A multicenter prospective observational study appraising the effectiveness of the Supera stent after subintimal recanalization of femoro-popliteal artery occlusion: The SUPERSUB II study.

BACKGROUND: Complex femoropopliteal artery disease represents a challenge. The Supera stent holds the promise of improving the results of endovascular therapy for complex femoropopliteal disease. AIMS: We aimed at appraising the early and long-term effectiveness of the Supera stent after successful subintimal angioplasty (SuperSUB strategy) for complex femoropopliteal lesions. METHODS: We conducted a multicenter, prospective, single-arm observational study including consecutive patients at participating centers in whom Supera was implanted after successful subintimal angioplasty for complex femoropopliteal lesions. RESULTS: A total of 92 patients were included Femoropopliteal arteries were the most common target, and lesion length was 261 ± 102 mm. Most procedures were technically demanding, with antegrade femoral access in 35 (38%) and retrograde distal access in 55 (60%). Supera stent length was 281 ± 111 mm, with 4, 5, and 6 mm devices being most commonly used: 32 (35%), 35 (38%), and 23 (25%), respectively. Technical success was achieved in 100% of subjects, as was clinical success (per subject), whereas procedural success (per subject) was obtained in 98%. At 24 months, freedom from clinically driven target lesion revascularization was 93%, whereas primary patency was 87%. When compared with a similar historical cohort, Supera stent use appeared to be associated with a reduction in resources. CONCLUSION: Use of Supera stent after successful subintimal recanalization of complex lower limb arterial lesions yields favorable procedural results, which are maintained over follow-up, and are associated also with a favorable resource use profile.

Outcomes of Off the Shelf Outer Branched Versus Inner Branched Endografts in the Treatment of Thoraco-Abdominal Aortic Aneurysm in the B.R.I.O. (BRanched Inner - Outer) Study Group.

OBJECTIVE: This study aimed to compare two commercially available off the shelf branched endografts for thoraco-abdominal aortic aneurysm (TAAA) repair, namely the E-nside (Artivion) and Zenith t-Branch (Cook Medical) devices. METHODS: This multicentre retrospective study (2020 - 2023) included patients treated by branched endovascular aortic repair (BEVAR) for TAAA using the inner branched E-nside or the outer branched t-Branch. Endpoints were 30 day technical success and major adverse events (MAEs) as well as one year freedom from target vessel instability and main endograft instability. RESULTS: The study included 163 patients: 79 (307 target vessels) treated with E-nside and 84 (325 target vessels) with t-branch. Aneurysm extent was I - III in 91 patients (55.8%; 47% of E-nside and 66% of t-Branch) and IV in 72 patients (44.2%; 53% of E-nside and 34% of t-Branch) (p = .011). An adjunctive proximal thoracic endograft was used in 43% of E-nside vs. 69% of t-Branch (p < .001), with less frequent thoracic endografting (14% vs. 76%; p < .001) and shorter length of coverage (p = .024) in extent IV TAAA treated by E-nside. E-nside cases had shorter renal artery bridging lengths (66 ± 17 mm vs. 76 ± 20 mm; p < .010) and less frequent use of a distal bifurcated endograft (53% vs. 80%; p < .001). Comparing 30 day results, the mortality rate was 1% vs. 2% (p = .62), any MAE occurred in 18% vs. 21% (p = .55), the stroke rate was 3% vs. 0% (p = .23), and the elective spinal cord ischaemia rate was 5% vs. 8% (p = .40) for E-nside and t-Branch, respectively. At one year, freedom from target vessel instability was 96 ± 3% for E-nside and 95 ± 3% for t-Branch (p = .58), and freedom from endograft instability was 98 ± 2% vs. 97 ± 3% (p = .46), respectively. CONCLUSION: Both off the shelf devices provided excellent early and one year results. The E-nside may require shorter thoracic aortic coverage and bridging length for the renal arteries, and less frequent implantation of a concomitant proximal thoracic or distal abdominal bifurcated endograft. However, these aspects did not determine significant differences in clinical outcomes.

European Multicentric Experience With Fenestrated-branched ENDOvascular Stent Grafting After Previous FAILed Infrarenal Aortic Repair: The EU-FBENDO-FAIL Registry.

OBJECTIVE: To report the mid-term outcomes of fenestrated-branched endovascular aneurysm repair (F-BEVAR) following a failed previous endovascular aneurysm repair (pEVAR) or previous open aneurysm repair (pOAR). METHODS: Data from consecutive patients who underwent F-BEVAR for pEVAR or pOAR from 2006 to 2021 from 17 European vascular centers were analyzed. Endpoints included technical success, major adverse events, 30-day mortality, and 5-year estimates of survival, target vessel primary patency, freedom from reinterventions, type I/III endoleaks, and sac growth >5 mm. BACKGROUND: Treatment of a failed previous abdominal aortic aneurysm repair is a complex undertaking. F-BEVAR is becoming an increasingly attractive option, although comparative data are limited regarding associated risk factors, indications for treatment, and various outcomes. RESULTS: There were 526 patients included, 268 pOAR and 258 pEVAR. The median time from previous repair to F-BEVAR was 7 (interquartile range, 4-12) years, 5 (3-8) for pEVAR, and 10 (6-14) for pOAR, P <0.001. Predominant indication for treatment was type Ia endoleak for pEVAR and progression of the disease for pOAR. Technical success was 92.8%, pOAR (92.2%), and pEVAR (93.4%), P =0.58. The 30-day mortality was 6.5% overall, 6.7% for pOAR, and 6.2% for pEVAR, P =0.81. There were 1853 treated target vessels with 5-year estimates of primary patency of 94.4%, pEVAR (95.2%), and pOAR (94.4%), P =0.03. Five-year estimates for freedom from type I/III endoleaks were similar between groups; freedom from reintervention was lower for pEVAR (38.3%) than for pOAR (56.0%), P =0.004. The most common indication for reinterventions was for type I/III endoleaks (37.5%). CONCLUSIONS: Repair of a failed pEVAR or pOARis safe and feasible with comparable technical success and survival rates. While successful treatment can be achieved, significant rates of reintervention should be anticipated, particularly for issues related to instability of target vessels/bridging stents.

Inner branched complex aortic repair outcomes from a national multicenter registry using the E-xtra design platform.

BACKGROUND: Complex aortic pathology still represents an open issue in contemporary endovascular management, with continuous technological advancement being introduced in practice over time aiming to improve outcomes. Thus far, the dualism between the fenestrated and branched configuration for visceral artery revascularization is yet unsolved, with each approach having its own pros and cons. The inner branched technology for endovascular aneurysm repair (iBEVAR) aims to take the best out of both strategies, offering wide applicability and stable bridging stent sealing. The objective of this study was to evaluate the early outcomes obtained with a single manufacturer custom-made inner-branched endograft in a multicenter Italian experience. METHODS: All patients consecutively treated with E-xtra design devices in three Italian facilities were enrolled. Anatomic characteristics and perioperative data were analyzed. The main objective was to asses technical and clinical success after iBEVAR. Secondary end points were overall survival, aortic-related mortality, target visceral vessel (TVV) patency, and freedom from target vessel instability during follow-up. RESULTS: From 2016 to 2021, 45 patients were treated with an E-xtra design device revascularizing at least one visceral vessel through an inner branch. The mean age at the time of the procedure was 71.1 ± 9.3 years and 77.8% were males. The total number of target visceral arteries to be bridged with an inner branch was 159. The extent of aortic repair was thoracoabdominal in 91.1% of the cases. Technical success was achieved in 93.3% of the procedures (42/45) with all failures owing to a type I endoleak at final angiography. Each TVV was successfully connected to the graft's main body as planned without complications. Following their intervention, five patients developed spinal cord ischemia and in three of these cases symptoms persisted after discharge (6.7%). At 30 days clinical success was 93.3% (42/45). No death as well as no TVV thrombosis occurred within 30 days from the primary procedures. The mean follow-up was 22.8 ± 14.2 months. The Kaplan-Meier estimate of overall survival and TVV patency at 36 months were 83.9% and 95.9%, respectively. CONCLUSIONS: Inner branches seem to be a promising technology in the complex aortic repair landscape, with an applicability ranging from type II thoracoabdominal aneurysm to type I endoleak repair after infrarenal endografting. Whether iBEVAR could offer results comparable with those provided by fenestrated/branched endovascular aneurysm repair in terms of target vessel patency and stent stability is yet to be established and further studies are, therefore, needed.

Effectiveness of the Rotarex Excisional Atherectomy System in Both Subacute and Chronic Aortoiliac Endograft Thrombosis: An Innovative Option for the Modern Endovascular Surgeon Toolkit.

PURPOSE: To report a successful revascularization case using the Rotarex™S atherothrombectomy system in a recent iliac limb thrombosis, and chronic hypogastric stent obstruction after previous aortoiliac aneurysm endovascular repair (EVAR). CASE REPORT: A 72-year-old patient was treated for recent right iliac limb thrombosis and left iliac branch chronic hypogastric stent occlusion, 5 years after EVAR. A total endovascular approach, using both upper extremity and femoral vascular access, was settled with 2 Rotarex™S (6Fr and 10Fr) devices. The Rotarex™S catheters removed most of the intraluminal material, allowing additional endografts and bare metal stents to be deployed to support a new healthy lumen surface. CONCLUSION: The total endovascular approach provided by the Rotarex™S device appears to be safe and effective in treating aortoiliac endografts occlusions, both in subacute and chronic phases. Larger studies could highlight differences and eventual advantages compared with more traditional solutions.

An International Expert-Based CONsensus on Indications and Techniques for aoRtic balloOn occLusion in the Management of Ruptured Abdominal Aortic Aneurysms (CONTROL-RAAA).

OBJECTIVE: To report on the recommendations of an expert-based consensus on the indications, timing, and techniques of aortic balloon occlusion (ABO) in the management of ruptured abdominal aortic aneurysms (rAAA). METHODS: Eleven facilitators created appropriate statements regarding the study issues that were voted on using a 4-point Likert scale with open-comment fields, by a selected panel of international experts (vascular surgeons and interventional radiologists) using a 3-round modified Delphi consensus procedure (study period: January-April 2023). Based on the experts' responses, only the statements reaching grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final study report. The consistency of each round's answers was also graded using Cohen's kappa, the intraclass correlation coefficient, and, in case of double resubmission, Fleiss kappa. RESULTS: Sixty-three experts were included in the final analysis and voted on 25 statements related to indication and timing (n=6), and techniques (n=19) of ABO in the setting of rAAA. Femoral sheath or ABO should be preferably placed in the operating room, via a percutaneous transfemoral access, on a stiff wire (grade B, consistency I), ABO placement should be suprarenal and last less than 30 minutes (grade B, consistency II), postoperative peripheral vascular status (grade A, consistency II) and laboratory testing every 6 to 12 hours (grade B, consistency) should be assessed to detect complications. Formal training for ABO should be implemented (grade B, consistency I). Most of the statements in this international expert-based Delphi consensus study might guide current choices for indications, timing, and techniques of ABO in the management of rAAA. Clinical practice guidelines should incorporate dedicated statements that can guide clinicians in decision-making. CONCLUSIONS: At arrival and during both open or endovascular procedures for rAAA, selective use of intra-aortic balloon occlusion is recommended, and it should be performed preferably by the treating physician in aortic pathology. CLINICAL IMPACT: This is the first consensus study of international vascular experts aimed at defining the indications, timing, and techniques of optimal use of ABO in the clinical setting of rAAA. Aortic occlusion by endovascular means (or ABO) is a quick procedure in properly trained hands that may play an important role as a temporizing measure until the definitive aortic repair is achieved, whether by endovascular or open means. Since data on its use in hemodynamically unstable patients are limited in the literature, owing to practical challenges in the performance of well-conducted prospective studies, understanding real-world use by experts is of importance in addressing critical issues and identifying main gaps in knowledge.

Outcomes of Percutaneous Access to the First Versus Third Segment of Axillary Artery During Aortic Procedures.

PURPOSE: This article aims at investigating the outcomes of percutaneous access via the first versus third axillary artery (AXA) segments with closure devices during aortic procedures. MATERIALS AND METHODS: All patients receiving percutaneous AXA access closed with Perclose ProGlide device (Abbott, Santa Clara, California) from 2008 to 2021 were included in a retrospective multicenter registry (NCT: 04589962). Efficacy endpoint was the technically successful percutaneous procedure (no open conversion). Safety endpoints were stroke and access complications according to the Valve Academic Research Consortium-3 reporting standards. The first (AXA1) or third (AXA3) axillary puncture sites were compared. RESULTS: A total of 412 percutaneous AXA accesses were included: 172 (42%) in AXA1 and 240 (58%) in AXA3. Left AXA was catheterized in 363 cases (76% of AXA1 vs 97% of AXA3, p<0.001) and 91% of fenestrated/branched endovascular repair (F/BEVAR) procedures were conducted from the left. A ≥12F internal diameter (ID) sheath was used in 49% of procedures. Open conversion rate was 1%, no major vascular complications occurred, and only one major non-vascular complication was recorded. Primary closure failure occurred in 18 AXA1 (11%) and 32 AXA3 accesses (13%), treated by covered (8.3%) or bare-metal (2.7%) stenting. Bailout stent patency was 100% at median follow-up of 12 months, with 6 of 6 stents still patent after >36 months of follow-up. Stroke rate was 4.4%. An introducer sheath >12F was independently associated with both access complications (p<0.001) and stroke (p=0.005), while a right-side access was associated with stroke only (p=0.034). Even after adjustment for covariates, AXA1 versus AXA3 showed an equal success rate (odds ratio [OR]=0.537, 95% confidence interval [CI]=0.011-1.22 for AXA3, p=0.104). The combination of AXA3 and a >10F introducer sheath provided worse outcomes compared with >10F sheaths through AXA1 (OR for success=0.367, 95% CI=0.176-0.767, p=0.008). This was not confirmed for >12F sheaths, associated with similar outcomes (p=0.31 AXA 1 vs AXA 3). CONCLUSION: Major local complications with the percutaneous axillary approach and ≤12F sheaths are infrequent and solvable by complementary endovascular interventions. Stroke risk remains an issue. First and third AXA segments are both amenable for access with good results, but larger sheaths (12F) perform better in AXA1. CLINICAL IMPACT: Percutaneous access with vascular closure devices at the first or third axillary artery (AXA) segments during aortic procedures is burdened by a negligible risk of open conversion. Local complications with the percutaneous axillary approach are infrequent and solvable by complementary endovascular interventions. First and third AXA segments are both amenable to access with excellent results, but larger sheaths (12F) perform better in the wider first AXA segment. In this setting, bailout stenting does not appear to be associated with mid-term stent occlusion.

Percutaneous transaxillary access for endovascular aortic procedures in the multicenter international PAXA registry.

BACKGROUND: The aim of the study was to demonstrate the safety and effectiveness of a suture-mediated vascular closure device to perform hemostasis after an axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. METHODS: A physician-initiated, international, multicenter, retrospective registry was designed to evaluate the success rate (VARC-2 reporting standards) of percutaneous transaxillary access closure with a suture-mediated closure device. Secondary end points were minor access vascular complications, transient peripheral nerve injury, stroke, and influence on periprocedural outcomes of puncture technique. RESULTS: Three hundred thirty-one patients (median age, 76 years; 69.2% males) in 11 centers received a percutaneous transaxillary access during endovascular cardiac (n = 166) or vascular (n = 165) procedures. The closure success rate was 84.6%, with 5 open conversions (1.5%), 45 adjunctive endovascular procedures (13.6%), and 1 nerve injury (0.3%). Secondary closure success was obtained in 325 patients (98%) after 7 bare stenting, 37 covered stenting, and 1 thrombin injection. Introducer sheaths 16F or larger (odds ratio, 3.70; 95% confidence interval, 1.22-11.42) and balloon-assisted hemostasis (odds ratio, 4.45; 95% confidence interval, 1.27-15.68) were associated with closure failure. A threshold of five percutaneous axillary accesses was associated with decreased rates of open conversion, but not with increased primary closure success. Primary closure success was 90.3% in the 175 patients with sheaths smaller than 16F, performed after the first 5 procedures in each center. Temporary nerve injury and stroke were observed in 2% and 4% of patients, respectively. CONCLUSIONS: Percutaneous transaxillary aortic procedures, in selected patients, can be performed with low rates of open conversion. The need for additional endovascular bailout procedures is not negligible when introducers sheaths 16F or larger are required.

Nineteen-year outcomes with the Anaconda stent graft system from two tertiary centers.

OBJECTIVE: The Anaconda stent graft device presents peculiar and unique features in its design and deployment sequence, available on the market for many years with minor modifications, among different generations. The aim of this study was to assess the long-term, real-life, outcomes obtained in two high-volume centers with this endograft for infrarenal aortic aneurysms treatment over a period of 19 years. METHODS: All patients treated with the investigated device between 2000 and 2019, with at least 1 year of follow-up, were entered into a prospective database and data were reviewed retrospectively. The long-term results were assessed according to the Kaplan-Meier method. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes were freedom from late reintervention, freedom from late conversion to open repair, freedom from late limb occlusion, and freedom from late EVAR failure. RESULTS: A total of 260 consecutive patients were treated during the study period. Technical success was achieved in 98.5% (256/260) of the cases. Two perioperative deaths (0.8%) and four major complications (1.5%) were recorded. At a mean follow-up of 54 ± 38 months (summary follow-up index = 0.86), the late survival estimate was 94.8% at 1 year, 75.2% at 5 years, 50.5% at 10 years, and 43.3% at 13 years, with no case of late AAA rupture or late AAA-related death. Late freedom from conversion was 99.2% at 1 year, 96.9% at 5 years, 94.0% at 10 years, and 94.0% at 13 years. Freedom from late limb thrombosis was 96.8% at 1 year and 91.0% at 5, 10, and 13 years. Estimates of freedom from late reintervention was 95.6% at 1 year, 87.0% at 5 years, 77.4% at 10 years, and 77.4% at 13 years. Estimates of limb thrombosis at 11 years were significantly different in patients receiving or not intraoperative iliac kissing balloon maneuver with noncompliant angioplasty catheters (98.0% vs 88.4%; P = .029). CONCLUSIONS: The Anaconda stent graft demonstrated effective and durable outcomes for AAA treatment over a 19-year period, with no case of late AAA rupture or AAA related death in the studied population. Late limb occlusion was the leading cause of reintervention; however, a positive prevention strategy was found in intraoperative kissing balloon, which was associated with significant reduced rate of iliac thrombosis over time.

The Effect of Manufacturer's Instructions for Use Compliance on Cook ZBIS Iliac-Branched Endograft Long-Term Outcomes.

BACKGROUND: Current guidelines indicate iliac-branched endografts (IBDs) as the ideal means to preserve pelvic perfusion during endovascular aortic repair. Because patient vascular anatomy represents the main limitation to extensive use of these devices, off-label application may be considered to expand the number of patients being treated. The aim of this study is to evaluate long-term outcomes obtained using the Cook ZBIS endograft in the treatment of aortoiliac aneurysms as per or outside manufacturer's instruction for use (IFU). METHODS: Data from all patients who underwent IBD implant in a single center were reviewed. Study population was divided into two subgroups: Group I treated as per manufacturer's IFU and group II treated outside IFU. RESULTS: During the study period (2008-2018), 119 patients were treated with 130 IBDs. Eighty-six patients were treated as per IFU (group I) and 44 outside IFU (group II). Overall technical success was 99.2%. Mean follow-up was of 63.5 ± 38.3 months for group I and 58.3 ± 35.9 months for group II (P = 0.45). Freedom from reintervention at ten years was 79.8% in group I and 69.6% in group II (P = 0.29). Freedom from IBD-related reintervention rate was 98.7% and 95.3% in groups I and II, respectively (P = 0.240). Iliac-branched module thrombosis occurred significantly more in patients treated outside IFU with 4 cases in group I (4.7%) and 10 cases in group II (22.7%), (P = 0.005). Cox regression analysis identified hypogastric artery aneurysm as the only independent predictor for both IBD thrombosis and hypogastric artery occlusion during follow-up. CONCLUSIONS: When used by an experienced team, Cook IBDs are safe and effective in the treatment of aortoiliac aneurysms both inside and outside IFU. Anyway a lower target hypogastric patency rate should be expected when treating patients with hypogastric aneurysms.

Branched Endograft Partial Deployment to Save Space for Vessel Cannulation When Treating Aneurysms with Narrow Aortic Lumen.

PURPOSE: To describe a novel technique developed for the treatment of patients with thoracoabdominal aortic aneurysms having narrow aortic lumens using branched endografts. TECHNIQUE: When treating patients with a narrow aortic inner diameter with branched endografts, we propose a partial graft deployment leaving the distal portion of the device inside the delivery system with the aim of spare space and facilitate target vessel cannulation. CONCLUSIONS: Partial endograft deployment could be considered in the case of expected difficulty associated with encumbrance deriving from the distal straight graft portion. This technique could be useful to avoid target vessel loss and therein save procedural and fluoroscopy time.

Late outcomes of different hypogastric stent grafts in aortoiliac endografting with iliac branch device: Results from the pELVIS Registry.

OBJECTIVE: The objective of this study was to evaluate long-term results of self-expanding vs balloon-expandable hypogastric stent grafts in conjunction with iliac branch devices (IBDs) for aortoiliac aneurysm repair in a multicenter experience (pErformance of iLiac branch deVIces for aneurysmS involving the iliac bifurcation [pELVIS] Registry). METHODS: All patients electively treated for aortoiliac aneurysm with the Cook IBD (Cook Medical, Bloomington, Ind) in nine European centers were reviewed. Clinical and imaging data were prospectively collected in each center, and a multicenter database was created and interrogated. The primary outcome was the primary patency of the IBDs. For the purpose of this investigation, three subgroups were identified: patients receiving a hypogastric balloon-expandable stent graft (BESg); those with a self-expanding stent graft (SESg); and those with any stent graft plus relining with a bare-metal stent (RESg). RESULTS: Between 2005 and 2017, there were 691 patients who underwent 747 elective endovascular repairs of aortoiliac aneurysms (n = 518 [75.0%]) or isolated iliac aneurysms (n = 173 [25.0%]) with Cook IBDs (n = 56 bilateral) in nine European centers. Mean age was 72 years (range, 41-93 years); 658 (95.2%) patients were male. In 364 patients (52.7%), BESg was used; in 127 (18.4%), SESg; and in 200 (28.9%), RESg. At 30 days, there were 3 (0.4%) perioperative deaths, 3 (0.4%) technical failures, 7 (1.0%) graft thromboses, 30 (4.3%) reinterventions, and 1 (0.1%) conversion to open repair. After a mean follow-up of 32 months (range, 0-128 months), 28 (3.7%) IBD occlusions and 17 (2.3%) IBD-related endoleaks occurred. In 10 patients, iliac diameter increased >5 mm (1.4%). Overall primary patency was 99.2% at 1 month, 97.9% at 12 months, and 95.1% at 72 months. Primary patency was not significantly different in the BESg vs SESg or RESg cohorts (P = .4). During follow-up, there were 126 (18.2%) reinterventions, 93 (13.5%) of which were IBD related, including 11 (1.6%) conversions. Overall, freedom from reintervention and conversion was 90.4% at 12 months and 71.0% at 72 months. IBD-related reinterventions during follow-up in the three cohorts were not significantly different (P = .3) Overall survival was 71.3% at 72 months without differences between the subgroups. At multivariate analysis, aneurysmal hypogastric artery (P < .001; Exp [B] = 4.44) and bilateral treatment (P = .02; Exp [B] = 1.87) were associated with an increase in late failure. CONCLUSIONS: In this wide real-world experience, long-term results of endovascular treatment of aortoiliac aneurysms with the IBD are favorable, with a low rate of late graft occlusion and aneurysm-related death. No significant differences in clinical outcomes were observed in patients receiving hypogastric BESg vs SESg or endovascular relining.

Long Term Outcomes of Endovascular Aortic Repair in Patients With Abdominal Aortic Aneurysm and Ectatic Common Iliac Arteries.

OBJECTIVE: The purpose of this study was to evaluate the long term results of endovascular aneurysm repair (EVAR) in patients with abdominal aortic aneurysm (AAA) and ectatic common iliac arteries (CIAs). METHODS: In a retrospective analysis of a prospectively collected database in two high volume centres, patients with AAAs undergoing elective standard EVAR were divided into two groups: those with both CIA diameters <18 mm, and those with at least one ectatic iliac artery (CIA ≥ 18 mm). Patients with an intentional external iliac artery landing zone were excluded. Primary outcomes were survival and freedom from re-intervention. Secondary end points were EVAR failure and iliac related endoleak and iliac re-intervention. RESULTS: From 2000 to 2015, 648 patients were included in the study, 277 (43%) had at least one CIA ≥ 18 mm. Pre-operative risk factors were similar between the two groups, with the exception of chronic renal insufficiency (p = .010) and cerebrovascular events (p = .040), which were higher in the ectatic CIA group. At 30 days from primary procedure, there was a higher rate of type Ib endoleak in patients with ectatic iliacs (p = .020). A statistically significant increase in the incidence of late type Ib endoleak in patients with ectatic iliac arteries was confirmed at a mean follow up of 74.8 months (p = .01). The need for iliac related re-intervention was higher in patients with CIAs ≥18 mm (odds ratio 1.94; 95% confidence interval 1.1-3.2). CONCLUSION: Ectatic iliac arteries are considered suitable landing zones for EVAR, although there is an increased risk of secondary interventions in time mainly due to late CIA dilation and secondary type Ib endoleak. Patients receiving EVAR with flared iliac limbs may benefit a more intensive surveillance to avoid late failures.

Forced Complete Femoral Approach for Urgent Thoracoabdominal Aneurysm Repair Using an Inner Branched Endograft.

BACKGROUND: A successful case of urgent type II thoracoabdominal aneurysm repair with an inner branched endograft conducted entirely through femoral accesses without the bailout possibility to achieve an upper extremity approach for bridging stents delivery is described. CASE REPORT: A 70-year-old male patient underwent hybrid treatment for a thoracic aortic aneurysm on complicated type B dissection in 2 steps. First, arch debranching with carotid-carotid-subclavian bypass and then ascending aortic replacement with reimplantation of the anonymous trunk plus TEVAR were performed. The scheduled 1-month control computed tomography angiography (CTA) showed a rapid increase of the false lumen thoracoabdominal aneurysm, with axial diameter measuring more than 10 cm. The repair procedure was based on the use, as off-the-shelf graft, of a prosthesis customized for another patient with inner branches for visceral vessels that well suited the characteristics of the case. A steerable guiding sheath was essential to stabilize the system in the selective and sequential cannulation of 2 of the 4 inner branches (for celiac trunk and superior mesenteric artery) and to complete the bridging stents deployment. Procedure was carried out without complications. CONCLUSIONS: In an urgent setting, total endovascular correction of a thoracoabdominal aortic aneurysm exclusively through femoral accesses appears to be feasible when the appropriate tools are available.

One-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease.

OBJECTIVE: The objective of this study was to report the methodology and 1-year experience of a regional service model of teleconsultation for planning and treatment of complex thoracoabdominal aortic disease (TAAD). METHODS: Complex TAADs without a feasible conventional surgical repair were prospectively evaluated by vascular surgeons of the same public health service (National Health System) located in a huge area of 22,994 km2 with 3.7 million inhabitants and 11 tertiary hospitals. Surgeons evaluated computed tomography scans and clinical details that were placed on a web platform (Google Drive; Google, Mountain View, Calif) and shared by all surgeons. Patients gave informed consent for the teleconsultation. The surgeon who submits a case discusses in detail his or her case and proposes a possible therapeutic strategy. The other surgeons suggest other solutions and options in terms of grafts, techniques, or access to be used. Computed tomography angiography, angiography, and clinical outcomes of cases are then presented at the following telemeetings, and a final agreement of the operative strategy is evaluated. Teleconsultation is performed using a web conference service (WebConference.com; Avaya Inc, Basking Ridge, NJ) every month. An inter-rater agreement statistic was calculated, and the κ value was interpreted according to Altman's criteria for computed tomography angiography measurements. RESULTS: The rate of participation was constant (mean number of surgeons, 11; range, 9-15). Twenty-four complex TAAD cases were discussed for planning and operation during the study period. The interobserver reliability recorded was moderate (κ = 0.41-0.60) to good (κ = 0.61-0.80) for measurements of proximal and distal sealing and very good (κ = 0.81-1) for detection of any target vessel angulation >60 degrees, significant calcification (circumferential), and thrombus presence (>50%). The concordance for planning and therapeutic strategy among all participants was complete in 16 cases. In one case, the consultation was decisive for creating an innovative therapeutic strategy; in the remaining seven cases, the strategy proposed by the patient's surgeon was changed completely after the discussion. Technical success was the same (100%) if concordance in planning was present initially or not. Overall 6-month mortality was 4%, 0% for those patients with initial concordance in planning vs 12% for those without initial concordance (P = .33). Surgery was always performed in a tertiary hospital by local surgeons, and in two cases (8%) external surgeons joined the local surgical team. CONCLUSIONS: Such a regional service of teleconsultation may be of value in standardizing the treatment and derived costs of complex TAADs in a huge region under the same health provider. The shared decision-making strategy may be of medical-legal value as well.

Fourteen-year outcomes of abdominal aortic endovascular repair with the Zenith stent graft.

OBJECTIVE: Long-term results of abdominal aortic aneurysm (AAA) endovascular repair are affected by graft design renewals that tend to improve the performance of older generation prostheses but usually reset the follow-up times to zero. The present study investigated the long-term outcomes of endovascular AAA repair (EVAR) using the Zenith graft, still in use without major modification, in a single center experience. METHODS: Between 2000 and 2011, 610 patients underwent elective EVAR using the Zenith endograft (Cook Inc, Bloomington, Ind) and represent the study group. Primary outcomes were overall survival, freedom from AAA rupture, and freedom from AAA-related death. Secondary outcomes included freedom from late (>30 days) reintervention, freedom from late (>30 days) conversion to open repair, freedom from aneurysm sac enlargement >5.0 mm and freedom from EVAR failure, defined as a composite of AAA-related death, AAA rupture, AAA growth >5 mm, and any reintervention. RESULTS: Mean age was 73.2 years. Mean aneurysm diameter was 55.3 mm. There were five perioperative deaths (0.8%) and three intraoperative conversions. At a mean follow-up of 99.2 (range, 0-175) months, seven AAA ruptures occurred, all fatal except one. Overall survival was 92.8% ± 1.1% at 1 year, 70.1% ± 1.9% at 5 years, 37.8% ± 2.9% at 10 years, and 24 ± 4% at 14 years. Freedom from AAA-rupture was 99.8% ± 0.02 at 1 year (one case), 99.4% ± 0.04 at 5 years (three cases), and 98.1% ± 0.07 at 10 and 14 years. Freedom from late reintervention and conversion was 98% ± 0.6 at 1 year, 87.7% ± 1.5 at 5 years, 75.7% ± 3.2 at 10 years, and 69.9% ± 5.2 at 14 years. Freedom from aneurysm sac growth >5.0 mm was 99.8% at 1 year, 96.6% ± 0.7 at 5 years, 81.0% ± 3.4 at 10 years, and 74.1% ± 5.8% at 14 years. EVAR failure occurred in 132 (21.6%) patients at 14 years. At multivariate analysis, independent predictors of EVAR failure resulted type I and III endoleak (hazard ratio [HR], 6.7; 95% confidence interval [CI], 4.6- 9.7; P < .001], type II endoleak (HR, 2.3; 95% CI, 1.6-3.4; P < .001), and American Society of Anesthesiologists grade 4 (HR, 1.6; 95% CI, 1.0-2.6; P = .034). CONCLUSIONS: EVAR with Zenith graft represents a safe and durable repair. Risk of rupture and aneurysm-related death is low, whereas overall long-term survival remains poor. Novel endograft models should be tested and evaluated considering that one-fourth of the operated patients will still be alive after 14 years.

Secondary Procedures Following Iliac Branch Device Treatment of Aneurysms Involving the Iliac Bifurcation: The pELVIS Registry.

PURPOSE: To evaluate the incidence and reasons for secondary procedures in patients treated with iliac branch devices (IBDs) for isolated iliac aneurysm or aortoiliac aneurysms involving the iliac bifurcation. METHODS: Between January 2005 and December 2015, 575 surgical-high-risk patients (mean age 72.0±8.4 years; 558 men) with isolated iliac aneurysms (n=79) or aortoiliac aneurysms involving the iliac bifurcation (n=496) were treated with placement of 650 ZBIS or Gore IBDs (75 bilateral) in 6 European centers. The primary outcome was procedure-related reinterventions for occlusion or high-grade (>70%) stenosis of the bridging device, occlusion of the ipsilateral common or external iliac artery (EIA), type I/III endoleak, rupture, or infection following IBD implantation. Clinical and radiological data were analyzed based on preset definitions of comorbidities, aneurysm morphology, intraoperative variables, and follow-up strategies. RESULTS: Nine (1.6%) reinterventions were performed within 30 days for occlusion or endoleak. Among 10 (1.5%) occluded EIAs ipsilateral to a deployed IBD, 6 underwent a reintervention with additional stent placement after thrombolysis (n=4) or a femorofemoral or iliofemoral crossover bypass (n=2). Three of 14 patients with early type I endoleak had a reintervention for an insufficient proximal sealing zone (stent-grafts in 2 common iliac arteries and 1 bifurcated endograft). Mean clinical and radiological follow-up were 32.6±9.9 and 29.8±21.1 months, respectively. Forty-two (7.3%) patients underwent reinterventions in the follow-up period. The overall postoperative reintervention rate was 8.9%. Both external and common iliac segments occluded in 30 (4.6%) IBDs; 2 patients had a crossover bypass and 14 were treated with endovascular techniques. In the other 14 patients, no specific treatment was performed. Seven (1.2%) patients with isolated EIA occlusion were treated during follow-up. Nineteen of the overall 28 patients with type I endoleak underwent endovascular repair. The other 9 were under radiological surveillance due to less significant (<5 mm) sac increase. No reintervention was performed to recanalize 11 (1.6%) occluded internal iliac arteries. CONCLUSION: Midterm experience with placement of IBDs is associated with a low incidence of secondary procedures due to type I endoleaks and occlusions. The main reasons for reinterventions seem to be short proximal sealing zone and poor conformability of the ZBIS device in elongated EIAs.

Rheolytic Thrombectomy with AngioJet® Is Safe and Effective in Revascularization of Renal Arteries' Acute Occlusion on Previous Complex Aortic Endovascular Repair.

Acute occlusion of the visceral arteries is a threatening complication following branched endovascular aortic repair (EVAR). Its prompt diagnosis and treatment are mandatory to restore renal function. Several techniques have been used to manage this complication. We report 2 clinical cases of patients, previously treated with implantation of an off-the-shelf thoracoabdominal aortic endograft, with acute bilateral occlusion of the renal arteries. Both patients were successfully treated with AngioJet rheolytic thrombectomy. Acute occlusion of the renal arteries can dramatically complicate the outcome of patients treated with branched EVAR. Prompt diagnosis and treatment are required. Rheolytic thrombectomy rapidly removes intra-arterial thrombus through Bernoulli effect, preventing the risk of distal embolization and rapidly restoring the renal function.

Long-term Results of Tapered Stents in Endovascular Treatment of Carotid Stenosis.

BACKGROUND: Recent technological developments allowed significant improvements in interventional approach to carotid artery stenosis. Tapered stents were specifically designed for extracranial carotid artery stenting (CAS) to deal with vessels mismatch with the objective of decreasing the risk of thrombosis. Nevertheless, whether the stent geometry may affect the outcomes of CAS is uncertain. This study aims to investigate the impact of stent configuration on perioperative and long-term results of this procedure. METHODS: All CAS procedures performed between 2005 and 2012 at a single high-volume center were reviewed. Primary end points of the study were 30-day mortality and any ipsilateral neurological event. Secondary end points were any late (>30 days) neurological event and restenosis >50%. RESULTS: About 1,368 procedures were performed in the period 2005-2012. 9.1% of the patients were symptomatic for recent focal neurological event. 883 patients were treated with a cylindrical stent while the others underwent a tapered design device implantation. Technical success was achieved in 96% of the procedures. No perioperative mortality was recorded; perioperative stroke occurred in 1.2% vs. 1.6% (P = not significant) in tapered and straight stent group respectively. Stent design did not predict perioperative ipsilateral neurological events neither at bivariate nor at multivariate analysis. At a mean follow-up of 30 months, late neurological events occurred in 26 cases (1.9%); conic stents resulted protective at Kaplan-Meier analysis (P = 0.027). CONCLUSIONS: The use of conic stents appears to be associated with similar perioperative results when compared with straight stents. Late outcomes suggest a lower risk of restenosis and late neurological events in patients with conical shape stents.

Mortality Risk for Ruptured Abdominal Aortic Aneurysm in Women.

BACKGROUND: Sex differences in presentation and outcomes of abdominal aortic aneurysms (AAA) with increased mortality rates in women are suggested. This study aimed to assess mortality risk after repair of ruptured AAA (rAAA) in women in the endovascular abdominal aortic repair (EVAR) era. METHODS: Patients treated between 2006 and 2015 for rAAA were included in a prospective database. Characteristics at presentation and outcomes were compared between women and men. Multivariable logistic regression and Cox proportional analyses were performed to identify the effect of sex adjusted for other predictors on mortality. RESULTS: One hundred thirteen patients were identified; of these, 17.7% (20/113) of the patients were women. Forty-four procedures (38.9%) were by EVAR, with comparable rates in women (45%) and men (37.6%, P = 0.62). On admission, women and men shared similar comorbidities and presentation (shock 45% vs. 43.0%, P = 0.81; free rupture 65.0% vs. 67.7%, P = 0.80) and comparable mean aneurysm diameter (76.5 vs. 78.8 mm, P = 0.68), but women were older (mean age 86.4 + 5.5 vs. 75.2 ± 10.6 years, P < 0.0001) and octogenarian women were twice as likely as men (90% vs. 40%, P < 0.0001). Perioperative mortality was comparable between women and men (40.0% vs. 38.7%) either after EVAR (22.2% vs. 40.0% in women and men respectively; odds ratio [OR] 0.45, 95% confidence interval [CI] 0.77-2.37) or after open surgery (54.5% vs. 37.9%; OR 2.0, 95% CI 0.54-7.21), even though there was a trend for lower mortality in women with EVAR. In adjusted analyses, female sex was not associated with perioperative mortality as it was for older age (octogenarians: OR 6.6, 95% CI 2.08-20.82, P = 0.001) and free rupture (OR 4.2, 95% CI 1.29-13.73, P = 0.02). Mean follow-up was 34.32 months. After controlling for age, surgical repair, free rupture, cardiac disease, and shock at presentation, female sex was not a predictor of late mortality. CONCLUSIONS: AAA repair is often delayed in women and applied at older age; nevertheless, currently women do not show increased perioperative mortality risks from rAAA treatment after the introduction of EVAR.