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Background The benefits of endovascular repair of ruptured abdominal aortic aneurysm remain controversial, without any strong evidence about advantages in specific subgroups. Methods An individual-patient data meta-analysis of three recent randomized trials of endovascular versus open repair of abdominal aortic aneurysm was conducted according to a prespecified analysis plan, reporting on results to 90 days after the index event. Results The trials included a total of 836 patients. The mortality rate across the three trials was 31·3 per cent for patients randomized to endovascular repair/strategy and 34·0 per cent for those randomized to open repair at 30 days (pooled odds ratio 0·88, 95 per cent c.i. 0·66 to 1·18), and 34·3 and 38·0 per cent respectively at 90 days (pooled odds ratio 0·85, 0·64 to 1·13). There was no evidence of significant heterogeneity in the odds ratios between trials. Mean(s.d.) aneurysm diameter was 8·2(1·9) cm and the overall in-hospital mortality rate was 34·8 per cent. There was no significant effect modification with age or Hardman index, but there was indication of an early benefit from an endovascular strategy for women. Discharge from the primary hospital was faster after endovascular repair (hazard ratio 1·24, 95 per cent c.i. 1·04 to 1·47). For open repair, 30-day mortality diminished with increasing aneurysm neck length (adjusted odds ratio 0·69 (95 per cent c.i. 0·53 to 0·89) per 15 mm), but aortic diameter was not associated with mortality for either type of repair. Conclusion Survival to 90 days following an endovascular or open repair strategy is similar for all patients and for the restricted population anatomically suitable for endovascular repair. Women may benefit more from an endovascular strategy than men and patients are, on average, discharged sooner after endovascular repair. [ABSTRACT FROM AUTHOR]

Background: Multiple treatment options are generally available for most diseases. Shared decision‐making (SDM) helps patients and physicians choose the treatment option that best fits a patient's preferences. This review aimed to assess the extent to which SDM is applied during surgical consultations, and the metrics used to measure SDM and SDM‐related outcomes. Methods: This was a systematic review of observational studies and clinical trials that measured SDM during consultations in which surgery was a treatment option. Embase, MEDLINE and CENTRAL were searched. Study selection, quality assessment and data extraction were conducted by two investigators independently. Results: Thirty‐two articles were included. SDM was measured using nine different metrics. Thirty‐six per cent of 13 176 patients and surgeons perceived their consultation as SDM, as opposed to patient‐ or surgeon‐driven. Surgeons more often perceived the decision‐making process as SDM than patients (43·6 versus 29·3 per cent respectively). SDM levels scored objectively using the OPTION and Decision Analysis System for Oncology instruments ranged from 7 to 39 per cent. Subjective SDM levels as perceived by surgeons and patients ranged from 54 to 93 per cent. Patients experienced a higher level of SDM during consultations than surgeons (93 versus 84 per cent). Twenty‐five different SDM‐related outcomes were reported. Conclusion: At present, SDM in surgery is still in its infancy, although surgeons and patients both think of it favourably. Future studies should evaluate the effect of new interventions to improve SDM during surgical consultations, and its assessment using available standardized and validated metrics. Heterogeneous data [ABSTRACT FROM AUTHOR]

The article focuses on the endovascular aneurysm repair (EVAR), a new and minimally invasive alternative to open repair. EVAR has potential and distinct advantages in the emergency setting, and for those with rupture, the endosvacular procedure can be performed partly under local anaesthesia without the need for laparotomy. It notes that suitability for emergency EVAR depends on the availability of an appropriate prosthesis.

This article explains that there is poor prognosis for patients with ruptured thoracic aorta based on the classic study of Parmley et al., who investigated victims of the Korean war in the 1950s. The usual cause of injury to thoracic aorta is deceleration trauma. Recent studies on road traffic accident victims show that 9-19 percent can expect to survive to reach hospital. Choosing an appropriate operative strategy can reduce the complications in aortic rupture surgery.

Introduction: Follicle stimulating hormone (FSH) is identified to play a role in postmenopausal disease and hypothesized to affect abdominal aortic aneurysm (AAA) onset/progression in postmenopausal women. We aimed to detect FSHR gene expression in AAA tissue and cell types involved in AAA formation. Methods: FSH stimulation of human umbilical cord endothelial cells (HUVECs), smooth muscle cells (HUCs) and PMA-differentiated macrophages to assess gene expression of FSHR and various markers. Human macrophages activated with various stimuli were assessed for FSHR gene expression. AAA dataset, AAA tissue samples and AAA-derived smooth muscle cells (SMC) obtained from elderly female donors were assessed for FSHR gene expression. AAA-SMCs were stimulated with FSH to assess its effect on gene expression. Lastly, oxidized low-density-lipoprotein (ox-LDL) uptake and abundance of cell surface protein markers were assessed by flow cytometry after FSH stimulation of human monocytes. Results: FSH stimulation showed similar levels of gene expression in HUVECs and HUCs. Only ACTA2 was downregulated in HUCs. In PMA-differentiated macrophages, gene expression of inflammation markers was unchanged after FSH stimulation. FSHR gene expression was found to be low in the AAA datasets. Female AAA-SMCs show occasional FSHR gene expression at a very low level, yet stimulation with FSH did not affect gene expression of SMC- or inflammation markers. FSH stimulation did not impact ox-LDL uptake or alter cell surface protein expression in monocytes. While FSHR gene expression was detected in human testis tissue, it was below quantification level in all other investigated cell types, even upon activation of macrophages with various stimuli. Conclusion: Despite previous reports, we did not detect FSHR gene expression in various extragonadal cell types, except in occasional female AAA-SMCs. No clear effect on cell activation was observed upon FSH stimulation in any cell type. Our data suggest that a direct effect of FSH in AAA-related extragonadal cells is unlikely to influence AAA. [ABSTRACT FROM AUTHOR]

Background: Previous studies have focused on patient-related risk factors to explain the higher mortality risk in women undergoing elective abdominal aortic aneurysm (AAA) repair. The aim of this study was to evaluate whether hospital-related factors influence outcomes following AAA repair in women. Methods: Patients undergoing elective AAA repair in 61 hospitals in the Netherlands were identified from the Dutch Surgical Aneurysm Audit registry (2013-2018). A mixed-effects logistic regression analysis was conducted to assess the effect of sex on inhospital and/or 30-day mortality. This analysis accounted for possible correlation of outcomes among patients who were treated in the same hospital, by adding a hospital-specific random effect to the statistical model. The analysis adjusted for patient-related risk factors and hospital volume of open surgical repair (OSR) and endovascular aneurysm repair (EVAR). Results: Some 12 034 patients were included in the analysis. The mortality rate was higher in women than among men: 53 of 1780 (3.0 per cent) versus 152 of 10 254 (1.5 per cent) respectively. Female sex was significantly associated with mortality after correction for patient- and hospital-related factors (odds ratio 1.68, 95 per cent c.i. 1.20 to 2.37). OSR volume was associated with lower mortality (OR 0.91 (0.85 to 0.95) per 10-procedure increase) whereas no such relationship was identified with EVAR volume (OR 1.03 (1.01 to 1.05) per 10-procedure increase). Conclusion: Women are at higher risk of death after abdominal aortic aneurysm repair irrespective of patient- and hospital-related factors. [ABSTRACT FROM AUTHOR]

Background: Considerable training is necessary to master laparoscopic suturing and knot-tying. Robotic systems are assumed to facilitate these skills and shorten the learning curve. The effect of laparoscopic experience and robotic assistance on the learning curve of vascular anastomoses was studied.Methods: A laparoscopically experienced surgeon and a laparoscopically inexperienced surgeon made alternating laparoscopic vascular anastomoses and robot-assisted laparoscopic vascular anastomoses using a Zeus-Aesop surgical robotic system with various prosthetic conduits and suture materials in a laparoscopic training box.Results: Neither laparoscopic method influenced the quality score or leakage rate, but with laparoscopic experience, significantly fewer failures were made. Suturing and knot-tying were faster with laparoscopic experience both with and without the robotic system, and fewer stitch actions and knot actions were performed. The learning curves of both surgeons were not improved by the robotic system.Conclusions: Experience is the most important factor in the performance of laparoscopic vascular anastomoses. The robotic system was not helpful in shortening the learning curve. [ABSTRACT FROM AUTHOR]

Clinical biobanks processing data of participants in the European Union (EU) fall under the scope of the General Data Protection Regulation (GDPR), which among others includes requirements for consent. These requirements are further specified by the Article 29 Working Party (WP29)—an EU advisory body currently known as the European Data Protection Board (EDPB). Unfortunately, their guidance is cause for some confusion. While the GDPR allows participants to give broad consent for research when specific research purposes are still unknown, the WP29 guidelines suggest that additional consent for specific uses should be obtained in addition to broad consent when this becomes applicable. This discrepancy elicits the question whether clinical biobanks can fail the requirement of consent if they obtain broad consent, but not a specific consent for each biomedical study. We analysed this discrepancy within the framework of contextual integrity, in order to describe the context-relative informational norms that govern information flows in clinical biobanks. However, our analysis demonstrates that there is no uniform set of norms that can be applied to all clinical biobanks. As such, neither the GDPR nor the WP29 guidance can act as a "one size fits all" approach to all clinical biobanks. Rather, differences between clinical biobanks—especially regarding the scientific aims and patient populations—make the case for context-relative norms that determine the appropriate type of consent. [ABSTRACT FROM AUTHOR]

Background: Shared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.Methods: The study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.Discussion: In the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.Trial Registration: Netherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487. [ABSTRACT FROM AUTHOR]

The article offers information on the differences between obtaining informed consent and practising shared decision-making (SDM). It mentions informed consent concerns the minimal legal requirements physicians must adhere to when informing the patient about a specific treatment; and also mentions SDM is the process to reach a shared treatment decision and involves physicians explaining the available treatment options to patients, including their benefits and harms.

Background: The complications discussed with patients by surgeons prior to surgery vary, because no consensus on major complications exists. Such consensus may improve informed consent and shared decision-making. This study aimed to achieve consensus among vascular surgeons on which complications are considered 'major' and which 'minor,' following surgery for abdominal aortic aneurysm (AAA), carotid artery disease (CAD) and peripheral artery disease (PAD). Methods: Complications following vascular surgery were extracted from Cochrane reviews, national guidelines, and reporting standards. Vascular surgeons from Europe and North America rated complications as major or minor on five-point Likert scales via an electronic Delphi method. Consensus was reached if ≥ 80% of participants scored 1 or 2 (minor) or 4 or 5 (major). Results: Participants reached consensus on 9–12 major and 6–10 minor complications per disease. Myocardial infarction, stroke, renal failure and allergic reactions were considered to be major complications of all three diseases. All other major complications were treatment specific or dependent on disease severity, e.g., spinal cord ischemia, rupture following AAA repair, stroke for CAD or deep wound infection for PAD. Conclusion: Vascular surgeons reached international consensus on major and minor complications following AAA, CAD and PAD treatment. This consensus may be helpful in harmonizing the information patients receive and improving standardization of the informed consent procedure. Since major complications differed between diseases, consensus on disease-specific complications to be discussed with patients is necessary. [ABSTRACT FROM AUTHOR]

Background: The aim of this study was to develop a 48‐h mortality risk score, which included morphology data, for patients with ruptured abdominal aortic aneurysm presenting to an emergency department, and to assess its predictive accuracy and clinical effectiveness in triaging patients to immediate aneurysm repair, transfer or palliative care. Methods: Data from patients in the IMPROVE (Immediate Management of the Patient With Ruptured Aneurysm: Open Versus Endovascular Repair) randomized trial were used to develop the risk score. Variables considered included age, sex, haemodynamic markers and aortic morphology. Backwards selection was used to identify relevant predictors. Predictive performance was assessed using calibration plots and the C‐statistic. Validation of the newly developed and other previously published scores was conducted in four external populations. The net benefit of treating patients based on a risk threshold compared with treating none was quantified. Results: Data from 536 patients in the IMPROVE trial were included. The final variables retained were age, sex, haemoglobin level, serum creatinine level, systolic BP, aortic neck length and angle, and acute myocardial ischaemia. The discrimination of the score for 48‐h mortality in the IMPROVE data was reasonable (C‐statistic 0·710, 95 per cent c.i. 0·659 to 0·760), but varied in external populations (from 0·652 to 0·761). The new score outperformed other published risk scores in some, but not all, populations. An 8 (95 per cent c.i. 5 to 11) per cent improvement in the C‐statistic was estimated compared with using age alone. Conclusion: The assessed risk scores did not have sufficient accuracy to enable potentially life‐saving decisions to be made regarding intervention. Focus should therefore shift to offering repair to more patients and reducing non‐intervention rates, while respecting the wishes of the patient and family. [ABSTRACT FROM AUTHOR]

Background Long-term survival is similar after open or endovascular repair of abdominal aortic aneurysm. Few data exist on the effect of either procedure on long-term health-related quality of life ( HRQoL) and health status. Methods Patients enrolled in a multicentre randomized clinical trial ( DREAM trial; 2000-2003) in Europe of open repair versus endovascular repair ( EVAR) of abdominal aortic aneurysm were asked to complete questionnaires on health status and HRQoL. HRQoL scores were assessed at baseline and at 13 time points thereafter, using generic tools, the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36®) and EuroQol 5D ( EQ-5D™). Physical ( PCS) and mental component summary scores were also calculated. Follow-up was 5 years. Results Some 332 of 351 patients enrolled in the trial returned questionnaires. More than 70 per cent of questionnaires were returned at each time point. Both surgical interventions had a short-term negative effect on HRQoL and health status. This was less severe in the EVAR group than in the open repair group. In the longer term the physical domains of SF-36® favoured open repair: mean difference in PCS score between open repair and EVAR −1·98 (95 per cent c.i. −3·56 to −0·41). EQ-5D™ descriptive and EQ-5D™ visual analogue scale scores for open repair were also superior to those for EVAR after the initial 6-week interval: mean difference −0·06 (−0·10 to −0·02) and −4·09 (−6·91 to −1·27) respectively. Conclusion In this study EVAR appeared to be associated with less severe disruption to HRQoL and health status in the short term. However, during longer-term follow-up to 5 years, patients receiving open repair appeared to have improved quality of life and health status. [ABSTRACT FROM AUTHOR]

Background Care for patients with a ruptured abdominal aortic aneurysm ( rAAA) in the Amsterdam ambulance region (The Netherlands) was concentrated into vascular centres with a 24-h full emergency vascular service in cooperation with seven referring regional hospitals. Previous population-based survival after rAAA in the Netherlands was 46 (95 per cent confidence interval (c.i.) 43 to 49) per cent. It was hypothesized that regional cooperation would improve survival. Methods This was a prospective observational cohort study carried out simultaneously with the Amsterdam Acute Aneurysm Trial. Consecutive patients with an rAAA between 2004 and 2011 in all ten hospitals in the Amsterdam region were included. The primary outcome was 30-day survival after admission. Multivariable logistic regression, including age, sex, co-morbidity, intervention (endovascular or open repair), preoperative systolic blood pressure, cardiopulmonary resuscitation and year of intervention, was used to assess the influence of hospital setting on survival. Results Of 453 patients with rAAA from the Amsterdam ambulance region, 61 did not undergo intervention; 352 patients were treated surgically at a vascular centre and 40 at a referring hospital. The regional survival rate was 58·5 (95 per cent c.i. 53·9 to 62·9) per cent (265 of 453). After multivariable adjustment, patients treated at a vascular centre had a higher survival rate than patients treated surgically at a referring hospital (adjusted odds ratio 3·18, 95 per cent c.i. 1·43 to 7·04). Conclusion After regional cooperation, overall survival of patients with an rAAA improved. Most patients were treated in a vascular centre and in these patients survival rates were optimal. [ABSTRACT FROM AUTHOR]

Background Minimally invasive endovascular aneurysm repair ( EVAR) could be a surgical technique that improves outcome of patients with ruptured abdominal aortic aneurysm ( rAAA). The aim of this study was to analyse the cost-effectiveness and cost-utility of EVAR compared with standard open repair ( OR) in the treatment of rAAA, with costs per 30-day and 6-month survivor as outcome parameters. Methods Resource use was determined from the Amsterdam Acute Aneurysm ( AJAX) trial, a multicentre randomized trial comparing EVAR with OR in patients with rAAA. The analysis was performed from a provider perspective. All costs were calculated as if all patients had been treated in the same hospital (Onze Lieve Vrouwe Gasthuis, teaching hospital). Results A total of 116 patients were randomized. The 30-day mortality rate was 21 per cent after EVAR and 25 per cent for OR: absolute risk reduction ( ARR) 4·4 (95 per cent confidence interval (c.i.) -11·0 to 19·7) per cent. At 6 months, the total mortality rate for EVAR was 28 per cent, compared with 31 per cent among those assigned to OR: ARR 2·4 (−14·2 to 19·0) per cent. The mean cost difference between EVAR and OR was €5306 (95 per cent c.i. -1854 to 12 659) at 30 days and €10 189 (−2477 to 24 506) at 6 months. The incremental cost-effectiveness ratio per prevented death was €120 591 at 30 days and €424 542 at 6 months. There was no significant difference in quality of life between EVAR and OR. Nor was EVAR superior regarding cost-utility. Conclusion EVAR may be more effective for rAAA, but its increased costs mean that it is unaffordable based on current standards of societal willingness-to-pay for health gains. [ABSTRACT FROM AUTHOR]

Background A substantial proportion of patients with a ruptured abdominal aortic aneurysm ( rAAA) die outside hospital. The objective of this study was to estimate the total mortality, including prehospital deaths, of patients with rAAA. Methods This was a systematic review and meta-analysis following the MOOSE guidelines. The Embase, MEDLINE and Cochrane Library databases were searched. All population-based studies reporting both prehospital and in-hospital mortality in patients with rAAA were included. Studies were assessed for methodological quality and heterogeneity, and pooled estimates of mortality from rAAA were calculated using a random-effects model. Results From a total of 3667 studies, 24 retrospective cohort studies, published between 1977 and 2012, met the inclusion criteria. The quality of included studies varied, in particular the method of determining prehospital deaths from rAAA. The estimated pooled total mortality rate was 81 (95 per cent confidence interval 78 to 83) per cent. A decline in mortality was observed over time ( P = 0·002); the pooled estimate of total mortality in high-quality studies before 1990 was 86 (83 to 89) per cent, compared with 74 (72 to 77) per cent since 1990. Some 32 (27 to 37) per cent of patients with rAAA died before reaching hospital. The in-hospital non-intervention rate was 40 (33 to 47) per cent, which also declined over the years. Conclusion The pooled estimate of total mortality from rAAA is very high, although it has declined over the years. Most patients die outside hospital, and there is no surgical intervention in a considerable number of those who survive to reach hospital. [ABSTRACT FROM AUTHOR]

Investigates the feasibility and safety of hand-assisted laparoscopic donor nephrectomy (HLDN). Advantages of HLDN over laparoscopic donor nephrectomy; Factors causing graft failure; Comparison of the result of left and right-sided HLDN procedure.