Outcomes of off-the-shelf preloaded inner branch device for urgent endovascular thoraco-abdominal aortic repair in the ItaliaN Branched Registry of E-nside EnDograft.

OBJECTIVE: The aim of this study was to report the outcomes of endovascular urgent thoracoabdominal aortic (TAAA) repair, using an off-the-shelf preloaded inner branch device (E-nside; Artivion). METHODS: Data from a physician-initiated national multicenter registry, including patients treated with E-nside endograft (INBREED) were prospectively collected (2020-2024); only urgent cases were included in this study. Primary outcomes were technical success and mortality at 30 days. Secondary outcomes were spinal cord ischemia rate, stroke rate, major adverse events (MAE) as also branch instability at 12 months. RESULTS: Of 185 patients enrolled in the INBREED, 64 (34.5%) were treated in a urgent setting and were included in the study. Reason for urgent repair was presence of aneurysm-related symptoms in 31 patients (48.4%), a contained rupture in eight (12.5%), and a large aneurysm >80 mm in 25 (39.1%). Extent of repair was I to III in 32 patients (50%) and IV in 32 (50%); 18 (28%) had a narrow (<25 mm) paravisceral aortic lumen. An adjunctive proximal thoracic endograft was deployed in 29 patients (45.3%); a distal bifurcated abdominal endograft was used in 33 (51.5%). Two hundred forty-nine target vessels (97.2%) were successfully incorporated through an inner branch from an upper arm (81.2%) or femoral (18.8%) access. A balloon expandable stent was used in 184 (75.7%) target vessels, a self-expandable stent in 59 (24.3%). Mean time for target vessel bridging was 39.9 ± 28.4 minutes per target vessel. Thirty-day cumulative major adverse event (MAE) rate was 28%, and mortality occurred in five patients (9.1%). There was one postoperative stroke (1.6%), and the spinal cord ischemia (SCI) rate was 8% (n = 5). For the 249 target vessels successfully incorporated through an inner branch, 1-year freedom from target vessel instability was 93% ± 3% after 1 year. CONCLUSIONS: The E-nside represents a valid solution for the urgent treatment of TAAAs, including symptomatic and ruptured TAAAs, as well as large asymptomatic TAAAs that cannot wait for a custom-made device. The preloaded inner branches and available proximal and distal graft diameters might be useful in urgent settings and provided satisfactory early and 1-year results, in terms of both endograft and target vessel stability. Further studies are required to assess the clinical role of E-nside for urgent TAAA repair.

Proximal sealing in the aortic arch for inner curve disease using the Custom Relay® Scalloped and Fenestrated stent graft.

OBJECTIVE: This study aims to analyze early and midterm results of custom-made proximal scallop and fenestrated stent-grafts for thoracic endovascular aortic repair (TEVAR) with proximal landing zone (PLZ) in the aortic arch. METHODS: All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc., Sunrise, USA) in ten Italian centers between January 2014 and December 2022 were included. The primary endpoints were technical success, incidence of intraoperative major adverse events (MAEs), deployment accuracy, and rate of early neurological complications, endoleaks (Els) and retrograde aortic dissection. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The PLZ was zone 0 in 25 cases (51%), zone 1 in 14 cases (28.6%), and zone 2 in 10 cases (20.4%). The supra-aortic debranching procedures were 38 (77.5%). Technical success was 97.9% (48/49) due to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III Els were detected. There were no cases of in-hospital mortality, MAEs and retrograde dissection. Three (6.1%) minor strokes (National Institutes of Health Stroke Scale score≤4) were observed. At a mean follow-up time of 36.3 + 21.3 months the rate of type I-III Els and reintervention was 4.1%, respectively. Four patients (8.2%) died during the follow-up period, one (2.1%) from abdominal aortic rupture and three (6.1%) for non-aortic causes. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Safety, Effectiveness and Pitfalls of Carbon Dioxide Routine Use as a Contrast Agent for Endovascular Abdominal Aortic Repair.

BACKGROUND: Despite the evidence of good performance, carbon dioxide (CO2) routine employment as a contrast agent for endovascular procedures is far from being adopted with its use currently limited to patients with renal impairment and known allergy to iodinated contrast medium (ICM). The purpose of our study is to evaluate the safety and effectiveness of CO2 guided endovascular abdominal aortic aneurysm repair (EVAR) in a standard population and to assess the rationale for a future widespread use. METHODS: We retrospectively collected data of every patient who underwent CO2 guided standard EVAR from September 2020 to May 2021 and compared them with the data of every patient who underwent EVAR using ICM from December 2019 to August 2020 in our unit. The selection of the contrast medium was not based on any preoperative factor as the contrast medium was routinely used in every patient in both periods. The primary end point of the study was the technical success rate. Secondary end points were the early and late complication rates, radiation exposure and renal function impairment. RESULTS: 49 patients underwent ICM guided EVAR and 52 patients underwent CO2 guided EVAR in our unit in the time frames specified above. The technical success rate was 100% in both groups with no accidental coverage of any target vessel. Intraoperative endoleaks were observed in 14% of ICM patients and 25% of CO2 patients. The radiation exposure was higher in the CO2 group if compared to the ICM group (311.48 vs. 159.86 median mGy/cm2 - P < 0.001). The incidence of postoperative acute kidney injury was low and similar in the 2 groups. No significant worsening over time of the renal function has been reported in both groups. CONCLUSIONS: EVAR can be safely performed under CO2 guidance without the integration of any quantity of ICM but with an increase in radiation exposure. The nephroprotective role of CO2 guided EVAR in a standard population is unclear and the same role in renal impaired patients should be validated with further studies on selected populations.

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.

First Case of Nellix Stent Rupture in a Huge Symptomatic Abdominal Aortic Aneurysm Who Underwent Endovascular Aneurysm Sealing 7 Years Before.

PURPOSE: Despite encouraging early results, mid- and long-term follow-up of endovascular aneurysm sealing (EVAS) has shown increased rates of failure mainly associated with endoleak detection and progressive bag separation with aneurysm reperfusion. CASE REPORT: We present the first case of a Nellix endograft stent fracture detected in a 91-year-old male patient, presenting with widespread abdominal pain, 7 years after elective treatment of an abdominal aortic aneurysm by EVAS. Considering the sudden and unexpected nature of the event, an in-depth analysis of the possible causes of this structural failure has been performed. CONCLUSION: Material fatigue could be another significant cause of late EVAS failure and should be carefully assessed in addition to endoleak detection during follow-up. CLINICAL IMPACT: The case presented in this article further underlines the importance of a strict long term follow-up protocol in every patients who underwent EVAS.

Endovascular Reconstruction for Total Aorto-Iliac Occlusion.

OBJECTIVES: To analyze outcomes following endovascular treatment of total occlusion of the infrarenal aorta and aorto-iliac bifurcation in a multicenter Italian registry. METHODS: It is a multicenter, retrospective, observational cohort study. From January 2015 to December 2018, 1306 endovascular interventions for aorto-iliac occlusive disease were recorded in the vascular registry. For this analysis, only patients treated for total occlusion of the infrarenal aorta and aorto-iliac bifurcation were included. Early (<30 days) primary outcomes of interest were technical success and mortality. Late major outcomes were primary and secondary patency and freedom from conversion to open aortic surgery. RESULTS: A total of 54 (4.1%) patients met the inclusion criteria. Total percutaneous revascularization was possible in 41 (75.9%) patients and hybrid (endo plus open) intervention in 13 (24.1%) patients. The kissing-stent-graft technique was used in 45 (83.3%) cases, covered endovascular reconstruction of the aortic bifurcation (CERAB) in 5 (9.2%), and a unibody endograft deployed in 4 (7.4%). Technical success was 98.1% (n = 53). There were no episodes of intraoperative or perioperative vessel rupture. Conversion to open surgery was not necessary, and there were no in-hospital deaths. The median patient follow-up time was 16 months (interquartrile range [IQR], 6-27). The estimated primary patency rate was 95.8% ± 0.03 (95% confidence interval [CI]: 85.5-98.9) at 1 year, 91.4% ± 0.05 (95% CI: 76.2-97.2) at 2 years, and 85 ± 0.08 (95% CI: 64.5-94.6) at 3 years. Cox regression analysis demonstrated that sex (hazard ratio [HR]: 0.96; 95% CI: 0.15-6.23, p = 0.963), extent of the occlusion (HR: 0.28; 95% CI: 0.05-1.46, p = 0.130), calcium score (HR: 1.88; 95% CI: 0.31-11.27, p = 0.490), or type of endovascular reconstruction (HR: 0.80; 95% CI: 0.13-5.15, p = 0.804) did not affect primary patency. Secondary patency was 95.5% ± 0.04 (95% CI: 78.4-99.2) at 3 years. No patients required late conversion to open surgical bypass. CONCLUSIONS: Endovascular reconstruction for total occlusion of the infrarenal aorta and aorto-iliac bifurcation was successful using a combination of percutaneous and hybrid revascularization techniques. Estimated patency rates at 3 years of follow-up are promising and are unaffected by the extent of occlusion or type of revascularization.

Management of Nellix migration and type Ia endoleak from proximal endovascular aneurysm sealing relining to late open conversion.

BACKGROUND: Despite promising early results, midterm failures of the Nellix endovascular aneurysm sealing (EVAS) system (Endologix Inc, Irvine, Calif) have been reported at higher than expected rates. The management of proximal endoleaks and migration differs from those after conventional endovascular aortic aneurysm repair (EVAR) owing to the peculiar design of the Nellix device. In the present study, we report a monocentric experience in the management of EVAS complications using various techniques. We also performed a comprehensive review of the relevant literature on both open surgical and endovascular management of proximal failure of EVAS from the MEDLINE database. METHODS: We retrospectively analyzed the reinterventions for type Ia endoleak and migration after elective infrarenal EVAS at our institution. We collected preoperative, intraoperative, and follow-up data. Open and endovascular techniques are described. Overall survival, aortic-related mortality, and the technical success rate (rate of exclusion of endoleaks) with endovascular techniques were the primary outcomes. RESULTS: We performed 101 infrarenal elective EVAS procedures from 2013 to 2018. Of the 101 patients, 20 (19.8%) had required reintervention for proximal sealing failure. The indications were type Ia (Is2, Is3) endoleak, migration >5 mm, sac expansion >5 mm, and secondary rupture. Of the 20 patients, 6 (30%) were treated with endovascular techniques-2 with a chimney Nellix-in-Nellix application and 4 with proximal relining with a covered stent. The remaining 14 patients (70%) were treated with late open conversion (OC). The average time from EVAS to reintervention was 36.1 months (range, 3-65 months). Six patients (30%) had undergone OC in an emergent setting because of secondary rupture. The technical success rate for the patients treated with endovascular reinterventions was 100%. The 30-day mortality was 20% (4 of 20), all emergent cases (four of six emergent repairs; 67%). The overall survival for the 20 patients was 75% (n = 15) at a mean follow-up of 15.1 months (range, 2-47 months). One patient had died after 7 months of non-aortic-related causes. CONCLUSIONS: The high reintervention rate of the Nellix graft mandates careful evaluation for its further use with the revised instructions for use, and it should not be used off-label. OC remains the strategy of choice when managing Nellix proximal sealing failures in fit patients. Chimney Nellix-in-Nellix application and transcatheter embolization are feasible alternative techniques. Proximal relining also appears to be an effective alternative to more complex interventions, although it requires further studies for validation.

Long-term failure after endovascular aneurysm sealing in a real-life, single-center experience with the Nellix endograft.

BACKGROUND: Endovascular aneurysm sealing (EVAS) is an innovative alternative to conventional endovascular aneurysm repair (EVAR). EVAS relies on sac anchoring without proximal fixation to achieve sealing and should have allowed for the treatment of a broader range of anatomic features compared with standard EVAR. Despite the encouraging early reports, the mid- and long-term follow-up data have shown increased rates of failure. To address the issue, the manufacturer introduced revised instructions for use (IFU) in 2016. The present study reports the outcomes of this system after a median follow-up of 45 months. METHODS: Data for all patients electively treated with EVAS at our institution were retrospectively collected. The patients were retrospectively reclassified according to the 2016 revised IFU of the device. All patients in the present series had undergone EVAS for the treatment of infrarenal abdominal aortic aneurysms (AAAs). The primary end point was therapeutic failure: graft migration >5 mm, sac expansion >5 mm, type IA endoleak (Is2 and Is3 using the Van den Ham classification), type Ib endoleak, and secondary rupture. The overall mortality, aortic-related mortality, and reintervention rates were also analyzed. RESULTS: A total of 101 patients had undergone elective treatment by EVAS from 2013 to 2018 for infrarenal AAAs. The median follow-up was 3.75 years. Therapeutic failure was observed in 31 of the 101 patients (30.7%), with no significant difference between the in-IFU and off-IFU 2016 subgroups. Failure occurred at a median interval of 34 months from the index procedure. Of the 101 patients, 6.9% had presented with secondary rupture. Freedom from aneurysm-related mortality was 96.9% at 1 and 2 years and 89.9% at 5 years. Freedom from reintervention decreased over time: 94.7% at 1 year, 77% at 4 years, and 52.1% at 6 years. Of the 101 patients, 14 (13.9%) had undergone emergent or elective graft explantation. CONCLUSIONS: EVAS performed worse than conventional endografts for several critical end points, regardless of any preoperative anatomic parameters. The incidence of therapeutic failures tended to increase over time, especially 4 years after the index procedure.

Prognostic risk factors for loss of patency after femoropopliteal bailout stenting with dual-component stent: results from the TIGRIS Italian Multicenter Registry.

PURPOSE: To identify the risk factors associated with patency loss after bailout stenting with third-generation hybrid heparin-bonded nitinol stent of the femoropopliteal segment. METHODS: Prospective, multicenter, single-arm registry including 156 patients (50 females, mean age 72 ± 11 years) subjected, from February 2017 to December 2018, to provisional stenting with Gore Tigris vascular stent of the distal superficial femoral artery, with or without involvement of the popliteal artery, in 9 different centers. The 194 lesions, with Rutherford score ≥ 3, were stented in case of recoil, dissection or residual stenosis not responding to percutaneous trans-luminal angioplasty (PTA). The follow-up (FU) was performed with clinical evaluation and duplex ultrasound (DUS) at 1, 6 and 12 months. RESULTS: The primary patency rate was 99(95%CI 98-100)% at 1 month, 86(80-92)% at 6 months and 81(74-88)% at-12 months. After patency loss, 13/23 (56.5%) patients were re-treated, yielding a primary assisted patency of 91(86-96)% at 6 months and 88(82-94)% at 12 months and a secondary patency of 94(90-98)% at 6 months and 90(84-95)% at 12 months. Rutherford score ≥ 4 (p = 0.03) and previous severe treatments (p = 0.01) were identified as risk factors for early patency loss during FU. The involvement of the popliteal artery was not an independent risk factor for loss of patency. CONCLUSIONS: The bailout stenting of the femoropopliteal segment with third-generation nitinol stents is a safe and effective option in case of recoil, dissection or residual stenosis not responding to PTA. Critical limb ischemia and history of previous major treatment at the same level are significant prognostic factors for patency loss during FU.

Impact of plaque dilation before carotid artery stent deployment.

OBJECTIVE: Plaque stability is of utmost importance for stroke prevention in the perioperative period (within 24 hours) following carotid artery stenting (CAS). Although carotid plaque is entrapped between stent struts after stent deployment, postdilation can cause a scissoring effect on the plaque, increasing the risk of postprocedural embolic events due to plaque prolapse. Maximum carotid plaque dilation before stent deployment may reduce this risk. This study analyzed the effect of maximum dilation of the carotid plaque before stent deployment (max-pre-SD) or after stent deployment (post-SD) on macroscopic plaque debris, hemodynamic depression (HD), and immediate major adverse events. METHODS: This prospective nonrandomized multicenter study analyzed patients treated for carotid artery stenosis with CAS from January 2014 to August 2016. Clinical and morphologic characteristics and operative details were analyzed with logistic regression analysis for macroscopic debris and HD. The number of microembolic signals (MESs) was assessed by transcranial Doppler and analyzed. RESULTS: A total of 309 patients were enrolled and treated with standard CAS performed using a proximal occlusion cerebral embolic protection device; 149 received max-pre-SD and 160 were treated with post-SD. Technical success was achieved in 100% of cases. Macroscopic debris and HD were significantly different between the two groups in favor of max-pre-SD (P < .001). A significant difference in intraprocedural MESs between the groups was detected. Compared with post-SD, max-pre-SD significantly reduced mean MES counts (8.1% vs 68.1%; P < .001). Patients treated with post-SD had a significantly increased risk of MESs in the immediate postoperative period compared with patients treated with max-pre-SD (41.9% vs 1.3%; P < .001).This result was mainly due to the small number of events encountered. Patients treated with post-SD had a 12-fold increased risk of macroscopic debris collection (odds ratio [OR], 12.36; 95% confidence interval [CI], 5.68-26.87; P < .001) and an 18 times increase in HD risk (OR, 17.80; 95% CI, 5.27-60.17; P < .001) compared with patients treated with max-pre-SD. The heterogeneous, mainly echolucent plaque type significantly highly increased the risk of macroscopic debris (OR, 78.45; 95% CI, 8.70-707.09; P < .001) while acting as a protective factor against HD (OR, 0.02; 95% CI, 0.006-0.11; P < .001) along with echogenic or echolucent complex plaques with irregular surface plaque types (OR, 0.10; 95% CI, 0.031-0.336; P < .001). No significant differences between groups (max-pre-SD group and post-SD) were detected in immediate major adverse events (minor stroke, 2.0% and 2.5% [P = .461]; major stroke, 0% and 0.6% [P = .334], respectively). CONCLUSIONS: Max-pre-SD seems to be a safe and feasible technical modification to the CAS procedure. Macroscopic debris, HD, and MESs are significantly reduced compared with CAS with post-SD. Further research with larger, randomized cohorts of patients is required to establish the superiority of this technical modification.

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.

iTalian RegIstry of doUble inner branch stent graft for arch PatHology (the TRIUmPH Registry).

OBJECTIVE: The objective of this study was to assess early and midterm results after endovascular aortic arch repair using a double inner branch stent graft (DIBSG) in patients with aortic arch aneurysm or dissection unfit for open surgery. METHODS: Between 2012 and 2018, there were 24 patients with aortic arch disease who were treated with a single model of a DIBSG (Terumo Aortic, Glasgow, United Kingdom) in nine Italian cardiovascular centers. We investigated technical success, mortality, occurrence of major complications, and need for reintervention in a multicenter, nonrandomized, retrospective fashion. RESULTS: The in-hospital mortality rate was 16.7%. Cerebrovascular events occurred in 25% of patients and major strokes in 12.5%. Two patients experienced a retrograde dissection (8.3%), whereas none reported any type I or type III endoleak. During a mean follow-up of 18 months (range, 1-60 months), one patient died of a nonaortic cause and one reported a nonarch-related major stroke. No late secondary intervention was needed during the follow-up. Excluding from the analysis the first six patients treated until 2014 as part of the learning curve, in-hospital mortality, major stroke, and retrograde dissection rates were 11.1%, 11.1%, and 5.6%, respectively. CONCLUSIONS: Endovascular aortic arch repair using this model of DIBSG is feasible, and results are acceptable for a new technique in a high-risk subset of patients. Operative mortality suffers the effect of a learning curve, whereas midterm aorta-related survival is promising. Endovascular repair of aortic arch disease with a DIBSG should always be considered to give high-risk patients a chance of repair. Large-scale studies are needed to assess the long-term durability of this technique.

Preliminary results of endovascular aneurysm sealing from the multicenter Italian Research on Nellix Endoprosthesis (IRENE) study.

OBJECTIVE: Because of advances in technology and experience of the operator, endovascular aneurysm repair (EVAR) has supplanted open repair to treat abdominal aortic aneurysm (AAA). The low 30-day mortality and morbidity of EVAR make the endovascular approach particularly suitable for patients at high surgical risk. However, endoleak or endograft migration requiring secondary intervention or open surgical conversion is a limitation of EVAR. The Nellix system (Endologix, Inc, Irvine, Calif) has been designed to seal the entire AAA to overcome these limitations with EVAR. We report the results of a retrospective, multicenter study with endovascular aneurysm sealing (EVAS) aimed to assess technical success, procedure-related mortality, complications, and reinterventions. METHODS: This study included patients selected for elective treatment with the Nellix device per the endovascular repair protocol at 16 Italian vascular centers. All patients were enrolled in a postoperative surveillance imaging program including duplex ultrasound investigations, computed tomography, and magnetic resonance controls following local standards of care. RESULTS: From 2013 to 2015, there were 335 patients (age, 75.5 ± 7.4 years; 316 men) who underwent elective EVAS. In 295 cases (88.0%), EVAS was performed under standard instructions for use of the Nellix system. Preoperative aneurysm diameter was 55.5 ± 9.4 mm (range, 46-65 mm). The inferior mesenteric artery and lumbar arteries emerging from the AAA were patent in 61.8% and 81.3% of cases, respectively. Chimney grafts were electively carried out in eight cases (2.4%). One (0.3%) intraprocedural type IB endoleak was observed and promptly corrected. Device deployment was successful in all patients, with no perioperative mortality. Early (≤30 days) complications included 1 (0.3%) type IA endoleak, 2 (0.6%) type II endoleaks (0.6%), 2 (0.6%) stent occlusions (0.6%), 3 (0.9%) distal embolizations, and 2 (0.2%) femoral artery dissections. Six (2.9%) patients underwent reinterventions. At 1-year follow-up, complications included 3 (1.1%) type II endoleaks, 4 (1.4%) type IA endoleaks, 1 (0.3%) type IB endoleak, 2 (0.7%) distal stent migrations, 5 (1.8%) distal embolizations, and 1 (0.3%) stent occlusion. Twelve patients (3.7%) underwent reinterventions, including four (1.4%) surgical conversions due to aortoduodenal fistula (1), endograft infection (1), and type IA endoleak that was unsuccessfully treated percutaneously (2). Two AAA-related deaths occurred. Freedom from aneurysm-related reintervention was 98.3% at 1-month and 94.7% at 12-month follow-up. CONCLUSIONS: The preliminary results of this real-world multicenter study showed that EVAS with Nellix for the management of AAAs appears feasible. This device platform is associated with acceptable procedure-related mortality and low overall complication and reintervention rates. Definitive conclusions on the value of this novel device await long-term follow-up data.

Comparison of outcomes for short-neck and juxtarenal aortic aneurysms treated with the Nellix endograft versus conventional endovascular aneurysm sealing.

OBJECTIVE: The objective of this study was to evaluate the results of the off-label use of the Nellix endograft (Endologix, Irvine, Calif) for the treatment of short-neck aneurysms and juxtarenal aortic aneurysms (JAAs) compared with the outcomes of patients with infrarenal abdominal aortic aneurysms treated in accordance with the manufacturer's instructions for use. METHODS: Data available from patients treated with the Nellix endograft from September 2013 to January 2016 were reviewed to create a case-control analysis (1:2). Fourteen elective patients with a short-neck aneurysm or JAA (<10 mm) and mild aortic neck angulation (<35 degrees) were included. As a control group, 28 elective patients who had been treated in accordance with instructions for use were included. Patients were matched for age, sex, aortic diameter, and aortic neck angulation. The final cohort group included 42 patients: 14 in the JAA off-label group (5 with aortic neck length ≤4 mm and 9 with necks of 5 to 10 mm) and 28 in the control group. Technical and clinical success, freedom from any secondary intervention, any type of endoleak, and aneurysm-related death were evaluated. RESULTS: There were no significant differences between the two groups in terms of comorbidity, intraoperative time, radiation time, contrast agent volume, and perioperative mortality and morbidity. Two patients of the JAA group subsequently underwent open repair (14%), both with aortic neck length <4 mm (2/5; 40%), for type Ia endoleak. Two of the control group also subsequently underwent open repair (7%). At a mean follow-up of 22 ± 3.9 months, freedom from any reintervention was 85% for the JAA off-label group vs 92% for the control group (log-rank test, P = .33). CONCLUSIONS: The off-label use of the Nellix endograft for the treatment of JAA showed a higher rate of subsequent conversion to open repair for JAA patients (aortic neck length ≤4 mm), underlining the need for a proximal sealing zone. Longer term data are needed to verify the possible use of the Nellix endograft in selected short-neck aneurysms with aortic neck length >5 mm.

Midterm Outcomes of the Nellix Endovascular Aneurysm Sealing System: A Dual-Center Experience.

PURPOSE: To report midterm outcomes of the Nellix Endovascular Aneurysm Sealing (EVAS) System in the treatment of abdominal aortic aneurysm (AAA). METHODS: Between September 2013 and July 2014, 64 AAA patients (mean age 76.6±6.8 years; 61 men) were treated with the EVAS system at 2 centers (only procedures performed at least 12 months prior to the analysis were included). Most patients were treated for a stable AAA, while 1 patient was treated for a ruptured aneurysm. Mean aneurysm diameter was 57.3±9.3 mm. The proximal neck measured a mean 21.5±3.3 mm in diameter and 27.0±12.1 mm long; the neck angle was 16.9°±19.3°. Eleven (17.2%) patients were treated outside the instructions for use (IFU). RESULTS: Technical success was achieved in 63 (98.4%) of 64 patients; 1 type Ia endoleak was treated intraoperatively. One (1.6%) aneurysm-related death occurred at 4 months due to a secondary aortoenteric fistula. Overall, endoleaks occurred in 3 (4.7%) patients (2 type Ia, 1 type II). The estimated rates for 18-month overall survival, freedom from aneurysm-related death, and freedom from secondary interventions were 92.7%, 98.4%, and 95.0%, respectively. Patients treated outside the IFU had a significantly higher incidence of device-related complications (p=0.03). CONCLUSION: The use of the Nellix device in everyday clinical practice is safe and offers promising midterm results. The risk of secondary aortoenteric fistula requires further analysis. Longer follow-up is needed to assess the actual efficacy of the device, although the risk of migration with late endoleak seems low.

Increasing efficacy of endovascular recanalization with covered stent graft for TransAtlantic Inter-Society Consensus II D aortoiliac complex occlusion.

OBJECTIVE: We compared the outcomes and the durability of endovascular recanalization (EVR) with the Viabahn (W. L. Gore and Associates, Flagstaff, Ariz) covered stent graft vs traditional aortobifemoral or aortofemoral bypass grafting for complex aortoiliac occlusions. METHODS: Between 2008 and 2014, 11 unilateral iliac occlusions and 11 aortobiiliac occlusions were treated by EVR. Also collected were data from the last 21 consecutive patients treated in the same period by aortofemoral (n = 6) or aortobifemoral (n = 15) bypass grafting. In accordance with the TransAtlantic Inter-Society Consensus II (TASC II) document, only patients with type D lesions were considered. Kaplan-Meier estimates for patency were calculated, and Cox proportional hazard modeling was performed. RESULTS: The difference in risk factors between the groups was not significant. General anesthesia was required in 100% of the surgical group, and local or locoregional anesthesia was used for EVR. Suprarenal aortic cross-clamping was required in nine of the open surgical procedures (41%). A brachial percutaneous approach was performed in all patients undergoing EVR, and technical success was 100% in both groups. All of the attempts at EVR were successful. At the 2-year follow-up, primary patency did not differ significantly between the endovascular (91%) and surgical (95%) groups. This was seen in the univariate model (hazard ratio [HR], 0.27; 95% confidence interval [CI], 0.02-2.95; P = .28) and in the multivariate model (HR, 0.77; 95% CI, 0.06-10.07; P = .84) for group (HR, 0.58; 95% CI, 0.04-7.72; P = .68), age (HR, 0.89; 95% CI, 0.73-1.08; P = .24), symptoms (HR, 1.98; 95% CI, 0.42-9.46; P = .39), and occlusion (HR, 3.22; 95% CI, 0.51-20.35; P = .21). The average hospital length of stay was shorter for patients treated with ERV than for those treated with open surgery (3.9 ± 2.2 vs 5.8 ± 3.1 days, respectively; P = .03). The complication rate was 4% for EVR vs 18% in the surgical group (P = .32). CONCLUSIONS: At 2 years of follow-up, the results of endoluminal bypass grafting with the Viabahn stent to treat complex aortoiliac disease are promising. Longer-term results are needed to fully evaluate the potential benefits and longer-term patency.

U Stent-Graft Technique as a Treatment for Homolateral Metachronous Common Iliac and Internal Iliac Arteries Aneurysms after Open Surgery.

We report a case of a metachronous common iliac artery and the internal iliac artery (IIA) aneurysm developed 8 years after an aortobi-femoral bypass for treatment of abdominal aortic aneurysm associated at chronic occlusion of the right iliac axis. To exclude the metachronous aneurysm on the left iliac axis and to maintain the pelvic circulation, an external to IIA endografts were positioned ("U stent-graft technique"). At 6-month follow-up, the computed tomography scan showed patency of the endografts, of the bypass and of the IIA, without endoleak, or other adverse events.

The First Case of a Nellix Sac-Anchoring Endoprosthesis Removal for Aortoenteric Fistula.

The Nellix device (Endologix, Irvine, CA), has been designed with a brand new concept to seal the abdominal aortic aneurysms, minimizing endoleaks and reducing reinterventions. We present the first open conversion of a Nellix endograft due to aortoduodenal fistula of a 74-year-old male patient treated for an abdominal aortic aneurysms of 62-mm diameter.

Aortic arch rupture after multiple multilayer stent treatment of a thoracoabdominal aneurysm.

Despite the improvement in diagnostic and therapeutic strategies, the treatment of thoracoabdominal aneurysms is still burdened with a high incidence of peri/postoperative morbidity and mortality. The multilayer flow modulator is a new and promising technique for the treatment of such disease; however, some limits are still evident. We report the case of a 76-year-old woman affected by a symptomatic thoracoabdominal aneurysm treated with multiple Cardiatis multilayer flow modulators complicated by aortic arch rupture on the fifth postoperative day, with subsequent patient death.

Abdominal aortic endograft collapse due to false lumen radial force of an acute type B aortic dissection.

We report a case of abdominal endograft proximal collapse due to acute type B aortic dissection in a patient previously treated with endovascular repair (EVAR) for an infrarenal abdominal aortic aneurysm. Patient underwent axillobifemoral bypass grafting, in emergency. The postoperative computed tomography scan showed reexpansion of the occluded endograft. The patient died after 2 days with evidence of progression of the thrombosis of the false lumen and with involvement of renal, visceral, and medullar artery. EVAR collapse associated to acute type B aortic dissection is a challenging condition, which requires aggressive approach.