OBJECTIVE: The aim of this study was to assess the effectiveness of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence at 3 and 5 years, building on preliminary results that show...OBJECTIVE: The aim of this study was to assess the effectiveness of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence at 3 and 5 years, building on preliminary results that showed feasibility, safety, and high occlusion rates at 1 year follow up. METHODS: Sixty patients who underwent MOCA for SSV incompetence at a single centre between January 2017 and December 2019 were included. Clinical and radiological data were reviewed retrospectively from a prospectively maintained database. Primary endpoints were SSV recanalisation and re-intervention at 3 and 5 years. Additional outcome measures included Venous Clinical Severity Score (VCSS), quality of life (QoL) using the Aberdeen Varicose Vein Questionnaire (AVVQ) and the visual analogue scale to assess pain during long term follow up, and signs and symptoms of chronic venous disease. Uni- and multivariable analyses were performed to identify risk factors for SSV recanalisation. RESULTS: Fifty patients completed the full 5 year follow up. Freedom from recanalisation was 84.7% at 3 years and 66.5% at 5 years. Freedom from re-intervention at the same time points was 86.7% and 72.6%, respectively. Although the VCSS and AVVQ scores decreased during the first year, a progressive increase was observed over the follow up period. The median VCSS increased significantly at 3 and 5 years. The AVVQ score increased from a median (interquartile range [IQR]) of 5.0 (IQR 3.0, 7.0) at 1 year to 8.2 (IQR 5.0, 11.0) at 3 years and 10.1 (IQR 6.0, 14.0) at 5 years (p < .001). Multivariable analysis identified body mass index > 25 kg/m and pre-operative SSV diameter > 6 mm as significant risk factors for SSV recanalisation. CONCLUSION: Treatment of SSV incompetence with MOCA had high 5 year recanalisation and re-intervention rates. Additionally, a progressive decrease in QoL and deterioration of patient reported outcomes over time were found, as reflected by rising VCSS and AVVQ scores.
OBJECTIVE: The 2023 European Society for Vascular Surgery (ESVS) guidelines on radiation safety recommended establishment of national diagnostic reference levels (DRLs) for endovascular procedures, which indicate an expe...OBJECTIVE: The 2023 European Society for Vascular Surgery (ESVS) guidelines on radiation safety recommended establishment of national diagnostic reference levels (DRLs) for endovascular procedures, which indicate an expected radiation dose for any given procedure for the average sized patient. The aim of this study was to propose a national DRL for Sweden for standard endovascular aortic repair (EVAR). METHODS: This was a national registry based study where all EVARs performed in Sweden over a two year period (2021 - 2022) were identified in the Swedish vascular registry, Swedvasc. Patient demographics were extracted from Swedvasc and radiation related parameters were collected at centre level. Multivariable analyses were performed to assess which factors affected fluoroscopy time, total dose area product (DAP), and cumulative air kerma (CAK). The national DRL was defined as the third quartile of all centre specific median values for DAP total. RESULTS: Nine hundred and thirty-three procedures at 23 centres were included; 831 (89.1%) intact abdominal aortic aneurysms (AAAs) and 102 (10.9%) ruptured AAAs. The median (interquartile range [IQR]) DAP for EVAR at centre level varied from 28.3 Gy·cm (IQR 14.1, 76.1) to 212.7 Gy·cm (IQR 196.8, 275.0). Overall, the third quartile of the DAP radiation dose for EVAR in Sweden was 152.6 Gy·cm. The DAP was a median 81.1 Gy·cm and 116.5 Gy·cm for intact and ruptured EVARs, respectively (p < .001). The DRL was 147.7 Gy·cm and 213.8 Gy·cm for intact and ruptured EVARs, respectively. In a multivariable linear regression analysis, rupture, iliac branched repair, access complication, obesity, low centre volume and larger aneurysm were predictors for higher DAP during EVAR. CONCLUSION: The current report proposes a DRL for DAP of 152.6 Gy·cm for EVAR procedures in Sweden, with specific benchmark DAP values proposed for subgroups of patients. There is a considerable difference in radiation dose between different centres, suggesting a potential for implementation of improved radiation routines in some centres based on benchmarking.
Troisi N, Pierozzi S, Artini V
… +8 more, Zenunaj G, Fargion AT, Garriboli L, de Donato G, Galzerano G, La Barbera G, Berchiolli R, FESTIVAL registry collaborative group
OBJECTIVE: The aim of this study was to evaluate early and midterm outcomes of endovascular treatment of primary common femoral artery (CFA) atherosclerotic disease with intravascular lithotripsy (IVL) in the framework o...OBJECTIVE: The aim of this study was to evaluate early and midterm outcomes of endovascular treatment of primary common femoral artery (CFA) atherosclerotic disease with intravascular lithotripsy (IVL) in the framework of a prospective, multicentre registry (FESTIVAL). METHODS: This was an analysis of early and midterm clinical and morphological outcomes in a prospective multicentre study based on patients undergoing IVL without stenting in CFA disease. A prospective dataset of consecutive IVLs without stenting in the treatment of de novo CFA disease in 21 centres between January 2024 and February 2025 was investigated. The Azéma classification was used to classify CFA lesions. A shockwave IVL catheter was used in all cases. Follow up included clinical examination and duplex scan at discharge, one and six months, one year, and annually thereafter. Primary outcome measures were primary patency, primary assisted patency, secondary patency, freedom from clinically driven target lesion re-stenosis (cdTLR), and freedom from any re-intervention(s). RESULTS: During the study period, 117 patients were enrolled. Thirty day technical success was 97.4%. The median duration of follow up was 19 months (interquartile range 12, 27). Estimated one and two year rates were, respectively: primary patency, 96.2% and 93.9%; primary assisted patency, 96.2% and 93.9%; secondary patency, 100% and 100%; freedom from cdTLR, 95.2% and 92.6%; and freedom from any re-intervention(s), 96.2% and 91.9%. In multivariable analysis, Azéma type III lesion negatively affected primary patency (p = .042; odds ratio [OR] 4.131) and freedom from cdTLR (p = .048; OR 3.914). CONCLUSION: IVL without stenting in the treatment of de novo CFA steno-obstructive disease is a safe and effective procedure when the lesion does not extend to the femoral bifurcation. This procedure yields acceptable early and midterm overall patency with low rates of re-intervention.
OBJECTIVE: The role of carotid revascularisation in asymptomatic carotid artery stenosis (ACAS) remains debated. Advances in best medical therapy (BMT) may have lowered the risk of cerebral ischaemic events (CIEs), but o...OBJECTIVE: The role of carotid revascularisation in asymptomatic carotid artery stenosis (ACAS) remains debated. Advances in best medical therapy (BMT) may have lowered the risk of cerebral ischaemic events (CIEs), but optimal treatment strategies are still unclear. This study presents the five year results from a prospective, observational cohort of ACAS patients treated with BMT in a real world setting. METHODS: The Carotid Asymptomatic Stenosis Study (CARAS) study (NCT04825080) enrolled patients with ACAS ≥60% (North American Symptomatic Carotid Endarterectomy Trial [NASCET] criteria) who were ineligible for revascularisation due to high surgical risk or absence of plaque vulnerability, between 2019 and 2020, with planned five year follow up. BMT was defined as appropriate use of antiplatelets, statins, antihypertensives, and smoking cessation. The primary endpoint was the rate of ipsilateral CIE (stroke, transient ischaemic attack [TIA], or amaurosis fugax). Secondary endpoints were plaque progression, identification of predictors of CIE, BMT adherence, and survival. Follow up included annual clinical and duplex scan assessments and six month telephone interviews. RESULTS: The study enrolled 307 patients with a mean age of 80 ± 7 years; 54.4% were men. Bilateral carotid artery stenosis ≥60% was present in 61 (19.9%) patients. At enrolment, 238 (77.5%) patients were on BMT. During follow up, there were eight (2.6%) ipsilateral strokes and 14 (4.6%) TIAs, for a total of 20 CIEs (two patients had TIA and stroke). The five year survival was 80 ± 2%, and the cumulative CIE rate was 6 ± 2% and CIE annual rate was 1.3%. Sixty five (21.2%) patients had carotid stenosis progression, which was associated with a higher risk of CIE compared with patients with stable plaques (9.2 ± 4% vs. 4.5 ± 1%; p = .010). Similarly, bilateral carotid artery stenosis ≥60% was associated with a higher CIE rate (9.3 ± 4% vs. 3.4 ± 1%; p = .001). These two factors were independently associated with high risk of CIE in the multivariable Cox analysis (hazard ratio [HR] 3.2, 95% confidence interval [CI] 1.1 - 9.2; and HR 3.6, 95% CI 1.2 - 10.5). CONCLUSION: ACAS patients under BMT have a relatively low CIE risk, but plaque progression and contralateral stenosis increase it. These findings may help refine indications for carotid revascularisation.