Journal of Endovascular Therapy最新文献

Objective: This study was performed to evaluate the anatomical feasibility of the off-the-shelf G-Branch device (Lifetech Scientific, Shenzhen, China) for the endovascular treatment of thoracoabdominal aortic aneurysms (TAAAs).

Methods: Digital computed tomography angiograms were analyzed in 171 consecutive patients with TAAAs who enrolled for imaging screening in a national multicentre clinical trial to evaluate the feasibility of the G-Branch system between November 12, 2021 and June 25, 2023. Anatomical feasibility was assessed based on the investigational protocols and the instructions for use (IFUs).

Results: According to the standard, conservative, and liberal IFU criteria, the overall feasibility of the G-Branch system was 74.9% (128/171), 59.1% (101/171), and 80.7% (138/171), respectively. The top 3 factors limiting feasibility by the standard IFU criteria were a stenosed or occlusive renal artery (19/171), an accessory renal artery with a diameter of ≥3 mm (15/171), and a renal artery landing zone of <15 mm (14/171).

Conclusions: The G-Branch system demonstrates favorable feasibility for the endovascular treatment of TAAAs, particularly with the aid of other endovascular techniques. The main limitations were stenosed or occlusive renovisceral arteries and accessory renal arteries.Clinical ImpactThe G-Branch system's high anatomical feasibility, especially with the aid of other endovascular techniques, has the potential to change clinical practice in the treatment of thoracoabdominal aortic aneurysms (TAAAs). For clinicians, it offers a more viable off-the-shelf option that can be applied to a large proportion of TAAA patients, expanding the scope of endovascular treatment and providing a more convenient and efficient alternative to traditional open surgery. The innovation behind this study lies in the comprehensive evaluation of the G-Branch system's anatomical feasibility based on a large sample size from a national multicentre clinical trial, which provides valuable insights into its clinical application and helps identify the main limitations that need to be addressed in future device development and clinical practice.

Objective: To investigate whether there was a difference in the rate of binary restenosis at 36 months post-endovascular treatment between procedures guided by addition of intravascular ultrasound (IVUS) guidance and procedures guided by angiography alone.

Materials and methods: This was a prospective single-center trial of 150 patients undergoing femoropopliteal endovascular intervention, randomized (1:1) to a control group (guidance by angiography) or treatment group (guidance by IVUS and angiography). Follow-up of outcome measures was up to 36 months. The primary outcome measure was freedom from binary restenosis as defined by a peak systolic velocity ratio ≥ 2.4 on duplex ultrasound. Secondary outcomes included clinically-directed target lesion revascularization (cdTLR) and major adverse events (MAEs). Analysis of binary restenosis and directed target lesion revascularization by treatment subgroup was also performed.

Results: Freedom from binary restenosis up to 36 months post-procedure was significantly higher in the treatment group (IVUS and angiographic guidance) (48.8% vs 34.7%, p=0.011). There was no difference between the groups in freedom from cdTLR (66.7% vs 64.9%, p=0.697) or MAEs (40.5% vs 32.9%, p=0.397). Freedom from binary restenosis was higher in the treatment group for cases treated with drug-coated balloons (68.2% vs 47.5%, p=0.005).

Conclusions: Guidance with combined IVUS and angiography resulted in a higher proportion of cases remaining free of binary restenosis at 36 months compared with cases guided by angiography alone but no difference was seen between the groups for cdTLR.

Clinical trials registry: ACTRN12614000006640Clinical ImpactThis randomised controlled trial comparing 3 year outcomes for femoropopliteal endovascular procedures guided either by angiography or by angiography and intravascular ultrasound (IVUS) found that the binary restenosis rates was lower when IVUS guidance was included. This represents the longest duration prospective evidence supporting the use of IVUS. The long-term clinical benefit of IVUS are less clear as there was no difference in target lesion revascularisation rates. The benefit appears to be primarily related to drug-coated balloon treatment and further studies powered specifically for this treatment are required to confirm whether clinical benefits are present.

Purpose: Endovascular treatment of aortic arch pathologies remains a significant challenge due to the anatomical complexity of the supra-aortic vessels. Traditional approaches, such as custom-made devices (CMDs) or hybrid procedures, are often limited by delayed availability, invasiveness, and long production or preparation times. Physician-modified stent-grafts (PMSGs) offer a viable alternative for high-risk emergency patients requiring urgent intervention.

Methods: This single-center study evaluated the safety and efficacy of a novel PMSG technique in 18 patients with acute aortic syndromes, including ruptured or impending rupture of aneurysms and complicated dissections. Patients were selected according to defined inclusion criteria, excluding those eligible for alternative surgical or endovascular procedures. Stent-graft modifications-including single-fenestrated and triple-fenestrated grafts-were performed on the Medtronic Valiant platform using patient-specific, sterile 3-dimensional-printed templates. Technical success, early outcomes, and medium-term follow-up data were assessed, with particular attention to neurological complications, endoleaks (EL), and survival, using serial computed tomography angiography.

Results: Early outcomes demonstrated 100% technical success (18 of 18 patients), with no deaths during the first 30-day postoperative period. Four patients experienced non-disabling strokes. One patient required surgical revision for access-site bleeding, and another developed transient spinal cord ischemia. Mid-term follow-up (median = 43 months) revealed an overall survival rate of 83%, with 3 deaths unrelated to the endovascular procedure. Endoleaks were detected in 5 patients. No cases of graft infection or migration were reported.

Conclusion: Physician-modified stent-grafts represent a feasible and effective treatment option for high-risk patients with aortic arch pathologies requiring urgent intervention. The technique enables tailored management in cases where off-the-shelf solutions or custom devices are unavailable, offering high technical success and promising mid-term durability. Further multicenter studies are warranted to confirm long-term safety and refine procedural techniques.Clinical ImpactThis study shows that physician-modified stent grafts (PMSGs) are a feasible option for high-risk patients who cannot undergo open surgery or access custom-made devices. Using 3D-printed templates improves fenestration accuracy and arterial alignment. The 100% technical success rate and absence of early mortality indicate strong short-term effectiveness. However, the off-label nature of the technique and lack of standardization require experienced teams and careful patient selection. If confirmed in larger cohorts, PMSGs could become part of emergency aortic treatment protocols and influence future device development.

We present a rare case of a 31-year-old female, gravida 7, para 3, who presented to the emergency department 2 days following an uncomplicated vaginal delivery with complaints of abdominal pain radiating to the left flank. Multiphasic computed tomography and conventional angiography subsequently confirmed the rupture of a left ovarian artery aneurysm. The patient was treated with transcatheter arterial embolization (TAE) using microcoils and was discharged from the hospital after 2 days. A review of the English literature revealed only 44 other documented cases of ovarian artery aneurysm ruptures, with most of these cases being associated with pregnancy. Transcatheter arterial embolization has emerged as the preferred treatment for pelvic hemorrhage and is as effective as surgery, while also reducing patient complications. Spontaneous rupture of an ovarian artery aneurysm should be considered in the differential diagnosis of multiparous postpartum women presenting clinically with hypotension or shock in the absence of another identifiable source of bleeding.Clinical ImpactThis article provides a detailed review of the pathophysiology underlying the formation and rupture of ovarian artery aneurysms, their clinical presentation, and the available treatment options, with the goal of helping physicians identify and manage this rare condition.

As the most severe manifestation of peripheral arterial disease, patients with chronic limb-threatening ischemia (CLTI) are at significant risk for adverse outcomes, such as amputation and mortality. A standard endovascular therapy for below the knee (BTK) intervention, percutaneous transluminal angioplasty (PTA), has shown high rates of restenosis and frequent re-interventions. Alternative technologies, such as drug-eluting stents (DES) and drug-coated balloons, have not consistently demonstrated superiority over PTA and have not received US regulatory approval. Esprit BTK, recently approved by the Food and Drug Administration (FDA), is a novel drug-eluting resorbable scaffold (DRS) designed for treatment of infrapopliteal artery disease in patients with CLTI. The Esprit BTK DRS has shown superior efficacy and non-inferior safety compared with PTA. This technology is an evolution of the coronary Absorb bioresorbable vascular scaffold (BVS) sought to improve upon the limitations of metallic DES. Coronary use of Absorb BVS provided both technical and clinical insights that informed the design and adaptation of bioresorbable scaffolds for infrapopliteal applications. Findings from the ABSORB coronary clinical trials and Absorb BTK studies for treating infrapopliteal atherosclerotic disease, including procedural and implantation best practices, were incorporated and implemented into the development of the Esprit BTK DRS and LIFE-BTK randomized controlled trial protocol.Clinical ImpactThe Esprit BTK drug-eluting resorbable scaffold is the first Food and Drug Administration (FDA)-approved bioresorbable device for infrapopliteal artery disease in patients with chronic limb-threatening ischemia (CLTI). In the LIFE-BTK randomized trial, it demonstrated superior efficacy and non-inferior safety versus angioplasty. Designed with thinner struts and optimized for BTK anatomy, Esprit BTK incorporates learnings from Absorb bioresorbable vascular scaffold and emphasizes intravascular imaging and procedural best practices. These innovations address clinical challenges, offering clinicians a novel, evidence-based alternative to percutaneous transluminal angioplasty with the potential to improve long-term outcomes in patients with CLTI.

We report a technique to preserve the internal iliac artery (IIA) using a physician-modified contralateral limb (PMCL) with an inner branch stent-graft (IBS) for patients with common iliac artery aneurysms not suitable for commercially-available iliac branch devices (cIBDs). A fenestration was created in the tapered or 13 mm segment of an Endurant II contralateral limb, and an IBS-2 mm larger in diameter than the fenestration-was inserted and deployed with 15-20 mm inside the PMCL and 5 mm externally. The IBS was fixed at three points in parallel to the limb. A preloaded wire was inserted, and the system reloaded and implanted. Two patients were treated using this method, with the IIA stent-graft deployed into the superior gluteal artery. One had a fenestration in the tapered segment, the other in the 13 mm segment. Follow-up computed tomography showed no endoleaks and satisfactory pelvic perfusion in both cases, with no complications. This technique maintains pelvic and lower extremity blood flow, ensures graft stability, and allows future endovascular reintervention. It may be a valuable alternative for patients for whom cIBDs are not indicated.Clinical ImpactPreserving the internal iliac artery is essential, but maintaining adequate lower-extremity perfusion during treatment of common iliac artery aneurysms is equally important. Our physician-modified contralateral limb with an inner branch stent-graft successfully achieved both goals in two cases. The construct also maintained its shape without deformation and resisted migration, even when additional endovascular procedures involved the inner branch stent-graft.

This case report describes a false aneurysm of the brachiocephalic artery in a 78-year-old woman who presented at our hospital with dyspnea and chest pain caused by impending rupture. The infectious aneurysm was strongly suspected. Brachiocephalic artery aneurysms are very rare but life-threatening, and are difficult to treat especially in cases of infected false aneurysms. The treatment option performed on the patient was intended to save the patient's life, despite the risk of worsening the infection. This study indicated that the combined use of endovascular and bypass surgery is an effective strategy for the treatment of brachiocephalic false aneurysms.Clinical ImpactWe believe that our study makes a significant contribution to the literature because it describes how the treatment option of combining endovascular treatment and artificial vessel bypass surgery successfully saved the patient's life despite the risk of worsening infection. We believe that this paper will be of interest to the readership of your journal because currently there are no clear guidelines in the literature for the treatment of false aneurysms of the brachiocephalic artery, so case reports are valuable references for cardiologists.