Journal of Endovascular Therapy最新文献

Introduction: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions.

Materials and methods: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status.

Results: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up.

Conclusion: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease.

Clinical impact: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures.

Purpose: We aim to quantify multiaxial cardiac pulsatility-induced deformation of the thoracic aorta after ascending thoracic endovascular aortic repair (TEVAR) as a part of the GORE ARISE Early Feasibility Study.

Materials and methods: Fifteen patients (7 females and 8 males, age 73±9 years) with ascending TEVAR underwent computed tomography angiography with retrospective cardiac gating. Geometric modeling of the thoracic aorta was performed; geometric features including axial length, effective diameter, and centerline, inner surface, and outer surface curvatures were quantified for systole and diastole; and pulsatile deformations were calculated for the ascending aorta, arch, and descending aorta.

Results: From diastole to systole, the ascending endograft exhibited straightening of the centerline (0.224±0.039 to 0.217±0.039 cm^-1, p<0.05) and outer surface (0.181±0.028 to 0.177±0.029 cm^-1, p<0.05) curvatures. No significant changes were observed for inner surface curvature, diameter, or axial length in the ascending endograft. The aortic arch did not exhibit any significant deformation in axial length, diameter, or curvature. The descending aorta exhibited small but significant expansion of effective diameter from 2.59±0.46 to 2.63±0.44 cm (p<0.05).

Conclusion: Compared with the native ascending aorta (from prior literature), ascending TEVAR damps axial and bending pulsatile deformations of the ascending aorta similar to how descending TEVAR damps descending aortic deformations, while diametric deformations are damped to a greater extent. Downstream diametric and bending pulsatility of the native descending aorta was muted compared with that in patients without ascending TEVAR (from prior literature). Deformation data from this study can be used to evaluate the mechanical durability of ascending aortic devices and inform physicians about the downstream effects of ascending TEVAR to help predict remodeling and guide future interventional strategies.

Clinical impact: This study quantified local deformations of both stented ascending and native descending aortas to reveal the biomechanical impact of ascending TEVAR on the entire thoracic aorta, and reported that the ascending TEVAR muted cardiac-induced deformation of the stented ascending aorta and native descending aorta. Understanding of in vivo deformations of the stented ascending aorta, aortic arch and descending aorta can inform physicians about the downstream effects of ascending TEVAR. Notable reduction of compliance may lead to cardiac remodeling and long-term systemic complications. This is the first report which included dedicated deformation data regarding ascending aortic endograft from clinical trial.

Purpose: To describe the transaxillary branch-to-branch-to-branch carotid catheterization technique (tranaxillary 3BRA-CCE IT) for cannulation of all supra-aortic vessels using only 1 femoral and 1 axillary access during triple-branch arch repair.

Technique: After deployment of the triple-branch arch device, catheterization and bridging of the innominate artery (IA) should be performed through a right axillary access (cutdown or percutaneous). Then, the retrograde left subclavian (LSA) branch should be catheterized (if not preloaded) from a percutaneous femoral access, and a 12×90Fr sheath should be advanced to the outside of the endograft. Subsequently, catheterization of the left common carotid artery (LCCA) antegrade branch should be performed, followed by snaring of a wire in the ascending aorta which was inserted through the axillary access, creating a branch-to-branch-to-branch through-and-through guidewire. Over the axillary access, a 12×45Fr sheath should be inserted into the IA branch and looped in the ascending aorta using a push-and-pull technique so that it faces the LCCA branch, allowing for stable catheterization of the LCCA. The retrograde LSA branch should then be bridged following the standard fashion.

Conclusions: This series of 5 patients demonstrates that triple-branch arch repair can be performed with the transaxillary 3BRA-CCE IT, allowing catheterization of the supra-aortic vessels without manipulation of the carotid arteries.

Clinical impact: The transaxillary 3BRA-CCE IT allows catheterization and bridging of all supra-aortic vessels in triple-branch arch repair through only 2 vascular access points, the femoral artery and the right axillary artery. This technique avoids carotid surgical cutdown and manipulation during these procedures, reducing the risk of access site complications, including bleeding and reintervention, reintubation, cranial nerve lesions, increased operating time, and so on, and has the potential to change the current vascular access standard used during triple-branch arch repair.

Purpose: Stroke is among the leading causes of mortality and morbidity worldwide. The coexistence of bilateral carotid and vertebral artery (VA) occlusion and/or stenosis is in the very rare entity group in the literature. Here, we present a case with bilateral carotid artery occlusion and bilateral VA stenosis, who presented with an atypical clinical presentation and underwent bilateral vertebral percutaneous transluminal angioplasty (PTA) and stenting in the same session.

Case report: A 67 year old male patient was brought to the emergency department with complaints of inability to speak and weakness in both legs for 1 day. There were bilateral infarct areas in the anterior cerebral artery region and an additional infarct area in the left middle cerebral artery region. First, the right VA stenosis level was crossed using a 0.14 guidewire. After PTA, balloon-expandable stenting was performed with a 3.0×12 mm NC (non-compliant) balloon, and nearly complete recanalization was observed. Therefore, it was decided to perform an intervention on the left VA in the same session.

Conclusion: As in this example case, in cases where cerebral perfusion is severely impaired, medical treatment after recanalization may be one of the best treatment options.

Clinical impact: The carotid arteries are the main arteries supplying the anterior circulation, and the vertebral arteries supply blood to the posterior circulation. However, in cases where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system. However, in cases such as this, where both carotid arteries are occluded/dysfunctional, all cerebral perfusion remains over the vertebrobasilar system and may be responsible for anterior circulation strokes. The situation becomes more severe if both vertebral artery critical stenosis is added. Synchronous carotid and vertebral artery revascularization is not recommended in the guidelines for patients with combined carotid and vertebral artery disease. In patients with four-vessel occlusion/stenosis, as in this particular case, the intervention method and priorities are unclear. We achieved a favorable clinical outcome with simultaneous bilateral vertebral artery angioplasty and stenting, a hazardous method that can be a guide as an approach option in similar cases.

Purpose: Newer generation abdominal endografts, including Treo (Terumo Aortic, Sunrise, Florida), have shown optimal safety and effectiveness in treating abdominal aortic aneurysms (AAAs), even with hostile anatomy over the short- and mid-term. The durability of such results, however, is still a controversial issue, due to the paucity of long-term data. Our aim is to show the long-term outcomes of endovascular aortic repair of both standard and hostile AAAs with the Treo endograft on a cohort of patients treated between 2016 and 2017.

Methods: We analyzed the postoperative follow-up of 37 consecutive patients who have undergone endovascular aortic repair (EVAR) with the Treo Endograft between 2016 and 2017, whose baseline clinical conditions, operative data, and short-term outcomes had been published in 2018. All patients were followed up by computed tomography angiography (CTA) at 6 and 12 months and 5 years postoperatively. Primary endpoints were aortic-related mortality, type I-III endoleak (EL), and reintervention rate. Secondary endpoints were the rates of type II ELs and aneurysm sac regression.

Results: Of 37 patients, 27 had at least one criterion of anatomic hostility and 11 were performed outside the device-specific instructions for use (IFU). In the perioperative period, we observed 100% technical success, with no perioperative mortality. Over a mean follow-up of 5.5 years (66 months), 3 patients (8.1%) were lost to follow-up and 3 (8.1%) died of non-aortic causes (overall survival: 91.9%). One type IA EL of an AAA with a hostile neck (but within the IFU) and a type III EL of an AAA with standard anatomy were observed and treated by endovascular relining (overall reintervention rate: 5.5%). Four type II ELs were associated with aneurysm sac stability over time and are still under surveillance. Mean aneurysm shrinkage was 11.25±8.30 mm.

Conclusion: The optimal results of the Treo Endograft in terms of complication and reintervention rates reported over the mid-term by the current literature (ITA-ENDOBOOT registry) are maintained on the long term, both in case of hostile and friendly aortic anatomy, with a satisfactory shrinkage rate of the aneurysm sac.

Clinical impact: The innovative characteristics of Treo and its short-term results are well-known and reported. The present case series contributes to the scientific validation of a new-generation abdominal aortic endograft over the long-term, focusing especially on its performance in treating AAAs with hostile anatomy. Its 5-years outcomes confirm the optimal results already reported over the short- and mid-term.

Purpose: To measure the long-term proximal aortic neck dilatation (AND) after elective endovascular aortic aneurysm repair (EVAR) with a variety of contemporary, third-generation, endograft devices.

Materials and methods: This is a noninterventional prospective cohort study of 157 patients that underwent standard EVAR with self-expanding abdominal endografts. Patients' recruitment lasted from 2013 to 2017, and postoperative follow-up was up to 5 years. A computed tomography angiography (CTA) was performed at the first month and then at 1, 2, and 5 years. Proximal aortic neck's (PAN) basic morphological characteristics (diameter, length, angulation) were measured based on the analysis of CTA in a standardized fashion. Neck-related adverse events, such as migration, endoleak or rupture, and reinterventions were recorded.

Results: Significant straightening of the PAN was evident even in the first-month CTA with concurrent neck shortening that became significant at 5 years. Both the suprarenal aorta and the PAN significantly dilated overtime, with PAN dilating more progressively. Mean neck dilatation at the juxtarenal level was 0.8±0.4 mm at 1 year, 1.8±0.8 mm at 2 years, and 3.9±1.7 mm at 5 years, with a mean neck dilatation rate of 0.07 mm/month overall. The incidence of AND ≥2.5 mm was 37.2% at 2 years and 58.1% at 5 years after EVAR and was considered important (≥5 mm) in 11.5% of patients at 2 years and 30.6% of patients at 5 years. A multivariate analysis performed showed that the endograft oversizing, the preoperative neck diameter, and the preoperative abdominal aortic aneurysm sac diameter served as independent predictors of AND at 5 years. At the 5-year follow-up, 8 late type Ia endoleaks (6.5%) and 7 caudal migrations (5.6%) were identified, while no late ruptures were reported. In total, 11 late endovascular reinterventions (8.9%) were performed. Overall, proximal neck-related adverse outcomes (5/7 migrations and 5/8 endoleaks) and reinterventions (7/11) were significantly associated with the presence of important late AND.

Conclusion: Proximal AND after EVAR is common. It can influence the long-term durability of proximal endograft fixation and is significantly associated with adverse outcomes, often leading to reinterventions. A systemic and extended surveillance protocol is needed for maintenance of good long-term results.

Clinical impact: This is a thorough and systematic analysis of the long-term geometric remodeling of the proximal aortic neck after EVAR, that highlights the importance of a strict, and extended surveillance protocol for maintenance of good long-term results of EVAR.

Clinical impact: Large thoracoabdominal aortic aneurysms due to chronic aortic dissection in patients with connective tissue disorders such as Loeys-Dietz syndrome present a challenging scenario, particularly in cases of variant anatomy and when patients are not candidates for conventional open repair. We demonstrate how by combining and modifying off-the-shelf devices during a hybrid procedure, one can create an endovascular solution tailored to the patient's complex anatomy, making use of an aberrant right subclavian artery, and allow for good clinical outcomes.

Objective: To report demographics and clinical, laboratory, and imaging features of acute renal infarction (ARI) due to symptomatic isolated spontaneous renal artery dissection (SISRAD) and to analyze outcomes after the initial therapy for SISRAD.

Methods: Thirteen patients with ARI due to SISRAD between January 2016 and March 2021 were enrolled in this retrospective study. We reviewed the demographics, clinical, laboratory, and imaging features (location of the infarct kidney, the branch artery involved by dissection, true lumen stenosis, false lumen thrombosis, and aneurysm), treatment modalities, and follow-up results; analyzed the difference between SISRAD and other causes of ARI; and propose an appropriate therapy strategy for SISRAD based on our data and literature.

Result: Patients with ARI due to SISRAD were mostly young men (43 [24-53] years; 12/13 [92%]). No patients had atrial fibrillation or acute kidney injury at admission (0/13). All 13 patients received conservative treatment as the initial treatment. Sixty-two percent (8/13) of patients progressed, and 88% (7/8) of them had dissection aneurysm on the admission computed tomographic angiography (CTA) image. Seventy-five percent (6/8) of patients underwent endovascular intervention as follows, stent placement in 1 patient, renal artery embolization in 1, and stent placement with embolization in 4. Two patients with disease progression died: 1 during the conservative treatment period and 1 after the stent placement. Thirty-eight percent (5/13) of patients in remission continued to receive conservative treatment, none of whom had dissection aneurysm on the admission CTA.

Conclusion: Symptomatic isolated spontaneous renal artery dissection is a rare and fatal disease. For young ARI patients with no previous history of tumors and cardiogenic diseases, CTA examination is recommended to exclude SISRAD. Dissection aneurysm seems to be a risk of progression for SISRAD in this series. Conservative treatment, a recognized initial treatment, has a good effect on patients without dissection aneurysm, and we recommend endovascular intervention as the initial treatment for the patient with dissection aneurysm at admission. Multicenter clinical studies are needed to explore a more-appropriate treatment for patients with SISRAD.

Clinical impact: This article report the related factors, risks, demographics and laboratory data of Acute renal infarction (ARI) due to Symptomatic isolated spontaneous renal artery dissection (SISRAD) and explore a better initial therapy strategy for SISRAD. It will help improve the effectiveness of SISRAD treatment and reduce the mortality rate from this rare but lethal disease.