Purpose: Bridging stent grafts (BSG) implanted during fenestrated and branched endovascular aortic repair (F/B-EVAR) are crucial for the successful exclusion of thoracoabdominal and complex abdominal aortic aneurysms (AAA). The aim of this study was to analyze the outcomes of the Gore Viabahn VBX stent graft as BSG for renal and visceral target vessels during F/B-EVAR.
Materials and methods: All consecutive patients undergoing F/B-EVAR for thoracoabdominal or complex AAAs from January 2019 to May 2023 who were treated with at least 1 VBX stent graft as BSG were included. Procedural, radiological, and follow-up data of the included patients were retrospectively reviewed. Primary outcome of the study was technical success of VBX stent graft implantation. Secondary endpoints were VBX-related adverse events, target vessel instability, endoleaks, and overall survival.
Results: A total of 273 VBX stent grafts were implanted in 263 target vessels in 38 FEVAR, 46 BEVAR, and 3 F/B-EVAR (combined design) stent grafts in 87 patients (74.7% male; mean age, 73.6 ± 7.0 years). Technical success of VBX stent graft implantation was 97.5% with 273 successful implantations in 280 attempts. The VBX-related secondary endpoints were evaluated for 269 VBX stent grafts in 259 target vessels. Target vessel designs included 107 fenestrations (41.3%), 82 outer-branches (31.7%), and 70 inner-branches (27.0%). Freedom from VBX-related adverse events at 12 months postoperatively was 96.6% (95% CI: 92.9%-100%) for target vessels with a fenestration and 93.6% (95% CI: 89.4%-98.0%) for target vessels with a branch. Freedom from target vessel instability at 12 months postoperatively for fenestrations and branches was 98.1% (95% CI: 94.4%-100%) and 97.6% (95% CI: 94.9%-100%) respectively. A total of 9 (3.5%) VBX-related endoleaks were detected during follow-up. Overall survival of all treated patients was 86.7% (95% CI: 79.1%-94.9%) at a median follow-up of 14 months.
Conclusion: The VBX stent graft shows an excellent performance as a BSG in F/B-EVAR. The VBX stent graft has a high technical implantation success and shows a high mid-term freedom from stent graft-related adverse events and target vessel instability for both target vessels with a fenestration and a branch. Long-term follow-up data of the performance of the VBX stent graft are to be awaited.
Clinical impact: This study evaluated the outcomes of the Gore Viabahn VBX stent graft as a bridging stent graft (BSG) for renal and visceral target vessels. It is important to evaluate the performance of such recently introduced stent grafts as these are essentially used in procedures outside of the Instructions for Use. This comprehensive analysis of the VBX stent graft as a BSG adds to the evidence of the performance of this stent graft as a BSG.
Purpose: To reveal the rate of 1-year freedom from restenosis and to determine the factors associated with the restenosis risk in femoropopliteal (FP) lesions treated with a Ranger drug-coated balloon (DCB) in real-world clinical settings.
Methods: This multicenter, prospective observational study enrolled 1131 patients and 1453 de novo or restenotic FP lesions (mean age=75±9 years; female=35.3%, mean lesion length=19.2±16.0 cm; chronic total occlusion [CTO]=33.7%; severe calcification=33.7%) that underwent successful Ranger DCB angioplatsy between March 2021 and December 2022.
Results: The primary endpoint was 1-year freedom from restenosis and its associated factors. Bail-out stenting was performed in 5.3%. During the follow-up, restenosis was detected in 249 cases. Freedom from restenosis by the Kaplan-Meier analysis was estimated to be 85.2% and 81.0% at 12 and 14 months, whereas freedom from target lesion revascularization (TLR) was 91.7% and 90.0% at 12 and 14 months. The patterns of restenosis were focal (39.2%), tandem (12.3%), diffuse (17.2%), and occlusive (31.3%). Independent risk factors of restenosis were female sex, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
Conclusions: Our study demonstrated that 1-year freedom from restenosis after Ranger DCB for FP lesions in a real-world clinical setting was acceptable. Independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
Clinical impact: Our study demonstrated the true performance of Ranger DCB in real-world practice, with a very low rate of bail-out stenting and no use of atherectomy devices. In addition, it also elucidated morphologies associated with restenosis and the risk factors for restenosis after DCB. Freedom from re-stenosis and TLR at 1-year after Range DCB angioplasty was 84.5% and 91.5%. Two thirds of restenosis had a non-occlusive pattern, and independent predictors of restenosis were female gender, diabetes mellitus, no runoff, history of revascularization, lesion length ≥25 cm, and CTO.
Background: Traumatic carotid artery pseudoaneurysms (PSAs) represent a vascular anomaly with potential for serious complications, including stroke. Traditional treatments involve endovascular stenting, which may not be ideally suited to otherwise healthy vessels that have the potential to remodel. Given the limitations of smaller animal models in replicating human vasculature and the need for improved treatment modalities, this study introduces a novel swine model for the creation and evaluation of carotid PSAs.
Methods: The PSAs were created from bovine dura and anastomosed in an end-to-side fashion to bilateral carotid arteries. The PSAs were radiologically followed up post-operatively and were harvested at 3 and 10 days for histological analysis.
Results: Pseudoaneurysms were successfully created in both animals without intra-operative or immediate post-operative complications. Radiological analysis showed well-perfused PSAs with intra-aneurysmal turbulence, hemodynamically mimicking human carotid artery PSAs. There was no evidence of thrombus or arterial stenosis. Histological examinations revealed thrombus maturation and tight anastomosis of the PSA sac with the native artery.
Conclusions: This PSA swine model offers a replicable, cost-effective, and easily implemented tool with the potential to advance carotid PSA management and educational efforts in vascular surgery.
Clinical impact: The model presented in this methodology paper allows for a standardized PSA animal model allowing for the standardization of a clinical entity which is frequently heterogenenous in morphology. This can allow for the development of new therapies or provide a ground truth for computer modelling for further in silico study.
Objective: Aorto-esophageal fistula (AEF) is a rare condition consisting in a fistula between the aorta and the esophagus. The thoracic endovascular aortic repair (TEVAR) has become an accepted treatment for initial AEF management, but large series are not available and outcomes are questionable. This study aims at evaluating the current evidence of TEVAR in AEF.
Methods: A search on PubMed/MEDLINE and EMBASE was conducted up to June 2023. Data on article type, patients' demographics, cause and type of AEF, clinical presentation, time from clinical presentation to TEVAR, strategies, mortality, and follow-up were analyzed.
Results: 106 reports published between 1997 and 2023 were deemed eligible for this study (92 case reports; 14 case-series). A total of 163 patients (mean age: 58.9±16.5 years), diagnosed with AEF and treated with TEVAR (with or without staged surgical repair of the esophagus or the aorta) were included. A thoracic aortic aneurysm (34.4%) was the most common cause of AEF, followed by esophageal cancer (25.2%), foreign body in esophagus (13.5%) and post-TEVAR complication (9.8%). Primary AEF were 129 (79.1%), and secondary AEF were 34 (20.9%). TEVAR alone was performed 80 times (49.1%), while TEVAR with staged esophageal or aortic surgery 83 times (50.9%). The overall 30-day mortality was 11.7% (n=19): 18.8% in TEVAR alone and 4.8% in TEVAR with staged surgery, respectively (p=0.006). Mean follow-up time was 12.3±14.7 months. The overall 6-month mortality was 34.4% (n=56): 48.8% in TEVAR alone and 20.5% in TEVAR with staged surgery (p<0.001). Bleeding for recurrence of AEF and sepsis were the main causes of death.
Conclusions: In case of AEF, TEVAR can be urgently performed for bleeding management and hemodynamic control. TEVAR alone is a valuable yet not definitive procedure. Instead, TEVAR followed by surgical repair may provide better outcomes and should be recommended, when possible.
Clinical impact: This review summarizes the published papers on endovascular aortic repair for the treatment of aorto-esophageal fistulae. The clinicians can find several important details on how to manage the presence of an esophageal fistulae wich represents a potential life-threatening problem for the patients. The implantation of a thoracic endovascular aortic prosthesis represents a fast and reliable procedure in case of emergency but a second step surgical repair provides better outcomes and should be recommended in suitable patients.
Objective: Knowledge of hostile factors and their influence on long-term seal in the iliac landing zone is limited. Currently endorsed clinical practice guidelines lack structural evidence on how the iliac landing zone should be assessed in the pre-, intra-, and postoperative phases. The goal of this study was to obtain an international, expert-based consensus on the definition of a hostile iliac landing zone, on how to size and plan stent-grafts to optimize sustainable distal seal, and on the postprocedural follow-up protocol.
Methods: Delphi consensus methodology was used, involving a panel of international vascular surgeons experienced in endovascular aneurysm repair (EVAR). The first round consisted of open-ended and multiple-choice questions to explore current practices, with subsequent rounds refining statements through a 4-point Likert scale. Consensus was defined as >75% agreement or disagreement, and the analysis included stability testing and strength of consensus.
Results: The study engaged 77 international vascular surgeons, reflecting diverse geographic locations and hospital affiliations. Consensus was achieved on critical preoperative planning elements for EVAR, including a clear definition for a hostile iliac landing zone. The importance of computed tomography angiography for postoperative follow-up imaging was emphasized, including evaluating distal seal length and recommending specific timing for follow-up computed tomography scans and intervention strategies for diminishing iliac seal.
Conclusions: This international expert-based Delphi consensus establishes a comprehensive set of consensus-driven recommendations focused on the definition and management of hostile iliac landing zones in EVAR. The key recommendation of this study is the definition of a hostile iliac landing zone as short (<15 mm), wide (>24 mm), or conical (>10% diameter difference along the landing zone). Although consensus was achieved on several critical aspects, the study also reveals ongoing debates and considerations that warrant further exploration, including how to tackle diminishing seal without a type IB endoleak.
Clinical impact: This Delphi consensus introduces a standardized definition of a hostile iliac landing zone as short (<15 mm), wide (>24 mm), or conical (>10% diameter difference), clinicians now have a clearer framework for assessing complex anatomies. This study provides a comprehensive set of consensus-driven recommendations focused on the definition and management of hostile iliac landing zones in EVAR which gives guidance where current guidelines lack specificity, particularly for distal iliac sealing. The study also reveals ongoing debates and considerations that warrant further exploration, including how to tackle diminishing seal without a type IB endoleak.
Introduction: In the current study, we hypothesized that the Japanese below-the-knee chronic total occlusion score could be used to stratify the lesion difficulty of endovascular therapy for below-the-knee chronic total occlusion through angiographic evaluation. We thus aimed to evaluate the prognostic impact of the Japanese below-the-knee chronic total occlusion score in patients with chronic limb-threatening ischemia after successful endovascular therapy for below-the-knee chronic total occlusion.
Methods: This was a retrospective, single-center observational study. We enrolled 139 consecutive patients with chronic limb-threatening ischemia (149 limbs), who underwent successful endovascular therapy for chronic total occlusion between February 2008 and December 2017. The Japanese below-the-knee chronic total occlusion score was assessed based on the definition of the target arterial path. The evaluation items were the rate of amputation-free survival and wound healing at 1 year, and the association between wound healing at 1 year and the Japanese below-the-knee chronic total occlusion score.
Results: The rates of amputation-free survival and wound healing at 1 year were 88.0 and 56.4%, respectively. Multivariate Cox proportional hazard analysis identified direct flow to the wound (hazard ratio: 2.34, 95% confidence interval: 1.28-4.66; p<0.01); Wound, Ischemia, and foot Infection stages 1-3 (hazard ratio: 2.81, 95% confidence interval: 1.63-5.18; p<0.01); and a Japanese below-the-knee chronic total occlusion score ≤1 (hazard ratio: 1.70, 95% confidence interval: 1.02-2.98; p=0.04) to be predictors of wound healing.
Conclusions: A Japanese below-the-knee chronic total occlusion score ≤1, direct flow to the wound, and Wound, Ischemia, and foot Infection stages 1-3 were found to be associated with wound healing after successful endovascular therapy for below-the-knee chronic total occlusion in patients with chronic limb-threatening ischemia.
Clinical impact: This study was conducted to evaluate the prognostic impact of the Japanese below-the-knee chronic total occlusion (J-BTK CTO) score in patients with chronic limb-threatening ischemia (CLTI) after successful endovascular treatment (EVT). The results showed that the J-BTK CTO score not only evaluates the difficulty of EVT but also can predict limb prognosis. Using the J-BTK CTO score, it seems possible to predict the limb prognosis and make it useful in clinical practice.
Clinical impact: This anatomical Merkmal method may facilitate anterolateral popliteal puncture.
Purpose: This prospective study from October 2016 to September 2020 aimed to identify the factors associated with non-revascularization and mortality rates in patients who underwent endovascular interventions for Trans-Atlantic Inter-Society Consensus (TASC) II A/B iliac artery occlusions at the Department of Vascular Surgery.
Methods: Patients with TASC II A/B iliac artery occlusions who underwent endovascular intervention, including balloon angioplasty and stent placement, were included. The primary outcomes were factors associated with non-revascularization and mortality rate.
Results: A total of 133 patients were enrolled in this study. Univariable analysis revealed significant associations between non-revascularization and diabetes (hazard ratio [HR]=2.61, 95% confidence interval [CI], p=0.03), chronic kidney disease (HR=16.2, 95% CI, p=0.01), and severe calcifications (HR=8.56, 95% CI, p<0.001). Subsequent multivariable analysis confirmed the significance of these factors, showing HRs of 3.04 (95% CI, p=0.02), 13.12 (95% CI, p=0.03), and 8.62 (95% CI, p<0.001), respectively. The overall mortality rate observed was 20.3%. Severe calcifications emerged as a significant risk factor for mortality in both univariable (HR=2.47, 95% CI, p=0.02) and multivariable (HR=3.01, 95% CI, p<0.001) analyses.
Conclusion: Severe calcifications correlate with non-revascularization and mortality, while comorbidities like diabetes mellitus and chronic kidney disease are also associated with non-revascularization. Recognizing these identified factors holds substantial promise in enhancing patient selection and procedural approaches, potentially bolstering the success rates of endovascular interventions. However, further research aimed at comprehending the underlying mechanisms and devising strategies to mitigate these risks is imperative for continued improvement in patient outcomes.
Clinical impact: The study provides valuable insights into patient selection and procedural planning for endovascular interventions in TASC II A/B iliac artery occlusions. Identifying severe calcifications, diabetes, and chronic kidney disease as key risk factors for non-revascularization and mortality equips clinicians with essential predictive tools, potentially improving outcomes by tailoring treatment approaches. The innovation lies in highlighting the impact of comorbidities and calcification severity, offering a pathway to refine patient eligibility criteria and optimize procedural decisions. This underscores the importance of further research to develop strategies that mitigate these risk factors and enhance intervention success rates.
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