Journal of Endovascular Therapy最新文献

Introduction: This is a descriptive study analyzing all surgically treated complex aneurysm patients in a tertiary referral center, during a 15-year time period in which complex endovascular aortic repair (complex EVAR) was introduced alongside open surgical repair (OSR). The goal was to present the real-world clinical profiles and surgical outcomes of complex (thoraco-)abdominal aneurysm patients, based on the current decision-making process.

Methods: Patients undergoing OSR and complex EVAR between January 2008 and August 2023 were retrospectively included. The reasoning behind each treatment decision was analyzed. Both groups were described in terms of baseline characteristics and outcomes. A subanalysis was made for the frailest complex EVAR patients, considered unfit for OSR.

Results: As of 2008, 112 patients underwent OSR, whereas 119 patients underwent complex EVAR since 2013. When both modalities were considered opportune, the patient's preference toward complex EVAR was often decisive in shared decision-making. Based on the current selection process, 47 patients were considered too frail for OSR. Complex EVAR patients had a higher Charlson Comorbidity Index (3.0 [IQR: 2.0,4.0] vs 4.0 [3.0, 5.0], p=0.002). More complications occurred after OSR (31.3% vs 18.5%, p=0.027), while reinterventions were more common after complex EVAR (20.2% vs 8.0%, p=0.008). The 47 frailest complex EVAR patients had a lower median survival time and high 1-year mortality of 23.8%.

Conclusion: Although less invasive compared to OSR regarding complications, complex EVAR still comes with considerable risks. For some frailest patients, complex EVAR might be a bridge too far. Specific insights in patient selection are warranted.Clinical ImpactWith the introduction of complex EVAR, more complex aneurysms were treated, in an overall frailer patient cohort. The frailest complex EVAR patients had a high 1-year mortality and a significantly lower mean survival compared to fit complex EVAR patients and patients undergoing OSR. The current selection process seems effective in recognizing the frailest patients and assigning them to complex EVAR, as guidelines propose. However, it might not yet be able to select patients that would benefit more from conservative non-surgical management. Specific insights in patient selection are warranted.

Objective: To report 1-year outcomes of real-world clinical data from patients with de novo or restenotic iliac artery lesions treated with the GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface (VSX) device.

Methods: Devices were implanted to treat de novo atherosclerotic or restenotic iliac artery lesions. The primary endpoint was freedom from device-related serious adverse events (SAEs) at 1 year. Additional endpoints included descriptive analyses and Kaplan-Meier estimates of primary patency, primary-assisted patency, and secondary patency; freedom from major amputation, freedom from target lesion revascularization (fTLR); and changes in Rutherford classification and the Ankle Brachial Index (ABI).

Results: The 100 patients were treated, mean age 66.9 years and 75.0% male, had a mean (±SD) lesion length of 102±60.9 mm and 62.2% were chronic total occlusions; 70.6% were classified as Trans-Atlantic Inter-Society Consensus Document (TASC) C/D, and 20 lesions were across the inguinal ligament. Maximum stenosis was 88.6±17.9%. Technical success was 100%. At 1 year, there were no device-related deaths, 97.8% of patients were free from device-related SAEs, and 99.0% were free from major amputations. Estimates of lesion primary patency, primary-assisted patency, and secondary patency were 95.0% (confidence interval [CI]=87.1, 98.1), 96.3% (CI=89.0, 98.8), and 97.4% (CI=90.1, 99.4), respectively; fTLR was 96.2% (CI=90.1, 98.5). Patients with restenotic lesions and patients <60 years old had lower primary patency, primary-assisted patency, and fTLR rates. Change from baseline to 1 year in the mean ABI was 0.56±0.17 to 0.88±0.15. The rate of asymptomatic patients (Rutherford 0) was 1.0% at baseline and 63.2% at 1 year; patients with intermittent claudication decreased from 52.0% to 35.1%, and critical limb-threatening ischemia from 37.0% to 1.8%.

Conclusions: The European registry 1-year outcomes demonstrated the safety and effectiveness of the VSX device in the treatment of iliac lesions evidenced by high patency, no device-related deaths, and low numbers of major amputation and reintervention procedures.Clinical ImpactThe European registry reflecting a 'real-world' setting of patients treated with the GORE^® VIABAHN^® Endoprosthesis with PROPATEN Bioactive Surface for aortoiliac occlusive disease demonstrated that the self-expanding covered stent was a safe and effective treatment option. At 1 year, 83% of patients had no-to-minimal pain and discomfort and 77% of patients rated no-to-slight mobility impairment issues (5Q-5D-5L assessment). There were no device-related deaths, only 1 amputation, and few reintervention procedures. This study revealed that patients younger than 60 years old or those treated for restenosis had greater risk for target lesion revascularization, device- or limb-related serious adverse events.

Introduction and objectives: Thoracic penetrating aortic ulcers are an infrequent, but potentially serious entity, and its treatment is still controversial. This study presents the long-term results of the endovascular treatment for penetrating ulcers of the thoracic aorta.

Methods: Between 1998 and 2023, 42 patients diagnosed with thoracic penetrating aortic ulcers were treated with endografts at a tertiary care hospital. Preoperative, intraoperative, and follow-up complications and mortality data were collected and analyzed. Survival rates during follow-up were estimated using Kaplan-Meier curves.

Results: Treatment was indicated for symptomatic cases in 14 patients (33.3%), most of whom presented with thoracic or dorsal pain, 1 with distal embolization, and 2 with aortic rupture. Standard thoracic endografts were used in 38 cases (90%), while branched/scalloped and/or fenestrated endografts were employed in 4 cases, with an average of 1.2 endografts per patient. Eight cases (19%) required prior revascularization of supra-aortic trunks. Technical success was 100%, with no intraoperative deaths or open conversions. In-hospital medical complications occurred in 16.6% of patients, and the 30-day cumulative mortality rate was 4.7%. After a mean follow-up of 71.7 months (range: 0.1-283 months), the endoleak rate was 19% and the cumulative 5-year reintervention-free survival rate was 80.6%. The overall survival rates at 1, 5, and 10 years were 87.4%, 77.5%, and 60.5%, respectively.

Conclusions: Endovascular treatment for penetrating ulcers of the thoracic aorta demonstrates favorable short and long-term outcomes, with high technical success and low aorta/procedure related mortality.Clinical ImpactThis study reinforces TEVAR as a safe and effective first-line therapy for penetrating aortic ulcers, offering clinicians strong long-term data to support decision-making in a high-risk, elderly population. The findings underscore that most PAUs can be treated with limited aortic coverage and minimal adjunctive procedures, reducing procedural complexity and morbidity. The extended follow-up-among the longest reported-highlights durable aortic exclusion, while emphasizing the importance of lifelong imaging due to endoleak-related reinterventions.

Background: Transradial arterial access (TRA) using 5 French (5F) devices is a new option to manage percutaneous aorto-iliac interventions, potentially reducing the rate of vascular complications and the length of hospital stay. However, evidence is limited on the efficacy and safety of this approach. The aim of our study was to assess the feasibility, efficacy and safety of TRA 5F approach, using Micro device portfolio by Qualimed, for the treatment of aorto-iliac artery lesions up to 12-month follow-up.

Methods: This is a single-center, all-comers, observational registry in which 60 consecutive patients undergoing transradial angioplasty due to aorto-iliac steno-occlusive disease were prospectively enrolled from April 2022 to September 2024. We assessed: procedural success of angioplasty using at least 1 TRA (primary efficacy outcome); primary patency at 12 months; length of hospital stay (secondary efficacy outcomes); freedom from major adverse events (MAEs) (primary safety outcome); and freedom from access-related vascular complications (secondary safety outcome).

Results: Procedural success of aorto-iliac angioplasty using at least one 5F transradial access was achieved in 58 of 60 patients (96.7%). In 66.7% of the cases, an additional transfemoral approach was required, whereas in 2 of 60 patients an unplanned switch from radial to femoral access occurred. Primary patency was 95.0%, since 3 patients underwent target vessel revascularization due to restenosis/thrombosis. Mean hospital stay was 2 days. As for safety, no MAEs were reported. Freedom from (radial) access-related vascular complications was 100% during index hospital stay and 88.3% after12-month follow-up, since 7 radial occlusions occurred.

Conclusions: These 12-month findings suggest mid-term efficacy and safety of transradial aorto-iliac artery interventions using 5F Micro devices by Qualimed, even in the setting of complex lesions (ie, TASC II classification ≥ C). Larger cohorts and randomized controlled trials will be needed to confirm these results.Clinical ImpactThe study suggests that 5F transradial access for aorto-iliac interventions is a feasible and safe alternative to the traditional femoral approach. The high procedural success, absence of major adverse events, and short hospital stay support its integration into routine practice. For clinicians, this technique may reduce access-site complications and facilitate faster patient mobilization without compromising technical outcomes. The main innovation lies in the availability of a complete 5F device platform, enabling treatment of complex lesions previously unsuitable for radial access. If confirmed in larger studies, this approach may shift practice toward safer, minimally invasive endovascular strategies.

This case report entails the percutaneous retrieval of a large iliac venous stent which migrated to the right atrium after placement. In select patients, a through-and-through wire technique in combination with balloon-mounted snares can facilitate safe and effective percutaneous stent retrieval.Clinical ImpactMigration of a large venous stent to the heart can be a challenging problem to manage. While open surgical retrieval is an effective management option, it also confers significant morbidity. Percutaneous techiques have evolved to faciliate minimally-invasive stent retrieval in select patients. This case report presents a unique approach to percutaneous retrieval in its utilization of a through-and-through wire and balloon-mounted snares.