Search

Background: Abdominal aortic aneurysm (AAA) has a prevalence of 4.8%. AAA rupture is associated with significant mortality, thus surgical intervention is generally required once the aneurysm diameter exceeds 5.5 cm. Endovascular aneurysm repair (EVAR) is the predominant repair modality for AAA. However, in patients with complex aortic anatomy, fenestrated or branched EVAR is a superior repair option vs standard EVAR. Fenestrated and branched endoprostheses can be off-the-shelf or custom-made, which offers a more individualised approach. Aim: To summarise and evaluate the clinical outcomes achieved by fenestrated EVAR (FEVAR) and branched EVAR (BEVAR), and to explore the role of custom-made endoprostheses in contemporary AAA management. Methods: A literature search using Ovid Medline and Google Scholar was conducted to identify literature pertaining to the use and outcomes of fenestrated, branched, fenestrated-branched and custom-made endoprostheses for AAA repair. Results: FEVAR is an effective repair modality for patients with AAA that offers similar early survival, improved early morbidity but higher rates of reintervention in comparison to open surgical repair (OSR). Compared with standard EVAR, FEVAR is associated with similar in-hospital mortality yet higher rates of morbidity, especially regarding renal outcomes. BEVAR outcomes are rarely reported exclusively in the context of AAA repair. When reported, BEVAR is an acceptable alternative to EVAR in the treatment of complex aortic aneurysms and has similar reported complication issues to FEVAR. Custom-made grafts are a good alternative treatment option for complex aneurysms where hostile aneurysm anatomy precludes the use of conventional EVAR and sufficient time is available for the manufacturing of such devices. Conclusion: FEVAR offers a very effective treatment for patients with complex aortic anatomy and has been well-characterised over the past decade. RCTs and longer-term studies are desirable for unbiased comparison of non-standard EVAR modalities. [ABSTRACT FROM AUTHOR]

This study aimed to analyze early and midterm results of custom-made proximal scallop and fenestrated stent grafts for thoracic endovascular aortic repair (TEVAR) with a proximal landing zone (PLZ) in the aortic arch. All consecutive patients treated with the custom made proximal scalloped and fenestrated Relay stent grafts (Terumo Aortic Bolton Medical Inc.) in 10 Italian centers between January 2014 and December 2022 were included. The primary end points were technical success, incidence of intraoperative major adverse events, deployment accuracy, and rate of early neurological complications, endoleaks (ELs) and retrograde aortic dissection. 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 proximal landing zone 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) owing to one case (2.0%) of inaccurate deployment. Intraoperatively, one (2.0%) type Ia and one (2.0%) type III EL were detected. There were no cases of in-hospital mortality, major adverse events, or retrograde dissection. Three minor strokes (6.1%) (National Institutes of Health Stroke Scale score of ≤4) were observed. At a mean follow-up time of 36.3 ± 21.3 months the rate of types I to 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%) from nonaortic causes. 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. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to report long-term results of an ongoing physician-sponsored, investigational device exemption (IDE) pivotal clinical trial using physician-modified endovascular grafts (PMEGs) for the treatment of patients with juxtarenal aortic aneurysms. Methods: Data from a nonrandomized, prospective, consecutively enrolling IDE clinical trial were used. Data collection began on April 1, 2011, and data lock occurred on January 2, 2024, with outcomes analysis through December 31, 2023. Primary safety and effectiveness end points were used to measure treatment success. The safety end point was defined as the proportion of subjects who experienced a major adverse event within 30 days of the procedure. The effectiveness end point was the proportion of subjects who achieved treatment success. Treatment success required the following at 12 months: technical success, defined as successful delivery and deployment of a PMEG with preservation of intended branch vessels; and freedom from: type I and III endoleak, stent graft migration >10 mm, aortic aneurysm sack enlargement >5 mm, and aortic aneurysm rupture or open conversion. Results: Over the 12-year study period, 228 patients were enrolled; 205 began the implant procedure, and 203 received PMEG. Thirteen patients withdrew prior to PMEG. Two withdrew ( <1.0%) after failure to deploy due to tortuous iliac anatomy and are tracked as intent to treat, and a total of 24 withdrew after receiving the PMEG implant. Forty-four patients died during the study period. A total of 14 were deemed lost to follow-up. Fifty-nine completed the 5-year follow-up period, and 62 remain active in follow-up visits. Aneurysm anatomy, operative details, and lengths of stay were recorded and included: aneurysm diameter (mean, 67.5 mm; range, 49-124 mm), proximal seal zone length (mean, 41.6 mm; range, 18.9-92.9 mm), graft modification time (mean, 48.7 min), procedure time (mean, 137.7 min), fluoroscopy time (mean, 33.8 min), contrast material use (mean, 93.0 mL), estimated blood loss (mean, 118.8 mL), length of hospital stay (mean, 3.7 d), and intensive care unit length of stay (mean, 1.6 d). A total of 575 fenestrations were created for 387 renal arteries, 181 superior mesenteric arteries (SMAs), and 7 celiac arteries. Renal arteries were in 96% of patients and included 410 renal artery stents in 203 patients. The SMA was stented as needed and included one patient with an SMA stent placed before the procedure, 19 during the procedure, and 2 patients who underwent stent placement after the procedure. There were no open conversions or device migrations and 1 partial explant due to late distal graft occlusion. Three ruptures (1.4%) were recorded on days 830, 1346, and 1460. There was 1 presumed graft infection at 750 days (< 0.5%) treated with? Thirty-day all-cause mortality was 2.9% (6/204). One type Ia, 1 type Ib, and 7 type III endoleaks were identified during follow-up and treated with successful reintervention at the 1-year period. The overall rate of major adverse events at 30 days was 15% (29/194). Technical success was 93.7%, and overall treatment success was 82.6%. Conclusions: PMEG can be performed with low rates of long-term morbidity and mortality, confirming our early and midterm reports that endovascular repair with PMEG is safe, durable, and effective for managing patients with juxtarenal aortic aneurysms. While historically considered experimental, these results suggest that PMEG is a safe and durable option and should be considered for patients where off-the-shelf devices are not available. [ABSTRACT FROM AUTHOR]

Female sex is a risk factor for adverse events after endovascular aortic repair. Sex comparative early and midterm outcomes of fenestrated and branched endovascular aortic arch repair (F/B-Arch) are presented. A single centre retrospective sex comparative analysis of consecutive patients managed with F/B-Arch was conducted according to STROBE. Primary outcomes were sex comparative technical success, death, and cerebrovascular morbidity at 30 days. Kaplan–Meier estimates were used for follow up outcomes. Among 209 patients, 38.3% were women. Coronary artery disease (p <.001) and previous myocardial infarction (p =.01) were more common in women. Non-native proximal aortic landing was higher in women (women: 51.3%; men: 31.8%, p =.005) and the aortic dissection rate was lower (28.8% vs. 48.1%, p =.005). Proximal landing to Ishimaru zones showed no difference (zone 0: p =.18; zone 1: p =.47; zone 2: p =.39). Graft configurations were equally distributed. In total, 416 supra-aortic trunks were bridged. The median number of revascularisations per patient was two (interquartile range 1, 3), with no difference between sexes (p =.54). Technical success (women: 97.5%; men: 96.9%, p =.80), 30 day mortality rate (women: 10%; men: 9.3%, p =.86), and cerebrovascular morbidity (women: 11.3%; men: 17.1%, p =.25) were similar. Women presented more access related complications (women: 32.5%; men: 16.3%, p =.006), without affecting access related re-interventions (p =.55). Survival (women: 81.1%, 95% confidence interval [CI] 76.3 – 85.9%; men: 79.8%, 95% CI 76.0 – 83.6%) and freedom from re-intervention (women: 56.6%, 95% CI 50.4 – 62.8%; men: 55.3%, 95% CI 50.1 – 60.5%) at 12 months were similar (log rank, p =.40 and p =.41, respectively). Both sexes presented similar outcomes after F/B-Arch. Appropriate patient selection may decrease the effect of sex in F/B-Arch outcomes. [ABSTRACT FROM AUTHOR]

Fenestrated and branched endovascular repair of complex abdominal and thoracoabdominal aortic aneurysms is increasingly replacing open repair as the primary modality of treatment. Mid- and long-term results are encouraging and support its use in the correct settings. Nevertheless, appropriateness of indication for treatment, patient selection, and surgeon and hospital performance has not been clearly evaluated and reviewed. The objective of this review article was to identify areas in which appropriateness of care is relevant and can be optimized when considering treatment of patients with fenestrated and branched endovascular repair for complex abdominal and thoracoabdominal aortic aneurysms. [ABSTRACT FROM AUTHOR]

Introduction: Initiating an endovascular aortic program for treatment of complex aortic aneurysms with fenestrated and branched grafts (FB-EVAR) is challenging. Using a Proctor is one option for training and development of the team. However, this approach has not been formally analyzed. The aim of this study was to analyze the learning curve and the effect of the Proctor regarding safety and effectiveness in FB-EVAR. Methods: A single-center retrospective cohort study was performed, including all consecutive elective patients submitted to FB-EVAR (including both thoraco-abdominal-TAAA and complex abdominal aortic aneurysms-C-AAA) from 2013 to 2021. Patients were divided into 2 groups, the first operated with the Proctor present and the second without. Primary outcomes were 30-day mortality (safety) and technical and procedure success (efficacy). Secondary outcomes included treatment performance (procedure time, blood loss, contrast, and radiation use), re-interventions, aneurysm shrinking, target vessel patency, 30-day mortality, aneurysm-related mortality, and overall mortality. Results: Overall, 105 patients were included in the study, 35 operated with Proctor and 70 operated without. The first 20 patients were operated always with the Proctor, and the remaining were operated with the Proctor selectively. Mean age was 71.8 (±7.3) years and 95 patients were male (90.5%). Overall, 62 (65%) patients had C-AAA or extent IV TAAAs and 43 (35%) had extensive TAAAs. There were no significant differences regarding 30-day mortality (Log Rank=0.99), technical success (p=0.4), or procedure success (p=0.8). Mean surgical time was longer in the non-Proctor group (p=0.005), as well as significant intra-operative blood loss (p=0.042). Contrast use (p=0.5) and radiation (p=0.53) were non-significantly different between groups. There were no significant differences regarding length of stay (p=0.4), major adverse events (p=0.6), target vessel patency (Log Rank=0.97), early (p=0.7) and late endoleaks (0.7), aneurysm shrinking (p=0.6), re-interventions (p=0.2), and overall mortality (Log Rank=0.87). Conclusion: In our experience, the use of a Proctor to start and accompany our complex endovascular aortic program for FB-EVAR was both safe and effective and may serve as a template by other countries and centers that aim to developing their programs. [ABSTRACT FROM AUTHOR]

The objective of this study is to present the current outcomes of fenestrated/branched endovascular repair (F/BEVAR) for post-dissection thoracoabdominal aortic aneurysms (PDTAAAs). A systematic review of the literature according to PRISMA guidelines up to October 2023 was conducted (protocol CRD42023473403). Studies were included if ≥10 patients were reported and at least one of the major outcomes was stated. A total of 10 studies with 585 patients overall were included. The pooled estimate for technical success was 94.3% (95% CI 91.4% to 96.2%). Permanent paraplegia developed with a pooled rate of 2.5% (95% CI 1.5% to 4.3%), whereas a cerebrovascular event developed with a pooled rate of 1.6% (95% CI 0.8% to 3.0%). An acute renal function impairment requiring new-onset dialysis occurred with a pooled rate of 2.0% (95% CI 1.0% to 3.8%). Postoperative respiratory failure was observed with a pooled estimate of 5.5% (95% CI 3.8% to 8.1%). The pooled estimate for 12-month overall survival was 90% (95% CI 85% to 93.5%), and the pooled estimates for 24-month and 36-month survival were 87.8% (95% CI 80.9% to 92.5%) and 85.5% (95% CI 76.5% to 91.5%), respectively. Freedom from reintervention was estimated at 83.9% (95% CI 75.9% to 89.6%) for 12 months, 82.8% (95% CI 68.7% to 91.4%) for 24 months and 76.1% (95% CI 60.6% to 86.8%) for 36 months. According to the present findings, F/BEVAR can be performed in PD-TAAAs with high rates of technical success and good mid-term results. [ABSTRACT FROM AUTHOR]

Purpose: To report a case of a patient with a large thoracoabdominal aortic aneurysm (TAAA) extent V treated with a custom-made fenestrated and branched endovascular repair (F/B-EVAR) after a failed and incomplete attempt of a Sandwich repair technique. Report: An 83-year-old patient was referred to our department after a failed attempt at endovascular repair of type V TAAA with a sandwich technique. The celiac trunk was inadvertently covered with the first endograft and a covered long superior mesenteric artery stent was placed and left facing upward inside the aorta. We performed a staged repair, by first catheterizing and stenting the celiac trunk and bringing it under and inside the main aortic endograft. In interval, a F/B-EVAR was performed using a bimodular custom-made device (CMD) with a proximal 2 branch module for the celiac trunk and superior mesenteric artery and distal module with fenestrations for both renal arteries. The intervention was successful, and the follow-up was uneventful at 6 months. Conclusions: Re-intervention after failed endovascular attempts of TAAA repair are technically challenging and require advanced endovascular techniques. The ability to construct CMDs allowed to extend repair to our patient which had severe anatomical constraints for other techniques. [ABSTRACT FROM AUTHOR]

Objectives: To assess the performance of dynamic or 4D CT in characterizing endoleaks in advanced endovascular aortic repair (branched and fenestrated) when other modalities fail to fully characterize the leak, most often conventional CTA. Methods: Retrospective review of 13 patients from 2008 to 2021 who underwent 16 4D CTs to characterize endoleaks in branched and fenestrated endovascular aortic repair (FB-EVAR). The 4D CTs were performed covering up to 16 cm of the z-axis, with anywhere between 10 and 40 iterations performed every 2 s. These settings were adjusted depending on graft characteristics and type of endoleak suspected. The scans were assessed for their ability to detect the endoleak (sensitivity), and further to characterize the endoleak by type and subtype (specificity). Results: Overall sensitivity in 16 scans for endoleak detection was 100%. There was a specificity of 87.5% for determining the type of endoleak (14/16). These results included two studies that were inconclusive and repeated due to technical difficulties. In patients where a specific subtype was not established, the leak was localized to the appropriate target vessel. Average dose for the 4D CT was 4724 mGy*cm (1108–11069), with the outlining higher dose scans secondary to higher iterations in those scans. Conclusions: 4D CT is a useful adjunctive tool in FB-EVAR surveillance with excellent sensitivity and specificity in characterizing endoleaks. This allows for accurate localization of leaks, which is critical for management planning. [ABSTRACT FROM AUTHOR]

Copyright of Hungarian Medical Journal / Orvosi Hetilap is the property of Akademiai Kiado and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Introduction: An abdominal aortic aneurysm (AAA) is a life-threatening abnormal dilation of the abdominal aorta that can be repaired either endovascularly or with open surgery. However, endovascular aortic repair (EVAR) has become the main treatment modality for AAA due to its more optimal results. EVAR devices can either be standard, fenestrated, or branched, with fenestrated EVAR (FEVAR) seemingly achieving superior prospects. Although EVAR is associated with excellent outcomes, it still carries a risk of certain complications requiring reintervention or 'rescue'. Several commercial EVAR devices are available on the global market, nevertheless, the Fenestrated Anaconda developed by Terumo Aortic can be considered the superior device due to the wide range of endovascular solutions that it offers along with its unique custom-made approach, excellent results and its highly promising potential to be used as a 'rescue' device for failed competitor endografts. Materials and methods: The current study represents a 9-year cross-sectional international analysis of a custom-made Fenestrated Anaconda™ device. For the statistical analysis, SPSS 28 for Windows and R were utilised. Pearson Chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at p < 0.05. Results: Out of 5058 EVARs performed using the Fenestrated Anaconda, 2987 (59%) were 'rescue' procedures for migrated Gore (n = 252) and Medtronic (n = 2735) devices. The Fenestrated Anaconda™ was indicated as the reintervention device either due to unsuitable/complex anatomy for the competitor (n = 2411) or based on surgeon preference (n = 576). Overall, the Fenestrated Anaconda was utilised to rescue 3466 (68.5%) failed previous EVARs using competitor devices. Yet, the primary endovascular solution offered by the Fenestrated Anaconda was FEVAR (91.3%), with 112 (2.2%) devices using custom-made iliac stents. Discussion: The use of the Fenestrated Anaconda endograft as a 'rescue' device to salvage failed competitor devices is well-established in the literature with excellent clinical outcomes achieved. The evidence in the literature also highlights the distinctive custom-made approach that the Fenestrated Anaconda offers which enables it to treat extremely complex aortic anatomy. [ABSTRACT FROM AUTHOR]

The use of fenestrated stent grafts to treat short neck, juxta- and suprarenal aortic aneurysms is increasing worldwide, but midterm outcome reports are scarce. This study aimed to report peri-operative results and midterm outcomes after five years from a single centre. Patients treated with primary fenestrated endovascular aortic aneurysm repair (FEVAR) for short neck, juxta- or suprarenal aortic aneurysms within the period January 2010 to May 2020 with follow up in the centre were included. Early (technical success, operative mortality, spinal cord ischaemia) and five year outcomes (cumulative survival, freedom from aortic related death, target vessel patency, target vessel instability [TVI], re-interventions) were analysed. A total of 349 patients (313 male, mean age 72.3 ± 7.7 years) were included in the study. Technical success was 98% (342/349). The thirty day mortality rate was 0.9% (3/349). Estimated survival at five years was 69.3 ± 3.1%. Freedom from aneurysm related death at five years was 98.8% ± 0.7%. Estimated target vessel patency at five years was 98.7 ± 0.4%. Estimated freedom from TVI at five years was 97.2 ± 0.6%. Estimated freedom from re-intervention at five years was 86.5 ± 2.3%. Survival did not differ significantly between patients with and without re-interventions (p =.088). Midterm results of FEVAR remain good as indicated by sustained target vessel patency and low aortic related mortality rates. An important proportion of patients require re-interventions, which do not have a negative impact on midterm survival. [ABSTRACT FROM AUTHOR]

Purpose: Fenestrated endovascular aneurysm repair (fEVAR) is established for the treatment of juxtarenal, pararenal, and thoracoabdominal aortic aneurysms (TAAAs). Bridging stents are used to connect the main body of the stent graft to the aortic branch vessels. Complications related to the bridging stents compromise the durability of the repair and require urgent re-intervention. Here we present the midterm results of the BeGraft stent graft system used for fEVAR. Materials and method: All consecutive patients treated with fEVAR and the current BeGraft Peripheral Stent Graft between November 2015 and September 2016 were included. Results: Thirty-nine consecutive patients (38 men) were enrolled and 101 BeGraft second-generation stent grafts were implanted. The median aneurysm diameter was 60 mm (54.5–67.0 mm). Aneurysms were juxtarenal and pararenal (19/39, 48.1%), type 4 TAAA (3/39, 7.7%), type 1, 2, and 3 TAAA (7/39, 17.8%), type 5 TAAA (4/39, 10.2%), and 15.4% (6/39) had a type I endoleak following a previous EVAR. Fifty-five BeGrafts were implanted in mesenteric arteries (22 in coeliac trunks, 31 in the superior mesenteric artery, and 2 in a hepatic or splenic artery) and 46 into renal arteries (24 right and 22 left). The renal artery diameters were 5, 6, 7, and 8 mm in 9, 7, 26, and 4 patients, respectively. Mesenteric arteries were exclusively stented with 9 and 10 mm diameter devices. The median follow-up was 33 months (IQ25 17–IQ75 36). During follow-up, 11 patients died (28%) from non–aneurysm-related causes. The overall patency rates for bridging stents were 98% and 97% at 1 and 2 years, respectively, with a freedom from secondary procedure rate on BeGraft stent grafts of 96% (97/101). All events occurred on stents implanted in renal arteries. Conclusion: Early favorable outcomes are confirmed during longer term follow-up. Vigilant surveillance is required. [ABSTRACT FROM AUTHOR]

Juxtarenal/pararenal aortic aneurysms and type IV thoracoabdominal aneurysms pose particular technical challenges for endovascular repair as they involve the visceral segment in addition to insufficient infrarenal neck for the use of standard endovascular aneurysm repair (EVAR) devices. To overcome these challenges, complex EVAR techniques have been developed to extend the proximal landing zone cephalad with maintaining perfusion to vital aortic branches, thereby broadening the applicability of endografting from the infrarenal to the suprarenal aorta. Complex EVAR can be divided into two broad categories: fenestrated endovascular aneurysm repair (FEVAR) and snorkel EVAR. FEVAR is a valid procedure with the standardized procedure, although it remains as a relatively complex procedure with a learning curve. Given time constraints for the custom fenestrated graft, snorkel EVAR may be an alternative for complex repairs in symptomatic or ruptured patients for whom custom-made endografts may not be immediately available. This article discusses these two most commonly used complex EVAR strategies.

Purpose: The aim of this study is to report an Italian multicenter experience analyzing the incidence and the risk factors associated with spinal cord ischemia (SCI) in a large cohort of thoracoabdominal aortic aneurysms (TAAAs) treated by fenestrated-branched endovascular aneurysm repair (F-/B-EVAR). Materials and Methods: All consecutive patients undergoing F-/B-EVAR in 4 Italian university centers between 2008 and 2019 were prospectively recorded and retrospectively analyzed. Spinal cord ischemia, 30 day/in-hospital adverse events, and mortality were assessed as early outcomes. Risk factors for SCI were determined by multivariable analysis. Results: A total of 351 patients received F-/B-EVAR for a TAAA. Twenty-eight (8.0%) patients died within 30 postoperative days or during the hospitalization. Regarding SCI, 47 patients (13.4%) developed neurological symptoms related to spinal cord impaired perfusion. Among them, 17 (4.8%) had a major permanent impairment. The multivariable analysis identified that SCI was associated with Crawford extent I to III (odds ratio [OR]: 20.90, p=0.004, 95% confidence interval [CI]=2.69–162.57), and with endovascular procedures performed for ruptured TAAA (OR: 5.74, p=0.010, 95% CI=1.53–21.57). Spinal cord ischemia was also significantly associated with a grade 3 bleeding during the visceral stage (OR: 4.34, p=0.005, 95% CI=1.55–12.16) and a grade 2 renal insufficiency at 30 days (OR: 7.45, p=0.002, 95% CI=2.12–26.18). Conclusion: The present study indicates that SCI is still an open issue after extent I to III TAAA endovascular repair, while its incidence in extent IV TAAA and pararenal/juxtarenal aneurysms is rare. Thoracoabdominal aortic aneurysms extension, urgent TAAA repair for rupture, severe bleeding, and 30 day renal insufficiency have been identified as significant risk factors for SCI. In the presence of such factors, adjunctive strategies may be considered to reduce SCI rates, while in low-risk patients invasive or potentially-risky maneuvers might not be justified. [ABSTRACT FROM AUTHOR]

There have been significant technologic advances in endovascular aortic therapies since the introduction of conventional infrarenal endovascular aortic aneurysm repair (EVAR). These advances have sought to address the weaknesses of conventional EVAR- particularly the difficult or "hostile" infrarenal aortic aneurysm neck. We review anatomical features that create a hostile neck and the most recent advancements to overcome these limitations. EndoAnchors replicate open suture fixation to seal endograft to aortic tissue and have been shown to be useful as a prophylactic measure in short, angulated necks as well as therapeutic for type Ia endoleaks. Fenestrated EVAR (FEVAR) devices such as the Z-fen (Cook Medical, Bloomington, IN, USA) raises the seal zone to the suprarenal segment while maintaining renal perfusion. Finally, multibranch aortic grafts such as the Thoracoabdominal Branch Endoprosthesis (Tambe; W. L. Gore & Associates, Flagstaff, AZ, USA) raise the seal zone above the visceral segment and can be used off the shelf with promising results. [ABSTRACT FROM AUTHOR]

Objective: Contemporary commercially available endovascular devices for the treatment of abdominal aortic aneurysm (AAA) include standard endovascular aortic repair (sEVAR) or fenestrated EVAR (fEVAR) endografts. However, aortic neck dilatation (AND) can occur in nearly 25% of patients following EVAR, resulting in loss of proximal seal with risk of aortic rupture. AND has not been well characterized in fEVAR, and direct comparisons studying AND between fEVAR and sEVAR have not been performed. This study aims to analyze AND in the infrarenal and suprarenal aortic segments, including seal zone, and quantify sac regression following fEVAR implantation compared to sEVAR. Method: A retrospective review of prospectively collected data on 20 consecutive fEVAR patients (Cook Zenith® Fenestrated) and 20 sEVAR (Cook Zenith®) patients was performed. Demographic data, anatomic characteristics, procedural details, and clinical outcome were analyzed. Pre-operative, post-operative (1 month), and longest follow-up CT scan at an average of 29.3 months for fEVAR and 29.8 months for sEVAR were analyzed using a dedicated 3D workstation (iNtuition, TeraRecon Inc, Foster City, California). Abdominal aortic aneurysm neck diameter was measured in 5 mm increments, ranging from 20 mm above to 20 mm below the lowest renal artery. Sub-analysis comparing the fEVAR to the sEVAR group at 12 months and at greater than 30 months was performed. Standard statistical analysis was done. Results: Demographic characteristics did not differ significantly between the two cohorts. The fEVAR group had a larger mean aortic diameter at the lowest renal artery, shorter infrarenal aortic neck length, increased prevalence of nonparallel neck shape, and longer AAA length. On follow-up imaging, the suprarenal aortic segment dilated significantly more at all locations in the fEVAR cohort, whereas the infrarenal aortic neck segment dilated significantly less compared to the sEVAR group. Compared to the sEVAR cohort, the fEVAR patients demonstrated significantly greater positive sac remodeling as evident by more sac diameter regression, and elongation of distance measured from the celiac axis to the most cephalad margin of the sac. Device migration, endoleak occurrence, re-intervention rate, and mortalities were similar in both groups. Conclusion: Compared to sEVAR, patients undergoing fEVAR had greater extent of suprarenal AND, consistent with a more diseased native proximal aorta. However, the infrarenal neck, which is shorter and also more diseased in fEVAR patients, appears more stable in the post-operative period as compared to sEVAR. Moreover, the fEVAR cohort had significantly greater sac shrinkage and improved aortic remodeling. The suprarenal seal zone in fEVAR may result in a previously undescribed increased level of protection against infrarenal neck dilatation. We hypothesize that the resultant decreased endotension conferred by better seal zone may be responsible for a more dramatic sac shrinkage in fEVAR. [ABSTRACT FROM AUTHOR]

To report the outcomes of fenestrated-branched endovascular repair (FBEVAR) for thoracoabdominal aortic pathology after total aortic arch replacement with frozen elephant trunk (TAR+FET). Interrogation of prospectively maintained databases from four high-volume aortic centers identified consecutive patients treated with distal FBEVAR after prior TAR+FET between August 2013 and September 2020. The primary end point was 30-day/in-hospital mortality. Secondary end points were technical success, early clinical success, midterm survival, and freedom from reintervention. Data are presented as median (interquartile range). A total of 39 patients (21 men; median age, 73 years [67-75 years]) with degenerative (n = 22) and postdissection thoracoabdominal aortic aneurysms (n = 17) (median diameter, 71 mm [61-78 mm]) were identified. Distal FBEVAR was intended in 27 patients (median interval, 9.8 months [6.2-16.6 months]), anticipated in 7, and unexpected in 5. A total of 31 patients had a two- (n = 24) or three-stage (n = 7) distal FBEVAR. Renovisceral target vessel preservation was 99.3% (145 of 146). Early primary and secondary technical success was 92% and 97%, respectively. Thirty-day mortality was 2.6% (n = 1; respiratory failure and spinal cord ischemia [SCI]). Six survivors also developed SCI, which was associated with complete (n = 4) or partial recovery (n = 2) at hospital discharge. No patients required renal replacement therapy or suffered a stroke. Early clinical success was 95%. Median follow-up was 30.5 months (23.7-49.7 months). Eleven patients required 16 late reinterventions. Estimated 3-year survival and freedom from reintervention were 84% ± 6% and 63% ± 10%, respectively. Distal FBEVAR after prior TAR+FET is associated with high technical success and low early mortality. The risk of SCI is significant although the majority of patients demonstrate full or partial recovery before hospital discharge. Midterm patient survival is favorable, but there remains a high requirement for late reintervention. FBEVAR represents an acceptable alternative to distal open thoracoabdominal aortic aneurysm repair. [ABSTRACT FROM AUTHOR]

The aim of this study was to identify trends in hospital length of stay (HLOS) and intensive care unit length of stay (ICULOS), and the relationship with cerebrospinal fluid drainage (CSFD) protocols in patients undergoing fenestrated-branched endovascular aortic repair (FB-EVAR) of thoracoabdominal aortic aneurysms (TAAAs). A retrospective review of patients who underwent elective FB-EVAR for extent I to IV TAAAs between 2008 and 2023 at a single aortic center of excellence was conducted. Patient demographics, cardiovascular comorbidities, surgical risk, technical details, CSFD strategy (prophylactic or therapeutic), procedural success, and perioperative outcomes were collected. Patients were divided into two groups based on CSFD protocol. Group 1 included patients treated before 2020 when prophylactic CSFD was performed widely, and Group 2 consisted of patients treated since 2020 with therapeutic CSFD. Primary end points were HLOS, ICULOS, major adverse events, and perioperative mortality. FB-EVAR was performed in 702 patients; 412 underwent elective TAAA repair and were included in the analysis. Mean age was 73 ± 8 years and 68% were male. Patient-specific manufactured devices were used in 252 patients (61%), physician-modified endografts in 110 (27%), and 50 patients (12%) were treated with off-the-shelf devices. Demographics, aneurysm extent, major adverse events (including spinal cord ischemia [SCI]), and mortality were similar in both groups. A significant reduction in mean HLOS between the groups (9 ± 9 vs 6 ± 5 days; P =.02) coincided with decreased use of prophylactic CSFD (70% vs 1.2%; P <.001), with similar rates of SCI (7.6% vs 4.9%; P =.627) and ICULOS (3 ± 3 vs 2.5 ± 3; P =.19). Patients in the therapeutic drainage cohort (group 2) had a higher incidence of congestive heart failure (24% vs 11%; P =.003), hypercholesterolemia (91% vs 80%; P =.015), chronic obstructive pulmonary disease (55% vs 37%; P =.004), and peripheral artery disease (39% vs 19%; P <.001) compared with group 1, suggesting treatment of a more complex patient cohort. On adjusted multivariable analysis accounting for American Society of Anesthesiologists score, comorbidities, and device type, the difference in HLOS remained statistically significant (P =.01). HLOS decreased over time in patients undergoing FB-EVAR for TAAA after transition from a prophylactic to a therapeutic CSFD protocol. This transition was the only modifiable, independent risk factor for a shorter HLOS, without an increase in SCI, albeit with similar ICULOS. [ABSTRACT FROM AUTHOR]

Fenestrated and branched thoracic endovascular repair (f/bTEVAR) have been successfully applied in patients with diverse aortic arch pathologies. The aim of this study is to present the early and mid-term outcomes of patients with native proximal aortic landing (NPAL) managed with f/bTEVAR. A single-center retrospective analysis of patients with NPAL, managed with f/bTEVAR, between September 1, 2011, and June 30, 2022, was conducted. All patients were treated with custom-made devices (Cook Medical) with landing within Ishimaru zones 0 to 2. Primary outcomes were technical success, mortality, stroke, and retrograde type A dissection at 30 days. Follow-up outcomes were considered secondary. A total of 126 patients were included (69.8% males; mean age, 70.8 ± 4.2 years; 18.3% urgent). The main indications (60.4%) for repair were aortic arch (29.4%) and thoracoabdominal aortic aneurysms (31.0%). Seventy-two patients (57.1%) were managed with fTEVAR. Proximal landing in zone 0 and 1 was chosen in 97.6%. Technical success was 94.4%, and 30-day mortality was 11.9%. Strokes were diagnosed in 13.5% of patients and major strokes were identified in 7.9% cases. Retrograde type A dissection rate was 3.9%. The multivariate analysis confirmed landing in Ishimaru zone 0 as an independently related factor for stroke (P =.005), whereas stroke (P <.001), pericardial effusion (P <.001), and acute kidney injury (P <.001) were independently related to 30-day mortality. Mean follow-up was 17.5 ± 9.3 months. The estimated survival rate and the freedom from reintervention rate were 72.6% (standard error, 4.4%) and 46.4% (standard error, 6.0%) at 24-month follow-up, respectively. Stroke rate after endovascular arch repair was alarming among patients with NPAL. Proximal landing to zone 0 was related to higher risk of stroke. Reinterventions were common within the 24-month follow-up. [ABSTRACT FROM AUTHOR]

Our purpose was to evaluate the risk associated with the learning curve of starting a complex aortic programme in an Eastern European country. A retrospective study was conducted involving the initial 20 patients (16 males, mean age: 65 ± 11 years) undergoing fenestrated/branched endovascular aortic repair in a single centre. Demographic, anatomical, procedural, and postoperative variables were collected. Our elective patient cohort consisted of 9 pararenal aneurysms (45%) and 11 thoracoabdominal aortic aneurysms (55%), with the latter including 4 chronic dissection cases (20%). A total of 71 branch vessels were incorporated (3.5 ± 0.9 per patient). The per vessel technical success rate was 100%. In-hospital mortality was 5% (1/20). At an average follow-up of 14 ± 22 months, the primary clinical success rate was 45% (9/20) and the secondary clinical success was achieved in 75% of cases (15/20). All-cause mortality at 14 months was 20% (4/20; aortic related: 1/20, 5%). Four bridging stent occlusions were found (5.6%). Mortality and reintervention rates were comparable to the initial results of high-volume centres, while the complexity of our cases and the per vessel technical success rate was comparable to the values reported as late experience. The morbidity of the learning curve could be decreased if operators are skilled in basic endovascular procedures. [ABSTRACT FROM AUTHOR]

Management of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres. Eight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts' responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers' consistency was graded using Cohen's k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k. Sixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage. Based on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues. [ABSTRACT FROM AUTHOR]

Objectives: To collect and analyse the available evidence in the outcomes of patients treated with fenestrated endovascular aortic repair (f-EVAR) technique focusing specifically on visceral vessel outcomes. Methods: The current meta-analysis was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. All the studies reporting the f-EVAR technique for the management of degenerative pararenal and/or type IV thoracoabdominal aortic aneurysms (TAAA) were considered eligible for inclusion in the study. The main study outcomes (technical success, type I endoleaks, fracture or occlusion of the bridging stents, overall aneurysm-related mortality, and the reintervention rate) were subsequently expressed as proportions and 95% confidence intervals. Results: Fourteen studies with a total of 1804 patients were included in a pooled analysis. The technical success of the procedure was 95.97% (95%CI = 92.35–98.60). Intraoperatively, the pooled proportion of reported type I endoleak was 7.6% (95%CI = 2.52–14.60) while during a median follow-up of 41 months (range 11–96) follow-up period the pooled rate of fracture and occlusion of the bridging stents was 2.79% (95%CI = 0.00–8.52) and 4.46% (95%CI = 1.93–7.77), respectively. The overall aneurysm-related mortality was detected to be 0.63% (95%CI = 0.04–1.63), and the pooled estimate for re-intervention rate was 15.69%. Conclusions: Fenestrated endovascular repair for p-AAA is an effective and safe treatment. Target vessel complications and endoleaks remain the two most important concerns for fenestrated endovascular procedures, contributing to most of the secondary interventions. The lack of computed tomography angiography follow-up evaluation does not allow us to draw robust conclusions about the complication rates for the superior mesenteric artery during f-EVAR. Due to the potential implications of SMA complications on aneurysm-related mortality, standardized reporting of short- and long-term target visceral vessel outcomes is required. [ABSTRACT FROM AUTHOR]

Background: Iliac artery anatomy can have a dramatic impact on the success of endovascular complex aortic aneurysm (CAA) procedures as endograft delivery systems need to be advanced and manipulated through these access vessels. The aim of this study was to evaluate the outcomes of iliac artery conduits with emphasizes on open vs endovascular conduits performed to facilitate CAA endovascular repair. Methods: All patients who had open or endovascular iliac conduits prior to endovascular CAA repair to treat thoracoabdominal, juxtarenal, or suprarenal aneurysms at the University of Colorado Hospital from January 2009 through January 2019 were included. Patients who presented with symptomatic or ruptured aortic aneurysms were excluded. Outcomes of interest included postoperative complications and mortality in patients undergoing iliac conduits. Results: Twenty-seven patients with a total of 42 conduits were included in the study. The majority of patients (N = 15, 56%) were female and the average age was 72 ± 9 years. The calculated VQI cardiac index was.6% (range,.3%–.8%). Eighteen (43%) endovascular and 24 (57%) open iliac conduits were performed during the study period. Thirty (71%) conduits were performed in a staged fashion, while 12 (29%) were performed at the same time as endovascular CAA repair. The mean time between conduit and definitive aneurysm repair surgery was 130 ± 68 days in the endovascular and 107 ± 79 days in the open groups (P =.87). No aneurysm rupture occurred during the staging period in either group. The median follow-up for the entire cohort was 18 ± 22 months. The median length of hospital stay for patients undergoing endovascular and open ICs was 6 (ranging, 1–28 days) and 7 days (ranging, 3–18 days), respectively. Patients undergoing open conduits had significantly more complications than those undergoing endovascular conduit (endoconduit) creation. A total of 4 (15%) patients died within 30 days after aneurysm repair. Out of 23 survivors, 18 (78%) patients were discharged home, 4 (18%) patients were discharged to a skilled nursing facility, and 1 (4%) patient was discharged to an acute rehabilitation facility. No mortality difference based on type of conduit was found. Conclusions: Overall complication rate associated with creation of open iliac artery conduits is not negligible. Endoconduits, which carry less morbidity than open conduits, are preferred as a first-line adjunctive access procedure to facilitate complex endovascular aortic aneurysm repair. [ABSTRACT FROM AUTHOR]

IntroductionSince the introduction of endovascular aortic repair (EVAR), it has demonstrated excellent clinical outcomes and has replaced open surgical repair (OSR) in the treatment of abdominal aortic aneurysms (AAA). AAA is a life-threatening abnormal dilation of the abdominal aorta to 1.5 times its normal diameter. Several commercial EVAR devices exist on the global market, with the Terumo Aortic Fenestrated Anaconda™ graft showing superiority. In this study, we sought to provide an international perspective using multicenter-multinational data on the Anaconda™ device characteristics, design, and delivery, and discuss relevant literature.Materials and MethodsThis study represents a cross-sectional international analysis of custom-made fenestrated Anaconda™ device. Ethical and legal approval for data collection was obtained from each of the local authorities. For the statistical analysis, SPSS 28 for Windows and R were utilized. Pearson’s chi-square analysis was used to assess differences in cumulative distribution frequencies between select variables. Statistical significance for all two-tailed tests was set at p < 0.05.ResultsA total of 5,030 Anaconda™ devices were implanted during the 9-year study period in 27 countries spanning 6 continents. The predominant device category was bifurcate (83.6%), whereas the most common proximal ring stent configuration being standard (64.5%). All devices were delivered within 8 weeks of diagnosis, with most being implanted within 6–8 weeks (55.4%). The Anaconda™ was indicated in the 3,891 (77.4%) patients due to competitor rejection/inability to treat unsuitable/complex aortic anatomy. In the remaining 1,139 (22.6%) patients, it was utilized based on surgeon preference. Almost all devices (95%) were delivered along with a prototype. Of the total 5,030 Anaconda™ devices, 438 (8.7%) used 0–1 fenestrations, 2,349 (46.7%) used 2–3, while 2,243 (44.6%) utilized 4, 5, or 6 fenestrations.DiscussionThe Terumo Aortic Fenestrated Anaconda™ device features a highly unique and innovative design that enables it to treat highly complex aortic anatomy while achieving excellent results. The Anaconda™’s custom-made approach allows it to be tailored to individual patient anatomy, in addition to the device prototype provided by Terumo Aortic optimize clinical outcomes. Finally, the fenestrated Anaconda™ is a highly versatile device offering a wide range of device categories, configurations, and sizes.

Fenestrated endovascular aortic aneurysm repair (FEVAR) for juxtarenal aortic aneurysm (jAAA) disease is safe and effective with good short- and mid-term outcomes. The durability issues have mainly focused on the proximal and distal seal and target vessel (TV) instability, and long-term data are scarce. In previous studies, we have reported the short-term outcomes after FEVAR and compared our early and late experience and the long-term results for the early cohort. In the present report, we have provided the long-term outcomes for our late experience cohort who had undergone FEVAR at the Vascular Center (Skåne University Hospital, Malmö, Sweden). Consecutive patients who had undergone FEVAR for jAAAs from 2007 to 2011 were included in the present study. Data were collected retrospectively from the medical and imaging records. The follow-up protocol consisted of a clinical examination 1 month postoperatively and computed tomography angiography combined with plain abdominal radiography at 1 and 12 months and annually thereafter. The primary endpoints were TV instability, reinterventions, and survival. Changes in the aneurysm diameter and renal function and the incidence and type of endoleaks were also analyzed. A total of 94 patients were included in the present study. The median follow-up time was 89 months (range, 0-152 months). A total of 280 fenestrations or scallops were used, of which 205 were stented. Technical success was 89.4%. Primary TV patency was 94% ± 1% at 1 year, 90% ± 2% at 3 years, and 89% ± 2% at 5 years. Of the 94 patients, 37 (39.4%) had required a total of 70 reinterventions. The mean time to the first reintervention was 21 ± 3.97 months. Five patients (5.3%) had died of aneurysm-related causes. Overall survival was 95.7% ± 2.1% at 1 year, 87.1% ± 3.5% at 3 years, and 71.0% ± 4.7% at 5 years. A stable or decreasing aortic diameter after treatment was seen in 91% of the cases. The mean glomerular filtration rate had decreased from 59.2 ± 14.9 mL/min/1.73 m2 preoperatively to 50.0 ± 18.6 mL/min/1.73 m2 at the end of follow-up. The results of the present study have shown that the long-term results after treatment of jAAAs with FEVAR remain good and the treatment is safe and effective. Although the need for reintervention remained high, long-term renal function and survival support the use of FEVAR as a valid treatment option for jAAA disease. [ABSTRACT FROM AUTHOR]

There have been significant technologic advances in endovascular aortic therapies since the introduction of conventional infrarenal endovascular aortic aneurysm repair (EVAR). These advances have sought to address the weaknesses of conventional EVAR- particularly the difficult or “hostile” infrarenal aortic aneurysm neck. We review anatomical features that create a hostile neck and the most recent advancements to overcome these limitations. EndoAnchors replicate open suture fixation to seal endograft to aortic tissue and have been shown to be useful as a prophylactic measure in short, angulated necks as well as therapeutic for type Ia endoleaks. Fenestrated EVAR (FEVAR) devices such as the Z-fen (Cook Medical, Bloomington, IN, USA) raises the seal zone to the suprarenal segment while maintaining renal perfusion. Finally, multibranch aortic grafts such as the Thoracoabdominal Branch Endoprosthesis (Tambe; W. L. Gore & Associates, Flagstaff, AZ, USA) raise the seal zone above the visceral segment and can be used off the shelf with promising results.

Symptoms of gallstone disease are the most common reason for cholecystectomy. Fenestration reduces the likelihood of severe inflammation or scarring after normal treatments are used, and it also enhances control over bile outflow. The goal of reconstituted cholecystectomy is to lessen symptoms like pain and jaundice without undergoing the high-risk procedures associated with more invasive procedures. The reconstituted and fenestrated procedures were assessed by a meta-analysis and systematic review. Of the five studies, 189 (34.2%) had a reconstituted subtotal cholecystectomy, and 363 (65.8%) had a fenestrated subtotal cholecystectomy, which had populations from the United States of America, the United Kingdom, Japan, and Turkey. Two individuals from three trials had bile duct injury, according to three studies. Whereas the fenestrated group reported no bile injury from 236 individuals (0%), the reconstituted group reported two bile duct injuries from 100 patients (2%). The incidence was found to be lower in the fenestrated group (OR 10.81; CI 95% 1.03-113.65; p = 0.39; I2 = 0%) than in the reconstituted group. Four studies revealed 92 cases of bile leaks: 19 out of 155 cases (12.3%) were reconstituted, and 73 out of 351 cases (20.8%) were fenestrated. Between the two groups, there was a significant difference in bile leakage (OR 0.72; CI 95% 0.23-2.32; p = 0.03; I2 = 66%). Two studies reported the establishment of fistulas following surgery in 58 patients in the reconstituted group (5.2%) and 120 patients in the fenestrated group (2.5%) (p = 0.56, I2 = 0%, and OR 0.65; CI 95% 0.12-3.38); however, there was no statistically significant difference between the groups. Following a fenestrated partial cholecystectomy, postoperative bile leakage, fistula development, wound infection, and retained stones are more prevalent. Additionally, we saw that the fenestrated method was being used more frequently for post-operative endoscopic retrograde cholangiopancreatography (ERCP). The subtotal cholecystectomy technique used should be chosen according to the surgeon's comfort level and experience with the various techniques and intraoperative findings, even if the reconstituted procedure could be preferred when feasible. To completely understand the role of each method in the general surgeon's toolkit for treating complex gallbladder (GB) patients, longer-term follow-up studies are still necessary., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Ravendran et al.)

Purpose: This study aims to assess the safety and efficacy of the fenestrated Anaconda device for the treatment of complex aortic aneurysms over 1 year in daily clinical practice., Materials and Methods: All patients who received the graft between October 2019 and October 2020 were prospectively enrolled in an observational, multicenter national registry. The primary endpoint was the aneurysm-related 1-year mortality rate. Secondary endpoints included all-cause mortality, technical success, device-related adverse events (AEs) and major complications, secondary reinterventions, endoleaks, target vessel (TV) outcomes, and a center-volume analysis comparing mortality and secondary reintervention rate between expert centers (>15 F/BEVAR per year) and nonexpert centers (≤15 F/BEVAR per year)., Results: Ninety-seven patients from 28 centers were treated. Aneurysms types included juxta-renal and short neck (84.6%), pararenal (5.2%), paravisceral (3.1%), and type IV thoracoabdominal (2.5%). Configurations with 1, 2, 3, and 4 fenestrations were used in 2, 12, 18, and 65 cases, respectively, totaling 350 TVs. Technical success was 98.0%, with 1 type Ic and 1 type IIIc endoleak. Mean follow-up was 468 days. Ten patients died, with 8 deaths (8.2%) due to non-aortic causes and 2 deaths (2.1%) from unknown causes. The estimated 1-year survival rate was 92.7% (95% CI: 87.8-98.1%). The reintervention rate at 30 days was 11.3% and the estimated reintervention rate at 1 year was 21.6% (95% CI: 12.7-29.6%). No type Ia endoleak occurred during follow-up. Three type III endoleaks occurred and required reintervention. Three TV occlusion occurred, yielding a 1-year TVI-free rate of 92.4% (95% CI: 89.4-99.3). No device-related major complication was recorded, and 3 device-related AEs occurred: 1 limb migration, 1 limb kinking and 1 limb thrombosis. There was no statistically significant difference in mortality and survival without reintervention between expert and nonexpert centers (Log rank p=0.52 and p=0.16, respectively)., Conclusion: The fenestrated Anaconda device demonstrated acceptable early and at 1-year safety and efficacy for treating primarily juxta-renal and short-neck aortic aneurysms, in centers with varying levels of experience., Clinical Impact: The Anaconda Fenestrated, as the second commercially available custom-made device for complex endovascular aortic surgery, might adress some anatomical challenges. Following market authorization, this registry presents the 1-year outcomes of real-world device usage in a large number of centers, including small clinics. The results indicate that the device provided adequate efficacy and safety for treating mostly juxta-renal and short neck aneurysms, with notable improvement in technical success rate compared to older reports., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AO, NF, YA, and J-NA have no conflict of interest to disclose. M-AV, VO, ED, and AM have engaged in proctoring activities for Terumo Aortic.

Objective: Despite the increasing number of fenestrated and branched endovascular aortic repair (F/B-EVAR) procedures, evidence on post-operative antiplatelet therapy is very limited. This study aimed to investigate the role of single antiplatelet therapy (SAPT) vs. double antiplatelet therapy (DAPT) after F/B-EVAR in 30 day and follow up outcomes., Methods: A multicentre retrospective analysis was conducted, including F/B-EVAR patients managed from 1 January 2018 to 31 December 2022. Comparative outcomes were assessed according to post-operative antiplatelet therapy. The cohort was divided into the SAPT group (acetylsalicylic acid [ASA] or clopidogrel) and DAPT group (ASA and clopidogrel). The duration of SAPT or DAPT was one to six months. Primary outcomes were 30 day death, and cardiovascular ischaemic and major haemorrhagic events. Secondary outcomes were survival and target vessel (TV) patency during follow up., Results: A total of 1 430 patients were included: 955 under SAPT and 475 under DAPT. The 30 day mortality rate was similar (SAPT 2.1% vs. DAPT 1.5%; p = .42). Cardiovascular ischaemic events were lower in the DAPT group (SAPT 11.9% vs. DAPT 8.2%; p = .040), with DAPT being an independent protector for acute mesenteric (p = .009) and lower limb ischaemia (p = .020). No difference was found in 30 day major haemorrhagic events (SAPT 7.5% vs. DAPT 6.3%; p = .40). The mean follow up was 21.8 ± 2.9 months. Cox regression showed no survival confounders, with similar rates between groups (log rank p = .71). DAPT patients enjoyed higher TV patency (SAPT 93.4%, standard error [SE] 0.7% vs. DAPT 97.0%, SE 0.6%; log rank p = .007) at thirty six months. Cox regression revealed B-EVAR as a predictor of worse TV patency (hazard ratio 2.03, 95% confidence interval 1.36 - 3.03; p < .001). DAPT was related to higher patency within B-EVAR patients (SAPT 87.2%, SE 2.1% vs. DAPT 94.9%, SE 1.9%; p < .001)., Conclusion: DAPT after F/B-EVAR was associated with lower risk of cardiovascular ischaemic events and higher TV patency, especially in B-EVAR cases. No difference in major haemorrhagic events was observed at 30 days., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies. This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan–Meier survival analysis. One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 – 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively. This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates. [ABSTRACT FROM AUTHOR]

Background: Intracranial hemorrhage (ICH) is a rare but devastating complication of thoracoabdominal aortic aneurysm (TAAA) repair with fenestrated/branched endograft (f/bEVAR). The cerebrospinal fluid drainage (CSFD) is considered one of the leading causes; however, other possible concomitant factors have not been individualized yet. The aim of the present work was to evaluate the pattern of ICH events after f/bEVAR for TAAA and to identify possible associated factors. Materials and Methods: All f/bEVAR procedures for TAAA performed in a single academic center from 2012 to 2020 were evaluated. ICH was assessed by cerebral computed tomography if neurological symptoms arose. Pre-, intra-, and postoperative characteristics were analyzed in order to identify possible factors associated. Results: A total of 135 f/bEVAR were performed for 72 (53%) type I, II, III and 63 (47%) type IV TAAA; 74 (55%) were staged procedures, 101 (73%) required CSFD, and 24 (18%) were performed urgently. The overall 30-day mortality was 8% (5% in elective cases); spinal-cord ischemia occurred in 11(8%) and ICH in 8 (6%) patients. All ICH occurred in patients with CSFD. ICH occurred intraoperatively in 1 case, inter-stage in 4 and after F/BEVAR completion in 3, after a median of 6 days the completion stage. Three (38%) of 8 patients with ICH died at 30 days and ICH was associated with 30-day mortality: odds ratio (OR) 13.2, 95% confidence interval (CI): 2.3–76, p=0.01. The analysis of the perioperative characteristics identified platelet reduction >60% (OR 11, 95% CI 1.6–77, p=0.03), chronic kidney disease (16% vs 0%, p=0.002), and total volume of liquor drained >50 mL (OR 8.1, 95% CI 1.1–69, p=0.03) as associated with ICH. Conclusions: Current findings may suggest that ICH is a potential lethal complication of the endovascular treatment for TAAAs and it mainly occurs in patients with CSFD. High-volume liquor drainage, platelet reduction, and chronic kidney disease seems increase significantly the risk of ICH and should be considered during the perioperative period and for further studies. [ABSTRACT FROM AUTHOR]

Fenestrated-branched endovascular aneurysm repair (FBEVAR) has expanded the treatment of patients with thoracoabdominal aortic aneurysms (TAAAs). Previous studies have demonstrated that women are less likely to be treated with standard infrarenal endovascular aneurysm repair because of anatomic ineligibility and experience greater mortality after both infrarenal and thoracic aortic aneurysm repair. The purpose of the present study was to describe the sex-related outcomes after FBEVAR for treatment of TAAAs. The data from 886 patients with extent I to IV TAAAs (excluding pararenal or juxtarenal aneurysms), enrolled in eight prospective, physician-sponsored, investigational device exemption studies from 2013 to 2019, were analyzed. All data were collected prospectively, audited and adjudicated by clinical events committees and/or data safety monitoring boards, and subject to Food and Drug Administration oversight. All the patients had been treated with Cook-manufactured patient-specific FBEVAR devices or the Cook t-Branch off-the-shelf device (Cook Medical, Brisbane, Australia). Of the 886 patients who underwent FBEVAR, 288 (33%) were women. The women had more extensive aneurysms and a greater prevalence of diabetes (33% vs 26%; P =.043) but a lower prevalence of coronary artery disease (33% vs 52%; P <.0001) and previous infrarenal endovascular aneurysm repair (7.6% vs 16%; P <.001). The women had required a longer operative time from incision to surgery end (5.0 ± 1.8 hours vs 4.6 ± 1.7 hours; P <.001), experienced lower technical success (93% vs 98%; P =.002), and were less likely to be discharged to home (72% vs 83%; P =.009). Despite the smaller access vessels, the women did not have an increased incidence of access site complications. Also, the 30-day outcomes were broadly similar between the sexes. At 1 year, no differences were found between the women and men in freedom from type I or III endoleak (91.4% vs 92.0%; P =.64), freedom from reintervention (81.7% vs 85.3%; P =.10), target vessel instability (87.5% vs 89.2%; P =.31), and survival (89.6% vs 91.7%; P =.26). The women had a greater incidence of postoperative sac expansion (12% vs 6.5%; P =.006). Multivariable modeling adjusted for age, aneurysm extent, aneurysm size, urgent procedure, and renal function showed that patient sex was not an independent predictor of survival (hazard ratio, 0.83; 95% confidence interval, 0.50-1.37; P =.46). Women undergoing FBEVAR demonstrated metrics of increased complexity and had a lower level of technical success, especially those with extensive aneurysms. Compared with the men, the women had similar 30-day mortality and 1-year outcomes, with the exception of an increased incidence of sac expansion. These data have demonstrated that FBEVAR is safe and effective for women and men but that further efforts to improve outcome parity are indicated. [ABSTRACT FROM AUTHOR]

Juxtarenal/pararenal aortic aneurysms and type IV thoracoabdominal aneurysms pose particular technical challenges for endovascular repair as they involve the visceral segment in addition to insufficient infrarenal neck for the use of standard endovascular aneurysm repair (EVAR) devices. To overcome these challenges, complex EVAR techniques have been developed to extend the proximal landing zone cephalad with maintaining perfusion to vital aortic branches, thereby broadening the applicability of endografting from the infrarenal to the suprarenal aorta. Complex EVAR can be divided into two broad categories: fenestrated endovascular aneurysm repair (FEVAR) and snorkel EVAR. FEVAR is a valid procedure with the standardized procedure, although it remains as a relatively complex procedure with a learning curve. Given time constraints for the custom fenestrated graft, snorkel EVAR may be an alternative for complex repairs in symptomatic or ruptured patients for whom custom-made endografts may not be immediately available. This article discusses these two most commonly used complex EVAR strategies.

Major branches of the aortic arch and visceral aorta pose a particular challenge for endovascular repair of aneurysms involving these regions. To preserve perfusion through these essential branches, fenestrated and branched endografts have been used. Current fenestrated and branched aortic endografts have evolved into modular devices in which the aortic main body provides appropriate access to the target branch vessel either through reinforced fenestrations or directional cuffs as the hinge point for bridging stent grafts (BSGs). BSGs are used to connect the aortic main body and target branch vessel, and must provide both unhindered flow and a seal. Appropriate selection of BSG for target vessels in branched and fenestrated endovascular aortic repair is critical for technical success and durability. At present, there are no dedicated devices for use as BSGs, and a variety of stent grafts are currently used off-label. In this report, we review the available published series on the performance of presently available BSGs in relation to their design and selection.

Purpose: To investigate feasibility and outcomes of endovascular repair for acute thoracoabdominal aortic aneurysms (TAAA).Materials and Methods: Data from a single center were retrospectively analyzed. Patients who underwent endovascular repair for acute TAAA between January 2010 and April 2020 were included. Perioperative and mid-term follow-up outcomes were analyzed. Survival, freedom from reintervention, and target vessel patency were calculated by Kaplan-Meier analysis.Results: A total of 30 patients (18 men, 67.5 ± 6.9 years) underwent endovascular repair for acute symptomatic (n = 15) or contained ruptured (n = 15) TAAA. An off-the-shelf four-branched stent-graft (T-Branch) was used in 19 (63.3%) patients, a custom-made device (CMD) with expedite order in 5 (16.7%) patients, a CMD with short anticipated delivery time in 3 (10.0%) patients, and a CMD available in the hospital in 3 (10.0%) patients. Technical success was 90.0% (n = 27). Thirty-day mortality was 10% (n = 3). There was no complete persistent paraplegia, but one (3.3%) patient suffered permanent limb weakness. Estimated survival at 1 and 2 years was 86.3% ± 6.4%, and 82.3% ± 7.2%, respectively. Estimated freedom from reintervention at 1 and 2 years was 81.4% ± 7.6% and 73% ± 8.8%. Estimated target vessel patency at 1 and 2 years was 96.6% ± 2% and 92.6% ± 2.9%.Conclusion: Endovascular treatment of acute TAAA in this selected group of patients was associated with low early mortality and excellent mid-term survival. The off-the-shelf stent-graft option (T-Branch) was used in the majority of patients. Endovascular repair should be considered the first option for suitable acute TAAA. [ABSTRACT FROM AUTHOR]

Background: In FEVAR, visceral stents provide continuity and maintain perfusion between the main body of the stent and the respective visceral artery. The aim of this study was to characterise the incidence and mode of visceral stent failure (type Ic endoleak, type IIIa endoleak, stenosis/kink, fracture, crush and occlusion) after FEVAR in a large cohort of patients at a high-volume centre. Methods: A retrospective review of visceral stents placed during FEVAR over 15 years (February 2003-December 2018) was performed. Kaplan-Meier analyses of freedom from visceral stent-related complications were performed. The outcomes between graft configurations of varying complexity were compared, as were the outcomes of different stent types and different visceral vessels. Results: Visceral stent complications occurred in 47/236 patients (19.9%) and 54/653 stents (8.3%). Median follow up was 3.7 years (IQR 1.7–5.3 years). There was no difference in visceral stent complication rate between renal, SMA and coeliac arteries. Visceral stent complications were more frequent in more complex grafts compared to less complex grafts. Visceral stent complications were more frequent in uncovered stents compared to covered stents. Visceral stent-related endoleaks (type Ic and type IIIa) occurred exclusively around renal artery stents. The most common modes of failure with SMA stents were kinking and fracture, whereas with coeliac artery stents it was external crush. Conclusion: Visceral stent complications after FEVAR are common and merit continued and close long-term surveillance. The mode of visceral stent failure varies across the vessels in which the stents are located. [ABSTRACT FROM AUTHOR]

Fenestrated endovascular aneurysm repair (FEVAR) is a well established treatment for complex abdominal aortic aneurysms (AAAs). FEVAR with custom made devices (CMDs) has limitations in both the emergency and elective settings due to time consuming manufacture. "Off the shelf" (OTS) fenestrated stent grafts are a potential solution. The primary goal was to evaluate the five year outcome of the COOK Zenith p-Branch OTS device at a single centre. Patients with juxtarenal AAA meeting the inclusion criteria for the COOK Zenith p-Branch device were enrolled in a prospective, non-randomised, non-comparative trial from July 2012 to September 2015. Demographic, anatomical, procedure related, and five year follow up data were collected, analysed, and adjudicated by a core laboratory. The primary aims were to assess intervention free survival and overall survival at five years. Twenty-three patients were treated and 21 completed follow up. Mean time to p-Branch implantation after patient presentation was 28 hours (range 0–122 hours) in emergency cases and 67 days (range 20–112 days) in elective cases. Median procedure time was 283 minutes (range 161–475 minutes) and technical success was 91%. Mean follow up was 45 months (standard deviation ± 24.4 months). The most common adverse events were renal injuries. Primary target vessel patency was 96.4% and 94.0% after one and five years respectively. Mean time to first re-intervention was 469 days (range 0–1 567 days). Survival during the follow up period was 76%, with no aneurysm related deaths. FEVAR with the COOK Zenith p-Branch device is safe and effective for juxtarenal AAA in a selected patient population, in both elective and emergency settings. Long term outcomes are acceptable although inferior to CMDs. Mid and long term outcomes emphasise the p-Branch as a possible endovascular treatment for juxtarenal aortic pathology where CMD is not an option. Further innovation to address target vessel complications is needed, as these seem more prevalent than after repair with CMDs. [ABSTRACT FROM AUTHOR]

Purpose: To determine whether low total psoas muscle area (tPMA), as a surrogate for sarcopaenia, is a predictor of adverse outcomes in patients undergoing advanced EVAR. Materials and Methods: A retrospective review of medical records was performed for 257 patients who underwent advanced EVAR (fenestrated or branched technique) in a single tertiary centre from 1 January 2008 to 1 September 2019. The study cohort was divided into tertiles based on tPMA measurement performed independently by two observers from a peri-procedural CT scan at the level of mid-L3 vertebral body. The low tertile was considered sarcopaenic. Logistic regression analysis was used to assess the association of tPMA with 30-day mortality and post-procedural complications. Univariable analysis and adjusted multivariable Cox regression were used to assess the association of tPMA with all-cause mortality. Results: A total of 257 patients comprised 193 males and 64 females with the mean age of 75.4 years (± 6.8) were included. Adjusted multivariable Cox regression revealed an 8% reduction in all-cause mortality for every 1 cm2 increase in tPMA, P < 0.05. TPMA was associated with 30-day mortality (OR 0.85, 95% CI 0.75–0.96, P < 0.05) and spinal cord ischaemia (SCI) (OR 0.89, 95% CI 0.82–0.97, P < 0.05). For remaining post-procedural complications, tPMA was not a useful predictive tool. TPMA correlated negatively with hospital stay length (rs-0.26, P < 0.001). Patients with lower tPMA were more likely to be discharged to a rehabilitation center (OR 0.93, 95% CI 0.87–0.98 , P < 0.05). Conclusion: Measurement of tPMA can be a useful predictive tool for adverse outcomes after advanced EVAR. Level of Evidence: Level 3, Retrospective cohort study. [ABSTRACT FROM AUTHOR]

In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting. We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure. All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively. The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting. [ABSTRACT FROM AUTHOR]