CASS (CyanoAcrylate closure versus Surgical Stripping for incompetent saphenous veins) study: a randomized controlled trial comparing clinical outcomes after cyanoacrylate closure and surgical stripping for the treatment of incompetent saphenous veins

Background Several modalities are used for the treatment of varicose veins. Open surgical treatment with ligation and stripping of the saphenous vein has been the standard of care for many years. Endovenous thermal ablation has been shown to be a safe and effective alternative with high, long-term, target-vein closure rates. Despite this, there is the possibility of thermal injury to surrounding structures. The recently introduced cyanoacrylate closure is also considered to be a good alternative and the risk of injury to surrounding structures is minimal. The purpose of this study is to demonstrate the non-inferiority of cyanoacrylate closure with the VenaSeal™ closure system compared to surgical stripping in terms of clinical outcomes for the treatment of incompetent great saphenous veins. Methods/design This is an open-label, multicenter, prospective, randomized controlled trial evaluating the non-inferior clinical outcomes of cyanoacrylate closure compared to surgical stripping for the treatment of incompetent saphenous veins. After baseline measurements, participants will be randomly allocated into either the cyanoacrylate closure group or the surgical-stripping group. The primary endpoint of the study is the complete closure rate of the target vein in the cyanoacrylate closure group, and the absence of venous reflux or residual venous tissue after surgical stripping in the surgical-stripping group. These endpoints will be measured by Doppler ultrasound performed by qualified vascular technologists or investigators at 3 months after treatment. Secondary outcomes include perioperative pain, postoperative ecchymosis, clinical assessment (including general and disease-specific quality of life evaluations), complete closure rate, and absence of venous reflux or residual venous tissue at the 12- and 24-month follow-ups, as well as all adverse event rates during the 24-month follow-up period. Discussion This multicenter randomized controlled trial is designed to show non-inferiority in terms of complete closure rate of cyanoacrylate compared to surgical stripping for the treatment of incompetent saphenous veins. Trial registration Clinical Research Information Service (CRIS), ID: KCT0003203. Registered on 20 September 2018.This is an investigator-sponsored study supported by a grant from Medtronic Korea Co., Ltd

Incidence and Risk Factors of Iliac Artery Rupture during Aortoiliac Stenting

Purpose: Aortoiliac occlusive disease (AIOD) is widely prevalent and leads to severe claudication or chronic limb-threatening ischemia. Stent placement for AIOD demonstrated excellent outcomes in terms of long-term patency. However, iliac artery rupture is the most fearful complication during the aortoiliac stenting (AIS). This study aimed to evaluate the incidence and risk factors of iliac artery rupture during AIS. Materials and Methods: A retrospective review of consecutive patients with AIOD treated with AIS from 2009 to 2021 was completed. We excluded patients with instent restenosis. All types of stents, including self-expanding stent (SES), balloon-expandable stent (BES), or balloon-expandable covered stent (CS), were used. Angiographic characteristics and procedural outcomes were analyzed. Procedural success was defined as the residual stenosis <30%. Results: A total of 242 patients (86.8% male; mean age 68.8±10.0 years) with de novo AIOD were treated with AIS. The procedural success rate was 100%. Rupture occurred in six patients (2.5%) and all ruptures were occurred in the external iliac artery (EIA). Stenting of the EIA and less calcified lesion were risk factors for iliac rupture (P=0.028). All cases of iliac artery rupture were successfully treated with the CSs. Overall primary patency rates were 98.0% and 93.4% at 12 and 36 months, respectively. Primary patency rates of SES, BES, and CS were 87.7%, 88.4%, and 100% at 36 months, respectively. Conclusion: The incidence of iliac artery rupture during AIS was 2.5%. Stent placement in the less calcified lesion and EIA was a risk factor for rupture during AIS. Placement of the CS can be the straightforward solution in case of iliac artery rupture during AIS

Prevalence and Risk Factors of Abdominal Aortic Aneurysms Detected with Ultrasound in Korea and Belgium

The objective was to investigate the prevalence of abdominal aortic aneurysms (AAAs) and the diameters of the aorta and common iliac arteries (CIAs) in a Korean cohort and secondly to analyze the differences in aortic diameter by comparison with a European cohort. The Korean cohort included participants ≥ 50 years who consented to AAA screening and data were analysed retrospectively. Aortic and common iliac diameters were measured using the outer-to-outer diameter method and prevalence rates were calculated. Common risk factors such as smoking, body mass index, pulmonary disease, hypertension, diabetes, hyperlipidaemia, ischaemic heart disease, and cerebrovascular disease were reported in association with AAA occurrence and AAA development. The aortic diameters were then compared with those in a Belgian cohort of 2487 participants identified in the Liège AAA Screening Program. An aortic size index (ASI) was also calculated to account for the potential size differences in the Belgian and Korean populations. A total of 3124 Korean participants were examined using ultrasound. The prevalence of AAAs in this cohort was 0.7%. The combined prevalence of subaneurysmal dilatation and AAA was 1.5%. The prevalence in male smokers older than 65 years was 2.7% (19/715). The mean infrarenal aortic diameter was 17.3 ± 3.1 mm in men and 15.7 ± 2.7 mm in women; the corresponding values in Belgian participants were 19.4 ± 3.0 mm in men and 17.9 ± 2.4 mm in women. The median aortic size index was 0.99 (interquartile range 0.88–1.12). The mean infrarenal aortic diameter was significantly smaller in the Korean cohort than in the Belgian cohort. Considering the observed prevalence of AAAs in different age groups, the age groups which would contribute to most cases was male persons above 66 years in both cohorts

Ultrasound Elastography to Differentiate the Thrombus and Plaque in Peripheral Arterial Diseases

Purpose: Arterial stiffness and steno-occlusion of the lower-extremity can result from many vascular lesions, including acute thromboembolisms, soft plaques, calcified plaques, or inflammatory disease. Ultrasound (US) elastography measures the tissue deformation response to compression and displays tissue stiffness. This study aimed to evaluate the characteristics of arterial lesions in the lower extremities using US elastography. Materials and Methods : We retrospectively analyzed the data of 20 patients who visited our institute for arterial disease treatment between May 2016 and November 2017. An US examination with B-mode and strain elastography (SE) was performed of four different lesion types at 45 sites: acute and subacute thromboembolisms, soft plaques, calcified plaques, and thromboangiitis obliterans lesions (TAOs). During SE, stress was externally applied by the operator using the transducer. Strain ratio (SR) was calculated as the fraction of the average strain in the reference area divided by the average strain in the lesion. The SR was compared among different lesion types, with the accompanying vein as the reference region of interest. Results : The strain was highest in the soft plaques (0.63%±0.23%), followed by the TAOs (0.45%±0.11%), calcified plaques (0.44%±0.13%), and acute thromboembolisms (0.34%±0.23%), which were statistically significant (P=0.026). However, the mean SR was highest for the calcified plaques (2.33%±0.80%), followed by the TAOs (1.63%±0.40%), acute thromboembolisms (1.60%±0.48%), and soft plaques (1.51±0.39), and which were statistically significant (P=0.013). Conclusion : Despite several limitations, vascular elastography may be useful for differentiating between lesion types in peripheral arterial disease

Additional file 1: of SAFE (Sarpogrelate Anplone in Femoro-popliteal artery intervention Efficacy) study: study protocol for a randomized controlled trial

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 121 kb