OBJECTIVE:To conduct a health and economic evaluation of different heparinisation strategies during elective open abdominal aortic aneurysm repair. METHODS:Costs were derived from the Dutch National Health Institute, the Dutch Pharmacotherapeutic Registry, and the local hospital ledger. Quality of life (QoL) was assessed using the EuroQol-5-dimension-5-level questionnaire at baseline and at one week, and one, three, and six months after the operation. Resource utilisation data were obtained through the Medical Consumption Questionnaire and the Productivity Cost Questionnaire. RESULTS:Two hundred and ninety-four patients were included; of these, 149 received activated clotting time (ACT) guided heparinisation and 145 received a single bolus of 5 000 IU of heparin. Total healthcare costs at six months were €3 035 313 for the ACT guided group (n = 149) compared with €2 627 682 for the control group (n = 145). The mean total costs per patient were €20 371 (95% confidence interval [CI] 17 090 - 23 653) in the ACT guided group and €18 122 (95% CI 14 849 - 21 395) in the control group (mean difference per patient €2 249, 95% CI -2 370 - 6 868, p = .34). Mean quality adjusted life years over six months was 0.365 (95% CI 0.345 - 0.385) in the ACT group and 0.395 (95% CI 0.375 - 0.415) in the control group (difference 0.030, 95% CI 0.002 - 0.059). QoL at six months was lower in the ACT group (p = .037). Incremental cost utility and cost effectiveness ratios were -€74 664 (95% bias corrected and accelerated CI -444 389 - 195 579) and €83 354 (95% bias corrected and accelerated CI -471 353 - 651 004), respectively. CONCLUSION:In the Activated Clotting Time Guided Heparinisation during Open Abdominal Aortic Aneurysm Repair trial, which was terminated early owing to futility, ACT guided heparinisation did not improve patient outcomes and resulted in a lower QoL at six months, along with negative cost utility.
BACKGROUND:Current literature on AAA is characterized by selective outcome reporting, while guideline recommendations are frequently based on studies of poor methodological quality. To improve evidence synthesis, standardization of outcome measures through a core outcome set (COS) is advocated, particularly in artificial intelligence (AI) research. A COS consists of essential outcomes for reporting in clinical research based on patient and expert consensus. This study aimed to create a COS for research on patients with AAA under surveillance. This COS will be innovatively applied in AI research focused on cardiovascular disease progression. METHODS:First, a longlist of AAA outcomes was identified through a systematic literature search and focus groups with patients, caregivers, and healthcare professionals. A three-round European Delphi survey was subsequently conducted with patients and healthcare professionals. In an expert consensus meeting with key opinion leaders and patients, the COS was finalized. RESULTS:The 91-outcome AAA longlist was used in the Delphi study, in which 104 patients and 153 healthcare professionals participated. The highest-rated outcomes from the third Delphi round were discussed in the expert consensus meeting, attended by 23 key opinion leaders, 2 patients, and 1 patient representative from a patient society. Ten core preoperative and postoperative outcomes were chosen across 6 health domains, with AAA rupture, survival, health-related quality of life, clinical success, and graft infection attaining 100% consensus for inclusion in the COS. CONCLUSION:This COS consists of 10 outcomes and should be implemented in clinical and AI research on AAA under surveillance.
OBJECTIVE:This study aimed to investigate the association between sarcopenia and spinal cord ischemia (SCI) after fenestrated and branched endovascular aortic repair (F/B-EVAR) using two- and three-dimensional measurements of the psoas and iliopsoas muscles on preoperative computed tomography angiography (CTA). METHODS:A retrospective, two-center study was conducted and reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Data were collected from patients with Crawford type I-IV thoracoabdominal aortic aneurysms (TAAA) and pararenal abdominal aortic aneurysms treated with F/B-EVAR between December 2010 and January 2024. One center included all consecutive patients, whereas from the other center, patients with SCI were actively selected together with non-SCI patients in a 1:1 fashion based on patient and procedural characteristics. Preoperative CTAs were analyzed for surrogate markers of sarcopenia, including the psoas muscle area (cm2), lean psoas muscle area (cm2∗HU [Hounsfield units]), iliopsoas muscle volume (cm3), and lean iliopsoas muscle volume (cm3∗HU). Area measurements were performed manually, whereas volume measurements were performed using an artificial intelligence-based segmentation tool. The primary outcome was to evaluate the predictive value of the measured sarcopenia surrogate markers for SCI occurrence. RESULTS:A total of 138 patients (35.5% female; median age 72 years, interquartile range [IQR]: 68-75 years), with 16 Crawford type I (11.6%), 45 type II (32.6%), 30 type III (21.7%), and 47 type IV/pararenal (34.1%) aneurysms, were included. Fifty-one patients had postoperative SCI (all severities), and 87 had no SCI symptoms. Compared with non-SCI patients, patients with SCI had higher American Society of Anesthesiologists classification (P = .005), more commonly type II TAAA (P < .001), and symptomatic presentation (P = .016). Other patient characteristics were similar between the groups. Psoas muscle area (6.97 cm2 [IQR: 5.22-8.73 cm2] vs 8.47 cm2 [IQR: 6.39-10.03 cm2], P = .003), lean psoas muscle area (253.3 cm2∗HU [IQR: 204.9-333.8 cm2∗HU] vs 335.6 cm2∗HU [IQR: 256.3-409.7 cm2∗HU], P = .002), iliopsoas muscle volume (247.6 cm3 [IQR: 184.0-303.8 cm3] vs 277.7 cm3 [IQR: 234.1-331.5 cm3], P = .018), and lean iliopsoas muscle volume (10,879 cm3∗HU [IQR: 8589-14,497 cm3∗HU] vs 13,445 cm3∗HU [IQR: 10,777-16,396 cm3∗HU], P = .004) were lower in patients with SCI in the unadjusted analyses. On multivariable analysis, only psoas muscle area was independently associated with SCI (odds ratio: 0.815; 95% confidence interval: 0.680-0.977, P = .027). CONCLUSIONS:Psoas muscle area was independently associated with SCI after F/B-EVAR, indicating that patients with signs of sarcopenia on preoperative CTA may be at a higher risk for SCI. Volumetric iliopsoas muscle measurements were not better predictors of SCI than two-dimensional measurements of the psoas muscle area.
The anti-Xa test is regarded as the standard assay to measure unfractionated heparin activity in a laboratory setting, but its use during arterial procedures has not been established. The objectives of this systematic review, designed as a scoping review, were to structure the existing body of evidence, identify possible research gaps, and provide guidance for future research on the applicability of anti-Xa to measure the heparin activity during arterial procedures. Literature search resulted in 55 included reports (cardiac procedures: 44 reports; noncardiac procedures: 9 reports; cardiac and noncardiac procedures: 2 reports). During arterial procedures, anti-Xa is widely used as reference laboratory test to validate heparin point-of-care assays, compare different heparinization strategies and measure residual heparin activity at the end of the procedure or after heparin reversal using protamine. There is considerable heterogeneity among included reports, which hampers the ability to draw firm conclusions. The available literature is insufficient to define optimal periprocedural heparin activity measured by anti-Xa. Currently, anti-Xa is not used as a primary heparin monitoring assay during arterial procedures. The impact of alterations in periprocedural anti-Xa activity on clinical outcomes has been rarely investigated. Anti-Xa measurements appear to be reproducible compared with point-of-care heparin activity essays but require standardization. In conclusion, anti-Xa is useful as a reference test to evaluate point-of-care heparin testing and compare heparin strategies during arterial procedures, but there is a high need for studies to investigate correlation of anti-Xa levels with clinical outcomes and to determine optimal anti-Xa levels for arterial procedures.
INTRODUCTION:Intravascular ultrasound (IVUS) provides cross-sectional information on the intraluminal features of blood vessels, aiding procedural planning and postprocedural assessment of results. Although the use of IVUS in aortic procedures is increasing worldwide, consensus on best practices in aortoiliac interventions is still lacking. This study aims to obtain experts' consensus and define recommendations regarding applications of intravascular ultrasound in aortoiliac endovascular interventionsMethods:Delphi consensus methodology was performed over 3 rounds, using a panel of 27 experts. Each member was asked to grade (grade A-grade D) 26 statements regarding various applications of IVUS in aortoiliac surgery. Statements that passed the first round were proposed at the second round unmodified. Statements that failed the first round underwent stylistic modifications without altering their meaning and were proposed in the second and third rounds. Agreement and consistency were used to develop recommendations on the applications of IVUS in aortoiliac endovascular interventions. RESULTS:After 3 rounds, 17 recommendations were made (16 grade B, 1 grade A), whereas 8 statements were rejected, and the core team eliminated 1. Ten recommendations (58.8%) obtained grade IV (poor), 1 (5.9%) grade III (fair), 2 (11.8%) grade II (high), and 4 (23.5%) were classified as grade I (very high). CONCLUSIONS:Intravascular ultrasound is an important adjunct imaging technology in hybrid rooms. Most of the recommendations concerned the use of IVUS in aortic dissection. Other important recommendations for preoperative planning and evaluation of postoperative results were made in radioprotection, aortic aneurysms, and blunt thoracic aortic injury. Intravascular ultrasound assistance in aortoiliac occlusive disease is not routinely recommended at the present time.Clinical ImpactThis international expert-based Delphi consensus provides a comprehensive perspective on the current applications of intravascular ultrasound across various aspects of aortoiliac endovascular therapy. Clinical practice guidelines are currently lacking recommendations on the use of intravascular ultrasound (IVUS) as an adjunctive tool in aortoiliac endovascular surgery; therefore, this study aims to fill the current gap in the literature by assessing the role of IVUS across high-volume aortic centers and offering recommendations on possible IVUS applications in aortoiliac endovascular interventions. Areas of ongoing debate regarding IVUS are also highlighted in this article, to provide inputs for further research.
Superior mesenteric artery (SMA) syndrome is a rare cause of proximal intestinal obstruction resulting from compression of the third portion of the duodenum between the aorta and the superior mesenteric artery. The Strong procedure offers a physiological alternative to duodenojejunostomy by performing full duodenal mobilization, thereby omitting the need for an intestinal bypass (e.g., duodenojejunostomy). We present the case of a woman with chronic postprandial abdominal pain, nausea, and bloating, refractory to conservative management. When the patient positioned herself in a left lateral fetal position, the complaints resolved. Preoperative imaging demonstrated a reduced SMA-aorta distance (8.1 mm) with a normal aortomesenteric angle (52.1°), as well as signs of duodenal stasis, all potentially consistent with SMA syndrome. The patient underwent a Robot Strong procedure consisting of division of the ligament of Treitz and full duodenal mobilization, including Kocherization. The postoperative course was uneventful. At 6 weeks of follow-up, symptoms were resolved completely, with improved oral intake. At imaging follow-up, the duodenum was placed more caudally, fitting with the expected outcome. These findings confirm the feasibility and clinical effectiveness of the Robot Strong procedure in highly selected patients with SMA syndrome.
BACKGROUND:Elective repair for an abdominal aortic aneurysm (AAA) is performed to prevent rupture and subsequent death. The risk of early mortality is higher after open repair than after endovascular repair and needs to be reduced. Registries lack granular individual data to investigate this increased mortality. An independent, detailed, patient-level analysis of the international randomized controlled ACTION-1 trial was performed to investigate the relation between thromboembolic, hemorrhagic, or other events with mortality after open AAA repair, thereby exploring the cascade of pathological events leading to death. METHODS:An adjudication committee was installed to assess the following domains: attributability of thromboembolic or bleeding event, whether the event occurred intraoperative or postoperative, cascade of pathological events, and cause of death. An intraoperative bleeding score was calculated to stratify the severity of bleeding. RESULTS:In 16 out of 20 deceased patients (80%), death was attributable to a thromboembolic or bleeding event. Four patients (20%) succumbed to causes unrelated to a thromboembolic or bleeding event. Intraoperative bleeding was the primary cause of death in 4 patients, all of whom underwent activated clotting time-guided heparinization. In contrast, an intraoperative thromboembolic event was the primary cause of death in one patient who had received 5,000 IU of heparin. CONCLUSION:In a randomized controlled trial on 297 patients with open AAA repair, 16 out of 20 (80%) deaths were due to bleeding or thromboembolic events. In most deceased patients, increased perioperative bleeding resulted in a pathological cascade of hypoperfusion, organ failure, and shock. Bleeding and thromboembolic complications must be addressed to reduce mortality after elective open AAA repair.
OBJECTIVE:This study was designed to investigate agreement between vascular surgeons and expert team consensus assessment, and inter-observer variability for endovascular aneurysm repair (EVAR) feasibility in patients with a ruptured abdominal aortic aneurysm (rAAA) on computed tomography angiography (CTA). METHODS:Sixteen vascular surgeons assessed EVAR feasibility in 20 rAAA patients based on CTA. The majority of patients had rAAA with challenging anatomy. Surgeons were observed, and time to treatment decision (EVAR or open surgical repair [OSR]) was monitored to mimic an acute setting. Reference measurements were determined by an expert team consensus assessment in an elective setting using central luminal line-generating software without time pressure, following the instructions for use (IFU) of the endografts available to the participants. Primary outcomes were: (1) agreement between vascular surgeons in the simulated emergency setting and the expert team on feasibility of EVAR and (2) time to decision on treatment by the 16 surgeons. RESULTS:Out of 20 rAAA cases, 10 (50%) were deemed feasible for EVAR according to the expert team. There was slight agreement between surgeons and the expert team on feasibility for EVAR (Cohen's kappa = 0.13, interquartile range [IQR] 0.25). In a median of 12 rAAA (60%) cases, surgeons chose the same treatment as the expert team. Interobserver variability comparing observers with each other was fair (Fleiss' kappa = 0.28, 95% CI, 0.24-0.32). Median time to treatment decision was 2 minutes and 26 seconds (IQR 2 minutes and 10 seconds). Agreement on main body endograft size between individual surgeons and the expert team occurred in a median of 2 (33%, IQR 1) cases. In 16 (80%) of the cases, EVAR was deemed the preferred treatment option, irrespective of IFU according to the expert team. CONCLUSION:Vascular surgeons showed minimal consensus when assessing the feasibility of EVAR for patients with rAAA with a challenging anatomy using CTA. The time taken to decide upon EVAR feasibility was notably brief.Clinical ImpactIn patients with ruptured abdominal aortic aneurysms and complex anatomy, vascular surgeons showed limited agreement when assessing EVAR feasibility using CTA compared with reference measurements determined by an expert team consensus assessment, and considerable interobserver variability. Agreement on main body endograft choice was low. Median time to treatment decision was 2 min and 26 s. Granting additional time for comprehensive assessment of EVAR feasibility, multidisciplinary team-decision making, the use of AI-supported tools such as CLL generating software, and higher levels of clinical experience in complex rAAA cases might improve interobserver agreement in both future research and clinical context.
BACKGROUND:Ruptured abdominal aortic aneurysm (RAAA) remains a medical catastrophe. Although early outcomes improved, contemporary data integrating early and long-term survival, and postdischarge care needs across sex- and age groups is limited. METHODS:This nationwide cohort included Dutch RAAA repairs between 2014 and 2023. Dutch Surgical Aneurysm Audit data were linked to Statistics Netherlands registries. Outcomes included 90-day mortality, long-term survival, and postdischarge care. RESULTS:Of the 3642 patients, 15.2% were women, who were older (76.3 vs. 74.0 y) and more often required open repair (61.4% vs. 54.0%). Ninety-day mortality increased with age and was higher in women (39.1% vs. 29.1%), but female sex was not independently associated with early mortality after adjustment.Among 90-day survivors, absolute long-term survival was similar, but relative survival was lower in women (5-year relative survival 68.0% vs. 78.3%). Women were less often discharged home (42.4% vs. 56.7%) and more frequently required early homecare (47.7% vs. 34.7%). Reinterventions were more common after EVAR than open repair and occurred less frequently in women. CONCLUSION:In this nationwide linked audit-registry analysis, outcomes after RAAA repair improved substantially, despite lower estimated in-hospital turndown rates than in earlier eras. The higher early mortality in women reflected by differences in age, presentation severity, and repair type, possibly reflecting less favorable aneurysm anatomy. Female sex also associated with an increased long-term excess mortality and greater postdischarge dependency. These findings indicate that optimization of care for women with a RAAA is not confined to perioperative mortality, but extends across the entire care pathway.
Background: Ruptured abdominal aortic aneurysm (RAAA) remains a medical catastrophe. Although early outcomes improved, contemporary data integrating early and long-term survival, and postdischarge care needs across sex- and age groups is limited. Methods: This nationwide cohort included Dutch RAAA repairs between 2014 and 2023. Dutch Surgical Aneurysm Audit data were linked to Statistics Netherlands registries. Outcomes included 90-day mortality, long-term survival, and postdischarge care. Results: Of the 3642 patients, 15.2% were women, who were older (76.3 vs. 74.0 y) and more often required open repair (61.4% vs. 54.0%). Ninety-day mortality increased with age and was higher in women (39.1% vs. 29.1%), but female sex was not independently associated with early mortality after adjustment. Among 90-day survivors, absolute long-term survival was similar, but relative survival was lower in women (5-year relative survival 68.0% vs. 78.3%). Women were less often discharged home (42.4% vs. 56.7%) and more frequently required early homecare (47.7% vs. 34.7%). Reinterventions were more common after EVAR than open repair and occurred less frequently in women. Conclusion: In this nationwide linked audit-registry analysis, outcomes after RAAA repair improved substantially, despite lower estimated in-hospital turndown rates than in earlier eras. The higher early mortality in women reflected by differences in age, presentation severity, and repair type, possibly reflecting less favorable aneurysm anatomy. Female sex also associated with an increased long-term excess mortality and greater postdischarge dependency. These findings indicate that optimization of care for women with a RAAA is not confined to perioperative mortality, but extends across the entire care pathway.
OBJECTIVE:To develop a non-contrast magnetic resonance angiography (NC-MRA) that offers an ionizing radiation and contrast agent-free alternative to computed tomography angiography (CTA) for detailed assessment of abdominal aortic aneurysms (AAAs). Secondly, the suitability of NC-MRA for endovascular aneurysm repair (EVAR) planning compared to CTA was assessed. METHODS:A motion-resolved 3-dimensional balanced steady-state free precession (bSSFP) magnetic resonance angiography (MRA) was performed at 3.0 T and optimized to achieve image quality comparable to CTA without requiring breath-holding. Nineteen morphometric measurements (diameter, length, and angle) in 9 prospectively included male patients (median age 66 [8] years; maximum AAA diameter 57 [10] mm, ClinicalTrials.gov ID: NCT05976711) were assessed by 5 observers and 3 aortic sizing specialists based on NC-MRA and standard CTA. The suitability of NC-MRA for EVAR planning was assessed through qualitative observer evaluation, interobserver agreement (2-way random-effects, absolute-agreement, single-measure intraclass correlation coefficient [ICC]), non-inferiority analysis with a 1-sided 1-sample t test, and agreement in Medtronic Endurant II/IIs endograft selection. RESULTS:The acquisition parameters of the resulting NC-MRA sequence are comparable to standard CTA. Image suitability was rated as excellent in 11 (20.4%) cases, good in 28 (51.9%) cases, and moderate in 15 (27.8%) cases. The interobserver variability for assessing morphometric parameters was comparable between NC-MRA (mean = 0.74) and CTA (mean = 0.73). The NC-MRA was non-inferior to CTA for all neck diameters, half of the iliac artery diameters, one of the length diameters, and for vessel angulation. Regarding stent selection: 1 observer showed complete agreement between modalities, 3 observers showed 1 discrepancy, and 2 observers showed 1 discrepancies. CONCLUSION:The developed NC-MRA sequence demonstrated interobserver variability comparable to CTA and was non-inferior for the majority of morphometric measurements. The sequence demonstrates potential for routine clinical use, as it is easily implementable within the current clinical workflow, with additional observer training likely to further enhance performance.Clinical ImpactThis study demonstrates a rapid, 3D non-contrast magnetic resonance angiography (NC-MRA) acquisition developed for endovascular aneurysm repair (EVAR) planning. Unlike most previously developed techniques the resulting acquisition parameters are highly comparable to computed tomography angiography (CTA), facilitating both implementation in the clinical workflow and reliable morphometric assessment. Morphometric parameters were assessed by EVAR specialists from diverse clinical backgrounds who were primarily experienced in CTA and received NC-MRA training, reflecting real-world clinical adoption. NC-MRA showed interobserver variability similar to CTA and was non-inferior for most morphometric measurements. With additional observer training, this technique may be suitable for clinical implementation.
OBJECTIVE:To perform a systematic review and meta-analysis of randomised trials and observational studies assessing outcomes of different endovascular management approaches for the treatment of acute lower limb ischaemia (ALI) when adjusted for Rutherford classification. DATA SOURCES:PubMed, Embase, Cochrane Library, and Web of Science. REVIEW METHODS:A literature search was performed in PubMed, Embase, Cochrane Library, and Web of Science on 30 January 2025. Studies recruiting patients after the year 2000, assessing at least 10 adult patients with ALI, reporting Rutherford classification, and comparing different endovascular management approaches were included. The main outcomes of interest were 30 day death, 30 day major amputation, major bleeding, distal embolisation, acute kidney injury, and fasciotomy. Comparative studies reporting patients undergoing a combination of therapies without a clear order were excluded. If at least three studies reported unadjusted effect sizes, providing Rutherford classification for the groups under comparison, a multiple meta-regression random effects model was used to adjust for disease severity. Evidence certainty was based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. RESULTS:A total of 9 801 publications were identified, of which 153 were selected for full text review, and seven were included in the systematic review and analysis. The available data only allowed one meta-regression analysis of three observational studies comparing AngioJet pharmacomechanical thrombolysis first vs. continuous catheter directed thrombolysis (recombinant tissue plasminogen activator) first, which showed no difference in 30 day mortality rates between groups in the unadjusted analysis (odds ratio 1.19, 95% confidence interval 0.38 - 3.67; p = .44; I2 = 13%). Heterogeneity was low (p = .31; I2 = 0%), and Rutherford classification IIb was not statistically significant (p = .58) in the meta-regression model. The level of certainty for the summarised evidence was very low. CONCLUSION:The putative benefit of percutaneous endovascular thrombectomy over continuous catheter directed thrombolysis was not proven. The quality of summarised evidence was very low. Adequately powered high quality randomised trials are needed to assess the comparative efficacy of endovascular therapies in ALI.
BACKGROUND:Documentation of perioperative bleeding during vascular procedures is crucial for monitoring efficacy, safety, and to evaluate patient outcomes. This study validated the European Multicenter Study on Coronary Artery Bypass Grafting (E-CABG) bleeding classification for evaluating perioperative bleeding in patients undergoing open peripheral arterial surgery (OPAS). METHODS:Prospective, multicenter cohort study including adult patients undergoing elective OPAS. Patients undergoing abdominal aortic surgery were excluded to maintain a homogeneous bleeding risk profile. Primary outcome was the incidence of complications categorized per E-CABG grade. Logistic regression was used to evaluate the predictive ability of Grade I or higher on patient outcomes. The model was adjusted for type of OPAS to minimize heterogeneity. RESULTS:A total of 778 patients were included. Ninety-four patients (12%) suffered a bleeding complication (Grade I: n = 47, 6.0%; Grade II: n = 47, 6.0%). Patients suffering Grade ≥ I had significantly more thrombo-embolic complications (TECs) (P < 0.001), myocardial infarction (P = 0.006), bowel ischemia (P < 0.001), graft thrombosis (P = 0.019), graft infection (P = 0.026), wound infection (P < 0.001), pneumonia (P = 0.024), prolonged duration of hospital admission (P < 0.001), higher reoperation (P < 0.001), and mortality (P < 0.001) than patients without a bleeding complication. In a multivariate model, Grade ≥ I predicted 30-day mortality (area under the curve (AUC) 0.81, 95% confidence interval [CI] 0.63-0.96), reoperation other than bleeding (AUC 0.75, 95% CI 0.66-0.85), wound infection (AUC 0.76, 95% CI 0.72-0.80), and TEC (AUC 0.67, 95% CI 0.58-0.76). CONCLUSION:The E-CABG bleeding classification is applicable for stratifying the severity of perioperative bleeding in OPAS and predicting adverse short-term postoperative outcomes for research and registry databases.
Objective: Peri-procedural antithrombotics are used extensively to prevent thromboembolic complications during non-cardiac arterial procedures (NCAP) worldwide. However, there is a lack of evidence to support recommendations on antithrombotic strategies, possibly leading to substantial variation in local practices. A comprehensive overview of antithrombotic strategies is needed to identify the most widely accepted protocols employed during NCAP, highlight variations in local practices, and identify new research targets to establish evidence based peri-procedural anticoagulation management. Methods: An international, web based survey study was conducted from March to October 2023, targeting vascular clinical specialists who applied antithrombotic strategies during NCAP in daily practice. Results: The survey was completed by 436 vascular clinical specialists from 45 countries (Europeans: 93%, vascular surgeons or vascular surgery residents: 98%). Systemic unfractionated heparin was used by nearly all vascular specialists during all procedures (varying between 98-99%, depending on the procedure type), but could vary depending on specific NCAP. A fixed starting dose (39-52%, most often 5 000 IU [80-89%]) or an actual bodyweight dependent dose (42-52%, most commonly 100 IU/kg [40-67%] or 50 IU/kg [17-40%]) was mainly used. Except during fenestrated or branched endovascular aneurysm repair procedures (51%), activated clotting time (ACT) was employed by a minority (26-31%). A large variety in measurement protocols was observed, yet a target ACT of 200 seconds was most often used for all NCAP types (44-54%). Most vascular specialists considered a heparin follow up dose (61-81%) and heparin reversal using protamine (54-63%), both for a variety of indications. Of the participants, 68% expressed discontent with their current antithrombotic Conclusion: This comprehensive, international survey study revealed large variation among vascular clinical specialists' heparinisation strategies during NCAP. Together with the considerable discontent expressed regarding protocols, this emphasises the urgent need for comparative, randomised studies on antithrombotic management (c) 2025 The Authors. Published by Elsevier Ltd on behalf of European Society for Vascular Surgery. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
Objective Inconsistencies in outcome data of therapeutic strategies for acute lower limb ischaemia (ALI) have hindered the synthesis of findings. A core outcome set (COS) may offer a solution to this problem by defining a minimum set of outcomes that are considered essential to all stakeholders involved. The first step in developing a COS is to review the previously reported outcomes on various treatment strategies for ALI. Data Sources PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science databases were searched from inception to August 2023. Review Methods This systematic review was conducted in accordance with the Core Outcome Measures in Effectiveness Trials (COMET) initiative framework, adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and was pre-registered with PROSPERO (CRD42022320073). Abstracts were independently screened by two authors for full text review. All outcomes and their definitions were extracted from selected papers. Outcomes with different terminologies were then categorised into an “agreed outcome term”. The list of agreed outcomes was given a standardised outcome domain and core area using a 38 item standardised taxonomy. Results Of 6 184 articles identified, 176 relevant studies were included, yielding 1 325 verbatim outcomes. After deduplication, 72 unique verbatim outcomes were categorised into five broad outcome domains. Outcomes considered key to the evaluation of treatment of ALI were further categorised as delivery of care (19.4%), vascular outcomes (13.8%), and adverse events (12.5%). The three most frequently reported agreed outcomes were amputation (14.1%), mortality (12.3%), and general bleeding (11.6%). Conclusion This systematic review provides an overview of currently reported outcomes in the literature of interventions for ALI. After categorisation into agreed outcome terms, 72 outcomes were identified that can be used in the development of a COS.
OBJECTIVE:The current literature on abdominal aortic aneurysms (AAAs) is characterised by heterogeneous outcome reporting and lack of standardisation. Thus, a core outcome set (COS) for patients with intact AAA not undergoing repair is being developed. The disease course in these patients is uncertain; some may progress, necessitating surgery, while others may remain stable over time. Therefore, both outcomes following conservative therapy and post-operative outcomes are important in research on AAA not undergoing repair. A systematic review identifying clinical and patient reported AAA related outcomes was conducted. DATA SOURCES:PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science were systematically searched from 1 January 2020 until 24 November 2023. REVIEW METHODS:The Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement was adhered to. The study protocol was pre-registered in the PROSPERO registry (CRD42023478594) and Core Outcome Measures in Effectiveness Trials (COMET) database (study no. 2856). All studies on clinical and or patient reported outcomes on all types of AAA, including those on AAA not undergoing repair and post-operative AAA, from 2020 onwards were included. Abstract and full text screening was performed by three independent authors. Outcomes and their definitions were extracted verbatim from each article. Each outcome was harmonised into an agreed outcome term based on similarities in definitions. Agreed outcome terms were categorised into domains according to the Dodd taxonomy. RESULTS:Of the 5 611 articles identified through the literature search, 612 full texts were screened for eligibility and 380 studies were included. A total of 264 unique outcomes were identified. The most frequently reported outcomes were death (n = 341), myocardial infarction (n = 148), and reintervention (n = 145). After classification into agreed outcome terms, the final longlist comprised 77 AAA outcomes. CONCLUSION:The definitive 77 item AAA outcome longlist will be used in a Delphi study to create a COS for research on intact AAA not undergoing repair.