European Journal of Vascular and Endovascular Surgery最新文献

Objective: To report the early results of a physician initiated clinical trial evaluating the safety and performance of the BeGraft Stent Graft (Bentley InnoMed, Hechingen, Germany) in fenestrated endovascular aneurysm repair (FEVAR).

Methods: This prospective, multicentre, single arm, physician initiated trial enrolled patients undergoing FEVAR for complex aortic aneurysms between March 2021 and September 2023 in nine high volume German centres. The BeGraft Stent Graft was used outside its initial intention for use as a bridging stent graft (BSG) for FEVAR. Primary endpoints were technical success, BSG patency, and absence of procedure related complications and BSG related endoleaks at 12 months.

Results: One hundred and three patients were prospectively enrolled. Three hundred and fifty BSGs were implanted as investigational devices and included in the analysis. Technical success was 98.3%. Two BSG occlusions were reported in the first 12 months. Primary patency at 12 months was 99.3%. The absence of procedure related complications was 88%. Freedom from BSG related endoleaks at 12 months was 99.6%. Freedom from BSG related re-interventions was 97%. Two device deficiencies occurred in two patients: one disconnection between the BSG and the balloon before deployment and one fracture of the BSG at one year. No migration > 10 mm of the BSG was recorded during the trial period.

Conclusion: This study shows favourable short term outcomes of the BeGraft Stent Graft as a BSG in FEVAR with good primary patency and low rates of BSG related complications.

Objective: The Wound, Ischemia, and foot Infection (WIfI) staging system for chronic limb threatening ischaemia (CLTI) predicts outcomes after revascularisation, but individual components of WIfI have not been evaluated. This study was designed to evaluate changes in WIfI ischaemia grade as a predictor of major amputation after open and endovascular revascularisation in the Best Endovascular versus Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.

Methods: A secondary analysis was conducted of patients with CLTI randomised to surgical bypass or endovascular therapy as part of the BEST-CLI trial with available WIfI ischaemia scores at baseline and 1 month post-procedure. Risk adjusted Cox regression models were used to assess the effect of change in WIfI ischaemia grade on the rate of major amputation, while controlling for potential confounders.

Results: Among 785 patients with CLTI who underwent revascularisation and were alive at 1 year, 629 (80.1%) achieved improvement in their WIfI ischaemia grade within 30 days after undergoing surgical and endovascular interventions. Patients with improved ischaemia grade were younger and were more likely to smoke, have lower baseline ankle brachial indices, and have worse overall WIfI stage at time of revascularisation compared with patients with worsening or no improvement in limb perfusion (p < .050 for all comparisons). Major amputation incidence at 1 year was 14% and was increased among those with higher baseline WIfI stage (3/4 vs. 1/2) and with unchanged or worse WIfI ischaemia grade after revascularisation. Patients with improved WIfI ischaemia grade early after revascularisation had a statistically significantly lower likelihood of major amputation at 1 year (hazard ratio 0.27, 95% confidence interval 0.18 - 0.41; p < .001) after risk adjustment.

Conclusion: Achieving early improvement in limb perfusion based on WIfI ischaemia grade predicts major amputation following revascularisation independent of other risk factors. Changes in ischaemia grade after interventions should be closely monitored to determine the adequacy of revascularisation, risk of CLTI progression, and need for major amputation.

Objective: To compare high ligation and stripping (HLS), endovenous laser ablation (EVLA), and ultrasound guided foam sclerotherapy (UGFS) for symptomatic great saphenous vein (GSV) reflux in the long term, given the limited comparative data beyond ten years.

Methods: Patients with symptomatic GSV reflux were randomised (1:1:1) to undergo HLS, EVLA, or UGFS. One hundred and ninety-six patients treated at Helsinki University Hospital were invited to 14 year follow up. Primary outcomes were above knee GSV reflux and GSV re-intervention rates. Secondary outcomes included quality of life.

Results: Of 233 randomised patients, 214 were included. UGFS increased the risk of GSV reflux recurrence compared with both HLS (risk ratio [RR] 11.7, 95% confidence interval [CI] 1.6 - 85.6) and EVLA (RR 5.0, 95% CI 1.5 - 16.6; 30.8% [12 of 39] after UGFS vs. 2.6% [1 of 38] and 6.1% [3 of 49] after HLS and EVLA, respectively; overall p < .001). UGFS was associated with a higher risk of GSV re-interventions compared with HLS (RR 4.3, 95% CI 1.8 - 10.2) and EVLA (RR 6.9, 95% CI 2.6 - 18.4; 56.4% for UGFS vs. 13.2% for HLS and 8.2% for EVLA; overall p < .001). Neovascularisation rates did not differ between the treatments (29.0%, 22.5%, and 23.1% for HLS, EVLA, and UGFS, respectively; overall p = .76). Aberdeen Varicose Vein Questionnaire scores were comparable across the groups (median [interquartile range] 8.9 [3.7, 13.3] in HLS, 6.1 [0.8, 12.2] in EVLA, and 8.8 [4.1, 13.4] in UGFS, with median differences of +2.8 [HLS vs. EVLA], +0.1 [HLS vs. UGFS], and -2.7 [EVLA vs. UGFS]; overall p = .21).

Conclusion: UGFS demonstrated inferior outcomes in terms of GSV recurrent reflux and re-intervention rates compared with both HLS and EVLA, whereas HLS and EVLA showed comparable performance across these outcomes. Long term quality of life was comparable across all groups.