ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.
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ABSTRACT:
SUBMITTER: Wiersema AM
PROVIDER: S-EPMC8449992 | biostudies-literature | 2021 Sep
REPOSITORIES: biostudies-literature
Publications
ACTION-1: study protocol for a randomised controlled trial on ACT-guided heparinization during open abdominal aortic aneurysm repair.
Wiersema Arno M AM Roosendaal Liliane C LC Koelemaij Mark J W MJW Tijssen Jan G P JGP van Dieren Susan S Blankensteijn Jan D JD Debus E Sebastian ES Middeldorp Saskia S Heyligers Jan M M JMM Fokma Ymke S YS Reijnen Michel M P J MMPJ Jongkind Vincent V
Trials 20210919 1
<h4>Background</h4>Heparin is used worldwide for 70 years during all non-cardiac arterial procedures (NCAP) to reduce thrombo-embolic complications (TEC). But heparin also increases blood loss causing possible harm for the patient. Heparin has an unpredictable effect in the individual patient. The activated clotting time (ACT) can measure the effect of heparin. Currently, this ACT is not measured during NCAP as the standard of care, contrary to during cardiac interventions, open and endovascular ...[more]
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Project description:Endovascular aneurysm repair (EVAR) has dramatically changed the management of abdominal aortic aneurysms (AAAs) as the number of open aneurysm repairs have declined over time. This report compares AAA-related demographics, operative data, complications, and mortality after treatment by open aneurysm repair or EVAR.We retrospectively reviewed 136 patients with AAAs who were treated over an 8-year time period with open aneurysm repair or EVAR.The mean age of the EVAR group was higher than that of the open repair group (p=0.001), and hospital mortality did not differ significantly between groups (p=0.360). However, overall survival was significantly lower in the EVAR group (p=0.033).Although EVAR is the primary treatment modality for elderly patients, it would be ideal to set slightly more stringent criteria within the anatomical guidelines contained in the instructions for use of the EVAR device when treating younger patients.
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Project description:OBJECTIVES:Emergency endovascular aneurysm repair (eEVAR) may improve outcomes for patients with ruptured abdominal aortic aneurysm (RAAA). The study aim was to compare the outcomes for eEVAR with conventional open surgical repair for the treatment of RAAA. SETTING:A systematic review of relevant publications was performed. Randomised controlled trials (RCTs) comparing eEVAR with open surgical repair for RAAA were included. PARTICIPANTS:3 RCTs were included, with a total of 761 patients with RAAA. INTERVENTIONS:Meta-analysis was performed with fixed-effects models with ORs and 95% CIs for dichotomous data and mean differences with 95% CIs for continuous data. PRIMARY AND SECONDARY OUTCOME MEASURES:Primary outcome was short-term mortality. Secondary outcome measures included aneurysm-specific and general complication rates, quality of life and economic analysis. RESULTS:Overall risk of bias was low. There was no difference between the 2 interventions on 30-day (or in-hospital) mortality, OR 0.91 (95% CI 0.67 to 1.22; p=0.52). 30-day complications included myocardial infarction, stroke, composite cardiac complications, renal complications, severe bowel ischaemia, spinal cord ischaemia, reoperation, amputation and respiratory failure. Reporting was incomplete, and no robust conclusion was drawn. For complication outcomes that did include at least 2 studies in the meta-analysis, there was no clear evidence to support a difference between eEVAR and open repair. Longer term outcomes and cost per patient were evaluated in only a single study, thus precluding definite conclusions. CONCLUSIONS:Outcomes between eEVAR and open repair, specifically 30-day mortality, are similar. However, further high-quality trials are required, as the paucity of data currently limits the conclusions.
| S-EPMC4762122 | biostudies-other
Project description: Not available
| S-EPMC10749584 | biostudies-literature
Project description:BackgroundThe sharp decrease in open surgical repair (OSR) for abdominal aortic aneurysm (AAA) has raised concerns about contemporary postoperative outcomes. The study was designed to analyse the impact of complications on clinical outcomes within 30 days following OSR.MethodsPatients who underwent OSR for intact AAA registered prospectively between 2016 and 2019 in the Dutch Surgical Aneurysm Audit were included. Complications and outcomes (death, secondary interventions, prolonged hospitalization) were evaluated. The adjusted relative risk (aRr) and 95 per cent confidence intervals were computed using Poisson regression. Subsequently, the population-attributable fraction (PAF) was calculated. The PAF reflects the expected percentage reduction of an outcome if a complication were to be completely prevented.ResultsA total of 1657 patients were analysed. Bowel ischaemia and renal complications had the largest impact on death (aRr 12·44 (95 per cent c.i. 7·95 to 19·84) at PAF 20 (95 per cent c.i. 8·4 to 31·5) per cent and aRr 5·07 (95 per cent c.i. 3·18 to 8.07) at PAF 14 (95 per cent c.i. 0·7 to 27·0) per cent, respectively). Arterial occlusion had the greatest impact on secondary interventions (aRr 11·28 (95 per cent c.i. 8·90 to 14·30) at PAF 21 (95 per cent c.i. 14·7 to 28·1) per cent), and pneumonia (aRr 2·52 (95 per cent c.i. 2·04 to 3·10) at PAF 13 (95 per cent c.i. 8·3 to 17·8) per cent) on prolonged hospitalization. Small effects were observed on outcomes for other complications.ConclusionThe greatest clinical impact following OSR can be made by focusing on measures to reduce the occurrence of bowel ischaemia, arterial occlusion and pneumonia.
| S-EPMC8438252 | biostudies-literature
Project description:BackgroundThere is a lack of evidence for the association between intensive statin therapy and outcomes following vascular surgery. The aim of this study was to evaluate the association between perioperative statin intensity and in-hospital mortality following open abdominal aortic aneurysm (AAA) repair.MethodsPatients undergoing open AAA repair between 2009 and 2015 were identified from the Premier Healthcare Database. Statin use was classified into low, moderate and high intensity, based on American College of Cardiology/American Heart Association guidelines. Supratherapeutic intensity was defined as doses higher than the recommended guidelines. Multivariable logistic regression analyses were undertaken to assess the association between statin intensity and postoperative major adverse events and in-hospital mortality.ResultsOf 6497 patients undergoing open AAA repair, 3217 (49·5 per cent) received perioperative statin. Statin users were more likely to present with three or more co-morbidities than non-users (26·5 versus 21·8 per cent; P < 0·001). Unadjusted postoperative mortality was significantly lower in statin users (2·6 versus 6·3 per cent; P < 0·001); however, there was no difference in the risk of developing major adverse events. Multivariable analysis showed that statin use was associated with lower odds of death (odds ratio 0·41, 95 per cent c.i. 0·31 to 0·54). Moderate, high and supratherapeutic statin intensities were not associated with lower odds of death or major adverse events compared with low-intensity statin therapy.ConclusionStatin use is associated with lower odds of death in hospital following open AAA repair. High-intensity statins were not associated with lower morbidity or mortality.
| S-EPMC6254010 | biostudies-literature
Project description:BackgroundOpen repair of abdominal aortic aneurysms (AAAs) is occasionally performed in conjunction with additional procedures; however, how these concomitant procedures affect outcome is unclear. This study determined the frequency of additional procedures during elective open AAA repair and the effect on perioperative outcomes.MethodsAll elective infrarenal open AAA repairs between January 2003 and November 2014 in the Vascular Study Group of New England (VSGNE) were identified. Patients were grouped by concomitant procedures, which included no concomitant procedure, renal artery bypass, lower extremity bypass, other abdominal procedure, or thromboembolectomy. Analyses were performed using multivariable logistic regression.ResultsOf 1314 patients who underwent elective AAA repair, 153 (11.6%) had a concomitant procedure, including renal bypass in 27 (2.1%), lower extremity bypass in 28 (2.1%), other abdominal procedures in 64 (4.9%), and thromboembolectomy in 48 (3.7%). Independent risk factors for 30-day mortality were renal bypass (odds ratio [OR], 7.2; 95% confidence interval [CI], 1.9-27.7), other abdominal procedures (OR, 4.8; 95% CI, 1.6-14.1), and thromboembolectomy (OR, 8.8; 95% CI, 3.1-24.9). Deterioration of renal function was predicted by renal bypass (OR, 5.1; 95% CI, 2.1-12.4) and thromboembolectomy (OR, 3.7; 95% CI, 1.8-7.6). Lower extremity bypass and thromboembolectomy were predictive of postoperative leg ischemia (OR, 8.9; 95% CI, 2.7-29.0; OR, 11.2; 95% CI, 4.4-28.8, respectively), and thromboembolectomy was also predictive of postoperative bowel ischemia (OR, 4.4; 95% CI, 1.6-12.0).ConclusionsPerforming additional procedures during infrarenal open AAA repair is associated with increased morbidity and mortality in the postoperative period. Careful deliberation of the operative risks and the necessity of the additional interventions are therefore advised during operative planning. This study also highlights the importance of avoiding perioperative thromboembolic events.
| S-EPMC5025327 | biostudies-literature
Project description:IntroductionIn patients with large abdominal aortic aneurysm (AAA), open surgical or endovascular aneurysm repair procedures are often used to minimise the risk of aneurysm-related rupture and death; however, aneurysm repair itself carries a high risk. Low cardiopulmonary fitness is associated with an increased risk of early post-operative complications and death following elective AAA repair. Therefore, fitness should be enhanced before aneurysm repair. High-intensity interval exercise training (HIT) is a potent, time-efficient strategy for enhancing cardiopulmonary fitness. Here, we describe a feasibility study for a definitive trial of a pre-operative HIT intervention to improve post-operative outcomes in patients undergoing elective AAA repair.Methods and analysisA minimum of 50 patients awaiting elective repair of a 5.5-7.0 cm infrarenal AAA will be allocated by minimisation to HIT or usual care control in a 1:1 ratio. The patients allocated to HIT will complete three hospital-based exercise sessions per week, for 4 weeks. Each session will include 2 or 4 min of high-intensity stationary cycling followed by the same duration of easy cycling or passive recovery, repeated until a total of 16 min of high-intensity exercise is accumulated. Outcomes to be assessed before randomisation and 24-48 h before aneurysm repair include cardiopulmonary fitness, maximum AAA diameter and health-related quality of life. In the post-operative period, we will record destination (ward or critical care unit), organ-specific morbidity, mortality and the durations of critical care and hospital stay. Twelve weeks after the discharge, participants will be interviewed to reassess quality of life and determine post-discharge healthcare utilisation. The costs associated with the exercise intervention and healthcare utilisation will be calculated.Ethics and disseminationEthics approval was secured through Sunderland Research Ethics Committee. The findings of the trial will be disseminated through peer-reviewed journals, and national and international presentations.Trial registrationCurrent Controlled Trials ISRCTN09433624.
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Project description:Objective: To find a new predictor of endoleak (EL) and aneurysm sac expansion after endovascular aneurysm repair (EVAR), we evaluated the platelet count recovery (PCR) process after EVAR. Materials and Methods: Two hundred five patients treated with elective EVAR from 2007 to 2015 were retrospectively analyzed. We compared the platelet count ratio until postoperative day (POD) 7 to the presurgical baseline between patients with and without persistent EL (≥ 6 months). Subsequently, we calculated the optimal platelet count ratio for distinguishing persistent EL using receiver-operating characteristics analysis. A platelet count ratio on POD7 ≥118% was defined as the PCR. We evaluated the PCR's influence on the cumulative aneurysm sac expansion rate. Results: The average platelet count ratio on POD7 rose above baseline (112%), and the ratio was attenuated by persistent EL (103%). Of 205 patients, 126 (61%) were assigned to the disturbed PCR group (PCR(-) group). Cumulative aneurysm sac expansion rate was higher in the PCR(-) group than the PCR(+) group (34.4% vs. 12.8% in 5 years, p=0.01). Conclusion: Disturbed PCR after EVAR may be associated with ELs and eventual aneurysm sac expansion.
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Project description:Aortic surgery results in ischemia-reperfusion injury that induces an inflammatory response and frequent complications. The magnitude of the inflammatory response in blood and bronchi may be associated with the risk of immediate complications. The purpose of the study was to evaluate bronchial microdialysis as a continuous monitoring of cytokines in bronchial epithelial lining fluid (ELF) and to determine whether bronchial ELF cytokine levels reflect the ischemia-reperfusion injury and risk for complications during open abdominal aortic aneurysm (AAA) repair. We measured cytokines in venous blood using microdialysis and in serum for comparison. Sixteen patients scheduled for elective open AAA repair were included in a prospective observational study. Microdialysis catheters were introduced into a bronchi and a cubital vein. Eighteen cytokines were measured using a Bio-Plex Magnetic Human Cytokine Panel. Samples were collected before and during cross-clamping of the aorta as well as from 0 to 60 min and from 60 to 120 min of reperfusion. The ELF levels of several cytokines changed significantly during reperfusion. In particular, IL-6 increased more than 10-fold and IL-13 more than 5-fold during ischemia and reperfusion. Also, the venous levels of several inflammatory and anti-inflammatory cytokines increased and exhibited their highest concentration during reperfusion. Both bronchial and venous cytokine levels correlated with duration of the procedure, intensive care days, and preoperative kidney disease. Three patients suffered organ failure as a direct consequence of the procedure, and in these patients the bronchial ELF concentrations of 17 of 18 cytokines differed significantly from patients without such complications. Bronchial microdialysis is suited for continuous monitoring of inflammation during open AAA repair. The bronchial ELF cytokine levels may be useful in predicting immediate complications such as organ failure in patients undergoing vascular surgery.
| S-EPMC5532484 | biostudies-other
Project description:IntroductionEndovascular aneurysm repair (EVAR) has a marked short-term advantage over open surgical repair in managing abdominal aortic aneurysms (AAA); however, this benefit is lost in the long term. The current trend towards stratified medicine has given rise to diverse prognostic prediction models and scoring systems for EVAR. These models could act as decision support tools that employ patient and operative factors, to improve long-term outcomes. Past literature evaluated and compared model performance for predicting one outcome, for example, mortality. None were deemed competent for clinical application. The proposed study will use a scoping review approach to capture literature on prognostic modelling in EVAR for all predictable outcomes. The results are anticipated to inform future research, identify knowledge gaps, and assist in determining the potential of models for clinical use.Methods and analysisThe proposed study will use the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) extension for scoping Reviews as a framework for conducting the review. PubMed Central, Embase and Cochrane Library will be searched and screened for peer-reviewed studies on prognostic modelling for EVAR, published between 2000 and 2022. No limits exist on predictor variables used and outcomes predicted by the model for inclusion, provided they apply to AAA patients managed with EVAR. Data will be abstracted using a charting form based on the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies guidelines and PRISMA guidelines for systematic reviews. The Prediction model Risk of Bias Assessment Tool and the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis checklist will be used to critically appraise included studies.Ethics and disseminationSince scoping reviews cover secondary data from published literature, ethical approval is not required. The findings will be disseminated via peer-reviewed publications and presentations at key conferences.
| S-EPMC9621180 | biostudies-literature