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Background: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature., Methods: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures., Results: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively., Conclusions: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

Objectives: The highest rate of embolization during carotid artery stenting occurs during post-dilation. We evaluated the ability of the Paladin system (Contego Medical, Raleigh, NC), a novel PTA balloon with an integrated 40-ɥm pore filter, to collect microemboli that may pass into the cerebral circulation when used during post-dilation., Methods: 25 symptomatic patients underwent transradial CAS using the Paladin system in conjunction with the Roadsaver (Terumo Corporation, Tokyo, Japan) micromesh stent. No additional embolic protection was used. The Paladin filters were collected following the procedure and preserved in formalin for histological analysis. The contents were evaluated for particle count and size. Subjects were followed for 30 days and evaluated for major cardiac adverse events (death, stroke and MI). Secondary endpoints included procedure success, device success, access site complications according to EASY score classification, major vascular or ischemic complications at follow up and in-stent restenosis rate evaluated with duplex ultrasound., Results: Mean age of patients was 68,5 years. Type 2 aortic arch was present in 77 % of patients and type 1 and type 3 in 12 % and 11 % of patients respectively. Procedural and device success was obtained in all cases without complications. The 30-day MAE rate was 0 %. Twenty-three filters underwent histological analysis. Microscopic debris was present in 100 % of filters, and 75 % of particles were less than 100ɥm in size. The mean number of particles per filter was 3352 ± 1567 (IQR 4300-2343), and the mean number of particles between 40-100ɥm per filter was 2499 ± 1240 (IQR 3227-1575)., Conclusion: CAS through radial approach can be safely and effectively performed using the IEP technology Paladin device and double-layer micromesh Roadsaver stent. This strategy can simplify the procedure and decrease peri-procedural complications and procedural time., Competing Interests: Declaration of competing interest RS reports that he has served as a consultant and advisory board member for Boston Scientific and Medtronic; has received institutional funds for research or clinical trials from Abbott Vascular, Boston Scientific, Bard Peripheral Vascular, Microvention, W.L. Gore and Associates, Medtronic, Terumo, and Veryan; and is a major shareholder of Contego Medical. ES is employed by Contego Medical. All other authors declared that they have no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background: The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS., Methods: This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without., Results: One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence., Conclusions: In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.

Aims: We aimed to evaluate the feasibility and safety of carotid artery stenting (CAS) with a newly designed double-layer micromesh stent using wrist approach in patients with significant carotid disease., Materials and Methods: Between January 2016 and December 2021, 105 patients undergoing CAS with Roadsaver™ stent were enrolled in a single center prospective study. Follow-up assessments included neurological exams, duplex ultrasound (DUS), and 12-lead ECG. The primary endpoint was the 30-day composite rate of stroke, death, and myocardial infarction. Secondary endpoints included procedure success, access site complications, device success, target lesion revascularization, and in-stent restenosis evaluated with DUS. Long-term outcomes up to 72 months of follow-up were assessed in all eligible patients., Results: The study population was predominantly male (69.5%) with a median age of 68 ± 8 years. Patients were symptomatic in 80% of the cases, and 35% fulfilled the high-risk criteria for surgical endarterectomy. The right internal carotid artery was the target artery in 56 (53.4%), and the left in 49 (46.6%) of the cases. All procedures were successfully completed from the right wrist, with right radial access in 94 (89.5%) cases and ulnar artery access with previous radial artery occlusion in 11 (10.5%) cases. All patients were treated successfully with the study device. The primary endpoint was met with a 30-day major adverse event rate of 0.9% (1/105). Up to 72 months of follow-up (median 30 ± 20 months) there were no strokes, neurological deaths, or target lesion revascularization of the treated lesion. Doppler ultrasound examination revealed nonsignificant in-stent restenosis in two asymptomatic patients. There was no hand ischemia detected in any patient., Conclusion: Results from this study demonstrate the radial and ulnar access for CAS with double layer micromesh Roadsaver™ stent is safe and feasible and associated with favorable early and long-term follow-up., (© 2022 Wiley Periodicals LLC.)

Aims: Preliminary studies suggest that direct stenting (DS) during percutaneous coronary intervention (PCI) may reduce microvascular obstruction and improve clinical outcome. Thrombus aspiration may facilitate DS. We assessed the impact of DS on clinical outcome and myocardial reperfusion and its interaction with thrombus aspiration among ST-segment elevation myocardial infarction (STEMI) patients undergoing PCI., Methods and Results: Patient-level data from the three largest randomized trials on routine manual thrombus aspiration vs. PCI only were merged. A 1:1 propensity matched population was created to compare DS and conventional stenting. Synergy between DS and thrombus aspiration was assessed with interaction P-values in the final models. In the unmatched population (n = 17 329), 32% underwent DS and 68% underwent conventional stenting. Direct stenting rates were higher in patients randomized to thrombus aspiration as compared with PCI only (41% vs. 22%; P < 0.001). Patients undergoing DS required less contrast (162 mL vs. 172 mL; P < 0.001) and had shorter fluoroscopy time (11.1 min vs. 13.3 min; P < 0.001). After propensity matching (n = 10 944), no significant differences were seen between DS and conventional stenting with respect to 30-day cardiovascular death [1.7% vs. 1.9%; hazard ratio 0.88, 95% confidence interval (CI) 0.55-1.41; P = 0.60; Pinteraction = 0.96) and 30-day stroke or transient ischaemic attack (0.6% vs. 0.4%; odds ratio 1.02; 95% CI 0.14-7.54; P = 0.99; Pinteraction = 0.81). One-year results were similar. No significant differences were seen in electrocardiographic and angiographic myocardial reperfusion measures., Conclusion: Direct stenting rates were higher in patients randomized to thrombus aspiration. Clinical outcomes and myocardial reperfusion measures did not differ significantly between DS and conventional stenting and there was no interaction with thrombus aspiration.

Percutaneous treatment of subclavian artery stenosis or occlusion has become more popular compared with surgical correction. We compared the early and late results of subclavian artery stenting with bilateral or single transradial access. From 2010 to 2015, we recruited 54 consecutive patients. In 35 cases, we used bilateral access, and in 19 cases, ipsilateral single access was used. Left subclavian artery was the culprit vessel in 72% of cases. There were more chronic total occlusions in the bilateral group (77% vs 21%, p = 0.0001). Transradial-only approach was used in all cases, except in 2 cases in the bilateral group where crossover to femoral access was required. Stents were implanted in 94% in bilateral group and 84% in single group (p = 0.47). Procedure duration (40 [35 to 60] vs 20 [15 to 30] minutes), contrast volume (200 [200 to 350] vs 150 [100 to 200] ml and fluoroscopy time (20 [12 to 30] vs 8 [4 to 11] minutes) were higher in bilateral group (all p values <0.0001). Procedural success was 96%. Overall, we observed three <5-cm hematomas and 3 asymptomatic radial artery occlusions at hospital discharge. After successful procedure, blood pressure equalized in 94% in bilateral group and 100% in single group (p = 0.54). Major cardiovascular and cerebrovascular event-free survival up to 5 years was 97% in bilateral group compared with 84% in single group (p = 0.12). Subclavian artery patency at late follow-up was 91% in bilateral group and 95% in single group (p = 1.00). Using single or bilateral transradial approach, subclavian artery lesions or occlusions can be effectively and safely treated without the risks of femoral or brachial access., (Copyright © 2016 Elsevier Inc. All rights reserved.)

We aimed to evaluate the feasibility and safety of performing percutaneous carotid stent implantation with a newly designed double-layer stent using transradial slender 5Fr techniques. We recruited 10 consecutive patients who underwent percutaneous carotid stenting using nitinol double-layer micromesh (Roadsaver) stents. Mean age of patients was 66 years. Seven patients had ≥2 high-risk criteria according to SAPPHIRE classification. Indication was neurologic symptoms in 7 and severe lesion without symptoms in 3 cases. Type 2 aortic arch was present in 8 patients and type 1 in 2 patients. Access was right radial artery in 9 cases and right ulnar artery in 1 case. Right carotid artery was stented in 4 cases and left carotid artery in 6 cases. Embolic protection device (EPD) was used in 6 cases. Nine stents were successfully delivered using 5Fr destination sheath (n = 7) or shuttle sheath (n = 2), and 1 was implanted using Mo-Ma 8Fr proximal EPD. Procedural success was obtained in all cases with only 1 case of temporary vasospasm due to distal EPD. Total procedural time was 21 minutes (13 to 30 minutes) with filter time of 5 ± 1 minutes. Fluoroscopy time was 8 minutes (5 to 12 minutes) and contrast volume was 150 ml (100 to 200 ml). Hospital stay was 1 ± 1 day with 4 patients discharged on the same day of the procedure. Using right transradial approach and slender 5Fr techniques, this new double-layer micromesh stent can be implanted in left and right carotid arteries with promising results., (Copyright © 2015 Elsevier Inc. All rights reserved.)

With recent advancement in percutaneous endovascular interventions, angioplasty and stenting of axillary artery lesions could become the treatment of choice vs. surgical intervention owing to its lower complication and mortality rates and shorter hospital stay.We report a Caucasian female case with axillary artery chronic total occlusion (CTO) with dual etiology (atherosclerotic and radiation induced), which was successfully managed with stent angioplasty. The strategy used was right radial retrograde approach with contralateral injections from left radial catheter. Two year follow-up revealed widely patent axillary stents.

The transradial approach (TRA) for treatment of aortoiliac occlusive disease (AIOD) is nowdays a more common approach than several years ago. This is due to less post-procedural bleeding complications and its impact on mortality. The main reason for the growing interest in the TRA is because of the safety profile of this access. Peripheral arterial disease (PAD) is a growing phenomenon. It is a common circulatory problem in which narrowed arteries reduce blood flow to lower extremities due to atherosclerotic arterial lesions. According to the Trans Atlantic Inter-Society Consensus on the Management of Peripheral Arterial Disease (TASC II), an endovascular approach is recommended in type A and B lesions, and an open surgical approach for type C and D lesions. The aim of the study is to put the accent on the advantages of the transradial approach (TRA) versus the transfemoral approach (TFA), its safety and efficacy in treating peripheral arterial disease (PAD) even in type C and D lesions, in well and properly selected patients on whom it may be performed, and to evaluate the outcomes of transradial iliac stenting (TRAIS), attempting to increase the demand for the new devices and tools for its treatment. These improvements will exclude some disadvantages and limitations of TRA in the field of endovascular peripheral interventions (distance from the puncture site to the lesion location, bigger support, thinner devices). Despite difficult lesions, TASC C/D, the overall primary procedural and technical success rate was 100%. The ankle brachial index (ABI) significantly improved from a mean of 0.46 to 0.90 and 0.94 on the six months follow-up. Angiographic estimated residual stenosis was 0%. No minor or major complications (haematoma, distal emboli, vessel dissection, rupture, death) were documented. The primary patency rate was 100% for the iliac and for the SFA. The secondary patency rate after 6 months follow-up was also 100%. Transradial access might be recommended as the first-choice vascular access site for interventions on the iliac, and even proximal femoral territories. This technique is still limited by the lack of adequate equipment. This issue should be overcome in the future.

Background: Carotid artery stenting (CAS) is an alternative to carotid endarterectomy (CEA) for revascularization of the internal carotid artery (ICA). CAS from the femoral approach may be problematic due to peripheral vascular disease, anatomical variations of the aortic arch, and access site complications. The purpose of this study was to evaluate the right radial approach (RRA) for CAS., Methods: A retrospective analysis of all patients who had undergone transradial (TR) CAS at two centers was performed. Demographics, the technique used to deploy the sheath in the common carotid, procedural details, results, and complications were evaluated., Results: CAS was attempted from TR in 382 patients (mean age 68, 70% male). CAS was successful in 347/382 (91%) patients; 201/216 (93%) right CA, 14/16 (88%) bovine left CA, 132/150 (88%) left CA. The specific technique varied with the anatomy. Seven different carotid artery stents (51% Xact) and seven different distal embolic protection devices were used. Adverse events included two major strokes (0.6%) one of whom died, three minor strokes (1%), and no myocardial infarction at 30 days. No bleeding complications occurred although 23 (6%) of patients had asymptomatic postprocedure radial occlusion. Inadequate catheter support at the origin of the CCA was the technical cause of failure in the unsuccessful cases which were then completed from femoral access as part of the same procedure., Conclusion: The transradial approach is an alternative for CAS in the presence of factors that increase the risk or difficulty of femoral access., (Copyright © 2012 Wiley Periodicals, Inc.)

Unlabelled: The increasing use of stenting to treat more complex lesions and highly thrombogenic situations still carries higher risk for subacute stent thrombosis. To assess new heparin-coated stents in a more stringent reality, 40 consecutive patients were randomized in 1:1 ratio to receive either heparin-coated (group 1, 25 stents) or uncoated Palmaz-Schatz stents (group 2, 32 stents). The two groups were similar in baseline clinical, pre-and post-procedural angiographic and angioscopic characteristics. High pressure stent deployment without intravascular ultrasound guidance was used. All pts received antiplatelet agents alone. We applied serial angioscopy (baseline and on 7th day) to evaluate thrombus formation and quantitative coronary angiography (QCA) to define late (6 months, n=39, 100% the eligible pts) neointimal regrowth. There was one subacute stent thrombosis with subsequent acute myocardial infarction and death in the uncoated group., Conclusion: The implantation of heparin-coated stents in nonselected population is well tolerated and associated with no clinical or angioscopic evidence of new thrombus formation, resulting in favorable long-term clinical and angiographic outcome.