Результаты стволовой эндовенозной механо-химической облитерации при варикозной болезни

ВАРИКОЗНОЕ РАСШИРЕНИЕ ВЕН /ХИРВАРИКОЗ /ХИРВАРИКОЗНАЯ БОЛЕЗНЬ /ХИРЭНДОВЕНОЗНАЯ МЕХАНО-ХИМИЧЕСКАЯ ОБЛИТЕРАЦИЯСТВОЛОВОЙ РЕФЛЮКСЦель. Изучить отдаленные (12-месячные) результаты лечения пациентов с варикозной болезнью методом эндовенозной механо-химической облитерации устройством Flebogrif в трех сосудистых центрах. Материал и методы. Исследование основано на результатах лечения 139 пациентов с ВБ. Оперативные вмешательства выполнялись с использованием катетера Flebogrif. 123 пациента (88,5%) были оперированы по поводу несостоятельности большой подкожной вены (БПВ) с одной стороны, 6 (4,3%) – по поводу билатерального поражения БПВ, 8 (5,8%) – по поводу поражения малой подкожной вены (МПВ) и 2 (1,4%) – в связи с рефлюксом в БПВ и МПВ. Средний диаметр целевых сегментов БПВ и МПВ составил 8,2±1,3 мм и 4,2±1,2 мм соответственно (M±сигма). Контрольные осмотры пациентов осуществляли через 1, 3, 6 и 12 месяцев после операции. Результаты. Через 1 месяц после оперативного вмешательства полное закрытие просвета БПВ и МПВ было подтверждено в 132/136 (97,1%) и 10/10 (100%) случаях соответственно. Через 6 месяцев после эндовенозной механо-химической облитерации окклюзия целевого сегмента БПВ и МПВ наблюдалась у 99/111 (89,2%) и 5/6 (83,3%) пациентов соответственно. Через 12 месяцев после операции количество окклюзированных БПВ и МПВ составило 72/85 (84,7%) и 5/6 (83,3%). Ни в одном случае каких-либо серьезных тромботических и неврологических осложнений отмечено не было. Гиперпигментация кожи по ходу 137 обработанных БПВ была обнаружена в 30 (21,9%) случаях, в проекции боковых притоков – на 22 (15,2%) конечностях. Транзиторный поверхностный тромбофлебит развился на 7 из 145 (4,8%) оперированных конечностях. Экхимозы в месте пункции возникли на 26 из 145 (17,9%) нижних конечностях. Заключение. Эндовенозная механо-химическая облитерация устройством Flebogrif является безопасным и эффективным методом устранения стволового рефлюкса при варикозной болезни, сопровождается минимальным уровнем периоперационной боли и малым количеством осложнений.Objective. To study the long-term (12-months follow-up) results of endovenous mechano-chemical ablation (MOCA) with Flebogrif occlusion catheter system for varicose veins (VV) in three vascular centers. Methods. The study is based on the treatment results of 139 patients with VV. Surgeries were performed using the Flebogrif catheter. 123 patients (88.5%) were operated on for incompetence of the great saphenous vein (GSV) on the one side, 6 (4.3%) for bilateral lesions of the GSV, and 8 (5.8%) for the small saphenous vein (SSV) and 2 (1.4%) due to reflux in GSV and SSV. The average diameter of the target GSV and SSV segments was 8.2±1.3 mm and 4.2±1.2 mm, respectively (M±sigma). Control examinations of patients were carried out 1, 3, 6 and 12 months after surgery. Results. One month after the operation, the GSV was completely occluded in 132/136 (97.1%) veins and SSV completely closed in 10/10 (100%) veins. Six months after the endovenous mechano-chemical ablation, the GSV was completely occluded in 99/111 (89.2%) veins and SSV completely closed in 5/6 (83.3%) veins. 12 months after surgery, GSV and SSV occlusion rates were 72/85 (84.7%) and 5/6 (83.3%). There were no significant thrombotic and neurological complications related to the procedure. Skin hyperpigmentation was found in 30/137 GSV treated (21.9%), and along the varicose tributaries in 22 legs (15.2%). Transient superficial phlebitis was reported in 7 of 145 (4.8%) legs. Ecchymosis from the puncture site was reported in 26/145 legs (17.9%). Conclusions. Flebogrif MOCA device is safe and effective method to eliminate the truncal venous reflux for varicose veins, associated with low perioperative pain and minimal complication rate

Status Update and Interim Results from the Asymptomatic Carotid Surgery Trial-2 (ACST-2)

Objectives: ACST-2 is currently the largest trial ever conducted to compare carotid artery stenting (CAS) with carotid endarterectomy (CEA) in patients with severe asymptomatic carotid stenosis requiring revascularization. Methods: Patients are entered into ACST-2 when revascularization is felt to be clearly indicated, when CEA and CAS are both possible, but where there is substantial uncertainty as to which is most appropriate. Trial surgeons and interventionalists are expected to use their usual techniques and CE-approved devices. We report baseline characteristics and blinded combined interim results for 30-day mortality and major morbidity for 986 patients in the ongoing trial up to September 2012. Results: A total of 986 patients (687 men, 299 women), mean age 68.7 years (SD ± 8.1) were randomized equally to CEA or CAS. Most (96%) had ipsilateral stenosis of 70-99% (median 80%) with contralateral stenoses of 50-99% in 30% and contralateral occlusion in 8%. Patients were on appropriate medical treatment. For 691 patients undergoing intervention with at least 1-month follow-up and Rankin scoring at 6 months for any stroke, the overall serious cardiovascular event rate of periprocedural (within 30 days) disabling stroke, fatal myocardial infarction, and death at 30 days was 1.0%. Conclusions: Early ACST-2 results suggest contemporary carotid intervention for asymptomatic stenosis has a low risk of serious morbidity and mortality, on par with other recent trials. The trial continues to recruit, to monitor periprocedural events and all types of stroke, aiming to randomize up to 5,000 patients to determine any differential outcomes between interventions. Clinical trial: ISRCTN21144362. © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved

Second asymptomatic carotid surgery trial (ACST-2): a randomised comparison of carotid artery stenting versus carotid endarterectomy

Background: Among asymptomatic patients with severe carotid artery stenosis but no recent stroke or transient cerebral ischaemia, either carotid artery stenting (CAS) or carotid endarterectomy (CEA) can restore patency and reduce long-term stroke risks. However, from recent national registry data, each option causes about 1% procedural risk of disabling stroke or death. Comparison of their long-term protective effects requires large-scale randomised evidence. Methods: ACST-2 is an international multicentre randomised trial of CAS versus CEA among asymptomatic patients with severe stenosis thought to require intervention, interpreted with all other relevant trials. Patients were eligible if they had severe unilateral or bilateral carotid artery stenosis and both doctor and patient agreed that a carotid procedure should be undertaken, but they were substantially uncertain which one to choose. Patients were randomly allocated to CAS or CEA and followed up at 1 month and then annually, for a mean 5 years. Procedural events were those within 30 days of the intervention. Intention-to-treat analyses are provided. Analyses including procedural hazards use tabular methods. Analyses and meta-analyses of non-procedural strokes use Kaplan-Meier and log-rank methods. The trial is registered with the ISRCTN registry, ISRCTN21144362. Findings: Between Jan 15, 2008, and Dec 31, 2020, 3625 patients in 130 centres were randomly allocated, 1811 to CAS and 1814 to CEA, with good compliance, good medical therapy and a mean 5 years of follow-up. Overall, 1% had disabling stroke or death procedurally (15 allocated to CAS and 18 to CEA) and 2% had non-disabling procedural stroke (48 allocated to CAS and 29 to CEA). Kaplan-Meier estimates of 5-year non-procedural stroke were 2·5% in each group for fatal or disabling stroke, and 5·3% with CAS versus 4·5% with CEA for any stroke (rate ratio [RR] 1·16, 95% CI 0·86–1·57; p=0·33). Combining RRs for any non-procedural stroke in all CAS versus CEA trials, the RR was similar in symptomatic and asymptomatic patients (overall RR 1·11, 95% CI 0·91–1·32; p=0·21). Interpretation: Serious complications are similarly uncommon after competent CAS and CEA, and the long-term effects of these two carotid artery procedures on fatal or disabling stroke are comparable. Funding: UK Medical Research Council and Health Technology Assessment Programme

Provisional focal stenting of complex femoropopliteal lesions using the Multi-LOC multiple stent delivery system-12-month results from the LOCOMOTIVE EXTENDED study

Background: This study aimed to evaluate a Multiple Stent Delivery System for provisional focal stenting of the femoropopliteal artery. Patient and methods: The LOCOMOTIVE EXTENDED study (Multi-LOC for flOw liMiting Outcomes after plain old balloon angioplasty and/or drug-coated balloon Treatment in the infrainguinal position with the objectIVE to implant multiple stent segments) is a prospective, single-arm, multicentre observational study. The Multi-LOC Multiple Stent Delivery System (B.Braun, Melsungen, Germany) was used for provisional focal stenting of the femoropopliteal artery. We enrolled 357 patients with 449 femoropopliteal lesions; all had flow-limiting dissections or recoil following angioplasty. Eligibility included Rutherford classification 2 to 5 with a de novo or non-stented restenotic femoropopliteal lesion undergoing plain balloon or drug-coated balloon angioplasty. The 6- A nd 12-month efficacy endpoints encompassed target lesion revascularisation and primary patency rates. Results: The mean patient age was 71 ± 10 years. The mean lesion length was 16.0 ± 9.7 cm; 44.5% were TASC II C/D lesions and 31.4% were chronic total occlusions. By operator choice, 45% of the patients underwent drugcoated balloon angioplasty. On average, 4.0 stents (each 13 mm long) were placed in each lesion, resulting in a scaffolding proportion of 56% of the total lesion length with a technical success rate of 98.3%. At 6 and 12 months, the freedom from clinically driven target lesion revascularisation was 95.5% and 88.7% and the primary patency rates were 88.7% and 82.3%, respectively. At 12 months, significant improvements were noted in Rutherford categories and ankle-brachial indices. In multiple regression analyses, both diabetes mellitus and no distal run-off vessel showed a trend toward worse TLR, while other factors such as DCB predilation or the lesion length were not predictive. Conclusions: The LOCOMOTIVE EXTENDED study demonstrated the safety and efficacy of the Multi-LOC stent system for focal provisional stenting of complex femoropopliteal lesions

Benefits and drawbacks of statins and non-statin lipid lowering agents in carotid artery disease

International guidelines strongly recommend statins alone or in combination with other lipid-lowering agents to lower low-density lipoprotein cholesterol (LDL-C) levels for patients with asymptomatic/symptomatic carotid stenosis (AsxCS/SCS). Lowering LDL-C levels is associated with significant reductions in transient ischemic attack, stroke, cardiovascular (CV) event and death rates. The aim of this multi-disciplinary overview is to summarize the benefits and risks associated with lowering LDL-C with statins or non-statin medications for Asx/SCS patients. The cerebrovascular and CV beneficial effects associated with statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statin lipid-lowering agents (e.g. fibrates, ezetimibe) are reviewed. The use of statins and PCSK9 inhibitors is associated with several beneficial effects for Asx/SCS patients, including carotid plaque stabilization and reduction of stroke rates. Ezetimibe and fibrates are associated with smaller reductions in stroke rates. The side-effects resulting from statin and PCSK9 inhibitor use are also highlighted. The benefits associated with lowering LDL-C with statins or non-statin lipid lowering agents (e.g. PCSK9 inhibitors) outweigh the risks and potential side-effects. Irrespective of their LDL-C levels, all Asx/SCS patients should receive high-dose statin treatment±ezetimibe or PCSK9 inhibitors for reduction not only of LDL-C levels, but also of stroke, cardiovascular mortality and coronary event rates. © 2022 Elsevier Inc

Benefits and drawbacks of statins and non-statin lipid lowering agents in carotid artery disease

International guidelines strongly recommend statins alone or in combination with other lipid-lowering agents to lower low-density lipoprotein cholesterol (LDL-C) levels for patients with asymptomatic/symptomatic carotid stenosis (AsxCS/SCS). Lowering LDL-C levels is associated with significant reductions in transient ischemic attack, stroke, cardiovascular (CV) event and death rates. The aim of this multi-disciplinary overview is to summarize the benefits and risks associated with lowering LDL-C with statins or non-statin medications for Asx/SCS patients. The cerebrovascular and CV beneficial effects associated with statins, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and other non-statin lipid-lowering agents (e.g. fibrates, ezetimibe) are reviewed. The use of statins and PCSK9 inhibitors is associated with several beneficial effects for Asx/SCS patients, including carotid plaque stabilization and reduction of stroke rates. Ezetimibe and fibrates are associated with smaller reductions in stroke rates. The side-effects resulting from statin and PCSK9 inhibitor use are also highlighted. The benefits associated with lowering LDL-C with statins or non-statin lipid lowering agents (e.g. PCSK9 inhibitors) outweigh the risks and potential side-effects. Irrespective of their LDL-C levels, all Asx/SCS patients should receive high-dose statin treatment±ezetimibe or PCSK9 inhibitors for reduction not only of LDL-C levels, but also of stroke, cardiovascular mortality and coronary event rates

Comparison of Recent Practice Guidelines for the Management of Patients With Asymptomatic Carotid Stenosis

Despite the publication of several national/international guidelines, the optimal management of patients with asymptomatic carotid stenosis (AsxCS) remains controversial. This article compares 3 recently released guidelines (the 2020 German-Austrian, the 2021 European Stroke Organization [ESO], and the 2021 Society for Vascular Surgery [SVS] guidelines) vs the 2017 European Society for Vascular Surgery (ESVS) guidelines regarding the optimal management of AsxCS patients. The 2017 ESVS guidelines defined specific imaging/clinical parameters that may identify patient subgroups at high future stroke risk and recommended that carotid endarterectomy (CEA) should or carotid artery stenting (CAS) may be considered for these individuals. The 2020 German-Austrian guidelines provided similar recommendations with the 2017 ESVS Guidelines. The 2021 ESO Guidelines also recommended CEA for AsxCS patients at high risk for stroke on best medical treatment (BMT), but recommended against routine use of CAS in these patients. Finally, the SVS guidelines provided a strong recommendation for CEA+BMT vs BMT alone for low-surgical risk patients with >70% AsxCS. Thus, the ESVS, German-Austrian, and ESO guidelines concurred that all AsxCS patients should receive risk factor modification and BMT, but CEA should or CAS may also be considered for certain AsxCS patient subgroups at high risk for future ipsilateral ischemic stroke

Comparison of Recent Practice Guidelines for the Management of Patients With Asymptomatic Carotid Stenosis

Despite the publication of several national/international guidelines, the optimal management of patients with asymptomatic carotid stenosis (AsxCS) remains controversial. This article compares 3 recently released guidelines (the 2020 German-Austrian, the 2021 European Stroke Organization [ESO], and the 2021 Society for Vascular Surgery [SVS] guidelines) vs the 2017 European Society for Vascular Surgery (ESVS) guidelines regarding the optimal management of AsxCS patients. The 2017 ESVS guidelines defined specific imaging/clinical parameters that may identify patient subgroups at high future stroke risk and recommended that carotid endarterectomy (CEA) should or carotid artery stenting (CAS) may be considered for these individuals. The 2020 German-Austrian guidelines provided similar recommendations with the 2017 ESVS Guidelines. The 2021 ESO Guidelines also recommended CEA for AsxCS patients at high risk for stroke on best medical treatment (BMT), but recommended against routine use of CAS in these patients. Finally, the SVS guidelines provided a strong recommendation for CEA+BMT vs BMT alone for low-surgical risk patients with >70% AsxCS. Thus, the ESVS, German-Austrian, and ESO guidelines concurred that all AsxCS patients should receive risk factor modification and BMT, but CEA should or CAS may also be considered for certain AsxCS patient subgroups at high risk for future ipsilateral ischemic stroke