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.

Preliminary results from an Italian National Registry on the outcomes of the Najuta fenestrated aortic arch endograft.

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

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.

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

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

One Year Outcomes of an International Multicentre Prospective Cohort Study on the Gore Excluder Iliac Branch Endoprosthesis for Aorto-Iliac Aneurysms.

OBJECTIVE: The Gore Excluder Iliac Branch Endoprosthesis (IBE) was developed to preserve perfusion in the hypogastric artery after endovascular repair of aorto-iliac aneurysms. This study reports the 12 month technical and clinical outcomes of treatment with this device. METHODS: This study was a physician initiated international multicentre, prospective cohort study. The primary endpoint was primary patency of the hypogastric branch at 12 months. Secondary endpoints included technical and clinical outcomes. Patients with an indication for elective treatment with the Gore Excluder IBE were enrolled between March 2015 and August 2018. Baseline and procedural characteristics, imaging data, physical examinations and questionnaire data (Walking Impairment Questionnaire [WIQ], EuroQol-5-Dimensions [EQ5D], International Index of Erectile Function 5 [IIEF-5]) were collected through 12 month follow up. RESULTS: One hundred patients were enrolled of which 97% were male, with a median age of 70.0 years (interquartile range [IQR] 64.5 - 75.5 years). An abdominal aortic aneurysm (AAA) above threshold for treatment was found in 42.7% and in the remaining patients the iliac artery diameter was the indication for treatment. The maximum common iliac artery (CIA) diameter on the Gore Excluder IBE treated side was 35.5 mm (IQR 30.8 - 42.0) mm. Twenty-two patients received a bilateral and seven patients had an isolated IBE. Median procedural time was 151 minutes (IQR 117 - 193 minutes) with a median hospital stay of four days (IQR 3 - 5 days). Primary patency of the IBE at 12 month follow up was 91.3%. Primary patency for patients treated inside and outside the instructions for use were 91.8% and 85.7%, respectively (p = .059). Freedom from secondary interventions was 98% and 97% at 30 days and 12 months, respectively. CIA and AAA diameters decreased significantly through 12 months. IIEF-5 and EQ5D scores remained stable through follow up. Patency of the contralateral internal iliac artery led to better IIEF-5 outcomes. WIQ scores decreased at 30 days and returned to baseline values through 12 months. CONCLUSION: Use of the Gore Excluder IBE for the treatment of aorto-iliac aneurysms shows a satisfactory primary patency through 12 months, with significant decrease of diameters, a low re-intervention rate, and favourable clinical outcomes.

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.

EVAR with Aortic Placement of a Single JOTEC E-iliac Stent-graft System in a Patient with Poliomyelitis Aortoiliac Deformities.

Small-sized vessels can represent a contraindication to standard endovascular aortic repair (EVAR), and more specifically, aortoiliac deformities resulting from poliomyelitis may add an adjunctive challenge for total endovascular repair. Herein we report a case of a 62-year-old man with a 55 mm abdominal aortic aneurysm (AAA) and a history of poliomyelitis. More specifically, a computed tomography angiogram (CTA) showed a very narrow infrarenal aortic neck, measuring 13 mm in maximum diameter, and severely atrophic external iliac and common femoral arteries. A total endovascular repair was planned and realized with a single aortic JOTEC iliac branch and contralateral VBX placement. All prosthetic materials were delivered from the nonatrophic side. At the 1-year CTA, the aneurysm was successfully excluded and both iliofemoral axes were patent.

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.

Standard "off-the-shelf" multibranched thoracoabdominal endograft in urgent and elective patients with single and staged procedures in a multicenter experience.

OBJECTIVE: The objective of this study was to assess immediate and midterm outcomes for urgent/emergent and elective patients with thoracoabdominal aortic aneurysms (TAAAs) treated with the first commercially available "off-the-shelf" multibranched endograft for endovascular aneurysm repair, with a single-step or a staged surgical approach. METHODS: A multicenter, nonrandomized, retrospective study was conducted of TAAA patients grouped by urgent/emergent and elective treatment with multibranched endograft for endovascular aneurysm repair at 13 Italian centers from November 2012 to August 2016. Urgent/emergent repair was classified as rupture in 16%, impending rupture in 9%, pain in 53%, or a maximum TAAA diameter ≥80 mm in 22%. Study end points were technical success, mortality, spinal cord ischemia, target visceral vessel (TVV) patency, and procedure-related reinterventions at 30 days and at follow-up. RESULTS: Seventy-three patients (274 TVVs) were enrolled. Treatment was performed in elective (n = 41 [56%]) or urgent/emergent (n = 32 [44%]) settings, according to a single-step (n = 30 [41%]) or staged (n = 43 [59%]) approach. Technical success was 92%. Mortality within 30 days was 4% (n = 3 urgent/emergent patients) due to myocardial infarction. Spinal cord ischemia was recorded in two patients (3%; elective group). The primary patency of TVVs was 99% (three renal branch occlusions). Procedure-related reinterventions were required in five cases (7%). At least one adverse event from any cause ≤30 days was registered in 42% (n = 31). At a median follow-up of 18 months (range, 1-43 months), eight (11%) deaths (elective vs urgent/emergent, 2% vs 22%; P = .018), three (1%) cases of branch occlusion or stenosis, and five (7%) reinterventions were recorded. A survival of 88% (standard error [SE], 4%), 86% (SE, 4%), and 82% (SE, 5%) was evidenced at 12, 24, and 36 months, respectively. Urgent/emergent repair and female gender were identified as independent risk factors for all-cause mortality (P < .001 and P = .015, respectively), and the staged approach was identified as protective (P = .026). Freedom from reintervention was 86% (SE, 4%) and 83% (SE, 5%) at 12 and 24 months. CONCLUSIONS: The first off-the-shelf multibranched endograft seems safe in both urgent/emergent and elective settings. The staged surgical approach appears to positively influence overall survival. This unique device and its operators will usher in a new treatment paradigm for TAAA repair.

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.

Midterm Results of Proximal Aneurysm Sealing With the Ovation Stent-Graft According to On- vs Off-Label Use.

PURPOSE: To compare the use of the Ovation stent-graft according to the ≥7-mm neck length specified by the original instructions for use (IFU) vs those treated off-label (OL) for necks <7 mm long. METHODS: A multicenter retrospective registry (TriVascular Ovation Italian Study) database of all patients who underwent endovascular aneurysm repair with the Ovation endograft at 13 centers in Italy was interrogated to identify patients with a minimum computed tomography (CT) follow-up of 24 months, retrieving records on 89 patients (mean age 76.4±2.4 years; 84 men) with a mean follow-up of 32 months (range 24-50). Standard CT scans (preoperative, 1-month postoperative, and latest follow-up) were reviewed by an independent core laboratory for morphological changes. For analysis, patients were stratified into 2 groups based on proximal neck length ≥7 mm (IFU group, n=57) or <7 mm (OL group, n=32). Outcome measures included freedom from type Ia endoleak, any device-related reintervention, migration, and neck enlargement (>2 mm). RESULTS: At 3 years, there was no aneurysm-related death, rupture, stent-graft migration, or neck enlargement. There were no differences in terms of freedom from type Ia endoleak (98.2% IFU vs 96.8% OL, p=0.6; hazard ratio [HR] 0.55, 95% CI 0.02 to 9.71 or freedom from any device-related reintervention (92.8% IFU vs 96.4% OL, p=0.4; HR 2.42, 95% CI 0.34 to 12.99). In the sealing zone, the mean change in diameters was -0.05±0.8 mm in the IFU group and -0.1±0.5 mm in the OL group. CONCLUSION: Use of the Ovation stent-graft in patients with neck length <7 mm achieved midterm outcomes similar to patients with ≥7-mm-long necks. These midterm data show that the use of the Ovation system for the treatment of infrarenal abdominal aortic aneurysm is not restricted by the conventional measurement of aortic neck length, affirming the recent Food and Drug Administration-approved changes to the IFU.

Predilation technique with balloon angioplasty to facilitate percutaneous groin access of large size sheath through scar tissue.

Purpose Percutaneous remote access for endovascular aortic repair is an advantageous alternative to open access. Previous surgery in the femoral region and the presence of synthetic vascular grafts in the femoral/iliac arteries represent major limitations to percutaneous remote access. The aim of this study was to evaluate an original technique used for enabling percutaneous remote access for thoracic or abdominal endovascular aortic repair in patients with scar tissue and/or a vascular graft in the groin. Methods Twenty-five consecutive patients with a thoracic (11/25; 44%) or an aortic aneurysm (14/25; 66%) and with a synthetic vascular graft in the groin (16/25; 64%) or a redo groin access (9/25; 36%) were managed through the percutaneous remote access. In all patients, a percutaneous transluminal angioplasty balloon was used to predilate the scar tissue and the femoral artery or the synthetic vascular graft after preclosing (ProGlide®; Abbott Vascular, Santa Clara, CA, USA). In 10 patients, requiring a 20 Fr sheath, a 6 mm percutaneous transluminal angioplasty balloon was used; and in the remaining 15, requiring a 24 Fr sheath, an 8 mm percutaneous transluminal angioplasty balloon. Preclosing was exclusively performed using ProGlide®. Mean follow-up was 15 months. Results In all cases, stent-graft deployment was successful. There was one surgical conversion (4%; 1/25) due to bleeding from a femoral anastomosis. Two cases required additional percutaneous maneuvers (postclosing with another system in one patient and endoluminal shielding with stent-graft in the other patient). No pseudoaneurysm or access complication occurred during the follow-up. Conclusions Percutaneous access in redo groins with scar tissue and/or synthetic vascular graft using ultrasound-guided punction, preclosing with ProGlide® system and predilation with percutaneous transluminal angioplasty balloon to introduce large size sheath as used for endovascular aortic repair showed to be feasible, safe and with few local complications.

The Gore Hybrid Vascular Graft in renovisceral debranching for complex aortic aneurysm repair.

OBJECTIVE: This study reports our initial experience with the Gore Hybrid Vascular Graft (GHVG; W. L. Gore & Associates, Flagstaff, Ariz) for staged hybrid open renovisceral debranching and endovascular aneurysm repair in patients affected by thoracoabdominal aortic aneurysms and pararenal abdominal aortic aneurysms (PAAAs). METHODS: Between December 2012 and December 2013, we analyzed outcomes of 13 patients who underwent open surgical debranching of renovisceral vessels for thoracoabdominal aortic aneurysm and PAAAs. All patients were considered at high risk for conventional surgery. Inclusion criterion was treatment by open surgical debranching of at least one visceral artery (renal artery, superior mesenteric artery [SMA], or celiac trunk [CT]) using the GHVG. In a second step, the aortic stent graft was implanted to exclude the aneurysm. If required, parallel grafts to the remaining visceral arteries were deployed in the same procedure. One patient had a symptomatic descending thoracic aortic aneurysm and another had a ruptured PAAA. Perioperative measured outcomes were immediate technical success rate, mortality, and morbidity. Median follow-up was 24.8 months (range, 0-15; mean, 8.2; standard deviation, 4 months). RESULTS: All open surgical debranching of renovisceral vessels were completed as intended. GHVG was used to revascularize 20 visceral vessels in 13 patients with a mean of 1.54 vessels per patient. Six renal arteries (30%; 2 right and 4 left), 9 SMAs (45%), and 5 CTs (25%) were debranched. In nine of 13 (66%) patients, other renovisceral arteries were addressed with chimney/periscope, Viabahn Open Revascularization Technique, and end-to-side anastomosis. Two of 13 patients (15%) died of bowel ischemia. Neither patient had GHVG revascularization to the SMA or CT. Perioperative complications occurred in three patients (23%; 1 renal hematoma, 1 respiratory insufficiency, and 1 small-bowel ischemia related to a SMA GHVG thrombosis). At 24 months, estimated survival was 85%, and estimated primary and secondary patency were 94% and 100%, respectively. CONCLUSIONS: This limited series extracted from a more consistent hybrid procedure experience showed a mortality rate similar to most recent reports. Technical feasibility and the short-term patency rate of the GHVG for renovisceral debranching during staged hybrid open and endovascular procedures were satisfactory. Use of GHVGs may represent a useful revascularization adjunct to minimize visceral ischemia in these challenging patients.

Aortic neck evolution after endovascular repair with TriVascular Ovation stent graft.

OBJECTIVE: Aortic neck dilation has been reported after endovascular aneurysm repair (EVAR) with self-expanding devices. With a core laboratory analysis of morphologic changes, this study evaluated midterm results of aortic neck evolution after EVAR by endograft with no chronic outward force. METHODS: This was a multicenter registry of all patients undergoing EVAR with the Ovation endograft (TriVascular, Santa Rosa, Calif). Inclusion criteria were at least 24 months of follow-up. Standard computed tomography (CT) scans were reviewed centrally using a dedicated software with multiplanar and volume reconstructions. Proximal aortic neck was segmented into zone A (suprarenal aorta/fixation area), zone B (infrarenal aorta, from lowest renal artery to the first polymer-filled ring), and zone C (infrarenal aorta, at level of the first polymer-filled ring/sealing zone). Images were analyzed for neck enlargement (≥2 mm), graft migration (≥3 mm), endoleak, barb detachment, neck bulging, and patency of the celiac trunk and superior mesenteric and renal arteries. RESULTS: Inclusion criteria were met in 161 patients (mean age, 75.2 years; 92% male). During a mean follow-up period of 32 months (range, 24-50), 17 patients died (no abdominal aortic aneurysm-related death). Primary clinical success at 2 years was 95.1% (defined as absence of aneurysm-related death, type I or type III endoleak, graft infection or thrombosis, aneurysm expansion >5 mm, aneurysm rupture, or conversion to open repair). Assisted primary clinical success was 100%. CT scan images at a minimum follow-up of 2 years were available in 89 cases. Patency of visceral arteries at the level of suprarenal fixation (zone A) was 100%. Neither graft migration nor barb detachment or neck bulging was observed. None of the patients had significant neck enlargement. The mean change in the diameter was 0.18 ± 0.22 mm at zone A, -0.32 ± 0.87 mm at zone B, and -0.06 ± 0.97 mm at zone C. Changes at zone B correlated significantly with changes at zone C (correlation coefficient, 0.183; P = .05), whereas no correlation was found with zone A (correlation coefficient, 0.000; P = 1.0). CONCLUSIONS: No aortic neck dilation occurred in this series at CT scan after a minimum 24-month follow-up. This may suggest that aortic neck evolution is not associated with EVAR at midterm follow-up when an endograft with no chronic outward radial force is implanted.