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: 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.

Objective: Juxtarenal abdominal aortic aneurysms (JRAAAs) are anatomically complex and technically challenging to treat. Traditional metrics such as mortality or complication rates may not adequately reflect care quality. Composite measures such as failure to rescue (FTR) and textbook outcome (TO) offer a more comprehensive, patient centred assessment, capturing complication management and peri-operative course. TO reflects an ideal post-operative course, and FTR represents the proportion of patients who die after a major complication. This study assessed the feasibility and added value of TO and FTR as quality indicators in elective JRAAA repair using national registry data from the Netherlands and Sweden.

Methods: This retrospective cohort study used prospectively collected data from the Dutch Surgical Aneurysm Audit (DSAA) and the Swedish Swedvasc registry. Patients undergoing elective JRAAA repair with open surgical repair (OSR) or complex endovascular aneurysm repair (cEVAR) between 2016 and 2023 were included. TO reflected an ideal post-operative course; FTR captured death after major complications (Clavien-Dindo ≥ IV). Multivariable logistic regression was used to assess associations between surgical approach and outcomes.

Results: This study included 1 925 patients from the Netherlands and 775 from Sweden. In the Dutch cohort, cEVAR was associated with statistically significantly lower FTR rates (1.6% vs. 4.3%; p < .001), 30 day mortality (2.6% vs. 6.1%; p < .001), severe complications (5.8% vs. 14.8%; p < .001), and higher TO achievement (81.4% vs. 73.6%; p < .001) compared with OSR. No statistically significant differences in FTR (1.6% vs. 1.8%; p = .83) or TO (92.5% vs. 88.4%; p = .086) were found between OSR and cEVAR in the Swedvasc cohort. The main structural difference between the registries was the absence of re-admission data in Swedvasc.

Conclusion: TO and FTR show future promise as standardised metrics to evaluate surgical quality in JRAAA repair. Their added value is conceptual and requires further validation. Registry differences and incomplete data remain limitations. Implementing key variables with standardised definitions will enable benchmarking and support international quality improvement.