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.

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.

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.

Off-label use of the Gore Excluder iliac branch endoprosthesis in association with the Rotarex S catheter to achieve total endovascular recanalization of an occluded aortobifemoral bypass.

We describe a successful case of hybrid revascularization of a totally occluded aortobifemoral bypass with retrograde use of the Rotarex S catheter (BD) and complete relining with a Gore Excluder iliac branch endoprosthesis (W.L. Gore & Associates). The repair procedure was performed with femoral surgical access and percutaneous brachial access. Despite left renal artery endoclamping, after the final angiography, deployment of a covered stent in the left renal artery was needed because of residual thrombotic material at the vessel ostium. The procedure was completed with reconstruction using a common femoral artery Dacron graft and bilateral complete iliac surgical branch relining using self-expanding covered stents, with recovery of distal pulses.

Preoperative factors affecting long-term mortality in patients survived to ruptured abdominal aortic aneurysm repair.

BACKGROUND: Aim of this study was to retrospectively evaluate preoperative factors affecting long-term mortality in patients survived to surgical repair for ruptured abdominal aortic aneurysms (rAAAs). METHODS: From January 2007 to December 2021, 444 patients have been treated for symptomatic or ruptured aortoiliac aneurysms in two tertiary referral centers. Only 405 with diagnosis of rAAA at computed tomography were included in the present study. Initial outcome measures were assessed during at 30 and 90 days post-treatment. Estimated 10-year survival of patients survived after 90 days from the index procedure was evaluated with Kaplan-Meier Test. Uni- and multivariate analyses of the preoperative factors affecting 10-year survival in survivor patients was performed by means of log-rank and multivariate Cox regression analysis. RESULTS: Among included patients, 94 (23.3%) underwent endovascular aortic repair (EVAR) and 311 (76.8%) open surgical repair (OSR). Intraoperative death occurred in 29 patients (7.2%). At 30 days, overall death rate was 24.2% (98/405 cases). Hemorrhagic shock (HR 15.5, 95% CI 3.5 to 41.1, P<0.001) was an independent predictor for 30-day mortality. The overall rate of 90-day mortality was 32.6%. In survivors estimated survival rates at 1, 5, and 10 years were 84.2%, 58.2%, and 33.3%, respectively. Type of treatment (OSR vs. EVAR) did not affect long-term freedom from AAA-related death (HR 0.6, P=0.42). In survivor patients, multivariate analysis confirmed the association between late mortality and female sex (HR 4.7, 95% CI 3.8 to 5.9, P=0.03), age >80 years (HR 28.5, 95% CI 25.1 to 32.3, P<0.001), and chronic obstructive pulmonary disease (HR 5.2, 95% CI 4.3 to 6.3, P=0.02). CONCLUSIONS: Late freedom from AAA-related death was not affected by the type of treatment (EVAR vs. OSR) in patients undergoing urgent repair for rAAA. In survivors, female gender, elderly age, and chronic obstructive pulmonary disease negatively affected long-term survival.

Endovascular thrombectomy devices for acute limb ischemia management.

Acute limb ischemia still represents a challenge for the contemporary vascular surgeon, representing an immediate threat for patients' limb but potentially also for the proper patient life in some settings. Technology recently evolved and focused on the treatment of such complex situation. Several devices are available as of today allowing a complete acute limb ischemia endovascular management, aiming to remove intraluminal material while leaving the possibility for treating the underlying pathology when needed. In this review, proper specific device characteristics, indications and advantages are reported and discussed. Despite the broad spectrum of different available devices could appear as potentially confounding, each device has its own features, indications, weak and strength point. Ideally the modern endovascular surgeon should master every single tool, tailoring revascularization strategy and timing for the proper patient and arterial segment to be treated, maximizing the benefits coming from technological improvements.

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.

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.

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.

The new educational project Televascular Games during the Coronavirus Disease 2019 pandemic.

Objective: To report methodology and first-year results of a new educational project called Televascular Games," which took place during coronavirus disease 2019 pandemic. Methods: Complex aneurysmal aortic disease was discussed during a 2-hour competition webinar, according to three modalities. (1) Planning case competition (PCC): Two to four preoperative computed tomography angiography (CTA) scans of an already performed selected case were submitted for the competition. CTA scans were uploaded anonymously, without any reference to the center or the surgeon who performed the case. The competitor had to prepare a presentation of how he or she would have diagnosed, sized, planned, treated, and followed up the case, of the medical therapy and of the bail-out maneuvers. (2) Challenging case competition (CCC): The competitor elaborates a presentation of an already treated case concerning an aortic topic and discusses sizing, planning, treatment, possible bail-out maneuvers and obtained results. For the CCC and PCC, the competitors with the best score were preselected to present and discuss their plan during the webinars. (3) Quiz competition: Two to six CTA scans of already performed selected aortic cases were submitted for the competition. A quiz with multiple choice questions was answered by the competitors. The top four competitors were selected for the webinars and then they discussed the cases during the webinar. Finally, at the end of the case discussion, the effective case resolution and follow-up were shown. A final winner was voted via televoting, based on six preestablished criteria. The project was endorsed by different national and international societies. Results: Between October 2020 and December 2021, there were 12 Italian and 1 international webinars with 1695 participants overall (mean, 130; range, 86-177). Competitors were 54 years of age (mean, 27 years; range, 22-38 years). Two editions were CCCs, two quiz competitions, and nine PCCs. The reliability of the interobserver sizing of competitors was κ = 0.43 and κ = 0.62 for the proximal and distal sealing measurements respectively and very good (κ = 0.88-0.95) in the evaluation of orientation of the vessels, presence of angulations, calcifications, and thrombus. The sizing discrepancy resulted in a significant variability of the planning (κ = 0.45). The project ranked 9.6 on a 10-point rating scale by all the participants and competitors. Conclusions: The formula of gaming and collegial discussion of aortic cases herein reported has proved valid and attractive during coronavirus disease 2019 pandemic period. The variability of the results on sizing and planning suggested to confer with a second opinion, especially for less experienced surgeons.

Long-term outcomes of endovascular aortic repair with flared iliac limb endografts in patients with abdominal aortic aneurysm and aneurysmal common iliac arteries.

BACKGROUND: The aim of this study was to evaluate the long-term outcomes of endovascular aneurysm repair with flared iliac limb grafts in patients with abdominal aortic aneurysm (AAA) and aneurysmal common iliac arteries (CIAs). METHODS: This is a multicenter, retrospective, observational cohort study that involves four tertiary referral hospitals between May 1, 2005, and April 30, 2019. Primary outcomes were freedom from aneurysm-related mortality (ARM), and freedom from iliac-related reintervention. RESULTS: We studied 995 aneurysmal iliac limbs in 795 (85.2%) patients who met the inclusion criteria. Median AAA diameter was 55mm (IQR: 51-60). Early mortality occurred in 3 (0.4%) patients. The median of follow-up time was 52 months (IQR: 26-88). Estimated freedom from ARM was 99±0.002% (95% CI: 99-99.9) at 1 year, and 99±0.004% (95% CI: 97.9-99.6) at 5-years. Chronic obstructive pulmonary disease (HR=6.4, 95% CI: 1.7-24.0, P=0.006), chronic kidney disease (HR=5.5, 95% CI: 1.4-21.9, P=0.016), and the presence of an aneurysmal left CIA (HR=5.3, 95% CI: 1.0.5-27.4, P=0.044) was associated with ARM. There were 42 (7.3%) late iliac-related events (limb occlusion, N.=5; iliac-related endoleaks, N.=37). Estimated freedom from iliac-related reintervention was 98±0.003% (95% CI: 97-99) at 1 year, and 95±0.01% (95% CI: 92.7-96.7) at 5-years, which was associated with an aneurysmal right CIA (HR=2.2, 95% CI: 1.3-3.9; P=0.005), and age ≥78 years (HR=1.9, 95% CI: 1.01-1.3; P=0.039). CONCLUSIONS: EVAR flared iliac limb grafts showed a high rate of freedom from ARM and a low reintervention rate. Owing to these results, it can be a durable and stable alternative for patients aged >78 years.

Open vascular surgery training in the endovascular era: 5-year experience with cadaver laboratory.

BACKGROUND: Vascular cadaver laboratory (CAD LAB) courses included vascular exposure techniques and simulations of open procedures. Aim of the study was to demonstrate the benefit of cadaver laboratory (CAD LAB) courses to improve trainees' experience in open surgical vascular procedures. METHODS: Between 2014 and 2020, 162 vascular surgeons or medical trainees (mean age 28 years) participated in vascular CAD LAB courses in Italy and France. Outcomes were measured using the Linkert survey, performed pre- and postcourse to evaluate self-efficacy/confidence, surgical experience, and resident perception of the course with a range score from 0 to 5 for each point. Anatomical knowledge improvement was measured using a questionnaire with multiple answers pre- and postcourse. The course was considered to have yielded a positive result if the postcourse Linkert Survey Score increased by ≥2 points, or in the case of an increase of at least 30% above the baseline value of the multiple questionnaires. RESULTS: Postcourse questionnaires were positive for all outcomes evaluated. Participants' perception of the usefulness of the CAD LAB evaluation was 4.8 out of 5. For the vascular CAD LAB, participant anatomical knowledge improved overall from an average of 55% to 93% (P<0.001), and self-efficacy/confidence improved from 2.3 to 4.5 out of 5 (P<0.001). Regarding the different operative procedures, the greatest self-efficacy/confidence improvement was recorded in carotid endarterectomy and aortic procedures (+50% and +66% respectively; P<0.001). The city location (Italy vs. France) did not affect the results. CONCLUSIONS: CAD LAB courses were shown to be effective in increasing participants' self-efficacy, confidence, and anatomical knowledge in open vascular surgical procedures.

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.

Results of adjunctive stenting with high-radial force stents to prevent or treat limb occlusion after EVAR.

BACKGROUND: The aim of this study was to report the results of a multicenter experience on the use of adjunctive stents deployed inside abdominal aortic endografts with the purpose to prevent or treat limb occlusion after endovascular aneurysm repair (EVAR). METHODS: Between 2010 and 2018, there were 35 patients with aorto-iliac aneurysm presenting one or more risk factors for endograft limb occlusion (narrow aortic bifurcation and/or stenotic, highly angulated or occluded iliac arteries), who were treated with standard bifurcated stent graft reinforced by the means of a single model of balloon-expandable platinum/iridium bare stent (CP Stent; NuMED, Inc., Hopkinton, NY, USA). Technical success, mortality, limb patency and reintervention rate during follow-up were the main endpoints assessed. RESULTS: Technical success was 100%. No patients died perioperatively and no major complication was registered. During a mean follow-up of 48 months (range 1-87), neither aortic-related death nor secondary intervention was registered. At a mean follow-up imaging of 39.4 months (range 1-81) no endograft limb lost its patency. CONCLUSIONS: The use of high-radial force balloon-expandable stents deployed inside bifurcated endografts to prevent or treat limb occlusion is a safe and effective adjunctive procedure, with outstanding long-term outcomes in terms of patency and reinterventions.

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.

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.

Mid-Term Outcomes of Complex Endografting for Chronic Post-Dissection Thoracoabdominal Aortic Aneurysms.

PURPOSE: To report early and mid-term results of post-aortic dissection thoracoabdominal aneurysms (pD-TAAA) treated by complex endografting in three tertiary referral hospitals. MATERIALS AND METHODS: A review of all patients with pD-TAAA unfit for open surgery treated with complex endovascular repair from 2012 to 2018 was performed. Simple thoracic endografts (TEVAR) were excluded. Staged procedures in case of extensive aortic coverage were always planned. RESULTS: In total, 21 patients (16 males, mean age 63 ± 10 years) with pD-TAAA underwent aortic repair by fenestrated or branched thoracoabdominal endografts for visceral vessels. Mean TAAA diameter was 61 ± 6.2 mm. Spinal cord drainage was performed in all patients. A staged approach was used in 12 (57%) cases. Technical success was achieved in 18 (86%) patients. No in-hospital deaths occurred. Two patients experienced transient post-procedural spinal cord ischemia. At 30 days, six type II endoleaks (29%), two type Ic endoleak (9.5%) and one type IIIc endoleak (5%) were reported. At a mean follow-up of 23 ± 13 months, no late aortic-related deaths occurred. Three patients underwent reintervention for type Ic and IIIc endoleaks. No visceral vessel occlusion was observed. Estimated freedom from reintervention at 12 and 24 months was 85.7 ± 0.7%. In 13 cases, TAAA diameter decreased at least 5 mm, while increased > 5 mm in only one case. Complete false lumen thrombosis was achieved in 18 patients (86%). CONCLUSION: Complex endografting for pD-TAAA showed favorable mid-term results. Staged and carefully planned endovascular procedures may represent a safe and effective therapeutic option in patients deemed at high risk of open repair.