Journal of Endovascular Therapy最新文献

Purpose: The purpose of this study was to assess the impact of oversizing in thoracic endovascular aortic repair (TEVAR) on early and long-term survival and major adverse events in patients with uncomplicated type B aortic dissection (TBAD).

Methods: Between January 2010 and December 2018, 226 patients who were diagnosed with uncomplicated TBAD and received TEVAR were analyzed retrospectively. The patients were divided into ≤5% oversizing (n=153) and >5% oversizing (n=73) groups. Primary end points were all-cause and aortic-related mortalities. Secondary end points were procedure-related complications, including retrograde type A aortic dissection (RTAD), endoleak, distal stent-induced new entry (SINE), and late reintervention. All-cause and aortic-related mortalities were assessed using the Kaplan-Meier survival method, while procedure-related complications were evaluated using a competing risk model with all-cause death as a competing risk.

Results: Mean oversizing was 2.1%±1.5% in the ≤5% oversizing group and 9.6%±4.1% in the >5% oversizing group. Differences in the 30-day mortality and adverse events between the 2 groups were statistically insignificant. The freedom from all-cause mortality was comparable between the ≤5% oversizing group and the >5% oversizing group (≤5%: 93.3% at 5 years, >5%: 92.3% at 5 years, p=0.957). No significant difference was observed between both groups in the freedom from aortic-related mortality (≤5%: 95.0% at 5 years, >5%: 96.7% at 5 years, p=0.928). However, the competing risk analyses revealed that the cumulative incidence of RTAD was statistically significantly greater in the >5% oversizing group than in the ≤5% oversizing group (≤5%: 1(0.7%) at 5 years, >5%: 6(6.9%) at 5 years, p=0.007). All RTADs occurred within a year of TEVAR. The differences in the cumulative incidences of type I endoleak, distal SINE, and late reintervention were not significant between the 2 groups.

Conclusion: The differences in the 5-year all-cause mortality and aortic-related mortality between patients with uncomplicated TBAD who received TEVAR with ≤5% oversizing and those who got TEVAR with >5% oversizing were insignificant. However, oversizing >5% was considerably associated with an increased risk of RTAD within a year of TEVAR, suggesting that oversizing ≤5% may be the appropriate size for TEVAR in patients with uncomplicated TBAD.

Clinical impact: For patients with uncomplicated TBAD, choosing oversizing ≤5% in endovascular treatment is beneficial to reduce the risk of postoperative retrograde type A aortic dissection. This finding provides a basis for stent size selection in endovascular repair. In addition, one year after TEVAR is the main time period for postoperative retrograde type A aortic dissection, and attention should be paid to the management and follow-up of this period.

Purpose: Carotid artery stenting (CAS) is an effective and minimally invasive method for the treatment of extracranial carotid artery stenosis. The aim of the present study was to explore independent risk factors to predict cerebrovascular events following CAS to identify high-risk patients and improve the safety of CAS in this population.

Materials and methods: HISPANIAS is a national prospective multicenter study that included 14 hospitals that collected data from patients who underwent CAS. We analyzed morbidity and mortality within 30 days after CAS, looking for factors that might be associated with cerebrovascular events (stroke and transient ischemic attack [TIA]).

Results: The HISPANIAS cohort included 757 patients: 80.32% were men, the mean age was 70.73 years, and 82.96% underwent symptomatic CAS. Cerebrovascular complications occurred in 42 patients (5.6%), including TIA in 24 patients (70.8% ipsilateral; mean 2.79 days after CAS) and stroke in 18 patients (72.2% ipsilateral; mean 6.72 days after CAS). The main independent clinical predictors of stroke/TIA identified by logistic regression were female sex (odds ratio [OR] 2.29, 95% CI 1.15-4.54) and diabetes (OR 3.29, 95% CI 1.71-6.40). Survival analysis showed that diabetic women, compared with the rest of the patients, had a higher number of events concentrated mainly in the first days after the intervention (p=0.003).

Conclusion: Cerebrovascular ischemic complications after CAS continue to be a challenge for the management of these patients. Although there are other factors, female sex and the presence of diabetes are emerging as strong risk factors for the development of complications after symptomatic CAS.

Clinical impact: Carotid artery stenting (CAS) is an effective and minimally invasive method for the treatment of extracranial carotid artery stenosis. Although CAS has been regarded as a reliable and safety approach, some studies reported that CAS was associated with a higher risk of procedure-related stroke. Cerebrovascular complications after CAS continue to be a main problem and a challenge for the management of these patients. Therefore, it is essential to identify the factors involved in the development of these complications. Our study shows that the combination of female sex and diabetes is associated with a clearly worse outcome, with a greater number of events concentrated mainly in the first days. This is different from other studies that have explored each factor separately. It would be interesting to perform separate interventions for this group given the increased risk of complications.

Introduction: The treatment of chronic postdissection aneurysms of the aortic arch is a challenge. This study aims to describe false lumen management after aortic arch endovascular repair of post-type A dissection aneurysms treated with a branched endograft.

Methods: In this single-center retrospective observational study, all consecutive patients undergoing endovascular treatment of aneurysmal degeneration of chronic type A aortic dissections following open repair were enrolled. The primary endpoint was maximal aortic diameter evolution measured on computed tomography angiography (CTA) performed during follow-up. Secondary endpoints included procedural success, aortic re intervention, and remodeling during follow-up.

Results: Between January 2017 and June 2020, 22 patients underwent endovascular branched arch repair for post type A dissection aneurysms. Technical success was 100%. Thirteen patients (59%) had dissection involvement of at least 1 supra-aortic vessel. Midterm follow-up CTA was performed for 20 patients, 23.1 (±13.3) months after the procedure. Maximal aortic diameter at the level of the repair was decreasing in 13 (65%) patients, increasing in 2 (10%) patients, and no change was observed in 5 (25%) patients. During follow-up, 7 patients (35%) required aortic reintervention. Thoracic candy plugs were implanted for distal false lumen occlusion in 15 patients and associated with a high rate of complete remodeling (6/15 patients, 40%).

Conclusion: Arch branch endografting of aneurysmal evolution of a post type A dissection aortic arch is a safe and feasible option in experienced hands. Candy plug use in favorable anatomies seems to be associated with accelerated remodeling of the aorta.

Clinical impact: There are currently no recommendations on dissected supra- aortic vessels management and the use of thoracic aorta false lumen occlusion devices during endovascular repair of chronic post dissection aneurysm of the aortic arch with branched endografts. Based on our clinical experience reported in the current manuscript, we propose a treatment algorithm for the management of the false lumen in this setting.

Purpose: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery.

Materials and methods: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data.

Results: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I²=60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I²=0%), dissection 3.1% (95% CI: 1.3%-7.3%, I²=0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I²=0%), infection <1% (95% CI: 0%-5.7%, I²=20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I²=0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013).

Conclusions: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications.

Clinical impact: Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site.

Purpose: The Provisional Extension to Induce Complete Attachment Technique (PETTICOAT) uses a bare-metal stent to scaffold the true lumen in patients with acute or subacute aortic dissections. While it is designed to facilitate remodeling, some patients with chronic post-dissection thoracoabdominal aortic aneurysms (TAAAs) require repair. This study describes the technical pitfalls of fenestrated-branched endovascular aortic repair (FB-EVAR) in patients who underwent prior PETTICOAT repair.

Technique: We report 3 patients with extent II TAAAs who had prior bare-metal dissection stents treated by FB-EVAR. Two patients required maneuvers to reroute the aortic guidewire, which was initially placed in-between stent struts. This was recognized before the deployment of the fenestrated-branched device. A third patient had difficult advancement of the celiac bridging stent due to a conflict of the tip of the stent delivery system into one of the stent struts, requiring to redo catheterization and pre-stenting with a balloon-expandable stent. There were no mortalities and target-related events after a follow-up of 12 to 27 months.

Conclusion: FB-EVAR following the PETTICOAT is infrequent, but technical difficulties should be recognized to prevent complications from the inadvertent deployment of the fenestrated-branched stent-graft component in-between stent struts.

Clinical impact: The present study highlights a few maneuvers to prevent or overcome possible complications during endovascular repair of chronic post-dissection thoracoabdominal aortic aneurysm following PETTICOAT. The main problem to be recognized is the placement of the aortic wire beyond one of the struts of the existing bare-metal stent. Moreover, encroachment of catheters or the bridging stent delivery system into the stent struts may potentially cause difficulties.

Objective: Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR.

Methods: A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR.

Results: A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups.

Conclusion: Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease.

Clinical impact: Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.

Purpose: To evaluate the safety and efficacy of Innospring^® stent, a novel self-expanding interwoven nitinol stent, in treating femoropopliteal atherosclerotic lesions.

Methods: A prospective, single-center, single-arm, first-in-human study enrolled 15 patients (mean age 73.1 years; 13 men) to evaluate the safety and efficacy of the Innospring^® stent monitored by core laboratories. The inclusion criteria were claudication or ischemic rest pain, de novo lesions or nonstented restenosis, >70% stenosis, lesion length <20 cm, and a reference vessel diameter of 4-7 mm. The primary safety endpoint was 30-day major adverse events. The primary efficacy end point was stent patency at 12 months. Follow-up evaluations were conducted at 30 days, 6 months, and 12 months.

Results: The lesion length was 6.1 ± 3.5 mm. Fourteen (93.3%) patients had lesions of the superficial femoral artery and 3 (20.0%) patients had lesions of the popliteal artery. Nine (60.0%) patients had moderate-to-severe calcified lesion. Technical and procedural success was 100%. No patients experienced major adverse events in the first 30 days. The Rutherford category showed significant and sustained improvement at 6 and 12 months. The 12-month follow-up radiographs obtained in 13 patients confirmed the absence of stent fractures in 100% of examinations. The cumulative primary stent patency rate at 6 and 12 months were 93.3% and 84.6%, respectively.

Conclusion: Stenting of the superficial femoral and popliteal arteries using the Innospring^® stent is safe and effective. This competing interwoven nitinol stent may provide superior stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.

Clinical impact: Endovascular recanalization is a widely accepted and recommended treatment for symptomatic peripheral artery diseases. The Innospring® stent is a novel self-expanding interwoven stent containing eight nitinol wires with additional radial force, fracture-resistance, and visibility under fluoroscopy. This first-in-human study using the Innospring® stent in patients with femoropopliteal occlusive disease reported that stenting of the superficial femoral and popliteal arteries using the Innospring® stent is safe and effective. This competing interwoven nitinol stent may provide an impressive stent integrity and fracture-resistance as well as serve areas under extreme mechanical stress.