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

Telemedicine in vascular surgery: clinical experience in a single centre.

Over a three-year period we performed 630 carotid endarterectomy procedures in 588 patients. From these we selected 90 patients (group A) who fulfilled the criteria for discharge one day after surgery. These patients were given an electronic blood pressure meter, a video phone for use at home and an antihypertensive drug (amlodipine). Using web-based video conferencing, we monitored the patients every 4 hours for the first two days. The other 498 patients (group B) were discharged on the second postoperative day. There were no significant differences between the groups in demographic characteristics, risk factors, carotid lesions, operative time, postoperative complications or blood loss. No cervical hematomas developed in group A. No patients needed to be readmitted because of major complications relating to the carotid endarterectomy. During the video-communication, 28 patients (31%) with a hypertensive crisis were treated by administration of amlodipine. At discharge, a questionnaire showed that there was a feeling of insecurity in both groups: 87% in group A vs. 79% in group B (P > 0.05). In group A, insecurity decreased after the first video connection and disappeared after the 8th day postoperatively. Telemedicine appears feasible and useful in carotid endarterectomy and may have other applications in vascular surgery care

Chirurgia Carotidea: il Controllo Morfologico post-operatorio e dopo Stenting. Angiografia

Importanza ed utilizzo dell?Angiografia nel controllo intra e post-operatori

Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux

Objective: The aim of our study was to compare three different endovenous thermal ablation (EVTA) modalities in the treatment of great saphenous vein (GSV) incompetence. Methods: We performed a single-center, prospective, comparative cohort study that included consecutive patients undergoing EVTA of the GSV. Patients were treated with either segmental radiofrequency ablation (sRFA) or endovenous laser ablation (EVLA) with a 1470-nm dual radial fiber or with a 1470-nm jacket-tip fiber. The clinical classification CEAP (clinical, etiologic, anatomic, pathophysiologic), 10-cm visual analog scale scores for pain, Venous Clinical Severity Scores (VCSSs), and chronic venous insufficiency quality-of-life questionnaire (CIVIQ-20) scores were recorded. The primary outcome was clinical success, which was defined as the absence of reflux or recanalization of the GSV and procedure-related complications, assessed at 7 and 30 days and 1 year postoperatively. The secondary outcomes were the assessment of postoperative pain using the VAS and improvement in the VCSSs and CIVIQ-20 scores. Results: A total of 153 patients (160 limbs) had undergone sRFA (sRFA group; n = 53 limbs), 1470-nm radial fiber EVLA (EVLA-R group; n = 55 limbs), or 1470-nm jacket-tip fiber EVLA (EVLA-J group; n = 52 limbs). The patient demographics, CEAP clinical class, and intraoperative details were comparable among the three groups. The GSV occlusion rate at 1 year was 93% in the sRFA group, 93% in the EVLA-R group, and 95% in the EVLA-J group. No major complications were observed postoperatively. Endothermal heat-induced thrombosis was observed in 2 (4.4%), 1 (2.2%), and 2 (4.4%) patients in the sRFA, EVLA-R, and EVLA-J groups, respectively (P >.5). The VCSS showed greater improvement in the EVLA-R group at 1 week compared with that in the sRFA (P =.05) and EVLA-J (P =.002) groups. Changes in the CIVIQ-20 score were in favor of the EVLA-R group at 7 days (−14.3 ± 10.3 vs −7.9 ± 5.9; adjusted difference, 6.06; 95% confidence interval [CI], 1.57-10.55; P =.01) and 30 days (−12 ± 8 vs −11.2 ± 7; adjusted difference, 5.5; 95% CI, 1.21-9.81; P =.02) postoperatively compared with the sRFA group and at 7 days compared with the EVLA-J group (−14.3 ± 10.3 vs −9.6 ± 7.9; adjusted difference, −4.4; 95% CI, −9.06 to 0.22; P =.05). Analyzing the different components of the CIVIQ-20, pain, and physical scores showed a greater reduction in the EVLA-R group in the early postoperative period compared with that in the sRFA and EVLA-J groups. Conclusions: All three EVTA modalities showed equal effectiveness and safety for the treatment of GSV reflux. EVLA with the 1470-nm radial fiber showed better outcomes in terms of early postoperative VCSSs and pain and physical CIVIQ scores. The clinical and quality of life benefits were similar for all modalities at 1 year postoperatively. © 2020 Society for Vascular Surger

Role of interactive home telemedicine for early and protected discharge 1 day after carotid endarterectomy.

Our aim was to prove the feasibility and safety of a protocol for early and protected discharge 1 day after carotid endarterectomy (CEA) using a system of telemedicine (TMD) monitoring. Among 147 patients operated upon for 163 CEAs, we selected a group (A) of 36 patients fulfilling criteria for discharge 1 day after surgery. An electronic blood pressure manometer, a videophone, an antihypertensive drug (amlodipine), and a customer satisfaction questionnaire were given to every group A patient. With a video-communication program linked to the Web, we monitored every 4 hours (from 8:00 a.m. to 8:00 p.m.) for 2 days the surgical wound, blood pressure, and heart frequency of the patients. Other patients were included in group B. No differences regarding demographic characteristics, risk factors, carotid lesions, operative time, postoperative complications, or blood loss were noted between group A and group B. Twenty-one patients in group A were actually discharged 1 day after surgery. No cervical hematoma developed. Three hypertensive crises were treated successfully in group A. From the questionnaire a feeling of insecurity at discharge emerged, but it rapidly resolved. The overall cost of video connections was 25.39 +/- 0.25 Euros per patient. CEA can be safely done as 1-day surgery using a TMD monitoring system in selected cases. Our protocol allowed early discharge safely, leading to reduced hospital cost

Large Diameter (≥29 mm) Proximal Aortic Necks Are Associated with Increased Complication Rates after Endovascular Repair for Abdominal Aortic Aneurysm

Background: The aim of this study is to investigate the impact of proximal aortic diameter on outcome after endovascular aneurysm repair (EVAR) of infrarenal abdominal aortic aneurysms (AAAs). Methods: This is a case–control (1:1) retrospective analysis of prospectively collected data on 732 AAA patients treated with EVAR in 2 university centers. Patients with an infrarenal neck diameter of 29–32 mm (wide neck, WN group) were compared with patients with a neck diameter of 26–28.9 mm (control group) matched for age, gender, and maximum aneurysmal sac diameter. Any patients treated outside the instructions for use of each endograft or with no adequate follow-up were excluded. The primary end point was any neck-related adverse event (a composite of type Ia endoleak, neck-related secondary intervention, and endograft migration) during follow-up. Results: Sixty-four patients with a proximal neck diameter of 29–32 mm (WN group) were compared with a matched control group of 64 patients with a neck diameter of 26–28.9 mm (control group). Oversizing was significantly higher in the study group (17.9% vs. 15.5%, P = 0.001). Overall median available follow-up was 24 months (range 12–84) (WN group 24 months vs. control group 18.5 months, P = 0.943). Primary end point was recorded in 8 patients (12.5%) of the WN group and in 1 patient (1.6%) of the control group. Freedom from the primary end point at 36 months (standard error 29 mm was the only independent risk factor for neck-related adverse events (odds ratio 7.4, 95% confidence interval 1.2–47.1). Conclusions: EVAR in the presence of a wide proximal aortic neck is likely to be associated with higher adverse neck-related event rates and thus, in such cases closer follow-up may be required. © 2019 Elsevier Inc

Prospective comparative study evaluating the role of flavonoids after endovenous thermal ablation

Objectives: The aim of our study was to evaluate the role of flavonoids in the improvement of post-operative symptoms after endovenous thermal ablation (EVTA). Methods: A prospective comparative study of 120 consecutive patients undergoing EVTA of the greater saphenous vein associated with phlebectomies was undertaken. Patients were grouped in those receiving micronized purified flavonoid fraction (MPFF- 60 patients) agent 500 mg Bid 7 days pre- and 30 days post- operatively (MPFF group) and those in the control group (60 patients) who did not. Demographics, intra-operative details, Clinical –Etiology- Anatomy- Pathophysiology (CEAP) clinical class, 10-cm Visual Analog Scale (VAS) for pain, Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CΙVIQ-20) were recorded. Primary outcome was the postoperative pain assessement using the VAS scale and CIVIQ pain score. Secondary outcomes included assessement of VCSS and CΙVIQ-20 scores. Results: There were no significant differences between the groups regarding demographics, clinical and procedural characteristics. Patients in MPFF group reported significantly lower VAS pain levels than control group at 7- (−3.6 ± 1.2 vs −2.7 ± 1.9, p <.0001) and 30- post-operative day (−4.9 ± 0.1 vs −4.2 ± 1, p <.0001). MPFF group also showed better outcome in terms of CIVIQ pain score at 7- (−3.7 ± 1.3 vs −3.5 ± 1.8, p =.008) and 30- post-operative day (−5.3. ± 1.1 vs −4.4 ± 1, p =.017). Both groups showed a significant improvement in VAS pain score (p =.047), global CIVIQ-20 (p =.009) and VCSS (p =.008) at 7- and 30-days post-operatively. Conclusions: Administration of flavonoids in patients undergoing EVTA associated with phlebectomies reduces pain by a small amount during early postoperative period. © The Author(s) 2021