Journal of Endovascular Therapy最新文献

Purpose: To identify prognostic factors for wound healing and major amputation in patients with chronic limb-threatening ischemia (CLTI) and inframalleolar lesions undergoing endovascular therapy (EVT).

Materials and methods: We conducted a multicenter, retrospective observational study involving 401 limbs in 318 patients with Rutherford classification 5 to 6 and inframalleolar disease treated with EVT between January 2018 and August 2022. The primary endpoint was 6-month wound healing, and the secondary endpoint was 1-year freedom from major amputation. We used the Cox proportional hazards models to identify independent predictors.

Results: The 6-month wound healing rate was 48.2%, and the 1-year freedom from major amputation was 87.9%. Rutherford classification 6 (hazard ratio [HR]=0.69; 95% confidence interval [CI]=0.50-0.95; p=0.022) and each 1-point increase in the medial arterial calcification (MAC) score (HR=0.84; 95% CI=0.77-0.93; p<0.001) were independently associated with delayed wound healing. Wound, Ischemia, and foot Infection (WIfI) clinical stage of 4, small artery disease (SAD) score 2, and a higher MAC score were significantly associated with an increased risk of major amputation.

Conclusion: The MAC score independently predicts delayed wound healing and major amputation in patients with CLTI and inframalleolar lesions undergoing EVT, supporting its use in preprocedural risk stratification.Clinical ImpactThis multicenter observational study highlights the prognostic value of integrating anatomical and clinical severity scores-medial arterial calcification (MAC), small artery disease (SAD), Wound, Ischemia, and foot Infection (WIfI), and Rutherford classifications-into preprocedural risk stratification for patients with chronic limb-threatening ischemia (CLTI) undergoing endovascular therapy (EVT). Identifying high MAC or SAD scores as independent predictors of poor outcomes underscores the need for personalized treatment planning. Clinicians can use these scores to guide EVT candidacy, optimize revascularization strategies, and anticipate wound healing and amputation risks. This evidence supports a shift toward more tailored, data-driven management approaches in high-risk CLTI populations, potentially improving limb salvage and patient outcomes in everyday vascular practice.

Purpose: To delineate the strategic approach of the renal branches x-crossing technique in enhancing endovascular treatment of thoracoabdominal (TAAA) and pararenal aortic aneurysms (PAA) using off-the-shelf T-Branch endograft.

Technique: A 72-year-old woman treated with urgent branched endovascular aneurysm repair (BEVAR) because of symptomatic type II thoracoabdominal aortic aneurysm (TAAA). The patient presented complex iliac and renal anatomy, with both renal arteries (RAAs) in upward takeoff, making cannulation from the respective renal branches impossible. In this case, the renal branches x-crossing technique was adopted to address that challenge, and after the deployment of the T-Branch, the cannulation of each renal artery (RA) became from the opposite renal branch, using an axillary access. To get better accommodation in RAAs, we used a self-expandable stent graft on both sides. This technique integrates procedural maneuvers and graft accommodations to ensure effective cannulation, especially in hostile renal artery configurations.

Conclusion: The renal branches' x-crossing technique using a T-Branch endograft seems to be feasible and allows better cannulation of hostile RAAs.Clinical ImpactTo outline the strategic approach of the renal branches x-crossing technique, improving the complex endovascular treatment in hostile aortic morphology using an off-the-shelf T-Branch endograft.

Purpose: To report a rare entity and its management that occurred at our facility: delayed traumatic aortocaval fistula with resultant cardiac, renal, and lower limbs symptoms.

Case report: A 25-year-old man with history of gunshot injury and abdominal exploration 7 years ago presented with signs of congestive heart failure, high pulse pressure, right lower limb edema, and audible bruit with felt thrill with dilated veins in the anterior abdominal wall and groin. After full physical examination and imaging studies, computed tomographic angiography confirmed the diagnosis of distal aortocaval fistula, and treatment was endovascular fistula repair using covered endovascular reconstruction of aortic bifurcation (CERAB) technique. Treatment outcome was satisfactory with significant improvement of cardiac, abdominal, and peripheral manifestations 10 days after the procedure.

Conclusion: This case demonstrates that endovascular management of distal aortocaval fistulas using CERAB technique is safe and effective.Clincal ImpactThis is the first reported case of delayed post traumatic Aorti-caval fistula has been managed using covered endovascular reconstruction of aortic bifurcation technique.

Objective: Three-dimensional models are increasingly used to facilitate the positioning of fenestrations on a physician-modified endograft (PMEG) during the fenestrated endovascular aortic repair (FEVAR) of complex abdominal aortic aneurysms (CAAA). The punch card technique was developed to eliminate the 3D printing workflow while preserving the benefits of having a 3D model. The objective of the current study is to evaluate the performance of the purpose-built software EndoDraft compared to manual punch card design.

Methods: An experimental study was performed to compare software-assisted and manual punch card creation. Fenestration data of readily available procedural plans were used for patients who underwent elective FEVAR for CAAA from May 2023 to September 2024. Time needed to complete punch card planning was recorded as well as inaccuracies of the manual technique were evaluated by measuring the vertical and circumferential position of the fenestrations on the punch card.

Results: A total of 76 punch cards and 288 fenestrations were made based on 38 patients' fenestration data. Preparation time was 233.0 ± 40.3 seconds for the manual group, whereas 63.2 ± 21.5 seconds for the software-aided group (p<0.001). Longitudinal imprecision of the manual punch card was 0.8 ± 0.6 mm for the celiac axis (CA), 1.0 ± 0.6 mm for the superior mesenteric artery (SMA), 0.8 ± 0.5 mm for the right renal artery (RRen), whereas 1.0 ± 0.6 mm for the left renal artery (LRen). Circumferential errors of the same fenestrations were 0.4 ± 0.4 mm for the CA, 0.4 ± 0.4 mm for the SMA, 0.6 ± 0.5 mm for the RRen, and 0.5 ± 0.4 mm for the LRen. No significant difference between the completion time recorded at the beginning and at the end of the software's learning curve was detected (77.8 ± 29.4 s vs 55.8 ± 18.5 s, p=0.15).

Conclusions: The software-assisted design of the punch card is associated with higher precision and a vast improvement in speed compared to the manual technique during PMEG planning for the endovascular treatment of CAAAs. The purpose-built EndoDraft tool was made freely available in an online repository offering a more streamlined workflow.Clinical ImpactEndoDraft® could meaningfully streamline the PMEG-FEVAR workflow by replacing manual punch-card drafting with rapid, software-generated, proportionally scaled templates that are produced in about one minute rather than several minutes, while reducing the small but measurable positioning errors inherent to hand drawing. For clinicians, this means a more reproducible planning step, less cognitive load and "ruler time" during preparation, and a workflow that is easier to standardize across operators with a short learning curve. The key innovation is purpose-built automation with integrated 2D/virtual 3D visualization and direct PDF output, made freely available to support wider adoption.

Purpose: The aim of this study was to evaluate the feasibility and mid-term results of combining polytetrafluoroethylene (PTFE)-based iliac limbs, having a short dilator tip, with a polyester (Dacron)-based bifurcated component during a fenestrated endovascular aortic repair (FEVAR).

Materials and methods: All patients who underwent a FEVAR procedure in a single tertiary center were screened for inclusion in the study. Data were collected retrospectively and all imaging was reviewed for the study. The criterion for inclusion in the study was the implantation of a PTFE-based iliac limb endoprosthesis at the contralateral side of the polyester-based bifurcated component during a FEVAR procedure landing in a native common iliac artery. The primary study endpoints were technical success, adverse events, and reinterventions related to limbs, migration between contralateral iliac limbs and bifurcated components, type Ib and IIIa endoleaks, and iliac limb patency.

Results: A total of 30 patients with a median age of 77 (70, 79) years, who underwent FEVAR procedures from June 2020 to July 2023, were included in the study. The total number of target vessels was 116, and the majority (N = 24) of patients received 4 fenestrations. Technical success was achieved for the iliac limb in all patients, and for the FEVAR, it was obtained in 29 cases (97%). Median follow-up was 24 (12, 30) months. There were no clinical limb-related adverse events or reinterventions. At the end of the follow-up period, all limbs remained patent. The median absolute and percentual change in overlap between the limb and the cuff of the bifurcated endograft was of -0.1 mm (-0.8, 1.1) and -0.4% (-2.7, 4), respectively. The estimated primary, secondary clinical success of the FEVAR, and survival rates (± standard error) at 2 years were 86 ±7%, 90±6, and 83±7%, respectively.

Conclusions: The present study demonstrated promising mid-term outcomes, with the absence of limb-related adverse events, reinterventions, and any significant change in the overlap of PTFE iliac limbs combined with polyester bifurcated device during FEVAR. Further validation in a larger cohort as well as comparative analysis between different component combinations are needed to confirm the findings of the present study.Clinical ImpactThis study underscores the feasibility and excellent mid-term clinical outcomes of combining PTFE-based iliac limbs with a short dilator tip and a polyester-based bifurcated component during fenestrated endovascular aortic repair. The absence of significant migration and adverse effects related to the iliac limbs, along with the lack of target vessel occlusions, suggests a potential advantage of using a delivery system that avoids crossing the fenestrations, thereby enhancing technical success and ensuring stable and durable results over time.

Background: Pedal medial arterial calcification (pMAC) has been reported as a predictor of poor clinical outcomes in patients with chronic limb-threatening ischemia (CLTI). However, the impact of pMAC in patients with CLTI undergoing endovascular therapy (EVT) for inframalleolar (IM) lesions has not been investigated.

Methods: We retrospectively analyzed 365 patients with CLTI and tissue loss undergoing EVT to IM lesions between April 2010 and December 2020. Pedal medial arterial calcification in foot arteries was assessed radiologically using dorsoplantar and lateral views. The pMAC score was determined as the sum of the presence of pMAC at the following sites: (1) dorsalis pedis, (2) lateral plantar, (3) first metatarsal, (4) first toe, and (5) other toe arteries. The severity of pMAC was classified into 3 groups: no pMAC (0-1 point), moderate pMAC (2-3 points), and severe pMAC (4-5 points). The primary outcome was the 1-year cumulative incidence of wound healing, analyzed using the Kaplan-Meier analysis. Predictors of wound healing were explored using a Cox regression model.

Results: One-year cumulative incidences of wound healing were 68.1%, 39.2%, and 36.7% in patients with no, moderate, and severe pMAC, respectively (log-rank p<0.001). In multivariate analysis, serum albumin < 3.0 g/dL (hazard ratio [HR] = 0.58; 95% confidence interval [CI] = 0.40, 0.86; p=0.006) and severity of pMAC (HR=0.68; 95% CI=0.52, 0.88; p=0.004, per 1-grade increase) were identified as independent predictors of wound healing.

Conclusion: Pedal medial arterial calcification was significantly associated with wound healing in CLTI patients undergoing EVT for IM lesions.Clinical ImpactThe results of this study indicated that pedal medial arterial calcification (pMAC) was significantly associated with wound healing and major amputation in patients with chronic limb-threatening ischemia (CLTI) who underwent EVT for IM lesions. As pMAC can be assessed using only radiography, it may serve as a practical tool for risk stratification prior to revascularization procedures, aiding in treatment decisions based on wound severity. For cases with severe wounds, timely decisions regarding major amputation or a transition to palliative care may be warranted. In contrast, for cases with less severe wounds, early initiation of adjunctive therapies or intensive foot care should be considered.

Purpose: This report describes endovascular treatment of saccular portal and splenic vein pseudoaneurysms using n-butyl-2-cyanoacrylate (nBCA) with balloon assistance.

Case report: The first case was a 39-year-old female who developed a gastric ulcer after undergoing living-donor liver transplantation (LDLT) due to liver failure following surgery for congenital biliary atresia. Two saccular pseudoaneurysms were developed in the main trunk of the splenic vein, caused by the gastric ulcer, and protruded into the stomach. The second case was a 43-year-old male who presented with a saccular pseudoaneurysm in the main portal vein after LDLT. Because these pseudoaneurysms caused severe hemorrhage in both cases, endovascular treatments were performed via the transhepatic approach in the first case and via the ileocolic approach in the second case. Each pseudoaneurysm was successfully packed with 50% nBCA under balloon-assisted flow control, while preserving the parent veins.

Conclusion: Balloon-assisted nBCA filling of saccular portal venous system pseudoaneurysms is an effective endovascular treatment that can preserve blood flow in parent veins. This technique could become a treatment option, especially when surgery or stent graft placement is difficult for clinical or technical reasons or due to limited stent availability.Clinical ImpactThis report presents an alternative endovascular method for embolizing portal venous system pseudoaneurysms while preserving parent veins. This approach, consisting of nBCA filling with balloon-assisted flow control, offers an alternative to stent graft or covered stent placement. Balloon-assisted nBCA filling can become a viable treatment option for saccular portal venous system pseudoaneurysms, particularly when surgery or stent graft placement is difficult for clinical or technical reasons, or due to limited stent availability.

Objective: Physician-modified endografts (PMEGs) are increasingly used for urgent or off-label repair of complex abdominal aortic aneurysms (AAAs) when custom-made devices are unavailable. A key technical step in PMEG preparation is reloading of the modified stent graft into its original delivery system. Aortic valve stent crimpers have recently been repurposed to assist in reloading, but direct comparisons are lacking with the traditional tourniquet technique. This study aims to compare the efficiency and reliability of tourniquet- and crimper-assisted reloading in a controlled benchtop setting.

Methods: Eighteen reloading procedures were performed using a Medtronic Valiant 38×200 mm thoracic stent graft, with 9 per technique. Trained operators conducted the reloading under standardized conditions. The primary outcome was reloading time. The secondary endpoints included the infolding potential following deployment in simulated aortic models with oversizing conditions of 21%, 34%, and 42%. Postdeployment morphology was assessed by computed tomography (CT) imaging and reviewed by a blinded observer. Continuous data were analyzed using the Mann-Whitney U test and categorical data by Fisher's exact test.

Results: The crimper technique significantly reduced the reloading time compared with the tourniquet method (median 3.98 minutes, interquartile range [IQR=3.27-5.23] vs 11.48 minutes [IQR=8.82-17.35]; p=0.001). No infolding was observed in any of the 18 deployed grafts across all oversizing subgroups. Inadvertent proximal clasp release complicated the tourniquet technique (n=3), while this issue was absent with the crimper (n=0, p=0.206). Device integrity was preserved throughout, although the delivery system required replacement once after repeated reuse.

Conclusion: This benchtop study demonstrates that the crimper technique provides a faster and more consistent alternative to the traditional tourniquet method for PMEG stent graft reloading. The use of an aortic valve crimper may enhance standardization and workflow efficiency, without infolding.Clinical ImpactIn this bench-top comparison of PMEG reloading techniques, a repurposed aortic valve stent crimper outperformed the traditional tourniquet method by reducing reloading time, without an increase in graft infolding. The improved efficiency associated with the crimper technique highlight its potential value as a standardized approach to PMEG preparation, particularly in time-critical scenarios.

Objective: Physician-modified endografts (PMEGs) are widely accepted as a viable option in the urgent management of patients with complex abdominal aortic aneurysms (CAAAs). While PMEGs have emerged as the predominant repair modality for CAAAs in the United States, their acceptance in Europe remains limited-particularly in the context of elective repair. The aim of this study was to present the initial experience with elective cases at pioneering European centers offering this treatment.

Methods: This is a retrospective observational study based on an international multicenter registry (REgistry of MOdified Treo endografts in Europe-REMOTE). Data were collected from 4 European centers on patients who underwent elective PMEG repair using the Treo device for CAAAs between August 2023 and February 2025. Demographic characteristics, clinical status, procedural details and follow-up data were recorded. Primary outcomes included technical success, overall and aortic-related mortality, and adverse events.

Results: Twenty-eight patients (20 males; mean age 76.3±6.8 years) underwent elective PMEG repair with the Treo device. Most procedures incorporated at least 3 target vessels (68.3%). The average time required for device modification was 47.4±20.3 minutes. Technical success was achieved in 96.4% of cases. The single technical failure was associated with a lost accessory renal artery, with no acute kidney injury occurred nor endoleak observed. There were no in-hospital deaths or major adverse events. At short-term follow-up (mean 5.9±4.8 months), overall mortality was 3.6% (n=1, non-aortic-related). Freedom from reintervention was 92.9% (n=26). Aneurysm sac shrinkage was observed in 25% of patients (n=7), with the remainder showing stability. Primary and secondary target vessel patency rates were both 98.8% (n=81), with one renal stent occlusion noted on follow-up imaging.

Conclusion: This multicenter retrospective observational study demonstrated that elective PMEG repair of CAAAs using the Treo device is associated with a high-technical-success rate and a low incidence of clinical complications, supporting the safety and feasibility of this approach in the elective setting.Clinical ImpactREMOTE provides a multicentre European snapshot of elective PMEG-FEVAR on a single abdominal platform (Treo), showing high technical success with major clinical complications being uncommon, supporting feasibility in the elective setting. This could change practice by enabling experienced centres to offer a structured elective PMEG pathway and reduce decision-to-operation time from the 1-4 months often seen with CMD logistics to days (or even hours), thereby lowering interval-rupture risk and patient anxiety. For clinicians, this means a more predictable workflow that can shorten the learning curve and broaden access where CMD availability/cost is limiting.