Prospective multicentre study of carotid artery stenting using the MER™ Stent - the OCEANUS study - 30-day and one-year follow-up results.

INTRODUCTION: Constant technological progress in the field of carotid stenting translates into improved short- and long-term results of endovascular treatment. The introduction of a new generation, self-expanding, open-cell stent has provided a new treatment option in endovascular management of carotid stenosis. AIM: To evaluate 30-day and 1-year clinical outcomes of non-consecutive patients with high risk of carotid endarterectomy, who underwent 5F cylinder-tapered MER™ open-cell carotid stent implantation. MATERIAL AND METHODS: It was a single-arm, prospective study conducted in four experienced catheterisation centres. The use of embolic protection devices was mandatory. The primary endpoint was stroke in 30-day follow-up. The secondary endpoints were 30-day and 1-year cumulative incidence of death, stroke and myocardial infarction, 1-year target vessel revascularisation, procedural success (residual stenosis ≤ 30%), restenosis rate (%DS ≥ 50%), and Serious Adverse Device Effect (SADE) rate in 1-year follow-up. RESULTS: In total 100 patients were recruited for the study, with the majority being males (n = 61). The mean age was 68.3 ±8.2 years, and most of the patients were asymptomatic (n = 56). In 55 (55%) patients direct stenting was performed, with the use of proximal protection devices in 19 (19%) patients. Mean internal carotid artery/common carotid artery stenosis before and after stent implantation was 81.98 ±9.15% and 12.52 ±8.70%, respectively (p < 0.001). Procedural success was achieved in all cases. One ischaemic stroke was observed at 30 days (1%, primary endpoint). At 1-year follow-up two myocardial infarctions and three deaths occurred with no additional stroke. CONCLUSIONS: The OCEANUS study indicated the safety and efficacy of the MER™ stent during 30-day and 1-year follow-up in both symptomatic and asymptomatic patients. The majority of patients were event-free. However, larger cohort studies are needed to evaluate MER™ stents in detail.

Clinical situations requiring radial or brachial access during carotid artery stenting.

INTRODUCTION: Radial or brachial access may be preferred in the case of severe peripheral artery disease (PAD) or difficult aortic arch anatomy during carotid artery stenting (CAS). AIM: To evaluate the clinical conditions indicating potential benefit from non-femoral access as well as feasibility and safety of transradial/transbrachial access (TRA/TBA) as an alternative approach for CAS. MATERIAL AND METHODS: Since 2013, 67 patients (mean age: 70 years old, 44 men, 42% symptomatic) were selected for CAS with the TRA/TBA approach. The composite endpoint was stroke/death/myocardial infarction within 30 days of the procedure and compared to the propensity score matched transfemoral approach (TFA) group. Clinical (including neurological) examination and Doppler ultrasonography were performed before the procedure, at discharge and at 30 days. RESULTS: CAS with TRA/TBA was successful in 63/67 patients. Transfemoral access was not feasible due to PAD in 35 (52.2%) patients, bovine arch in 10 (14.9%), obesity (BMI > 35 kg/m2) in 9 (13.4%), severe degenerative disease of the spine in 7 (10.5%), arch type III in 5 (7.5%) and excessive subclavian stent protrusion in 1 (1.5%) patient. Mean NASCET carotid artery stenosis was reduced from 81% to 9% (p < 0.001). The composite endpoint occurred in 3 (4.8%) cases and it was not statistically significantly different from the matched TFA group (6.3%; p = 0.697). No access site complications requiring surgical intervention or blood transfusion developed. CONCLUSIONS: Transradial and transbrachial CAS may be an effective and safe procedure, and it may constitute a viable alternative to the femoral approach in patients with severe PAD, difficult aortic arch anatomy or obesity.

Carotid artery stenting with Roadsaver stent. Early and four-year results from a single-center registry.

INTRODUCTION: Prevention of peri- and postprocedural complications is still a challenge in carotid artery stenting (CAS). AIM: To assess immediate and long-term safety and effectiveness of CAS using the Roadsaver double-nitinol-layer-micromesh stent. MATERIAL AND METHODS: Since 2014, 298 CAS procedures in 287 non-consecutive patients (203 men, mean age 70.5 ±8.6 years, 100% symptomatic/high risk lesions) have been performed using the Roadsaver stent and proximal (40%) or distal (60%) neuroprotection system. Clinical and neurological examinations as well as duplex ultrasound were completed before CAS, before discharge, at 1, 6 and 12 months, then annually. RESULTS: All CAS procedures were successful. Carotid stenosis was reduced from 84.9 ±9.9% to 11.0 ±9.4% (p < 000.1). In hospital, 1 ipsilateral periprocedural major (0.3%) and 3 minor (1.34%) ischemic strokes occurred, 2 (0.7%) patients died due to a cerebral hemorrhage on day 9 and 21. Three (1.0%) additional ipsilateral minor strokes within 30 consecutive days occurred. Thus, 30-day complications were observed in 9 (3.0%) patients. Two minor strokes were associated with in-stent thrombosis (0.7%). The 4-year follow-up showed 82% overall survival (95% CI: 69-91%) with no significant difference between asymptomatic (77%) and symptomatic patients (97%; p = 0.076). The stroke-free survival was 89% (95% CI: 77-95%), 84% asymptomatic vs. 98% symptomatic (p = 0.187). Seven (2.3%) patients developed > 50% in-stent restenosis. CONCLUSIONS: Carotid artery stenting using the Roadsaver stent for symptomatic patients and high risk lesions showed to be safe and effective, with a low complication rate and acceptable in-stent restenosis risk in 4-year follow-up.

Comparison of drug-eluting and bare metal stents for extracranial vertebral artery stenting.

INTRODUCTION: Drug-eluting stents of the first (DES I) and second generation (DES II) proved superior to bare metal stents (BMS) in the coronary territory. However, there are limited data on whether they have any advantage over BMS in vertebral artery stenosis (VAS). AIM: To compare outcomes of DES (DES I, DES II) and BMS in the treatment of symptomatic extracranial VAS. MATERIAL AND METHODS: During 13-year study period (2003-2016), 392 consecutive patients underwent VAS angioplasty in 428 arteries, including implantation of 148 DES (DES I: 21; DES II: 127 lesions), and 280 BMS. RESULTS: The technical success rates for DES and BMS groups were 96.7% and 94.6% (p = 0.103), with similar periprocedural complication rates (1.4% vs. 2.2%; p = 0.565). VAS degree was reduced from 86 ±9.7 to 2.7 ±5.0% in DES (p < 0.001) and from 84.1 ±9.4 to 4.3 ±6.9% in BMS (p < 0.001). Angiography confirmed in-stent restenosis/occlusion (ISR/ISO) 50-99% in 53 (14.2%) and 21 (5.6%) out of 373 patients (409 arteries) with at least 6-month follow-up. ISR/ISO rates were similar in DES vs. BMS (22.8% vs. 19.4%; p = 0.635), as well as in DES I vs. DES II (6/19; 31.6% vs. 25/92; 27.2%, p = 0.325). Stainless steel (24/135; 17.8%) and cobalt-chromium (23/121;19%) BMS had significantly lower incidence of ISR/ISO, as compared to platinum-chromium (7/18; 38.9%), p = 0.034. ISR/ISO was associated with age (p = 0.01) and CRP level > 5 mg/l (p = 0.043), while greater stent length was associated with ISR only in the DES group (p = 0.024). CONCLUSIONS: Our results do not support significant differences in ISR/ISO rates between DES and BMS, although differences between particular stent types and ISR rates require further investigation.

Prevalence and predictors of coronary artery disease in patients undergoing carotid artery stenting.

INTRODUCTION: A relationship between carotid stenosis and coronary arterial disease (CAD) is widely accepted; however, data on the exact prevalence of coronary disease in patients with severe carotid stenosis are lacking. Information on the prevalence and predictors of CAD among these patients could impact diagnostic and treatment approaches. AIM: The primary aim of this study was to determine the prevalence of significant CAD among patients referred for carotid artery revascularization. The secondary objectives included characterizing the association between the level of advancement of carotid stenosis and the presence of CAD, and between atherosclerotic risk factors and the presence of CAD in patients with carotid stenosis, and also to determine whether there was a difference in the prevalence of CAD between patients with symptomatic versus asymptomatic carotid stenosis. PATIENTS AND METHODS: We included 200 patients with severe carotid stenosis, of whom 77 (38.5%) had symptomatic stenosis. All patients underwent coronary angiography no more than 6 months before the scheduled carotid revascularization. Of the 200 total of patients, 192 underwent carotid stenting, six underwent carotid endarterectomy, and two were treated conservatively. CAD was defined as stenosis of at least 50% on recent coronary angiography or a history of previous percutaneous coronary intervention and/or coronary aortic bypass graft; the prevalence was 77.5% among our patients. There was no statistically significant difference in the prevalence of CAD between patients with unilateral versus bilateral carotid stenosis or contralateral carotid occlusion. The difference in the severity of coronary disease, which was given by the SYNTAX score, was not significant between these groups. Factors associated with the presence of CAD were male sex, a history of smoking, and global or regional wall motion disorder on echocardiography. We did not find any significant difference in the prevalence of CAD between patients with symptomatic versus asymptomatic carotid stenosis. CONCLUSION: We observed a very high prevalence of concomitant CAD in patients with severe carotid stenosis. The results of our study suggest that routine preprocedural screening for CAD in patients with carotid artery stenosis could identify a large proportion of patients with silent CAD; whether treatment for CAD before carotid revascularization can prevent periprocedural myocardial infarction should be addressed in a randomized-controlled trial.

Mesh-covered (Roadsaver) stent as a new treatment modality for symptomatic or high-risk carotid stenosis.

INTRODUCTION: Prevention of periprocedural stroke has a crucial role in carotid artery stenting (CAS) procedures. AIM: To assess retrospectively 30-day safety and effectiveness of 41 procedures of internal and common carotid artery stenting using the Roadsaver double nitinol layer micromesh stent in 40 non-consecutive patients with symptomatic or high-risk carotid artery stenosis. MATERIAL AND METHODS: The patients were men (n = 31) and women (n = 9); mean age was 67.8 ±7.9 years. Femoral access was used in 39 cases, whereas radial access was used in 2. Proximal (n = 27) or distal (n = 14) embolic neuroprotection was used. RESULTS: The Roadsaver stents (nominal diameter 7, 8 or 9 mm, length 25 or 30 mm) were implanted successfully in all cases. One minor stroke occurred after common carotid artery intubation with a guiding catheter (before stent deployment) and one transient postprocedural ischemic attack (TIA) of the ipsilateral cerebral hemisphere was observed. Internal/common carotid artery stenosis severity was evaluated by duplex Doppler. Maximal peak systolic velocity (PSV) before CAS was in the range: 2.0-7.0 m/s, mean: 3.9 ±1.0 m/s, at 24-48 h after stenting mean PSV was 1.1 ±0.4 m/s (p < 0.05), and at 30 days 1.1 ±0.3 m/s (p < 0.05). Maximal end-diastolic velocity (EDV) was 0.85-3.5 m/s, mean 1.4 ±0.5 m/s, at 24-48 h after stenting mean EDV was 0.3 ±0.1 m/s (p < 0.05), and at 30 days 0.4 ±0.1 m/s (p < 0.05). No restenosis or thrombosis was observed. Angiographic stenosis decreased from 82.9 ±9.1% (range: 61-97%) to 19.3 ±7.3% (range: 0-34%) (p < 0.05). CONCLUSIONS: The CAS using the Roadsaver stent seems to be safe and effective. Further studies involving larger patient populations and longer follow-up are needed.

Simultaneous vertebral and subclavian artery stenting.

INTRODUCTION: Vertebrobasilar territory ischemia leads to disabling neurological symptoms and may be caused both by vertebral artery (VA) and subclavian artery (SA) stenosis. The coexisting symptomatic ipsilateral VA and proximal SA stenosis should be considered as a true bifurcation lesion for percutaneous treatment. AIM: To evaluate the safety and efficacy of simultaneous angioplasty of vertebral and subclavian stenosis. MATERIAL AND METHODS: Fifteen patients (age 69.5 years, 46.7% men, all symptomatic from posterior circulation (history of stroke, transient ischemic attack, chronic ischemia symptoms)) were scheduled for simultaneous SA/VA angioplasty. Clinical and duplex ultrasound follow-up was conducted 1, 6 and 12 months after the procedure. RESULTS: The technical success rate was 100%. Single balloon-mounted stent angioplasty was performed for all VAs and for 13 (86.7%) SAs. In 4 cases a simultaneous radial and femoral approach was required. The mean North American Symptomatic Carotid Endarterectomy Trial (NASCET) VA stenosis was reduced from 88.7 ±9.7% to 5.7 ±6.8% and SA stenosis from 80 ±12.2% to 11 ±12.3% (p < 0.01). No periprocedural death, stroke, myocardial infarction or transient ischemic attack occurred. During follow-up (range: 6-107 months) in 10 of 15 (66.7%) patients relief of chronic ischemic symptoms was observed. No stroke/TIA occurred. One cardiovascular and 2 non-cardiovascular deaths were recorded. There was 1 symptomatic vertebral and 1 subclavian in-stent restenosis, and 2 cases of asymptomatic VA in-stent occlusion occurred. CONCLUSIONS: Simultaneous vertebral and subclavian artery stenting is safe and effective. The restenosis rate remains at an acceptable level and it may be treated successfully with drug-eluting balloon angioplasty. In selected patients a dual radial and femoral approach may facilitate the procedure.

Transradial approach for vertebral artery stenting.

INTRODUCTUION: Symptomatic severe vertebral artery (VA) stenosis may be treated safely with stent supported angioplasty via femoral access. There is limited clinical data on transradial approach for VA angioplasty in case of peripheral artery disease. AIM: To evaluate the safety and efficacy of transradial angioplasty of symptomatic VA stenosis. MATERIAL AND METHODS: Fifteen patients (age 66 ±7.4 years, 73% men, with VA > 80% stenosis, 11 right-side, all symptomatic from posterior circulation (history of stroke, TIA, or chronic ischaemia symptoms)) with peripheral artery disease (PAD) or unsuccessful attempt via femoral approach were scheduled for VA angioplasty by radial access. Clinical and duplex ultrasound (DUS) follow-up were performed before discharge and 1, 12, and 24 months after VA angioplasty. RESULTS: The technical success rate was 100%. In all cases VA angioplasty was performed with the use of single balloon-mounted stent (9 bare metal stents, 6 drug-eluting stents). The mean NASCET VA stenosis was reduced from 85.3% to 5.3% (p < 0.001). No periprocedural death, stroke, myocardial infarction, or transient ischaemic attack occurred. During 24-months follow-up, in 12 of 15 patients chronic ischaemia symptoms release was observed, and no new acute ischaemic neurological symptoms were diagnosed in all patients. One patient died 20 months after intervention from unknown causes. There was one symptomatic borderline VA in-stent stenosis 12 months after angioplasty. CONCLUSIONS: Transradial VA stenting may be a very effective and safe procedure, and it may constitute an alternative to the femoral approach in patients with symptomatic VA stenosis.

[Anomalous right upper pulmonary venous drainage into the superior vena cava with coexistence sinus venosus atrial septal defect (ASD)]. / Nieprawidlowy splyw zyly plucnej górnej prawej do zyly glównej górnej wraz ze wspólistniejacym ubytkiem w przegrodzie miedzyprzedsionkowej o typie zatoki zylnej (ASD).

Article presents a case of a 71-year old woman with pulmonary right upper venous drainage into the superior vena cava and with coexistence sinus venous type Atrial Septal Defect (ASD) which was revealed as interesting finding in multislices computed tomography angiography during estimation of coronary arteries.

Carotid artery stenting according to the "tailored CAS" algorithm performed in the very elderly patients: the thirty day outcome.

OBJECTIVES: To assess safety and efficacy of carotid artery stenting (CAS) according to "tailored-CAS" algorithm in the elderly (≥75 years) in relation to younger patients. BACKGROUND: Although CAS has grown as an alternative to carotid endarterectomy the data on safety of CAS in the very elderly are inconsistent. MATERIAL AND METHODS: 1,139 patients with significant carotid stenosis underwent 1,252 CAS procedures in one high-volume center between years 2001-2011. CAS procedures were performed with lesion and patient dependent selection of neuroprotection type ("tailored-CAS"). There were 193 subjects ≥75-years-old (17%) and 946 <75-years-old. No major differences in atherosclerosis risk factors and comorbidities between groups were noted. In both groups the majority of patients were male (70.4% vs. 68.6%, P = NS) and half of the patients were symptomatic (50.2% vs. 55.2%, P = NS). Bilateral carotid stenosis was present in 25% of patients from CAS ≥75 group and 22% from CAS< 75 group, P = NS. Proximal neuroprotection devices use for high risk or symptomatic lesions accounted for 31% in CAS≥ 75 group and 32% in CAS<75 group, P = NS. RESULTS: In symptomatic patients aged ≥75 years 30-day stroke and death rate was 7% versus 1.9% in symptomatic patients aged <75; P = 0.01 and vs. 1.8% in asymptomatic elderly, P = 0.09. No myocardial infarcts were noted. CONCLUSIONS: Symptomatic elderly is a group of highest CAS risk and the use of "tailored CAS" algorithm does not equalize CAS risk in this patients' group. "Tailored CAS" remains a safe procedure for asymptomatic elderly as well as symptomatic and asymptomatic young patients.