack (2,18% males vs. 1,48% females, P= 0,56) were recorded. At a medium follow-up 57 months, 32 stroke (8 major strokes, 24 minor strokes) episodes (5,6%, males 5,7% vs. females 5,4%, P= 0,88), 24 AMIs (4,2%, males 4,6% vs. females 3,46%, P= 0,5;), 13 restenosis (2,8%, males 2,4% vs. females 1,9%, P= 0,71) and 223 deaths (39,2%, males 34,9% vs. females 47%, P= 0,0048) were noted. CONCLUSIONS: Our results showed no differences in immediate, and long-term CAS outcomes between gender. Larger, prospective studies are required to assess the real importance and significance of gender in determining CAS procedures' benefit and outcome.

Comparison of Outcomes Following EVAR Based on Aneurysm Diameter and Volume and Their Postoperative Variations.

PURPOSE: to evaluate the impact of bi- and 3-dimensional preoperative aortic morphological features and their immediate postoperative variations on the outcome of abdominal aortic aneurysms (AAA) treated by endovascular exclusion with standard devices (EVAR). MATERIALS AND METHODS: Double centre retrospective analysis of prospectively collected registry data of EVAR patients. For all patients, preoperative and 30-day computed tomographic angiography images (CTA) were reviewed. Preoperative maximum AAA diameter >59 mm and volume >159 cm3, and any 30-day postoperative increasing at CTA, were considered as potentially influencing the outcome. The outcome measures were: primary technical success; 30-day, 1-year, and mean follow-up reintervention, all-cause and AAA-related mortality rates, and also endoleak-related reinterventions. RESULTS: Three hundred and thrity-three patients were enrolled. Mean preoperative and 30-day AAA diameter and volume were 50.4 mm ± 11.8 vs. 49.1 mm ± 12.1, and 112.9 cm3 ± 79.5 vs. 112.1 cm3 ± 80.5, respectively. Primary technical success was achieved in all cases. At 34.9 months follow-up, cumulative reintervention rate was 12.0%, mortality rates 7.2%, without AAA-related deaths. Endoleak-related reintervention rate was 7.5%. At uni- and multi-variate analysis, preoperative AAA diameter >59 mm, and AAA volume >159 cm3 were significantly associated to reintervention (P = 0.012; P = 0.002), and reintervention and death (P = 0.002; P = 0.001) during follow-up. Additionally, any increase in postoperative AAA diameter or volume was significantly associated with reintervention (P = 0.001, P = 0.001) and reintervention and death (P = 0.006, P = 0.001). Endoleak-related reintervention were also significantly associated with all of the analysed morphological parameters (P = 0.019, P = 0.005, P = 0.005, and P = 0.002, respectively). CONCLUSIONS: Patients with larger baseline AAA size and volume as well as unfavourable early remodelling of the sac are associated to worse long-term EVAR outcome.

Endovascular aortic repair in patients with challenging anatomies: the EXTREME study.

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.

Intravascular Lithotripsy for Treatment of Calcified Lesions During Carotid Artery Stenting.

PURPOSE: To report the use of intravascular lithotripsy (IVL) in the treatment of calcified carotid artery lesions. MATERIALS AND METHODS: The records of 21 high-surgical-risk patients (mean age 75.1±8.1 years; 17 men) who were treated at 8 centers for carotid artery stenosis ≥70% were retrospectively reviewed. Twelve patients had a history of cerebrovascular disease. All patients had heavily calcified carotid artery lesions: 19 de novo and 2 in-stent restenoses (ISR). The mean baseline stenosis was 82.3%±9.7%. IVL was utilized at the discretion of the operator, followed by balloon angioplasty. Embolic protection devices were used in all cases. RESULTS: In 19 patients, IVL was followed by stent implantation; the 2 ISR lesions were dilated only. The mean IVL balloon diameter was 4.64±1.13 mm, and the mean number of IVL pulses applied was 67.2±61.4 (range 10-180). All procedures were technically successful (<30% residual stenosis). No patients developed symptomatic bradycardia or hypotension due to IVL, and there were no adverse events associated with IVL delivery. All patients were discharged on dual antiplatelet therapy. Seventeen days after the procedure, 1 patient experienced an ischemic stroke that was deemed due to aortic arch manipulation during transfemoral access. Carotid duplex ultrasound examination identified significant restenosis (>70%) in 1 asymptomatic patient at 12 months after the index procedure. No patients required reintervention during a median follow-up of 6 months (range 1-12). CONCLUSION: This preliminary experience demonstrates that IVL can be a safe and effective approach for the management of severely calcified carotid lesions. Further research is warranted to determine the longer-term safety and efficacy of IVL for dilation of calcified carotid artery lesions as an adjunct to carotid artery stenting.

Unibody bifurcated aortic endograft: device description, review of the literature and future perspectives.

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.

Revascularization of occluded renal artery stent grafts after complex endovascular aortic repair and its impact on renal function.

BACKGROUND: Acute occlusion of renal bridging stent grafts after fenestrated/branched endovascular aortic repair (F/B-EVAR) is an acknowledged complication with high morbidity that often results in chronic dialysis dependence. The feasibility and effect of timely or late (≥6 hours of ischemia) renal artery revascularization has not been adequately reported. METHODS: We performed a retrospective, multicenter study across 11 tertiary institutions of all consecutive patients who had undergone revascularization of renal artery stent graft occlusions after complex EVAR. The end points were technical success, association between ischemia time and renal function salvage, interventional complications, mortality, and mid-term outcomes. RESULTS: From 2009 to 2019, 38 patients with 46 target vessels (TVs; eight bilateral occlusions) were treated for renal artery occlusions after complex EVAR (mean age, 63.5 ± 10 years; 63.2% male). Six patients had a solitary kidney (15.8%). Of the 38 patients, 16 (42.1%) had undergone FEVAR and 22 (57.9%) had undergone BEVAR. The technical success rate was 95.7% (44 of 46 TVs). The recanalization technique used was sole aspiration thrombectomy in 5.3%, aspiration thrombectomy and stent graft relining in 52.6%, and sole stent graft relining in 36.8%. The median renal ischemia time was 27.5 hours (range, 4-720 hours; interquartile range, 4-36 hours). Most patients (94.4%) had been treated after ≥6 hours of renal ischemia time, and 55.6% had been treated after 24 hours. In 14 patients (36.8%), renal function had improved after intervention (mean glomerular filtration rate improvement, 14.2 ± 9 mL/min/1.73 m2). However, 24 patients (63.2%) showed no improvement. Improvement of renal function did not correlate with the length of renal ischemia time. Of the 14 patients with bilateral renal artery occlusion or a solitary kidney, 9 experienced partial recovery of renal function and no longer required hemodialysis. In-hospital mortality was 2.6%. The cause of renal stent graft occlusion could not be identified in 50% of the TVs (23 of 46). However, in 19 (41.3%), significant stenosis or a kink of the renal stent graft was found. The median follow-up was 11 months (interquartile range, 0-28 months). The estimated 1-year patient survival and patency rate of the renal stent grafts was 97.4% and 83.8%, respectively. CONCLUSIONS: Revascularization of occluded renal bridging stent grafts after F/B-EVAR is a safe and feasible technique and can lead to significant improvement of renal function, even after long ischemia times (>24 hours) of the renal parenchyma or bilateral occlusion, as long as residual perfusion of the renal parenchyma has been preserved. Also, the long-term patency rates justify aggressive management of renal artery occlusion after F/B-EVAR.

1-Month Results From a Prospective Experience on CAS Using CGuard Stent System: The IRONGUARD 2 Study.

OBJECTIVES: This study sought to evaluate 30-day safety and efficacy of dual-layer mesh-covered carotid stent systems for carotid artery stenting (CAS) in the clinical practice. BACKGROUND: When compared with carotid endarterectomy, CAS has been associated with a higher rate of post procedural neurologic events; these could be related to plaque's debris prolapsing through stent's mesh. Consequently, the need for increased plaque coverage has resulted in the development of dual-layer mesh-covered carotid stent systems. METHODS: From January 2017 to June 2019, a physician-initiated, prospective, multispecialty registry enrolled 733 consecutive patients undergoing CAS using the CGuard embolic prevention system in 20 centers. The primary endpoint was stroke up to 30 days; secondary endpoints were technical and procedural success; external carotid artery occlusion; and in-hospital and 30-day transient ischemic attack (TIA), acute myocardial infarction (AMI), and death rates. RESULTS: Symptoms were present in 131 (17.87%) patients. An embolic protection device was used in 731 (99.72%) patients. Procedural success was 100%, technical success was obtained in all but 1 (99.86%) patient, who died in hospital due to a hemorrhagic stroke. Six TIAs, 2 minor strokes, and 1 AMI occurred during in-hospital stay, and external carotid artery occlusion was evident in 8 (1.09%) patients. Between hospital discharge and 30-day follow-up, 2 TIAs, 1 minor stroke, and 3 AMIs occurred. Therefore, the cumulative stroke rate was 0.54%. CONCLUSIONS: This real-world registry suggests that use of CGuard embolic prevention system in clinical practice is safe and associated with a minimal occurrence of adverse neurological events up to 30-day follow-up.

Use of Dual-Layered Stents for Carotid Artery Angioplasty: 1-Year Results of a Patient-Based Meta-Analysis.

OBJECTIVES: This study sought to evaluate 1-year safety and efficacy of dual-layered mesh-covered carotid stent systems (DLS) for carotid artery stenting (CAS). BACKGROUND: Small clinical studies evaluating 1-year outcomes of CAS performed with 2 available DLS, Roadsaver (RS) (Terumo Corp., Tokyo, Japan) and CGuard (CG) (InspireMD, Boston, Massachusetts), have been published. METHODS: The authors performed an individual patient-level meta-analysis including studies enrolling more than 100 CAS with DLS. The primary endpoint was the death and stroke rate; secondary endpoints were restenosis and in-stent thrombosis rates at 1 year. RESULTS: Patients were divided into 2 groups according to DLS (RS n = 250; CG n = 306). At 1 year, 11 patients died (1.97%), 7 patients in the group RS (2.8%) and 4 patients in the CG one (1.31%); and 10 strokes occurred, 4 in the group RS (1.6%) and 6 in the CG one (1.96%). Overall death and stroke rate was 3.77% (n = 21), 11 events in the group RS group (4.4%) and 10 in the CG group (3.27%). Symptomatic status was the only predictor of death and or stroke. At 1 year, restenosis occurred in 12 patients (2.1%), 10 in the group RS (4%) and 2 in the CG one (0.65%) (p = 0.007). In-stent thrombosis occurred in 1 patient (0.18%) in the CG group (0.32%). RS use was the only independent predictor of restenosis. CONCLUSIONS: This study suggests that DLS use for CAS is associated with a low 1-year death and stroke rate, and the specific DLS stent used could affect the restenosis rate.

Correction: Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study.

[This corrects the article DOI: 10.2196/16959.].

Unibody Endograft Using AFX 2 for Less Invasive and Faster Endovascular Aortic Repair: Protocol for a Multicenter Nonrandomized Study.

BACKGROUND: Since the introduction of endovascular aortic repair (EVAR) for treatment of abdominal aortic aneurysms (AAAs), progressive improvements in results have been achieved. However, conventional bifurcated stent grafts have been proven to have a nonnegligible risk of failure and secondary intervention, principally due to the lack of adequate proximal sealing. The unique AFX 2 Endovascular AAA System (Endologix, Irvine, CA) unibody device, which provides different sealing and fixation features compared with conventional devices, seems to overcome these limitations. OBJECTIVE: The aim of this study is to evaluate intraoperative, perioperative, and postoperative results in patients treated with the AFX 2 Endovascular AAA System endografts for elective AAA repair in a large cohort of consecutive patients. METHODS: All eligible EVAR patients will be included in this observational, multicenter, prospective, nonrandomized study. The number of patients to be enrolled is 500. RESULTS: The primary endpoint of the study is to evaluate the technical and clinical success of EVAR with unibody endografts in short- (90-day), mid- (1-year), and long-term (5-year) follow-up periods. The following secondary endpoints will also be addressed: operative time, intraoperative radiation exposure, contrast medium usage, AAA sac shrinkage at 12-month and 5-year follow-up, and any potential role of patients' baseline characteristics and device configuration on primary endpoint. The actual start date of the investigation was November 2019. The final patient is expected to be treated by the end of December 2020, and the estimated study completion date is December 2025. CONCLUSIONS: This study will provide verified real-world data on AAAs treated by AFX 2 endografts and followed for a long-term interval. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/16959.

Infrarenal Abdominal Aortic Aneurysm Endovascular Treatment: Long-term Results From a Single-Center Experience in an Unselected Patient Population.

BACKGROUND: The aim of the present study was to evaluate early-, mid-, and long-term outcomes in an unselected population of patients treated for abdominal aortic aneurysms (AAAs) by endovascular aneurysm repair (EVAR) with different commercially available off-the-shelf devices. MATERIALS AND METHODS: A retrospective study was conducted on a prospectively compiled computerized database on patients presenting an infrarenal AAA treated between January 2008 and December 2015 in a high-volume Italian tertiary referral Center. Demographic, clinical, and specific morphological features were considered as potentially influencing the outcomes and the type of the implanted device. Outcome measures were procedure-related reintervention, AAA-related, and all-cause mortality rates at 30-day, 12-month, and long-term follow-up. Reinterventions considered for the analysis were AAA rupture, graft infection, type I or III endoleaks, type II endoleaks with sac enlargement > 5 mm, graft stenosis or occlusions, procedures related to renal or visceral ischemia, and reintervention for access vessel injury. RESULTS: Of 498 EVAR procedures performed for elective infrarenal AAA treatment during the entire study period, 479 patients were enrolled, the mean age was 73.5 ± 7.34 years (range 51-91), and 416 (86.84%) were men. The mean maximum AAA diameter was 52.02 ± 8.04 mm (range 39-90.2), a maximum AAA diameter ≥59 mm was recorded in 107 patients (22.33%), and an aortic neck length was <10 mm in 137 (28.60%). Technical success was achieved in all patients. At a mean follow-up of 52.97 ± 26.16 months (range 1-120), overall reintervention and death rates were 8.14% and 20.04%, respectively, without AAA-related deaths. At univariate analysis, hypertension was the only demographical variable found to be associated with higher risk of reintervention, P = 0.04 (OR: 2.34; CI 95%: 1.00-5.42). Furthermore, male sex (P = 0.02; OR: 2.62; CI 95%: 1.09-6.27) and chronic renal insufficiency (P = 0.003; OR: 2.08; CI 95%: 1.27-3.42) were associated with higher mortality rates. AAA diameter ≥59 mm was statistically associated with a higher rate of both reintervention and mortality: P < 0.001 (OR: 9.05; CI 95%: 4.52-18.11) and <0.001 (4.00; 2.46-6.49), respectively. CONCLUSIONS: Our experience seems to suggest that EVAR could be safely and effectively performed in an unselected patients' population, with encouraging results up to a ten-year follow-up.

Expert Opinion on Hostile Neck Definition in Endovascular Treatment of Abdominal Aortic Aneurysms (a Delphi Consensus).

BACKGROUND: Endovascular aneurysm repair (EVAR) is currently accepted as an alternative to open repair for the treatment of abdominal aortic aneurysm (AAA). Approximately 40-60% of AAA patients are not considered eligible for EVAR due to unfavorable anatomy. There is currently no consensus on the definition of "hostile" aortic neck for EVAR procedure. METHODS: An Expert Panel (EP), made up of 9 Italian vascular surgeons from high-volume centers (>50 EVAR procedures/year), was assembled to share their opinion about the definition of hostile aortic neck anatomy for EVAR procedure. The process included a review of the current literature by the EP, a face-to-face meeting, and an on-line survey completed by the EP prior to and following the face-to-face meeting, using the Delphi method. RESULTS: Of the 66 reviewed studies, only 38 (58%) reported at least 1 aortic neck hostility criterion. Five anatomic parameters were identified, namely, aortic neck length, aortic neck angulation, aortic neck diameter, conical neck, and presence of circumferential calcification. Based on the results of the first survey round, these criteria and related definitions were discussed in depth during the face-to-face meeting. For 3 parameters (aortic neck diameter, aortic neck angulation, conical neck), the agreement among the EP members was already high during the first survey round while for the remaining 2 (aortic neck length, circumferential calcification) it remarkably increased from the first to the second survey round. For each of these criteria, as well as combinations of at least 2 of these criteria, specific threshold values were identified above or below which a standard EVAR approach was not considered ideal by the EP due to high/moderate risk of complications. CONCLUSIONS: EP agreed on the definition of 5 aortic neck hostility criteria, according to which they gave their opinion on the feasibility and risks of a standard EVAR approach. Further agreement will be needed and examined on the best nonstandard EVAR technique which may be offered in the presence of different combinations of hostility criteria.

Urgent Mechanical Thrombectomy by Indigo System® in Acute Thrombosed Popliteal Artery Aneurysms: A Report of Two Cases.

The aim of this study is to report the outcome of immediate and direct revascularization by mechanical thrombectomy in acute limb ischemia due to thrombosed popliteal artery aneurysm (PAA). Two patients with acute limb ischemia due to PAA thrombosis were admitted at our hospital, and immediately treated by mechanical thrombectomy (Indigo System). The first patient had a complete recanalization after thrombectomy, while the second one required urokinase infusion (12 hr) due to a suboptimal result. After revascularization, both patients were treated by a polytetrafluoroethylene bypass to definitively exclude PAA. Follow-up showed the patency of the femoropopliteal bypass with good distal outflow. In these 2 reported cases, the Indigo System® has proven to be safe and effective, allowing an immediate limb reperfusion, reducing the necessity for thrombolytic drug infusion.