NEXUS Arch: A Multicenter Study Evaluating the Initial Experience With a Novel Aortic Arch Stent Graft System.

OBJECTIVE: To assess the initial clinical experience with a novel endograft system (NEXUS Aortic Arch Stent Graft System) designed to treat aortic arch pathologies and address the morphology and hemodynamic challenges of the aortic arch. SUMMARY BACKGROUND DATA: The aortic arch remains the most challenging part of the aorta for both open and endovascular repair. Transcatheter aortic arch repair has the potential to significantly reduce surgical risks. METHODS: Patients underwent transcatheter aortic arch repair with a single branch, 2 stent graft system, implanted over a through-and-through guidewire from the brachiocephalic trunk, to the descending aorta with an ascending aorta stent graft. The ascending aorta stent graft is deployed into a designated docking sleeve to connect the 2 stent grafts and isolate the aortic arch pathology. Proximal landing zone in all cases was in Zone 0. Anatomical inclusion criteria included adequate landing zone in the ascending aorta, brachiocephalic trunk, and descending thoracic aorta. Preparatory debranching procedure was performed in all patients with carotid-carotid crossover bypass and left carotid to left subclavian bypass, or parallel graft from descending aorta to left subclavian artery. Safety and performance were evaluated through 1 year. Survival analysis used the Kaplan-Meier method. RESULTS: Twenty-eight patients, 79% males, with a mean age of 72.2 ± 6.2 years were treated with 100% procedural success. Isolated aortic arch aneurysm was the principle pathology in 17 (60.7%) of patients, while chronic aortic dissection was the principle pathology in 6 (21.4%) of patients. The remaining 5 (17.8%) had combined or other pathologies. At 1 month, the vascular pathology was excluded in 25 of 26 alive patients (96.1%). The 30 days mortality rate was 7.1%, stroke rate was 3.6% (all nondisabling), and combined mortality/stroke rate was 10.7%. One-year mortality was 10.7%, without device or aneurysm-related death. Two patients (7.1%) reported stroke or transient ischemic attack at 1 year that recovered completely. One year combined mortality/stroke rate was 17.8%. There were 3 patients (10.7%) that had device-related unplanned reinterventions through 1 year. CONCLUSIONS: The NEXUS Aortic Arch Stent Graft System, a novel single branch, 2 stent graft system used for endovascular aortic arch repair that requires landing in the ascending aorta, demonstrates a high success rate with excellent 1 year safety and performance.

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.

Outcomes of multibranched off-the-shelf stent graft in elective and urgent/emergent repair of complex aortic aneurysms with narrow internal aortic lumen.

OBJECTIVES: To assess the outcomes of Cook t-Branch off-the-shelf multibranched stent graft in the treatment of complex aortic aneurysms with narrow internal aortic lumen. METHODS: Between 2016 and 2020, 48 patients (mean age, 73 years) underwent elective or urgent or emergent Cook t-Branch implantation for thoracoabdominal or para/juxtarenal aortic aneurysms in two Italian vascular centers. Among these, 20 patients presented a paravisceral or pararenal luminal diameter of less than 25 mm. Major clinical and radiologic outcomes of patients with narrow aortic lumen were compared with patients with a larger lumen in a multicenter, nonrandomized, retrospective fashion. RESULTS: The in-hospital mortality was 10% (5% in the elective setting). Spinal cord ischemia occurred in 6% of the cases. During a mean follow-up of 18 months (range, 1-63 months), late t-Branch procedure-related mortality and the need for reintervention was 0% and 12%, respectively. Comparing the outcomes of patients with large internal aortic lumen (group 1) with patients with small lumen (group 2), no significant difference was found regarding fluoroscopy time (P = .3); technical success (P = 1); early (P = .4) and late (P = 1) mortality; spinal cord ischemia (P = .2); bowel ischemia (P = .5); renal (P = .7), cardiac (P = 1), and respiratory complications (P = 1); reintervention rate (P = 1); and primary patency rate of stented target vessels (P = 1). CONCLUSIONS: The use of the Cook t-Branch in our experience was safe and effective in the treatment of complex aortic aneurysms regardless the caliber of the aortic lumen. With all the limitations of a small sample size, this approach has demonstrated to be feasible when maneuverability is decreased, with low mortality and morbidity, and acceptable reintervention rates. Perioperative mortality remains closely related to clinical presentation. Large-scale studies are needed to confirm these results.

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.

Outcomes of endovascular repair of abdominal aortic aneurysms in narrow aortic bifurcations using the ultra-low profile "INCRAFT" device: A retrospective multicenter study.

OBJECTIVE: Although the long-term results of endovascular aortic repair (EVAR) with low-profile devices in patients with hostile iliac anatomies have been published, there are no reported results specifically for narrow aortic bifurcations (NAB). This study investigated the outcomes of EVAR with the INCRAFT device in NAB (<16 mm). METHODS: This multicenter retrospective study involved five vascular surgery centers. From November 2014 until June 2018, 127 patients were treated with the INCRAFT device. The patient population was divided into two groups based on aortic bifurcation diameter. They were designated as the (1) standard aortic bifurcation (SAB) group (>16 mm) and the (2) the NAB group (<16 mm). Primary end points were the differences between the two groups in terms of technical success, survival at 30 days, iliac limb patency, and reinterventions. RESULTS: The SAB group included 96 patients and the NAB group included 31 patients. The mean aortic bifurcation diameter was 25.5 mm in the SAB group and 13.2 mm in the NAB group. It is noteworthy that, in the NAB group, 21.8% of patients had aortic bifurcations with focal calcific lesions (less than one-third of the circumferential length of the bifurcation) and 48.3% showed extensive calcifications (two-thirds of the circumferential length of the bifurcation), for 29.9% of the patients in the NAB group the aortic bifurcation had a circumferential highly calcific lesion (complete occlusion of the circumferential length of the bifurcation). Technical success was 98.9% in the SAB group and 96.7% in the NAB group (P = .1). The need for iliac component stenting was not significantly different between the groups (SAB 2.0% vs NAB 3.2%; P = .07). The 1-year survival was 97.9% and 96.7% in the SAB and NAB groups, respectively, with no aneurysm-related mortality. The mean follow-up was 18.4 months and 15.3 months in the SAB and NAB groups, respectively. The iliac primary patency was 98.9 % in the SAB group and 96.8% in the NAB group (P = .088), and the primary assisted patency was 100% in both groups. CONCLUSIONS: EVAR with INCRAFT in NABs showed acceptable results. In this multicenter study, the results were comparable in terms of technical success and iliac patency rate between patients with SABs and NABs.

Early Renal Function Alterations in Renal Branches vs. Renal Fenestrations - A Dynamic Scintigraphy Based Prospective Study.

OBJECTIVE: The objective of this prospective single centre study was to assess whether branches and fenestrations have different outcomes on renal function in the early phase. METHODS: From March 2018 to June 2019, 67 patients who underwent elective fenestrated and branched endovascular aneurysm repair (F/BEVAR) procedures were enrolled in this study. The patients were divided into two groups according to the renal bridging component configuration (fenestration vs. branch). All of them underwent dynamic renal scintigraphy with 99mTc diethylenetriaminepentaacetic acid (DTPA), two weeks pre-operatively, and three months and one year post-operatively. The primary end points were peri-procedural technical success, 30 day major adverse events, differences in glomerular filtration rate (GFR) between the branch and fenestration configurations, and variations between the pre-operative and the post-operative dynamic renal scintigraphy. RESULTS: Overall, 135 kidneys were analysed: 63 in the 32 patients treated with fenestrations, and 72 in the 35 patients treated with branches; the mean GFR on baseline scintigraphy was 58.4 ± 30.9 mL/min in the fenestration group, and 65.1 ± 29.2 mL/min in the branch group. Only kidneys associated with a patent fenestration/branch were included in the split GFR final analysis. The mean total GFR at three month scintigraphy decreased by 6.0 ± 2.9 mL/min in the fenestration group and by 23.4 ± 6.4 mL/min in the branch group. The split GFR decreased by 3.5 ± 0.6 mL/min in the fenestration group, and by 15.4 ± 5.4 mL/min in the branch group. The GFR decrease remained stable at one year. CONCLUSION: In this study, the use of branches for renal arteries during F/BEVAR resulted in a greater decrease in the GFR than in those patients who were treated with fenestrations alone. The scintigraphic alterations were evident at an early phase.

The Italian Multicentre Registry of Fenestrated Anaconda™ Endografts for Complex Abdominal Aortic Aneurysms Repair.

OBJECTIVE: The aim was to describe the outcomes of the Anaconda™ Fenestrated endograft Italian Registry for complex aortic aneurysms (AAAs), unsuitable for standard endovascular aneurysm repair (EVAR). METHODS: Between 2012 and 2018 patients with a proximal neck unsuitable for standard EVAR, treated with the fenestrated Anaconda™ endograft, were prospectively enrolled in a dedicated database. Endpoints were peri-operative technical success (TS) and evaluation of type Ia/b or 3 endoleaks (T1/3 EL), target visceral vessel (TVV) occlusion, re-interventions, and AAA related mortality at 30 days, six months, and later follow up. RESULTS: One hundred twenty seven patients (74 ± 7 years, American Society Anesthesiology (ASA) II/III/IV: 12/85/30) were included in the study in 49 Italian Vascular Surgery Units (83 juxta/para-renal AAA, 13 type IV thoraco-abdominal AAA, 16 T1aEL post EVAR, and 15 short neck AAA). Configurations with one, two, three, and four fenestrations were used in 5, 56, 39, and 27 cases, respectively, for a total of 342 visceral vessels. One hundred and eight (85%) bifurcated and 19 (15%) tube endografts were implanted. In 35% (44/127) of cases the endograft was repositioned during the procedure, and 37% (128/342) of TVV were cannulated from brachial access. TS was 87% (111/127): five T1EL, six T3EL (between fenestration and vessel stent), and six loss of visceral vessels (one patient with a Type Ia EL had also a TVV loss) occurred. Thirty day mortality was 4% (5/127). Two of the five T1EL resolved spontaneously at 30 days. The overall median follow up was 21 ± 16 months; one T1EL (5%) occurred at six months and one T3EL (4%) at the three year follow up. Another two (3%) TVV occlusions occurred at six months and five (3%) at three years. The re-intervention rate at the 30 days, six months, and three year follow up was 5%, 7%, and 18 ± 5%, respectively. CONCLUSION: The fenestrated Anaconda™ endograft is effective in the treatment of complex AAA. Some structure properties, such as the re-positionability and the possibility of cannulation from above, are specific characteristics helpful for the treatment of some complex anatomies.

Jetstream Atherectomy System for Treatment of Femoropopliteal Artery Disease: A Single Center Experience and Mid-term Outcomes.

BACKGROUND: The aim of this study is to assess our experience and mid-term outcomes using Jetstream atherectomy system for treatment of femoropopliteal artery disease (FPAD). METHODS: Data of 30 patients with FPAD treated at our center between 2013 and 2016 were analyzed. Two subgroups of patients were identified: Group A included patients (n = 18) with de novo lesions; Group B (n = 12) included those with in-stent restenosis. The primary study end points assessed were technical success, perioperative mortality, and major adverse event (MAE) rate at 30 days (distal embolization, major amputation, and target lesion revascularization). Other outcomes measured were survival, primary, and secondary patency, and freedom from amputation at 1 and 3 years of follow-up, respectively. RESULTS: Technical success was 100% for both groups. The MAE rate was 8.7%. No distal filter was adopted during intervention. Angioplasty was associated with 93.3% of cases (93.3% vs. 100%; P = 0.15), drug-eluting balloon (DEB) in 12 cases (22.2% vs. 66.6%; P = 0.008), drug-eluting stent and bare metal implantation in 1 (5.6% vs. 0%; P = 1) and 4 cases (11.1% vs. 16.7%; P = 1), respectively. The cumulative primary and secondary patency rates were 75.1% and 95.5% at 1 year, and 70.4% and 84.8% at 3 years of follow-up, respectively. The survival and freedom from amputation were 96.4% and 85.8% at 1 and 3 years of follow-up, respectively. The freedom from target lesion revascularization was 91.7% and 83.4% at 1 and 3 years from intervention. CONCLUSIONS: The use of the Jetstream appears to be safe and feasible with no distal embolization and low rate perioperative complications. Moreover, encouraging outcomes were observed when atherectomy was associated to DEB angioplasty.

The "bare branch" for safe spinal cord ischemia prevention after total endovascular repair of thoracoabdominal aneurysms.

OBJECTIVE: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs) with temporary perfusion of the sac through a branch left unstented or a dedicated branch is a strategy intended to reduce the risk of postoperative spinal cord ischemia (SCI). However, potential complications of this approach are aneurysm sac progression between stages, visceral embolism, and occlusion or displacement of components. We here present the "bare branch" technique, a safe adjunct to TAAA repair in terms of interstage complications. METHODS: In the first step, one branch, preferentially the one for the celiac trunk, is stented by a bare stent; in the second step, the bare branch is relined with a covered stent. There were 32 TAAAs (5 type I, 6 type II, 16 type III, 5 type IV) treated by this approach at our center from January 2015 to December 2017 (median follow-up, 13 months [range, 2-24 months]). Data were prospectively collected and retrospectively analyzed. Primary end points were aneurysm sac exclusion and freedom from major adverse events, which included SCI. Secondary end points were freedom from aneurysm growth between the stages and freedom from minor adverse events. RESULTS: Preoperative mean maximum diameter was 68.4 mm; 32 endografts (8 off-the-shelf and 24 custom-made devices) were used. The mean aortic coverage was 364 mm. The mean interval time between the two stages was 10.5 weeks (range, 7-20 weeks). In-hospital mortality was 0%. Type I or type III endoleak rate was 3.2%, whereas one type II endoleak was registered (3.2%). Two patients showed paraparesis, one after the first stage and one after the second stage, both noted at 4/5 on the Tarlov scale, and fully recovered so that the SCI rate was 6.4% with 0% permanent neurologic deficit. Interstage mean maximum diameter was 68.6 mm (P > .05). After the second step, there was an average of 4.7 spinal arteries (standard deviation, 1.4; P < .05) per patient with an increase in visibility and of diameter by 0.7 mm (standard deviation, 0.4 mm). CONCLUSIONS: This is a reproducible adjunct to staged TAAA endovascular repair. The use of a bare branch instead of a branch left completely open has the clear advantage of an easy catheterization in the second step. Furthermore, by having the target vessel stented with a bare stent, the risk of embolism is avoided. In this experience, there was no significant aneurysm sac growth in between the steps. Further comparative studies may determine whether there are different hemodynamic forces with this technique with respect to those already described in the literature.

The "Destino-guided BEVAR" to Catheterize Downward Branches from a Femoral Access: Technical Note and Case Report.

BACKGROUND: The aim of this study is to report the Destino-guided branched endovascular aortic repair approach as a valid alternative to catheterization downward branches in complex aortic arch/descending thoracic anatomies. METHODS & RESULTS: A 53-year-old woman with Marfan syndrome underwent a thoracoabdominal aortic aneurysm (TAAA) repair for a type III dissecting aneurysm. A custom repair with an endograft having 3 fenestrations (for renal arteries and superior mesenteric artery) and 1 branch for the celiac trunk was planned. The right axillary artery was chronically occluded; the left subclavian artery (LSA) was aneurysmatic. The catheterization of the celiac trunk branch was demanding but ultimately a bare stent was used as a bridging component between the graft and the target vessel, for spinal cord preconditioning. At the 2-month computed tomography angiography, when planning the relining of the bare metal stent, a 1 cm increase in diameter of the LSA aneurysm was documented and therefore a Destino-guided branched endovascular aortic repair was planned. This approach consists of branch catheterization via femoral access using the Destino steerable guiding sheath inside which, after bending, a smaller Cook Flexor is placed to easily deliver the stent, while maintaining stability. CONCLUSIONS: The Destino-guided branched endovascular aortic repair is a reproducible and effective alternative to the classic catheterization of side branches via brachial/axillary access allowing their completion from a femoral access.

Type 2 Endoleak Incidence and Fate After Endovascular Aneurysms Repair in a Multicentric Series: Different Results with Different Devices?

BACKGROUND: The aim of this work is describing incidence and fate of type 2 endoleaks (T2ELs) in a multicentric cohort of patients treated by endovascular aneurysms repair using the Ovation device (Endologix) and comparing them with a group treated using the Excluder (W. L. Gore & Associates). METHODS: This is a retrospective study conducted on 261 patients treated using the Ovation device and 203 using the Excluder. Outcomes were intraprocedural, 30-day, 12-month, and mean time follow-up T2EL incidence and related reinterventions. Patent inferior mesenteric artery (IMA), ≥3 lumbar arteries (LAs), intrasac thrombus volume, the mean diameter of common and external iliac arteries, external iliac artery stenosis (>70%), diameter ≤5 mm, iliac tortuosity ratio ≤0.5, thrombosis, and calcification were noted and considered as potentially influencing outcomes. RESULTS: Patients of the Ovation group presented significantly more thrombosed, calcified, and tortuous iliac vessels than those in the Excluder group. No significant differences were noted in sac thrombosis, IMA, and LA patency. At completion angiography, T2EL was evident in 57 Ovation and 46 Excluder patients (P = 0.832). At 1 month, it was evident in 33 Ovation group and 28 Excluder group patients (P = 0.726). At 12-month and mean time (30.14 months) follow-up, no differences were evident between the 2 groups (P = 0.940 and 0.951, respectively). The log-rank test showed that the rate of T2EL-related reintervention was not different between the 2 groups (P = 0.46). Regarding anatomical characteristics, a statistically significant difference was not observed between patients presenting or not with T2EL (P > 0.05). CONCLUSIONS: Data showed no significant differences in terms of T2EL incidence between the 2 study groups. None of preoperative anatomical features were found to be significantly associated with the appearance of T2EL.

Collected Transatlantic Experience From the PERICLES Registry: Use of Chimney Grafts to Treat Post-EVAR Type Ia Endoleaks Shows Good Midterm Results.

PURPOSE: The aim of this retrospective analysis was to evaluate the performance of the chimney (ch) technique in the treatment of type Ia endoleaks after standard endovascular aneurysm repair (EVAR). METHODS: Between January 2008 and December 2014, 517 chEVAR procedures were performed in 13 US and European vascular centers (PERICLES registry). Thirty-nine patients (mean age 76.9±7.1 years; 33 men) were treated for persistent type Ia endoleak and had computed tomography angiography or magnetic resonance angiography follow-up at >1 month. Endurant abdominal stent-grafts were used in the 20 cases. Single chimney graft placement was performed in 18 (46%) patients and multiple in 21 (54%). Overall, 70 visceral vessels were targeted for revascularization. RESULTS: Technical success was achieved in 35 (89.7%) cases; 3 persistent type Ia endoleaks and 1 chimney graft occlusion were detected within the first 30 days. Thirty-day mortality was 2.6%. Two other deaths (not aneurysm related) occurred during a mean follow-up of 21.9 months (0.23-71.3). Primary patency of the chimney grafts was 94.3% at 36 months. In a subgroup analysis comparing Endurant to other stent-grafts, no significant differences were observed regarding persistent endoleak [1/20 (5%) vs 2/19 (11%), p=0.6] or reintervention [1/20 (5%) vs 0/19 (0%)]. CONCLUSION: The present series demonstrates that chEVAR in the treatment of post-EVAR type Ia endoleaks has satisfactory results independent of the abdominal and chimney graft combinations. Midterm results show that chEVAR is an effective method for treating type Ia endoleaks.

"Over-SIRIX": A New Method for Sizing Aortic Endografts in Combination with the Chimney Grafts: Early Experience with Aortic Arch Disease.

BACKGROUND: Large gutters after chimney procedures are one of the main causes of type I endoleak (EL-I). This study aims to evaluate a new tailored planning named "Over-SIRIX," based on Osirix Imaging Software, to choose the correct main graft oversizing in order to minimize EL-I incidence. METHODS: From 2008 to 2015, 34 patients were treated with parallel grafts for aortic arch diseases at our institution. The study included 22 patients with single stent and antegrade flow configuration; they were divided into 2 groups (PRE- and POST-"Over-SIRIX"). "Over-SIRIX" was carried out in the retrospective group (PRE-"Over-SIRIX"), and it was used to plan the endovascular procedure in the prospective group (POST-"Over-SIRIX"). Through the multiplanar reconstruction (MPR) of the preoperative computed tomography angiography (CTA), the proximal neck of the chimney grafts was studied. Stent and endograft configurations were drawn in order to minimize the "gutters." To obtain the ideal main graft sizing (I-Size), a formula was used by adding the custom sizing (C-Size) to the disease oversizing (D-Over). The same MPR imaging was evaluated on postoperative CTA to study gutters area and presence of EL-I. RESULTS: The mean I-Size was 41.67 mm that was equivalent to an ideal oversizing of 19.3% (range 10-28%). The gutters area decreased from 7.3 to 1.7 mm2 (PRE/POST) and EL-I rate from 28.5% to 0% (PRE/POST). Gutters area bigger than 7.5 mm2 and planning made without "Over-SIRIX" were significantly associated (P < 0.05) to EL-I. CONCLUSIONS: "Over-SIRIX" appears to be a feasible method to customize planning during chimney technique, reducing the risk of EL-I which is significantly related to the presence and size of the gutters.

The "Open Branch" Technique: A New Way to Prevent Paraplegia After Total Endovascular Repair of Thoracoabdominal Aneurysm.

INTRODUCTION: Staged endovascular treatment of thoracoabdominal aortic aneurysms (TAAA) has been proved to be an effective strategy to reduce the risk of spinal cord ischemia (SCI). Several techniques have been described: some imply the staged coverage of the aorta, other the temporarily perfusion of the sac through a branch left unstented or a dedicated branch that will be occluded later. The aim of those is to facilitate the expansion of the collateral network that perfuses the spinal cord. However, each of them, have some disadvantages such as the need of two interventions of big magnitude and the risk of target vessel occlusion or endograft displacement. We describe a new technique to treat TAAA in a staged manner. TECHNIQUE: The first step of our technique is the thoracoabdominal endograft deployment with the branching of all target vessels; one of these is branched with a bare stent inside which a covered stent will be placed in a second step, which can be perfomed under local anesthesia. We named this technique "open branch" (OB). Before insertion of the covered stent, a balloon is inflated inside the bare stent to simulate the complete sac exclusion to evaluate eventual neurological complication. RESULTS: Two patients with Crawford type II TAAA and one with a suprarenal aneurysm following the open repair of an infrarenal aortic aneurysm were treated. No cases of SCI were observed after the two procedures. Median interval time between the two procedures was 8, 6 weeks (4-16). Between the two steps, no aneurysm growth or rupture and no branch occlusion or endograft displacement was observed. CONCLUSIONS: These three cases of "OB" technique show that this is a safe and feasible alternative strategy to treat TAAA in a staged manner.

Outcomes of 1000 Carotid Wallstent Implantations: Single-Center Experience.

PURPOSE: To evaluate the outcomes of carotid artery stenting (CAS) with Wallstents in a single-center experience. METHODS: From January 2003 to December 2013, 1000 carotid artery lesions were treated with Carotid Wallstents under cerebral protection in 877 patients (mean age 71.7 ± 8 years; 621 men). Indications for treatment were de novo lesions (>70% asymptomatic and >60% symptomatic); stenoses following carotid endarterectomy, radiation, or neck surgery; contralateral laryngeal nerve palsy; and high surgical risk. All the patients underwent duplex ultrasound and clinical evaluation during follow-up; radiography was performed when fracture or stent migration was suggested by ultrasound. RESULTS: Procedure success was achieved in 99.3% of patients. Major and minor 30-day adverse events occurred in 2.1% of patients, including stroke (1.8%: 1.3% minor, 0.5% major), myocardial infarction (0.1%), and death (0.2%). Plaque morphology, nature of stenosis, and symptomatic status were significantly associated with the risk of postoperative neurologic events. Restenosis occurred in 3.2% at a mean 45.5-month follow-up and was significantly associated with diabetes, smoking, symptomatic stenosis, de novo stenosis, and calcification (plaque III/IV). No fracture or migration was registered during follow-up. CONCLUSION: CAS is a valid method for treating carotid artery disease, with very low rates of major adverse events and neurologic complications. The Carotid Wallstent seems to have excellent results, even with complex plaque morphology, and a low incidence of restenosis at follow-up.

Surgical conversion with graft salvage as a definitive treatment for persistent type II endoleak causing sac enlargement.

OBJECTIVE: The goal of this study was to present open surgical conversion with graft salvage or "semiconversion" as a definitive and safe treatment for untreatable and persistent type II endoleaks causing sac enlargement after endovascular aneurysm repair. METHODS: Between January 2001 and December 2014, 25 of 1623 endovascular aortic repair (EVAR) patients were selected as candidates for open semiconversion. The indication was persistent type II endoleak in 13 patients (12 of whom received previous attempts of embolization), type I and II endoleak in 2 patients, and sac growth without imaging evidence of endoleak in the other 10. After the infrarenal aorta was prepared (via a retroperitoneal access, whenever possible), the technique consisted of performing a banding of the neck with Teflon (DuPont, Wilmington, Del), a sacotomy to remove the thrombus or the hygroma, or both, and then suturing all of the feeding vessels that were found. Proximal and distal fenestrations were performed to avoid sac repressurization. RESULTS: The semiconversion was performed after a mean of 74 months after the initial EVAR. The mean aneurysm size at the time of the EVAR was 6.0 cm (range, 5.0-9.5 cm), and the mean aneurysm size at the time of the semiconversion was 7.7 cm (range, 5.5-11.5 cm). The overall aneurysm size increase was 38%, and the average growth rate was 8.2% per year. One patient had a stable aneurysm size but was treated because of an emergency condition. Technical success was 100%, with resolution of the endoleak and no perioperative deaths. Four cardiac deaths were registered at 12, 26, 30, and 60 months (mean follow-up, 42 months; range, 1-80 months). CONCLUSIONS: Graft salvage appears to be a valid option compared with open repair when considering treatment of persistent type II endoleak. This case series shows that semiconversion is a safe and effective treatment for otherwise untreatable type II endoleak.

Endovascular treatment options for complex abdominal aortic aneurysms.

PURPOSE: To report short-term and midterm outcomes of endovascular aneurysm repair (EVAR) of complex aneurysms requiring revascularization of visceral arteries. MATERIALS AND METHODS: Prospective data were collected from patients deemed unsuitable for conventional EVAR and conventional surgery who were treated with different endovascular approaches according to the clinical presentation of the aneurysm. Custom-made fenestrated endovascular aneurysm repair (CM f-EVAR) was used in the elective setting, homemade fenestrated endovascular aneurysm repair (HM f-EVAR) or HM f-EVAR combined with chimney endovascular aneurysm repair (ch-EVAR) was used in the emergent setting in patients with hemodynamic stability, and ch-EVAR was used in unstable cases. The study included 34 consecutive patients. Primary outcomes measured were perioperative mortality and morbidity, renal function impairment (RFI), target vessel patency, and survival at mean follow-up. RESULTS: In the CM f-EVAR group (7 of 34 patients; 20.6%), an intraoperative type III endoleak (1 of 7 patients; 14%) sealed spontaneously. At 8.9 months of follow-up, 1 (1 of 7 patients; 14%) death and 1 (1 of 7 patients; 14%) episode of transient RFI were documented. Visceral vessel patency rate was 95.2%. In the HM f-EVAR group (4 of 34 patients; 11.7%) and the combination of HM f-EVAR and ch-EVAR group (3 of 34 patients; 8.8%), no complications were observed at 17.3 months of follow-up. In the ch-EVAR group (20 of 34 patients; 58.8%), visceral patency was 95% at 30.9 months of follow-up. Two cases of transient RFI and 2 cases of permanent RFI were registered (2 of 20 patients; 10%). One asymptomatic renal artery branch occlusion was observed at 11 months of follow-up. No endoleaks were documented. CONCLUSIONS: Endovascular aneurysm repair techniques including CM f-EVAR, HM f-EVAR or HM f-EVAR in combination with ch-EVAR, and ch-EVAR are valid tools to maintain blood flow in visceral arteries during treatment of complex aortic aneurysms. The proposed interventional protocol based on clinical presentation was feasible in all cases.

Hybrid Endovascular Solutions for Supra-Aortic Vessels Extra-Anatomic Bypass Infection.

The use of extra-anatomic bypasses for the hybrid repair of thoracic aortic pathologies should consider the risk of vascular graft infection. Graft infections at cervical level are extremely rare and are associated with high mortality and morbidity rates. We report 2 cases of infected extra-anatomic bypasses for supra-aortic vessels debranching treated with a hybrid approach: re-extra-anatomical bypass with the Viabahn Open Revascularization Technique (VORTEC) in the first patient and the EndoVAC approach in the second case. Endovascular techniques may offer bail-out solutions in a hybrid fashion to treat vascular graft infection in patients considered unfeasible for the conventional surgical repair, associated with appropriate antibiotic therapy.

Ten years' experience in endovascular repair of popliteal artery aneurysm using the Viabahn endoprosthesis: a report from two Italian vascular centers.

BACKGROUND: Although rare, popliteal artery aneurysms (PAAs) are the most commonly observed peripheral arterial aneurysms. Surgical repair is considered the gold standard, even if with debated results. The aim of our study is to evaluate the outcome of endovascular treatment of PAAs using the Viabahn peripheral endograft (W. L. Gore and Associates, Inc., Flagstaff, AZ) in 2 high-volume Italian centers. METHODS: All consecutive PAA patients treated by endovascular procedures between January 2004 and December 2013 were retrospectively reviewed. True atherosclerotic aneurysms, symptomatic and asymptomatic, were included in the analysis. All patients were treated by high-skilled vascular surgeons. The outcome measures were graft thrombosis, reintervention rate, and limb salvage at early and long-term follow-up. RESULTS: Fifty-three PAAs were treated. Patients were more frequently male (98.1%) with a mean age of 73.6 ± 7.8 years. Twelve patients (22.6%) were symptomatic and in 8 of them a local fibrinolysis was required before definitive surgery. Mean PAA diameter was 30.9 ± 10.9 mm (range 17-60). Fifty-two patients (98.1%) had at least 1 patent runoff vessel. Technical success was achieved in all patients. Overall, 80 stent grafts were deployed and in 21 patients (39.6%) more than 1 stent graft was deployed. In-hospital mortality rate and 30-day reinterventions were null. At a mean follow-up of 37.4 ± 29.3 months, primary patency, secondary patency, and limb salvage were respectively 73.6%, 92.4%, and 100%. CONCLUSION: In our limited, retrospective experience, the endovascular treatment of PAA by Viabahn stent graft allowed satisfactory technical and clinical results even at long-term follow-up.