OBJECTIVE: Treatment of superficial venous insufficiency has been associated with high rates of recurrent symptoms and/or recurrent varicose veins; therefore, there is a need for new treatment options associated with lon...OBJECTIVE: Treatment of superficial venous insufficiency has been associated with high rates of recurrent symptoms and/or recurrent varicose veins; therefore, there is a need for new treatment options associated with longlasting outcomes. This study reports the 7 year durability of mechanochemical ablation (MOCA) and thermal ablation (TA) in treatment of great saphenous vein (GSV) insufficiency in patients with Clinical Etiological Anatomical Pathophysiological (CEAP) class 2-4 (C2-C4) venous insufficiency in the GSV in a single leg. METHODS: After recruitment in 2014 - 2015 at Helsinki University Hospital, patients were randomised 2 : 1 : 1 for MOCA, EVLA, and RFA. The GSV was evaluated with a duplex Doppler ultrasound examination, and disease specific quality of life (QoL) was assessed with the Aberdeen Varicose Vein Questionnaire (AVVQ). The primary outcome measures were patency and reflux of the GSV at 1 month, 1 year, 3 years, and, instead of the pre-specified 5 years, at 7 years due to the COVID-19 pandemic. The secondary outcome was the need for further interventions in the treated GSV. RESULTS: Originally, 125 patients received the allocated treatment. The 7 year follow up visits were attended by 89 of 125 (71.2%) patients. In the proximal part of the treated GSV (upper 20 cm), reflux was detected in 10 of 44 (23%) / 3 of 42 (7%) patients in the MOCA / TA groups (p = .032). Between the 3 year and 7 year follow up visits, two patients in the MOCA group had reoperations on the previously treated GSV segment, while no reoperations were required in the TA group. No QoL differences as measured by the AVVQ were shown between MOCA and TA. CONCLUSION: Seven years after the treatment of GSV insufficiency, MOCA is more often associated with vein recanalisation, recurrent reflux, and additional treatments than is TA.
OBJECTIVE: The aim of this study was to evaluate clinical and radiographic differences between men and women with acute type B aortic dissection (TBAD) and non-A non-B aortic dissection (AD). METHODS: This was a retrospe...OBJECTIVE: The aim of this study was to evaluate clinical and radiographic differences between men and women with acute type B aortic dissection (TBAD) and non-A non-B aortic dissection (AD). METHODS: This was a retrospective analysis of patients treated from 2009 to 2022 at a single aortic centre, following STROBE guidelines. Patients with acute TBAD and non-A non-B AD were included. Clinical characteristics, management, outcomes, and imaging findings were compared between sexes. Computed tomography scans were analysed using multiplanar reconstruction. Patients with previous AD or death before admission were excluded. Univariable Cox regression identified mortality predictors; variables with p < .10 were entered into a multivariable model. Sex-risk factor interactions were explored. RESULTS: Among 236 patients (151 men, 85 women), age did not differ statistically significantly (p = .30). Women had higher rates of heritable thoracic aortic disease (15% vs. 6.6%; p = .031) and aortic rupture (18% vs. 6.8%; p = .011). Dissection morphology and relative dimensions were comparable between sexes. Absolute aortic dimensions were larger in men (p < .001). Regarding high risk features, a difference was observed for aortic diameter > 40 mm (57% vs. 77%; p = .002). Treatment strategies were comparable between groups, with an overall intervention rate of 75% (including thoracic endovascular aortic repair and open repair) (p = .80). Sex was a univariable mortality risk factor (p = .013), while multivariable analysis identified malperfusion and acute aortic rupture as independent predictors. Women had worse five year survival (log rank p = .009). CONCLUSION: Baseline aortic anatomy, management strategies, and early outcomes were similar between women and men. However, women demonstrated significantly worse five year survival. These findings suggest sex related differences in long term outcomes and highlight the need for further investigation into sex specific risk stratification, disease mechanisms, and follow up strategies.
OBJECTIVE: The periprocedural window surrounding percutaneous transluminal angioplasty (PTA) for dysfunctional arteriovenous fistula (AVF) is a high risk phase often complicated by metabolic instability and temporary cen...OBJECTIVE: The periprocedural window surrounding percutaneous transluminal angioplasty (PTA) for dysfunctional arteriovenous fistula (AVF) is a high risk phase often complicated by metabolic instability and temporary central venous catheter (CVC) dependence. This study characterised this window and evaluated a "zero catheter" multidisciplinary strategy centred on the single needle distal return (SNDR) technique. METHODS: This single centre, retrospective cohort study included all maintenance haemodialysis patients undergoing PTA for AVF dysfunction. The study had two phases: phase 1 (conventional care, February 2023 - March 2024) and phase 2 ("zero catheter" SNDR protocol, April 2024 - February 2026). Patients were categorised by source (in centre vs. referred). Clinical characteristics at presentation were compared between sources. Periprocedural outcomes were compared between phases. The primary outcome was temporary CVC utilisation. RESULTS: A total of 452 patients (700 procedures) were included. Referred patients (n = 186) exhibited significantly worse profiles at presentation than in centre patients (n = 266): higher potassium (6.2 ± 1.9 vs. 5.1 ± 0.8 mmol/L), elevated NT-proBNP (1 850 vs. 852 pg/mL), and higher prevalence of pre-existing CVCs (31.7% vs. 0.8%, all p < .001). After SNDR protocol implementation, phase 2 (n = 237) demonstrated more dramatic improvements than phase 1 (n = 215): CVC utilisation decreased from 24.2% to 0% (p < .001), time to PTA shortened from 4.2 ± 2.5 to 1.9 ± 1.3 days (p < .001), and first post-PTA dialysis adequacy (spKt/V) improved from 1.21 ± 0.18 to 1.48 ± 0.15 (p < .001). All 32 referred patients arriving with CVCs in phase 2 had them removed within 24 hours. Ninety day re-intervention free survival significantly improved in phase 2 (log rank p < .01). CONCLUSION: Referred patients bear a disproportionately higher burden of periprocedural complications. Implementation of a "zero catheter" SNDR based strategy effectively eliminated temporary catheter dependence, stabilised metabolic profiles, and improved access outcomes, offering a reproducible framework for optimising peri-PTA care.
OBJECTIVE: The aim of this study was to evaluate the efficacy of adding sub-ulcer ultrasound guided foam sclerotherapy (UGFS) to the treatment of venous leg ulcers (VLUs). METHODS: This was a multicentre, non-blinded, pa...OBJECTIVE: The aim of this study was to evaluate the efficacy of adding sub-ulcer ultrasound guided foam sclerotherapy (UGFS) to the treatment of venous leg ulcers (VLUs). METHODS: This was a multicentre, non-blinded, parallel group, randomised controlled trial. The FINNULCER trial recruited patients with VLU from four vascular surgery units in Finland. Eligible participants were randomly allocated either to the study group, which received immediate sub-ulcer UGFS in addition to conventional treatment, or to the control group, which received conventional treatment only. Conventional treatment included scheduled endothermal ablation for insufficient truncal veins, UGFS for tributaries, compression therapy, and local ulcer care. The recommended compression therapy was a class 2 (23 - 32 mmHg) thigh high compression stocking. The primary outcome was time to ulcer healing within 1 year of follow up. Secondary outcomes included quality of life questionnaires, treatment characteristics, and complications. RESULTS: Seventy-three patients were randomised (35 to the study group, 38 to the control group). During follow up, all ulcers healed in the study group, whereas 4 of 38 ulcers did not heal in the control group. The median time to ulcer healing was 55 days (95% confidence interval [CI] 42 - 68 days) in the study group and 91 days (95% CI 73 - 109 days) in the control group. In a Cox proportional hazards model adjusted for study site, ulcer healing was faster in the study group (hazard ratio 1.81, 95% CI 1.10 - 2.96; p = .019). Quality of life improved similarly in both groups. Overall complication rates were similar in both groups. CONCLUSION: Adding sub-ulcer UGFS to conventional VLU treatment shortened ulcer healing time without increasing the overall complication rate. These findings suggest that treatment of the sub-ulcer venous plexus may represent a useful addition to the management of VLUs, although the results should be interpreted in the context of a smaller study population than originally planned.
Becker D, Prendes CF, Bosiers MJ
… +10 more, Garguilo M, Pratesi G, Kahlberg A, Mani K, Veraldi GF, Tschomba Y, Azhar A, Berchiolli R, Khashram M, Tsilimparis N
OBJECTIVE: This multicentre, retrospective cohort study aimed compare fenestrated endovascular (FEVAR) with open surgical repair (OSR) for treatment of juxtarenal and pararenal aortic aneurysms (J/PAAA). METHODS: Consecu...OBJECTIVE: This multicentre, retrospective cohort study aimed compare fenestrated endovascular (FEVAR) with open surgical repair (OSR) for treatment of juxtarenal and pararenal aortic aneurysms (J/PAAA). METHODS: Consecutive patients undergoing elective repair of J/PAAA between 2017 - 2022 in ten high volume centres across five countries were examined. Primary endpoints were midterm mortality and re-intervention. Secondary endpoints included 30 day mortality and re-intervention. Propensity score matching (PSM; 1:1) was performed to adjust for baseline differences. The Strengthening the Reporting of Observational Studies in Epidemiology guidelines were followed. RESULTS: A total of 714 patients were included: 399 (55.9%) FEVAR and 315 (44.1%) OSR. Thirty day mortality (1.5% vs. 1.0%; p = .74) and re-interventions (9.0% vs. 6.3%; p = .21) were similar after FEVAR and OSR. Mean follow up was 26.2 months, without loss to follow up in either group. The 1, 3, and 5 year survival rates were 94.7%, 86.1%, and 71.7% after FEVAR vs. 95.6%, 90.3%, and 86.5% after OSR (p = .042). Re-intervention free survival at 1, 3, and 5 years was lower after FEVAR (89.2%, 81.4%, and 73.3% vs. 98.9%, 97.7%, and 96.3%; p < .001). Similarly, major re-intervention free survival was lower after FEVAR (96.6%, 92.3%, and 91.3% vs. 98.9%, 97.7%, and 96.3% after OSR; p = .045). FEVAR was identified as a predictor of all re-interventions (hazard ratio [HR] 4.40, 95% confidence interval [CI] 1.65 - 11.74; p = .003) but not major re-interventions (HR 2.44, 95% CI 0.98 - 6.04; p = .054) or survival (HR 1.8, 95% CI 0.92 - 3.60; p = .085) on Cox regression analysis. Cox regression analysis of the PSM cohorts confirmed similar results. CONCLUSION: Both FEVAR and OSR achieved excellent early outcomes for elective J/PAAAs. Although FEVAR was associated with increased overall re-interventions, it was not a predictor of major re-intervention or mortality. In adequately matched patients, overall survival, and freedom from major re-intervention appear comparable between approaches.
OBJECTIVE: Preventive surgeries, such as carotid endarterectomy (CEA), involve immediate procedural risks for every patient, yet only survivors experience benefit. Conventional analyses such as Kaplan-Meier estimates and...OBJECTIVE: Preventive surgeries, such as carotid endarterectomy (CEA), involve immediate procedural risks for every patient, yet only survivors experience benefit. Conventional analyses such as Kaplan-Meier estimates and Cox models fail to adequately address competing risks and the timing of events, limiting their ability to assess the risk-benefit trade off. This study aimed to evaluate alternative methodologies, specifically competing risk analysis and restricted mean survival time (RMST), using a landmark CEA trial as an example. METHODS: Methodological re-evaluation was performed on reconstructed individual patient data from the ACST-1 trial, a randomised clinical trial of 3 120 patients comparing immediate vs. deferred CEA for asymptomatic carotid stenosis. Data were derived from published Kaplan-Meier curves and supplemental materials, with mortality modelled from a comparable study. Key parameters for the reconstructed data fell within 1% of the original data. The Aalen-Johansen estimator and RMST were used to quantify stroke free days and life years gained or lost. RESULTS: Accounting for competing risks reduced Kaplan-Meier based ten year stroke risk estimates by 20% and lowered the estimated risk reduction for immediate CEA from 6.1% to 5.6%. Alternative analysis strategies did not indicate a difference in stroke free days between the two arms at 10 years: difference, 40 stroke free days (95% confidence interval [CI] -52 - 129 days; p = .375). Across mortality scenarios, the overall balance between prevented stroke related deaths and procedural deaths resulted in a small net disadvantage for immediate CEA ranging from 1 (95% CI -21 - 39; p = .53) to 16 (95% CI -39 - 4; p = .12) life days lost over 10 years. CONCLUSION: Competing risk analysis and RMST overcome the limitations of traditional analyses, enabling comprehensive evaluation of the surgical trade off in preventive surgery and potentially altering study conclusions based on traditional approaches. By providing more tangible outcome measures, this framework facilitates intertrial comparisons and medical decision making.
OBJECTIVE: Supervised exercise programmes are first line treatment for patients with intermittent claudication. Their prescription comprises a combination of components, namely frequency, intensity, time, and type of exe...OBJECTIVE: Supervised exercise programmes are first line treatment for patients with intermittent claudication. Their prescription comprises a combination of components, namely frequency, intensity, time, and type of exercise. However, the optimal prescription (i.e., the most effective combination of these components) remains unknown. This leads to a paucity of comprehensive programme guidelines, poor programme provision, uptake, and completion rates and potentially ineffective programmes. The aim of this systematic review with network and component network meta-analyses was to identify evidence for the optimal supervised exercise prescription for patients with intermittent claudication. DATA SOURCES: CENTRAL, MEDLINE, Embase, CINAHL, trial registries, and Web of Science. REVIEW METHODS: Randomised controlled trials of patients with intermittent claudication comparing a supervised exercise programme with an appropriate, non-invasive comparator group or another, alternative supervised exercise programme were included. The primary outcome was mean difference in maximum walking distance between the exercise and control groups. A component network meta-analysis was planned to identify the most effective combination of components. However, the assumption required for a valid component network meta-analysis was violated, requiring alternative primary analyses. This involved initially grouping trials by their common components and undertaking standard network meta-analyses for each group to identify the likely effective levels (e.g., once or twice per week). These results were supported by other analyses to identify a likely optimal prescription. RESULTS: Searches returned 13 714 unique results. Sixty four trials (n = 3 427) were included in the primary analysis. The likely optimal supervised exercise prescription is intermittent walking, performed three times a week, utilising a pain based prescription (ranging from pain free/pain onset to maximal pain) for 30 - 60 minutes per session, for a period of twelve weeks (moderate to high quality evidence). CONCLUSION: This study identified the likely optimal supervised exercise prescription for patients with intermittent claudication, which should inform future guidelines, clinical practice, and clinical trials.
OBJECTIVE: The aim of this French physician initiated, multicentre, prospective, randomised trial with blinded criteria for re-intervention was to evaluate the efficacy of paclitaxel coated balloons (DCBs) in the treatme...OBJECTIVE: The aim of this French physician initiated, multicentre, prospective, randomised trial with blinded criteria for re-intervention was to evaluate the efficacy of paclitaxel coated balloons (DCBs) in the treatment of arteriovenous fistula stenosis. METHODS: One hundred and fifty patients with an arteriovenous fistula stenosis were included, and 145 were randomised 1:1 in the ABISS trial (Angioplastie au Ballon Imprégné de paclitaxel vs. angioplastie Standard pour le traitement des Sténoses sur fistule artérioveineuse; ClinicalTrials.gov identifier: NCT02753998) between a DCB (Lutonix, BD, Franklin Lakes, NJ, USA) and a placebo balloon. The main outcome was the rate of primary patency loss at 6 months. The primary analysis was performed in the modified intention to treat population. Missing outcome data were handled using a conservative imputation approach. The per-protocol analysis excluded patients who were included by mistake, not treated according to the randomisation arm, lost to follow up, or who missed a visit. RESULTS: In the modified intention to treat analysis, there was no significant difference between the groups regarding primary patency loss at 6 months (31% [22 of 70] in the DCB group vs. 42% [30 of 71] in the placebo group; p = .09; hazard ratio = 0.62 [95% confidence interval {CI} 0.36 - 1.07]). Primary patency loss was lower in the DCB than in the placebo group at 3 months (4.2% vs. 22.5%; p = .002; hazard ratio = 0.18 [95% CI 0.05 - 0.60]), but not at 12 months (58.6% vs. 57.7%; p = .57; hazard ratio = 0.88 [95% CI 0.57 - 1.35]). In the per-protocol analysis, the primary patency loss was significantly lower in the DCB group than in the placebo group (26% [16 of 61] in the DCB group vs. 50% [28 of 56] in the placebo group; p = .004). CONCLUSION: In the ABISS trial, the use of a DCB was not superior to a placebo balloon at 6 months in the modified intention to treat analysis.
OBJECTIVE: This study aimed to assess the effect of bridging stent graft (BSG) selection on the outcomes of endovascular aneurysm repair using an iliac branch device (IBD) and to compare the performance of the Advanta V1...OBJECTIVE: This study aimed to assess the effect of bridging stent graft (BSG) selection on the outcomes of endovascular aneurysm repair using an iliac branch device (IBD) and to compare the performance of the Advanta V12 and BeGraft Plus stent grafts for this purpose. METHODS: This was a retrospective, single centre cohort study including all patients undergoing elective implantation of a Cook Zenith IBD between January 2010 and May 2024. Primary endpoints were technical success, primary patency of the BSG, and IBD related endoleaks, re-interventions, and target vessel instability (TVI). Secondary endpoints were aneurysm related mortality and procedure related complications. RESULTS: During the study period, 212 IBDs were implanted in 156 patients (148 men [94.9%]; mean age 68 ± 8 years). Fifty-six patients (35.9%) received a bilateral IBD. The BSGs implanted were Advanta V12 in 114 IBDs (53.8%), BeGraft Plus in 88 IBDs (41.5%), and other BSG types in ten IBDs (4.7%). Primary technical success was achieved in 211 of 212 implanted devices (99.5%), with no early mortality. During a median follow up of 31 months (interquartile range 12, 66), 18 (8.5%) internal iliac artery (IIA) branches occluded in 14 patients. Estimated IIA branch patency at 1, 2, and 4 years was 99.5 ± 0.5%, 91 ± 2.6%, and 84 ± 3.6%, respectively, with no statistically significant differences regarding the BSG used (log rank p = .55). There were 17 (8.0%) IBD related endoleaks during follow up, and 25 patients (16.0%) required a late re-intervention, most of them due to endoleaks or in stent stenosis. Estimated freedom from TVI at 1, 2, and 4 years was 94 ± 1.9%, 84 ± 3.3%, and 76 ± 4%, respectively, with no statistically significant differences regarding the BSG used (log rank p = .35). CONCLUSION: Advanta V12 and BeGraft Plus performed well as BSG in combination with the Cook Zenith IBD for endovascular aorto-iliac aneurysm repair and they both showed similar outcomes in terms of primary patency and freedom from IBD related endoleaks, re-interventions, and TVI.
OBJECTIVE: This study aimed to evaluate the role and clinical outcomes of coeliac artery (CA) revascularisation in patients undergoing median arcuate ligament release (MALR) for median arcuate ligament syndrome (MALS). M...OBJECTIVE: This study aimed to evaluate the role and clinical outcomes of coeliac artery (CA) revascularisation in patients undergoing median arcuate ligament release (MALR) for median arcuate ligament syndrome (MALS). METHODS: Patients who underwent MALR from 2001 to 2024 were retrospectively reviewed. From those patients, those who underwent CA revascularisation were analysed. Variables included symptoms, imaging, operative findings, and outcomes. Propensity score matching (PSM) with 1 : 1 nearest neighbour matching was performed using prespecified covariates. RESULTS: Among the 274 patients who underwent MALR, 34 patients underwent CA revascularisation either concurrently or as a delayed intervention. The median age was 43 years (interquartile range [IQR] 36, 50), and 25 of 34 patients (74%) were women. Revascularisation was performed concurrently with MALR in 26 patients (76%), including 17 aortocoeliac bypasses and 9 patch angioplasties. Positive pain response was reported in 21 of 26 patients (81%) and positive nausea response in 22 of 26 patients (86%). PSM identified 33 matched pairs of patients with and without CA revascularisation. Baseline covariates were well balanced (standardised mean differences < 0.1). Symptom response rates were similar between groups, with positive pain response reported in 24 of 33 patients (73%) in the revascularisation group and 26 of 33 patients (79%) in the non-revascularisation group (p = 0.57). Similarly, among patients who reported nausea, a positive response was observed in 22 of 25 patients (88%) and 19 of 21 patients (90.5%), respectively (p = 0.79). CONCLUSION: In this large single institution cohort, coeliac revascularisation after MALR declined substantially over time, with comparable symptom outcomes to MALR alone. These findings suggest that, for most patients, MALR alone is appropriate, with revascularisation reserved for highly selected cases.