Three-year outcomes of a US pivotal trial substudy for conformable endoprosthesis in ≥10 mm nonangulated neck anatomy.

OBJECTIVE: To report the midterm clinical outcomes from the GORE® EXCLUDER® Conformable AAA Endoprosthesis system (EXCC) pivotal regulatory trial in the United States (U.S.). METHODS: This is a prospective, multicenter, investigational device exemption clinical trial at 31 U S. sites with Core Laboratory assessment of imaging and independent adjudication of safety. The study enrolled patients with abdominal aortic aneurysms (AAA) with a minimum proximal landing zone ≥10 mm and proximal neck angulation of ≤60 degrees between December 2017 and February 2019 as part of a larger study to gain indications of the EXCC device. Endpoints included patient survival, freedom from secondary interventions, and stent-graft related outcomes. RESULTS: There were 80 patients enrolled (88.8% male, mean 73.5 ± 8.14 years-old). Mean maximum aortic diameter was 57.7±8.0 mm (range, 42.5-82.7). There was 100% freedom from type I and III endoleak and aneurysm-related mortality at 36-months. Freedom from secondary intervention was 91.9 ± (0.83, 0.96, 95% C.I.) at 36-months. There were no device fractures, migrations (≥10 mm), or aneurysm ruptures. At 36 months, thirteen patients (26.5%) had type 2 endoleak, 32 patients (58.2%) had AAA sac regression, 17 (30.9%) had no change in diameter, and 6 (10.9%) had sac enlargement. Seven patients (8.8%) through 36 months underwent reintervention. CONCLUSIONS: The 3-year outcomes have continued to show an adequate safety and efficacy profile of the EXCC device with no aneurysm related mortality or Type I/III endoleak. These results demonstrate durability for an EVAR device in US regulatory trials.

Successful Factors for Improving Aortic Remodeling with Thoracic Endovascular Repair and Bare Stent Extension.

OBJECTIVE: Proximal ExTension to Induce COmplete ATtachment (PETTICOAT), which utilizes downstream bare metal stents for structural support, demonstrates potential, yet its adoption is limited by variable outcomes. This study elucidates the potential of PETTICOAT in aortic dissection, emphasizing the determinants that guide patient selection. METHODS: A retrospective analysis of 60 patients who underwent full PETTICOAT for aortic dissections was conducted. A multivariate logistic regression model identified predictors of favorable aortic remodeling. Patients underwent standardized follow-up with CT scans to assess size, volumetric changes, and anatomical conditions. Selection criteria included full PETTICOAT application and a minimum three-month follow-up. Demographics, preoperative conditions, and procedural details were collected and analyzed. RESULTS: The analysis identified predictors of favorable aortic remodeling, including age over 60, a larger downstream aorta stent graft, a smaller abdominal aorta (<450mm2), and oral angiotensin II receptor blocker (ARB) administration. Over a median 47.5-month follow-up, survival rates in the favorable remodeling (97.3%) and unfavorable groups (100%) were similar. Downstream aortic event-free survival rates did not significantly differ (89.2% vs. 73.9%), although the unfavorable group had a relatively higher incidence of distal stent-induced new entries (26.1% vs. 8.1%). CONCLUSIONS: The PETTICOAT concept effectively enhances aortic remodeling in complex aortic dissections. Predictors for favorable remodeling, including age, stent graft sizing, aortic diameter, and ARB therapy, offer insights for optimizing patient selection. This approach improves survival outcomes, mitigates risks associated with untreated aortic segments, and provides a minimally invasive solution for aortic dissections. Despite some outcome variations, the technique holds promise for addressing the challenges of aortic dissections, with the potential for further refinement in patient selection and technique application.

A three-year experience with the balloon expandable GORE® VIABAHN® VBX in the treatment of thoraco-abdominal aortic aneurysms within the EXPAND Trial.

OBJECTIVE: The EXPAND registry is a post-market, multicenter registry that aims at evaluating the safety and performance of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX stent) implanted in peripheral vessels. This subgroup analysis assesses the three-year outcomes of the VBX stent as a bridging stent-graft (BSG) for visceral vessels during branched endovascular aortic repair (BEVAR). METHODS: This prospective, multicenter, observational registry includes 16 European sites. Patients were enrolled from November 2018 to March 2022. Endpoints included three-year primary patency (PP), secondary patency (SP), and stent graft-related death and serious adverse events (SAE). RESULTS: Seventy-three patients of whom 57 (78.1%) were male with a mean age of 73 years (± 8.1) were included. At three years, 42 (57.5%) patients returned for follow-up. Overall, 223 target vessels (TV) were treated. The estimated freedom from loss of TV primary patency was 93.6%. Per target vessel primary patency rates were 97.0% for the celiac trunk, 93.9% for the superior mesenteric artery (SMA), 91.2% for the left renal artery, and 92.5% for the right renal artery. The overall estimated freedom from loss of secondary patency was 96.8%, and freedom from target vessel instability was 94.5%. CONCLUSIONS: The VBX stent demonstrated excellent sustained results at three years with almost 94% primary patency, 97% secondary patency, and 94.5% freedom from target vessel instability. Patency in the renal arteries was lower than in the celiac trunk and SMA. The VBX stent appears to be a reliable bridging stent for target vessels in BEVAR.

Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft.

OBJECTIVE: 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. METHODS: 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. RESULTS: During the study period, 49 patients received TEVAR with Relay custom-made endograft in Italy were enrolled. The median patient age was 70.1 years (interquartile range, 23-86 years) and 65.3% were male. The indication for treatment was atherosclerotic aneurysms in 59.2% of cases and penetrating aortic ulcer in 22.4%. The endograft configuration was proximal fenestration in 55.1% and scallop in 44.9%. The 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. CONCLUSIONS: Our early and midterm outcomes suggest that scalloped and fenestrated TEVAR may provide an acceptable alternative treatment option for aortic arch pathologies. Large-scale studies are needed to assess the long-term durability of this technique.

Ten-year single-center outcomes following endovascular repair for abdominal aortic aneurysm using the INCRAFT device.

OBJECTIVE: This study aimed to report the long-term outcomes beyond 10 years of endovascular aneurysm repair (EVAR) for abdominal aortic aneurysms using the low-profile INCRAFT device. METHODS: This was a single-center, retrospective cohort study of all patients undergoing EVAR using the INCRAFT device as part of the regulatory trial between 2012 and 2013. Primary endpoint was aneurysm-related death. Secondary endpoints were all-cause death, reintervention, late open conversion, and aneurysm status (shrinkage, stable, and growth). RESULTS: Thirty patients with a mean age of 71.8 ± 7.7 years were included in this study. The median aneurysm diameter at EVAR was 54.5 mm (interquartile range, 53-56.8 mm). All abdominal aortic aneurysms in this study were treated following the device's instructions for use. At index EVAR, the INCRAFT device was successfully implanted in all patients using a percutaneous approach under local anesthesia. No patients experienced major adverse events or procedure-related complications 30 days after EVAR. During the median follow-up of 125 months (interquartile range, 98-131 months) with follow-up rates of 100% at 5 years and 96.7% at 10 years, aneurysm-related mortality was 0%, and freedom from all-cause mortality was 82.9% at 5 years and 75.3% at 10 years. Reintervention was required in 10 patients with 15 procedures. Sac growth was observed in 11 patients (36.7%), six of whom eventually required late open conversion; five of these patients underwent open aneurysmorrhaphy with stent graft preservation, and one underwent open surgical repair with endograft explantation. Late rupture was identified in one case, where type Ia endoleak led to rupture at 69 months, and open repair was successfully performed. Freedom from reintervention was 89.0% at 5 years but declined to 60.9% at 10 years; freedom from late open conversion was 100% at 5 years but declined to 70.8% at 10 years. CONCLUSIONS: Long-term outcomes of the INCRAFT stent graft showed no aneurysm-related deaths. However, sac growth occurred persistently throughout the follow-up period, resulting in a relatively high rate of reinterventions in the later periods, which highlights the importance of lifelong postoperative surveillance and appropriate reinterventions when indicated.

Total aortic arch repair with double-fenestrated physician-modified endografts, at least 3-year follow-up.

OBJECTIVE: This study aims to report the efficacy and safety of double-fenestrated physician-modified endovascular grafts (PMEGs) for total aortic arch repair with at least 3 years of follow-up. METHODS: All consecutive patients with a pathological aortic arch who underwent aortic arch repair combined with a homemade double-fenestrated stent graft from 2017 to 2020 were reviewed. RESULTS: 74 patients were treated for pathological arch conditions with a double-fenestrated PMEG. Of these, 81% were male, the mean age was 69.9 years, and 59% were classified as American Society of Anesthesiology 3 or 4. Thirty-five percent were treated for a postdissection aneurysm, 36% for a degenerative aneurysm, and 14% for acute type B dissection. Fifteen percent had supra-aortic trunk dissection. Fenestration on the subclavian artery was performed in 96%; if not, a carotid-subclavian bypass was carried out. Technical success was 100%. The proximal landing zone is consistently in zone 0. Early outcomes revealed a 3% occurrence of type 1 endoleak, which was successfully treated by prompt reintervention. One retrograde dissection occurred, and one patient died from hemorrhage on an iliac conduit. A 5% stroke rate was reported. During long-term follow-up (mean time 40.7 months), one type 1 endoleak appeared and was successfully treated; no type 2 or type 3 endoleak requiring intervention occurred. No stent fractures or migrations were reported. Four percent of patients required reintervention, but no surgical conversion to open surgical repair was needed on the aortic arch. No patient died from a cause related to the main procedure. CONCLUSIONS: Total aortic arch repair with double-fenestrated PMEGs is associated with acceptable early and midterm major morbidity and mortality. It is suitable for the main aortic pathologies. Moreover, it is easily available for emergency situations.

Clinical impact of proximal fixation augmentation using the Najuta thoracic fenestrated stent graft during endovascular treatment for distal aortic arch aneurysm.

OBJECTIVE: Prevention of late type Ia endoleaks is the main concern in thoracic endovascular aortic aneurysm repair (TEVAR) for thoracic aortic aneurysm. Since 2017, we have performed zone 0 TEVAR with proximal fixation augmentation using a Najuta thoracic fenestrated stent graft in addition to zone 2 TEVAR for distal arch aneurysms. We report the early and midterm outcomes of TEVAR performed using this strategy. METHODS: This single-center retrospective study enrolled 386 cases of TEVAR for thoracic aortic disease between January 2013 and December 2020. Patients with thoracic aortic aneurysm treated by TEVAR landing at zone 2 was referred to as the standard group, whereas those treated by TEVAR landing at zone 0 using a Najuta fenestrated stent graft in addition to zone 2 TEVAR was referred to as the augmentation group. We retrospectively compared the clinical outcomes between the two groups. The primary end point was secondary intervention for postoperative type Ia endoleaks. Secondary end points were technical success, aneurysm-related death, and major adverse events (MAEs), including stroke, paraplegia, endoleaks, and secondary interventions. RESULTS: We performed TEVAR in 41 and 30 cases in the standard and augmentation groups, respectively. The mean aneurysm sizes in the standard and augmentation groups were 54.5 and 57.3 mm (P = .23), and the proximal neck lengths were 16.8 and 17.4 mm (P = .65), respectively. The anatomical characteristics seemed to be similar in both groups. The technical success rate in both groups was 100%. Three cases in the standard group had MAEs, including two stroke and one brachial artery pseudoaneurysm; whereas two cases had MAEs in the augmentation group, including one stroke and one paraplegia. There was no 30-day mortality or retrograde type A dissection in both groups. The mean observation periods in the standard and augmentation groups were 46 months (range, 1-123 months) and 35 months (range, 1-73 months), respectively. At 36 and 60 months after the procedure, the freedom from aneurysm-related death was 97.6% and 97.6% in the standard group, 100.0% and 100.0% in the augmentation group (P = .39); and the freedom from reintervention for type Ia endoleaks was 79.2% and 65.2% in the standard group, 100.0% and 100.0% in the augmentation group (P = .0087). A statistically significant decrease in reinterventions for type Ia endoleaks was observed in the augmentation group. CONCLUSIONS: Proximal fixation augmentation using the Najuta fenestrated stent graft during TEVAR for distal arch aneurysm is effective in preventing the postoperative late type Ia endoleaks.

Outcomes of thoracic endovascular aortic repair with physician-manufactured partial micropore stent grafts for aortic arch pathologies.

OBJECTIVE: Thoracic endovascular aortic repair (TEVAR) has been used extensively in the management of thoracic aortic diseases. Numerous efforts have been made to enhance clinical outcomes through the use of stent grafts. This study aimed to investigate the effectiveness and safety of physician-manufactured partial micropore stent grafts (PSMGs) in TEVAR. METHODS: Between December 2017 and June 2022, data were collected from 56 patients who underwent TEVAR using physician-manufactured PSMGs. The evaluation encompassed technical success, perioperative and follow-up morbidity and mortality, stroke incidence, and branch artery patency. RESULTS: In this investigation, 56 patients received treatment with physician-manufactured PSMGs. Of these patients, 46 were male, with a mean age of 62.1 ± 11.2 years. Aortic pathologies comprised aortic dissection (n = 31 [55.4%]), aortic aneurysms (n = 10 [17.9%]), penetrating aortic ulcer (n = 8 [14.3%]), and intramural hematoma (n = 7 [12.5%]). During a median follow-up of 18 months (interquartile range, 13-25 months), the stroke rate, supra-aortic branch patency rate, and endoleak rate were 0%, 100%, and 7.1%, respectively. There were no occurrences of all-cause mortality, stroke, or the necessity for open conversion. CONCLUSIONS: TEVAR with physician-manufactured PSMGs is a viable alternative for addressing aortic arch pathologies in proficient medical centers. The approach demonstrates favorable branch patency, a low complication rate, and minimal postoperative mortality.

A Predictive Model for Prolonged Mechanical Ventilation After Triple-Branched Stent Graft for Acute Type A Aortic Dissection.

INTRODUCTION: The aim of this study is to develop a model for predicting the risk of prolonged mechanical ventilation (PMV) following surgical repair of acute type A aortic dissection (AAAD). METHODS: We retrospectively collected clinical data from 381 patients with AAAD who underwent emergency surgery. Clinical features variables for predicting postoperative PMV were selected through univariate analysis, least absolute shrinkage and selection operator regression analysis, and multivariate logistic regression analysis. A risk prediction model was established using a nomogram. The model's accuracy and reliability were evaluated using the area under the curve of the receiver operating characteristic curve and the calibration curve. Internal validation of the model was performed using bootstrap resampling. The clinical applicability of the model was assessed using decision curve analysis and clinical impact curve. RESULTS: Among the 381 patients, 199 patients (52.2%) experienced postoperative PMV. The predictive model exhibited good discriminative ability (area under the curve = 0.827, 95% confidence interval: 0.786-0.868, P < 0.05). The calibration curve confirmed that the predicted outcomes of the model closely approximated the ideal curve, indicating agreement between the predicted and actual results (with an average absolute error of 0.01 based on 1000 bootstrap resampling). The decision curve analysis curve demonstrated that the model has significant clinical value. CONCLUSIONS: The nomogram model established in this study can be used to predict the risk of postoperative PMV in patients with AAAD. It serves as a practical tool to assist clinicians in adjusting treatment strategies promptly and implementing targeted therapeutic measures.

Small Oversized Stent Graft Is Associated With Increased Patency for the Treatment of Central Venous Disease in Hemodialysis Patients.

PURPOSE: The purpose of this study was to identify the independent predictors of higher patency rates and investigate the selection of specifications of stent graft in the treatment of central venous disease. MATERIALS AND METHODS: This retrospective study included 54 patients who underwent stent-grafts' placement for the treatment of central venous disease between March 2017 and September 2022 at a tertiary hospital. The demographic data for the patients and the clinical data of the treated lesions were collected and analyzed. The patency rates of the treated lesions with different oversizing range were calculated via the Kaplan-Meier and log-rank analyses. The multivariate Cox proportional hazard models were constructed to identify the independent predictor of the target site primary patency. RESULTS: The median follow-up period was 21.5 months. The primary patency rates of the target sites were 90.7%, 72.2%, and 55.1% at 6, 12, and 24 months, respectively. The assisted primary patency rates of the lesions were 96.3%, 92.5%, and 80.3% at 6, 12, and 24 months, respectively. The log-rank analysis showed that the stent-grafts' placement with small oversizing had significantly higher primary patency rates than those with large oversizing (p=0.022). The multivariate analysis revealed that concomitant stenosis and large oversizing stent graft were the independent predictors of target site primary patency. CONCLUSIONS: Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing. CLINICAL IMPACT: Stent grafts showed reasonable primary patency for the treatment of central venous disease in hemodialysis patients. Few studies, however, have explored the efficiency of stent grafts to treat CVD by considering different factors such as sizing considerations, the rate of oversizing percentage, etc. A stent graft with small oversizing is associated with better target site primary patency rates than those with large oversizing. Excessive oversizing should be avoided to prevent infolding or stent collapse.

Bifurcated Endografts for the Treatment of Aortoiliac Disease a Systematic Review and Individual Patient Data (IPD) Meta-Analysis.

BACKGROUND: This review aimed to assess the efficacy and safety of bifurcated endografts in the treatment of aortoiliac disease (AOID). METHODS: A systematic search on PubMed, Scopus, and Web of Science was performed. The primary endpoint was primary patency, whereas secondary endpoints included reintervention, technical, clinical success, and overall postoperative complications. RESULTS: Ten studies with a total of 365 patients were included in this review. Most included studies used the AFX unibody endograft, one study the Excluder endograft, and one the Powerlink endograft. The majority of included patients displayed TransAtlantic InterSociety Consensus (TASC) D aortoiliac lesions (56.1% 205/365). The pooled primary patency estimates at 12, 24, and 36 months were 93.93% (95% confidence interval [CI]: 87.7-100), 91.46% (95% CI: 84.6-98.8), and 90.25% (95% CI: 82.6-98.6), respectively. The mean primary patency time was 85.74 months (95% CI: 71.99-86.88). The pooled freedom from reintervention estimates at 12, 24, and 36 months were 91.94% (95% CI: 81.4-100), 91.03% (95% CI: 79.8-100), and 91.03% (95% CI: 79.8-100), respectively. The pooled estimates of major complications (rupture, graft thrombosis, amputation) were 11.12% (95% CI, 0.05%-3.03%), 3.76% (0.32%-9.45%), and 0.38% (0%-2.59%), whereas the pooled estimates for minor complications (hematoma, groin infection, dissection) and overall mortality were 5.27% (95% CI, 1.11%-11.38%), 6.93% (95% CI, 2.94%-12.16%), 2.19% (95% CI, 0.06%-6.14%), and1.57% (95% CI, 0.13-3.97), respectively. Technical and clinical success estimates were 99.92% (95% CI: 98.86%-100%) and 99.47% (95% CI: 94.92%-100%), respectively. CONCLUSION: The application of bifurcated endografts may present a safe and viable option in the treatment of AOID, with preliminary results indicating promising primary patency outcomes. However, the definitive assessment of their efficacy and safety will be better determined through long-term follow-up studies and high-quality randomized controlled trials, which are essential to substantiate these initial findings. CLINICAL IMPACT: Bifurcated endograft application may be a safe and viable alternative for high-risk patients with complex AOID TASC C and D lesions with encouraging primary patency outcomes potentially comparable to those of open surgery. Non-negligible postoperative complication rates were also noted. High-quality randomized controlled trials and studies comparing CERAB, kissing stenting, and the use bifurcated endografts for the treatment of AOID is necessary to draw more definite conclusions.

Six Years' Experience With a Novel Dissection-Specific Stent-Graft to Prevent Distal Stent-Graft-Induced New Entry.

INTRODUCTION: Thoracic endovascular aortic repair (TEVAR) in chronic dissection is associated with a risk for distal stent-graft-induced new entry (dSINE) in up to a quarter of cases. We assess the mid-term outcome of a novel dissection-specific stent-graft (DSSG), which is a custom-made device based on the Cook Alpha platform, with a modified graft design and a distal endovascular elephant trunk without any supporting stent to reduce the radial force on the dissection membrane at the distal landing zone. METHODS: A retrospective single-center study of chronic dissection patients at high risk of dSINE who received an elective endovascular repair with DSSG from January 2017 to June 2023. The primary outcome is Kaplan-Meier (KM) estimated freedom from dSINE during follow-up. Secondary outcomes included technical success, aortic remodeling, and anatomical evaluation of the distal landing zone in cases with dSINE during follow-up versus those without. RESULTS: Thirty patients (24 males) with a median age of 66 years [range=31-78] underwent elective TEVAR with the DSSG. The majority, n=27 (90%), had previous aortic repair; 7 (23%) had established connective tissue disease, and 6 (20%) had established dSINE after previous stent-graft implantation as an indication for TEVAR. Technical success was achieved in n=29 (97%). Median follow-up was 38.5 months (4.3-76.4), and KM estimated freedom from dSINE at 1 and 3 years was 95.6% (SE 0.043) and 89% (SE 0.081), respectively Four cases developed dSINE during follow-up. The median distance from the distal stent-graft to the coeliac trunk was 74mm (range=18-123) in the dSINE group versus 26mm (range=0-74) in the non-dSINE group (p=0.049). Median proximal tangential aortic angulation in the distal landing zone was 38.5° (range=26°-50°) in the dSINE group compared to 21° (range=3-61°) in the non-dSINE group (p=0.052). CONCLUSIONS: The Use of a novel DSSG with low radial force for TEVAR in the setting of chronic dissection is safe and feasible, with remodeling outcomes comparable with standard TEVAR. The reduced distal radial force in the DSSG does not eliminate the risk for dSINE over time, with new entries occurring, particularly in cases where the distal landing zone is in a tortuous aortic segment and not close to the coeliac trunk. CLINICAL IMPACT: Using the novel dissection-specific stent-graft with reduced radial force is safe and feasible but does not completely eliminate the risk of dSINE occurring over time. The exact positioning of the distal stent-graft in a straight aortic segment, close to the coeliac trunk, may be of importance to further mitigate the risk.

iCover as Bridging Stent Graft in Fenestrated Endovascular Aortic Aneurysm Repair.

BACKGROUND: Complex endovascular repair with fenestrated or branched stent grafts is a common approach for treating various types of aortic aneurysms. Bridging stent grafts (BSs) are crucial in connecting aortic endoprosthesis to target vessels, yet current options have demonstrated significant complications. OBJECTIVE: This retrospective single-center study evaluates the initial outcomes and durability of the iCover stent graft (iCover-SG) when used as a BS in fenestrated endovascular aneurysm repair (FEVAR). METHODS: Retrospective analysis screened procedures for complex aortic aneurysms between August 2021 and January 2024. Patients who underwent FEVAR with iCover-SG as BS were included. Primary and secondary endpoints focused on freedom from iCover-SG-related target vessel instability, technical success, and postoperative outcomes. RESULTS: Within the cohort of 28 patients, 94 iCover-SGs were used as BS, supplying 87 target vessels. The freedom from iCover-SG-related target vessel instability throughout the study reached 94% (82/87). Technical success rates were notably high, with primary success achieved in 94% of cases and secondary success in 99%. Over the follow-up duration, there were instances necessitating reintervention related to iCover-SG, including 4 cases of endoleak, 2 cases of T1cEL, and 2 cases of T3cEL. In-hospital mortality was 7% (n=4), with 2 cases attributed to intraoperative complications. Importantly, no deaths were directly attributed to iCover-SG-related issues. CONCLUSION: The iCover-SG demonstrates promising initial outcomes as a BS in FEVAR, with high technical success rates and satisfactory rates of target vessel instability. Continued monitoring and further studies are warranted to assess long-term durability and outcomes. CLINICAL IMPACT: This study shows that the iCover stent graft achieves satisfactory technical success and target vessel stability in the short- and mid-term when used as a bridging stent graft in FEVAR procedures. Its successful integration into clinical practice broadens the range of available options, providing clinicians with more versatile tools for managing complex endovascular aortic aneurysms. This expanded selection of bridging stent grafts allows for more personalised treatment strategies, improving procedural precision and patient outcomes. The iCover stent graft's reliable performance highlights its potential as a valuable addition to current endovascular techniques, ultimately enhancing patient care in challenging cases.

Endovascular Salvage of Type Ia and Ib Endoleaks Using a Physician-Modified Fenestrated/Branched Endograft and an Iliac Branch Device Via Unilateral Transfemoral Arterial Access.

PURPOSE: This study aims to explore the feasibility and effectiveness of a unilateral transfemoral access endovascular salvage technique for complex abdominal aortic aneurysms with concurrent type Ia and Ib endoleaks following previous endovascular repair. CASE REPORT: A 69-year-old female with multiple comorbidities presented with an extent IV thoracoabdominal aortic aneurysm complicated by type Ia and Ib endoleaks and chronically occluded left iliac endoprosthesis after prior endovascular repair. Given the patient's medical complexities, open explant repair was deemed high risk. The case was successfully managed using a physician-modified fenestrated/branched endograft (PM-F/BEVAR) and an iliac branch device (IBD) deployed through a single percutaneous transfemoral access. CONCLUSION: The presented case demonstrates the safety and efficacy of PM-F/BEVAR with concomitant IBD deployment via unilateral transfemoral access. This innovative approach allows endovascular salvage in cases with restricted iliofemoral access and avoids the complexities associated with upper extremity or aortic arch manipulation. While acknowledging the technical challenges, this technique offers a viable alternative for salvaging failed endovascular repairs, emphasizing the importance of real-time modifications in achieving successful outcomes. Further studies and long-term follow-up are warranted to validate the broader applicability and durability of this approach in the management of complex abdominal aortic aneurysms with multiple endoleaks. CLINICAL IMPACT: Although not the conventional approach, unilateral transfemoral access can be utilized to implant either a physician-modified fenestrated aortic endograft or an iliac branch device. Such an approach avoids complicating issues related to upper extremity access. This innovative technique may be necessary when there is a failed prior EVAR in the setting of significant contralateral iliofemoral occlusive disease. Doing both procedures in the same setting to resolve a type Ia and Ib endoleak is feasible as demonstrated in this case report. Expanding the endovascular armamentarium to address EVAR failure will be increasingly useful in the future, especially given the morbidity profile of EVAR explantation.

Early Experience With Fenestration Modification of Castor Branched Stent-Graft for Aortic Arch Diseases.

PURPOSE: This study aimed to assess the safety and viability of combining branched stent graft with fenestrated thoracic endovascular aortic repair (TEVAR) in treating aortic arch lesions. MATERIALS AND METHODS: The cohort included patients presenting with aortic arch lesions who underwent treatment with a combination of branched stent graft and fenestrated TEVAR between July 2020 and November 2022. Technical success was defined as the precise deployment of the stent graft, maintenance of branch vessel patency, and the absence of type I endoleak. The secondary outcomes examined were complications and all-cause mortality. RESULTS: The study cohort comprised 21 patients (average age: 61.0±14.8 years) with aortic arch lesions from 3 tertiary care hospitals. The aortic arch lesions encompassed aortic dissection (N=8), aortic aneurysm (N=8), pseudoaneurysm (N=1), intramural hematoma (N=1), and penetrating aortic ulcer (N=3). The technical success rate achieved was 95.2% (20/21). Failure in one case was due to an intraoperative type I endoleak, which was rectified with an additional stent graft placement. The 30-day mortality rate was 4.8% (1/21). One patient suffered a stroke but responded well to medical intervention. The median hospital stay was 10.9±5.4 days. During the follow-up period, one death (4.8%) was associated with aortic complications. A type II endoleak was observed and managed with close monitoring. Two patients underwent re-interventions for retrograde type A dissection and stent migration, respectively. No occlusions were observed in the target branch arteries. CONCLUSIONS: The combination of branched stent graft with fenestrated TEVAR emerges as a viable strategy for addressing specific lesions in the aortic arch. CLINICAL IMPACT: This study demonstrates the feasibility of using branched stent grafts with fenestrated TEVAR for treating aortic arch lesions, achieving a technical success rate of 95.2%. Compared to traditional open surgery, this innovative, minimally invasive approach reduces perioperative mortality and complications, such as stroke and spinal cord ischemia. For clinicians, it offers a viable alternative for patients unfit for open repair, particularly in complex aortic arch cases. While the initial outcomes are promising, further research is needed to assess long-term durability and risks, including stent graft migration and late endoleak, ensuring the technique's safety and efficacy over time.

A Free-Floating Aortic Thrombus: An Uncommon Approach to Handle a Rare Clinical Entity.

BACKGROUND: Thrombotic material in the non-aneurysmatic and non-atherosclerotic aorta is a rare entity without any recommended standard treatment so far. We present a successful treatment strategy for patients who do not fit into any of the common approaches. CASE REPORT: A free-floating thrombus in the descending aorta was found as source of embolism in an 82-year-old female patient with lower limb ischemia. After initial heparinization of the patient without relevant reduction of the thrombotic mass, the thrombus was removed using an interdisciplinary approach. Under echocardiographic guidance to locate the thrombus, the AngioVac device, usually licensed to remove floating thrombi from the venous system, was used off-label to remove the thrombus by a transfemoral approach. To avoid rebuilding of a new thrombus, the attachment point with an exulcerated plaque in the descending aorta was covered by a stent graft via the same femoral access. The patient did not experience any further embolic events, and the postoperative course was uncomplicated. CONCLUSION: Patients with uncommon aortic diseases, such as the reported free-floating thrombus, should be treated by an individualized, interdisciplinary approach. Besides the recommended treatment options, there are other uncommon approaches that might offer an alternative in complex cases. CLINICAL IMPACT: Evidence is rare for the treatment of a free-floating thrombus in the descending aorta and the treatment strategy remains discussed controversially. We present a rather uncommon approach of successful off-label treatment for patients who do not fit into any of the common approaches (operative, endovascular, or conservative treatment based on patient's comorbidities). The AngioVac System has already been successfully used off-label in the arterial system but not in the above presented way of treating a free-floating thrombus in a patient with high embolization risk and treatment-limiting comorbidities.

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

PURPOSE: 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). MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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. CLINICAL IMPACT: 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.

Covered Endovascular Reconstruction of the Iliac Artery Bifurcation (CERIB).

PURPOSE: The aim of this study was to present the covered endovascular reconstruction of the iliac artery bifurcation (CERIB) technique as a revascularization option for aorto-iliac occlusive disease (AIOD) involving the iliac artery bifurcation. METHODS: This was a retrospective single-center study including all patients undergoing a CERIB procedure from January 2021 until December 2022. Covered endovascular reconstruction of the iliac artery bifurcation procedures were performed percutaneously with bilateral femoral access, excepting cases where simultaneous open femoral artery reconstruction was required due to the extension of peripheral arterial occlusive disease. Standard patient, procedural, and follow-up (FU) data including survival and arterial reinterventions were gathered and analyzed. RESULTS: A total of 13 patients were included (11/13 male, median age=70 [60-76] years). Additional open and/or endovascular procedures included endarterectomy of the femoral bifurcation (n=6), rotational atherectomy (n=2), and 1 axillary artery cutdown for upper limb access (n=1). Median operating time was 2.9 hours (1.5-4.9 hours); median radiation duration and dose were 28.4 (14.3-63.3 minutes) and 4090.6 (384.4-9430.1 cGray/cm2), respectively. The stent grafts used for CERIB were BeGraft peripheral n=31, BeGraft Aortic n=4 and BeGraft peripheral plus n=1 (Bentley InnoMed GmbH, Hechingen, Germany). In 2 patients with prior stenting of the common iliac artery (CIA), only the internal and external iliac arteries (IIA and EIA) were treated in this study, and in 2 cases, additional uncovered stents were required for relining. Technical success was 100%. During a midterm FU (median 18 [4-31] months), 2 patients died from cardiovascular reasons and 1 patient with prior iliac stenting required reinterventions for recurring occlusion. CONCLUSION: Covered endovascular reconstruction of the iliac artery bifurcation is a straightforward option for treating AIOD involving the iliac artery bifurcation that allows preservation of internal iliac artery perfusion and shows good early and midterm results. Prior iliac artery stenting may be a risk factor for early occlusion after CERIB. CLINICAL IMPACT: Aorto-iliac occlusive disease with involvement of the internal iliac artery is encountered regularly in vascular surgical practice, but the internal iliac artery is often not included in the revascularization strategy. The present article will increase the awareness for the relevance of including the internal iliac artery in revascularization strategies and presents CERIB as another method to be added to the armamentarium of (endo-)vascular surgeons and interventionalists.

Total Endovascular Repair of a Giant Iliac Vein Aneurysm: A Case Report and Review of Literature.

PURPOSE: The iliac veins are the least frequent location for venous aneurysms, with only a few cases described globally. The etiology and clinical presentation of this extremely rare entity is diverse and unclear and no treatment consensus has been reached yet. Our purpose is to present an interesting iliac vein aneurysm (IVA) case that we treated in our department, with a brief review of the literature. CASE REPORT: We report a case of a 74-year-old male patient with a giant, 55 mm in diameter, asymptomatic, right common IVA, with concurrent aplasia of the left common iliac vein and an extensive network of venous collaterals. The patient was treated, under general anesthesia, with total endovascular iliocaval reconstruction through implantation of a 32 × 100 mm thoracic aortic tubular Ankura stent graft. The computed tomography venography at first-month follow-up showed the complete exclusion of the IVA, without any endoleak and the patient remains up to date free of symptoms and thromboembolic events. CONCLUSION: Twelve cases of endovascular treatment of IVA have been reported so far, and our case is the first with implantation of a thoracic aortic stent graft. Our results suggest that this technique is safe, effective, and may be considered for appropriately selected patients. CLINICAL IMPACT: This is the first case with total endovascular repair of an iliac vein aneurysm with contralateral iliac vein aplasia through endovenous implantation of a thoracic aortic stent-graft. Our results suggest that this technique is safe and effective and thus, may be considered for appropriately selected cases.

Acute Type B Aortic Dissection: Insights From a Single-Center Retrospective Experience Over 12 Years.

INTRODUCTION: The treatment of acute type B aortic dissection (ATBAD) is currently a challenge for vascular surgeons, because of the early morbidity and mortality rates and the high risk of late aortic events up to 50% at 5 years. This study presents the initial outcomes of ATBAD treatment using optimal medical therapy alone or combined with proximal entry tear stent-graft coverage. Additionally, it provides an analysis of the evolution of the aortic diameter and its clinical consequences during the chronic phase in each group. MATERIALS AND METHODS: Conducted as a retrospective, single-center study, we enrolled all consecutive ATBAD patients (n=130) treated between 2008 and 2020. The primary analysis studies the entire patient cohort based on their initial management approach, namely, medical treatment alone for uncomplicated ATBAD (n=67) or combined with stent-graft entry tear coverage (n=63). We also conducted a subgroup analysis to investigate factors associated with disease progression in the medical management group. RESULTS: Median follow-up was 29.5 months. During this time aneurysmal evolution was observed in: 42.4% of cases in the medical group compared with 21.8% in the stent-graft group, primarily affecting the thoracic aorta. The stent-graft group exhibited significant aortic remodeling, with a decrease in false lumen (FL) and thoracic aortic diameters. Initial aortic diameter ≥40 mm and FL ≥22 mm were independent risk factors for aneurysmal degeneration. Five-year survival was consistent at 76.1% in both groups. CONCLUSION: This study confirms the safety and efficacy of stent-graft entry tear coverage for ATBAD. Initial thoracic endovascular aortic repair (TEVAR) appears to reduce late aortic events by promoting aortic remodeling. Considering TEVAR's safety and potential to prevent late aortic complications, it may be considered for uncomplicated ATBAD patients with an initial aortic diameter ≥40 mm or an FL ≥22 mm. CLINICAL IMPACT: This study validates the efficacy and safety of using endovascular stent grafts to seal the proximal entry tear in cases of acute type B aortic dissections, compared to optimal medical therapy. Aortic remodelling significantly benefits from endovascular stent graft coverage of the proximal entry tear. Given the heightened risk of late aortic events observed in the medical therapy cohort, there appears to be a necessity for including endovascular interventions in the management of uncomplicated acute type B aortic dissections, particularly when aortic diameter is ≥40 mm and false lumen diameter is ≥22 mm.