RSS 1.0Vascular Surgery
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Paclitaxel- or sirolimus-coated balloons used for ArterioVEnous fistulas-2 (PAVE-2): study protocol for a randomised controlled trial to determine the efficacy of paclitaxel- or sirolimus-coated balloons in arteriovenous fistulas used for haemodialysisBackground: In view of the conflicting results from previous studies, the benefit of paclitaxel-coated balloons for arteriovenous fistulas is uncertain and equipoise remains. Although an industry-led trial testing the efficacy of sirolimus-coated balloons in AVFs is in progress, the benefit of sirolimus-coated balloons for arteriovenous fistulas is currently unknown. The purpose of this trial is to compare the efficacy of additional paclitaxel-coated or sirolimus-coated balloons on outcomes after a plain balloon fistuloplasty to preserve the patency of arteriovenous fistulae used for haemodialysis. Methods: The study design is a multicentre randomised controlled trial. Following a successful plain balloon fistuloplasty, participants will be randomised to further treatment with a paclitaxel-coated balloon, a sirolimus-coated balloon, or an uncoated control balloon. We will recruit 642 patients, each with one or two treatment segments, over a 3-year period. Patients will remain in the trial and be followed up for 1 year. The primary endpoint is time to loss of treatment segment primary patency. Cox-proportional hazards models will be used to estimate hazard ratios for the time to loss of treatment segment primary patency for each treatment group relative to the control group. Analysis of the primary endpoint will be based on treatment segments rather than participants and a shared frailty will be estimated to account for the clustering of treatment segments within patients. Secondary endpoints are time to loss of primary patency at any treatment segment; time to end of access circuit primary patency; time to AVF abandonment; number of radiological or surgical interventions; adverse events; intima-media thickness and degree of stenosis at 3 months on ultrasound; and patient quality of life assessed by EQ-5D-5L and VASQoL. Discussion: The three-armed design in this proposal will provide an answer on the efficacy of both paclitaxel- and sirolimus-coated balloons in the same trial. This trial is likely to provide a clear answer regarding the efficacy of drug-coated balloons for arteriovenous fistulas.
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Vein bypass first vs. best endovascular treatment first revascularisation strategy for chronic limb-threatening ischaemia due to infra-popliteal disease: the BASIL-2 RCTParticipants were randomised to a vein bypass-first or a best endovascular treatment-first revascularisation strategy. The original sample size of 600 participants (247 events) was based on a hazard ratio of 0.66 with amputation-free survival rates of 0.72, 0.62, 0.53, 0.47 and 0.35 in years 1-5 in the best endovascular treatment-first group with 90% power and alpha at p = 0.05. The sample size was revised to an event-based approach as a result of increased follow-up time due to slower than anticipated recruitment rates. Participants were followed up for a minimum of 2 years. A cost-effectiveness analysis was employed to estimate differences in total hospital costs and amputation-free survival between the groups. Additionally, a cost-utility analysis was carried out and the total cost and quality-adjusted life-years, 2 and 3 years after randomisation were used.
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The addition of lipid-based contrast medium does not Inactivate the detergent sclerosant sodium tetradecyl sulfate in-vitro.Purpose: To investigate if the detergent sclerosant sodium tetradecyl sulfate (STS) is deactivated by the lipid-based contrast agent ethiodised oil. Method: 3% STS was mixed with ethiodised oil and room air in a 2:1:4 ratio in two luer lock syringes and a three way connector and agitated to make foam (the Tessari technique) to replicate the clinical use of the products. The assay of STS in the mixture was assessed using the British Pharmacopoeia method. Briefly this is a manual titration method where the solution of STS is mixed with an indicator solution and titrated with hyamine solution of known concentration; the concentration of the STS can then be calculated with the titration results. To further mimic the clinical environment with the presence of blood, the effect of adding increasing amounts of albumin to the STS-ethiodised oil mixture was assessed. Results: The assay of STS in the solution after mixing with ethiodised oil was 3% indicating that the ethiodised oil did not deactivate the STS. The addition of albumin to the STS-contrast mixture resulted in near linear neutralisation of the STS with increasing concentrations in the same quantities as with STS alone. Conclusions: The mixture of the lipid-based contrast agent ethiodised oil with the detergent sclerosant STS did not affect the availability of the sclerosant. The continued use of STS-ethiodised oil in the management of vascular malformations can be supported.
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Current practices in carotid surgeryWe outline the indications and contraindications of carotid endarterectomy (CEA) and appraise four key areas still debated to this day; shunting versus non-shunting, patch angioplasty (PA) versus primary closure (PC) and local anaesthesia (LA) versus general anaesthesia (GA). Importantly, we compare CEA with Best Medical Therapy (BMT), which is an area that is still largely debated, principally because many of the studies conducted to date do not reflect the era of modern BMT practices, and these outcomes are eagerly awaited. Literature searches were conducted using Pubmed with the keywords 'carotid', and 'endarterectomy', which provided a wide variety of journals and articles. We further stratified our data by using only randomised control trials (RCTs), meta-analyses, and systematic reviews, and then excluded studies with asymptomatic disease, diabetes, and plaque-imaging studies, including studies that did not fit our four desired topics for discussion. For each of the different domain's, results demonstrated similar peri-operative outcomes when comparing shunting vs. non-shunting and modality of anaesthesia and therefore practice still remains dependent on operator experience and preference. Patch-angioplasty reduces the risk of subsequent stroke, transient ischaemic attack (TIA), and re-stenosis compared to PC. In carotid stenosis >50% BMT offers limited benefits without accompanying surgical intervention and BMT alone tends to be advantageous primarily for patients with <50% carotid stenosis. Where CEA is appraised in terms of superiority of the procedural components; the literature does not support wildly contrasting outcomes to change majority practice. However, the area of considerable interest is superiority of BMT to surgical intervention in terms of both carotid artery stenting (CAS) and CEA and more studies need to be conducted in this area.
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Procedural and 12-month in-hospital costs of primary infra-popliteal bypass surgery, infrapopliteal best endovascular treatment, and major lower limb amputation for chronic limb threatening ischemiaObjective: Chronic limb-threatening ischemia (CLTI) is a growing global problem due to the widespread use of tobacco and increasing prevalence of diabetes. Although the financial consequences are considerable, few studies have compared the relative cost-effectiveness of different CLTI management strategies. The Bypass vs Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial is randomizing patients with CLTI to primary infrapopliteal (IP) vein bypass surgery (BS) or best endovascular treatment (BET) and includes a comprehensive within-trial cost-utility analysis. The aim of this study is to compare over a 12-month time horizon, the costs of primary IP BS, IP best endovascular treatment (BET), and major limb major amputation (MLLA) to inform the BASIL-2 cost-utility analysis. Methods: We compared procedural human resource (HR) costs and total in-hospital costs for the index admission, and over the following 12-months, in 60 consecutive patients undergoing primary IP BS (n = 20), IP BET (n = 20), or MLLA (10 transfemoral and 10 transtibial) for CLTI within the BASIL prospective cohort study. Results: Procedural HR costs were greatest for BS (BS £2551; 95% confidence interval [CI], £1934-£2807 vs MLLA £1130; 95% CI, £1046-£1297 vs BET £329; 95% CI, £242-£390; P < .001, Kruskal-Wallis) due to longer procedure duration and greater staff requirement. With regard to the index admission, MLLA was the most expensive due to longer hospital stay (MLLA £13,320; 95% CI, £8986-£18,616 vs BS £8714; 95% CI, £6097-£11,973 vs BET £4813; 95% CI, £3529-£6097; P < .001, Kruskal-Wallis). The total cost of the index admission and in-hospital care over the following 12 months remained least for BET (MLLA £26,327; 95% CI, £17,653-£30,458 vs BS £20,401; 95% CI, £12,071-£23,926 vs BET £12,298; 95% CI, £6961-£15,439; P < .001, Kruskal-Wallis). Conclusions: Over a 12-month time horizon, MLLA and IP BS are more expensive than IP BET in terms of procedural HR costs and total in-hospital costs. These economic data, together with quality of life data from BASIL-2, will inform the calculation of incremental cost-effectiveness ratios for different CLTI management strategies within the BASIL-2 cost-utility analysis.
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Pre-loaded fenestrated thoracic endografts for distal aortic arch pathologies: multicentre retrospective analysis of short and mid term outcomes.Objective: To determine short and midterm outcomes of a pre-loaded fenestrated thoracic endograft (f-TEVAR) for exclusion of distal aortic arch pathologies. Methods: This was a multicentre, retrospective study including consecutive patients from six experienced European vascular centres undergoing f-TEVAR for distal arch pathologies. Primary endpoints included peri-operative mortality and peri-operative stroke and/or spinal cord ischaemia rates. Secondary outcomes were technical success and mid to late events, including death and re-interventions. Statistical analysis was performed with SPSS 26. Mid to late term events were calculated using Kaplan-Meier survival analysis. Results: One hundred and eight patients were included (mean age 68 ± 11 years, 70% men). A total of 38% (n = 42) had a prior history of aortic dissection, and 24% (n = 26) prior aortic surgery. The mean aneurysm diameter was 59 ± 12 mm and the most frequent indication for treatment was post-dissection aneurysms (n = 42, 39%). Technical success was 99% (n = 107) despite intra-operative wire entanglement occurring in 29% (n = 31). The 30 day mortality rate was 3.7% (n = 4), with a 5.6% major stroke incidence (n = 6) and 3.7% (n = 4) spinal cord ischaemia rate. Three cases of retrograde dissection occurred (two of which were fatal), all in post-type B dissecting aneurysm patients without prior aortic surgery (three of 19, 15.8%). Median follow up was 12 months (range, 1 - 26). Endoleaks were documented during follow up, with 3.5% type Ia (4/104) and 2.9% type Ib (3/104) as a result of persistent false lumen perfusion. The one, two, and three year survivals and freedom from re-intervention rates were 93.2% and 92.1%, 89.1% and 86.3%, and 84.4% and 73%, respectively. Conclusion: This multicentre study shows that treatment of the distal aortic arch by f-TEVAR is feasible, with promising 30 day mortality, stroke, and spinal cord ischaemia rates.
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The impact of atrial fibrillation on outcomes of peripheral arterial disease: analysis of routinely collected primary care data.Background: The combination of peripheral arterial disease and atrial fibrillation is linked with high risk of mortality and stroke. This study aims to investigate the impact of atrial fibrillation on patients with diagnosed peripheral arterial disease. Methods: This is a retrospective study using The Health Improvement Network database, which contains prospectively collected data from participating primary care practices. Patients with a new diagnosis of peripheral arterial disease between January 8, 1995 and January 5, 2017 were identified in the database alongside relevant demographic information, clinical history, and medications. Every patient in the dataset with peripheral arterial disease and baseline atrial fibrillation (case) was matched to a patient without atrial fibrillation (control) with similar characteristics using propensity score matching. Cox-regression analysis was performed and hazard ratios (HR) calculated for the outcomes of death, stroke, ischemic heart disease, heart failure, and major amputation. Results: Prevalence of atrial fibrillation in this cohort was 10.2%. All patients with peripheral arterial disease and atrial fibrillation (n = 5685) were matched with 5685 patients without atrial fibrillation but otherwise similar characteristics. After multivariate analysis, atrial fibrillation was independently associated with mortality (HR 1.18; 95% confidence interval [CI], 1.12-1.26; P < .01), cerebrovascular events (HR 1.35; 95% CI, 1.17-1.57; P < .01), and heart failure (HR 1.87; 95% CI, 1.62-2.15; P < .01), but not with ischemic heart disease or limb loss. Conclusion: In peripheral arterial disease patients, atrial fibrillation is a risk factor for mortality, stroke, and heart failure. This emphasizes the need for proactive surveillance and holistic management of these patients.
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TEVAR for complicated and uncomplicated type B aortic dissection-systematic review and meta-analysis.Background: Type B aortic dissection (TBAD), is defined as a dissection involving the aorta distal to left subclavian artery with the ascending aorta and the aortic arch not affected. TBAD is classified due to the time frame and presence of complications. Complicated TBAD (co-TBAD) patients have a greater mortality rate than uncomplicated TBAD (un-TBAD) and thoracic endovascular aortic repair (TEVAR) is considered the gold-standard intervention for these clinical challenges. Methods: We undertook a systematic review of the literature regarding TEVAR intervention in co-TBAD and un-TBAD. A comprehensive search was undertaken across four major databases and was evaluated and assessed until June 2020. Results: A total of 16,104 patients were included in the study (7772 patients co-TBAD and 8352 un-TBAD). A significantly higher proportion of comorbidities were seen in co-TBAD patients compared with un-TBAD. Acute dissection was more frequent in the co-TBAD group (73.55% vs. 66.91%), while chronic dissection was more common in un-TBAD patients (33.8% vs. 70.73%). Postprocedure stroke was higher in co-TBAD (5.85% vs. 3.92%; p < .01), while postprocedural renal failure was higher in un-TBAD patients (7.23 vs. 11.38%; p < .01). No difference was observed in in-hospital mortality however the 30 days mortality was higher in the co-TBAD group. One-year survival was higher in the uncomplicated group but this difference was not observed in the 5-year survival. Conclusion: In our analysis we can appreciate that despite significantly higher comorbidities in the co-TBAD cohort, there was no difference in in-hospital mortality between the two groups and the 5-year survival did not have any difference.
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Percutaneous arteriovenous fistula creation with the 4F WavelinQ EndoAVF SystemBackground: Percutaneous devices for creation of native arteriovenous fistulae offer an alternative to traditional open surgical techniques. The 4F WavelinQ EndoAVF System was developed as a lower profile alternative to facilitate access through smaller vessels and minimize access site complications; The current report is the original first experience of this device, assessing outcome in 120 patients followed for 6 months. Methods: The use of the 4F WavelinQ system in three studies, EASE (32 patients), EASE-2 (24 patients), and the EU postmarket clinical follow-up study (64 patients) was aggregated and analyzed. Patients were followed with duplex ultrasound at discharge and follow-up visits at 1, 3, and 6 months. Primary, assisted primary, and secondary patency rates were evaluated as Kaplan-Meier estimates and standard errors. Time to maturity and time to successful cannulation were defined as the mean ± standard deviation days from the procedure in patients enrolled on dialysis. Results: Procedural success was achieved in 116 patients (96.7%). Primary, assisted-primary, and secondary 6-month patency rates were 71.9% ± 4.5%, 80.7% ± 4.1%, and 87.8% ± 3.3%, respectively. Time to maturity averaged 41 ± 17 days. Time to successful cannulation averaged 68 ± 51 days. Device-related serious adverse events were reported in 3 of 120 patients (2.5%) and procedure-related serious adverse events occurred in 7 of 120 patients (5.8%). Arterial or venous access complications were not reported in any of the patients. Access circuit reinterventions were performed in 23 patients (19.2%), split between those performed for EndoAVF maturation (13/120 [10.8%]) and maintenance (11/120 [9.2%]). Conclusions: Percutaneous creation of native dialysis fistulae with the 4F WavelinQ EndoAVF System is safe and effective, with favorable durability and a low rate of serious complications and reinterventions through 6-month follow-up. Use of the 4F device allows for percutaneous fistula creation between the radial artery and radial vein or the ulnar artery and ulnar vein. These findings suggest that the 4F device is a useful percutaneous alternative to open surgical AVF or endovascular AVF with larger bore devices.
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A Comparison of Outcome in Patient With and Without Undergoing Cardiopulmonary Exercise Testing (CPET).There were 38 patients at each centre. The mean duration of stay in ICU for patients in CPET centre was 2.5 ± 2.13 days whilst in non-CPET centre it was 3.68 ± 4.08 days (P = 0.05). The mean duration of stay in ICU and total length of stay was significantly shorter in CPET centre (P = 0.05 and P = 0.015 respectively). Mortality in CPET centre was 2.63% and 5.26% in non-CPET centre (not significant). The number of patients developing AKI post-operatively was 13.61% in CPET vs 28.95% in non-CPET centre.
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Multicenter study on physician-modified endografts for thoracoabdominal and complex abdominal aortic aneurysm repair.Background: Physician modified endografts (PMEGs) have been widely used in the treatment of complex abdominal aortic aneurysm and thoracoabdominal aortic aneurysm, however, previous data are limited to small single center studies and robust data on safety and effectiveness of PMEGs are lacking. We aimed to perform an international multicenter study analyzing the outcomes of PMEGs in complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Methods: An international multicenter single-arm cohort study was performed analyzing the outcomes of PMEGs in the treatment of elective, symptomatic, and ruptured complex abdominal aortic aneurysms and thoracoabdominal aortic aneurysms. Variables and outcomes were defined according to the Society for Vascular Surgery reporting standards. Device modification and procedure details were collected and analyzed. Efficacy outcomes included technical success and safety outcomes included major adverse events and 30-day mortality. Follow-up outcomes included reinterventions, endoleaks, target vessel patency rates and overall and aortic-related mortality. Multivariable analysis was performed aiming at identifying predictors of technical success, 30-day mortality, and major adverse events. Results: Overall, 1274 patients were included in the study from 19 centers. Median age was 74 (IQR, 68-79), and 75.7% were men; 45.7% were complex abdominal aortic aneurysms, and 54.3% were thoracoabdominal aortic aneurysms; 65.5% patients presented electively, 24.6% were symptomatic, and 9.9% were ruptured. Most patients (83.1%) were submitted to a fenestrated repair, 3.6% to branched repair, and 13.4% to a combined fenestrated and branched repair. Most patients (85.8%) had ≥3 target vessels included. The overall technical success was 94% (94% in elective, 93.4% in symptomatic, and 95.1% in ruptured cases). Thirty-day mortality was 5.8% (4.1% in elective, 7.6% in symptomatic, and 12.7% in ruptured aneurysms). Major adverse events occurred in 25.2% of cases (23.1% in elective, 27.8% in symptomatic, and 30.3% in ruptured aneurysms). Median follow-up was 21 months (5.6-50.6). Freedom from reintervention was 73.8%, 61.8%, and 51.4% at 1, 3, and 5 years; primary target vessel patency was 96.9%, 93.6%, and 90.3%. Overall survival and freedom from aortic-related mortality was 82.4%/92.9%, 69.9%/91.6%, and 55.0%/89.1% at 1, 3, and 5 years. Conclusions: PMEGs were a safe and effective treatment option for elective, symptomatic, and ruptured complex aortic aneurysms. Long-term data and future prospective studies are needed for more robust and detailed analysis.
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Physician Transfer Versus Patient Transfer for Mechanical Thrombectomy in Patients With Acute Ischemic Stroke: A Systematic Review and Meta-Analysis.We conducted a systematic review to identify studies that evaluate the effect of physician transfer in patients with acute ischemic stroke who undergo mechanical thrombectomy. A search of PubMed, Scopus, and Web of Science was undertaken, and data were extracted. A statistical pooling with random-effects meta-analysis was performed to examine the odds of reduced time interval between stroke onset and recanalization, functional independence, death, and angiographic recanalization. A total of 12 studies (11 nonrandomized observational studies and 1 nonrandomized controlled trial) were included, with a total of 1894 patients. Physician transfer was associated with a significantly shorter time interval between stroke onset and recanalization with a pooled mean difference estimate of -62.08 (95% CI, -112.56 to -11.61]; P=0.016; 8 studies involving 1419 patients) with high between-study heterogeneity in the estimates (I2=90.6%). The odds for functional independence at 90 days were significantly higher (odds ratio, 1.29 [95% CI, 1.00-1.66]; P=0.046; 7 studies with 1222 patients) with physician transfer with low between-study heterogeneity (I2=0%). Physician transfer was not associated with higher odds of near-complete or complete angiographic recanalization (odds ratio, 1.18 [95% CI, 0.89-1.57; P=0.25; I2=2.8%; 11 studies with 1856 subjects).
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Galectin-9 mediates neutrophil capture and adhesion in a CD44 and β2 integrin-dependent manner.Neutrophil trafficking is a key component of the inflammatory response. Here, we have investigated the role of the immunomodulatory lectin Galectin-9 (Gal-9) on neutrophil recruitment. Our data indicate that Gal-9 is upregulated in the inflamed vasculature of RA synovial biopsies and report the release of Gal-9 into the extracellular environment following endothelial cell activation. siRNA knockdown of endothelial Gal-9 resulted in reduced neutrophil adhesion and neutrophil recruitment was significantly reduced in Gal-9 knockout mice in a model of zymosan-induced peritonitis. We also provide evidence for Gal-9 binding sites on human neutrophils; Gal-9 binding induced neutrophil activation (increased expression of β2 integrins and reduced expression of CD62L). Intra-vital microscopy confirmed a pro-recruitment role for Gal-9, with increased numbers of transmigrated neutrophils following Gal-9 administration. We studied the role of both soluble and immobilized Gal-9 on human neutrophil recruitment. Soluble Gal-9 significantly strengthened the interaction between neutrophils and the endothelium and inhibited neutrophil crawling on ICAM-1. When immobilized, Gal-9 functioned as an adhesion molecule and captured neutrophils from the flow. Neutrophils adherent to Gal-9 exhibited a spread/activated phenotype that was inhibited by CD18 and CD44 neutralizing antibodies, suggesting a role for these molecules in the pro-adhesive effects of Gal-9. Our data indicate that Gal-9 is expressed and released by the activated endothelium and functions both in soluble form and when immobilized as a neutrophil adhesion molecule. This study paves the way for further investigation of the role of Gal-9 in leukocyte recruitment in different inflammatory settings.
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Groin wound infection after vascular xxposure (GIVE) risk prediction models: development, internal validation, and comparison with existing risk prediction models identified in a systematic literature review.Objective: This study aimed to develop and internally validate risk prediction models for predicting groin wound surgical site infections (SSIs) following arterial intervention and to evaluate the utility of existing risk prediction models for this outcome. Methods: Data from the Groin wound Infection after Vascular Exposure (GIVE) multicentre cohort study were used. The GIVE study prospectively enrolled 1 039 consecutive patients undergoing an arterial procedure through 1 339 groin incisions. An overall SSI rate of 8.6% per groin incision, and a deep/organ space SSI rate of 3.8%, were reported. Eight independent predictors of all SSIs, and four independent predictors of deep/organ space SSIs were included in the development and internal validation of two risk prediction models. A systematic search of the literature was conducted to identify relevant risk prediction models for their evaluation. Results: The "GIVE SSI risk prediction model" ("GIVE SSI model") and the "GIVE deep/organ space SSI risk prediction model" ("deep SSI model") had adequate discrimination (C statistic 0.735 and 0.720, respectively). Three other groin incision SSI risk prediction models were identified; both GIVE risk prediction models significantly outperformed these other risk models in this cohort (C statistic 0.618 - 0.629; p < .050 for inferior discrimination in all cases). Conclusion: Two models were created and internally validated that performed acceptably in predicting "all" and "deep" groin SSIs, outperforming current existing risk prediction models in this cohort. Future studies should aim to externally validate the GIVE models.
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Long-term Outcome Comparison of 2 Techniques for Embolization of Splenic Artery Aneurysms.Purpose: The aim of the study is to analyze our single-center experience in endovascular treatment of splenic artery aneurysms (SAAs) with transcatheter coil embolization, comparing long-term outcomes of packing and sandwich techniques. Materials and methods: Between January 2010 and December 2021, 28 patients with certain diagnosis of non-ruptured asymptomatic SAA were treated with 2 different embolization techniques (packing, n=10, and sandwich, n=18). Early outcomes assessed were technical success, overall mortality, mean hospital stay, post-embolization syndrome rate, and freedom from splenectomy rate. Estimated 5-year outcomes in terms of freedom from sac reperfusion, and freedom from reintervention were evaluated and compared between the 2 different embolization techniques. Results: The mean SAA diameter was 2.8±0.8 cm. Overall technical success rate was 100%. Intraoperative and 30-day mortality rates were 0 in both groups. One patient in the sandwich group required a postoperative splenectomy. The mean follow-up period was 58.3±44.5 months. Estimated overall 5-year survival was 86.7%. Five-year freedom from sac reperfusion was 100% in the sandwich group, and 85.7% in the packing group, with no difference between the 2 groups (p=0.131), whereas freedom from reintervention was 100% in the sandwich group, and 75% in the packing group with a statistically significant difference (p=0.049; log-rank=3.750). Conclusions: Embolization of SAAs seemed to be safe and effective with 100% of technical success rate and good perioperative results. Both sandwich and packing techniques yielded promising results also in the long-term period. Clinical impact: Transcatheter coil embolization of splenic artery aneurysms seems to be a safe and effective procedure with a 100% technical success and satisfactory perioperative outcomes. Sandwich and packing techniques offer good results in the long-term period. Freedom from reintervention seems to be optimal and comparable between the 2 techniques. Keywords: embolization; packing technique; sandwich technique; splenic artery aneurysms; visceral aneurysms.
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Infective native aortic aneurysm: a delphi consensus document on treatment, follow up, and definition of cure.Objective: Evidence is lacking to guide the management of infective native aortic aneurysm (INAA). The aim of this study was to establish expert consensus on surgical and antimicrobial treatment and follow up, and to define when an INAA is considered cured. Methods: Delphi methodology was used. The principal investigators invited 47 international experts (specialists in infectious diseases, radiology, nuclear medicine, and vascular and cardiothoracic surgery) via email. Four Delphi rounds were performed, three weeks each, using an online questionnaire with initially 28 statements. The panellists rated the statements on a five point Likert scale. Comments on statements were analysed, statements were revised and added or deleted, and the results were presented in the iterative rounds. Consensus was defined as ≥ 75% of the panel rating a statement as strongly agree or agree on the Likert scale, and consensus on the final assessment was defined as Cronbach's alpha > 0.80. Results: All 49 panellists completed all four rounds, resulting in 100% participation. One statement was added based on the results and comments of the panel, resulting in 29 final statements: three on need for consensus, 20 on treatment, five on follow up, and one on definition of cure. All 29 statements reached agreement of ≥ 86%. Cronbach's alpha increased for each consecutive round; round 1, 0.85; round 2, 0.90; round 3, 0.91; and round 4, 0.94. Thus, consensus was reached for all statements. Conclusion: INAAs are rare, and high level evidence to guide optimal management is lacking. This consensus document was established with the aim of helping clinicians manage these challenging patients, as a supplement to current guidelines. The presented consensus will need future amendments in accordance with newly acquired knowledge.
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Fenestrated-branch endovascular repair after prior abdominal aortic aneurysm repair.Objective: To report the outcome of fenestrated and branch endovascular aortic repair (FEVAR-BEVAR) for asymptomatic and acute symptomatic proximal aortic pathology in patients with prior open (OSR) or endovascular (EVAR) abdominal aortic aneurysm (AAA) repair. Methods: This was a single centre retrospective study of consecutive patients with non-ruptured (asymptomatic and acute symptomatic) proximal aortic pathology after prior OSR or EVAR treated between December 2007 and February 2020. The primary endpoint was 30 day/in hospital mortality. Secondary endpoints were technical success, primary clinical success, and Kaplan-Meier estimates of medium term survival and freedom from re-intervention. Data are presented as median (interquartile range [IQR]). The effect of covariates on medium term survival was estimated using multivariable (Cox proportional hazards model) analysis. A p value < .05 was considered to be statistically significant. Results: Ninety-two patients (83 men; median age 75 years [IQR 71 - 80 years]; median diameter 73 mm [IQR 64 - 89 mm]; 82 elective, 10 acute) underwent FEVAR-BEVAR after prior OSR (n = 47) or EVAR (n = 45). Indications for intervention were aneurysmal degeneration with or without type 1a endoleak (n = 57; four juxtarenal [JR] AAA, 21 extent II/III, 32 extent IV thoraco-abdominal aortic aneurysms); type 1a endoleak alone (n = 27) and to create a more durable repair after acute infrarenal EVAR (n = 8; JRAAA). In total, 348 renovisceral vessels were targeted for preservation and 324 were stent grafted. Twenty-four unstented vessels comprised one bypass, 11 scallops and six fenestrations intentionally not stent grafted, two vessels occluded before graft implantation, and four vessels occluded intra-operatively. Primary technical success was 95.6%. The thirty day mortality rate was 1.1% and one patient each (1.1%) required permanent dialysis or developed temporary spinal cord ischaemia. Early primary clinical success was 94.6%. Median follow up was 36 months (IQR 23 - 64 months). Estimated overall survival (± standard error) at one, two, and three years was 86% ± 4%, 85% ± 4%, and 70% ± 5%, respectively. Multivariable analysis did not demonstrate any independent predictors of survival. Four target vessels occluded during follow up. Nineteen patients underwent 28 late re-interventions, with almost half performed for issues arising distal to the FEVAR-BEVAR. Patients treated with a cuff were statistically significantly more likely to require distal re-intervention compared with those treated by relining (9/49 vs. 1/43, p = .018 [odds ratio 9.3, 95% confidence interval 1.2 - 423]). In patients with prior EVAR alone, this did not reach statistical significance (cuff 7/25 vs. relining 1/20, p = .059 [odds ratio 7.1, 95% confidence interval 0.8 - 350]). Estimated freedom from re-intervention at one, two, and three years was 88% ± 3%, 81% ± 4%, and 81% ± 4%, respectively. Conclusion: FEVAR-BEVAR after prior OSR or EVAR is associated with low peri-operative morbidity and mortality, and acceptable medium term survival and freedom from re-intervention. Treatment with a FEVAR-BEVAR cuff is associated with a higher requirement for distal re-intervention than relining of the original repair.
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Editor's Choice - PRINciples of optimal antithrombotiC therapy and coagulation managEment during elective fenestrated and branched EndovaScular aortic repairS (PRINCESS): An International Expert Based Delphi Consensus Study.Objective: Management of antithrombotic therapy in patients undergoing elective fenestrated branched endovascular aortic repair (F-BEVAR) is not standardised, nor are there any recommendations from current guidelines. By designing an international expert based Delphi consensus, the study aimed to create recommendations on the pre-, intra-, and post-operative management of antithrombotic therapy in patients scheduled for elective F-BEVAR in high volume centres. Methods: Eight facilitators created appropriate statements regarding the study topic that were voted on, using a four point Likert scale, by a selected panel of international experts using a three round modified Delphi consensus process. Based on the experts' responses, only those statements reaching Grade A (full agreement ≥ 75%) or B (overall agreement ≥ 80% and full disagreement < 5%) were included in the final document. The round answers' consistency was graded using Cohen's k, the intraclass correlation coefficient, and, in case of double re-submission, the Fleiss k. Results: Sixty-seven experts were included in the final analysis and voted the initial 43 statements related to pre- (n = 15), intra- (n = 10), and post-operative (n = 18) management of antithrombotic drugs. At the end of the process, six statements (13%) were rejected, 20 statements (44%) received a Grade B consensus, and 18 statements (40%) reached a Grade A consensus. Most statements (27; 71%) exhibited very high or high consistency grades, and 11 (29%) a fair or poor grading. The intra-operative statements mostly concentrated on threshold for and monitoring of proper heparinisation. The pre- and post-operative statements mainly focused on indications for dual antiplatelet therapy and its management, considering the possible need for cerebrospinal fluid drainage. Conclusion: Based on the elevated strength and high consistency of this international expert based Delphi consensus, most of the statements might guide current clinical management of antithrombotic therapy for elective F-BEVAR. Future studies are needed to clarify the debated issues.