Fenestrated Endovascular Aortic Repair Research Articles

Multicentric Use of Commercially Available Infrarenal Endografts During Fenestrated Endovascular Aortic Repair: A Feasibility Study.

This study aimed to assess the feasibility and short-term outcomes of different manufactured proximal and distal stent graft components during fenestrated endovascular aortic repair (FEVAR). A multicenter retrospective review was conducted at 3 aortic centers, involving all consecutive patients who underwent FEVAR utilizing a customized Dacron-based tubular proximal and a distal bifurcated polytetrafluoreten (PTFE)-based commercially available stent grafts. Primary outcomes were 30 day mortality, major adverse events, and technical and clinical success. Secondary outcomes assessed stent graft migration, occurrence of types I/III endoleak, and reintervention. A total of 23 FEVAR cases across all centers were included in this study. Technical success was achieved in all cases, with a median procedure time of 183 (153-244) minutes. There were no major adverse events, except for 1 transient acute renal failure. The median follow-up period was 23 (17-28) months. All target vessels retained patent with the exception of 1 right renal fenestration that showed signs of kinking at the first follow-up, and despite secondary intervention with relining and distal extension, there was an occlusion afterward and 1 hepatic artery with a separate fenestration. This and 1 successful relining of a superior mesenteric artery kink were the only reinterventions in this cohort. One case of persistent type 1b endoleak was reported in a patient with chronic type B aortic dissection, which resolved with distal extension on the external iliac artery 5 months after the index procedure. No deaths occurred throughout the follow-up with, and there were no signs of stent graft migration or type 3 endoleak. The use of commercially available PTFE-based bifurcated stent grafts to extend distally the tubular graft appears to be a feasible approach during FEVAR, with promising short-term outcomes. Further studies are necessary to define the applicability of this solution and evaluate long-term outcomes. This multicentric study on fenestrated endovascular aortic repair (FEVAR) demonstrates the feasibility and good short-term outcomes of utilizing a PTFE-based commercially available stent graft to extend the proximal tubular custom-made fenestrated stent graft. The high technical success rate, absence of major adverse events, and low occurrence of complications such as stent graft migration and endoleaks highlight the potential clinical benefits of this approach with an off-the-shelf distal extension whose delivery system does not cross the fenestrations intraoperatively.

Bridging Stent-Graft Implantation in the Renal Artery During Complex Endovascular Aortic Procedures does not alter the Renal Sonographic Resistance Index

Abstract Background Ultrasound examination of the resistance index (RI) of both kidneys can provide evidence of renal artery stenosis. The extent to which the RI is changed after bridging stent-graft implantation due to altered flow characteristics is not known. Aims The aim of the study was to investigate the influence of renal bridging stent-grafts on the RI of the kidneys after fenestrated endovascular aortic repair (FEVAR). Methods Ultrasound examinations of the kidneys were conducted using a GE LOGIQ S7 XDclear ultrasound system (GE Medical Systems AG, Glattburg, Switzerland). The evaluation was performed according to SGUM 2D standard criteria. The RI was determined in all consecutive patients on the day before and after renal bridging stent-graft implantation. For this purpose, the kidneys were divided into 3 areas according to the standard protocol and 2 RI values were recorded per area by evaluating intrarenal arterial Doppler signals. Mean values were calculated and compared for each kidney. Results For 64 kidneys in 32 consecutive patients (73.9±7.8 years, 4 female, 28 male) treated with FEVAR and renal bridging stent–graft implantation pre- and postinterventional examinations were carried out. Sono-morphologically, the kidneys examined were inconspicuous (pre: size at least 107.1x52.4 mm, parenchymal margin 18.3 mm versus post: size at least 107.9x52.9 mm, parenchymal margin 18.6 mm, p>0.4). The arborization of the renal perfusion was preserved pre and post implantation. The RI did not differ before and after implantation (0.66±0.06 versus 0.67±0.07; p=0.10). None of the patients experienced severe impairment of renal function. Conclusion After successful implantation of a bridging stent-graft in a non-stenosed renal artery, there is no relevant change in the RI of the kidney. The RI seems therefore to be suitable for assessing renal perfusion after complex endovascular aortic therapy.

Three-Dimensional Geometric Analysis of Viabahn VBX Bridging Stent Grafts in Fenestrated Endovascular Aortic Repair: A Multicenter, Retrospective Cohort Study.

The primary aim of this study was to assess the 3-dimensional flare geometry of the Gore Viabahn VBX balloon-expandable covered stent (BECS) after fenestrated endovascular aortic repair (FEVAR) and to determine and visualize BECS-associated complications. This multicenter retrospective study included patients who underwent FEVAR between 2018 and 2022 in 3 vascular centers participating in the VBX Expand Registry. Patients with at least one visceral artery treated with the VBX and with availability of 2 post-FEVAR computed tomography angiography (CTA) scans (follow-up [FU] 1: 0-6 months; FU2: 9-24 months) were included. The flare geometry of the VBX, including flare-to-fenestration distance, flare-to-fenestration diameter ratio, flare angle, and apposition with the target artery were assessed using a vascular workstation and dedicated CTA applied software. In total, 90 VBX BECS were analyzed in 43 FEVAR patients. The median CTA FU for FU1 and FU2 was 35 days (interquartile range [IQR], 29-51 days) and 14 months (IQR, 13-15 months), respectively. The mean flare-to-fenestration distance was 5.6±2.0 mm on FU1 and remained unchanged at 5.7±2.0 mm on FU2 (p=.417). The flare-to-fenestration diameter ratio was 1.19±0.17 on FU1 and remained unchanged at 1.21±0.19 (p=.206). The mean apposition length was 18.6±5.3 mm on FU1 and remained 18.6±5.3 mm (p=.550). The flare angle was 31°±15° on FU1 and changed to 33°±16° (p=.009). On FU1, the BECS-associated complication rate was 1%, and the BECS-associated reintervention rate was 0%. On FU2, the BECS-associated complication rate was 3%, and the BECS-associated reintervention rate was 1%. The flare geometry of the VBX bridging stent did not change significantly during 14 months follow-up in this study. Three-dimensional geometric analysis of the flare may contribute to identify the origin of endoleaks and occlusions, but this should be confirmed in a larger study including enough patients and BECS to compare complicated and uncomplicated cases. The three-dimensional flare geometry of the Gore Viabahn VBX BECS was assessed on the first and second postoperative CTA scans, and geometrical changes during this period were identified. For BECS that were diagnosed with a type 3c endoleak or occlusion, the BECS geometry was analyzed to detect geometrical components that were related to the complication. Geometric analysis of the flare may help to better detect and identify the cause of such complications.

Individualizing Surveillance after Endovascular Aortic Repair Using a Modular Imaging Algorithm.

Surveillance after endovascular aortic repair (EVAR) and fenestrated EVAR (FEVAR) is mainly directed by one-size-fits-all approaches instead of personalized decision making, even though treatment strategies and often endografts themselves are tailor-made to adjust for individual patients. We propose a modular imaging algorithm that escalates surveillance imaging based on invasiveness and need. In this retrospective observational study of single-center data, results of a modular imaging algorithm were analyzed. The algorithm is characterized by initiating the examination with standard B-mode then transitioning to Duplex ultrasound, B-Flow, and CEUS. Additional CT(A) studies are conducted where required. The study population included both patients receiving EVAR or FEVAR. A comparative analysis was conducted regarding endoleak detection. The study population included 28 patients receiving EVAR and 40 patients receiving FEVAR. They accounted for 101 follow-up visits, which led to 431 distinct imaging studies. CEUS has the highest endoleak detection rate, followed by CTA and B-Flow. Duplex ultrasound and B-Flow resulted in 0 and 1 false positive cases, respectively, considering CEUS the reference standard. In a select group of six patients, CEUS was omitted after endoleaks were displayed by Duplex ultrasound or B-Flow, leading to a successful type II coiling and no aneurysm-related adverse events. The proposed modular algorithm showed great potential to incorporate principles of personalized medicine in surveillance after endovascular aortic treatment. Since Duplex ultrasound and B-Flow rarely cause false positive endoleaks, more resource-intensive and invasive imaging studies such as CEUS and CTA can be omitted after positive identification.

A procedural step analysis of radiation exposure in fenestrated endovascular aortic repair

ObjectiveRadiation exposure during complex endovascular aortic repair may be associated with tangible adverse effects in patients and operators. This study aimed to identify the steps of highest radiation exposure during fenestrated endovascular aortic repair (FEVAR) and to investigate potential intraoperative factors affecting radiation exposure. MethodsProspective data of 31 consecutive patients managed exclusively with four-fenestration endografts between March 1, 2020, and July 1, 2022 were retrospectively analyzed. Leveraging the conformity of the applied technique, every FEVAR operation was considered a combination of six overall stages composed of 28 standardized steps. Intraoperative parameters, including air kerma, dose area product, fluoroscopy time, and number of digital subtraction angiographies (DSAs) and average angulations were collected and analyzed for each step. ResultsThe mean procedure duration and fluoroscopy time was 140 minutes (standard deviation [SD], 32 minutes), and 40 minutes (SD, 9.1 minutes), respectively. The mean air kerma was 814 mGy (SD, 498 mGy), and the mean dose area product was 66.8 Gy cm2 (SD, 33 Gy cm2). The percentage of air kerma of the entire procedure was distributed throughout the following procedure stages: preparation (13.9%), main body (9.6%), target vessel cannulation (27.8%), stent deployment (29.1%), distal aortoiliac grafting (14.3%), and completion (5.3%). DSAs represented 23.0% of the total air kerma. Target vessel cannulation and stent deployment presented the highest mean lateral angulation (67 and 63 degrees, respectively). Using linear regression, each minute of continuous fluoroscopy added 18.9 mGy of air kerma (95% confidence interval, 17.6-20.2 mGy), and each DSA series added 21.1 mGy of air kerma (95% confidence interval, 17.9-24.3 mGy). Body mass index and lateral angulation were significantly associated with increased air kerma (P < .001). ConclusionsCannulation of target vessels and bridging stent deployment are the steps requiring the highest radiation exposure during FEVAR cases. Optimized operator protection during these steps is mandatory.

Reinterventions and sac dynamics after fenestrated endovascular aortic repair with physician-modified endografts for index aneurysm repair and following proximal failure of prior endovascular aortic repair

ObjectiveThe high frequency of reinterventions after fenestrated endovascular aortic repair (FEVAR) with physician-modified endografts (PMEGs) has been well-studied. However, the impact of prior EVAR on reinterventions and sac behavior following these procedures remains unknown. We analyzed 3-year rates of reinterventions and sac dynamics following PMEG for index aneurysm repair compared with PMEG for prior EVAR with loss of proximal seal. MethodsWe performed a retrospective analysis of 122 consecutive FEVARs with PMEGs at a tertiary care center submitted to the United States Food and Drug Administration in support of an investigational device exemption trial. We excluded patients with aortic dissection (n = 5), type I to III thoracoabdominal aneurysms (n = 13), non-elective procedures (n = 4), and prior aortic surgery other than EVAR (n = 8), for a final cohort of 92 patients. Patients were divided into those who underwent PMEG for index aneurysm repair (primary FEVAR) and those who underwent PMEG for rescue of prior EVAR with loss of proximal seal (secondary FEVAR). The primary outcomes were freedom from reintervention and sac dynamics (regression as ≥5 mm decrease, expansion as ≥5 mm increase, and stability as <5 mm increase or decrease) at 3 years. Secondary outcomes were perioperative mortality and 3-year survival. ResultsOf the 92 patients included, 56 (61%) underwent primary FEVAR and 36 (39%) underwent secondary FEVAR. Secondary FEVAR patients were older (78 years [interquartile range (IQR), 74.5-83.5 years] vs 73 years [IQR, 69-78.5 years]; P < .001), more frequently male (86% vs 68%; P = .048), and had larger aneurysms (72.5 mm [IQR, 65.5-81 mm] vs 59 mm [IQR, 55-65 mm]; P < .001). Perioperative mortality was 1.8% for primary FEVAR and 2.7% for secondary FEVAR (P = .75). At 3 years, overall survival was 84% for primary FEVAR and 71% for secondary FEVAR (P = .086). Freedom-from reintervention was significantly higher for primary FEVAR than secondary FEVAR, specifically 82% vs 38% at 3 years (P < .001). Primary FEVAR also had more desirable sac dynamics relative to secondary FEVAR at 3 years (primary: 54% stable, 46% regressed, 0% expanded vs secondary: 33% stable, 28% regressed, and 39% expanded; P = .038). ConclusionsFEVAR for primary aortic repair and FEVAR for rescue of prior EVAR with loss of proximal seal are two distinct entities. Following primary FEVAR, less than a quarter of patients have undergone reintervention at 3 years, and sac expansion was not seen in our cohort. Comparatively, 3 years after secondary FEVAR, over one-half of patients have undergone reintervention and over one-third have had ongoing sac expansion. Vigilant surveillance and a low threshold for further interventions are crucial following secondary FEVAR.

Effect of narrow paravisceral aorta on target vessel instability after fenestrated and branched endovascular aortic repair

ObjectiveTo investigate the effect of narrow paravisceral aorta (NPA) on target vessel instability (TVI) after fenestrated-branched endovascular aortic repair. MethodsWe conducted a single-center retrospective study (2014-2023) of patients treated by fenestrated-branched endovascular aortic repair for thoracoabdominal aortic aneurysms (TAAA) or pararenal aortic aneurysms. The paravisceral aorta was defined as the aortic segment limited by the diaphragmatic hiatus proximally and the emergence of lower renal artery distally, and was considered “narrow” in case of a minimum inner diameter of <25 mm. The minimum aortic diameter, location, longitudinal extension, angulation, calcification, and thrombus thickness of NPA were evaluated at the preoperative computed tomography angiogram. End points were 30-day technical success and freedom from TVI. ResultsThere were 142 patients with JRAA/pararenal aortic aneurysm (n = 85 [59%]) and extent IV (n = 24 [17%]) or extent I-III (n = 33 [23%]) TAAA, with 513 target arteries successfully incorporated through a fenestration (n = 294 [57%]) or directional branch (n = 219 [43%]). A NPA was present in 95 patients (70%), 73 (86%) treated by fenestrated endovascular aortic repair (FEVAR) and 22 (39%) by branched endovascular aortic repair (BEVAR). The overall 30-day mortality was 2% and technical success was 99%, without differences between NPA and non-NPA (P = .99). Kaplan-Meier estimated freedom from TVI at 4 years was 82%, 81% (95% CI, 75-95) in patients with a NPA and 80% (95% CI, 68-94) and in those without NPA (P = .220). The result was maintained for both FEVAR (NPA: 81% [95% CI, 62-88]; non-NPA: 76% [95% CI, 60-99]; P = .870) and BEVAR (NPA: 77% [95% CI, 69-99]; non-NPA: 80% [95% confidence interval (CI) 66-99]; P = .100). After multivariate analysis, the concomitant presence of a NPA <20 mm and angulation of >30° was significantly associated with TVI in FEVAR (HR, 3.21; 95% CI, 1.03-48.70; P = .036), being the result mostly driven by target vessel occlusion. In BEVAR, a NPA diameter of <25 mm was not associated with TVI (HR, 2.02; 95% CI, 0.59-5.23; P = .948); after multivariate analysis, the use of outer branches in case of a NPA longitudinal extension of >25 mm (hazard ratio [HR], 3.02; 95% CI, 1.01-36.33; P = .040) and NPA severe calcification (HR, 1.70; 95% CI, 1.00-22.42; P = .048) were associated with a higher chance for TVI. ConclusionsFEVAR and BEVAR are both feasible in cases of NPA and provide satisfactory target vessels durability. The use of outer branches should be avoided in cases with an inner aortic diameter of <25 mm with a longitudinal extension of >25 mm or moderate to severe NPA calcifications. In FEVAR, bridging stent patency may be negatively influenced by NPA of <20 mm in association with aortic angulation of >30°.

Clinical Impact and Determinants of Fenestration to Target Vessel Misalignment in Fenestrated Endovascular Aortic Repair

This single centre, retrospective study (2014 - 2022) on juxta-, pararenal, or thoraco-abdominal aortic aneurysms treated by fenestrated endovascular aortic repair (FEVAR) was conducted to investigate the clinical impact and determinants of fenestration to target vessel misalignment in FEVAR. Pre-operative supracoeliac, pararenal, and infrarenal aortic angles were measured on three dimensional computed tomography angiography (CTA) reconstructions. Two components of misalignment were measured on the first post-operative CTA: horizontal misalignment (angle between the fenestration and the target vessel ostium on perpendicular CTA cuts) and vertical misalignment (vertical distance between the fenestration and the target vessel at its origin). Endpoints were freedom from target vessel instability (TVI) and alignment change over time. Of 65 patients treated by FEVAR, 60 (202 target arteries) with juxta-, pararenal (80%), or thoraco-abdominal aortic aneurysm (20%) were included. Mean horizontal misalignment was 9 ± 12° (median 5°; IQR 0 - 16) and mean vertical misalignment was 0.7 ± 1 mm (median 0 mm, IQR 0 - 1). Freedom from TVI was 92% (95% CI 88 - 98) at 36 months. Horizontal misalignment > 15° was significantly associated with TVI (HR 5.19; 95% CI 1.54 - 17.48; p=.008); vertical misalignment did not significantly impact TVI (HR 0.99; 95% CI 0.56 - 1.73; p= .97). By multivariable analysis, pararenal aortic angle (OR 1.01 per increased degree of angulation; 95% CI 1.00 - 1.02; p= .044), bridging distance > 5 mm (OR 1.07; 95% CI 1.02 - 1.11; p= .003), and use of higher profile endografts in tortuous iliac access (OR 7.55; 95% CI 4.55 - 1.11; p= .003) were associated with clinically significant misalignment. Bridging distance > 5 mm (OR 2.00; 95% CI 1.02 - 11.29; p= .044), degree of baseline misalignment (OR 1.04; 95% CI 1.01 - 1.08; p= .036), and persistence of any primary endoleak for > 6 months (OR 5.85; 95% CI 1.23 - 29.1; p= .023) were associated with misalignment increase during follow up. Horizontal misalignment > 15° is associated with worsened target vessel outcomes. This may occur as a result of excessive iliac access tortuosity, high pararenal aortic angulation, and bridging distance > 5 mm.

The Effect of Age on Peri-Operative Outcomes after FEVAR.

Fenestrated endovascular aortic repair (FEVAR) has become a popular custom-made treatment option for juxtarenal and pararenal aneurysms. It has been previously investigated whether octogenarians as a distinct subgroup are at increased risk for adverse outcomes after FEVAR. With diverging results and an inconclusive understanding of age as a risk factor in general, an analysis of the historical data of a single center was conducted to add to the available body of evidence and further investigate the effect of age as a continuous risk factor. A retrospective data analysis of a prospectively maintained single-center database of all patients who underwent FEVAR at a single department of vascular surgery was performed. The main endpoint was post-operative survival. In addition to association analyses, potential confounders such as co-morbidities, complication rates, or aneurysm diameter were examined. In terms of sensitivity analyses, logistic regression models were created for the dependent variables of interest. During the observation period from April 2013 to November 2020, 40 patients over the age of 80 and 191 patients under the age of 80 were treated by FEVAR. The 30-day survival showed no significant difference between the groups (95.1% in octogenarians and 94.3% in patients under 80 years of age). The sensitivity analyses conducted also showed no difference between the two groups, and complication and technical success rates were comparable. The aneurysm diameter was 67 ± 13 mm in the study group and 61 ± 15 mm in those under 80 years of age. Additionally, the sensitivity analyses showed that age as a continuous variable exhibits no effect on the outcomes of interest. In the present study, age was not associated with adverse peri-operative outcomes after FEVAR, including mortality, lower technical success rates, complications, or length of hospital stay. Essentially, the most highly associated factor with hospital and ICU length of stay was time spent in surgery. However, octogenarians had a significantly larger aortic diameter at the time of treatment, which might indicate the potential introduction of bias by pre-interventional patient selection. Nevertheless, the usefulness of research on octogenarians as a distinct subgroup might be questionable regarding the scalability of results, and future studies might focus on age as a continuous risk factor instead.

Post-Operative and Mid-Term Renal Function Impairment Following Elective Fenestrated Endovascular Aortic Repair for Complex Aortic Aneurysms: Incidence and Risk Factors Analysis.

Background. The aim of this study was to assess the incidence of two post-operative acute kidney injury (AKI) stages according to the Risk, Injury, Failure, Loss of function, End-stage (RIFLE) criteria in patients undergoing fenestrated endovascular aortic repair (FEVAR) for complex aortic aneurysms. Furthermore, we analyzed predictors of post-operative AKI and mid-term renal function deterioration and mortality. Methods. We included all patients who underwent elective FEVAR for abdominal and thoracoabdominal aortic aneurysms between January 2014 and September 2021, independently from their preoperative renal function. We registered cases of post-operative acute kidney injury (AKI) both at risk (R-AKI) and injury stage (I-AKI) according to the RIFLE criteria. Estimated glomerular filtration rate (eGFR) was noted preoperatively, at the 48th post-operative hour, at the maximum post-operative peak, at discharge, and then during follow-up approximately every six months. Predictors of AKI were analyzed with univariate and multivariate logistic regression models. Predictors of mid-term chronic kidney disease (CKD) (stage ≥ 3) onset and mortality were analyzed using univariate and multivariate Cox proportional hazard models. Results. Forty-five patients were included in the present study. Mean age was 73.9 ± 6.1 years and 91% of patients were males. Thirteen patients (29%) presented with a preoperative CKD (stage ≥ 3). Post-operative I-AKI was detected in five patients (11.1%). The aneurysm diameter, thoracoabdominal aneurysms and chronic obstructive pulmonary disease were identified as predictors of AKI in univariate analysis (OR 1.05, 95% CI [1.005-1.20], p = 0.030; OR 6.25, 95% CI [1.03-43.97], p = 0.046; OR 7.43, 95% CI [1.20-53.36], p = 0.031; respectively), yet none of these factors were significative on multivariate analysis. Predictors of CKD onset (stage ≥3) during follow-up on multivariate analysis were age (HR 1.16, 95% CI [1.02-1.34], p = 0.023), post-operative I-AKI (HR 26.82, 95% CI [4.18-218.10], p < 0.001) and renal artery occlusion (HR 29.87, 95% CI [2.33-309.05], p = 0.013), while aortic-related reinterventions where not significantly associated with this outcome in univariate analysis (HR 0.66, 95% CI [0.07-2.77], p = 0.615). Mortality was influenced by preoperative CKD (stage ≥3) (HR 5.68, 95% CI [1.63-21.80], p = 0.006) and post-operative AKI (HR 11.60, 95% CI [1.70-97.51], p = 0.012). R-AKI did not represent a risk factor for CKD (stage ≥ 3) onset (HR 1.35, 95% CI [0.45-3.84], p = 0.569) or for mortality (HR 1.60, 95% CI [0.59-4.19], p = 0.339) during follow-up. Conclusions. In-hospital post-operative I-AKI represented the main major adverse event in our cohort, influencing CKD (≥ stage 3) onset and mortality during follow-up, which were not influenced by post-operative R-AKI and aortic-related reinterventions.

Comparison of Fenestrated Stentgrafts and Open Repair for Juxtarenal Aortic Aneurysms Using a Propensity Score Matching

The purpose of this study was to compare postoperative morbi-mortality and medium-term follow-up of fenestrated stent grafting and open repair (OR) for patients with juxtarenal aortic aneurysms (JRAAs). All consecutive patients who underwent custom-made fenestrated endovascular aortic repair (FEVAR) or OR for complex abdominal aortic aneurysm between 2005 and 2017 in 2 tertiary centers were scrutinized. Patients with JRAA constituted the study group. Suprarenal and thoracoabdominal aortic aneurysms were excluded. The groups were made comparable through the use of a propensity score matching. 277 patients with JRAAs were included, 102 (36.8%) in the FEVAR group and 175 (63.2%) in the OR group, respectively. After propensity score matching, 54 FEVAR patients (52.9%) and 103 OR patients (58.9%) were included for analysis. In-hospital mortality rates were 1.9% (n=1) in the FEVAR group versus 6.9% (n=7) in the OR group (P=0.483). Postoperative complications were less common in the FEVAR group (14.8% vs. 30.7%; P=0.033). Mean follow-up was 42.1months in the FEVAR group and 40months in the OR group. Overall mortality rates at 12 and 36months were 11.5% and 24.5% in the FEVAR group versus 9.1 % (P=0.691) and 11.6% (P=0.067) in the OR group. Late reinterventions were more frequent in the FEVAR group (11.3% vs. 2.9%; P=0.047). However, freedom from reintervention rates were not significantly different at 12months (FEVAR: 86% vs. OR: 90%; P=0.560) and 36months (FEVAR: 86% vs. OR: 88.4%, P=0.690). In the FEVAR group, persistent endoleak during follow-up was identified in 11.3% of cases. In the present study, there was no statistical difference in terms of mortality in-hospital at 12 or 36months between FEVAR and OR groups for JRAA. FEVAR for JRAA was associated with a significant reduction of overall postoperative major complications compared with OR. There were significantly more late reinterventions in the FEVAR group.

Two-Year Outcomes With Bentley BeGraft as Bridging Stent-Grafts for Reno-Visceral Target Vessels During Fenestrated Endovascular Aortic Repair.

The aim of this study was to present the short-term and 2-year outcomes after use of the Bentley BeGraft as bridging stent-graft (BSG) for reno-visceral target vessel (TV) during fenestrated endovascular aortic repair (FEVAR) from a contemporary multicentric experience. A retrospective review of all consecutive patients who underwent elective FEVAR at 7 institutions located in Italy from 2015 to 2021 was performed. The main outcomes of interest for this study were technical success and TV instability, defined in accordance with current reporting standards. Patients' survival was also assessed. Overall, 81 patients received elective FEVAR during the study period. Mean age of patients was 78 years, and 89% were men. Most patients were treated for a juxta-pararenal abdominal aortic aneurysm (AAA) (68%), and 23% had already received an infrarenal aortic reconstruction. Most endografts had 3-vessel or 4-vessel design (27% and 55%, respectively), and a Cook endograft was used in 73% of cases. Overall, 266 Bentley BeGraft were implanted, of which 44 (16.5%) in the celiac trunk, 69 (26%) in the superior mesenteric artery, 79 (29.5%) in the right renal artery, and 74 (28%) in the left renal artery. Technical success was 94%, with 5 instances of technical failure that were recorded and required an additional intraoperative procedure. The early mortality rate was 4%, and acute kidney injury occurred in 14 cases with 1 requiring definitive hemodialysis. Survival at 6, 12, and 24 months in the overall cohort was 98.8%, 95.3%, and 83.4%, respectively. Freedom from TV instability at 6, 12, and 24 months in the overall cohort was 98.4%, 97.9%, and 97.2%, respectively. Events of TV instability included 3 cases of type 1C endoleak and 3 cases of type 3C endoleak, while no events of BSG fracture or thrombosis were noted. Five out of 6 cases of TV instability occurred in renal arteries, and they were all successfully treated by endovascular means. The data from this multicentric study show favorable short-term and 2-year outcomes of the Bentley BeGraft as BSG for reno-visceral TV during FEVAR, with low rates of TV-related endoleak and no stent occlusion up to 2 years. The data from this multicentric study show satsfactory outcomes up to two years of follow-up for the Bentley BeGraft when used for brdiging reno-visceral vessels during fenestrated endovascular aortic repair. Further research will be needed to identify predictors of stent-related reinterventions and ascertain the long-term durability.

Outcomes Following Fenestrated Endovascular Aortic Repair for Failed Infrarenal Endovascular Aortic Repair Compared With Primary Fenestrated Endovascular Aortic Repair

Fenestrated endovascular aortic repair (FEVAR) is a potential treatment option in patients with failed EVAR due to proximal disease progression. However, studies evaluating the outcomes after FEVAR in patients with prior EVAR are limited to data from single-center and high-volume institutions. Therefore, we compared the outcomes after FEVAR in patients with prior EVAR vs without any prior aortic surgery (primary FEVAR). We identified patients undergoing elective FEVAR for complex abdominal aortic aneurysm in the Vascular Quality Initiative between 2014 and 2022 and included those who underwent no prior aortic surgery (n = 2362) or prior EVAR (n = 117). Perioperative outcomes and 5-year mortality were analyzed using logistic regression and Cox regression models. Sac changes were assessed based on differences in aneurysm sac diameter between the 1-year computed tomography scan and preoperative imaging and were categorized as regression (>5 mm decrease), stability (<5 mm change in size), and expansion (>5 mm increase) for analysis. We included 2362 primary FEVAR patients and 117 patients who underwent FEVAR after EVAR. The FEVAR after EVAR patients were older (76 [72-82] years vs 74 [68-79] years; P < .001), less frequently female (12% vs 23%; P = .004), had larger aneurysm diameters (68 [60-80] mm vs 58 [55-63] mm; P < .001), and more preoperative comorbidities. After EVAR patients, FEVAR patients were more likely to undergo repairs at high-volume centers performed by high-volume surgeons (P < .001). Furthermore, FEVAR after EVAR involved more proximal aortic zones with a higher number of branches and longer procedural time and radiation (all P < .05). Despite these differences, FEVAR after EVAR showed comparable perioperative outcomes relative to primary FEVAR (Table I). However, in the FEVAR, after EVAR group, 1-year sac regression rates were lower (24% vs 51%; P = .005), whereas sac expansion was more likely (39% vs 7.3%; P < .001) compared with the primary FEVAR group (Table II). At 2-year follow-up, FEVAR after EVAR was associated with similar mortality (26% vs 19%; hazard ratio: 1.4, 95% confidence interval: 0.84-2.2; P = .20) and reinterventions (14% vs 13%; hazard ratio: 1.04, 95% confidence interval: 0.36-3.0; P = .91) compared with primary FEVAR. FEVAR after EVAR has a similar risk of perioperative and 2-year mortality compared with primary FEVAR. However, the higher rate of sac expansion at 1 year in these patients raises significant concerns about the durability of these repairs. Therefore, patients undergoing FEVAR after EVAR may benefit from closer surveillance or even consideration for open conversion. Future studies should evaluate open conversion as an alternative to endovascular treatment for proximal failure of EVAR.Table IPerioperative outcomes after primary FEVAR vs FEVAR after prior EVARPrimary FEVAR (n = 2373)FEVAR after EVAR (n = 130)P valueFEAVR after EVAR vs primary FEVARP valueUnadjusted rates, %Adjusteda OR [95% CI]Perioperative death2.82.3.800.62 [0.13-2.2].50Any complication9.611.770.65 [0.29-1.4].30 Stroke0.60.66NANA AKI1214.700.75 [0.38-1.4].4 Postoperative dialysis1.72.3.740.73 [0.10-3.28].71 Bowel ischemia1.91.51.01.4 [0.18-6.2].71 Spinal cord ischemia1.53.1.270.85 [0.11-4.0].85 Leg ischemia1.92.3.740.68 [0.10-3.0].65 Pulmonary complications3.64.6.620.70 [0.21-2.0].52 Cardiac complications3.53.81.00.53 [0.14-1.6].30 Completion type 1A endoleak3.40.8.120.32 [0.02-1.73].29Reintervention during index hospitalization4.26.2.380.73 [0.48-1.1].12Unadjusted rates, %P valueAdjusteda HR [95% CI]P value2-year reintervention1314.201.04 [0.36-3.0].912-year mortality1926.701.4 [0.84-2.2].20AKI, Acute kidney injury; CI, confidence interval; EVAR, endovascular aortic repair; FEVAR, fenestrated EVAR; HR, hazard ratio; OR, odds ratio.aAdjusted for age, gender, diameter (>65 mm), hypertension, diabetes, prior myocardial infarction, prior chronic obstructive pulmonary disease, obesity, prior chronic kidney disease, anemia, proximal sealing zone, center volume, and physician volume. Open table in a new tab Table IISac dynamics at 1 year after primary FEVAR vs FEVAR after prior EVARPrimary FEVAR (n = 853), %FEVAR after EVAR (n = 33), %P valueSac regression, >5 mm5124.005Stable sac, <5 mm4232.67Sac expansion, >5 mm7.339<.001EVAR, Endovascular aortic repair; FEVAR, fenestrated EVAR.Boldface P value represents significance P < .05. Open table in a new tab

Midterm Results of Supraceliac vs Infraceliac Sealing for Fenestrated Endovascular Aortic Repair of Juxtarenal Aortic Aneurysms

The complexity of fenestrated endovascular aortic repair (FEVAR) for juxtarenal abdominal aortic aneurysms has increased over time including a more proximal sealing zone despite a similar disease extent. Prior studies demonstrated that supraceliac sealing is associated with higher perioperative morbidity, although mortality seems to be similar. Durability of sealing at a supra celiac level vs an infraceliac level remains unknown. The aim of our study was to examine outcomes of FEVAR for juxtarenal abdominal aortic aneurysms comparing a supraceliac vs an infraceliac sealing zone. We included patients undergoing elective juxtarenal FEVAR from 2008 to 2021 at two large hospitals in the Netherlands. The definition of a supraceliac sealing zone was incorporation of the celiac trunk by either a scallop or fenestration. The primary outcome was 5-year aneurysm-related procedures. Secondary outcomes included perioperative complications, 5-year mortality and 1-year aneurysm sac dynamics. These outcomes were analyzed using t tests, Kaplan-Meier methods, multivariable Cox regression analysis, and χ2 tests. One-year aneurysm sac dynamics were evaluated between the groups with imaging data (sac regression/stable sac/sac expansion, based upon 5% volume change compared with 30-day volume). Among 173 patients identified, 114 (66%) had a supraceliac and 59 (34%) had an infraceliac sealing zone. Patients with supraceliac sealing more often had prior EVAR (26.3% vs 12%; P = .045). Furthermore, supraceliac sealing had similar rates of perioperative complications and mortality. No differences were found in one-year aneurysm sac dynamics. Supraceliac sealing was associated with significantly lower risks of secondary aneurysm-related procedures at 5 years compared to use of infraceliac sealing (25% vs 45%; hazard ratio, 0.37; 95% confidence interval, 0.17-0.79; P = .012) (Figure). Finally, supraceliac sealing had similar risks of 5-year mortality compared with infraceliac sealing (hazard ratio, 0.93; 95% confidence interval, 0.49-1.74; P = .813). FEVAR with supraceliac sealing is more durable with less secondary aneurysm-related procedures as compared to infraceliac sealing for juxtarenal aneurysms. Future research has to examine whether supraceliac sealing should be the standard for juxtarenal aneurysms.

Predicting Features of Visceral Stent Failure in Fenestrated Endovascular Aortic Aneurysm Repair.

Visceral stents in fenestrated endovascular aortic repair (FEVAR) have a significant risk of complications and carry a considerable burden of reinterventions. The aim of this study is to identify preoperative and intraoperative predictors of visceral stent failure. A retrospective review of 75 consecutive FEVARs in a single center from 2013 to 2021 was undertaken. Data on mortality, stent failure, and reintervention pertaining to 226 visceral stents were collected. Anatomical features including aortic neck angulation, aneurysm diameter, and angulation of target viscerals were obtained from preoperative computed tomography (CT) scans. Stent oversizing and intraprocedural complications were recorded. Postoperative CT scans were analyzed to determine the length of cover of target vessels. Only bridging stents through fenestrations to visceral vessels were considered; 28 (37%) cases had 4 visceral stents, 24 (32%) had 3, 19 (25%) had 2, 4 (5%) had 1. Thirty day mortality was 8%, a third of which was related to visceral stent complications. Intraprocedural complexity was documented during the cannulation of 8 (3.5%) target vessels, with a technical success rate of 98.7%. A significant endoleak or visceral stent failure was identified in 22 stents (9.8%) postoperatively, of which 7 (3%) had in-patient reintervention within 30 days. Further reinterventions at 1, 2, and 3 years were 12 (5.4%), 2 (1%), and 1 (0.4%), respectively. Most reinterventions were for renal stents (n=19, 86%). A smaller stent diameter and a shorter length of visceral stent were significant predictors of failure. No other anatomical feature or stent choice was found to be a significant predictor of failure. The modality of visceral stent failures varies, but renal stents with a smaller diameter and/or shorter length are more likely to fail over time. Their complications and reinterventions are common and carry a significant burden; therefore, close surveillance must be continued long term. With this work we share the methodology adopted at our centre to treat juxtarenal aneurysm with FEVAR. Thanks to this detailed review of anatomical and technical features we provide guidance for endovascular surgeons to face hostile aneurysm with peculiar visceral vessels anatomy. With our findings will also motivate industries in their attempt to produce improved technologies able to overcome issues identified in this paper.

Fenestrated Endovascular Aortic Repair After Failed Endovascular Aortic Repair.

Fenestrated endovascular aortic repair (FEVAR) is technically more challenging when performed after a failing EVAR procedure (FEVAR after EVAR). This study aims to assess the technical outcome of FEVAR after EVAR and to identify factors that may influence complication rates. A retrospective observational study was conducted at a single department of vascular and endovascular surgery. The rate of FEVAR after EVAR compared to primary FEVAR is reported. Complication and primary unconnected fenestration (PUF) rates as well as survival were assessed for the FEVAR after EVAR cohort. PUF rates and operating time were also compared to all primary FEVAR patients. Patient characteristics and technical factors such as number of fenestrations or use of a steerable sheath were assessed as possible influencers on technical success when performing FEVAR after EVAR. Two hundred and nine fenestrated devices were implanted during the study period (2013 to April 2020). Thirty-five patients (16.7% of all FEVAR patients) had undergone FEVAR after EVAR and were included in the study. Overall survival at last follow-up (20.2±19.1 months) was 82.9% in FEVAR after EVAR patients. Rates of technical failure dropped significantly after 14 procedures (42.9% vs. 9.5%; p=0.03). Primary unconnected fenestrations were seen in 3 cases of FEVAR after EVAR (8.6%) and 14 of 174 primary FEVAR cases (8.0%; p>0.99). Operating time for FEVAR after EVAR was significantly higher than for primary FEVAR (301.1±110.5 minutes vs. 253.9±103.4 minutes; p=0.02). The availability of a steerable sheath was a significant predictor of reduced risk of PUFs, whereas age and gender, number of fenestrations or suprarenal fixation of the failed EVAR did not significantly influence PUF rates. Fewer technical complications were seen over the study period in FEVAR after EVAR patients. While rates of PUFs were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR can be a valuable and safe tool to treat patients with progression of aortic disease or type Ia endoleak after EVAR but may be more complex to achieve than primary FEVAR. This retrospective study assesses the technical outcome of fenestrated endovascular aortic repair (fenestrated EVAR; FEVAR) after prior EVAR. While rates of primary unconnected fenestrations were not different from primary FEVAR, operating time was significantly longer in patients undergoing FEVAR for failed EVAR. Fenestrated EVAR after prior EVAR may be technically more challenging than primary FEVAR procedures, but could be performed with equally good results in this patient cohort. FEVAR offers a feasible treatment option for patients with progression of aortic disease or type Ia endoleak after EVAR.

Acute Kidney Injury and Mortality After Fenestrated Endovascular Aortic Repair

IntroductionAcute kidney injury (AKI) is a common complication following endovascular aortic repair (EVAR). An association of AKI with patient survival after fenestrated EVAR (FEVAR) is currently under investigation. MethodsPatients undergoing FEVAR between April 2013 and June 2020 were included in the study. AKI was defined according to acute kidney injury network criteria. Demographic and perioperative data, complications, and survival are reported for the study cohort. The data were analyzed to identify possible predictors of AKI. ResultsTwo hundred and seventeen patients underwent FEVAR during the study period. Survival at last follow-up (20.4 ± 20.1 mo) was 75.1%. Thirty patients experienced AKI (13.8%). Six of 30 patients with AKI (20%) died within 30 days or in-hospital and 1 (3.3%) progressed to hemodialysis. Within 1 y, renal function had recovered in 23 patients (76.7%). In-hospital mortality was higher in patients with AKI (20% versus 4.3%, P = 0.006). A higher rate of AKI was seen in patients in whom an intraoperative technical complication had been documented (38.5% versus 8.4%, P = 0.001). ConclusionsPatients undergoing FEVAR are at risk of developing AKI, especially if they experience technical intraoperative complications. Most patients see recovery of renal function within the first 30 days to 1 y, but AKI remains associated with significantly increased in-hospital mortality.

Surgeon eye lens dose monitoring in interventional neuroradiology, cardiovascular and radiology procedures

PurposeThis study investigated the radiation dose to surgeon eye lens for single procedure and normalised to exposure parameters for eight selected neuroradiology, cardiovascular and radiology interventional procedures. MethodsThe procedures investigated were diagnostic study, Arteriovenous Malformations treatment (AVM) and aneurysm embolization for neuroradiology procedures, Coronary Angiography and Percutaneous Transluminal Coronary Angioplasty (CA-PTCA), Pacemaker and Implantable Cardioverter-Defibrillator implantation (PM-ICD), Endovascular Aortic Repair (EVAR) and Fenestrated Endovascular Aortic Repair (FEVAR) for cardiovascular and electrophysiology procedures. CT-guided lung biopsy was also monitored.All procedures were performed with table-mounted and ceiling-suspended shields (0.5 mm lead equivalent thickness), except for FEVAR and PM-ICD where only a table mounted shield was present, and CT-guided lung biopsy where no shield was used. Dose assessment was performed using a dosemeter positioned close to the most exposed eye of the surgeon, outside the protective eyewear. ResultsThe surgeon most exposed eye lens median Hp(3) equivalent dose for a single procedure, without protective eyewear contribution, was 18 μSv for neuroradiology diagnostic study, 62 μSv for AVM, 38 μSv for aneurysm embolization, 33 μSv for CA-PTCA, 39 μSv for PM-ICD, 49 μSv for EVAR, 2500 μSv for FEVAR, 153 μSv for CT-guided lung biopsy. ConclusionsIn interventional procedures, the 20 mSv/year dose limit for surgeon eye lens exposure might be exceeded if shields or protective eyewear are not used.Surgeon eye lens doses, normalised to single procedures and to exposure parameters, are a valuable tool for determining appropriate radiation protection measures and dedicated eye lens dosemeter assignment.

Can the Fenestrated Anaconda™ salvage failed competitor endografts? An international frame of reference.

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. 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. 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. 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.

Disparities in reporting and representation by sex, race, and ethnicity in endovascular aortic device trials

Vulnerable populations, including women and racial and ethnic minorities, have been historically underrepresented in clinical trials. We, therefore, studied the demographics of patients enrolled in pivotal endovascular aortic device trials in the United States. We queried the Food and Drug Administration (FDA) medical devices database for all FDA-approved endografts for the treatment of aortic aneurysms, transections, and dissections from September 1999 to November 2021. These included abdominal endovascular aortic repair (EVAR), thoracic EVAR (TEVAR), fenestrated EVAR (FEVAR) devices, and dissection stents. Multiple cases of approval for expanded indications were included separately. The primary outcomes included the proportion of trials reporting participant sex, race, and ethnicity and the proportion of enrolled participants across sex, racial, and ethnic groups. The FDA provided 29 approvals from 29 trials of 24 devices: 15 EVAR devices (52%), 12 TEVAR devices (41%), 1 FEVAR device (3.4%), and 1 dissection stent (3.4%). These trials had included 4046 patients. Of the 29 trials, all had reported on the sex of the participants, and the median female enrollment was 21% (interquartile range [IQR], 11%-34%). The EVAR trials had the lowest female enrollment (11%; IQR, 8.7%-13%) compared with 41% (IQR, 27%-45%) in the TEVAR trials, 21% in the FEVAR trial, and 34% in the dissection stent trial (P< .01 for the difference). Only 52% of the trials had reported the three most common racial groups (White, Black, Asian), and only 48% had reported Hispanic ethnicity. The TEVAR trials were the most likely to report all three racial groups and Hispanic ethnicity (92% and 75%, respectively), while the EVAR trials had the lowest reporting rates (13% and 20%, respectively). Where reported, the median enrollment of racial and ethnic groups across the trials was as follows: Black patients, 9.8% (FEVAR, 0%; EVAR, 1.9%; TEVAR, 12%; dissection stent, 25%; P= .01); Asian patients, 2.4% (EVAR, 0.6%; FEVAR, 2.4%; TEVAR, 2.5%; dissection stent, 11%; P= .24); and Hispanic patients, 3.8% (EVAR, 1.3%; FEVAR, 2.4%; TEVAR, 3.9%; dissection stent, 4.1%; P= .75). Racial and ethnic minority groups were underrepresented and underreported in pivotal aortic device trials that led to FDA approval. Female patients were also underrepresented in these aortic trials, especially for EVAR. These data suggest the need for standardization of reporting practices and minimum thresholds for minority and female participation in pivotal trials to promote equitable representation.