Optimising surveillance and re-intervention strategy following elective endovascular repair of abdominal aortic aneurysms

Background Elective endovascular aneurysm repair (EVAR) for abdominal aortic aneurysm has an initial survival advantage over open repair (OR), but more frequent complications increase costs and long-term aneurysm-related mortality. Randomised controlled trials of EVAR versus OR have shown EVAR is not cost-effective over a patient’s lifetime. However, in the EVAR-1 trial, post-operative surveillance may have been sub-optimal, as the importance of sac growth as a predictor of graft failure was overlooked. Methods Real-world data informed a discrete event simulation model of post-operative outcomes following EVAR. Outcomes observed EVAR-1 were compared with those from five alternative post-operative surveillance and re-intervention strategies. Key events, quality-adjusted life years and costs were predicted. The impact of using complication and rupture rates from more recent devices, imaging and re-intervention methods was also explored. Results Compared with observed EVAR-1 outcomes, modelling full adherence to the EVAR-1 scan protocol reduced AAA deaths by 3% and increased elective re-interventions by 44%. European Society re-intervention guidelines provided the most clinically effective strategy, with an 8% reduction in AAA deaths, but a 52% increase in elective re-interventions. The cheapest and most cost-effective strategy used lifetime annual ultrasound in primary care with confirmatory CT if necessary, and reduced AAA-related deaths by 5%. Using contemporary rates for complications and rupture did not alter these conclusions. Conclusions All alternative strategies improved clinical benefits compared with the EVAR-1 trial. Further work is needed regarding the cost and accuracy of primary care ultrasound, and the potential impact of these strategies in the comparison with OR.Financial support from National Institute of Health Research and Camelia Botnar Arterial Foundation. The National Institute of Health Research (NIHR) had no role in study design, data collection, data analysis, data interpretation, in the writing of the report or in the decision to submit the article for publication. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the NIHR, UK NHS, or Department of Health. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication

Optimizing Surveillance and Re-intervention Strategy Following Elective Endovascular Repair of Abdominal Aortic Aneurysms

Background: EVAR for abdominal aortic aneurysm has an initial survival advantage over OR, but more frequent complications increase costs and long-term aneurysm-related mortality. Randomized controlled trials of EVAR versus OR have shown EVAR is not cost-effective over a patient's lifetime. However, in the EVAR-1 trial, postoperative surveillance may have been sub-optimal, as the importance of sac growth as a predictor of graft failure was overlooked. Methods: Real-world data informed a discrete event simulation model of postoperative outcomes following EVAR. Outcomes observed EVAR-1 were compared with those from 5 alternative postoperative surveillance and reintervention strategies. Key events, quality-adjusted life years and costs were predicted. The impact of using complication and rupture rates from more recent devices, imaging and re-intervention methods was also explored. Results: Compared with observed EVAR-1 outcomes, modeling full adherence to the EVAR-1 scan protocol reduced abdominal aortic aneurysm (AAA) deaths by 3% and increased elective re-interventions by 44%. European Society re-intervention guidelines provided the most clinically effective strategy, with an 8% reduction in AAA deaths, but a 52% increase in elective re-interventions. The cheapest and most cost-effective strategy used lifetime annual ultrasound in primary care with confirmatory computed tomography if necessary, and reduced AAA-related deaths by 5%. Using contemporary rates for complications and rupture did not alter these conclusions. Conclusions: All alternative strategies improved clinical benefits compared with the EVAR-1 trial. Further work is needed regarding the cost and accuracy of primary care ultrasound, and the potential impact of these strategies in the comparison with OR.Peer reviewe

Determinants of carotid microembolization

AbstractPurpose: Earlier studies have highlighted risk factors for perioperative stroke after carotid endarterectomy, such as female sex, preoperative symptoms, and cerebral infarction. In this study, we investigated the relationship between these factors and perioperative microembolization. Methods: A total of 235 patients were entered in the study at two centers. Transcranial Doppler ultrasound scanning was possible in 190 patients (81%) and was performed for 1 hour preoperatively and continuously intraoperatively as a means of detecting microemboli and monitoring mean middle cerebral artery velocity. The findings of transcranial Doppler ultrasound scanning were related to perioperative risk factors by means of univariate analysis. Results: Microemboli were detected in 28 (15%), 79 (42%), and 98 (52%) patients preoperatively, during carotid artery dissection, and after closure of the artery, respectively. Having 10 or more emboli after carotid artery closure was more common in women (P =.04) and in patients with symptomatic carotid artery disease (P =.04) and was demonstrated in three of the six patients who had a perioperative stroke. These three patients also had preoperative evidence of cerebral infarction and an intraoperative middle cerebral artery velocity less than 40 cm/s. Conclusion: In this study, perioperative microembolization was more common in women and patients with symptomatic carotid artery disease. These findings may explain the increased risk of carotid surgery in these patients. (J Vasc Surg 2001;34:1060-4.

Clinical follow-up rather than duplex surveillance after carotid endarterectomy

AbstractPurpose: The value of duplex surveillance and the significance of contralateral carotid disease after endarterectomy have been assessed.Methods: Three hundred five patients were observed prospectively after carotid endarterectomy for a median time of 36 months (range, 6 to 96 months), with duplex surveillance performed at 1 day; 1 week; 3, 6, 9, and 12 months; and then each year after endarterectomy.Results: Thirty patients (10%) had ipsilateral symptoms (13 strokes, 17 transient ischemic attacks [TIAs]) at a median time of 6 months (range, 0 to 60 months). Life table analysis demonstrated that ipsilateral stroke was equally common for patients who had ≥50% restenosis (3% at 36 months) and those who did not (6% at 36 months, p > 0.5). Twenty-three patients (8%) developed symptoms (stroke 5, TIA 14) attributable to the contralateral carotid artery at a median time of 9 months (range, 0 to 36 months) after endarterectomy. By life table analysis, 40% of patients with 70% to 99%, 6% with 50% to 69%, 1% with <50% contralateral internal carotid stenosis, and 5% with contralateral carotid occlusion at the time of endarterectomy had a contralateral TIA in the 36 months after endarterectomy ( p < 0.01). However, contralateral stroke was not significantly more common for patients with severe contralateral internal carotid stenosis demonstrated at the time of endarterectomy (<50% stenosis, 0%; 50% to 69%, 3%; 70% to 99%, 7%; occlusion, 6% stroke rate at 36 months). Seven of the 32 patients who developed progression of contralateral disease had a TIA, compared with 11 of 227 patients who did not develop progression of contralateral disease ( p < 0.01). None of the 12 patients who progressed from a <70% to a 70% to 99% contralateral stenosis had a stroke.Conclusions: After carotid endarterectomy restenosis is rarely associated with symptoms; contralateral stroke is rare and is not associated with progressive internal carotid artery disease suitable for endarterectomy. This study has shown no benefit from long-term duplex surveillance after carotid endarterectomy. Selective clinical follow-up of patients who have high-grade contralateral stenoses would appear more appropriate. (J Vasc Surg 1997;25:55-63.

Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial.

OBJECTIVE: To assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm. DESIGN: Randomised controlled trial. SETTING: 30 vascular centres (29 UK, 1 Canadian), 2009-13. PARTICIPANTS: 613 eligible patients (480 men) with a clinical diagnosis of ruptured aneurysm. INTERVENTIONS: 316 patients were randomised to the endovascular strategy (275 confirmed ruptures, 174 anatomically suitable for endovascular repair) and 297 to open repair (261 confirmed ruptures). MAIN OUTCOME MEASURES: 30 day mortality, with 24 hour and in-hospital mortality, costs, and time and place of discharge as secondary outcomes. RESULTS: 30 day mortality was 35.4% (112/316) in the endovascular strategy group and 37.4% (111/297) in the open repair group: odds ratio 0.92 (95% confidence interval 0.66 to 1.28; P=0.62); odds ratio after adjustment for age, sex, and Hardman index 0.94 (0.67 to 1.33). Women may benefit more than men (interaction test P=0.02) from the endovascular strategy: odds ratio 0.44 (0.22 to 0.91) versus 1.18 (0.80 to 1.75). 30 day mortality for patients with confirmed rupture was 36.4% (100/275) in the endovascular strategy group and 40.6% (106/261) in the open repair group (P=0.31). More patients in the endovascular strategy than in the open repair group were discharged directly to home (189/201 (94%) v 141/183 (77%); P<0.001). Average 30 day costs were similar between the randomised groups, with an incremental cost saving for the endovascular strategy versus open repair of £1186 (€1420; $1939) (95% confidence interval -£625 to £2997). CONCLUSIONS: A strategy of endovascular repair was not associated with significant reduction in either 30 day mortality or cost. Longer term cost effectiveness evaluations are needed to assess the full effects of the endovascular strategy in both men and women. TRIAL REGISTRATION: Current Controlled Trials ISRCTN48334791

Predicting risk of rupture and rupture-preventing re-interventions utilising repeated measures on aneurysm sac diameter following endovascular abdominal aortic aneurysm repair

Clinical and imaging surveillance practices following endovascular aneurysm repair (EVAR) for intact abdominal aortic aneurysm (AAA) vary considerably and compliance with recommended lifelong surveillance is poor. This study developed a dynamic prognostic model to enable stratification of patients at risk of future secondary rupture or rupture preventing re-intervention (RPR) to enable the development of personalised surveillance intervals. Baseline data and repeat measurements of post-operative aneurysm sac diameter from the EVAR-1 and EVAR-2 trials were used to develop the model with external validation in a cohort from Helsinki. Longitudinal mixed-effects models were fitted to trajectories of sac diameter and model-predicted sac diameter and rate of growth were used in prognostic Cox proportional hazards models. 785 patients from the EVAR trials were included of which 155 (20%) suffered at least one rupture or RPR during follow-up. An increased risk was associated with pre-operative AAA size, rate of sac growth, and the number of previously detected complications. A prognostic model using only predicted sac growth had good discrimination at 2-years (C-index = 0.68), 3-years (C-index= 0.72) and 5-years (C-index= 0.75) post-operation and had excellent external validation (C-indices 0.76 to 0.79). After 5-years post-operation, growth rates above 1mm/year had a sensitivity of over 80% and specificity over 50% in identifying events occurring within 2 years. Secondary sac growth is an important predictor of rupture or RPR. A dynamic prognostic model has the potential to tailor surveillance by identifying a large proportion of patients who may require less intensive follow-up

Novel study design to assess the utility of the copd assessment test in a primary care setting

The quality of a consultation provided by a physician can have a profound impact on the quality of care and patient engagement in treatment decisions. When the COPD Assessment Test (CAT) was developed, one of its aims was to aid the communication between physician and patient about the impact of COPD. We developed a novel study design to assess this in a primary care consultation. Primary care physicians across five countries in Europe conducted videoed consultations with six standardised COPD patients (played by trained actors) which had patient-specific issues that the physician needed to identify through questioning. Half the physicians saw the patients with the completed CAT, and half without. Independent assessors scored the physicians on their ability to identify and address the patient-specific issues, review standard COPD aspects, their understanding of the case and their overall performance. This novel study design presented many challenges which needed to be addressed to achieve an acceptable level of robustness to assess the utility of the CAT. This paper discusses these challenges and the measures adopted to eliminate or minimise their impact on the study results

Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial.

AIMS: To report the longer term outcomes following either a strategy of endovascular repair first or open repair of ruptured abdominal aortic aneurysm, which are necessary for both patient and clinical decision-making. METHODS AND RESULTS: This pragmatic multicentre (29 UK and 1 Canada) trial randomized 613 patients with a clinical diagnosis of ruptured aneurysm; 316 to an endovascular first strategy (if aortic morphology is suitable, open repair if not) and 297 to open repair. The principal 1-year outcome was mortality; secondary outcomes were re-interventions, hospital discharge, health-related quality-of-life (QoL) (EQ-5D), costs, Quality-Adjusted-Life-Years (QALYs), and cost-effectiveness [incremental net benefit (INB)]. At 1 year, all-cause mortality was 41.1% for the endovascular strategy group and 45.1% for the open repair group, odds ratio 0.85 [95% confidence interval (CI) 0.62, 1.17], P = 0.325, with similar re-intervention rates in each group. The endovascular strategy group and open repair groups had average total hospital stays of 17 and 26 days, respectively, P < 0.001. Patients surviving rupture had higher average EQ-5D utility scores in the endovascular strategy vs. open repair groups, mean differences 0.087 (95% CI 0.017, 0.158), 0.068 (95% CI -0.004, 0.140) at 3 and 12 months, respectively. There were indications that QALYs were higher and costs lower for the endovascular first strategy, combining to give an INB of £3877 (95% CI £253, £7408) or €4356 (95% CI €284, €8323). CONCLUSION: An endovascular first strategy for management of ruptured aneurysms does not offer a survival benefit over 1 year but offers patients faster discharge with better QoL and is cost-effective. CLINICAL TRIAL REGISTRATION: ISRCTN 48334791

"They brought you back to the fact you're not the same": Sense of self after traumatic brain injury

This paper considers contexts following traumatic brain injury, exploring what may be at stake when dominant expectations predict a ‘lost’ or ‘broken’ self. I explore stories co-constructed with one young man and his mother to illustrate their personal and intersubjective understandings of identity, at times conflicting, within family interactions and when encountering normative practices of neurorehabilitation clinicians. The ower relations portrayed confront this man’s narrative attempts to align his present and pre-injury self, including standard assessments delineating change, administered by healthcare professionals. I consider a need for greater attention to interaction-generated disruption to sense of self, wthin contemporary conceptualisations of ‘person-centred care’

Health Outcome Prioritization in Alzheimer's Disease:Understanding the Ethical Landscape

Objective: Health outcome prioritisation is the ranking in order of desirability or importance of a set of disease related objectives and their associated cost or risk. We analyse the complex ethical landscape in which this takes place in the most common dementia, Alzheimer’s disease. Background: Dementia has been described as the greatest global health challenge in the 21st century on account of longevity gains increasing its incidence, escalating health and social care pressures. These pressures highlight ethical, social, political challenges about healthcare resource allocation, what health improvements matter to patients, and how they are measured. This study highlights the complexity of the ethical landscape, relating particularly to the balances that need to be struck when allocating resources; when measuring and prioritising outcomes; and when individual preferences are sought. Methods: Narrative review of literature published since 2007, incorporating snowball sampling where necessary. We identified, thematised and discussed key issues of ethical salience. Results: Eight areas of ethical salience for outcome prioritisation emerged: (1) Public health and distributive justice, (2) Scarcity of resources, (3) Heterogeneity and changing circumstances, (4) Knowledge of treatment, (5) Values and circumstances, (6) Conflicting priorities, (7) Communication, autonomy and Caregiver issues, (8) Disclosure of risk. Conclusion: These areas highlight the difficult balance to be struck when allocating resources, when measuring and prioritising outcomes, and when individual preferences are sought. We conclude by reflecting on how tools in social sciences and ethics can help address challenges posed by resource allocation, measuring and prioritising outcomes, and eliciting stakeholder preferences.</p